Page Range | 31161-31487 | |
FR Document |
Page and Subject | |
---|---|
81 FR 31167 - Occupational Exposure to Respirable Crystalline Silica | |
81 FR 31487 - Continuation of the National Emergency With Respect to Burma | |
81 FR 31485 - World Trade Week, 2016 | |
81 FR 31483 - Peace Officers Memorial Day and Police Week, 2016 | |
81 FR 31481 - National Hurricane Preparedness Week, 2016 | |
81 FR 31479 - National Defense Transportation Day and National Transportation Week, 2016 | |
81 FR 31475 - Emergency Medical Services Week, 2016 | |
81 FR 31161 - Delegation of Authority Pursuant to Section 3136(h) of the National Defense Authorization Act for Fiscal Year 2016 | |
81 FR 31239 - Sunshine Act; Notice of Meeting | |
81 FR 31263 - Dominion Virginia Power; North Anna, Unit 3 | |
81 FR 31234 - NESHAP for Brick and Structural Clay Products Manufacturing; and NESHAP for Clay Ceramics Manufacturing | |
81 FR 31238 - Notice of Agreements Filed | |
81 FR 31201 - Equal Access to Housing in HUD's Native American and Native Hawaiian Programs-Regardless of Sexual Orientation or Gender Identity; Correction | |
81 FR 31172 - Quaternary Ammonium Compounds, Benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium Salts With Sepiolite; and Quaternary Ammonium Compounds, Benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium Salts With Saponite; Exemptions From the Requirement of a Tolerance | |
81 FR 31252 - 60-Day Notice of Proposed Information Collection: FHA Technology Open to Approved Lenders (TOTAL) Mortgage Scorecard | |
81 FR 31212 - Approval and Promulgation of Implementation Plans; California; San Joaquin Valley; Revisions to Motor Vehicle Emissions Budgets for Ozone and Particulate Matter | |
81 FR 31259 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Yoga Bridge Accreditation | |
81 FR 31226 - Foreign-Trade Zone 244-Riverside, California; Application for Reorganization; (Expansion of Service Area); Under Alternative Site Framework | |
81 FR 31259 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Heterogeneous System Architecture Foundation | |
81 FR 31259 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Members of SGIP 2.0, Inc. | |
81 FR 31228 - Department of Defense Military Family Readiness Council (MFRC); Notice of Federal Advisory Committee Meeting | |
81 FR 31227 - Aluminum Extrusions From the People's Republic of China: Notice of Correction to Amended Final Results of Countervailing Duty Administrative Review; 2013 | |
81 FR 31227 - Proposed Information Collection; Comment Request | |
81 FR 31261 - Vogtle Electric Generating Station, Units 3 and 4; Southern Nuclear Operating Company, Main Control Room Emergency Habitability System (VES) Design Changes | |
81 FR 31224 - USDA Increases the Fiscal Year 2016 Raw Sugar Tariff-Rate Quota | |
81 FR 31242 - Office of the Assistant Secretary; Statement of Delegation of Authority | |
81 FR 31290 - Updated List of Goods and Services Produced by Independent Cuban Entrepreneurs Authorized for Importation | |
81 FR 31289 - 60-Day Notice of Proposed Information Collection: Nonimmigrant Treaty Trader/Investor Application | |
81 FR 31290 - Notice of Public Meeting | |
81 FR 31252 - Notice of Intent To Prepare a Master Leasing Plan, Amend the Resource Management Plans for the Price and Richfield Field Offices, and Prepare an Associated Environmental Assessment, Utah | |
81 FR 31295 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel GRACE; Invitation for Public Comments | |
81 FR 31268 - Excepted Service; February 2016 | |
81 FR 31263 - Excepted Service; January 2016 | |
81 FR 31294 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel AVALANCHE; Invitation for Public Comments | |
81 FR 31292 - South Carolina Division of Public Railways d/b/a Palmetto Railways-Acquisition Exemption-Hampton & Branchville Railroad Company | |
81 FR 31267 - Submission for Review: 3206-0237, Information and Instructions on Your Reconsideration Rights, RI 38-47 | |
81 FR 31294 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel TRUE NORTH II; Invitation for Public Comments | |
81 FR 31295 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel COOL BEANS III; Invitation for Public Comments | |
81 FR 31293 - Eighteenth Meeting: RTCA NextGen Advisory Committee (NAC) | |
81 FR 31296 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel FEEL THE MAGIC; Invitation for Public Comments | |
81 FR 31171 - Drawbridge Operation Regulation; Lake Champlain, North Hero Island, VT | |
81 FR 31232 - Chaves County Solar, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
81 FR 31231 - Combined Notice of Filings #2 | |
81 FR 31234 - Combined Notice of Filings #1 | |
81 FR 31233 - Combined Notice of Filings #2 | |
81 FR 31232 - Combined Notice of Filings #1 | |
81 FR 31258 - Certain Document Cameras and Software for Use Therewith; Commission's Determination Not To Review an Initial Determination Terminating Recordex USA, Inc.; Request for Written Submissions on Remedy, the Public Interest, and Bonding | |
81 FR 31224 - Solicitation of Commodity Board Topics and Contribution of Funding Under the Agriculture and Food Research Initiative Competitive Grants Program | |
81 FR 31230 - Update on Reimbursement for Costs of Remedial Action at Active Uranium and Thorium Processing Sites | |
81 FR 31237 - Notice to all Interested Parties of the Termination of the Receivership of 10370, First Commercial Bank of Tampa, Tampa, Florida | |
81 FR 31261 - NASA Advisory Council; Science Committee; Planetary Protection Subcommittee; Meeting | |
81 FR 31298 - Sanctions Action Pursuant to Executive Order 13726 of April 19, 2016, “Blocking Property and Suspending Entry into the United States of Persons Contributing to the Situation in Libya.” | |
81 FR 31260 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Labor Organization and Auxiliary Reports | |
81 FR 31236 - Information Collection Being Reviewed by the Federal Communications Commission | |
81 FR 31223 - Petitions for Reconsideration of Action in Rulemaking Proceeding | |
81 FR 31241 - Submission for OMB Review; Prompt Payment | |
81 FR 31239 - Information Collection; Anti-Kickback Procedures | |
81 FR 31240 - Submission for OMB Review; Make-or-Buy Program | |
81 FR 31298 - Supplemental Information for 57 Individuals and 42 Entities Designated Pursuant to Executive Orders 12947, 13224, and/or 13582 | |
81 FR 31308 - Veterans' Advisory Committee on Rehabilitation; Notice of Meeting | |
81 FR 31243 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting | |
81 FR 31169 - Burmese Sanctions Regulations | |
81 FR 31230 - Agency Information Collection Activities; Comment Request; 2018 Teaching and Learning International Survey (TALIS 2018) Main Study Recruitment and Field Test | |
81 FR 31244 - Agency Information Collection Activities: Proposed Collection: Public Comment Request | |
81 FR 31293 - Railroad Safety Advisory Committee; Charter Renewal | |
81 FR 31245 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request | |
81 FR 31238 - Pro Transport, Inc., Pro Transport Jacksonville, Inc., Pro Transport Savannah, Inc., and Pro Transport Charleston, Inc. V. Seaboard Marine of Florida, Inc. and Seaboard Marine Ltd., Inc.; Notice of Filing of Complaint and Assignment | |
81 FR 31257 - Certain Wireless Headsets; Commission Determination To Affirm With Modification an Initial Determination, Granting Respondents' Motion for Summary Determination of Patent Invalidity Due to Indefiniteness; Termination of Investigation | |
81 FR 31292 - Determination Regarding Waiver of Discriminatory Purchasing Requirements With Respect to Goods and Services of Ukraine | |
81 FR 31254 - Ferrovanadium From Korea | |
81 FR 31255 - Certain Sleep-Disordered Breathing Treatment Systems and Components Thereof; Institution of Investigation | |
81 FR 31229 - Vietnam War Commemoration Advisory Committee; Notice of Federal Advisory Committee Meeting | |
81 FR 31306 - Proposed Collection; Comment Request for Form 8404 | |
81 FR 31226 - Certain Frozen Warmwater Shrimp From Brazil: Rescission of Antidumping Duty Administrative Review; 2015-2016 | |
81 FR 31251 - National Institute of Dental & Craniofacial Research; Notice of Closed Meetings | |
81 FR 31248 - Center for Scientific Review; Notice of Closed Meetings | |
81 FR 31250 - Prospective Grant of Start-up Exclusive License: Development of Virus Like Particles for the Treatment of Breast Cancer, Lung Cancer, Melanoma, Pancreatic Cancer, and Hepatocellular Cancer | |
81 FR 31251 - Prospective Grant of an Exclusive License: The Development of an Anti-GPC3 Chimeric Antigen Receptor (CAR) Based on YP7 for the Treatment of Human Cancers | |
81 FR 31246 - Prospective Grant of an Exclusive License: The Development of an Anti-GPC3 Chimeric Antigen Receptor (CAR) Based on HN3 for the Treatment of Human Cancers | |
81 FR 31247 - Submission for OMB Review; 30-Day Comment Request; Survey To Assess the Feasibility of Establishing a Gynecologic Specimen Bank (NCI) | |
81 FR 31243 - Agency Information Collection Activities: Proposed Collection: Public Comment Request | |
81 FR 31304 - Proposed Collection; Comment Request for Regulation Project | |
81 FR 31306 - Proposed Collection; Comment Request for Form 2439 | |
81 FR 31307 - Proposed Collection; Comment Request for Form 8498 | |
81 FR 31260 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act | |
81 FR 31279 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to Split-Price Priority | |
81 FR 31286 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Exchange Rule 612, Aggregate Risk Manager (“ARM”) | |
81 FR 31304 - Proposed Collection; Comment Request for Form 4506T-EZ, 4506-T-EZ (SP) | |
81 FR 31305 - Proposed Collection; Comment Request for Regulation Project | |
81 FR 31307 - Proposed Collection; Comment Request for Form 8816 | |
81 FR 31165 - Removal of Allocation Rule for Disbursements From Designated Roth Accounts to Multiple Destinations | |
81 FR 31277 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule To Amend the Fees Schedule | |
81 FR 31270 - Self-Regulatory Organizations; International Securities Exchange, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Schedule of Fees | |
81 FR 31272 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change Amending NYSE Arca Equities Rule 7.31P(h) To Add a New Discretionary Pegged Order | |
81 FR 31272 - Self-Regulatory Organizations; Bats EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the Description of Price Improving Orders Under Subparagraph (6) to Rule 21.1(d) and Add Subparagraph (4) to Rule 21.1(h) Modifying the Operation of Orders Subject to the Display Price Sliding Process When a Contra-Side Post Only Order Is Received by the Bats EDGX Exchange Options Platform | |
81 FR 31283 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Add Subparagraph (5) to Rule 21.1(h) Modifying the Operation of Orders Subject to the Display Price Sliding Process When a Contra-Side Post Only Order Is Received by the Bats BZX Exchange Options Platform | |
81 FR 31283 - Submission for OMB Review; Comment Request | |
81 FR 31276 - Submission for OMB Review; Comment Request | |
81 FR 31254 - Certain Sleep-Disordered Breathing Treatment Systems and Components Thereof; Commission's Determination To Suspend Remedial Orders Issued in This Investigation | |
81 FR 31256 - Petroleum Wax Candles from China | |
81 FR 31296 - Guidelines for the Safe Deployment and Operation of Automated Vehicle Safety Technologies. | |
81 FR 31238 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
81 FR 31242 - Proposed Information Collection Activity; Comment Request | |
81 FR 31206 - Determination of Attainment of the 1-Hour Ozone National Ambient Air Quality Standard in the San Joaquin Valley Nonattainment Area in California | |
81 FR 31202 - Extension of the Attainment Date for the Oakridge, Oregon 24-Hour PM2.5 | |
81 FR 31222 - Protection of Stratospheric Ozone: Proposed New Listings of Substitutes; Changes of Listing Status; and Reinterpretation of Unacceptability for Closed Cell Foam Products Under the Significant New Alternatives Policy Program; and Revision of Clean Air Act Section 608 Venting Prohibition for Propane | |
81 FR 31163 - Single Family Housing Guaranteed Loan Program | |
81 FR 31309 - Superior Pharmacy I and Superior Pharmacy II Decision and Order | |
81 FR 31177 - Environmental Protection Agency Acquisition Regulation; Improper Business Practices and Personal Conflicts of Interest, Solicitation Provisions and Contract Clauses | |
81 FR 31375 - Nondiscrimination in Health Programs and Activities | |
81 FR 31181 - Narrowing the Digital Divide Through Installation of Broadband Infrastructure in HUD-Funded New Construction and Substantial Rehabilitation of Multifamily Rental Housing | |
81 FR 31192 - Modernizing HUD's Consolidated Planning Process To Narrow the Digital Divide and Increase Resilience to Natural Hazards | |
81 FR 31343 - National Pollutant Discharge Elimination System (NPDES): Applications and Program Updates |
National Institute of Food and Agriculture
Rural Housing Service
Foreign-Trade Zones Board
International Trade Administration
Federal Energy Regulatory Commission
Children and Families Administration
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Coast Guard
Land Management Bureau
Antitrust Division
Drug Enforcement Administration
Occupational Safety and Health Administration
Federal Aviation Administration
Federal Railroad Administration
Maritime Administration
National Highway Traffic Safety Administration
Foreign Assets Control Office
Internal Revenue Service
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.thefederalregister.org and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.
Rural Housing Service, USDA.
Final rule.
The Rural Housing Service (RHS or Agency) is amending the current regulation for the Single Family Housing Guaranteed Loan Program (SFHGLP) on the subject of liquidation value appraisals. In order to reduce overall processing time, reduce cost, and expedite claim submission, lenders will order the liquidation value appraisal used to estimate a loss claim against the SFHGLP instead of the Agency. Currently, if a Real Estate Owned (REO) property remains unsold by the lender at the end of the permissible marketing period, the Agency orders a liquidation value appraisal and applies an acquisition and management resale factor to estimate holding and disposition cost. This amendment requires the servicing lender to order the liquidation value appraisal. The costs associated with obtaining the liquidation value appraisal can then be included in the liquidation costs paid under the guarantee.
Lilian Lipton, Finance and Loan Analyst, Single Family Housing Guaranteed Loan Division, STOP 0784, Room 2250, USDA Rural Development, South Agriculture Building, 1400 Independence Avenue SW., Washington, DC 20250-0784, telephone: (202) 260-8012, email is
RHS amends the current regulation for the Single Family Housing Guaranteed Loan Program (SFHGLP) on the subject of liquidation value appraisals. In order to reduce overall processing time, reduce cost, and expedite claim submission, lenders will order the liquidation value appraisal used to estimate a loss claim against the SFHGLP instead of the Agency. Specifically, RHS amends 7 CFR 3555.306(f)(3), 3555.352(e), 3555.353(b)(1), and 3555.354(b)(1)(i) and (ii) and (b)(2).
This rule has been determined to be non-significant and, therefore was not reviewed by the Office of Management and Budget (OMB) under Executive Order 12866.
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Except where specified, all State and local laws and regulations that are in direct conflict with this rule will be preempted. Federal funds carry Federal requirements. No person is required to apply for funding under SFHGLP, but if they do apply and are selected for funding, they must comply with the requirements applicable to the Federal program funds. This final rule is not retroactive. It will not affect agreements entered into prior to the effective date of the rule. Before any judicial action may be brought regarding the provisions of this rule, the administrative appeal provisions of 7 CFR part 11 must be exhausted.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effect of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, the Agency generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, or tribal governments, in the aggregate, or to the private sector, of $100 million, or more, in any one year. When such a statement is needed for a rule, section 205 of the UMRA generally requires the Agency to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule.
This rule contains no Federal mandates (under the regulatory provisions of Title II of the UMRA) for State, local, and tribal governments or the private sector. Therefore, this rule is not subject to the requirements of sections 202 and 205 of the UMRA.
This document has been reviewed in accordance with 7 CFR part 1940, subpart G, “Environmental Program.” It is the determination of the Agency that this action does not constitute a major Federal action significantly affecting the quality of the human environment, and, in accordance with the National Environmental Policy Act of 1969, Public Law 91-190, neither an Environmental Assessment nor an Environmental Impact Statement is required.
The policies contained in this rule do not have any substantial direct effect on States, on the relationship between the national government and States, or on the distribution of power and responsibilities among the various levels of government. Nor does this rule impose substantial direct compliance costs on State and local governments. Therefore, consultation with the States is not required.
In compliance with the Regulatory Flexibility Act (5 U.S.C. 601
Executive Order 13175 imposes requirements on RHS in the development of regulatory policies that have Tribal implications or preempt
These loans are subject to the provisions of Executive Order 12372, which require intergovernmental consultation with State and local officials. RHS conducts intergovernmental consultations for each SFHGLP in accordance with 2 CFR part 415, subpart C.
The program affected by this regulation is listed in the Catalog of Federal Domestic Assistance under Number 10.410, Very Low to Moderate Income Housing Loans (Section 502 Rural Housing Loans).
The information collection and record keeping requirements contained in this regulation have been approved by OMB in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). The assigned OMB control number is 0570-0179.
The Agency is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.
The U.S. Department of Agriculture (USDA) prohibits discrimination against its customers, employees, and applicants for employment on the bases of race, color, national origin, age, disability, sex, gender identity, religion, reprisal, and where applicable, political beliefs, marital status, familial or parental status, sexual orientation, or all or part of an individual's income is derived from any public assistance program, or protected genetic information in employment or in any program or activity conducted or funded by the Department. (Not all prohibited bases will apply to all programs and/or employment activities.)
If you wish to file a Civil Rights program complaint of discrimination, complete the USDA Program Discrimination Complaint Form (PDF), found online at
Individuals who are deaf, hard of hearing or have speech disabilities and you wish to file either an EEO or program complaint please contact USDA through the Federal Relay Service at (800) 877-8339 or (800) 845-6136 (in Spanish).
Persons with disabilities, who wish to file a program complaint, please see information above on how to contact us by mail directly or by email. If you require alternative means of communication for program information (
On October 6, 2015, RHS published a proposed rule with request for comments for the Single Family Housing Guaranteed Loan Program (SFHGLP) (80 FR 60298-60300). Rural Development received comments from one respondent. The comments are addressed below.
Home improvement, Loan programs—housing and community development, Mortgage insurance, Mortgages, Rural areas.
Therefore, chapter XXXV, title 7 of the Code of Federal Regulations is amended as follows:
5 U.S.C. 301; 42 U.S.C. 1471
(f) * * *
(3) The lender must notify the Agency when the property has not been sold within 30 days of the expiration of the permissible marketing period. If the REO remains unsold at the end of the permissible marketing period, the lender will order a liquidation value appraisal and the Agency will apply an acquisition and management resale factor to estimate holding and disposition cost. Interest expenses accrued beyond 90 days of the foreclosure sale date or expiration of any redemption period, whichever is later, will be the responsibility of the lender and not covered by the guarantee.
(e)
(b) * * *
(1) The value of the property as determined by a liquidation value appraisal. The value should be determined as if the property would be sold without the market exposure it would ordinarily receive in a normal transaction, or within 90 days, minus;
(b) * * *
(1) The lender must submit a loss claim request that includes a completed liquidation value appraisal within 30 calendar days of the period ending:
(i) Nine (9) months after either foreclosure or the end of any applicable redemption period, whichever is later, if the property remains unsold and is not located on American Indian restricted land; or
(ii) Twelve (12) months after either foreclosure or the end of any applicable redemption period, whichever is later, if the property remains unsold and is located on American Indian restricted land. Late claims made beyond this period of time, or submitted with a liquidation value appraisal not completed within the timeframes described in paragraphs (b)(1)(i) and (ii) of this section, may be rejected.
(2) The lender must submit a loss claim that includes the completed liquidation value appraisal within 30 calendar days of receiving the appraisal. Late claims made beyond this period of time, or submitted with a liquidation value appraisal not completed within the timeframes described in paragraphs (b)(1)(i) and (ii) of this section, may be rejected.
Internal Revenue Service (IRS), Treasury.
Final regulations.
This document contains final regulations eliminating the requirement that each disbursement from a designated Roth account that is directly rolled over to an eligible retirement plan be treated as a separate distribution from any amount paid directly to the employee and therefore separately subject to the rule in section 72(e)(2) of the Internal Revenue Code (the Code) allocating pretax and after-tax amounts to each distribution. As a result of this change, if disbursements are made from a taxpayer's designated Roth account to the taxpayer and also to the taxpayer's Roth IRA or designated Roth account in a direct rollover, then pretax amounts will be allocated first to the direct rollover, rather than being allocated pro rata to each destination. Also, a taxpayer will be able to direct the allocation of pretax and after-tax amounts that are included in disbursements from a designated Roth account that are directly rolled over to multiple destinations, applying the same allocation rules to distributions from designated Roth accounts that apply to distributions from other types of accounts. These regulations affect participants in, beneficiaries of, employers maintaining, and administrators of designated Roth accounts under tax-favored retirement plans.
Michael Brewer at (202) 317-6700 (not a toll-free number).
Section 402(a) provides generally that any amount distributed from a trust described in section 401(a) that is exempt from tax under section 501(a) is taxable to the distributee under section 72 in the taxable year of the distributee in which distributed. Under section 403(b)(1), any amount distributed from a section 403(b) plan is also taxable to the distributee under section 72.
If a participant's account balance in a plan qualified under section 401(a) or in a section 403(b) plan includes both after-tax and pretax amounts, then, under section 72(e)(8), each distribution (other than a distribution that is paid as part of an annuity) from the plan will include a pro rata share of both after-tax and pretax amounts. (Under section 72(d), a different allocation method applies to annuity distributions.)
Section 402(c) prescribes rules for amounts that are rolled over from qualified trusts to eligible retirement plans, including individual retirement accounts or annuities (“IRAs”). Subject to certain exceptions, section 402(c)(1) provides that if any portion of an eligible rollover distribution paid to an employee from a qualified trust is transferred to an eligible retirement plan, the portion of the distribution so transferred is not includible in gross income in the taxable year in which paid.
Under section 402(c)(2), the maximum portion of an eligible rollover distribution that may be rolled over in a transfer to which section 402(c)(1) applies generally cannot exceed the portion of the distribution that is otherwise includible in gross income. However, under section 402(c)(2)(A) and (B), the general rule does not apply to such a distribution to the extent that such portion is transferred in a direct trustee-to-trustee transfer to a qualified trust or to an annuity contract described in section 403(b) and such trust or contract provides for separate accounting for amounts so transferred (and earnings thereon), including separately accounting for the portion of such distribution which is includible in gross income and the portion of such distribution which is not so includible, or such portion is transferred to an IRA.
In addition, section 402(c)(2) provides that, in the case of a transfer described in subparagraph (A) or (B), the amount transferred shall be treated as consisting first of the portion of such distribution that is includible in gross income (determined without regard to section 402(c)(1)).
Under section 402A, an applicable retirement plan may include a
Under section 402A(d)(4), section 72 is applied separately with respect to distributions and payments from a designated Roth account and other distributions and payments from the plan.
Section 1.402A-1, Q&A-5(a), of the Income Tax Regulations prescribes taxability rules for a distribution from a designated Roth account that is rolled over. Q&A-5(a) provides, in part, that “any amount paid in a direct rollover is treated as a separate distribution from any amount paid directly to the employee” (the “separate distribution rule”).
Proposed regulations limiting the applicability of the separate distribution rule of § 1.402A-1, Q&A-5(a), were published on September 19, 2014 (REG-105739-11, 79 FR 56310). The proposed regulations achieved this result by adding, after the separate distribution rule in paragraph A-5(a), the following sentence: “The preceding sentence does not apply to distributions made on or after January 1, 2015; in addition, a taxpayer may elect not to apply the preceding sentence to distributions made on or after an earlier date that is no earlier than September 18, 2014.” Thus, under the proposed regulations, an amount paid in a direct rollover is not required to be treated as a separate distribution from any amount paid directly to the employee.
The proposed regulations were issued in conjunction with Notice 2014-54 (2014-41 IRB 670 (October 6, 2014)), which specified that a taxpayer may direct after-tax and pretax amounts that are simultaneously disbursed to multiple destinations so as to allocate them to specific destinations. Under Notice 2014-54, a taxpayer may direct the allocation of after-tax and pretax amounts in connection with disbursements that are directly rolled over, as well as in connection with disbursements that are rolled over in 60-day rollovers.
No comments were received regarding the proposed regulations.
These regulations finalize the proposed regulations, with a 1-year delay of the applicability date (from January 1, 2015, to January 1, 2016). They are substantively the same as the proposed regulations, but express the rule differently to better reflect the ongoing rule and the transition rule. For distributions made on or after January 1, 2016, the final regulations remove the sentence in the existing regulations that provided the separate distribution rule. For earlier distributions, the final regulations add a sentence at the end of the paragraph which provides that a separate distribution rule applies to distributions made prior to January 1, 2016, unless a taxpayer elects not to apply that rule with respect to a distribution made on or after September 18, 2014.
These regulations apply to distributions from designated Roth accounts made on or after January 1, 2016, and for such distributions taxpayers are required to follow the allocation rules described in Notice 2014-54.
These regulations also preserve the separate distribution rule for distributions made prior to the January 1, 2016, applicability date, except that a taxpayer is permitted to choose not to apply the separate distribution rule to distributions that are made on or after September 18, 2014, and before January 1, 2016. Taxpayers choosing not to apply the separate distribution rule to distributions made during that transition period, must apply a reasonable interpretation of the last sentence of section 402(c)(2) (generally requiring that pretax amounts be treated as rolled over first) to allocate pretax and after-tax amounts among disbursements made to multiple destinations. For this purpose, a reasonable interpretation of the last sentence of section 402(c)(2) includes the rules described in Notice 2014-54.
Notice 2014-54 is published in the Internal Revenue Bulletin and is available from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402, or by visiting the IRS Web site at
Certain IRS regulations, including this one, are exempt from the requirements of Executive Order 12866, as supplemented and reaffirmed by Executive Order 13563. Therefore, a regulatory impact assessment is not required. It has also been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations, and because the regulation does not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply.
Pursuant to section 7805(f) of the Code, the notice of proposed rulemaking preceding these regulations was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.
The principal author of these regulations is Michael Brewer, Office of the IRS Associate Chief Counsel (Tax Exempt and Government Entities). However, other personnel from the IRS and the Department of Treasury participated in the development of the regulations.
Income taxes, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 1 is amended as follows:
26 U.S.C. 7805 * * *
A-5. (a) * * * For distributions made prior to January 1, 2016, any amount paid in a direct rollover is treated as a separate distribution from any amount paid directly to the employee, except that taxpayers may choose not to apply this sentence to distributions made on or after September 18, 2014, and before January 1, 2016.
In rule document 2016-04800 appearing on pages 16285-16890 in the issue of March 25, 2016, make the following corrections:
Office of Foreign Assets Control, Treasury.
Final rule.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is amending the Burmese Sanctions Regulations to add a general license authorizing certain transactions related to U.S. persons residing in Burma. OFAC is also incorporating a general license authorizing certain transactions incident to exports to and from Burma that has, until now, appeared only on OFAC's Web site on the Burma sanctions page, and expanding this authorization to allow certain transactions incident to the movement of goods within Burma that otherwise would be prohibited. Finally, OFAC is expanding and updating another existing authorization allowing most transactions involving certain blocked financial institutions.
The Department of the Treasury's Office of Foreign Assets Control: Assistant Director for Licensing, tel.: 202-622-2480, Assistant Director for Regulatory Affairs, tel.: 202-622-4855, Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; or the Department of the Treasury's Office of the Chief Counsel (Foreign Assets Control), Office of the General Counsel, tel.: 202-622-2410.
This document and additional information concerning OFAC are available from OFAC's Web site (
On June 30, 2014, the Department of the Treasury's Office of Foreign Assets Control (OFAC) amended and reissued in their entirety the Burmese Sanctions Regulations, 31 CFR part 537 (the “Regulations”), to implement Executive Order 13448 of October 18, 2007, “Blocking Property and Prohibiting Certain Transactions Related to Burma,” Executive Order 13464 of April 30, 2008, “Blocking Property and Prohibiting Certain Transactions Related to Burma,” Executive Order 13619 of July 11, 2012, “Blocking Property of Persons Threatening the Peace, Security, or Stability of Burma,” and Executive Order 13651 of August 6, 2013, “Prohibiting Certain Imports of Burmese Jadeite and Rubies” (79 FR 37106).
Following Burma's peaceful and competitive elections in 2015, the U.S. Government is taking additional steps to support Burma's political reforms and broad-based economic growth.
Because the Regulations involve a foreign affairs function, the provisions of Executive Order 12866 and the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date are inapplicable. Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.
The collections of information related to the Regulations are contained in 31 CFR part 501 (the “Reporting, Procedures and Penalties Regulations”). Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), those collections of information have been approved by the Office of Management and Budget under control number 1505-0164. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number.
Administrative practice and procedure, Banks, Banking, Blocking of assets, Credit, Burma, Exportation, Exports, Foreign trade, Investments, Loans, New investment, Securities, Services, Specially Designated Nationals.
For the reasons set forth in the preamble, the Department of the Treasury's Office of Foreign Assets Control amends 31 CFR part 537 as set forth below:
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890 (28 U.S.C. 2461 note); Sec. 570, Pub. L. 104-208, 110 Stat. 3009; Pub. L. 110-96, 121 Stat. 1011 (50 U.S.C. 1701 note); Pub. L. 110-286, 122 Stat. 2632 (50 U.S.C. 1701 note); E.O. 13047, 62 FR 28301, 3 CFR, 1997 Comp., p. 202; E.O. 13310, 68 FR 44853, 3 CFR, 2003 Comp., p. 241; E.O. 13448, 72 FR 60223, 3 CFR, 2007 Comp., p. 304; E.O. 13464, 73 FR 24491, 3 CFR, 2008 Comp., p. 189; E.O. 13619, 77 FR 41243, 3 CFR, 2012 Comp., p. 279; E.O. 13651, 78 FR 48793, 3 CFR, 2014 Comp., p. 324; Determination No. 2009-11, 74 FR 3957, 3 CFR, 2009 Comp., p. 330.
(a) U.S. persons are authorized to engage in transactions in Burma ordinarily incident to the routine and necessary maintenance within Burma, including payment of living expenses and acquisition of goods or services for personal use, of U.S. person individuals who reside in Burma.
(b) Nothing in this section authorizes transactions related to employment of a U.S. person by a person whose property and interests in property are blocked pursuant to § 537.201(a).
See § 537.210(c) for an exemption for transactions ordinarily incident to travel to or from Burma, including maintenance within Burma, such as payment of living expenses and acquisition of goods or services for personal use.
(a) Except as provided in paragraphs (b) through (f) of this section, all transactions involving Asia Green Development Bank, Ayeyarwady Bank, Innwa Bank, and Myawaddy Bank are authorized.
(b) This section does not authorize transactions involving any person whose property and interests in property are blocked pursuant to § 537.201(a) other than Asia Green Development Bank, Ayeyarwady Bank, Innwa Bank, and Myawaddy Bank.
(d) This section does not authorize any new investment, as defined in § 537.311, including in or with Asia Green Development Bank, Ayeyarwady Bank, Innwa Bank, or Myawaddy Bank.
As a result of the authorization contained in this section, the special measures against Burma imposed under Section 311 of the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA PATRIOT) Act of 2001 (Pub. L. 107-56) (USA PATRIOT Act) do not apply to the operation of correspondent accounts for Asia Green Development Bank, Ayeyarwady Bank, Innwa Bank, and Myawaddy Bank, or to transactions conducted through such accounts, provided the transactions are
(a)
(b)
(1) A copy of the original blocking report filed with OFAC pursuant to § 501.603(b)(1) of this chapter;
(2) The date the property was unblocked;
(3) If applicable, the amount unblocked;
(4) The name of the party to whom the blocked property was returned; and
(5) A reference to this general license as the legal authority under which the property was unblocked and the blocked property was returned.
(c) Paragraphs (a) and (b) of this section do not authorize:
(1) The unblocking of any property or interests in property that were blocked pursuant to § 537.201(a) prior to April 1, 2015.
(2) A U.S. financial institution to advise or confirm any financing by a person whose property and interests in property are blocked pursuant to § 537.201(a).
(d)
(e) Paragraph (d) of this section does not authorize:
(1) The unblocking of any property or interests in property that were blocked pursuant to § 537.201(a).
(2) A U.S. financial institution to advise or confirm any financing by a person whose property and interests in property are blocked pursuant to § 537.201(a).
(f) For the purposes of this section, the term
See § 537.529 for a general license authorizing the exportation or reexportation of financial services to Burma.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the US2 Bridge across Lake Champlain (The Gut), mile 91.8, between North Hero and South Hero Island, Vermont. This deviation is necessary to allow the bridge owner to perform mechanical and electrical repairs at the bridge.
This deviation is effective without actual notice from May 18, 2016 to 8 a.m. on June 15, 2016. For the purposes of enforcement, actual notice will be used from 8 a.m. on May 15, 2016, until May 18, 2016.
The docket for this deviation, USCG-2016-0406, is available at
If you have questions on this temporary deviation, call or email Jim Rousseau; Project Officer, First Coast Guard District, telephone (617) 223-8619, email
The US2 Bridge across Lake Champlain, at North Hero Island, Vermont, has a vertical clearance in the closed position of 18 feet at mean high water. The existing bridge operating regulations are found at 33 CFR 117.993(b).
The subject waterway is typically transited by seasonal, recreational vessels of various sizes. Several marina facilities are in the area of the bridge with local vessels requesting bridge openings several times a week.
The bridge owner, Vermont Agency of Transportation, requested a temporary deviation from the normal operating schedule to facilitate mechanical and electrical repairs at the bridge. In response to the request, the Coast Guard's First District has approved a deviation from 8 a.m. on May 15, 2016 until 8 a.m. June 15, 2016.
During the time of this temporary deviation, the US2 Bridge shall open on signal on the hour, but it will not open on the half hour. Also during the time of this temporary deviation, the US2 Bridge will be open by use of an auxiliary drive system not designed for high-speed openings, which means the bridge will open more slowly than it does under normal operations.
Vessels that are able to pass under the bridge in the closed position may do so at anytime. The bridge will be able to open for emergencies, and there is an alternate route for vessels to pass to the north under the Alburg Passage US2 fixed bridge, which has a vertical clearance of 26 feet at mean high water.
The Coast Guard will inform the users of the waterways through our Local Notice and Broadcast to Mariners of the change in operating schedule for the bridge so that vessel operations can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes an exemption from the requirement of a tolerance for residues of quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite (CAS Reg. No. 1574487-61-8) when used as an inert ingredient (suspending or structuring agent) in pesticide formulations applied to growing crops at a concentration not to exceed 2.0% by weight in the formulation, asbestos free and containing less than 1% crystalline silica. This regulation also establishes an exemption from the requirement of a tolerance for residues of quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with saponite (CAS Reg. No. 1588523-05-0) when used as an inert ingredient (suspending or structuring agent) in pesticide formulations applied to growing crops at a concentration not to exceed 1.0% by weight in the formulation. Technology Sciences Group on behalf of BYK Additives Inc. submitted petitions to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with saponite.
This regulation is effective May 18, 2016. Objections and requests for hearings must be received on or before July 18, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The dockets for these actions, identified by docket identification (ID) number EPA-HQ-OPP-2015-0018, EPA-HQ-OPP-2015-0020 are available at
Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0018 (CAS Reg. No. 1574487-61-8), EPA-HQ-OPP-2015-0020 (CAS Reg. No. 1588523-05-0) in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before July 18, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0018, EPA-HQ-OPP-2015-0020 by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
That document referenced a summary of the petitions prepared by Technology Science Group, the petitioner, which is available in the docket,
Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”
EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite, and quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with saponite including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and with quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with saponite follows.
EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
Specific information on the studies received and the nature of the adverse effects caused by both quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and with saponite as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.
Based on data in structurally similar quaternary ammonium clay substances, quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and with saponite have low acute toxicity via the oral, dermal and inhalation routes in rats. The substances are expected to be a slight skin and eye irritant. A structurally similar quaternary ammonium clay substance did not cause skin sensitization in guinea pigs.
Multiple 28-day repeat-dose studies consistently showed high No Observed
Clays treated with quaternary ammonium compounds have low water solubility, a high hydrophobic partition coefficient and relatively high molecular weight. All three factors indicate likely limited absorption following ingestion, dermal exposure or inhalation. Based on similarities to other quaternary ammonium clays (high molecular weights, low water solubility, high hydrophobicity), both benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and with saponite would also be almost completely eliminated from the body shortly after oral dosing. Therefore, the biological availability is expected to be low.
1. The available toxicity studies indicate that both quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and with saponite have very low overall toxicity. The NOAELs were
1.
Under this exemption from the requirement of a tolerance, residues of quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and with saponite may be found on foods from crops that were treated with pesticide formulations containing both quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite and with saponite. However, quantitative dietary exposure assessments were not conducted since endpoints for risk assessment were not identified.
2.
3.
4.
As part of its qualitative assessment, the Agency did not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children. Based on the lack of toxicity of ammonium acetate in the available studies and its chemical properties, EPA has concluded that there are no toxicological endpoints of concern for the U.S. population, including infants and children.
Taking into consideration all available information both quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite when used as an inert ingredient (suspending or structuring agent) with a limitation of 2.0% in formulation, asbestos free and containing less than 1% crystalline silica and quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with saponite when used as an inert ingredient (suspending or structuring agent) with a limitation of 1.0% in formulation, EPA has determined that there is a reasonable certainty that no harm to any population subgroup will result from aggregate exposure to both
1.
2.
3.
4.
5.
6.
Although EPA is establishing a limitation on the amount of quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite; and quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with saponite that may be used in pesticide formulations, an analytical enforcement methodology is not necessary for this exemption from the requirement of tolerance. The limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nation Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has not established a MRL for quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite, and quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with saponite.
Therefore, exemptions from the requirement of a tolerance are established under 40 CFR 180. 920 for quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite (CAS Reg. No. 1574487-61-8) when used as an inert ingredient (suspending or structuring agent) in pesticide formulations applied to growing crops with a limitation of 2.0% in formulation, asbestos free and containing less than 1% crystalline silica; and for quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with saponite (CAS Reg. No. 1588523-05-0) when used as an inert ingredient (suspending or structuring agent) in pesticide formulations applied to growing crops with a limitation of 1.0% in formulation.
This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
Environmental Protection Agency (EPA).
Direct final rule.
The Environmental Protection Agency (EPA) is issuing a final rule to make administrative changes to the Environmental Protection Agency Acquisition Regulation (EPAAR). EPA does not anticipate any adverse comments.
This rule is effective on July 18, 2016 without further action, unless EPA receives adverse comment by June 17, 2016. If EPA receives adverse comment, a timely withdrawal will be published in the
Submit your comments, identified by Docket ID No. EPA-HQ-OARM-2015-0662, at
Julianne Odend'hal, Policy, Training, and Oversight Division, Acquisition Policy and Training Service Center (3802R), Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone number: (202) 564-5218; email address:
EPA is publishing this rule without a prior proposed rule because EPA views this as a noncontroversial action and anticipates no adverse comment. EPAAR parts 1503 and 1552 are amended to conform to the format of the Federal Acquisition Regulation (FAR) and to correct, clarify and update information. If EPA receives adverse comment, a timely withdrawal will be published in the
The EPAAR applies to contractors who have a contract with the EPA.
A.
B.
• Identify the rulemaking by docket number and other identifying information (subject heading,
• Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
• Explain why you agree or disagree, suggest alternatives, and substitute language for your requested changes.
• Describe any assumptions and provide any technical information and/or data that you used.
• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
• Provide specific examples to illustrate your concerns, and suggest alternatives.
• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
• Make sure to submit your comments by the comment period deadline identified.
EPAAR parts 1503 and 1552 are amended to conform to the format of the Federal Acquisition Regulation (FAR) and to correct, clarify and update information.
This direct final rule makes the following changes: (1) Updates the title and clarifies the information in section 1503.101-370 including correcting statute citations; (2) corrects section number “1503.104-5” to read “1503.104-4” and corrects the reference to “FAR 3.104-5” to read “FAR 3.104-4”; (3) removes section 1503.408,
This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.
This action does not impose an information collection burden under the PRA because it does not contain any information collection activities.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small entities subject to the rule. This action amends EPAAR parts 1503 and 1552 to conform to the format of the Federal Acquisition Regulation (FAR) and to correct, clarify and update information. We have therefore concluded that this action will have no net regulatory burden for all directly regulated small entities.
This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). Thus, Executive Order 13175 does not apply to this action. In the spirit of Executive Order 13175, and consistent with EPA policy to promote communication between EPA and Tribal governments, EPA specifically solicits additional comment on this proposed rule from Tribal officials.
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation. This action is not subject to Executive Order 13045 because it does not establish an environmental standard intended to mitigate health or safety risks.
This action is not subject to Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not a significant regulatory action under Executive Order 12866.
This rulemaking does not involve technical standards.
Executive Order 12898 (59 FR 7629, (February 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. EPA has determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment.
The Congressional Review Act, 5 U.S.C. 801
Government procurement.
For the reasons stated in the preamble, 48 CFR parts 1503 and 1552 are amended as set forth below:
5 U.S.C. 301 and 41 U.S.C. 418b.
This part implements FAR part 3, cites EPA regulations on employee responsibilities and conduct, establishes responsibility for reporting violations and related actions, and provides for authorization of exceptions to policy.
(a) Each EPA employee (including special government employees as defined by 18 U.S.C. 202 and 1503.600-71(b)) engaged in source evaluation and selection is required to abide by and be
(b) Pursuant to the financial conflict of interest statute, 18 U.S.C. 208 and 5 CFR part 2635, subparts D and E, each employee must abide by ethics requirements regarding financial conflict of interest and impartiality in performing official duties. The employee shall inform his or her Deputy Ethics Official and the Source Selection Authority (SSA) in writing if his/her participation in the source evaluation and selection process may raise possible or apparent conflict of interest or impartiality concerns. The employee must cease work on the source evaluation and selection process until the appropriate ethics official makes a determination. Please note that only the Office of General Counsel can direct employees to divest of financial interests or to recommend any waivers of the financial conflict of interest standards.
(a)(1) The Chief of the Contracting Office (CCO) is the designated official to make the decision whether support contractors are used in proposal evaluation (as authorized at FAR 15.305(c) and restricted at FAR 37.203(d)).
(2) The following written certification and agreement shall be obtained from non-Government evaluator prior to the release of any proposal to that evaluator:
1. I hereby certify that to the best of my knowledge and belief, no conflict of interest exists that may diminish my capacity to perform an impartial, technically sound, objective review of this proposal(s) or otherwise result in a biased opinion or unfair competitive advantage.
2. I agree to use any proposal information only for evaluation purposes. I agree not to copy any information from the proposal(s), to use my best effort to safeguard such information physically, and not to disclose the contents of nor release any information relating to the proposal(s) to anyone outside of the evaluation team assembled for this acquisition or individuals designated by the Contracting Officer.
3. I agree to return to the Government all copies of proposals, as well as any abstracts, upon completion of the evaluation.
(b) Information contained in proposals will be protected and disclosed to the extent permitted by law, and in accordance with FAR 3.104-4, 15.207, and Agency procedures at 40 CFR part 2.
This subpart implements and supplements FAR subpart 3.6 and sets forth EPA policy and procedures for identifying and dealing with conflicts of interest and improper influence or favoritism in connection with contracts involving current or former EPA employees. This subpart does not apply to agreements with other departments or agencies of the Federal Government, nor to contracts awarded to State or local units of Government.
(a)
(b)
(a) No contract may be awarded without competition to a former employee or special government employee (or to a business concern or other organization owned or substantially owned or controlled by a former employee) whose employment terminated within 365 calendar days before submission of a proposal to EPA.
(b) No contract shall be awarded without competition to a firm which employs, or proposes to employ, a current employee or special government employee, or a former EPA employee or special government employee, whose employment terminated within 365 calendar days before submission of a proposal to EPA, if either of the following conditions exists:
(1) The current or former EPA employee or special government employee is or was involved in development or negotiating the proposal for the prospective contractor; or
(2) The current or former EPA employee or special government employee will be involved directly or indirectly in the management, administration, or performance of the contract.
The Assistant Administrator for the Office of Administration and Resources Management may authorize an exception, in writing, to the policy in FAR 3.601 and 1503.601 for the reasons stated in FAR 3.602, if the exception would not involve a violation of 18 U.S.C. 203, 18 U.S.C. 205, 18 U.S.C. 207, 18 U.S.C. 208, the Standards of Ethical Conduct for Employees of the Executive Branch at 5 CFR part 2635, or the EPA supplemental regulations at 5 CFR part 6401. The Assistant Administrator shall consult with the Designated Agency Ethics Official before authorizing any exceptions.
The Contracting Officer shall insert the provision at 1552.203-70,
The Assistant Administrator for the Office of Administration and Resources Management is designated as the recipient of the written report of findings by the Inspector General. The Assistant Administrator shall ensure that the report of findings is disseminated in accordance with FAR 3.905(c).
Government contractors must conduct themselves with the highest degree of integrity and honesty. Contractors should have standards of conduct and internal control systems that:
(a) Are suitable to the size of the company and the extent of their involvement in Government contracting;
(b) Promote such standards;
(c) Facilitate timely discovery and disclosure of improper conduct in connection with Government contracts; and
(d) Ensure corrective measures are promptly instituted and carried out.
(a) A contractor's system of management controls should provide for:
(1) A written code of business ethics and conduct and an ethics training program for all employees;
(2) Periodic reviews of company business practices, procedures, policies and internal controls for compliance with standards of conduct and the special requirements of Government contracting;
(3) A mechanism, such as a hotline, by which employees may report suspected instances of improper conduct, and instructions that encourage employees to make such reports;
(4) Internal and/or external audits, as appropriate;
(5) Disciplinary action for improper conduct;
(6) Timely reporting to appropriate Government officials of any suspected or possible violation of law in connection with Government contracts or any other irregularities in connection with such contracts; and
(7) Full cooperation with any Government agencies responsible for either investigation or corrective actions.
(b) Contractors who are awarded an EPA contract of $1 million or more must display EPA Office of Inspector General Hotline Posters unless the contractor has established an internal reporting mechanism and program as described in paragraph (a) of this section.
As required by EPAAR 1503.1003(b), the contracting officer shall insert the clause at 1552.203-71,
5 U.S.C. 301 and 41 U.S.C. 418b.
As prescribed in 1503.670, insert the following provision in all EPA solicitations for sole-source acquisitions.
The offeror (quoter) hereby certifies that:
(a) He/She is [ ] is not [ ] a former employee or special government employee whose EPA employment terminated within one year prior to submission of this offer (quote).
(b) He/She does [ ] does not [ ] employ or propose to employ a current/former employee or special government employee whose EPA employment terminated within one year prior to submission of this offer (quote) and who has been or will be involved, directly or indirectly, in developing or negotiating this offer (quote) for the offeror (quoter), or in the management, administration or performance of any contract resulting from this offer (quote).
(c) He/She does [ ] does not [ ] employ or propose to employ as a consultant or subcontractor under any contract resulting from this offer (quote) a current/former employee or special government employee whose EPA employment terminated within one year prior to submission of this offer (quote).
(d) A former employee or special government employee whose EPA employment terminated within one year prior to submission of this offer (quote) or such former employee's spouse or minor child does [ ] does not [ ] own or substantially own or control the offeror's (quoter's) firm.
(e) See EPAAR part 1503.600-71 for definitions of the terms “employee” and “special government employee.”
As prescribed in 1503.1004, insert the following clause in all contracts valued at $1,000,000 or more including all contract options.
(a) For EPA contracts valued at $1,000,000 or more including all contract options, the contractor shall prominently display EPA Office of Inspector General Hotline posters in contractor facilities where the work is performed under the contract.
(b) Office of Inspector General hotline posters may be obtained from the EPA Office of Inspector General, ATTN: OIG Hotline (2443), 1200 Pennsylvania Avenue NW., Washington, DC 20460, or by accessing the OIG Web site at:
(c) The Contractor need not comply with paragraph (a) of this clause if it has established a mechanism, such as a hotline, by which employees may report suspected instances of improper conduct, and has provided instructions that encourage employees to make such reports.
Office of the Secretary, HUD.
Proposed rule.
Through this proposed rule, HUD continues its efforts to narrow the digital divide in low-income communities served by HUD by providing, where feasible and with HUD funding, broadband infrastructure to communities in need of such infrastructure. Broadband is the common term used to refer to a very fast connection to the Internet. Such connection is also referred to as high-speed broadband, broadband Internet, or high-speed Internet. In this proposed rule, HUD proposes to require installation of broadband infrastructure at the time of new construction or substantial rehabilitation of multifamily rental housing that is funded or supported by HUD. Installation of broadband infrastructure at the time of new construction or substantial rehabilitation is generally easier and less costly than when such installation is undertaken as a stand-alone effort. The proposed rule, however, recognizes that installation of broadband infrastructure may not be feasible for all new construction or substantial rehabilitation, and, therefore, the proposed rule allows limited exceptions to the installation requirements. Installing unit-based broadband infrastructure in multifamily rental housing that is newly constructed or substantially rehabilitated with or supported by HUD funding will provide a platform for individuals and families residing in such housing to participate in the digital economy, and increase their access to economic opportunities.
Interested persons are invited to submit comments regarding this proposed rule. All communications must refer to the above docket number and title. To receive consideration as public comments, comments must be submitted through one of the two methods specified below.
For Community Planning and Development programs, Marion McFadden, Office of Community Planning and Development, Room 7204, telephone, 202-708-2111 (this is not a toll-free number). For Office of Multifamily Housing programs, Katie Buckner, Office of Housing, Room 6222, telephone 202-402-7140 (this is not a toll-free number). For Office of Public and Indian Housing programs, Dominique Blom, Office of Public and Indian Housing, Room 4130, telephone 202-402-4181 (this is not a toll-free number). The address for all individuals is Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410-0500. Persons with hearing or speech impairments may access these numbers through TTY by calling the Federal Relay Service at 800-877-8339 (this is a toll-free number).
The purpose of this proposed rule is to require installation of broadband infrastructure at the time of new construction or substantial rehabilitation of multifamily rental housing that is funded or supported by HUD.
This proposed rule would require installation of broadband infrastructure at the time of new construction or substantial rehabilitation of multifamily rental units funded by the following programs:
1. Choice Neighborhoods Implementation Grant program;
2. Community Development Block Grant (CDBG) program, including the CDBG Disaster Recovery program;
3. Continuum of Care program;
4. HOME Investment Partnerships program;
5. Housing Opportunities for Persons With AIDS program;
6. Housing Trust Fund program;
7. Project-Based Voucher program;
8. Public Housing Capital Fund program;
9. Section 8 project-based housing assistance payments programs, including, but not limited to, the Section 8 New Construction, Substantial Rehabilitation, Loan Management Set-Aside, and Property Disposition programs; and
10. Supportive Housing for the Elderly and Persons with Disabilities program.
The requirements of the proposed rule would not apply to multifamily rental housing that only has a mortgage insured by HUD's Federal Housing Administration or with a loan guaranteed under a HUD loan guarantee program.
HUD is proposing to define broadband infrastructure as cables, fiber optics, wiring, or other permanent infrastructure, including wireless infrastructure, as long as the installation results in broadband infrastructure in each dwelling unit meeting the definition created by the Federal Communications Commission (FCC), which currently is 25 Megabits per second (Mbps) download, 3 Mbps upload. In addition, HUD is proposing that, for programs that do not already have a definition of substantial rehabilitation, substantial rehabilitation be defined as work on the electrical system that is equal to or greater than 75 percent of the cost of replacing the entire electrical system, or when the cost of the rehabilitation is equal to or greater than 75 percent of the total estimated cost of replacing the multifamily rental housing after the rehabilitation is complete.
The costs and benefits of this proposed rule are difficult to quantify, but they can be described qualitatively. This proposed rule only requires that the broadband infrastructure provided is to receive high-speed Internet that is “accessible” in each unit; it does not require those recipients of funding undertaking new construction or substantial rehabilitation to provide a regular subscription to broadband service (even at a cost) to current or future residents. Furthermore, the definition of broadband infrastructure in the proposed rule is broad enough to include coaxial cable television (TV) wiring that supports cable modem access or even permanent infrastructure that would provide broadband speeds to dwelling units wirelessly. The rulemaking also provides for exceptions to the installation requirements for where the installation is too costly to provide due to location or building characteristics.
A recent survey by the National Association of Homebuilders found that just 4 percent of the surveyed multifamily housing developers never installed landline wires and jacks in multifamily units completed in the past 12 months.
Given the wide range of technologies that may be employed to meet the requirements of this proposed rule, it is not possible to specify the cost of the technology and how much additional burden this may be for owners or developers building or providing substantial rehabilitation to HUD-assisted rental housing. If the broadband infrastructure is wiring connected to proximate telephone or cable company networks, the cost is not expected to be significant, as all electrical work in a multifamily project is estimated to be only about 10 percent of the construction cost;
Materials on the benefits of narrowing the digital divide are voluminous. Having broadband Internet in the home increases household income
On March 23, 2015, President Obama issued a Presidential memorandum on “Expanding Broadband Deployment and Adoption by Addressing Regulatory Barriers and Encouraging Investment and Training.”
On July 15, 2015, HUD launched its Digital Opportunity Demonstration, known as “ConnectHome,” in which HUD provided a platform for collaboration among local governments, public housing agencies, Internet service providers, philanthropic foundations, nonprofit organizations, and other relevant stakeholders to work together to produce local solutions for narrowing the digital divide in communities across the nation served by HUD. The demonstration, or pilot, commenced with the participation of 28 communities.
The importance of all Americans having access to the Internet cannot be overstated. As HUD stated in its announcement of the Digital Opportunity Demonstration, published in the
This proposed rule would apply to new construction and substantial rehabilitation of multifamily rental housing in the HUD programs that authorize and fund such activities. These programs are listed in Section II.B of this preamble. The proposed rule would not apply to multifamily rental housing with a mortgage insured by HUD's Federal Housing Administration (FHA) or with a loan guaranteed under a HUD loan guarantee program.
HUD proposes to require installation of broadband infrastructure in individual housing units at the time of new construction or substantial rehabilitation of multifamily rental housing, because while such installation is not without cost, the cost can be reduced by providing the installation at the time when housing is first being built or substantially rehabilitated.
As provided in section I.B. of this preamble, this proposed rule would apply to multifamily rental housing that is to be newly constructed or substantially rehabilitated with funds under the following HUD programs, as implemented through the regulations or under authorities cited below:
1. Choice Neighborhoods Implementation Grant program, for which the requirements are found in HUD notices of funding availability (NOFAs);
2. Community Development Block Grant (CDBG) program, for which the regulations are found in 24 CFR part 570;
3. Continuum of Care (CoC) program, for which the regulations are found in 24 CFR part 578;
4. HOME Investment Partnerships (HOME) program, for which the regulations are found in 24 CFR part 92;
5. Housing Opportunities for Persons With AIDS (HOPWA) program, for which the regulations are found in 24 CFR part 574;
6. Housing Trust Fund (HTF) program, for which the regulations are found in 24 CFR part 93;
7. Project-Based Voucher program, for which the regulations are found in 24 CFR part 983;
8. Public Housing Capital Fund program, for which the regulations are found in 24 CFR part 905;
9. Section 8 project-based housing assistance payments programs, including, but not limited to, the Section 8 New Construction, Substantial Rehabilitation, Loan Management Set-Aside, and Property Disposition programs; and
10. Supportive Housing for the Elderly and Persons with Disabilities program, for which the regulations are found in 24 CFR part 891.
One of HUD's major new construction and substantial rehabilitation programs, the Choice Neighborhoods program, already requires broadband infrastructure in new construction units and permits the use of Choice Neighborhood funds for broadband infrastructure in substantially rehabilitated units. In addition, Choice Neighborhood grantees may use up to 15 percent of their grants for Critical Community Improvements, of which neighborhood broadband programs are considered an eligible expense. The Choice Neighborhoods program supports locally driven strategies to address struggling neighborhoods with distressed public or HUD-assisted housing through a comprehensive approach to neighborhood transformation. The program is designed to catalyze critical improvements in neighborhood assets, including vacant property, housing, services, and schools. One of the three core goals of the Choice Neighborhoods program is to replace distressed public and assisted housing with high-quality, mixed-income
As noted in the Summary, HUD recognizes that installation of broadband infrastructure will not be feasible for every new construction or substantial rehabilitation of multifamily rental housing proposed to be covered by this proposed rule. For example, HUD recognizes that constructing or undertaking substantial rehabilitation of multifamily rental housing in certain areas may make installation of broadband infrastructure infeasible. As the Rural Utilities Service of the U.S. Department of Agriculture (USDA) stated in a final rule entitled “Economic Benefits of Broadband Deployment in Rural Areas,” published on February 6, 2013,
As noted in the Summary, “broadband” is the common term used to refer to a very fast connection to the Internet. Such connection is also referred to as high-speed broadband or high-speed Internet. HUD recognizes that broadband is defined by several agencies as Internet access of at least a certain speed.
The broadband infrastructure that needs to be installed to provide families in covered multifamily rental housing with broadband access will vary according to the housing being constructed or rehabilitated and the plans of the entity doing such construction or rehabilitation. Therefore, HUD proposes a flexible definition, allowing entities undertaking new construction or substantial rehabilitation to install the broadband infrastructure that is most feasible given the specifics of the construction or substantial rehabilitation to be undertaken. HUD proposes to require installation of cables, fiber optics, wiring, or other infrastructure, as long as the installation results in broadband accessibility in each dwelling unit. HUD proposes only to require the installation of broadband infrastructure on the property, not to require that grantees be responsible for ensuring an external connection between the property and an Internet service provider (ISP).
While some of the HUD programs listed in Section II.B of this preamble define what is meant by “substantial rehabilitation,” the majority of the covered programs do not define this term. Therefore, for the sole purpose of determining when substantial rehabilitation of covered multifamily rental housing would trigger installation of broadband infrastructure and, except in the HOPWA program, where substantial rehabilitation is already defined, HUD proposes to define “substantial rehabilitation” to mean:
(1) Significant work on the electrical system of the multifamily rental housing. “Significant work” is defined as work that is equal to or greater than 75 percent of the cost of replacing the entire electrical system. In the case of multifamily rental housing with multiple buildings with more than 4 units, “entire system” refers to the electrical system of the building(s) undergoing rehabilitation; or
(2) Rehabilitation of the multifamily rental housing in which the estimated cost of the rehabilitation is equal to or greater than 75 percent of the total estimated cost of replacing the multifamily rental housing after the rehabilitation is complete. In the case of multifamily rental housing with multiple buildings with more than 4 units, the replacement cost used in this determination would be the replacement cost of the building(s) undergoing rehabilitation.
HUD intends for this proposed rule to apply to projects that have not yet established their budgets and had funding approved, in order to give recipients and owners adequate time to factor the installation of broadband infrastructure into their new construction or substantial rehabilitation plans.
With this proposed rule, HUD seeks to take another important step toward narrowing the digital divide by providing residents in covered multifamily rental housing that is to be newly constructed or substantially rehabilitated with infrastructure that supports access to broadband Internet service, thereby increasing access to educational and economic opportunities for these residents.
While HUD welcomes comments on all aspects of this proposed rule, HUD is seeking specific comment on the following questions:
1. In light of the policy objectives discussed in the preamble, should this proposed rule be applied to other HUD programs, particularly additional multifamily housing programs (such as Rental Supplement (RS), Rental Assistance Payment (RAP), Moderate Rehabilitation Programs (Mod Rehab), etc.) or programs addressing single-family housing? Should any programs covered by this proposed rule be removed?
2. Given that the definition of the term “substantial rehabilitation” will determine which projects (other than new construction) are affected by this rulemaking, should the definition be changed in any way?
3. How much does it cost to add the installation of broadband infrastructure to a pre-planned new construction or rehabilitation project? Are HUD's estimates for the labor and materials costs for installing broadband infrastructure accurate? What data can the public share with HUD about the most cost-effective way for broadband infrastructure to be installed during a new construction or rehabilitation project?
4. The proposed rule provides exceptions to the requirements if compliance would be infeasible due to cost, location, or structural concerns. Are these exceptions too broad or too narrow? What is the best way for grantees to demonstrate to HUD that installation of broadband infrastructure is infeasible, and what would appropriate sanctions be if grantees do not comply even if it was feasible? Do any grantees have experience with a project in which installing broadband infrastructure was physically or economically infeasible, and under what circumstances was it infeasible?
5. When evaluating whether the rehabilitation being done meets the threshold in the definition of substantial rehabilitation, should HUD use the pre-rehabilitation estimates for the project alone, or should HUD include increases in rehabilitation costs that arise in the process of rehabilitation?
Under Executive Order 12866 (Regulatory Planning and Review), a determination must be made whether a regulatory action is significant and, therefore, subject to review by the Office of Management and Budget (OMB) in accordance with the requirements of the order. Executive Order 13563 (Improving Regulations and Regulatory Review) directs executive agencies to analyze regulations that are “outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned. Executive Order 13563 also directs that, where relevant, feasible, and consistent with regulatory objectives, and to the extent permitted by law, agencies are to identify and consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public. This proposed rule was determined to be a “significant regulatory action” as defined in section 3(f) of the Executive order (although not an economically significant regulatory action, as provided under section 3(f)(1) of the Executive order).
As discussed, this proposed rule furthers HUD's efforts to narrow the digital divide in low-income communities served by HUD. Specifically, HUD proposes to require installation of broadband infrastructure at the time of new construction or substantial rehabilitation of multifamily rental housing that is funded by HUD. As noted in the Executive Summary, the costs and benefits of this proposed rule are difficult to quantify, but they can be described qualitatively.
The evidence demonstrating the benefits of narrowing the digital divide is well documented. In just one example, a study conducted by a former Chair of the President's Council of Economic Advisers used data on the amount of time Internet users spend online to estimate that Internet access produces thousands of dollars of consumer surplus per user each year.
HUD recognizes that the proposed rule's limited scope in only requiring the installation of infrastructure, instead of providing Internet access, also limits the benefits of the proposed rule. Specifically, the benefit of the proposed rule is that where broadband Internet can be made available at a limited price, the tenant, residing in housing with broadband infrastructure, will be assured of the ability to access broadband Internet service, whether they choose and are able to afford Internet service or not. This proposed rule, therefore, would put broadband Internet service within reach where other charitable and public social programs, including HUD's ConnectHome program, provide free or reduced cost service.
It is not possible to specify the exact costs that recipients and owners may incur as a result of the proposed rule, given the variety of available technologies that may be used to satisfy the new broadband requirements. However, available data indicates that any costs associated with this proposed rule will be minimal.
As is displayed on table I, broadband Internet access can be provided using two general technologies: Wired and wireless, each with several specific technologies. Broadband can be delivered over wired lines using very-high-bit-rate digital subscriber lines (VDSL), cable lines, power lines (BPL), or fiber optic platforms. Using wireless technologies, broadband can be provided using satellite, fixed wireless, mobile wireless, and Wi-Fi platforms.
Whereas wired lines technologies may require some sort of physical infrastructure consisting of internal wiring within the dwelling unit, wireless technologies do not require any additional physical infrastructure within the building. With wireless technology, the signal travels through the air to the customer, who uses a connection technology, such as a modem, to access the services. For wireless technologies, the infrastructure cost to the property boundary (connection to the service provider) is nil ($0). However, the availability of wireless broadband service is limited and evolving, so HUD expects many builders will opt to install wired broadband infrastructure.
Building costs of installing wired infrastructure are limited to in-dwelling wiring, as this is all that is required by the proposed rule. Within the unit or the building, the electrical work consists of running cable (meeting the requirements of category (Cat) 5e or Cat 6 wire), installing jacks and plates, and minor construction work (such as drilling and patching walls). Fiber optic cables are rarely run in the dwelling unit but are installed by the service provider outside the unit; the non-fiber optic wiring then makes broadband accessible within the unit. Depending on the market, some of the cost is also born by the service provider.
The average per-unit cost for wiring for broadband Internet is approximately $200
HUD also notes that the proposed rule is drafted so as to minimize the costs of the new installation requirements. For example, the proposed rule does not mandate any rehabilitation or construction, and the decision to undertake such activities appropriately remains with recipients and owners. Rather, the scope of the proposed regulatory changes is limited to requiring the installation of broadband infrastructure if the recipient or owner elects to undertake new construction or substantial rehabilitation. The proposed rule minimizes the economic impacts on recipients and owners by recognizing that the installation of broadband infrastructure is generally less burdensome and costly at the time of new construction or substantial rehabilitation than when such installation is undertaken as a stand-alone effort.
Moreover, this proposed rule only requires the installation of broadband infrastructure that is “accessible” in each unit. The proposed rule does not require recipients or owners to provide a regular subscription to broadband Internet service (even at a cost) to residents. Also minimizing the economic costs of the proposed regulatory changes is the fact that the proposed definition of broadband infrastructure is broad enough to include cable television, fiber optic cabling, and wireless infrastructure providing appropriate broadband connectivity to the individual units. As discussed above in this Executive Summary, multifamily HUD or standard- market new construction typically provides telephone landline and cable TV connectivity. Further, HUD's competitive grants for new construction under the Choice Neighborhoods program have, in recent years, sought the provision of broadband.
A review of HUD internal databases, summarized on table III, shows that in 2013, the 58,677 units within the targeted programs were newly constructed or rehabilitated. However, HUD's data did not contain specific information to be able to determine how many of the units that underwent rehabilitation met the definition of “substantial rehabilitation” contained in the proposed rule, so the number of
Further, a review found that multifamily (5-plus unit) HUD or standard-market new construction typically provides telephone landline and many provide cable TV connectivity.
Accordingly, most recipients and owners already meet the standards established in the proposed rule, and the new regulatory requirements will impose minimal, if any, new economic costs. HUD has addressed those rare situations where the proposed new requirements may prove too costly by granting exceptions to the installation requirements where the installation is economically infeasible due to location or building characteristics.
The docket file is available for public inspection in the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street SW., Room 10276, Washington, DC 20410-0500. Due to security measures at the HUD Headquarters building, please schedule an appointment to review the docket file by calling the Regulation Division at 202-708-3055 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number via TTY by calling the Federal Relay Service at 800-877-8339 (this is a toll-free number).
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601
The proposed rule would provide that for new construction or substantial rehabilitation of multifamily rental housing funded by HUD, as part of the new construction or substantial rehabilitation to be undertaken, such activity must include installation of broadband infrastructure. None of the HUD-covered programs listed in this proposed rule require a grantee to undertake new construction or substantial rehabilitation. Instead, new construction and substantial rehabilitation are eligible activities that grantees may take using HUD funds. Therefore, small entities will not incur any costs than they otherwise would incur by voluntarily undertaking new construction or substantial rehabilitation, since the costs of these activities, including the installation of broadband infrastructure, are funded by HUD. For these reasons, this proposed rule will not have a significant economic impact on a substantial number of small entities.
Notwithstanding HUD's determination that this proposed rule will not have a significant economic effect on a substantial number of small entities, HUD specifically invites comments regarding any less burdensome alternatives to this proposed rule that will meet HUD's objectives, as described in this preamble.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. This proposed rule will not impose any Federal mandates on any State, local, or tribal governments or the private sector within the meaning of the UMRA.
The information collection requirements contained in this proposed rule must be submitted to OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) for review and approval. In accordance with the Paperwork Reduction Act, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection displays a currently valid OMB control number.
The burden of the information collections in this proposed rule is estimated to be minimal. The reporting of new construction or substantial rehabilitation activity under the programs covered by this proposed rule is not increased through the installation of broadband infrastructure. However, the information collection that is new is the documentation required of the grantee that the location of proposed new construction makes installation of broadband infrastructure infeasible, or that the cost of installing the infrastructure would result in a fundamental alteration in the nature of its program or activity or in an undue financial burden. The total number of grantees that undertake new construction or substantial rehabilitation, as defined in this proposed rule, with HUD funds is currently low, and this is reflected in the respondents.
In accordance with 5 CFR 1320.8(d)(1), HUD is soliciting comments from members of the public and affected agencies concerning this collection of information to:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
Interested persons are invited to submit comments regarding the information collection requirements in this proposed rule. Comments must refer to the proposal by name and docket number (FR-5890-P-01) and must be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503, Fax number: 202-395-6947, and Collette Pollard, Reports Liaison Officer, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410.
A Finding of No Significant Impact (FONSI) with respect to the environment has been made in accordance with HUD regulations in 24 CFR part 50 that implement section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)). The FONSI is available for public inspection, during regular business hours, in the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street SW., Room 10276, Washington, DC 20410-0500, or online at
Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial direct compliance costs on State and local governments and is not required by statute, or the rule preempts State law, unless the agency meets the consultation and funding requirements of section 6 of the Executive order. This proposed rule does not have federalism implications and does not impose substantial direct compliance costs on State and local governments nor preempt State law within the meaning of the Executive order.
The Catalog of Federal Domestic Assistance numbers applicable to the programs that would be affected by this rule are: 14.218, 14.225, 14.228, 14.239, 14.241, 14.267, 14.850, 14.871, and 14.872.
Administrative practice and procedure, Aged, Claims, Crime, Government contracts, Grant programs-housing and community development, Individuals with disabilities, Intergovernmental relations, Loan programs-housing and community development, Low and moderate income housing, Mortgage insurance, Penalties, Pets, Public housing, Rent subsidies, Reporting and recordkeeping requirements, Social security, Unemployment compensation, Wages.
Administrative practice and procedure, Low and moderate income housing, Manufactured homes, Rent subsidies, Reporting and recordkeeping requirements.
Administrative practice and procedure, Grant programs-housing and community development, Low and moderate income housing, Manufactured homes, Rent subsidies, Reporting and recordkeeping requirements.
Administrative practice and procedure, American Samoa, Community development block grants, Grant programs-education, Grant programs-housing and community development, Guam, Indians, Loan programs-housing and community development, Low and moderate income housing, Northern Mariana Islands, Pacific Islands Trust Territory, Puerto Rico, Reporting and recordkeeping requirements, Student aid, Virgin Islands.
Community facilities, Grant programs-housing and community development, Grant programs-social programs, HIV/AIDS, Low and moderate income housing, Reporting and recordkeeping requirements.
Community development, Community facilities, Grant programs-housing and community development, Grant programs-social programs, Homeless, Reporting and recordkeeping requirements.
Grant programs-housing and community development, Rent subsidies, Reporting and recordkeeping requirements.
Grant programs-housing and community development, Rent subsidies, Reporting and recordkeeping requirements.
Grant programs-housing and community development, Rent subsidies, Reporting and recordkeeping requirements.
Grant programs-housing and community development, Rent subsidies, Reporting and recordkeeping requirements, Rural areas.
Grant programs-housing and community development, Lead poisoning, Rent subsidies, Reporting and recordkeeping requirements.
Aged, Grant programs-housing and community development, Individuals with disabilities, Loan programs-housing and community development, Rent subsidies, Reporting and recordkeeping requirements.
Grant programs-housing and community development, Public housing, Reporting and recordkeeping requirements.
Grant programs-housing and community development, Low and moderate income housing, Rent subsidies, Reporting and recordkeeping requirements.
Accordingly, for the reasons stated in the preamble, HUD proposes to amend 24 CFR parts 5, 92, 93, 570, 574, 578, 880, 881, 883, 884, 886, 891, 905, and 983 as follows:
42 U.S.C. 1437a, 1437c, 1437f, 1437n, 3535(d), Sec. 327, Pub. L. 109-115, 119 Stat. 2936, Sec. 607, Pub. L. 109-162, 119 Stat. 3051, E.O. 13279, and E.O. 13559.
(1) Significant work on the electrical system of the multifamily rental housing. “Significant work” means complete replacement of the electrical system or other work that is equal to or greater than 75 percent of the cost of replacing the entire electrical system. In the case of multifamily rental housing with multiple buildings with more than 4 units, “entire system” refers to the electrical system of the building undergoing rehabilitation; or
(2) Rehabilitation of the multifamily rental housing in which the estimated cost of the rehabilitation is equal to or greater than 75 percent of the total estimated cost of replacing the multifamily rental housing after the rehabilitation is complete. In the case of multifamily rental housing with multiple buildings with more than 4 units, the replacement cost must be the replacement cost of the building undergoing rehabilitation.
42 U.S.C. 3535(d) and 12701-12839.
(a) * * *
(2)
* * *
(vi)
(A) The location of the new construction makes installation of broadband infrastructure infeasible; or
(B) The cost of installing the infrastructure would result in a fundamental alteration in the nature of its program or activity or in an undue financial burden.
(b) * * *
(1) * * *
(x)
(A) The location of the substantial rehabilitation makes installation of broadband infrastructure infeasible;
(B) The cost of installing broadband infrastructure would result in a fundamental alteration in the nature of its program or activity or in an undue financial burden; or
(C) The structure of the housing to be substantially rehabilitated makes installation of broadband infrastructure infeasible.
42 U.S.C. 3535(d), 12 U.S.C. 4568.
(a) * * *
(2)
* * *
(vi)
(A) The location of the new construction makes installation of broadband infrastructure infeasible; or
(B) The cost of installing broadband infrastructure would result in a fundamental alteration in the nature of its program or activity or in an undue financial burden.
(b) * * *
(1) * * *
(x)
(A) The location of the substantial rehabilitation makes installation of broadband infrastructure infeasible;
(B) The cost of installing broadband infrastructure would result in a fundamental alteration in the nature of its program or activity or in an undue financial burden; or
(C) The structure of the housing to be substantially rehabilitated makes installation of broadband infrastructure infeasible.
42 U.S.C. 3535(d) and 5301-5320.
(g)
(1) The location of the substantial rehabilitation makes installation of broadband infrastructure infeasible;
(2) The cost of installing broadband infrastructure would result in a fundamental alteration in the nature of its program or activity or in an undue financial burden; or
(3) The structure of the housing to be substantially rehabilitated makes installation of broadband infrastructure infeasible.
(a) * * *
(5) Any new construction or substantial rehabilitation, as defined by 24 CFR 5.100, of a building with more than 4 rental units must include installation of broadband infrastructure, as this term is also defined in 24 CFR 5.100, except where the grantee documents that:
(i) The location of the new construction or substantial rehabilitation makes installation of broadband infrastructure infeasible;
(ii) The cost of installing broadband infrastructure would result in a fundamental alteration in the nature of its program or activity or in an undue financial burden; or
(iii) The structure of the housing to be substantially rehabilitated makes installation of broadband infrastructure infeasible.
(c) * * *
(4)
(i) The location of the new construction or substantial rehabilitation makes installation of broadband infrastructure infeasible;
(ii) The cost of installing broadband infrastructure would result in a fundamental alteration in the nature of its program or activity or in an undue financial burden; or
(iii) The structure of the housing to be substantially rehabilitated makes installation of broadband infrastructure infeasible.
42 U.S.C. 3535(d) and 12901-12912.
Any new construction or substantial rehabilitation, as substantial rehabilitation is defined by 24 CFR 574.3, of a building with more than 4 rental units must include installation of broadband infrastructure, as this term is defined in 24 CFR 5.100, except where the grantee documents that:
(1) The location of the new construction or substantial rehabilitation makes installation of broadband infrastructure infeasible;
(2) The cost of installing broadband infrastructure would result in a fundamental alteration in the nature of its program or activity or in an undue financial burden; or
(3) The structure of the housing to be substantially rehabilitated makes installation of broadband infrastructure infeasible.
42 U.S.C. 11371
(d)
(1) The location of the substantial rehabilitation makes installation of broadband infrastructure infeasible;
(2) The cost of installing broadband infrastructure would result in a fundamental alteration in the nature of its program or activity or in an undue financial burden; or
(3) The structure of the housing to be substantially rehabilitated makes installation of broadband infrastructure infeasible.
(c)
(1) The location of the new construction makes installation of broadband infrastructure infeasible; or
(2) The cost of installing broadband infrastructure would result in a fundamental alteration in the nature of its program or activity or in an undue financial burden.
42 U.S.C. 1437a, 1437c, 1437f, 3535(d), 12701, and 13611-13619.
Any new construction or substantial rehabilitation, as defined by 24 CFR 5.100, of a building with more than 4 rental units must include installation of broadband infrastructure, as this term is also defined in 24 CFR 5.100, except where the owner documents that:
(1) The location of the new construction or substantial rehabilitation makes installation of broadband infrastructure infeasible;
(2) The cost of installing broadband infrastructure would result in a fundamental alteration in the nature of its program or activity or in an undue financial burden; or
(3) The structure of the housing to be substantially rehabilitated makes installation of broadband infrastructure infeasible.
42 U.S.C. 1437a, 1437c, 1437f, 3535(d), 12701, and 13611-13619.
Any new construction or substantial rehabilitation, as defined by 24 CFR 5.100, of a building with more than 4 rental units must include installation of broadband infrastructure, as this term is also defined in 24 CFR 5.100, except where the owner documents that:
(1) The location of the new construction or substantial rehabilitation makes installation of broadband infrastructure infeasible;
(2) The cost of installing broadband infrastructure would result in a fundamental alteration in the nature of its program or activity or in an undue financial burden; or
(3) The structure of the housing to be substantially rehabilitated makes installation of broadband infrastructure infeasible.
42 U.S.C. 1437a, 1437c, 1437f, 3535(d), and 13611-13619.
Any new construction or substantial rehabilitation, as defined by 24 CFR 5.100, of a building with more than 4 rental units must include installation of broadband infrastructure, as this term is also defined in 24 CFR 5.100, except where the owner documents that:
(1) The location of the new construction or substantial rehabilitation makes installation of broadband infrastructure infeasible;
(2) The cost of installing broadband infrastructure would result in a fundamental alteration in the nature of its program or activity or in an undue financial burden; or
(3) The structure of the housing to be substantially rehabilitated makes installation of broadband infrastructure infeasible.
42 U.S.C. 1437a, 1437c, 1437f, 3535(d), and 13611-13619.
Any new construction or substantial rehabilitation, as defined by 24 CFR 5.100, of a building with more than 4 rental units must include installation of broadband infrastructure, as this term is also defined in 24 CFR 5.100, except where the owner documents that:
(1) The location of the new construction or substantial rehabilitation makes installation of broadband infrastructure infeasible;
(2) The cost of installing broadband infrastructure would result in a fundamental alteration in the nature of its program or activity or in an undue financial burden; or
(3) The structure of the housing to be substantially rehabilitated makes installation of broadband infrastructure infeasible.
42 U.S.C. 1437a, 1437c, 1437f, 3535(d), and 13611-13619.
Any new construction or substantial rehabilitation, as defined by 24 CFR 5.100, of a building with more than 4 rental units must include installation of broadband infrastructure, as this term is also defined in 24 CFR 5.100, except where the owner documents that:
(1) The location of the new construction or substantial rehabilitation makes installation of broadband infrastructure infeasible;
(2) The cost of installing broadband infrastructure would result in a fundamental alteration in the nature of its program or activity or in an undue financial burden; or
(3) The structure of the housing to be substantially rehabilitated makes installation of broadband infrastructure infeasible.
Any new construction or substantial rehabilitation, as defined by 24 CFR 5.100, of a building with more than 4 rental units must include installation of broadband infrastructure, as this term is also defined in 24 CFR 5.100, except where the owner documents that:
(1) The location of the new construction or substantial rehabilitation makes installation of broadband infrastructure infeasible;
(2) The cost of installing broadband infrastructure would result in a fundamental alteration in the nature of its program or activity or in an undue financial burden; or
(3) The structure of the housing to be substantially rehabilitated makes installation of broadband infrastructure infeasible.
12 U.S.C. 1701q; 42 U.S.C. 1437f, 3535(d), and 8013.
(f)
(1) The location of the new construction or substantial rehabilitation makes installation of broadband infrastructure infeasible;
(2) The cost of installing broadband infrastructure would result in a fundamental alteration in the nature of its program or activity or in an undue financial burden; or
(3) The structure of the housing to be substantially rehabilitated makes installation of broadband infrastructure infeasible.
Any new construction or substantial rehabilitation, as defined by 24 CFR 5.100, of a building with more than 4 rental units must include installation of broadband infrastructure, as this term is also defined in 24 CFR 5.100, except where the owner documents that:
(1) The location of the new construction or substantial rehabilitation makes installation of broadband infrastructure infeasible;
(2) The cost of installing broadband infrastructure would result in a fundamental alteration in the nature of its program or activity or in an undue financial burden; or
(3) The structure of the housing to be substantially rehabilitated makes installation of broadband infrastructure infeasible.
42 U.S.C. 1437g, 42 U.S.C. 1437z-2, 42 U.S.C. 1437z-7, and 3535(d).
(e)
(1) The location of the new construction or substantial rehabilitation makes installation of broadband infrastructure infeasible;
(2) The cost of installing broadband infrastructure would result in a fundamental alteration in the nature of its program or activity or in an undue financial burden; or
(3) The structure of the housing to be rehabilitated makes installation of broadband infrastructure infeasible.
42 U.S.C. 1437f and 3535(d).
Any new construction or substantial rehabilitation, as defined by 24 CFR 5.100, of a building with more than 4 rental units must include installation of broadband infrastructure, as this term is also defined in 24 CFR 5.100, except where the owner documents that:
(1) The location of the new construction or substantial rehabilitation makes installation of broadband infrastructure infeasible;
(2) The cost of installing broadband infrastructure would result in a fundamental alteration in the nature of its program or activity or in an undue financial burden; or
(3) The structure of the housing to be substantially rehabilitated makes installation of broadband infrastructure infeasible.
Office of the Assistant Secretary for Community Planning and Development, Department of Housing and Urban Development.
Proposed rule.
HUD's Consolidated Plan is a planning mechanism designed to help States and local governments to assess their affordable housing and community development needs and to make data-driven, place-based investment decisions. The consolidated planning process serves as the framework for a community-wide dialogue to identify housing and community development priorities that align and focus funding from HUD's formula block grant programs. This proposed rule would amend HUD's Consolidated Plan regulations to require that jurisdictions consider two additional concepts in their planning efforts.
The first concept is how to address the need for broadband access for low- and moderate-income residents in the communities they serve. Broadband is the common term used to refer to a high-speed, always on connection to the Internet. Such connection is also referred to as high-speed broadband or high-speed Internet. Specifically, the proposed rule would require that States and localities that submit a consolidated plan describe the broadband access in housing occupied by low- and moderate-income households. If low-income residents in the communities do not have such access, States and jurisdictions must consider providing broadband access to these residents into their decisions on how to invest HUD funds. The second concept to be added to the Consolidated Plan process would require jurisdictions to consider incorporating resilience to natural hazard risks, taking care to anticipate how risks will increase due to climate change, into development of the Plan in order to begin addressing impacts of climate change on low- and moderate-income residents.
Interested persons are invited to submit comments responsive to this proposed rule to the Office of General Counsel, Regulations Division, Department of Housing and Urban Development, 451 7th Street SW., Room 10276, Washington, DC 20410-0001. All submissions should refer to the above docket number and title. Submission of public comments may be carried out by hard copy or electronic submission.
1.
2.
Lora Routt, Senior Advisor, Office of Community Planning and Development, Department of Housing and Urban Development, Office of Community Planning and Development, 451 7th Street SW., Suite 7204, Washington, DC 20410 at 202-402-4492, (this is not a toll-free number). Individuals with speech or hearing impairments may access this number via TTY by calling the Federal Relay Service, toll-free, at 800-877-8339.
Persons with hearing or speech impairments may access this number through TTY by calling the Federal Relay Service at 800-877-8339 (this is a toll-free number).
The purpose of this proposed rule is to require States and local governments to evaluate the availability of broadband access and the vulnerability of housing occupied by low- and moderate income households to natural hazard risks, many of which may be increasing due to climate change, in their consolidated planning efforts. These evaluations will be conducted using readily available data sources developed by Federal government agencies and other available data and analyses, including State, Tribal, and local hazard mitigation plans that have been approved by the Federal Emergency Management Agency (FEMA). Where access to broadband Internet service is not currently available or is minimally available (such as in certain rural areas), States and local governments must consider ways to bring broadband Internet access to low- and moderate-income residents, including how HUD funds could be used to narrow the digital divide for these residents. Further, where low- and moderate-income communities are at risk of natural hazards, including those that are expected to increase due to climate change, States and local governments must consider ways to incorporate appropriate hazard mitigation and resilience into their community planning and development goals, codes, and standards, including the use of HUD funds. These two planning considerations reflect emerging needs of communities in this changing world. Broadband access provides access to a wide range of resources, services, and products and such access not only can assist individuals in improving their economic outlook, but also assists communities in this same way. Analysis of natural hazards, including the anticipated effects of climate change on those hazards, is important to help ensure that jurisdictions are aware of existing and developing vulnerabilities in the geographic areas that they serve that can threaten the health and safety of the populations they serve.
The current regulations require that local governments and States consult public and private agencies that provide assisted housing, health services, and social and fair housing services during preparation of the consolidated plan. Under the current regulations, local governments and States are also required in their citizen participation plan to encourage the participation of local and regional institutions and businesses in the process of developing and implementing their consolidated plans. The proposed rule would require States and local governments, in preparing their consolidated plans, to add to the list of public and private agencies and entities that they now must consult with for preparation of their plans, to consult with public and private organizations, including broadband Internet service providers, organizations engaged in narrowing the digital divide (
The proposed rule would also require jurisdictions to describe broadband access in housing occupied by low- and moderate-income households based on an analysis of data for its low- and moderate-income neighborhoods in the National Broadband Map
The proposed rule would also require that jurisdictions provide, as part of their required housing market analysis, an assessment of natural hazard risks, including risks expected to increase due to climate change, to low- and moderate-income residents based on an analysis of data, findings, and methods in (1) the most recent National Climate
HUD's Consolidated Plan process, established by regulation in 1994, provides a comprehensive planning process for HUD programs administered by HUD's Office of Community Planning and Development, specifically the Community Development Block Grant (CDBG) program, the HOME Investment Partnerships (HOME) program, Emergency Solutions Grants (ESG) program and the Housing with Opportunities for Persons With AIDS (HOPWA). Comprehensive community planning provides officials with an informative profile of their communities in terms of population, housing, economic base, community facilities, and transportation systems, and such information aids officials in their investment decisions. HUD's Consolidated Planning process assists State and local officials that are recipients of HUD funds under the above-listed programs in determining the housing and community development needs of their respective communities. Requiring consolidated plan jurisdictions to consider the broadband and natural hazard resilience needs of their communities helps to ensure a more complete profile of the needs of their communities. As discussed in this preamble, the importance of providing broadband access to all cannot be overstated. Broadband access is not only important to increasing opportunity for an individual's success, but to the success of a community. Consideration of the impact of natural hazard risks, many of which are anticipated to increase due to climate change, in one's community, and how communities can help mitigate any such adverse impacts, is equally important as it will help to guide the best use of land and orderly and sustainable growth. In brief, the benefits of this proposed rule are to promote a balanced planning process that more fully considers the housing, environmental, and economic needs of communities.
HUD does not anticipate that the costs of the revised consultation and reporting requirements will be significant since the regulatory changes proposed by this proposed rule merely build upon similar existing requirements for other elements covered by the consolidated planning process rather than mandating completely new procedures. Further, the required assessments will be based on data readily available on the Internet. Therefore, jurisdictions will not have to incur the expense and administrative burdens associated with collecting data. Moreover, this proposed rule does not mandate that actions be taken to address broadband needs or climate change adaptation needs. Consolidated plan jurisdictions are in the best position to decide how to expend their HUD funds. However, HUD believes that the additional analyses required by this rule may highlight areas where expenditure of funds would assist in opening up economic opportunities through increased broadband access or mitigate the impact of possible natural hazards, including those that may be exacerbated due to climate change. HUD leaves it to jurisdictions to consider any appropriate methods to promote broadband access or protect against the adverse impacts of climate change, taking into account the other needs of their communities, and available funding, as identified through the consolidated planning process.
On March 23, 2015, President Obama issued a Presidential Memorandum on “Expanding Broadband Deployment and Adoption by Addressing Regulatory Barriers and Encouraging Investment and Training.”
The memorandum established an interagency Broadband Opportunity Council, including representatives from the Executive Branch agencies, for the purposes of consulting with State, local, tribal, and territorial governments, as well as telecommunications companies, utilities, trade associations, philanthropic entities, policy experts, and other interested parties to identify and assess regulatory barriers and opportunities to broadband adoption. The council's report, published by the White House on September 21, 2015, included a number of specific actions that agencies (including HUD) agreed to take to promote greater broadband deployment and adoption. This change to the Consolidated Planning process is one of those actions.
On July 15, 2015, HUD launched its Digital Opportunity Demonstration, known as “ConnectHome,” in which HUD provided a platform for collaboration among local governments, public housing agencies, Internet service providers, philanthropic foundations, nonprofit organizations and other relevant stakeholders to work together to produce local solutions for narrowing the digital divide in communities across the nation served by HUD.
On March 9, 2016, President Obama launched the ConnectALL initiative to ensure that more Americans have the broadband they need to get a job, engage their community, and deliver opportunity to their children.
The importance of all Americans having access to the Internet cannot be overstated. As HUD stated in its announcement of the Digital Opportunity Demonstration, published in the
On November 1, 2013, President Obama signed Executive Order 13653, on “Preparing the United States for the Impacts of Climate Change.”
Section 7 of Executive Order 13653 established the President's State, Local, and Tribal Leaders Task Force on Climate Change Resilience and Preparedness (Task Force). Co-chaired by the Chair of the White House Council on Environmental Quality and the Director of the White House Office of Intergovernmental Affairs, the Task Force consisted of 26 governors, mayors, county officials, and Tribal leaders from across the United States. Members brought first-hand experiences in building climate preparedness and resilience in their communities and conducted broad outreach to thousands of government agencies, trade associations, planning agencies, academic institutions, and other stakeholders, to inform their recommendations to the Administration.
The President charged the Task Force with providing recommendations on how the Federal government can respond to the needs of communities nationwide that are dealing with the impacts of climate change by removing barriers to resilient investments, modernizing Federal grant and loan programs to better support local efforts, and developing the information and tools they need to prepare, among other measures. In November 2014, Task Force members presented their recommendations for the President at a White House meeting with Vice President Biden and other senior Administration officials.
HUD's consolidated planning process serves as the framework for a community-wide dialogue to identify housing and community development priorities that align and focus funding from the HUD formula block grant programs: Community Development Block Grant (CDBG) program, HOME Investment Partnerships (HOME) program, Emergency Solutions Grant (ESG) program, and Housing Opportunities for Persons With AIDS (HOPWA) program. HUD's regulations for the consolidated planning are codified at 24 CFR part 91(entitled “Consolidated Submissions for Community Planning and Development Programs”).
The Consolidated Plan, which may have a planning duration of between 3 and 5 years, is designed to help States and local governments assess their affordable housing and community development needs, in the context of market conditions at the time of their planning, and to make data-driven, place-based decisions on how to expend HUD funds in their jurisdictions. In developing their consolidated plans, States and local governments are required to engage their communities, both in the process of developing and reviewing the proposed plan, and as partners and stakeholders in the implementation of the plan. By consulting and collaborating with other public and private entities, States and local governments can better align and
The regulatory amendments proposed by this rule would require States and local governments to consider broadband access and natural hazard resilience as part of their consolidated planning efforts. As provided in this proposed rule, States and local governments will need to consider the broadband needs of their low- and moderate-income residents, and the extent that available broadband Internet service providers and technology support these residents' broadband access needs. Where the required analysis demonstrates that such support is not currently available or is minimally available, States and local governments should consider ways to bring broadband Internet access to these residents, such as the extent to which broadband Internet service providers could be solicited to contribute to the broadband access needs of low-income residents, or how HUD funds could be used to narrow the digital divide for low- and moderate-income residents.
Further, where the required analysis demonstrates that low- and moderate-income communities are at risk of natural hazards, including those that may be exacerbated due to climate change, States and local governments should consider ways to incorporate hazard mitigation and resilience into their community planning and development goals, development codes, and standards, including how HUD funds could be used to mitigate natural hazard risks, including increasing risks due to climate change, with other Federal, State, local, philanthropic, and private sector funding. In this regard, President Obama's Administration is committed to giving communities across the United States the information and tools they need to plan for current and future climate change impacts, such as flooding and sea-level rise. In March 2014, the Administration launched the Climate Data Initiative, an effort to make vast Federal data resources on climate change risks and impacts openly available to the public.
This proposed rule is one part of a broader set of Administration and HUD initiatives to narrow the digital divide and enhance climate resilience in low-income communities. Given the focus of the consolidated plan on housing needs, the assessments required by the proposed rule are limited to broadband access in housing and the vulnerability of housing to natural hazard risks. HUD, however, is cognizant of the critical non-housing needs of low-income communities. The adoption of broadband, which includes digital literacy by low-income residents is an equally critical component of closing the digital divide. Likewise, the evaluation of vulnerability to natural hazard risks on a broader, community-wide, level is an equally significant component of ensuring the resilience of low-income households. Under 24 CFR 91.215 (for local governments) and 24 CFR 92.315 (for States), jurisdictions must provide a description of priority non-housing community development needs eligible for assistance under HUD's community development programs. Given the importance of broadband adoption to communities and the goals of this rulemaking, HUD strongly encourages jurisdictions to consider implementing such actions in their non-housing community development efforts. Similarly, HUD strongly encourages jurisdictions to consider the use of block grant funds for actions that enhance the resilience of communities to natural hazard risks as a whole. To this end, jurisdictions should consider basing such actions on the FEMA-approved State, Tribal, and local hazard mitigation plans that may be used to conduct the housing-specific assessments required by the proposed rule.
In addition, HUD continues to encourage regional planning considerations, and maintains the requirement for local governments and States to, in their citizen participation plan, encourage the participation of local and regional institutions and businesses in the process of developing and implementing their consolidated plans.
The proposed rule would make the following changes to the Consolidated Plan regulations:
1.
2.
Second, the jurisdiction must also describe broadband needs in housing occupied by low- and moderate-income households based on an analysis of data for its low- and moderate-income
Third, the proposed rule would also require the jurisdiction to provide an assessment of natural hazard risk to low- and moderate-income residents based on an analysis of data, findings and methods in (1) the most recent National Climate Assessment, the Climate Resilience Toolkit, the Impact of Climate Change and Population Growth on the National Flood Insurance Program Through 2100, or the Community Resilience Planning Guide for Buildings and Infrastructure Systems prepared by the National Institute of Standards and Technology (NIST); (2) other climate risk-related data published by the Federal government or other State or local government climate risk related data, including FEMA-approved hazard mitigation plans which incorporate climate change; or (3) other climate risk data identified by the jurisdiction, for which the source is cited in the jurisdiction's Consolidated Plan.
The National Climate Assessment, located at
The Climate Resilience Toolkit, located at
FEMA sponsored the report on Impact of Climate Change and Population Growth on the National Flood Insurance Program (available at
The National Institute of Standards and Technology's (NIST) Community Resilience Planning Guide for Buildings and Infrastructure Systems, located at
By undertaking these two analyses as part of their consolidated planning, HUD believes that jurisdictions become better informed of two emerging community needs in the world today: (1) The importance of broadband access, which opens up opportunity to a wide range of services, markets, jobs, educational, cultural and recreational opportunities; and (2) the importance of being cognizant and prepared for environmental and geographical conditions that may threaten the health and safety of communities. As noted earlier in this preamble, HUD is not mandating that jurisdictions take actions in either of these areas, but HUD believes that these are two areas that must be taken into consideration in a jurisdiction's planning for its expenditure of HUD funds.
Under Executive Order 12866 (Regulatory Planning and Review), a determination must be made whether a regulatory action is significant and therefore, subject to review by the Office of Management and Budget (OMB) in accordance with the requirements of the order. Executive Order 13563 (Improving Regulations and Regulatory Review) directs executive agencies to analyze regulations that are “outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned. Executive Order 13563 also directs that, where relevant, feasible, and consistent with regulatory objectives, and to the extent permitted by law, agencies are to identify and consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public. This rule was determined to be a “significant regulatory action” as defined in section 3(f) of Executive Order (although not an economically significant regulatory action, as provided under section 3(f)(1) of the Executive Order).
As noted in this preamble, the proposed regulatory amendments are designed to assist Consolidated Plan jurisdictions assess two emerging needs of communities in this changing world. Specifically, the proposed rule will direct States and local governments to consider broadband access and natural hazard resilience in their consolidated planning efforts by using readily available online data sources. Where access to broadband Internet service is either not currently available or only minimally available, jurisdictions will be required to consider ways to bring broadband Internet access to low- and moderate-income residents, including how HUD funds could be used to narrow the digital divide for these residents. Further, where low- and moderate-income communities are at risk of natural hazards, including those that may be exacerbated due to climate change, States and local governments must consider ways to incorporate hazard mitigation and resilience into their community planning and development goals, including the use of HUD funds.
The Consolidated Planning process benefits jurisdictions by establishing the framework for a community-wide dialogue to identify housing and community development needs for over a thousand communities across the Nation.
New housing and community development needs have arisen in the 21 years since the Consolidated Plan was created. As noted in this preamble, two of the most pressing emerging needs facing communities in the twenty-first century are the digital divide and climate change:
• In a recent analysis, the President's Council of Economic Advisers (CEA) noted that the benefits of broadband Internet technology have not been evenly distributed.
• As President Obama has noted, climate change is happening now; it is not a distant threat. Its effects are already being felt in communities across the Nation. In some regions, droughts, wildfires, and floods are becoming more frequent and/or intense.
Despite the benefits described above of a comprehensive approach to planning and the allocation of scarce Federal dollars, jurisdictions are not currently required to consider either the digital divide or climate change resilience in development of their Consolidated Plans. Jurisdictions may therefore place a low priority on assessing, and using Federal dollars to address, these critical issues than on other needs included in the Consolidated Plan. As a worst case scenario, it could mean that communities elect to defer considering these needs.
The direct benefits provided by the proposed rule are, therefore, to help ensure that Consolidated Plan jurisdictions consider broadband access and natural hazard resilience as part of their comprehensive assessment and planning efforts, including the most effective use of HUD grant funds. The CEA broadband analysis discussed above noted that closing the digital divide can increase productivity and open ladders of opportunity. Likewise, community investment in natural hazard resilience may help to insure security and quality of life against the rising environmental tolls associated with climate change.
HUD does not anticipate that the costs of the revised consultation and reporting requirements will be substantial since the regulatory changes proposed by this proposed rule merely build upon similar existing requirements for other elements covered by the consolidated planning process rather than mandating completely new procedures. The economic costs of completing the Consolidated Plan are not significant. A complete Consolidated Plan that contains both a Strategic Plan and Annual Action Plan is submitted once every 3 to 5 years. An Annual Action Plan is submitted once a year. HUD data indicate that the cost of preparing the Strategic Plan for a locality is $5,236, and for a State is $14,382. The cost of preparing the Annual Action Plan is $1,904 for a locality and $6,392 for each State. While these are not trivial amounts, they are not substantial when considered in proportion to HUD grant funding (for example, the average CDBG grant to entitlement communities in FY 2012 was approximately $1.7 million).
HUD does not anticipate the proposed regulatory changes will add much, if anything, to these costs. As noted above, the required assessments will be based on data that are already readily available on the Internet. Therefore, jurisdictions will not have to incur the expense and administrative burdens associated with collecting data. Moreover, the proposed rule does not mandate that actions be taken to address broadband needs or climate change needs. Consolidated plan jurisdictions are in the best position to decide how to expend their HUD funds. However, HUD believes that the additional analyses required by this proposed rule may highlight areas where expenditure of funds would assist in opening up economic opportunities through increased broadband access or mitigate the impact of possible natural hazard risks and climate change impacts. HUD leaves it to jurisdictions to consider any appropriate methods to promote broadband access or protect against the adverse impacts of climate change, taking into account the other needs of their communities, and available funding, as identified through the consolidated planning process.
Accordingly, HUD believes that the benefits of enhancing the ability of State and local government to comprehensively plan for housing and community development needs outweigh the minimal costs that may be associated with the revised Consolidated Plan requirements. The docket file is available for public inspection in the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street SW., Room 10276, Washington, DC 20410-0500. Due to security measures at the HUD Headquarters building, please schedule an appointment to review the docket file by calling the Regulation Division at 202-402-3055 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number via TTY by calling the Federal Relay Service at 800-877-8339.
The information collection requirements contained in this rule have been submitted to the Office of
The burden of the information collections in this rule is estimated as follows:
In accordance with 5 CFR 1320.8(d)(1), HUD is soliciting from members of the public and affected agencies comments on the following concerning this collection of information:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology;
Interested persons are invited to submit comments regarding the information collection requirements in this rule. Under the provisions of 5 CFR part 1320, OMB is required to make a decision concerning this collection of information between 30 and 60 days after the publication date. Therefore, a comment on the information collection requirements is best assured of having its full effect if OMB receives the comment within 30 days of the publication. This time frame does not affect the deadline for comments to the agency on the proposed rule, however. Comments must refer to the proposal by name and docket number (5891-P-01) and must be sent to:
Interested persons may submit comments regarding the information collection requirements electronically through the Federal eRulemaking Portal at
The Regulatory Flexibility Act (5 U.S.C. 601
As noted above in this preamble, the proposed regulatory amendment will impose minimal, if any, economic burdens on HUD grantees, irrespective of their size. The proposed rule will amend the Consolidated Plan regulations to require that States and local governments consider (1) broadband Internet service access for low- and moderate-income households to; and (2) the risk of potential natural hazards, including those that may be exacerbated due to climate change, to low- and moderate-income residents in their jurisdictions. The regulatory changes build upon their existing consolidated planning process rather than mandating completely new procedures. As discussed above, the economic costs of preparing the Consolidated Plan are not significant, and it is unlikely that the proposed changes will increase those costs since the required assessments will be mostly based on data that has already been compiled and readily available on the Internet. Jurisdictions will, therefore, not have to incur the expense and administrative burdens associated with collecting and analyzing data.
Moreover, the proposed rule does not mandate that any actions be taken in response to the required assessments. Where access to broadband Internet service is not currently available or is minimally available, States and local governments must consider ways to bring broadband Internet access to low- and moderate-income residents, including how HUD funds could be used to narrow the digital divide for these residents. Further, where low- and moderate-income communities are at risk of natural hazards, including those that may be exacerbated due to climate change, States and local governments must consider ways to incorporate hazard mitigation and resilience into their community planning and development goals, including the use of HUD funds. However, jurisdictions retain the discretion to consider the most appropriate methods to address their assessments, taking into account other needs identified as part of the consolidated planning process as well as financial and other resource constraints. This proposed rule therefore, which only requires consideration of the broadband and
Notwithstanding HUD's determination that this proposed rule will not have a significant economic effect on a substantial number of small entities, HUD specifically invites comments regarding any less burdensome alternatives to this rule that will meet HUD's objectives, as described in this preamble.
This proposed rule does not direct, provide for assistance or loan and mortgage insurance for, or otherwise govern, or regulate, real property acquisition, disposition, leasing, rehabilitation, alteration, demolition, or new construction, or establish, revise or provide for standards for construction or construction materials, manufactured housing, or occupancy. Accordingly, under 24 CFR 50.19(c)(1), this proposed rule is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).
Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any rule that has federalism implications if the rule imposes either substantial direct compliance costs on state and local governments and is not required by statute, or the rule preempts state law, unless the agency meets the consultation and funding requirements of section 6 of the Executive Order. This proposed rule would not have federalism implications and would not impose substantial direct compliance costs on state and local governments or preempt state law within the meaning of the Executive Order.
Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) (UMRA) establishes requirements for federal agencies to assess the effects of their regulatory actions on state, local, and tribal governments, and on the private sector. This proposed rule would not impose any federal mandates on any state, local, or tribal governments, or on the private sector, within the meaning of the UMRA.
Aged, Grant programs—housing and community development, Homeless, Individuals with disabilities, Low- and moderate-income housing, Reporting and recordkeeping requirements.
For the reasons discussed in the preamble, HUD proposes to amend part 91 as follows:
42 U.S.C. 3535(d), 3601-3619, 5301-5315, 11331-11388, 12701-12711, 12741-12756, and 12901-12912.
(a) * * *
(1) * * * When preparing the consolidated plan, the jurisdiction shall also consult with public and private organizations, including broadband Internet service providers, organizations engaged in narrowing the digital divide, agencies whose primary responsibilities include the management of floodprone areas, public land or water resources, and emergency management agencies.
(a) * * *
(2) * * *
(ii) * * * The jurisdiction shall encourage the participation of public and private organizations, including broadband Internet service providers, organizations engaged in narrowing the digital divide, agencies whose primary responsibilities include the management of floodprone areas, public land or water resources, and emergency management agencies in the process of developing the consolidated plan.
(a) * * * When preparing the consolidated plan, the State shall also consult with public and private organizations, including broadband Internet service providers, organizations engaged in narrowing the digital divide, agencies whose primary responsibilities include the management of floodprone areas, public land or water resources, and emergency management agencies.
(a) * * *
(2) * * *
(ii) * * * The State shall also encourage the participation of public and private organizations, including broadband Internet service providers, organizations engaged in narrowing the digital divide, agencies whose primary responsibilities include the management of floodprone areas, public land or water resources, and emergency management agencies in the process of developing the consolidated plan.
(b) * * *
(3) * * *
(iv) Public and private organizations, including broadband Internet service providers and organizations engaged in narrowing the digital divide;
(v) Agencies whose primary responsibilities include the management of floodprone areas, public land or water resources, and emergency management agencies; and
(a)
(2) Data on the housing market should include, to the extent information is available, an estimate of the number of vacant or abandoned buildings and whether units in these buildings are suitable for rehabilitation.
(3) The jurisdiction must also identify and describe any areas within the jurisdiction with concentrations of racial/ethnic minorities and/or low-income families, stating how it defines the terms “area of low-income concentration” and “area of minority concentration” for this purpose. The locations and degree of these
(4) The jurisdiction must also describe the broadband needs of housing occupied by low- and moderate-income households based on an analysis of data for its low- and moderate-income neighborhoods in the National Broadband Map. Jurisdictions may also use broadband availability data in the FCC Form 477 or other data identified by the jurisdiction, for which the source is cited in the jurisdiction's Consolidated Plan. These needs include the need for broadband wiring and for connection to the broadband service in the household units, the need for increased competition by having more than one broadband Internet service provider serve the jurisdiction.
(5) The jurisdiction must also describe the vulnerability of housing occupied by low- and moderate-income households to increased natural hazard risks associated with climate change based on an analysis of data, findings, and methods in:
(i) The National Climate Assessment, the Climate Resilience Toolkit, the Impact of Climate Change and Population Growth on the National Flood Insurance Program, or the NIST Community Resilience Planning Guide for Buildings and Infrastructure Systems;
(ii) Other climate risk-related data published by the Federal government or other State or local government climate risk-related data, including hazard mitigation plans approved by the Federal Emergency Management Agency that incorporate climate change; or
(iii) Other climate risk data identified by the jurisdiction, for which the source is cited in the jurisdiction's Consolidated Plan.
(b) * * *
(3) * * *
(iv) Public and private organizations, including broadband Internet service providers and organizations engaged in narrowing the digital divide;
(v) Agencies whose primary responsibilities include the management of floodprone areas, public land or water resources, and emergency management agencies; and
(a)
(2) The State must describe the broadband needs of housing in the State based on an analysis of data in the National Broadband Map. States may also use broadband availability data in the FCC Form 477 or other data identified by the jurisdiction, for which the source is cited in the jurisdiction's Consolidated Plan. These needs include the need for broadband wiring and for connection to the broadband service in the household units, the need for increased competition by having more than one broadband Internet service provider serve the jurisdiction.
(3) The State must also describe the vulnerability of housing occupied by low- and moderate-income households to increased natural hazard risks due to climate change based on an analysis of data, findings, and methods in:
(i) The National Climate Assessment, the Climate Resilience Toolkit, the Impact of Climate Change and Population Growth on the National Flood Insurance Program, or the NIST Community Resilience Planning Guide for Buildings and Infrastructure Systems;
(ii) Other climate risk-related data published by the Federal government or other State or local government climate risk-related data, including hazard mitigation plans approved by the Federal Emergency Management Agency that incorporate climate change; or
(iii) Other climate risk data identified by the jurisdiction, for which the source is cited in the jurisdiction's Consolidated Plan.
Office of the Assistant Secretary for Public and Indian Housing, HUD.
Proposed rule; correction.
On May 9, 2016, HUD published a proposed rule that would revise regulations for HUD's Native American and Native Hawaiian programs to incorporate existing rules that require HUD programs to be open to all eligible individuals and families regardless of sexual orientation, gender identity, or marital status. After publication, HUD discovered an inadvertent mistake in the preamble to the document. The preamble contained incomplete information in the
This document corrects the proposed rule published on May 9, 2016 (81 FR 28037). The comment due date for that proposed rule remains unchanged as July 8, 2016.
With respect to this supplementary document, contact Camille E. Acevedo, Associate General Counsel for Legislation and Regulations, Department of Housing and Urban Development, 451 7th Street SW., Room 10238, Washington, DC 20410; telephone number 202-708-1793 (this is not a toll-free number). Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at 800-877-8339.
In proposed rule FR Doc. 2016-10753, beginning on page 28037 in the issue of May 9, 2016, make the following correction in the
“Randy Akers, Acting Deputy Assistant Secretary, Office of Native
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to grant a 1-year extension of the attainment date for the Oakridge, Oregon nonattainment area to meet the 2006 24-hour PM
Written comments must be received on or before June 17, 2016.
Submit your comments, identified by Docket ID No. EPA-R10-OAR-2016-0051 at
Justin Spenillo at (206) 553-6125, or email address
Throughout this document whenever “we,” “us,” or “our” is used, it is intended to refer to the EPA.
On October 17, 2006, the EPA issued its final action to revise the PM
On November 13, 2009, the EPA issued a final rule designating all areas throughout the country for the 2006 24-hour PM
On January 4, 2013, the D.C. Circuit Court issued a decision in
On June 2, 2014, in response to the
A Moderate PM
The EPA begins processing and analyzing data related to the attainment of the PM
CAA section 188(d) allows states to apply for, and the EPA the discretion to grant, a 1-year extension to the statutory attainment date for Moderate PM
The provisions of section 188(d) thus allow a state an opportunity to demonstrate that a Moderate area should continue to be classified as Moderate and not reclassified to Serious, even if the area has monitor data exceeding the level of the applicable PM
The most significant issue that the EPA must address is how to interpret the air quality requirement of section 188(d)(2) in light of the fact that the statutory language refers to PM
The statutory language addressing PM
For this action, the EPA is proposing to interpret section 188(d) for purposes of the 2006 PM
An additional issue that the EPA must address concerning the air quality requirement of section 188(d)(2) is whether a state seeking an extension for purposes of a 24-hour PM
The EPA is proposing to interpret section 188(d) for the 2006 24-hour PM
Section 188(d)(1) of the Act also provides that the state must have “. . . complied with all requirements and commitments pertaining to the area in the applicable implementation plan.” As with section 188(d)(2), the EPA believes that there are some ambiguities in the statutory language that warrant interpretation in order to evaluate the State's extension request. The EPA proposes to interpret this provision to mean that the state has submitted a SIP submission to address the attainment plan requirements for the applicable PM
Under this proposed interpretation, therefore, the state has to demonstrate that it has submitted an attainment plan to the EPA for the relevant PM
In sum, in order for the EPA to make a decision on whether to grant a 1-year attainment date extension, the state is required to submit sufficient information to demonstrate that it has both complied with all requirements and commitments in the applicable implementation plan, and that it had “clean” air quality data in the attainment year, as explained above. Any decision made by the EPA to extend the attainment date for an area would be based on facts specific to the nonattainment area at issue.
Section 188(d) does not specify the process by which the EPA should evaluate and act upon requests from states for an extension of the Moderate PM
On December 14, 2015, the State of Oregon submitted a request to extend the Moderate area attainment date for the Oakridge NAA for the 2006 24-hour PM
The LRAPA implements the CAA on behalf of the State in the Oakridge NAA. The LRAPA monitors ambient PM
The ODEQ submitted complete certified PM
As explained above, the EPA is interpreting the air quality criterion of section 188(d)(2) in order to reflect the different form of the NAAQS for the PM
Because the Oakridge NAA is designated nonattainment only for the 2006 24-hour PM
For these reasons, the EPA is proposing to find that the State meets the ambient air quality criterion for a 1-year attainment date extension for the Oakridge NAA pursuant to CAA section 188(d)(2).
On December 12, 2012, the Oregon Department of Environmental Quality (ODEQ) submitted a SIP revision to address attainment plan requirements for the 2006 PM
The State developed the 2012 Oakridge Plan in order to address the ambient PM
The 2012 Oakridge Plan included new control measures to address RWC emissions by requiring the curtailment of RWC during times when elevated levels of PM
Subsequent to the submission of the 2012 Oakridge Plan submission, the City of Oakridge enacted revisions on November 15, 2012 and again on October 15, 2015 to strengthen the RWC ordinance which included lowering the threshold for triggering a curtailment or “burn ban,” imposing a more stringent opacity limit, and requiring that only dry, seasoned wood be burned for RWC. The State plans to submit a SIP revision to the EPA in December 2016 that will include the most recent RWC ordinance revisions. The State and LRAPA provided evidence of the adoption and implementation of the new revised ordinance in support of the extension request. Although the State has not yet submitted the ordinance revisions to the EPA for evaluation, and thus the revisions are not yet part of the applicable implementation plan, the Agency nevertheless considers these revisions an important part of the State's strategy for attainment of the 2006 PM
As explained above, the EPA is proposing to interpret the compliance with applicable implementation plan criterion of section 188(d)(1) to require that a state have made a submission intended to meet the attainment plan requirements for the 2006 PM
The State developed and submitted the 2012 Oakridge Plan to the EPA for evaluation. The State also submitted information to establish that the control measures in the 2012 Oakridge Plan are
For these reasons, the EPA is proposing to find that the State meets the compliance with the applicable implementation plan criterion for a 1-year attainment date extension for the Oakridge NAA pursuant to CAA section 188(d)(1).
The EPA is proposing to find that the State has met the criteria for receiving a 1-year extension to the Moderate area attainment date for the 2006 PM
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this proposed action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to determine that the San Joaquin Valley nonattainment area has attained the 1-hour ozone National Ambient Air Quality Standard. This proposed determination is based on the most recent three-year period (2012-2014) of sufficient, quality-assured, and certified data. Preliminary data for 2015 are consistent with continued attainment of the standard in the San Joaquin Valley.
Any comments must arrive by June 17, 2016.
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2016-0164 at
Anita Lee, (415) 972-3958, or by email at
Throughout this document whenever “we,” “us,” or “our” is used, we mean the EPA.
The Clean Air Act (CAA or “Act”) requires the EPA to establish National Ambient Air Quality Standards (NAAQS or “standards”) for certain widespread pollutants, such as ozone, that cause or contribute to air pollution that is reasonably anticipated to endanger public health or welfare.
An area is considered to have attained the 1-hour ozone standard if there are no violations of the standard, as determined in accordance with the regulation codified at 40 CFR 50.9, based on three consecutive calendar years of complete, quality-assured and certified monitoring data. A violation occurs when the ambient ozone air quality monitoring data show greater than one (1.0) “expected number” of exceedances per year at any site in the area, when averaged over three consecutive calendar years. An “expected number” of exceedances is a statistical term that refers to an arithmetic average. An “expected number” of exceedances may be equivalent to the number of observed exceedances plus an increment that accounts for incomplete sampling.
The Act, as amended in 1990, required the EPA to designate as nonattainment any ozone areas that were still designated nonattainment under the 1977 Act Amendments, and any other areas violating the 1-hour ozone standard, generally based on air quality monitoring data from the 1987 through 1989 period.
The control requirements and date by which attainment of the one-hour ozone standard was to be achieved varied with an area's classification. Marginal areas were subject to the fewest mandated control requirements and had the earliest attainment date, November 15, 1993, while Severe and Extreme areas were subject to more stringent planning requirements and were provided more time to attain the standard.
The San Joaquin Valley (SJV or “Valley”) covers approximately 23,000 square miles and includes all of Fresno, Kings, Madera, Merced, San Joaquin, Stanislaus, and Tulare counties, as well as the western half of Kern County.
In 1997, the EPA promulgated an 8-hour ozone standard of 0.08 ppm (“1997 8-hour ozone standard”), to replace the 1-hour ozone standard.
In this action, we are proposing to determine that the San Joaquin Valley has attained the 1-hour ozone standard. Under 40 CFR 50.1118, if this action is finalized as proposed and to the extent not already fulfilled, the requirement for this area to submit an attainment demonstration and associated planning requirements related to attainment of the 1-hour ozone standard, including reasonably available control measures, reasonable further progress plans, contingency measures for failure to attain, or make reasonable progress, shall be suspended until such time as the area is redesignated as attainment for the current ozone NAAQS or a redesignation substitute for the 1-hour ozone standard is approved, at which time the requirements no longer apply.
Over the decades since the 1990 CAA Amendments, despite high rates of growth in population and regional vehicle miles traveled (VMT), 1-hour ozone concentrations in San Joaquin Valley have decreased, primarily due to emissions reductions from mobile source and consumer product control measures adopted by the California Air Resources Board (CARB) and from stationary source control measures adopted by the San Joaquin Valley Air Pollution Control District (SJVAPCD or “District”). For instance, despite regional growth, 1-hour ozone exceedance-days within the Valley (
Since then, the trend towards fewer 1-hour ozone exceedance-days has continued, and on February 11, 2016, CARB requested that the EPA determine that the San Joaquin Valley has attained the 1-hour ozone standard (also referred to as a “clean data determination”).
In addition to the request for a clean data determination, the District provided documentation in its staff report intended to support a finding that attainment of the 1-hour ozone standard is due to permanent and enforceable emission reductions. In our final implementation rule for the 2008 ozone standard (80 FR 12264, March 6, 2015), we established a mechanism, referred to as a “redesignation substitute,” through which an area may shift to contingency status those requirements, such as penalty fee program requirements under CAA section 185, to which an area had remained subject under the EPA's anti-backsliding regulations governing the transition from revoked ozone standards (such as the 1-hour ozone standard) to current ozone standards. To invoke this mechanism, a state must submit a demonstration that the area has attained the revoked ozone NAAQS due to permanent and enforceable emission reductions and that the area will maintain the revoked NAAQS for 10 years from the date of the EPA's approval of this showing.
A determination of whether an area's air quality meets the 1-hour ozone NAAQS is generally based upon three years of complete, quality-assured and certified air quality monitoring data gathered at established State and Local Air Monitoring Stations (SLAMS) in the nonattainment area and entered into the EPA's Air Quality System (AQS) database.
When the EPA determined that the San Joaquin Valley had failed to attain the November 15, 2010 attainment date, the Agency made its determination based on 2008 to 2010 data from a network of 22 ozone monitoring sites.
CARB or SJVAPCD operates 23 of the monitoring sites: Seven within Kern County, six within Fresno County, two within Madera, San Joaquin, Stanislaus, and Tulare counties, and one within Kings and Merced counties.
The Sequoia National Park—Ash Mountain (AQS ID 06-107-0009) NPS monitoring site is designated as regulatory and comparable to the NAAQS. NPS annually certifies that the data it submits to AQS are quality-assured.
Table 1 summarizes the expected 1-hour ozone exceedances, per year and as an average over the 2012-2014 period, at the regulatory monitoring sites in the San Joaquin Valley. Generally, the highest ozone concentrations in the San Joaquin Valley have occurred in the central and southern portions of the nonattainment area, but in recent years, the highest ozone concentrations have occurred in the central portion of the valley (
As noted above, a “complete” data set for determining attainment of the ozone standard is generally one that includes three years of data with an average percent of days with valid monitoring data greater than 90 percent with no single year less than 75 percent. Based on these criteria, the data summarized in Table 1 from all of the sites meet the
To address the data gap at the Bakersfield—Municipal Airport, CARB prepared a missing data analysis to identify an upper bound on the ozone concentrations and exceedance days that might have been recorded at this site during the first half of 2012 if it had been operational during that time.
In support of its request to EPA for a Clean Data Determination, CARB submitted analyses of the 1-hour ozone design value and concentration trends, along with analyses of topography, meteorology, and ozone precursor emissions in the Valley. Based on its analyses, CARB concluded that the ozone site within the Valley with the maximum 1-hour ozone concentration is currently located in the Fresno Metropolitan Statistical Area (MSA). Between 1990 and 2007, the maximum 1-hour ozone concentrations in the Valley alternated between the Bakersfield MSA in the southern portion of the Valley and the Fresno MSA in the central portion of the Valley.
CARB's analyses suggest that the Valley's topography, weather, and transport patterns strongly influence the geographic distribution of ozone, resulting in lower levels in the north, with higher levels in the central and southern portions of the Valley. In addition, CARB's analysis of emission inventories show decreasing trends in anthropogenic emissions of nitrogen oxides and reactive organic gases throughout the Valley from 2000 to 2014, with the fastest rates of decrease expected in the Bakersfield MSA, providing further support that the Valley's design value is likely to continue to occur in the Fresno MSA.
The Arvin—Bear Mountain monitoring site in the Bakersfield MSA was closed in 2010. Prior to its ceasing operation, a monitor intended to replace it began operating nearby at the Arvin—Di Giorgio site. The request to replace the Arvin—Bear Mountain monitoring site with the Arvin—Di Giorgio monitoring site and the EPA's analysis of the request are discussed in section II.C., below. At the time of its closure, the Arvin—Bear Mountain monitoring site had not recorded the maximum ozone concentration in the Valley in more than five years. However, in order to ensure that all sites that had been violating the 1-hour ozone NAAQS would be attaining the standard, CARB conducted a detailed analysis of the daily maximum 1-hour ozone concentrations expected at the Arvin—Bear Mountain monitoring site following its closure in 2010 because it had been one of the Valley sites that, in some prior years, recorded the highest ozone concentration in the Valley. CARB conducted rank-by-rank regression analyses and comparisons using 2010 data from the Arvin—Bear Mountain, Arvin—Di Giorgio, and Edison monitoring sites to estimate daily maximum 1-hour ozone concentrations and estimated expected exceedances at the Arvin—Bear Mountain monitoring site for 2011-2015 had the monitor remained operational until this time. CARB's analyses indicated that the Arvin—Bear Mountain monitoring site would have attained the 1-hour ozone NAAQS in the 2012-2014 period and would have continued to attain the standard for 2013-2015 based on the most recent preliminary data for 2015.
In addition to CARB's analyses, the District conducted predictive regression calculations of daily maximum 1-hour ozone concentrations for 2012 through 2014 at the Arvin—Bear Mountain and Arvin—Di Giorgio monitoring sites.
Based on our review of the submitted documentation, we find that CARB's and the District's methods and analyses regarding 1-hour ozone trends in the San Joaquin Valley and estimates of post-2010 ozone concentrations and expected exceedances at the Arvin—Bear Mountain site to be reasonable and agree with the conclusions drawn therefrom.
Within the San Joaquin Valley, CARB and the District are jointly responsible for assuring that the area meets air quality monitoring requirements. The SLAMS network of ozone monitors in the Valley includes monitors operated by the District and monitors operated by CARB. The District submits annual monitoring network plans to the EPA. The District's network plans describe the various monitoring sites operated by the District as well as those operated by CARB. These plans discuss the status of the air monitoring network, as required under 40 CFR 58.10.
The EPA reviews the District's annual network plans and conducts technical systems audits and has generally found the combined ambient air monitoring network meets or exceeds the requirements for the minimum number of SLAMS monitoring sites for ozone and is in compliance with the applicable reporting requirements in 40 CFR part 58 for ozone except for the requirement to identify a maximum concentration ozone site within the Bakersfield MSA.
Specifically, 40 CFR part 58 requires, among other things, that at least one ozone site for each MSA must be designated to record the maximum concentration for that particular area. The closure of the Arvin—Bear Mountain site without subsequent approval of a replacement site prevented the designation of a maximum concentration ozone site for the Bakersfield MSA. On April 29, 2016, CARB submitted a request letter to the EPA for the relocation of the San Joaquin Valley Arvin—Bear Mountain ozone air monitoring site to the Arvin—Di Giorgio air monitoring site, which is 2.2 miles away and began operation prior to closure of the Arvin—Bear Mountain site.
The EPA is proposing to determine that the San Joaquin Valley has attained the 1-hour ozone standard based on sufficient, quality-assured and certified ambient air quality monitoring data for the 2012-2014 monitoring period. Preliminary data for 2015 are consistent with the continued attainment of the standard in San Joaquin Valley.
If we finalize this determination as proposed, to the extent not already fulfilled, the requirements for the state to submit attainment demonstrations and associated reasonably available control measures, reasonable further progress plans, contingency measures for failure to attain or make reasonable progress and other plans related to attainment of the 1-hour ozone standard for San Joaquin Valley shall be suspended until such time as the area is redesignated as attainment for the current ozone NAAQS or a redesignation substitute for the 1-hour ozone standard is approved, at which time the requirements no longer apply.
The EPA is soliciting public comments on the issues discussed in this document or on other relevant matters. We will accept comments from the public on this proposal for the next 30 days. We will consider these comments before taking final action.
This action proposes to make a determination based on air quality data and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and,
• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this proposed clean data determination does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), and will not impose substantial
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Oxides of nitrogen, Ozone, Volatile organic compounds.
Environmental Protection Agency.
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve and conditionally approve revisions to the State of California's State Implementation Plan (SIP) for the San Joaquin Valley (SJV) area. The revisions consist of an update to the Motor Vehicle Emissions Budgets (“budgets”) for nitrogen oxides (NO
Comments must be received on or before June 17, 2016.
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2015-0711 at
Karina O'Connor, Air Planning Office (AIR-2), U.S. Environmental Protection Agency, Region IX, (775) 434-8176,
Throughout this document, whenever “we,” “us,” or “our” is used, we mean the EPA. This
The EPA is proposing action on a SIP revision submitted by the State of California (“State”) on November 13, 2015. The SIP submittal revises budgets applicable to control strategy or maintenance plans for the SJV for three different NAAQS. We are proposing to approve revised budgets for the 1997 8-hour ozone standard and the 2006 24-hour PM
In 1997, the EPA revised the ozone standard to set the acceptable level of ozone in the ambient air at 0.08 parts per million, averaged over an 8-hour period. 62 FR 38856 (July 18, 1997).
In 2006, the EPA revised the PM
In 1987, the EPA revised the particulate matter standard, replacing standards for total suspended particulates with new standards applying only to PM
For all three pollutants, the SJV nonattainment area includes all of seven counties, including Fresno, Kings, Madera, Merced, San Joaquin, Stanislaus, and Tulare counties, and the western half of Kern County. See the NAAQS-specific tables in 40 CFR 81.305.
Under the CAA, states are required to submit, at various times, control strategy SIP revisions and maintenance plans for nonattainment and maintenance areas for a given NAAQS. These emission control strategy SIP revisions (
Under section 176(c) of the CAA, transportation plans, Transportation Improvement Programs (TIPs), and transportation projects must “conform” to (
Before budgets can be used in conformity determinations, the EPA must affirmatively find the budgets adequate. However, adequate budgets do not supersede approved budgets for the same CAA purpose. If the submitted SIP budgets are meant to replace budgets for the same purpose, the EPA must approve the budgets, and can affirm that they are adequate at the same time. Once the EPA approves the submitted budgets, they must be used by state and federal agencies in determining whether transportation activities conform to the SIP as required by section 176(c) of the CAA. The EPA's substantive criteria for determining the adequacy of budgets are set out in 40 CFR 93.118(e)(4).
The EMFAC model (short for EMission FACtor) is a computer model developed by the California Air Resources Board (CARB). CARB updates EMFAC on a regular basis and releases new versions generally every three or four years. The current version can estimate emission rates for on-road mobile sources (“motor vehicles”) operating in California for calendar years from 2000 to 2050. Pollutant emissions for VOCs,
EMFAC is used to calculate current and future inventories of motor vehicle emissions at the state, air district, air basin, or county level. EMFAC contains default vehicle activity data, and the option of modifying that data, so it can be used to estimate a motor vehicle emissions inventory in tons/day for a specific year, month, or season, and as a function of ambient temperature, relative humidity, vehicle population, mileage accrual, miles of travel and speeds. Thus the model can be used to make decisions about air pollution policies and programs at the local or state level. Inventories based on EMFAC are also used to meet the federal CAA's SIP and transportation conformity requirements.
Most budgets in the California SIP were developed using EMFAC2007 (released by CARB in October 2007) or EMFAC2011 (released by CARB in September 2011). The EPA approved EMFAC2007 at 73 FR 3464 (January 18, 2008) and EMFAC2011 at 78 FR 14533 (March 16, 2013) for all areas in California.
EMFAC2011 was considered a major update to previous versions of EMFAC and most budgets in the California SIP were updated with EMFAC2011 in the 2012-2014 timeframe. EMFAC2011 included a new model structure, new data and methodologies regarding calculation of motor vehicle emissions, and revisions to implementation data for control measures.
The EPA approved EMFAC2014 for use in SIP revisions and transportation conformity at 80 FR 77337 (December 14, 2015). EMFAC2014 includes significant changes to its model interface, new data and methodologies regarding calculation of motor vehicle emissions and revisions to implementation data for control measures. EMFAC2014 includes updated data on car and truck activity, and emissions reductions associated with CARB's Advanced Clean Cars regulations.
The EPA previously approved the SJV budgets for the 1997 8-hour ozone standard and the 24-hour PM
The EPA previously proposed to approve the SJV budgets for the 2006 24-hour PM
The current EPA-approved budgets for the 1997 8-hour ozone standard and PM
The revised budgets for the 1997 8-hour ozone, 2006 24-hour PM
CAA sections 110(a)(1) and (2) and 110(l) require a state to provide reasonable public notice and opportunity for public hearing prior to the adoption and submittal of a SIP or SIP revision. To meet this requirement, every SIP submittal should include evidence that adequate public notice was given and an opportunity for a public hearing was provided consistent with the EPA's implementing regulations in 40 CFR 51.102.
CARB satisfied applicable statutory and regulatory requirements for reasonable public notice and hearing prior to adoption and submittal of the revised budgets. In the documentation included as part of the November 13, 2015 SIP revision submittal, CARB provided evidence of the required public notice and opportunity for public comment prior to its October 22, 2015 public hearing and adoption of the revised budgets. We find, therefore, that the submittal of the revised budgets meets the procedural requirements for public notice and hearing in CAA sections 110(a) and 110(l).
CAA section 110(k)(1)(B) requires the EPA to determine whether a SIP submittal is complete within 60 days of receipt. This section also provides that any plan submittal that the EPA has not affirmatively determined to be complete or incomplete will be deemed complete by operation of law six months after the date of submittal. The EPA's SIP completeness criteria are found in 40 CFR part 51, Appendix V. The EPA determined that CARB's November 13, 2015 SIP revision submittal was complete on April 21, 2016.
Under section 110(l) of the CAA, SIP revisions must not interfere with any applicable requirements concerning attainment or RFP or any other applicable requirement of the Act. Generally, the EPA reviews budgets for adequacy or approval in the context of the Agency's review of a control strategy implementation plan (
In addition, revised budgets that are intended to replace adequate (but not approved) budgets must meet the adequacy criteria found in our transportation conformity regulations at 40 CFR 93.118(e)(4). These criteria include endorsement by the Governor (or designee); prior consultation among relevant air and transportation agencies; clear identification and precise quantification of the budgets; consistency of the budgets, when considered with all other emissions sources, with applicable requirements for RFP, attainment or maintenance; consistency with and clear relation to the emissions inventory and control measures; and explanation and documentation of changes relative to previously submitted budgets. In this instance, the adequacy criteria do not
Table 1 lists the revised budgets by subarea included in the State's submittal for the SJV budgets applicable to the 1997 8-hour ozone, 2006 24-hour PM
Tables 2 and 3 below compare the current EPA-approved NO
The revised NO
First, we note that the 2007 Ozone Plan relied upon motor vehicle emissions inventories, from which the budgets
Second, we have reviewed the analysis CARB prepared in support of the revised budgets and contained in the staff report included with the November 13, 2015 SIP revision submittal. In that analysis, CARB prepared updated NO
Therefore, we find that the 2007 Ozone Plan will continue to meet applicable requirements for RFP and attainment when the previously-approved EMFAC2007-based budgets are replaced with the revised EMFAC2014-based budgets, and that the changes in the growth and control strategy assumptions for non-motor vehicle sources do not change the overall conclusions of the 2007 Ozone Plan. As such, we find that approval of the revised NO
Table 6 below compares the current direct PM
The revised 2017 direct PM
First, we note that the 2012 PM
Second, we have reviewed the analysis that CARB prepared in support of the revised budgets and contained in the staff report included with the November 13, 2015 SIP revision submittal. In that analysis, CARB included a comparison of the estimated direct PM
Therefore, we find that the 2012 PM
In addition, we have reviewed the revised direct PM
Lastly, approval of the revised budgets would not affect our January 13, 2015 proposal, or rationale therein, to approve the trading mechanism as described on page C-32 in appendix C of the 2012 PM
Table 8 below compares the current EPA-approved direct PM
The revised
First, we note that the 2007 PM
Second, we have reviewed the analysis CARB prepared in support of the revised budgets. To further demonstrate that the changes to the direct PM
The primary differences between the inventories in the 2007 PM
Table 9 shows that CARB's current estimates of NO
From our
Step 1. The District will examine the event and determine if it needs to be classified as a natural or exceptional event in accordance with the EPA's final rulemaking (72 FR 13560). If the data qualify for flagging under this rule, the District would proceed with preparing and submitting the necessary documentation for a natural/exceptional event, and would not consider the monitored level as a trigger for the maintenance plan contingency plan.
Step 2. If the event does not qualify as a natural or exceptional event, the District would then analyze the event to determine its possible causes. It would examine emission reductions from adopted rules or rule commitments in adopted and approved plans to see if emission reductions not used in demonstrating maintenance of the PM
Step 3. If reductions from Step 2 above are insufficient, the District would proceed with identifying control measures from any feasibility studies (
In a March 11, 2016 letter to the EPA,
In their March 11, 2016 letter to the EPA, the District identified multiple rules and regulations that reduce PM
• Evaluation of PM
• Analysis of PM
• Analysis of available chemical speciation data including additional filter speciation analysis as appropriate to assess potential source types contributing to each exceedance; and
• Analysis of wind speed and direction, along with geographic visualization tools to help identify the types of sources impacting each monitor.
Based on these analyses, CARB and the District will determine the appropriate remedy to address the nature of each exceedance. This may include submittal of documentation for exceptional events, or analysis and evaluation of the further emission reductions that will accrue from ongoing implementation of current control programs or development of new control measures as part of upcoming attainment plans.
For exceedances that qualify as natural or exceptional events, CARB and the District will follow the notification and data flagging process that is contained in the EPA's revised Exceptional Event Rule (“EE Rule”). This will include a commitment to notify the EPA by July 1 of each year of the PM
Based on the 2020 revised direct PM
Lastly, approval of the revised budgets would not affect the trading mechanism first included in the SJV Amended 2003 PM
For the reasons discussed above, the EPA is proposing to approve the revised ozone and PM
More specifically, under CAA section 110(k)(3), the EPA is proposing to approve the revised VOC and NO
Second, the EPA is also proposing to approve the revised direct PM
Third, under CAA section 110(k)(4), the EPA is proposing to conditionally approve the revised direct PM
Lastly, if the EPA takes final action to approve the revised budgets as proposed, the San Joaquin Valley MPOs and DOT must use the revised budgets for future transportation conformity determinations.
The EPA is soliciting public comments on the issues discussed in this document or on other relevant matters. We will accept comments from the public on this proposal for the next 30 days. We will consider these comments before taking final action.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve State choices, provided that they meet the criteria of the CAA. Accordingly, this action merely proposes to approve a state plan as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this proposed action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide the EPA with the discretionary authority to address disproportionate human health or environmental effects with practical, appropriate, and legally permissible methods under Executive Order 12898 (59 FR 7629, February 16, 1994).
Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires the EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have Tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian Tribes.”
Eight Indian tribes are located within the boundaries of the San Joaquin Valley air quality planning area for the 1997 8-hour ozone, 2006 24-hour PM
The EPA's proposed approval of the revised budgets submitted by CARB to address the 1997 8-hour ozone, 2006 24-hour PM
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental regulations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur dioxide, Volatile organic compounds.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Notice of proposed rulemaking; extension of public comment period.
The Environmental Protection Agency (EPA) is announcing that the period for providing public comments on the April 18, 2016, proposed “Protection of Stratospheric Ozone: Proposed New Listings of Substitutes; Changes of Listing Status; and Reinterpretation of Unacceptability for Closed Cell Foam Products under the Significant New Alternatives Policy Program; and Revision of Clean Air Act Section 608 Venting Prohibition for Propane” is being extended by 14 days.
Chenise Farquharson, Stratospheric Protection Division, Office of Atmospheric Programs (Mail Code 6205 T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 202-564-7768; email address:
The EPA is extending the public comment period for the proposed rule (81 FR 22810; April 18, 2016) an additional 14 days. The public comment period will end on June 16, 2016, rather than June 2, 2016. This will provide the public additional time to review and comment on all of the information available, including the proposed rule and other materials in the docket.
Environmental protection, Administrative practice and procedure, Air pollution control, Incorporation by reference, Recycling, Reporting and recordkeeping requirements, Stratospheric ozone layer.
Federal Communications Commission.
Petitions for reconsideration.
Petitions for Reconsideration (Petitions) have been filed in the Commission's rulemaking proceeding by: Lawrence M. Miller, on behalf of Public Broadcasting Parties, Sylvia Strobel, on behalf of American Public Media Group, Todd D. Gray, on behalf of NCE Licensees and Joseph B. Porter, on behalf of The State University of New York.
Oppositions to the Petitions must be filed on or before June 2, 2016. Replies to an opposition must be filed on or before June 13, 2016.
Federal Communications Commission, 445 12th Street SW., Washington, DC 20554.
Jessica Campbell, Media Bureau, (202) 418-3609, email:
This is a summary of Commission's document, Report No. 3043, released May 9, 2016. The full text of the Petitions is available for viewing and copying at the FCC Reference Information Center, 445 12th Street SW., Room CY-A257, Washington, DC 20554 or may be accessed online via the Commission's Electronic Comment Filing System at
Subject: Promoting Diversification of Ownership in the Broadcasting Services, published at 81 FR 19432, April 4, 2016, in MB Docket Nos. 07-294 and 10-103, MD Docket No. 10-234, and FCC 16-1. This
Office of the Secretary, USDA.
Notice.
The Office of the Secretary of the Department of Agriculture is providing notice of an increase in the fiscal year (FY) 2016 raw cane sugar tariff-rate quota (TRQ) of 127,006 metric tons raw value (MTRV).
Effective May 18, 2016.
Souleymane Diaby, Import Policies and Export Reporting Division, Foreign Agricultural Service, Stop 1021, U.S. Department of Agriculture, Washington, DC 20250-1021; or by telephone (202) 720-2916; or by fax to (202) 720-8461; or by email to
The Office of the Secretary of the Department of Agriculture is providing notice of an increase in the fiscal year (FY) 2016 (October 1, 2015-September 30, 2016) raw cane sugar tariff-rate quota (TRQ) of 127,006 metric tons raw value (MTRV). On June 15, 2015, the Office of the Secretary established the FY 2016 TRQ for raw cane sugar at 1,117,195 MTRV (1,231,497 short tons raw value, STRV *
* Conversion factor: 1 metric ton = 1.10231125 short tons.
This action is being taken after a determination that additional supplies of raw cane sugar are required in the U.S. market. USDA will closely monitor stocks, consumption, imports and all sugar market and program variables on an ongoing basis, and may make further program adjustments during FY 2016 if needed.
National Institute of Food and Agriculture, USDA.
Notice of opportunity for commodity boards to submit topics and contribute funding under the Agriculture and Food Research Initiative Competitive Grants Program.
As part of the National Institute of Food and Agriculture's (NIFA) strategy to implement section 7404 of Public Law 113-79, the Agricultural Act of 2014, NIFA is soliciting topics from eligible commodity board entities (Federal and State-level commodity boards, as defined below) which they are willing to equally co-fund with NIFA. Such topics must relate to the established priority areas of the Agriculture and Food Research Initiative Competitive Grants Program (AFRI) to be considered for inclusion in future AFRI Requests for Applications (RFAs).
Commodity boards are those entities established under a commodity promotion law (as such term is defined under section 501(a) of the Federal Agriculture Improvement and Reform Act of 1996 (7 U.S.C. 7401(a)) or a State commodity board (or other equivalent State entity).
If proposed topics are accepted for inclusion in an AFRI RFA after evaluation by NIFA, they will be incorporated into AFRI competitive grants program RFAs. As a condition of funding grants in a topic, NIFA will require an agreement with the commodity board to provide funds that are equal to the amount NIFA is contributing under the agreed upon topic.
This Notice invites topic submissions from commodity boards as defined above, outlines the process NIFA will use to evaluate the appropriateness of these topics for inclusion in AFRI RFAs, and describes the commitment commodity boards will be required to make in order for NIFA to jointly fund AFRI applications competitively selected for award within a topic area submitted by the commodity boards.
Topics may be submitted by commodity boards at any time; however, all topics to be considered for the fiscal year 2017 AFRI RFAs must be received by 5:00 p.m., EDT on July 18, 2016. Topics submitted by eligible commodity board entities after this date will be considered for RFAs to be issued in future years. NIFA will hold a webinar and workshop to respond to questions from commodity boards interested in submitting topics. Details including the date and time, and access information will be posted on the NIFA Web site (
You may submit topics, identified by NIFA-2016-0001, by the following method:
Mark Mirando; Phone: (202) 401-4336, or Robert Hedberg; Phone: (202) 720-5384, or Email:
This Notice begins the second topic submission cycle to implement section 7404 of the Agricultural Act of 2014, Public Law 113-79, which amends section 2(b) of the Competitive, Special, and Facilities Research Grant Act (7 U.S.C. 450i(b)) to require that NIFA “establish procedures, including timelines, under which an entity established under a commodity promotion law (as such term is defined under section 501(a) of the Federal Agriculture Improvement and Reform Act of 1996 (7 U.S.C. 7401(a)) or a State commodity board (or other equivalent State entity) may directly submit to the Secretary [(NIFA)] for consideration proposals for requests for applications . . .” within the AFRI Program.
Stakeholder feedback gathered as a result of the September 2014 Notice and during the initial year of implementation (in fiscal year 2016) informed this Notice and the process NIFA is using to implement section 7404. This Notice invites entities established under a commodity promotion law or State commodity boards (or other equivalent State entities) to submit topics which they are proposing for inclusion in upcoming AFRI RFAs in fiscal year 2017. Topics must relate to the established AFRI priority areas, which are plant health and production and plant products; animal health and production and animal products; food safety, nutrition, and health; bioenergy, natural resources, and environment; agriculture systems and technology; and agriculture economics and rural communities. A summary statement on AFRI is included below. To learn more about AFRI programs, including program priorities, typical award budget amounts, and examples of RFAs, please visit:
The AFRI program is the largest agricultural competitive grants program in the United States and a primary funding source for research, education, and extension projects that bring practical solutions to some of today's most critical societal challenges. AFRI programs impact all components of agriculture, including farm and ranch efficiency and profitability, bioenergy, forestry, aquaculture, rural communities, human nutrition, food safety, biotechnology, and genetic improvement of plants and animals.
In FY 2017, NIFA will issue at least seven AFRI RFAs to solicit applications in the six statutory priority areas in AFRI (Plant health and production and plant products; Animal health and production and animal products; Food safety, nutrition, and health; Bioenergy, natural resources, and environment; Agriculture systems and technology; Agriculture economics and rural communities). It is anticipated that these will include five Challenge Area RFAs, which address the following major societal challenges: Sustainable Bioenergy; Climate Variability and Change; Water for Food Production Systems; Childhood Obesity Prevention; and Food Safety. The Challenge Area RFAs solicit grant applications for focused problem-solving efforts and provide large awards (typically $1 million or more) for periods of up to 5 years to enable collaboration among multiple organizations and the integration of research with education and/or extension. The sixth RFA is the Foundational Program RFA issued annually which solicits grant applications that focus predominately, but not exclusively, on fundamental scientific research that addresses statutory priorities. The final RFA is the AFRI Food, Agriculture, Natural Resources, and Human Sciences Education and Literacy Initiative (ELI) RFA which solicits grant applications for undergraduate research and extension experiential learning fellowships, and pre- and post-doctoral fellowships.
Eligible commodity board entities are those established under a commodity promotion law (as such term is defined under section 501(a) of the Federal Agriculture Improvement and Reform Act of 1996 (7 U.S.C. 7401(a))) or a State commodity board (or other equivalent State entity). Language in 7 U.S.C. 7401(a) defines a “commodity promotion law” as “a Federal law that provides for the establishment and operation of a promotion program regarding an agricultural commodity that includes a combination of promotion, research, industry information, or consumer information activities, is funded by mandatory assessments on producers or processors, and is designed to maintain or expand markets and uses for the commodity (as determined by the Secretary).” Section 7401(a) includes a list of such Federal laws.
A current list of approved entities is maintained at (
Topics may be submitted at any time and will be evaluated by NIFA on an annual basis. However, to be considered for the proposed fiscal year 2017 AFRI RFAs, topics must be received by COB (5 p.m. Eastern Daylight Time) on July 18, 2016.
Each topic proposed must be submitted using the template provided at:
If topics are accepted for funding, they will be incorporated into AFRI RFAs, and grants supporting the topic area may be awarded to AFRI eligible entities based on a competitive peer review process. As a condition of funding grants in a topic, NIFA will require an agreement to provide funds by the commodity board that is equal to the amount NIFA is contributing under the agreed upon topic. If a topic is selected for inclusion in an RFA, the commodity board submitting the topic will be required to maintain the confidentiality of the topic until the RFA is issued by NIFA. Commodity board funds must be made available to NIFA no later than the time awards are
NIFA will screen proposed research topics to ensure they were submitted by eligible commodity boards and consult with USDA's Agricultural Marketing Service (AMS) to determine that submissions and proposed financial contributions are consistent with commodity promotion laws and commodity boards' charters as applicable.
Commodity board topics will be reviewed by an internal panel based on evaluation criteria that were developed using stakeholder input from commodity boards and other stakeholders from government, industry, and academe. Each topic will be evaluated based on: Alignment with one or more of the statutory AFRI priority areas (six AFRI priority areas authorized in the Farm Bill and described in 7 CFR 3430.309); alignment with the President's budget proposal for NIFA, as identified in the Department of Agriculture's annual budget submission; and alignment with the priority areas in the AFRI RFAs to be released by NIFA during the fiscal year for which the commodity board is proposing a topic for funding (for example, within the AFRI Foundational Program RFA, the AFRI Animal Health and Production and Animal Product's “Animal Reproduction” priority area).
From those topics received by COB (5 p.m. Eastern Daylight Time) on July 18, 2016, NIFA will select the topic(s) that were evaluated favorably for inclusion in the appropriate FY 2017 AFRI RFA. NIFA will notify commodity boards whether their topics will be included by August 16, 2016. Based on the evaluation, NIFA reserves the right to negotiate with commodity boards should changes be required for topics and funding amounts to be accepted. Any changes to topics and funding amounts will be reviewed by USDA's AMS to determine if such changes are consistent with applicable commodity promotion laws.
NIFA will evaluate topics submitted after the July 18, 2016 deadline on an annual basis and notify commodity boards whether their topics will be included in subsequent RFAs within two weeks following the meeting of the internal evaluation panel, the date of which will be published on NIFA's Commodity Boards Web page at (
An application has been submitted to the Foreign-Trade Zones (FTZ) Board by the March Joint Powers Authority, grantee of Foreign-Trade Zone 244, requesting authority to reorganize the zone to expand its service area under the alternative site framework (ASF) adopted by the FTZ Board (15 CFR Sec. 400.2(c)). The ASF is an option for grantees for the establishment or reorganization of zones and can permit significantly greater flexibility in the designation of new subzones or “usage-driven” FTZ sites for operators/users located within a grantee's “service area” in the context of the FTZ Board's standard 2,000-acre activation limit for a zone. The application was submitted pursuant to the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the FTZ Board (15 CFR part 400). It was formally docketed on May 12, 2016.
FTZ 244 was approved by the FTZ Board on August 21, 2000 (Board Order 1104, 65 FR 54196, September 7, 2000) and reorganized under the ASF on May 13, 2011 (Board Order 1761, 76 FR 29725, May 23, 2011). The zone currently has a service area that includes western Riverside County, California.
The applicant is now requesting authority to expand the service area of the zone to include the City of Lake Elsinore, as described in the application. If approved, the grantee would be able to serve sites throughout the expanded service area based on companies' needs for FTZ designation. The application indicates that the proposed expanded service area is adjacent to the Los Angeles/Long Beach U.S. Customs and Border Protection Port of Entry.
In accordance with the FTZ Board's regulations, Christopher Kemp of the FTZ Staff is designated examiner to evaluate and analyze the facts and information presented in the application and case record and to report findings and recommendations to the FTZ Board.
Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is July 18, 2016. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to August 1, 2016.
A copy of the application will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the FTZ Board's Web site, which is accessible via
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) is rescinding the administrative review of the antidumping duty order on certain frozen warmwater shrimp from Brazil for the period February 1, 2015, through January 31, 2016.
Effective May 18, 2016.
Kate Johnson or Terre Keaton Stefanova, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202)
On February 3, 2016, the Department published in the
On February 24, 2016, in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.213(b), the Department received a timely request from the Ad Hoc Shrimp Trade Action Committee (the petitioner),
On April 7, 2016, the Department published in the
On April 11, 2016, the petitioner timely withdrew its request for a review of AMASA.
Pursuant to 19 CFR 351.213(d)(1), the Department will rescind an administrative review, in whole or in part, if a party that requested a review withdraws the request within 90 days of the date of publication of notice of initiation of the requested review. The petitioner timely withdrew its request for review before the 90-day deadline, and no other party requested an administrative review of the antidumping duty order. Therefore, we are rescinding the administrative review of the antidumping duty order on certain frozen warmwater shrimp from Brazil covering the period February 1, 2015, through January 31, 2016.
The Department will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries. Antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). The Department intends to issue appropriate assessment instructions directly to CBP 15 days after the date of publication of this notice in the
This notice serves as the only reminder to importers of their responsibility, under 19 CFR 351.402(f)(2), to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement may result in the presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
This notice serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
This notice is published in accordance with section 751 of the Act and 19 CFR 351.213(d)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Davina Friedmann, Tyler Weinhold or Robert James, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-0698, (202) 482-1121 or (202) 482-0649, respectively.
On March 22, 2016, the Department of Commerce (the Department) published the
This correction to the
Corporation for National and Community Service.
Notice.
The Corporation for National and Community Service (CNCS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. Sec. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirement on respondents can be properly assessed.
Currently, CNCS is soliciting comments concerning its proposed use of the AmeriCorps NCCC Medical/Mental Health Information Form. An individual must have the physical and mental capacity required to perform the essential functions of the AmeriCorps NCCC member position, with or without reasonable accommodation, for which he or she is otherwise eligible.
Copies of the information collection request can be obtained by contacting the office listed in the Addresses section of this Notice.
Written comments must be submitted to the individual and office listed in the
You may submit comments, identified by the title of the information collection activity, by any of the following methods:
(1) By mail sent to: Corporation for National and Community Service, AmeriCorps NCCC; Attention Tara Lind-Zajac, Lead Medical Nurse, 3237-Q; 250 E Street SW., Washington, DC 20525.
(2) By hand delivery or by courier to the CNCS mailroom at the mail address given in paragraph (1) above, between 9:00 a.m. and 4:00 p.m. Eastern Time, Monday through Friday, except Federal holidays.
(3) Electronically through
Individuals who use a telecommunications device for the deaf (TTY-TDD) may call 1-800-833-3722 between 8:00 a.m. and 8:00 p.m. Eastern Time, Monday through Friday.
Tara Lind-Zajac, 202-360-8082, or by email at
CNCS is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of CNCS, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are expected to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology (
An individual must have the physical and mental capacity required to perform the essential functions of the AmeriCorps lNCCC member position, with or without reasonable accommodation, for which he or she is otherwise eligible. Individuals applying to the AmeriCorps NCCC program provide the information collected on this form in order to be cleared to participate in the program.
This is a new information collection request. The Medical/Mental Health Information Form is completed at the time individuals complete the AmeriCorps NCCC program application. This allows individuals to submit a “complete” application to AmeriCorps NCCC, allowing a shortened and simplified application/review/clearance process. The Medical/Mental Health Information Form is not reviewed until after an applicant receives a conditional invitation to participate in the AmeriCorps NCCC program. Forms are submitted via pre-addressed, tracked, UPS envelopes included with the mailings in which applicants receive the blank forms.
Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.
Department of Defense.
Notice.
The Department of Defense is publishing this notice to announce a Federal advisory committee meeting of the Department of Defense Military Family Readiness Council. This meeting will be open to the public.
Thursday, June 16, 2016, from 1:00 p.m. to 3:00 p.m.
Pentagon Conference Center B6 (escorts will be provided from the Pentagon Metro entrance).
Ms. Melody McDonald or Ms. Betsy Graham, Office of the Deputy Assistant Secretary of Defense (Military Community & Family Policy), Office of Family Readiness Policy, 4800 Mark Center Drive, Alexandria, VA 22350-2300, Room 3G15. Telephones (571) 372-0880; (571) 372-0881 and/or email: OSD Pentagon OUSD P-R Mailbox Family Readiness Council,
This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C. Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150. The purpose of the Council is to review and make recommendations to the Secretary of Defense regarding policy and plans;
Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, this meeting is open to the public, subject to the availability of space. The process for the public entering the Pentagon has changed. Persons without Pentagon access must submit their Full Name, Full SSN, and Date of Birth by fax at 571-372-0884 or email to
The purpose of this meeting is to receive an update on ongoing items of Council interest, and to determine Military Family Readiness Council focus items for Fiscal Year 2016.
Exact order may vary.
DoD.
Meeting notice.
The Department of Defense is publishing this notice to announce the following Federal advisory committee meeting of the Vietnam War Commemoration Advisory Committee. This meeting is open to the public.
The public meeting of the Vietnam War Commemoration Advisory Committee (hereafter referred to as “the Committee”) will be held on Friday, June 3, 2016. The meeting will begin at 1:00 p.m. and end at 4:00 p.m.
U.S. Access Board Conference Room, 1331 F Street NW., Suite 1000, Washington, DC 20004.
Committee's Designated Federal Officer: The committee's Designated Federal Officer is Mr. Michael Gable, Vietnam War Commemoration Advisory Committee, 241 18th Street South, Arlington VA 22202,
This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150.
Special Accommodations: Individuals requiring special accommodations to access the public meeting should contact Mr. Michael Gable, Mr. Mark Franklin or Ms. Scherry Chewning at the number listed in the
Written comments should be received by the DFO at least five (5) business days prior to the meeting date so that the comments may be made available to the Committee for their consideration prior to the meeting. Written comments should be submitted via email to the address for the DFO given in the
National Center for Education Statistics (NCES), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501
Interested persons are invited to submit comments on or before July 18, 2016.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Kashka Kubzdela at
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Department of Energy.
Notice of the Title X claims during fiscal year (FY) 2016.
This Notice announces the Department of Energy's (DOE) acceptance of claims in FY 2016 from eligible active uranium and thorium processing site licensees for reimbursement under Title X of the Energy Policy Act of 1992 (Public Law 102-486, as amended). The Consolidated Appropriations Act, 2016 (Public Law 114-113) provided $32,959,000 for Title X uranium and thorium reimbursements to be made available to the Title X licensees on a prorated basis. The FY 2017 Department of Energy Office of Environmental Management's Congressional Budget Request requests $30 million for the Title X Program.
The closing date for the submission of FY 2016 Title X claims is September 16, 2016. The claims will be processed for payment together with any eligible unpaid approved claim balances from prior years, based on the availability of funds from congressional appropriations. If the total approved claim amounts exceed the available funding, the approved claim amounts will be reimbursed on a prorated basis. All reimbursements are subject to the availability of funds from congressional appropriations.
Claims should be forwarded by certified or registered mail, return receipt requested, to U.S. Department of Energy, Office of Legacy Management, Attn: Deborah Barr, Title X Lead for Review of Reimbursement of Claims, U.S. Department of Energy, Office of Legacy Management, 2597 Legacy Way, Grand Junction, Colorado 81503. Two copies of the claim should be included with each submission.
Theresa Kliczewski, Title X Program Coordinator, at (202)586-3301, of the U.S. Department of Energy, Office of Environmental Management, Office of Disposition Planning & Policy.
DOE published a final rule under 10 CFR part 765 in the
Section 1001-1004 of Public Law 102-486, 106 Stat. 2776 (42 U.S.C. 2296a
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following qualifying facility filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
This is a supplemental notice in the above-referenced proceeding of Chaves County Solar, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is June 1, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following PURPA 210(m)(3) filings:
Take notice that the Commission received the following electric reliability filings.
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Environmental Protection Agency (EPA).
Notice of action denying in part and granting in part petitions for reconsideration.
This action provides notice that the U.S. Environmental Protection Agency (EPA) Administrator, Gina McCarthy, denied in part and granted in part petitions for reconsideration of the final National Emission Standards for Hazardous Air Pollutants (NESHAP) for Brick and Structural Clay Products (BSCP) Manufacturing and the final NESHAP for Clay Ceramics Manufacturing published in the
This action is effective on May 18, 2016.
Ms. Sharon Nizich, Minerals and
This
All documents in the dockets are listed on the
Section 307(b)(1) of the Clean Air Act (CAA) indicates which Federal Courts of Appeals have venue for petitions for review of final EPA actions. This section provides, in part, that the petitions for review must be filed in the Court of Appeals for the District of Columbia Circuit if: (i) The agency action consists of “nationally applicable regulations promulgated, or final action taken, by the Administrator,” or (ii) such actions are locally or regionally applicable, if “such action is based on a determination of nationwide scope or effect and if in taking such action the Administrator finds and publishes that such action is based on such a determination.”
The EPA has determined that its denial of the petitions for reconsideration is nationally applicable for purposes of CAA section 307(b)(1) because the actions directly affect the BSCP Manufacturing NESHAP and Clay Ceramics Manufacturing NESHAP, which are nationally applicable regulations. Thus, any petitions for review of the letters and enclosures denying the petitions for reconsideration described in this document must be filed in the United States Court of Appeals for the District of Columbia Circuit by July 18, 2016.
To the extent that EPA is granting the petitions for reconsideration with respect to certain issues, such grant is not final agency action, but only begins an agency process to consider whether the rule should be revised. If EPA in the future takes final agency action to revise the rule, notice of such action will be published in the
The initial NESHAP for BSCP Manufacturing and initial NESHAP for Clay Ceramics Manufacturing were published in the
On December 23, 2015, Kohler Company submitted a petition for reconsideration of the final rule for Clay Ceramics Manufacturing (80 FR 65470). In support of its petition, Kohler Company claimed that: (1) The final rule introduced new stack temperature monitoring requirements for demonstrating compliance with the dioxin/furan emission limits without an opportunity for comment by the petitioner; (2) the EPA failed to adequately respond to the petitioner's public comments regarding visible emissions monitoring in the response to comments and final rule; (3) the EPA should reconsider its exclusion of emissions averaging from the final rule as a compliance option for clay ceramics manufacturing; (4) the EPA should reconsider its improper use of scrubber emissions data from the petitioner's South Carolina Kiln 10 for determining the maximum achievable control technology (MACT) floor; (5) the EPA should reconsider the frequency of onerous and unnecessary visual inspection requirements for system ductwork and control device equipment for water curtain spray booths; and (6) the EPA should clarify the testing threshold for cooling stacks to be tested to limit it to those stacks with an oxygen content at or below 20.4 percent.
Also on December 23, 2015, the Brick Industry Association (BIA) submitted a petition for reconsideration of the final rule for BSCP Manufacturing (80 FR 65470). In support of its petition, the BIA claimed that: (1) The EPA failed to give notice that it would change its method for calculating the existing source MACT floor for emissions of non-mercury (Hg) hazardous air pollutant (HAP) metals; (2) the EPA incorrectly used tests conducted below capacity in its revised MACT floor approach; (3) the EPA failed to give notice that it would include a variability calculation in its determination of the MACT floor for Hg or how it would make this variability calculation; (4) it was impracticable for the petitioner to request a variability factor for non-Hg metal emission limits for the final rule; and (5) the EPA failed to give notice that it would include opacity as a compliance method for the non-Hg HAP metals standard.
On December 24, 2015, the Tile Council of North America, Inc. (TCNA) and its members submitted a petition for reconsideration of the final rule for Clay Ceramics Manufacturing (80 FR 65470). In support of its petition, the TCNA claimed that: (1) In promulgating the final rule, the EPA relied on legal positions/rationales for regulating ceramic tile that were advanced for the first time in the preamble to the final rule; (2) for the final rule, the EPA introduced for the first time the technical rationale that Method 23 field
Section 307(d)(7)(B) of the CAA sets forth the criteria for reconsideration. That section states that “(o)nly an objection to a rule or procedure which was raised with reasonable specificity during the period for public comment (including any public hearing) may be raised during judicial review. If the person raising an objection can demonstrate to the Administrator that it was impractical to raise such objection within such time or if the grounds for such objection arose after the period for public comment (but within the time specified for judicial review) and if such objection is of central relevance to the outcome of the rule, the Administrator shall convene a proceeding for reconsideration of the rule and provide the same procedural rights as would have been afforded had the information been available at the time the rule was proposed.”
The EPA has carefully considered the petitions and supporting information. In separate letters to the petitioners, the EPA Administrator, Gina McCarthy, denied in part and granted in part the Kohler Company petition, denied the BIA and TCNA petitions, and explained the reasons for the denials. These letters and the accompanying enclosures are available in the dockets for this action.
For the reasons discussed in the letters and accompanying enclosure to the petitioners, the petitions to reconsider the final NESHAP for BSCP Manufacturing and final NESHAP for Clay Ceramics Manufacturing are denied in part and granted in part.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Written PRA comments should be submitted on or before July 18, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Nicole Ongele, FCC, via email
For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Written PRA comments should be submitted on or before July 18, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
47 CFR 74.783(b) requires licensees of television translators whose station identification is made by the television station whose signals are being rebroadcast by the translator, must secure agreement with this television station licensee to keep in its file, and available to FCC personnel, the translator's call letters and location, giving the name, address and telephone number of the licensee or his service representative to be contacted in the event of malfunction of the translator. It shall be the responsibility of the translator licensee to furnish current information to the television station licensee for this purpose.
47 CFR 73.1201(b)(1) requires that the official station identification consist of the station's call letters immediately followed by the community or communities specified in its license as the station's location. The name of the licensee, the station's frequency, the station's channel number, as stated on the station's license, and/or the station's network affiliation may be inserted between the call letters and station location. Digital Television (DTV) stations, or DAB Stations, choosing to include the station's channel number in the station identification must use the station's major channel number and may distinguish multicast program streams. For example, a DTV station with major channel number 26 may use 26.1 to identify a High Definition Television (HDTV) program service and 26.2 to identify a Standard Definition Television (SDTV) program service. A radio station operating in DAB hybrid mode or extended hybrid mode shall identify its digital signal, including any free multicast audio programming streams, in a manner that appropriately alerts its audience to the fact that it is listening to a digital audio broadcast. No other insertion between the station's call letters and the community or communities specified in its license is permissible. A station may include in its official station identification the name of any additional community or communities, but the community to which the station is licensed must be named first.
47 CFR 74.783(e) permits low power TV permittees or licensees to request to be assigned four-letter call signs in lieu of the five-character alpha-numeric call signs.
47 CFR 74.1283(c)(1) requires a FM translator station licensee whose identification is made by the primary station must arrange for the primary station licensee to furnish the translator's call letters and location (name, address, and telephone number of the licensee or service representative) to the FCC. The licensee must keep this information in the primary station's files.
No comments concerning the termination of this receivership will be considered which are not sent within this time frame.
The Commission hereby gives notice of the filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments on the agreements to the Secretary, Federal Maritime Commission, Washington, DC 20573, within twelve days of the date this notice appears in the
By Order of the Federal Maritime Commission.
Notice is given that a Complaint has been filed with the Federal Maritime Commission (Commission) by Pro Transport, Inc., Pro Transport Jacksonville, Inc., Pro Transport Savannah, Inc. and Pro Transport Charleston, Inc., hereinafter “Complainants,” against Seaboard Marine of Florida, Inc., and Seaboard Marine Ltd., Inc., hereinafter “Respondents.” Complainants state that they are “motor carriers that provide transportation and transportation services, primarily to and from commercial ports along the southeastern seaboard of the United States.” Complainants allege that Respondents “acted as an ocean common carrier, a marine terminal operator, and/or as an agent for an ocean common carrier.”
Complainants allege that Respondents have violated Sections 10(b)(10), 10(d)(3), and 10(d)(4) of the Shipping Act of 1984, 46 U.S.C. 41104(10) and 46 U.S.C. 41106(2-3), because they refused to pay Complainants for services, terminated their relationship, and refuse to cooperate on outstanding insurance claims.
Complainants request the following relief: That Seaboard answer the charges in the complaint; be ordered to cease and desist from the aforesaid violations of the Shipping Act; establish and put in force such practices as the Commission determines to be lawful and reasonable; pay reparations to Complainants for alleged unlawful conduct in an amount the Commission may determine to be proper, with interest and attorney's fees and costs; and that the Commission issue such other and further order(s) as the Commission determines to be proper.
The full text of the complaint can be found in the Commission's Electronic Reading Room at
This proceeding has been assigned to the Office of Administrative Law Judges. The initial decision of the presiding officer in this proceeding shall be issued by May 12, 2017 and the final decision of the Commission shall be issued by November 27, 2017.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than June 10, 2016.
A. Federal Reserve Bank of Dallas (Robert L. Triplett III, Senior Vice President) 2200 North Pearl Street, Dallas, Texas 75201-2272:
1.
Federal Retirement Thrift Investment, Joint Board Member/ETAC Meeting, May 23, 2016, 8:30 a.m. (In-Person), 77 K Street NE., Training Room, Washington, DC 20002.
Kimberly Weaver, Director, Office of External Affairs, (202) 942-1640.
Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Notice of request for public comments regarding an extension of an existing OMB clearance.
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning anti-kickback procedures.
Submit comments on or before July 18, 2016.
Submit comments identified by Information Collection 9000-0091, Anti-Kickback Procedures, by any of the following methods:
•
Submit comments via the Federal eRulemaking portal by searching the OMB control number. Select the link “Submit a Comment” that corresponds with “Information Collection 9000-0091, Anti-Kickback Procedures”. Follow the instructions provided at the “Submit a Comment” screen. Please include your name, company name (if any), and “Information Collection 9000-0091, Anti-Kickback Procedures” on your attached document.
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Ms. Cecelia L. Davis, Procurement Analyst, Office of Governmentwide Acquisition Policy, GSA, 202-219-0202 or email
Federal Acquisition Regulation (FAR) 52.203-7, Anti-Kickback Procedures, requires that all contractors have in place and follow reasonable procedures designed to prevent and detect in its own operations and direct business relationships, violations of 41 U.S.C. chapter 87, Kickbacks. Whenever prime contractors or subcontractors have reasonable grounds to believe that a violation of the statute may have occurred, they are required to report the possible violation in writing to the contracting agency inspector general, the head of the contracting agency if an agency does not have an inspector general, or the Department of Justice. The information is used to determine if any violations of the statute have occurred.
There is no Governmentwide data collection process or system which identifies the number of alleged violations of 41 U.S.C. chapter 87, Kickbacks that are reported annually to agency inspectors general, the heads of the contracting agency if an agency does not have an inspector general, or the Department of Justice.
Public comments are particularly invited on: Whether this collection of information is necessary for the proper
Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street Street NW., Washington, DC 20405, telephone 202-501-4755.
Please cite OMB Control No. 9000-0091, Anti-Kickback Procedures, in all correspondence.
Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Notice of request for an extension to an information collection requirement for an existing OMB clearance.
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning the Make-or-Buy Program.
Submit comments on or before June 17, 2016.
Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods:
•
•
Mr. Edward Loeb, Procurement Analyst, Office of Acquisition Policy, GSA, 202-501-0650 or via email at
Price, performance, and/or implementation of socio-economic policies may be affected by make-or-buy decisions under certain Government prime contracts. Accordingly, FAR 15.407-2, Make-or-Buy Programs:
(i) Sets forth circumstances under which a Government contractor must submit for approval by the contracting officer a make-or-buy program,
(ii) Provides guidance to contracting officers concerning the review and approval of the make-or-buy programs; and
(iii) Prescribes the contract clause at FAR 52.215-9, Changes or Additions to Make-or-Buy Programs, which specifies the circumstances under which the contractor is required to submit for the contracting officer's advance approval a notification and justification of any proposed change in the approved make-or-buy program.
The information is used to assure the lowest overall cost to the Government for required supplies and services. A notice was published in the
Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the Federal Acquisition Regulation (FAR), and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Notice of request for public comments regarding an extension to an existing OMB clearance.
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension to a previously approved information collection requirement concerning prompt payment.
Submit comments on or before June 17, 2016.
Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods:
•
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Ms. Kathlyn Hopkins, Procurement Analyst, Office of Acquisition Policy, GSA 202-969-7226 or email
Part 32 of the FAR and the clause at FAR 52.232-5, Payments Under Fixed-Price Construction Contracts, require that contractors under fixed-price construction contracts certify, for every progress payment request, that payments to subcontractors/suppliers have been made from previous payments received under the contract and timely payments will be made from the proceeds of the payment covered by the certification, and that this payment request does not include any amount which the contractor intends to withhold from a subcontractor/supplier. Part 32 of the FAR and the clause at 52.232-27, Prompt Payment for Construction Contracts, further require that contractors on construction contracts:
(a) Notify subcontractors/suppliers of any amounts to be withheld and furnish a copy of the notification to the contracting officer;
(b) Pay interest to subcontractors/suppliers if payment is not made by 7 days after receipt of payment from the Government, or within 7 days after correction of previously identified deficiencies;
(c) Pay interest to the Government if amounts are withheld from subcontractors/suppliers after the Government has paid the contractor the amounts subsequently withheld, or if the Government has inadvertently paid the contractor for nonconforming performance; and
(d) Include a payment clause in each subcontract which obligates the contractor to pay the subcontractor for satisfactory performance under its subcontract no later than seven days after such amounts are paid to the contractor, include an interest penalty clause which obligates the contractor to pay the subcontractor an interest penalty if payments are not made in a timely manner, and include a clause requiring each subcontractor to include these clauses in each of its subcontractors and to require each of its subcontractors to include similar clauses in their subcontracts.
These requirements are imposed by Public Law 100-496, the Prompt Payment Act Amendments of 1988.
Contracting officers will be notified if the contractor withholds amounts from subcontractors/suppliers after the Government has already paid the contractor the amounts withheld. The contracting officer must then charge the contractor interest on the amounts withheld from subcontractors/suppliers. Federal agencies could not comply with the requirements of the law if this information were not collected. A notice was published in the
Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the FAR, and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
Please cite OMB Control No. 9000-0102, Prompt Payment, in all correspondence.
In compliance with the requirements of section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington DC 20201. Attn: ACF Reports Clearance Officer. Email address:
The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.
Notice is hereby given that on January 27, 2016, the Assistant Secretary for Children and Families re-delegated certain responsibilities under the Trafficking Victims Protection Act of 2000 (TVPA), as amended, to the Director of the Office on Trafficking in Persons (OTIP), an office within the Immediate Office of the Assistant Secretary. In addition, the Assistant Secretary delegated to OTIP other authorities under sections 107(b) and 107(f) of the TVPA. By virtue of these re-delegations, certain previously delegated authorities to the Office of Refugee Resettlement (ORR) were rescinded.
By virtue of the authority vested in the Assistant Secretary by the Secretary of Health and Human Services on April 30, 2004, I rescinded the following delegation to the Director of ORR made on January 11, 2008 (73 FR 5198) and re-delegated the responsibilities to the Director of OTIP, with the authority to re-delegate:
Authority to conduct public awareness and information activities under section 106(b) of the TVPA (22 U.S.C. 7104(b)).
By virtue of the authority vested in the Assistant Secretary by the Secretary of Health and Human Services on March 28, 2001 (66 FR 18642), I rescinded the following delegation to the Director of ORR made on April 10, 2001 (66 FR 19960-61) and re-delegated the responsibilities to the Director of OTIP, with authority to re-delegate:
Authority to conduct certification activities under section 107(b)(1) of the TVPA, (22 U.S.C. 7105(b)(1)). In exercising this authority, personnel in OTIP will consult with the Secretary of Homeland Security.
By virtue of the authority vested in the Assistant Secretary by the Secretary of Health and Human Services on March 23, 2009 (74 FR 14564), I rescinded the following delegations to the Director of ORR made on April 10, 2009 (74 FR 19233) and re-delegated the responsibilities to the Director of OTIP, with authority to re-delegate:
Authority under section 107(b)(1) of the TVPA (22 U.S.C. 7105(b)(1)) to provide interim assistance to children who may have been subjected to a severe form of trafficking and to issue eligibility letters and conduct related activities. In issuing eligibility letters, personnel in the Administration for Children and Families will consult with the Attorney General, the Secretary of Homeland Security, and nongovernmental organizations with expertise on victims of trafficking.
Authority to train Federal staff and State and local officials to improve identification and protection for victims of a severe form of trafficking under section 107(c)(4) of the TVPA (22 U.S.C. 7105(c)(4)).
These delegations of authority supersede any prior delegations or re-delegations on these subjects to the extent such delegations or re-delegations may be inconsistent herewith.
I hereby affirm and ratify any actions taken by the Director of Refugee Resettlement and the OTIP Director, or his or her subordinates, which involved the exercise of authorities prior to the effective date of these January 27, 2016, delegations.
These authorities shall be exercised under the Department's policy on regulations and the existing delegation of authority to approve and issue regulations.
These delegations shall be exercised under financial and administrative requirements applicable to these Administration for Children and Families authorities.
The delegations listed were effective January 27, 2016.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
The meeting will be held on June 28, 2016, from 8 a.m. to 5 p.m.
Hilton Washington DC/Rockville Hotel & Executive Meeting Center, Plaza Ballroom, 1750 Rockville Pike, Rockville, MD 20852. The hotel's telephone number is 301-468-1100. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at:
LaToya Bonner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533,
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact LaToya Bonner at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Health Resources and Services Administration, HHS.
Notice.
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces
Comments on this ICR should be received no later than July 18, 2016.
Submit your comments to
To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email
When submitting comments or requesting information, please include the information request collection title for reference.
HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Health Resources and Services Administration, HHS.
Notice.
In compliance with the requirement for opportunity for public
Comments on this Information Collection Request must be received no later than July 18, 2016.
Submit your comments to
To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email
When submitting comments or requesting information, please include the information request collection title for reference.
HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Health Resources and Services Administration, HHS.
Notice.
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Comments on this ICR should be received no later than June 17, 2016.
Submit your comments, including the Information Collection Request Title, to the desk officer for HRSA, either by email to
To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at
This program will further support integrated rural health networks that can partner with local community colleges and other accredited educational institutions (such as vocational and technical colleges) to develop formal clinical training programs.
National Institutes of Health, Public Health Service, Department of Health and Human Services.
Notice.
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in:
The patent rights to these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America.
The prospective exclusive licensed territory may be the United States, Australia, Canada, the European Union, Russia, China, Hong Kong, Japan, Taiwan, South Korea and Singapore, and the field of use may be limited to: “The development of a glypican-3 (GPC3) chimeric antigen receptor (CAR)-based immunotherapy using autologous (meaning one individual is both the donor and the recipient) primary human lymphocytes (T cells or NK cells) transfected with a lentiviral or retroviral vector, wherein the vector expresses a CAR having (1) a single antigen specificity and (2) comprising at least: (a) the complementary determining region (CDR) sequences of the anti-GPC3 antibody known as HN3; and (b) a T cell signaling domain; for the prophylaxis and treatment of GPC3-expressing cancers.”
Only written comments and/or applications for a license which are received by the NCI Technology Transfer Center on or before June 2, 2016 will be considered.
Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: David A. Lambertson, Ph.D., Senior Licensing and Patenting Manager, National Cancer Institute, 9609 Medical Center Drive, Rm 1-E530 MSC9702, Rockville, MD 20850-9702, Email:
This invention concerns an anti-GPC3 (Glypican-3) chimeric antigen receptor (CAR) and methods of using the CAR for the treatment of GPC3-expressing cancers. GPC3 is a cell surface antigen that is preferentially expressed on certain types of cancer cells, particularly liver cancers such as hepatocellular carcinoma (HCC). The anti-GPC3 CARs of this technology contain (1) antigen recognition sequences that bind specifically to GPC3 and (2) signaling domains that can activate the cytotoxic functions of a T cell. The anti-GPC3 CAR can be transduced into T cells that are harvested from a donor, followed by (a) selection and expansion of the T cells expressing the anti-GPC3 CAR, and (b) reintroduction of the T cells into the patient. Once the anti-GPC3 CAR-expressing T cells are reintroduced into the patient, the T cells can selectively bind to GPC3-expressing cancer cells through its antigen recognition sequences, thereby activating the T cell through its signaling domains to selectively kill the cancer cells. Through this mechanism of action, the selectivity of the a CAR allows the T cells to kill cancer cells while leaving healthy, essential cells unharmed. This can result in an effective therapeutic strategy with fewer side effects due to less non-specific killing of cells.
The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404.7. The prospective exclusive license may be granted unless the NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.7 within fifteen (15) days from the date of this published notice.
Complete applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive start-up option license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute, the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the
To obtain a copy of the data collection plans and instruments, or request more information on the proposed project, contact: Goli Samimi, Program Director, Breast and Gynecologic Cancer Research Group, Division of Cancer Prevention. 9609 Medical Center Drive, MSC 9783, Bethesda, MD 20892, or call non-toll-free number (240) 276-6582, or Email your request, including your address to:
Proposed Collection: Survey to assess the feasibility of establishing a gynecologic specimen bank (NCI), 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH).
OMB approval is requested for 1 year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 42 hours.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
National Institutes Of Health, Public Health Service, HHS.
Notice.
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7, that the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Patent License to practice the inventions embodied in the following patent applications to Chimeron Bio Corporation, a company incorporated under the laws of Delaware and having an office in Philadelphia, PA.
The patent rights to these inventions have been assigned to the Government of the United States of America.
The prospective exclusive start-up licensed territory may be worldwide and the field of use may be limited to: “Use of virus like particles comprising MHCII and CD80 for the treatment of breast cancer, lung cancer, melanoma, pancreatic cancer, and hepatocellular cancer.”
Only written comments and/or applications for a license which are received by the NCI Technology Transfer Center on or before June 2, 2016 will be considered.
Requests for copies of the patent application, inquiries, and comments relating to the contemplated exclusive license should be directed to: Lauren Nguyen-Antczak, Ph.D., J.D., Sr. Licensing and Patenting Manager, Technology Transfer Center, National Cancer Institute, 8490 Progress Drive, Riverside 5, Suite 400, Frederick, MD 21701; Telephone: (301) 624-8752; Email:
The invention is directed to virus-like particles (“VLPs”) that serve to induce transgene expression of at least one recombinant protein of interest in specific, targeted cells. This technology can be used to treat a variety of diseases, depending on the cell type to be targeted. Preferably, invention VLPs may be used to treat tumor bearing cancers, including breast cancer, lung cancer, melanoma, pancreatic cancer, and hepatocellular cancer.
The prospective Start-Up Exclusive Patent License, which will be royalty bearing, is being considered under the small business initiative launched on 1 October 2011 and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404.7. The prospective Start-Up Exclusive Patent License may be granted unless the NIH receives written evidence and argument, within fifteen (15) days from the date of this published notice, that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.7.
Complete applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive start-up license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Public Health Service, National Institutes of Health, HHS.
Notice.
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in:
U.S. Provisional Patent Application 61/654,232 entitled “High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof” [HHS Ref. E-136-2012/0-US-01]; PCT Patent Application PCT/US2013/043633 entitled “High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof” [HHS Ref. E-136-2012/0-PCT-02]; Chinese Patent Application 201380039993.7 entitled “High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof” [HHS Ref. E-136-2012/0-CN-03]; Japanese Patent Application 2015-515243 entitled “High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof” [HHS Ref. E-136-2012/0-JP-04]; South Korea Patent Application 10-2014-7037046 entitled “High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof” [HHS Ref. E-136-2012/0-KR-05]; Singapore Patent Application 11201407972R entitled “High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof” [HHS Ref. E-136-2012/0-SG-06]; United States Patent Application 14/403,896 entitled “High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof” [HHS Ref. E-136-2012/0-US-07];
The patent rights to these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America.
The prospective exclusive licensed territory may be the United States, Australia, Canada, the European Union, Russia, China, Hong Kong, Japan, Taiwan, South Korea and Singapore, and the field of use may be limited to: “The development of a glypican-3 (GPC3) chimeric antigen receptor (CAR)-based immunotherapy using autologous (meaning one individual is both the donor and the recipient) primary human lymphocytes (T cells or NK cells) transfected with a lentiviral or retroviral vector, wherein the vector expresses a CAR having (1) a single antigen specificity and (2) comprising at least: (a) The complementary determining region (CDR) sequences of the anti-GPC3 antibody known as YP7; and (b) a T cell signaling domain; for the prophylaxis and treatment of GPC3-expressing cancers.”
Only written comments and/or applications for a license which are received by the NCI Technology Transfer Center on or before June 2, 2016 will be considered.
Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: David A. Lambertson, Ph.D., Senior Licensing and Patenting Manager, National Cancer Institute, 9609 Medical Center Drive, Rm 1-E530 MSC9702, Rockville, MD 20850-9702, Email:
This invention concerns an anti-GPC3 (Glypican-3) chimeric antigen receptor (CAR) and methods of using the CAR for the treatment of GPC3-expressing cancers. GPC3 is a cell surface antigen that is preferentially expressed on certain types of cancer cells, particularly liver cancers such as hepatocellular carcinoma (HCC). The anti-GPC3 CARs of this technology contain (1) antigen recognition sequences that bind specifically to GPC3 and (2) signaling domains that can activate the cytotoxic functions of a T cell. The anti-GPC3 CAR can be transduced into T cells that are harvested from a donor, followed by (a) selection and expansion of the T cells expressing the anti-GPC3 CAR, and (b) reintroduction of the T cells into the patient. Once the anti-GPC3 CAR-expressing T cells are reintroduced into the patient, the T cells can selectively bind to GPC3-expressing cancer cells through its antigen recognition sequences, thereby activating the T cell through its signaling domains to selectively kill the cancer cells. Through this mechanism of action, the selectivity
The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404.7. The prospective exclusive license may be granted unless the NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.7 within fifteen (15) days from the date of this published notice.
Complete applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive start-up option license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Room 4176, Washington, DC 20410-5000; telephone 202-402-3400 (this is not a toll-free number) or email at
Kevin Stevens, 451 7th Street SW., Washington, DC 20410; email
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Bureau of Land Management, Interior.
Notice.
In compliance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM) Price and Richfield Field Offices intend to prepare a Master Leasing Plan (MLP) and Resource Management Plan (RMP) amendments with a single Environmental Assessment (EA). The BLM will consider resource management plan decisions related to oil and gas leasing and post-leasing oil and gas development on approximately 525,000 acres of public land in the San Rafael Desert, located in Emery and
This notice initiates the public scoping process for the San Rafael Desert MLP, RMP amendments, and associated EA. Comments on issues may be submitted in writing until the end of the scoping period, which is June 17, 2016. The date(s) and location(s) of any scoping meetings will be announced at least 15 days in advance through local news media, newspapers and the BLM Web site at:
Comments may be submitted on issues and planning criteria related to the San Rafael Desert MLP and RMP amendments/EA by any of the following methods:
•
•
•
Tyler Ashcroft, National Project Manager; telephone (801) 539-4068; email
This document provides notice that the BLM Price and Richfield Field Offices in Utah intend to prepare an MLP and RMP amendments with a single EA for the San Rafael Desert, announces the beginning of the scoping process, and seeks public input on issues and planning criteria.
The planning area is located in Emery and Wayne counties in Utah and encompasses approximately 525,000 acres of public land that are primarily located south of Interstate 70 and east of Highway 24. The eastern boundary of the MLP planning area is generally the Green River. A small portion of the MLP area is located north of Interstate 70, west of the City of Green River, UT, and East of the San Rafael Swell. U.S. Highway 6 bisects this part of the planning area.
The BLM will prepare the MLP in accordance with Washington Office Instruction Memorandum No. 2010-117, Oil and Gas Leasing Reform—Land Use Planning and Lease Parcel Reviews, May 17, 2010, which has been incorporated and supplemented in various BLM handbooks, including H-1624-1, Planning for Fluid Mineral Resources. The MLP process will provide additional planning and analysis for areas prior to new leasing of oil and gas resources. The MLP process will enable the Price and Richfield Field Offices to: (1) Resolve long-standing lease protests relating to parcels of land for which BLM received lease offers subject to protest, but for which BLM has not issued leases in the planning area; (2) Determine whether the BLM should cancel, modify, or lift the suspensions on suspended leases in the planning area; (3) Evaluate potential development scenarios; (4) Identify and address potential resource conflicts and environmental impacts from development; (5) Create oil and gas development mitigation strategies; and (6) Consider a range of new conditions, including prohibiting surface occupancy or closing certain areas to leasing.
The MLP process could result in new oil and gas leasing stipulations and development scenarios which would require amendments to the Price and Richfield RMPs completed in 2008. The EA will analyze likely oil and gas development scenarios and land use plan alternatives with varying mitigation levels for leasing.
The purpose of the public scoping process is to determine relevant issues, identify alternatives, and guide the planning process. Preliminary issues for the plan amendment area have been identified by BLM personnel; Federal, State, and local agencies; and other stakeholders. The potential issues include: Air quality, climate change, cultural resources, paleontological resources, recreation, visual resources, night skies, riparian resources, soil and water resources, vegetation, wildlife resources, special status species, special designations, and wilderness characteristics.
The BLM established preliminary planning criteria for this effort. As part of those criteria, the BLM will: (1) Limit the scope to resource management plan decisions pertaining to oil and gas leasing and post-leasing development of the area; (2) resolve long-standing lease protests and decide whether to cancel, modify, or lift the suspension on suspended leases in the planning area; (3) recognize valid existing rights; (4) only address management of public lands (including federal mineral estate under non-federal surface in a “split estate” situation); (5) use a collaborative, multi-jurisdictional approach to determine how mineral leasing will be managed; (6) ensure that its management decisions are as consistent as possible with local, State, and other Federal agency plans; (7) prepare development scenarios for oil and gas resources based on historical, existing, and projected levels of development; (8) consider a range of alternatives that focus on mitigating the impacts of development on resources that are of concern; (9) address the socioeconomic impacts of the alternatives; and, (10) use the best available scientific information and inventory and monitoring information to determine appropriate decisions for oil and gas leasing.
You may submit comments on issues and planning criteria in writing to the BLM at any public scoping meeting, or you may submit them to the BLM using one of the methods listed in the
The BLM will utilize the NEPA scoping process to help fulfill the public involvement requirements under the National Historic Preservation Act (54 U.S.C. 306108), as provided in 36 CFR 800.2(d)(3). The information about historic and cultural resources within the area potentially affected by the proposed action will assist the BLM in identifying and evaluating impacts to such resources.
The BLM will consult with Indian tribes on a government-to-government basis in accordance with Executive Order 13175 and other policies. Tribal concerns, including impacts on Indian trust assets and potential impacts to cultural resources, will be given due consideration. Federal, State, and local agencies, along with tribes and other stakeholders that may be interested in or affected by the proposed action that the BLM is evaluating, are invited to participate in the scoping process and, if eligible, may request or be requested by the BLM to participate in the development of the EA as a cooperating agency.
The BLM will use an interdisciplinary approach to develop the plan amendment in order to consider the variety of resource issues and concerns identified. Specialists with expertise in the following disciplines will be involved in the planning process: Minerals and geology, outdoor
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
40 CFR 1501.7 and 43 CFR 1610.2
On the basis of the record
Pursuant to section 207.18 of the Commission's rules, the Commission also gives notice of the commencement of the final phase of its investigation. The Commission will issue a final phase notice of scheduling, which will be published in the
On March 28, 2016, the Vanadium Producers and Reclaimers Association and its members AMG Vanadium, LLC, Cambridge, Ohio; Bear Metallurgical Company, Butler, Pennsylvania; Gulf Chemical & Metallurgical Corporation, Freeport, Texas; and Evraz Stratcor, Inc., Hot Springs, Arkansas, filed a petition with the Commission and Commerce, alleging that an industry in the United States is materially injured and threatened with material injury by reason of LTFV imports of ferrovanadium from Korea. Accordingly, effective March 28, 2016, the Commission, pursuant to section 733(a) of the Tariff Act of 1930 (19 U.S.C. § 1673b(a)), instituted antidumping duty investigation No. 731-TA-1315 (Preliminary).
Notice of the institution of the Commission's investigation and of a public conference to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the
The Commission made this determination pursuant to section 733(a) of the Tariff Act of 1930 (19 U.S.C. § 1673b(a)). It completed and filed its determination in this investigation on May 12, 2016. The views of the Commission are contained in USITC Publication 4611 (May 2016), entitled
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined to suspend the limited exclusion order and cease and desist orders issued in this investigation pending remand proceedings.
Panyin A. Hughes, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-3042. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (
The Commission instituted this investigation on August 23, 2013, based on a complaint filed by ResMed Corporation of San Diego, California; ResMed Incorporated of San Diego, California; and ResMed Limited of New South Wales, Australia (collectively, “ResMed”). 78 FR 52564 (Aug. 23, 2013). The complaint alleged violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the
On January 9, 2014, the Administrative Law Judge (“ALJ”) issued an initial determination (“ID”) granting a motion by ResMed to amend the complaint and notice of investigation to substitute U.S. Patent No. RE 44,453 (“the '453 patent”) for the '398 patent and to terminate the investigation as to the '398 patent.
On February 24, 2014, the ALJ issued an ID granting a motion by ResMed to withdraw its allegations with respect to the '116 patent.
On August 21, 2014, the ALJ issued his final ID, finding a violation of section 337 by BMC with respect to certain asserted claims of the '392, '267, '060, '883, '527, and '453 patents. The ALJ found no violation of section 337 with respect to the asserted claims of the '487 patent.
On September 3, 2014, the parties filed petitions for review of the ID. On September 11, 2014, the parties filed responses to the petitions for review.
On October 16, 2014, the Commission determined to review the final ID in part. 79 FR 63163-65 (Oct. 22, 2014). On review, the Commission determined to affirm the ALJ's finding of violation of section 337. The Commission, however, found the '453 patent invalid for anticipation. Having found a violation of section 337, the Commission determined that the appropriate form of relief was (1) a limited exclusion order prohibiting the unlicensed entry of sleep-disordered breathing treatment systems and components thereof that infringe one or more of claims 1, 9, 32, 89, and 92 of the '527 patent; claims 19, 21, 29, 32, and 36 of the '392 patent; claims 32, 33, 34, and 53 of the '267 patent; claims 30, 37, and 38 of the '060 patent; and claims 1, 3, 5, 11, 28, 30, 31, and 56 of the '883 patent that are manufactured by, or on behalf of, or are imported by or on behalf of BMC Medical Co., Ltd., 3B Medical, Inc., or 3B Products L.L.C. or any of their affiliated companies, parents, subsidiaries, agents, or other related business entities, or their successors or assigns, except for service and replacement parts for customers that purchased their covered products prior to the date the exclusion order becomes final; and (2) cease and desist orders prohibiting domestic respondents BMC Medical Co., Ltd., 3B Medical, Inc. from conducting any of the following activities in the United States: Importing, selling, marketing, advertising, distributing, transferring (except for exportation), and soliciting U.S. agents or distributors for, sleep-disordered breathing treatment systems and components thereof covered by claims 1, 9, 32, 89, and 92 of the '527 patent; claims 19, 21, 29, 32, and 36 of the '392 patent; claims 32, 33, 34, and 53 of the '267 patent; claims 30, 37, and 38 of the '060 patent; and claims 1, 3, 5, 11, 28, 30, 31, and 56 of the '883 patent.
On February 18, 2015, ResMed filed a notice of appeal in the U.S. Court of Appeals for the Federal Circuit, seeking review of the Commission's determination as to the '453 patent (Appeal No. 2015-1360). On April 14, 2015, BMC filed a notice of appeal in the Federal Circuit, seeking review of the Commission's domestic industry determination as well as the Commission's finding that prior art does not render the asserted claims of the '267 patent invalid for obviousness (Appeal No. 2015-1576). The Court consolidated the two appeals on April 23, 2015.
On March 16, 2016, the parties jointly moved to dismiss ResMed's appeal as to the '453 patent. On March 17, 2016, the Commission moved to remand BMC's appeal in light of intervening domestic industry precedent in
The Commission has determined to suspend the remedial orders issued in this investigation pending the outcome of the remand.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on April 14, 2016, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of ResMed Corp. of San Diego, California; ResMed Inc. of San Diego, California; and ResMed Ltd. of Australia. A corrected complaint was filed on April 18, 2016, and a supplement was filed on April 19, 2016. The corrected complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain sleeping-disordered breathing treatment systems and components thereof by reason of infringement of certain claims of U.S. Patent No. RE44,453 (“the '453 patent”); U.S. Patent No. 8,020,551 (“the '551 patent”); U.S. Patent No. 8,006,691 (“the '691 patent”); and U.S. Patent No. 9,072,860 (“the '860 patent”). The complaint
The complainants request that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
The complaint, except for any confidential information contained therein, is available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Room 112, Washington, DC 20436, telephone (202) 205-2000. Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at (202) 205-2000. General information concerning the Commission may also be obtained by accessing its internet server at
The Office of Unfair Import Investigations, U.S. International Trade Commission, telephone (202) 205-2560.
Scope of Investigation: Having considered the complaint, the U.S. International Trade Commission, on May 11, 2016,
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain sleeping-disordered breathing treatment systems and components thereof by reason of infringement of one or more of claims 23 and 24 of the '453 patent; claims 1-24 and 26-33 of the '551 patent; claims 1-31, 40-43, 52-59, 61-67, 69-84, 86-120, 122-158, 160, 161, 164, 165, 167, 168, and 173 of the '691 patent; and claims 16-30 of the '860 patent, and whether an industry in the United States exists as required by subsection (a)(2) of section 337;
(2) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a) The complainants are:
(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:
(3) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.
The Office of Unfair Import Investigations will not participate as a party in this investigation.
Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.
Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.
By order of the Commission.
On the basis of the record
The Commission, pursuant to section 751(c) of the Tariff Act of 1930 (19 U.S.C. 1675(c)), instituted this review on December 1, 2015 (80 FR 75130) and determined on March 7, 2016 that it would conduct an expedited review (81 FR 15122, March 21, 2016).
The Commission made this determination pursuant to section 751(c) of the Tariff Act of 1930 (19 U.S.C. 1675(c)). It completed and filed its determination in this review on May 12, 2016. The views of the Commission are contained in USITC Publication 4610 (May 2016), entitled
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined to affirm with certain modifications an initial determination (“ID”) (Order No. 17), granting respondents' motion for summary determination of patent invalidity due to indefiniteness. The Commission finds no violation of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 (“section 337”). The investigation is terminated.
Megan M. Valentine, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone 202-708-2301. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (
The Commission instituted this investigation on January 13, 2015, based on a complaint filed by One-E-Way, Inc. of Pasadena, California (“One-E-Way”). 80 FR 1663 (Jan. 13, 2015). The complaint alleges violations of section 337, in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain wireless headsets by reason of infringement of certain claims of U.S. Patent Nos. 7,865,258 (“the '258 patent”) and 8,131,391 (“the '391 patent”).
On August 10, 2015, respondents Sony, BlueAnt, Creative Labs, and GN Netcom (collectively, “Respondents”) filed a motion for summary determination that asserted claim 8 of the '258 patent and asserted claims 1, 3-6, and 10 of the'391 patent are invalid as indefinite under 35 U.S.C. 112, ¶ 2. On August 20, 2015, the Commission investigative attorney (“IA”) filed a response in support of the motion. Also on August 20, 2015, One-E-Way filed an opposition to the motion. On August 27, 2015, Respondents moved for leave to file a reply to One-E-Way's opposition, which the presiding administrative law judge (“ALJ”) granted that same day.
On September 21, 2015, the ALJ issued the subject ID (Order No. 17), granting Respondents' motion for summary determination that all of the asserted claims of the '258 and '391 patents are invalid as indefinite under 35 U.S.C. 112, ¶ 2 and finding no violation of section 337. On October 2, 2015, One-E-Way filed a petition for review of the subject ID. On October 9, 2015, Respondents and the IA each filed responses to the petition.
On December 1, 2015, the Commission determined to review Order No. 17 and posed several questions to the parties. 80 FR 76038-40 (Dec. 7, 2015). The parties filed initial submissions on December 11, 2015, and filed response submissions on December 18, 2015.
Having examined the record of this investigation, including the subject ID, the petitions for review, and the responses thereto, and the parties' submissions in response to the Commission's request for additional briefing, the Commission has determined to affirm Order No. 17 with modification. In particular, the Commission corrects the statement on pages 7, 61, and 65-66 of the subject ID that the limitations “free from interference” and “virtually free from interference” coexist in the asserted claims. The asserted claims recite the limitation “virtually free from interference” only. The Commission also clarifies that the ALJ's statement on page 85 of subject ID that the intrinsic evidence fails to explain how the invention both “transmits” and “reproduces” audio “virtually free from interference” should be made with reference to claims 1 and 5 of the '391 patent, not to claims 1 and 3 of the '391 patent.
The Commission finds no violation of section 337. The investigation is terminated.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review the presiding administrative law judge's (“ALJ”) initial determination (“ID”) (Order No. 19) terminating Recordex USA, Inc. The Commission requests written submissions, under the schedule set forth below, on remedy, public interest, and bonding.
Amanda Pitcher Fisherow, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2737. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server at
The Commission instituted this investigation on September 24, 2015, based on a complaint filed on behalf of Pathway Innovations & Technologies, Inc. of San Diego, California (“Complainant”). 80 FR 57642 (September 24, 2015). The complaint alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, in the sale for importation, importation, or sale within the United States after importation of certain document cameras and software for use therewith by reason of infringement of certain claims of U.S. Design Patent No. D647,906; U.S. Design Patent No. D674,389; U.S. Design Patent No. D715,300; and U.S. Patent No. 8,508,751. The Commission's notice of investigation named the following respondents: Recordex USA, Inc., of Long Island City, New York (“Recordex”); QOMO HiteVision, LLC, of Wixom, Michigan (“QOMO”); and Adesso, Inc. of Walnut, California (“Adesso”). The Office of Unfair Import Investigations was named as a party but has subsequently withdrawn from the investigation. Adesso was terminated based on a consent order stipulation and consent order. Order No. 5 (unreviewed) (Nov. 23, 2015). QOMO was found to be in default. Order No. 10 (unreviewed) (Dec. 7, 2015). Recordex is the last remaining respondent in this investigation.
On April 11, 2016, Complainant and Recordex filed a joint motion to terminate the investigation as to Recordex based on a settlement agreement. Complainant and Recordex stated that other than the settlement agreement, “[t]here are no other agreements, written or oral, express or implied between the moving parties concerning the subject matter of the investigation.”
On April 20, 2016, the ALJ granted the joint motion. The ID agreed with Complainant and Recordex that termination of the investigation as to Recordex will not negatively impact the public interest. ID at 2. The parties provided public and confidential versions of the settlement agreement.
The Commission has determined not to review the subject ID.
As noted above, QOMO was previously found to be in default. Section 337(g)(1) and Commission Rule 210.16(c) authorize the Commission to order relief against a respondent found in default, unless, after considering the public interest, it finds that such relief should not issue. Complainant seeks a limited exclusion order and a cease and desist order.
In connection with the final disposition of this investigation, the Commission may: (1) Issue an order that could result in the exclusion of articles manufactured or imported by the defaulting respondent; and/or (2) issue a cease and desist order that could result in the defaulting respondent being required to cease and desist from engaging in unfair acts in the importation and sale of such articles. Accordingly, the Commission is interested in receiving written submissions that address the form of remedy, if any, that should be ordered. If a party seeks exclusion of an article from entry into the United States for purposes other than entry for consumption, the party should so indicate and provide information establishing that activities involving other types of entry either are adversely affecting it or likely to do so. For background, see
If the Commission contemplates some form of remedy, it must consider the effects of that remedy upon the public interest. The factors that the Commission will consider include the effect that the exclusion order and/or cease and desists orders would have on (1) the public health and welfare, (2) competitive conditions in the U.S. economy, (3) U.S. production of articles that are like or directly competitive with those that are subject to investigation, and (4) U.S. consumers. The Commission is therefore interested in receiving written submissions that address the aforementioned public interest factors in the context of this investigation.
If the Commission orders some form of remedy, the U.S. Trade Representative, as delegated by the President, has 60 days to approve or disapprove the Commission's action.
The written submissions and proposed remedial orders must be filed no later than close of business on May 23, 2016. Reply submissions must be filed no later than the close of business on May 31, 2016. No further submissions on these issues will be permitted unless otherwise ordered by the Commission.
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to section 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the investigation number (“Inv. No. 337-TA-967”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
Notice is hereby given that, on April 12, 2016, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and HSA Foundation intends to file additional written notifications disclosing all changes in membership.
On August 31, 2012, HSA Foundation filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on January 20, 2016. A notice was published in the
Notice is hereby given that, on March 24, 2016, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Pursuant to Section 6(b) of the Act, the name and principal place of business of the standards development organization is: YBA (Yoga Bridge Accreditation), Portland, OR. The nature and scope of YBA's standards and development activities are: To set industry standards for a diverse research based yoga training & education. YBA works on two fronts: To certify individuals interested in yoga according to our Standards, and, to offer certified continuing education classes for professionals in non-yoga related fields to incorporate YBA teachings into their existing professions.
Notice is hereby given that, on April 12, 2016, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Also, Hydro-Quebec, Montreal, CANADA; Valley View Corporation, Rockville, MD; Michigan Public Service Commission, Lansing, MI; WiMAX Forum, Portland, OR; Lakeview Consulting Group, Morgan Hill, CA; Buford Goff & Associates, Inc., Columbia, SC; Qualcomm Technologies, Inc., San Diego, CA; Z-Wave Alliance, Milpitas, CA; Wells Fargo, San Francisco, CA; Cetecom, Milpitas, CA; JKN Consulting, Scotts Valley, CA; Energy Central, Aurora, CO; and Jamaica Public Service Company Ltd., Kingston 5, JAMAICA, have withdrawn as parties to this venture.
No other changes have been made in either the membership or planned
On February 5, 2013, MSGIP 2.0 filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on January 14, 2016. A notice was published in the
On May 9, 2016, the Department of Justice lodged a proposed consent decree with the United States District Court for the District of Minnesota in the lawsuit entitled
The United States and the State of Minnesota filed this lawsuit under the Clean Water Act. The complaint seeks injunctive relief and civil penalties for violations of Defendant's National Pollutant Discharge Elimination System (“NPDES”) permit issued by the State to Southern Minnesota Beet Sugar Cooperative's sugar beet processing facility in Renville County, Minnesota. The consent decree requires the defendant to perform injunctive relief, pay a $1,000,000.00 civil penalty (split evenly between the United States and the State), and pay restitution to the State of $49,155.83.
The publication of this notice opens a period for public comment on the consent decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to
During the public comment period, the consent decree may be examined and downloaded at this Justice Department Web site:
Please enclose a check or money order for $17.00 (25 cents per page reproduction cost) payable to the United States Treasury. For a paper copy without the exhibits and signature pages, the cost is $7.50.
Notice.
The Department of Labor (DOL) is submitting the Office of Labor Management Standards (OLMS) sponsored information collection request (ICR) revision titled, “Labor Organization and Auxiliary Reports,” to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501
The OMB will consider all written comments that agency receives on or before June 17, 2016.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at
Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OLMS, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or sending an email to
This ICR seeks approval under the PRA for revisions to the Labor Organization and Auxiliary Reports information collection. The Labor-Management Reporting and Disclosure Act requires a union to file an annual financial report and a copy of the union's constitution and bylaws with the DOL. Under certain circumstances, reports are required of a union officer and employee, employer, labor relations consultant, and surety company. Any such report is available for public disclosure. A filer is required to retain supporting records for five years; a union is also required to retain election records for one year. This information collection has been classified as a revision, because the OLMS is changing the instructions to the Form LM-3 and LM-4 Labor Organization Annual Reports, in order to mandate electronic filing, as well as amend the hardship exemption process for Form LM-2 filers. If approved, the changes for the Forms LM-2, LM-3, and LM-4 will apply to fiscal years beginning on or after January 1, 2017.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
44 U.S.C. 3507(a)(1)(D).
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Planetary Protection Subcommittee of the NASA Advisory Council (NAC). This Subcommittee reports to the Science Committee of the NAC. The meeting will be held for the purpose of soliciting, from the scientific community and other persons, scientific and technical information relevant to program planning.
Wednesday, June 1, 2016, 9:30 a.m. to 5:00 p.m., and Thursday, June 2, 2016, 8:45 a.m. to 3:30 p.m., Local Time.
NASA Headquarters, Room 1Q39, 300 E Street SW., Washington, DC 20546.
Ms. Ann Delo, Science Mission Directorate, NASA Headquarters, Washington, DC 20546, (202) 358-0750, fax (202) 358-2779.
The meeting will be open to the public up to the capacity of the room. The meeting will also be available telephonically and by WebEx. Any interested person may call the conference call number 1-888-324-3811 (USA toll free) or 1-210-234-8402, passcode 94125, to participate in this meeting by telephone. The WebEx link is
Attendees will be requested to sign a register and to comply with NASA security requirements, including the presentation of a valid picture ID to Security before access to NASA Headquarters. Due to the Real ID Act, Public Law 109-13, any attendees with drivers licenses issued from non-compliant states/territories must present a second form of ID. [Federal employee badge; passport; active military identification card; enhanced driver's license; U.S. Coast Guard Merchant Mariner card; Native American tribal document; school identification accompanied by an item from LIST C (documents that establish employment authorization) from the “List of the Acceptable Documents” on Form I-9]. Non-compliant states/territories are: American Samoa, Illinois, Minnesota, Missouri, New Mexico and Washington. Foreign nationals attending this meeting will be required to provide a copy of their passport and visa in addition to providing the following information no less than 10 working days prior to the meeting: full name; gender; date/place of birth; citizenship; visa information (number, type, expiration date); passport information (number, country, expiration date); employer/affiliation information (name of institution, address, country, telephone); title/position of attendee; and home address to Ann Delo via email at
Nuclear Regulatory Commission.
Exemption and combined license amendment; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is granting an exemption to allow a departure from the certification information of Tier 1 of the generic design control document (DCD) and is issuing License Amendment No. 48 to Combined Licenses (COLs), NPF-91 and NPF-92. The COLs were issued to Southern Nuclear Operating Company, Inc. (SNC); Georgia Power Company; Oglethorpe Power Corporation; MEAG Power SPVM, LLC; MEAG Power SPVJ, LLC; MEAG Power SPVP, LLC; Authority of Georgia; and the City of Dalton, Georgia (together “the licensee”) for construction and operation of the Vogtle Electric Generating Plant (VEGP) Units 3 and 4, located in Burke County, Georgia.
The granting of the exemption allows the changes to Tier 1 information asked for in the amendment. Because the acceptability of the exemption was determined in part by the acceptability of the amendment, the exemption and amendment are being issued concurrently.
Please refer to Docket ID NRC-2008-0252 when contacting the NRC about the availability of information regarding this document. You may access information related to this document, which the NRC possesses and is publicly available, using any of the following methods:
•
•
•
Paul Kallan, Office of New Reactors, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2809, email:
The NRC is granting an exemption from paragraph B of Section III, “Scope and Contents,” of appendix D, “Design Certification Rule for the AP1000,” to part 52 of title 10 of the
Part of the justification for granting the exemption was provided by the review of the amendment. Because the exemption is necessary in order to issue the requested license amendment, the NRC granted the exemption and issued the amendment concurrently, rather than in sequence. This included issuing a combined safety evaluation containing the NRC staff's review of both the exemption request and the license amendment. The exemption met all applicable regulatory criteria set forth in 10 CFR 50.12, 10 CFR 52.7, and Section VIII.A.4 of appendix D to 10 CFR part 52. The license amendment was found to be acceptable as well. The combined safety evaluation is available in ADAMS under Accession No. ML16053A177.
Identical exemption documents (except for referenced unit numbers and license numbers) were issued to the licensee for VEGP Units 3 and 4 (COLs NPF-91 and NPF-92). The exemption documents for VEGP Units 3 and 4 can be found in ADAMS under Accession Nos. ML16053A133 and ML16053A136, respectively. The exemption is reproduced (with the exception of abbreviated titles and additional citations) in Section II of this document. The amendment documents for COLs NPF-91 and NPF-92 are available in ADAMS under Accession Nos. ML16053A146 and ML16053A148, respectively. A summary of the amendment documents is provided in Section III of this document.
Reproduced below is the exemption document issued to Vogtle Units 3 and Unit 4. It makes reference to the combined safety evaluation that provides the reasoning for the findings made by the NRC (and listed under Item 1) in order to grant the exemption:
1. In a letter dated May 7, 2015, the licensee requested from the Commission an exemption from the provisions of 10 CFR part 52, appendix D, Section III.B, as part of license amendment request 15-006, “Main Control Room Emergency Habitability System (VES) Design Changes (LAR-15-006).”
For the reasons set forth in Section 3.1, “Evaluation of Exemption,” of the NRC staff's Safety Evaluation, which can be found in ADAMS under Accession No. ML16053A177, the Commission finds that:
A. The exemption is authorized by law;
B. the exemption presents no undue risk to public health and safety;
C. the exemption is consistent with the common defense and security;
D. special circumstances are present in that the application of the rule in this circumstance is not necessary to serve the underlying purpose of the rule;
E. the special circumstances outweigh any decrease in safety that may result from the reduction in standardization caused by the exemption; and
F. the exemption will not result in a significant decrease in the level of safety otherwise provided by the design.
2. Accordingly, the licensee is granted an exemption from the certified DCD Tier 1, as described in the licensee's request dated May 7, 2015. This exemption is related to, and necessary for the granting of License Amendment No. 48, which is being issued concurrently with this exemption.
3. As explained in Section 5.0, “Environmental Consideration,” of the NRC staff's Safety Evaluation (ADAMS Accession No. ML16053A177), this exemption meets the eligibility criteria for categorical exclusion set forth in 10 CFR 51.22(c)(9). Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental
4. This exemption is effective as of the date of its issuance.
By letter dated May 07, 2015, the licensee requested that the NRC amend the COLs for VEGP, Units 3 and 4, COLs NPF-91 and NPF-92. The proposed amendment is described in Section I of this
The Commission has determined for these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR Chapter I, which are set forth in the license amendment.
A notice of consideration of issuance of amendment to facility operating license or combined license, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the
The Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments.
Using the reasons set forth in the combined safety evaluation, the staff granted the exemption and issued the amendment that the licensee requested on May 7, 2015. The exemption and amendment were issued on March 30, 2016 as part of a combined package to the licensee (ADAMS Accession No. ML16053A091).
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Combined license application; receipt.
The U.S. Nuclear Regulatory Commission (NRC) is giving notice once each week for four consecutive weeks of the North Anna Unit 3 combined license (COL) application from Dominion Virginia Power (Dominion).
May 18, 2016.
Please refer to Docket ID NRC-2008-0066 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using the following methods:
•
•
•
James Shea, Office of New Reactors, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-1388, email:
The Virginia Electric and Power Company, doing business as Dominion Virginia Power (Applicant) has filed an application for a COL with the NRC under Section 103 of the Atomic Energy Act of 1954, as amended, and part 52 of title 10 of the
For the Nuclear Regulatory Commission.
U.S. Office of Personnel Management (OPM).
Notice.
This notice identifies Schedule A, B, and C appointing authorities applicable to a single agency that were established or revoked from January 1, 2016, to January 31, 2016.
Senior Executive Resources Services, Senior Executive Services and Performance Management, Employee Services, 202-606-2246.
In accordance with 5 CFR 213.103, Schedule A, B, and C appointing authorities available for use by all agencies are codified in the Code of Federal Regulations (CFR). Schedule A, B, and C appointing authorities applicable to a single agency are not codified in the CFR, but the Office of Personnel Management (OPM) publishes a notice of agency-specific authorities established or revoked each month in the
No Schedule A Authorities to report during January 2016.
No Schedule B Authorities to report during January 2016.
The following Schedule C appointing authorities were approved during January 2016.
The following Schedule C appointing authorities were revoked during January 2016.
5 U.S.C. 3301 and 3302; E.O. 10577, 3 CFR, 1954-1958 Comp., p. 218.
U.S. Office of Personnel Management.
U.S. Office of Personnel Management.
60-Day Notice and request for comments.
The Retirement Services, Office of Personnel Management (OPM) offers the general public and other Federal agencies the opportunity to comment on a revised information collection request (ICR) 3206-0237, Information and Instruction on Your Reconsideration Rights, RI 38-47. As required by the Paperwork Reduction Act of 1995 (Public Law 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. Law 104-106), OPM is soliciting comments for this collection.
Comments are encouraged and will be accepted until July 18, 2016. This process is conducted in accordance with 5 CFR 1320.1.
Interested persons are invited to submit written comments on the proposed information collection to Retirement Services, U.S. Office of Personnel Management, 1900 E Street NW., Washington, DC 20415, Attention: Alberta Butler, Room 2347-E or sent by email to
A copy of this ICR with applicable supporting documentation, may be obtained by contacting the Retirement Services Publications Team, Office of
The Office of Management and Budget is particularly interested in comments that:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of functions of OPM, including whether the information will have practical utility;
2. Evaluate the accuracy of OPM's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
RI 38-47 outlines the procedures required to request reconsideration of an initial OPM decision about Civil Service or Federal Employees retirement, Federal or Retired Federal Employees Health Benefits requests to enroll or change enrollment or Federal Employees' Group Life Insurance coverage. This form lists the procedures and time periods required for requesting reconsideration.
U.S. Office of Personnel Management (OPM).
Notice.
This notice identifies Schedule A, B, and C appointing authorities applicable to a single agency that were established or revoked from February 1, 2016, to February 29, 2016.
Senior Executive Resources Services, Senior Executive Services and Performance Management, Employee Services, 202-606-2246.
In accordance with 5 CFR 213.103, Schedule A, B, and C appointing authorities available for use by all agencies are codified in the Code of Federal Regulations (CFR). Schedule A, B, and C appointing authorities applicable to a single agency are not codified in the CFR, but the Office of Personnel Management (OPM) publishes a notice of agency-specific authorities established or revoked each month in the
No Schedule A Authorities to report during February 2016.
One position of Deputy Director; and one position of Associate Director of the Division of Supervision, Enforcement, and Fair Lending.
The following Schedule C appointing authorities were approved during February 2016.
The following Schedule C appointing authorities were revoked during February 2016.
5 U.S.C. 3301 and 3302; E.O. 10577, 3 CFR, 1954-1958 Comp., p. 218.
U.S. Office of Personnel Management.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The ISE proposes to eliminate Priority Customer complex order rebates for certain “net zero” complex orders. The text of the proposed rule change is available on the Exchange's Web site (
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The self-regulatory organization has prepared summaries, set forth in sections A, B and C below, of the most significant aspects of such statements.
Currently, the Exchange provides rebates to Priority Customer
Recently, a market participant has been entering a large volume of valueless complex orders that trade at a net price at or near $0.00 (
A “Non-ISE Market Maker” is a market maker as defined in Section 3(a)(38) of the Securities Exchange Act of 1934, as amended, registered in the same options class on another options exchange.
A “Firm Proprietary” order is an order submitted by a member for its own proprietary account.
A “Broker-Dealer” order is an order submitted by a member for a broker-dealer account that is not its own proprietary account.
A “Professional Customer” is a person or entity that is not a broker/dealer and is not a Priority Customer.
By entering essentially valueless complex orders, this market participant or others employing the same strategy are able to recover rebates for essentially non-economic trades at the expense of the Exchange and the market participants on the other side of the trade. This behavior is a form of rebate arbitrage, and the Exchange believes that it is in the best interest of the Exchange and its members to remove the incentives that promote this activity. The Exchange therefore proposes to eliminate Priority Customer rebates for “net zero” complex orders that are entered on behalf of originating market participants that execute an ADV of at least 10,000 “net zero” complex orders in a given month. For purposes of determining which complex orders qualify as “net zero” the Exchange will count all complex orders that leg in to the regular order book and are executed at a net price that is within a range of $0.01 credit and $0.01 debit.
The Exchange believes that the proposed rule change is consistent with the provisions of Section 6 of the Act,
The Exchange believes that the proposed fee change is reasonable and equitable as it is designed to remove financial incentives for market participants to engage in rebate arbitrage by entering “net zero” complex orders on the Exchange that do not have any economic substance. As explained above, Priority Customer complex orders, including “net zero” complex orders that leg in to the regular order book, are currently paid significant rebates by the Exchange, which are funded in part by charging higher fees to the market participants that trade against these orders. The Exchange believes that eliminating the rebate provided to “net zero” complex orders will discourage market participants from entering these valueless orders, which are entered for the sole purpose of earning a rebate. The Exchange also believes that the proposed rule change is not unfairly discriminatory as it is designed to stop market participants from taking advantage of Exchange rebates by entering orders that lack economic substance. The Exchange is proposing to eliminate Priority Customer complex order rebates for all market participants that enter a large number of “net zero” complex orders. To the extent that those market participants enter legitimate complex orders, however, they will continue to receive the same rebates that they do today. In addition, market participants that enter an insubstantial volume of “net zero” complex orders will also continue to receive rebates. The Exchange does not believe that it is unfairly discriminatory to continue to offer rebates to firms that do not hit the proposed “net zero” ADV threshold as this more limited trading activity is not indicative of rebate arbitrage.
In accordance with Section 6(b)(8) of the Act,
The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any unsolicited written comments from members or other interested parties.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On March 11, 2016, NYSE Arca, Inc. (“Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission finds that it is appropriate to designate a longer period within which to take action on the proposed rule change so that it has sufficient time to consider the proposed rule change. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange filed a proposal to: (i) Amend the description of Price
The text of the proposed rule change is available at the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant parts of such statements.
The Exchange is proposing to: (i) Amend the description of Price Improving Orders under subparagraph (6) to Rule 21.1(d); and (ii) add subparagraph (4) to Rule 21.1(h) modifying the operation of orders subject to the display price sliding process when a contra-side Post Only Order is received by EDGX Options.
Price Improving Orders are orders to buy or sell an option at a specified price at an increment smaller than the minimum price variation in the security.
As described above, Price Improving Orders may be priced at an increment smaller than the minimum price variation in the security (
First, the Exchange proposes to amend the description of Price Improving Orders under subparagraph (6) to Rule 21.1(d) to prevent Price Improving Orders subject to the Price Adjust process from being ranked at a non-displayed price on the EDGX Options Book. Under the Price Adjust process, an order that, at the time of entry, would lock or cross a Protected Quotation of another options exchange or the Exchange will be ranked and displayed by the System at one minimum price variation below the current NBO (for bids) or to one minimum price variation above the current NBB (for offers). This could result in Price Improving Orders in securities with minimum quoting increments of five (5) or ten (10) cents
The following examples describe the proposed operation of Price Improving Orders subject to the Price Adjust process.
Assume the NBBO is $1.00 x $1.05 and that the security's minimum quoting increment is five (5) cents. Further assume that there is no liquidity to sell resting on the EDGX Options Book at a price below $1.05. A Price Improving Order to buy priced at $1.03 is entered and the User has elected the Price Adjust process. Under current functionality, the order will be ranked, non-displayed on the EDGX Options Book at $1.03, the price of the order, and displayed at $1.00. As proposed, the order would be ranked and displayed at $1.00, the displayed price.
Assume the same example as above except that when the Price Improving Order is entered (
The Exchange also proposes to amend subparagraph (6) to Rule 21.1(d) to clarify how Price Improving Orders subject to the display price sliding process are currently handled on the EDGX Options Book. While the Exchange believes the current operation of Price Improving Orders is clear based on existing rules, the Exchange believes this clarification is necessary due to the proposed changes. Particularly, in light of the change proposed above regarding Price Improving Orders subject to the Price Adjust process, the Exchange proposes to add language to subparagraph (d)(6) clarifying the operation of Price Improving Orders subject to the display price sliding process. As proposed, Exchange Rule 21.1(d)(6) would state that Price Improving Orders subject to the display-price sliding process will be ranked at the price entered by the User down to the current NBB (for offers) or up to the current NBO (for bids). The proposed language would make clear the current operation of such orders vis-a vis the proposed operation of Price Improving Orders subject to the Price Adjust process.
Under current Exchange Rule 21.1(h), an order subject to the display price sliding process that, at the time of entry,
In order to facilitate the entry of orders priced at the National Best Bid or Offer (“NBBO”), the Exchange proposes to add subparagraph (4) to Rule 21.1(h) modifying the operation of orders subject to the display price sliding process when a contra-side Post Only Order is received by EDGX Options. Under proposed subparagraph (4), to the extent an incoming Post Only Order would be ranked and displayed at a price equal to the ranked price of a contra-side order subject to display-price sliding (
The below examples describe the operation of orders subject to display price sliding under proposed subparagraph (4) to Rule 21.1(h).
Securities Quoted in Penny Increments—Proposed Operation. Assume the NBBO is $1.00 x $1.01 and that the Exchange's displayed best bid and offer (“BBO”) is $1.00 x $1.02. Also assume that a non-routable order to buy at $1.01 subject to display price sliding is resting on the EDGX Options Book, ranked at $1.01 and displayed at $1.00. Assume a Post Only Order to sell at $1.01 is entered and, under current functionality, would be rejected because it is executable at the locking price of the order to buy subject to display price sliding resting on the EDGX Options Book. As proposed, the order to buy subject to display price sliding would be re-ranked and would remain displayed at $1.00, one (1) cent below the current NBO. The Post Only Order to sell would be posted to the EDGX Options Book, ranked and displayed at $1.01 (
Securities Quoted in Non-Penny Increments—Proposed Operation. Assume the NBBO is $1.00 x $1.05 and that the Exchange's BBO is $1.00 x $1.10. Also assume that a non-routable order to buy at $1.05 subject to display price sliding is resting on the EDGX Options Book, ranked at $1.05 and displayed at $1.00. Assume a Post Only Order to sell at $1.05 is entered and, under current functionality, would be rejected because it is executable at the locking price of the order to buy subject to display price sliding resting on the EDGX Options Book. As proposed, the order to buy subject to display price sliding would be re-ranked at $1.04, one (1) cent below the NBO, and would remain displayed at $1.00. The Post Only Order to sell would be posted to the EDGX Options Book, ranked and displayed at $1.05 (
The Exchange notes that similar behavior currently exists on the Bats BZX Exchange, Inc. (“BZX”) equities platform that permits an order to buy(sell) subject to display price sliding to be executed at one-half minimum price variation more(less) than the price of a contra-side displayed BZX Post Only Order.
The Exchange believes that its proposal is consistent with the requirements of the Act and the rules and regulations thereunder that are applicable to a national securities exchange, and, in particular, with the requirements of Section 6(b) of the Act.
The proposed changes to the description of Price Improving Orders under Rule 21.1(d)(6) promote just and equitable principles of trade and foster cooperation and coordination with persons engaged in facilitating transactions in securities. Specifically, the proposed change regarding Price Improving Orders subject to the Price Adjust process is designed to prevent the possibility of an internally crossed book where a Price Improving Order has already been submitted and is ranked non-displayed by the Exchange and a Post Only Order subject to the Price Adjust process is entered at a price increment smaller than the security's minimum price increment and that crosses the resting order.
In addition, the proposed amendment to Exchange Rule 21.1(d)(6) to clarify that Price Improving Orders subject to the display-price sliding process will be ranked at the price entered by the User down to the current NBB (for offers) or up to the current NBO (for bids) also promotes just and equitable principles of trade because it is consistent with and further clarifies the current operation of such orders. In addition, the addition of such language should avoid potential investor confusion regarding the operation of such orders with regard to the proposed language amending the operation of Price Improving Orders subject to the Price Adjust process.
Under current functionality, an incoming Post Only Order would be rejected if it is executable at the locking price of a contra-side order subject to display price sliding resting on the EDGX Options Book. This, at times, inhibits market participants, including Market Makers
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. To the contrary, the Exchange believes the proposed rule change regarding display price sliding and Post Only Orders would enhance competition by enabling market participants to post liquidity at the NBBO, thereby increasing the liquidity on the Exchange at the NBBO. In addition, the Exchange believes the proposed amendments to Price Improving Orders would does not impact competition, but rather seeks to avoid the potential of an internally crossed book on the Exchange as well as to further clarify the operation of such orders when subject to the display price sliding process. For all the reasons stated above, the Exchange does not believe that the proposed rule changes will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act, and believes the proposed change will enhance competition.
The Exchange has neither solicited nor received written comments on the proposed rule change. The Exchange has not received any written comments from members or other interested parties.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6) under the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 13e-1 (17 CFR 240.13e-1) under the Securities Exchange Act of 1934 (U.S.C. 78
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.
The public may view the background documentation for this information collection at the following Web site,
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange proposes to amend the Frequent Trader Program. The text of the proposed rule change is available on the Exchange's Web site (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend its Fees Schedule. On April 1, 2016, the Exchange adopted a program that offers transaction fee rebates to Customers (origin code “C”) that meet certain volume thresholds in CBOE VIX Volatility Index options (“VIX options”) and S&P 500 Index options (“SPX”), weekly S&P 500 options (“SPXW”) and p.m.-settled SPX Index options (“SPXpm”) (collectively referred to as “SPX options”) provided the Customer registers for the program (the “Frequent Trader Program” or “Program”).
To participate in the Frequent Trader Program, Customers register with the Exchange. Once registered, the Customer is provided a unique identification number (“FTID”) that can be affixed to each of its orders. The FTID allows the Exchange to identify and aggregate all electronic and manual trades during both the Regular Trading Hours and Extended Trading Hours sessions from that Customer for purposes of determining whether the Customer meets any of the various volume thresholds. The Customer has to provide its FTID to the Trading Permit Holder (“TPH”) submitting that Customer's order to the Exchange (executing agent” [sic] or “executing TPH”) and that executing TPH would have to enter the Customer's FTID on each of that Customer's orders.
The Exchange now proposes to provide that for the month of April 2016, it will not enforce the requirement that the Corrections Form be submitted within 3 business days and instead provide that the Corrections Form will be accepted through May 4, 2016 (by 5:00 p.m. CST), for all transactions, regardless of when in April the transaction(s) occurred. Specifically, the Exchange notes that a number of executing TPHs were unable to (i) affix FTIDs onto their Customers' orders and (ii) complete and submit the Corrections Form within 3 business days for their Customers registered in the Frequent Trader Program. Many TPHs are still familiarizing themselves with this new program and its requirements and as such the Exchange desires to give them additional time to implement their systems and procedures, including their systems and procedures related to completing and submitting the Corrections Form. Additionally, the Exchange does not wish to penalize the Customers who would miss out on rebates they would otherwise be entitled to if the deadline is not extended. Accordingly, the Exchange does not wish to enforce the 3 business day rule for April 2016. The Exchange believes providing additional time to submit Corrections Forms will ensure Customers are not unfairly deprived of any rebates that they are entitled to under the Frequent Trader Program for the month of April.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, the Exchange believes not enforcing the 3 business day rule for
CBOE does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act because the proposed change applies uniformly to all executing TPHs of Customer FTID orders and because it provides for a clear process to rectify scenarios in which a FTID(s) were not or could not be applied to Customer's order and where Corrections Forms were not submitted in a timely manner in April 2016. The Exchange believes that the proposed rule change will not cause an unnecessary burden on intermarket competition because it only applies to trading on CBOE. To the extent that the proposed changes make CBOE a more attractive marketplace for market participants at other exchanges, such market participants are welcome to become CBOE market participants.
The Exchange neither solicited nor received comments on the proposed rule change.
Because the proposed rule change does not (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule change should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to amend its rules related to split-price priority. The text of the proposed rule change is provided below.
When used in these Rules, unless the context otherwise requires:
(a)-(eee) No change.
(fff) The term “Voluntary Professional” means any person or entity that is not a broker or dealer in securities that elects, in writing, to be treated in the same manner as a broker or dealer in securities for purposes of Rules 6.2A, 6.2B, 6.8C, 6.9, 6.13A, 6.13B, 6.25, 6.45, 6.45A (except for Interpretation and Policy .02), 6.45B (except for Interpretation and Policy .02),
(ggg) The term “Professional” means any person or entity that (i) is not a broker or dealer in securities, and (ii) places more than 390 orders in listed options per day on average during a calendar month for its own beneficial account(s). A Professional will be treated in the same manner as a broker or dealer in securities for purposes of Rules 6.2A, 6.2B, 6.8C, 6.9, 6.13A, 6.13B, 6.25, 6.45, 6.45A (except for Interpretation and Policy .02), 6.45B (except for Interpretation and Policy .02),
(a) [Purchase or sale]
(b) [Purchase or sale]
(c) Two or [m]
The text of the proposed rule change is also available on the Exchange's Web site (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
Rule 6.47 establishes priority principles for split-price transactions occurring in open outcry. Generally, a Trading Permit Holder that purchases (sells) one or more contracts of a series at a particular price will have priority over other Trading Permit Holders, other than those representing orders in the limit order book, in purchasing (selling) up to an equivalent number of contracts of the same order at the next lower (higher) price. For orders of 100 or more contracts, Trading Permit Holders that trade 50 or more contracts of such orders at a particular price will have this priority over all other Trading Permit Holders at the next best price, including those representing orders in the limit order book. This priority is awarded for split-price transactions that occur in open outcry only.
The Exchange proposes to add Rule 6.47(e) to codify an exception to the availability of split-price priority when the width of a series' quote is at the minimum increment width. If the width of the quote for a series is the minimum increment for that series (
For example, assume the market for a series with a minimum increment of $0.05 is $1.00-$1.05 (with the $1.00 bid and $1.05 offer each representing a customer order for 25 contracts), and a Floor Broker receives an order from a customer that would like to buy 100 contracts at a price or prices no higher than $1.05. The Floor Broker attempts to execute the order in open outcry at a price better than the displayed offer of $1.05. Assume a Market-Maker is willing to sell 50 contracts at $1.00 and 50 contracts at $1.05. The “first transaction” of this split-price transaction would be 50 contracts at $1.00. However, there is customer interest resting at $1.00, which would have time priority to trade at $1.00.
The proposed rule change provides that “either side of the market” must trade for split-price priority to become available. The rule provides that a Trading Permit Holder is eligible to receive split-price priority, which could include the Trading Permit Holder representing the order or offer (quote). Thus, the proposed rule change allows for the Trading Permit Holder on either side of a transaction to be eligible for split-price priority. Assume the market for a series with a minimum increment of $0.05 is $1.00-$1.05 (with the $1.00 bid and $1.05 offer each representing a customer order for 25 contracts), and a Floor Broker receives an order from a customer that would like to buy 100 contracts at a price or prices no higher than $1.05. After receiving no interest from the crowd to sell 100 contracts at $1.00, the Floor Broker represents to the crowd that it would like to buy 50 contracts at $1.00 and 50 contracts at $1.05. Assume a Market-Maker is willing to sell 50 contracts at $1.00 and 50 contracts at $1.05. In a separate transaction, the public customer order at $1.05 trades against an order of another market participant. The “first transaction” of this split-price transaction would be 50 contracts at $1.05 (at which price there is no more resting public customer offer) and the “second transaction” of this split-price transaction would be 50 contracts at $1.00, the next best price for the Floor Broker. In this situation, the Floor Broker is eligible to receive split-price priority at $1.00 over the resting customer interest at $1.00 and achieve a better net price execution of $1.025 for its customer order.
Other than the limited exception to customer priority afforded in Rule 6.47(b) (and as elsewhere set forth in the rules),
Rule 6.47(a) and (b) currently provides that split-price priority may apply to executions of an order at multiple prices. The proposed rule change removes the references to multiple prices from those paragraphs. The Exchange believes the priority should only apply at the next price level rather than multiple price levels.
The Exchange proposes to make the following nonsubstantive changes to Rule 6.47(a), (b) and (c):
• The proposed rule change amends the headings of and adds introductory language to paragraphs (a) and (b).
• The proposed rule change revises the language in paragraphs (a) and (b) to simplify the description of when the split-price priority applies to improve readability. The priority will still apply in the same manner—a Trading Permit Holder may buy (sell) one or more contracts for one series of an order or offer (bid) (the “first transaction”)
• Paragraph (a) currently provides that the Trading Permit Holder must yield to the Order Book Official. The proposed rule change amends the term Order Book Official to public customer. Other priority rules refer to “public customer” priority,
• Paragraphs (a) and (b) currently state that a Trading Permit Holder's bid (offer) at the next best price must be made promptly following the purchase (sale) at the initial price. The proposed rule change deletes that language from those paragraphs and adds it to new paragraph (d) to include with other conditions to which split-price priority is subject. In addition, the proposed rule change adds that the second bid (offer) may also be made at the same time as the first bid (offer). If a Trading Permit Holder makes the first bid (offer) with the intent of taking advantage of the split-price priority, then it may be more efficient for the Trading Permit Holder to announce both bids (offers) at the same time than to wait for the first execution.
• Paragraphs (a) and (b) currently state that they apply only to open outcry transactions. The proposed rule change deletes that language from those paragraphs and adds it to new paragraph (d) to include with other conditions to which split-price priority is subject. Paragraphs (a) and (b) also state that split-price priority applies to transactions in a particular series (
• Paragraphs (a) and (b) currently state that the Trading Permit Holder eligible for split-price priority must make its bid (offer) promptly and the purchase (sale) represents the opposite side of a transaction with the same
• The proposed rule change makes other administrative and clerical changes to paragraphs (a), (b) and (c) (
• The proposed rule change refers to the priority afforded by Rule 6.47(a) and (b) as “split-price priority” to further simplify the rule text.
The Exchange believes these nonsubstantive changes more clearly describe the applicability of the split-price priority and better reflect the use of split-price priority on the trading floor.
The Exchange believes the proposed rule change is consistent with the Act and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, the Exchange believes the proposed rule change is consistent with the purpose of the existing split-price priority, which is to induce Trading Permit Holders to bid (offer) at better prices for an order or offer (bid) that may require execution at multiple prices (such as larger orders), which will result in a better average price for the originating Trading Permit Holder (or its customer).
The proposed rule change to codify the split-price priority exception when the width of a series' quote is the minimum increment for that series and each side of the quote represents public customer interest will benefit investors by including all information regarding when split-price priority is available in a single rule. This proposed rule change is consistent with the Exchange's priority and allocation rules. The Exchange believes the proposed rule change to codify this exception, as well as the proposed rule change to eliminate split-price priority at multiple price levels, balances the availability of split-price priority, which benefits investors by providing opportunities for price improvement, with customer priority, which promotes just and equitable principles of trade by providing public customers access to CBOE's market.
The proposed rule change to amend the definitions of Voluntary Professional and Professional clarify that, for purposes of Rule 6.47, as is the case for all other allocation rules, those participants will be treated as broker-dealers rather than public customers for allocation purposes. The same result occurs under current allocation rules, as those rules provide with respect to open outcry priority that public customers in the book receive priority (and the definitions of Voluntary Professional and Professional provide that those participants are treated as broker-dealers for purposes of those rules); this merely clarifies it in the Rules.
The Exchange believes the nonsubstantive changes to Rule 6.47 will benefit investors by describing the applicability of split-price priority more simply and clearly. The revised language is also more consistent with other Exchange rules regarding priority.
CBOE does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The priority afforded by Rules 6.47(a) and (b) continues to be available to all Trading Permit Holders who trade open outcry, of which all Trading Permit Holders that engage in open outcry trading may avail themselves. Rules often apply to open outcry trading only because of the different nature of the open outcry market versus the electronic market (such as allocation rules). The proposed rule change may result in better pricing for customer orders submitted to the trading floor, particularly those that may require execution at multiple prices, and market participants may submit orders to CBOE to take advantage of these better prices. CBOE believes that the proposed rule change will continue to encourage Trading Permit Holders on CBOE's trading floor to bid or offer better prices, thus creating more opportunities for price improvement, which ultimately enhances competition. The nonsubstantive changes and codification of the applicability of split-price priority in a minimum width market do not impact the manner in which split-price priority applies and thus have no effect on competition.
The Exchange neither solicited nor received comments on the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission will institute proceedings to determine whether the proposed rule change should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Schedule 14D-9F (17 CFR 240.14d-103) under the Securities Exchange Act of 1934 (15 U.S.C. 78
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.
The public may view the background documentation for this information collection at the following Web site,
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange filed a proposal to add subparagraph (5) to Rule 21.1(h) modifying the operation of orders subject to the display price sliding process when a contra-side Post Only Order
The text of the proposed rule change is available at the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant parts of such statements.
The Exchange is proposing to add subparagraph (5) to Rule 21.1(h) modifying the operation of orders subject to the display price sliding process when a contra-side Post Only Order is received by BZX Options.
Under current Exchange Rule 21.1(h), an order subject to the display price sliding process that, at the time of entry, would lock or cross a Protected Quotation of another options exchange will be ranked at the locking price in the BZX Options Book
In order to facilitate the entry of orders priced at the National Best Bid or Offer (“NBBO”), the Exchange proposes to add subparagraph (5) to Rule 21.1(h) modifying the operation of orders subject to the display price sliding process when a contra-side Post Only Order is received by BZX Options. Under proposed subparagraph (5), to the extent an incoming Post Only Order would be ranked and displayed at a price equal to the ranked price of a contra-side order subject to display-price sliding (
The below examples describe the operation of orders subject to display price sliding under proposed subparagraph (5) to Rule 21.1(h).
Securities Quoted in Penny Increments—Proposed Operation. Assume the NBBO is $1.00 × $1.01 and that the Exchange's displayed best bid and offer (“BBO”) is $1.00 × $1.02. Also assume that a non-routable order to buy at $1.01 subject to display price sliding is resting on the BZX Options Book, ranked at $1.01 and displayed at $1.00. Assume a Post Only Order to sell at $1.01 is entered and, under current functionality, would be rejected because it is executable at the locking price of the order to buy subject to display price sliding resting on the BZX Options Book. As proposed, the order to buy subject to display price sliding would be re-ranked and would remain displayed at $1.00, one (1) cent below the current NBO. The Post Only Order to sell would be posted to the BZX Options Book, ranked and displayed at $1.01 (
Securities Quoted in Non-Penny Increments—Proposed Operation. Assume the NBBO is $1.00 × $1.05 and that the Exchange's BBO is $1.00 × $1.10. Also assume that a non-routable order to buy at $1.05 subject to display price sliding is resting on the BZX Options Book, ranked at $1.05 and displayed at $1.00. Assume a Post Only Order to sell at $1.05 is entered and, under current functionality, would be rejected because it is executable at the locking price of the order to buy subject to display price sliding resting on the BZX Options Book. As proposed, the order to buy subject to display price sliding would be re-ranked at $1.04, one (1) cent below the NBO, and would remain displayed at $1.00. The Post Only Order to sell would be posted to the BZX Options Book, ranked and displayed at $1.05 (
The Exchange notes that similar behavior currently exists on its equities platform that permits an order to buy(sell) subject to display price sliding to be executed at one-half minimum price variation more(less) than the price of a contra-side displayed BZX Post Only Order.
The Exchange believes that its proposal is consistent with the requirements of the Act and the rules and regulations thereunder that are applicable to a national securities exchange, and, in particular, with the requirements of Section 6(b) of the Act.
Under current functionality, an incoming Post Only Order would be rejected if it is executable at the locking price of a contra-side order subject to display price sliding resting on the BZX Options Book. This, at times, inhibits market participants, including Market Makers
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. To the contrary, the Exchange believes the proposed rule change would enhance competition by enabling market participants to post liquidity at the NBBO, thereby increasing the liquidity on the Exchange at the NBBO. For all the reasons stated above, the Exchange does not believe that the proposed rule changes will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act, and believes the proposed change will enhance competition.
The Exchange has neither solicited nor received written comments on the proposed rule change. The Exchange has not received any written comments from members or other interested parties.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6) under the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to the provisions of Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”)
The Exchange is filing a proposal to amend Exchange Rule 612, Aggregate Risk Manager (“ARM”).
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend Exchange Rule 612, Aggregate Risk Manager (“ARM”), to modify the minimum Allowable Engagement Percentage (as described below) determined by Exchange Market Makers, and to codify the Exchange's existing practice of establishing default ARM settings, as described below. The Exchange is also proposing two minor technical amendments to Rule 612(a), as described below.
ARM protects MIAX Market Makers
Any eQuotes
Currently, Exchange Rule 612(a) states that the Market Maker will establish for each option class an AEP that cannot be less than 100%.
First, the proposed amendments to Rule 612(a) would modify the existing rule to allow a Market Maker to establish an AEP at any percentage level for an option class in which such Market Maker is appointed. The Exchange believes that this change will give Market Makers the ability to better manage their risk and help them avoid trading a number of contracts that exceeds the Market Maker's risk tolerance level across multiple series when multiple series are executed in rapid succession.
The purpose of the proposed rule change is to enable individual Market Makers to enhance their risk management for an individual option class or for multiple classes as market conditions warrant, based on their own risk tolerance level and quoting behavior. Market Makers will be able to more precisely customize their risk management within the MIAX System than previously permitted, taking into account such factors as the market conditions both present and anticipated, news that may affect an option class in which they are appointed, a sudden change in the volatility of an option, and other considerations affecting their risk management, without any limitation as to the level of the AEP that will trigger the Aggregate Risk Manager. The proposed rule change will provide greater ability for Market Makers to adapt more exact and precise risk controls based on the Market Maker's risk tolerance levels.
Additionally, the Exchange proposes to amend Exchange Rule 612 to codify the Exchange's existing practice of establishing a default specified time period and a default AEP if such values are not established by a Market Maker. Currently, Exchange Rule 612(a) states that the specified time period cannot exceed 15 seconds. The proposed rule change would provide that the 15-second maximum will apply whether the specified time period is established by the Market Maker or as a default setting.
The proposed rule change codifies that the Exchange will establish a default specified time period and a default AEP (“default settings”) on behalf of Market Makers that have not established a specified time period and/or an AEP. The purpose of the default settings is to assist Market Makers in managing their risk in the event that they have not established a specified time period and/or an AEP in a particular appointed option and trading in such appointed option becomes active. For example, a Market Maker might not establish a specified time period or an AEP in an appointed option that has a relatively low average daily volume. If such an appointed option becomes extremely active due to news, world events or overall market changes, the default settings are in place to ensure that the Market Maker's quotations are protected and removed from the Exchange's disseminated quotation when the default setting threshold has been reached. The default settings benefit not only the Market Maker but the marketplace as a whole by enhancing stability and maintaining fair and orderly markets on MIAX when the settings are not established by the Market Maker, and ensure that all Exchange Market Makers are protected by ARM regardless of whether they establish ARM settings on their own. The default settings will be determined by the Exchange on an Exchange-wide basis and announced to Members via Regulatory Circular. The proposed rule change will serve to notify all market participants that the Exchange will establish the default settings for Market Makers and will apply them to all appointed option classes in which a Market Maker has not determined its specified time period or AEP. Any changes to the default settings will also be announced to Members via Regulatory Circular.
The current rule states that the specified time period cannot exceed 15 seconds. This 15-second limitation will apply to the specified time period whether it is established by a Market Maker or set by the Exchange by default; thus the proposed rule change would clarify in the rule text that the specified time period cannot exceed 15 seconds, whether established by the Market Maker or as a default setting. Additionally, although the proposed rule states that the default AEP shall not be less than 100%, this Exchange-established default AEP setting will not limit a Market Maker's ability to establish an AEP of less than or greater than 100%. A Market Maker may establish the AEP for an appointed option class at any level. The Exchange will apply the default settings when a specified time period and/or an AEP has not been established by a Market Maker appointed in an option class. The current default specified time period setting is 1 second. The current default AEP setting is 105%. The Exchange does not propose to change the current default settings in the instant proposed rule change.
The Exchange is proposing two minor technical changes to Exchange Rule 612(a). First, the Rule currently refers to a Market Maker's “assigned” option classes. In order to maintain uniformity within Rule 612, the Exchange proposes to replace the word “assigned” with the word “appointed,” as it is used later in the Rule.
The Exchange will announce the implementation date of the proposed rule change by Regulatory Circular to be published no later than 60 days following the operative date of the proposed rule. The implementation date will be no later than 60 days following the issuance of the Regulatory Circular.
MIAX believes that its proposed rule change is consistent with Section 6(b) of the Act
Market Makers are obligated to submit continuous two-sided quotations in a certain number of series in their appointed option classes for a certain percentage of each trading session,
The proposed default settings further protect investors and the public interest by enhancing the risk management features provided by the Exchange on behalf of Market Makers that have not established a specified time period and/or AEP. The default settings provide Market Makers with risk management tools implemented by the Exchange in the event that a Market Maker has not determined the duration of the specified time period or the AEP for an option class in which the Market Maker is appointed.
Without adequate risk management tools in place on the Exchange, the incentive for Exchange Market Makers to quote aggressively respecting both price and size could be diminished, and could result in a concomitant reduction in the depth and liquidity they provide to the market. Such a result may undermine the quality of the markets that would otherwise be available to customers and other market participants. Accordingly, the Exchange proposes to help Market Makers better manage their risk exposure by giving them the ability to more precisely tailor their AEP to the market conditions present. This should encourage Market Makers to provide additional depth and liquidity to the Exchange's markets, thereby removing impediments to and perfecting the mechanisms of a free and open market and a national market system and, in general, protecting investors and the public interest.
Significantly, the proposed rule change removes impediments to and perfects the mechanisms of a free and open market and a national market system and, in general, protects investors and the public interest because it codifies and enhances certain features of a risk management tool that is currently available to MIAX Market Makers. The elimination of the minimum AEP threshold requirement simply provides more alternatives to Market Makers in setting their AEP, on a class-by-class basis, without affecting their firm quote obligations. A Market Maker may set its AEP at any level (whether greater than, equal to, or less than 100%) in an appointed option, depending on that Market Maker's evaluation of its own risk tolerance level for that appointed option. The default settings serve to further enhance Market Makers' confidence in the Exchange's ability to assist them in their management of risk, and Market Makers are therefore likely to quote more aggressively in price and size, resulting in potentially narrower bid/ask differentials and deeper liquidity on the Exchange, serving to benefit and protect investors and the public interest.
The proposed rule change also promotes just and equitable principles of trade by codifying the Exchange's current practice of establishing the default settings, thus providing Exchange Market Makers with additional protection in risk management mechanisms on the Exchange. The default settings are proposed to reduce the risks associated with their Market Making obligations. Finally, the proposed rule change is designed to protect investors and the public interest by helping Market Makers prevent executions resulting from activity that exceeds their risk tolerance level under these rules as established by the Exchange and by codifying the Exchange's existing practices concerning default ARM settings.
The Exchange further notes that its proposal regarding minimum and default settings is consistent with rules that are currently in place on other exchanges.
For example, the International Securities Exchange LLC (“ISE”) does not impose any minimum AEP or specified time period equivalent on its market makers, but the requirement for ISE market makers to provide these parameters is mandatory. ISE Rule 804(g) requires its market makers to provide parameters by which the Exchange will automatically remove a market maker's quotations. ISE Rule 804(g) differs from the instant proposed rule change in that it has no default percentage or time period settings if not established by the ISE market maker.
BATS BZX Exchange, Inc. (“BATS BZX”) Rule 21.16, Risk Monitor Mechanism, states that a single BATS user may configure a single counting program or multiple counting programs to govern its trading activity (
The Exchange notes that the proposed rule change will not relieve Exchange Market Makers of their continuous quoting obligations under Exchange Rule 604 and under Reg NMS Rule 602.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
On the contrary, the Exchange believes that the proposed rule change will foster competition by providing Exchange Market Makers with the ability to enhance and specifically customize their use of the Exchange's risk management tools in order to compete for executions and order flow.
As to inter-market competition, the Exchange believes that the proposed rule change should promote competition because it is designed to allow Exchange Market Makers with flexibility to modify their risk exposure in order to protect them from unusual market conditions or events that may increase their exposure in the market.
For all the reasons stated, the Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act, and believes the proposed change will in fact enhance competition.
Written comments were neither solicited nor received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days after the date of the filing, or such shorter time as the Commission may designate, it has become effective pursuant to 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice of request for public comment.
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.
The Department will accept comments from the public up July 18, 2016.
You may submit comments by any of the following methods:
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Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to Taylor Mauck, who may be reached at 202-485-7635 or at
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
Section 101(a)(15)(E) of the Immigration and Nationality Act (INA), 8 U.S.C. 1101(a)(15)(E), includes provisions for the nonimmigrant classification of a national of a country with which the United States maintains an appropriate treaty of commerce and navigation who is coming to the United States to: (i) Carry on substantial trade, including trade in services or technology, principally between the United States and the treaty country; or (ii) develop and direct the operations of an enterprise in which the national has invested, or is actively in the process of investing. Form DS-156E is completed by foreign nationals seeking nonimmigrant treaty trader/investor visas to the United States. The Department will use the DS-156E to elicit information necessary to determine a foreign national's visa eligibility.
After completing Form DS-160, Online Nonimmigrant Visa Application, applicants will fill out the DS-156E online, print the form, and submit it in person or via mail.
The Department of State will conduct an open meeting at 10:00 a.m. on Wednesday, June 1st, 2016, in Room 2N23-02, United States Coast Guard Headquarters, 2703 Martin Luther King, Jr. Ave. SE., Washington, DC 20593-7213. The primary purpose of the meeting is to prepare for the 103rd Session of the International Maritime Organization's (IMO) Legal Committee to be held at the IMO Headquarters, United Kingdom, June 8-10, 2016.
The agenda items to be considered include:
Members of the public may attend this meeting up to the seating capacity of the room. To facilitate the building security process, and to request reasonable accommodation, those who plan to attend should contact the meeting coordinator, Ms. Bronwyn Douglass, by email at
In the case of inclement weather where the Federal Government is closed or delayed, a public meeting may be conducted virtually by calling (202) 475-4000 or 1-855-475-2447, Participant code: 887 809 72. The meeting coordinator will confirm whether the virtual public meeting will be utilized. Members of the public can find out whether the Federal Government is delayed or closed by visiting
Department of State.
Notice, publication of updated list of goods and services produced by independent Cuban entrepreneurs authorized for importation into the United States.
On April 22, 2016, the Department of State published on its Web site an updated list of goods and services produced by independent Cuban entrepreneurs whose importation into the United States is authorized by the Department of the Treasury's Cuban Assets Control Regulations (“CACR”). This list updates the version of the list published on February 13, 2015. These changes allow for more engagement with Cuba's private sector through new business opportunities.
April 22, 2016.
Office of Economic Sanctions Policy and Implementation, tel.: 202-647-7489; Office of the Coordinator for Cuban Affairs, tel.: 202-647-9273, Department of State, Washington, DC 20520 (not toll-free numbers).
This document and additional information concerning the List are available from the Department of State's Web site (
On January 16, 2015, the Department of the Treasury's Office of Foreign Assets Control (OFAC) published a final rule in the
On April 22, 2016, the State Department updated the Section 515.582 List, authorizing persons subject to U.S. jurisdiction to import coffee and additional textiles and textile articles produced by independent Cuban entrepreneurs, in addition to the items previously authorized. The updated List also removes the requirement that imports of authorized goods need to be made directly from Cuba. These changes allow for more engagement with Cuba's private sector through new business opportunities.
The List published on the State Department's Web site on April 22, 2016, replaces in full the version of the List published on February 13, 2015. The List is as follows, and may be updated by the State Department periodically.
In accordance with the policy changes announced by the President on December 17, 2014, to further engage and empower the Cuban people, Section 515.582 of the Cuban Assets Control Regulations (31 CFR part 515—the CACR) authorizes the importation into the United States of certain goods and services produced by independent Cuban entrepreneurs as determined by the State Department as set forth on the Section 515.582 List, below.
The goods whose import is authorized by Section 515.582 are goods produced by independent Cuban entrepreneurs, as demonstrated by documentary evidence, that are imported into the United States,
**Please note that exporters will be required to prove that they have met all sanitary and phytosanitary standards, including food safety.
For travelers importing authorized goods into the United States pursuant to § 515.582 as accompanied baggage, the $400 monetary limit set forth in § 515.560(c)(3) does not apply to such goods, but goods may be subject to applicable duties, fees, and taxes.
The authorized services pursuant to 31 CFR 515.582 are services supplied by an independent Cuban entrepreneur in Cuba, as demonstrated by documentary evidence. Persons subject to U.S. jurisdiction engaging in import transactions involving services supplied by an independent Cuban entrepreneur pursuant to § 515.582 are required to obtain documentary evidence that demonstrates the entrepreneur's independent status, such as a copy of a license to be self-employed issued by the Cuban government or, in the case of an entity, evidence that demonstrates that the entrepreneur is a private entity that is not owned or controlled by the Cuban government. Supply of services must comply with other applicable state and federal laws.
All payments in settlement of transactions authorized by § 515.582 should reference this section in order to avoid having them rejected.
The authorization in § 515.582 of the CACR does not supersede or excuse compliance with U.S. laws or regulations or any other additional requirements.
The Department of State, in consultation with other federal agencies, reserves the right to update this document periodically. Any subsequent updates will take effect when published on the Web page of the Bureau of Economic and Business
For provisions relating to recordkeeping and reports, see 31 CFR 501.601 and 501.602 and 19 CFR part 163.
With this notice, the Department of State is publishing its April 22, 2016, Section 515.582 List.
South Carolina Division of Public Railways d/b/a Palmetto Railways (Palmetto), a Class III rail carrier, has filed a verified notice of exemption under 49 CFR 1150.41 to acquire three connecting line segments that constitute the entire rail line of Hampton & Branchville Railroad Company (H&B), a total distance of approximately 45.77 miles in Colleton and Hampton Counties, S.C. (H&B Line): (1) From a connection with CSX Transportation, Inc., at milepost 0.0 in Hampton to milepost 16.8 at H&B Junction, a distance of 16.8 miles; (2) from the end of track at milepost 462.37 in Lodge through H&B Junction and Stokes to the end of track at milepost 443.18 in Walterboro, a distance of 19.19 miles; and (3) from approximately milepost 447 at Stokes to the end of track at milepost 456.78 in Canadys, a distance of 9.78 miles.
Palmetto has certified that the transaction does not involve any provision or agreement that would limit future interchange with a third-party connecting carrier.
Palmetto states that its projected annual revenues as a result of this transaction will not result in Palmetto's becoming a Class II or Class I rail carrier, but that its projected annual revenues will exceed $5 million. Accordingly, Palmetto is required, at least 60 days before this exemption is to become effective, to send notice of the transaction to the national offices of the labor unions with employees on the affected line, post a copy of the notice at the workplace of the employees on the affected line, and certify to the Board that it has done so. 49 CFR 1150.42(e). Palmetto's verified notice, however, includes a request to waive that requirement. Palmetto states that H&B has not conducted any rail operations in more than three years and does not have any employees, other than its president. Palmetto asserts that providing the 60-day notice would serve no useful purpose because it is merely acquiring the Line to prevent abandonment. Palmetto's waiver request will be addressed in a separate decision.
Palmetto states that it expects to consummate the transaction on or after August 5, 2016.
If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions to stay must be filed no later than May 25, 2016.
An original and 10 copies of all pleadings, referring to Docket No. FD 35995, must be filed with the Surface Transportation Board, 395 E Street SW., Washington, DC 20423-0001. In addition, a copy of each pleading must be served on Thomas J. Litwiler, Fletcher & Sippel LLC, 29 North Wacker Drive, Suite 920, Chicago, IL 60606.
Board decisions and notices are available on our Web site at “
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
Office of the United States Trade Representative.
Determination regarding waiver of discriminatory purchasing requirements under the Trade Agreements Act of 1979.
Effective May 18, 2016.
Scott Pietan, Director of International Procurement Policy, Office of the United States Trade Representative, (202) 395-9646.
On November 11, 2015, the WTO Committee on Government Procurement approved the accession of Ukraine to the World Trade Organization (“WTO”) Agreement on Government Procurement (“GPA”). Ukraine submitted its instrument of accession to the Secretary-General of the WTO on April 18, 2016. The GPA will enter into force for Ukraine on May 18, 2016. The United States, which is also a party to the GPA, has agreed to waive discriminatory purchasing requirements for eligible products and suppliers of Ukraine beginning on May 18, 2016. Section 1-201 of Executive Order 12260 of December 31, 1980 delegated the functions of the President under sections 301 and 302 of the Trade Agreements Act of 1979 (“the Trade Agreements Act”) (19 U.S.C. 2511, 2512) to the United States Trade Representative.
Determination: In conformity with sections 301 and 302 of the Trade Agreements Act, and in order to carry out U.S. obligations under the GPA, I hereby determine that:
1. Ukraine has become a party to the GPA and will provide appropriate reciprocal competitive government procurement opportunities to United States products and services and suppliers of such products and services. In accordance with section 301(b)(1) of the Trade Agreements Act, Ukraine is so designated for purposes of section 301(a) of the Trade Agreements Act.
2. Accordingly, beginning on May 18, 2016, with respect to eligible products (namely, those goods and services covered under the GPA for procurement by the United States) of Ukraine and suppliers of such products, the application of any law, regulation, procedure, or practice regarding government procurement that would, if applied to such products and suppliers, result in treatment less favorable than that accorded—
(A) to United States products and suppliers of such products, or
(B) to eligible products of another foreign country or instrumentality which is a party to the GPA and suppliers of such products, shall be waived. This waiver shall be applied by all entities listed in United States Annexes 1 and 3 of GPA Appendix 1.
3. The Trade Representative may modify or withdraw the designation in paragraph 1 and the waiver in paragraph 2.
Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).
Notice of Eighteenth RTCA NextGen Advisory Committee Meeting.
The FAA is issuing this notice to advise the public of the Eighteenth RTCA NextGen Advisory Committee meeting.
The meeting will be held June 17, 2016 from 9:00 a.m.-3:00 p.m.
The meeting will be held at The Boeing Company, 929 Long Bridge Drive, Arlington, VA 22202.
The RTCA Secretariat, 1150 18th Street NW., Suite 910, Washington, DC, 20036, or by telephone at (202) 833-9339, fax at (202) 833-9434, or Web site at
Pursuant to section 10(a) (2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is hereby given for a meeting of RTCA NextGen Advisory Committee. The agenda will include the following:
Although the NAC meeting is open to the public, the meeting location has security protocols that require advanced registration. Please email
Federal Railroad Administration (FRA), U.S. Department of Transportation (DOT).
Announcement of charter renewal of the Railroad Safety Advisory Committee (RSAC).
FRA announces the charter renewal of the RSAC, a Federal Advisory Committee that develops railroad safety regulations through a consensus process. This charter renewal will take effect on May 16, 2016, and will expire after 2 years.
Mr. Larry Woolverton, RSAC Designated Federal Officer/Administrative Officer, FRA, 1200 New Jersey Avenue SE., Mailstop 25, Washington, DC 20590, (202) 493-6212; or Mr. Robert Lauby, Associate Administrator for Railroad Safety/Chief Safety Officer, FRA, 1200 New Jersey Avenue SE., Mailstop 25, Washington, DC 20590, (202) 493-6474.
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), FRA is giving notice of the charter renewal for the RSAC. The RSAC was established to provide advice and recommendations to FRA on railroad safety matters. The RSAC is composed of 63 voting representatives from 37 member organizations, representing various rail industry perspectives. In addition, there are nonvoting advisory representatives from the agencies with railroad safety regulatory responsibility in Canada and Mexico, the National Transportation Safety Board, the Transportation Safety Administration, and the Federal Transit Administration. The diversity of the committee ensures the requisite range of views and expertise necessary to discharge its responsibilities. See the RSAC Web site for details on pending tasks at:
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before June 17, 2016.
Comments should refer to docket number MARAD-2016-0049. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-9309, email
As described by the applicant the intended service of the vessel AVALANCHE is:
The complete application is given in DOT docket MARAD-2016-0049 at
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before June 17, 2016.
Comments should refer to docket number MARAD-2016-0047. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel TRUE NORTH II is:
The complete application is given in DOT docket MARAD-2016-0047 at
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before June 17, 2016.
Comments should refer to docket number MARAD-2016 0048. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel COOL BEANS III is:
The complete application is given in DOT docket MARAD-2016-0048 at
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before June 17, 2016.
Comments should refer to docket number MARAD-2016-0046. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel GRACE is:
The complete application is given in DOT docket MARAD-2016-0046 at
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before June 17, 2016.
Comments should refer to docket number MARAD-2016-0050. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel FEEL THE MAGIC is:
The complete application is given in DOT docket MARAD-2016-0050 at
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
National Highway Traffic Safety Administration (NHTSA), DOT.
Extension of comment period for proposed Guidelines for the Safe Deployment and Operation of Automated Vehicle Safety Technologies
This document extends the comment period on planned guidelines for the safe deployment and operation of automated vehicles. The intent of the operational guidance is to encourage innovative and safe deployment of automated vehicle technologies. Written statements and supporting information submitted during the comment period will be considered with the same weight as oral comments and supporting information presented at the public meetings. The comment due date was May 9, 2016.
Comments continue to come in and requests have been made to extend the period to provide comments on this important topic. This document grants that request and extends the comment due date for the planned Guidelines to May 31, 2016.
The due date for comments on DOT Docket No. NHTSA-2016-0036 is extended to May 31, 2016
Please submit all written comments no later than May 31, 2016, by any of the following methods:
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DOT recently announced a series of actions to remove potential roadblocks to the integration of innovative automotive technology. As part of this effort, the Department announced several milestones for 2016, including development of guidance on the safe deployment and operation of automated vehicles.
NHTSA held two public meetings where participants could address a panel on the topic of guidance on the safe deployment and operation of automated vehicles. The meetings were held in Washington, DC on April 8, 2016, and in Stanford, CA on April 27, 2016.
During the public meetings NHTSA sought input on the following topics:
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Issued in Washington, DC, under authority delegated by 49 CFR 1.95.
Office of Foreign Assets Control, Treasury.
Notice.
The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the name of one individual whose property and interests in property are blocked pursuant to Executive Order 13726 of April 19, 2016, “Blocking Property and Suspending Entry into the United States of Persons Contributing to the Situation in Libya,” and whose name has been added to OFAC's list of Specially Designated Nationals and Blocked Persons (SDN List).
OFAC's actions described in this notice were effective May 13, 2016.
Associate Director for Global Targeting, tel.: 202/622-2420, Assistant Director for Sanctions Compliance & Evaluation, tel.: 202/622-2490, Assistant Director for Licensing, tel.: 202/622-2480, Office of Foreign Assets Control, or Chief Counsel (Foreign Assets Control), tel.: 202/622-2410, Office of the General Counsel, Department of the Treasury (not toll free numbers).
The SDN List and additional information concerning OFAC sanctions programs are available from OFAC's Web site (
On May 13, 2016, OFAC blocked the property and interests in property of the following individual pursuant to Executive Order 13726 of April 19, 2016, “Blocking Property and Suspending Entry into the United States of Persons Contributing to the Situation in Libya:”
ESSA, Agila Saleh (a.k.a. GWAIDER, Ageela Salah Issa; a.k.a. GWAIDER, Agila Saleh Issa; a.k.a. ISSA, Aguila Saleh; a.k.a. QUYDIR, Aqilah Salih; a.k.a. SALEH, Aqilah); DOB 01 Jun 1942; POB Elgubba, Libya; nationality Libya; Passport D001001 (Libya) issued 22 Jan 2015 expires 22 Jan 2017; President and Speaker of the Libyan House of Representatives (individual) [LIBYA3].
Office of Foreign Assets Control, Treasury.
Notice.
The Treasury Department's Office of Foreign Assets Control (OFAC) is publishing supplemental information on the List of Specially Designated Nationals and Blocked Persons (SDN List) for 57 individuals and 42 entities whose property and interests in property are blocked pursuant to one or more of the following authorities: Executive Order 13224, “Blocking Property and Prohibiting Transactions with Persons who Commit, Threaten to Commit, or Support Terrorism;” Executive Order 12947, “Prohibiting Transactions With Terrorists Who Threaten To Disrupt the Middle East Peace Process;” and Executive Order 13582, “Blocking Property of the Government of Syria and Prohibiting Certain Transactions With Respect to Syria.” The SDN List entry for each of these individuals and entities has been amended to include the language “Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations.”
The amendments to the SDN List described in this notice were published on April 15 and May 11, 2016.
Associate Director for Global Targeting, tel.: 202/622-2420, Assistant Director for Sanctions Compliance & Evaluation, tel.: 202/622-2490, Assistant Director for Licensing, tel.: 202/622-2480, Office of Foreign Assets Control, or Chief Counsel (Foreign Assets Control), tel.: 202/622-2410, Office of the General Counsel, Department of the Treasury (not toll free numbers).
The SDN List and additional information concerning OFAC sanctions programs are available from OFAC's Web site (
On April 15 and May 11, 2016, OFAC amended the SDN List to include supplemental information for 57 individuals and 42 entities whose property and interests in property are blocked pursuant to one or more of the following authorities: Executive Order 13224, “Blocking Property and Prohibiting Transactions with Persons who Commit, Threaten to Commit, or Support Terrorism;” Executive Order 12947, “Prohibiting Transactions With Terrorists Who Threaten To Disrupt the Middle East Peace Process;” and Executive Order 13582, “Blocking Property of the Government of Syria and Prohibiting Certain Transactions With Respect to Syria.” As amended, the SDN List entries for the individuals and entities are as follows:
1. ABDALLAH, Muhammad Yusif, Avenue Presidente Juscelino Kubistcheck 338, Apartment 1802, Center, Foz do Iguacu, Brazil; Avenue Presidente Juscelino Kubistcheck 133, Apartment 102, Center, Foz do Iguacu, Brazil; DOB 15 Jun 1952; POB Khalia, Lebanon; citizen Lebanon; alt. citizen Paraguay; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Cedula No. 1110775 (Paraguay); Passport 670317 (Lebanon); alt. Passport 137532 (Paraguay) (individual) [SDGT].
2. ALIQ, Qasim (a.k.a. ALEIK, Kassem; a.k.a. 'ALIQ, Hajj Qasim; a.k.a. 'ALIQ, Qasem; a.k.a. 'ULAYQ, Qasim); DOB 1956; POB Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations (individual) [SDGT].
3. AL-MUSAWI, Ali Mussa Daqduq (a.k.a. 'ABD AL-YUNIS, Hamid Majid; a.k.a. AL-LAMI, Hamid Muhammad; a.k.a. AL-MASUI, Husayn Muhammad Jabur; a.k.a. AL-MUSAWI, Hamid Muhammad Daqduq; a.k.a. AL-MUSAWI, Hamid Muhammad Jabur; a.k.a. AL-MUSUI, Hamid Muhammad Jabur; a.k.a. DAQDUQ, Ali Mussa; a.k.a. JABUR AL-LAMI, Hamid Muhammad); DOB 01 Sep 1969; alt. DOB 31 Dec 1971; alt. DOB 09 Aug 1971; alt. DOB 09 Sep 1970; alt. DOB 09 Aug 1969; alt. DOB 05 Mar 1972; POB Beirut, Lebanon; alt. POB Al-Karradah, Baghdad, Iraq; nationality Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah
4. AL-QUBAYSI, Abd-al-Munim (a.k.a. KOBEISSI, Abd Al Menhem; a.k.a. KOBEISSI, Abdel Menhem; a.k.a. KOBEISSI, Abdul Menhem; a.k.a. KOBEISSY, Abdul Menhem; a.k.a. KUBAYSY, Abd Al Munhim; a.k.a. QUBAYSI, Abd Al Menhem); DOB 01 Jan 1964; alt. DOB 1961; POB Beirut, Lebanon; nationality Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Passport RL 1622378 (Lebanon) (individual) [SDGT].
5. AL-SHAMI, Ahmad; DOB 1965; POB Beirut, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations (individual) [SDGT].
6. AL-SHAMI, Husayn (a.k.a. AL-SHAMI, Haj Husayn; a.k.a. AL-SHAMY, Husayn; a.k.a. ASHAMI, Husayn; a.k.a. SHAIMI, Husayn; a.k.a. SHAMAI, Husayn; a.k.a. SHAMY, Husayn), Lebanon; DOB 1948; alt. DOB 1954; alt. DOB 1960; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations (individual) [SDGT].
7. AL-WATFA, Ali Ibrahim (a.k.a. AL-WAFA, Ali Ibrahim; a.k.a. AL-WAFA, Alie Ibrahim; a.k.a. AL-WATFA, Alie Ibrahim; a.k.a. IBRAHIM, Al Hajj Alie), 26 Malama Thomas Street, Freetown, Sierra Leone; DOB 1969; POB Al Qalamun, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations (individual) [SDGT].
8. AMHAZ, Kamel Mohamad (a.k.a. AL-AMHAZ, Kamel; a.k.a. AMHAZ, Kamel; a.k.a. AMHAZ, Kamel Mohamed; a.k.a. AMHAZ, Kamil), 5th Floor, Ghadir Building, Kods Street, Haret Hreik, Baabda, Lebanon; Ghadir, 5th Floor, Safarat, Bir Hassan, Jenah, Lebanon; Ghadir 5th Floor, Embassies Street, Bir Hasan, Lebanon; Dallas Center, Saida Old Street, Chiah, Baabda, Lebanon; DOB 04 Aug 1973; nationality Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Passport RL2244333 (Lebanon); Identification Number 61 Niha El-Mehfara; President and Chief Executive Officer, Stars Group Holding (individual) [SDGT].
9. AMHAZ, Issam Mohamad (a.k.a. AMHAZ, 'Isam; a.k.a. AMHAZ, Issam Mohamed), Ghadir, 5th Floor, Safarat, Bir Hassan, Jenah, Lebanon; Issam Mohamad Amhaz Property, Ambassades (Safarate), Bir Hassan Area, Ghobeiri, Baabda, Lebanon; DOB 04 Mar 1967; POB Baalbek, Lebanon; nationality Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Passport RL0000199 (Lebanon); Identification Number 61 Nabha; Chairman, Stars Group Holding; General Manager, Teleserveplus (individual) [SDGT].
10. AQIL, Ibrahim (a.k.a. AKIEL, Ibrahim Mohamed; a.k.a. AKIL, Ibrahim Mohamed); DOB 24 Dec 1962; alt. DOB 01 Jan 1962; POB Bidnayil, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations (individual) [SYRIA] (Linked To: HIZBALLAH).
11. ATRIS, Hussein (a.k.a. HUSSEIN, Atris); DOB 11 Nov 1964; POB Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations (individual) [SDGT].
12. ATWA, Ali (a.k.a. BOUSLIM, Ammar Mansour; a.k.a. SALIM, Hassan Rostom), Lebanon; DOB 1960; POB Lebanon; citizen Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations (individual) [SDGT].
13. BADR AL DIN, Mustafa (a.k.a. AL FIQAR, Dhu; a.k.a. BADREDDINE, Mustafa Amine; a.k.a. BADREDDINE, Mustafa Youssef; a.k.a. ISSA, Sami; a.k.a. SAAB, Elias Fouad; a.k.a. SA'B, Ilyas), Beirut, Lebanon; DOB 06 Apr 1961; POB Al-Ghobeiry, Beirut, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations (individual) [SDGT] [SYRIA] (Linked To: HIZBALLAH).
14. BARAKAT, Hatim Ahmad (a.k.a. BARAKAT, Hatam Ahmad; a.k.a. BARAKAT, Hatem Ahmad; a.k.a. BARAKAT, Hattem Ahmad; a.k.a. BARAKAT, Hotem Ahmad); DOB 25 Sep 1961; POB Mousaitbe, Lebanon; alt. citizen Lebanon; alt. citizen Paraguay; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Passport 183319 (Paraguay); alt. Passport 148842 (Paraguay); alt. Passport 106318 (Paraguay); Identification Number 2.194.575 (Paraguay); alt. Identification Number 2.194.975 (Paraguay) (individual) [SDGT].
15. BARAKAT, Mohammad Fayez; DOB 11 Mar 1969; POB Rubtlatine, Lebanon; alt. citizen Lebanon; alt. citizen Paraguay; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Identification Number 2.121.948 (Paraguay) (individual) [SDGT].
16. BARAKAT, Assad Ahmad (a.k.a. BARAKAT, Assaad Ahmad; a.k.a. BARAKAT, Assad; a.k.a. BARAKAT, Assad Ahmed Muhammad; a.k.a. BARAKAT, Assad Hassan; a.k.a. BARAKAT, Jach Assad Ahmad; a.k.a. “HAJJ AS'AD AHMAD”), Rue Taroba 1005, Beatriz Menez Building, Foz do Iguacu, Brazil; Rua Rio Branco Lote 682, Quadra 13, Foz do Iguacu, Brazil; Rua Xavier Da Silva 535, Edificio Martin Terro, Apartment 301, Foz do Iguacu, Brazil; Rua Silva Jardim 290, Foz do Iguacu, Brazil; Arrecife Apartment Building, Iquique, Chile; Apartment 111, Panorama Building, Iquique, Chile; Piribebuy Y A. Jara, Ciudad del Este, Paraguay; DOB 25 Mar 1967; POB Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations (individual) [SDGT].
17. CHARARA, Ali Youssef (a.k.a. SHARARA, Ali Youssef; a.k.a. SHARARA, 'Ali Yusuf), Ghobeiry Center, Mcharrafieh, Beirut, Lebanon; Verdun 732 Center, 17th Floor, Verdun, Rachid Karameh Street, Beirut, Lebanon; Al-Ahlam, 4th Floor, Embassies Street, Bir Hassan, Beirut, Lebanon; DOB 25 Sep 1968; POB Sidon, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Gender Male (individual) [SDGT] (Linked To: HIZBALLAH).
18. CHEHADE, Ali Ahmad (a.k.a. CHEADE, Ali; a.k.a. CHEHADE, Abou Hassan Ali; a.k.a. JAWAD, Abou Hassan; a.k.a. JAWAD, Abu Hassan; a.k.a. SHIHADI, Ali), Abidjan, Cote d Ivoire; DOB 05 Jan 1961; POB Ansarie, Lebanon; citizen Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Passport RL0516070 (Lebanon) (individual) [SDGT].
19. CHERRI, Adel Mohamad (a.k.a. CHERRI, Adel Mohammad; a.k.a. SHIRRI, 'Adil), Suite 15A, Mingshang GE Shenganghao Yuan Building, Bao An Nan Road, Luohu District, Shenzhen, Guangdong, China; 1/F, Bei Fang Building, Shennan Zhong Road, Shenzhen, Guangdong, China; Flat/Room 1610, Nan Fung Tower, 173 Des Voeux Road Central, Hong Kong; Cherri Building, Main Street, Beer Al Salasel, Kherbet Selem, Nabatieh, Lebanon; DOB 03 Oct 1963; POB Beirut, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Gender Male; Passport RL2566575 (Lebanon) expires 03 Jul 2018 (individual) [SDGT] (Linked To: HIZBALLAH).
20. FADLALLAH, Shaykh Muhammad Husayn; DOB 1938; alt. DOB 1936; POB Najf Al Ashraf (Najaf), Iraq; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Leading Ideological Figure of HIZBALLAH (individual) [SDT].
21. FARAH, Meliad (a.k.a. “HUSSEIN”; a.k.a. “HUSSEIN, Hussein”); DOB 05 Nov 1980; citizen Australia; alt. citizen Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations (individual) [SDGT].
22. FA'UR, Husayn Ali (a.k.a. FAOUR, Housein Ali); DOB 1966; POB Al-Khayam, Lebanon; nationality Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Gender Male (individual) [SDGT] (Linked To: HIZBALLAH).
23. FAWAZ, Fouzi Reda Darwish (a.k.a. DARWISH-FAWAZ, Fawzy Reda; a.k.a. DARWISH-FAWAZ, Fouzi Reda; a.k.a. FAWAZ, Fawzi Reda; a.k.a. FAWAZ, Fawzy; a.k.a. FAWAZ, Fowzy; a.k.a. FAWWAZ, Fawzi); DOB 12 Feb 1968; alt. DOB 24 Mar 1973; POB Jwaya, Lebanon; alt. POB Sierra Leone; citizen Lebanon; alt. citizen Nigeria; alt. citizen Sierra Leone; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Passport 0107516 (Lebanon); alt. Passport 0258649 (individual) [SDGT] (Linked To: HIZBALLAH).
24. FAWAZ, Mustapha Reda Darwish (a.k.a. DARWISH-FAWAZ, Moustafa Reda; a.k.a. FAWAZ, Mostafa Reda Darwich; a.k.a. FAWAZ, Moustapha; a.k.a. FAWAZ, Mustafa; a.k.a. FAWAZ, Mustafa Darwish; a.k.a. FAWAZ, Mustapha; a.k.a. FAWAZ,
25. FAWAZ, Abbas Loutfe (a.k.a. FAWWAZ, 'Abbas Abu-Ahmad; a.k.a. FOUAZ, Abbas), Dakar, Senegal; DOB 07 Aug 1978; POB Jwaya, Lebanon; alt. POB Dakar, Senegal; citizen Lebanon; alt. citizen Senegal; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Personal ID Card 096574S (Senegal) (individual) [SDGT].
26. FAYAD, Saleh Mahmoud (a.k.a. FAYYAD, Saleh Mahmud); DOB 20 Oct 1972; POB Al-Taybe, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations (individual) [SDGT].
27. FAYAD, Sobhi Mahmoud (a.k.a. FAYAD, Soubi Mamout; a.k.a. FAYADH, Sobhi Mahmoud; a.k.a. FAYYAD, Subhi Mahmud), 315, Piso 3, Galeria Page, Ciudad del Este, Paraguay; DOB 20 Aug 1965; POB Al-Taybe, Lebanon; alt. citizen Lebanon; alt. citizen Paraguay; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Passport 1035562 (Paraguay); alt. Passport 220705 (Paraguay); alt. Passport 189103 (Paraguay); alt. Passport 142517 (Paraguay); alt. Passport 002301585 (Paraguay) (individual) [SDGT].
28. HAMIYAH, Talal (a.k.a. HAMIYAH, Talal Husni; a.k.a. MEZERANI, Ismat); DOB 27 Nov 1952; alt. DOB 18 Mar 1960; alt. DOB 05 Mar 1958; alt. DOB 08 Dec 1958; POB Tarayya, Lebanon; alt. POB Sojad, Lebanon; nationality Lebanon; citizen Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations (individual) [SDGT].
29. HARB, Khalil Yusif (a.k.a. AHMAD, Sayyid; a.k.a. HARB, Hajj Ya'taqad Khalil; a.k.a. HARB, Khalil Yusuf; a.k.a. HARB, Mustafa Khalil; a.k.a. MUSTAFA, Abu); DOB 09 Oct 1958; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations (individual) [SDGT].
30. HASSAN, Hassan el-Hajj (a.k.a. HASSAN, Hassan El Hajj); DOB 22 Mar 1988; citizen Canada; alt. citizen Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations (individual) [SDGT].
31. IBRAHIM, Ayman (a.k.a. IBRAHIM, Ayman Ahmad); DOB 01 Apr 1979; POB 'Adlun, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; General Manager, Unique Stars Mobile Phones LLC (individual) [SDGT] (Linked To: UNIQUE STARS MOBILE PHONES LLC).
32. IZZ-AL-DIN, Hasan (a.k.a. SALWWAN, Samir; a.k.a. “GARBAYA, AHMED”; a.k.a. “SA-ID”), Lebanon; DOB 1963; POB Lebanon; citizen Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations (individual) [SDGT].
33. KAN'AN, Fawzi Mustafa (a.k.a. CANAAN, Fazi; a.k.a. CAN'AN, Faouzi; a.k.a. GANAN, Fauzi; a.k.a. KANAAN, Fauzi; a.k.a. KANAAN, Maustaf Fawzi (Faouzi); a.k.a. KAN'AN, Fawzi; a.k.a. KANAN, Fouzi), Calle 2, Residencias Cosmos, Fifth Floor, Apartment 5D, La Urbina, Caracas, Venezuela; Esquina Bucare, Building 703, Second Floor, Apartment 20, Caracas, Venezuela; DOB 07 Jun 1943; alt. DOB Feb 1943; alt. DOB 01 Jun 1943; POB Lebanon; alt. POB Betechelida, Lebanon; alt. POB Baalbeck, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Passport 0877677 (Venezuela); National ID No. V-6.919.272 (Venezuela) (individual) [SDGT].
34. KAWTHARANI, Muhammad (a.k.a. AL-KAWTHARANI, Jafar; a.k.a. AL-KAWTHARANI, Muhammad; a.k.a. KAWTARANI, Muhammad; a.k.a. KAWTHARANI, Mohammad); DOB 1945; alt. DOB 1959; alt. DOB 1961; POB Najaf, Iraq; nationality Lebanon; alt. nationality Iraq; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations (individual) [SDGT].
35. KAZAN, Ali Muhammad (a.k.a. KASSAN, Ali Mohamad; a.k.a. QAZAN, Ali Mohamad), Avenue Taroba, 1005 Edificio Beatriz Mendes, Apt 1704, Foz do Iguacu, Brazil; DOB 19 Dec 1967; POB Taibe, Lebanon; alt. citizen Lebanon; alt. citizen Paraguay; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Passport 0089044 (Lebanon) (individual) [SDGT].
36. KHALIFEH, Hanna Elias (a.k.a. KHALIFAH, Hanna; a.k.a. KHALIFE, Hanna), Midan Street, Mazraat Yachouh, Metn, Lebanon; Asaad Karam Building, Midan Street, Mazraat Yachouh, Lebanon; DOB 09 Jul 1955; nationality Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Passport RL2033216 (Lebanon) (individual) [SDGT].
37. KHANAFER, Hicham Nmer (a.k.a. KANAFER, Hicham; a.k.a. KANAFER, Hisham; a.k.a. KHANAFAR, Hisham; a.k.a. KHANAFIR, Hisham); DOB 23 May 1965; POB Ainata, Lebanon; alt. POB Kuntair, The Gambia; nationality Lebanon; alt. nationality The Gambia; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Passport 1617889 (Lebanon) (individual) [SDGT].
38. KUNTAR, Samir (a.k.a. AL-KUNTAR, Samir; a.k.a. CANTAR, Samir; a.k.a. KANTAR, Sameer; a.k.a. KINTAR, Samir; a.k.a. QANTAR, Samir; a.k.a. QINTAR, Samir; a.k.a. QUNTAR, Samir); DOB 20 Jul 1962; alt. DOB 1961; POB Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations (individual) [SDGT] (Linked To: HIZBALLAH).
39. MANSUR, Muhammad Yusuf Ahmad (a.k.a. HALAWI, Hani; a.k.a. MANSOUR, Mohammad Yousef; a.k.a. MANSOUR, Mohammad Youssef; a.k.a. MANSUR, Mohammad Yusuf Ahmad; a.k.a. MANSUR, Muhammad Yusif Ahmad; a.k.a. SHEHAB, Sami; a.k.a. SHIHAB, Sami Hani; a.k.a. “HILLAWI, Jamal Hani”; a.k.a. “SAMI, Salem Bassem”; a.k.a. “SHIHAB, Muhammad Yusuf Mansur Sami”), Beirut, Lebanon; DOB 14 Sep 1970; alt. DOB 01 Jan 1974; alt. DOB 1980; POB Bint Jubayl, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations (individual) [SDGT].
40. NASR AL DIN, Ghazi (a.k.a. NASR AL-DIN, Hajj Ghazi 'Atif; a.k.a. NASR EL DIN GHASSAN, Ghassan; a.k.a. NASRALDINE, Ghazi 'Atef; a.k.a. NASSER AL-DIN, Ghazil; a.k.a. NASSER EL-DIN, Gazi; a.k.a. NASSERDDINE, Ghassan Attef Salame; a.k.a. NASSERDDINE, Ghazi; a.k.a. NASSERDINE GHASAN, Atef Salameh; a.k.a. NASSEREDDINE, Ghazi; a.k.a. NASSEREDDINE, Haj Ghazzi; a.k.a. NASSEREDINE, Haj Ghazi; a.k.a. NASSERIDINE, Gazi); DOB 13 Dec 1962; POB Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations (individual) [SDGT].
41. NASRALLAH, Hasan (a.k.a. NASRALLAH, Hasan Abd-al-Karim); DOB 31 Aug 1960; alt. DOB 31 Aug 1953; alt. DOB 31 Aug 1955; alt. DOB 31 Aug 1958; POB Al Basuriyah, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Passport 042833 (Lebanon); Secretary General of HIZBALLAH (individual) [SDT] [SYRIA].
42. NOUREDDINE, Mohamad (a.k.a. NUR-AL-DIN, Muhammad Mustafa); DOB 23 Oct 1974; POB Beirut, Lebanon; nationality Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Gender Male; Passport RL0629138 (Lebanon) (individual) [SDGT] (Linked To: HIZBALLAH).
43. OMAIRI, Farouk (a.k.a. AL-OMAIRI, Faruk; a.k.a. AL-UMAYRI, Faruz; a.k.a. OMAIRI, Farouk Abdul Haj; a.k.a. UMAIRI, Faruq), 605 Avenida Brasil, Apt No. 48, Foz do Iguacu, Brazil; DOB 06 Dec 1945; POB Hermel, Lebanon; citizen Brazil; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations (individual) [SDGT].
44. QABALAN, Muhammad (a.k.a. QABLAN, Muhammad; a.k.a. “AL-GHUL, Hassan”), Southern Suburbs, Beirut, Lebanon; DOB 1969; citizen Lebanon;
45. SALEH, Ali Mohamad (a.k.a. SALAH, Ali Mohammad; a.k.a. SALEH, Ali Mohamed; a.k.a. SALEH, Ali Mohammad; a.k.a. SALIH, Ali Abd-Al-Amir Muhammad; a.k.a. SALIH, Ali Muhammad; a.k.a. SALIH, Ali Muhammad Abd-Al-Amir); DOB 01 Jan 1974; POB Adchit, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Cedula No. 1124006380 (Colombia); Passport AJ911608 (Colombia); alt. Passport 2071362 (Lebanon); alt. Passport 1183967 (Lebanon) (individual) [SDNTK] [SDGT] (Linked To: ALMACEN BATUL; Linked To: COMERCIAL ESTILO Y MODA).
46. SERHAN, Fadi Hussein (a.k.a. SARHAN, Fadi Husayn; a.k.a. SIRHAN, Fadi), Own Building, Kanisat Marmkhael, Saliba Street, Corniche, Al-Mazraa, Beirut, Lebanon; Jaafar Building, Mazraa Street, Beirut, Lebanon; Jaafar Building, Mseytbi Street, Beirut, Lebanon; Jaafar Building, Salim Slam Street, Beirut, Lebanon; Jishi Building, Salim Slam Street, Beirut, Lebanon; Own Building, Main Street, Kfar Kila, Lebanon; DOB 01 Apr 1961; POB Kafr Kila, Lebanon; nationality Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Gender Male; Passport RL0962973 (Lebanon) (individual) [SDGT] (Linked To: HIZBALLAH).
47. SHALAN, Abd Al Nur (a.k.a. CHAALAN, Abdul Nur Ali; a.k.a. SHAALAN, Abdul Nur Ali; a.k.a. SHALAN, Abd Al Nur Ali; a.k.a. SHA'LAN, Abdul Nur Ali; a.k.a. SHALAN, Abdul-Nur Ali); DOB 17 May 1964; alt. DOB 1961; POB Baabda, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations (individual) [SDGT] (Linked To: HIZBALLAH).
48. SHUKR, Fu'ad (a.k.a. CHAKAR, Fu'ad; a.k.a. “CHAKAR, Al-Hajj Mohsin”), Harat Hurayk, Lebanon; Ozai, Lebanon; Al-Firdaws Building, Al-'Arid Street, Haret Hreik, Lebanon; DOB 1962; POB An Nabi Shit, Ba'labakk, Biqa' Valley, Lebanon; alt. POB Beirut, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations (individual) [SYRIA] (Linked To: HIZBALLAH).
49. TABAJA, Adham Husayn (a.k.a. TABAJA, Adham Hussein; a.k.a. TABAJAH, Adham); DOB 24 Oct 1967; POB Kfartebnit 50, Lebanon; alt. POB Kfar Tibnit, Lebanon; alt. POB Ghobeiry, Lebanon; alt. POB Al Ghubayrah, Lebanon; nationality Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Gender Male; Passport RL1294089 (Lebanon); Identification Number 00986426 (Iraq) (individual) [SDGT] (Linked To: HIZBALLAH).
50. TAHINI, Abdallah Asad (a.k.a. THAHINI, Abdallah; a.k.a. THINI, Abdalla As'ad; a.k.a. “TAHINI, Ahmad”); DOB 20 Jun 1965; POB Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations (individual) [SDGT] (Linked To: HIZBALLAH).
51. TAJIDEEN, Ali (a.k.a. TAGEDDINE, Ali Mohamed; a.k.a. TAJ AL DIN, Ali; a.k.a. TAJEDDIN, Ali Mohammad Abdel Hassan; a.k.a. TAJEDDIN, Ali Mohammad Abed Al-Hassan; a.k.a. TAJEDDINE, Ali); DOB 1961; alt. DOB 1963; POB Hanaway, Lebanon; alt. POB Hanouay, Lebanon; alt. POB Hanawiya, Lebanon; nationality Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations (individual) [SDGT].
52. TAJIDEEN, Husayn (a.k.a. TAJ AL DIN, Husayn; a.k.a. TAJIDEEN, Hussein; a.k.a. TAJIDINE, Hajj Hussein), The Gambia; DOB 1963; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations (individual) [SDGT].
53. TARABAIN CHAMAS, Mohamad (a.k.a. CHAMS, Mohamad; a.k.a. TARABAY, Muhammad; a.k.a. TARABAYN SHAMAS, Muhammad), Avenida Jose Maria De Brito 606, Apartment 51, Foz do Iguacu, Brazil; Cecilia Meirelles 849, Bloco B, Apartment 09, Foz do Iguacu, Brazil; DOB 11 Jan 1967; POB Asuncion, Paraguay; alt. citizen Lebanon; alt. citizen Brazil; alt. citizen Paraguay; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; National Foreign ID Number RNE: W031645-8 (Brazil) (individual) [SDGT].
54. WEHBE, Bilal Mohsen (a.k.a. WAHBE, Bilal; a.k.a. WAHBI, Bilal Mohsen; a.k.a. WAHBI, Bilal Muhsin; a.k.a. WAHBI, Muhsin Bilal; a.k.a. WEHBI, Bilal Mohsem; a.k.a. WEHBI, Bilal Mohsen; a.k.a. WIHBI, Bilal Muhsin), Avenida Jose Maria de Brito 929, Centro,, Foz Do Iguacu, Parana State, Brazil; DOB 07 Jan 1967; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Passport CZ74340 (Brazil); alt. Passport 0083628 (Lebanon); Identification Number 77688048 (Brazil); Shaykh (individual) [SDGT].
55. ZAHER EL DINE, Hamdi (a.k.a. ZAHREDDINE, Hamdi); DOB 20 Jul 1984; nationality Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Gender Male; Passport RL2146270 (Lebanon) (individual) [SDGT] (Linked To: HIZBALLAH).
56. ZEAITER, Ali (a.k.a. ZOEITER, Ali; a.k.a. ZU'AYTAR, 'Ali; a.k.a. ZU'AYTIR, Ali Husayn), Tianhelu 351 Hao, Tianhequ, Guangzhou, China; Room 2203A, Grand Tower, No. 228 Tianhe Road, Tianhe District, Guangzhou, China; Room 2203A, Guangcheng Building, No. 228 Tianhe Road, Guangzhou, China; 204 No. 253 Tianhebei Road, Guangzhou, China; DOB 24 Feb 1977; nationality Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Passport RL1924321 (Lebanon); alt. Passport RL0877465 (Lebanon); General Manager, Stars International Ltd (individual) [SDGT].
57. ZURAIK, Ali Hasan (a.k.a. ZRAIQ, Ali; a.k.a. ZREIK, Ali; a.k.a. ZREIK, Ali Hassan; a.k.a. ZURAYQ, Ali); DOB 1952; POB Al Khiyam, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Passport RL0266714 (Lebanon); alt. Passport 1082625 (Lebanon) (individual) [SDGT].
1. AERO SKYONE CO. LIMITED (a.k.a. AERO SKY ONE LTD; a.k.a. AEROSKYONE CO. LTD), Tianhe Qu, Tianhe Bei Lu, 255 Hao, 1606 Fang, Guangzhou, China; Room 1501 (340), 15/F, SPA Center, 53-55 Lockhart Road, Wan Chai, Hong Kong; Room 1501 (340), Lockhart, Wan Chai, Hong Kong; Web site
2. AL MANAR TV, Al Manar TV, Abed al Nour Street, Haret Hriek, Beirut, Lebanon; PO Box 354/25, Beirut, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations;
3. AL NOUR RADIO (a.k.a. AL NOUR BROADCASTING STATION; a.k.a. AL NUR RADIO; a.k.a. RADIO ANNOUR), Abed Al Nour Street, PO Box 197/25, Alghobeiri, Haret Hriek, Beirut, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations;
4. AL-INMAA ENGINEERING AND CONTRACTING (a.k.a. AL-INMAA GROUP FOR ENGINEERING AND CONTRACTING; a.k.a. INMAA 'AL' FOR ENGINEERING AND CONTRACTING SARL), Ground Floor, Inmaa Building, New Airport Highway, Beirut, Lebanon; Airport Highway, Bir Hassan, Beirut, Lebanon; Aljadriya, Baghdad, Iraq; Aljazzar Road, Basra, Iraq; Al-Jaza'ir Street, 'Oman Neighborhood, Basra, Iraq; Web site
5. AL-INMAA FOR ENTERTAINMENT AND LEISURE PROJECTS (a.k.a. AL-INMAA FOR ENTERTAINMENTS AND LEISURE PROJECTS; a.k.a. AL-INMAA GROUP FOR ENTERTAINMENT AND LEISURE PROJECTS), Ground Floor, Al Rabieh Building, New Airport Highway, Beirut, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations [SDGT] (Linked To: AL-INMAA GROUP FOR TOURISM WORKS, LLC).
6. AL-INMAA GROUP FOR TOURISM WORKS, LLC (a.k.a. AL-INMAA GROUP; a.k.a. AL-INMAA GROUP FOR TOURISM WORK, LLC; a.k.a. AL-INMAA GROUP, LLC), Al-Inmaa Group Building, New Airport Highway, Beirut, Lebanon; Web site
7. AL-QARD AL-HASSAN ASSOCIATION (a.k.a. AL-QUARD AL-HASSAN ASSOCIATION; a.k.a. AL-QUARDH AL-HASSAN ASSOCIATION; a.k.a. KARADH AL-HASSAN), Beirut, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations [SDGT].
8. AMIGO SUPERMARKET LIMITED (a.k.a. AMIGO SUPERMARKET), 1023, Adetokunbo Ademola Crescent, Wuse II, Abuja, Nigeria; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations [SDGT] (Linked To: FAWAZ, Mustapha Reda Darwish; Linked To: FAWAZ, Fouzi Reda Darwish).
9. BARAKAT IMPORT EXPORT LTDA, Iquique, Chile; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Tax ID No. AABA 670850 Y [SDGT].
10. BAYT AL-MAL (a.k.a. BAYT AL-MAL LIL MUSLIMEEN), Harat Hurayk, Beirut, Lebanon; Burj al-Barajinah, Lebanon; Sidon, Lebanon; Tyre, Lebanon; Al-Nabatiyah, Lebanon; Ba'albak, Lebanon; Hirmil, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations [SDGT].
11. BIBLOS TRAVEL AGENCY (a.k.a. BIBLIOS TRAVEL; a.k.a. BIBLOS TRAVEL CA; a.k.a. BIBLOS TRAVEL, C.A.), Avenida Baralt, Esquina Maderero, Edificio Santa Isabel II, PB, Loc. 1, Caracas, Venezuela; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations [SDGT].
12. CAR CARE CENTER (a.k.a. CAR CARE CENTER CCC; a.k.a. CAR CARE CENTER COMPANY; a.k.a. “CCC COMPANY”), Hadeth Kafaat, Hadi Nasrallah Highway, Baabda, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations [SDGT] (Linked To: HIZBALLAH).
13. CASA APOLLO, Galeria Page, Ciudad del Este, Paraguay; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations [SDGT].
14. FASTLINK SARL (a.k.a. FAST LINK SAL), Hadi Nasrallah Av, MEAB Building, 1st Floor, Beirut, Lebanon; Cendrella Street, Dalas Center, Chyah, Baabda, Lebanon; Dallas, 6th Floor, Saida Old Road, Chiyah, Beirut, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations [SDGT] (Linked To: STARS GROUP HOLDING).
15. GALERIA PAGE (a.k.a. GALERIA PAGE I), 899 Calle Regimento Pirebebuy, Ciudad del Este, Paraguay; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations [SDGT].
16. GOODWILL CHARITABLE ORGANIZATION, INC. (f.k.a. AL-SHAHID SOCIAL ASSOCIATION; f.k.a. EDUCATIONAL DEVELOPMENT ASSOCIATION), 13106 Warren Ave. Suite #4, Dearborn, MI 48126, United States; PO Box 1794, Dearborn, MI 48126, United States; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations [SDGT].
17. HILAL TRAVEL AGENCY (a.k.a. HILAL TRAVEL C.A.; a.k.a. KANAAN TRAVEL), Avenida Baralt, Esquina Maderero, Edificio Santa Isabel, Caracas, Venezuela; Avenida Baralt, Esquina Maderero, Edificio Santa Isabel, PB, Local 1, Caracas, Venezuela; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Business Registration Document # 80074366 (Venezuela) [SDGT].
18. HIZBALLAH (a.k.a. ANSAR ALLAH; a.k.a. FOLLOWERS OF THE PROPHET MUHAMMED; a.k.a. ISLAMIC JIHAD; a.k.a. ISLAMIC JIHAD FOR THE LIBERATION OF PALESTINE; a.k.a. ISLAMIC JIHAD ORGANIZATION; a.k.a. ORGANIZATION OF RIGHT AGAINST WRONG; a.k.a. ORGANIZATION OF THE OPPRESSED ON EARTH; a.k.a. PARTY OF GOD; a.k.a. REVOLUTIONARY JUSTICE ORGANIZATION); Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations [FTO] [SDGT] [SDT] [SYRIA].
19. IMAM KHOMEINI RELIEF COMMITTEE (LEBANON BRANCH) (a.k.a. COMITE ISLAMIQUE DAIDES ET DE BIEM LIBAN; a.k.a. EMDAD ASSISTANCE FOUNDATION; a.k.a. EMDAD COMMITTEE FOR ISLAMIC CHARITY; a.k.a. IMAM KHOMEINI EMDAD COMMITTEE; a.k.a. IMAM KHOMEINI FOUNDATION; a.k.a. IMAM KHOMEINI IMDAD COMMITTEE; a.k.a. IMAM KHOMEINI RELIEF ORGANIZATION; a.k.a. IMAM KHOMEINI SUPPORT COMMITTEE; a.k.a. IMAM KHOMEINY AID COMMITTEE; a.k.a. IMDAD ASSOCIATION OF THE ISLAMIC PHILANTHROPIC COMMITTEE; a.k.a. IMDAD COMMITTEE FOR ISLAMIC CHARITY; a.k.a. IMDAD ISLAMIC ASSOCIATION COMMITTEE FOR CHARITY; a.k.a. ISLAMIC CHARITY EMDAD; a.k.a. ISLAMIC CHARITY EMDAD COMMITTEE; a.k.a. ISLAMIC EMDAD CHARITABLE COMMITTEE; a.k.a. KHOMEINI CHARITABLE FOUNDATION; a.k.a. KHOMEINI SOCIAL HELP COMMITTEE; a.k.a. KOMITE EMDAD EMAM; a.k.a. “AL-IMDAD”), P.O. Box 25-211 Beirut AiRabi' Building, 2nd Floor,, Mokdad Street, Haret Hreik, Beirut, Lebanon; P.O. Box 25/221 El Ghobeiry, Beirut, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions; alt. Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations [SDGT] [IFSR].
20. ISLAMIC RESISTANCE SUPPORT ORGANIZATION (a.k.a. HAYAT AL-DAM LIL-MUQAWAMA AL-ISLAMIYA; a.k.a. ISLAMIC RESISTANCE SUPPORT ASSOCIATION), Beirut, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations [SDGT].
21. JIHAD AL-BINA (a.k.a. CONSTRUCTION FOR THE SAKE OF THE HOLY STRUGGLE; a.k.a. CONSTRUCTION JIHAD; a.k.a. HOLY CONSTRUCTION FOUNDATION; a.k.a. JIHAD AL BINAA; a.k.a. JIHAD CONSTRUCTION; a.k.a. JIHAD CONSTRUCTION FOUNDATION; a.k.a. JIHAD CONSTRUCTION INSTITUTION; a.k.a. JIHAD-AL-BINAA ASSOCIATION; a.k.a. JIHADU-I-BINAA; a.k.a. STRUGGLE FOR RECONSTRUCTION), Beirut, Lebanon; Bekaa Valley, Lebanon; Southern Lebanon, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations [SDGT].
22. KAFAK ENTERPRISES LIMITED, 88B, T/Balewa Road, Kano State, Nigeria; Sierra Leone; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations [SDGT] (Linked To: FAWAZ, Mustapha Reda Darwish; Linked To: FAWAZ, Fouzi Reda Darwish).
23. KAIRABA SUPERMARKET (a.k.a. KAIRABA SHOPPING CENTER), Kairaba Ave, P.O. Box 2176, Banjul, The Gambia; 62 Buckle Street, Banjul, The Gambia; Pipeline Road, Banjul, The Gambia; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations [SDGT].
24. LABICO SAL OFFSHORE (a.k.a. LABICO SAL (OFF SHORE)), Bou Ghannam Building, Azhar Street, Kobbe Doha, Aramoun, Aaley, Lebanon; Labico Building, Azhar Street, Aramoun, Aaley, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations [SDGT] (Linked To: ZEAITER, Ali).
25. LEBANESE MEDIA GROUP (a.k.a. LEBANESE COMMUNICATION GROUP), Al Manar Building, Ahmad Kassir Street, Haret Hriek, Baabda, Lebanon; Abed Al Nour Street, Haret Hriek, PO Box 354/25, Beirut, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Company ID: No. 59 531 at Commercial Registry of the Civil Court of First Instance at Baabda, Lebanon [SDGT].
26. LE-HUA ELECTRONIC FIELD CO. LIMITED (a.k.a. LE-HUA ELEC F CO. LTD), Room B, 5/F, Building 2, Guilong Jiayuan Gui Yuan North Road, Guiyuan Neighborhood St Office, Luohu District, Shenzhen, Guangdong, China; 15th Floor, Ming Shang Ge Building, Bao'an Street, Luo Hu Area, Shenzhen, Guangdong, China; Flat/Room 1610, Nan Fung Tower, 173 Des Voeux Road Central, Hong Kong; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations [SDGT] (Linked To: CHERRI, Adel Mohamad).
27. MARTYRS FOUNDATION (a.k.a. AL-SHAHID ASSOCIATION FOR MARTYRS AND INTERNEES FAMILIES; a.k.a. AL-SHAHID CORPORATION; a.k.a. BONYAD SHAHID; a.k.a. BONYAD-E SHAHID; a.k.a. BONYAD-E SHAHID VA ISARGARAN; a.k.a.
28. MARTYRS FOUNDATION IN LEBANON (a.k.a. AL-MUA'ASSAT AL-SHAHID; a.k.a. AL-SHAHID CHARITABLE AND SOCIAL ORGANIZATION; a.k.a. AL-SHAHID FOUNDATION; a.k.a. AL-SHAHID ORGANIZATION; a.k.a. HIZBALLAH MARTYRS FOUNDATION; a.k.a. ISLAMIC REVOLUTION MARTYRS FOUNDATION; a.k.a. LEBANESE MARTYR ASSOCIATION; a.k.a. LEBANESE MARTYR FOUNDATION; a.k.a. MARTYRS INSTITUTE), P.O. Box 110 24, Bir al-Abed, Beirut, Lebanon; Biqa' Valley, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations [SDGT].
29. PALESTINIAN MARTYRS FOUNDATION (a.k.a. AL-SHAHID FOUNDATION- PALESTINIAN BRANCH; a.k.a. MUASSASAT SHAHID FILISTIN; a.k.a. PALESTINIAN MARTYRS INSTITUTION GROUP; a.k.a. SHAHID FUND), Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations [SDGT].
30. SPECTRUM INVESTMENT GROUP HOLDING SAL (a.k.a. SPECTRUM INTERNATIONAL INVESTMENT HOLDING SAL; a.k.a. SPECTRUM INVESTMENT GROUP HOLDING; a.k.a. SPECTRUM INVESTMENT GROUP SAL HOLDING; a.k.a. SPECTRUM INVESTMENT HOLDING; a.k.a. “SPECTRUM HOLDING”), Floor 17, Verdun 732 Building, Rachid Karameh Street, Verdun, Beirut, Lebanon; Verdun 732 Center, Rachid Karame Street, Beirut, Lebanon; P.O. Box 113-5333, Beirut, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Business Registration Document # 1990106 (Lebanon) [SDGT] (Linked To: CHARARA, Ali Youssef).
31. STARS COMMUNICATIONS LTD (a.k.a. STARS COMMUNICATIONS; a.k.a. STARS COMMUNICATIONS LLC; a.k.a. STARS COMMUNICATIONS LTD SARL), Hadi Nasrallah Av, MEAB Building, 1st Floor, Beirut, Lebanon; Bir el Abed, Snoubra Street, Haret Hreyk, Beirut, Lebanon; Tayyouneh, Haret Hreyk, Beirut, Lebanon; Port, Nahr, Beirut, Lebanon; Ras El Ain, Baalbeck, Lebanon; Hadeth, Lebanon; Nabatiyeh, Lebanon; Old Saida Road, Beirut Mall, Beirut, Lebanon; Duty-Free Airport, Rafik Hariri International Airport, Beirut, Lebanon; Sharl Helo Street, Beirut Seaport, Lebanon; Kamil Shamoun Street, Dekwaneh, Beirut, Lebanon; Hermel, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Commercial Registry Number 2001929 (Lebanon) [SDGT] (Linked To: AMHAZ, Kamel Mohamad; Linked To: STARS GROUP HOLDING).
32. STARS COMMUNICATIONS OFFSHORE SAL (a.k.a. STARS COMMUNICATION SAL OFF-SHORE; a.k.a. STARS COMMUNICATIONS OFFSHORE; a.k.a. STARS OFFSHORE), Hojeij Building, 2nd Floor, Zaghloul Street, Haret Hreik, Baabda, Lebanon; Bdeir Building, Ground Floor, Snoubra Street, Ghobeiry, Baabda, Lebanon; Hadi Nasrallah Av, MEAB Building, 1st Floor, Beirut, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Commercial Registry Number 1801374 (Lebanon) [SDGT] (Linked To: STARS GROUP HOLDING).
33. STARS GROUP HOLDING (a.k.a. STARS GROUP HOLDING SAL; a.k.a. STARS GROUP SAL (HOLDING)), Property Number 5208/62, Issam Mohamed Amha, 6th Floor, Dallas Center, Old Saida Road, C, Lebanon; Postal Box 13-5483, Lebanon; Bdeir Building, Snoubra Street, Bir El-Abed Area, Haret Hreik, Baabda, Lebanon; Bir El Abed, Hadi Nasrallah Highway, Middle East & Africa Bank Building, First Floor, Beirut, Lebanon; Old Saida Road, Dallas Center, 6th Floor, Beirut, Lebanon; Web site
34. STARS INTERNATIONAL LTD (a.k.a. STARS INTERNATIONAL CO. LTD), Room 2203A, Grand Tower, No. 228 TianHe Road, TianHe District, Guangzhou, China; F-18, Dubai Airport Free Zone, Dubai, United Arab Emirates; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations [SDGT] (Linked To: ZEAITER, Ali; Linked To: STARS GROUP HOLDING).
35. TAJCO (a.k.a. GRAND STORES (THE GAMBIA LOCATION ONLY); a.k.a. TAJCO COMPANY; a.k.a. TAJCO COMPANY LLC; a.k.a. TAJCO LTD; a.k.a. TAJCO SARL; a.k.a. TRADEX CO), 62 Buckle Street, Banjul, The Gambia; 1 Picton Street, Banjul, The Gambia; Dohat Building 1st Floor, Liberation Avenue, Banjul, The Gambia; Tajco Building, Main Street, Hannawiyah, Tyre, Lebanon; Tajco Building, Hanouay, Sour (Tyre), Lebanon; 30 Sani Abacha Street, Freetown, Sierra Leone; Web site
36. TELESERVE PLUS SAL (a.k.a. TELESERVEPLUS), 4th Floor, Dalas Center, Old Saida Road, Chiyah, Baabda, Lebanon; Postal Box 13-5483, Lebanon; Old Saida Avenue, Dallas Center, 6th Floor, Beirut, Lebanon; 6th Floor, Dallas Center, Old Saida Road, Chiyah, Baabda, Lebanon; Web site
37. TRADE POINT INTERNATIONAL S.A.R.L., 3rd Floor, Gulf Building, Block B, Hafez Al Asad Street, Airport Highway, Bir Hassan, Beirut, Lebanon; Gulf Building, 3rd Floor, Hafiz Al Asad Autostrade, Ghobeiri, Baabda, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Registration ID 2020615 [SDGT] (Linked To: NOUREDDINE, Mohamad).
38. UNIQUE STARS MOBILE PHONES LLC (a.k.a. UNIQUE STARS LLC), Postal Box 98498, Dubai, United Arab Emirates; Al Maktoum Road, Deira, Al Kabira Building, First Floor, Office #103, PO Box 98498, Dubai, United Arab Emirates; Office 103, 1st Floor, Sheikh Rashed Building, Al Maktoum Road, Deira, DXB Municipality, Dubai, United Arab Emirates; Gargash Center, Nasser Square, Shop No. 41, Dubai, United Arab Emirates; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Dubai Chamber of Commerce Membership No. 116340; Commercial Registry Number 591610 (United Arab Emirates) [SDGT] (Linked To: IBRAHIM, Ayman; Linked To: STARS GROUP HOLDING).
39. VATECH SARL (a.k.a. VATECH LEBANON; a.k.a. VATECH VIDEO AND PRO AUDIO; a.k.a. “VATECH”), P.O. Box 14-5728, Jishi Building, Salim Slam Street, Mazraa, Beirut, Lebanon; P.O. Box 14-5728, Borj al Salam Building, Salim Slam Street, Beirut, Lebanon; Jaafar Building, Mazraa Street, Beirut, Lebanon; Jaafar Building, Moseitbi Street, Beirut, Lebanon; Jaafar Building, Salim Slam Street, Mazraa, Beirut, Lebanon; Jishi Building, Mazraa Street, Beirut, Lebanon; Web site
40. WAAD PROJECT (a.k.a. AL-WAAD AL-SADIQ; a.k.a. 'MASHURA WAAD LAADAT AL-AAMAR; a.k.a. WAAD; a.k.a. WA'AD AS SADIQ; a.k.a. WAAD COMPANY; a.k.a. WAAD FOR REBUILDING THE SOUTHERN SUBURB; a.k.a. WAAD PROJECT FOR RECONSTRUCTION; a.k.a. WA'D PROJECT; a.k.a. WAED; a.k.a. WA'ED ORGANIZATION; a.k.a. WA'ID COMPANY), Harat Hurayk, Lebanon; Beirut, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Telephone No. 009613679153; Telephone No. 009613380223; Telephone No. 03889402; Telephone No. 03669916 [SDGT].
41. WONDERLAND AMUSEMENT PARK AND RESORT LTD (a.k.a. WONDERLAND AMUSEMENT PARK), B1 Kukbawa, Opposite National Stadium, Abuja, FCT, Nigeria; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations [SDGT] (Linked To: FAWAZ, Mustapha Reda Darwish; Linked To: FAWAZ, Fouzi Reda Darwish).
42. YOUSSER COMPANY FOR FINANCE AND INVESTMENT, Lebanon; Additional Sanctions Information—Subject to Secondary
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 4506T-EZ, Short Form Request for Individual Tax Return Transcript, and 4506T-EZ(SP), Formulario Abreviado para la Solicitud de un Trasunto de la Declaracion de Impuestos Personales.
Written comments should be received on or before July 18, 2016 to be assured of consideration.
Direct all written comments to Tuawana Pinkston, Internal Revenue Service, room 6526, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to R. Joseph Durbala, (202) 317-5746, at Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224, or through the internet at
Individuals can use Form 4506T-EZ to request a tax return transcript that includes most lines of the original tax return. The tax return transcript will not show payments, penalty assessments, or adjustments made to the originally filed return. Form 4506T-EZ (SP) is the Spanish translated version of the Form 4507T-EZ. It is also used to request a tax return transcript that includes most lines of the original tax return.
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments on the information collection burden relating to basis and transfer statement reporting for covered securities, including debt instruments, options, and other securities.
Written comments should be received on or before July 18, 2016 to be assured of consideration.
Direct all written comments to Tuawana Pinkston, Internal Revenue Service, room 6526, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the regulations should be directed to Sara Covington, at Internal Revenue Service, room 6526, 1111 Constitution Avenue NW., Washington, DC 20224, or through the internet, at
T.D. 9616—Basis Reporting by Securities Brokers and Basis
T.D. 9713—Basis Reporting by Securities Brokers and Basis Determination for Debt Instruments and Options;
T.D. 9750—Basis and Transfer Reporting by Securities Brokers for Debt Instruments and Options.
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning source of income from certain space and ocean activities; source of communications income.
Written comments should be received on or before July 18, 2016 to be assured of consideration.
Direct all written comments to Tuawana Pinkston, Internal Revenue Service, room 6528, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the regulation should be directed to R. Joseph Durbala at Internal Revenue Service, room 6129, 1111 Constitution Avenue NW., Washington, DC 20224, or at (202) 317-5746, or through the internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Request for Comments: Comments submitted in response to this notice will
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 8404, Interest Charge on DISC-Related Deferred Tax Liability.
Written comments should be received on or before July 18, 2016 to be assured of consideration.
Direct all written comments to Tuawana Pinkston, Internal Revenue Service, Room 6528, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to R. Joseph Durbala, Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224, or through the Internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13(44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 2439, Notice to Shareholder of Undistributed Long-Term Capital Gains.
Written comments should be received on or before July 18, 2016 to be assured of consideration.
Direct all written comments to Tuawana Pinkston, Internal Revenue Service, room 6526, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to R. Joseph Durbala, at (202) 317-5746, or at Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224, or through the internet, at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 8816, Special Loss Discount Account and Special Estimated Tax Payments for Insurance Companies.
Written comments should be received on or before July 18, 2016 to be assured of consideration.
Direct all written comments to Tuawana Pinkston, Internal Revenue Service, room 6526, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to R. Joseph Durbala, at (202) 317-5746, or at Internal Revenue Service, room 6129, 1111 Constitution Avenue NW., Washington, DC 20224, or through the internet, at
Abstract: Form 8816 is used by insurance companies claiming an additional deduction under Internal Revenue Code section 847 to reconcile estimated tax payments and to determine their tax benefit associated with the deduction. The information is needed by the IRS to determine that the proper additional deduction was claimed and to insure the proper amount of special estimated tax was computed and deposited.
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 8498, Continuing Education Provider Application and Request for Provider Number.
Written comments should be received on or before July 18, 2016 to be assured of consideration.
Direct all written comments to Tuawana Pinkston, Internal Revenue Service, room 6526, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the form should be directed to
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that a meeting of the Veterans' Advisory Committee on Rehabilitation (VACOR) will be held on Wednesday, June 15, 2016, via teleconference, from 1:00 p.m. (EST) until 3:00 p.m. (EST). The meeting is open to the public.
The purpose of the Committee is to provide advice to the Secretary on the rehabilitation needs of Veterans with disabilities and on the administration of VA's rehabilitation programs.
During the meeting, Committee members will participate in new members' orientation and review administrative guidelines. The primary agenda topics will be to discuss the purpose, vision and direction of VACOR.
Although no time will be allocated for receiving oral presentations from the public, members of the public may submit written statements for review by the Committee to Anthony Estelle, Designated Federal Officer, Veterans Benefits Administration (28), 810 Vermont Avenue NW., Washington, DC 20420, or via email at
Individuals who wish to call in to the meeting should RSVP to Anthony Estelle at (202) 461-9912, no later than close of business, June 8, 2016. The dial in number to attend the conference is: 1-800-767-1750. At the prompt, enter access code 33489 then press #. During the day of the meeting, please call in at least 15 minutes prior to the start of the meeting; callers will not be given access after 1:00 p.m. Any member of the public seeking additional information should contact Anthony Estelle at the phone number or email address noted above.
This is a consolidated proceeding involving two pharmacies located in Tampa, Florida with common ownership. On October 8, 2014, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration issued an Order to Show Cause to Superior Pharmacy, L.L.C. (hereinafter, Superior II), which proposed the revocation of its DEA Certificate of Registration BS9699731, pursuant to which it is authorized to dispense controlled substances in schedules II through V as a retail pharmacy, at the registered location of 5416 Town `N' Country Blvd. ALJ Ex. 1, at 1 (No. 15-7). The next day, the Deputy Assistant Administrator issued an Order to Show Cause to Superior Pharmacy, L.L.C. (hereinafter, Superior I), which proposed the revocation of its DEA Certificate of Registration BS9255274, pursuant to which it is authorized to dispense controlled substances in schedules II through V as a retail pharmacy, at the registered location of 3007 W. Cypress Street, Suite 1. ALJ Ex. 1, at 1 (No. 15-6).
As grounds for the proposed actions (which also included the denial of any pending applications), the Show Cause Orders alleged that each pharmacy's “continued registration is inconsistent with the public interest, as that term is defined in 21 U.S.C. 823(f).”
The Show Cause Orders further alleged that each pharmacy's “pharmacists dispensed controlled substances when they knew or should have known that the prescriptions were not issued in the usual course of professional practice or for a legitimate medical purpose, including circumstances where the pharmacist knew or should have known that the controlled substances were abused and/or diverted by the customer.” ALJ Ex. 1, at 2 (No. 15-6); ALJ Ex. 1, at 2 (No. 15-7). Each Show Cause Order then listed various red flags which each Respondent's pharmacists allegedly failed to resolve before dispensing prescriptions, including: (1) “Multiple individuals presenting prescriptions for the same drugs in the same quantities from the same doctor”; (2) “individuals presenting prescriptions for controlled substances known to be highly abused, such as oxycodone and hydromorphone”; (3) “individuals paying . . . for controlled substances with cash”;
Each Show Cause Order further alleged that Respondents' pharmacists dispensed hydromorphone, notwithstanding that the “dosage amounts . . . if taken as directed, far exceeded the recommended dosages of hydromorphone that should be taken on a daily basis.” ALJ Ex. 1, at 2 (No. 15-6); ALJ Ex. 1, at 3 (No. 15-7). The Superior I Order also alleged that its pharmacists dispensed prescriptions, which were written by the same doctor on the same day, for “large and substantially similar quantities of” oxycodone 30 mg, “to two customers . . . both of whom resided at the same address,” in a town “located approximately [449 miles] from” the pharmacy. ALJ Ex. 1, at 2 (No. 15-6). Likewise, the Superior II order alleged that its “pharmacists dispensed large and substantially similar quantities of hydromorphone and oxycodone to two individuals with the same last name who received their prescriptions on the same day from doctors at the same clinic.” ALJ Ex. 1, at 3 (No. 15-7).
In addition, the Superior I Order alleged that the pharmacy “failed to create and maintain accurate [schedule II order forms] in violation of 21 U.S.C. 842(a)(5),” and that “[a]t least two [of its] pharmacists . . . shared a private key (password) for digitally signing” controlled substances orders, “in violation of 21 CFR 1311.30(a), (c), and (e).” ALJ Ex. 1, at 3-4 (No. 15-6). Finally, the Superior I Order alleged that a DEA audit for the period of May 2, 2011 through February 4, 2013 found,
The Superior II Order alleged that it had also failed to maintain accurate schedule II order forms and had failed to retain copy three of these forms as required by DEA regulations. ALJ Ex. 1, at 3 (No. 15-7) (citing 21 CFR 1305.13(a) & (e);
The Show Cause Order issued to Superior I was served on October 17, 2014, and the Show Cause Order issued to Superior II was served on October 16, 2014.
On December 3, 2014, the ALJ issued an Order for Prehearing Statements and Setting the Matter for Hearing (hereinafter, Prehearing Order) in each case.
Provide a brief summary of the testimony of each witness, with counsel for the Government to indicate clearly each and every act, omission or occurrence upon which it relies in seeking to revoke the Respondent's Certificate of Registration, and counsel for Respondent to indicate clearly each and every matter as to which Respondent intends to introduce evidence in opposition. The summaries are to state what the testimony will be, rather than merely listing the areas to be covered. The parties are reminded that testimony not disclosed in the prehearing statements or pursuant to subsequent rulings is likely to be excluded at the hearing.
The ALJ's Orders also provided that “[a]ny requests for subpoena[s] are to be filed by 2:00 p.m. E.S.T. on January 12, 2015,” and that “[s]ubpoena requests that do not comply with these instructions will be returned to the requestor without further action.”
Finally, the ALJ's Orders directed the parties to file their proposed exhibits with his Office no later than 2:00 p.m. on January 12, 2015; it also directed that a copy of the exhibits be served on the opposing party. ALJ Ex. 5, at 2 (No. 15-6); ALJ Ex. 6, at 2 (No. 15-7). The ALJ's Orders further directed that “[w]hen any party seeks to . . . present proposed exhibits,” the party must “timely provid[e] the OALJ with a facsimile copy” and “must mail hard copy filings sufficiently in advance of the due date to assure timely receipt by the hearing clerk” as well as “that documents are to be filed in triplicate.” ALJ Ex. 5, at 5-6 (No. 15-6); ALJ Ex. 6, at 5-6 (No. 15-7).
In his Orders, the ALJ also noted that the cases appeared to “involve common questions of law or fact” and thus directed the parties to address whether they should be consolidated. ALJ Ex. 5, at 3 (No. 15-6); ALJ Ex. 6, at 3 (No. 15-7). Thereafter, the Government moved to consolidate the cases (as well as two other cases). Respondent opposed the Government's motion.
On December 22, 2014, the Government filed its Prehearing Statements with respect to each pharmacy. In each of these, the Government disclosed that it intended to elicit testimony from an expert regarding his review of “numerous controlled substance prescriptions filled by Respondent that contained one or more red flags for diversion which Respondent never resolved.” ALJ Ex. 6, at 3 (No. 15-6); ALJ Ex. 8, at 3-4 (No. 15-7). The Government then identified the same set of seven red flags. ALJ Ex. 6, at 3 (No. 15-6); ALJ Ex. 8, at 3-4 (No. 15-7). With respect to both pharmacies, the Government then set forth the expert's proposed testimony regarding various oxycodone 30 mg prescriptions and the red flags they presented, as well as his proposed testimony regarding the pharmacy's dispensing of large quantities of hydromorphone and the red flags they presented. ALJ Ex. 6, at 4 (No. 15-6); ALJ Ex. 8, at 3-4 (No. 15-7). And with respect to Superior I, the Government also disclosed that the expert “will also testify about a customer who willingly purchased a prescription for oxycodone . . . that costs 37% more than the same prescription four months earlier,” and “that this fact, combined with the fact that the prescription was facially invalid [as it contained] no patient address constituted a red flag for diversion.” ALJ Ex. 6, at 5 (No. 15-6).
The Government then noticed both Respondents that its expert “will testify that the facts surrounding the prescriptions listed above constituted red flags for diversion and that there is no evidence that any of the red flags were resolved prior to distributing the controlled substances to the customers.”
On January 5, 2015, each Respondent filed a “Motion to Compel” and a “Motion for Enlargement of Time to File . . . Pre-hearing Statement,” as well as a Prehearing Statement. ALJ Exs. 9, 10, 11 (No. 15-6); ALJ Exs. 9, 10, 12 (No. 15-7). In their Motions to Compel, each Respondent noted that on February 4, 2013, DEA had executed an Administrative Inspection Warrant at it and sought an Order from the ALJ requiring the Government to disclose the documents and testimony submitted by DEA Investigators to the Federal Magistrate Judge in obtaining the Warrants. ALJ Ex. 10, at 2 (No.15-6); ALJ Ex 10, at 2 (No. 15-7). Each Respondent's Motion to Compel also sought to require the Government to: (1) Provide “full and complete copies of all computer data seized . . . during the execution of the” warrant; (2) identify “all DEA personnel involved in the preparation and execution of the [warrant] and the subsequent review and analysis of the information, records, and data seized”; and (3) provide “reports of, and the substance of, any statements made to DEA investigators by [Respondent's] staff.” ALJ Ex. 10, at 5 (No.15-6); ALJ Ex 10, at 5 (No. 15-7).
Each Respondent also sought an extension of the time to file its Prehearing Statement to the end of March 2015 and sought to reschedule the hearing “to no sooner than June 2015.” ALJ Ex. 11, at 3 (No. 15-6); ALJ Ex. 9 (No. 15-7). As support for the motions, Respondents argued that since the execution of the warrants, the Government had 20 months to review the records, and that “[d]uring this time, the information was not available to Respondent.” ALJ Ex. 11, at 3 (No. 15-6); ALJ Ex. 9, at 3 (No. 15-7). Respondents further argued “[w]hile a portion of the seized information, most notably the prescriptions, was provided to Respondent[s] in electronic format, the sheer volume of information coupled with the unreasonably short deadlines surrounding the holiday season make analysis of the information by [it] impossible.” ALJ Ex. 11, at 3 (No. 15-6); ALJ Ex. 9, at 3 (No. 15-7). Respondents further argued that “due process requires, and good cause exists, for a significant” extension of the time to file the Prehearing Statements and “to prepare for a lengthy hearing in” these
The Government opposed these motions. With respect to the Motions to Compel, the Government argued that in its Prehearing Statements, it had provided a summary of the testimony it intended to elicit as well as a list of the exhibits it intended to offer; the Government also noted that several weeks earlier, it had met with one of Respondents' counsels and that at no time then or since its motion, had Respondents' counsel “communicate[d] a need for, or request[ed] any” of the information it sought through the motions. ALJ Ex. 16, at 3 (No. 15-7). The Government further argued that it had fully complied with its disclosure obligations, and that to the extent Respondents were seeking discovery, “ `[t]here is . . . no general right to discovery under either the APA or DEA regulations, but rather only a limited right to receive in advance of the hearing the documentary evidence and summaries of the testimony which the Government intends to rely upon.' ” ALJ Ex. 16, at 4 (No. 15-7) (quoting
Each Respondent filed a Reply to [the] Government's Response to Motion to Compel. ALJ Ex. 27 (No. 15-6); ALJ Ex.18 (No. 15-7). Therein, Respondents contended that they were entitled to the documents as a matter of due process because the Government had represented that one of its proposed witnesses (a Diversion Investigator) would testify regarding his/her interviews with Respondents' staff and that they would be prejudiced if the Government did not provide the “same.” ALJ Ex. 27, at 2 (No. 15-6); ALJ Ex. 18, at 2 (No. 15-7). Respondents further asserted that the “information is essential,” because the Government intended to put on evidence that the prescriptions raised red flags and that “Respondent[s] fail[ed] to exercise [their] corresponding responsibility to resolve the `red flag[s],' ” and the Government “has not identified one patient or doctor related to the prescriptions allegedly containing unresolved red flags.” ALJ Ex. 27, at 2 (No. 15-6); ALJ Ex. 18, at 2 (No. 15-7).
The Government also opposed Respondents' Motions for Enlargement of Time. ALJ Ex. 16, at 6 (No. 15-7). The Government argued that the Show Cause Orders and Prehearing Statements had “specifically outlined” the allegations, “as well as the approximate number of documents it intend[ed] to introduce into evidence.”
On January 5, 2015, the ALJ denied Respondents' Motions for Enlargement. ALJ Ex. 11, at 3 (No. 15-7); ALJ Ex. 12, at 4 (No. 15-6). The ALJ specifically noted “that since at least October 16, 2014, Respondent[s] ha[ve] been informed of the nature of the charges presented in the Order to Show Cause,” and that in their motions, Respondents had acknowledged that the Government had provided them with the prescriptions. ALJ Ex. 11, at 3 (No. 15-7); ALJ Ex. 12, at 3 (No. 15-6). The ALJ explained that neither Respondent had “established that it has been prevented from evaluating those prescriptions identified in the Order to Show Cause [or] that it has been prevented from preparing its prehearing statement.” ALJ Ex. 11, at 3 (No. 15-7); ALJ Ex. 12, at 3 (No. 15-6). The ALJ also explained that Respondents had known since the issuance of his Prehearing Orders that they were required “to object to any term of that Order by not later than December 10, 2014,” and that they failed to object to the orders until the day their Prehearing Statements were due. ALJ Ex. 11, at 3 (No. 15-7); ALJ Ex. 12, at 3 (No. 15-6). The ALJ thus concluded that:
I am compelled to consider the nature of the allegations, which if proved suggest Respondent[s'] ability to fill controlled substance prescriptions would be inconsistent with the public interest. I am further compelled to consider Respondent[s'] own role in attempting to delay th[ese] proceeding[s], given that [they] failed to timely object to the deadlines set forth in the Order[s]. I am further compelled to consider fairness to all parties, and the convenience of witnesses now identified by the Government in its timely prehearing statement[s]. I am further compelled to consider the need for orderly and prompt administration of justice. All of these considerations compel my finding that good cause has not been shown for either enlarging the time for Respondent[s] to file [their] prehearing statement[s], or for continuing the hearing now set to being on January 27, 2015.
The same day (according to OALJ date stamps), each Respondent filed its Prehearing Statement. ALJ Ex. 9 (No. 15-6); ALJ Ex. 12 (No. 15-7). Each Respondent proposed as witnesses “[a]ny and all patients whose prescriptions were seized . . . pursuant to the Administrative Inspection Warrant executed [on] February 4, 2013 or whose prescriptions for controlled substances were dispensed between January 1, 2011 and February 4, 2013.” ALJ Ex. 9, at 3 (No. 15-6); ALJ Ex. 12, at 3 (No. 15-7). Respondent Superior I further attached a list of 2,355 purported patients, ALJ Ex. 9, at Attachment A (No. 15-6); and Respondent Superior II attached a list of 2,253 purported patients. ALJ Ex. 12, at Attachment A (No. 15-7). As for the required summary of anticipated testimony, each Respondent proposed that:
These patients will each be asked to provide testimony regarding their medical history, injuries and related pathology, interactions with treating physicians and dispensing pharmacists, effectiveness of the prescribed controlled substances, continuity of treatment, their reasons for patronage of Superior Pharmacy, LLC . . . such other testimony relevant to the Government's allegation that any of these prescriptions raised `red flags' which should have caused pharmacists to refuse to dispense the prescribed controlled substances.
Respondents further proposed as witnesses “[a]ny and all physicians who issued the prescriptions seized . . . pursuant to the Administrative Inspection Warrant[s] . . . or whose prescriptions for controlled substances were dispensed at [them] between January 1, 2011 and February 4, 2013,” as well as “[a]ny and all physicians who issued prescriptions for controlled substances to the patients identified . . . above after February 4, 2013.” ALJ Ex. 9, at 3 (No. 15-6); ALJ Ex. 12, at 3 (No. 15-7). Each Respondent attached a list of several hundred physicians who had purportedly issued the controlled substance prescriptions dispensed by them. ALJ Ex. 9, at Attachment B (No. 15-6); ALJ Ex. 12, at Attachment B (No. 15-7). As for the anticipated testimony of the physicians, Respondents represented that:
These physicians will confirm they performed adequate and appropriate physical examinations of the patients to whom they
Next, Respondents proposed as witnesses “[a]ny and all pharmacists who dispensed prescriptions for controlled substances to the patients identified . . . above
Respondents also proposed as a witness Mr. Sam Badawi, a pharmacist and attorney. ALJ Ex. 9, at 3 (No. 15-6); ALJ Ex. 12, at 3 (No. 15-7). As for Mr. Badawi's anticipated testimony, Respondents represented that he:
Respondents further proposed as a witness Mr. Jack Crowley of Gates Healthcare Associates. Respondents represented that Mr. Crowley:
On January 9, 2012, each Respondent filed a motion to enlarge the time for filing its proposed exhibits or to alternatively provide its proposed exhibits electronically, as well as a motion to enlarge the time to file its requests for subpoenas. ALJ Ex. 22 (No. 15-6); ALJ Ex. 23 (No. 15-7). In its motion, Superior I explained that its “Prehearing Statement identifies four categories of proposed exhibits which consist of 23,032 documents,” of which “20,925 pages represent the documents seized, and provided to Respondent electronically, by the DEA.” ALJ Ex. 22, at 2 (No. 15-6). Superior I explained that to comply with the ALJ's Pre-hearing Order, which required that three copies of each exhibit be filed with the OALJ and one copy be filed with opposing counsel, this would require more than 92,000 pages and “approximately nineteen standard boxes of paper, which is approximately 950 pounds.”
Superior II made similar assertions to Superior I, noting that its proposed exhibits “consist of 32,123 documents,” of which “30,441 pages represent the documents seized, and provided to [it] electronically, by the DEA,” and that to comply with the ALJ's Prehearing Order, it would have to provide more than 128,000 pages of documents, and require “approximately 1,300 pounds” of paper. ALJ Ex. 23, at 2 (No. 15-7). As did Superior I, Superior II asserted that it would have to use a third-party to perform the necessary copying, which could not “be completed in the allotted time.”
On January 12, 2015, each Respondent submitted a letter (dated Jan. 9) to the Hearing Clerk along with thumb drives which contained “the images of each of the exhibits in [its] Prehearing Statement.” ALJ Ex. 24 (No. 15-6); ALJ Ex. 24 (No. 15-7). Each Respondent's letter also advised that the paper copies of the subpoena requests would be hand delivered on Monday, January 12, 2015, and on that date, the ALJ “received more than 3,000 written requests for the issuance of subpoenas in the[] two cases.” Tr. 18;
The same day, the ALJ's Law Clerk sent a letter under his own signature to each Respondent's Counsel noting that the OALJ had received the thumb drives. ALJ Ex. 28 (No. 15-6); ALJ Ex. 28 (No. 15-7). The Law Clerk then explained that he was returning the thumb drives to each Respondent's counsel because “[t]he submission of the thumb drive does not adhere to the” ALJ's Prehearing Order of December 3, 2014. ALJ Ex. 28 (No. 15-6); ALJ Ex. 28 (No. 15-7).
On January 12, the ALJ denied each Respondent's Motion to Compel. The ALJ noted that in the case of
The same day, in the Superior I matter, the Government submitted its request for the issuance of subpoenas for four witnesses, and in the Superior II matter, the Government submitted its request for the issuance of subpoenas for five witnesses, all of whom had been previously identified in the respective Prehearing Statement.
On January 13, 2015, the Government moved to consolidate the cases, along with a third matter (Jet Pharmacy). ALJ Ex. 31 (No. 15-6); ALJ Ex. 31 (No. 15-7). In its motions, the Government argued that there were common issues of law and fact with respect to the pharmacies, noting that it intended to call the same expert in each of the cases and each Respondent had stated that it intended to call the same two experts. ALJ Ex. 31, at 2-3 (No. 15-6); ALJ Ex. 31, at 2-3 (No. 15-7). The Government further argued that the expert's testimony would “account for the bulk of the Government's and likely the Respondents' cases in terms of length of testimony,” and that consolidation would “result in a tremendous conservation of time and resources by allowing the Government to present its expert's testimony in one proceeding rather than in three separate proceedings.” ALJ Ex. 31, at 5 (No. 15-6); ALJ Ex. 31, at 5 (No. 15-7).
The Government also argued that, although “each of the Respondent pharmacies is a separate business entity, there are also strong indications of common ownership, management, and/or control between the Respondents,” and that Superior I and II “are both owned and operated by Victor Obi-Anadiume.”
Each Respondent filed identical oppositions to the Government's motions.
Respondents then maintained that “because each prescription represents a different pattern of facts, it appears there is no overlapping factual issue between the two matters,” and “[a]s such, there is no risk of inconsistent results” which would support consolidation. ALJ Ex. 30, at 5 (No. 15-6); ALJ Ex. 32, at 5 (No. 15-7). Respondents further maintained that “there is a high risk that one defendant could be prejudiced by evidence relating to another defendant.” ALJ Ex. 30, at 5 (No. 15-6); ALJ Ex. 32, at 5 (No. 15-7). Respondents also asserted that consolidation would not promote judicial economy “[b]ecause of the large number . . . and limited overlap of” the witnesses and because “the time necessary to complete the hearing as to both parties could exceed ninety (90) days.” ALJ Ex. 30, at 6 (No. 15-6); ALJ Ex. 32, at 6 (No. 15-7).
On January 15, 2015, each Respondent filed a further pleading, which appear to be identical, on the issue of consolidation. ALJ Ex. 40 (No. 15-6); ALJ Ex. 40 (No. 15-7). In addition to the arguments they previously raised, Respondents contended that “[t]o the extent the government seeks to rely on a single expert to prove its case in all three matters, it heightens the risk of confusion or attempts to conflate issues between three distinct defendants.” ALJ Ex. 40, at 6 (No. 15-6); ALJ Ex. 40, at 6 (No. 15-7). They also argued that “although Respondent[s] share Mr. Obi as a common owner, [he] is not responsible for the day-to-day operations or the implementation of policies and procedures at these separate businesses” as each pharmacy had a “different pharmacy manager[ ].” ALJ Ex. 40, at 7 (No. 15-6); ALJ Ex. 40, at 7 (No. 15-7). Respondents further contended that “Mr. Obi did not dispense medication or otherwise process prescriptions at these pharmacies during all relevant time periods described in the Orders to Show Cause.” ALJ Ex. 40, at 7 (No. 15-6); ALJ Ex. 40, at 7 (No. 15-7).
On January 21, 2015, the ALJ granted the Government's motions with respect to Superior I and Superior II. ALJ Ex. 1 (No. 15-6 & 15-7). The ALJ specifically found that “the Government ha[d] demonstrated the presence of common questions of law and fact with respect to Superior I and Superior II, and ha[d] shown the need to take steps to avoid unnecessary cost or delay.”
The ALJ also rejected Respondents' contention that there was “a substantial risk of prejudice to Respondents in either case.”
On January 15, 2015, the Government also filed a Motion
As for Respondents' disclosures pertaining to the testimony of Mr. Crowley, the Government argued that “no facts [were] proffered to give [it] any notice regarding [his] conclusions regarding audit errors, or the basis for those conclusions, should they exist.” ALJ Ex. 36, at 5 (No. 15-6); ALJ Ex. 36, at 5 (No. 15-7). The Government also argued that while Respondents proposed that this witness would testify regarding their procedures for resolving red flags and complying with other requirements, Respondent had not “offer[ed] a single fact or detail to describe, identify, or explain that procedure.” ALJ Ex. 36, at 5 (No. 15-6); ALJ Ex. 36, at 5 (No. 15-7). The Government further contended that it is unclear whether this witness's proposed testimony would discuss the procedures in place during the period of the alleged misconduct or as to procedures subsequently instituted. ALJ Ex. 36, at 6 (No. 15-6); ALJ Ex. 36, at 6 (No. 15-7). Finally, the Government argued that Respondents' disclosure was “void of any detail about the information [this witness] reviewed to form his opinions about the DEA audits or the procedures Respondents employed at their pharmacy.” ALJ Ex. 36, at 6 (No. 15-6); ALJ Ex. 36, at 6 (No. 15-7).
Addressing Respondents' proposed taking of the testimony of the numerous patients who filled controlled substance prescriptions at Respondents, the Government maintained that Respondents' disclosure “constitute[d] a wholesale failure to describe `each and every matter as to which [they] intend[ed] to introduce evidence in opposition,' ” as required by the ALJ's Pre-hearing Order. ALJ Ex. 36, at 6 (No. 15-6); ALJ Ex. 36, at 6 (No. 15-7). As for the physicians who wrote the prescriptions, the Government argued that the disclosures were inadequate because “Respondent[s] merely indicate[ ] that these unknown individuals will testify regarding `communication[s] with the dispensing pharmacists regarding such prescriptions,” and “no facts about any such communications are revealed.”
The Government also contended that testimony and documentation regarding prescriptions which it did not intend to offer into evidence was irrelevant. ALJ Ex. 36, at 8 (No. 15-6) ALJ Ex. 36, at 8 (No. 15-7). Finally, with respect to the physicians who issued prescriptions filled by Respondents after February 4, 2013 and the pharmacists who filled the prescriptions, the Government argued that Respondent had not even identified these persons and that their proposed testimony was “stated only in general terms [and] lack[ed] conclusions.” ALJ Ex. 36, at 7 (No. 15-6); ALJ Ex. 36, at 7 (No. 15-7).
In its motion, the Government also addressed Respondents' use of a thumb drive to provide its exhibits. ALJ Ex. 36, at 3 (No. 15-6); ALJ Ex. 39, at 3 (No. 15-7). According to the Government, the thumb drive contained “hundreds of different files, which contain, collectively, thousands of pages of documents,” of which only one file, which “consist[ed] of 1490 pages,” “appeared to be marked for identification.” ALJ Ex. 36, at 3-4 (No. 15-6); ALJ Ex. ALJ Ex. 36, at 3-4 (No. 15-7). The Government further stated that the other files were “neither marked for identification nor paginated.” ALJ Ex. 36, at 4 (No. 15-6); ALJ Ex. 36, at 4 (No. 15-7). The Government argued that Respondents' submission of their proposed documentary evidence did not “comply with the ALJ's order in terms of labeling and form.” ALJ Ex. 36, at 8 (No. 15-6); ALJ Ex. 36, at 8 (No. 15-7). The Government also argued that because “none of [Respondents'] summarized testimony reference[d] any particular documents or page, [it was] unable to ascertain whether any of the documents . . . would be relevant to [the] proceeding.” ALJ Ex. 36, at 9 (No. 15-6); ALJ Ex. 36, at 9 (No. 15-7).
On January 21, 2015, each Respondent filed a Response to the Government's Motion; as with Respondents' other filings, the Responses appear to be identical.
Respondents further took issue with the Government's contention (with respect to both pharmacies) that only a small number of the thousands of persons listed in their Prehearing Statements were actually identified as patients. ALJ Ex. 53, at 2 (No. 15-6); Superior II Response to Motion
As for the Government's contention that Respondents had failed to disclose the proposed testimony of the patients, doctors and pharmacists with adequate specificity, Respondents argued that “without the identification of the prescriptions and/or patients at issue (as defined by the OSC), a specific summary of each and every potentially relevant witness is impossible within the timeframe provided.” ALJ Ex. 53, at 6 (No. 15-6); Superior II Response to Motion
As for the Government's attempt to bar the testimony of Mssrs. Badawi and Crowley, Respondents argued that they “ha[d] summarized [their] testimony to the same extent that the Government summarized its proposed testimony.” ALJ Ex. 53, at 5 (No. 15-6); Superior II Response to Motion
As for the Government's attempt to bar their proposed documentary evidence, Respondents argued that they were “prejudiced by the Government's inadequate Prehearing Statement which forced Respondent[s] to incorporate and include all potential documents and witnesses from the relevant time period.” ALJ Ex. 53, at 4 (No. 15-6); Superior II Response to Motion
Concluding, Respondents argued that the Government had nearly two years to review the documents and that between February 4, 2013 (the date the AIWs were served) and the dates of service of the Show Cause Orders), “Respondent[s] had no access to these records.” ALJ Ex. 53, at 5 (No. 15-6); Superior II Response to Motion
On January 27, 2015, the ALJ conducted the initial day of the hearing during which he addressed the Government's Motions
As for the proposed testimony of the physicians, the ALJ found that Respondents' Pre-hearing Statement did “not sufficiently identify the anticipated testimony of the witnesses, nor . . . make a sufficient showing that their testimony would constitute relevant evidence.”
The ALJ also granted the Government's motion to exclude the testimony of Mssrs. Badawi and Crowley. As for Mr. Badawi, the ALJ found that Respondent had not complied with his Prehearing Order because “[u]nlike the articulation of specific red flags provided by the Government in its description of testimony for its expert, the Respondents' Prehearing Statements do not reveal the substance of this testimony, but instead presented only a list of areas to be discussed.”
As for Mr. Crowley's proposed testimony regarding errors in the DEA audit, the ALJ found that Respondents “fail[ed] to articulate what those errors were.”
The ALJ also addressed the Government's contention that Respondents' documentary evidence should be excluded. In his Order, the ALJ explained that in his Prehearing Orders he had directed the parties to exchange their exhibits on or before January 12, 2015, and that the “failure to timely do so would result in the exclusion of the documents.”
Subsequently, on February 3, 2015, the Government filed a “Notice of Objections to Respondent's Exhibits.” ALJ Ex. 15 (Nos. 15-6 and 15-17). Therein, the Government noted that it had received eight binders of evidence totaling nearly 4,300 pages, of which five binders appeared to be related to Superior I and three binders Superior II.
At the first day of the evidentiary phase of the hearing, the ALJ addressed the Government's objection. Tr. 54. After re-affirming his earlier ruling which barred Respondents from introducing any documentary evidence, the ALJ then turned to the Government's contention that Respondents had not complied with 21 CFR 1316.60. On the issue of whether Respondents had made an adequate offer of proof, the ALJ asked one of Respondents' counsel if he was “correct in understanding that the Respondent[s'] Pre-hearing Statements and the premises that [he] articulated during the initial day of hearing in support of receiving these exhibits should, taken together, be regarded as containing the statement of the substance of the evidence which you would have accompany the excluded documents?” Tr. 58. Respondents' counsel answered “[y]es.”
During the January 27 hearing, the ALJ also addressed each Respondent's request for subpoenas. Tr. 17-23. As explained above, each Respondent submitted requests for an extensive number of subpoenas but failed to include with its requests a certificate of service establishing that they had provided copies to the Government.
Asked by the ALJ to address its requests, Respondents' counsel asserted that “the request for subpoenas was copied to [Government counsel] timely as to each of the subpoenas.”
The ALJ then explained that in his Prehearing Orders, he had advised the parties that subpoena requests that did not comply with his instructions would be returned without further action; he also explained that Respondents had neither objected to nor sought clarification of the Prehearing Orders.
On January 15, 2015, Respondents also filed motions to exclude the testimony of the Government's pharmacy expert Robert Parrado. ALJ Ex. 41 (No. 15-6); ALJ Ex. 41 (No. 15-7). The basis of Respondents' motions was that “Mr. Parrado's proposed opinions are based on nothing more than a cursory review of the written prescriptions to the exclusion of all
Respondents argued that the ALJ was required to perform a “gatekeeping” function in determining whether Mr. Parrado's testimony was admissible. ALJ Ex. 41, at 2 (No. 15-6); ALJ Ex. 41, at 2 (No. 15-7). They further argued that under
The Government opposed the motions. Quoting agency precedent, the Government argued that where, as here, non-scientific expert testimony is at issue, the expert's “ `knowledge and experience' ” may provide a sufficient foundation for concluding that his testimony is reliable. ALJ Ex. 50, at 3 (quoting
The ALJ denied Respondents' motions. The ALJ reasoned that in each Show Cause Order and its Prehearing Statements, “the Government identifie[d] red flags or other conditions which, according to the Government, triggered a corresponding obligation on the part of pharmacies who were presented with a number of prescriptions. The thrust of this evidence is [not] dependent upon scientific or technical analysis, but upon documentary or testimonial evidence establishing or rebutting the claimed corresponding obligation.” ALJ Ex. 7, at 7 (Nos. 15-6 and 15-7).
The ALJ then held that “[t]he Government ha[d] made a sufficient showing to permit Mr. Parrado to appear and give testimony.”
On January 15, 2015, each Respondent also moved for a continuance. ALJ Ex. 42 (No. 15-6); ALJ Ex. 42 (No. 15-7). Respondents sought a continuance of the proceeding “to commence no sooner than June 2015.”
Respondents argued that “the Government has had years to prepare its case whereas [they have] only been afforded a few months.”
On January 27, 2015 (during the initial day of the hearing), the ALJ denied Respondents' motions.
Likewise, Respondents represented that “Mr. Crowley will testify regarding errors in the audits performed by the agent/investigators of Superior Pharmacy [I and II]. Mr. Crowley reviewed the prescriptions, inventory and CSOS records of Superior Pharmacy [I and II]. Mr. Crowley will further testify regarding Superior Pharmacy[I and II]'s procedure for resolving potential `red flag' issues and compliance with recordkeeping requirements related to inventory records, DEA-222 order forms and CSOS issues.” ALJ Ex. 9, at 5 (No. 15-6); ALJ Ex. 12, at 5 (No. 15-7).
With the evidentiary phase of the hearing set to begin on February 10, 2015, on February 6, 2015, Respondents filed a second Motion for Continuance. ALJ Ex. 12, at 1 (No. 15-6/15-7). The basis for the motion was that on January 28, 2015, they had retained a third counsel, who previously been involved in resolving a matter involving another of Mr. Obi's pharmacies.
The same day, the Government objected. ALJ Ex. 19 (Nos. 15-6/15-7). It argued that Respondents had been aware of the allegations since October 16 and 17, 2014, and that “neither Respondent has been without counsel since” they were served with the Show Cause Orders, and that Superior I had previously retained an additional counsel.
The ALJ denied Respondents' motion. ALJ Ex. 24, at 2 (Nos. 15-6/15-7). As with Respondents' previous motions for a continuance, the ALJ explained that he had considered various factors and found that “cause has not been shown to delay the hearing.”
On February 10 and 11, the ALJ conducted the evidentiary phase of the hearing at the DEA Hearing Facility in Arlington, Virginia. At the hearing, the Government elicited the testimony of four witnesses, including its expert witness, Mr. Robert Parrado; the Government also introduced various documents into evidence. Consistent with the ALJ's order granting the Government's Motions
Following the hearing, both parties submitted briefs containing proposed findings of fact and conclusions of law (hereinafter, referred to as Post-Hearing Brief). On April 9, 2015, the ALJ issued his Recommended Decision (hereinafter, cited as R.D.); according to the Certificate of Service, on April 10, the ALJ's law clerk sent a copy of the Decision to all three of Respondents' counsels by Federal Express.
In the Recommended Decision, the ALJ relied on the Government's evidence with respect to factors two and four to conclude that “the Government has established its
On May 4, 2015, the ALJ transmitted the record to my Office. On May 6, 2015, Respondents filed a brief captioned as: Exceptions to the Recommended Decision and Request for Removal of the ALJ (hereinafter, cited as Resp.' Exceptions). Respondents, however, offered no showing of good cause to excuse the untimely filing of their brief.
Having carefully considered the entire record in this matter and, in particular, the claims of error raised by Respondents in their Post-hearing Brief, I do not adopt the ALJ's findings of fact and conclusions of law with respect to the allegations that each Respondent's pharmacists violated 21 CFR 1306.04(a) and 1306.05(a). I do, however, adopt the ALJ's findings of fact and legal conclusions with respect to: (1) The allegations pertaining to the audits conducted of each pharmacy, (2) the allegations that Respondents were not properly maintaining required records including their schedule II order forms, and (3) that for purchases made using the electronic Controlled Substance Order System, Superior II was not electronically linking its receipt records to its purchase records. I further find that Respondent Superior II violated DEA regulations by allowing a non-authorized person to place electronic orders using the key assigned to an authorized person. I therefore conclude that the Government has made out a
The parties stipulated that Respondent Superior I holds DEA Certificate of Registration BS9255274, pursuant to which it is authorized to dispense controlled substances in schedules II through V as a retail pharmacy, at the registered address of 3007 W. Cypress St., Suite 1, Tampa, Florida. ALJ Ex. 7, at 2 (Nos. 15-6/15-7).
The parties stipulated that Respondent Superior II holds DEA Certificate of Registration BS9699731, pursuant to which it is authorized to dispense controlled substances in schedules II through V as a retail pharmacy, at the registered address of 5416 Town `N' Country Blvd., Tampa, Florida.
On February 4, 2013, DEA Investigators executed Administrative Inspection Warrants at Respondents Superior I and Superior II. Tr. 370-71; 471. With respect to Superior I, the Investigators seized the original
Likewise, with respect to Superior II, the lead Investigator on the warrant testified that she seized the original schedule II prescriptions and the pharmacy's purchasing records for the drugs that were subject of the audit; the DI also testified she obtained the pharmacy's schedule II order forms as well as a perpetual inventory maintained by the pharmacy which was dated July 31, 2012.
As part of the investigations, the Government provided various schedule II prescriptions which were dispensed by each pharmacy to its expert Mr. Robert Parrado, who reviewed them to determine if they were dispensed in compliance with the Controlled Substances Act. Mr. Parrado testified that he obtained his B.S. in Pharmacy in 1970 from the University of Florida College of Pharmacy and that he has held a Florida pharmacist's license since 1971. Tr. 122; GX 2, at 1 (No. 15-6/15-7). Mr. Parrado testified that he has practiced as a pharmacist at both community pharmacies as well as hospital pharmacies; he also testified that he had been the Pharmacy Department Manager at multiple pharmacies, including two pharmacies that he owned for approximately 19 years. Tr. 124-26; GX 2, at 1-2.
Mr. Parrado was a member of the Florida Board of Pharmacy from January 2001 through February 2009, and had served as both Vice Chairman and Chairman of the Board. Tr. 128-29; GX 2, at 3. He is a member of the Florida Pharmacy Association, having served as both its President and then Chairman of the Board. GX 2, at 3. He is also a member of the Hillsborough County Alcohol & Drug Abuse Task Force, the National Community Pharmacists Association, and the American Society for Pharmacy Law.
Asked to explain what the standard of care (in Florida) requires of a pharmacist who is presented with a prescription for a controlled substance, Mr. Parrado testified:
You have to ensure that the prescription is appropriate and that it's valid. And in doing that he has to look at the prescription. He has to understand the nature of the drug, the nature of the disease state that they're treating, the appropriateness of the therapy and the dosing.
And then make sure that the prescription was issued under . . . the valid circumstances of a physician . . . having written the prescription in the course of his practice and that the prescription is . . . for [a] legitimate medical purpose.
Asked to explain what a “red flag” is as it relates to the dispensing of controlled substances, Mr. Parrado then testified that:
[a] red flag is anything that will cause the pharmacist concern as to the validity of that prescription. It could be numerous things.
And a lot of times it's just dependent on the patient presenting the prescriptions or the circumstances. Or just looking at the prescription itself might raise a red flag . . . and cause you concern.
Mr. Parrado then proceeded to identify various red flags, including if the prescription was for “a known drug of abuse” and if the dosing is “appropriate.”
Mr. Parrado also identified other red flags to include “[m]ultiple people presenting with identical or very similar prescriptions from the same clinic,” as well as where a person presents prescriptions for “cocktails that are known to be abused on the street.”
Mr. Parrado further identified as a red flag the circumstance where multiple persons present the “same prescriptions” from either “the same practitioner” or “clinic.”
Mr. Parrado then identified two more red flags. The first of these is when “two people in the same household or [with the] same address were needing the exact same drugs.”
Asked by the Government what steps a pharmacist should take upon being presented with a prescription that raises a red flag, Mr. Parrado explained:
At that point the pharmacist—first thing he has to do, he has to verify that prescription with the prescriber. Florida law says you check with the prescriber.
Not the prescriber's office, with the prescriber. And then you speak with the prescriber and get his opinion.
You ask him the questions that you feel, you know, address your concerns. And then at that point I have to . . . use my professional judgment. Did I believe him or not.
Because a physician who had written a script is always going to say, yes they wrote it. But I'm trying to determine if it was written for a legitimate medical purpose. So that's why I'm asking the questions I'm asking.
Continuing, the Government asked Mr. Parrado if some red flags are unresolvable, prompting objections by each Respondent that this testimony was beyond the scope of the summary of the testimony disclosed by the Government in its Prehearing Statements.
One of the fundamental tenets of Due Process is that the Agency must provide a respondent with notice of those acts which the Agency intends to rely on in seeking the revocation of its registration so as to provide a full and fair opportunity to challenge the factual and legal basis for the Agency's action.
However, “ `[p]leadings in administrative proceedings are not judged by the standards applied to an indictment at common law.' ”
The Agency has thus recognized that “the parameters of the hearing are determined by the prehearing statements.”
However, consistent with numerous court decisions, the Agency has also held that even where an allegation was not raised in either the show cause order or the prehearing statements, the parties may nonetheless litigate an issue by consent.
Here, I conclude that the ALJ erred when he overruled Respondents' objections to the testimony, as neither the Show Cause Orders, nor the Government's Prehearing Statements ever identified any prescription as presenting red flags that could not be resolved. As the Second Circuit has explained, “[t]he primary function of notice is to afford [a] respondent an opportunity to prepare a defense by investigating the basis of the complaint and fashioning an explanation that refutes the charge of unlawful behavior.”
Well anytime that there is a red flag my job is to resolve that red flag. And at that point I'm having to use my professional judgment when I'm weighing all the different factors that are causing me concern.
If I cannot resolve all these things that are bothering me, at that point that becomes unresolvable and I cannot fill that prescription.
The Government then asked Mr. Parrado if a retail pharmacist would document his/her resolution of a red flag “somewhere?”
On Respondent's
On further
When asked whether his opinions were based on information in the DEA
Mr. Parrado then testified that he was retained to “review the prescriptions.”
The Government then proceeded to question Mr. Parrado regarding the 25 prescriptions contained in Government Exhibit 3 (No. 15-6).
Each page of this exhibit contains two images; one showing the front of the prescriptions; the other showing the back.
The Government then asked Mr. Parrado whether there were “any red flags associated with” the 16 prescriptions, which were filled on August 5, 2011.
Well first thing I would see was the drug, [o]xycodone, 30 milligrams. Then I would see that they're all coming from the same clinic. They're all for the same strength written by the same physician on the same day.
So there's multiple patients coming from the same clinic. Which was one of my concerns earlier. Multiple people presenting from the same clinic with a like or similar prescription.
These are definitely alike in similar prescriptions. So that would be my first red flag.
Then the next red flag I would have looked at was the dosing. The appropriateness of therapy. A red flag I would have to resolve at this point was knowing that 80 milligrams a day of [o]xycodone is a lethal dose to an opioid naïve patient. These are much higher than 80 milligrams a day dosing.
I would have to verify—I'd have to feel good about the fact that the patient had been on this drug therapy and established to this dose. Would have been the first thing.
Then the next thing I would have looked at would have been the patient[']s address. How far he drove to get there.
Then another thing I would have looked at was what . . . did he pay for it with cash. And how much did he pay. How much is he willing to pay for.
As to the issue of foundation, Mr. Parrado testified that “I know the pharmacy I was working in at that time [was] paying about $.33 a pill for [o]xycodone.” Tr. 182. He then added that the average price charged to a patient “may have gotten to a $1.00.”
Mr. Parrado further testified that each of the 16 prescriptions was paid for in cash.
The Government then questioned Mr. Parrado regarding the red flags presented by the relative location of the patients to the prescriber and Superior I. With respect to the prescriptions reproduced at pages one (112 oxycodone 30 to M.L.) and nine (224 oxycodone 30 to V.P.), both patients' addresses were listed as being in Spring Hill, Florida.
It is correct that the Government did not disclose in its Prehearing Statement for Superior I that Mr. Parrado would specifically testify about the distances between Superior I and the towns of Spring Hill (as well as New Port Richey and others). It also true that in its Prehearing Statement, the Government indicated that it intended to call a different witness (an intelligence analyst) to testify about a chart she created showing the large number of Superior I's patients who lived long distances from the pharmacy. However, the Government also disclosed that it intended to ask the ALJ to take official notice of the approximate mileage between Superior I and the various municipalities where the patients lived. Moreover, the distances between Superior I and the towns of Spring Hill and New Port Richey are disputable only to the extent one argues over the precise addresses used to ascertain that distance or the route taken. I thus conclude that Respondent cannot show how it was prejudiced by the ALJ's overruling of its objection.
Regarding the prescriptions reproduced at page four (168 oxycodone 30 S.M.) and 16 (224 oxycodone 30 for S.A.), Mr. Parrado testified that both patients gave addresses in New Port Richey.
Next, the Mr. Parrado testified that each of the 16 prescriptions was “facially invalid” because the prescribing physician did not include the patient's address.
The Government then asked Mr. Parrado about the prescriptions found at pages 11 (RX#452161), 12 (RX#452160), 14 (RX#452156), 15 (RX#452155), and 16 (RX#452159). Tr. 194-95. Of note, these prescriptions were issued to patients who reported their addresses respectively as being in High Springs, Alachua, Middleburg, Florida; Uvalda, Georgia; and New Port Richey, Florida.
Yes. Yes, it would have caught my attention that we had people coming from long distances and places that were close together, coming to get these prescriptions.
What I don't see on there is, you know, it looks like the [patient address] sticker was put on the front to resolve the red flag. It doesn't tell me how they resolved the red flag.
The Government then asked Mr. Parrado about the prescriptions reproduced at pages 13 (RX#452157) and 14 (RX#452156); these prescriptions listed the patient's addresses as being in Jacksonville (J.M.) and Middleburg, Florida (B.M.).
As for Respondent's objection on the ground that the testimony was “rank speculation,” given that Mr. Parrado testified and the prescriptions show that: (1) These two patients had the same last name, (2) provided addresses which suggested that they lived near each other, and (3) their prescriptions bore sequential prescription numbers, Mr. Parrado's testimony was a permissible inference. In any event, even if the patients did not travel together, each of these prescriptions presented red flags.
Moreover, even acknowledging that the Government did not disclose that Mr. Parrado would testify that these two persons could have travelled to Superior together, the Government nonetheless disclosed that it intended to elicit testimony regarding Respondent's filling of multiple prescriptions for patients who travelled long distances to obtain their prescriptions. ALJ Ex. 1, at 2-3 (No. 15-6); ALJ Ex 7, at 3-5 (No. 15-6).
Next, the Government asked Mr. Parrado about the prescriptions reproduced at pages 14 and 15. Of note, the latter prescription was issued to a patient (C.M.), who provided an address in Uvalda, Georgia and who has the same last name as that of the patients discussed in the preceding paragraph.
These are the kinds of prescriptions that would cause me not to be able to resolve that—this many red flags together. The long distance, the same name, the like, similar drugs, thousands of dollars involved here, in cash, would cause me . . . concern.
It's not, in my practice, it's not been—the average customer doesn't come into the pharmacy with $1,000 in their pocket. You know, it's average you tell the person they have a $20 copay they get upset.
For these process [sic] to be charged, you know, it's just—that's a red flag that I would have a hard time resolving.
I agree with Respondent that this testimony was speculative because the patients could well have paid for their prescriptions with credit cards. However, the prescriptions list their respective prices as $833 (RX 452157), $952 (RX452156), and $833 (RX452155). GX3, at 13-15. Regardless of the method of payment used to purchase them, Mr. Parrado testified that the cost of the prescriptions was also a red flag.
The Government then asked Mr. Parrado whether, with respect to the 16 oxycodone 30 prescriptions (GX 3, at 1-16), which were issued and filled on August 5, 2011, there was any evidence, other than the placement of the address stickers, that the red flags they presented “were resolved?” Tr. 200. Mr. Parrado testified: “[t]here is no documentation to that effect on any of these prescriptions.”
In some of the partial medical records I looked at, there wasn't any evidence of any conversations between the clinics and the
Mr. Parrado then opined that it “would be outside the standard of care for a pharmacist to fill these without having resolved the red flags before dispensing.”
The Government then questioned Mr. Parrado about the remaining prescriptions in its Exhibit 3. These included a prescription for 240 oxycodone 30 issued on December 10, 2011 to J.M.; as with the other prescriptions, the prescriber had not written the patient's address on the prescription but the prescription contained a small sticker listing J.M.'s address as Lenoir, Tennessee. GX 3, at 22 (No. 15-6). Asked if the prescription raised any red flags, Mr. Parrado noted J.M.'s address and explained that his “first concern” was the “person coming from Tennessee.” Tr. 202. Mr. Parrado identified additional red flags presented by the prescriptions, including the physician's failure to include the patient address on the prescription, that the quantity of 240 pills was a “very high dose” for oxycodone 30, that the prescription came “from the same clinic,” and that it cost $1,155.
However, when asked by the Government if he could tell who filled the prescription, Mr. Parrado testified that the prescription bore the initials “CD,” thus indicating “the pharmacist responsible” for the script; he then added that “there's a scribble on the front from somebody that canceled the prescription.”
Next, the Government asked Mr. Parrado whether the prescriptions (reproduced at GX 3, at 17-18), which are dated August 6, 2011 and bear sequential prescription numbers presented any red flags. Both of these prescriptions were issued by Dr. S.A.H., a physician at the same 24th Century Medical Center in Tampa, to two persons (E.P. and R.B.) for 150 and 140 tablets respectively of oxycodone 30. GX 3, at 17-18. Here too, the front of each prescription lacked the patient's address.
Asked by the Government whether the prescriptions presented any red flags, Mr. Parrado identified the patients' addresses and added that “Milton, Florida is way in the [w]estern panhandle of Florida. It's well over 400 miles” to the pharmacy. Tr. 204.
After noting that E.P.'s prescription cost $562 and R.B.'s prescription cost $525, Mr. Parrado testified that “two people from one address paying over $1,000 would be a red flag from somebody coming . . . from 400 miles away.”
Next, the Government asked Mr. Parrado about a prescription issued by Dr. V.S. (also of the 24th Century Medical Center) and dispensed on December 2, 2011 to B.W., for 200 tablets of Dilaudid (hydromorphone) 8 mg.
Asked if the prescription presented any red flags, Mr. Parrado testified that there were multiple red flags, including that “it's a very, very potent drug” and that the quantity was for 200 pills. Tr. 208. Continuing, Mr. Parrado testified that:
I have never seen a prescription in my 41 years as a pharmacist for a quantity like that of . . . Dilaudid 8 milligrams as being dosed at every . . . three to four hours.
Which would be six to eight times a day. So 48 to 72 milligrams . . . would be the daily dose for a drug that the recommended upper dose be probably 24 milligrams.
So it's a much higher dose then [sic] what I have ever seen as a pharmacist. And that would have caused me serious concern that I had to resolve before I could do anything, period.
The fact that they came a long way, again, from Fort Ogden, from that same clinic that I'm seeing all these prescriptions from, would cause me not to be able to resolve that red flag.
Mr. Parrado was then asked whether a prescription (GX 3, at 19) for 196 Dilaudid 8 mg issued by Dr. P.C. and dispensed on December 1, 2011 to R.L. (Largo, Fl.) also presented red flags. Tr. 209. Mr. Parrado testified that the quantity and dosing raised the “exact same concern” as the dosing was “well outside the recommended upper dosage of that drug.”
Asked whether R.L.'s address in Largo was also a red flag (here too, the patient's address had not been written on the prescription but had been added by a sticker), Mr. Parrado testified that the distance was 20 to 25 miles.
As for the prescription (GX 3, at 20), which was issued by Dr. R. (also of 24th Century) to C.L. for 224 Dilaudid 8 mg on December 1, 2011 and filled the same day, Mr. Parrado again found the quantity to be a red flag, testifying that this would be “a lethal dose to an opioid naïve patient.” Tr. 211. He then explained that “there's nothing here to show that the patient has developed a tolerance to this drug.”
Concluding its direct examination of Mr. Parrado regarding the Superior I prescriptions, the Government asked if he had an opinion as to whether the pharmacists who dispensed the prescriptions knew or had reason to know that they were issued without a valid doctor-patient relationship. Tr. 220-21. After the ALJ overruled Respondent's objection,
Even assuming that the first ground for objection was that the Government did not provide notice that it intended to ask whether the pharmacists knew or should have known that the prescriptions were issued without a valid doctor-patient relationship, in its Prehearing Statement, the Government advised that Mr. Parrado “will testify that, based on his expertise, training, and experience, and based on his review of the evidence summarized above, Respondent's pharmacists failed to exercise their corresponding responsibility to ensure that prescriptions for controlled substances were issued for a legitimate medical purpose in the usual course of professional practice.” ALJ Ex. 7, at 5. Asking whether the prescriptions “were issued without a valid-doctor patient relationship” is just another way of asking whether the prescriptions “were issued for a legitimate medical purpose in the usual course of professional practice,” as a physician must establish and maintain a valid doctor-patient relationship to act in the usual course of practice and to issue a prescription for a legitimate medical purpose.
Nor was it beyond Mr. Parrado's expertise to opine on whether the prescriptions were issued outside of a valid doctor-patient relationship.
There's no documentation that I saw that there was any conversation with a physician determining that. Because at these doses there would had to have been conversation determining tolerance. There would have been conversation determining medical need at this dosing.
So at that point I would have had a question in my mind, as a pharmacist filling or being presented with this prescription, that there may have been . . . not a very good valid patient-doctor relationship going on at that point in time.
On cross-examination, Mr. Parrado acknowledged that he could not offer an opinion as to whether any of the patients, whose prescriptions were provided in GX 3, were opioid naïve. Tr. 235-36. Asked whether it was true that he had no knowledge as to the procedures used at Superior I to revolve red flags, Mr. Parrado answered that “[n]othing that was documented on the prescriptions showed that anything had been done.”
While Mr. Parrado testified that he knew one of the pharmacists who worked at Superior I, he stated that he had not spoken with her about any of the prescriptions.
Mr. Parrado further testified that he asked DEA “for complete profiles on all these patients” but was told to look at only the prescriptions.
Mr. Parrado testified that he had not consulted with any other pharmacists in forming his opinions.
Asked by Respondent whether, based on the materials provided to him by DEA, he knew if Superior I's pharmacists had called the prescribers “to discuss any issues related to the patients or the prescriptions,” Mr. Parrado answered that “did not see anything to that effect.”
Mr. Parrado did not know whether Superior I kept a paper file which included medical records on their patients.
In the partial patient records that I did receive, there was evidence of some MRIs. What struck me was that these MRIs were old and not ordered by the physician who was writing these prescriptions, which would have been a red flag to me. Some of these MRIs were two/three years old. They were ordered by someone else.
There were some . . . MRIs, reports didn't even have a referring prescription on it. That would have concerned me as a pharmacist filling that prescription.
Respondent then asked Mr. Parrado if, based on the information provided to him, he was “aware that the pharmacists were obtaining copies of radiographic studies [and] reports of radiographic studies?”
No, I didn't say I saw it in the pharmacy records. I saw it in the medical records. If the pharmacist would have had access to that, that would have presented another red flag in the fact that that was an old record ordered by someone else. That would have raised the bar there if you will.
Mr. Parrado acknowledged patients become dependent and develop tolerance to opioid analgesics and that there is no upper limit as to the quantity or dose that can be prescribed.
Continuing, Mr. Parrado acknowledged that there is an expressway which runs from Spring Hill to Tampa, and that people may commute from the former to the latter for work.
Next, Mr. Parrado testified that a pharmacist can add an address to a prescription if “you've checked with the physician and gotten the correct thing and that matches what the patient is telling you.”
On re-direct, Mr. Parrado was asked whether the one patient profile he was provided with was for P.D. (GX 3, at 24) and whether the profile showed that there was a gap in care. Tr. 268. Asked to describe what was on the document, Mr. Parrado testified that:
[t]there was a list of dates for Mr. P.D. that showed the dates he had prescriptions filled for this drug and there was a gap of two months in there which, as a pharmacist, anybody that stops taking opioids or if I don't know he's continued taking opioids, at that point I can't fill a further prescription till I've established that.
He could have been in jail. He could have been in a rehab unit. It is well-documented that patients that have gone into these things, gone back in the community and accessed a prescription at the old dosage they were on would kill them and it has killed them.
Questioned by the ALJ as to where he would document the red flags presented by a prescription, Mr. Parrado testified that: “I would have identified the red flags that concerned me when the prescription was presented. I would have noted that on the back and I would have noted what I did to resolve each one of those if there was more than one.”
The ALJ then asked Mr. Parrado if, in his “experience working with other pharmacists, . . . they have other ways of making records . . . to keep track of the red flags and how they've been resolved?”
On further re-cross, Respondent asked Mr. Parrado: “Not all pharmacists document in the same way that you do, do they?”
With respect to the Superior II prescriptions, Mr. Parrado testified that he reviewed them in the same manner as he did the Superior I prescriptions.
The first of these was a prescription issued by Dr. H.V.D. (also of the 24th Century Medical Center) to J.T. of Fort Meyers, Florida, for 280 oxycodone 30. GX 3, at 1-2 (No. 15-7). Here again, the patient's address was left blank and the address was provided by a sticker, which was affixed to the front of the prescription.
The second prescription was issued on December 2, 2011 by Dr. R. (the same Dr. R. of 24th Century), to R.B. of Milton, Florida (the same R.B. discussed in the Superior I findings) for 168 oxycodone 30. GX 3, at 3-4 (No. 15-7). Here again, the patient's address was left blank and the address was provided by a sticker, which was affixed to the front of the prescription.
Asked if these prescriptions presented any red flags, Mr. Parrado testified that “[t]hese were the same two patients that had gotten prescriptions filled at the other pharmacy, both with the same Milton, Florida address, both paying $924 in cash, travelling a long way, very high dosing, all the same concerns I had with the previous prescriptions.” Tr. 280-81. He also observed that the prescriptions “were filled consecutively” and that the dispensing labels show that the same pharmacist (M.F.) filled the prescriptions, and that these circumstances would have caused him concern.
The next prescription was issued on September 18, 2012 by Dr. V.S. (the same Dr. V.S. who had worked at 24th Century) to L.P. of Jacksonville, for 168 oxycodone 30. GX 3, at 7-8. Mr. Parrado testified that the prescription presented multiple red flags including “the drug,” the “very high quantity,” that the patient was “coming from Jacksonville . . . over 200 miles” from Tampa, and that the patient was “paying $1,344 in
After Respondent “object[ed] to the repetitive nature of this,” the ALJ asked Mr. Parrado if he had found “the same kinds of red flags” throughout the Exhibit.
The Government then questioned Mr. Parrado about two prescriptions which were issued on May 22, 2102 by Dr. C. (also of 24th Century) to L.B. of Dover, Florida, which the latter filled the same day. GX 3, at 11-14. The prescriptions were for 168 oxycodone 30 and 84 Dilaudid 8 mg.
The ALJ overruled the objection, explaining that “I'd like to know.”
On May 22, 2012, Respondent filled prescriptions for 168 oxycodone 30 and 56 Dilaudid 8 issued by Dr. S.A.H. (of 24th Century) to V.B., who has the same last name and lived in the same town as L.B.
On October 22, 2012, Dr. V.S. (who, according to the prescription was then working at the MD Plus Clinic in Lakeland), issued a prescription for 168 oxycodone 30 to J.P., whose address (which again was not written on the prescription) was in Ft. Walton Beach, Florida; Respondent filled the prescription the same day. GX 3, at 19-20. Upon being asked “what kind of route J.P. [would have] follow[ed] if he came from home, went to the doctor's office in Lakeland and then went to Tampa” to fill the prescription, Respondent objected on the ground that the testimony would be speculative because Dr. V.S. could legally prescribe at any place in the State. Tr. 293-94. After the ALJ overruled the objection, Mr. Parrado testified that while he did not “know the exact route [J.P.] took . . . the triangle between . . . the three places is very large [and] would have to be resolved.”
On October 23, 2012, Dr. V.S. (of the MD Plus Clinic) issued a prescription to K.B. of Jacksonville, for 168 oxycodone 30; Respondent filled the prescription on November 7, 2012. GX 3, at 21-22. On October 22, 2012, Dr. R.R. (of the 24th Century Medical Center) issued a prescription to R.B. of Milton for 168 oxycodone 30; Respondent filled the prescription on November 1, 2012.
On November 5, 2012, Dr. H.D. (of the 24th Century Medical Center) issued a prescription to J.S. of Panama City Beach, for 180 oxycodone 30; Respondent filled 120 tablets of the prescription the same day. GX 3, at 25-26. Asked where Panama City Beach is in relation to Tampa, Mr. Parrado testified that it is located in the “extreme western part of the Florida panhandle” and 450 miles from Tampa. Tr. 297.
Notably, the prescription contains a handwritten notation: “120 per pat” with the rest of the word obscured by the address sticker, below which is the date and time. GX 3, at 25. According to Mr. Parrado, “this was the only form of any kind of notation or documentation I saw on any of the records showing that they did document at one point and the only thing they documented was that they shorted the person pills.”
On November 5, 2012, Dr. R.R. (24th Century) issued a prescription to A.R. for 180 oxycodone 30; Respondent filled the prescription the same day. GX 3, at 27-28. While the prescription lists the patient's address as Lawtey, Florida, both the address sticker attached to the prescription and the dispensing label list A.R.'s address as in Gainesville, Florida.
On April 23, 2012, Dr. S.A.H. (24th Century) issued a prescription to T.P. of St. Augustine, Florida for 180 oxycodone 30; Respondent filled the prescription the same day. GX 3, at 29-30. Noting that Saint Augustine is located “just below Jacksonville” in “the upper northeast corner of Florida,” Mr. Parrado testified that “the distance” between T.P.'s residence and Respondent was a red flag. Tr. 301-02.
Also on April 23, 2012, Dr. P.C. (24th Century) issued a prescription to A.W. of Mayo, Florida, for 200 oxycodone 30; Respondent filled the prescription the same day. GX 3, at 31-32. Mr. Parrado testified that Mayo is located 150 to 200 miles from Tampa and that this was a red flag “along with all the other things,” including “the drug and the price paid,” which was $1,400. Tr. 302-03; GX 3, at 32.
On April 23, 2012, Dr. P.C. issued a prescription to D.T. of Gainesville for 190 oxycodone 30; Respondent filled the prescription the same day. GX 3, at
On November 2, 2012, Dr. R.R. issued a prescription for 112 Dilaudid 8 mg to T.N., which Respondent filled the same day. GX 3, at 37-38. Of note, while the prescription as prepared by Dr. R.R. listed T.N.'s address as being in Port Salerno, Florida, both the address sticker placed on the front of the prescription and the dispensing label listed an address in Gainesville.
The final prescription in the exhibit was issued on November 5, 2012 by Dr. H.D. to K.P. of Spring Hill for 140 Dilaudid 8 mg. GX 3, at 39-40. Asked the same question as with previous prescription (“How about the drug and the amount?”), Mr. Parrado testified: “[t]he answer will be the same.” Tr. 304. Thereafter, the Government moved Exhibit 3 into evidence in the Superior II matter, and the ALJ admitted the exhibit.
The Government then moved to admit into evidence its Exhibits 4 and 14.
As for the prescriptions in GX 4, Mr. Parrado testified that they all presented the red flag of the patients travelling long distances. Tr. 308. He further testified that he used Google to “get an approximation of the mileage” for those cities for which he did not know the exact mileage.
Asked by the Government whether he had seen any evidence that Superior II's pharmacists attempted to resolve the red flags presented by the prescriptions in both its Exhibits 3 and 4, Mr. Parrado testified that “[t]he only documentation I saw was that shortage of tablets. That's the only thing I saw documented anywhere.” Tr. 312. With respect to these prescriptions, Mr. Parrado then testified that he did not “see any evidence” that the dispensing pharmacist had complied with his/her corresponding responsibility to ensure that prescriptions were issued for a legitimate medical purpose.
The Government concluded its direct examination of Mr. Parrado, asking him—over Respondent's objection—whether the pharmacists, who filled the prescriptions in GXs 3 and 4, “knew or had reason to know that the prescriptions were being issued without a valid doctor/patient relationship?”
All these red flags would have caused me concern to where I had to call that physician to verify all these things.
And at that point I would have to use my professional judgment and whether or not even though possibly faced with what could ostensibly be a valid prescription I should know or either knew or should have known that these were being used . . . for not a legitimate medical purpose, just based on all the red flags that are present.
So even if the doctor had told me, yes, he did fill it, I would still, I still would not have filled them.
On cross-examination, Mr. Parrado adhered to his earlier testimony that if the resolution of a red flag was not documented on the prescription, “it wasn't done.”
Asked by Respondent whether he “wouldn't think twice about” a prescription he received from a reputable prescriber which was missing the patient's address, Mr. Parrado testified that “I would do something to address that and fix it.”
When then asked whether “one of those circumstances would be if you knew the prescribing practitioner and . . . . [his] practice[] and . . . protocols and . . . knew that when you called them [he] answered your questions about the diagnoses and the reasons for things,” the ALJ, without any objection by the Government, stated that he would not allow Mr. Parrado to answer the question because there was “no evidence that the Respondent, through any of its pharmacists, did that.”
However, Mr. Parrado subsequently agreed with Respondent that in trying to determine whether a red flag had been resolved, it is “important to know what the pharmacist knew about” the patient.
Mr. Parrado then testified that he was given some “partial medical records,” and that these showed that “these people were on multiple controlled substances [and] not just the prescriptions that were given to me.”
Asked if his opinions were based on these medical records, Mr. Parrado testified that the medical records did not form his opinions but “just reinforced” them, because he did not “see any documentation of conversations between the pharmacy and the clinic” and the records “showed on a lot of these patients the cocktails.”
Mr. Parrado then acknowledged that there is “no upper limit on the amount of an opioid that a patient can develop a tolerance to” and that there is no federal limit on the quantity of a drug that can be prescribed.
Asked whether it was
Mr. Parrado acknowledged that patients have the right to pay for their prescriptions in cash and that in some States, the law requires a pharmacy to allow a patient to pay in cash.
While Mr. Parrado agreed that physicians may use a particular drug as their default option in treating a patient such as in prescribing a cholesterol-lowering medication, he disagreed that this practice also applies to pain management.
Asked if when he verified the identity of a person filling a prescription, he would place a photocopy of the patient's identification on the prescription, Mr. Parrado acknowledged that “[a] lot of times we did,” or we had “another page with it,” or we “scanned it into our computer where it showed up as part of that patient's profile.”
Mr. Parrado subsequently agreed with Respondent that “not every failure to catch a red flag is intentional” and that pharmacists can make mistakes.
The question is that it doesn't happen over and over and over and over, which was my concern in this case and the records I was looking at. Could a person come from a long distance once? Sure. Does it happen every day from a long distance multiple times? No.
Turning more specifically to the prescriptions filled by Superior II, Mr. Parrado reiterated that he did not interview any of the patients or prescribers, as well as that DEA did not provide him with any statements made by the patients or information about the patients' conditions.
Mr. Parrado agreed with Respondent that it would be permissible for a physician to prescribe pain medicine to “two people who share a residence” and who “have chronic pain due to a car accident.”
As for the “partial medical files” he reviewed, Mr. Parrado could not answer as to how many of them were for Superior II's patients.
Mr. Parrado acknowledged that as long as a prescriber is registered within a State, he can prescribe from anywhere in the State.
Regarding the prescription issued to J.S. for 180 oxycodone 30 but which was only filled for 120 tablets,
After Mr. Parrado noted that some of the partial medical records contained an opioid contract that required the patient to fill the prescriptions at one pharmacy, that being Respondent, he then acknowledged “that there are a number of experts who believe that the one doctor, one pharmacy, one patient is the best way to prevent diversion when it comes to pain management.”
Next to testify for the Government was a Diversion Investigator (DI) who participated in the execution of the Administrative Inspection Warrant at Superior I.
According to the DI, “we collected original prescriptions,” as well as DEA 222s (schedule II order forms), invoices and inventory records.
With respect to the closing inventory, the DI testified that this involved a count of the drugs the pharmacy had on hand at the time of the inspection and that he was assisted by the pharmacist in performing the closing inventory.
The DI then explained that in conducting the audit he reviewed the purchase records, “the distribution transfers,” “any returns,” and “any disposition records” which included the actual prescriptions.”
According to the DI, “we use whatever we have as well . . . to make cross checks and to verify that there are no inconsistencies.”
The DI testified that his audit found that Superior I had shortages of multiple drugs.
The DI also testified regarding the manner in which Superior I kept its Schedule II order forms (DEA 222). According to the DI, one of the order forms (GX 5, at 2) should not have been used because the pharmacist had lined out the National Drug Code (NDC) number for the drug being ordered and added a new NDC number. Tr. 383-84;
On cross-examination regarding the altered order form (GX 5, at 2), the DI conceded that according to the regulation, the manufacturer should not have filled the order. Tr. 387. Then asked whether there was “any problem with the pharmacy having corrected the Form 222, or is the problem that the manufacturer filled the order,” the DI explained that “the regulation says any alteration, any erasure, and that should not be used.”
On cross-examination regarding the audit, Respondent's counsel asked the DI if there were any spreadsheets that showed how the DEA 222s were counted and how the dispensings were counted. Tr. 393. The DI answered: “No, I don't have that at this time, sir.”
Respondent's counsel then represented that when DEA provided Respondent with the CDs (which contained the records obtained from them) after the Order to Show Cause was served, the CDs included “some scratch papers.” Tr. 393. Counsel then
Respondent's counsel then asserted that the documents were “not intended to be used as an exhibit” but “merely to check the math.”
Then asked whether he did his calculations “by hand” or by creating a spreadsheet, the DI testified that he could not recall what procedure he used because he did the audit two years earlier.
The Government called another DI, who testified regarding the execution of the AIW at Superior II and the subsequent audit of its handling of controlled substances.
The Government then asked the DI about a number of Superior II's schedule II order forms.
Turning to the second form, she also identified the second line of the form as not being properly completed, apparently because it did not list the number of packages received and the date received.
As for the next four forms, the DI testified that each was a copy and not the original and was thus a violation. Tr. 474-75;
However, on cross-examination, the DI testified that she relied on the entries on the forms maintained by Respondent and did not verify whether every line on the 222s had been actually shipped by the distributors.
Moving back to the audit, the DI testified that “we asked for purchasing records
According to the DI, the audit found that Superior II was short 40 du of hydromorphone 4 mg and had an overage of 2,576 du of hydromorphone 8 mg.
Most significantly, Respondent ignores that the DI testified multiple times that she asked for an actual physical count which was at least six months old and used what Superior II gave her.
On cross-examination, the DI testified that she did not do any interviews and was not present during any interviews.
On further cross, the DI testified that in performing the audit, she did not compare the 222 forms she obtained from Superior II with those its suppliers provided to the Agency.
The DI further testified that she kept track of the serial numbers on the 222s by spreading them out on a desk but did not “make a document.”
Subsequently, the DI acknowledged that pharmacy personnel filling a prescription could make an error when counting the pills.
The Government's final witness was a DI from the Tampa office with 19 years of experience as such, who was the lead investigator in the Superior II matter.
The DI testified that she was not present at Superior II when the AIW was executed.
Thereafter, the DI acknowledged that various notations made on the Superior II order forms were her initials and that she did not keep a clean copy of the documents.
Turning to Superior's II ordering of controlled substances using the Controlled Substances Order System (CSOS), the DI testified that during the November 30, 2012 inspection, she met with a pharmacist (Mr. Majed) and asked to see its primary records for the receipt of controlled substances.
Continuing, the Government asked the DI whether a printout of an electronic 222 form complied with DEA regulations.
The DI further explained that in order for a person to use the CSOS, the person has to have a pass key.
On cross-examination, the DI acknowledged that because she had the PDMP records she could determine whether the patients were opioid tolerant or opioid naïve.
The DI further testified that electronic 222 forms found in Government Exhibit 7 were obtained during the AIW, when she was not present.
The DI also testified that Mr. Majed told her that the handwritten notations on printouts of the electronic 222 forms were of the packages that the pharmacy had actually received and the date received.
Respondent's counsel further attempted to ask the DI if she had investigated if Superior II had stopped ordering oxycodone after the AIW.
Before the Government rested, it requested a ruling from the ALJ clarifying whether Respondents would be allowed to call any witnesses.
Asked by the ALJ to provide “the legal basis for . . . Superior II to produce any witnesses, given [his] prior orders,” Superior II's counsel stated that “we have noticed witnesses in the Pre-hearing Statement,” including Mr. Obi-Anadiume.
After Superior II's counsel represented that he was making the same motion with respect to Superior I, the ALJ asked if he was relying on the Government's Prehearing Statements as his proffer.
The ALJ denied the motion, noting that the proffer “clearly . . . exceed[ed] what the Government presented in its Pre-hearing Statement.”
With all due respect to your colleagues, I think these were well informed lawyers making strategic decisions to keep as little information in the Pre-hearing Statements as possible. And I think it ill-served the course of justice and makes this proceeding a much more difficult process merely because of a strategic decision to keep me in the dark.
I'm not attributing that to you at all. And I don't expect a response, nor will I care to hear a response with respect to that. I've already given Mr. Sisco the opportunity to explain why the record is as it is in documents that I've received from Respondents.
And that record will stand, I will address that at another time in another forum. But from what you've told me, I don't see a legal justification for allowing the Respondent to, in either case . . . present testimony.
Superior II's counsel then sought to allow Mr. Obi to testify by asking and “answering the questions [himself] that are posed in the Government's Pre-hearing Statement.”
Explaining that he wanted to understand how the proffer would be done, Superior II's counsel then asked the ALJ if he wished for him “to proffer what would be said” by Mr. Obi.
In response, the ALJ stated that Superior II's counsel had made “a sufficient proffer,” noting that he had sought to go “beyond the scope of what the Government covered and enter[] into the area of acknowledgment and remediation [which] would not be permitted[,] [b]ecause you did not disclose it in advance.”
Superior II's counsel then explained that his “statements about the Government's Pre-hearing statement and the broader subject matters [was] not the proffer [and] that the proffer is substantially broader [as] it addresses individual patients, because the Government's Pre-hearing Statement called for those things.”
The ALJ rejected the request, explaining that “[y]ou were permitted to do so. That's what the Pre-hearing Statement was for.”
The Government then rested.
Under the CSA, “[a] registration pursuant to section 823 of this title to manufacture, distribute, or dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has committed such acts as would render [its] registration under section 823 of this title inconsistent with the public interest as determined under such section.” 21 U.S.C. 824(a)(4). In the case of a retail pharmacy, which is deemed to be a practitioner,
(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing or conducting research with respect to controlled substances.
(3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety.
“[T]hese factors are . . . considered in the disjunctive.”
Under the Agency's regulation, “[a]t any hearing for the revocation or suspension of a registration, the Administration shall have the burden of proving that the requirements for such revocation or suspension pursuant to . . . 21 U.S.C. 824(a) . . . are satisfied.” 21 CFR 1301.44(e). In this matter, while I have considered all of the factors, the Government's evidence in support of its
As to factor three, I acknowledge that there is no evidence that either of the Respondents, or Mr. Obi-Anadiume, or any of the Respondents' pharmacists, has been convicted of an offense under either federal or Florida law “relating to the manufacture, distribution or dispensing of controlled substances.” 21 U.S.C. 823(f)(3). However, there are a number of reasons why even a person who has engaged in criminal misconduct may never have been convicted of an offense under this factor, let alone prosecuted for one.
As to factor five, no evidence was offered with respect to it.
“Except as authorized by” the CSA, it is “unlawful for any person [to] knowingly or intentionally . . . manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense, a controlled substance.” 21 U.S.C. 841(a)(1). Under the Act, a pharmacy's registration authorizes it “to dispense,”
The CSA's implementing regulations set forth the standard for a lawful controlled substance prescription. 21 CFR 1306.04(a). Under the regulation, “[a] prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.”
[t]he responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner,
As the Agency has made clear, to prove a violation of the corresponding responsibility, the Government must show that the pharmacist acted with the requisite degree of scienter.
Here, the Government makes no claim that any of Respondents' pharmacists dispensed the prescriptions having actual knowledge that the prescriptions lacked a legitimate medical purpose. Instead, relying primarily on
As proof for its assertion that the red flags were not resolved, the Government points to its Expert's testimony “that, in the practice of pharmacy, a red flag which is resolved must be documented and that the documentation should be placed on the prescription itself.”
Here, I assume that the red flags with respect to each prescription or the convergence of red flags—as there were typically multiple red flags associated with each prescription—establishes that the pharmacists “subjectively believed that there was a high probability” that the various prescriptions lacked a legitimate medical purpose.
As noted above, as proof that the pharmacists failed to resolve the red flags, the Government relies solely on the absence of such documentation on the prescriptions themselves and the Expert's testimony that it is the custom in pharmacy practice to document the resolution of a red flag on the prescription. Yet as the Expert conceded, no provision of the Controlled Substances Act, DEA regulations, Florida law, or the Florida Board of Pharmacy's regulations requires that a pharmacist document the resolution of red flags on the prescription itself.
Here, a regulation of the Florida Board of Pharmacy (then in effect) specifically required that “[a] patient record system . . . be maintained by all pharmacies for patients to whom new or refill prescriptions are dispensed” and that the “system shall provide for the immediate retrieval of information necessary for the dispensing pharmacist to identify previously dispensed drugs at the time a new or refill prescription is presented for dispensing.” Fla. Admin. Code 64B-16-27.800. This rule also required that the pharmacy maintain “[a] list of all new and refill prescriptions obtained by the patient at the pharmacy . . . during the two years immediately preceding the most recent entry” and include the “prescription number, name and strength of the drug, the quantity and date received, and the name of the prescriber.”
Of further note, the Board of Pharmacy's rules require that a pharmacist “review the patient record and each new and refill prescription presented for dispensing in order to promote therapeutic appropriateness.” Fla Admin Code r. 64B16-27.810. This rule specifically requires that a pharmacist identify such issues as: “[o]ver-utilization,” “[t]herapeutic duplication,” “[d]rug-drug interactions,” “[i]ncorrect drug dosage,” and “[c]linical abuse/misuse.”
On cross-examination, the Expert testified that he asked DEA “for complete profiles on all these patients” but was told to look at only the prescriptions. Tr. 247;
The Government nonetheless argues that it had no obligation to produce the patient profiles and that the Respondents' position would force the Government to “search the entire universe for exculpatory evidence.” Gov. Mot. to Supplement the Record, Strike Respondent's Untimely Exceptions, . . . Or, In the Alternative, Respond to Exceptions, at 15. It further argues that it is entitled to an adverse inference that Respondents' pharmacists did not resolve the various red flags because such evidence, if it does exist, is “under the complete control of the Respondent” and “not DEA” and Respondent “fail[ed] to produce” it.
As for the contention that Respondents' position would force the Government to “search the entire universe for exculpatory evidence,” it does no such thing. Indeed, the Government ignores that its own Expert sought to review the patient profiles and that the Board of Pharmacy's rules mandate that a pharmacist review the patient's profile as part of the prospective drug use review which is required before filling a prescription. Unexplained by the Government is why it would be improper for pharmacists to document their resolution of a red flag in the patient profile given that the Board's rules required (and still require) that a pharmacist document his/her “comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug,” as well as “any related information indicated by a licensed health care practitioner” in that record.
Of further consequence, the Government produced no evidence establishing when the various patients first filled prescriptions at Respondents for the drugs in the prescriptions at issue here. Unexplained by the Government is why, if the red flags associated with a specific patient and prescription had been previously resolved and this was documented in the patient profile, the pharmacists were nonetheless required to document this on subsequent prescriptions.
I also reject the Government's contention that it is entitled to an adverse inference based on the failure of Respondents to produce any evidence showing that they resolved the red flags. Under the adverse inference rule, if a party has evidence within its control that “would in fact strengthen [its] case, [it] can be expected to introduce it even if it is not subpoenaed.”
Here, the Government has the burden of proof.
As further support for its contention that the absence of documentation on the prescriptions is proof that the red flags were not resolved, the Government points to the evidence showing that where the physicians failed to include the patients' address, the pharmacists placed address stickers on the prescriptions. It also points to a single prescription, which was partially filled, and that the pharmacist documented this on the face of the prescription.
Yet Florida law expressly required (and still requires) that a patient's address “appear on the face of the prescription.” Fla. Sta. Ann. § 893.04(c);
Of note, the DEA Office of Diversion Control maintains a Web page of “Questions & Answers” pertaining to prescriptions.
Accordingly, I find that the Government's allegations that Respondents' pharmacists violated 21 CFR 1306.04(a) and Fla. Stat. Ann. § 465.016(1)(s)) when they dispensed controlled substance prescriptions without resolving the red flags presented by the prescriptions are not supported by substantial evidence.
While in the Show Cause Orders, the Government made conclusory allegations to the effect that the Respondents' “pharmacists dispensed controlled substances when they knew or should have known that the prescriptions were not issued in the usual course of professional practice or for a legitimate medical purpose,” ALJ Ex. 1, at 2 (No. 15-6), which implies that the red flags could not be resolved, the Government never identified a specific prescription in either Show Cause Order or any of its Prehearing Statements that could not be resolved. As explained previously, while the ALJ overruled Respondents' objections, the correct standard is not whether the ALJ wanted to know the answer to the Government's question, Tr. 287, but whether Respondents knew “what conduct was being alleged and ha[d] a fair opportunity to present [their] defense.”
Because the Government never alleged that any of the prescriptions could not be resolved, and Respondents objected to this line of inquiry, there is no basis for a finding of litigation by consent. Accordingly, I do not consider the testimony that the some of the prescriptions presented unresolvable red flags.
The evidence nonetheless shows that both Respondents violated the CSA by failing to maintain and/or properly maintain required records. With respect to Superior I, the evidence is particularly egregious, as an audit conducted by Agency Investigators found that the pharmacy had shortages of 15,560 du of oxycodone 30 mg and 11,951 du of hydromorphone 8 mg. In addition, Superior I was short 946 du of hydromorphone 4 mg, 864 du of methadone 10 mg, 474 du of morphine sulfate 100 mg ER, and 447 du of morphine sulfate 30 mg ER. Thus, Superior I was short more than 30,000 du of highly abused controlled substances. And while Superior II had only a small shortage of a single drug, it had substantial overages in several drugs, including 2,576 du of hydromorphone 8 mg and 1,189 du of oxycodone 30 mg.
“Recordkeeping is one of the CSA's central features; a registrant's accurate and diligent adherence to this obligation is absolutely essential to protect against the diversion of controlled substances.”
During the hearing, Respondents raised various challenges to the validity of the audits. With respect to the Superior I audit, Respondent's counsel attempted to impeach the DI's result by using a document he described as “scratch paper” which, according to his representation, had been included among the documents returned to Respondents on the CD and which listed the DEA 222 forms for Superior I's morphine sulfate orders; Respondent's counsel further represented that when he added up the orders, he got a number of 7,200 du. Tr. 395.
I need not decide whether the ALJ erred when he barred Superior I's counsel from using this document to impeach the DI, Tr. 394-95, because Respondent did not properly preserve the claim of error. Notably, Respondent's counsel did not seek to submit the document even as a rejected impeachment exhibit, and in its Post-hearing Brief, Respondent did not specifically identify this ruling as being in error. Indeed, while in its Post-hearing Brief, Superior I proposes as a factual finding that it “proffered Exhibits 3 through 9 including invoices and other records that demonstrate errors in the DEA audit which resolve the alleged inventory
Furthermore, while throughout the proceeding, Respondents have argued that their due process rights have been violated because the Agency's Lead Investigator “unlawfully retained” records seized pursuant to the Administrative Inspection Warrants for some 611 days, Resp. Post-Hrng. Br. 18, Respondents were provided with the records on or about the same day they were served with the Show Cause Orders, which made specific allegations as to the audits. Thus, Respondents had approximately 80 days from the date they were informed of the allegations to the date on which they were required to file their Prehearing Statements to investigate the allegations pertaining to the audits and prepare a defense.
While Respondents argue that “[t]he first access [they] had to what may or may not be all of the evidence was on the day that DEA served its Order to Show Cause,” Resp. Post-Hrng. Br. 19, they did not identify any records that were necessary to complete their audits which were not provided to them when their records were returned.
Respondent also questioned the validity of the audits on the ground that while the DIs could have verified their calculations as to the level of Respondents' purchases of the drugs by obtaining data from the Agency's ARCOS database, they “willfully chose to ignore that evidence which would have demonstrated the accuracy of the pharmacies' records with respect to [their] purchases.”
Respondent Superior II questioned the validity of the audit pertaining to it, on the ground that the DI based her initial inventory figures on a perpetual inventory which Respondent is not lawfully required to maintain. However, the DI testified multiple times that she asked for an actual physical count which was at least six months old and used what Superior II gave her. Tr. 491-92. I thus reject Respondent's challenge to the findings of the audit of Superior II, which establishes that it had overages in several drugs.
I thus find that both pharmacies failed to maintain complete and accurate records as required by 21 U.S.C. 827(a)(1) & (3). While this finding alone supports the conclusion that each pharmacy has committed such acts as to render its continued registration “inconsistent with the public interest,”
The Government further alleges that Respondents failed to properly complete various schedule II order forms. More specifically, with respect to Superior I, the Government's evidence included an Order Form for oxycodone 30 on which the National Drug Code was changed. GX 5, at 1 (No. 15-6). However, while the DI testified that “any alteration or any erasure or change of description” should result in the form not being used,” the applicable regulation actually states that the order “
The DI also testified that a second order form was not filled out properly, because “information in regard to the number of package[s] receive [sic] . . . was omitted.” Tr. 384. However, the Government offered no evidence that any portion of the two orders listed on the form were filled. While DEA's regulation states that “[t]he purchaser must record on Copy 3 of the . . . 222 the number of commercial or bulk containers on each item and the dates on which the containers are received by the purchaser,” 21 CFR 1305.13(e), the Government points to no provision which requires, where no portion of a line entry has been filled by the expiration of the 60-day period in which the Order Form is valid,
The Government made similar claims with respect to Superior II. For example, it identified the first two pages of GX 6 (No. 15-7) as examples of Order Forms that were not properly completed because the second entry on each form did not list the number of packages received and the date received. Putting aside that these two documents bear the exact same serial number, here again, the Government put forward no evidence that any portion of the order listed in the second line item was filled. While here too, this DI insisted that “after 60 days, the 222 is invalid” and that Respondent “should go back and put a zero and the date they put the zeros” on the form, as explained above, the regulations do not so require. And while the DI also asserted that the
While the DI further identified other Order Forms in this Exhibit which she alleged were not properly completed, she did not identify a single instance in which a line item had actually been shipped to Respondent and the entry had not been made. Indeed, with respect to the Exhibit, the only violations the DI identified were that the forms were copies and not the original. Tr. 474-75, 521. Under a DEA regulation, “[t]he purchaser must retain Copy 3 of each executed DEA Form 222.” 21 CFR 1305.13(a). Standing alone these violations would be of minimal consequence.
The evidence further showed that while Superior II used the electronic Controlled Substances Ordering System to purchase controlled substances, it did not comply with 21 CFR 1305.22(g). Under this provision, “[w]hen a purchaser receives a shipment, the purchaser must create a record of the quantity of each item received and the date received. The record
The record thus supports the conclusion that Superior II's receipts were not documented electronically and were not linked to the original order. Thus, I conclude Superior II violated 21 CFR 1305.22(g) with respect to the numerous electronic orders it placed.
The DI also testified that Mr. Majed represented that he had a key which is required under the Agency's regulations for placing electronic orders through the CSOS. Tr. 557-58. Under DEA's regulation, a person must “obtain a CSOS digital certificate from the DEA Certification Authority to sign electronic orders for controlled substances.” 21 CFR 1311.10. However, a person is eligible to obtain a CSOS digital certificate only if he/she: (1) is the person who “signed the most recent registration application or renewal application,” (2) is “a person authorized to sign a registration application,” or (3) has been “granted power of attorney by [the] registrant to sign orders for one or more schedules of controlled
Accordingly, I conclude that the evidence with respect to factor four—Respondents' compliance with applicable laws related to controlled substances—establishes that each Respondent “has committed such acts as would render [its] registration . . . inconsistent with the public interest.” 21 U.S.C. 824(a)(4).
Under Agency precedent, where, as here, “the Government has proved that a registrant has committed acts inconsistent with the public interest, a registrant must ` “present sufficient mitigating evidence to assure the Administrator that it can be entrusted with the responsibility carried by such a registration.” ' ”
While a registrant must accept responsibility and demonstrate that it will not engage in future misconduct in order to establish that its continued registration is consistent with the public interest, DEA has repeatedly held these are not the only factors that are relevant in determining the appropriate sanction.
The Agency has also held that “ `[n]either
Here, the record contains no evidence that the principals of either Respondent acknowledge its misconduct. So too, the record contains no evidence that either Respondent has undertaken any remedial measures.
Respondents attribute this to the ALJ's ruling barring Mr. Obi (Respondents' owner) from testifying. They argue that the ALJ's ruling denied them their right to due process and a fair hearing under the Administrative Procedure Act.
As for their claim of bias, none of their assertions establish bias. As found above, while several of the ALJ's rulings on objections were erroneous, many of them were not, and some of Respondents' objections were clearly lacking in merit. In any event, “judicial rulings alone almost never constitute a valid basis for a bias or partiality motion.”
As for the contention that bias is established by the ALJ's refusal to require the DI to obey the Federal Magistrate Judge's order, Respondents point to no provision of law which grants an Administrative Law Judge authority to order the Government to comply with an order of a Federal Magistrate Judge.
Respondents thus assert that the ALJ erred in barring Mr. Obi from testifying because he was an interested person within the meaning of the APA. That Mr. Obi is an interested person is hardly disputable. However, while an interested person has a right to participate in a proceeding, that right is subject to the reasonable procedural rules of the Agency and rulings of the ALJ.
Here, in his Orders for Prehearing Statements, which were issued more than one month before Respondents' Prehearing Statements were due, the ALJ specifically warned Respondents that if their “corporate representative intends to testify, the representative must be listed as a witness, and a summary of anticipated testimony as described below must be provided.” ALJ Ex. 5, at 2 (No. 15-6); ALJ Ex. 6, at 2 (No. 15-7). The Orders for Prehearing Statements also cautioned Respondents that their summaries of testimony must “indicate clearly each and every matter as to which Respondent[s] intend[ ] to introduce evidence in opposition” and that “[t]he summaries are to state what the testimony will be rather than merely listing the areas to be covered.” ALJ Ex. 5, at 2 (No. 15-6); ALJ Ex. 6, at 2 (No. 15-7). And finally, the Orders for Prehearing Statements further warned “that testimony not disclosed in the prehearing statements or pursuant to subsequent rulings is likely to be excluded at the hearing.” ALJ Ex. 5, at 2 (No. 15-6); ALJ Ex. 6, at 2 (No. 15-7).
Respondents thus had fair notice of the steps they were obligated to take to present Mr. Obi's testimony. While Respondents represented in their Prehearing Statements that they intended to call “[a]ny and all witnesses identified in the Government's Prehearing Statement[s] in th[ese] matter[s],” and the Government identified Mr. Obi as a potential witness therein, Respondents entirely failed to provide a summary of the testimony they intended to elicit from him. ALJ Ex. 9, at 4 (No. 15-6); ALJ Ex. 12, at 4 (No. 15-7).
While at the hearing Respondents asserted that there would be no prejudice to the Government because “the summary of Mr. Obi's testimony” was “covered sufficiently” by the Government in its Prehearing Statements, the Government's summary of Mr. Obi's anticipated testimony was confined to questioning him about past acts. Tr. 597-98;
Respondents also cite to
Neither case, however, raised the issue of whether a party could be barred from putting on testimony when the party entirely failed to comply with an agency rule which requires disclosure of the substance of that testimony in advance of the proceeding to prevent prejudice. While Respondents also argue that the ALJ did not neutrally apply this rule, I have carefully reviewed the parties' respective Prehearing Statements, and conclude otherwise.
Here, while Respondents failed to set forth any proposed testimony by Mr. Obi on the issue of acceptance of responsibility in advance of the hearing, this would not have been a bar to Mr. Obi's testimony as to Respondents' corrective measures, had such proposed testimony on the latter issue been disclosed in advance of the hearing. Just as in federal court, evidence that a respondent had undertaken remedial measures is not proof that it has engaged in culpable conduct.
While a respondent retains the right to challenge the allegations at the proceeding, when the Government serves a party with a show cause order, a respondent should assume that the Government has probable cause to support the allegations and a good faith basis for seeking the action (revocation or suspension) it proposes. A wise respondent conducts its own investigation to determine whether the allegations are true, and if they are, to then determine what measures are needed to correct the violations or offending practices. Thus, while a respondent retains the right to challenge the Government's evidence at the hearing, it is still properly charged with the obligation to disclose the remedial measures it has undertaken as a condition of being able to present such evidence at the hearing. Of course, where the Government fails to prove an allegation at the hearing, a respondent need not put on evidence of any corrective measures relevant to that allegation.
Indeed, in their Post-Hearing Brief, Respondents argue that “Mr. Obi's testimony could have been restricted to the issues discussed in the DEA's prehearing statement.” Resp. Post-Hrng. Br. 24. However, as explained above, to rebut the Government's
As for the thousands of pages of exhibits that include records of Respondents' purchases and dispensings of the controlled substances audited by the Government, because Respondents failed to make an adequate proffer as to their audit results prior to the hearing, the ALJ did not abuse his discretion in declining to admit this evidence.
Because Respondents failed to produce any evidence of remedial measures undertaken to address the numerous recordkeeping issues that I find proven on the record, I conclude that Respondents have not rebutted the Government's
I acknowledge that Superior II's recordkeeping violations did not involve large shortages but rather overages. However, the pharmacy nonetheless failed to maintain complete and accurate records as required by the CSA, did not properly document its receipts on electronic order forms, and allowed an unauthorized person to access the electronic ordering system. In addition, the pharmacies have common ownership in that they are both owned by Mr. Obi. Thus, while the conduct proven with respect to Superior I is more egregious than that proved with respect to Superior II, given that Mr. Obi owns and controls each pharmacy, I conclude that revocation is warranted with respect to Superior II as well.
Pursuant to the authority vested in me by 21 U.S.C. 824(a)(4) and 823(f), as well as 28 CFR 0.100(b), I order that DEA Certificates of Registration BS9255274 and BS9699731 issued to Superior Pharmacy, L.L.C., be, and they hereby are, revoked. I further order that any application of Superior Pharmacy, L.L.C., to renew or modify either registration, be, and it hereby is, denied. This Order is effective June 17, 2016.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) proposes revisions to the National Pollutant Discharge Elimination System regulations to eliminate regulatory and application form inconsistencies; improve permit documentation, transparency and oversight; clarify existing regulations; and remove outdated provisions. This proposal would make specific targeted changes to the existing regulations and would not reopen the regulations for other specific or comprehensive revision. These proposed regulatory changes cover 15 topics in the following major categories: permit applications; the water quality-based permitting process; permit objection, documentation and process efficiencies; the vessels exclusion; and the Clean Water Act (CWA) section 401 certification process. These revisions would further align NPDES regulations with statutory requirements from the 1987 CWA Amendments and more recent case law requirements. By modernizing the NPDES regulations, the proposed revisions would provide NPDES permit writers with improved tools to write well-documented permits to protect human health and the environment. The revisions would also provide the public with enhanced opportunities for public participation in permitting actions.
Comments must be received on or before July 18, 2016.
EPA has set up two Dockets for submitting comments. Submit your comments on the NPDES Application and Updates rule to Docket ID No. EPA-HQ-OW-2016-0145 at
Erin Flannery-Keith, Water Permits Division, Office of Wastewater Management, Mail Code 4203M, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; (202) 566-0689;
EPA is proposing targeted revisions to the NPDES regulations. These revisions would make the regulations consistent with the 1987 CWA Amendments and with applicable judicial decisions. These revisions would delete certain regulatory provisions that are no longer in effect and clarify the level of documentation that permit writers must provide for permitting decisions. EPA is also asking for public comments on potential ways to enhance public notice and participation in the permitting process. CWA section 402 established the NPDES permitting program and gives EPA authority to write regulations to implement the NPDES program. 33 U.S.C. 1342(a)(1), (2).
Entities potentially affected by this action are: EPA; authorized state, territorial, and tribal programs; and the regulated community. This table is not intended to be exhaustive; rather, it provides a guide for readers regarding entities that this action is likely to regulate.
If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
EPA is proposing targeted revisions to the NPDES regulations. These revisions would make the regulations consistent with the 1987 CWA Amendments and with requirements established by judicial decisions. These revisions would delete certain regulatory provisions that are no longer in effect, and clarify the level of documentation that permit writers must provide for permitting decisions. These revisions would also allow permit writers to use more consistent data for permitting decisions and would modernize opportunities for public notice and participation in NPDES permitting actions.
CWA section 402 established the NPDES permitting program and gives EPA authority to write regulations to implement the NPDES program. 33 U.S.C. 1342(a)(1), (2).
This proposal involves several revisions to the NPDES regulations. It is EPA's view that these revisions would generally not result in new or increased workload or information collection by authorized states or the regulated community. The proposed fact sheet documentation requirements may impose only a minimal burden for the permit writer to document permit development analyses that he or she has already conducted. The assessment of impacts is provided for each topic in section IV of this proposal.
The Federal Water Pollution Control Act Amendments of 1972, commonly referred to as the Clean Water Act, were enacted to restore and maintain the chemical, physical, and biological integrity of the nation's waters. CWA section 301 prohibits the discharge of any pollutant to waters of the United States except in compliance with certain sections of the Act, including CWA section 402. Section 402 established the NPDES permit program to be administered by EPA or authorized states, territories or eligible tribes.
Under the NPDES regulations, EPA has developed eight individual permit application forms for applicants seeking coverage under individual permits. 40 CFR 122.21. Each individual permit application form corresponds to a different category of dischargers subject to permitting.
The first major step in the permit development process is deriving technology-based effluent limits (TBELs). 40 CFR 122.44(a). The permit writer then determines whether, after application of the TBELs, the discharge will cause, have the reasonable potential to cause, or contribute to an excursion above a narrative or numeric criterion within a state water quality standard (WQS). If the permit writer determines that, notwithstanding application of technology-based limits, the discharge “will cause, have the reasonable potential to cause, or contribute to an excursion above any [s]tate water quality standard,” the permit writer derives effluent limitations necessary to meet state WQS (
After the draft permit is complete, the permitting authority provides an opportunity for public participation in the permitting process. A public notice announces the availability of the draft permit and administrative record and gives interested parties an opportunity to submit comments and request a public hearing. 40 CFR 124.10 and 124.11. After taking into account all significant comments raised during the comment period, the permitting authority develops the final permit with careful attention to documenting the process and decisions for the administrative record. The permitting authority then issues the final permit to the facility. 40 CFR 124.10, 124.15, and CWA section 402(b).
Under CWA section 402(b), a state or eligible tribe
If a state or tribe does not have an approved NPDES program, EPA administers the NPDES program. Under CWA section 401, a federal agency may not issue a permit or license for an activity that may result in a discharge to waters of the United States until the state or tribe
EPA regulations establish permit application requirements and corresponding forms for use by all applicants for EPA-issued permits. Where a state chooses not to use the EPA forms, the state is responsible for developing and using its own forms; however, the state forms must collect all of the data that the EPA regulations require.
EPA has developed several guidance documents to help permitting authorities manage the quality and consistency of NPDES permits. The
The revised
This proposed rule addresses application, permitting, monitoring, and reporting requirements that have become obsolete or outdated due to programmatic and technical changes that have occurred over the past 35 years. These topics were selected from previous NPDES regulatory streamlining efforts, recommendations from EPA Headquarters and Regional offices, and recommendations from state NPDES permitting agencies. With these proposed revisions and requests for public comment, EPA aims to allow easier determination of who is regulated, clarify applicable compliance requirements, and improve transparency by providing permitting authorities and the public with timely and quality access to information on regulated entities' activities. These revisions would make specific, targeted changes to several sections of the NPDES regulations, and are not intended to reopen the regulations for other revisions.
EPA identified this proposal in response to Executive Order 13563
The proposed rule covers 15 topics grouped into major categories of changes: Permit application requirements; the water quality-based permitting process; permit objection, documentation, and process efficiencies; vessels exclusion; and the CWA section 401 certification process. This is a table of the proposed or discussed changes in those categories.
(a) NPDES contact information.
EPA is correcting contact information included in the Note to § 122.1 by deleting outdated references to program contact information that is no longer available to “Information concerning the NPDES program and its regulations can be obtained by contacting the Water Permits Division (4203), Office of Wastewater Management, U.S.E.P.A., 1200 Pennsylvania Avenue NW., Washington, DC 20460 and by visiting the homepage at
EPA proposes to add a definition of “pesticide applications to waters of the United States.” In 2009, the decision in
This proposal defines the term “pesticide applications to waters of the United States” to mean point source discharges to waters of the United States resulting from the application of biological pesticides or chemical pesticides that leave a residue. This definition would clarify who is already regulated by ensuring that the NPDES regulations are consistent with the 6th Circuit decision. By defining “pesticide applications to waters of the United States” in its comprehensive NPDES definitions at 40 CFR 122.2 in the same way as the PGP defines covered activities, EPA would increase clarity and consistency. This definition would not in any way change which pesticide discharges are subject to NPDES permitting.
EPA seeks comments on this proposed definition.
EPA proposes to revise the existing definition of “proposed permit.” The definition would be expanded to include a state-issued NPDES permit designated as a “proposed permit” under a new section of the regulations, § 123.44(k).
EPA seeks comments on this proposed definition, described below in the discussion of the proposed new § 123.44(k). See preamble section III.B.1, “Objection to Administratively Continued Permits (40 CFR 123.44).”
EPA is correcting a typographical error in subsection (d) of this definition by changing “NDPES” to “NPDES.”
EPA proposes to revise the existing definition of WET to refer to both acute (lethal) and chronic (lethal and sublethal) WET test endpoints. The current WET definition in § 122.2 states that WET is “the aggregate toxic effect of an effluent measured directly by a toxicity test.” The proposed clarified definition would specify that toxicity can include both acute and chronic effects.
This clarification would be consistent with EPA's interpretation of its existing WET regulations, as reflected in the preamble to the NPDES regulations establishing the existing WET definition, and in EPA's WET test methods. In the preamble to the regulations that established this definition, EPA stated, “effluent limitations may be expressed as chronic toxicity or acute toxicity (or both),” recognizing that toxicity can include both endpoints. 54 FR 23871 (June 2, 1989). Similarly, EPA's 2002 promulgated WET freshwater and saltwater test methods include definitions for both acute and chronic (sublethal) toxicity, and procedures for testing for both acute and chronic (sublethal) toxic effects, also demonstrating that WET encompasses both types of toxicity. 40 CFR 136.3; 67 FR 69952, November 19, 2002.
This proposed clarification would also be consistent with WET program guidance documents
Defining toxicity to include sublethal effects is consistent with the CWA, which establishes a national goal of “water quality which provides for the protection and propagation of fish, shellfish and wildlife.” CWA section 101(a)(2). CWA sections 301 and 302 contain various other references to the “protection and propagation” of aquatic organisms, evidencing an intent to protect against not only lethality but also sublethal effects on fish and wildlife. CWA sections 301(h)(2), 301(g)(2)(C), 302(a), 304(a)(5)(B).
EPA notes that this proposed clarification would not change any existing regulatory requirements with respect to inclusion of acute or chronic WET limits in permits. Specifically, it would not change the existing requirement that NPDES permits include WET limits where necessary to meet state numeric and narrative water quality criteria for aquatic life protection. 40 CFR 122.44(d)(1)(iv) and (v). Under this regulation, permit limits must be written to meet states' WET WQS. Thus, if a state's WET WQS require controls for both acute and chronic toxic effects, permit limits must be written to meet both WET test endpoints. If a state's WET WQS require controls only on either acute or chronic toxicity, then the permit WET limits would be written to meet protection of
EPA seeks comment on this proposed clarification of its current definition of WET.
EPA proposes to revise § 122.3(a) to clarify which vessel discharges are excluded from the requirement to obtain NPDES permits.
The exclusion for discharges incidental to the normal operation of a vessel at 40 CFR 122.3(a), as it currently appears in EPA's regulations, was challenged in
EPA appealed the District Court's decision to the U.S. Court of Appeals for the Ninth Circuit, and on July 23, 2008, the Ninth Circuit upheld the decision.
In late July 2008, Congress enacted two pieces of legislation to exempt discharges incidental to the normal operation of certain types of vessels from the need to obtain an NPDES permit. The Clean Boating Act of 2008 amended the CWA to provide that discharges incidental to the normal operation of recreational vessels are not subject to NPDES permitting, and are instead subject to a new regulatory regime to be implemented by EPA and the U.S. Coast Guard under a new section 312(o) of the CWA. S. 2766, Public Law 110-188 (July 29, 2008). As defined in section 3 of that law, which amends CWA section 502, “recreational vessel” means a vessel manufactured or used primarily for pleasure, or leased, rented or chartered to a person for the pleasure of that person. It does not include a vessel that is subject to Coast Guard inspection and is either engaged in commercial use or carries paying passengers. As a result of this legislation, discharges incidental to the normal operation of recreational vessels are not subject to NPDES permitting. EPA proposes adding a new subsection, 40 CFR 122.3(a)(2), to incorporate this statutory exemption.
The second piece of legislation provides for a temporary moratorium on NPDES permitting for discharges incidental to the normal operation of a vessel from (1) commercial fishing vessels (as defined in 46 U.S.C. 2101 and regardless of size) and (2) those other non-recreational vessels less than 79 feet in length. S. 3298, Public Law 110-299 (July 31, 2008). The statute's NPDES permitting moratorium ran for a two-year period beginning on its July 31, 2008 enactment date, during which time EPA studied the relevant discharges and prepared a report which was submitted to Congress in August 2010. Congress subsequently extended this moratorium to December 18, 2013 by Public Law 111-215. On December 18, 2014, President Obama signed into law the Howard Coble Coast Guard and Maritime Transportation Act of 2014, S. 2444, which extended the moratorium for an additional three years until December 18, 2017. EPA proposes text in 40 CFR 122.3(a) to reflect this law. The new proposed text also reiterates that the statute's NPDES permitting moratorium does not extend to ballast water discharges, or to other discharges that the permitting authority determines contribute to a water quality standards violation or which pose an unacceptable risk to human health and the environment.
EPA is also proposing an update to the existing exclusion to incorporate language regarding discharges incidental to the normal operation of vessels of the Armed Forces that was added to the CWA definition of “pollutant” after the promulgation of the original § 122.3(a) vessel discharge exclusion. Section 301(a) of the CWA provides that “the discharge of any pollutant by any person shall be unlawful” unless the discharge is in compliance with certain other sections of the Act, including the section 402 NPDES program. 33 U.S.C. 1311(a), 1342. Under CWA section 402(a), EPA may “issue a permit for the discharge of any pollutant, or combination of pollutants, notwithstanding section 1311(a)” subject to certain conditions required by the Act. The Act's definition of “pollutant” specifically excludes “sewage from vessels
These changes would reduce confusion by accurately reflecting the current scope of the exclusion from NPDES permitting for discharges incidental to the normal operation of a vessel operating in a capacity as a means of transportation, which has narrowed since the exclusion was originally promulgated. These clarifications align with the decision in
EPA requests comments on whether the proposed changes to 40 CFR 122.3(a)
EPA proposes to update and clarify the permit application requirements in 40 CFR 122.21. As the NPDES program has evolved, many existing application requirements and associated forms have become outdated with respect to current program practices. Therefore, revisions to the application requirements at 40 CFR 122.21 and to the accompanying application forms are needed to update and improve their consistency, accuracy, and usability.
CWA section 304(i)(1) (previously section 304(h)(1)) required EPA to promulgate guidelines for “establishing uniform application forms and other minimum requirements for the acquisition of information” from point sources within 60 days after its enactment. In 1973, EPA promulgated short forms to meet these deadlines and standard forms to gather additional information from certain dischargers.
Amendments to the CWA in 1977 refocused EPA priorities on regulating toxic pollutants. As a result, the NPDES program expanded beyond regulating conventional pollutants to regulating toxic pollutants including certain metals and organic chemicals, and nonconventional pollutants such as ammonia, chlorine, and nitrogen.
To simplify permitting across several environmental programs, EPA published regulations on May 19, 1980 (45 FR 33290) to consolidate the requirements and procedures for five of the permit programs that EPA administers: The NPDES program, the Underground Injection Control (UIC) program under the Safe Drinking Water Act (SDWA), state “dredge or fill” programs under section 404 of the CWA, the Hazardous Waste Management program under the Resource Conservation and Recovery Act (RCRA), and the Prevention of Significant Deterioration (PSD) program under the Clean Air Act (CAA). This effort sought to eliminate gaps and overlaps and ensure consistency among the programs where appropriate.
At the same time, EPA consolidated the requirements and procedures for the five permit programs, it revised the permit application regulations. EPA created three new application forms: Form 1, Form 2B, and Form 2C. Form 1 requires general information about permit applicants and is required to be completed by applicants for each of the five types of permits under the consolidated permit rule. Form 2B is specific to NPDES permit applications for CAFOs and aquatic animal production dischargers. Form 2C applies to NPDES permit applications for manufacturing, commercial, mining, and silvicultural operations. All three forms reflected EPA's emphasis on toxic pollutants and other modifications to the CWA and NPDES program regulations.
Following promulgation of the consolidated permit regulations, interested parties commented that the consolidated format made the regulations unnecessarily difficult to use. They commented that dividing responsibilities among various entities at the state and federal levels caused additional problems. In practice, consolidated processing of multiple permits was rare because the various permit programs regulated different activities with different standards and thus imposed different types of requirements on permittees.
In response to problems permit writers encountered, EPA deconsolidated the five permitting programs on April 1, 1983 (48 FR 14146). The NPDES regulations remain in part 122 (substantive permit requirements) and part 123 (state program requirements). Part 124 (common permitting procedures) remains applicable to all of the programs. On September 1, 1983, EPA promulgated additional revisions covering a number of issues affecting the consolidated permit program. 48 FR 39611.
The NPDES program continued to use these application forms
In 1987, Congress made extensive revisions to the CWA. Water Quality Act (WQA), Public Law 100-4. A new provision, CWA section 402(p), required EPA to establish NPDES requirements for stormwater discharges in two phases. To implement these requirements, EPA published the Stormwater Phase I Rule which established permit application requirements for certain categories of stormwater discharges associated with industrial activity (creating Form 2F) and discharges from large and medium municipal separate storm sewer systems (MS4s). 55 FR 47990. On December 8, 1999, EPA published the Stormwater Phase II Rule regulating stormwater discharges from small construction sites and from certain small MS4s. 64 FR 68722.
In 1999, EPA also amended the permit application requirements and application forms for POTWs and treatment works treating domestic sewage (TWTDSs). 64 FR 42434. The new Form 2A for POTWs addressed a number of changes to the NPDES program that had occurred since 1973 (
In 2000, EPA issued amendments to streamline the NPDES program in response to a Presidential Directive to review regulatory programs to eliminate any obsolete, ineffective, or unduly burdensome regulations. 65 FR 30886. As part of this streamlining effort, EPA revised several permit application provisions to reduce duplicative requirements and clarify certain application requirements.
On February 12, 2003, EPA issued a final rule revising NPDES requirements for CAFOs. 68 FR 7176. This rule revised the information requirements for entities seeking coverage under an NPDES permit for CAFOs, and revised the NPDES individual permit application for CAFOs (Form 2B for CAFOs and aquatic animal production facilities). Further, in response to an order issued in
On October 22, 2015, EPA's NPDES Electronic Reporting Rule went into effect, amending 40 CFR part 127. 80 FR 64063. This rule requires electronic submittal of NPDES permitting and compliance monitoring reporting information. This rulemaking changed
EPA is proposing specific, targeted changes to the current application requirements and is not proposing, or seeking comment on, other changes to the information or pollutant screening data required by the existing regulations and forms. Several revisions included in this proposal are necessary in order to ensure the information required by the application forms across the different categories of facilities submitting applications is consistent with EPA's current data standards
EPA proposes updating the industrial code classification requirement to include the facility's North American Industry Classification System (NAICS) code, which is part of the established data standard.
EPA proposes the following revisions to 40 CFR 122.21:
a. NPDES Contact Information—EPA proposes to update contact information for those interested in obtaining application forms. 40 CFR 122.21(a)(2) will be updated to: U.S. EPA, Mail Code 4203M, 1200 Pennsylvania Ave. NW., Washington, DC 20460 or by visiting
b. North American Industry Classification System (NAICS) Codes—For all applicants except publicly owned treatment works (POTWs) and treatment works treating domestic sewage (TWTDSs), EPA proposes to revise the requirements at 40 CFR 122.21(f)(3) to include NAICS codes, in addition to Standard Industrial Classification (SIC) codes, that reflect the products or services provided by the facility. This proposed revision would update the classification code requirement to be consistent with EPA's current data standard (NAICS) until EPA completely phases out the use of SIC codes in other program areas, such as the effluent guidelines program.
c. Latitude and Longitude—To improve the consistency and precision of locational information required in permit applications, and to be consistent with EPA data standards, EPA proposes several revisions:
i. For existing manufacturing, commercial, mining, and silvicultural dischargers, EPA proposes revising 40 CFR 122.21(g)(1) and 122.21(h)(1) to require outfall latitude and longitude to the nearest second, including the method of data collection (
ii. EPA proposes revising 40 CFR 122.21(j)(1)(i) and 122.21(j)(3)(i) for new and existing POTWs, and 40 CFR 122.21(k)(1) for new sources and new discharges, to require the latitude and longitude of the discharging facility to the nearest second, including the method of data collection.
iii. For all applicants except POTWs and TWTDSs, EPA proposes to revise 40 CFR 122.21(f)(2) to require the latitude and longitude of the discharging facility to the nearest second, including the method of data collection. In addition, EPA is proposing to update the corresponding form (Form 1) to include a check box to indicate whether the location represents the primary entry point to the facility or the centroid of the facility site location.
iv. For new and existing concentrated animal feeding operations (CAFOs) and concentrated aquatic animal production (CAAP) facilities, EPA proposes revising 40 CFR 122.21(i)(1)(iii) to require latitude and longitude to the nearest second and the method of data collection.
v. For certain TWTDSs, EPA proposes revising the following paragraphs to require the site latitude and longitude to the nearest second including the method of data collection: 40 CFR 122.21(q)(1)(i), 122.21(q)(8)(ii)(A), 122.21(q)(9)(iii)(B), 122.21(q)(10)(iii)(B), 122.21(q)(11)(iii)(B) and 122.21(q)(12)(i).
vi. For combined sewer systems, EPA proposes revising 40 CFR 122.21(j)(8)(ii)(A)(3) to require the method of collection for the latitude and longitude of the combined sewer overflow (CSO) outfall.
vii. For cooling water intake structures, EPA proposes revising 40 CFR 122.21(r)(3)(ii) to require the intake structure latitude and longitude to the nearest second including the method of data collection.
EPA seeks comments on the availability of longitude and latitude coordinates for the specific locations identified above as well as whether there are any other considerations it should consider relating to submitting these coordinates as part of the application requirements.
EPA proposes revisions to the length of time given to new dischargers to submit effluent information. This revision would ensure that new dischargers submit effluent characterization data in a manner that is timely and consistent for both POTW and non-POTW dischargers. 40 CFR 122.21(k) currently requires new non-POTW sources to submit data within two years of the commencement of discharge, while 40 CFR 122.21(j) does not establish a timeframe for new POTWs to submit information. EPA's proposed revision would establish a new timeframe of 18 months for both POTW and non-POTW dischargers to submit effluent information to the permitting authority. Specifying a time frame for a POTW to submit actual monitoring results and reducing the time frame (from two years to 18 months) required for a new industrial discharger to submit actual monitoring results would ensure that permitting authorities have more timely access to actual effluent data upon which to confirm or rebut the estimates provided by new dischargers on their initial permit applications. While the estimates provided in the initial applications are useful and appropriate for determining the need for effluent limits, the actual effluent data are vital to confirm that permit conditions developed based on the estimated pollutant concentrations
d. New Discharger Data Submission—EPA proposes making the time provided for effluent data submission for new POTWs consistent with the requirement for new industrial dischargers. EPA also proposes to reduce the time period that is provided for new non-POTW dischargers to submit effluent data. Specifically, the proposed revisions to application requirements for new sources and new discharges at 40 CFR 122.21(k)(5)(vi) would require applicants to submit items V and VI of Form 2C no later than 18 months after the commencement of discharge. The current requirement for submission is two years. The proposed revisions to application requirements for new POTWs at 40 CFR 122.21(j)(4)(i) and 122.21(j)(5)(i) would require submission of data no later than 18 months after the commencement of discharge.
EPA specifically seeks comments on whether 18 months is an adequate period of time for new dischargers to submit effluent data.
EPA proposes revisions to the effluent data submission requirements for non-POTWs to be consistent with those for POTWs. The instructions for Form 2C currently direct applicants to provide all representative data where the applicant has multiple results for a particular parameter. The Form 2C instructions also indicate that data from the past three years should be included. These requirements are not specifically identified in the current regulations and the instructions are not consistent with the requirements for POTWs. When applying for an NPDES permit, an existing POTW must provide effluent data from the previous 4.5 years. The 4.5-year requirement for Form 2A was established to ensure the permittee summarizes all the data collected during its existing five-year permit term with consideration that the application would be submitted six months prior to the end of the permit term (
e. Data Age for Permit Renewal—EPA proposes adding 40 CFR 122.21(g)(7)(ix) to ensure that the effluent data submission requirements for non-POTWs are consistent with those for POTWs. EPA proposes to revise the application Form 2C instructions and include a new paragraph in the regulations at § 122.21(g)(7)(ix) to require the submission of effluent data representing the previous 4.5 years for non-POTW facilities.
f. Reporting Electronic Mail Address—EPA proposes revising the following paragraphs in 40 CFR 122.21 to request the applicant's electronic mailing address (email): § 122.21(c)(2)(ii)(B), § 122.21(f)(4), § 122.21(j)(1)(ii), § 122.21(j)(1)(viii)(2) and (3), § 122.21(j)(9), § 122.21(q)(1)(i), § 122.21(q)(2)(i), § 122.21(q)(8)(vi)(A), § 122.21(q)(9)(iii)(D) and (E), § 122.21(q)(9)(iv)(A), § 122.21(q)(10)(ii)(A), § 122.21(q)(10)(iii)(K)(1), § 122.21(q)(11)(ii)(A), § 122.21(q)(12)(i), and § 122.21(q)(13).
EPA proposes specific targeted changes to the NPDES application requirements for POTWs that would bring the NPDES regulations in concert with changes to the general pretreatment regulations at 40 CFR 403.3(v). Application requirements at 40 CFR 122.21(j) ensure that POTWs submit information for both significant industrial users (SIUs) and categorical industrial users (CIUs), including industrial waste trucked or hauled to the POTW, in order to properly identify types of industries and characterize the wastewater discharged to the POTW. This application information is used by the pretreatment control authority to determine whether a pretreatment program must be developed. Control authorities are POTWs with an approved POTW pretreatment program, an authorized state pretreatment program, or EPA where there is no authorized state pretreatment program.
Prior to the 2005 national pretreatment program regulations revisions, all CIUs were considered a subset of the broader term “significant industrial users.” In 2005, the general pretreatment regulation at 40 CFR 403.3(v) was revised to allow a control authority to designate certain CIUs, after qualifying and demonstrating continued compliance with categorical standards, as a non-significant CIU (NSCIU). 40 CFR 403.3(v)(ii). Users categorized as NSCIUs must submit an annual certification to maintain their “non-significant” status, but are no longer subject to annual sampling, inspections or permitting requirements such as local limits, which are required for significant users. This resulted in a reporting and permitting burden reduction on these CIUs and the control authorities. However, all CIUs (both those classified as SIUs and NSCIUs) are still subject to industrial sector-specific national categorical standards established in 40 CFR chapter I, subchapter N.
The proposed language at 40 CFR 122.21(j)(6) will clarify that POTWs are required to submit, as part of their application, relevant information from all industrial users (SIUs and NSCIUs). The proposed revision would align the NPDES application requirements with the existing pretreatment regulations at 40 CFR 403.3(v), and would impose no new burden.
g. Reporting Numbers of Significant Industrial Users (SIUs) and Non-Significant Categorical Industrial Users (NSCIUs)—EPA proposes revising 40 CFR 122.21(j)(6)(i) and (ii) to clarify that the reporting requirements under these sections apply to both SIUs and NSCIUs, including trucked or hauled waste, that discharge to a POTW.
EPA is also proposing to revise 40 CFR 122.21(f) to require applicants to indicate whether their facility uses cooling water and to identify the source of that cooling water. This would clarify the need for and ensure the permitting authority receives all of the necessary information required under existing 40 CFR 122.21(r) for the facility. This proposal will not alter any of the existing requirements under 40 CFR 122.21(r), and imposes no new burden.
h. Cooling Water Intake Structure Indication—EPA proposes adding a new paragraph 40 CFR 122.21(f)(9) to require the applicant to indicate whether the facility uses cooling water and to specify the source of the cooling water and to remind applicants they must comply with any applicable requirements at 40 CFR 122.21(r).
Finally, EPA proposes to revise §§ 122.21(f) and 122.21(j) to require applicants to indicate whether they are requesting any of the variances permitted under 40 CFR 122.21(m) (for non-POTWs) and (n) (for POTWs). This would ensure the permitting authority is aware of the request at the time of permit application and could better determine whether the facility has submitted all of the required information. This proposal would not alter any of the existing requirements of 40 CFR 122.21(m) and (n), and imposes no new burden.
i. Request for Variance Indication—EPA proposes adding a new paragraph 40 CFR 122.21(f)(10) to require the applicant to indicate whether he or she is requesting any of the variances under § 122.21(m). EPA also proposes adding 40 CFR 122.21(j)(1)(ix) to require the applicant to indicate whether he or she is operating under the variance for POTWs provided in § 122.21(n).
In this rulemaking, EPA is seeking comment only on these specific proposed targeted changes to the current application requirements. EPA is not proposing or seeking comment on other changes to the information or pollutant screening data that the existing regulations and forms require and will not respond to any such comments as part of this rulemaking. However, in the future, EPA may examine all the application forms to determine whether they should be revised further, for example, to address any potentially obsolete elements or information requests inconsistent with regulatory requirements at 40 CFR 122.21. If you would like to address changes to current application requirements other than those raised by this rulemaking, please submit those comments to Docket ID No. EPA-HQ-OW-2016-0146 at
EPA proposes to revise 40 CFR 122.44(d) to include a reference to 40 CFR 131.12 in order to ensure consistency with the state antidegradation requirements established under that section. CWA section 301(b)(1)(C) requires that NPDES permit limits be as stringent as necessary to meet water quality standards. Consistent with this requirement, the NPDES regulations at 40 CFR 122.44(d)(1) provide that NPDES permits shall include “any requirements in addition to or more stringent than promulgated effluent limitations guidelines or standards . . . necessary to: (1) Achieve water quality standards established under CWA section 303, including state narrative criteria for water quality.” Water quality standards consist principally of three elements: Designated uses, water quality criteria and antidegradation policies. 40 CFR 131.6, 131.10-12. Pursuant to EPA's regulations at 40 CFR 131.12, states must adopt antidegradation policies. An antidegradation policy “specifies the framework to be used in making decisions about proposed activities that will result in changes in water quality” and “can play a critical role in helping states protect the public resource of water whose quality is better than established criteria levels and ensure that decisions to allow reductions in water quality are made in a public manner and serve the public good.” NPDES PWM, 6.1.1.3. EPA expects permitting authorities to develop NPDES permit terms and conditions consistent with and in consideration of applicable state antidegradation policies and/or requirements. However, this interpretation has not explicitly been included in the NPDES regulations. The federal antidegradation policy has a long legislative history. The Secretary of the Interior established the basic federal antidegradation policy on February 8, 1968. When the CWA was enacted in 1972, the WQS of all 50 states included antidegradation provisions. By providing in 1972 that existing state WQS would remain in force until revised, the CWA ensured that states would continue their antidegradation programs. EPA's first WQS regulation, promulgated on November 28, 1975, included a similar antidegradation policy at 40 CFR 130.17. 40 FR 55,340-41.
Section 101(a) of the CWA emphasizes the prevention of water pollution and expressly includes the objective “to restore and
The CWA section 101(a)(2) goals call for the protection and propagation of fish, shellfish and wildlife, and recreation in and on waters. Although designated uses and criteria are the primary tools states use to achieve this goal, antidegradation complements these by, in part, providing a framework for maintaining and protecting waters that are of higher quality than necessary to support the CWA section 101(a)(2) goals, or are Outstanding National Resource Waters (ONRWs). Antidegradation plays a critical role in allowing states and tribes to maintain and protect the valuable resource of high quality water by ensuring that decisions to allow a lowering of high quality water are made in a transparent and public manner and are based on a sound technical record.
In the 1987 WQA, Congress expressly affirmed CWA section 101's antidegradation principle and referenced antidegradation policies in section 303(d)(4)(B) of the Act (33 U.S.C. 1313(d)(4)(B)), simultaneously confirming that antidegradation policies are an integral part of the CWA and explaining the relationship of antidegradation policies to other CWA regulatory programs:
Standard Attained—For waters identified under paragraph (1)(A) where the quality of such waters equals or exceeds levels necessary to protect the designated use for such waters or otherwise required by applicable WQS, any effluent limitation based on a total maximum daily load or other waste load allocation established under this section, or any WQS established under this section, or any permitting standard may be revised only if such revision is subject to and consistent with the antidegradation policy established under this section.
As the Supreme Court stated in
A 1987 amendment to the Clean Water Act makes clear that section 303 also contains an `antidegradation policy' . . . Specifically, the Act permits the revision of certain effluent limitations . . . only if such revision is subject to and consistent with the antidegradation policy established under CWA section 303, 33 U.S.C.1313(d)(4)(B)).
The court also acknowledged the long-standing federal antidegradation policy and EPA's authority to promulgate antidegradation requirements. Id. 704-05, 718.
Based on this authority, EPA promulgated its current antidegradation regulation at 40 CFR 131.12 on August 21, 2015. 80 FR 51020. Section 131.12 requires states to develop and adopt a statewide antidegradation policy and develop methods for implementing that policy. It built upon and refined the pre-existing 1983 regulation which EPA had promulgated at 40 CFR 131.12 on November 8, 1983. 48 FR 51400. Consistent with the Supreme Court decision,
This interpretation is not expressly included in the existing regulations at 40 CFR 122.44(d)(1); thus, EPA now proposes to revise 40 CFR 122.44(d)(1) to expressly include a reference to 40 CFR 131.12, in order to ensure consistency with the antidegradation provisions in that section. Similar to the existing provision at 40 CFR 122.44(d)(1) noting that “narrative criteria for water quality” are components of water quality standards, including the reference to 40 CFR 131.12 serves notice that antidegradation policies are also components of state water quality standards and must be considered in in permitting decisions where applicable. EPA proposes revising 40 CFR 122.44(d)(1) to include, explicitly, “the state antidegradation requirement” as one of the elements of state WQS that must be applied when deriving WQBELs.
As noted above, because antidegradation is an existing component of all state WQS, the existing regulations at 40 CFR 122.44(d) require state and EPA permitting authorities to ensure that effluent limits derive from and comply with antidegradation requirements. EPA does not propose to change any of its existing interpretations of WQS, antidegradation or any related existing EPA interpretations of state implementation responsibilities. This proposed revision is intended solely as a clarification, and imposes no new burden. The only burden related to this new reference would be where state permitting authorities are not currently implementing elements of their EPA-approved WQS. It is EPA's view that currently, permit writers consider antidegradation, although NPDES permit records might not necessarily currently reflect this analysis.
EPA seeks comments on this proposed revision to 40 CFR 122.44(d)(1).
EPA proposes to revise 40 CFR 122.44(d) to specify that any allowance for dilution provided under this paragraph must comply with applicable dilution and mixing zone requirements and low flows established in state WQS
The CWA and its implementing regulations require that NPDES permits include limitations as stringent as necessary to meet applicable WQS. CWA 301(b)(1)(C); 40 CFR 122.44(d)(1). When determining the need for conditions necessary to meet WQS, 40 CFR 122.44(d)(1)(ii) indicates that the permitting authority shall consider, “where appropriate, the dilution of the effluent in the receiving water.” When developing WQS pursuant to CWA section 303(c), EPA regulations at 40 CFR 131.13 provide that states may include in the state standards “general policies” affecting the application of WQS such as mixing zones, low flows and variances. Alternatively, states may address dilution and mixing considerations through implementation policies and guidance. Consistent with these provisions, many state WQS and implementation procedures allow some consideration of dilution and mixing when determining the need for and calculating WQBELs.
The ambient environment mitigates the impact of an effluent discharge on a receiving water in a number of ways, generally related to the nature of the discharged pollutant and the physical, chemical and biological characteristics of the effluent and receiving water. For many toxic pollutants, dilution is the primary mitigation mechanism. For oxygen-demanding pollutants, such as biochemical oxygen demand (BOD), mitigation may be achieved through both dilution and biodegradation. For other pollutants, mitigation may be achieved through multiple processes, including dilution, biodegradation, chemical reactivity and volatilization. The concentration or mass of a pollutant or pollutant parameter that can be safely mitigated by these various processes in the receiving water without exceeding any applicable WQS and without causing adverse effects is commonly referred to as the “assimilative capacity” of the receiving water.
For any consideration of the dilution of an effluent in a receiving water, modelers must account for the level of the pollutant already present in the receiving water prior to the introduction of the effluent. This is often referred to as the “background” pollutant concentration. The background pollutant concentration can be based on measurements from the receiving water, or where data are unavailable, can be assumed. Where data are available, modelers assess the data and select a value that is considered representative of the site. The selection of the background value might be based on an average of the data, or on an upper or lower statistical boundary, and is generally a matter of state policy or procedure. In any case, modeling requires that the modeler select some background pollutant value.
Where no measured data are available, the modeler could either postpone the analysis to obtain data, or could instead assume a background concentration. For NPDES permitting purposes, the assumed background value could range from zero to a value at or above the applicable water quality criteria. An assumption of zero indicates that the full assimilative capacity of the water is available, while an assumption that the background concentration is at or above the applicable water quality criteria indicates that there is no remaining assimilative capacity. As noted above, the selection of one of the end point values, or some value between these two extremes, is typically a matter of state policy.
As discussed above, granting any dilution allowance requires the consideration of the background pollutant concentration. NPDES permit reviews have shown that in many instances permitting authorities grant dilution allowances for pollutants assuming the complete absence of the pollutant in the upstream receiving waters. An assumption of “zero background” levels of a pollutant in an upstream water, in the absence of data or analyses to validate such an assumption, results in permit conditions that use as much as 100 percent of the receiving water's dilution capacity to the discharging facility. Thus, in situations where some of the pollutant is actually present in the upstream waters, an assumption of “zero background” concentration overestimates the available assimilative capacity of the receiving water and could result in limits that are not protective of applicable WQS. EPA has long intended that permit writers should consider information regarding the actual assimilative capacity of the receiving waters and the amount of the pollutant already present in the receiving water when determining dilution allowances and mixing zones.
The current regulations allow consideration of dilution “. . . where appropriate.” However, the current provision does not indicate what is meant by “appropriate.” EPA proposes to update its NPDES regulations concerning dilution allowances to clarify that while existing regulations allow consideration of dilution “where appropriate,” any allowance for dilution and mixing must be applied in a manner
EPA proposes clarifying 40 CFR 122.44(d)(1) to specify that the appropriateness of any consideration of dilution or mixing must derive from the applicable state WQS, including any general policies related to dilution and mixing. Further, the proposed revision to 40 CFR 122.44(d)(1) would require that decisions regarding the assimilative capacity of the receiving water, for the purpose of determining a dilution allowance, must be supported by data or analyses quantifying or accounting for the presence or absence of each assessed pollutant or pollutant parameter in the receiving water. Conducting a basic background inquiry into a receiving water's assimilative capacity would be necessary to grant the dilution allowance. Where the actual assimilative capacity of the receiving water cannot be accurately determined or predicted (
This revision would ensure that the permitting authority considers data or other available and applicable information before granting a dilution allowance for either rapid and complete or incomplete mixing. Under the proposed revisions, every time a dilution allowance is granted, assuming either rapid and complete or incomplete mixing, the permitting authority would be required to include a basis grounded in analyses of available information. This revision would not require the collection of new data and will not impose a new burden; it is intended to ensure that the permitting authority considers existing valid and representative ambient water quality data and to enhance decision-making transparency when permitting authorities consider a dilution allowance. States also may choose to collect data and information on the receiving water from the applicants, either prior to issuance of the permit or as a condition of the permit. Potential sources of data and information on ambient water quality and flow are maintained by regulatory agencies such as EPA, the United States Geological Survey (USGS) and state-level authorities. Dischargers, monitoring consortia, or non-governmental organizations may also provide ambient monitoring data for these analyses, although permitting authorities should ensure that all data used in any dilution analysis are subject to quality assurance and quality control. In limited circumstances (
EPA seeks comments on this proposed revision to 40 CFR 122.44(d).
EPA proposes to revise 40 CFR 122.44(d) to specify that a “reasonable potential” determination (explained below) must consider relevant qualitative or quantitative data, analyses, or other valid and representative information for pollutants or pollutant parameters that could support the need for effluent limitations for new discharges.
Where TBELs are not sufficient to attain applicable WQS, CWA section 301(b)(1)(C) requires that permits include any more stringent limits necessary to meet such standards. 40 CFR 122.44(d)(1). These limits are known as water quality-based effluent limits, or WQBELs. EPA regulations state that “[l]imitations must control all pollutants or pollutant parameters (either conventional, nonconventional, or toxic pollutants) which the Director determines are or may be discharged at a level that will cause, have the reasonable potential to cause, or contribute to an excursion above any [s]tate water quality standard, including [s]tate narrative criteria for water quality.” 40 CFR 122.44(d)(1)(i). Based on this language, EPA refers to the process that a permit writer uses to determine whether a WQBEL is required in an NPDES permit as a reasonable potential analysis. NPDES PWM, 6.3.1. However, the current regulatory language is unclear regarding the types and quantities of data and information (including qualitative information) permitting authorities must consider when conducting a reasonable potential analysis. Because of this lack of clarity in the regulations, EPA has found that permitting authorities often defer the reasonable potential determination and development of WQBELs until a minimum data set has been collected. Permit reviews have also revealed a lack of reasonable potential determinations where quantitative data was not yet available, despite the availability of studies and effluent analyses for facilities with similar operations and effluent characteristics.
Permit writers must determine whether the limits and conditions of an NPDES permit are as stringent as necessary to attain any applicable WQS. CWA section 301(b)(1)(C). Once the permitting authority determines that a discharge causes, has the reasonable potential to cause, or contributes to an excursion above water quality criteria, 40 CFR 122.44(d)(1) requires the permitting authority to develop effluent limits to control the discharge of such pollutant(s). The cumulative impact of point and nonpoint sources on a water body may cause an excursion. In determining the need for a permit limit, the permitting authority must, at a minimum, consider existing controls on both point and nonpoint sources of pollution, the variability of the pollutant or pollutant parameter in the effluent, the sensitivity of the involved species to toxicity testing (when evaluating WET), and where appropriate, the effluent dilution in the receiving water. 40 CFR 122.44(d)(1)(ii). EPA's TSD specifically discusses conducting a reasonable potential evaluation in the “absence of effluent data.” These factors include the type of discharge, the available dilution, the type of receiving water and designated use, existing data on toxic pollutants and the history of compliance problems and toxic impact. TSD 3.2. The NPDES PWM similarly suggests that permit writers use “any available effluent and receiving water data as well as other information pertaining to the discharge and receiving water,” including type of industry, existing TBELs, compliance history and stream surveys. NPDES PWM, 6.3.2.
Consistent with this existing guidance and policy, this proposal would require the Director to make a reasonable potential determination based on relevant qualitative or quantitative data, analyses or other valid and representative information for pollutants or pollutant parameters that could support the need for effluent limitations. When determining effluent limitations for new dischargers where effluent data is not yet available,
This proposed revision would codify EPA's long-standing policy that the permitting authority should consider available and relevant data and information (as described above) pertaining to the discharge in order to make an informed judgment.
EPA seeks comments on this proposed revision to 40 CFR 122.44(d).
EPA is correcting publication contact information included in the Note to § 122.44(k)(4) by deleting outdated references to information sources that are no longer available to read: “Additional technical information on BMPs and the elements of BMPs is contained in the following documents: Guidance Manual for Developing Best Management Practices (BMPs), October 1993, EPA No. 833/B-93-004, NTIS No. PB 94-178324, ERIC No. W498); Storm Water Management for Construction Activities: Developing Pollution Prevention Plans and Best Management Practices, September 1992, EPA No. 832/R-92-005, NTIS No. PB 92-235951, ERIC No. N482); Storm Water Management for Construction Activities, Developing Pollution Prevention Plans and Best Management Practices: Summary Guidance, EPA No. 833/R-92-001, NTIS No. PB 93-223550; ERIC No. W139; Storm Water Management for Industrial Activities, Developing Pollution Prevention Plans and Best Management Practices, September 1992; EPA 832/R-92-006, NTIS No. PB 92-235969, ERIC No. N477; Storm Water Management for Industrial Activities, Developing Pollution Prevention Plans and Best Management Practices: Summary Guidance, EPA 833/R-92-002, NTIS No. PB 94-133782; ERIC No. W492. EPA guidance documents can be obtained through the National Service Center for Environmental Publications (NSCEP) at
EPA proposes to revise 40 CFR 122.44(l) to incorporate the anti-backsliding provisions that are currently in the CWA and have not yet been incorporated into the NPDES regulations. As a general matter, the anti-backsliding provisions prohibit the renewal, modification or reissuance of an NPDES permit with effluent limitations that are less stringent than the effluent limitations that existed in the prior permit. Anti-backsliding requirements are found in the CWA in sections 402(o) and 303(d)(4) and in the NPDES regulations at 40 CFR 122.44(l).
EPA revised the existing regulatory language at 40 CFR 122.44(l) in January 1989 under the 1987 WQA. 54 FR 245. The WQA amended the CWA to include sections 402(o) and 303(d)(4). EPA's 1989 regulatory revision did not, however, incorporate the entirety of the WQA's provisions on anti-backsliding. The proposed revision would incorporate into the NPDES regulations the omitted WQA anti-backsliding provisions applicable to effluent limitation.
The following is a list of the anti-backsliding sections and where EPA proposes to incorporate them into the regulation: The second sentence of CWA section 402(o)(1) would be incorporated into 40 CFR 122.44(l) as a new section 122.44(l)(2); the second sentence of CWA section 402(o)(2)(E) would be incorporated into 40 CFR 122.44(l) as a note at the end of § 122.44(l)(2); and CWA sections 303(d)(4)(A) and 303(d)(4)(B) would be incorporated into 40 CFR 122.44(l) as new §§ 122.44(l)(3)(i) and 122.44(l)(3)(ii), respectively. In each case, EPA is incorporating statutory language verbatim.
Since EPA is including anti-backsliding statutory language verbatim, EPA is not seeking comments on the added language or on the existing regulation.
EPA proposes revisions to 40 CFR 122.45(b) to clarify that permit writers would be required to calculate permit effluent limits for POTWs using design flow only where the limits are based on technology standards. The revisions would provide permit writers with additional flow options for calculating WQBELs. The existing regulation applies to production-based limits and currently states that POTW permit effluent limitations, standards or prohibitions shall be calculated based on design flow. The current regulation at 40 CFR 122.45(b)(2)(i) provides that for dischargers other than POTWs, permit effluent limitations, standards or prohibitions shall be based upon “a reasonable measure of actual production of the facility.” This has led to some confusion as to whether the requirement for POTW “production-based” limits should be applied to the calculation of WQBELs. This requirement pre-dates EPA's current WQBEL regulations developed to address the 1987 WQA. The administrative record for the existing regulations provides no indication that the production-based requirement was intended to apply to the calculation of WQBELs.
The CWA does not provide any indication that WQBELs for POTWs should be derived in a manner that is distinct from other categories of dischargers. When determining the need
Where the POTW limits are water quality-based, such limits could be based on effluent flows other than design flow (
This option would be appropriate when modeling the impact of any type of pollutant, including when BOD and suspended solids are used as surrogate parameters for applicable WQS. Although this proposal would clarify this flexibility for POTWs, it is not intended to preclude or restrict a permitting authority from using the POTW design flow for the purpose of developing WQBELs. In many cases, the POTW design flow is a reasonable and appropriate value for use in water quality modeling, and this proposed clarification is not intended to discourage permitting authorities from current practices under which design flow is used for WQBEL development. This proposed revision provides additional flexibility for permit writers in calculating effluent limitations and will not impose new burden.
EPA seeks comments on this proposed revision.
EPA proposes revising 40 CFR 123.44 to allow EPA to designate certain administratively continued permits as “proposed permits.”
Section 402(d) of the CWA generally provides that authorized state NPDES permitting authorities should submit proposed state permits to the EPA Administrator for review and objection, where deemed appropriate. 40 CFR 123.44. MOAs between EPA and the authorized state provide the timeframe within which each EPA Regional Administrator (RA), to whom the review and objection duties have been delegated, may comment on or object to a proposed permit, up to 90 days from receipt of the proposed permit. Within this time period, the RA must submit to the State Director a statement of the reasons for any objection, and the effluent limitations and conditions that such permit would include if it were issued by the RA.
When a permittee has submitted a timely and complete renewal application but the State Director has not acted on the permittee's application before the existing permit expires, state laws often provide that the existing permit continues in effect by operation of law until the state takes final action on the permittee's application (that is, until the state makes a final decision to issue or not issue the new permit). This is often referred to as “administrative continuance.” These state laws, like the corresponding federal provisions in 40 CFR 122.6 and the federal Administrative Procedure Act (APA) at 5 U.S.C. 558(c), aim to protect a permittee that has submitted a timely and complete application for renewal from losing its authorization to discharge simply because the permitting authority did not issue a new permit before the existing permit expired.
In some cases, administratively continuing expired permits provides states with flexibility to prioritize their action without significant adverse impacts on receiving waters. However, administrative continuance also can lead to inappropriate delays in reissuing permits that need revision to comply with current regulatory and statutory requirements and policy practices. State administrative continuance laws typically allow an expired permit to remain administratively continued indefinitely, which can significantly delay the implementation of revised or new effluent limitations (both technology-based and water-quality based). Under EPA's existing regulations, there is no mechanism by which to invoke EPA's permit review and objection authority to avoid indefinite delays in permit reissuance. A lengthy administrative continuance of a permit can significantly delay implementation of new effluent guidelines, WQS or TMDLs, and such a delay can affect a permitting authority's ability to protect water quality. As of September 2015, there were approximately 17,000 facilities covered by expired non-tribal and tribal permits (both state and EPA-issued, not including facilities covered by non-major stormwater permits).
Under this proposed revision, expired permits that have been administratively continued and are considered environmentally significant may be subject to objections by EPA regional offices. EPA would expect to exercise this authority only in very limited circumstances, such as for permits involving environmental and public health issues, where other means of working with the state to reissue an updated permit have failed. Under the current regulations, the RA may review and object to an NPDES permit that an authorized state proposes to issue. 40 CFR 123.44. EPA proposes adding a new mechanism that grants the RA discretion to initiate these procedures where the state has not reissued an expired, administratively continued permit. The RA would have discretion to exercise this authority if a state does not produce a draft permit within a certain period of time, as described below. If a state has not reissued an expired, administratively continued permit, the state would be encouraged to explain to EPA the reasons for not reissuing the expired permit and EPA would carefully consider any such explanation before proceeding with an objection, as further described below.
Consistent with 40 CFR 122.6(d), which currently addresses administratively continued permits, the proposed regulation would apply to only those expired state-issued permits for which state law has provided for continuation of the expired permit. The new provision would not apply to expired permits that have not been administratively continued, nor would it apply to other unpermitted discharges. A similar regulatory change allowing for EPA objection to administratively continued permits, under certain conditions, was previously proposed, commented on and finalized as a part of EPA's July 2000 Total Maximum Daily Load (TMDL) Rule. 68 FR 13608. However, the final rule was withdrawn in March 2003 as a result of widespread controversy and disagreement over the rule and its legal authority, including a case filed in the D.C. Circuit Court.
Given the current backlog of administratively continued state permits, EPA views this proposed revision as providing an important potential mechanism through which to carry out its authorities under the CWA. 33 U.S.C. 1361(a). Under CWA section 402(c)(2), authorized state programs must comply with the requirements of the Act including CWA section 402(b)(1)(B), which provides that NPDES permits may not be issued for periods exceeding five years. The purpose of this statutory limitation is to ensure that permits be reviewed and revised regularly by the state, and by EPA in its CWA 402(d) oversight role, to ensure compliance with the Act and its implementing regulations, including those pertaining to both TBELs and WQBELs.
EPA currently addresses expired, administratively continued permits through its “priority permits” measure. Priority permits are those permits that have been expired longer than two years, and which EPA has asked the permitting authority to target for reissuance. EPA's general trigger for identifying priority permits is when a permit is expired two years (outlined in a 2004 memorandum from the Director of EPA's Office of Wastewater Management to EPA's Regional Water Division Directors on the topic of permit issuance, priority permits and permitting backlog).
EPA proposes that an administratively continued permit could be designated as “proposed” after either a two-year or five-year period following the initial five-year permit term, and is seeking comment on which time frame is appropriate. A two-year period after which an administratively continued permit could be designated by EPA as “proposed” would be consistent with EPA's general trigger for identifying priority permits. EPA's view is that it is reasonable to consider a two-year delay as an indication that the state is unable to take action on the permit. A five-year period after which an administratively continued permit could be designated as “proposed” would allow for EPA to first address the administratively continued permit through the priority permits measure. A five-year expired permit would be designated as a priority permit after being expired for two years, and the state would have had at least three additional years to work on and reissue the permit. Additionally, a five-year expired permit would have been expired for an entire permit cycle. EPA's view is that it is reasonable for a state to take action to reissue a permit that has been expired and administratively continued for five years.
EPA expects to exercise its discretion to use this authority only in very limited circumstances, such as for particularly environmentally significant permits, to ensure that these expired permits may be reissued in a timelier manner and, when reissued, reflect the most current statutory and regulatory requirements. EPA has used the priority permits measure since 2004 to target administratively continued permits which should be a priority for reissuance. The parameters by which permits generally may be designated as priority permits were identified in the above referenced 2004 memorandum, which is included in this rule's docket. EPA is considering using similar parameters to identify permits for candidates for administratively continued permit objections. Under this approach, permits with the following significant adverse impacts, changes or issues could be potential candidates for the new objection process:
• New or revised water quality standards;
• New or revised effluent limitations guidelines;
• Potentially significant impacts to an impaired or threatened waterbody;
• Potentially significant impacts to a drinking water resource;
• National program priorities (
• Protection of threatened or endangered species;
• Significant changes to a facility's operations, treatment, or effluent characteristics; or
• Public concerns or environmental justice issues.
Under the proposed provision, EPA would be required to give the state and the permittee notice of its intent to designate the administratively continued permit as a proposed permit submitted to EPA for review under 40 CFR 123.44. EPA proposes to give the state and the permittee 180 days' notice of its intent to designate an administratively continued permit as a proposed permit, and is requesting comment on whether this time frame is appropriate. This proposed provision would not create a new mechanism for EPA to take over a state's NPDES permit. During EPA's review of the “designated” proposed permit, the state permitting authority may decide to proceed with the development of its own draft or proposed permit. EPA would encourage this effort, as the intent is always to have a state permitting authority reissue an administratively continued permit incorporating all of the appropriate terms and conditions. For this reason, the proposed amendment provides that if the state, under 40 CFR 123.43(a), submits a draft or proposed permit for EPA review at any time before authority to issue the permit would pass to EPA under 40 CFR 123.44(h), EPA would withdraw its designation of the administratively continued permit as a proposed permit. EPA would then review the state's draft or proposed permit in accordance with the 40 CFR 123.44 procedures. If, after EPA reviews the permit under 40 CFR 123.44, the state does not proceed with the timely issuance of the final permit (within 180 days of the completion of EPA's review), EPA may again determine that the state does not intend to reissue the permit and may reassert its previous determination that the administratively continued permit is to be designated as a proposed permit. EPA would then proceed with the review of the designated “proposed” permit at the
EPA is seeking comments on whether to make this proposed regulatory change. Specifically, EPA seeks comments on whether considering administratively continued permits as “proposed permits” under CWA section 402(d) would effectively achieve EPA's goal of more timely reissuance of state NPDES permits, or whether EPA should consider other regulatory mechanisms to achieve this goal. EPA is also seeking comment on the potential parameters or criteria that EPA could use to more clearly define or limit the scope of this administratively continued permit objection process, including but not limited to those described in the memorandum referenced above, and whether any such parameters or criteria should be included in regulatory language. Additionally, EPA seeks comments on whether two years, or five years, or some other time period is the appropriate threshold at which EPA may designate an administratively continued permit as a proposed permit for the purposes of exercising its objection authority, and whether the proposed 180 days or some other period of time is an appropriate notice period for EPA to notify the state and permittee of its intent to designate the administratively continued permit as a proposed permit. Specifically, if commenters believe other time periods for designating proposed permits and providing notice would be appropriate, EPA requests comments describing the reasoning for such time frames.
EPA proposes revising 40 CFR 124.10(c) to allow permitting authorities to provide public notice of permitting actions for NPDES major individual and general permits on the permitting authority's publicly available Web site in lieu of the newspaper publication requirement.
CWA section 402(b)(3) requires that notice be provided to the public, as well as any other state whose waters may be affected, of each NPDES permit application and that an opportunity be provided for a public hearing before ruling on each permit application. 33 U.S.C. 1342(a)(1). In addition, the statute provides that “public participation in the development, revision and enforcement of standard, effluent limitation, plan, or program established by the Administrator or any State under [the CWA] shall be provided for, encouraged, and assisted by the Administrator and the States.” 33 U.S.C. 1251(e). EPA's regulations also address the issue of public participation in its programs. 40 CFR 124.10. 40 CFR part 25 sets forth minimum requirements for public participation under the CWA, RCRA and SDWA. 40 CFR 25.4(b) explains that “providing information to the public is a necessary prerequisite to meaningful, active public involvement. Agencies shall design informational activities to encourage and facilitate the public's participation in all significant decisions . . . particularly where alternative courses of action are proposed.” These minimum requirements are intended to be met not only by EPA but also by authorized states and state agencies. In clarifying the minimum requirements for public participation, 40 CFR part 25 highlights that the requirements for public information, public notification and public consultation are “intended to foster public awareness and open processes of government decision making and are applicable to all covered activities and programs.” 40 CFR 25.3(c)(7) specifically emphasizes that agencies should “use all feasible means to create opportunities for public participation, and to stimulate and support participation.” Neither the CWA nor its implementing regulations specify the best or preferred method for providing notice to the public.
Currently, 40 CFR 124.10(c)(2)(i) requires notice of specified NPDES permitting activities, such as preparation of a draft permit, through publication “in a daily or weekly newspaper within the area affected by the facility or activity.” Indeed, publication of public notice in newspapers was appropriate when 40 CFR 124.10(c)(2)(i) was promulgated in 1982, 12 years before the internet became widely available for public and commercial use. Web sites are often more appropriate avenues for widely disseminating information to the public and many states currently supplement the required newspaper publication by posting draft and final permits on their state Web sites.
EPA proposes revising 40 CFR 124.10(c) to allow permitting authorities (EPA, state, tribe and territories) to provide public notice for activities listed under 124.10(a) on the permitting authority's publicly available Web site in lieu of the newspaper publication requirement. If a permitting authority exercises this option, the permitting authority would be required to meet all of the required elements of § 124.10(c) and also post all draft permits and fact sheets on the Web site during the public comment period and post all final permits, fact sheets and response to comments on the Web site for the entire term of the permit. The purpose of this revision would be to provide states and EPA with an alternative method of providing notice of permit applications and hearings, and affirm flexibility in reaching the public through a variety of methods that would greatly expand public access to the draft and final permits and fact sheets.
This option would not in any way affect the requirements of 40 CFR 124.10(c)(1)(ix) which state that a copy of the notice must be mailed directly to persons who have joined the appropriate mailing list. This option also would not alter the original requirements of 40 CFR 124.10(c)(2)(i) if a permitting authority chooses to continue the traditional method of providing notice of an NPDES permit action in a newspaper publication. Also, this option would not alter the existing requirements for other types of permits covered in this section (
Finally, nothing in the proposed revisions to 40 CFR 124.10(c) is intended to alter or affect the notice requirements for issuance of a final permit decision in 40 CFR 124.15. Section 124.10(a) establishes notice requirements as to certain enumerated actions, but those actions do not include “issuance” of a final permit decision, the requirements for which are established in 40 CFR 124.15. The inclusion in the proposed revision to 40 CFR 124.10(c) of an internet posting requirement in certain circumstances for final permits is not intended to imply that internet posting fulfills the final permit decision notice requirements of 40 CFR 124.15.
EPA is seeking comment on an alternative option for revising 40 CFR 124.10(c) that would
EPA is also seeking comment on whether proposed revisions to public notice requirements in 40 CFR 124.10(c) should be expanded to include NPDES non-major individual and general permits. This would increase public access to permit and hearing information on the entire NPDES-permitted universe.
In addition, EPA is seeking comments on ways in which NPDES permits and fact sheets could be posted electronically to make it easier for EPA's Enforcement and Compliance History Online (ECHO) information system to link to the permit fact sheets (
Given the wide availability of the internet, it is EPA's view that publication through such means would be effective in informing the public of all such permit applications and hearings.
A permitting authority that uses the web in lieu of a newspaper to post notices could realize significant financial savings and post more information over a longer period of time, fostering greater public access to information and greatly reducing state burden with regard to public notice. Providing the draft permit and fact sheet during the full public comment period and making the final permit electronically available over the lifetime of the permit can significantly increase the public's access to permitting information compared to the single-day newspaper notice and access to paper copies of the permit at the agency's office.
EPA has carefully evaluated the potential effect of this proposed revision on underserved communities with environmental justice (EJ) concerns. EPA consulted a recent study conducted by Native Public Media that found that the primary source for national and international news among Native American tribes is the internet.
EPA seeks comments on both the proposed revision and on the possible alternative option described.
40 CFR 124.55(b) addresses the circumstances under which a state may issue a modified CWA section 401 certification in connection with an EPA-issued NPDES permit and the effect of a modified section 401 certification on such a permit. Pursuant to this regulation, if a court of competent jurisdiction or an appropriate state board or agency invalidates a certification condition after final agency action on the permit, EPA can modify such permits only to delete state certification conditions upon request of the permittee. Under the current rule, EPA cannot modify already-issued permits to reflect state court, board or agency decisions that would require the state certifications (and arguably the federal permits subject to that certification) to include more stringent provisions.
The proposed revisions to 40 CFR 124.55(b) would broaden the circumstances under which federal NPDES permits can be modified after issuance to include the addition of permit conditions based on more stringent section 401 certification provisions that result from state administrative or judicial decisions.
Such permit modifications may be requested by anyone and not just the permittee. This change would recognize the importance of state administrative and judicial review process for CWA section 401 certifications by allowing decisions made by state administrative bodies and courts regarding challenges to state certification conditions to be fully reflected in the federal permit, even after the permit is issued. If, upon review, a state administrative body or court determines that more stringent section 401 certification conditions are necessary to adequately protect water quality or to be consistent with state laws, EPA would have the discretion to modify already-issued federal permits to include those more stringent conditions. It is EPA's view that its current ability to only delete section 401 certification-based permit conditions hinders its
EPA seeks comments on this proposed revision, including comments that estimate how often this provision may be used and on any anticipated impacts.
EPA proposes to revise 40 CFR 124.56 to require specific documentation in the fact sheet developed to support an individual or general permit. Fact sheets, required for major NPDES permits and general permits per 40 CFR 124.8, “sets forth the principal facts and the significant factual, legal, methodological, and policy questions considered in preparing the draft permit.” NPDES PWM, 11.2.2. The existing regulations at 40 CFR 124.56 contain basic requirements for information that must be presented in a fact sheet. It is EPA's view that more precisely outlining the required fact sheet information would result in more comprehensive and focused fact sheets, and correspondingly, would facilitate more efficient, transparent and effective documentation of permitting decisions.
The proposed revisions to 40 CFR 124.56(a) are in two parts—one part for individual permits and one part for general permits. This accommodates differences in the information that permit writers use to develop effluent limits and conditions for individual facilities versus the information used to develop effluent limits and conditions for multiple facilities covered under one general permit.
EPA specifically seeks comments on proposed revisions to fact sheet requirements, as described below.
An NPDES permit is developed based on careful consideration of existing data and available information relevant to the potential discharge. While the permit itself contains the terms and conditions required of the permittee, the rationale and basis for the decisions made in developing those terms and conditions are contained within the fact sheet and administrative record for that permit. The existing regulations at 40 CFR 124.56 contain basic requirements for information that must be presented in a fact sheet.
However, EPA reviews of state-issued NPDES permits within the past ten years have identified widespread deficiencies in state fact sheet quality. Many fact sheets do not meet the requirements of the existing regulations. Currently, many fact sheets omit critical information regarding limitation development, such as available water quality data, impairment status, existence and implementation of TMDLs and implementation of antidegradation policies. Furthermore, while the existing regulation at 40 CFR 124.56(a) requires fact sheets to generally include “calculations and other necessary explanation,” it does not explicitly identify what is required in terms of “calculations” or “other necessary explanation.” Fact sheet quality and clarity affects permittees' and the public's ability to meaningfully participate in the permitting process. It is EPA's view that the public and permit applicants should have access to a clear and transparent record of the permit decision making process. By clearly explaining what the 40 CFR 124.56(a) “calculations and other necessary explanations” requirement means, this proposed revision would enable all NPDES permitting authorities to know precisely the kind of thorough and transparent explanations fact sheets should contain to create this clear record. EPA also expects that these clarifications will enable permittees and other members of the public to more easily understand the permit limit development record.
Where the proposed regulation requires an “explanation,” “information sufficient,” “discussion” or a “description,” the proposed language in 40 CFR 124.56(a) allows the fact sheet to include a brief summary of the required information along with a specific reference to the source document in the administrative record. This would relieve the permitting authority from repeatedly providing this information. EPA is clarifying, however, that where the proposed regulations require a “citation” or “identification,” a summary would be inappropriate and the fact sheet would need to provide the specific information required. It is EPA's view that this would eliminate redundancy, reduce permit writer workload in fact sheet development, and ensure that the permitting authority is clearly demonstrating and making available all required information. The proposed changes to the regulations would address observed deficiencies and explicitly require fact sheets to include the information necessary to understand the rationale behind permit development.
The existing regulations at 40 CFR 124.56 provide basic fact sheet requirements for NPDES permits. While the regulations provide the requirements for content of these fact sheets, they lack specificity, which has led to fact sheets with very little or inconsistent justification of the permit terms and conditions. The proposed regulations would provide specific requirements for both individual and general permits, to provide permit writers with more detail on what information to include in fact sheets.
The current fact sheet regulation at 40 CFR 124.56(a) requires “a citation to the applicable effluent limitation guideline (ELG), performance standard, or standard for sewage sludge use or disposal as required by 40 CFR 122.44.” EPA proposes to redesignate this provision for citations from the existing paragraph (a) as proposed paragraph (a)(1)(i) to allow the inclusion of additional provisions in paragraph (a) in a logical manner.
40 CFR 124.56(a) currently requires fact sheets to include “any calculations or other necessary explanation of the derivation of specific effluent limitations and conditions or standards.” The current regulations do not provide any further clarification regarding what constitutes “calculations or other necessary explanation.”
The proposed paragraphs (ii)(A) and (ii)(B) would require the fact sheet to contain the name of the receiving water and include explicit reference to the applicable state WQS. EPA intends to provide information to the public and the permittee on designated uses of the receiving water(s) and to provide a clear reference to the applicable numeric and narrative criteria for the specific receiving water segment. In order to write WQBELs, permit writers must already consider the receiving water and applicable state WQS, and already has this information available. Explicitly documenting this known information in a fact sheet would add only a minimal
The proposed paragraphs (ii)(C) and (ii)(D) would require the fact sheet to include information regarding the condition of the receiving water(s), including whether the water body has been listed as impaired or threatened for any uses. Where the water body is impaired, the fact sheet must indicate whether EPA has approved or established a TMDL for any of the impairing pollutants or pollutant parameters. This requirement is intended to ensure that the permitting authority has considered the condition of the receiving water as part of the permit development process and provides additional transparency regarding the rationale for permit conditions. When developing WQBELs, permit writers are already required to consider the condition of the receiving water(s), any impairments, and whether there is a TMDL for the receiving water. Because the permit writer already has this information available, it should add only a minimal burden to document this information in a permit fact sheet.
The proposed paragraph (iii) would require the fact sheet to include the rationale for TBELs developed pursuant to 40 CFR 122.44(a), and an explanation of any best management practices (BMPs) required pursuant to 40 CFR 122.44(k). This explanation should include a discussion of whether any ELGs apply to the facility, and if so, which performance standard(s) (
The proposed paragraph (iv) would require documentation of the reasonable potential determination, and, where necessary, the development of WQBELs pursuant to 40 CFR 122.44(d).
The proposed paragraph (iv)(A) would require the fact sheet to describe the pollutants or pollutant parameters analyzed in order to determine a need for WQBELs. EPA's review of state-issued permits has found that even where fact sheets contained reasonable potential determinations and WQBEL calculations, they frequently contain little discussion or demonstration regarding how the permitting authority established the “pollutants of concern” list. EPA is proposing this new paragraph to ensure that the permitting authority considers and clearly identifies “pollutants of concern” for the purposes of water quality analyses, and provides a rationale for the decision reached. Permit writers already have the information that they use to identify pollutants of concern, complete a reasonable potential analysis and develop WQBELs, so this proposed revision would not impose any additional burden of collecting new information. It should be only a minimal additional burden for a permit writer to document the calculations and analyses that he or she has already conducted.
The proposed paragraph (iv)(B) would require the fact sheet to provide the ambient (receiving water) pollutant concentration data, or an explanation of why such data is not applicable or available, for pollutants granted a dilution or mixing allowance pursuant to 40 CFR 122.44(d)(1)(ii). The “background” concentration of a pollutant in the receiving water is a critical factor in determining the assimilative capacity of the receiving water. EPA's review of state-issued permits conducted over the past ten years found that fact sheets contained little information regarding background pollutant data, and little explanation regarding how permitting authorities used or did not use background data in limit calculations. This proposed requirement is intended to provide additional transparency with respect to the use of ambient pollutant concentration data in water quality assessments, reasonable potential determinations and permit limit calculations. In order to write permit limits, the permit writer would have already considered background pollutant data, so this proposed revision would not impose any additional information collection burden, and would only impose a minimal burden for documenting analyses that the permit writer has already conducted.
The proposed paragraph (iv)(C) would require that the fact sheet discuss any dilution or mixing considered in water quality evaluations or permit limit development, and where dilution or mixing were considered, how ambient (background) pollutant concentrations were considered in the water quality assessment. This requirement relates to the proposed requirement in paragraph (iv)(B) and is intended to ensure that the permitting authority has considered and justified the appropriateness of any dilution or mixing allowance consistent with provisions of state WQSs. In order to determine a mixing zone or dilution analysis, the permit writer would have already considered background pollutant data. This proposed revision would not impose any additional information collection burden, and would only impose a minimal burden for documenting analyses that the permit writer has already conducted.
The proposed paragraph (iv)(D) would require that where an EPA-approved or established TMDL has assigned a WLA to the point source, the fact sheet must describe how the permit incorporates limits and permit conditions consistent with the assumptions of any WLA assigned to the applicant/permittee discharge. This requirement is based on findings from both EPA's review of state-issued permits and a 2007 Office of Inspector General (OIG) report
The proposed paragraph (iv)(E) would require the fact sheet to provide a description of how the permit ensures compliance with applicable state narrative water quality criteria and standards, where a reasonable potential determination has been made for an excursion of narrative water quality criterion. The regulations at 40 CFR 122.44(d)(1) specifically require permits to include limits and conditions that achieve WQS, including any state narrative criteria for water quality. EPA's review of state-issued permits related to the surface coal mining sector as well as other reviews of state-issued permits informed EPA that fact sheets rarely discuss whether or how the permitting authority has assessed the need for, or developed, WQBELs or other permit conditions to ensure
Fact sheets frequently do not adequately document the antidegradation analysis to ensure that the permitting authority is meeting requirements to protect existing uses and high quality waters (where applicable). In particular, fact sheets often omit information regarding whether the permitting authority conducted a “Tier 2” review consistent with the state's antidegradation requirements in order to demonstrate that allowing a lowering of water quality was consistent with the state's antidegradation requirements. Numerous state NPDES permit challenges have raised this issue. The proposed language would ensure that the permitting authority has considered the applicable antidegradation requirements and has documented that the state's antidegradation requirements are met (
(c) EPA's review of state practices and policy has shown that the determination of monitoring location(s), the frequency at which the permit requires the permittee to sample and analyze each regulated pollutant, the sampling technique (
While current fact sheet regulations at 40 CFR 124.8(a) require development of fact sheets for draft NPDES general permits, the regulations at 40 CFR 124.56 do not include requirements specific to the contents of fact sheets for these permits. General permits are “umbrella” permits that cover classes or categories of dischargers, and are usually used when there are multiple facilities that have very similar discharges. General permits are an efficient tool used by permitting authorities to provide permit coverage for many facilities under just one permit. Fact sheets for general permits are especially essential in providing the rationale for the development of terms and conditions for general permits and provide applicants and the public with background and information on how the limits, terms and conditions in the permit were developed. Because of the unique nature of general permits, EPA believes that the regulations should describe the specific fact sheet requirements that more accurately describe and document the development of the terms and conditions of general permits.
EPA proposes the following new 40 CFR 124.56(a)(2) to address the specific information necessary to document permitting decisions for NPDES general permits. The proposed general permit fact sheet requirements closely track the general permit structure in 40 CFR 122.28.
Proposed paragraph (a)(2)(i) would require the fact sheet for a general permit to contain a description of how the issuance of the general permit meets the requirements of 40 CFR 122.28, including the geographic area of coverage: The types, classes or categories of waters to which the general permit authorizes discharge and the sources that the general permit would cover. This information would ensure that the permitting authority provides a transparent record of the types of facilities covered under the general permit and the criteria under which categories or classes of facilities were identified. Furthermore, the fact sheet would be specifically required to provide a record of decision for selecting the geographic area of coverage, including any areas or water bodies where general permit coverage is not available. In order to develop a general permit, permit writers will have already considered all of the relevant data regarding the geographic area of coverage and the kinds of facilities and discharges that the general permit covers. This proposed revision would impose no new burden on permit writers to obtain new information or conduct new analyses. It may impose only a minimal burden to document the analyses that permit writers have already conducted.
The current fact sheet regulation requires “a citation to the applicable effluent limitation guideline, performance standard, or standard for sewage sludge use or disposal as required by § 122.44.” The proposed paragraph moves the original language into paragraph 124.56(a)(2)(ii) and would not substantively change the existing requirement.
The proposed paragraph (iii) requires that the fact sheet provide the rationale for TBELs developed pursuant to 40 CFR 122.44(a), and an explanation of any BMPs required pursuant to 40 CFR 122.44(k). This explanation would include a discussion of whether any ELGs apply to the facility, and if so, which performance standard(s) (
The proposed paragraph (iv) deals with documentation of the reasonable potential determination and, where necessary, the development of WQBELs or conditions. Because general permits cover facilities that may be widely dispersed across multiple water bodies and watersheds, the water quality analysis would likely differ significantly from the site-specific type of analysis performed for an individual discharger. Therefore, fact sheet requirements must account for the unique approaches taken in general permits to ensure compliance with state WQS. However, while the approaches and rationales may differ, paragraph (iv) would require that the fact sheet provide a rationale that describes how the permit will ensure compliance with state WQS, which includes consideration of applicable state antidegradation policies and applicable WLAs from EPA-approved or established TMDLs. In order to develop WQBELs for general permits that ensure compliance with state WQS, permit writers will have already considered relevant analytical data pertaining to WQS (including antidegradation policies and requirements) and TMDLs. This proposed revision would not impose an additional burden on permit writers to collect any new data or perform additional analyses, and may impose only a minimal burden for the permit writer to document the analyses he or she has already conducted.
The proposed paragraph (v) addresses documentation of monitoring and reporting provisions of a draft NPDES general permit that current fact sheet regulations do not currently specifically address. Based on past practices and state policy, determination of monitoring location(s), the frequency at which the permit requires the permittee to sample and analyze each regulated pollutant, the sampling technique (
The proposed paragraph (vi) would require that the fact sheet provide an explanation of the administrative elements of the general permit, including the process by which a facility would seek and be granted coverage under the general permit. Where the general permit does not require a NOI, the fact sheet must also provide a description of why the NOI process is inappropriate in accordance with the criteria established in 40 CFR 122.28(b)(2)(v). Permit writers already include NOI provisions in general permits, so documenting these processes in fact sheets would not impose an additional burden on permit writers to develop a new process, and may impose only a minimal burden to document this process in the fact sheet.
EPA Requests comments on the proposed revisions to § 124.56(a).
40 CFR 124.56(b)(1) mandates an explanation of why a draft permit includes particular conditions. The proposed rule would include a requirement to provide a rationale for the use of compliance schedules in fact sheets for draft NPDES permits. In 2007, EPA addressed concerns over the use of compliance schedules in draft permits through a memorandum titled, “Compliance Schedules for Water Quality-Based Effluent Limitations in NPDES Permits” from James A. Hanlon, Director of EPA's Office of Wastewater Management, to Alexis Strauss, Water Division Director of EPA Region 9.
The current provisions of paragraph (c) require, when appropriate, a sketch or detailed description of the location of the discharge or regulated activity. The proposed rule would add to this paragraph a requirement that the fact sheet provide geographic coordinates (
With respect to NPDES general permits, locational information is generally provided through the Notice of Intent (NOI) submitted by a facility after issuance of the general permit. The fact sheet for the general permit would include a description of the geographic area within which facilities may seek coverage under the general permit. This is consistent with the existing
This revision would not increase the level of effort for permittees and would not alter the requirements for data submission as part of the permit application process. The changes also would not alter the current substantive requirements for developing NPDES permits, but rather would more clearly specify the information required for the documentation of how those requirements were developed.
EPA seeks comments on the proposed revisions to 40 CFR 124.56(b) and (c).
EPA proposes to delete 40 CFR 125.3(a)(1)(ii) from the NPDES regulations. The statutory authority supporting this provision was repealed in 1981 making this requirement no longer applicable to POTWs covered under NPDES permits. Public Law 97-117. Therefore, EPA proposes to remove this provision from the regulations in order to avoid confusion regarding its applicability.
Since EPA is removing language to be consistent with repealed statutory language, EPA is not seeking comments on the proposed removal or on the existing regulation.
This proposal involves numerous revisions to the NPDES regulations. It is EPA's view that these revisions would generally not result in a new or increased impacts or information collection by authorized states or the regulated community. EPA expects that any additional effort for documenting existing analyses and calculations would be minimal. It is also EPA's view that in some cases, these proposed revisions could reduce burden: Deleting outdated information and requirements could make it easier for the public to understand which NPDES regulations apply. The impacts assessment is provided for each topic. EPA specifically requests comments on the impacts and estimated level of effort resulting from the totality of this proposal as well as the individual requirements of the proposal.
In general, revisions may result in a state having to make statutory or regulatory revisions in order to maintain a program that is at least as stringent as the federal program. Existing Information Collection Requests (ICRs) related to the NPDES regulations account for program revisions where they are necessary because the controlling federal statutes or regulations were modified. This proposal does not impose any changes to the procedures for revising state programs at 40 CFR 123.62 and it would not result in a new or increased effort beyond what has already been accounted for in the existing ICRs.
The revision to this note is being made to inform the public of ways to contact the NPDES program and would not result in changes to the existing program or program requirements. The note in the existing regulation contains an outdated address and telephone number for the Office of Water. Providing updated information will save the permitting authorities and the public time when they seek to contact EPA about these regulations.
The proposed revisions to the NPDES program definitions at 40 CFR 122.2 for “pesticide applications to waters of the United States,” “new discharger,” “proposed permit” and “whole effluent toxicity” would not result in an increase in effort or information collection. These revisions are being made to improve programmatic clarity and would not result in substantive changes to the existing program or program requirements.
Adding a definition of “pesticide applications to waters of the United States” brings the NPDES definitions into concert with the way the PGP has been interpreting and regulating such applications since 2011. This definition would not increase burden and would not expand the universe of permittees and activities that the PGP covers.
EPA proposes correcting a typographical error in subsection (d) of this definition by changing “NDPES” to “NPDES.” This will not increase burden and will enable the public to clearly understand EPA's regulations.
It is EPA's view that the revised definition of “proposed permit” also would not add any burden. This definition would correlate with the changes EPA proposes regarding objection to administratively continued permits. EPA proposes that an administratively continued permit could be designated as “proposed” after either a two-year or five-year period following the initial five-year permit term. Under the proposed revisions, EPA could then object to these proposed permits according to the existing permit objection regulations at 40 CFR 123.44. Although this revised definition could increase the number of permits to which EPA could object, EPA does not anticipate that this revised definition would increase burden for states, permittees, or any other stakeholders. Permittees will have already submitted the required permit renewal applications in a timely manner. After EPA designates an expired, administratively continued permit as a “proposed permit,” the state NPDES permitting authority can choose to issue its own new draft permit based on the permittee's timely application, and the state permitting process would proceed as usual. If the state permitting authority were to choose not to issue its own new draft permit, EPA could issue the permit and would assume any additional workload.
The revised definition of WET would reflect current implementation practice and would impose no additional burden. The revised definition would clarify that WET includes both acute (lethal) and chronic (lethal and sublethal) WET test endpoints. As discussed in section III of this preamble, this clarification would be consistent with EPA's existing WET interpretation and implementation. Clarifying this definition would not change the existing requirement that NPDES permits include WET limits where necessary to meet state numeric and narrative water quality aquatic life protection criteria. 40 CFR 122.44(d)(1)(iv) and (v).
The proposed revision to 40 CFR 122.3(a) to remove an outdated provision related to vessel discharges would not result in an increase in effort or information collection. This proposed revision would incorporate or otherwise address CWA provisions that were enacted after the current regulations were promulgated as well as a judicial decision vacating the 40 CFR 122.3(a) exclusion for discharges incidental to the normal operation of a vessel from NPDES permitting. As a result, this proposed revision would not result in a new or increased effort and would not change the universe of permittees covered by the existing VGP.
The proposed revision to 40 CFR 122.21 related to updates and clarifications to the existing application requirements and corresponding forms would not result in an increase in effort
In 2008, EPA submitted an ICR to the Office of Management and Budget (OMB) that, in part, updated EPA's estimates for applicants to complete Forms 1, 2A, 2C-2F, and 2S and for permitting authorities to review applications for point source and sewage sludge management permits.
USEPA, “Information Collection Request (ICR) for Cooling Water Intake Structures at Phase III Facilities (Final Rule),” OMB Control No. 2040-0268, EPA ICR No. 2169.02, February 2009.
USEPA, “Information Collection Request (ICR) for Cooling Water Intake Structures Phase II Existing Facilities (Renewal),” OMB Control No. 2040-0257, EPA ICR No. 2060.03, May 2007.
USEPA, “Information Collection Request (ICR) for Cooling Water Intake Structures New Facility Rule (Renewal),” OMB Control No. 2040-0241, EPA ICR No. 1973.04, June 2008.
In the final rule, EPA will submit to OMB an updated ICR that describes the estimated effort associated with the proposed revisions made to the application regulations and forms. The changes proposed in this rule are minor, and do not change the estimated burden for completing the forms established in the existing ICRs.
The proposed revision to 40 CFR 122.44(d) would include a reference to 40 CFR 131.12 in order to ensure consistency with the state antidegradation requirements established under that section and would not result in an increase in level of effort or information collection. This addition clarifies that permitting authorities should use applicable antidegradation requirements when deriving WQBELs. All state water quality standards include antidegradation policies. EPA's longstanding policy has been that permitting authorities should develop NPDES permit terms and conditions consistent with, and in consideration of applicable state antidegradation requirements. NPDES permit writers are already required to consider how the final WQBELs established in the permit not only derive from the numeric and narrative water quality criteria, but also how they satisfy the antidegradation elements of state WQS. This would remain the case regardless of whether EPA includes this provision as a reminder. Because the NPDES regulations do not presently explicitly include this requirement, this proposal would revise the regulations at 40 CFR 122.44(d)(1) to explicitly clarify this existing assumption. This proposed revision would not result in a new or increased effort.
The proposed revisions to 40 CFR 122.44(d) specify that a dilution allowance under this paragraph must comply with applicable dilution and mixing zone requirements and low flows established in state WQS and be supported by data or analyses quantifying or accounting for the presence of each assessed pollutant or pollutant parameter in the receiving water. This proposal would not require collecting new information or conducting any new calculations, but rather is intended to ensure transparency in the permitting authority's decision to grant a dilution allowance. The information necessary to support a dilution allowance may be based on existing information, or the permitting authority may choose to ask the applicant seeking coverage for more information. This proposed revision would not require new or increased effort or costs.
The proposed revision to 40 CFR 122.44(d) specifies that a reasonable potential determination must consider applicable qualitative or quantitative data, analyses or other valid and representative information for pollutants or pollutant parameters to support the need for effluent limitations, conditions or standards. This proposal does not require collecting new information, but rather is intended to ensure that the permitting authority uses all available information when determining the need for an effluent limitation for a new discharge. In addition, the revision ensures that the permitting authority is transparent regarding the process used to make the determination by including documentation in the permit fact sheet. This proposed revision would not result in a new or increased effort.
The proposed revision to 40 CFR 122.44(l) to be consistent with CWA section 402(o) provisions regarding “anti-backsliding” from permit limitations would not result in an increase in effort or information collection. This revision would incorporate the existing statutory requirement into the regulations verbatim and would not create any new requirements or information collection burdens.
The proposed revision to 40 CFR 122.45(b) would clarify that permit effluent limitations based on technology standards for POTWs must be calculated using design flow. This revision also clarifies that the permitting authority has the flexibility to use other appropriate measures of a representative critical condition when developing effluent limitations based on WQS for a POTW. A WQBEL for a POTW could instead be based on effluent flows other than design flow (
The proposed revision to 40 CFR 123.44 to allow EPA to review an administratively continued permit as a
The proposal to revise 40 CFR 124.10(c) to allow permitting authorities to provide public notice of NPDES major individual and general permits on the permitting authority's publicly available Web site in lieu of the newspaper publication requirement would not result in an increase in effort or information collection. EPA is not proposing to alter the existing requirement related to newspaper publication, but is providing an optional provision that the permitting authority may choose at its discretion. However, to qualify for this provision, the permitting authority would be required to post the draft permit and fact sheet on the Web site during the public comment period and post the final permit and fact sheet for the entire term of the permit. The purpose of this proposed revision is to provide the permitting authority with an alternative method of providing notice of permit applications and hearings and provide flexibility to reach communities in a variety of methods. It is EPA's understanding that the traditional approach to newspaper publication has become costly for permitting authorities to implement. EPA's proposal intends to alleviate those costs by allowing the permitting authority to use its publicly available Web site in lieu of the traditional publication.
EPA estimates that public notice of draft permits in newspapers for NPDES major facilities, sewage sludge facilities and general permits currently costs approximately $1.6 million per year, nationally.
This proposed revision would not result in an increase in effort or information collection. EPA specifically seeks comments on the potential cost savings for the public notice of NPDES major individual and general permits on a publicly available Web site in lieu of the newspaper publication requirement.
The proposal to revise 40 CFR 124.55(a)(2) would broaden the circumstances under which federal NPDES permits could be modified after issuance to include conditions necessary to reflect more stringent section 401 certification provisions that result from state administrative or judicial decisions. EPA cannot predict how often this proposed provision would cause a permit to be modified. Any modifications resulting from requirements in state administrative or judicial decisions would follow EPA's existing permit modification regulations at 40 CFR 122.62. Any new permit requirements would be the result of an administrative or judicial decision and would not result directly from this proposed revision. Therefore, this proposed revision would not result in an increase in effort or information collection.
The proposal to revise 40 CFR 124.56 to require specific documentation within the fact sheet content of the individual and general permit development would not result in an increase in effort or information collection. The proposed changes to the fact sheet content requirements do not establish any permit conditions or technical or administrative analyses that are not already required by the existing regulations. The revised regulations would require the permitting authority to document NPDES permit development work that the existing regulations already require. These proposed revisions would not impose any additional burdens for collecting new data or conducting new analyses, and may impose only a minimal burden for permit writers to document analyses that have already been conducted.
The proposed deletion of 40 CFR 125.3(a)(1)(ii) from the NPDES regulations would not result in an increase in effort or information collection. By deleting this outdated provision, EPA would clarify that this provision no longer applies to regulated entities.
Following issuance of this rule, authorized states have up to one year to revise, as necessary, their NPDES regulations to adopt the requirements of this rule, or two years if statutory changes are needed, as provided at 40 CFR 123.62.
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is a “significant regulatory action” because it raises novel legal and policy issues. Accordingly, EPA submitted this action to the OMB for review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011) and any changes made in response to OMB recommendations have been documented in the docket for this action. Information regarding all statutes and executive orders discussed in this document can be found at
The changes being proposed to the applications and forms as well as all other information collection activities in this proposed rule will be submitted for approval to the Office of Management and Budget (OMB) under the PRA. The Information Collection Request (ICR) document that the EPA prepared has been assigned EPA ICR number 2529.01. You can find a copy of the ICR in the
The ICR will describe the burden and costs associated with revisions made to regulations and forms related to preparing and reviewing applications for individual NPDES permits for point source and sewage sludge management permits. These revisions were necessary to clarify NPDES definitions and application requirements, increase fact sheet and permit transparency, timeliness and environmental effectiveness, and modernize public notice methods.
The proposed revisions to 40 CFR 122.21 related to clarifications of NPDES definitions and application requirements would not result in an increase in level of effort or information collection. EPA is making revisions to several data fields on the forms to refine the content and to improve consistency with EPA's current data standards. The application forms is available in the docket for this rule. EPA estimates that the burden associated with these proposed changes would not change from the burden estimates contained in existing ICRs. This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB OMB Control No. 2040-0004, EPA ICR No. 0229.21.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9.
EPA requests comment on the impact of the specific changes set out in this proposal on NPDES application requirements, forms and other information collections. EPA also requests comment on whether and how a separate future action should address the utility and clarity of the information requests and on how to minimize the information collection burden on respondents, including the use of appropriate automated, electronic, mechanical, or other forms of information technology. Comments relating to this separate future action should be submitted to Docket ID No. EPA-HQ-OW-2016-0146 at
I certify that this action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (RFA). In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small entities subject to the rule. This proposal would eliminate inconsistencies between regulations and application forms, improve permit documentation, transparency and oversight, provide clarifications to existing regulations and delete outdated provisions. We have therefore concluded that this action would have no net regulatory burden for directly regulated small entities.
EPA continues to be interested in the potential impacts of the proposed rule on small entities and welcomes comments on issues related to such impacts.
This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This proposal would eliminate inconsistencies between regulations and application forms, improve permit documentation, transparency and oversight, provide clarifications to existing regulations and delete outdated provisions. This proposed action will not impose significant burden on EPA, states or the regulated community, or specifically, any significant burden on any small entity. With respect to any impacts on authorized state programs, the costs involved in this action are imposed only by participation in a voluntary federal program. UMRA generally excludes from the definition of “federal intergovernmental mandate” duties that arise from participation in a voluntary federal program. Thus, this proposed rule is not subject to the requirements of section 202 and 205 of the UMRA. For the same reason, EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments. Thus, this proposed rule is not subject to the requirements of section 203 of UMRA.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This proposed rule does not have tribal implications, as specified in Executive Order 13175. EPA considered the potential impacts on tribes, and concluded that there would be no substantial direct compliance costs or impact on tribes. Because the purpose of the proposed rule is to eliminate inconsistencies between regulations and application forms, improve permit documentation, transparency and oversight, provide clarifications to existing regulations, and delete outdated provisions, it is not expected to have substantial direct effects on tribal governments, on the relationship between the federal government and Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes, as specified in Executive Order 13175. Executive Order 13175 does not apply to this action and EPA determined that tribal consultation is not necessary for this action.
EPA specifically solicits input on this proposed action from tribal officials.
The proposed rule is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866 and because EPA does not believe that the environmental health and safety risks addressed by this action present a disproportionate risk to children. This proposed rule would eliminate inconsistencies between regulations and application forms, improve permit documentation, transparency and oversight, provide clarifications to existing regulations, and delete outdated provisions.
This rulemaking is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. This proposed rule would eliminate inconsistencies between regulations and application forms, improve permit documentation, transparency and oversight, provide clarifications to existing regulations, and delete outdated provisions.
This proposed rulemaking does not involve technical standards.
The EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations. This proposed rule would eliminate inconsistencies between regulations and application forms, improve permit documentation, transparency and oversight, provide clarifications to existing regulations and delete outdated provisions.
Administrative practice and procedure, Confidential business information, Environmental protection, Hazardous substances, Reporting and recordkeeping requirements, Water pollution control.
Administrative practice and procedure, Confidential business information, Hazardous substances, Indians—lands, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Water pollution control.
Administrative practice and procedure, Air pollution control, Hazardous waste, Indians—lands, Reporting and recordkeeping requirements, Water pollution control, Water supply.
Reporting and recordkeeping requirements, Waste treatment and disposal, Water pollution control.
For the reasons set out in the preamble, the EPA proposes to amend Chapter I of Title 40 of the Code of Federal Regulations as follows:
The Clean Water Act, 33 U.S.C. 1251
[
The revisions and additions read as follows:
(d) Which has never received a finally effective NPDES permit for discharges at that “site.”
(a) Any discharge of sewage from vessels and any effluent from properly functioning marine engines, laundry, shower, and galley sink wastes, or any other discharge incidental to the normal operation of:
(1) A vessel of the Armed Forces within the meaning of section 312 of the CWA; and
(2) A recreational vessel within the meaning of section 502(25) of the CWA. Until December 18, 2017, an NPDES permit is not required for a vessel that is less than 79 feet in length or a fishing vessel as defined in 46 U.S.C. 2101 except for any discharge of ballast water or any discharge in a case in which the Administrator or State, as appropriate, determines that the discharge either contributes to a violation of a water quality standard or poses an unacceptable risk to human health or the environment. None of these exclusions apply to rubbish, trash, garbage, or other such materials discharged overboard; nor to other discharges when the vessel is operating in a capacity other than as a means of transportation such as when used as an energy or mining facility, a storage facility or a seafood processing facility, or when secured to a storage facility or a seafood processing facility, or when secured to the bed of the ocean, contiguous zone or waters of the United States for the purpose of mineral or oil exploration or development.
The additions and revisions read as follows:
(a) * * *
(2) * * *
(i) All applicants for EPA-issued permits must submit applications on EPA permit application forms. More than one application form may be required from a facility depending on the number and types of discharges or outfalls found there. Application forms may be obtained by contacting: U.S. EPA, Mail Code 4203M, 1200 Pennsylvania Ave. NW., Washington, DC 20460 or by visiting
(A) All applicants, other than POTWs, TWTDS, vessels, and pesticide applicators must submit Form 1.
(c) * * *
(2) * * *
(ii) * * *
(B) The applicant's name, address, telephone number, electronic mail address and ownership status;
(f)
(2) Name, mailing address, and location, including latitude and longitude to the nearest second and method of collection, of the facility for which the application is submitted.
(3) Up to four SIC and NAICS codes that best reflect the principal products or services provided by the facility.
(4) The operator's name, address, telephone number, electronic mail address, ownership status, and status as Federal, State, private, public, or other entity.
(9) An indication of whether the facility uses cooling water and the source of the cooling water. (Facilities that use a cooling water intake structure as described at 40 CFR 125.91 must comply with requirements at 40 CFR 122.21(r)).
(10) An indication of whether the facility is requesting any of the variances at 40 CFR 122.21(m).
(g)
(1)
(7) * * *
(ix) Existing data may be used, if available, in lieu of sampling done solely for the purpose of this application. All existing data for pollutants specified in paragraphs (g)(7)(i) through (viii) of this section that is collected within four and one-half years of the application must be included in the pollutant data summary submitted by the applicant. If, however, the applicant samples for a specific pollutant on a monthly or more frequent basis, it is only necessary, for such pollutant, to summarize all data collected within one year of the application.
(h) * * *
(1)
(i) * * *
(1) * * *
(iii) Latitude and longitude of the production area (entrance to production area) to the nearest second, including method of collection;
(j) * * *
(1) * * *
(i)
(ii)
(viii) * * *
(D) * * *
(
(
(ix) An indication of whether applicant is operating under or requesting to operate under a variance as specified at 40 CFR 122.21(n).
(3) * * *
(i) * * *
(C) Latitude and longitude, to the nearest second, including the method of collection;
(4) * * *. (i) As provided in paragraphs (j)(4)(ii) through (x) of this section, all applicants must submit to the Director effluent monitoring information for samples taken from each outfall through which effluent is discharged to waters of the United States, except for CSOs. The Director may allow applicants to submit sampling data for only one outfall on a case-by-case basis, where the applicant has two or more outfalls with substantially identical effluent. The Director may also allow applicants to composite samples from one or more outfalls that discharge into the same mixing zone. For POTWs applying prior to commencement of discharge, data shall be submitted no later than 18 months after the commencement of discharge;
(5) * * *. (i) All applicants must provide an identification of any whole effluent toxicity tests conducted during the four and one-half years prior to the date of the application on any of the applicant's discharges or on any receiving water near the discharge. For POTWs applying prior to commencement of discharge, data shall be submitted no later than 18 months after the commencement of discharge.
(6) * * *
(i) Number of significant industrial users (SIUs) and non-significant categorical industrial users (NSCIUs), as defined at 40 CFR 403.3(v), including trucked or hauled waste, discharging to the POTW; and
(ii) POTWs with one or more SIUs or NSCIUs shall provide the following information for each SIU and NSCIU that discharges to the POTW:
(B) Description of all industrial processes that affect or contribute to the SIU's or NSCIU's discharge;
(C) Principal products and raw materials of the SIU that affect or contribute to the SIU's or NSCIU's discharge;
(E) Whether the SIU or NSCIU is subject to local limits;
(G) Whether any problems at the POTW (
(8) * * *
(ii) * * *
(A) * * *
(
(9)
(k)
(1)
(5) * * *
(vi) No later than 18 months after the commencement of discharge from the proposed facility, the applicant is required to complete and submit items V and VI of NPDES application Form 2C (see § 122.21(g)). However, the applicant need not complete those portions of Item V requiring tests which have already been performed and reported under the discharge monitoring requirements of the NPDES permit.
(q) * * *
(1) * * *
(i) The name, mailing address, and location, including latitude and longitude to the nearest second and method of collection, of the TWTDS for which the application is submitted;
(2) * * *
(i) The name, mailing address, telephone number, and electronic mail address,
(8) * * *
(ii) * * *
(A) The name, mailing address, and location, including the latitude and longitude to the nearest second and the method of collection, of the other facility;
(vi) If sewage sludge from the applicant's facility is provided to another “person who prepares,” as defined at 40 CFR 503.9(r), and the sewage sludge is not subject to paragraph (q)(8)(iv) of this section, the applicant must provide the following information for each facility receiving the sewage sludge:
(A) The name, mailing address, and electronic mail address of the receiving facility;
(9) * * *
(iii) * * *
(B) The site's latitude and longitude to the nearest second and method of collection;
(D) The name, mailing address, telephone number, and electronic mail address of the site owner, if different from the applicant;
(E) The name, mailing address, telephone number, and electronic mail address of the person who applies sewage sludge to the site, if different from the applicant;
(iv) * * *
(A) Whether the applicant has contacted the permitting authority in the State where the bulk sewage sludge subject to § 503.13(b)(2) will be applied, to ascertain whether bulk sewage sludge subject to § 503.13(b)(2) has been applied to the site on or since July 20, 1993, and if so, the name of the permitting authority and the name, phone number, and electronic mail address if available, of a contact person at the permitting authority;
(10) * * *
(ii) * * *
(A) The site name or number, contact person, mailing address, telephone number, and electronic mail address for the surface disposal site; and
(iii) * * *
(B) The unit's latitude and longitude to the nearest second and method of collection;
(K) * * *
(
(11) * * *
(ii) * * *
(A) The name and/or number, contact person, mailing address, telephone number, and electronic mail address of the sewage sludge incinerator; and
(iii) * * *
(B) The incinerator's latitude and longitude to the nearest second and method of collection;
(12) * * *
(i) The name, contact person, mailing address, electronic mail address, location (including latitude and longitude to the nearest second and the method of collection), and all applicable permit numbers of the MSWLF;
(13)
(r) * * *
(3) * * *
(ii) Latitude and longitude to the nearest second and the method of collection for each cooling water intake structure;
The additions and revisions read as follows:
(d) * * *
(1) Achieve water quality standards established under section 303 of the CWA, including State narrative criteria for water quality, and ensure consistency with the State antidegradation policy established under § 131.12.
(ii) When determining whether a discharge causes, has the reasonable potential to cause, or contributes to an in-stream excursion above a narrative or numeric criteria within a State water quality standard, the permitting authority shall use procedures which account for existing controls on point and nonpoint sources of pollution, the variability of the pollutant or pollutant parameter in the effluent, the sensitivity of the species to toxicity testing (when evaluating whole effluent toxicity), the use of relevant qualitative or quantitative data, analyses, or other information on pollutants or pollutant parameters to assess the need for a water quality-based effluent limitation, and where appropriate, the dilution of the effluent in the receiving water. A dilution allowance under this paragraph must comply with applicable dilution and mixing zone requirements and low flows established in State water quality standards and must be supported by data or analyses that account for the presence of each assessed pollutant or pollutant parameter in the receiving water (see fact sheet requirements at § 124.56(a)).
(vii) * * *
(C) Any dilution allowance complies with applicable dilution and mixing zone requirements and low flows established in State water quality standards and must be supported by data or analyses quantifying or accounting for the presence of each limited pollutant or pollutant parameter in the receiving water (see fact sheet requirements at § 124.56(a)).
(k) * * *
(4) * * *
Additional technical information on BMPs and the elements of BMPs is contained in the following documents: Guidance Manual for Developing Best Management Practices (BMPs), October 1993, EPA No. 833/B-93-004, NTIS No. PB 94-178324, ERIC No. W498); Storm Water Management for Construction Activities: Developing Pollution Prevention Plans and Best Management Practices, September 1992, EPA No. 832/R-92-005, NTIS No. PB 92-235951, ERIC No. N482); Storm Water Management for Construction Activities, Developing Pollution Prevention Plans and Best Management Practices: Summary Guidance, EPA No. 833/R-92-001, NTIS No. PB 93-223550; ERIC No. W139; Storm Water Management for Industrial Activities, Developing Pollution Prevention Plans and Best Management Practices, September 1992; EPA 832/R-92-006, NTIS No. PB 92-235969, ERIC No. N477; Storm Water Management for Industrial Activities, Developing Pollution Prevention Plans and Best Management Practices: Summary Guidance, EPA 833/R-92-002, NTIS No. PB 94-133782; ERIC No. W492. EPA guidance documents can be obtained through the National Service Center for Environmental Publications (NSCEP) at
(l) * * *
(2)(i) In the case of effluent limitations established on the basis of section 402(a)(1)(B) of the CWA, a permit may not be renewed, reissued, or modified on the basis of effluent guidelines promulgated under section 304(b) subsequent to the original issuance of such permit, to contain effluent limitations which are less stringent than the comparable effluent limitations in the previous permit.
(ii) In the case of effluent limitations established on the basis of section 301(b)(1)(C) or section 303(d) or (e) of the CWA, a permit may not be renewed, reissued, or modified to contain effluent limitations that are less stringent than the comparable effluent limitations in the previous permit except in compliance with paragraph (l)(3) of this section.
(iii)
(A) Material and substantial alterations or additions to the permitted facility occurred after permit issuance which justify the application of a less stringent effluent limitation;
(B)(1) Information is available which was not available at the time of permit issuance (other than revised regulations, guidance, or test methods) and which would have justified the application of a less stringent effluent limitation at the time of permit issuance; or
(2) The Administrator determines that technical mistakes or mistaken interpretations of law were made in issuing the permit under section 402(a)(1)(b);
(C) A less stringent effluent limitation is necessary because of events over which the permittee has no control and for which there is no reasonably available remedy;
(D) The permittee has received a permit modification under section 301(c), 301(g), 301(h), 301(i), 301(k), 301(n), or 316(a); or
(E) The permittee has installed the treatment facilities required to meet the effluent limitations in the previous permit and has properly operated and maintained the facilities but has nevertheless been unable to achieve the previous effluent limitations, in which case the limitations in the reviewed, reissued, or modified permit may reflect the level of pollutant control actually achieved (but shall not be less stringent than required by effluent guidelines in effect at the time of permit renewal, reissuance, or modification).
(iv)
Paragraph (2)(iii)(B)(1) of this section shall not apply to any revised waste load allocations or any alternative grounds for translating water quality standards into effluent limitations, except where the cumulative effect of such revised allocations results in a decrease in the amount of pollutants discharged into the concerned waters, and such revised allocations are not the result of a discharger eliminating or substantially reducing its discharge of pollutants due to complying with the requirements of this chapter or for reasons otherwise unrelated to water quality.
(3)(i)
(ii)
(b)
The Clean Water Act, 33 U.S.C. 1252
(k)(1) Where a State does not submit a proposed permit (or draft permit, if applicable under paragraph (j) of this section) to EPA within two years, after the expiration of the existing permit, and the permit is administratively continued under state law in accordance with § 122.6(d), EPA may, in its discretion, review the administratively continued permit as a proposed permit, in accordance with the procedures in paragraphs (a)(1) through (h)(3) of this section.
(k)(1) Where a State does not submit a proposed permit (or draft permit, if applicable under paragraph (j) of this section) to EPA within five years, after the expiration of the existing permit, and the permit is administratively continued under state law in accordance with § 122.6(d), EPA may, in its discretion, review the administratively continued permit as a proposed permit, in accordance with the procedures in paragraphs (a)(1) through (h)(3) of this section.
(2) To review an expired and administratively continued permit under this paragraph, EPA must provide the State and the permittee with written notice stating that if a proposed permit (or draft permit, if applicable under paragraph (j) of this section) is not provided within 180 days, the Regional Administrator will designate the expired permit as a proposed permit submitted to EPA for review under this section. EPA may submit this notice any time beginning two years after permit expiration.
(2) To review an expired and administratively continued permit under this paragraph, EPA must provide the State and the permittee with written notice stating that if a proposed permit (or draft permit, if applicable under paragraph (j) of this section) is not provided within 180 days, the Regional Administrator will designate the expired permit as a proposed permit submitted to EPA for review under this section. EPA may submit this notice any time beginning five years after permit expiration.
(3) If the State submits a draft or proposed permit for EPA review at any time before exclusive authority to issue the permit passes to EPA under paragraph (h) of this section, EPA will suspend its designation of the administratively continued permit as a proposed permit under this paragraph and will evaluate the proposed permit (or draft permit, if applicable under paragraph (j) of this section) submitted by the State in accordance with the procedures described in paragraphs (a)(1) through (h)(3) of this section.
(i) If the State does not reissue the permit within 180 days following completion of EPA's review of the draft or proposed permit submitted by the State in accordance with paragraph (k)(3) of this section, EPA may reinstate its designation of the administratively continued permit as the proposed permit, and the procedures and timelines established in paragraphs (a)(1) through (h)(3) of this section will proceed from the point of the suspension. EPA must provide the State and permittee written notice of this decision to reinstate the designation.
(ii) [Reserved]
The Clean Water Act, 33 U.S.C. 1253
(c) Methods (applicable to State programs, see 40 CFR 123.25 (NPDES), 145.11 (UIC), 233.26 (404), and 271.14 (RCRA)). Public notice of activities described in paragraph (a)(1) of this section shall be given by the following methods:
(2) * * *
(iv) For NPDES major permits and NPDES general permits, in lieu of the requirement to post a notice in a daily or weekly newspaper, as described in paragraph (2)(i) of this section, the Director may post all notices required by this paragraph to the permitting authority's public Web site. If the Director selects this option, in addition to meeting the requirements in § 124.10(d), the Director must post the draft permit and fact sheet on the Web site during the public comment period, and must post the final permit, fact sheet and response to comments (if any) on the Web site from the date of issuance of the permit until the permit is reissued or terminated.
The Director is encouraged to ensure that the method(s) of public notice effectively informs all interested communities and allows access to the permitting process for those seeking to participate.
(b) If there is a change in the State law or regulation upon which a certification is based, or if a court of competent jurisdiction or appropriate State board or agency stays, vacates, or remands a certification, a State which has issued a certification under § 124.53 may issue a modified certification or notice of waiver and forward it to EPA. If the modified certification or notice of
The additions and revision read as follows:
(a) Any calculations or other necessary explanation of the derivation of all effluent limitations, standards and other permit conditions specific to the permitted discharge, including sewage sludge use or disposal conditions. Where effluent limitations and conditions are carried forward from a previous permit, explanation of the basis of the existing limitations and conditions must be included in the fact sheet or administrative record for the draft permit. Where the information in paragraphs (a)(1) and (2) of this section is contained in other documents that are part of the administrative record, the fact sheet may provide a brief summary of the required information and a specific reference to the source document within the administrative record, rather than repeating the information. Where applicable, fact sheets must contain:
(1) For NPDES individual permits:
(i) A citation to the specific federal or state effluent limitation guideline, performance standard, or standard for sewage sludge use or disposal as required by § 122.44 from which effluent limitations and conditions are derived;
(ii) An identification of:
(A) The receiving water(s);
(B) The State water quality standards that apply to the receiving water(s);
(C) The CWA section 303(d)/305(b) assessment status of the receiving water(s), and;
(D) Whether a total maximum daily load has been established for any pollutant or pollutant parameter for which the receiving water(s) is listed as impaired;
(iii) An explanation and calculations for effluent limits or conditions necessary to achieve technology-based standards required by § 122.44(a) and best management practices required pursuant to § 122.44(k);
(iv) An explanation of the basis for the inclusion of requirements in addition to, or more stringent than, promulgated effluent limitations guidelines or standards consistent with § 122.44(d), including, but not limited to, a description of:
(A) How pollutants and pollutant parameters were selected for analysis for the need for effluent limitations under § 122.44(d) to achieve water quality standards, including a summary of effluent characteristics;
(B) The receiving water ambient pollutant concentration data for all pollutants for which a dilution or mixing allowance is granted pursuant to § 122.44(d)(1)(ii), or an explanation of why such data are not applicable or available;
(C) For any proposed water quality-based effluent limitation or condition required by § 122.44(d), any dilution or mixing allowance, including a discussion of how ambient pollutant concentrations were considered in the water quality analysis;
(D) If an EPA-approved or established total maximum daily load has assigned a waste load allocation to the proposed discharge, how permit effluent limitations and conditions were developed consistent with the assumptions of the waste load allocation, and; where the permitting authority determines that a discharge will cause, have a reasonable potential to cause, or contribute to an excursion above any State narrative water quality criterion, how the permit ensures compliance with applicable State narrative water quality criteria consistent with § 122.44(d)(1)(v) and (vi);
(v) For any proposed effluent limitation or condition required by § 122.44, information sufficient to ensure that the discharge is consistent with the State's antidegradation requirements; and
(vi) a discussion of the permit's monitoring and reporting requirements, including an assurance that the prescribed analytical methods meet the requirements of § 122.44(i).
(2) For NPDES general permits:
(i) A description of how the issuance of the general permit conforms with the requirements of § 122.28, including the geographic area of coverage, the types, classes, or categories of waters to which the general permit authorizes discharge, and the sources that will be covered by the general permit;
(ii) A citation to the specific federal or State effluent limitation guideline, performance standard, or standard for sewage sludge use or disposal as required by § 122.44 from which effluent limitations and conditions are derived;
(iii) A description and rationale for other requirements included in the general permit, including effluent limits or conditions necessary to achieve technology-based standards required by § 122.44(a) and best management practices required pursuant to § 122.44(k);
(iv) A description of how the general permit ensures that discharges are controlled as necessary to meet applicable State water quality standards, including consideration of State antidegradation policies and applicable waste load allocations from EPA approved or established total maximum daily loads, in accordance with the requirements of § 122.44(d);
(v) A discussion of proposed monitoring and reporting conditions, including assurance that prescribed analytical methods meet the requirements of § 122.44(i); and
(vi) A description of the Notice of Intent information and submission requirements, and the process by which the permit provides authorization to discharge or authorization to engage in sludge use and disposal practices. Where the general permit does not require a Notice of Intent, a description of why the Notice of Intent process is inappropriate in accordance with the criteria established in § 122.28(b)(2)(v).
(b)(1) * * *
(vi) Waivers from monitoring requirements granted under § 122.44(a) of this chapter; or
(vii) Compliance schedules granted under § 122.47 of this chapter.
(c) When appropriate, a sketch or detailed description of the location of each discharge or regulated activity, including the geographic coordinates, described in the application; and
The Clean Water Act, 33 U.S.C., 1251
Office for Civil Rights (OCR), Office of the Secretary, HHS.
Final rule.
This final rule implements Section 1557 of the Affordable Care Act (ACA) (Section 1557). Section 1557 prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities. The final rule clarifies and codifies existing nondiscrimination requirements and sets forth new standards to implement Section 1557, particularly with respect to the prohibition of discrimination on the basis of sex in health programs other than those provided by educational institutions and the prohibition of various forms of discrimination in health programs administered by the Department of Health and Human Services (HHS or the Department) and entities established under Title I of the ACA. In addition, the Secretary is authorized to prescribe the Department's governance, conduct, and performance of its business, including, here, how HHS will apply the standards of Section 1557 to HHS-administered health programs and activities.
Eileen Hanrahan at (800) 368-1019 or (800) 537-7697 (TDD).
This
Section 1557 of the ACA provides that an individual shall not, on the grounds prohibited under Title VI of the Civil Rights Act of 1964 (Title VI), 42 U.S.C. 2000d
Section 1557(c) of the ACA authorizes the Secretary of the Department to promulgate regulations to implement the nondiscrimination requirements of Section 1557. In addition, the Secretary is authorized to prescribe regulations for the Department's governance, conduct, and performance of its business, including how HHS applies the standards of Section 1557 to HHS-administered health programs and activities.
On August 1, 2013, the Office for Civil Rights of the Department (OCR) published a Request for Information (RFI) in the
On September 8, 2015, OCR issued a proposed rule, “Nondiscrimination in Health Programs and Activities,” in the
This final rule adopts the same structure and framework as the proposed rule: Subpart A sets forth the rule's general provisions; Subpart B contains the rule's nondiscrimination provisions; Subpart C describes specific applications of the prohibition on discrimination to health programs and activities; and Subpart D describes the procedures that apply to enforcement of the rule.
OCR has made some changes to the proposed rule's provisions, based on the comments we received. Among the significant changes are the following.
Section 92.4 now provides a definition of the term “national origin.”
OCR decided against including a blanket religious exemption in the final rule; however, the final rule includes a provision noting that insofar as application of any requirement under the rule would violate applicable Federal statutory protections for religious freedom and conscience, such application would not be required.
OCR has modified the notice requirement in § 92.8 to exclude publications and significant communications that are small in size from the requirement to post all of the content specified in § 92.8; instead, covered entities will be required to post only a shorter nondiscrimination statement in such communications and publications, along with a limited number of taglines. OCR also is translating a sample nondiscrimination statement that covered entities may use in fulfilling this obligation. It will be available by the effective date of this rule.
In addition, with respect to the obligation in § 92.8 to post taglines in at least the top 15 languages spoken nationally by persons with limited English proficiency, OCR has replaced the national threshold with a threshold
OCR has changed § 92.101 to provide that sex-specific health programs or activities are allowable only where the covered entity can demonstrate an exceedingly persuasive justification,
OCR has changed § 92.201, addressing the obligation to take reasonable steps to provide meaningful access. That section now requires the Director to evaluate, and give substantial weight to, the nature and importance of the health program or activity and the particular communication at issue to the individual with limited English proficiency, and to take into account all other relevant factors, including whether the entity has developed and implemented an effective language access plan, appropriate to its particular circumstances. The final rule deletes the specific list of illustrative factors set out in the proposed rule.
Also, OCR has changed § 92.203, addressing accessibility of buildings and facilities for individuals with disabilities, to require covered entities that were covered by the 2010 Americans with Disabilities Act (ADA) Standards for Accessible Design prior to the effective date of this final rule to comply with those standards for new construction or alterations by the effective date of the final rule. The final rule also narrows § 92.203's safe harbor for building and facility accessibility so that compliance with the Uniform Federal Accessibility Standards (UFAS) will be deemed compliance with this part only if construction or alteration was commenced before the effective date of the final rule and the facility or part of the facility was not covered by standards under the ADA. As nearly all covered entities under the final rule are already covered by the ADA standards, these changes impose a de minimis cost.
Section 92.301 has been changed to clarify that compensatory damages for violations of Section 1557 are available in administrative and judicial actions to the extent they are available under the authorities referenced in Section 1557. Finally, we have added a severability clause to § 92.2, to indicate our intention that the rule be construed to give the maximum effect permitted by law to each provision.
In responding to the comments it received on the proposed rule, OCR has provided a thorough explanation of each of these changes in the preamble. OCR has also clarified some of the nondiscrimination requirements of Section 1557 and made some technical changes to the rule's provisions. In addition, we have added some definitions to proposed § 92.4, as summarized in the preamble to this final rule.
OCR received a large number of comments asking that we categorically declare in the final rule that certain actions are or are not discriminatory. For example, some commenters asked that OCR state that a modification to add medically necessary care, or a prohibition on exclusions of medically necessary services, is never a fundamental alteration to a health plan. Similarly, other commenters asked that OCR include a statement in the final rule that an issuer's refusal to cover core services commonly needed by individuals with intellectual disabilities is discrimination on the basis of disability. Still other commenters asked that OCR state that limiting health care and gender transition services to transgender individuals over the age of 18 is discriminatory. Other commenters asked that OCR state that it is discriminatory to require individuals with psychiatric disabilities to see a mental health professional in order to continue receiving treatment for other conditions.
Many of these same commenters asked that OCR supplement the final rule with in-depth explanations and analyses of examples of discrimination. For example, several commenters asked that OCR add an example of discrimination in research trials. Similarly, many other commenters asked that OCR add an example of what they considered to be disability discrimination in health insurance practices, such as higher reimbursement rates for care in segregated settings.
OCR appreciates the commenters' desire for further information on the application of the rule to specific circumstances. OCR's intent in promulgating this rule is to provide consumers and covered entities with a set of standards that will help them understand and comply with the requirements of Section 1557. Covered entities should bear in mind the purposes of the ACA and Section 1557—to expand access to care and coverage and eliminate barriers to access—in interpreting requirements of the final rule. But we neither address every scenario that might arise in the application of these standards nor state that certain practices as a matter of law are “always” or “never” permissible. The determination of whether a certain practice is discriminatory typically requires a nuanced analysis that is fact-dependent. Nonetheless, OCR has included in the preamble a number of examples of issues and circumstances that may raise compliance concerns under the final rule.
OCR also received several comments, primarily from representatives of the insurance industry, recommending that where specific Centers for Medicare & Medicaid Services (CMS) or State requirements apply to covered entities, OCR should either (1) harmonize all standards with existing CMS rules, or (2) allow issuers to be deemed compliant with Section 1557 if they are compliant with existing Federal or State law. For example, some commenters requested that compliance with CMS regulations that pertain to qualified health plans or insurance benefit design, such as prescription drug formularies designed by a pharmacy and therapeutics committee, be deemed compliance with the final rule on Section 1557. These commenters were concerned that CMS or a State might approve a plan that OCR might later find discriminatory. The commenters sought clarification on how OCR will handle cases involving health plans regulated by multiple authorities, and suggested that a “deeming” approach would reduce confusion and avoid duplication of costs and administrative effort. Other commenters asked that compliance with language access standards promulgated by CMS or the States be deemed compliance with the final rule; those comments are discussed in more detail in the preamble at § 92.201.
OCR recognizes the efficiencies inherent in harmonizing regulations to which covered entities are subject under various laws. Indeed, entities covered under Section 1557 are likely also subject to a host of other laws and regulations, including CMS regulations, the Genetic Information Nondiscrimination Act of 2008,
That said, OCR declines to adopt a deeming approach whereby compliance with another set of laws or regulations automatically constitutes compliance with Section 1557. As to State laws, it
In § 92.1, we proposed that the purpose of this part is to implement Section 1557 of the ACA, which prohibits discrimination in certain health programs and activities on the grounds prohibited under Title VI, Title IX, the Age Act, and Section 504, which together prohibit discrimination on the basis of race, color, national origin, sex, age, or disability.
We also proposed that the effective date of the Section 1557 implementing regulation shall be 60 days after the publication of the final rule in the
The comments and our responses regarding the proposed effective date are set forth below.
For the reasons set forth in the proposed rule and considering the comments received, we are finalizing the provisions as proposed in § 92.1 with one modification. We recognize that some covered entities will have to make changes to their health insurance coverage or other health coverage to bring that coverage into compliance with this final rule. We are sensitive to the difficulties that making changes in the middle of a plan year could pose for some covered entities and are committed to working with covered entities to ensure that they can comply with the final rule without causing excessive disruption for the current plan year. Consequently, to the extent that provisions of this rule require changes to health insurance or group health plan benefit design (including covered benefits, benefits limitations or restrictions, and cost-sharing mechanisms, such as coinsurance, copayments, and deductibles), such provisions, as they apply to health insurance or group health plan benefit design, have an applicability date of the first day of the first plan year (in the individual market, policy year) beginning on or after January 1, 2017.
Section 92.2 of the proposed rule stated that Section 1557 applies to all health programs and activities, any part of which receives Federal financial assistance from any Federal agency. It also stated that Section 1557 applies to all programs and activities that are administered by an Executive Agency or any entity established under Title I of the ACA.
In paragraph (a), we proposed to apply the proposed rule, except as otherwise provided in § 92.2, to: (1) All health programs and activities, any part of which receives Federal financial assistance administered by HHS; (2) health programs and activities administered by the Department, including the Federally-facilitated Marketplaces; and (3) health programs and activities administered by entities established under Title I of the ACA, including the State-based Marketplaces.
In paragraph (b), we proposed limitations to the application of the final rule. We proposed the adoption of the existing limitations and exceptions that already, under the statutes referenced in Section 1557, govern the health programs and activities subject to Section 1557. We noted that these limitations and exceptions are found in the Age Act and in the regulations implementing the Age Act, Section 504, and Title VI, which apply to all programs and activities that receive Federal financial assistance.
In paragraph (b)(1), we proposed to incorporate the exclusions found in the Age Act, such that the provisions of the proposed rule would not apply to any age distinction contained in that part of a Federal, State, or local statute or ordinance adopted by an elected, general purpose legislative body which provides any benefits or assistance to persons based on age, establishes criteria for participation in age-related terms, or describes intended beneficiaries to target groups in age-related terms.
We invited comment on whether the regulation should include any specific exemptions for health service providers, health plans, or other covered entities with respect to requirements of the proposed rule related to sex discrimination. We stated that we wanted to ensure that the proposed rule had the proper scope and appropriately protected sincerely held religious beliefs to the extent that those beliefs may conflict with provisions of the proposed regulation. We noted that certain protections already exist with respect to religious beliefs, particularly with respect to the provision of certain health-related services; for example, we noted that the proposed rule would not displace the protections afforded by provider conscience laws,
We noted that a fundamental purpose of the ACA is to ensure that health services are available broadly on a nondiscriminatory basis to individuals throughout the country. Thus, we requested comment on any health care consequences that would ensue were the regulation to provide additional exemptions.
We also requested comment on the scope of additional exemptions, if any, that should be included and the processes for claiming them, including whether those processes should track those used under Title IX, at 45 CFR 86.12.
The comments and our responses regarding § 92.2 are set forth below.
In the alternative, commenters recommended that we collaborate with other Departments to effectuate the provisions of the final rule and ensure that other Departments enter into delegation agreements or Memoranda of Understanding that grant HHS interpretation and enforcement authority over health programs funded and administered by other Departments or that commit other Departments to move quickly to engage in their own rulemaking on Section 1557.
Most of the organizations that commented on this issue, including professional medical associations and civil rights organizations, and the overwhelming majority of individual commenters, many of whom identified themselves as religious, opposed any religious exemption on the basis that it would potentially allow for discrimination on the bases prohibited by Section 1557 or for the denial of health services to women. Several religious organizations also opposed a religious exemption, asserting that RFRA, the Federal provider conscience statutes, and State RFRA statutes, which many States have enacted, provide sufficiently strong protections for religious providers and institutions. Many commenters said that mergers of religiously-affiliated hospitals with other hospitals have deepened concerns that would be raised by providing a religious exemption, as the mergers may leave individuals in many communities with fewer health care options offering the full range of women's health services. Many commenters also pointed to the language in the majority opinion in the Supreme Court's decision in
Some religious organizations that submitted comments strongly supported a religious exemption, arguing that faith-based health care providers and employers would be substantially burdened if required to provide or refer for, or purchase insurance covering, particular services such as gender transition services. Supporters of an exemption recommended that Section 1557 incorporate the religious exemption in Title IX, which exempts educational institutions controlled by religious organizations from the prohibition of sex discrimination if the application would be inconsistent with the religious tenets of the organization.
Although some commenters urged us also to incorporate Title IX's blanket religious exemption into this final rule, we believe that applying the protections in the laws identified above offers the best and most appropriate approach for resolving any conflicts between religious beliefs and Section 1557 requirements. With regard to abortion, for example, specific ACA provisions concerning abortion will continue to control, including, but not limited to, provisions that bar qualified health plans offered through a Marketplace
In other cases, application of RFRA is the proper means to evaluate any religious concerns about the application of Section 1557 requirements. The RFRA analysis evaluates whether a legal requirement substantially burdens the exercise of religion; if so, the question becomes whether the legal requirement furthers a compelling interest and is the least restrictive means to further that interest.
We believe that the government has a compelling interest in ensuring that individuals have nondiscriminatory access to health care and health coverage and, under RFRA, would assess whether a particular application of Section 1557 substantially burdened a covered entity's exercise of religion and, if so, whether there were less restrictive alternatives available. Claims under RFRA are individualized and fact specific and we would make these determinations on a case-by-case basis, based on a thorough analysis and relying on the extensive case law interpreting RFRA standards.
We decline to adopt commenters' suggestion that we import Title IX's blanket religious exemption
First, students or parents selecting religious educational institutions typically do so as a matter of choice; a student can attend public school (if K-12) or choose a different college. In the health care context, by contrast, individuals may have limited or no choice of providers, particularly in rural areas or where hospitals have merged with or are run by religious institutions. Moreover, the choice of providers may be even further circumscribed in emergency circumstances.
Second, a blanket religious exemption could result in a denial or delay in the provision of health care to individuals and in discouraging individuals from seeking necessary care, with serious and, in some cases, life threatening results. Thus, it is appropriate to adopt a more nuanced approach in the health care context, rather than the blanket religious exemption applied for educational institutions under Title IX.
Based on the foregoing, we have included a provision in this final regulation making clear that where application of this regulation would violate applicable Federal statutory protections for religious freedom and conscience, that application will not be required. The Department also retains the discretion to provide other accommodations or exemptions where permitted by Federal law and supported by sound public policy.
Consistent with the Department's Title VI regulation,
Finally, we have added a severability clause to § 92.2, to indicate our intention that the rule be construed to give the maximum effect permitted by law to each provision. The rule provides that if a provision is held to be unenforceable in one set of circumstances, it should be construed to give maximum effect to the provision as applied to other persons or circumstances. Similarly, if a provision is held to be invalid or unenforceable, that provision should be severable from, and have no impact on the application of, the remainder of the rule. This provision is consistent with our interpretation of the Department's regulations implementing Title VI, Title IX, Section 504, and the Age Act.
For the reasons set forth in the proposed rule and considering the comments received, we are finalizing the provisions as proposed in § 92.2, with two modifications. We are adding § 92.2(b)(2), which clarifies that if an application of Section 1557 requirements or this part would violate applicable Federal statutory protections for religious freedom and conscience, application of Section 1557 is not required. In addition, we have added § 92.2(c), containing a severability clause.
In § 92.3 of the proposed rule, we proposed an explanation of the relationship of the rule to existing laws. Paragraph (a) proposed that Section 1557 is not intended to apply lesser standards for the protection of individuals from discrimination than the standards under Title VI, Title IX, Section 504, the Age Act, or the regulations issued pursuant to those laws. Consistent with the statute, paragraph (b) proposed that nothing in this part shall be interpreted to invalidate or limit the existing rights, remedies, procedures, or legal standards available to individuals aggrieved under other Federal civil rights laws or to supersede State or local laws that provide greater or equal protection against discrimination on the basis of race, color, national origin, sex, age, or disability. OCR explained that this intent is derived from Section 1557(b) of the ACA. In addition to the statutes that are cited directly in Section 1557(b), the proposed rule cited the Architectural Barriers Act of 1968,
OCR did not receive any comments on this provision. Therefore, for the reasons set forth in the proposed rule, we are finalizing the provisions as proposed in § 92.3 without modification.
In § 92.4 of the proposed rule, we set out proposed definitions of various terms. The comments and our responses regarding § 92.4 are set forth below.
For the reasons set forth in the proposed rule and considering the comments received, we are finalizing the definition of “disability” as proposed without modification.
Specifically, on February 27, 2015, the Access Board proposed to revise and update its standards for electronic and information technology developed, procured, maintained, or used by Federal agencies covered by Section 508.
For the reasons set forth above and considering the comments received, we have changed the definition of “electronic and information technology” as proposed in § 92.4 to state that it means the same as “electronic and information technology,” or any term that replaces it at 36 CFR 1194.4.
For the reasons set forth in the proposed rule and considering the comments received, we are finalizing this definition as proposed in § 92.4 with minor technical revisions for clarity and for consistency with other parts of the final rule. We are making minor technical corrections to correct the ERISA citation to read “29 U.S.C. 1191b(a)(1)”; to clarify that the term “sponsored wellness program” is an “employer-sponsored” wellness program; to add “coverage” to the term “health insurance”; and to clarify that long term care coverage or insurance is provided or administered “for the benefit of an employer's employees.”
An additional clause was added to the proposed regulatory provision, modeled on the definition of “Federal financial assistance” in the regulation implementing Title IX, which clarifies that in the educational context, Federal financial assistance includes wages, loans, grants, scholarships and other monies that are given to any entity for payment to or on behalf of students who are admitted to that entity or that are given directly to these students for payment to that entity.
That said, there are numerous ways in which health services providers are recipients in their own right, whether the Federal financial assistance they receive comes through certain Medicare payments, Medicaid payments, or other funds from the Department. Therefore, instead of falling outside of Section 1557's purview, many health care providers will be subject to Section 1557 irrespective of their relationship to issuers receiving Federal financial assistance.
Moreover, nothing in the rule authorizes qualified health plan issuers or other issuers that are covered entities to contract away their own nondiscrimination obligations. Issuers must ensure that enrollees have equal access to health services provided by their coverage without discrimination on the basis of a prohibited criterion. Thus, even if individual providers do not independently receive Federal financial assistance, an issuer maintains a duty to ensure compliance with civil rights laws with respect to the treatment of its enrollees who use its networks.
Section 1557 applies to a recipient of Federal financial assistance, whether a hospital, clinic, medical practice, or individual physician. Where, for example, a doctor is an employee of a hospital and the hospital receives Federal financial assistance, the hospital's program is the relevant health program or activity and it is the hospital that will be held accountable for discrimination under Section 1557. Where, similarly, a doctor contracts as an individual to provide health services at a free neighborhood clinic that receives Federal financial assistance, the clinic is the recipient of Federal financial assistance and liable for discrimination; the doctor is simply a contractor who is assisting the clinic in performing clinic services.
When a doctor has a private medical practice that receives Federal financial assistance, and the doctor, through her practice, works as an attending physician at a hospital, it is the medical practice that is providing the services at the hospital, and thus the practice that is liable for the discrimination.
This approach is consistent with longstanding interpretations of civil rights law and the definition of a “recipient” of Federal financial assistance in the regulations implementing Section 504, Title VI, Title IX and the Age Act.
Finally, regarding receipt of student loan payments as Federal financial assistance, we clarify that the educational institution—not the student—is the recipient of the Federal financial assistance in that circumstance. Although the money is paid directly to the student, the university or other educational institution is the intended recipient. This is consistent with longstanding regulations implementing civil rights laws.
We made two clarifying changes to the definition of Federal financial assistance. In the proposed rule, we defined Federal financial assistance in subsection (1) as any type of arrangement in which the Federal government “provides or makes available” assistance. In subsection (2), we explained that Federal financial assistance “provided or administered by the Department” includes tax credits and other subsidies under Title I of the ACA and other funds providing health insurance coverage. Because our intention was to explain further the meaning of (1) as it applies to the Department in (2), we have changed (2) to use the same terms used in (1). Thus, (2) now refers to Federal financial assistance “provided or made available” by the Department.
In addition, in the proposed rule, subsection (2) provided that “Federal financial assistance provided or administered by the Department includes all tax credits under Title I of the ACA,” as well as other funds extended by the Department for providing health coverage. Because the Department plays a role in administering tax credits under Title I of ACA but does not have primary responsibility for administering that credit, and to ensure that tax credits under Title I of the ACA are understood to be included within the definition, we have modified this subsection to state that Federal financial assistance the Department provides or makes available includes Federal financial assistance that the Department plays a role in providing or administering.
For the reasons set forth in the proposed rule and considering the comments received, we are finalizing this definition as proposed in § 92.4 with two modifications. The language of Subsection (2) of the definition has been modified to state that Federal financial assistance the Department provides or makes available includes Federal financial assistance that the Department plays a role in providing or administering.
For the reasons set forth in the proposed rule and considering the comments received, we are finalizing the definition as proposed in § 92.4 with three modifications. The first sentence of the definition of gender identity has been revised to reference the application of the rule to individuals with non-binary gender identities. OCR also made a technical edit to the last sentence to delete reference to the term “transgender identity.” Finally, for clarity and consistency within the final rule, OCR has made a technical revision to the definition of gender identity to clarify that a transgender individual is an individual whose gender identity is different from the sex assigned to that person at birth.
In the proposed rule, OCR stated that we intended the plural “health programs or activities” used in this part to have the same meaning as the term “health program or activity” in the singular. Similarly, we noted that the proposed part's use of “health programs and activities,” a variation of “health program or activity,” does not reflect a change in the substance of the definition of “health program or activity.”
We proposed to interpret “health programs and activities” to include programs such as health education and health research programs. Because Federal civil rights laws already prohibit discrimination on the basis of race, color, national origin, disability, or age in all health research programs and activities that receive Federal financial assistance and prohibit discrimination on the basis of sex in all health research programs conducted by colleges and universities, we determined that the application of Section 1557 to health research should impose limited additional burden on covered entities.
However, OCR recognized that health research is conducted to answer scientific questions and improve health through the advancement of knowledge; it is not designed to result in direct health benefits to participants. We also recognized that research projects are often limited in scope for many reasons, such as the principal investigator's scientific interest, funding limitations, recruitment requirements, and other nondiscriminatory considerations. Thus, we noted that criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
We invited comment on programs and activities that should be considered health programs or activities.
Although the definition does not and could not specifically identify all health programs and activities covered by the rule (for example, we do not specifically mention programs that provide physical and/or behavioral health services, although they are health programs), we are adding the Children's Health Insurance Program and the Basic Health Program as additional examples, given their significance.
We decline to include “all the operations of Medicare” in the definition of health program or activity. While we agree that all parts of the Medicare program are a health program or activity, not all operations in the Medicare program constitute Federal financial assistance; as discussed above, Medicare Part B is excluded from the definition of Federal financial assistance under this rule and other HHS civil rights authorities.
This approach is consistent with the approach Congress adopted in the CRRA, which amended the four civil rights laws referenced in Section 1557 and defines “program or activity” to mean “all of the operations of . . . an entire corporation, partnership, or other private organization, or an entire sole proprietorship . . . which is principally engaged in the business of providing,” among other things, a range of social and health services. The CRRA establishes that the entire program or activity is required to comply with the prohibitions on discrimination if any part of the program or activity receives Federal financial assistance. The CRRA has been consistently applied since its enactment in 1988, and we believe that Congress adopted a similar approach with respect to the scope of health programs and activities covered by Section 1557. If any part of a health care entity receives Federal financial assistance, then all of its programs and activities are subject to the discrimination prohibition.
For the reasons set forth in the proposed rule and considering the comments received, we are modifying the definition as proposed in § 92.4 to include the Children's Health Insurance Program and the Basic Health Program as additional examples of a health program or activity.
Commenters addressing this definition overwhelmingly supported its codification from the HHS LEP Guidance to regulatory text. We did not receive suggested revisions to the wording of this definition.
For the reasons set forth in the proposed rule and considering the comments received, we are finalizing this definition as proposed in § 92.4, without modification.
We did not receive suggested revisions to the wording of this definition. Comments we received on the specific types of language assistance services mentioned in the definition are addressed in the relevant portions of the preamble to § 92.4 for those respective terms.
For clarity and consistency within the final rule, we are replacing several phrases in this definition with other terms to conform to changes made in other provisions of the final rule. First, in paragraph (1) regarding oral language assistance, we are adding the words “for an individual with limited English proficiency” after “qualified interpreter” because § 92.4 now defines “qualified interpreter for an individual with limited English proficiency” separately from a “qualified interpreter for an individual with a disability.” Also, because § 92.4 defines “qualified bilingual/multilingual staff,” we are replacing “bilingual or multilingual staff competent to communicate, in non-English languages using any necessary specialized vocabulary” with “the use of qualified bilingual/multilingual staff to communicate.” In paragraph (2) regarding written translation, we are replacing the reference to written translation of “documents and Web sites” to “written content in paper or electronic form.” Finally, because § 92.4 defines “qualified translator,” we are adding “performed by a qualified translator” after “written translation.”
For the reasons set forth in the proposed rule and considering the comments received, we are finalizing the definition as proposed in § 92.4 with technical revisions, as described in the preceding paragraph, to ensure consistency with other provisions of the final rule.
By contrast, we decline to include the term “immigration status” in the definition of “national origin.” An individual's national origin is not the same as her citizenship or immigration status, and neither Title VI nor Section 1557 explicitly protects individuals against discrimination on the basis of citizenship or immigration status. However, as under Title VI, Section 1557 and this part protect individuals present in the United States, whether lawfully or not, who are subject to discrimination based on race, color, national origin, sex, age, or disability. Moreover, OCR considers an immigrant or noncitizen to state a cognizable national origin discrimination claim under Title VI,
For the reasons set forth above and considering the comments received, we are defining the term “national origin” in § 92.4 to include an individual's manifestation of the physical, cultural, or linguistic characteristics of a national origin group as well as an individual's or her ancestor's place of origin.
We noted that Section 1557 extends the grounds for discrimination found in the nondiscrimination laws cited in the statute (
We noted that the proposed inclusion of sex stereotyping reflects the Supreme Court's holding in
We proposed that discrimination on the basis of sex further includes discrimination on the basis of gender identity. We noted that like other Federal agencies,
OCR stated that as a matter of policy, we also support banning discrimination in health programs and activities on the basis of sexual orientation. We noted that current law is mixed on whether existing Federal nondiscrimination laws prohibit discrimination on the basis of sexual orientation as a part of their prohibitions on sex discrimination. However, we further noted that a recent U.S. EEOC decision,
We proposed that the final rule reflect the current state of nondiscrimination law, and we sought comment on the best way of ensuring that this rule includes the most robust set of protections supported by the courts on an ongoing basis.
Additionally, the final rule balances an individual's right to access health programs and activities free from discrimination with protections for religious beliefs and practices. As we explained in the preamble to the proposed rule and have reiterated here, this rule does not displace existing protections afforded by, for example, Federal provider conscience laws and RFRA. Again, with respect to concerns about potential conflicts between provisions of the final rule and individuals' or organizations' sincerely held religious beliefs, we refer to the discussion at § 92.2 in this preamble. With respect to abortion, moreover, nothing in Section 1557 displaces the ACA provisions regarding abortion, including but not limited to the provision that no qualified health plan offered through a Marketplace may discriminate against an individual health care provider or health care facility because of its unwillingness to provide, pay for, provide coverage of, or refer for abortions;
Conversely, a few commenters opined that the inclusion of gender identity discrimination as a form of discrimination on the basis of sex was based on erroneous interpretations of Title IX legislative history because Congressional intent to ban sex discrimination was based only on the biological classifications of males and females, not gender identity. A few commenters thought that OCR's reliance on previously adopted Federal agencies' interpretations was weak and unpersuasive and that the reliance on cases arising under Federal civil rights laws other than Title IX was misplaced, further pointing to a few recent court decisions under Title IX that rejected claims that discrimination on the basis of sex includes discrimination on the basis of gender identity.
A few commenters also suggested that the inclusion of “gender identity” as a prohibited basis of discrimination on the basis of sex may infringe upon individual patients' constitutional right to privacy by requiring those patients to participate in sex-specific programs or activities with a “non-biological” male or female and additionally contravenes employees' and faith-based organizations' religious beliefs by forcing them to participate in services affirming gender identity in violation of their religious convictions.
OCR also believes that its inclusion of gender identity is well grounded in the law and disagrees with those commenters who argued to the contrary. As the Supreme Court made clear in
OCR's approach accords with well-accepted legal interpretations adopted by other Federal agencies and courts.
The fact that there may be circumstances in which it is permissible to make sex-based distinctions is not a license to exclude individuals from health programs and activities for which they are otherwise eligible simply because their gender identity does not align with other aspects of their sex, or with the sex assigned to them at birth. The Department has a responsibility to ensure that health programs and activities of covered entities are carried out free from such discrimination.
To the extent that privacy considerations may be relevant in an anti-discrimination analysis, OCR will consider these interests in the context of individual complaints. We note, however, that at least one court has rejected a claim that an individual's legal right to privacy is violated simply by permitting another person access to a sex-specific program or facility that corresponds to their gender identity.
The preamble to the proposed rule stated our policy position and noted that “[t]he final rule should reflect the current state of nondiscrimination law, including with respect to prohibited bases of discrimination” while seeking comment on the issue. While the preamble observed that no Federal appellate court has concluded to date “that Title IX's prohibition of discrimination `on the basis of sex'—or Federal laws prohibiting sex discrimination more generally—prohibits sexual orientation discrimination,” it also noted recent court decisions that have prohibited discrimination in cases involving allegations of discrimination relating to an individual's sexual orientation on the grounds that such discrimination is discrimination on the basis of sex stereotyping.
Based on this understanding, some courts have recognized in the wake of
In addition, in
For all of these reasons, OCR concludes that Section 1557's prohibition of discrimination on the basis of sex includes, at a minimum, sex discrimination related to an individual's sexual orientation where the evidence establishes that the discrimination is based on gender stereotypes. Accordingly, OCR will evaluate complaints alleging sex discrimination related to an individual's sexual orientation to determine whether they can be addressed under Section 1557.
OCR has decided not to resolve in this rule whether discrimination on the basis of an individual's sexual orientation status alone is a form of sex discrimination under Section 1557. We anticipate that the law will continue to evolve on this issue, and we will continue to monitor legal developments in this area. We will enforce Section 1557 in light of those developments and will consider issuing further guidance on this subject as appropriate.
For the reasons set forth in the proposed rule and considering the comments received, we are finalizing this definition as proposed in § 92.4 without modification.
For the reasons set forth above and considering the comments received, we are defining the term “qualified bilingual/multilingual staff” in § 92.4 to clarify that such an individual must be proficient in speaking and understanding both spoken English and at least one other spoken language, including any necessary specialized vocabulary, terminology and phraseology, and must be able to effectively, accurately, and impartially communicate directly with individuals with limited English proficiency in their primary languages.
We proposed that the definition of “qualified interpreter” includes criteria regarding interpreter ethics, including maintaining client confidentiality. As we stated in the proposed rule, bilingual or multilingual staff members may not possess competence in the skill of interpreting nor have knowledge of generally accepted principles of interpreter ethics. A qualified bilingual/multilingual nurse who is competent to communicate in Spanish directly with Spanish-speaking individuals may not be a qualified interpreter for an individual with limited English proficiency if serving as an interpreter would pose a conflict of interest with the nurse's treatment of the patient.
Second, there are several organizations, both for-profit and non-profit, that offer certification programs for interpreters. Even if the credentialing standards developed by those organizations currently satisfy Section 1557 requirements, the organizations' standards are subject to change and there is no assurance that such standards would consistently meet the standards of Section 1557. In addition, other national credentialing organizations could be established whose standards failed to meet the requirements of the law. Similar issues with respect to new and changing standards could also arise in the State licensing context.
Third, there are factors unrelated to credentials that could cause OCR to determine that an interpreter is unqualified. For example, if an interpreter has not practiced in a long time or is late to appointments, the interpreter might be unqualified regardless of the interpreter's State or non-profit credentials. For all of these reasons, we decline to amend the definition of qualified interpreter in the ways these commenters proposed.
For the reasons set forth above and considering the comments received, we no longer define “qualified interpreter” as one term. We are using the content from proposed paragraphs (1), (1)(i), and (2) to create a separate definition for “qualified interpreter for an individual with a disability” and similarly use the content from proposed paragraphs (1) and (1)(ii) to create a separate definition for “qualified interpreter for an individual with limited English proficiency.” For both definitions, we added “terminology and phraseology” to the lexicon a qualified interpreter in both contexts must possess.
For the reasons set forth above and considering the comments received, we are defining the term “qualified translator” in § 92.4 to set out the competencies an individual must have to translate written content in paper or electronic form in the covered entity's health programs or activities.
Several commenters suggested that OCR clarify the definition of “sex stereotypes” to address the relationship between sex stereotypes and sexual orientation. In this regard, commenters suggested that OCR revise the definition of “sex stereotypes” to add that “sex-stereotypes also include gendered expectations related to the appropriate roles of men and women, such as the expectation that women are primary caregivers, and aspects of an individual's sexual orientation, such as the sex of an individual's sexual or romantic partners.”
For the reasons set forth in the proposed rule and considering the comments received, we are finalizing the definition as proposed in § 92.4 with the following modifications: We have clarified that sex stereotypes can be based on expectations about gender roles.
For the reasons set forth in the proposed rule and considering the comments received, we are finalizing this definition as proposed in § 92.4 without modification.
In § 92.5, we proposed that each entity applying for Federal financial assistance, each issuer seeking certification to participate in a Health Insurance Marketplace
The comments and our responses regarding § 92.5 are set forth below.
For the reasons set forth in the proposed rule and considering the comments received, we are finalizing the provisions proposed in § 92.5 without modification.
In § 92.6, we proposed provisions addressing remedial action and voluntary action by covered entities. In paragraph (a), we proposed that a recipient or State-based Marketplace
The comments and our responses regarding § 92.6 are set forth below.
For the reasons set forth in the proposed rule and considering the comments received, we are finalizing the provisions as proposed in § 92.6 without modification.
In § 92.7, we proposed requirements for each covered entity that employs 15 or more persons to designate a responsible employee to coordinate the entity's compliance with the rule and adopt a grievance procedure. Many entities covered by Section 1557 and this part are already required to designate a compliance coordinator and have a written process in place for handling grievances with respect to disability discrimination in all programs and activities or sex discrimination in education programs or activities.
In paragraph (a), we proposed that a covered entity that employs 15 or more persons be required to designate at least one employee to coordinate compliance with the requirements of the rule. We noted that a covered entity that has already designated a responsible employee pursuant to the regulations implementing Section 504 or Title IX may use that individual to coordinate its efforts to comply with Section 1557.
In paragraph (b), we proposed that a covered entity that employs 15 or more persons be required to adopt a grievance procedure that incorporates appropriate due process standards and allows for the prompt and equitable resolution of complaints concerning actions prohibited by Section 1557 and this part. We noted that a covered entity that already has a grievance procedure addressing claims of disability discrimination that meets the standards established under the Section 504 regulation may use that procedure to address disability claims under Section 1557. In addition, we noted that covered entities may use that procedure to address all other Section 1557 claims, provided that the entity modifies the procedure to apply to race, color, national origin, sex, and age discrimination claims.
We proposed that for the Department, including Federally-facilitated Marketplaces, OCR will be deemed the responsible employee. In addition, we proposed that OCR's procedures for addressing complaints of discrimination on the grounds protected under Section 1557 will be deemed grievance procedures for the Department, including for the Federally-facilitated Marketplaces.
In the proposed rule, OCR invited comment on whether all covered entities, not only those that employ 15 or more persons, should be required to designate responsible employees and establish grievance procedures.
The comments and our responses regarding § 92.7 are set forth below.
In addition, we disagree with commenters that proposed § 92.7 is costly, limits covered entities' flexibility, or conflicts with existing internal or State-mandated grievance procedures. As we stated in the proposed rule, recipients of Federal financial assistance with 15 or more employees, as well as the State-based Marketplaces, could increase the responsibilities of an already-designated coordinator to include the coordination of compliance with Section 1557 and this part.
Some commenters observed that the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule already requires many entities covered by Section 1557 and this part to implement grievance policies and identify compliance coordinators, regardless of the number of employees of the entity.
Conversely, some commenters suggested that compliance with § 92.7 would be too time consuming and costly for covered entities with fewer than 15 employees. These commenters explained that due to the small number of employees, small covered entities may have difficulty identifying an unbiased third-party employee to investigate and respond to grievances. For instance, commenters noted that it is not uncommon for the chief physician or other professional to serve as the compliance coordinator for a small covered entity, but that such a role would be inappropriate if that individual was the subject of a grievance. These commenters also observed that requiring a covered entity to handle internal grievances under Section 1557 might expose the entity to the risk of civil liability, because Section 1557 allows for private enforcement. These commenters recommended that OCR allow small covered entities flexibility in determining when to defer to outside counsel or other independent, unbiased third parties to address grievances and thus mitigate their liability risk.
Although we decline to extend the requirement of § 92.7 to covered entities with fewer than 15 employees, nothing in the final rule bars a covered entity with fewer than 15 employees from designating an employee to coordinate compliance with Section 1557 and this part or from adopting and implementing a grievance procedure. As we stated in the proposed rule, in OCR's experience, the presence of a coordinator and grievance procedure enhances the covered entity's accountability and helps bring concerns to prompt resolution, oftentimes prior to an individual bringing a private right of action.
For the reasons described in the proposed rule and considering the comments received, we are finalizing the provisions as proposed in § 92.7 with one technical modification in § 92.7(a): We replaced the reference to the “Office for Civil Rights” with “Director,” as § 92.4 defines “Director” to mean the Director of the Department's OCR. We have also added a sample grievance procedure as Appendix C to the final rule to provide covered entities an example of a grievance procedure that meets the requirements of § 92.7(b).
In § 92.8, OCR proposed that each covered entity take initial and continuing steps to notify beneficiaries, enrollees, applicants, or members of the public of individuals' rights under Section 1557 and this part and of covered entities' nondiscrimination obligations with respect to their health programs and activities. We modeled this section generally after the notice requirements found in regulations implementing Title VI, Title IX, Section 504, and the Age Act, which require covered entities to have a notice in place.
Paragraphs (a)(1)-(7) of proposed § 92.8 identify the components of the notice. Specifically, paragraph (a)(1) proposed that the notice include that the covered entity does not discriminate on the basis of race, color, national origin, sex, age, or disability.
Paragraph (a)(2) proposed that the notice include a statement that the covered entity provides auxiliary aids and services, free of charge, in a timely manner, to individuals with disabilities, when such aids and services are necessary to provide an individual with a disability an equal opportunity to benefit from the entity's health programs or activities. Paragraph (a)(3) proposed that the notice state that the covered entity provides language assistance services, free of charge, in a timely manner, to individuals with limited English proficiency, when those services are necessary to provide an individual with limited English proficiency meaningful access to a covered entity's health programs or activities.
Paragraph (a)(4) proposed that the notice include information on how an individual can access the aids and services referenced in (a)(2) and (a)(3).
Paragraph (a)(5) proposed that the notice provide contact information for the responsible employee coordinating compliance with Section 1557 and this part, where such a responsible employee is required by § 92.7(a).
Paragraph (a)(6) proposed that the notice state that the covered entity has a grievance procedure where such a grievance procedure is required by § 92.7(b), and information on how to file a grievance.
Paragraph (a)(7) proposed that the notice provide information on how to file a complaint with OCR. We noted that inclusion of this requirement ensures that covered entities inform individuals about the enforcement mechanisms outside of the covered entity's internal process.
Proposed paragraph (b) stated that within 90 days of the effective date of this part, each covered entity shall post the notice required in § 92.8(a) in English, consistent with paragraph (f) of this section.
Paragraph (c) proposed that the Director shall make available a sample notice. We provided that covered
OCR invited comment on whether the proposed rule should permit covered entities to combine the content of the notice with the content of other notices that covered entities may be required to disseminate or post under Federal laws. OCR further invited comment on what steps covered entities may or should take to ensure that notices that combine the content required in § 92.8(a)(1)-(7) with other required notices do so without compromising the intent of § 92.8 to inform individuals of their civil rights under Section 1557 and this part. OCR also invited comment on whether the final rule should allow the notice to be modified for publications and other communication vehicles that may not have sufficient space to accommodate the full notice.
Paragraph (c) also proposed that the Director shall translate the sample notice into the top 15 languages spoken by individuals with limited English proficiency nationally and make the translated notices available to covered entities electronically and in any other manner the Director determines appropriate. We encouraged covered entities to post one or more of the translated notices that the Director provides and to make the notice available in non-English languages other than those provided by the Director. OCR sought comments on requiring, rather than merely encouraging, covered entities to post one or more of the notices in the most prevalent non-English languages frequently encountered by covered entities in their geographic service areas.
With regard to the proposal that the Director provide translations of the sample notice, we described that we selected the top 15 languages spoken by individuals with limited English proficiency nationally as a data driven policy.
Paragraph (d) proposed that within 90 days of the effective date of this part, each covered entity shall post, consistent with paragraph (f) of this section, taglines in at least the top 15 languages spoken nationally by individuals with limited English proficiency. We requested comment on a sample tagline in Appendix B to the proposed rule.
Paragraph (e) proposed that the Director shall make available taglines in the top 15 languages spoken nationally by individuals with limited English proficiency for use by covered entities. OCR proposed this approach to maximize efficiency and economies of scale by enabling covered entities to receive the benefits of having multi-language taglines available without incurring the associated translation costs.
In paragraph (f), we proposed that covered entities must post the English-language notice required in § 92.8(a) and taglines required in § 92.8(d) in a conspicuously-visible font size in: Significant publications or significant communications targeted to beneficiaries, enrollees, applicants, or members of the public, which may include patient handbooks, outreach publications, or written notices pertaining to rights or benefits or requiring a response from an individual; in conspicuous physical locations; and in a conspicuous location on the home page of a covered entity's Web site. We sought comment on the scope of significant publications and significant communications.
We noted that covered entities that distribute significant publications or significant communications will need to update these publications to include the notice required in § 92.8(a) and taglines required in § 92.8(d). However, we proposed allowing entities to exhaust their current stock of hard copy publications rather than requiring a special printing of the publications to include the new notice.
We stated that covered entities may satisfy the requirement to post the notice on the covered entity's home page by including a link in a conspicuous location on the covered entity's home page that immediately directs the individual to the content of the notice elsewhere on the Web site. Similarly, we stated with regard to the requirement to post taglines that covered entities can comply by posting “in language” Web links, which are links written in each of the 15 non-English languages posted conspicuously on the home page that direct the individual to the full text of the tagline indicating how the individual may obtain language assistance services. For instance, a tagline directing an individual to a Web site with the full text of a tagline written in Haitian Creole should appear as “Kreyòl Ayisien” rather than “Haitian Creole.”
In the proposed rule, we invited comment on a State-based methodology for identifying the languages in which covered entities would be required to post taglines and for which the OCR Director would be required to translate the notice. We explained that the top 15 languages spoken by individuals with limited English proficiency nationally can differ from the languages spoken most frequently by individuals within the areas served by covered entities' health programs and activities. Thus, we invited comment on a requirement for entities to make taglines available in the top 15 languages spoken State-wide, rather than nationwide, by individuals with limited English proficiency. This threshold aligns with Federal regulations governing the Health Insurance Marketplaces and qualified health plan issuers.
To reduce the burden on covered entities, proposed subsection (g) of this section stated that a covered entity's compliance with § 92.8 satisfies the notice requirements under HHS's Title VI, Section 504, Title IX, and Age Act regulations. We requested comment on this proposal.
The comments and our responses regarding § 92.8 are set forth below.
We have revised § 92.8(a)(3) to list examples of language assistance services to parallel § 92.8(a)(2), which lists examples of auxiliary aids and services. We decline to modify the standards in paragraphs (a)(2) and (a)(3) because “meaningful access” is not the proper standard used in Section 504 for ensuring effective communication for individuals with disabilities.
Finally, as we stated in the proposed rule, Appendix A to part 92 is a sample notice. Covered entities are free to draft their own notices that convey the content in § 92.8(a)(1)-(7).
Some commenters expressed concern that posting the notice and the taglines in a “conspicuously-visible font size” as proposed in § 92.8(f)(1) and a “conspicuous physical location” as proposed in § 92.8(f)(1)(ii) would occupy prohibitive amounts of space for covered entities operating in small physical spaces, such as pharmacies. These commenters suggested that OCR permit covered entities operating in smaller physical spaces to post taglines in fewer than 15 non-English languages. Other commenters requested clarification from OCR on what constitutes a “conspicuous physical location” in § 92.8(f)(ii) and “conspicuously visible font size” in § 92.8(f)(1).
A number of commenters recommended that the final rule require covered entities to post the notice of individuals' rights—and not just taglines—in non-English languages.
For instance, we will permit covered entities to combine the content of the notice in § 92.8(a)(1)-(7) with the content of other notices, such as notices required under other Federal civil rights laws. The content of the combined notice still must clearly convey the information required in § 92.8 (a)(1)-(7) and must separately meet any applicable notice requirements under relevant legal authorities. For instance, the regulations implementing Title IX and Section 504 require that a recipient provide a notice of individuals' rights to employees and applicants for employment.
Specifically, § 92.8(h) now clarifies that covered entities may combine the content of the notice in § 92.8(a)(1)-(7) with the content of other notices as long as the combined notice clearly informs individuals of their civil rights under Section 1557 and this part. In addition to having flexibility with respect to combining notices, covered entities also have flexibility in determining the exact size and location of notices and taglines within their facilities as long as they do not compromise the intent of § 92.8 to clearly inform individuals of their civil rights under Section 1557 and this part.
The touchstone by which we will assess whether a covered entity's provision of notice and taglines is effective is whether the content is sufficiently conspicuous and visible that individuals seeking services from, or participating in, the health program or activity could reasonably be expected to see and be able to read the information.
Although we encourage covered entities to post the notice of individuals' rights in one or more of the most prevalent non-English languages frequently encountered by covered entities in their geographic service areas, we decline to require such posting in the final rule because of the resource burdens and opportunity costs to covered entities. Posted taglines sufficiently alert individuals to the language assistance services available and appropriately balance the educational value of the notices with the burdens to covered entities.
Given that we are not requiring covered entities to post notices in non-English languages, having taglines available in multiple languages is even more important to provide notice to individuals with limited English proficiency of the availability of language assistance services. Thus, we decline to reduce the number of languages in which taglines are required to appear, even for covered entities operating in smaller physical spaces. Covered entities have flexibility in determining the exact size and location of notices and taglines as long as they meet the requirements of this section.
In addition, we decline to authorize placement of taglines on the inside of an envelope. Such a placement would diminish the visibility of the taglines, downgrade their importance, and fail to adequately notify individuals because envelopes are generally torn open and then discarded.
With respect to use of an icon, we appreciate the commenters' suggestion and believe that it may hold promise in the future. However, we also decline to require the use of an icon in the final rule. At this point in time, use of an icon alone would not provide consumers with sufficient notice of the availability of language assistance services, which is the intent of § 92.8(d).
Other commenters opposed any exceptions for significant publications and significant communications that are small-sized, given the importance of notifying individuals about their rights under Section 1557, such as how to obtain auxiliary aids and services for individuals with disabilities and how to obtain language assistance services for individuals with limited English proficiency.
We disagree, however, with fully exempting significant publications and significant communications that are small-sized from the notice and tagline requirements because these documents, such as tri-fold brochures, pamphlets, and postcards, often serve as a gateway for an individual to apply for, or participate in, a particular health program or activity. To this end, the final rule establishes a separate requirement for small-sized significant publications and significant communications: A covered entity must include a nondiscrimination statement in lieu of the full notice, and taglines in two non-English languages in lieu of all 15 taglines, on small-size significant publications and significant communications.
Specifically, we moved most of the text from proposed paragraph (b) into a new paragraph (b)(1) and added paragraph (b)(2), which addresses the obligation to post a nondiscrimination statement that conveys the information in § 92.8(a)(1) on small-sized significant publications and significant communications. Similarly, we moved most of the text from proposed paragraph (d) into a new paragraph (d)(1) and added paragraph (d)(2), which addresses the obligation to post taglines in at least the top two languages spoken by individuals with limited English proficiency in the relevant State or States on small-size significant publications and significant communications. Finally, we re-designated proposed paragraph (g) as paragraph (h) and we added new paragraphs (g)(1)-(2) to address the posting standards applicable to small-sized significant publications and significant communications.
In choosing a lower threshold than at least the top 15 languages spoken by
In addition, we have added a sample nondiscrimination statement in Appendix A that conveys the information in § 92.8(a)(1), for which the Director will also provide translations. Accordingly, we have modified paragraph (c) of § 92.8 to state that the Director will provide translations of the sample nondiscrimination statement. The translations of the sample notice and sample nondiscrimination statement are for covered entities' discretionary use only—the final rule does not require the posting of the notice or nondiscrimination statement in non-English languages.
Most commenters disfavoring a national methodology recommended that the languages in which covered entities must post taglines should be the top 15 languages spoken State-wide by individuals with limited English proficiency. Commenters explained that the State-wide threshold would be more attuned to the diversity of languages spoken by individuals with limited English proficiency in each State and would align with Federal regulations governing the Marketplaces and qualified health plan issuers.
Other commenters recommended other approaches, such as requiring taglines in languages in which at least 10% of individuals with limited English proficiency county-wide are exclusively literate,
We adopt a State-based approach for three main reasons. First, a State-based methodology is more attuned to the diversity of languages spoken by individuals with limited English proficiency and thus provides notice to more individuals with limited English proficiency.
Second, this State-wide approach better harmonizes with the number of languages in which taglines must be provided by Marketplaces and qualified health plan issuers under 45 CFR
Third, a county-level approach is impractical because detailed language data are not available for counties with populations of less than 100,000. For counties with populations of at least 100,000 for which detailed language data are available, there are limited data for individuals who speak English less than “very well” and speak a non-English language other than Spanish.
With regard to the data used to identify the languages under the State-based methodology in which the Director will translate the sample notice, sample nondiscrimination statement, and taglines, as required by § 92.8(c) and (e) of the final rule, we rely on the most recent bundled and unbundled five-year
We intend the threshold's application in § 92.8(d)(1)-(2), which applies to the “relevant State or States,” to permit covered entities that serve individuals in more than one State
We reiterate, however, that the requirements of § 92.8(d)(1)-(2) establish a floor; covered entities are free to include taglines in additional languages beyond 15 languages. For instance, a covered entity that has chosen to aggregate languages may choose to post taglines in all languages on the aggregated list rather than posting just the top 15 languages. Moreover, a covered entity that that operates health programs in multiple States or that administers a health program with a multi-State service area may decide not to aggregate. Instead, the entity may choose to tailor the taglines posted in its physical locations for the specific State in which the physical location exists; similarly, the entity may choose to tailor the taglines on a certain significant communication based on the State in which an individual with limited English proficiency, with whom the entity communicates, lives.
In addition, we note that complying with § 92.8(d)(1)-(2) is not a substitute for complying with the prohibition of national origin discrimination as it affects individuals with limited English proficiency under Section 1557 or this part, including the general nondiscrimination provisions in § 92.101 and the meaningful access provisions in § 92.201 of this final rule. Thus, although this section identifies the languages in which covered entities must post taglines, it does not relieve those entities of the separate obligation to take reasonable steps to provide meaningful access to individuals with limited English proficiency who communicate in other languages.
Although the law requires that individuals receive sufficient notice of language assistance services available to assist individuals with limited English proficiency in understanding the content of a covered entity's Web site, we believe that the use of in-language links permitted under this provision of the proposed rule is the approach that best balances notice to individuals against burden to covered entities.
Other commenters were concerned about OCR's statement in the preamble of the proposed rule that OCR intended the scope of “significant publications and significant communications” to include not only documents meant for the public but also individual letters or notices to an individual, such as a letter to a consumer notifying the individual of a change in benefits. These commenters observed that, pursuant to existing Federal and State law, many letters already include disclosures and other legally mandated information; consequently, the requirement to post both the notice and taglines required in proposed § 92.8(a) and (d), respectively, might dilute the primary message of the letter and confuse or frustrate consumers. Some commenters requested clarification on how “vital documents” as used in the Department's LEP Guidance relates to “significant publications and significant communications” in § 92.8(f)(1)(i) of the proposed rule.
We decline to limit the posting requirement in § 92.8(f)(iii) to an annual frequency. The notice requirements in other Federal civil rights laws on which we modeled § 92.8 do not contain a similar limitation. Moreover we also note that not every covered entity sends annual notices.
We also decline to enshrine a list of examples of “significant publications and significant communications” in regulation for two main reasons. First, the final rule applies to such a diverse range of covered entities that codifying examples likely would not provide meaningful guidance to the full spectrum of covered entities regulated. Second, we intend to maximize covered entities' flexibility, and each covered entity is in the best position to determine which of its communications and publications with respect to its health programs and activities are significant.
In response to commenters who requested that “significant publications and significant communications” be limited to documents intended for the public, rather than those intended for specific individuals, we decline to limit the intended scope of such documents to those aimed only at the public at-large. We intend the scope of significant publications and significant communications to include not only documents intended for the public, such as outreach, education, and marketing materials, but also written notices requiring a response from an individual and written notices to an individual, such as those pertaining to rights or benefits. We have no reasoned basis to distinguish and exempt significant publications and significant communications intended for specific individuals from significant publications and significant communications intended for the public at-large. Indeed, in some situations, a written notice with information tailored to a specific individual's benefits or participation may be even more important to that individual than a significant publication or significant communication conveying information to the public. Accordingly, an individual's awareness of his or her rights under Section 1557, such as the availability of auxiliary aids and services for persons with disabilities (required in § 92.8(a)(2) to be in the nondiscrimination notice) is just as important as information communicated to the public at-large.
The HHS LEP Guidance uses the term “vital documents” to refer to the documents for which covered entities should prioritize written translations for individuals with limited English proficiency.
OCR intends for “vital documents” to represent a subset of “significant communications and significant publications”” in which covered entities must post the notice (or nondiscrimination statement in § 92.8(b), where applicable) and taglines required by § 92.8(d) and (f), among other electronic and physical locations. In clarifying this point, we emphasize that the HHS LEP Guidance uses the term “vital documents” to address how a covered entity should meet its Title VI obligations to translate entire documents. By contrast, we refer to “significant communications and significant publications” in this rule to identify the documents in which covered entities are required to post the notice of individuals' rights (or nondiscrimination statement, where applicable) and taglines. We are not adopting an across-the-board requirement for covered entities to translate certain written documents into a threshold number of languages.
One commenter objected to the conditional tense of the sample tagline in Appendix B, which stated that “[i]f you speak [insert language], language assistance services may be available to you . . . ,” expressing concern that it might deter an individual from asking for or about language assistance services. In addition, commenters suggested that the conditional phrasing of “may be available” is inconsistent with covered entities' obligations under § 92.201 to take reasonable steps to provide meaningful access to each individual with limited English proficiency.
A few commenters recommended that the sample tagline in Appendix B be shortened but offered no specific recommendations on shorter language. Some commenters suggested that OCR consumer test the sample notice in Appendix A of the proposed rule before providing it as a sample in the final rule.
In addition, we have added a nondiscrimination statement to Appendix A that covered entities can post on significant publications and significant communications that are small-sized.
We appreciate commenters' attention to the details of the sample tagline's phrasing. We have modified Appendix B to the final rule to address commenters' concerns that the tagline's conditional wording might deter an individual from asking for or about language assistance services. With technological advancements in language assistance services, we are confident that covered entities have the ability, at a minimum, to obtain qualified oral interpretation services in the languages in which covered entities will provide taglines, consistent with § 92.8(d)(1)-(2); thus, the sample tagline as modified states that language services “are” available. In addition, we replaced the word “contact” with “call” to simplify the vocabulary used for average literacy levels. The modifications we have made amplify taglines' function as a critical gateway to language assistance services. Taglines derive value not only from informing individuals with limited English proficiency of language assistance services but also from prompting individuals to contact the covered entity to obtain language assistance. We decline to shorten the sample tagline because we are concerned that doing so would compromise the tagline's message and intent. We remind covered entities that Appendix B is a sample; covered entities are free to develop their own taglines as long as they provide taglines consistent with § 92.8(d)(1)-(2) of this part.
For the reasons described in the proposed rule and considering the comments received, we have modified § 92.8 and Appendices A and B to part 92 as follows:
In § 92.8(a), we made technical modifications to paragraph (a) and paragraphs (a)(1)-(3). In paragraph (a) we replaced the conjunction “or” with “and.” In paragraph (a)(1), we clarified that the nondiscrimination statement of the notice applies to the health programs and activities of a covered entity. In paragraph (a)(2), we inserted the phrase “for individuals with disabilities” after “qualified interpreters” because the final rule now defines qualified interpreters for individuals with disabilities separately from qualified interpreters for individuals with limited English proficiency. In paragraph (a)(3), we added examples of language assistance services to promote alignment with paragraph (a)(2), which provides examples of auxiliary aids and services.
Most of the text in proposed § 92.8(b) is now reflected in new paragraph (b)(1). We added paragraph (b)(2) that requires a covered entity to post a nondiscrimination statement consistent with newly-designated paragraph (g)(1), which applies to significant publications and significant communications that are small-sized. In newly-designated paragraph (b)(1) and (f)(1), we eliminated “English-language” before “notice” to avoid the incongruous result that a significant publication or significant communication written in a non-English language must include a notice written in English.
In § 92.8(c), we added language to convey OCR's plans to translate the sample nondiscrimination statement for covered entities to use at their discretion.
In paragraph (d) of § 92.8, we added paragraph designations (1) and (2) to distinguish the final rule's tagline requirements for significant publications and significant communications that are not small-sized from those that are small-sized. Most of the text in proposed paragraph (d) is now reflected in paragraph (d)(1). In newly-designated (d)(1), we replaced the national threshold with a threshold requiring taglines in at least the top 15 languages spoken by the limited English proficient population of the relevant State or States. In addition, we added a reference to the posting requirement in paragraph (f)(1) of § 92.8 for clarity. Paragraph (d)(2) identifies the tagline requirement for significant publications and significant communications that are small-sized. In paragraphs (c) and (e) of § 92.8, we replaced the national threshold with a reference to the languages triggered by the State-wide methodology described in paragraph (d)(1).
In § 92.8(f), we revised paragraph (f)(1) and paragraphs (f)(1)(i) and (iii). Specifically, in paragraph (f)(1), we made a technical revision to remove an errant reference to paragraph (b) and we replaced the reference to paragraph (d) with (d)(1) to conform to the new paragraph designations of the final rule. In § 92.8(f)(1)(i), we replaced the conjunction “or” with “and” as a technical revision to align the text with the same technical revision in § 92.8(a). In addition, we excluded publications and significant communications that are small-sized from the requirement to post the notice conveying all content in § 92.8(a)(1)-(7) and from the requirement to post all 15 taglines. In paragraph (f)(1)(iii), we clarified the location of the tagline when posted to the covered entity's Web site.
We re-designated paragraph (g) in the proposed rule as paragraph (h) in this final rule. In the final rule, paragraph (g) addresses covered entities' requirements to post a nondiscrimination statement and taglines in significant publications and significant communications that are small-sized. Specifically, paragraph (g)(1) addresses the requirement to post a nondiscrimination statement and paragraph (g)(2) addresses the requirement to post taglines.
Newly re-designated paragraph (h) no longer treats an entity's compliance with particular paragraphs of § 92.8 as constituting compliance with the notice provisions of other Federal civil rights authorities. We revised the paragraph to address a covered entity's permissive authority to combine the content of the notice in paragraphs (a)(1)-(7) of this section with the content of other notices.
In Appendix A to the final rule, we made the following changes to improve the plain language reading of the sample notice and to streamline the sample notice's messaging:
• Deleted “sex stereotypes and gender identity” from the end of the first sentence;
• Replaced “worse” with “differently,” and deleted the pronoun “their” prior to listing the bases on which the covered entity does not discriminate;
• Replaced “first language” with “primary language”;
• Deleted “when needed to communicate effectively with us”;
• Added “qualified” to modify “interpreters” with respect to serving individuals with limited English proficiency;
• Replaced “translated into other languages” with “written in other languages”;
• Added placeholders for a covered entity to provide not only the name of its civil rights coordinator but also the individual's title; and
• Added contact information for filing a complaint with OCR.
In addition, we added a sample nondiscrimination statement in Appendix A for covered entities to post in significant publications and significant communications that are small-sized and accordingly broadened the title of Appendix A to reflect its revised scope.
In Appendix B to the final rule, we modified the language by replacing “may be available” with “are available” and by adding language to improve the plain language reading of the sample tagline, by replacing “[c]ontact” with “call.”
Subpart B of the final rule incorporates regulatory provisions implementing the application of the civil rights statutes referenced in Section 1557(a): Title VI, Title IX, the Age Act, and Section 504.
We proposed that § 92.101 of subpart B prohibit discrimination on the basis of race, color, national origin, sex, age, or disability under any health program or activity to which Section 1557 or this part applies. We proposed that paragraphs (a) and (b) follow the structure of the implementing regulations for Title VI, Section 504, Title IX, and the Age Act by including a general nondiscrimination provision in paragraph (a) followed by a provision identifying specific discrimination prohibited in paragraph (b). In paragraph (c), we proposed to address exceptions to discrimination prohibited under the Title VI, Section 504, and Age Act regulations. We proposed that paragraph (d) effectuate technical changes in terminology to apply the provisions incorporated from other regulations to the covered entities obligated to comply with this proposed rule.
In paragraph (a)(1) of § 92.101 of the proposed rule, we restated the core objective of Section 1557(a), which prohibits discrimination on the grounds prohibited under Title VI (race, color, or national origin), Title IX (sex), the Age Act (age), or Section 504 (disability) in any health program or activity to which this part applies.
In paragraph (a)(2), we proposed to limit the ways in which the proposed rule applies to employment. We noted that except as provided in § 92.208, which addresses employee health benefit programs, the proposed rule does not generally apply to discrimination by a covered entity against its own employees. Thus, the proposed rule would not extend to hiring, firing, promotions, or terms and conditions of employment outside of those identified in § 92.208; such claims could continue to be brought under other laws, including Title VII, Title IX, Section 504, the ADA and the Age Discrimination in Employment Act,
We proposed that paragraph (b) incorporate into the regulation the specific discriminatory actions prohibited by each civil rights statute which Section 1557 references. We considered harmonizing each of the specific discriminatory actions prohibited across each civil rights law addressed by Section 1557. We noted that although harmonization could reduce redundancy in the specific discriminatory actions incorporated that are similar to one another, harmonization would likely lead to confusion and unintended differences in interpretation that are subtle yet significant. We therefore proposed that paragraphs (b)(1)-(4) incorporate the specific discriminatory actions prohibited under each civil rights law on which Section 1557 is grounded. We sought comment on this proposed approach.
We proposed that paragraph (b)(1) adopt the specific discriminatory actions prohibited by the Title VI implementing regulation, which appear at 45 CFR 80.3(b)(1)-(6).
In paragraph (b)(2)(i), we proposed to address the specific prohibition of discrimination on the basis of disability with which recipients and State-based Marketplaces must comply. In paragraph (b)(2)(i), we proposed to adopt relevant provisions in the Section 504 implementing regulation for federally assisted programs and activities at 45 CFR part 84. We provided that the provisions incorporated are the specific discriminatory actions prohibited at § 84.4(b); the program accessibility provisions at §§ 84.21 through 84.23(b); and the provisions governing education, health, welfare, and social services at §§ 84.31, 84.34, 84.37, 84.38, and 84.41-84.55.
We proposed that paragraph (b)(2)(ii) address the specific prohibitions of discrimination on the basis of disability with which the Department, including the Federally-facilitated Marketplaces, must comply. We proposed that this paragraph adopt relevant provisions in the Section 504 implementing regulation for federally administered programs and activities at 45 CFR part 85. We provided that the provisions adopted are the specific discriminatory actions prohibited at § 85.21(b) and the program accessibility provisions at §§ 85.41 through 85.42 and 84.44 through 84.51.
We proposed that paragraph (b)(3) adopt the specific discriminatory actions prohibited by the Title IX implementing regulation, which appear at 45 CFR 86.3(b)(1) through (8).
We also proposed that paragraph (b)(4) adopt the specific discriminatory actions prohibited by the Age Act implementing regulation, which appear at 45 CFR 91.11(b).
In paragraph (b)(5), we proposed that the specific discriminatory actions prohibited in § 92.101(b)(1) through (4) do not limit the general prohibition of discrimination in § 92.101(a). We noted that this statement is consistent with regulatory provisions in the implementing regulations for Title VI at 45 CFR 80.3(b)(5) and the Age Act at 45 CFR 91.11(c).
In paragraph (c), we proposed to incorporate the exceptions to the general prohibition of discrimination that appear in the implementing regulations for Title VI, Section 504, and the Age Act, as these exceptions have applied to health programs and activities for nearly 40 years. We noted that, generally, the exceptions in the Title VI, Section 504, and Age Act implementing regulations provide that it is not discriminatory to exclude a person from the benefits of a program that Federal law limits to a protected class. We did not address the sex-based distinctions authorized in Title IX and its implementing regulation in the context of education programs or activities. We noted that these distinctions do not necessarily apply in the health care context. However, we also noted that Title IX and the Department of Education's Title IX regulations allow some single-sex education programs when certain requirements are met.
Finally, we proposed that paragraph (d) effectuate technical changes to apply
The comments and our responses regarding § 92.101 of subpart B are set forth below.
Commenters asked for such regulatory language based on concerns that some covered entities administer their programs in a manner that discriminates based on national origin by delaying or denying access to public benefits based on practices such as: Erecting onerous documentation requirements; denying eligible applicants the opportunity to prove eligible income, identity, citizenship status, or immigration status; or making generalized assumptions about applicants' eligibility based on the actual or perceived immigration status or national origin of any family member.
Second, regulatory modifications to the proposed rule are unnecessary to allow OCR to address a covered entity's policy or practice, such as requiring the disclosure of SSNs or certain citizenship or immigration status information, that raises compliance concerns under Section 1557's prohibition of national origin discrimination. OCR addresses such issues under Title VI.
Thus, to the extent that the Tri-Agency Guidance identifies situations that may raise Title VI compliance concerns and offers best practices for resolving those concerns, this information is equally applicable to health programs and activities covered under Section 1557 as it is to the health and human service programs addressed in the Tri-Agency Guidance. The Department continues to adhere to the principles set forth in the Tri-Agency Guidance in the implementation of the Department's programs
As explained in the Director's original notice adopting this policy, OCR believes that Section 504's auxiliary aids and services requirement should be applied to covered entities with fewer than 15 employees in the interest of uniformity and consistent administration of law. Under Title III of the ADA, privately operated public accommodations are obligated to provide appropriate auxiliary aids and services, regardless of their size, where necessary to ensure effective communication with individuals with disabilities, unless they can demonstrate that taking such steps would fundamentally alter the nature of their program, services or activities, or would result in undue financial and administrative burdens.
Under this demanding standard, as adapted in this rule, a sex-specific health program or activity classification is unlawful unless the covered entity can show an exceedingly persuasive justification for it, that is, that the sex-based classification is substantially related to the achievement of an important health-related or scientific objective. In evaluating a complaint of discrimination challenging a covered entity's sex-specific health program or activity, OCR may consider a variety of factors relevant to the particular program or activity. In all cases, however, OCR will expect a covered entity to supply objective evidence, and empirical data if available, to justify the need to restrict participation in the program to only one sex. In no case will OCR accept a justification that relies on overly broad generalizations about the sexes.
Under this standard, OCR anticipates that most health researchers will be able to justify sex-specific clinical trials, such as those that test treatments for sex-specific conditions or that evaluate differences in responses to treatment regimens among the sexes, based upon the scientific purposes of the study. Where there is no clinical or scientific rationale for making a program sex-specific, by contrast, a covered entity that offers such a program would need to demonstrate, through such means as research literature, empirical data, accepted professional standards, and/or facts specific to participants in the program, that maintaining the sex segregation of the program is necessary for the program to achieve its purpose. Overly broad generalizations would not be sufficient.
No commenters asked OCR to adopt the sex-specific standards authorized in Title IX or the Department of Education's Title IX regulations. OCR has chosen to apply an adapted constitutional standard under Section 1557 rather than the standard authorized in Title IX and the Department of Education's Title IX regulations because, as noted in the proposed rule, and by several commenters, the single-sex educational exceptions found in Title IX and the Department of Education's Title IX regulations—such as exceptions for some single-sex education programs (
In addition, we note that OCR's adaptation of the constitutional standard as the standard to be applied to sex-specific health programs or activities under Section 1557 is consistent with the constitutional standard that already applies to sex-specific public health programs and activities, which are covered entities under this rule if they receive Federal financial assistance. OCR has adapted the standard to use the term “important health-related or scientific objective,” in recognition of the fact that the rule's provision on sex-specific programs or activities applies to both private and public covered entities in the context of health programs and activities. The same Section 1557 nondiscrimination standards, including this adapted standard, apply to health programs or activities subject to this rule whether public or private covered entities operate them.
Finally, as we initially noted in the proposed rule, we do not intend to prohibit separate toilet, locker room, and shower facilities where comparable facilities are provided to individuals, regardless of sex. OCR recognizes that under some existing Federal, State and local laws, rules or regulations, certain types of sex-specific facilities such as restrooms may be permitted. The approach taken by OCR is consistent with the long standing approach taken to these types of facilities.
However as previously stated in the discussion of the definition of “on the basis of sex” in § 92.4, even where it is permissible to make sex-based distinctions, individuals may not be excluded from health programs and activities for which they are otherwise eligible based on their gender identity.
For the reasons set forth in the proposed rule and considering the comments received, we are finalizing the provisions as proposed in § 92.101 with the following modifications:
We have re-designated § 92.101(b)(1) as § 92.101(b)(1)(i), and added a new section § 92.101(b)(1)(ii), which prohibits aiding or perpetuating discrimination against an individual by providing significant assistance to an entity or person that discriminates on the basis of race, color, or national origin against beneficiaries of the covered entity's health program or activity. Similarly, we have re-designated § 92.101(b)(4) as § 92.101(b)(4)(i), and added a new section § 92.101(b)(4)(ii), which prohibits aiding or perpetuating discrimination against an individual by providing significant assistance to an entity or person that discriminates on the basis of age against health program or activity beneficiaries. These provisions complement similar provisions incorporated in the final rule with respect to disability and sex discrimination and are included to ensure that we are providing the same protections from race, color, national origin, and age discrimination as are provided with respect to sex and disability discrimination.
In addition, we have changed the language in § 92.101(b)(2)(i) to exclude reference to 45 CFR 84.52(d). We are re-designating the existing regulation text at § 92.202 as § 92.202(a), and adding a
We have re-designated the existing regulation text at § 92.101(b)(3) as § 92.101(b)(3)(i). We have added new subsections, § 92.101(b)(3)(ii) and § 92.101(b)(3)(iii) to clarify the full breadth of discriminatory actions prohibited by Section 1557 on the basis of sex. Last, we have added a new subsection, § 92.101(b)(3)(iv) to clarify when covered entities may provide a sex-specific health program or activity.
Section 1557 is unique among Federal civil rights laws in that it specifically addresses discrimination in health programs and activities. To provide additional specificity regarding nondiscrimination requirements in this setting, Subpart C builds upon pre-existing civil rights regulations referenced in Subpart B.
In § 92.201, OCR proposed to effectuate Section 1557's prohibition on national origin discrimination as it affects individuals with limited English proficiency in health programs and activities of covered entities.
We explained that for individuals with limited English proficiency, lack of proficiency in English—and the use of non-English languages—is a direct outgrowth of, and is integrally tied to, their national origins.
The key to providing meaningful access for LEP persons is to ensure that the recipient/covered entity and LEP person can communicate effectively. The steps taken by a covered entity must ensure that the LEP person is given adequate information, is able to understand the services and benefits available, and is able to receive those for which he or she is eligible. The covered entity must also ensure that the LEP person can effectively communicate the relevant circumstances of his or her situation to the service provider.
In § 92.201(a), we proposed to adopt the well-established principle that covered entities must take reasonable steps to provide meaningful access to health programs and activities for all individuals with limited English proficiency whom the covered entities serve or encounter.
We stated that the proposed standard balances two core principles critical in effectuating Section 1557's prohibition of national origin discrimination. First, the Department must “ensure that [health programs and activities] aimed at the American public do not leave some behind simply because they face challenges communicating in English.”
For these reasons, proposed paragraph (b) identified how the Director will evaluate whether a covered entity has met the requirement in paragraph (a).
In paragraphs (b)(2)(i) and (ii), OCR proposed to identify the length, complexity, and context of the
In paragraph (b)(2)(iii), we provided that the prevalence of the primary language in which the individual with limited English proficiency communicates, among those eligible to be served or likely to be encountered by the health program or activity, might also be relevant.
In paragraphs (iv) and (v) of proposed § 92.201(b)(2)—the final illustrative factors listed—we noted that the resources available to the covered entity and the costs of language assistance services might also be relevant in a particular case.
In proposed paragraph (c), we clarified that language assistance services required under paragraph (a) must be provided free of charge, be accurate and timely, and protect the privacy and independence of the individual with limited English proficiency.
In paragraphs (d) and (e), OCR proposed to codify standards described in the Department's LEP Guidance regarding qualified interpreters for individuals with limited English proficiency and the use of family members or friends as interpreters or to facilitate communication.
Specifically, in paragraph (d), OCR proposed to address standards applicable to oral interpretation. We provided that when a covered entity is required by paragraph (a) to provide oral interpretation as a reasonable step to provide meaningful access to an individual with limited English proficiency, the covered entity must offer that individual a qualified interpreter.
In paragraph (e), we proposed restrictions on the use of certain persons to interpret or facilitate communication for an individual with limited English proficiency. We proposed that paragraph (e) apply in addition to, and regardless of, the appropriate level, type or manner of language assistance services a covered entity is required to provide. In paragraph (e)(1), we proposed to prohibit a covered entity from requiring an individual with limited English proficiency to provide his or her own interpreter. However, in paragraphs (e)(2)(i) and (ii), we proposed to identify narrow and finite situations in which a covered entity may rely on an adult accompanying an individual with limited English proficiency to interpret. In paragraph (e)(3), we proposed to prohibit a covered entity from relying on a minor child to interpret or facilitate communication and identified an exception to this prohibition that is narrower in scope than the exception identified in (e)(2)(i) and (ii).
We explained that in lieu of the approach we proposed in paragraphs (d) and (e), we considered proposing that all covered entities have the capacity to provide, in their health programs or activities, qualified interpreters for individuals with limited English proficiency through telephonic oral interpretation services available in at least 150 non-English languages. OCR invited comment on what oral interpretation services, if any, we should require and how such approaches appropriately balance the provision of meaningful access to individuals with limited English proficiency and covered entities' flexibility to identify the means of providing such access.
In paragraph (f), we proposed that no individual with limited English proficiency should be required to accept language assistance services, consistent with an individual's right to self-determination. We provided that a covered entity cannot coerce an individual to decline language assistance services. We also provided that if an individual with limited English proficiency voluntarily declines an offer of language assistance services from the covered entity, a covered entity could denote, in the individual's file or records, the language assistance services offered and the declination.
In the proposed rule, we described alternate approaches we considered and requested comment on these approaches and any others to effectuate Section 1557's prohibition of national origin discrimination as it affects individuals with limited English proficiency. For instance, we noted that independent of the proposed requirements of § 92.201, covered entities, including Health Insurance Marketplaces, State agencies administering Medicaid and Children's Health Insurance Program (CHIP) programs, and qualified health plan issuers, must comply with any applicable language access requirements in other laws and regulations.
We also stated that we considered a regulatory scheme requiring covered entities to provide meaningful access to each individual with limited English proficiency by providing effective language assistance services, at no cost, unless such action would result in an undue burden or a fundamental alteration of the health program or activity.
We further noted that we considered a regulatory scheme requiring covered entities to provide a range of language assistance services in the non-English languages spoken by State-wide populations with limited English proficiency that meet defined thresholds. Such thresholds would provide a minimum number of non-English languages in which covered entities would be required to deliver oral interpretation services; to translate written vital documents and Web site content; and to include taglines on vital documents and on Web sites.
We also noted that we considered a regulatory scheme that would impose enhanced obligations on a subset of covered entities. We sought comment on what characteristics should define covered entities that could have enhanced obligations, such as whether the covered entity is of a certain type or size, has frequent contact with individuals with limited English proficiency, or operates particularly important health programs or activities, among other potential factors. We listed potential categories of covered entities that could have enhanced obligations, such as State agencies administering Medicaid or CHIP; Health Insurance Marketplaces; the Department in its operation of its health programs or activities; or covered entities that have a minimum number of beds, employees, or locations, such as hospitals, nursing homes or skilled nursing facilities, home health agencies, and retail pharmacies (including mail-order pharmacies).
We further requested comment on whether covered entities should be required to systematically prepare to provide language assistance services in their health programs or activities, such as through the establishment of policies and procedures or through other advance planning mechanisms. We stated that in OCR's experience, covered entities are in a better position to meet their obligations to provide language assistance services in a timely manner to individuals with limited English proficiency when those entities identify, in advance, the types and levels of services that will be provided in each of the contexts in which the covered entity encounters individuals with limited English proficiency.
OCR noted that an advance planning requirement could require each covered entity to identify all resources for providing language assistance services; annually assess the frequently-encountered or highly prevalent languages in the service area of the health program or activity; establish written procedures to which frontline staff could refer when encountering individuals with limited English proficiency; and monitor and oversee the quality of language assistance services provided. We also noted that an advance planning requirement could require each covered entity to build its capacity to provide language assistance services to meet the needs of the national origin populations that the entity serves. We requested comment on the types of advance planning mechanisms, if any, that should be required and why.
In the proposed rule, OCR advised that covered entities that are already developing or implementing language access plans, or otherwise assessing their language assistance needs, should continue such efforts. However, OCR stated that engaging in such planning is not a defense for failing to provide language assistance services to any particular individual at all, or in an untimely manner, if such services are reasonable steps to provide meaningful access. We advised that covered entities that are conducting advance planning should consider how they can ensure that language assistance services are available in their health programs and activities as they simultaneously improve their operational capacities to provide effective language assistance services into the future.
The comments and our responses regarding § 92.201 are set forth below:
Overall, commenters supported the proposed rule's inclusion of specific provisions addressing meaningful access for individuals with limited English proficiency. We received numerous comments written in non-English languages submitted by individuals with limited English proficiency who expressed how essential it is to have language assistance services, at no cost, to understand forms, invoices, and medication instructions. Many comments from the health care provider and insurance industry, as well as from organizations representing individuals with limited English proficiency, agreed that it is essential that individuals, regardless of national origin, be able to access covered entities' health programs and activities. We received many comments, however, regarding the scope and parameters of covered entities' obligations under the final rule.
We chose the phrase “eligible to be served or likely to be encountered” because it is one of the formulations in the HHS LEP Guidance of the population to which a covered entity has an obligation.
These commenters suggested that language assistance should be provided in every situation and that oral interpretation, in particular, should be provided “on demand.” Commenters
As we stated in the proposed rule, safe and quality health care requires an exchange of information between the health care provider and patient for the purposes of diagnoses, treatment options, the proper use of medications, obtaining informed consent, and insurance coverage of health-related services, among other purposes.
Some commenters offered proposals for minimizing the costs to covered entities for providing language assistance services—oral interpretation services in particular. These recommendations included that OCR facilitate access to telephonic oral interpretation, at no cost to covered entities, and that OCR ensure that covered entities have adequate funding to provide qualified interpreters for individuals with limited English proficiency.
OCR encourages covered entities to work together to leverage their ability to provide language assistance services in the most cost-effective and efficient ways to meet their respective obligations under § 92.201(a) before using costs as a reason to limit language assistance services.
We further remind State agencies receiving Federal financial assistance for Medicaid and the Children's Health Insurance Program that States may claim Federal matching funds for the costs of written translation and oral interpretation as administrative expenses or as medical assistance-related expenses.
We decline to accept the recommendation that OCR facilitate access to telephonic oral interpretation services for all covered entities. Such facilitation is beyond the scope of the Federal government's role and is an impractical solution to address the needs of diverse Section 1557 covered entities. However, OCR does share best practices and useful resources, such as through the Federal government's Interagency Working Group on Limited English Proficiency, at
One commenter observed that many covered entities already evaluate the type of language assistance services they are obligated to provide, pursuant to the current HHS LEP Guidance, and thus that codifying this requirement would not impose a significant additional burden on covered entities. This commenter also asserted that an advance planning requirement is analogous to the approach of § 92.7, which requires certain covered entities to have a grievance procedure in place. Another commenter shared that in updating her employer's language access plan, the availability of online tools and resources greatly reduced the commenter's anticipated burden of what advance planning would require.
We received many comments recommending that the final rule identify specific required components of a language access plan, including the types of language access services the covered entity will provide and in what languages, based on the languages spoken by eligible individuals with limited English proficiency in the covered entity's service area. One commenter underscored that to increase efficiency and maximize cost savings, a language access plan should identify multiple types of language assistance services that a covered entity can use for different situations or even within one encounter. This commenter asserted that relying on just one kind of language assistance service may not be appropriate for all communications.
Another commenter recommended that the final rule mirror California's regulations on advance planning mechanisms for the provision of language assistance services.
We received a small number of comments opposing a requirement for advance planning. One commenter acknowledged that a language access plan is important in ensuring that covered entities are systematically prepared to provide language assistance services but recommended that OCR should merely encourage, not require, advance planning activities. The commenter observed that developing a language access plan may be too burdensome for small covered entities.
We note that a written language access plan has long been recognized as an essential tool to ensure adequate and timely provision of language assistance services, including compliance with the general obligation in § 92.201(a) and the quality standards in § 92.201(d)-(f). For instance, for over 15 years, Executive Order 13166 has required each Federal agency to create and implement a language access plan responsive to the needs of the limited English proficient population it serves.
We decline to outline the minimum expectations for a language access plan, if a covered entity chooses to develop and implement one, because that approach would be too prescriptive. Nonetheless, in our experience, effective language access plans often, among other components, address how the entity will determine an individual's primary language, particularly if the language is an unfamiliar one; identify a telephonic oral interpretation service to be able to access qualified interpreters when the need arises; identify a translation service to be able to access qualified translators when the need arises; identify the types of language assistance services that may be required under particular circumstances; and identify any documents for which written translations should be routinely available. OCR remains available to covered entities as a resource for technical assistance in the development and implementation of language access plans in their health programs and activities. HHS offers helpful guidance on this subject,
• The frequency with which a covered entity encounters, or is likely to encounter, a particular non-English language;
• the impact to the consumer if language assistance services are not provided;
• the extent to which covered entities can lessen their own cost burdens through technology and reasonable business practices, if the Director considers the costs of language assistance services; and
• if and when a covered entity is permitted to choose a less costly language assistance service than the one an individual may request.
Second, many commenters recommended that we combine the “costs of language assistance services” in proposed § 92.201(b)(2)(v) with “[a]ll resources available to the covered entity” in proposed § 92.201(b)(2)(iv) into a single factor because the two are inherently intertwined.
Third, some commenters requested that OCR clarify in the final rule how the factors in proposed § 92.201(b)(2)(i)-(v) would be weighted relative to each other, if relevant and thus evaluated by the Director in a given case. Most commenters who requested clarification recommended that the costs of language assistance services and the resources available to the covered entity not be weighted more heavily than the other factors or become dispositive.
Fourth, a number of commenters requested clarification on the function that the length and complexity of the communication in proposed § 92.201(b)(2)(i) would have in the Director's evaluation of a particular case.
Given these concerns, § 92.201(b)(1)-(2) of the final rule requires the Director to evaluate, and give substantial weight to, the nature and importance of the health program or activity and the particular communication at issue to the individual with limited English proficiency, and requires the Director to take into account all other relevant factors, including whether the entity has developed and implemented an effective language access plan. We have identified this factor in particular to provide a concrete reminder to covered entities that they may wish to take action to prepare to provide language assistance services to the individuals with limited English proficiency that they will serve or encounter. We reiterate, however, that adoption of a language access plan is a voluntary measure that is not required by the rule; we will continue to evaluate, on a case-by-case basis, whether entities have taken reasonable steps to provide meaningful access and will evaluate all relevant factors in making that assessment.
We recognize that the absence of illustrative factors in regulation text may diminish clarity regarding the Director's evaluation of a covered entity's compliance with § 92.201(a). To provide guidance to covered entities on our intended interpretation of § 92.201(b)(2) and to be responsive to
As an initial matter, we note that one of the factors commenters recommended we add, which is the impact to the individual of failing to provide language assistance services, is necessarily encompassed within § 92.201(b)(1) regarding an evaluation of the nature and importance of the health program or activity and the particular communication at issue.
Factors that may be relevant in a particular case for the Director to consider pursuant to § 92.201(b)(2) include but are not limited to: the length, complexity, and context of the communication; the prevalence of the language in which the individual communicates among those eligible to be served or likely to be encountered by the health program or activity; the frequency with which a covered entity encounters the language in which the individual communicates; whether a covered entity has explored the individual's preference, if any, for a type of language assistance service, as not all types of language assistance services may work as well as others in providing an individual meaningful access to the covered entity's health program or activity; the cost of language assistance services and whether a covered entity has availed itself of cost-saving opportunities; and all resources available to the covered entity, including the entity's capacity to leverage resources among its partners or to use its negotiating power to lower the costs at which language assistance services could be obtained.
We decline to adopt commenters' suggestions to create a regulatory scheme that assigns particular weight to any specific relevant factor because the Director will consider and weigh all relevant factors pursuant to § 92.201(b)(2) on a case-by-case basis.
Because we have eliminated the factors in proposed 92.201(b)(2)(i)-(v), it is moot whether OCR should combine the proposed factor on the costs of language assistance services with the proposed factor on resources available to the covered entity. Nevertheless, costs and resources are intertwined, which is a principle reflected in the HHS LEP Guidance with respect to Title VI
With respect to commenters' requests for clarification on the relevance that the length and complexity of a particular communication has on the type of language assistance a covered entity should provide, we note that this factor is emblematic of the fact-based nature of the inquiry described in § 92.201(b)(1)-(2). Where a document is long and complex, it may in some cases be necessary for a covered entity to provide a written translation so that an individual with limited English proficiency can refer back to or study it at a later time. In other cases, however, a covered entity may meet the requirements of this section by summarizing the document orally for a qualified interpreter to then convey to the individual with limited English proficiency, if such approach is sufficient to provide the individual with limited English proficiency meaningful access to the information.
We do, however, agree with commenters' concerns regarding the use of some automatic translation technologies, which “is particularly dangerous, and can lead to very serious misunderstandings and adverse consequences for medical documents.”
Second, we added a new paragraph (4) to § 92.201(e) to restrict covered entities from relying on staff who do not meet the definition of “qualified bilingual/multilingual staff” in § 92.4. In OCR's enforcement experience, covered entities too frequently rely on staff members who possess only a rudimentary familiarity speaking and understanding a non-English language (for example relying on their “high school” level of language proficiency) to communicate with individuals with limited English proficiency. This can result in miscommunication and the omission of relevant information, which can in turn result in a lower standard of care and raise questions about whether consent provided by an individual with limited English proficiency was truly informed. Similarly, we have found that qualified bilingual staff members sometimes serve as interpreters even though they do not possess the non-verbal skills of interpreting nor adhere to generally accepted principles of interpreter ethics.
In contrast, numerous commenters supported the proposed rule's standards for oral interpretation and the proposed restrictions on certain persons to interpret or facilitate communication. For instance, one health care provider shared that a high risk hospital was unprepared to provide oral interpretation to a woman in labor. The patient's child had to interpret what her mother was saying but the child did not know the proper terminology to understand the provider's medical questions about a fatal high risk condition.
In addition, many commenters who are limited English proficient shared that some covered entities have required individuals to bring their own interpreters, at a cost to the individual. Others shared that family members and children have served as interpreters for them, which has been insufficient because such family members and children do not have the requisite skills to interpret accurately.
Determining the relationship between the interpreter and the covered entity is a covered entity's HIPAA obligation and is unchanged by Section 1557 or this part. We encourage covered entities to review OCR's HIPAA Frequently Asked Questions (FAQ) regarding business associates at
To address concerns that video remote interpreting technologies may result in less comprehensible communication, we are setting performance standards in § 92.201(f) of this final rule for video remote interpreting services
Commenters suggested that when the individual who declines language assistance services is a patient, the health care provider's ability to accurately diagnose medical conditions is undermined. Commenters similarly stated that when the individual who declines language assistance services is a limited English proficient health care decision-maker for a child, that decision-maker would not be able to appropriately consent to, or participate in, a child's treatment plan. These commenters recommended requiring that a covered entity's insistence on a qualified interpreter be made in a non-coercive and culturally-appropriate manner.
Commenters supporting thresholds for written translation suggested that this policy improves access for individuals with limited English proficiency; streamlines OCR's compliance determinations; eliminates ambiguity by providing clear, quantifiable standards for covered entities; is consistent with other Departmental regulations specifying thresholds for written translation; and mitigates the risk that covered entities forgo written translation entirely.
Commenters recommended a variety of thresholds, such as those requiring translation based on the number of languages, percentage of language speakers, or the number of language speakers in a covered entity's service area, or composite thresholds mixing and matching these approaches. Some commenters simply stated that vital documents should be translated into the most commonly encountered languages in a covered entity's service area. Others suggested that OCR codify the threshold for translation of vital documents that is articulated as a safe harbor in the HHS LEP Guidance: translation into languages spoken by at least 1,000 persons or at least 5% of those present in the service area.
For instance, a threshold requiring all covered entities, regardless of type or size, to provide language assistance services in languages spoken by 5% of a county's limited English proficient population could result in the provision of language assistance services in more languages than the entity would otherwise be required to provide under its obligation in § 92.201(a). This threshold would apply regardless of the number of individuals with limited English proficiency who are eligible to be served or likely to be encountered by the covered entity's health program or activity and regardless of the covered entity's operational capacity. Similarly, this threshold could leave behind significant numbers of individuals with limited English proficiency, served by a covered entity's health program or activity, who communicate in a language that constitutes less than 5% of the county's limited English proficient population.
Although some Departmental regulations set thresholds, those regulations address entities or health programs of similar sizes and types, such as qualified health plan issuers, Marketplaces, Medicare Advantage, and Medicare Part D. In comparison, Section 1557 and this part regulate more diverse types of covered entities with potentially more diverse limited English proficient populations. We are concerned that significant limited English proficient populations might receive no or inadequate language assistance services under a threshold-based regulation. We are also concerned about the burden an across-the-board translation threshold might place on small covered entities.
Moreover, we value the flexibility inherent in the contextualized approach we have chosen to assess compliance with the requirement to take reasonable steps to provide meaningful access. We thus decline to impose the prescriptive standards recommended by the commenters as inconsistent with this customized regulatory approach.
Commenters also addressed the scope of enhanced language access obligations, suggesting that such obligations should include requiring oral interpretation in at least 150 languages and the translation of documents into languages spoken by individuals with limited English proficiency when such individuals constitute 5% of, or 500 people in, the State population or the covered entity's service area.
A few commenters opposed enhanced language access obligations for certain types of covered entities. Specifically, one commenter asserted that there was no principled reason for retail pharmacies, which the proposed rule listed as an example of a covered entity that could have enhanced obligations under § 92.201,
However, we decline to adopt an approach that otherwise automatically harmonizes nondiscrimination rules or deems compliance with other laws sufficient for compliance with Section 1557. As we noted above in the discussion of deeming in the General Comments, it is common for entities to be subject to multiple State and Federal regulations, even when some of those regulations have been adopted by a single Federal agency. Indeed, even under CMS regulations for instance, Health Insurance Marketplaces,
With specific regard to language assistance services, there are likely numerous situations in which a qualified health plan issuer's compliance with the meaningful access provisions of 45 CFR 155.205(c) would suffice to meet the requirements of Section 1557; indeed, there are instances in which 45 CFR 155.205(c) (
In addition, automatically harmonizing requirements imposed on particular entities regulated by both Section 1557 and other laws that the Department enforces would undermine an equally important form of consistency: consistency in enforcement of the standards of Section 1557 and this part across all of the diverse categories of entities covered under the law.
For these reasons and the reasons discussed in the General Comments
For the reasons set forth in the proposed rule and considering the comments received, we are finalizing the provisions in § 92.201 with several modifications.
In § 92.201(a), we replaced the phrase “that it serves or encounters” with “eligible to be served or likely to be encountered.”
In § 92.201(b), we implemented a technical revision in paragraph (b)(1) and we modified paragraph (b)(2). With respect to the technical revision in paragraph (b)(1), we modified this proposed phrase: “the nature and importance of the health program or activity, including the particular communication at issue, to the individual with limited English proficiency” by replacing “including” with the conjunction “and.” This technical revision clarifies OCR's intent that the particular communication at issue will routinely be a component of the Director's evaluation when the Director gives substantial weight to the nature and importance of the health program or activity. In addition, we modified § 92.201(b)(2) to state that the Director, in evaluating compliance, will take into account all relevant factors, which includes whether a covered entity has developed and implemented an effective written language access plan, appropriate to its circumstances. We eliminated paragraphs (i) through (v) of § 92.201(b)(2).
In § 92.201(d), we broadened the title to reflect that this paragraph now addresses specific requirements for written translation in addition to oral interpretation services. The text in proposed paragraph (d) addressing specific requirements for oral interpretation is now reflected under a new paragraph (d)(1). We added paragraph (d)(2) to require covered entities to use a qualified translator when translating written content in paper or electronic form for its health programs or activities.
In § 92.201(e)(2)(i) and (e)(3), we added “for the individual with limited English proficiency” after “qualified interpreter” to conform to the revision of this term as defined in § 92.4 of the final rule. In addition, we added a new paragraph (e)(4) to address restrictions on a covered entity's use of staff other than qualified bilingual/multilingual staff to communicate directly with individuals with limited English proficiency, in their primary languages.
We re-designated paragraph (f) of § 92.201 in the proposed rule as paragraph (g) of § 92.201 in this final rule, and we added a new paragraph (f). New paragraph (f) provides that when a covered entity uses video remote interpreting services as the means to provide an individual with limited English proficiency oral language assistance, the video remote interpreting technology must meet the standards listed in § 92.201(f)(1)-(4) of this final rule.
In § 92.202 of the proposed rule, we proposed to incorporate the provisions governing effective communication with individuals with disabilities found in the regulation implementing Title II of the ADA, which applies to State and local government entities and requires covered entities to ensure that communications with individuals with disabilities are as effective as they are with individuals without disabilities. We noted that OCR typically looks to the ADA for guidance in interpreting Section 504 as the two laws contain very similar standards.
In the proposed rule, OCR considered whether to incorporate the standards in the regulation implementing Title II of the ADA or in the regulation implementing Title III of the ADA, or the standards in both regulations. Standards regarding effective communication under both regulations are very similar. We noted that there are, however, limited differences between the Title II and Title III regulations, regarding limitations on the duty to provide a particular aid or service where doing so may impose undue financial and administrative burdens, and the obligation under the Title II regulation to give primary consideration to the choice of an aid or service requested by the individual with a disability.
OCR proposed to apply the Title II standards to all entities covered under the proposed rule. We noted that although OCR could apply Title II standards to States and local government entities and Title III standards to private entities, we believe it is appropriate to hold all recipients of Federal financial assistance from HHS to the higher Title II standards as a condition of their receipt of that assistance. We also noted that it is appropriate to hold HHS itself to the same standards to which the Department subjects the recipients of its financial assistance.
We also proposed that where the regulatory provisions referenced in § 92.202 use the term “public entity,” that term shall be replaced with “covered entity.”
The comments and our responses regarding § 92.202 are set forth below.
For the reasons set forth in the proposed rule and considering the comments received, including comments regarding the auxiliary aids and services requirement in § 92.101(b)(2)(i) (discussed above), we are finalizing the provisions proposed in § 92.202 by re-designating the existing regulation text at § 92.202 as § 92.202(a), and adding a new subsection, § 92.202(b) requiring covered entities—regardless of the number of people they employ—to provide appropriate auxiliary aids and services to persons with impaired sensory, manual, or speaking skills, where necessary to afford such persons an equal opportunity to benefit from the service in question.
The Section 504 regulatory provisions incorporated into Subpart B in this regulation contain program accessibility requirements that apply to existing facilities as well as new construction and alterations. In § 92.203 of the proposed rule, we proposed to establish specific accessibility standards for new construction and alterations. We noted that these standards are consistent with existing standards under the ADA.
Under paragraph (a), we proposed that each facility or part of a facility in which health programs or activities are conducted that is constructed or altered by or on behalf of, or for the use of, a recipient or State-based Marketplace
We also proposed that new construction and alterations of such facilities would also be subject to the new construction standards found in the Section 504 implementing regulation at 45 CFR 84.23(a) and (b).
Under paragraph (b), we proposed that each facility or part of a facility in which health programs or activities are conducted that is constructed or altered by or on behalf of, or for the use of, a recipient or State-based Marketplace
In paragraph (c), we proposed that each building or part of a building that is constructed or altered by or on behalf of, or for the use of, the Department must be designed, constructed, or altered so as to be readily accessible to and usable by individuals with disabilities. We proposed that the definitions, requirements, and standards of the Architectural Barriers Act, as established in Appendices C and D to 36 CFR pt 1191, apply to buildings and facilities covered by this section.
OCR considered adding specific language regarding accessibility standards for medical diagnostic equipment. However, we noted that the United States Access Board is currently developing standards for accessible medical diagnostic equipment and, therefore, we are deferring proposing specific accessibility standards for medical equipment. We further noted that a health program or activity's use of medical diagnostic equipment would be covered by Section 1557 under the general prohibition of discrimination on the basis of disability in § 92.101.
The comments and our responses regarding § 92.203 are set forth below.
However, we also note that the ADA applies to employment and, in addition, that nearly all of the entities subject to the facility access requirements in the final rule are also subject to facility access requirements under Section 504. Complaints of discrimination related to program accessibility can be brought by employees under the ADA and Section 504, and entities should ensure that they are in compliance with accessibility requirements, including the 2010 Standards, under the ADA.
For the reasons set forth above and considering the comments received, we have revised § 92.203(a) to state that each covered facility must comply with the 2010 Standards, if the construction or alteration was commenced on or after the effective date of the final rule, except that if a covered facility was not covered by the 2010 Standards prior to the effective date of the final rule, it must comply with the 2010 Standards if the construction was commenced after 18 months after the effective date of the final rule.
For the reasons set forth above and considering the comments received, we have also modified the language in § 92.203(b) to state that each covered facility constructed or altered in conformance with the 1991 Standards or the 2010 Standards will be deemed to comply with the requirements of this section and with 45 CFR 84.23(a) and (b), cross-referenced in § 92.101(b)(2)(i) with respect to those facilities, if the construction or alteration was commenced before the effective date of the final rule. Further, each covered facility that was constructed or altered in conformance with UFAS will be deemed to comply with the requirements of this section and with 45 CFR 84.23(a) and (b), cross-referenced in § 92.101(b)(2)(i) with respect to those facilities, if the construction was commenced before the effective date of the final rule and the facility was not covered by the 1991 Standards or 2010 Standards.
In § 92.204(a), we proposed to require covered entities to ensure that their health programs or activities provided through electronic and information technology are accessible to individuals with disabilities, unless doing so would impose undue financial and administrative burdens or would result in a fundamental alteration in the nature of an entity's health program or activity.
We noted that this provision is consistent with existing standards applicable to covered entities. Specifically, Section 508 of the Rehabilitation Act requires that electronic and information technology developed, procured, maintained, or used by Federal agencies be accessible for individuals with disabilities. Section 508 applies to HHS administered health programs or activities, including the Federally-facilitated Marketplaces. Section 504, which applies to recipients of Federal financial assistance, including issuers that receive Federal financial assistance, and Titles II and III of the ADA, which apply to State and local government entities and places of public accommodation, respectively, similarly have been interpreted to require that covered entities' programs, services, and benefits provided through electronic and information technology be accessible to individuals with disabilities.
In paragraph (b), we proposed to require State-based Marketplaces and recipients of Federal financial assistance to ensure that their health programs and activities provided through Web sites comply with the accessibility requirements of Title II of the ADA. We noted that our proposed regulatory text cross-references the Title II regulations as a whole, therefore incorporating any future changes to the Title II regulations. We also noted that these requirements are informed by the Department's extensive experience with web-based technology through Federal grant-making programs, including programs that provide funds for State infrastructure changes to allow electronic applications for coverage through the Medicaid program and the Health Insurance Marketplaces, provider adoption of electronic health records, and the development of web-based curricula for health care professionals.
In the proposed rule, we explained that based on the Department's prior experience in this field, we believe that
Given the existing requirements under Section 504, Section 508, and the ADA applicable to information provided through electronic and information technology as a whole, and given the importance of technologies, such as kiosks and applications, to access to health care, health-related insurance and other health-related coverage, we proposed to include an explicit accessibility requirement that applies to all of a covered entity's electronic and information technology, rather than to web access only. We sought comment on this proposal.
We also proposed a general accessibility performance standard for electronic and information technology, rather than a requirement for conformance to a specific set of accessibility standards. We provided that the application of this general accessibility performance standard would be informed by future rulemaking by the Access Board and the Department of Justice. We sought comment on whether the regulation should impose a general accessibility performance standard for electronic and information technology or require that electronic and information technology comply with standards developed pursuant to Section 508 by the Access Board,
As noted above, we proposed that covered entities would have a defense to making their health programs and activities provided through electronic and information technology accessible if doing so would impose undue financial and administrative burdens or would result in a fundamental alteration in the nature of the health program or activity. In determining whether an action would impose such undue burdens, we proposed that a covered entity must consider all resources available for use in the funding or operation of the health program or activity.
We noted that when undue financial and administrative burdens or a fundamental alteration are determined to exist, the covered entity is still required to provide information in a format other than an accessible electronic format that would not result in such undue financial and administrative burdens or a fundamental alteration, but would ensure, to the maximum extent possible, that individuals with disabilities receive the benefits or services of the health program or activity that are provided through electronic and information technology.
The comments and our responses regarding § 92.204 are set forth below.
Similarly, in considering the application of the requirement in the final rule to accessibility of health programs and activities offered through electronic and information technology,
We also note that the ADA and Section 504 apply to employment, and virtually all of the entities subject to the requirement for accessibility of health programs and activities offered through electronic and information technology in the final rule are also subject to similar general accessibility requirements in the ADA and Section 504. Entities covered by the final rule should be mindful of their obligations under these other laws.
Conversely, one commenter stated that OCR should not impose a specific accessibility standard for electronic and information technology, arguing that a specific standard may slow innovation and the establishment of potentially effective electronic information technology alternatives.
However, many other commenters urged OCR to reject any requests to delay or phase-in the requirements of § 92.204. These commenters pointed out that § 92.204 builds on and reinforces other longstanding accessibility requirements in Federal law; accordingly, it should not be overly burdensome for covered entities to adjust to the requirements of this rule.
Another commenter pointed out that, when blind patients seek treatment at a doctor's office, they are often expected to make appointments or fill out required documentation expected of new patients using an inaccessible online portal. In these situations, the blind patient is forced to rely on a third party for assistance and, regardless of their personal relationship, disclose confidential information to that person such as the patient's medical history, illnesses, medications, and history of disease or genetic patterns running in the patient's family. Accordingly, this commenter asked that OCR clarify that covered entities need to make online portals accessible so that blind individuals have the same level of privacy and confidentiality as other individuals.
For the reasons set forth in the proposed rule and considering the comments received, we are finalizing the provisions proposed in § 92.204 without modification.
In § 92.205, we proposed to require covered entities to make reasonable modifications in policies, practices, or procedures when necessary to avoid discrimination on the basis of disability, unless they can demonstrate that the modification would fundamentally alter the nature of the health program or activity.
We did not receive any significant comments regarding § 92.205. For the reasons set forth in the proposed rule, we are finalizing the provisions proposed in § 92.205 without modification.
In § 92.206, we proposed that covered entities be required to provide individuals equal access to their health programs or activities without discrimination on the basis of sex and to treat individuals consistent with their gender identity. We proposed that this provision applies to all covered health programs and activities, and prohibits, among other forms of adverse treatment, the discriminatory denial of access to facilities administered by a covered entity. We noted that this proposed approach is consistent with the principle that discrimination on the basis of sex includes discrimination on the basis of gender identity and that failure to treat individuals in accordance with their gender identity may constitute prohibited discrimination.
We proposed one limited exception to the requirement that covered entities treat individuals consistent with their gender identity: That a covered entity may not deny or limit health services that are ordinarily or exclusively available to individuals of one gender based on the fact that the individual's
For clarity and consistency within the final rule, we have made some technical revisions to § 92.206. First, regarding a covered entity being prohibited from denying or limiting health services, we are adding the words “to a transgender individual” after “a covered entity shall treat individuals consistent with their gender identity, except that a covered entity may not deny or limit health services, that are ordinarily or exclusively available to individuals of one gender,” to clarify that the exception is limited to transgender individuals. We note that similar to the discussion in § 92.207(b)(3), we recognize that not every health service that is typically or exclusively provided to individuals of one sex will be a health service that is appropriately provided to a transgender individual. Nothing in the rule would, for example, require a covered entity to provide a traditional prostate exam to an individual who does not have a prostate, regardless of that individual's gender identity. But for health services that are appropriately provided to an individual, the covered entity must provide coverage for those health services on the same terms regardless of an individual's sex assigned at birth, gender identity, or recorded gender. Second, we are deleting the phrase “in a medical record” to address concerns that “medical records” could be understood as referring only to clinical notes of a health care provider.
The comments and our responses regarding § 92.206 are set forth below:
For the reasons set forth in the proposed rule and considering the comments received, we are finalizing the provision as proposed in § 92.206 with technical revisions to clarify our intent and ensure consistency with other parts of the final rule.
In § 92.207 of the proposed rule, we provided specific details regarding the prohibition of discrimination on the basis of race, color, national origin, sex, age, or disability in the provision and administration of health-related insurance or other health-related coverage. We proposed that this prohibition applies to all covered entities that provide or administer health-related insurance or other health-related coverage, including health insurance issuers and group health plans that are recipients of Federal financial assistance and the Department in the administration of its health-related coverage programs. We noted that this section is independent of, but complements, the nondiscrimination provisions that apply to the Health Insurance Marketplaces
Based on the longstanding civil rights principles discussed in connection with the definition of “health program or activity” in § 92.4, we proposed to apply this part to all of the coverage and services of issuers that receive Federal financial assistance, whether those issuers' coverage is offered through the Marketplace
Paragraph (a) proposed a general nondiscrimination requirement, and paragraph (b) provided specific examples of prohibited actions. Paragraphs (b)(1) and (2) proposed to address the prohibition on denying, cancelling, limiting, or refusing to issue or renew a health-related insurance plan or policy or other health-related coverage, denying or limiting coverage of a claim, or imposing additional cost sharing or other limitations or
In the proposed rule, we did not propose to require plans to cover any particular benefit or service, but we provided that a covered entity cannot have coverage that operates in a discriminatory manner. For example, the preamble stated that a plan that covers inpatient treatment for eating disorders in men but not women would not be in compliance with the prohibition of discrimination based on sex. Similarly, a plan that covers bariatric surgery in adults but excludes such coverage for adults with particular developmental disabilities would not be in compliance with the prohibition on discrimination based on disability.
In paragraphs (b)(3) through (5) of the proposed rule, we proposed to address discrimination faced by transgender individuals in accessing coverage of health services. We proposed in paragraph (b)(3) that to deny or limit coverage, deny a claim, or impose additional cost sharing or other limitations or restrictions on coverage of any health service is impermissible discrimination when the denial or limitation is due to the fact that the individual's sex assigned at birth, gender identity, or gender otherwise recorded by the plan or issuer is different from the one to which such services are ordinarily or exclusively available.
In addition, we noted that many health-related insurance plans or other health-related coverage, including Medicaid programs, currently have explicit exclusions of coverage for all care related to gender dysphoria or associated with gender transition. Historically, covered entities have justified these blanket exclusions by categorizing all transition-related treatment as cosmetic or experimental.
OCR proposed to apply basic nondiscrimination principles in evaluating whether a covered entity's denial of a claim for coverage for transition-related care is the product of discrimination. We noted that based on these principles, an explicit, categorical (or automatic) exclusion or limitation of coverage for all health services related to gender transition is unlawful on its face under paragraph (b)(4); in singling out the entire category of gender transition services, such an exclusion or limitation systematically denies services and treatments for transgender individuals and is prohibited discrimination on the basis of sex.
Moreover, we proposed in § 92.207(b)(5) to bar a covered entity from denying or limiting coverage, or denying a claim for coverage, for specific health services related to gender transition where such a denial or limitation results in discrimination against a transgender individual. In evaluating whether it is discriminatory to deny or limit a request for coverage for a particular service for an individual seeking the service as part of transition-related care, we provided that OCR will start by inquiring whether and to what extent coverage is available when the same service is not related to gender transition. If, for example, an issuer or State Medicaid agency denies a claim for coverage for a hysterectomy that a patient's provider says is medically necessary to treat gender dysphoria, OCR will evaluate the extent of the covered entity's coverage policy for hysterectomies under other circumstances. We noted that OCR will also carefully scrutinize whether the covered entity's explanation for the denial or limitation of coverage for transition-related care is legitimate and not a pretext for discrimination.
We noted that these provisions do not, however, affirmatively require covered entities to cover any particular procedure or treatment for transition-related care; nor do they preclude a covered entity from applying neutral standards that govern the circumstances in which it will offer coverage to all its enrollees in a nondiscriminatory manner.
We invited comment as to whether the approach of § 92.207(b)(1)-(5) is over- or underinclusive of the types of potentially discriminatory claims denials experienced by transgender individuals in their attempts to access coverage and care, as well as on how nondiscrimination principles apply in this context.
Paragraph (c) of § 92.207 of the proposed rule provided that the enumeration of specific forms of discrimination in paragraph (b) does not limit the general applicability of the prohibition in paragraph (a) of this section. Paragraph (d) of the proposed rule provided that nothing in § 92.207 is intended to determine, or restrict a covered entity from determining, whether a particular health care service is medically necessary or otherwise meets applicable coverage requirements in any individual case.
The comments and our responses regarding § 92.207 are set forth below.
In addition, other commenters sought clarification as to the applicability of the rule to wellness programs
While we reject deeming, OCR will consider a covered entity's compliance with other applicable Federal laws in evaluating a covered entity's compliance with this final rule, and will continue to coordinate with other Federal agencies to promote consistency and avoid duplication in enforcement efforts.
Further, we clarify that evidence-based insurance designs and wellness programs offered through covered entities, such as a health insurance issuer or a group health plan that receives Federal financial assistance, are health programs or activities that are subject to the final rule. We decline to expressly prohibit a particular type of practice by wellness programs in the final rule, as complaints will be reviewed on a case-by-case basis. We note that CMS has made clear that covered entities are responsible for ensuring compliance with other applicable Federal and State laws, including nondiscrimination obligations under Federal laws.
By contrast, one commenter supported maintaining the proposed effective date, arguing that the benefits of more immediate implementation of the final rule outweigh any expenses or confusion associated with mid-year policy revisions.
That said, we recognize that some covered entities will have to make changes to their health insurance coverage or other health coverage to bring that coverage into compliance with this final rule. We are sensitive to the difficulties that making changes in the middle of a plan year could pose for some covered entities and are committed to working with covered entities to ensure that they can comply with the final rule without causing excessive disruption for the current plan year.
Consequently, to the extent that provisions of this rule require changes to health insurance or group health plan benefit design (including covered benefits, benefits limitations or restrictions, and cost-sharing mechanisms, such as coinsurance, copayments, and deductibles), such provisions, as they apply to health insurance or group health plan benefit design, have an applicability date of the first day of the first plan year (in the individual market, policy year) beginning on or after January 1, 2017.
Nothing in the text of Section 1557 limits its coverage only to health programs and activities created or regulated by other provisions of the ACA. Indeed, Section 1557's incorporation of the four civil rights laws to which it refers, as those laws were amended by the CRRA, conclusively suggests otherwise. Moreover, Title VI, Section 504, and the Age Act independently apply to these benefits,
There are several statutorily-defined categories of excepted benefits that are exempt from the ACA market reforms and HIPAA portability requirements if certain conditions are satisfied, such as when medical benefits are incidental or secondary to other insurance benefits, when the benefits are limited in scope or supplemental, or when the benefits are provided as independent, non-coordinated benefits.
Some commenters representing issuers and larger employers also objected to language in footnote 73
Third party administrator services are undeniably a health program or activity, as they involve the administration of health services. Under the final rule, if an entity that receives Federal financial assistance is principally engaged in providing or administering health services, health insurance coverage, or other health coverage, then, consistent with the approach taken under the civil rights laws referenced in Section 1557 and under the CRRA, as discussed
Commenters' assertion that employers or group health plans may have an incentive to contract with third party administrators that are operated by entities that do not receive Federal financial assistance does not justify exempting third party administrator services from the rule. Commenters' rationale would undermine the application of all of the civil rights laws that attach obligations to the receipt of Federal financial assistance; if any competitive disparity exists here, it is no different than in other types of businesses in which some entities receive Federal financial assistance and others do not.
Moreover, the fact that third party administrators are governed by other Federal laws such as ERISA is not a reason to exempt them from Section 1557. ERISA itself explicitly preserves the independent operation of civil rights laws, by providing that nothing in ERISA “shall be construed to alter, amend, modify, invalidate, impair, or supersede any law of the United States . . . or any rule or regulation issued under any such law.”
Commenters expressed a number of concerns related to the relationship between third party administrators and the employers whose self-insured group health plans they administer. OCR clarifies here that, contrary to the understanding of some commenters, Section 1557's coverage of a third party administrator under the rule does
In response to commenters' arguments on this point, however, OCR recognizes that third party administrators are generally not responsible for the benefit design of the self-insured plans they administer and that ERISA (and likely the contracts into which third party administrators enter with the plan sponsors) requires plans to be administered consistent with their terms.
Based on these comments, OCR is adjusting the way in which it will process claims that involve alleged discrimination in self-insured group health plans administered by third party administrators that are covered entities. Fundamentally, OCR will determine whether responsibility for the decision or other action alleged to be discriminatory rests with the employer or with the third party administrator. Thus, where the alleged discrimination is related to the administration of the plan by a third party administrator that is a covered entity, OCR will process the complaint against the third party administrator because it is that entity that is responsible for the decision or other action being challenged in the complaint. Where, for example, a third party administrator denies a claim because the individual's last name suggests that she is of a certain national origin or threatens to expose an employee's transgender or disability status to the employee's employer, OCR will proceed against the third party administrator as the decision-making entity. Where, by contrast, the alleged discrimination relates to the benefit design of a self-insured plan—for example, where a plan excludes coverage for all health services related to gender transition—and where OCR has jurisdiction over a claim against an employer under Section 1557 because the employer falls under one of the categories in § 92.208, OCR will typically address the complaint against that employer.
As part of its enforcement authority, OCR may refer matters to other Federal agencies with jurisdiction over the entity. Where, for example, OCR lacks jurisdiction over an employer responsible for benefit design, OCR typically will refer or transfer the matter to the EEOC and allow that agency to address the matter. The EEOC has informed OCR that, provided the filing meets the requirements for an EEOC charge, the date a complaint was filed with OCR will be deemed the date it was filed with the EEOC (although any subsequent denial of a renewed coverage request could be separately challenged by a timely complaint).
This approach is consistent with our efforts to ensure coordination with other Federal agencies that can also exercise jurisdiction over the subject of a particular complaint. Thus, we will also coordinate with the Office of Personnel Management (OPM) in the handling of claims alleging discrimination in the Federal Employees Health Benefits (FEHB) Program. OPM is charged by
In response to the comments requesting additional clarification on footnote 73 in the proposed rule, we reiterate that we will engage in a case-by-case inquiry to evaluate whether a third party administrator is appropriately subject to Section 1557 as a recipient in situations in which the third party administrator is legally separate from an issuer that receives Federal financial assistance for its insurance plans. This analysis will rely on principles developed in longstanding civil rights case law, such as the degree of common ownership and control between the two entities,
OCR will analyze whether a design feature is discriminatory on a case-by-case basis using the framework discussed above. We reiterate that our determination of whether a practice constitutes discrimination will depend on our careful analysis of the facts and circumstances of a given scenario. OCR recognizes that covered entities have discretion in developing benefit designs and determining what specific health services will be covered in their health insurance coverage or other health coverage. The final rule does not prevent covered entities from utilizing reasonable medical management techniques; nor does it require covered entities to cover any particular procedure or treatment. It also does not preclude a covered entity from applying neutral, nondiscriminatory standards that govern the circumstances in which it will offer coverage to all its enrollees in a nondiscriminatory manner. The rule prohibits a covered entity from employing benefit design or program administration practices that operate in a discriminatory manner.
We note that some products known as excepted benefits, which are subject to this final rule as discussed
For instance, many commenters strongly supported the proposed rule's prohibition against categorical or automatic exclusions of coverage for all health services related to gender transition. These commenters further supported the proposed rule's prohibition against otherwise denying or limiting coverage, or denying a claim, for health services related to gender transition if such a denial or limitation results in discrimination against a transgender individual. These commenters expressed hope that these prohibitions will serve to eliminate the significant barriers that transgender individuals have faced in accessing coverage for transition-related care, such as counseling, hormone therapy, and surgical procedures that they said had previously been denied to them because they have been viewed as cosmetic or experimental. Many commenters also favored the prohibition against denying, limiting, or otherwise restricting coverage for health services that are ordinarily or exclusively available to individuals of one sex based on an individual's gender identity. Commenters indicated that the proposed rule's protections will help to resolve various health care disparities suffered by transgender individuals.
Several commenters, however, opposed the protections that the proposed rule affords to transgender individuals. Some commenters suggested that covered entities should
Further, we disagree with commenters who asserted that sex-based discrimination does not include discrimination based on gender identity. As discussed previously,
Thus, we reject commenters' suggestion that the rule require covered entities to provide coverage for all medically necessary health services related to gender transition regardless of the scope of their coverage for other conditions.
At the same time, the rule does require that a covered entity apply the same neutral, nondiscriminatory criteria that it uses for other conditions when the coverage determination is related to gender transition. Thus, if a covered entity covers certain types of elective procedures that are beyond those strictly identified as medically necessary or appropriate, it must apply the same standards to its coverage of comparable procedures related to gender transition. As a result, we decline to limit application of the rule by specifying that coverage for the health services addressed in § 92.207(b)(3)-(5) must be provided
With regard to § 92.207(b)(3), we recognize that not every health service that is typically or exclusively provided to individuals of one sex will be a health service that is appropriately provided to a transgender individual. Nothing in the rule would, for example, require an issuer to cover a traditional prostate exam for an individual who does not have a prostate, regardless of that individual's gender identity. However, the issuer must cover the health services that are appropriately provided to an individual by applying the same terms and conditions, regardless of an individual's sex assigned at birth, gender identity, or recorded gender.
We also clarify that the prohibition in § 92.207(b)(4) on categorically limiting coverage for all health services related to gender transition is intended to prevent issuers from placing categorical, arbitrary limitations or restrictions on coverage for all gender transition-related services, such as by singling out services related to gender transition for higher co-pays; it is not intended to prevent issuers from placing nondiscriminatory limitations or restrictions on coverage under the plan. We have revised the language of the provision to clarify that intent.
The range of transition-related services, which includes treatment for gender dysphoria, is not limited to surgical treatments and may include, but is not limited to, services such as
Moreover, there are available interim methods for correcting initial coverage denials due to computer systems flagging a gender mismatch that issuers can use as their computer systems are updated. For instance, we understand that current billing code practices include general billing code modifiers that are used to identify situations in which issuers need to evaluate further claims that might otherwise be automatically rejected. As a result, issuers could advise health care providers to submit an existing billing code modifier along with a claim for sex-specific services for a transgender patient to flag the billing for the issuer's further review.
For the reasons set forth in the proposed rule and considering the comments received, we are finalizing the provisions proposed in § 92.207 with minor technical revisions for clarity, to make our intent clear, and to ensure consistency with other parts of the final rule. We are making technical corrections to paragraphs (b)(1), (b)(3) and (b)(5) to add the word “coverage” where appropriate to reconcile with other parts of the rule. In (b)(1), we are making two modifications to the language. We are reconciling the usage of “health-related insurance” and “other health-related coverage” by adding “related” to those terms in (b)(1). We are also removing reference to “enrollees” as it unintentionally limited application of the paragraph. In (b)(2), we are replacing text that prohibited employing discriminatory marketing practices or benefit designs with text that prohibits having or implementing discriminatory marketing practices or benefit designs to clarify our intent that both having and applying discriminatory marketing practices and benefit design are prohibited. This clarification does not substantively modify the prohibition set forth in the proposed rule. In (b)(3), we are adding the words “to a transgender individual” for clarity, and are deleting the words “by the plan or issuer” for consistency with other parts of the rule. In (b)(4), we are revising the language to be clear that our intent was to prohibit categorical exclusions or limitations in both benefit design and administration; thus, we are replacing language prohibiting categorical or automatic exclusions or limitations of coverage with language that prohibits having or implementing a categorical exclusion or limitation of coverage. This clarification does not substantively modify the prohibition set forth in the proposed rule. In (b)(5), we also are revising the description of the prohibited actions to reconcile the language with other paragraphs in § 92.207(b).
In § 92.208, we proposed to address the application of Section 1557 to employers that offer health benefit programs to their employees. Under our proposed approach, where an entity that receives Federal financial assistance provides an employee health benefit program to its employees, it will be liable for discrimination in that employee health benefit program under this part only in three defined circumstances.
In paragraph (b), we proposed that where an entity receives Federal financial assistance the primary objective of which is to fund an employee health benefit program, that entity's provision or administration of the health benefit program will be covered by Section 1557 regardless of the business in which the entity is engaged.
In paragraph (c), we proposed that an employer that is not principally engaged in providing or administering health services or health insurance coverage, but that operates a health program or activity (that is not an employee health benefit program) that receives Federal financial assistance, will be covered for its provision or administration of an employee health benefit program, but only with regard to employees in the health program or activity. Thus, we noted that when a State receives Federal financial assistance for its Medicaid program, the State will be governed by Section 1557 in the provision of employee health benefits for its Medicaid employees, but not for its transportation department employees, assuming no part of the State transportation department operates a health program or activity.
In summary, unless the primary purpose of the Federal financial assistance is to fund employee health benefits, we proposed that Section 1557 would not apply to an employer's provision of employee health benefits where the provision of those benefits is the only health program or activity operated by the employer.
We explained that absent the limitations in § 92.208, employers that receive Federal financial assistance for any purpose could be held liable for discrimination in the employee health benefit programs they provide or administer, even where those employers are not otherwise engaged in a health program or activity and where the use of Federal funds for employee health benefits is merely incidental to the purpose of the assistance. We noted that claims of discrimination in such benefits, brought against employers that do not operate other health programs or activities, could be better addressed under other applicable laws. For example, Title VII of the Civil Rights Act of 1964,
We proposed to apply the same analysis of employer liability under Section 1557 whether the employee health benefit program is self-insured or fully-insured by the employer. We provided that where an employer that would otherwise be covered under this section creates a separate legal entity to administer its employee health benefit plan, the employer would continue to be liable for the nondiscriminatory provision of employee health benefits to its employees; the employer, as a recipient, may not, through contractual or other arrangements, discriminate on
The comments and our responses regarding § 92.208 are set forth below.
For the reasons set forth in the proposed rule and considering the comments received, we are finalizing the provisions proposed in § 92.208 with minor technical revisions to ensure consistency with other parts of the final rule by adding the words “or other health coverage.”
In § 92.209 of the proposed rule, we specifically addressed discrimination
(“Where a plaintiff claims discrimination based upon an interracial marriage or association, he alleges by definition that he has been discriminated against because of his race.”)
The comments and our responses regarding § 92.209 are set forth below.
For the reasons set forth in the proposed rule and considering the comments received, we are finalizing the provisions proposed in § 92.209 as proposed without modification.
In proposed § 92.301, we restated the language of Section 1557 regarding enforcement, which provides that the enforcement mechanisms under Title VI, Title IX, the Age Act, or Section 504 apply for violations of Section 1557. We noted that these existing enforcement mechanisms include requiring covered entities to keep records and submit compliance reports to OCR, conducting compliance reviews and complaint investigations, and providing technical assistance and guidance. We further noted that where noncompliance or threatened noncompliance cannot be corrected by informal means, the enforcement mechanisms provided for and available under the civil rights laws referenced in Section 1557 include suspension of, termination of, or refusal to grant or continue Federal financial assistance; referral to the Department of Justice with a recommendation to bring proceedings to enforce any rights of the United States; and any other means authorized by law.
The comments and our responses regarding § 92.301 are set forth below.
Under this approach, given that the Age Act authorizes a private right of action for disparate impact claims, a private right of action would exist for disparate impact claims of discrimination on the basis of race, color, or national origin.
The commenters primarily rely on reasoning in
Similarly, many commenters requested that the regulation clarify that a private right of action exists for disparate impact claims, arguing, like commenters discussed above, that all enforcement mechanisms should be available to all Section 1557 complainants. A few commenters requested that the availability of a private right of action be addressed in the final rule itself, rather than in the preamble.
For the reasons set forth above and in the proposed rule and considering the comments received, we have revised § 92.301 to re-designate existing text as § 92.301(a) and add a new subsection (b) stating that compensatory damages for violations of Section 1557 are available in administrative and judicial actions, as they are under authorities referenced in Section 1557.
In § 92.302, we proposed the procedures that will apply to enforcement of Section 1557 in health programs and activities conducted by recipients and State-based Marketplaces. We noted that the administrative procedures provided for and available under Title VI are found in the regulation implementing Title VI.
We also explained that the administrative procedures provided for and available under the Age Act are found in the regulation implementing the Age Act.
In paragraph (c), we provided that an individual may bring a civil action in a United States District Court in which a recipient or State-based Marketplace
The comments and our responses regarding § 92.302 are set forth below.
For the reasons set forth in the proposed rule and considering the comments received, we are finalizing the provisions proposed in § 92.302 with two modifications. As addressed previously in the discussion of the comments on § 92.5 (Assurances), the text that was previously found at § 92.302(c) has been moved to § 92.302(d), and § 92.302(c) now clarifies OCR's ability to initiate enforcement procedures where a recipient or State-based Marketplace
In the proposed rule, we noted that Section 1557 expressly states that the enforcement mechanisms provided for and available under Title VI, Title IX, Section 504, or the Age Act shall apply for purposes of violations of Section 1557. We also noted that the administrative procedures provided for and available under Section 504—the only one of these statutes that applies to federally conducted, as well as federally assisted, programs—for programs and activities administered by the
In the proposed rule, we proposed to add two provisions that are not found in Section 504 enforcement procedures for programs conducted by the Department. We proposed that the first provision, which reflects OCR's practice under Section 504 and mirrors similar requirements under the Title VI regulation with regard to access to information, is designed to ensure that OCR has the ability to obtain all of the relevant information needed to investigate a complaint or determine compliance in a particular health program or activity administered by the Department.
We further proposed language prohibiting the Department, including Federally-facilitated Marketplaces, from retaliating against any individual for the purpose of interfering with any right or privilege under Section 1557 or the proposed rule or because the individual has made a complaint, testified, assisted, or participated in any manner in an investigation, proceeding, or hearing under Section 1557 or this proposed rule. We explained that Section 504 of the Rehabilitation Act, to which the Department is already subject, provides that the procedures, rights, and remedies under Title VI are available to any individual aggrieved by an act or failure to act by any recipient of Federal financial assistance or Federal provider of such financial assistance under Section 504. Thus, we noted that the prohibition on retaliation under Title VI
We did not receive any significant comments regarding § 92.303. For the reasons set forth in the proposed rule, we are finalizing the provisions proposed in § 92.303 without modification.
The notice of proposed rulemaking called for new collections of information under the Paperwork Reduction Act of 1995.
The final rule calls for the same collections of information as the notice of proposed rulemaking, with one addition: The cost estimates for covered entities to develop and implement a language access plan, should the covered entities choose to do so, given that development and implementation of a language access plan is one of the factors that the Director will consider, if relevant, in assessing whether a covered entity has met its obligation to take reasonable steps to provide meaningful access to each individual with limited English proficiency.
Title: Nondiscrimination in Health Programs and Activities.
OMB Control Number: XXXX-XXXX.
Summary of the Collection of Information: The final rule estimates four categories of information collection: (1) Submission of an assurance of compliance form, per § 92.5; (2) posting of a nondiscrimination notice and posting of taglines, under § 92.8; (3) development and implementation of a language access plan, anticipated per § 92.201; and (4) designation of a compliance coordinator and adoption of grievance procedures for covered entities with 15 or more employees, per § 92.7. Each category is described in the following analysis.
Under the final rule, each entity applying for Federal financial assistance, each health insurance issuer seeking certification to participate in a Marketplace
In addition, each covered entity subject to the final rule is required to post a notice of individuals' civil rights and covered entities' obligations, including acknowledging that the covered entity provides auxiliary aids and services, free of charge, in a timely manner, to individuals with disabilities, when such aids and services are necessary to provide an individual with a disability an equal opportunity to benefit from the entity's health programs or activities; and language assistance services, free of charge, in a timely manner, to individuals with limited English proficiency, when those services are necessary to provide an individual with limited English proficiency meaningful access to a covered entity's health programs or activities. Furthermore, each covered entity is required to post taglines in the top 15 languages spoken by individuals with limited English proficiency by relevant State or States, informing individuals with limited English proficiency that language assistance services are available.
Although the final rule does not require covered entities to develop a language access plan, the development and implementation of a language access plan is one factor that the Director will consider when evaluating a covered entity's compliance with this rule. We anticipate that some proportion of covered entities will develop and implement a language access plan following issuance of the rule.
Additionally, each covered entity that employs 15 or more persons is required to adopt grievance procedures that incorporate appropriate due process standards and that provide for the prompt and equitable resolution of grievances alleging any action that would be prohibited by Section 1557. Each covered entity is also required to designate at least one individual to coordinate its efforts to comply with and carry out its responsibilities under Section 1557, including the investigation of any grievance communicated to it alleging noncompliance with Section 1557.
Need for Information: The requirement that every entity applying for Federal financial assistance, seeking certification to participate in a Health Insurance Marketplace
The posting of a notice of individuals' rights and covered entities' obligations and the posting of taglines in the top 15 languages spoken by individuals with limited English proficiency by relevant State or States are necessary to ensure that individuals are aware of their protections under the law, and are grounded in OCR's experience that failures of communication based on the absence of auxiliary aids and services and language assistance services raise particularly significant compliance concerns under Section 1557, as well as Section 504 and Title VI.
The development and implementation of a language access plan helps ensure meaningful access to persons with limited English proficiency to a covered entity's health programs and activities. While Title VI has long required covered entities to take reasonable steps to provide persons with limited English proficiency meaningful access, the addition of a language access plan brings specificity and increased probability of implementation of the requirement. Although the final rule does not require development and implementation of a language access plan, covered entities may choose to develop and implement a language access plan because the Director will consider, if relevant, the language access plan as one factor when assessing a covered entity's compliance with this rule.
The requirements that every covered entity that employs 15 or more persons adopt grievance procedures and designate at least one individual to coordinate its efforts to comply with and carry out its responsibilities under Section 1557 are similar to requirements included in the Title IX and Section 504 implementing regulations. Through its case investigation experience, OCR has observed that the presence of a coordinator and grievance procedures helps to bring concerns to prompt resolution within an entity, leading to lower compliance costs and more efficient outcomes.
Use of Information: OCR will use this information to ensure covered entities' adherence to the statutory requirements imposed under Section 1557 and this final rule. OCR will enforce the requirements by verifying during investigations of covered entities that an entity has submitted an assurance of compliance and posted the notice and taglines and, for each covered entity that employs 15 or more persons, that an individual has been designated to coordinate its compliance efforts and that appropriate grievance procedures have been adopted, as required.
Description of the Respondents: The respondents are: the Department, each entity that operates a health program or activity, any part of which receives Federal financial assistance, and each entity established under Title I of the ACA that administers a health program or activity. These include such entities as hospitals, home health agencies, community mental health centers, skilled nursing facilities, and health insurance issuers.
Number of Respondents: The number of respondents is estimated to include the 275,002 covered entities affected by the final rule.
Burden of Response: Because the Department provides the assurance of compliance and the final rule provides a sample Notice, sample taglines in 64 languages, and sample grievance procedures, the burden on respondents is minimal. Additionally, because all recipients of Federal financial assistance with 15 or more employees are already expected under other laws to have in place grievance procedures and a designated individual to coordinate their compliance responsibilities, the burden to comply with this requirement will be minimal for most respondents.
The requirement to sign and submit an assurance of compliance exists under other civil rights regulations (Title VI, Section 504, Title IX, the Age Act), and since the Department provides a copy of the Assurance of Compliance form to covered entities, OCR believes this requirement adds no extra burden. OCR believes that the time, effort, and financial resources necessary to comply with this requirement are considered part of the usual and customary business practice and would be incurred by covered entities during their ordinary course of business.
OCR estimates that the burden for responding to the proposed notice requirement is an average of 17 minutes to download and post the notice and that the burden to download and post taglines in the top 15 languages by relevant State or States is also an average of 17 minutes, for a burden total of 34 minutes on average at each of the 405,534 affected establishments (associated with the affected covered entities) in the first year following publication of the final rule. (See Regulatory Impact Analysis, II. Costs, B.2.for a more detailed explanation of the differences between “firm” and “establishment.”) We estimate that administrative or clerical support personnel would perform these functions. Based on the wage rate for a Clerical Support Worker ($15.52) we estimate the annual burden for these two requirements to be approximately $7.1 million after adjusting for overhead and benefits by adjusting the wage rate upward by 100%.
OCR estimates that the burden for developing a language access plan is approximately three hours of medical and health service manager staff time in the first year, and an average of one hour of medical and health service manager staff time per year to update the plan in subsequent years. The value of an hour of time for people in this occupation category, after adjusting for overhead and benefits, is estimated to be $89.24 based on Bureau of Labor Statistics (BLS) data. As discussed later in this analysis, we estimate that approximately 135,000 entities will develop and implement language access plans, as part of the requirement to take reasonable steps to provide meaningful communication with persons with limited English proficiency. These assumptions imply that the total cost of the development of language access plans will be approximately $36.0 million (269,141 entities × 50% of entities × 3 hours per entity × $89.24 per hour) in the first year and approximately $12.0 million (269,141 entities × 50% of entities × 1 hour per entity × $89.24 per hour) per year in subsequent years.
Regarding the requirement that every covered entity that employs 15 or more persons adopt grievance procedures and designate at least one individual to coordinate its efforts to comply with and carry out its responsibilities under Section 1557, based on OCR's complaint workload increase since the enactment of Section 1557, we anticipate that within the first five years following the rule's enactment, complaints will increase approximately 0.5% in the first year, 0.75% in the second year, and 1% in years three through five, but eventually will drop off as covered entities modify their policies and practices in response to this final rule. We estimate that medical and health service managers will handle the grievances, and that a 1% increase in complaints will require 1% of an FTE at each covered entity. Using the annual wage rate for medical and health service managers ($103,680), adjusting for fringe benefits and overhead, and multiplying by the 41,250 entities
Thus, the total estimated annual burden cost for the proposed information collection requirements will be approximately $86.0 million in the first year, $76.2 million in the second year, and $97.5 million per year in years three through five following publication of the final rule.
We asked for public comment on the proposed information collection to help us determine:
1. Whether the proposed collection of information is necessary for the proper performance of the functions of OCR, including whether the information will have practical utility;
2. The accuracy of the estimated burden associated with the proposed collection of information;
3. How the quality, utility, and clarity of the information to be collected may be enhanced; and
4. How the burden of complying with the proposed collection of information may be minimized, including through the application of automated collection techniques or other forms of information technology.
We received no comments with specific data in response to numbers one, two, or three above. With regard to question four, we received comments asking that the proposed collection of information be minimized and stating that it is burdensome for covered entities to develop notices to put in several locations in all their facilities. OCR responded by proposing that OCR develop a model notice of important information and model taglines, to minimize the burden on covered entities. The new cost analysis is included above, in this Information Collection section, as well as in the Regulatory Impact Analysis.
Executive Order 12866
In general, we received few comments with regard to the Regulatory Impact Analysis (RIA), and thus the analysis in the final rule remains fairly similar to the proposed rule, although there are some changes. The comments will be addressed in each section below, as appropriate.
Section 1557 of the ACA prohibits an individual from being excluded from participation in, denied the benefits of, or otherwise subjected to discrimination on the basis of race, color, national origin, sex, age or disability in certain health programs and activities. It applies to any health program or activity, any part of which is receiving Federal financial assistance, and to any program or activity that is administered by an Executive Agency or any entity established under Title I of the ACA.
One of the central aims of the ACA is to expand access to health care and health coverage for all individuals. Equal access for all individuals without discrimination is essential to achieving this goal. Discrimination in the health care context can often lead to poor and inadequate health care or health insurance or other coverage for individuals and exacerbate existing health disparities in underserved communities. Individuals who have experienced discrimination in the health care context often postpone or do not seek needed health care; individuals who are subject to discrimination are denied opportunities to obtain health care services provided to others, with resulting adverse effects on their health status. Moreover, discrimination in health care can lead to poor and ineffective distribution of health care resources, as needed resources fail to reach many who need them. The result is a marketplace comprised of higher medical costs due to delayed treatment, lost wages, lost productivity, and the misuse of people's talent and energy.
We received comments suggesting that we consider either writing a more informative than prescriptive regulation or delaying the regulation. The Department's current experience, however, points to the importance of a regulation that is prescriptive in the sense that it provides concrete guidance. The Department continues to receive many complaints of discrimination and continues to provide technical assistance and outreach in order to promote compliance. In addition, the majority of the comments from the public in response to the proposed rule favored speedy issuance of a strong regulation.
To help address the issues of nondiscrimination in health programs and activities, this regulation seeks to clarify the application of the nondiscrimination provision in the ACA to any health program or activity receiving Federal financial assistance from or administered by HHS or any entity established under Title I. Such clarity will promote understanding of and compliance with Section 1557 by covered entities and the ability of individuals to assert and protect their rights under the law.
In addition, Executive Order 13563 directs Federal agencies to improve regulations and regulatory review by promoting the simplification and harmonization of regulations and to ensure that regulations are accessible, consistent, and easy to understand. Regulations implementing the civil rights laws referenced in Section 1557 contain certain inconsistencies across common areas and subject matters, reflecting, among other things, differences in time and experience when the regulations were issued. The regulation attempts to harmonize these variations where possible.
We received comments asking that the regulation be written in plain language. The approach we adopt in the final rule is to simplify and make uniform, consistent, and easy to understand the various nondiscrimination requirements
The analysis that follows is similar to the analysis set forth in the proposed rule, except as specified in each of the sections that follow.
This final rule applies to any entity that has a health program or activity, any part of which receives Federal financial assistance from the Department, any health program or activity administered by the Department, or any health program or activity administered by an entity created under Title I of the ACA. The following are examples of covered entities as well as health programs or activities under the final rule.
This Department, through agencies such as the Health Resources and Services Administration (HRSA), the Substance Abuse and Mental Health Services Administration (SAMHSA), the Centers for Disease Control and Prevention (CDC), and the Centers for Medicare and Medicaid Services (CMS), provides Federal financial assistance through various mechanisms to health programs and activities of local governments, State governments, and the private sector. An entity may receive Federal financial assistance from more than one component in the Department. For instance, federally qualified health centers receive Federal financial assistance from CMS by participating in the Medicare or Medicaid programs and also receive Federal financial assistance from HRSA through grant awards. Because more than one funding stream may provide Federal financial assistance to an entity, the examples we provide may not uniquely receive Federal financial assistance from only one HHS component.
(1) Entities receiving Federal financial assistance through their participation in Medicare (excluding Medicare Part B) or Medicaid (about 133,343 facilities).
(2) Laboratories that are hospital-based, office-based, or freestanding that receive Federal financial assistance through Medicaid payments for covered laboratory tests (about 445,657 laboratories with Clinical Laboratory Improvement Act certification).
(3) Community health centers receiving Federal financial assistance through grant awards from HRSA (1,300 community health centers).
(4) Health-related schools in the United States and other health education entities receiving Federal financial assistance through grant awards to support 40 health professional training programs that include oral health, behavioral health, medicine, geriatric, and physician's assistant programs.
(5) State Medicaid agencies receiving Federal financial assistance from CMS to operate CHIP (includes every State, the District of Columbia, Puerto Rico, Guam, the Northern Marianas, U.S. Virgin Islands, and American Samoa).
(6) State public health agencies receiving Federal financial assistance from CDC, SAMHSA, and other HHS components (includes each State, the District of Columbia, Puerto Rico, Guam, the Northern Marianas, U.S. Virgin Islands, and American Samoa).
(7) Qualified health plan issuers receiving Federal financial assistance through advance payments of premium tax credits and cost-sharing reductions (which include at least the 169 health insurance issuers in the Federally-facilitated Marketplaces receiving Federal financial assistance through advance payments of premium tax credits and cost sharing reductions and at least 11 issuers operating in the State-Based Marketplaces that we were able to identify).
(8) Physicians receiving Federal financial assistance through Medicaid payments, “meaningful use” payments, and other sources, but not Medicare Part B payments, as the Department does not consider Medicare Part B payments to physicians to be Federal financial assistance. The Medicare Access and CHIP Reauthorization Act amended Section 1848 of the Act to sunset “meaningful use” payment adjustments for Medicare physicians after the 2018 payment adjustment.
In the proposed rule, we estimated that the regulation would likely cover almost all licensed physicians because they accept Federal financial assistance from sources other than Medicare Part B. We noted that most physicians participate in more than one Federal, State, or local health program that receives Federal financial assistance, and many practice in several different settings,
In the proposed rule, we provided our best estimate of the number of physicians receiving Federal financial assistance by analyzing and comparing different data sources and drawing conclusions from this analysis. We noted that, based on 2010 Medicaid Statistical Information System data, about 614,000 physicians accept Medicaid payments and are covered under Section 1557 as a result.
Earlier, before issuing the proposed rule, we identified several grant programs from various Department
In the proposed rule, when we compared the upper bound estimated number of physicians participating in Federal programs other than Medicare Part B (over 900,000) to the number of licensed physicians counted in HRSA's Area Health Resource File (approximately 890,000), we concluded that almost all practicing physicians in the United States are reached by Section 1557 because they accept some form of Federal remuneration or reimbursement apart from Medicare Part B.
We invited the public to submit information regarding physician participation in health programs and activities that receive Federal financial assistance. We received no comments that would change the estimates that we provided; thus, the analysis in this final rule includes the same numbers of physicians as in the proposed rule.
This final rule applies to the Department's health programs and activities, such as those administered by CMS, HRSA, CDC, Indian Health Service (IHS), and SAMHSA. Examples include the IHS tribal hospitals and clinics operated by the Department and the National Health Service Corps.
This final rule applies to entities established under Title I of the ACA. According to the CMS Center for Consumer Information and Insurance Oversight (CCIIO), there are Health Insurance Marketplaces covering 51 jurisdictions: (17 State-based-Marketplaces and 34 Federally-facilitated Marketplaces). The final rule covers these Health Insurance Marketplaces.
It is important to recognize that this final rule, except in the area of sex discrimination, applies pre-existing requirements in Federal civil rights laws to various entities, the great majority of which have been covered by these requirements for years. Because Section 1557 restates existing requirements, we do not anticipate that covered entities will undertake new actions or bear any additional costs in response to the issuance of the regulation with respect to the prohibition of race, color, national origin, age, or disability discrimination, except with respect to the voluntary development of a language access plan. However, we also note that the prohibition of sex discrimination is new for many covered entities, and we anticipate that the enactment of the regulation will result in changes in action and behavior by covered entities to comply with this new prohibition. We note that some of these actions will impose costs and others will not.
Section 1557 applies to the Health Insurance Marketplaces. We note that these entities, along with the qualified health plan issuers participating in the Health Insurance Marketplaces, are already covered by regulations issued by CMS that prohibit discrimination on the basis of race, color, national origin, sex, gender identity, sexual orientation, age, or disability. Thus, we note that the impact of Section 1557 on these entities is limited.
We received a few comments that indicated that the costs of compliance may be more than anticipated in the proposed rule. We have revised the analysis in this final rule based upon the comments and upon an updated statistical review of the health programs and activities.
The following regulatory analysis examines the costs and benefits that are attributable to this regulation only.
We first analyze the costs we expect the final rule to create for covered entities. We anticipate that the final rule will place costs on the covered entities in the areas of: (1) Training and familiarization, (2) enforcement, (3) posting of the nondiscrimination notice and taglines, and (4) revisions in policies and procedures, and may place costs on covered entities in the voluntary area of development of a language access plan. Then we examine the potential benefits the rule is likely to produce. In the subsequent analyses of costs in this RIA and the Regulatory Flexibility Act (RFA), we use data sets from the Census Bureau
In the proposed rule, we made the following cost assessment based on certain key assumptions, which include: (1) We assume that promulgation of this regulation will trigger voluntary activity on the part of covered entities that would not have occurred absent the promulgation of the regulation—which generates both costs and corresponding benefits; (2) to the extent that certain actions are required under the final rule where the same actions are already required by prior existing civil rights regulations, we assume that the actions are already taking place and thus that they are not a burden imposed by the rule; (3) although the regulation does not require training at any specific time, we assume that covered entities may voluntarily provide one-time training to some employees on the requirements of the regulation at the time that the regulation is published; and (4) we assume that employers are most likely to train employees who interact with the public and will therefore likely train between 40% and 60% of their employees, as the percentage of employees that interact with patients and the public varies by covered entity. For purposes of the analysis, we assume that 50% of the covered entity's staff will receive one-time training on the requirements of the regulation. We use the 50% estimate as a proxy, given the lack of certain information as described below. For the purposes of the analysis, we do not distinguish between employees whom covered entities will train and those who obtain training independently of a covered entity.
In the proposed rule, we counted the cost of training on all aspects of the
In the proposed rule, we also assumed that covered entities will provide some workers (not all workers) a one-time awareness or familiarization training regarding the requirements in the regulation at the time of its issuance. We noted that many employees may work “behind the scenes” at large entities, and may not have contact with patients or the general public or otherwise have duties impacted by the final rule's requirements and therefore may have little need for training. However, we noted that we are uncertain which employees those are. Furthermore, we noted that we do not know whether an entity rotates employees into different positions that may have patient contact or relevant duties, or whether, over time, an employee will switch to a position that places him or her in such a position, which may create a need for training. Although we received one comment suggesting that we include all employees in the training, the comment did not provide evidence or data to support including all employees. Otherwise, we received no comments to the contrary; therefore, the final rule makes the same assumption that the proposed rule did, that covered entities will provide some (not all) workers a one-time familiarization training.
In the proposed rule, we also noted that we lack information on State and local regulations that may require employees to receive training on civil rights provisions and whether those provisions are more or less rigorous than the ones we propose. Thus, workers in covered entities in State and local jurisdictions with civil rights provisions more robust than the ones we propose may need only minimal training. In State and local jurisdictions where civil rights provisions are not more robust, workers may need more training. As stated above, because we lack data on covered entities' training practices, we are assuming that covered entities will voluntarily provide training on the final rule for between 40% and 60% of their staffs. Further analysis of state requirements revealed that the states do vary in the robustness of their civil rights requirements, as we assumed in the proposed rule. Therefore, we chose 50% of the employees, the average between 40% and 60%.
Based on comments we received, we added a category of training, for a one-time familiarization by a manager, after the final rule has been published. The manager will need to study and understand the regulation well enough to make assessments of how the entity will promote compliance with the rule, including assessing the training needs of the staff and the costs associated with the training.
In the following section, we identify the pool of workers and staff that we anticipate may need education about the final rule. Next, we identify the covered entities that may choose to train their staffs to provide this knowledge. Last, we estimate the costs of the training materials and the worker time that will be spent in training.
The first category of health care staff that may receive training is comprised of health diagnosing and treating practitioners. This category includes physicians, dentists, optometrists, physician assistants, occupational, physical, speech and other therapists, audiologists, pharmacists, registered nurses, and nurse practitioners. The BLS occupational code for this grouping is 29-1000 and the 2014 reported count for this occupational group is approximately 4.8 million.
The second category of health care staff that we assume will receive training is comprised of degreed technical staff (Occupation code 29-2000) and accounts for 2.9 million workers. Technicians work in almost every area of health care: From x-ray to physical, speech, psychiatric, dietetic, laboratory, nursing, and records technicians, to name but a few areas.
The third category of health care staff that we assume will receive training is comprised of non-degreed medical assistants (Occupation code 31-0000), and includes psychiatric and home health aides, orderlies, dental assistants, and phlebotomists. Health care support staffs (technical assistants) operate in the same medical disciplines as technicians, but often lack professional degrees or certificates. We refer to this workforce as non-degreed compared to medical technicians who generally have degrees or certificates. There are approximately 3.9 million individuals employed in these occupations.
The fourth category of health care staff that we assume will receive training is health care managers (approximately 0.3 million based on BLS data for occupation code 11-9111). Because we assess costs of familiarization with the regulation for one manager at each entity, we assume that those managers will have already become familiar with the regulation and will not need additional training.
The fifth category of health care staff that we assume will receive training is office and administrative assistants—Office and Administrative Support Occupation (Occupation code 43-0000). These workers are often the first staff patients encounter in a health facility and, because of this, covered entities might find it important that staff, such as receptionists and assistants, receive training on the regulatory requirements. Approximately 2.7 million individuals were employed in these occupations in health facilities in 2014.
One comment asked that outreach workers be explicitly included as a category to be trained. We assume that outreach workers are included in the five categories listed above, especially in the manager category.
Below is a summary table of individuals employed in the health care sector.
We have data from CMS/CCIIO on the number of issuers offering qualified health plans in the Federally-facilitated Marketplaces.
We performed this imputation by first identifying the number of issuers offering qualified health plans in the Federally-facilitated Marketplaces. To determine the number of issuers offering qualified health plans in the Federally-facilitated Marketplaces, we looked at the 2015 Qualified Health Plan Landscape Individual and Small Business Health Options Program Market Medical files.
In addition to 169 issuers participating in Federally-facilitated Marketplaces, we are aware of 11 issuers participating only in the State-based Marketplaces. Thus, we calculated that the total number of issuers included in the analysis of covered issuers equals 180.
We next analyzed the number of employees working in the health insurance industry in the following way. Using Census Bureau 2011 payroll and employment data (the latest data available) for North American Industry Classification System 524114—Direct Health Insurance,
The Census data shows 805 small issuers and 180 large issuers. The ratio of small to large issuers is about 4.5 small issuers for every large issuer. We assume the ratio of small to large issuers in the Health Insurance Marketplaces is approximately the same as the ratio in the Census table. We asked for public comment on this assumption, and we received no comments to the contrary.
Applying this ratio to the issuers in the Federally-facilitated Marketplaces, we get 131 small issuers and 38 large issuers. We assume that the 11 issuers (for which we have data and have thus identified) operating in the State-based Marketplaces are likely to be classified as small, based on Census workforce data. Therefore, we are adding them to the 131 small issuers identified above, bringing the total number of small issuers to 142.
Based on the Census data, the average number of employees in a small issuer is 34 and the average number of employees in a large issuer is 2,300. If we multiply the number of issuers by the number of employees, there are 4,828 employees of the 142 small issuers and 87,400 employees of the 38 large issuers. The combined total number of employees for small and large issuers in the Marketplaces is estimated to be 92,228 employees.
With respect to the majority of issuers operating in a State-based Marketplace
At the same time that we include employees who work for issuers operating in both the Federally-facilitated Marketplaces and State-based Marketplaces, we lack direct data on issuers participating only in State-based Marketplaces. We are not able to include employees that work for insurance issuers that operate only in State-based Marketplaces, such as New York or California, which would be subject to the proposed rule. We invited public comment on ways we could identify issuers that participate only in State-based Marketplaces and the number of employees they employ. We did not receive any comments that identified ways we can better identify these issuers.
A third category of workers who may need to be trained are navigators receiving Federal financial assistance to support the functions they perform in Federally-facilitated Marketplaces, such as assisting applicants to enroll in qualified health plans through the Marketplace
We invited public comment on our approach to estimating the number of employees per issuer based on the Census data and sought any public information on issuers who operate only in State-based Marketplaces. We did not receive comments that changed our assumptions regarding types and numbers of employees working for Marketplaces. Thus, the final rule applies the estimate of the number of navigators per Navigator entity to the most recent number of Navigator grantees.
The Census Bureau State government payroll and employment data for 2012 shows the number of full-time employees working in State hospitals and departments of health as 531,251.
To address this problem, we looked at the BLS industry data for North American Industry Classification System code 999201: State government, including schools and hospitals, we identified 442,680 personnel employed by State governments.
The 2012 Census data for all U.S. industries identifies 43,343 pharmacy establishments. The number of employees presented in the Census data includes both pharmacists and non-pharmacist personnel. At this point, we must refer back to the BLS data on the number of health care workers reported for 2014 because the BLS data divides the pharmacy workforce by occupation. The number of employees that BLS reports were employed in pharmacies for 2014 is 708,660. The number of health care workers discussed in subsection II.C.1.a. above includes 348,190 individuals counted above in occupation codes 11-9111, 29-0000 and 31-0000 reported to be working in pharmacies.
The following table shows the total number of employees whom we estimate will receive training; that is, the table shows the 50% of total workers whom we estimate may receive training. The table does not include HHS employees conducting HHS health programs or activities because there are roughly 65,000 HHS total employees and many of these employees do not work in health programs or activities administered by HHS. For those employees who do work in health programs or activities administered by HHS, many may not have direct beneficiary contact. Given these limitations, we estimate the number of employees added would be small and have little impact on overall cost.
Just as there are a number of data sources for counting workforce, there are various sources for counting the number of health care entities. Many covered entities are controlled or owned by a single corporate entity, and one can count each individual entity separately or count only the single corporate enterprise. For example, a multi-campus facility or vertically integrated entity that owns a hospital, a nursing home, and a home health agency and also operates an accountable care organization could count each of these entities separately—as does Medicare—or count them only once, with each entity treated as part of the corporate entity. At this point, we make two assumptions: (1) Albeit not required to do so by the regulation, each covered entity will provide some training to its staff on the requirements of the regulation; and (2) when entities are controlled or owned by a corporate entity, the corporate entity will supplement or make any desired modification to the OCR training materials and distribute the training materials. We believe this last point to be especially true because rather than have each entity prepare its own training materials, the corporate entity is more likely to prepare one set of training materials and distribute the materials to its individual entities. This is because the corporate entity saves money by preparing a limited set of training materials and assures uniform quality and consistency in its policies across all its entities. It is also possible that some local health centers in a State may be managed from a central location that handles logistics and training materials. Therefore, we propose using the 2012 Census table that presents the number of entities, referred to as firms in the Census tables, to count the number of health care entities. In the Census data, a corporate entity is referred to as a “firm” and the corporation's facilities are “establishments.” When a firm has one
Another difficulty we face in using these data sources is that the Census data captures all entity types that fit the definition of a health care service entity, including entities such as private retirement communities that are unlikely to receive Federal financial assistance and thus would not be covered by Section 1557. In our use of the Census data, we attempted to exclude types of entities that are not likely to receive Federal financial assistance by excluding retirement communities and other similar type entities in the file, but we have included entities that may receive Federal financial assistance, such as community health centers and residential centers for individuals with intellectual disabilities.
To test our success in producing a list of covered entities from the Census data, we compared the number of entities we selected from the Census data and the number of entities included in the CMS Provider of Service file. However, to make the lists comparable, we had to remove the count of Clinical Laboratory Improvement Act laboratories from the CMS Provider of Service data files. There are close to 450,000 Clinical Laboratory Improvement Act laboratories located in hospitals, clinics, outpatient centers, and doctors' offices. Only a few thousand of these laboratories serve the public. The majority of laboratories serve the facility in which they are housed—including them in our comparison would grossly distort this comparison.
If we add the entities in the Provider of Service file (excluding Clinical Laboratory Improvement Act laboratories) and the number of community health centers to our list of affected entities that are not included in the Provider of Service file, we get a total of 134,543 entities. Using the Census data, minus the categories for medical laboratories, we obtain a total of 139,164 covered entities. It is evident that these numbers are very similar. However, as discussed earlier, we propose using only the number of firms for the analysis of the number of entities possibly conducting training, that is, 70,384 firms. As noted, we believe firms and not establishments will modify or supplement materials and train employees.
In addition to the firms we include from the Census file, we must add physicians' office firms and pharmacy firms because they may also need to train some workers. Physicians' office firms and pharmacy firms are generally referred to as physician group practices and pharmacy chains.
Below we present the types and number of firms that we estimate will take part in the training for the regulation.
There are two components to the cost of training the workers we identified in the previous section: (1) The cost of training materials that is based on the number of covered entities identified in the previous section; and (2) the cost of employee time spent in training.
OCR estimates, based on its experience of training employees on other regulations it enforces, that training employees on this regulation will take about one hour of an employee's time. Based on discussions with firms that develop training materials, we estimate that developing or presenting materials for a one-hour course would cost about $500. However, before the effective date of the rule, OCR will provide covered entities with training materials that will cover the key provisions of the regulation that can be used by entities in conjunction with their own training materials. We estimate that OCR preparing the training materials on the regulation will substantially reduce the material preparation burden to covered entities and reduce the cost by about three quarters, or about $375 per entity. Therefore, the costs to entities will equal $125 multiplied by the number of entities that will prepare and present training materials. Based on its experience in preparing training materials for other civil rights and HIPAA regulations, OCR expects to spend $10,000 to develop training materials that will prepare health care workers and managers to effectively implement the Section 1557 regulation.
Training materials can be presented in a number of ways. A common method for offering training materials is through e-courses that are distributed over an entity's computer network. Another method is to offer lectures to selected employees/staff and then have attendees present the materials to their co-workers as part of train-the-trainer programs. For small entities, one lecture session may be given to all employees. Regardless of presentation mode, we estimate that the cost of training via an e-course will be
Applying the $125 per course materials to the number of firms ($125 × 275,002)—including the 169 health insurance issuers—equals $34.4 million for the cost of developing training materials.
The next step is to compute the cost of employee time for training and familiarization. This involves taking the hourly wage rate times the amount of time that a new activity will require, times the number of employees expected to undertake the activity as a result of the rule. We use data from the BLS on median wage rates by occupation to estimate wages throughout this analysis. We are uncertain about how many employees identified in the workforce above will actually seek and obtain training and how many firms in the health sector will offer training. However, for the purposes of this analysis we assume that all firms may offer some training to their staffs, but because the training is voluntary, and because only a portion of employees who have direct patient contact or otherwise have duties impacted by the regulation may require or take training, we assume that 50% of employees will receive training. We assume that training will require an average of one hour of time for each participating employee.
The occupation code 29-1000 (health care practitioners) applies to the 4.8 million professional staff and degreed technical staffs we discussed above. The BLS reports the median hourly wage for this code as $36.26. We estimate one hour of a worker's time would be required for training. To this amount we must add 100% for fringe benefits and overhead, which yields an adjusted hourly wage per employee of $72.52. Assuming that half of the 4.8 million health care practitioners identified earlier receive or obtain training (2.4 million workers), and multiplying this number by the hourly employee wage plus fringe benefits and overhead for one hour equals slightly more than $175.3 million in training costs for practitioners.
We note that one commenter suggested that we use a factor higher than 100% to adjust wages for overhead and benefits. However, the commenter's argument is based on Federal overhead rates for contracts, and not evidence of the resource costs associated with reallocating employee time. As a result, we do not adopt the commenter's recommendation, and we continue to use the Department's standard of 100% for overhead and fringe benefits.
For the degreed health care work force in occupation 29-2000, the median hourly wage is $19.92. Adding 100% for fringe benefits and overhead equals $39.84. The total training cost for one hour of training for half of the 2.9 million degreed technical staff (1.44 million workers) is about $57.3 million. In addition, we must add the cost of training non-degreed staff (reported in occupation 31-0000) who earn a median hourly wage of $12.71. Adding 100% for fringe benefits and overhead to the $12.71 median hourly wage rate yields an adjusted wage of $25.42. Multiplying this amount by half of the 3.9 million workforce yields a cost of $50.1 million.
To these amounts we must add the cost associated with familiarization and training for the medical and health service managerial staff, of which there are 300,320 individuals with a median hourly pay rate of $44.62. Adding 100% for fringe benefits and overhead gives us an adjusted hourly wage of $89.24. We assume that an average of one person in this occupation will spend an average of two hours becoming familiar with the final rule's requirements upon its publication at each of the 275,002 entities covered by the rule. These assumptions imply familiarization costs of $49.1 million. We assume that half of the remaining managers receive training. This implies that 12,659 managerial staff will receive an hour of training, which results in a cost of $1.1 million. This implies that total costs for training and familiarization for this occupation category comes to $50.2 million.
The cost of training occupation code 43-0000, office and administrative support workers employed in covered health care entities, is the product of the median hourly rate of $15.52 adjusted for fringe benefits and overhead multiplied by the 2.7 million workers reported for North American Industry Classification System code 62: Health Care and Social Assistance (including private, State, and local government hospitals). Adding 100% for fringe benefits and overhead to the $15.52 equals $31.04. Multiplying the pay rate by half the number of support and administrative personnel equals $42.6 million.
The 2013 BLS data for North American Industry Classification System pharmacies and drugstores reports a total workforce of 708,660 workers. As with the analysis for State employees, we must remove the 348,190 health care workers who are already counted in our training costs analysis of the health care workforce. To avoid double counting training costs for these occupations, we removed them from the count of the pharmacy workforce. (The entities that employ these workers will still bear the cost for training them.) Their median weighted wage is $17.22, which is derived from BLS data for medical pharmacy personnel, and the cost associated with an hour of their time is $34.44 after adjusting for overhead and benefits. We estimate $6.0 million in costs for training half of these medical pharmacy personnel.
For the 360,470 non-medical pharmacy personnel, their weighted median hourly rate for pharmacy employees is $11.87, which is derived from BLS data for non-medical pharmacy personnel. After adjusting for overhead and benefits, the cost of one hour of time in this category is $23.74. We estimate $4.3 million in costs for training half of these non-medical pharmacy personnel.
For the 3,040 navigators, we lack data to determine their wages. As a proxy, we use the wage rate for medical and health service managerial staff, with a median hourly pay rate of $44.62. Adding 100% for fringe benefits and overhead gives us an adjusted hourly wage of $89.24. We estimate $0.1 million in costs for training half of these navigators.
For the remaining entities for which we cannot use BLS data, we must use the industry payroll and employment Census data. To arrive at an estimate of the cost of time for training employees of health insurance issuers and State health and Medicaid agencies, we must divide the total annual payroll reported for these entities by the total number of employees and divide that number by the annual hours paid (2,080 hours), adjusted for fringe benefits and overhead.
For workers employed by the issuers participating in the Health Insurance Marketplaces, it was necessary to determine the hourly wage rate for workers employed in small and large issuers as we have described them above. The total number of workers in small entities (fewer than 500 workers) is 27,269 and the annual payroll is $1.68 billion. The average wage per employee is $61,895. Using the 2,080 hours for the annual number of work hours, we obtain an hourly rate of $29.76.
The total number of employees employed by large issuers (500 or more) is 415,017 and the annual payroll is $30.8 billion. The average annual wage is $74,219. Dividing this figure by 2,080 hours yields an hourly wage rate of $35.68. Multiplying by 100% for fringe benefits and overhead yields $71.36. Multiplying this amount by 50% of the 87,400 workers equals slightly more than $3.12 million in training costs.
For State government workers employed in welfare, health, and hospital services, we divided the total number of workers the 2012 Annual Census Bureau reported (873,289 employees) into the monthly payroll reported for the period ($3,774,775,691).
In the State Medicaid Operations Survey: Second Annual Survey of Medicaid Directors, States reported the median number of full-time Medicaid employees is 421. Using this number multiplied by the 53 Medicaid agencies in the 50 States, the District of Columbia, Puerto Rico, Guam, and the other territories, we added 22,313 workers to the total of health and hospital workers reported in the Census data, bringing the total number of workers in covered State government entities to 553,564. We then subtracted the 442,680 medical personnel we accounted for in the training costs for all health care personnel and therefore were considered to be duplicative of the medical personnel previously counted in our analysis of medical staff workforce (occupations 29-1000, 29-2000 and 31-0000). This left a net of 110,884 State employees receiving training. Taking half of this number and multiplying it by $49.87 equals a training cost of slightly more than $2.76 million.
Although we removed the cost of training the 442,680 medical personnel from the State training cost analysis to avoid double counting training costs, the cost of training half the medical staff may still fall to the States where they are employed. We estimate the cost to train State medical personnel to be approximately $11.1 million.
As noted above, total familiarization costs are estimated to be $49.1 million. The following table summarizes the training costs we estimate for this rule.
Pursuant to the regulations implementing Section 504, recipients of Federal financial assistance with 15 or more employees are required to designate a responsible employee to coordinate compliance with respect to nondiscrimination requirements and to have grievance procedures to address complaints of discrimination under this law. Of the 275,002 covered entities, approximately 15% employ more than 15 employees, resulting in approximately only slightly more than 41,250 covered entities being required to have grievance procedures and designate a responsible official. Thus, all recipients of Federal financial assistance with 15 or more employees are already expected to have in place grievance procedures and a designated employee to coordinate their compliance responsibilities. The rule standardizes the requirement to designate a responsible employee and adopt grievance procedures across all bases of discrimination prohibited under Section 1557.
To implement the rule, a recipient of Federal financial assistance could increase the responsibilities of an already-designated employee to handle compliance with the rule's nondiscrimination requirements. In addition, a recipient of Federal financial assistance could increase the scope of existing grievance procedures to accommodate complaints of discrimination under all bases prohibited under Section 1557. The costs associated with these requirements are the costs of training the designated employee on the employee's increased responsibilities and the costs associated with modifying the existing grievance procedures to reflect the additional bases of race, color, national origin, sex, and age. Here we are referring to employee training to perform their specific enforcement responsibilities, not one-time training in the provisions of the final rule described in the training section above. We also note that grievance officials will probably receive specific training on their new responsibilities and that covered entities will probably provide this additional training and absorb the costs, which are expected to be de minimis. Many covered entities already may be using their existing grievance procedures to address the additional cases covered under Section 1557.
State-based Marketplaces are required to designate an employee to handle compliance responsibilities and to adopt grievance procedures under the ADA. The duties of the employee and
We have not estimated the additional costs of training grievance officials on their individual enforcement responsibilities, but we believe such cost would be absorbed in general training costs of all employees on their job responsibilities. Costs associated with modifying existing grievance procedures are covered in the section of the analysis on enforcement.
The implementing regulations of Title VI, Section 504, Title IX, and the Age Act require recipients of Federal financial assistance and, in the case of Section 504, the Department, to notify individuals that recipients (and, under Section 504, the Department) do not discriminate. The content of the nondiscrimination notices varies based on the applicable civil rights law.
The final rule harmonizes notification requirements under Title VI, Section 504, Title IX and the Age Act, and standardizes the minimum information for a notice. The final rule also requires initial and continuing notification of individuals. OCR drafted a sample notice (located in Appendix A to Part 92) in English that meets the requirements and will translate that notice into 64 additional languages, in advance of the effective date of this rule. Covered entities have discretion to use the OCR sample notice or their own notice, if preferred, and to post the notice in non-English languages.
As all Section 1557 covered entities will need to create or update an existing notice of nondiscrimination, all covered entities can discharge their responsibilities under § 92.8(a) by replacing their current notices with the sample notice developed by OCR (found in Appendix A), available to all covered entities pursuant to § 92.8(c). Using the sample OCR notice means that covered entities will not have to compose their own notices; we expect nearly all covered entities will use the sample OCR notice.
All covered entities will incur costs, however, to implement § 92.8(a) of the final rule, which requires “initial and continuing” notification. Such notification is expected to involve:
• Downloading the notice from the OCR Web site;
• Printing copies of the notice for posting;
• Posting hard copies of the notice in public spaces of the office or facility; and
• Posting the notice on the entity's Web site, if it has one.
While many costs to comply with this rule are incurred at the entity level, the costs of downloading, printing, and posting the notice are incurred at the establishment level. There are approximately 275,000 covered entities covered by this final rule. According to 2012 Census data, these covered entities are associated with 405,534 establishments. We estimate that a clerical worker at each establishment would spend an average of one minute downloading the notice from the OCR Web site, an average of one minute printing copies of the notice for posting, an average of five minutes posting hard copies of the notice in public areas, and an average of ten minutes total between preparing the OCR notice for posting on the facility's Web site and posting the notice on the Web site. This implies that the estimated cost associated with posting is $8.79 ($31.04 per hour × 17 minutes × 1 hour per 60 minutes) per establishment, which implies that the total estimated cost associated with this requirement is $3.6 million ($8.79 per establishment × 405,534 establishments).
Covered entities will need to update their significant publications and significant communications to include the new notice. However, as noted above, OCR is allowing entities to exhaust their current publications, rather than do a special printing of the publications to include the new notice. When covered entities restock their printed materials, they will be expected to include in those printed materials the notice that OCR will provide with this final rule.
Because we are permitting covered entities to exhaust their existing stock of publications with the current notices before using the new notice, we conclude that the notice requirement imposes no resource costs related to including updated notices in the publications.
Section 92.8 provides covered entities discretion to post the OCR sample notice of nondiscrimination in non-English languages, which can include languages that differ from OCR's list. In addition, covered entities can draft and translate their own notice in however many languages they choose, if they prefer.
We examined CMS contractual cost for translating a one page notice into 13 languages. It was $1,000 per page. Based on this figure, we expect total costs to the government to be limited to $64,000 to translate the notice into 64 languages and place the translated notices on OCR's Web site. The sample notice is one page long. In addition, we expect total costs to the government for translating the statement of nondiscrimination for small-size publications to be $50 for each of the 64 languages. We count the nondiscrimination statement as .05 pages long.
Although not required, we expect that many covered entities would choose to post the OCR-provided notice in one or more non-English languages on their Web sites, in their physical office space, and in certain publications they may have. We do not know how many covered entities would take this action or how many non-English language versions of the notice they would choose to post, or where they would make the non-English versions of the notice available.
Section 92.8 requires covered entities to publish taglines indicating the availability of language assistance services in the top 15 languages of the relevant State or States. Before the effective date of the rule, OCR will make these taglines available electronically in 64 languages; therefore, there will be no burden to the covered entity other than the cost of printing and posting these taglines, as described above with respect to the notice. We are uncertain of the exact volume of taglines that will be printed or posted, but we estimate that covered entities will print and post the same number of taglines as notices and therefore the costs would be comparable to the costs for printing and disseminating the notice, or $3.6 million. The costs to the Federal government for translating the taglines will be approximately $50, based on counting each tagline as being .05 pages long. We estimate that the combined costs of printing and distributing notices, nondiscrimination statements, and taglines will be $7.1 million for entities and $70,400 for the Federal government.
In the proposed rule, we said that § 92.201, which effectuates Section 1557's prohibition of national origin discrimination as it affects individuals with limited English proficiency, does not pose any new burden on covered entities. This is because, with regard to recipients of Federal financial assistance, the proposed rule adopted recipients' existing obligations under Title VI to take reasonable steps to provide meaningful access to individuals with limited English proficiency and codified the standards consistent with long-standing principles from the HHS LEP Guidance regarding the provision of oral interpretation and written translation services. However,
Although Title VI does not apply to the Department, Executive Order 13166 “Improving Access to Services for Persons with Limited English Proficiency” has applied to HHS for nearly 15 years.
In order to estimate the costs of developing a language access plan for recipients of Federal financial assistance, we assume that developing a plan requires approximately three hours of medical and health service managers staff time for the first year, and then an average of one hour of medical and health service managers staff time per year to update the plan in subsequent years. We based our assumption of three hours on feedback from covered entities included in our pre-award compliance review program. This program reviews civil rights compliance of 2,000 to 3,000 health care provider applicants for Medicare Part A per year.
The health care providers that receive Medicare Part A funds already have to develop a written language access plan as a requirement of participation in the Medicare Part A program. Thus, we can reduce the number of covered entities from having a new burden of developing a language access plan. CMS reports data on Medicare hospital spending per claim which identifies 3,209 unique hospitals, which suggests that at least 3,209 hospitals participate in Medicare Part A. As discussed previously, Census data reports that there are a total of 3,688 hospital firms in the United States. Census data reports that there are 6,741 establishments associated with these firms, which in turn suggests that at least 47.6% (3,209/6,741) participate in Medicare Part A. Census data also reports that there are 8,623 nursing care facility entities in the United States. For the purpose of this analysis, we assume that 47.6% of hospitals and nursing care facilities participate in Medicare Part A. Applying 47.6% to all hospitals and nursing care facilities, we estimate that 5,861 entities (47.6% × 3,688 hospital entities (firms) + 47.6% × 8,623 nursing care facility entities) covered by this rule participate in Medicare Part A. This implies that 269,141 entities (firms) will potentially make changes and develop a language access plan as a response to the rule. We arrived at the 269,141 number by subtracting the number of entities participating in Medicare Part A (5,861) from the total number of entities (275,002). We estimate that 50% of these entities will make these changes. Taken together, these assumptions imply that the total cost of the development of language access plans will be approximately $36.0 million (269,141 entities × 50% of entities × 3 hours per entity × $89.24 per hour) in the first year and approximately $12.0 million (269,141 entities × 50% of entities × 1 hour per entity × $89.24 per hour) per year in subsequent years.
We received a number of comments stating that developing a language access plan imposes a cost burden on covered entities. We revised the proposed rule to include cost estimates, in this final rule, for the development of language access plans, as outlined in the paragraph above. We also received comments that providing interpreters imposes a heavy burden on covered entities. The obligation to provide interpreters as part of taking reasonable steps to provide meaningful communication with individuals with limited English proficiency has been a requirement under Title VI for many years. As a result of developing a language access plan, a covered entity might find increased efficiencies in providing language assistance services. Another covered entity might incur extra costs for the provision of language assistance services on more occasions. We are unable to estimate at this point how many covered entities will incur extra costs or the extent of such costs or the savings realized in increased efficiencies. We anticipate that the potential increased efficiencies and increased costs may offset each other to some degree. Thus, we do not believe this rule will impose a greater burden regarding the costs of language assistance services than exist under Title VI.
Section 1557 prohibits discrimination on the basis of sex in certain health programs and activities. When providing services, including access to facilities, covered entities must provide individuals with equal program access on the basis of sex, and covered entities are required to treat individuals in a manner consistent with their gender identity.
Title IX applies to educational institutions. Therefore, medical schools, nursing programs, and other health education programs were already prohibited from discriminating on the basis of sex prior to the enactment of Section 1557. Under Section 1557 and this regulation, health insurance issuers receiving Federal financial assistance, hospitals, clinics and other health facilities, HHS health programs and activities, and Title I entities, along with the staff and practitioners working in these health programs, are now similarly prohibited from discriminating on the basis of sex.
Covered entities that provide or administer health services or health insurance coverage are covered by the prohibition of discrimination on the basis of sex. The costs that we anticipate that covered entities would incur relate to: (1) Training; (2) enforcement; (3) the posting of the notice; (4) the revision of policies and procedures; and (5) some costs associated with changes in discriminatory practices. This section discusses costs related to changes in policy and procedures and potential changes in discriminatory practices.
The rule would not invalidate specialties that focus on men or women,
Under the sex discrimination prohibition, however, providers of health services may no longer deny or limit services based on an individual's sex, without a legitimate nondiscriminatory reason. Although a large number of providers may already be subject to state laws or institutional policies that prohibit discrimination on the basis of sex in the provision of health services, the clarification of the prohibition of sex discrimination in this regulation, particularly as it relates to discrimination on the basis of sex stereotyping and gender identity, may be new. We anticipate that a large number of providers may need to develop or revise policies or procedures to incorporate this prohibition. For example, if a hospital or other provider has specific protocols in place for domestic violence victims, but engages that protocol only for women, the provider would have to revise its procedures to require that protocol for all domestic violence victims regardless of sex. A provider specializing in gynecological services that previously declined to provide a medically necessary hysterectomy for a transgender man would have to revise its policy to provide the procedure for transgender individuals in the same manner it provides the procedure for other individuals.
We assume that it will take, on average, three to five hours for a provider to develop or modify policies and procedures concerning sex discrimination. We are selecting four hours, or the midpoint of this range, for our analysis. We further assume that an average of three of the hours will be spent by a mid-level manager equivalent to a front-line supervisor (Occupation code 43-1011), at a cost of $48.84 per hour after adjusting for overhead and benefits, and an average of one hour will be spent by executive staff equivalent to a general and operations manager (Occupation code 11-1021), at a cost of $93.54 per hour after adjusting for overhead and benefits. We further assume that 75% of covered entities will need to develop or modify policies and procedures, given that some proportion of health care providers already prohibit sex discrimination based on State law or institutional policies prohibiting discrimination generally. The total cost for the estimated 206,252 covered entities to make their policies and procedures consistent with the regulatory prohibition on discrimination on the basis of sex is estimated to be approximately $49.5 million, which we assume is divided evenly between the first two years of compliance.
The above estimates of time and number of entities that would have to revise their policies under the regulation is an approximate estimate based on general BLS data. Due to the wide range of types and sizes of covered entities, from complex multi-divisional hospitals to small neighborhood clinics and physician offices, the above estimates of time and number of entities that would have to revise their policies under the regulation is difficult to calculate.
For providers that discriminate on the basis of sex in violation of the rule, some changes in behavior or action would be necessary to come into compliance. We anticipate some change in the patient population for which a particular provider provides care or the extent of services provided. However, the infrastructure and protocols for providing services or treatment are already in place; providers would simply have to start providing those existing services in a nondiscriminatory manner to individuals regardless of sex. For example, a provider could not refuse to treat a patient for a cold or a broken arm based on the patient's gender identity. Similarly, if the provider is accepting new patients, it must accept a new patient request from a transgender individual and cannot decline to accept a transgender individual in favor of a person who is not transgender.
However, the rule does not impose a burden on covered entities with respect to the number of patients treated. The rule does not require a covered entity to change the total number of patients it sees or to treat more patients than it currently accepts. Providers may continue to treat the same number of patients that were accepted prior to the issuance of this final rule, but they must do so in a nondiscriminatory manner. Thus, for example, if a provider is not accepting new patients, the provider does not have to accept a new patient request from a transgender individual. We anticipate that the costs associated with these types of changes would be de minimis.
Moreover, costs associated with administering care or treating a new patient generally would be offset by the reimbursement received by the provider for providing the care, in the same way the provider gets paid for existing care or treatment of patients. Thus, for example, for the hospital or other provider that needs to revise its protocol for domestic violence to require that protocol for all domestic violence victims regardless of sex, rather than just women, there would be little to no net increase in costs for treating men because the hospital or provider would be paid for its services in the same way it is paid to treat women.
The ACA, including Section 1557, changed the health care landscape for millions of people by instituting protections against sex discrimination in the provision of health care and health insurance coverage. Prior to the ACA, it was standard health insurance practice to treat women differently in premium pricing and coverage of benefits,
The ACA addresses inequitable treatment by health plans based on sex in multiple ways. The regulations from CMS implementing the ACA prohibit Title I entities
In addition, the ACA prohibits many health insurance issuers from charging higher premiums based on sex;
Section 92.207 (Nondiscrimination in health insurance and other health coverage) of the rule prohibits discrimination on the basis of sex by a covered entity providing or administering health insurance or other health coverage. As noted, many of the same covered entities subject to Section 1557, including Health Insurance Marketplaces and health insurance issuers in the individual and small group markets that are recipients of Federal financial assistance, are also subject to existing nondiscrimination provisions in CMS regulations. Although the CMS regulations complement and do not replace Section 1557 or this part, the existing nondiscrimination requirements applicable to health insurance issuers and Health Insurance Marketplaces have made these entities aware that they are not permitted to discriminate on the basis of sex, sexual orientation, or gender identity, and thus they are familiar with their nondiscrimination obligations under the law. We assume that these covered entities have already taken steps to comply with CMS regulations and so instituted changes in their policies and actions. To the extent these existing obligations overlap with Section 1557 and covered entities have complied with the CMS regulations that prohibit discrimination on the basis of sex, sexual orientation, and gender identity, this rule will impose little or no burden on health insurance issuers and Title I entities to comply with Section 1557's and this part's prohibition on sex discrimination. However, the rule nonetheless imposes some costs.
There may be some incremental burden on issuers and Title I entities in terms of the additional guidance that this rule provides related to sex discrimination, because, in some circumstances, it provides more detail than CMS regulations or guidance. Therefore, covered entities may have an increased burden when incorporating this rule into their existing nondiscrimination policies and procedures. For example, this rule specifies that a categorical coverage exclusion or limitation for all health care services related to gender transition is discriminatory on its face. If a covered entity had not previously understood sex discrimination on the basis of gender identity in this way, the covered entity would have to revise its policies and procedures to provide coverage consistent with this final rule's parameters, which might include revising policies to include gender transition-related care.
However, we note that the number of major U.S. employers providing transgender-inclusive health care coverage has been increasing, from 0 in 2002, to 49 in 2009, 278 in 2013, 336 in 2014, 418 in 2015, and at least 511 in 2016.
Similar to the estimate for providers of health services, we assume that it will take, on average, three to five hours for issuers of health insurance coverage to develop or modify policies and procedures concerning sex discrimination. We are selecting four hours, or the midpoint of this range, for our analysis. We further assume that three of the hours will be spent by a mid-level manager, at a salary, with fringe benefits and overhead of $57.60 per hour,
In addition to the cost some covered health insurance providers may have for revising policies and procedures to comply with the rule, such providers may also incur a de minimis cost related to the cost of coverage. In this regard, we note that the April 2012 California
Two other studies also support the conclusion that the cost is de minimis for entities providing or administering health insurance coverage to come into compliance with this rule's provision of nondiscrimination on the basis of sex. One is a 2013 Williams Institute study of 34 public and private employers, and the second consists of cost projections of providing transition-related health-care benefits to members of the military.
The first of these two studies, a 2013 study of 34 employers that provided nondiscriminatory health care coverage, found that providing transition-related benefits to treat gender dysphoria had “zero to very low costs.”
The second study, published in the
Although Section 1557 requires covered entities to ensure that the health programs, services, and activities provided through electronic and information technology are accessible to individuals with disabilities, all covered entities affected by Section 1557 already have these obligations under Section 508, Section 504 or the ADA.
Section 508 requires that electronic and information technology developed, procured, maintained, or used by Federal agencies be accessible for individuals with disabilities (both members of the public and Federal employees). Section 504 also establishes general obligations for Federal agencies to make their programs that are provided through electronic and information technology accessible to individuals with disabilities. Both Section 504 and Section 508 were in place before the passage of the ACA. There is, therefore, no additional burden under Section 1557 for HHS health programs, including the Federally-facilitated Marketplaces, as the Section 1557 requirements are consistent with the obligations these programs already have under Section 504 and Section 508.
Section 504 also establishes general obligations for entities receiving Federal financial assistance to make their programs, services, and activities provided through electronic and information technology accessible to individuals with disabilities. The ADA imposes similar accessibility requirements on covered entities. This rule thus imposes no additional burden on recipients of Federal financial assistance from HHS because Section 1557 is consistent with existing standards these entities are already obligated to meet under the ADA and Section 504. Title I entities have no Section 1557 burden with respect to this proposed requirement, as the Title I entities must already be compliant with the ADA, which is consistent with the Section 1557 accessibility standards.
After grievances are filed with covered entities or complaints are filed with OCR, there are associated costs to investigate and resolve those grievances and complaints. We believe the following costs result from enforcement of the Section 1557 regulation:
• Costs to covered entities for modifying and implementing grievance procedures to cover grievances filed under Section 1557.
• Costs to OCR for reviewing and investigating complaints, monitoring corrective action plans, and taking other enforcement actions against covered entities.
In the analysis below, we estimate the aggregate costs of these enforcement procedures, and analyze the costs to covered entities separately from the costs to OCR.
Federal civil rights laws that were in place before the enactment of Section 1557 apply to entities that receive Federal financial assistance. Entities subject to those laws are already required to have in place established grievance procedures to address complaints of disability discrimination and complaints of sex discrimination in education programs. We anticipated that additional costs arising from the expansion of the grievance process to cover all bases included in Section 1557, including race, color, national origin, and age, as well as sex discrimination in health care, could impose additional costs on covered entities. We assumed a slight increase in the number of grievances filed, and a
To compute the anticipated costs for covered entities to enforce the regulation, we looked to OCR data. The current number of civil rights complaints filed annually with OCR is approximately 3,000. Since the passage of Section 1557, OCR's complaint workload has increased slightly, with approximately 15 to 20 unique Section 1557 cases filed each year. If we include another ten cases per year as a result of the promulgation of the regulation, we calculate an increase of 30 cases per year or 1% of the annual caseload of 3,000. We assume the incremental workload will be similar for affected entities and thus will be approximately 1%. We anticipate that within the first five years following the promulgation of the regulation, complaints will initially increase, but then will eventually drop off as covered entities modify their policies and practices in response to the rule. Due to the likelihood that applicable changes will need to be phased in, we assume one half of the annual projected costs for investigating discrimination complaints will be incurred during the first year and three quarters of the annual projected enforcement costs will be spent in the second year and the full amounts in the third through fifth years. Although we have data on OCR's caseload, we have no data on the caseload of affected covered entities.
We assume that as a result of promulgating the regulation, the 41,250 covered entities with 15 or more employees will require an average of an additional 1% of a Full Time Equivalent (FTE) for designated grievance officials to investigate discrimination grievances in years three through five following publication of the final rule, with costs half as large in the first year and costs three quarters as large in the second year. We assume the grievance official's salary is equivalent to that of medical and health service managers (occupation code 11-9111), who have annual median wages of $103,680. These assumptions imply costs, after adjusting for fringe benefits and overhead, of $42.8 million in the first year, $64.2 million in the second year, and $85.5 million in years three through five following publication of the final rule.
One comment suggested that litigation costs may also rise as a result of issuance. We assume that the costs of litigation are included in the costs listed in the paragraph above.
The same incremental calculations apply to the workloads of State agencies and the officials working in these agencies. If we assume the same increases in workload at each State agency as discussed previously, and the average mid-level State official salary is $94,580 (including fringe benefits and overhead), we must multiply $94,580 by the number of State covered entities.
• We assume that there are 56 Medicaid State agencies;
• We assume that there are 56 State health departments;
• We assume that there are 1,003 State and local government community hospitals;
• We assume that each of 3,143 counties has a county health department that provides direct health services (
The total number of State covered entities is 4,252. Multiplying $94,580 by 4,252 equals $402.2 million. One percent of this value equals $4.0 million. This implies costs of $2.0 million in the first year, $3.0 million in the second year and $4.0 million in subsequent years following the publication of the final rule.
We considered the various OCR enforcement costs together, based on OCR average salary data presented in its annual budgets. According to the FY 2016 President's Budget, $28,400,000 and 137 FTEs were requested for Enforcement and Regional Operations, at a cost of approximately $201,000 per FTE. Of the 137 FTEs, approximately 40 FTEs spend 100% of their investigative time enforcing the civil rights laws.
The table below summarizes the costs attributable to the regulation that covered entities may incur following enactment of the final regulation. We assume that half of the training costs and changes to policies and procedures on the prohibition of discrimination on the basis of sex will be incurred in the first year and the second half will be expended in the second year. For covered entities that will be printing and distributing notices to their patients and policy holders, we assume that all of the estimated printing and distribution costs will be expended in the first year after the effective date of the rule. Familiarization costs, information collection requirements and paperwork burden costs would be incurred within the first year after the effective date of the final regulation. Cost of enforcement, by contrast, will increase over the course of the first five years.
This completes our analysis of the costs of the final rule. Next, we examine the benefits that can be expected to accrue as a result of the final rule.
In enacting Section 1557 of the ACA, Congress recognized the benefits of equal access to health services and health insurance that all individuals should have, regardless of their race, color, national origin, age, or disability. Section 1557 brought together the rights to equal access that had been guaranteed under Title VI, the Age Act and Section 504. At the same time, Congress extended these protections and rights to individuals seeking access to health services and health insurance without discrimination on the basis of sex.
This rule implements the provisions of Section 1557. In most respects, the rule clarifies existing obligations under existing authorities, and we have noted in the cost analysis that we do not expect that covered entities will incur costs related to the clarification of those existing obligations in the final rule. As the HHS LEP Guidance
Studies show that individuals with limited English proficiency experience barriers to receiving regular and adequate health care. However, according to the Institute of Medicine, when reliable language assistance services are utilized, patients experience treatment-related benefits, such as enhanced understanding of physician instruction, shared decision-making, provision of informed consent, adherence with medication regimes, preventive testing, appointment attendance, and follow-up compliance.
Health service providers also benefit from providing language assistance services for individuals with limited English proficiency. Providers can more confidently make diagnoses, prescribe medications, reach treatment decisions, and ensure that treatment plans are understood by patients.
We have also noted that we expect that the prohibition of sex discrimination in the final rule will generate certain actions and other changes in behavior by covered entities and that these actions and changes will impose costs. These actions and other
The provisions prohibiting sex discrimination in the ACA increase the affordability and accessibility of health care for women and transgender individuals. However, despite the ACA improving access to health services and health insurance, many women and transgender individuals continue to experience discrimination in the health care context, which can lead to denials of adequate health care and increases in existing health disparities in underserved communities. This continued discrimination demonstrates the need for further clarification regarding the prohibition of discrimination on the basis of sex.
Prior to the enactment of the ACA, insurance companies were allowed to impose higher premiums on women or deny women coverage altogether. If issuers did cover women, they frequently did not cover a number of women's health services, including routine preventive services, such as pap smears or mammograms. Insurance premiums previously could differ by sex, and were often higher for females relative to males. The ACA prohibits differential treatment based on sex, includes maternity coverage in essential health benefits, and requires non-grandfathered plans to cover women's preventive services without copays, among other benefits.
For transgender individuals, a major barrier to receiving care is a concern over being refused medical treatment based on bias against them.
Another potential barrier for transgender individuals to care is covered entities' nondiscrimination policies, which often do not include gender identity. The 2014 Human Rights Campaign Healthcare Equality Index, which evaluates health care facilities' LGBT policies and practices, found that among the 640 hospitals it evaluated, 501 had patient nondiscrimination policies but of those only 257 had a patient nondiscrimination policy that included both the terms “sexual orientation” and “gender identity.”
Yet another barrier to care for transgender individuals is the process of obtaining health insurance coverage. A study by the Center for American Progress found that transgender individuals have often experienced difficulties when seeking insurance coverage.
Ultimately, transgender individuals who have experienced discrimination in the health care context often postpone or do not seek needed health care, which may lead to negative health consequences.
By prohibiting discrimination on the basis of sex, Section 1557 would result in more women and transgender individuals obtaining coverage and accessing health services. Since 2013, the uninsured rate for women has declined, with nearly 9.5 million women gaining health coverage as of 2016.
For a representative example, we look to a State of California economic impact assessment of State practices prohibiting gender discrimination in health care, which cites the following benefits:
1. Reduced violence against affected individuals;
2. Reduced depression and suicide attempts among the affected population; and
3. Overall declines in substance abuse, smoking and alcohol abuse rates, and improvements in mental health among treated individuals in LGBT populations who receive appropriate medical treatment.
Moreover, because discrimination contributes to health disparities, the prohibition of sex discrimination in health care under Section 1557 can help
The health and longevity benefits discussed above as potential effects of this rule assume additional or higher-quality medical services are provided to affected individuals. These services would be associated with costs (which we lack data to estimate). As mentioned in the earlier discussion of actuarial risk, to the extent that changes in insurance premiums do not alter how society uses its resources, the final rule would result in transfers between members of society, rather than social costs or benefits. In addition to women and transgender individuals, health service providers and the Federal government could also be recipients of these transfers. For example, in 2013, $53.3 billion was paid to offset uncompensated care, of which the Federal government paid for approximately $32.8 billion.
Aside from the specific benefits and transfers that women and transgender individuals, and the health care community can be expected to gain from the enactment of the regulation, there are additional benefits that are intangible and unquantifiable that derive from providing equal access to health care for all.
In the course of developing this regulation, OCR considered various alternatives. Some of those alternatives are discussed in the preamble. A discussion of alternatives cannot cover all alternatives considered by OCR. The following alternatives are meant to be a representative sample to show how burden reduction was a major consideration in constructing the standards in this regulation.
The first option is no new regulatory action. We did not select this option because we believe the regulation provides substantial benefits to society, net of the costs. We received a comment suggesting that we consider either writing a more informative than prescriptive regulation or delaying the regulation, based on a possible trend of increased voluntary compliance by health care agencies with nondiscrimination statutes. OCR's current experience, however, points to the importance of and need for a prescriptive regulation. OCR provides education and information on the civil rights statutes and regulations, conducts technical assistance and outreach to promote compliance, and is developing training materials to provide information and technical assistance on this rule. However, OCR has found that providing information and outreach is not sufficient to ensure nondiscrimination in health care programs and activities. OCR continues to receive and resolve many complaints of discrimination and to hear of ongoing discrimination through outreach and communications with stakeholders. The regulation will inform stakeholders of their rights so that affected individuals know that they can seek OCR's assistance, and will provide clarity for covered entities, limiting uncertainty and promoting compliance. In addition, the majority of the comments from the public in response to the proposed rule favored issuance of a regulation.
OCR considered requiring covered entities to provide separate notices, covering separate content,
OCR decided to further reduce the burden imposed on covered entities by the notice requirement by making available a sample notice, located in Appendix A. OCR allows covered entities flexibility in complying with the notice requirement by giving covered entities the option of using the sample notice or developing their own notice. Although OCR considered requiring covered entities to post the notice in 15 languages (Spanish (or Spanish Creole), Chinese, Vietnamese, Korean, Tagalog, Russian, Arabic, French Creole, French (including Patois, Cajun), Portuguese (or Portuguese Creole), Polish, Japanese, Italian, German, and Persian (Farsi)), we rejected that option. Instead, we are providing the notice translated into 64 languages, and are allowing covered entities the discretion to post one or more of the translated notices. We believe that making translated notices readily available to covered entities maximizes efficiency and economies of scale, provides flexibility while minimizing burden, and helps provide greater access for beneficiaries and consumers. Additionally, although OCR considered requiring covered entities to create their own taglines in the top 15 national languages spoken by individuals with limited English proficiency, we rejected that option. Instead, OCR is making available to covered entities the taglines in 64 languages. As the tagline requirement for the covered entities only requires the cost of printing and posting, this burden is expected to be minimal.
OCR considered not providing training materials to covered entities on the requirements of the regulation. However, in order to reduce costs and burden, OCR is providing these materials, which will reduce covered entities' costs of developing training materials from $500 per entity to $125 per entity, resulting in a savings of approximately $104 million. Entities are assumed to bear one quarter of the total costs. These costs result from paying the presenters who will run the training sessions, providing classroom space, and supplementing the training materials that OCR is making available (should they choose to do so).
OCR considered remaining silent on covered entities' obligations to comply with Section 1557's prohibition of national origin discrimination as it affects individuals with limited English proficiency. We rejected this approach because we were concerned that OCR's silence would create ambiguity about covered entities' obligations to individuals with limited English proficiency and could jeopardize the access of individuals with limited
OCR considered a regulatory scheme requiring covered entities to provide meaningful access to each individual with limited English proficiency by providing effective language assistance services, at no cost, unless such action would result in an undue burden or fundamental alteration. OCR also considered requiring covered entities of a certain type or size to have enhanced obligations to provide language assistance services. Such enhanced obligations would include providing a predetermined range of language assistance services in certain non-English languages that met defined thresholds. A covered entity that was not of a certain type or size still would be required to provide meaningful access to each individual with limited English proficiency in its health programs and activities, but the covered entity would not have to provide a predetermined range of language assistance services in certain non-English languages. OCR also explored applying the threshold requirement to standardized vital documents on a national, State, or county level, as well as specific to a covered entity's geographic service area.
The strengths of these alternate regulatory schemes included limited obligations for small businesses providing health programs or activities and defined standards for larger entities. The costs of these approaches included the complexity of the regulatory scheme and the potential burden on the covered entities of a certain type or size that would have enhanced applications. OCR determined these costs outweigh the benefits.
OCR considered drafting new provisions addressing effective communication (apart from communication through electronic and information technology) with individuals with disabilities, but instead is incorporating provisions of the regulation implementing Title II of the ADA to ensure consistency for covered entities and potentially reduce burden by limiting resources spent on training and modification of policies and procedures.
Options regarding communication through electronic and information technology are discussed in the preamble to the regulation. Regarding the accessibility requirements under the proposed regulation, OCR at first considered a narrower interpretation that the rule applied only to access to health programs and activities provided through covered entities' Web sites. However, we chose a broader interpretation, to include both Web sites and other means of electronic and information technology. While this could potentially increase the burden on recipients of Federal financial assistance and State-based Marketplaces, this would offer clarity to covered entities, increase the benefit of the rule, and help enhance access for individuals with disabilities.
In the area of compliance, OCR considered having one set of procedures for all compliance activities involving recipients of Federal financial assistance and State-based Marketplace
With regard to other areas of compliance, OCR considered developing a separate set of procedures for Section 1557 compliance activities involving HHS health programs and activities, but decided to largely adopt the existing procedures for disability compliance activities involving HHS health programs and activities (with some enhancement) to improve efficiencies for OCR and the HHS health programs and activities covered by Section 1557.
Section 202 of the Unfunded Mandates Reform Act of 1995 requires that agencies assess anticipated costs and benefits before issuing any rule that includes a Federal mandate that could result in expenditure in any one year by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million in 1995 dollars, updated annually for inflation. In 2016, that threshold level is approximately $146 million.
The Unfunded Mandates Reform Act does not address the total cost of a final rule. Rather, it focuses on certain categories of cost, mainly those “Federal mandate” costs resulting from: (1) Imposing enforceable duties on State, local, or tribal governments, or on the private sector; or (2) increasing the stringency of conditions in, or decreasing the funding of, State, local, or tribal governments under entitlement programs.
Our impact analysis shows that burden associated with training staff working for covered entities will be spread widely across health care entities, State and local governmental entities, and a substantial number of health insurance issuers. The analysis estimates the unfunded burden will be about $422 million in training and familiarization costs. We project that for the first few years following promulgation of the final rule, private sector costs for investigating discrimination complaints may amount to $87 million per year. Within the first five years following the final rule's promulgation, we anticipate complaints will increase, and then eventually drop off as covered entities modify their policies and practices in response to the final rule.
As we explain in the RIA, we believe there will be benefits gained from the promulgation of this regulation in the form of reduction in discrimination based on race, color, national origin, sex, age, and disability, and the corresponding improvement in the quality of care to underserved communities. In response to comments concerning the costs to covered entities, we note that we have not included some changes that would have been beneficial to individuals because we recognize that they would be costly for covered entities.
As required by Executive Order 13132
The regulation attempts to balance State autonomy with the necessity of creating a Federal floor that will provide a uniform level of nondiscrimination protection across the country. The regulation restricts regulatory preemption of State law to the minimum level necessary to achieve the objectives of the underlying Federal statute, Section 1557 of the ACA.
It is recognized that the States generally have laws that relate to nondiscrimination against individuals on a variety of bases. State laws continue to be enforceable, unless they prevent application of the final rule. The final rule explicitly provides that it is not to be construed to supersede State or local laws that provide additional protections against discrimination on any basis articulated under the regulation. Provisions of State law relating to nondiscrimination that is “more stringent” than the proposed Federal regulatory requirements or implementation specifications will continue to be enforceable.
Section 3(b) of Executive Order 13132 recognizes that national action limiting the policymaking discretion of States will be imposed only where there is constitutional and statutory authority for the action and the national activity is appropriate in light of the presence of a problem of national significance. Discrimination issues in relation to health care are of national concern by virtue of the scope of interstate health commerce. The ACA's provisions reflect this position.
Section 3(d)(2) of Executive Order 13132 requires that where possible, the Federal government defer to the States to establish standards. Title I of the ACA authorized the Secretary to promulgate regulations to implement Section 1557, and we have done so accordingly.
Section 4(a) of Executive Order 13132 expressly contemplates preemption when there is a conflict between exercising State and Federal authority under a Federal statute. Section 4(b) of the Executive Order authorizes preemption of State law in the Federal rulemaking context when “the exercise of State authority directly conflicts with the exercise of Federal authority under the Federal statute.” The approach in this regulation is consistent with these standards in the Executive Order in superseding State authority only when such authority is inconsistent with standards established pursuant to the grant of Federal authority under the statute.
Section 6(b) of Executive Order 13132 includes some qualitative discussion of substantial direct compliance costs that State and local governments could incur as a result of a proposed regulation. We have determined that the costs of the final rule will not impose substantial direct compliance costs on State or local governments. We have considered the cost burden that this rule will impose on State and local health care and benefit programs, and estimate State and local government costs will be in the order of $17.8 million in the first two years of implementation. The $17.8 million represents the sum of the costs of training State workers and enforcement costs attributable to State agencies analyzed above.
The RFA requires agencies that issue a regulation to analyze options for regulatory relief of small businesses if a rule will have a significant impact on a substantial number of small entities. The RFA generally defines a “small entity” as:
(1) A proprietary firm meeting the size standards of the Small Business Administration (SBA);
(2) A nonprofit organization that is not dominant in its field; or
(3) A small government jurisdiction with a population of less than 50,000 (States and individuals are not included in the definition of “small entity”).
HHS uses as its measure of significant economic impact on a substantial number of small entities a change in revenues of more than 3% for 5% or more of affected small entities.
In instances where OCR judged that the final rule would have a significant impact on a substantial number of small entities, we considered alternatives to reduce the burden. To accomplish our task, we first identified all the small entities that may be impacted, and then evaluated whether the economic burden we determined in the RIA represents a significant economic impact.
HHS has traditionally classified most health care providers as small entities even though some nonprofit providers would not meet the definition of “small entity” were they proprietary firms. Nonprofit entities are small if they are independently owned and operated and are not dominant in their fields.
The CMS Provider of Service file has indicators for profit and nonprofit entities, but these have proven to be unreliable. The Census data identifies firms' tax status by profit and non-profit status but only reports revenues and does not report them by the profit and non-profit status of the entity.
One class of providers we do not automatically classify as small businesses is physician practices. Physician practices are businesses and therefore are “small” if they meet the SBA's definition. The current size standard for physicians (excluding mental health specialists) (North American Industry Classification System code 62111) is annual receipts of less than $11 million.
Pharmacies also are businesses, and the size standard for them is annual receipts of less than $27.5 million. According to Census Statistics of U.S. Businesses, there are 18,852 pharmacy and drug store firms (North American Industry Classification System code 44611). Because of the lack of revenue or receipt data for pharmacies, we are unable to estimate the number of small pharmacies based on the SBA size standard. However, using the number of employees taken from the Statistics of U.S. Businesses as a proxy for revenues, the data is divided by number of employees per firm and shows the number of employers with fewer than 20 employees and those with more than 20 employees.
Another class of covered entities that are business enterprises is health insurance issuers. The SBA size standard for health insurance issuers is annual receipts of $38.5 million. Although the Blue Cross/Blue Shield companies that operate in some markets are organized as nonprofit entities, they often are large enough so as to not meet the definition of “small entity.”
Unfortunately, we cannot use the Census revenue data for estimating the number of small health insurance issuers because the Census data combines life and health insurance. Substituting costs for revenues allows us to obtain a rough estimate of the number of large insurance issuers, realizing that cost will probably be less than revenues, thus giving us a lower count of large issuers. Using the National Health Expenditure for 2013, net cost of health insurance equaled $173.6 billion. However, the 2012 Census data report a total of 815 health insurance issuers. Dividing the $174 billion in costs by the number of insurance issuers reported in the census tables yields average costs of over $213 million, which means that average annual revenues per issuer exceeds $213 million. We concluded, therefore, that there are almost no small insurance issuers. The above analysis comports with the conclusion CMS published in the Health Insurance Web Portal Requirements.
We also excluded local governmental entities from our count of small entities because we lack the data to classify them by populations of fewer than 50,000. The following table shows the number of small covered entities we estimated could be affected by the proposed rule.
Total undiscounted costs associated with the final rule are an average of $189 million per year over a five year period. If all of those costs are borne by small entities, this amounts to an average of $739 each year over that five year period. As a result, we believe that fewer than 5% of all small entities will experience a burden of greater than 3% of their revenues. Ambulatory health care services facilities (North American Industry Classification System 621), for example, are small entities with an average of 13 employees and revenue of $1.7 million based on 2012 reported data for employees of 6.4 million and total revenues of $825.7 million for 485,235 firms.
For the most part, because this regulation is consistent with existing standards applicable to the covered entities, the new burdens created by its issuance are minimal. The major impacts are in the areas of voluntary training, posting of notices, enforcement (where increased caseloads pose incremental costs on covered entities), voluntary development of language access plans, and revisions or development of new policies and procedures. The final rule does not include broad expansions of existing civil rights requirements on covered entities, and therefore minimizes the imposition of new burdens. Nevertheless, it is still a major rule with economically significant costs. The annualized cost of this rule over the first five years following its publication is $192.5 million using a discount rate of 3%, and $197.8 million using a discount rate of 7%. This RIA was organized and designed to explain the origin of these cost impacts and to incorporate relevant public comments.
Administrative practice and procedure, Civil rights, Discrimination, Elderly, Health care, Health facilities, Health insurance, Health programs and activities, Individuals with disabilities, Nondiscrimination, Reporting and recordkeeping requirements, Sex discrimination.
For the reasons set forth in the preamble, the Department of Health and Human Services adds 45 CFR part 92 as follows:
42 U.S.C. 18116, 5 U.S.C. 301.
The purpose of this part is to implement Section 1557 of the Patient Protection and Affordable Care Act (ACA) (42 U.S.C. 18116), which prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities. Section 1557 provides that, except as provided in Title I of the ACA, an individual shall not, on the grounds prohibited under Title VI of the Civil Rights Act of 1964, Title IX of the Education Amendments of 1972, the Age Discrimination Act of 1975, or Section 504 of the Rehabilitation Act of 1973, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under, any health program or activity, any part of which is receiving Federal financial assistance or under any program or activity that is administered by an Executive Agency or any entity established under Title I of the ACA. This part applies to health programs or activities administered by recipients of Federal financial assistance from the Department, Title I entities that administer health programs or activities, and Department-administered health programs or activities. The effective date of this part shall be July 18, 2016, except to the extent that provisions of this part require changes to health insurance or group health plan benefit design (including covered benefits, benefits limitations or restrictions, and cost-sharing mechanisms, such as coinsurance, copayments, and deductibles), such provisions, as they apply to health insurance or group health plan benefit design, have an applicability date of the first day of the first plan year (in the individual market, policy year) beginning on or after January 1, 2017.
(a) Except as provided otherwise in this part, this part applies to every health program or activity, any part of which receives Federal financial assistance provided or made available by the Department; every health program or activity administered by the Department; and every health program or activity administered by a Title I entity.
(b)(1) Exclusions to the application of the Age Discrimination Act of 1975, as set forth at 45 CFR 91.3(b)(1), apply to claims of discrimination based on age under Section 1557 or this part.
(2) Insofar as the application of any requirement under this part would violate applicable Federal statutory protections for religious freedom and conscience, such application shall not be required.
(c) Any provision of this part held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, shall be construed so as to continue to give maximum effect to the provision permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event the provision shall be severable from this part and shall not affect the remainder thereof or the application of the provision to other persons not similarly situated or to other, dissimilar circumstances.
(a)
(b)
As used in this part, the term—
(1) Qualified interpreters on-site or through video remote interpreting (VRI) services, as defined in 28 CFR 35.104 and 36.303(b); note takers; real-time computer-aided transcription services; written materials; exchange of written notes; telephone handset amplifiers; assistive listening devices; assistive listening systems; telephones compatible with hearing aids; closed caption decoders; open and closed captioning, including real-time captioning; voice, text, and video-based telecommunication products and systems, text telephones (TTYs), videophones, and captioned telephones, or equally effective telecommunications devices; videotext displays; accessible electronic and information technology; or other effective methods of making aurally delivered information available to individuals who are deaf or hard of hearing;
(2) Qualified readers; taped texts; audio recordings; Braille materials and displays; screen reader software; magnification software; optical readers; secondary auditory programs; large print materials; accessible electronic and information technology; or other effective methods of making visually delivered materials available to individuals who are blind or have low vision;
(3) Acquisition or modification of equipment and devices; and
(4) Other similar services and actions.
(1) An entity that operates a health program or activity, any part of which receives Federal financial assistance;
(2) An entity established under Title I of the ACA that administers a health program or activity; and
(3) The Department.
(1) Health benefits coverage or health insurance coverage provided to employees and/or their dependents established, operated, sponsored or administered by, for, or on behalf of one or more employers, whether provided or administered by entities including but not limited to an employer, group health plan (as defined in the Employee Retirement Income Security Act of 1974 (ERISA), 29 U.S.C. 1191b(a)(1)), third party administrator, or health insurance issuer.
(2) An employer-provided or employer-sponsored wellness program;
(3) An employer-provided health clinic; or
(4) Long term care coverage or insurance provided or administered by an employer, group health plan, third party administrator, or health insurance issuer for the benefit of an employer's employees.
(i) Funds;
(ii) Services of Federal personnel; or
(iii) Real and personal property or any interest in or use of such property, including:
(A) Transfers or leases of such property for less than fair market value or for reduced consideration; and
(B) Proceeds from a subsequent transfer or lease of such property if the Federal share of its fair market value is not returned to the Federal government.
(2) Federal financial assistance the Department provides or otherwise makes available includes Federal financial assistance that the Department plays a role in providing or administering, including all tax credits under Title I of the ACA, as well as payments, subsidies, or other funds extended by the Department to any entity providing health-related insurance coverage for payment to or on behalf of an individual obtaining health-related insurance coverage from that entity or extended by the Department directly to such individual for payment to any entity providing health-related insurance coverage.
(1) Oral language assistance, including interpretation in non-English languages provided in-person or remotely by a qualified interpreter for an individual with limited English proficiency, and the use of qualified bilingual or multilingual staff to communicate directly with individuals with limited English proficiency;
(2) Written translation, performed by a qualified translator, of written content in paper or electronic form into languages other than English; and
(3) Taglines.
(1) Is proficient in speaking and understanding both spoken English and at least one other spoken language, including any necessary specialized vocabulary, terminology and phraseology, and
(2) is able to effectively, accurately, and impartially communicate directly with individuals with limited English proficiency in their primary languages.
(i) Adheres to generally accepted interpreter ethics principles, including client confidentiality; and
(ii) is able to interpret effectively, accurately, and impartially, both receptively and expressively, using any necessary specialized vocabulary, terminology and phraseology.
(2) For an individual with a disability, qualified interpreters can include, for example, sign language interpreters, oral transliterators (individuals who represent or spell in the characters of another alphabet), and cued language transliterators (individuals who represent or spell by using a small number of handshapes).
(1) Adheres to generally accepted interpreter ethics principles, including client confidentiality;
(2) has demonstrated proficiency in speaking and understanding both spoken English and at least one other spoken language; and
(3) is able to interpret effectively, accurately, and impartially, both receptively and expressly, to and from such language(s) and English, using any necessary specialized vocabulary, terminology and phraseology.
(1) Adheres to generally accepted translator ethics principles, including client confidentiality;
(2) has demonstrated proficiency in writing and understanding both written English and at least one other written non-English language; and
(3) is able to translate effectively, accurately, and impartially to and from such language(s) and English, using any necessary specialized vocabulary, terminology and phraseology.
(a)
(b)
(c)
(a)
(2) Where a recipient is found to have discriminated against an individual on the basis of race, color, national origin, sex, age, or disability, in violation of Section 1557 or this part, and where another recipient exercises control over the recipient that has discriminated, the Director, where appropriate, may require either or both entities to take remedial action.
(3) The Director may, where necessary to overcome the effects of discrimination in violation of Section 1557 or this part, require a recipient or State-based Marketplace
(i) Individuals who are no longer participants in the recipient's or State-based Marketplace
(ii) Individuals who would have been participants in the health program or
(b)
(a)
(b)
(a) Each covered entity shall take appropriate initial and continuing steps to notify beneficiaries, enrollees, applicants, and members of the public of the following:
(1) The covered entity does not discriminate on the basis of race, color, national origin, sex, age, or disability in its health programs and activities;
(2) The covered entity provides appropriate auxiliary aids and services, including qualified interpreters for individuals with disabilities and information in alternate formats, free of charge and in a timely manner, when such aids and services are necessary to ensure an equal opportunity to participate to individuals with disabilities;
(3) The covered entity provides language assistance services, including translated documents and oral interpretation, free of charge and in a timely manner, when such services are necessary to provide meaningful access to individuals with limited English proficiency;
(4) How to obtain the aids and services in paragraphs (a)(2) and (3) of this section;
(5) An identification of, and contact information for, the responsible employee designated pursuant to § 92.7(a), if applicable;
(6) The availability of the grievance procedure and how to file a grievance, pursuant to § 92.7(b), if applicable; and
(7) How to file a discrimination complaint with OCR in the Department.
(b) Within 90 days of the effective date of this part, each covered entity shall:
(1) As described in paragraph (f)(1) of this section, post a notice that conveys the information in paragraphs (a)(1) through (7) of this section; and
(2) As described in paragraph (g)(1) of this section, if applicable, post a nondiscrimination statement that conveys the information in paragraph (a)(1) of this section.
(c) For use by covered entities, the Director shall make available, electronically and in any other manner that the Director determines appropriate, the content of a sample notice that conveys the information in paragraphs (a)(1) through (7) of this section, and the content of a sample nondiscrimination statement that conveys the information in paragraph (a)(1) of this section, in English and in the languages triggered by the obligation in paragraph (d)(1) of this section.
(d) Within 90 days of the effective date of this part, each covered entity shall:
(1) As described in paragraph (f)(1) of this section, post taglines in at least the top 15 languages spoken by individuals with limited English proficiency of the relevant State or States; and
(2) As described in paragraph (g)(2) of this section, if applicable, post taglines in at least the top two languages spoken by individuals with limited English proficiency of the relevant State or States.
(e) For use by covered entities, the Director shall make available, electronically and in any other manner that the Director determines appropriate, taglines in the languages triggered by the obligation in paragraph (d)(1) of this section.
(f)(1) Each covered entity shall post the notice required by paragraph (a) of this section and the taglines required by paragraph (d)(1) of this section in a conspicuously-visible font size:
(i) In significant publications and significant communications targeted to beneficiaries, enrollees, applicants, and members of the public, except for significant publications and significant communications that are small-sized, such as postcards and tri-fold brochures;
(ii) In conspicuous physical locations where the entity interacts with the public; and
(iii) In a conspicuous location on the covered entity's Web site accessible from the home page of the covered entity's Web site.
(2) A covered entity may also post the notice and taglines in additional publications and communications.
(g) Each covered entity shall post, in a conspicuously-visible font size, in significant publications and significant communications that are small-sized, such as postcards and tri-fold brochures:
(1) The nondiscrimination statement required by paragraph (b)(2) of this section; and
(2) The taglines required by paragraph (d)(2) of this section.
(h) A covered entity may combine the content of the notice required in paragraph (a) of this section with the content of other notices if the combined notice clearly informs individuals of their civil rights under Section 1557 and this part.
(a)
(2) This part does not apply to employment, except as provided in § 92.208.
(b)
(1)(i) Each covered entity must comply with the regulation implementing Title VI, at § 80.3(b)(1) through (6) of this subchapter.
(ii) No covered entity shall, on the basis of race, color, or national origin, aid or perpetuate discrimination against any person by providing significant assistance to any entity or person that discriminates on the basis of race, color, or national origin in providing any aid, benefit, or service to beneficiaries of the covered entity's health program or activity.
(2)(i) Each recipient and State-based Marketplace
(ii) The Department, including the Federally-facilitated Marketplaces, must comply with the regulation implementing Section 504, at §§ 85.21(b), 85.41 through 85.42, and 85.44 through 85.51 of this subchapter.
(3)(i) Each covered entity must comply with the regulation implementing Title IX, at § 86.31(b)(1) through (8) of this subchapter. Where this paragraph cross-references regulatory provisions that use the term “student,” “employee,” or “applicant,” these terms shall be replaced with “individual.”
(ii) A covered entity may not, directly or through contractual or other arrangements, utilize criteria or methods of administration that have the effect of subjecting individuals to discrimination on the basis of sex, or have the effect of defeating or substantially impairing accomplishment of the objectives of the program with respect to individuals on the basis of sex.
(iii) In determining the site or location of a facility, a covered entity may not make selections that have the effect of excluding individuals from, denying them the benefits of, or subjecting them to discrimination under any programs to which this regulation applies, on the basis of sex; or with the purpose or effect of defeating or substantially impairing the accomplishment of the objectives of the program or activity on the basis of sex.
(iv) A covered entity may operate a sex-specific health program or activity (a health program or activity that is restricted to members of one sex) only if the covered entity can demonstrate an exceedingly persuasive justification, that is, that the sex-specific health program or activity is substantially related to the achievement of an important health-related or scientific objective.
(4)(i) Each covered entity must comply with the regulation implementing the Age Act, at § 91.11(b) of this subchapter.
(ii) No covered entity shall, on the basis of age, aid or perpetuate discrimination against any person by providing significant assistance to any agency, organization, or person that discriminates on the basis of age in providing any aid, benefit, or service to beneficiaries of the covered entity's health program or activity.
(5) The enumeration of specific forms of discrimination in this paragraph does not limit the generality of the prohibition in paragraph (a) of this section.
(c) The exceptions applicable to Title VI apply to discrimination on the basis of race, color, or national origin under this part. The exceptions applicable to Section 504 apply to discrimination on the basis of disability under this part. The exceptions applicable to the Age Act apply to discrimination on the basis of age under this part. These provisions are found at §§ 80.3(d), 84.4(c), 85.21(c), 91.12, 91.15, and 91.17-.18 of this subchapter.
(d) Where the regulatory provisions referenced in paragraphs (b)(1), (b)(3), and (b)(4), and paragraph (c) of this section use the term “recipient,” the term “covered entity” shall apply in its place. Where the regulatory provisions referenced in paragraphs (b)(1), (b)(3), and (b)(4) and paragraph (c) of this section use the terms “program or activity” or “program” or “education program,” the term “health program or activity” shall apply in their place.
(a)
(b)
(1) Evaluate, and give substantial weight to, the nature and importance of the health program or activity and the particular communication at issue, to the individual with limited English proficiency; and
(2) Take into account other relevant factors, including whether a covered entity has developed and implemented an effective written language access plan, that is appropriate to its particular circumstances, to be prepared to meet its obligations in § 92.201(a).
(c)
(d)
(1) A covered entity shall offer a qualified interpreter to an individual with limited English proficiency when oral interpretation is a reasonable step to provide meaningful access for that individual with limited English proficiency; and
(2) A covered entity shall use a qualified translator when translating written content in paper or electronic form.
(e)
(1) Require an individual with limited English proficiency to provide his or her own interpreter;
(2) Rely on an adult accompanying an individual with limited English proficiency to interpret or facilitate communication, except:
(i) In an emergency involving an imminent threat to the safety or welfare of an individual or the public where there is no qualified interpreter for the individual with limited English proficiency immediately available; or
(ii) Where the individual with limited English proficiency specifically requests that the accompanying adult interpret or facilitate communication, the accompanying adult agrees to provide such assistance, and reliance on that adult for such assistance is appropriate under the circumstances;
(3) Rely on a minor child to interpret or facilitate communication, except in an emergency involving an imminent threat to the safety or welfare of an individual or the public where there is no qualified interpreter for the individual with limited English proficiency immediately available; or
(4) Rely on staff other than qualified bilingual/multilingual staff to communicate directly with individuals with limited English proficiency.
(f)
(1) Real-time, full-motion video and audio over a dedicated high-speed, wide-bandwidth video connection or wireless connection that delivers high-quality video images that do not produce lags, choppy, blurry, or grainy images, or irregular pauses in communication;
(2) A sharply delineated image that is large enough to display the interpreter's
(3) A clear, audible transmission of voices; and
(4) Adequate training to users of the technology and other involved individuals so that they may quickly and efficiently set up and operate the video remote interpreting.
(g)
(a) A covered entity shall take appropriate steps to ensure that communications with individuals with disabilities are as effective as communications with others in health programs and activities, in accordance with the standards found at 28 CFR 35.160 through 35.164. Where the regulatory provisions referenced in this section use the term “public entity,” the term “covered entity” shall apply in its place.
(b) A recipient or State-based Marketplace
(a) Each facility or part of a facility in which health programs or activities are conducted that is constructed or altered by or on behalf of, or for the use of, a recipient or State-based Marketplace
(b) Each facility or part of a facility in which health programs or activities are conducted that is constructed or altered by or on behalf of, or for the use of, a recipient or State-based Marketplace
(a) Covered entities shall ensure that their health programs or activities provided through electronic and information technology are accessible to individuals with disabilities, unless doing so would result in undue financial and administrative burdens or a fundamental alteration in the nature of the health programs or activities. When undue financial and administrative burdens or a fundamental alteration exist, the covered entity shall provide information in a format other than an electronic format that would not result in such undue financial and administrative burdens or a fundamental alteration but would ensure, to the maximum extent possible, that individuals with disabilities receive the benefits or services of the health program or activity that are provided through electronic and information technology.
(b) Recipients and State-based Marketplaces shall ensure that their health programs and activities provided through Web sites comply with the requirements of Title II of the ADA.
A covered entity shall make reasonable modifications to policies, practices, or procedures when such modifications are necessary to avoid discrimination on the basis of disability, unless the covered entity can demonstrate that making the modifications would fundamentally alter the nature of the health program or activity. For the purposes of this section, the term “reasonable modifications” shall be interpreted in a manner consistent with the term as set forth in the ADA Title II regulation at 28 CFR 35.130(b)(7).
A covered entity shall provide individuals equal access to its health programs or activities without discrimination on the basis of sex; and a covered entity shall treat individuals consistent with their gender identity, except that a covered entity may not deny or limit health services that are ordinarily or exclusively available to individuals of one sex, to a transgender individual based on the fact that the individual's sex assigned at birth, gender identity, or gender otherwise recorded is different from the one to which such health services are ordinarily or exclusively available.
(a)
(b)
(1) Deny, cancel, limit, or refuse to issue or renew a health-related insurance plan or policy or other health-related coverage, or deny or limit coverage of a claim, or impose additional cost sharing or other limitations or restrictions on coverage, on the basis of race, color, national origin, sex, age, or disability;
(2) Have or implement marketing practices or benefit designs that discriminate on the basis of race, color, national origin, sex, age, or disability in a health-related insurance plan or policy, or other health-related coverage;
(3) Deny or limit coverage, deny or limit coverage of a claim, or impose additional cost sharing or other
(4) Have or implement a categorical coverage exclusion or limitation for all health services related to gender transition; or
(5) Otherwise deny or limit coverage, deny or limit coverage of a claim, or impose additional cost sharing or other limitations or restrictions on coverage, for specific health services related to gender transition if such denial, limitation, or restriction results in discrimination against a transgender individual.
(c) The enumeration of specific forms of discrimination in paragraph (b) does not limit the general applicability of the prohibition in paragraph (a) of this section.
(d) Nothing in this section is intended to determine, or restrict a covered entity from determining, whether a particular health service is medically necessary or otherwise meets applicable coverage requirements in any individual case.
A covered entity that provides an employee health benefit program to its employees and/or their dependents shall be liable for violations of this part in that employee health benefit program only when:
(a) The entity is principally engaged in providing or administering health services, health insurance coverage, or other health coverage;
(b) The entity receives Federal financial assistance a primary objective of which is to fund the entity's employee health benefit program; or
(c) The entity is not principally engaged in providing or administering health services, health insurance coverage, or other health coverage, but operates a health program or activity, which is not an employee health benefit program, that receives Federal financial assistance; except that the entity is liable under this part with regard to the provision or administration of employee health benefits only with respect to the employees in that health program or activity.
A covered entity shall not exclude from participation in, deny the benefits of, or otherwise discriminate against an individual or entity in its health programs or activities on the basis of the race, color, national origin, sex, age, or disability of an individual with whom the individual or entity is known or believed to have a relationship or association.
(a) The enforcement mechanisms available for and provided under Title VI of the Civil Rights Act of 1964, Title IX of the Education Amendments of 1972, Section 504 of the Rehabilitation Act of 1973, or the Age Discrimination Act of 1975 shall apply for purposes of Section 1557 as implemented by this part.
(b) Compensatory damages for violations of Section 1557 are available in appropriate administrative and judicial actions brought under this rule.
(a) The procedural provisions applicable to Title VI apply with respect to administrative enforcement actions concerning discrimination on the basis of race, color, national, origin, sex, and disability discrimination under Section 1557 or this part. These procedures are found at §§ 80.6 through 80.11 of this subchapter and part 81 of this subchapter.
(b) The procedural provisions applicable to the Age Act apply with respect to enforcement actions concerning age discrimination under Section 1557 or this part. These procedures are found at §§ 91.41 through 91.50 of this subchapter.
(c) When a recipient fails to provide OCR with requested information in a timely, complete, and accurate manner, OCR may find noncompliance with Section 1557 and initiate appropriate enforcement procedures, including beginning the process for fund suspension or termination and taking other action authorized by law.
(d) An individual or entity may bring a civil action to challenge a violation of Section 1557 or this part in a United States District Court in which the recipient or State-based Marketplace
(a) This section applies to discrimination on the basis of race, color, national origin, sex, age, or disability in health programs or activities administered by the Department, including the Federally-facilitated Marketplaces.
(b) The procedural provisions applicable to Section 504 at §§ 85.61 through 85.62 of this subchapter shall apply with respect to enforcement actions against the Department concerning discrimination on the basis of race, color, national origin, sex, age, or disability under Section 1557 or this part. Where this section cross-references regulatory provisions that use the term “handicap,” the term “race, color, national origin, sex, age, or disability” shall apply in its place.
(c) The Department shall permit access by OCR to its books, records, accounts, other sources of information, and facilities as may be pertinent to ascertain compliance with Section 1557 or this part. Where any information required of the Department is in the exclusive possession of any other agency, institution or individual, and the other agency, institution or individual shall fail or refuse to furnish this information, the Department shall so certify and shall set forth what efforts it has made to obtain the information. Asserted considerations of privacy or confidentiality may not operate to bar OCR from evaluating or seeking to enforce compliance with Section 1557 or this part. Information of a confidential nature obtained in connection with compliance evaluation or enforcement shall not be disclosed except where necessary under the law.
(d) The Department shall not intimidate, threaten, coerce, or discriminate against any individual for the purpose of interfering with any right or privilege secured by Section 1557 or this part, or because such individual has made a complaint, testified, assisted, or participated in any manner in an investigation, proceeding or hearing under Section 1557 or this part. The identity of complainants shall be kept confidential by OCR, except to the extent necessary to carry out the purposes of Section 1557 or this part.
[Name of covered entity] complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. [Name of covered entity] does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex.
[Name of covered entity]:
• Provides free aids and services to people with disabilities to communicate effectively with us, such as:
○ Qualified sign language interpreters
○ Written information in other formats (large print, audio, accessible electronic formats, other formats)
• Provides free language services to people whose primary language is not English, such as:
○ Qualified interpreters
○ Information written in other languages
If you need these services, contact [Name of Civil Rights Coordinator]
If you believe that [Name of covered entity] has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: [Name and Title of Civil Rights Coordinator], [Mailing Address], [Telephone number ], [TTY number—if covered entity has one], [Fax], [Email]. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, [Name and Title of Civil Rights Coordinator] is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at
Complaint forms are available at
Nondiscrimination statement for significant publications and signification communications that are small-size:
[Name of covered entity] complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex.
ATTENTION: If you speak [insert language], language assistance services, free of charge, are available to you. Call 1-xxx-xxx-xxxx (TTY: 1-xxx-xxx-xxxx).
It is the policy of [Name of Covered Entity] not to discriminate on the basis of race, color, national origin, sex, age or disability. [Name of Covered Entity] has adopted an internal grievance procedure providing for prompt and equitable resolution of complaints alleging any action prohibited by Section 1557 of the Affordable Care Act (42 U.S.C. 18116) and its implementing regulations at 45 CFR part 92, issued by the U.S. Department of Health and Human Services. Section 1557 prohibits discrimination on the basis of race, color, national origin, sex, age or disability in certain health programs and activities. Section 1557 and its implementing regulations may be examined in the office of [Name and Title of Section 1557 Coordinator], [Mailing Address], [Telephone number], [TTY number—if covered entity has one], [Fax], [Email], who has been designated to coordinate the efforts of [Name of Covered Entity] to comply with Section 1557.
Any person who believes someone has been subjected to discrimination on the basis of race, color, national origin, sex, age or disability may file a grievance under this procedure. It is against the law for [Name of Covered Entity] to retaliate against anyone who opposes discrimination, files a grievance, or participates in the investigation of a grievance.
Procedure:
• Grievances must be submitted to the Section 1557 Coordinator within (60 days) of the date the person filing the grievance becomes aware of the alleged discriminatory action.
• A complaint must be in writing, containing the name and address of the person filing it. The complaint must state the problem or action alleged to be discriminatory and the remedy or relief sought.
• The Section 1557 Coordinator (or her/his designee) shall conduct an investigation of the complaint. This investigation may be informal, but it will be thorough, affording all interested persons an opportunity to submit evidence relevant to the complaint. The Section 1557 Coordinator will maintain the files and records of [Name of Covered Entity] relating to such grievances. To the extent possible, and in accordance with applicable law, the Section 1557 Coordinator will take appropriate steps to preserve the confidentiality of files and records relating to grievances and will share them only with those who have a need to know.
• The Section 1557 Coordinator will issue a written decision on the grievance, based on a preponderance of the evidence, no later than 30 days after its filing, including a notice to the complainant of their right to pursue further administrative or legal remedies.
• The person filing the grievance may appeal the decision of the Section 1557 Coordinator by writing to the (Administrator/Chief Executive Officer/Board of Directors/etc.) within 15 days of receiving the Section 1557 Coordinator's decision. The (Administrator/Chief Executive Officer/Board of Directors/etc.) shall issue a written decision in response to the appeal no later than 30 days after its filing.
The availability and use of this grievance procedure does not prevent a person from pursuing other legal or administrative remedies, including filing a complaint of discrimination on the basis of race, color, national origin, sex, age or disability in court or with the U.S. Department of Health and Human Services, Office for Civil Rights. A person can file a complaint of discrimination electronically through the Office for Civil Rights Complaint Portal, which is available at:
Complaint forms are available at:
[Name of covered entity] will make appropriate arrangements to ensure that individuals with disabilities and individuals with limited English proficiency are provided auxiliary aids and services or language assistance services, respectively, if needed to participate in this grievance process. Such arrangements may include, but are not limited to, providing qualified interpreters, providing taped cassettes of material for individuals with low vision, or assuring a barrier-free location for the proceedings. The Section 1557 Coordinator will be responsible for such arrangements.
Category | Regulatory Information | |
Collection | Federal Register | |
sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
Publisher | Office of the Federal Register, National Archives and Records Administration |