|Page and Subject|
|81 FR 90669 - Northern Bering Sea Climate Resilience|
|81 FR 90667 - Amending the Order of Succession in the Department of Homeland Security|
|81 FR 90665 - Human Rights Day and Human Rights Week, 2016|
|81 FR 90663 - Death of John Glenn|
|81 FR 90355 - Proposed Information Collection Request; Comment Request; Reporting and Recordkeeping Requirements Under EPA's Natural Gas STAR Methane Challenge Program|
|81 FR 90297 - Endangered and Threatened Wildlife and Plants; Listing Determinations for Five Poecilotheria Tarantula Species From Sri Lanka|
|81 FR 90370 - Quarterly IRS Interest Rates Used in Calculating Interest on Overdue Accounts and Refunds on Customs Duties|
|81 FR 90375 - John H. Chafee Coastal Barrier Resources System; Availability of Final Revised Maps for Louisiana, Puerto Rico, and the U.S. Virgin Islands|
|81 FR 90369 - Meeting of the National Advisory Committee on Children and Disasters and the National Preparedness and Response Science Board|
|81 FR 90314 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Coastal Migratory Pelagic Resources in the Gulf of Mexico and Atlantic Region; Amendment 26|
|81 FR 90356 - Removal of Certain Inert Ingredients From the Approved Chemical Substance List for Pesticide Products|
|81 FR 90363 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals|
|81 FR 90363 - Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2017|
|81 FR 90186 - Amendments to Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications To Provide for the User Fee Program|
|81 FR 90411 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board Amended; Notice of Meeting|
|81 FR 90360 - Agency Information Collection Activities: Proposed Collection; Comment Request|
|81 FR 90338 - Proposed Collection; Comment Request|
|81 FR 90358 - Notice of Agreements Filed|
|81 FR 90211 - Medicare Program; Conditions for Coverage for End-Stage Renal Disease Facilities-Third Party Payment|
|81 FR 90319 - Confidentiality Pledge Revision Notice|
|81 FR 90292 - East Pearl River, Within the Acoustic Buffer Area of the John C. Stennis Space Center, and Adjacent to Lands, in Hancock County, Mississippi; Danger Zone|
|81 FR 90407 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Notice of Landing Area Proposal|
|81 FR 90406 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Aircraft Registration|
|81 FR 90409 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Aviation Research Grants Program|
|81 FR 90326 - Request for Information on Identification of New Capabilities Needed by the Hollings Manufacturing Extension Partnership Program|
|81 FR 90410 - Reasonable Charges for Medical Care or Services; v3.21, 2017 Calendar Year Update and National Average Administrative Prescription Drug Charge Update|
|81 FR 90407 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Aging Aircraft Program (Widespread Fatigue Damage)|
|81 FR 90372 - Agency Information Collection Activities: DHS Civil Rights Compliance Form|
|81 FR 90207 - Determination of Nonattainment and Reclassification of the Houston-Galveston-Brazoria 2008 8-hour Ozone Nonattainment Area; Texas|
|81 FR 90361 - Public Meeting on Patient-Focused Drug Development for Sarcopenia; Request for Comments|
|81 FR 90406 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Helicopter Air Ambulance, Commercial Helicopter, and Part 91 Helicopter Operations|
|81 FR 90408 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Commercial Aviation Safety Team Safety Enhancements|
|81 FR 90408 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Automatic Dependent Surveillance Broadcast (ADS-B) Out Performance Requirements To Support Air Traffic Control (ATC) Service|
|81 FR 90379 - Final Environmental Impact Statement and a Revised Draft Conformity Determination for the Proposed Wilton Rancheria Fee-to-Trust and Casino Project, Sacramento County, California|
|81 FR 90365 - Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”); Guidance for Industry and Food and Drug Administration Staff; Availability|
|81 FR 90185 - Amendment to the Egg Research and Promotion Rules and Regulations To Update Patents, Copyrights, Trademarks, and Information Provisions|
|81 FR 90198 - Drawbridge Operation Regulation; Sacramento River, Sacramento, CA|
|81 FR 90241 - Atlantic Highly Migratory Species; Commercial Retention Limit for Blacknose Sharks and Non-Blacknose Small Coastal Sharks in the Atlantic Region|
|81 FR 90255 - Regulations Under the Perishable Agricultural Commodities Act (PACA): Growers' Trust Protection Eligibility and Clarification of “Written Notification”|
|81 FR 90411 - Agency Information Collection Activity (Residency Verification Report-Veterans and Survivors (FL 21-914))|
|81 FR 90412 - Agency Information Collection Activity: (Request for Information To Make Direct Payment to Child Reaching Majority (FL 21-863))|
|81 FR 90411 - Agency Information Collection Activity (Declaration of Status of Dependents (VA Form 21-686c)|
|81 FR 90341 - Judicial Proceedings Since Fiscal Year 2012 Amendments Panel (Judicial Proceedings Panel); Notice of Federal Advisory Committee Meeting|
|81 FR 90413 - Agency Information Collection Activity: (Nonprofit Research and Education Corporations (NPCs) Data Collection)|
|81 FR 90413 - Agency Information Collection Activity Under OMB Review: (Submission of School Catalog to the State Approving Agency)|
|81 FR 90322 - Seamless Refined Copper Pipe and Tube from the People's Republic of China: Preliminary Results of Administrative Review; 2014-2015|
|81 FR 90405 - Notice of Railroad-Shipper Transportation Advisory Council Vacancies|
|81 FR 90336 - 36(b)(1) Arms Sales Notification|
|81 FR 90384 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest|
|81 FR 90377 - Endangered Species Recovery Permit Applications|
|81 FR 90332 - 36(b)(1) Arms Sales Notification|
|81 FR 90380 - Notice of Intent To Prepare an Environmental Impact Statement and Notice of Public Meetings for a Federal Coal Lease by Application (MTM 105485), Application To Modify Federal Coal Lease (MTM 94378), and Applications To Amend Land Use Permit (MTM 96659), and Land Use Lease (MTM 74913), Big Horn County, MT|
|81 FR 90267 - Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry; Availability|
|81 FR 90383 - Notice of Realty Action: Proposed Amendment to Noncompetitive Land Use Lease MTM 74913, Montana|
|81 FR 90339 - 36(b)(1) Arms Sales Notification|
|81 FR 90409 - Sanctions Actions Pursuant to Executive Order 13224|
|81 FR 90386 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved Collection: Office for Victims of Crime Training and Technical Assistance Center-Trafficking Information Management System (TIMS)|
|81 FR 90385 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Records of Acquisition and Disposition, Collectors of Firearms|
|81 FR 90335 - 36(b)(1) Arms Sales Notification|
|81 FR 90387 - Webinar Meeting of the Federal Advisory Committee on Juvenile Justice|
|81 FR 90228 - NASA Federal Acquisition Regulation Supplement: Revised Voucher Submission & Payment Process (NFS Case 2016-N025)|
|81 FR 90198 - Advanced Practice Registered Nurses|
|81 FR 90370 - Notice of Meeting Center for Mental Health Services|
|81 FR 90330 - 2017 Annual Determination to Implement the Sea Turtle Observer Requirement|
|81 FR 90325 - Environmental Technologies Trade Advisory Committee (ETTAC) Public Meeting|
|81 FR 90358 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Extension|
|81 FR 90318 - Codex Alimentarius Commission: Meeting of the Codex Committee on Spices and Culinary Herbs|
|81 FR 90404 - Notice of Public Meeting|
|81 FR 90194 - Establishment of a New Drug Code for Marihuana Extract|
|81 FR 90402 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Designation of a Longer Period for Commission Action on Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change, as Modified by Amendments No. 1 and 2 Thereto, Relating to Amendments to NYSE MKT Rules 1600 et seq. and the Listing Rules Applicable to the Shares of the Nuveen Diversified Commodity Fund and the Nuveen Long/Short Commodity Total Return Fund|
|81 FR 90389 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Extend the Pilot Period for the Exchange's Retail Liquidity Program|
|81 FR 90391 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending the Exchange's Schedule of Fees and Charges Relating to the Listing and Annual Fees Applicable to Certain Structured Products|
|81 FR 90326 - Advisory Committee on Supply Chain Competitiveness: Notice of Public Meetings|
|81 FR 90343 - Applications for New Awards; Opening Doors, Expanding Opportunities|
|81 FR 90394 - Hartford Life Insurance Company, et al; Notice of Application|
|81 FR 90398 - Hartford Life Insurance Company, et al; Notice of Application|
|81 FR 90390 - ALAIA Market Linked Trust and Beech Hill Securities, Inc.; Notice of Application|
|81 FR 90403 - Pennsylvania Disaster #PA-00077|
|81 FR 90328 - Gulf of Mexico Coast Conservation Corps (GulfCorps) Program|
|81 FR 90354 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; International Computer and Information Literacy Study (ICILS 2018) Field Test Questionnaires Change Request|
|81 FR 90342 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; NPEFS 2016-2018: Common Core of Data (CCD) National Public Education Financial Survey|
|81 FR 90403 - Data Collection Available for Public Comments|
|81 FR 90196 - Procedures for Handling Retaliation Complaints Under Section 31307 of the Moving Ahead for Progress in the 21st Century Act (MAP-21)|
|81 FR 90319 - Notice of Public Meeting of the Virginia Advisory Committee To Discuss Potential Projects of Study Including a Proposal on Hate Crimes|
|81 FR 90229 - Rules Relating to Board-Initiated Investigations|
|81 FR 90294 - Notice of Data Availability Concerning the Renewables Enhancement and Growth Support Rule|
|81 FR 90388 - DTE Electric Company; Establishment of Atomic Safety and Licensing Board|
|81 FR 90387 - Records Schedules; Availability and Request for Comments|
|81 FR 90270 - Release of Official Information and Appearance of Witnesses in Litigation|
|81 FR 90258 - Use of Mobile Wireless Devices for Voice Calls on Aircraft|
|81 FR 90632 - Housing Counseling: New Certification Requirements|
|81 FR 90295 - World Trade Center Health Program; Petition 012-Atherosclerosis; Finding of Insufficient Evidence|
|81 FR 90246 - Fisheries of the Northeastern United States; Atlantic Mackerel, Squid, and Butterfish Fisheries; Amendment 16|
|81 FR 90373 - Federal Housing Administration (FHA): Direct Endorsement Program Timeframe for Conducting Pre-Endorsement Review|
|81 FR 90524 - Adoption and Foster Care Analysis and Reporting System|
|81 FR 90600 - Americans With Disabilities Act (ADA) Accessibility Guidelines for Transportation Vehicles|
|81 FR 90416 - Federal Motor Vehicle Safety Standards; Minimum Sound Requirements for Hybrid and Electric Vehicles|
Agricultural Marketing Service
Food Safety and Inspection Service
International Trade Administration
National Institute of Standards and Technology
National Oceanic and Atmospheric Administration
Centers for Medicare & Medicaid Services
Children and Families Administration
Food and Drug Administration
Substance Abuse and Mental Health Services Administration
U.S. Customs and Border Protection
Fish and Wildlife Service
Indian Affairs Bureau
Land Management Bureau
Alcohol, Tobacco, Firearms, and Explosives Bureau
Drug Enforcement Administration
Justice Programs Office
Occupational Safety and Health Administration
Federal Aviation Administration
National Highway Traffic Safety Administration
Foreign Assets Control Office
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.
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Agricultural Marketing Service, USDA.
This final rule amends the Patents, Copyrights, Trademarks, Publications, and Product Formulations (IP) language of the Egg Research and Promotion Rules and Regulations (Regulations) to conform with commodity research and promotion program orders created under the Commodity Promotion, Research, and Information Act of 1996 (1996 Act).
Effective January 13, 2017.
Kenneth R. Payne, Research and Promotion Division; Livestock, Poultry, and Seed Program; AMS, USDA; 1400 Independence Avenue SW., Room 2610-S; Washington, DC 20250; telephone (202) 720-5705; fax (202) 720-1125; or email
The Office of Management and Budget (OMB) has waived the review process required by Executive Order 12866 for this action.
This rule was reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have a retroactive effect. This action will not preempt any state or local laws, regulations, or policies unless they present an irreconcilable conflict with this rule. The Egg Research and Consumer Information Act (Act) [7 U.S.C. 2701
In accordance with the Regulatory Flexibility Act (RFA) [5 U.S.C. 601-612], the Agricultural Marketing Service (AMS) has determined that this rule will not have a significant economic impact on a substantial number of small entities as defined by RFA. The purpose of RFA is to fit regulatory action to scale on businesses subject to such action so that small businesses will not be disproportionately burdened. As such, these changes will not impose a significant impact on persons subject to the program.
According to the American Egg Board (Board), in 2015, approximately 181 egg producers were subject to the provisions of the Order, including paying assessments. Under the current Order, producers in the 48 contiguous States of the U.S. and the District of Columbia who own more than 75,000 laying hens currently pay a mandatory assessment of 10 cents per 30-dozen case of eggs sold. Egg handlers are responsible for collecting and remitting assessments to the Board. According to the Board, of those 181 egg producers, about 138 egg handlers collect assessments. Assessments under the program are used by the Board to finance promotion, research, and consumer information programs designed to increase consumer demand for eggs in domestic and international markets.
In 13 CFR part 121, the Small Business Administration (SBA) defines small agricultural producers as those having annual receipts of no more than $750,000 and small agricultural service firms as those having annual receipts of no more than $7 million. Under this definition, the vast majority of egg producers that would be affected by this rule would not be considered small entities. Producers owning 75,000 or fewer laying hens are eligible to be exempt from this program. This rule does not impose additional recordkeeping requirements on egg producers or handlers. There are no Federal rules that duplicate, overlap, or conflict with this rule.
In accordance with OMB regulation 5 CFR part 1320, which implements the Paperwork Reduction Act of 1995 [44 U.S.C. Chapter 35], the information collection and recordkeeping requirements that are imposed by the Order and Rules and Regulations have been approved previously under OMB control number 0581-0093. This rule does not result in a change to those information collection and recordkeeping requirements.
The Act established a national egg research and promotion program—administered by the Board—that is financed through industry assessments and subject to oversight by USDA's AMS. This program of promotion, research, and consumer information is designed to strengthen the position of eggs in the marketplace and to establish, maintain, and expand markets for eggs.
Under the current Regulations initially established in 1976, any IP financed by assessment funds or other revenues of the Board shall become property of the U.S. Government as represented by the Board. The language does not allow for alternative ownership arrangements. In addition, there is no explicit allowance for alternative ownership arrangements in cases where the Board is not providing all of the funding for a project. According to the Board, the current language in the Order has made negotiating contracts for
As a result, USDA is amending § 1250.542 of the Regulations to incorporate language utilized by research and promotion boards created under the 1996 Act that would provide the Board with flexibility in negotiating over the ownership of IP rights. The research and promotion boards created under the 1996 Act have utilized this language to negotiate ownership rights over IP to effectively expend assessment funds to promote agricultural commodities.
AMS published the notice of proposed rulemaking in the
Administrative practice and procedure, Advertising, Agricultural research, Eggs and egg products, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, 7 CFR part 1250 is amended as follows:
7 U.S.C. 2701-2718; 7 U.S.C. 7401.
(a) Except as provided in paragraph (b) of this section, any patents, copyrights, inventions, trademarks, information, publications, or product formulations developed through the use of funds collected by the Board under the provisions of this subpart shall be the property of the U.S. Government, as represented by the Board, and shall, along with any rents, royalties, residual payments, or other income from the rental, sales, leasing, franchising, or other uses of such patents, copyrights, inventions, trademarks, information, publications, or product formulations, inure to the benefit of the Board; shall be considered income subject to the same fiscal, budget, and audit controls as other funds of the Board; and may be licensed subject to approval by the Secretary. Upon termination of this subpart, § 1250.358 shall apply to determine disposition of all such property.
(b) Should patents, copyrights, inventions, trademarks, information, publications, or product formulations be developed through the use of funds collected by the Board under this subpart and funds contributed by another organization or person, the ownership and related rights to such patents, copyrights, inventions, trademarks, information, publications, or product formulations shall be determined by an agreement between the Board and the party contributing funds towards the development of such patents, copyrights, inventions, trademarks, information, publications, or product formulations in a manner consistent with paragraph (a) of this section.
Food and Drug Administration, HHS.
The Food and Drug Administration (FDA, the Agency, or we) is amending its regulations on accreditation of third-party certification bodies to conduct food safety audits and to issue certifications to provide for a reimbursement (user fee) program to assess fees for the work FDA performs to establish and administer the third-party certification program under the FDA Food Safety Modernization Act (FSMA).
This rule is effective January 13, 2017.
Sylvia Kim, Office of Foods and Veterinary Medicine, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3212, Silver Spring, MD 20993-0002, 301-796-7599.
FSMA (Pub. L. 111-353), signed into law by President Obama on January 4, 2011, is intended to allow FDA to better protect public health by helping to ensure the safety and security of the food supply. FSMA enables us to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides new enforcement authorities to help achieve higher rates of compliance with risk-based, prevention-oriented safety standards and to better respond to and contain problems when they do occur. In addition, the law contains important new tools to better ensure the safety of imported foods and encourages partnerships with State, local, tribal, and territorial authorities and international collaborations with foreign regulatory counterparts.
FSMA added section 808 to the FD&C Act (21 U.S.C. 384d), which directs FDA to establish a program for accreditation of third-party certification bodies
On November 27, 2015, FDA published in the
Under FSMA section 307 (21 U.S.C. 384d), accredited third-party certification bodies must perform unannounced facility audits conducted under the third-party certification program, notify FDA upon discovering a condition that could cause or contribute to a serious risk to the public health, and submit to FDA reports of regulatory audits conducted for certification purposes. The regulation includes stringent requirements to prevent conflicts of interest from influencing the decisions of recognized accreditation bodies and accredited third-party certification bodies.
This rulemaking implements section 808(c)(8) of the FD&C Act to establish a reimbursement (user fee) program to assess fees and require reimbursement for the work we perform to establish and administer the third-party certification program. In this document, we amend the third-party certification regulation (21 CFR part 1, subpart M) to provide for the assessment of user fees on accreditation bodies that include application fees for accreditation bodies seeking FDA recognition and annual monitoring fees, once recognized. We also provide for the assessment of user fees that include application fees for only those third-party certification bodies that seek FDA direct accreditation and annual monitoring fees for any third-party certification body participating in FDA's program, whether accredited directly by FDA or by an FDA-recognized accreditation body.
FDA published a proposed rule titled “User Fee Program to Provide for Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and To Issue Certifications” on July 24, 2015 (80 FR 43987). The proposed rule on the third-party certification program user fees includes the following: (1) Who would be subject to a user fee; (2) how user fees would be computed; (3) how FDA would notify the public about annual fee rates; (4) how the user fee would be collected; and (5) what the consequences would be for not paying a user fee. The comment period closed on October 7, 2015.
FDA received comments from accreditation bodies, certification bodies, foreign governments, industry associations, consumer groups, and members of industry. In the remainder of this document, we describe the comments that are within the scope of this rulemaking, respond to them, and explain any revisions we made from the proposed rule.
Section 307 of FSMA, Accreditation of Third-Party Auditors, amends the FD&C Act to create a new provision, section 808, under the same name. Section 808 of the FD&C Act directs us to establish a new program for accreditation of third-party certification bodies conducting food safety audits and issuing food and facility certifications to eligible foreign entities (including registered foreign food
Our authority for this rule is derived in part from section 808(c)(8) of the FD&C Act, which requires us to establish by regulation a reimbursement (user fee) program by which we assess fees and require accredited third-party certification bodies and audit agents to reimburse us for the work performed to establish and administer the third-party certification program under section 808. Accordingly, section 808(c)(8) of the FD&C Act authorizes us to assess fees and require reimbursement from accreditation bodies applying for recognition under section 808, third-party certification bodies applying for direct accreditation under section 808, and recognized accreditation bodies and accredited third-party certification bodies participating in the third-party certification program under section 808.
Further, section 701(a) of the FD&C Act (21 U.S.C. 371(a)) authorizes us to issue regulations for the efficient enforcement of the FD&C Act, including this rule establishing a user fee program for the third-party certification program under section 808 of the FD&C Act. Thus, FDA has the authority to issue this rule under sections 808 and 701(a) of the FD&C Act.
We proposed in § 1.700 that four main groups would be subject to a user fee under the regulation: (a) Accreditation bodies submitting applications, including renewal applications, for recognition in the third-party certification program; (b) recognized accreditation bodies participating in the third-party certification program; (c) third-party certification bodies submitting applications, including renewal applications, for direct accreditation; and (d) accredited third-party certification bodies participating in the third-party certification program. On our own initiative, and consistent with the third-party certification regulation, in this final rule we are using the term “third-party certification body” rather than the term “third-party auditor/certification body” that was used in the proposed rule.
Additionally, in the proposed rule we noted that the proposed user fee program would not recover all costs associated with the establishment and administration of the third-party certification program, such as the costs of any work by FDA in reviewing requests for reconsideration and waivers, revoking recognition of accreditation bodies, or withdrawing accreditation of third-party certification bodies, where necessary (80 FR 43987 at 43989). We also identified some of FDA's initial startup costs that would not be fully recouped, such as for some previously incurred costs for training employees and developing the third-party certification program IT portal that will accept applications for recognition and for direct accreditation and submissions from recognized accreditation bodies and accredited third-party certification bodies. We solicited comment on whether the costs for activities other than application processing and monitoring (
FDA received no adverse comments specific to our proposal to assess user fees on accreditation bodies submitting applications to FDA for recognition, third-party certification bodies submitting applications to FDA for direct accreditation, and recognized accreditation bodies and accredited third-party certification bodies participating in the program.
(Comment 1) In response to our request for comments on unaccounted for costs, some comments suggest that these costs should be recouped through fees paid by recognized accreditation bodies and accredited third-party certification bodies. Some comments opine that accreditation bodies should be responsible for paying any additional user fees related to maintenance of a database for recognized accreditation bodies and accredited certification bodies for the third-party certification bodies they accredit under the FDA program, as some accreditation bodies already invoice the certification bodies for these services. The comments do not address the feasibility of calculating or collecting such fees.
(Response 1) We decline the suggestion to assess additional fees on recognized accreditation bodies and accredited third-party certification bodies. Section 808(c)(8) of the FD&C Act requires us to establish a user fee program that assesses fees to reimburse FDA for the work in establishing and administering the third-party certification program. The statute further provides that FDA must not generate surplus revenue from the user fee program.
In implementing this provision, FDA is estimating the average costs of work it will perform to establish the program by recognizing accreditation bodies under section 808(b)(1) of the FD&C Act to accredit third-party certification bodies to participate in the third-party certification program (and, in limited circumstances under section 808(b)(1)(A)(ii), to directly accredit third-party certification bodies). Additionally, FDA is estimating the average costs of work it will perform in administering the program through monitoring, under section 808(f) of the FD&C Act, of recognized accreditation bodies and accredited third-party certification bodies, including through onsite audits of eligible entities issued certifications. The user fee program gives us flexibility to adjust estimates of the number of hours various activities will require and the hourly rates for performing the work, which will allow us to ensure that we are not generating a surplus.
We do not think it would be feasible at this time to accurately calculate and collect fees for all additional unaccounted for costs. For example, we do not have information on the number of, if any, waiver requests, revocations, and withdrawals we may get. It would be difficult to project a fee based on this limited information and assess it on accreditation bodies and certification bodies.
Additionally, it would be difficult to fairly distribute a fee for startup costs to future participants. We also do not want to disincentivize early participants from applying by imposing higher fees early on to cover initial program start-up costs related to setting up an IT portal or training employees.
(Comment 2) Some comments agree that both accreditation bodies and certification bodies are the appropriate parties to be assessed fees.
(Response 2) We agree and are finalizing § 1.700 as proposed, with conforming editorial changes as discussed previously.
Under the proposed user fee program we would assess user fees for two types of activities: (1) Application review; and (2) performance monitoring.
We proposed in § 1.705(a) that application fees would be assessed on accreditation bodies seeking FDA recognition or renewal of recognition and on third-party certification bodies seeking direct accreditation (and renewal of direct accreditation) by FDA. The application fees would be based on
We requested comment on an alternative approach for calculating application fees by tracking the actual number of hours it takes FDA staff to conduct relevant activities for each applicant, multiply that number by the fully supported FTE hourly rate calculated by the Agency for the applicable fiscal year, and then bill each applicant separately for the actual application costs attributable to it.
We requested comment on whether the proposed or alternative approach would create more favorable incentives for quality of the application. For the alternative approach, we specifically requested comment on possible consequences we should impose for not paying the application fee on time, since with this approach we would likely not be able to bill the applicant until after it learns whether it is accepted into the program. We also requested comment on whether we should adopt the alternative approach for a portion of the application review process (
Under proposed § 1.705(b), recognized accreditation bodies would be subject to an annual fee for the estimated average cost of the work FDA performs to monitor performance of recognized accreditation bodies under § 1.633. Under § 1.633(a), FDA will periodically evaluate the performance of each recognized accreditation body at least 4 years after the date of recognition for a 5-year term of recognition, or by no later than the mid-term point for a term of recognition of less than 5 years. We would estimate the average number of hours it would take for FDA to conduct relevant activities and multiply that by the appropriate fully supported FTE hourly rate for the applicable fiscal year. To calculate the annual fee for each recognized accreditation body, FDA would take the estimated average cost of work FDA performs to monitor performance of a single recognized accreditation body and annualize that over the average term of recognition (
The proposed user fee program also would assess fees for the estimated average cost for the work FDA will perform in monitoring the performance of third-party certification bodies accredited by FDA-recognized accreditation bodies, and third-party certification bodies directly accredited by FDA. We estimated the average number of hours it would take for FDA to conduct relevant monitoring activities for each, including a representative sample of onsite audits, and multiplied that by the appropriate fully supported FTE hourly rate. We further proposed that these monitoring fees would be annualized over the length of the term of accreditation (
In developing the proposed rule, we also considered annualizing the cost of application review over the length of the term of recognition (
(Comment 3) Some comments propose a different approach whereby FDA would establish one application fee for accreditation bodies which encompasses all of the anticipated costs (and specify what those costs are for each part of the assessment process) and then provide for reimbursements upon completion of the process for costs that were not incurred. The comment suggests that this would create incentives for an accreditation body to have a well-documented and implemented accreditation process and to cooperate fully to facilitate the assessment by FDA. Some comments request that we simplify the user fee program, but do not provide suggestions as to what changes would simplify the program.
(Response 3) We decline to accept the alternative approach, for a couple of reasons: First, we expect that the costs for reviewing applications for recognition will not vary significantly among the accreditation bodies, because we expect most, if not all, of the accreditation bodies that seek recognition under the third-party certification program will use documentation of their conformance with International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) 17011:2004, Conformity assessment—General requirements for accreditation bodies accrediting conformity assessment bodies (ISO/IEC 17011:2004) (Ref. 1) to support their applications. This will allow FDA to use a common approach in reviewing accreditation body applications and, as a result, will help keep the costs of application review fairly steady and predictable across applications, making the alternative approach unnecessary.
Second, in authorizing FDA to assess fees and recover the costs associated with establishing and administering the third-party certification program, section 808(c)(8) of the FD&C Act helps to ensure that FDA has a stable funding base for the program. The alternative approach would limit our ability to develop and execute program plans or to sustain program services and operations at predictable levels. Third, the alternative approach would be administratively burdensome and would generate new administrative costs associated with providing a series of reimbursements at various steps in the processing of a single application. The net result would be to drive up program costs, which would increase user fee rates.
With respect to the comments requesting that we simplify the user fee program, we decline to adopt a different approach absent any feasible suggestions as to what changes would simplify the program. Further, the approach we have established in this final rule limits the types of fees that are assessed to just application fees and annual fees. Our approach is designed to be simple. It is similar to the fee structure used by several accreditation bodies, who charge third-party certification bodies initial fees and annual fees (Ref. 2).
(Comment 4) Some comments recommend that the recognized accreditation bodies and accredited third-party certification bodies pay for monitoring as it is conducted. The comments note that for a recognized accreditation body this would assume that the level of monitoring would be related to its performance, the number of third-party certification bodies it accredited, and their performance. The comments further assert that the level of
(Response 4) We disagree. As explained in Response 3, the user fee program is designed to provide FDA a stable funding base for operating the program. The proposed approach of paying for monitoring as it is conducted would not offer stability and predictability for FDA or for recognized accreditation bodies and accredited certification bodies. In addition, we note that the number of certification bodies the accreditation body has accredited under the program is only one of several factors we may consider in developing our plans for monitoring a recognized accreditation body. Under § 1.633(b) we may elect to observe a representative sample of certification bodies the recognized accreditation body accredited when conducting an assessment of its accreditation body. The size of the representative sample may depend on a number of factors including the scope of accreditation of the certification bodies accredited by the accreditation body, how many years the accreditation body has been in the program, how many prior assessments of the accreditation body we have performed, and the length of time since any prior assessments, in addition to the number of third-party certification bodies it has accredited. Similarly, when monitoring an accredited third-party certification body under § 1.662 we may elect to observe regulatory audits the accredited third-party certification body performs, and we will base our decision regarding how many onsite observations to conduct based on a number of factors such as how many years the certification body has been in the program, how many prior assessments we have performed and the length of time since the last assessment, in addition to the number of eligible entities the certification body certifies. Further, we do not anticipate that the cost of monitoring will vary greatly among accreditation bodies or among certification bodies. We note that the third-party certification regulations allow recognized accreditation bodies and accredited third-party certification bodies to use documentation of their conformance with applicable ISO/IEC standards, which we expect will allow FDA greater consistency and efficiency in conducting monitoring activities.
(Comment 5) Some comments recommend that FDA establish application and monitoring fees that relate to costs for the services by FDA and that these be paid in the years the services are provided, rather than annualized fees.
(Response 5) We decline the recommendation to change the fee structure from an estimated average cost to a pay-as-you go system. As explained in Response 3, the estimated average cost approach to the fee assessments provides prospective applicants, participants, and FDA predictability that allows for proper planning and budgeting. The monitoring fee is structured to annualize the payments for the total cost of monitoring recognized accreditation bodies and accredited third-party certification bodies, which provides predictability that helps accreditation bodies, third-party certification bodies, and FDA in planning and budgeting. Additionally, the recommended approach would be administratively burdensome and would generate new administrative costs associated with billing for various monitoring activities across the duration of each accreditation body's recognition and each third-party certification body's accreditation. The net result would be to drive up program costs, which would increase user fee rates. Further, we do not think that system suggested in the comment would be particularly beneficial to participants, since we do not anticipate that there will be much variability in the cost of monitoring services. We note that the user fee program is flexible. The fee rates are adjusted annually, as appropriate, so estimates regarding the cost of monitoring will be refined regularly.
We proposed to notify the public of the fee schedule annually prior to the beginning of the fiscal year for which the fees apply. We further proposed that each new fee schedule would be calculated based on the parameters in the proposed rulemaking and adjusted for improvements in the cost to FDA of performing relevant work for the upcoming year and inflation. At our own initiative, we revised proposed § 1.710 to create an exception to the requirement to provide notice prior to the start of the fiscal year for which the fees apply, in order to provide notice of the FSMA Third-Party Certification Program User Fee Rate for FY 2017, which is published elsewhere in this issue of the
(Comment 6) Several comments address user fee costs. Some raise general concerns that user fees may serve as a disincentive to program participation by accreditation bodies and third-party certification bodies, especially during the initial phase of the program. One such comment characterized the estimated user fee amounts as “somewhat high.” Other comments noted the proposed fees were reasonably aligned with the third-party certification body fees assessed under the Global Food Safety Initiative (GFSI). (By way of background, a group of international retailers established GFSI in 2000 with the goal of reducing the need for duplicative third-party audits by benchmarking private food safety schemes against a harmonized set of criteria for food safety and management systems.)
(Response 6) With respect to the comments suggesting that user fees may serve as a disincentive to program participation by accreditation bodies and third-party certification bodies, we note that the FD&C Act requires us to establish by regulation a user fee program by which we assess fees and require accredited third-party auditors and audit agents to reimburse us for the work performed to establish and administer the third-party accreditation program under section 808 of the FD&C Act. With respect to comments suggesting that the estimated user fee rates in the proposed rule may be too high, we disagree. We have designed the proposed user fee program to be flexible—that is, we expect that the estimates of the number of FTE hours used to calculate the actual user fees for accreditation bodies and third-party certification bodies will be informed by FDA's experience with the program each year (80 FR 43987 at 43990). Once the program begins we will update the estimates used to calculate the annual user fees as appropriate on a yearly basis. For example, if we determine it takes less time, on average, for us to prepare written reports documenting our onsite assessments of recognized accreditation bodies, we will use that information to decrease the fee for the following year.
(Comment 7) Some comments contend that the third-party certification program user fees and the indirect costs of complying with the third-party certification regulation will be passed down to food firms, negatively impacting the number of foreign food facilities that will become certified under the program and resulting in
(Response 7) The comments did not provide any data to support assertions regarding the indirect impacts of the proposed rule on dynamics of markets for third-party audits of foreign food facilities and private audit standards. Absent data or other information to support changes to the proposal, we are not modifying § 1.710 in anticipation of possible market forces on third-party audits and private audit schemes.
(Comment 8) Some comments discourage FDA from annually reviewing its fees for at least one 5-year cycle because fluctuations in the fees could significantly disadvantage accreditation bodies or third-party certification bodies that enter the program early.
(Response 8) We disagree with the suggestion to review fees less frequently than annually. Section 808(c)(8) of the FD&C Act provides that FDA shall not generate a surplus from the user fee program. By annually reviewing (and, if appropriate, adjusting) the fee rates, we can help ensure that we do not generate a surplus.
We proposed to require accreditation bodies applying for recognition and third-party certification bodies applying for direct accreditation to submit their application fees concurrently with submitting an application, including a renewal application. We also proposed that recognized accreditation bodies and accredited third-party certification bodies subject to an annual fee must submit payment within 30 days of receiving billing for the fee.
(Comment 9) Some comments support having initial and renewal application fees paid upon application. The comments also assert that FDA should not review any applications until payment has been received.
(Response 9) We agree and are maintaining these requirements in the final rule.
Under proposed § 1.720, user fees would not be refundable. We requested comment on whether we should consider refund requests under this program, and if so, under what circumstances.
At our own initiative, we are revising § 1.720 to clarify that we will not refund any fees accompanying completed applications or annual user fees. However, user fees submitted with applications will not be considered to have been accepted until the application is complete and ready for FDA review. Applications for recognition and direct accreditation will not be substantively reviewed by FDA until a completed submission with all of the required elements is received in accordance with §§ 1.631(a) and 1.671(a).
(Comment 10) Some comments recommend that FDA charge a flat fee for the application fees, but provide for refunds of portions of the initial application and renewal application fees if we do not incur all the anticipated costs during review of the application. This would ensure that FDA has adequate funding to cover costs up front without overburdening accreditation bodies or third-party certification bodies financially if we don't end up using all the costs.
(Response 10) We disagree with providing a refund as described by the comment. As noted in Response 3, we anticipate that costs for reviewing applications for recognition will not vary significantly among the accreditation bodies. In addition, it would be administratively burdensome to track and process refunds at various stages of the application process for each applicant and would potentially drive up the costs of the program.
In proposed § 1.725(a), we proposed that applications would not be considered complete until FDA receives the application fee. In proposed § 1.725(b), we proposed that a recognized accreditation body that fails to submit its annual user fee within 30 days of the due date would have its recognition suspended. We proposed that FDA would notify the accreditation body electronically that its recognition is suspended and would notify the public of the suspension on the Web site that lists the recognized accreditation bodies. We requested comment on our tentative conclusion that there is no reason for the process of notifying the accreditation body and the public of suspension to differ from the process of notifying the accreditation body and the public of revocation in these respects. We also requested comment on whether FDA should notify a certification body if the recognition of its accreditation body has been suspended.
We further proposed that while an accreditation body's recognition is suspended, it will not be able to accredit additional third-party certification bodies. However, we proposed that any certification bodies accredited by such accreditation body prior to the suspension would be unaffected by the suspension, as would any food or facility certification issued by such certification body. We also proposed that if payment is not received within 90 days of the payment due date, FDA would revoke the accreditation body's recognition and provide notice of such revocation in accordance with the procedures in § 1.634. Accordingly, we proposed to amend § 1.634(a)(4) by adding proposed § 1.634(a)(4)(iii), which would explicitly include failure to pay the annual user fee within 90 days of the payment due date as a basis for revoking an accreditation body's recognition.
In proposed § 1.725(c), we proposed that an accredited third-party certification body that fails to submit its annual user fee within 30 days of the due date would have its accreditation suspended. We proposed that FDA would electronically notify the certification body that its accreditation is suspended and would notify the public of the suspension on the Web site that lists the recognized accreditation bodies and accredited third-party certification bodies. While a certification body's accreditation is suspended, it would not be allowed to issue food or facility certifications as part of FDA's third-party certification program. However, we proposed that food or facility certifications issued by a certification body prior to the suspension of its accreditation would remain in effect. We proposed that if payment is not received within 90 days of the payment due date, FDA would withdraw the third-party certification body's accreditation under § 1.664(a), and provide notice of such withdrawal in accordance with the procedures in § 1.664. Accordingly, we proposed to amend § 1.664(a) by adding proposed § 1.664(a)(4), which would explicitly include failure to pay the annual user fee within 90 days of the payment due date as a basis for withdrawal of accreditation. We requested comment on whether the consequences of a third-party certification body failing to pay a user fee by the due date are appropriate.
(Comment 11) Some comments agree with FDA's proposal to suspend an accreditation body's recognition or a third-party certification body's accreditation if it fails to submit its annual user fee within 30 days of the payment due date and to revoke the accreditation body's recognition or withdraw a certification body's accreditation if it fails to submit its annual user fee within 90 days of the payment due date.
(Response 11) We agree and are retaining these provisions in the final rule.
(Comment 12) One comment recommends that notice of the suspension or revocation on FDA's Web site differentiate between suspension and revocation for financial reasons and suspension or revocation for failure to conform to requirements.
(Response 12) We agree with respect to notice of revocation or withdrawal. In accordance with §§ 1.634(f) and 1.664(h), FDA will provide the basis for revocation of recognition and for withdrawal of accreditation on its Web site, as applicable. With respect to suspension of recognition or accreditation by FDA, failure to pay the user fee would be the only reason for FDA suspension.
(Comment 13) One comment recommends that FDA should notify a third-party certification body if its accreditation body's recognition has been suspended and that FDA should notify an accreditation body if a third-party certification body accredited by that accreditation body is suspended.
(Response 13) At this time FDA has determined that, unlike notice of withdrawal of accreditation and notice of revocation of recognition, notice of suspension is not essential to the operation of an accredited certification body or a recognized accreditation body. For example, accredited certification bodies would remain accredited even if their accreditation body had their recognition suspended. Further, we note that FDA's electronic portal for the third-party certification program currently does not have the capability to provide notice of suspension. We will consider the feasibility of adding this capability as resources allow.
We did not propose a small business exemption or reduction in the proposed rule because no statutory requirement to establish or consider an exemption or reduction in user fees exists in section 808 of the FD&C Act. However, we requested comment on whether we should account for small businesses in other ways, including whether an exemption or fee reduction would be appropriate. We requested that comments in favor of an exemption or fee reduction for small businesses state who should be eligible for an exemption or fee reduction; if recommending a fee reduction, how much of a reduction should be granted; and why.
(Comment 14) Some comments recommend that there be no exemption or reduced fee for small businesses or entities because the costs to FDA for performing the work activities are not lower for small businesses or entities. Other comments recommend that the user fees for public-sector and private-sector accreditation bodies or third-party certification bodies be the same because the costs to FDA are not lower for one group compared to the other. Some comments recommend that the program offer reduced fees or exemptions for small businesses to be consistent with the principles embedded in FSMA. Other comments request a reduction in fees or an exemption for public-sector accreditation bodies or third-party certification bodies.
(Response 14) We agree that there be no exemptions or reduced fees for small businesses or entities or for public-sector entities. Section 808(c)(8) of the FD&C Act makes no distinction between public and private bodies for purposes of the user fee program, and, as noted previously, contains no requirement to establish or consider an exemption or reduction in user fees. As explained in Responses 3 and 4, we agree that the cost to FDA for performing the application review and monitoring will not vary greatly across entities participating in the third-party certification program, regardless of the entity's size or public versus private status. Moreover, creating exemptions or fee reductions would hinder FDA's ability to create a stable funding base for the third-party certification program.
We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this final rule is not a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. This rule demonstrates how user fees will be calculated and assessed for different activities FDA conducts under FDA's third-party accreditation program. This rule does not require action by entities affected by the Third-Party Certification regulation; it merely provides additional information so that affected entities can make an informed decision on whether to participate in FDA's third-party certification program. FDA analyzed the costs and benefits of FDA's third-party certification program including imposition of user fees resulting from participating in the third-party certification program in the regulatory impact analysis of the Third-Party Certification final rule. Therefore because this rule does not require actions by affected entities, we certify that the final rule will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $146 million, using the most current (2015) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in an expenditure in any year that meets or exceeds this amount.
The full analysis of the economic impacts of the Third-Party Certification regulation is available at
This rule contains no collection of information. Therefore, clearance by OMB under the Paperwork Reduction Act of 1995 is not required.
We previously considered the environmental effects of this rule, as stated in the proposed rule “User Fee Program to Provide for Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and To Issue Certifications” published on July 24, 2015 (80 FR 43987). We stated that we had determined, under 21 CFR 25.30(h), that this action “is of a type that does not individually or cumulatively have a significant effect on the human environment” such that neither an environmental assessment nor an environmental impact statement is required. We have not received any new information or comments that
We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that 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. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.
The following references are on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fisher Lane, Rm. 1061, Rockville, MD 20852 and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at
1. International Organization for Standardization/International Electrotechnical Commission, ISO/IEC “17011:2004 Conformity Assessment—General Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies,” Copies are available from the International Organization for Standardization, 1, rue de Varembe, Case postale 56, CH-1211 Geneve 20, Switzerland, or on the Internet at
2. FDA, “Preliminary Regulatory Impact Analysis for the proposed rules on Foreign Supplier Verification Programs (Docket No. FDA-2011-N-0143) and Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (Docket No. FDA-2011-N-0146) under Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520),”
3. FDA, “Final Regulatory Impact Analysis: Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications,”
Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 1 is amended as follows:
15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350e, 350j, 350k, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 373, 374, 379j-31, 381, 382, 384a, 384b, 384d, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264, 271; Pub. L. 107-188, 116 Stat. 594, 668-69; Pub. L. 111-353, 124 Stat. 3885, 3889.
(a) * * *
(4) * * *
(iii) Failure to pay the annual user fee within 90 days of the payment due date, as specified in § 1.725(b)(3).
(a) * * *
(4) If payment of the third-party certification body's annual fee is not received within 90 days of the payment due date, as specified in § 1.725(c)(3).
(a) Accreditation bodies submitting applications or renewal applications for recognition in the third-party certification program;
(b) Recognized accreditation bodies participating in the third-party certification program;
(c) Third-party certification bodies submitting applications or renewal applications for direct accreditation; and
(d) Accredited third-party certification bodies (whether accredited by recognized accreditation bodies or by FDA through direct accreditation) participating in the third-party certification program.
(a) The following application fees:
(1) Accreditation bodies applying for recognition are subject to an application fee for the estimated average cost of the work FDA performs in reviewing and evaluating applications for recognition of accreditation bodies.
(2) Recognized accreditation bodies submitting renewal applications are subject to a renewal application fee for the estimated average cost of the work FDA performs in reviewing and evaluating renewal applications for recognition of accreditation bodies.
(3) Third-party certification bodies applying for direct accreditation are subject to an application fee for the estimated average cost of the work FDA performs in reviewing and evaluating applications for direct accreditation.
(4) Accredited third-party certification bodies applying for renewal of direct accreditation are subject to an application fee for the estimated average cost of the work FDA performs in reviewing and evaluating renewal applications for direct accreditation.
(b) The following annual fees:
(1) Recognized accreditation bodies are subject to an annual fee for the estimated average cost of the work FDA performs to monitor performance of recognized accreditation bodies under § 1.633.
(2) Third-party certification bodies directly accredited by FDA are subject to an annual fee for the estimated average cost of the work FDA performs to monitor directly accredited third-party certification bodies under § 1.662.
(3) Third-party certification bodies accredited by recognized accreditation bodies are subject to an annual fee for the estimated average cost of the work
FDA will notify the public of the fee schedule annually. The fee notice will be made publicly available prior to the beginning of the fiscal year for which the fees apply, except for the first fiscal year in which this regulation is effective. Each new fee schedule will be adjusted for inflation and improvements in the estimates of the cost to FDA of performing relevant work for the upcoming year.
(a) Accreditation bodies applying for recognition and third-party certification bodies applying for direct accreditation must submit a fee concurrently with submitting an application or a renewal application.
(b) Accreditation bodies and third-party certification bodies subject to an annual fee must submit payment within 30 days of receiving billing for the fee.
User fees accompanying completed applications and annual fees under this subpart are not refundable.
(a) An application for recognition or renewal of recognition will not be considered complete for the purposes of § 1.631(a) until the date that FDA receives the application fee. An application for direct accreditation or for renewal of direct accreditation will not be considered complete for the purposes of § 1.671(a) until FDA receives the application fee.
(b) A recognized accreditation body that fails to submit its annual user fee within 30 days of the due date will have its recognition suspended.
(1) FDA will notify the accreditation body electronically that its recognition is suspended. FDA will notify the public of the suspension on the Web site described in § 1.690.
(2) While an accreditation body's recognition is suspended, the accreditation body will not be able to accredit additional third-party certification bodies. The accreditation of third-party certification bodies that occurred prior to an accreditation body's suspension, as well as food or facility certifications issued by such third-party certification bodies, would remain in effect.
(3) If payment is not received within 90 days of the payment due date, FDA will revoke the accreditation body's recognition under § 1.634(a)(4)(iii), and provide notice of such revocation in accordance with § 1.634.
(c) An accredited third-party certification body that fails to submit its annual fee within 30 days of the due date will have its accreditation suspended.
(1) FDA will notify the third-party certification body that its accreditation is suspended, electronically and in English. FDA will notify a recognized accreditation body, electronically and in English, if the accreditation of one if its third-party certification bodies is suspended. FDA will notify the public of the suspension on the Web site described in § 1.690.
(2) While a third-party certification body's accreditation is suspended, the third-party certification body will not be able to issue food or facility certifications. A food or facility certification issued by a third-party certification body prior to the suspension of the auditor/certification body accreditation will remain in effect.
(3) If payment is not received within 90 days of the payment due date, FDA will withdraw the third-party certification body's accreditation under § 1.664(a)(4), and provide notice of such withdrawal in accordance with § 1.664.
Drug Enforcement Administration, Department of Justice.
The Drug Enforcement Administration is creating a new Administration Controlled Substances Code Number for “Marihuana Extract.” This code number will allow DEA and DEA-registered entities to track quantities of this material separately from quantities of marihuana. This, in turn, will aid in complying with relevant treaty provisions.
Under international drug control treaties administered by the United Nations, some differences exist between the regulatory controls pertaining to marihuana extract versus those for marihuana and tetrahydrocannabinols. The DEA has previously established separate code numbers for marihuana and for tetrahydrocannabinols, but not for marihuana extract. To better track these materials and comply with treaty provisions, DEA is creating a separate code number for marihuana extract with the following definition: “Meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant.” Extracts of marihuana will continue to be treated as Schedule I controlled substances.
Michael J. Lewis, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone (202) 598-6812.
As provided in 21 CFR 1308.03, each controlled substance or basic class thereof is assigned a four digit Administration Controlled Substance Code Number (“Code number” or “drug code”) that is used to track quantities of the controlled substance imported and exported to and from the United States. Additionally, the DEA uses these code numbers in establishing aggregate production quotas for basic classes of controlled substances listed in Schedules I and II as required by 21 U.S.C. 826.
Consistent with the Controlled Substances Act (CSA), the schedules contained in DEA regulations include marihuana (drug code 7360) in Schedule I. 21 CFR 1308.11(d)(23). This listing includes (unless specifically excepted or unless listed in another schedule) any material, compound, mixture, or preparation, which contains any quantity of the substance, or which contains any of its salts, isomers, and salts of isomers that are possible within the specific chemical designation. Because the definition of marihuana in 21 U.S.C. 802(16) includes both derivatives and preparations of marihuana, the DEA until now has used drug code 7360 for extracts of marihuana. This final rule finalizes a
The United Nations Conventions on international drug control treats extracts from the cannabis plant somewhat differently than marihuana or tetrahydrocannabinols. The creation of a new drug code in the DEA regulations for marihuana extracts will allow for more appropriate accounting of such materials consistent with treaty provisions.
The Single Convention on Narcotic Drugs, 1961 (“Single Convention”) and the 1971 Convention on Psychotropic Substances (“Psychotropic Convention”) provide for the international control of marihuana constituents. Many of the CSA's provisions were drafted to comply with these Conventions. The CSA includes schemes of drug scheduling and procedures for adding, removing, and transferring drugs among the schedules that are similar, in some ways, to those in the Single Convention. With respect to those drugs that are subject to control under the Single Convention, the CSA mandates that DEA control such drugs in a manner that will ensure the United States meets its obligations under the Single Convention. 21 U.S.C. 811(d)(1).
Somewhat similar to the CSA, the Single Convention lists substances in four schedules. However, under the Single Convention, the drugs that are subject to the most stringent controls are in Schedule IV. Another difference between the CSA and the Single Convention is that, under the latter, a drug can be listed in more than one schedule. Cannabis and cannabis resin are listed in both Schedule IV and Schedule I of the Single Convention. Schedule I controls under the Single Convention include: Requirements for import and export authorization, licensing of manufacturers/distributors, recordkeeping requirements, a requirement for prescriptions for medical use, annual estimate of needs, quotas, annual statistical reporting, and a requirement that use be limited to medical and scientific purposes. Schedule II of the Single Convention is similar in controls to Schedule I with a few exceptions, and Schedule III is less restrictive. All substances listed in Schedule IV are also listed in Schedule I under the Single Convention in order to encompass the requirements mentioned above. In addition, as indicated, the Single Convention imposes certain heightened measures of control with respect to Schedule IV drugs. The placing of a drug into both Schedule I and Schedule IV, therefore imposes the most stringent controls under the Single Convention. Although cannabis and cannabis resin are listed in Schedules I and IV of the Single Convention, cannabis extracts are listed only in Schedule I.
In response to the July 5, 2011, Notice of Proposed Rulemaking (76 FR 39039), the DEA received six submissions from five commenters. Three of the comments raised issues relating to the medical use or legality of marihuana/cannabis; these comments were not germane to the issues addressed by this rulemaking. A fourth comment was merely a clarification of a comment previously submitted.
One comment requested clarification of whether the new drug code will be applicable to cannabidiol (CBD), if it is not combined with cannabinols.
Another comment from a pharmaceutical firm currently involved in cannabinoid research and product development praised DEA's efforts to establish a new drug code for marihuana extracts as a means to more accurately reflect the activities of scientific research and provide more consistent adherence to the requirements of the Single Convention. However, the comment expressed concerns that the proposed definition for the new drug code (
As discussed in the NPRM, a new drug code is necessary in order to better account for these materials in accordance with treaty obligations. The Single Convention placed “cannabis” and “cannabis resin” under both Schedule I and IV of the Convention, the most stringent level of control under the Convention. While “cannabis resin” is extracted from “cannabis,” the Single Convention specifically controls “extracts” separately. Extracts of cannabis are controlled only under Schedule I of the Convention, which is a lower level of control than “cannabis resin.”
Accordingly, it is the DEA's intent to define the term “marihuana extract” so as to exclude material referenced as “cannabis resin” under the Single Convention on Narcotics. “Cannabis resin” (regulated under the CSA as a resin of marihuana) contains a variety of “cannabinoids” and will continue to be regulated as marihuana under drug code 7360. The new drug code for marihuana extracts under 21 CFR 1308.11(d)(58) will exclude the resin. Cannabis resin and marihuana resin remain captured under the drug code for marihuana (drug code 7360), thus differentiating this material from marihuana extracts (new drug code 7350). This will maintain compliance with the Single Convention.
After careful consideration of all comments, the DEA is hereby amending 21 CFR 1308.11(d) to include a new subparagraph (58) which creates a new code number in Schedule I as follows:
“Meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant.”
The creation of this new drug code in the DEA regulations for marihuana extracts allows for more appropriate accounting of such materials consistent with treaty provisions. Such marihuana
This regulation has been drafted and reviewed in accordance with the principles of Executive Orders 12866 and 13563. This rule is not a significant regulatory action under Executive Order 12866.
This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.
This rulemaking does not have federalism implications warranting the application of Executive Order 13132. The rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government.
This rule does not have tribal implications warranting the application of Executive Order 13175. It does not have substantial direct effects on one or more Indian tribes, 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.
The Administrator, in accordance with the Regulatory Flexibility Act (RFA), 5 U.S.C. 601-602, has reviewed this rule and by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities. This rule establishes a new drug code for marihuana extracts. DEA already registers persons handling marihuana extracts but within another already-established drug code. Thus, persons who handle these marihuana extracts have already met DEA's registration, security, and other statutory and regulatory requirements. The only direct effect to registrants who handle marihuana extracts will be the requirement to add the new drug code to their registration. Therefore, DEA has concluded that this rule will not have a significant effect on a substantial number of small entities.
On the basis of information contained in the “Regulatory Flexibility Act” section above, DEA has determined and certifies pursuant to the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501
This action does not impose a collection of information requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. 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.
This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act (CRA)). This rule will not result in: An annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of U.S.-based companies to compete with foreign based companies in domestic and export markets. However, pursuant to the CRA, the DEA has submitted a copy of this final rule to both Houses of Congress and to the Comptroller General.
Drug traffic control, Controlled substances.
For the reasons set out above, 21 CFR part 1308 is amended as follows:
21 U.S.C. 811, 812, 871(b), unless otherwise noted.
(d) * * *
Meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant.
Occupational Safety and Health Administration, Labor.
On March 16, 2016, the Occupational Safety and Health Administration (OSHA) of the U.S. Department of Labor (Department) issued an interim final rule (IFR) that provided procedures for the Department's processing of complaints under the employee protection (retaliation or whistleblower) provisions of Section 31307 of the Moving Ahead for Progress in the 21st Century Act (MAP-21). The IFR established procedures and time frames for the
This final rule is effective December 14, 2016.
Britania C. Smith, Program Analyst, Directorate of Whistleblower Protection Programs, Occupational Safety and Health Administration, U.S. Department of Labor, Room N-4618, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-2199. This is not a toll-free number. Email:
The Moving Ahead for Progress in the 21st Century Act, Public Law 112-141, 126 Stat. 405, was enacted on July 6, 2012 and, among other things, funded surface transportation programs at over $105 billion for fiscal years 2013 and 2014. Section 31307 of the Act, codified at 49 U.S.C. 30171 and referred to throughout this rulemaking as MAP-21, prohibits motor vehicle manufacturers, parts suppliers, and dealerships from discharging or otherwise retaliating against an employee because the employee provided, caused to be provided or is about to provide information to the employer or the Secretary of Transportation relating to any motor vehicle defect, noncompliance, or any violation or alleged violation of any notification or reporting requirement of Chapter 301 of title 49 of the U.S. Code (Chapter 301); filed, caused to be filed or is about to file a proceeding relating to any such defect or violation; testified, assisted or participated (or is about to testify, assist or participate) in such a proceeding; or objected to, or refused to participate in, any activity that the employee reasonably believed to be in violation of any provision of Chapter 301, or any order, rule, regulation, standard or ban under such provision. Chapter 301 is the codification of the National Traffic and Motor Vehicle Safety Act of 1966, as amended, which grants the National Highway Traffic Safety Administration (NHTSA) authority to issue vehicle safety standards and to require manufacturers to recall vehicles that have a safety-related defect or do not meet federal safety standards. This final rule adopts, without change, the provisions in the IFR which established procedures for the handling of whistleblower complaints under MAP-21.
On March 16, 2016, OSHA published in the
After the OSHA investigation, the complainant should have a reasonable chance to respond to whatever the investigation found before the final determination. The investigation should rely on facts: Any witness remarks need to be substantiated by facts, and the complainant should be able to respond to them. Investigations need to be conducted according to strict guidelines with facts checked perhaps by another investigator.
OSHA is making no revisions to the MAP-21 rule in response to this comment. OSHA believes that the procedures in the IFR, see
This rule contains a reporting provision (filing a retaliation complaint, Section 1988.103) which was previously reviewed and approved for use by the Office of Management and Budget (OMB) under the provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13). The assigned OMB control number is 1218-0236.
The notice and comment rulemaking procedures of Section 553 of the Administrative Procedure Act (APA) do not apply “to interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice.” 5 U.S.C. 553(b)(A). This is a rule of agency procedure, practice, and interpretation within the meaning of that section. Therefore, publication in the
Furthermore, because this rule is procedural and interpretative rather than substantive, the normal requirement of 5 U.S.C. 553(d) that a rule be effective 30 days after publication in the
The Department has concluded that this rule is not a “significant regulatory action” within the meaning of Executive Order 12866, reaffirmed by Executive Order 13563, because it is not likely to: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy
The notice and comment rulemaking procedures of Section 553 of the APA do not apply “to interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice.” 5 U.S.C. 553(b)(A). Rules that are exempt from APA notice and comment requirements are also exempt from the Regulatory Flexibility Act (RFA). See SBA Office of Advocacy, A Guide for Government Agencies: How to Comply with the Regulatory Flexibility Act, at 9; also found at:
Administrative practice and procedure, Automobile dealers, Employment, Investigations, Motor vehicle defects, Motor vehicle manufacturers, Part suppliers, Reporting and recordkeeping requirements, Whistleblower.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Tower Drawbridge across the Sacramento River, mile 59.0, at Sacramento, CA. The deviation is necessary to allow the community to participate in the New Year's Eve fireworks. This deviation allows the bridge to remain in the closed-to-navigation position during the deviation period.
This deviation is effective from 8:30 p.m. on December 31, 2016 to 12:15 a.m. on January 1, 2017.
The docket for this deviation, [USCG-2016-1044], is available at
If you have questions on this temporary deviation, call or email David H. Sulouff, Chief, Bridge Section, Eleventh Coast Guard District; telephone 510-437-3516, email
California Department of Transportation has requested a temporary change to the operation of the Tower Drawbridge, mile 59.0, over Sacramento River, at Sacramento, CA. The vertical lift bridge navigation span provides a vertical clearance of 30 feet above Mean High Water in the closed-to-navigation position. The draw operates as required by 33 CFR 117.189(a). Navigation on the waterway is commercial and recreational.
The drawspan will be secured in the closed-to-navigation position from 8:30 p.m. on December 31, 2016 to 12:15 a.m. on January 1, 2017, to allow the community to participate in the New Year's Eve fireworks. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised.
Vessels able to pass through the bridge in the closed position may do so at any time. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators 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.
Department of Veterans Affairs.
Final rule with comment period.
The Department of Veterans Affairs (VA) is amending its medical regulations to permit full practice authority of three roles of VA advanced practice registered nurses (APRN) when they are acting within the scope of their VA employment. Certified Registered Nurse Anesthetists (CRNA) will not be included in VA's full practice authority
This final rule is effective January 13, 2017. Comments on full practice authority for CRNAs must be received by VA on or before January 13, 2017.
Written comments may be submitted: Through
David J. Shulkin, M.D., Under Secretary for Health, (202) 461-7000 or Linda M. McConnell, Office of Nursing Services, (202) 461-6700, 810 Vermont Avenue NW., Washington, DC 20420. (These are not toll-free numbers.)
In a document published in the
The Office of the Federal Register has prepared a document, A Guide to the Rulemaking Process, that states that an agency is not permitted to base its final rule on the number of comments received in support of the rule over those in opposition to it or vice versa. The document further states that an agency must base its reasoning and conclusions on the rulemaking record, which consists of the comments received, scientific data, expert opinions, and facts accumulated during the pre-rule and proposed rule stages. This final rule adheres to the guidance established by the Office of the Federal Register.
Section 7301 of title 38 United States Code (U.S.C.) establishes the Veterans Health Administration (VHA) within VA, and establishes that its primary function is to “provide a complete medical and hospital service for the medical care and treatment of veterans, as provided in this title and in regulations prescribed by the Secretary pursuant to this title.” To allow VA to carry out its medical care mission, Congress also established a comprehensive personnel system for certain medical employees in VHA, independent of the civil service rules. See Chapters 73 and 74 of title 38, U.S.C. As an integrated Federal health care system with the responsibility to provide comprehensive care under 38 U.S.C. 7301, it is essential that VHA wisely manage its resources and fully utilize the skills of its health care providers to the full extent of their education, training, and certification.
By permitting the three APRN roles, Certified Nurse Practitioner (CNP), Clinical Nurse Specialist (CNS), or Certified Nurse-Midwife (CNM), throughout the VHA system with a way to achieve full practice authority in order to provide advanced nursing services to the full extent of their professional competence, VHA furthers its statutory mandate to provide quality health care to our nation's veterans. This regulatory change to nursing policy permits three roles of APRNs to practice to the full extent of their education, training and certification, without the clinical supervision or mandatory collaboration of physicians. Standardization of APRN full practice authority, without regard for individual State practice regulations, helps to ensure a consistent delivery of health care across VHA by decreasing the variability in APRN practice that currently exists as a result of disparate State practice regulations. Certified Registered Nurse Anesthetists (CRNA) will not be included in VA's full practice authority under this final rule, but comment is requested on whether there are access issues or other unconsidered circumstances that might warrant their inclusion in a future rulemaking.
Standardization of full practice authority to the three APRN roles also aids VA in making the most efficient use of VHA APRN staff capabilities, which increases VA's capacity to provide timely, efficient, and effective primary care services, as well as other services. This increases veteran access to needed VA health care, particularly in medically-underserved areas and decreases the amount of time veterans spend waiting for patient appointments. In addition, standardizing APRN practice authority enables veterans, their families, and caregivers to understand more readily the health care services that VA APRNs are authorized to provide. This preemptive rule increases access to care and reduces the wait times for VA appointments utilizing the current workforce already in place. VA's position to not include the CRNAs in this final rule does not stem from the CRNAs' inability to practice to the full extent of their professional competence, but rather from VA's lack of access problems in the area of anesthesiology.
To ensure that VA would have available highly qualified medical personnel, Congress mandated the basic qualifications for certain health care positions, including registered nurses. Sections 7401 through 7464 of title 38, U.S.C., grant VA authority to regulate the professional activities of such personnel. To be eligible for appointment as a VA employee in a health care position (other than Director) covered by section 7402(b), of title 38, U.S.C., a person must, among other requirements, be licensed, registered, or certified to practice their profession in a State. The standards prescribed in section 7402(b) establish only the basic qualifications necessary “[t]o be eligible for appointment” and
To continue to provide high quality health care to veterans, this final rule will allow three roles of APRNs to practice to the full extent of their education, training, and certification when acting within the scope of their VA employment, regardless of State restrictions that limit such full practice authority, except for applicable State restrictions on the authority to prescribe and administer controlled substances.
The proposed rule stated that VA was proposing to grant full practice authority to four APRN roles. We received 104,256 comments against granting full practice authority to VA CRNAs. The American Society of Anesthesiologists lobbied heavily against VA CRNAs having full practice authority. They established a Web site that would facilitate comments against the CRNAs, which went as far as providing the language for the comment. These comments were not substantive in nature and were akin to votes in a ballot box. The main argument against the VA CRNAs was that by granting CRNAs full practice authority VA would be eliminating the team based concept of care in anesthesia, which is currently established in VA policy via VHA Handbook 1123, Anesthesia Service. Team based care was not addressed in the proposed rule because we consider it to be an integral part in addressing all of a veteran's health care needs. Establishing full practice authority to VA APRNs, including CRNAs, would not eliminate any well-established team based care. The second argument posed against granting full practice authority to VA CRNAs was that there is “no shortage of physician anesthesiologists in VA and the current system allows for sufficient flexibility to address the needs of all VA hospitals.” Again, most of these comments were not substantiated by evidence, though as discussed further below, VA does believe that evidence exists that there is not currently a shortage of anesthesiologists that critically impacts access to care, and therefore VA agrees with the sentiment of this argument.
We similarly received 45,915 comments in support of full practice authority for APRNs as a whole without specific mention of CRNAs. We received 9,613 comments in support of full practice authority for CRNAs. The CRNA-specific commenters stated that “CRNAs currently exercise their full scope of practice in 17 states and in the Army, Navy, Air Force, Combat Support Hospitals, Forward Surgical Teams, and the Indian Health Services, even in some VAs where CRNAs are the only anesthesia providers. Evidence shows that APRN provided care increases access, improves quality, and reduces costs for all Americans. By extending Full Practice authority to CRNAs and other APRNs at the VHA, we can help end delays to high-quality, safe, and cost-effective care for America's Veterans. Implement this well researched policy change promptly.” The commenters also stated that “APRN's and CRNAs practicing in a manner which they have been educated and trained to provide expert care has been backed by decades of research.” Several other commenters stated “Over 900 CRNAs provide every type of anesthesia care, as well as chronic pain management services, for our Veterans in the VHA. The safety of CRNA services has long been recognized by the VHA and underscored by peer-reviewed scientific studies, including a major study published in Health Affairs which found that anesthesia care by CRNAs was equally safe with or without physician supervision.” VA agrees with these comments, but has chosen not to include CRNAs in this final rule due to VA's lack of access problems in the area of anesthesiology.
Commenters raised anesthesia issues related to the RAND Assessment, which the public can view at
We reviewed the Veterans Health Administration payroll data revealed that, as of August 31, 2016, VHA employs 940 Physician Anesthesiologists (physicians), 5,444 Nurse Practitioners, 937 CRNAs, and 386 Nurse Specialists. Nurse Practitioner is currently #3 in the top 5 difficult to recruit and retain nurse specialties. Additional workforce trend data is available in the Regulatory Impact Analysis.
In a 2015 independent survey of VA general facility Chief of Staffs conducted by the Rand Corporation, approx. 38% (43 of 111) reported problems
Similarly, nearly 30% (33 of 111) of Chiefs of Staffs reported problems
In fiscal years 2011 through 2015, CRNAs were in the top 10 VHA Occupations of Critical Need, but dropped to 12th place in FY 2015. Despite the challenges discussed above, within VHA the occupation has grown approximately 27% between FY 2010 and FY 2014 (166 employees). Total loss rates decreased from 6.6% in FY 2013 to 6.2% in FY 2014, but have ranged from 9.4% to 6.2% between FY 2009 and FY 2014. Voluntary retirements decreased from 3.2% in FY 2013 to 2.7% in FY 2014. Quits increased from 1.9% in FY 2013 to 2.6% in FY 2014. VA has taken steps to improve recruitment of CRNAs, including partnering with the U.S. Army to educate interested and qualified VA registered nurses in the field of nurse anesthesia.
Anesthesiology is not in the top 5 difficult to recruit and retain physician specialties. However, in a 2015 independent survey of VA general facility Chief of Staffs conducted by the Rand Corporation, 25% (27 of 111) reported problems
Recruiting, hiring, and retention challenges, as reported by VA facility Chiefs of Staffs struggling with these issues, are similar among advanced practice or specialist nurses and anesthesiologists. These managers did not view lack of advancement opportunity or practice autonomy as significant barriers to retention, which may indicate that increased use of advanced practice authority is unlikely to fully resolve this challenge—both because it may not address the root causes of these problems and because similar challenges constrain hiring of both doctors and nurses. On the other hand, the perceptions of potential applicants and staff may not be fully reflected by a survey of facility management. Further, it is possible that resources might be available to address some of these underlying issues if efficiencies were realized as a result of advanced practice nursing authority. VA welcomes comment on whether lack of advanced practice authority is a hiring, recruitment, or retention barrier for CRNAs, as well as on the extent to which advanced practice authority could help to resolve these issues either directly or indirectly.
Based on this analysis, VHA believes that VA does not have immediate and broad access problems in the area of anesthesia care across the full VA health care system that require full practice authority for all CRNAs.
However, VA requests comment on the question of whether there are current anesthesia care access issues for particular states or VA facilities and whether permitting CRNAs to practice to the full extent of their advanced authority would resolve these issues. VA also requests comment on potential future anesthesia care access issues, particularly in light of projected increases in demand for VA care, including surgical care, in coming years.
We will, therefore, not finalize the provision including CRNAs in the rule as one of the APRN roles that may be granted full practice authority at this time. However, we request comment on this decision. If we learn of access problems in the area of anesthesia care in specific facilities or more generally that would benefit from advanced practice authority, now or in the future, or if other relevant circumstances change, we will consider a follow-up rulemaking to address granting full practice authority to CRNAs.
VA CRNAs that have already been granted full practice authority by their State license will continue to practice in VA in accordance with their State license and subject to credentialing and privileging by a VA medical facility's medical executive committee. VA will not restrict or eliminate these CRNAs' full practice authority.
This final rule uses the term “full practice authority” to refer to the APRN's authority to provide advanced nursing services without the clinical oversight of a physician when that APRN is working within the scope of their VA employment. Such full practice authority is granted by VA upon demonstrating that the advanced educational, testing, and licensing requirements established in this rulemaking are met and upon the recommendation and approval of the medical executive committee when the provider is credentialed and privileged.
In this rulemaking, VA is exercising Federal preemption of State nursing licensure laws to the extent such State laws conflict with the full practice authority granted to VA APRNs while acting within the scope of their VA employment. Preemption is the minimum necessary action for VA to allow APRNs full practice authority. It is impractical for VA to consult with each State that does not allow full practice authority to APRNs to change their laws regarding full practice authority.
The campaign in support of the proposed rule was not as extensive as the campaign against granting full practice authority to CRNAs. The main lobbyists in support of the proposed rule were the American Nurses Association and the American Association of Nurse Practitioners, who supported a letter campaign. We received 45,915 comments in support of the proposed rule. Of these 45,915, we received specific support of individual APRN roles as follows: 9,613 in support of CRNAs, 1,079 in support of CNM, and 495 in support of CNPs. These
We received a comment in support of the proposed rule from the Federal Trade Commission (FTC). The FTC focuses on the “impact of regulation on competition in the private sector and, ultimately, on consumers.” The FTC's main interest in the proposed rule was “the extent that the VA's actions may encourage entry into health care service provider markets, broaden the availability of health care services outside the VHA system, as well as within it, and yield information about new models of health care delivery.” The FTC believes that its experience “may inform and support the VA's endeavor.” The FTC staff supports the granting of full practice authority to APRNs, which will benefit “VA's patients and the institution itself, by improving access to care, containing costs, and expanding innovation in health care delivery.” VA's actions could also spur competition among “health care providers and generate additional data in support of safe APRN practice,” which could also spill into the private health care sector. We thank the FTC for their support of the proposed rule and make no edits based on this comment.
Several commenters stated that they were concerned with proposed § 17.415(d)(1)(i)(B), where we stated that a Certified Nurse Practitioner (CNP) may order, perform, or supervise laboratory studies. The commenters stated that the proposed language does not “adequately appreciate the levels of complexity involved in laboratory testing” and that there are rigid standards for laboratory tests that require rigorous academic and practical training, which are not part of the training for APRNs. Another commenter stated, “While the VHA uses the word `interpret' in reference to laboratory and imaging studies,” the commenter “. . . infers that the VA's intent is to grant the ability for CNPs to interpret laboratory and imaging results, not to interpret or report raw images or data.” The commenter suggested that VA amend the term “`interpret' and recommends instead to use `integrate results into clinical decision making,' or some other phrase” in order to avoid confusion between the duties of an APRN and those of a laboratory specialist. We agree with the commenter in that the proposed language might be construed as allowing CNPs the ability to perform laboratory studies. It is not VA's intent to have APRNs take over the role of laboratory specialists. These specialists perform a crucial role at VA medical facilities and are skillfully trained in performing the various testing techniques that allow health care professionals to properly treat a veteran's medical condition. We are amending proposed § 17.415(d)(1)(i)(B) to now state that a CNP may be granted full practice authority to “Order laboratory and imaging studies and integrate the results into clinical decision making.”
Other commenters were similarly concerned with the language in proposed § 17.415(d)(1)(i)(B), but as it refers to ordering, performing, supervising and interpreting imaging studies. The commenters stated that only trained radiologists, who undergo 10 years of comprehensive training to accurately interpret high-tech imaging exams and safely account for the radiation used in many scans should perform these duties. The commenters further stated that imaging exams should only be performed by registered radiological technologists. It is not VA's intent to replace our highly qualified radiologists or radiological technologists. VA is committed to providing high quality health care for our nation's veterans and is proud of the outstanding work performed by radiologists in our system. We note, however, that during the course of care, other health care providers may review radiology exams and make evaluations based upon the radiologist's findings. These health care providers include providers in emergency departments, primary care clinics, and specialty clinics throughout the VA health care system. All radiology studies are formally performed and read by individuals who are credentialed in radiology. This rulemaking will not change this practice. In order to avoid confusion, we are amending § 17.415(d)(1)(i)(B) by removing performing, supervising, and interpreting imaging studies and replacing it with “Order laboratory and imaging studies and integrate the results into clinical decision making.”
Some commenters were also concerned that CNPs “may order more imaging studies, which increases the total cost and the radiation dose to the patient.” One commenter cited a study that indicated that CNPs may order imaging more frequently than primary care physicians. However, the study defined advanced practice clinicians to include CNPs and physician assistants, and did not differentiate between these two different types of health care providers in the study. This rulemaking only addresses APRNs, and it is unclear how the study was influenced by including physician assistants. It's also unclear whether there is actually a significantly higher rate of ordering imaging among these groups. We found no other significant evidence provided by the commenters to support the claim that CNPs order more imaging studies than physicians. For these reasons, we make no changes based on this comment.
Several commenters were concerned that the value of team-based care would be undermined by granting full practice authority to APRNs. They stated that physicians and other members of a health care team bring unique value to patient care that is based on the individual member's education, skill, and training. The commenters argued that by eliminating team-based care, patients would be placed at risk. Team-based care is an integral part of VA health care and is used in a wide range of settings, which include polytrauma care, nutrition support, and primary care. VA will continue to provide the already established team-based care to properly treat the veteran's individual health care needs. The proposed rule only addressed the granting of full practice authority to APRNs and does not address team-based care. Any change to current VA team-based health
Other commenters questioned an APRN's years of training versus those of a physician, citing an American Medical Association statement that “physicians typically receive a combined total of over 10,000 hours of training and patient experience prior to beginning practice, whereas the typical APRN receives less than 1,000 hours of training and patient experience.” The commenters added that trained physicians should be taking care of the veterans' medical needs as opposed to a nurse who has not received the same training and education as physicians. APRN education is competency based and APRNs must demonstrate that they have integrated the knowledge and skill to provide safe patient care. Entry into APRN practice is predicated on the requirement to attain national certification. APRNs are held to the same standard as physicians in measuring patient outcomes for safe and effective care. VHA acknowledges the fact there are differences in physician and APRN educational and training models and is not planning on replacing physicians with APRNs in any health care setting within VHA.
APRNs are valuable members of VA's health care system and provide a degree of much needed experience to alleviate the current access problems that are affecting VA. APRNs, like physicians, are required to maintain their State license and their health care skills are continuously assessed through the privileging process. As we stated in the proposed rule “APRNs would not be authorized to replace or act as physicians or to provide any health care services that are beyond their clinical education, training, and national certification” and an APRN will require approval of their credentials and privileges by the VA medical facility's medical executive committee. An APRN will refer patients to a physician for care that goes beyond that of the APRN's training. We will not make any edits based on these comments.
Several commenters stated that they would like all veterans to receive the best and safest medical care in VA and do not believe that granting APRNs full practice authority will lead to such care. As previously stated in this final rule, VHA's primary function is to “provide a complete medical and hospital service for the medical care and treatment of veterans” under 38 U.S.C. 7301(b). We also stated in the proposed rule that in carrying out this function, VHA has an obligation to ensure that patient care is appropriate and safe and its health care practitioners meet or exceed generally-accepted professional standards for patient care. The general qualifications for a person to be appointed as a VA nurse are found in 38 U.S.C. 7402(b)(3). In addition to these general qualifications, the proposed rule stated that APRNs would now be required to have “successfully completed a nationally-accredited, graduate-level educational program that prepares the advanced practice registered nurse in one of the four APRN roles; and to possess, and maintain, national certification and State licensure in that APRN role.” VA believes that these additional qualifications for APRNs ensure that VA has highly qualified health care personnel to provide safe health care to veterans. In addition, the VA medical facility's medical executive committee will be responsible for the quality and oversight of the health care provider. Additionally, the IOM Report states that “the contention that APRNs are less able than physicians to deliver care that is safe, effective, and efficient is not supported by the decades of research that has examined this question (Brown and Grimes, 1995; Fairman, 2008; Groth et al., 2010; Hatem et al., 2008; Hogan et al., 2010; Horrocks et al., 2002; Hughes et al., 2010; Laurant et al., 2004; Mundinger et al., 2000; Office of Technology Assessment, 1986). No studies suggest that care is better in states that have more restrictive scope-of-practice regulations for APRNs than in those that do not.” We will not make any edits based on these comments.
Several commenters stated that the proposed rule would undermine the State requirement that CNPs need to collaborate with or be supervised by physicians. They were also concerned that the rule would eliminate local control of licensing and regulation of physicians and health care providers, which would result in lower standard of care. We note that there may be discrepancies between State practice acts and this final rule which is why this regulation preempts conflicting state and local law. As we stated in the proposed rule, “In circumstances where there is a conflict between Federal and State Law, Federal law prevails in accordance with Article VI, clause 2, of the U.S. Constitution (Supremacy Clause).” We also stated “where there is conflict between State law and Federal law with regard to full practice authority of APRNs working within the scope of their federal VA employment, this regulation would control.” Again, we emphasize that this rule only preempts State law for VA employees practicing within the scope of their VA employment, and that as a result, any such infringement upon State authority would be limited. Further, this final rule does not eliminate the APRN's need to possess a license from a State licensing board in one of the recognized APRN roles. This is a requirement in proposed § 17.415(a)(3). Proposed § 17.415(a)(4) also requires an APRN to maintain both the national certification and licensure. In addition to these requirements, an APRN must demonstrate the knowledge and skills necessary to provide the services described in proposed § 17.415(d) without the clinical oversight of a physician, and is thus qualified to be privileged for such scope of practice by the medical executive committee. These measures will ensure that patients receive care from an APRN that is credentialed and privileged to perform the specified tasks and will promote patient safety. We will not make any edits based on these comments.
Several commenters were concerned that APRNs would be at a higher risk of malpractice, especially when the APRN's State license does not grant full practice authority. A commenter asserted that the APRN's defense would be diminished when the “state in which the APRN is practicing in deems an act beyond the provider's scope of practice, but the Federal government has given all APRNs the broadest rights available.” Under the Federal Tort Claims Act, 28 U.S.C. 1346(b), 2401(b), 2671-2680, and the Westfall Act, 28 U.S.C. 2679(b)-(d), employees furnishing medical care or services in the exercise of their duties for VHA are immune from personal liability for malpractice in the scope of their employment; the rule clarifies the intent of VA that APRNs will be acting within the scope of employment when performing their duties in the capacities set forth herein. The commenters further stated that the preemption of State law would create a discrepancy with VA policy in that VA states in the proposed rule that an APRN must be licensed by a State. As previously stated in this rulemaking, where there is conflict between State law and Federal law with regard to full practice authority of APRNs working within the scope of their Federal employment, this regulation would control. In doing so, VA is better able to protect the APRNs against any challenge of their State license when practicing within the scope of their VA employment. VA does not see a disconnect between preemption and the requirement that an APRN must have a State license. Such requirement is established in statute
One commenter indicated that the proposed rule stated “Section 4 of Executive Order 13132 requires that when an agency proposes to act through rulemaking to preempt state law, `the agency shall consult, to the
Another commenter stated that the proposed rule “will directly affect many individuals and will directly affect small entities.” The commenter further stated that the rule should not be exempt from the initial regulatory flexibility analysis as stated in the Regulatory Flexibility Act (5 U.S.C. 603 and 604), will not maximize net benefits and equity and will raise novel and legal policy issues. Another comment emphasizes only that “some private-sector anesthesiology services” are provided by small physician practices, which “may” include nurse anesthetists. It further notes that in a “limited” number of states, there is a “possibility” that private sector anesthetists could be induced to work at VA instead of in the private sector. None of these claims demonstrate that the regulation would have a significant economic effect on a substantial number of small entities; VA found no such effect would result in its proposed rule, and certified this finding as required by 5 U.S.C. 605(b). We further note that private sector providers are not subject to the proposed regulation, which would only regulate the activities of VA employees, and hence would be outside the scope of a required analysis under the Regulatory Flexibility Act. See,
Another commenter was in support of the proposed rule, but had concerns regarding prescriptive authority, namely that in some States the prescriptive authority regulations “are linked to scope of practice laws which would create confusion in VA facilities operating within those states.” The commenter further stated that “collaborative agreements may limit the scope of practice of the advanced practice registered nurse and inhibit full practice authority.” VA understands that the proposed change could create confusion, and as a result, VA will train and educate its APRNs in their authorities based upon this rule to reduce the potential for confusion and to ensure they can practice to the full extent of their authority. We make no edits based on this comment.
A commenter stated a belief that there is a distinction “between the ability of APRNs to perform tasks autonomously and their ability to practice independently. The former is a well-established practice, while the latter is controversial.” The commenter distinguished “ `autonomy' from `independence,' the latter referring to practitioners acting alone and not in a team-based model.” The commenter stated that they support “highly trained APPs who are part of a care team practicing autonomously within the scope and ability of their licensure. This is generally accomplished with collaborative practice between a collaborating physician and APPs on the care team.” We previously stated in this final rule that team-based care was not addressed in the proposed rule. Team-based care is an integral part of VA health care, and we will continue to adhere to the already established team-based models of care within VA. We are not making any edits based on this comment.
Several commenters stated that VA should include physician assistants (PA) in the final rule and grant them full practice authority as well. Other commenters were opposed to the granting of full practice authority to PAs. We similarly received comments requesting that we include pharmacist practitioners in the rule. The granting of full practice authority to PAs and pharmacist practitioners was not addressed in the proposed rule and granting such authority in this final rule is beyond the scope of the proposed rule. VA would only be able to address
One commenter opposed the proposed rule and urged VA “to instead focus on ways to improve access to care provided to veterans in community settings through the Choice Program. This would reduce wait times for appointments for all veterans, and free up VA clinicians to care for sicker and more complex patients in VA facilities prepared to address their unique needs.” The Veterans Choice Program is authorized by section 101 of the Veterans Access, Choice, and Accountability Act of 2014. The program is implemented in 38 CFR 17.1500 through 17.1540. The proposed rule did not address the Veterans Choice Program, and in no way affects the Veterans Choice Program. This comment is beyond the scope of this rulemaking. We are not making any edits based on this comment.
One commenter suggested that VA amend its application process for hiring physicians citing that there are delays in the
VA received many comments that expressed general support or opposition to this rulemaking and raised various issues related to administration of the VA health care system or VA benefits that are beyond the scope of this rulemaking. We make no changes based on these comments.
We are making a minor typographical edit by adding a comma in proposed § 17.415(e) to correct an error in the proposed rule. We are also amending the last sentence of the paragraph to now read “Any State or local law, or regulation pursuant to such law, is without any force or effect on, and State or local governments have no legal authority to enforce them in relation to, activities performed under this section or decisions made by VA under this section.” The proposed rule inadvertently did not include the phrase “activities performed under”. We are now adding this clarifying language.
Based on the rationale set forth in the Supplementary Information to the proposed rule and in this final rule, VA is amending the proposed rule with the edits stated in this final rule.
Section 4 of Executive Order 13132 (titled “Federalism”) requires an agency that is publishing a regulation that preempts State law to follow certain procedures. Section 4(b) of the Executive Order requires agencies to “construe any authorization in the statute for the issuance of regulations as authorizing preemption of State law by rulemaking only when the exercise of State authority directly conflicts with the exercise of Federal authority under the Federal statute or there is clear evidence to conclude that the Congress intended the agency to have the authority to preempt State law.” Section 4(d) of the Executive Order requires that when an agency proposes to act through rulemaking to preempt State law, “the agency shall consult, to the extent practicable, with appropriate State and local officials in an effort to avoid such a conflict.” Section 4(e) of the Executive Order requires that when an agency proposes to act through rulemaking to preempt State law, “the agency shall provide all affected State and local officials notice and an opportunity for appropriate participation in the proceedings.”
Section 6(c) of Executive Order 13132 states that “no agency shall promulgate any regulation that has federalism implications and that preempts State law, unless the agency, prior to the formal promulgation of the regulation, (1) consulted with State and local officials early in the process of developing the proposed regulation; (2) in a separately identified portion of the preamble to the regulation as it is to be issued in the
Because this regulation addresses preemption of certain State laws, VA conducted prior consultation with State officials in compliance with Executive Order 13132. Such State officials include State Senators from Georgia and Illinois, State Representatives from Florida, Ohio, Vermont, North Carolina, Georgia, and Illinois, County Commissioners from Nevada, Ohio, and North Carolina, and the State Comptroller and Secretary of State from Illinois, to name a few. Although not necessarily required by the Executive Order, VA sent a letter to the National Council of State Boards of Nursing to state VA's intent to allow full practice authority to VA APRNs and for the National Council of State Boards of Nursing (NCSBN) to notify every State Board of Nursing of VA's intent and to seek feedback from such Boards of Nursing. In response to its request for comments, VA received correspondence from the Executive Director and other relevant staff members within NCSBN, which agreed with VA's position that this rulemaking properly identifies the areas in VA regulations that preempt State laws and regulations.
VA additionally engaged other relevant external groups on the proposed changes in this rulemaking, including the American Association of Nurse Anesthetists, American Association of Nurse Practitioners, American College of Surgeons, American Academy of Family Practice Physicians, American Society of Anesthesiologists, American Medical Association, Association of American Medical Colleges, The Joint Commission-Office of Accreditation and Certification, American Association of Retired Persons, American Legion, Blinded Veterans Association, Vietnam Veterans of America, American Women Veterans, Disabled American Veterans, Paralyzed Veterans of America, and Veterans of Foreign Wars. VA also engaged the Senate and House Veterans' Affairs Committees and the Senate and House Armed Services Committees.
Many external stakeholders expressed general support for VA's positions taken in the proposed rule, particularly with respect to full practice authority of APRNs in primary health care. However, we also received comments opposing full practice authority for CRNAs when providing anesthetics. To aid in VA's full consideration to this issue, VA encouraged any comments regarding the proposed full practice authority. In this way, VA provided all affected State and local officials notice and an opportunity for appropriate participation in the proceedings.
VA's promulgation of this regulation complies with the requirements of Executive Order 13132 by (1) in the absence of explicit preemption in the authorizing statute, identifying where the exercise of State authority conflicts with the exercise of Federal authority under Federal statute; (2) limiting the preemption to only those areas where we find a conflict exists; (3) restricting the regulatory preemption to the minimum level necessary to achieve the objectives of the statute; (4) receiving and considering input from State and
Title 38 of the Code of Federal Regulations, as revised by this final rulemaking, represents VA's implementation of its legal authority on this subject. Other than future amendments to this regulation or governing statutes, no contrary guidance or procedures are authorized. All existing or subsequent VA guidance must be read to conform with this rulemaking if possible or, if not possible, such guidance is superseded by this rulemaking.
This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This final rule directly affects only individuals and would not directly affect small entities. Therefore, pursuant to 5 U.S.C. 605(b), this amendment is exempt from the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB), unless OMB waives such review, as “any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.”
The economic, interagency, budgetary, legal, and policy implications of this regulatory action have been examined, and it has been determined to be a significant regulatory action under Executive Order 12866 because it is likely to result in a rule that may raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order. VA's impact analysis can be found as a supporting document at
The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule has no such effect on State, local, and tribal governments, or on the private sector.
The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are: 64.007, Blind Rehabilitation Centers; 64.008, Veterans Domiciliary Care; 64.009, Veterans Medical Care Benefits; 64.010, Veterans Nursing Home Care; 64.011, Veterans Dental Care; 64.012, Veterans Prescription Service; 64.013, Veterans Prosthetic Appliances; 64.014, Veterans State Domiciliary Care; 64.015, Veterans State Nursing Home Care; 64.018, Sharing Specialized Medical Resources; 64.019, Veterans Rehabilitation Alcohol and Drug Dependence; 64.022, Veterans Home Based Primary Care; and 64.024, VA Homeless Providers Grant and Per Diem Program.
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Robert D. Snyder, Chief of Staff, Department of Veterans Affairs, approved this document on September 2, 2016, for publication.
Administrative practice and procedure, Alcohol abuse, Alcoholism, Claims, Day care, Dental health, Drug abuse, Foreign relations, Government contracts, Grant programs—health, Grant programs—veterans, Health care, Health facilities, Health professions, Health records, Homeless, Medical and dental schools, Medical devices, Medical research, Mental health programs, Nursing homes, Philippines, Reporting and recordkeeping requirements, Scholarships and fellowships, Travel and transportation expenses, Veterans.
For the reasons set forth in the preamble, we amend 38 CFR part 17 as follows:
38 U.S.C. 501, and as noted in specific sections.
Section 17.415 is also issued under 38 U.S.C. 7301, 7304, 7402, and 7403.
(1) Has completed a nationally-accredited, graduate-level educational program that prepares them for one of the three APRN roles of Certified Nurse Practitioner (CNP), Clinical Nurse Specialist (CNS), or Certified Nurse-Midwife (CNM);
(2) Has passed a national certification examination that measures knowledge in one of the APRN roles described in paragraph (a)(1) of this section;
(3) Has obtained a license from a State licensing board in one of three recognized APRN roles described in paragraph (a)(1) of this section; and
(4) Maintains certification and licensure as required by paragraphs (a)(2) and (3) of this section.
(1) Verification that the APRN meets the requirements established in paragraph (a) of this section; and
(2) Determination that the APRN has demonstrated the knowledge and skills necessary to provide the services described in paragraph (d) of this section without the clinical oversight of a physician, and is thus qualified to be privileged for such scope of practice.
(i) A CNP has full practice authority to:
(A) Take comprehensive histories, provide physical examinations and other health assessment and screening activities, diagnose, treat, and manage patients with acute and chronic illnesses and diseases;
(B) Order laboratory and imaging studies and integrate the results into clinical decision making;
(C) Prescribe medication and durable medical equipment;
(D) Make appropriate referrals for patients and families, and request consultations;
(E) Aid in health promotion, disease prevention, health education, and counseling as well as the diagnosis and management of acute and chronic diseases.
(ii) A CNS has full practice authority to provide diagnosis and treatment of health or illness states, disease management, health promotion, and prevention of illness and risk behaviors among individuals, families, groups, and communities within their scope of practice.
(iii) A CNM has full practice authority to provide a range of primary health care services to women, including gynecologic care, family planning services, preconception care (care that women veterans receive before becoming pregnant, including reducing the risk of birth defects and other problems such as the treatment of diabetes and high blood pressure), prenatal and postpartum care, childbirth, and care of a newborn, and treating the partner of their female patients for sexually transmitted disease and reproductive health, if the partner is also enrolled in the VA healthcare system or is not required to enroll.
(2) The full practice authority of an APRN is subject to the limitations imposed by the Controlled Substances Act, 21 U.S.C. 801
Environmental Protection Agency (EPA).
The Environmental Protection Agency (EPA) is determining that the Houston-Galveston-Brazoria, Texas 2008 8-hour ozone nonattainment area (HGB area) failed to attain the 2008 8-hour ozone national ambient air quality standard (NAAQS) by the applicable attainment deadline of July 20, 2016, and thus is classified by operation of law as “Moderate”. In this action, EPA is also determining January 1, 2017 as the deadline by which Texas must submit to the EPA the State Implementation Plan (SIP) revisions that meet the Clean Air Act (CAA) statutory and regulatory requirements that apply to 2008 ozone NAAQS nonattainment areas reclassified as Moderate.
This rule is effective December 14, 2016.
The EPA has established a docket for this action under Docket ID No. EPA-R06-OAR-2016-0275. All documents in the docket are listed on the
Ms. Nevine Salem, (214) 665-7222,
Throughout this document “we,” “us,” and “our” means the EPA.
The background for this action is discussed in detail in our September 27, 2016, (81 FR 66240) proposal. In that document, we proposed to determine that the HGB area failed to attain the 2008 ozone NAAQS by the applicable attainment deadline of July 20, 2016,
Under APA section 553(d)(3), 5 U.S.C. 553(d)(3), an agency may make a rule immediately effective “for good cause found and published with the rule.” The EPA believes that there is “good cause” to make this rule effective upon publication in the
The EPA published the proposed rule for this action on September 27, 2016, (81 FR 66240), and started a public comment period that ended on October 27, 2016. We received one set of comments from one commenter, Texas Commission on Environmental Quality (TCEQ) during this period. The comments received from TCEQ can be found in the electronic docket for this action.
The attainment period (to attain by July 20, 2016) for the HGB area is based on the most recent three full years of ozone available data (which in the case of the HGB area after the first 1-year extension would be 2013-2015 data). The 2015 preliminary air quality data indicated that HGB area would not likely attain the July 20, 2016 attainment date. On April 25, 2016, TCEQ submitted quality assured and certified data with no changes from preliminary data for 2015 air quality data. In addition, the design values TCEQ submitted to EPA on December 2015, demonstrated that Texas was aware they would not attain by the July 20, 2016, date or be eligible for a second 1-year extension and that EPA would propose to reclassify the HGB area as Moderate. Our longstanding policy, as stated in the 1994 EPA Berry Memorandum,
As stated in the 1994 Berry Memo, EPA's policy regarding attainment date extensions and reclassifications of marginal areas explicitly cautions: “When requesting an extension, States should consider the consequences of eventually not attaining the NAAQS. Although areas can request two 1-year extensions, those that ultimately fail to attain the NAAQS will be bumped up to at least a moderate classification. Consequently, areas that are bumped up will be under very tight timeframes to implement the new SIP requirements, in
Region 6 staff regularly participates in monthly calls with TCEQ, including the April/May 2016 timeframe where TCEQ insisted on the impossibility of submitting a SIP revision for a reclassified HGB area by January 1, 2017. Region 6 notified TCEQ in a May 2016 monthly call that if we didn't get the green light to proceed with a later SIP submittal deadline as they requested, our proposal would be published with a January 1, 2017, SIP submittal deadline and require Reasonable Available Control Technology (RACT) implementation by the same deadline. Ultimately, the January 1, 2017, SIP submission deadline was chosen as being consistent and reasonable based on the information discussed above.
Also, EPA has offered assistance to states as they consider the most appropriate course of action for Marginal areas that may be at risk for failing to meet the NAAQS within the three-year timeframe. States can choose to adopt additional controls for such areas or they can seek a voluntary reclassification to a higher classification category (as Texas did for the HGB area with regard to the 1997 ozone standard). See, 73 FR 56983, October 1, 2008. Also we will continue to offer assistance as we have in the past during the monthly calls regarding the TCEQ Dallas-Fort Worth and HGB 2008 Ozone nonattainment areas. A regular topic on the meetings' agenda is to discuss any issues/updates/actions with TCEQ and offer, assistance/guidance on any issues requested by TCEQ. As TCEQ knows, the determination of how to reach attainment is a state decision. It's up to EPA to determine whether the plan submitted meets the requirements of the CAA. EPA's ability to extend deadlines for areas being reclassified as required by CAA section 181(b)(2) is governed by section 182(i) of the CAA, which directs that the state shall meet the new requirements according to the schedules prescribed in those requirements, but provides “that the Administrator may adjust any applicable deadlines (other than attainment dates) to the extent such adjustment is necessary or appropriate to assure consistency among the required submissions.” CAA section 182(b), as interpreted by 40 CFR 51.1100
In determining an appropriate deadline for the moderate area SIP revisions for the HGB area, EPA had to consider that pursuant to 40 CFR 51.1108(d), the state must provide for implementation of all control measures needed for attainment no later than the beginning of the attainment year ozone season. The attainment year ozone season is the complete ozone season immediately preceding a nonattainment area's attainment date. In the case of nonattainment areas classified as moderate for the 2008 ozone NAAQS, the attainment year ozone season is the 2017 ozone season (40 CFR 51.1100(h)). Because an extension of the attainment date is not appropriate here, and control measures for other moderate areas are to be implemented no later than the beginning of the 2017 ozone season, EPA determined it would not be appropriate to adjust the attainment date beyond the beginning of the 2017 ozone season for the HGB area. Further, because ozone seasons begin as early as January 1, EPA determined that a SIP submission deadline of January 1, 2017, is the latest submittal deadline that allows all states to meet 40 CFR 51.1108(d) requirements, and thus assures consistency as directed by 182(i).
We believe based on the facts discussed above that TCEQ was aware of the likelihood of a January 1, 2017 submission deadline, which lines up with the deadlines of the Marginal areas reclassified as Moderate in the 81 FR 26697, (May 4, 2016) action. In that action, we stated that we recognized the value of providing states as much time as possible to develop an attainment demonstration, however, we also recognized the value in establishing a single due date for Moderate area SIP submissions—including RACT—that would not extend beyond the deadline for implementing such controls. We believe the area was provided adequate notice that time to develop and submit a moderate area attainment plan was likely to be short given that the moderate area attainment year ozone season is the 2017 ozone season for the 2008 ozone NAAQS and that other moderate areas were also required to submit their plans in January 2017.
While the commenter objected to the deadline, citing the need to accelerate schedules and expend added resources to have RACT implemented by the proposed deadline, the state, nonetheless, committed to have their state requirements in place by the deadline proposed by EPA. We acknowledge that the timeline for submitting SIP revisions and implement
A review of the State's SIP revision proposal of September 21, 2016,
In addition, the EPA notes that after a state's SIP revisions are submitted to EPA, the agency has 6 months to determine completeness of the SIP. Within that timeframe, the state may submit updates or revisions to their SIP submission. After 6 months, if the EPA has not determined the SIP to be complete, the SIP submission is deemed complete by operation of law. There will also be a time span before EPA initiates action to provide notice and comment on EPA's action to approve/disapprove the state's attainment plan. When EPA approves a SIP revision, it becomes federally enforceable at that time. The EPA believes these timeframes provide adequate time for all affected entities to have implemented RACT.
We are determining that the HGB area failed to attain the 2008 ozone NAAQS by the attainment deadline date of July 20, 2016, and to reclassify the area as Moderate. Texas must submit to us the SIP revisions to address the Moderate ozone nonattainment area requirements of the CAA by January 1, 2017. This action is being taken under section 181(b)(2) of the Act. The requirements of this final action is effective immediately upon publication. See, 5 U.S.C. 553(d)(3).
A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review
This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget for review.
This final 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. This action merely determines that the HGB area failed to meet an ozone NAAQS attainment deadline, reclassifies the area, and sets the date when a revised SIP is due to EPA.
This action does not contain any unfunded mandate 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. This action does not apply on any Indian reservation land, any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction, or non-reservation areas of Indian country. Thus, Executive Order 13175 does not apply to this action.
EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it merely determines that the HGB area failed to meet an ozone NAAQS attainment deadline, reclassifies the area, and sets the date when a revised SIP is due to EPA.
This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.
This rulemaking does not involve technical standards.
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 action merely determines that the HGB area failed to meet an ozone NAAQS attainment deadline, reclassifies the area, and sets the date when a revised SIP is due to EPA.
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 13, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control.
42 U.S.C. 7401
40 CFR part 81 is amended as follows:
42 U.S.C. 7401
Centers for Medicare & Medicaid Services (CMS), HHS.
Interim final rule with comment period.
This interim final rule with comment period implements new requirements for Medicare-certified dialysis facilities that make payments of premiums for individual market health plans. These requirements apply to dialysis facilities that make such payments directly, through a parent organization, or through a third party. These requirements are intended to protect patient health and safety; improve patient disclosure and transparency; ensure that health insurance coverage decisions are not
In commenting, please refer to file code CMS-3337-IFC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one of the ways listed)
Please allow sufficient time for mailed comments to be received before the close of the comment period.
a. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201
(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786-9994 in advance to schedule your arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. For information on viewing public comments, see the beginning of the
Lauren Oviatt, (410) 786-4683, for issues related to the ESRD Conditions for Coverage.
Lina Rashid, (301) 492-4103, for issues related to individual market health plans.
Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received:
Comments received timely will be also available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.
End-Stage Renal Disease (ESRD) is a kidney impairment that is irreversible and permanent. Dialysis is a process for cleaning the blood and removing excess fluid artificially with special equipment when the kidneys have failed. People with ESRD require either a regular course of dialysis or kidney transplantation in order to live.
Given the high costs and absolute necessity of transplantation or dialysis for people with failed kidneys, Medicare provides health care coverage to qualifying individuals diagnosed with ESRD, regardless of age, including coverage for kidney transplantation, maintenance dialysis, and other health care needs. The ESRD benefit was established by the Social Security Amendments of 1972 (Pub. L. 92-603). This benefit is not a separate program, but allows qualifying individuals of any age to become Medicare beneficiaries and receive coverage. Under the statute, individuals under 65 who are entitled to Medicare through the ESRD program, or individuals over age 65 who are diagnosed with ESRD while in Original Medicare, generally cannot enroll in Medicare Advantage. Additionally, as access to Medigap policies is generally governed by state law, individuals under age 65 who are entitled to Medicare through the ESRD program cannot sign up for a Medigap policy in many States.
The ESRD Amendments of 1978 (Pub. L. 95-292), amended title XVIII of the Social Security Act (the Act) by adding section 1881 of the Act. Section 1881(b)(1) of the Act further authorizes the Secretary of the Department of Health and Human Services (the Secretary) to prescribe additional requirements (known as conditions for coverage or CfCs) that a facility providing dialysis and transplantation services to dialysis patients must meet to qualify for Medicare payment.
Medicare pays for routine maintenance dialysis provided by Medicare-certified ESRD facilities, also known as dialysis facilities. To gain certification, the State survey agency performs an on-site survey of the facility to determine if it meets the ESRD CfCs at 42 CFR part 494. If a survey indicates that a facility is in compliance with the conditions, and all other Federal requirements are met, CMS then certifies the facility as qualifying for Medicare payment. Medicare payment for outpatient maintenance dialysis is limited to facilities meeting these conditions. The ESRD CfCs were first adopted in 1976 and comprehensively revised in 2008 (73 FR 20369). There are approximately 6,737 Medicare-certified dialysis facilities in the United States, providing dialysis services and specialized care to people with ESRD.
In addition to Medicare, Medicaid provides coverage for some people with ESRD. Many individuals enrolled in
According to data published by the United States Renal Data System (USRDS), Medicare is the predominant payer of ESRD services in the United States, covering (as primary or secondary payer) about 88 percent of the United States ESRD patients receiving hemodialysis in 2014. Among those enrolled in Medicare on the basis of ESRD and receiving hemodialysis in 2015, CMS has determined 41 percent were enrolled in both Medicare and Medicaid (including full and partial duals). Among those enrolled in Medicare on the basis of ESRD under age 65, 51 percent were dual enrollees.
The Patient Protection and Affordable Care Act (Pub. L. 111-148) was enacted on March 23, 2010. The Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152), which amended and revised several provisions of the Patient Protection and the Affordable Care Act, was enacted on March 30, 2010. In this interim final rule with comment, we refer to the two statutes collectively as the “Affordable Care Act.”
The Affordable Care Act reorganizes and amends the provisions of title XXVII of the Public Health Service Act (PHS Act) relating to group health plans and health insurance issuers in the group and individual markets. The Affordable Care Act enacted a set of reforms to make health insurance coverage more affordable and accessible to millions of Americans. These reforms include the creation of competitive marketplaces called Affordable Insurance Exchanges, or “Exchanges” through which qualified individuals and qualified employers can purchase health insurance coverage.
In addition, many individuals who enroll in qualified health plans (QHPs) through individual market Exchanges are eligible for advance payments of the premium tax credit (APTC) to make health insurance premiums more affordable, and cost-sharing reduction (CSR) payments to reduce out-of-pocket expenses for health care services. Individuals enrolled in Medicare or Medicaid are not eligible for APTC or CSRs. The Affordable Care Act also established a risk adjustment program and other measures that are intended to mitigate the potential impact of adverse selection and stabilize the price of health insurance in the individual and small group markets.
The Public Health Service Act, as amended by the Affordable Care Act, generally prohibits group health plans and health insurance issuers offering group or individual health insurance coverage from imposing any preexisting condition exclusions. Health insurers can no longer charge different cost sharing or deny coverage to an individual because of a pre-existing health condition. Health insurance issuers also cannot limit benefits for that condition. The pre-existing condition provision does not apply to “grandfathered” individual health insurance policies.
Beginning January 1, 2014, the Affordable Care Act prohibited insurers in the individual and group markets (with the exception of grandfathered individual plans) from imposing pre-existing condition exclusions. The Affordable Care Act's prohibition on pre-existing condition exclusions enables consumers to access necessary benefits and services, beginning from their first day of coverage. The law also requires insurance companies to guarantee the availability and renewability of non-grandfathered health plans to any applicant regardless of his or her health status, subject to certain exceptions. It imposes rating restrictions on issuers prohibiting non-grandfathered individual and small group market insurance plans from varying premiums based on an individual's health status. Issuers of such plans are now only allowed to vary premiums based on age, family size, geography, or tobacco use.
In previous rulemaking, CMS outlined major provisions and parameters related to many Affordable Care Act programs. This includes regulations at 45 CFR 156.1250, which require, among other things, that issuers offering individual market QHPs, including stand-alone dental plans, and their downstream entities, accept premium payments made on behalf of QHP enrollees from the following third party entities (in the case of a downstream entity, to the extent the entity routinely collects premiums or cost sharing): (1) A Ryan White HIV/AIDS Program under title XXVI of the PHS Act; (2) an Indian tribe, tribal organization, or urban Indian organization; and (3) a local, state, or Federal government program, including a grantee directed by a government program to make payments on its behalf. This regulation made clear that it did not prevent issuers from contractually prohibiting other third party payments. The regulation also reiterated that CMS discouraged premium payments and cost sharing assistance by certain other entities, including hospitals and other health care providers, and discouraged issuers from accepting premium payments from such providers.
Individuals who are already covered by Medicare generally cannot become concurrently enrolled in coverage in the individual market. Section 1882(d)(3) of the Act makes it unlawful to sell or issue a health insurance policy (including policies issued on and off Exchanges) to an individual entitled to benefits under Medicare Part A or enrolled under Medicare part B with the knowledge that the policy duplicates the health benefits to which the individual is entitled. Therefore, while an individual with ESRD is not required to apply for and enroll in Medicare, once they become covered by Medicare it is unlawful for them to be sold a commercial health insurance policy in the individual market if the seller knows the individual market policy would duplicate benefits to which the individual is entitled.
HHS has recently become concerned about the inappropriate “steering” of individuals eligible for or entitled to Medicare or Medicaid into individual market plans. In particular, HHS is concerned that because individual market health plans typically provide significantly greater reimbursement to health care providers than public coverage like Medicare or Medicaid, providers and suppliers may be engaged in practices designed to encourage individual patients to forego public coverage for which they are eligible and instead enroll in an individual market plan.
Based on these concerns, in August 2016, CMS issued a request for information (RFI), titled “Request for Information: Inappropriate Steering of Individuals Eligible for or Receiving Medicare and Medicaid Benefits to Individual Market Plans”, which published in the
Comments indicated that dialysis facilities are involving themselves in ESRD patients' coverage decisions and that this practice is widespread. In addition, all commenters on the topic—including insurance companies, dialysis facilities, patients, and non-profit organizations—stated that they believe many dialysis facilities are paying for or arranging payments for individual market health care premiums for patients they serve.
Comments show that some ESRD patients are satisfied with their current premium arrangements. In particular, more than 600 individuals currently receiving assistance for premiums participated in a letter writing campaign in response to the RFI and stated that charitable premium assistance supports patient choice and is valuable to avoid relying on “taxpayer dollars.”
However, comments also documented a range of concerning practices, with providers and suppliers influencing enrollment decisions in ways that put the financial interest of the supplier above the needs of patients. As explained further below, commenters detailed that dialysis facilities benefit financially when individuals enroll in individual market health care coverage. Comments also described that, even though it is financially beneficial to suppliers, enrollment in individual market coverage paid for by dialysis facilities or organizations affiliated with dialysis facilities can lead to three types of harm to patients: Negatively impacting their determination of readiness for a kidney transplant, potentially exposing patients to additional costs for health care services, and putting them at significant risk of a mid-year disruption in health care coverage. Based on these comments, HHS has concluded that the differences between providers' and suppliers' financial interests and patients' interests may result in providers and suppliers taking actions that put patients' lives and wellbeing at risk.
All commenters who addressed the issue made clear that enrolling a patient in commercial coverage (including coverage in the individual market) rather than public coverage like Medicare and/or Medicaid is of significant financial benefit to dialysis facilities. For example, one comment cited reports from financial analysts estimating that commercial coverage generally pays dialysis facilities an average of four times more per treatment ($1,000 per treatment in commercial coverage, compared to $260 per treatment under public coverage). For a specific subset of individual market health plans—QHPs—the analysts estimated that the differential could be somewhat smaller, but that QHPs would still provide an average of an additional $600 per treatment when compared to public coverage. Based on these reports, dialysis facilities would be estimated to be paid at least $100,000 more per year per patient if a typical patient enrolled in commercial coverage rather than public coverage, despite providing the exact same services to patients. Another commenter estimated that a dialysis facility would earn an additional $234,000 per year per patient by enrolling a patient in commercial coverage rather than Medicaid ($312,000 per year rather than $78,000 per year). A number of other commenters explained that commercial coverage reimburses dialysis facilities at significantly higher rates overall. These figures are consistent with other sources of data. For example, USRDS data show that for individuals with ESRD enrolled in Medicare receiving hemodialysis, health care spending averaged $91,000 per individual in 2014, including dialysis and non-dialysis services. By contrast, using the Truven MarketScan database, a widely-used database of health care claims, we estimate that average total spending for individuals with ESRD who are enrolled in commercial coverage was $187,000 in 2014. In addition, recent filings with a federal court by one insurance company concluded that commercial coverage could pay more than ten times more per treatment than public coverage ($4,000 per treatment rather than $300 per treatment).
As described, the comments in response to the RFI, data related to CMS's administration of the risk adjustment program, and registry data from the USRDS demonstrate that dialysis facilities can be paid tens or even hundreds of thousands of dollars more per patient when patients enroll in individual market coverage rather than public coverage. On the other hand, the premiums for enrollment in individual market coverage average $4,200 per year according to data related to CMS's administration of the risk adjustment program. Dialysis facilities therefore have much to gain financially (on the order of tens or even hundreds of thousands of dollars per patient) by making a relatively small outlay to pay
Commercial coverage pays at higher rates than public coverage for many health care services, and therefore this pattern could theoretically appear in a variety of contexts. Dialysis patients are, however, particularly vulnerable to harmful steering practices for a number of reasons. First, ESRD is the only health condition for which nearly all patients are eligible to apply for and enroll in Medicare coverage and with eligibility linked specifically to the diagnosis. Thus, individuals with ESRD face a unique situation where they have alternative public coverage options, but these coverage options may be less profitable from the perspective of the facilities providing their treatment due to lower reimbursement rates. Second, as described above, patients with ESRD must receive services from a dialysis facility several times per week for the remainder of their lives (unless and until they obtain a kidney transplant). This sort of ongoing receipt of specialized care from a particular facility is not typical of most health conditions and it creates especially strong incentives and opportunities for dialysis facilities to influence the coverage arrangements of the patients under their care.
Supporting premium payments to facilitate enrollment of their patients in individual market coverage is, as illustrated above, in the financial interest of the dialysis facilities. It is often not, however, in the best interests of individual patients. The comments in response to the RFI illustrated three types of potential harm to patients that these arrangements create for ESRD patients: Negatively impacting patients' determination of readiness for a kidney transplant, potentially exposing patients to additional costs for health care services, and putting individuals at significant risk of a mid-year disruption in health care coverage.
While each of these potential harms is itself cause for concern, they collectively underscore the complexity of the decision for a patient with ESRD of choosing between coverage options, decisions that have very significant consequences for these patients in particular. The involvement of their providers in incentivizing, and steering them to enroll in, individual market coverage is highly problematic absent safeguards to ensure both that the individual is making a decision fully informed of these complex tradeoffs and that the risk of a mid-year disruption in health care coverage is eliminated. Each of these specific potential harms to the patient is discussed further below.
Access to kidney transplantation is a major and immediate concern for many patients with ESRD; transplantation is the recommended course of treatment for individuals with severe kidney disease, and is a life-saving treatment, as the risk of death for transplant recipients is less than half of that for dialysis patients. In addition to improving health outcomes, receipt of a transplant can dramatically improve patients' quality of life; instead of being required to undergo dialysis several times per week, individuals who have received transplants are able to resume a more typical pattern of daily life, travel, and employment. Of the approximately 700,000 people with ESRD in the United States, more than 100,000 are on formal waiting lists to receive a kidney transplant. Further, in 2015 more than 80 percent of kidney transplants went to patients under age 65, suggesting that transplantation is of special concern to nonelderly patients, who are most likely to be targeted by dialysis facilities for enrollment in individual market coverage because they may not already be enrolled in Medicare.
Therefore, any practice that interferes with patients' ability to pursue a kidney transplant is of significant concern. Even a small reduction in the likelihood of a patient receiving a transplant would be detrimental to a patient's health and wellbeing. The comments in response to the RFI support the conclusion that, today, enrollment in individual market coverage for which there are third party premium payments is hampering patients' ability to be determined ready for a kidney transplant. Comments make clear that, consistent with clinical guidelines, in order for a transplant center to determine that a patient is ready for a transplant, they must conclude that the individual will have access to continuous health care coverage. (This is necessary to ensure that the patient will have ongoing access to necessary monitoring and follow-up care, and to immunosuppressant medications, which must typically be taken for the lifetime of a transplanted organ to prevent rejection.) However, when individuals with ESRD are enrolled in individual market coverage supported by third parties, they may have difficulty demonstrating continued access to care due to loss of premium support after transplantation. Documents in the comment record indicate that major non-profits that receive significant financial support from dialysis facilities will support payment of health insurance premiums only for patients currently receiving dialysis. Documents in the record show that these non-profits will not continue to provide financial assistance once a patient receives a successful kidney transplant, nor will the non-profit cover any costs of the transplant itself, living donor care, post-surgical care, post-transplant immunosuppressive therapy, or long-term monitoring, which can cause significant issues for patients that cannot afford their coverage without financial support. This policy is consistent with the conclusion that these third party payments are being targeted based on the financial interest of the dialysis facilities who contribute to these non-profits, rather than the patients' interests. Once a patient has received a transplant, it is no longer in the dialysis facility's financial interest to continue to support premium payments, although there are severe consequences to individuals when that support ceases. If this occurs after transplantation, individuals enrolled in individual market coverage could be required to pay the full amount of the premium, which may be unaffordable for many patients who previously relied on third party premium assistance.
Theoretically, individuals could arrange for Medicare coverage to begin at the time of transplantation, thereby demonstrating continued access to care. In practice, however, patients struggle to understand their coverage options and rapidly navigate the Medicare sign-up process during a period where they are particularly sick and preparing for major surgery. Some commenters to the RFI emphasized that this is an extremely vulnerable group of patients who have difficulty navigating their health insurance options. As evidenced by the rate of dually eligible individuals discussed above, many ESRD patients are low income and have limited access to the resources necessary to navigate these sorts of coverage transitions, and patients are particularly vulnerable during the short window when they are preparing for transplants. Consistent with this, a number of comments describe how these arrangements and patients' vulnerability and confusion
In addition to impeding access to transplants, enrollment in individual market coverage, even when third parties cover costs, is financially disadvantageous for some patients with ESRD. That is, while it is in dialysis facilities' financial interest to support enrollment in the individual market, those arrangements may cause financial harms to patients that would have been avoided had the patients instead enrolled in public coverage.
People with ESRD often have complex needs and receive care from a wide variety of health care providers and suppliers. Data from USRDS show that total health care spending per Medicare ESRD enrollee receiving hemodialysis averaged more than $91,000 in 2014, but spending on hemodialysis is only 32 percent of that amount, meaning that a typical patient may incur thousands of dollars in costs for other services. While some of the non-dialysis services these patients receive may also be provided by their dialysis facilities, half or more of Medicare spending on this population is for care that is likely delivered by other providers and suppliers, including creation and maintenance of vascular access, inpatient hospital care, skilled nursing facility services, home health services, palliative services, ambulance services, treatment for primary care and comorbid conditions, and prescription drugs. Thus, when considering the financial impact of coverage decisions, it is important to consider costs that a patient will incur for services received that go beyond dialysis.
As described above, many people with ESRD are eligible for Medicaid. Indeed, more than half of ESRD Medicare enrollees under age 65 are also enrolled in Medicaid.
For individuals with ESRD not eligible for Medicaid, enrolling in the individual market rather than Medicare may also pose significant financial risks. As noted above, these patients generally require access to a wide variety of services received outside of a dialysis facility. Patients with ESRD are generally enrolled in Original Medicare (including Part A and Part B) and can therefore receive services from any Medicare-participating provider or supplier. However, unlike Original Medicare, which provides access to a wide range of eligible providers and suppliers, and which has standard cost-sharing requirements for all Medicare-eligible providers and suppliers, individual market plans generally limit access to a set network of providers that is more restrictive than what is available to an Original Medicare beneficiary. If the individual sees providers or suppliers outside of that network, they will incur higher cost-sharing for necessary out-of-network services, and may have very limited coverage for non-emergency out-of-network health care.
There may be other personal circumstances that lead to financial burden caused by enrolling in an individual market plan rather than Medicare. For example, individuals who are entitled to Part A and do not enroll in Part B generally will incur a Part B late enrollment penalty when they do ultimately enroll in Medicare Part B. Accordingly, an individual who enrolls in Part A based on ESRD but does not enroll in or drops Part B will generally be subject to a late enrollment penalty should they decide to enroll in Part B later while still entitled to Part A on the basis of ESRD. Individuals who receive a kidney transplant may also face higher cost-sharing for immunosuppressant drugs if they delay Medicare enrollment as immunosuppressive drugs are covered under Part B only if the transplant recipient established Part A effective with the month of the transplant.
As noted above, for some members of this group, there is potentially an offsetting financial benefit from individual market coverage if total premiums and cost sharing are lower in an individual market plan with third party premium assistance than in Medicare. In particular, non-grandfathered individual markets plans are required to cap total annual out-of-pocket expenditures for essential health benefits at a fixed amount, the
Finally, the comments in response to the RFI demonstrate that there is a significant risk of mid-year disruptions in coverage for patients/individuals who have individual market coverage for which third parties make premium payments. It is critically important that patients on dialysis have continuous access to health care coverage. Prior to transplantation this population requires an expensive health care service several times per week in order to live; any interruption in their access to care is serious and life-threatening. Moreover, as noted, this group generally has health care needs beyond dialysis that require care from a variety of medical professionals.
However, the comments reveal that patients/individuals who have individual market coverage for which third parties make premium payments are presently at risk of having their coverage disrupted at any point during the year. CMS does not require that issuers accept premium payments made by third parties except in certain circumstances consistent with applicable legal requirements,
When payments are rejected, commenters noted that individuals are typically unable to continue their coverage because of the increased financial burden. Indeed, patients may not even realize for some period that their premiums, which are being paid by third parties, are being rejected and that their coverage will be terminated if they do not have an ability to pay themselves. HHS received 600 comments from ESRD patients participating in a letter-writing campaign that describe the adverse impact on patients receiving third party payment premium assistance if those funds were no longer available. Other patients who commented described significant and unexpected disruptions in coverage such as no longer being able to afford the high cost of prescriptions and office visit copays, delays receiving dialysis treatments, or no longer being able to receive treatments. Due to the life-sustaining nature of dialysis, dialysis facilities are not permitted to involuntarily discharge patients, except in very limited circumstances. However, one of those circumstances is lack of payment (42 CFR 494.180 (f)(1)). While we believe that such discharges are rare, and that dialysis facilities try to avoid them, they are permitted. Moreover, even when patients are able to enroll in other public coverage (which may have retroactive effective dates) disruptions in coverage still force patients to navigate a complicated set of coverage options. They may face gaps in care or be forced to appeal health care claims. Comments emphasized that many ESRD patients are low-income and do not have a great deal of familiarity with the health care system, leaving them more vulnerable to gaps in coverage. Therefore, any disruption in coverage is problematic and can interrupt patient care.
In sum, the lack of transparency in how these payments are made and whether or not they are accepted means that patients are at risk of sudden gaps in coverage which may be dangerous to patients' health.
As described above, dialysis facilities have very meaningful financial incentives to have their patients enroll in individual market coverage rather than public coverage programs. However, enrollments in individual market coverage are often not in patients' best interest: It can complicate and potentially delay the process for obtaining a kidney transplant; is often financially costly for patients, especially when they are eligible for Medicaid; and places consumers at risk of a mid-year coverage disruption. These risks make the task of deciding among coverage options complex for ESRD patients. Furthermore, the asymmetry between facilities' and patients' interests and information with respect to enrollment decisions creates a high likelihood that a conflict of interest will develop. Comments submitted in response to the RFI support the conclusion that this conflict of interest is harming patients, with dialysis facility patients being steered toward enrollment in individual market coverage with third party premium payments, rather than enrollment in the public coverage for which they are likely eligible and which is frequently the better coverage option for them.
Many comments were submitted by social workers or other professionals who work or have worked with ESRD patients. Those comments describe a variety of ways in which dialysis facilities have attempted to influence coverage decisions made by patients or have failed to disclose information that is relevant to determining consumers' best interest. Specific practices described in comments include:
• Facilities engaging in systematic efforts to enroll people in the individual market, often targeting Medicaid enrollees, without assessing any personal needs. One commenter explained, “My experience was that the provider wanted anyone [who] was Medicaid only to be educated about the opportunity to apply for an individual plan. . . . The goal was 100%
• Patients are not always informed about eligibility for Medicare or Medicaid, or the benefits of those programs. For example, one social worker explained, “The patient is frequently not educated about the benefits that are available with Medicaid (that is, transportation, dental, and other home support services).” Another former social worker said that facility employees “may not tell patients that they could be subject to premium penalties and potentially higher out-of-pocket costs than they would have with traditional Medicare.” Another commenter said, “Enrollment counselors offer no information about Medicare eligibility to members. In several cases members were not aware that they were Medicare eligible.”
• Patients are sometimes specifically discouraged from pursuing Medicare or Medicaid. One commenter said: “In the transplant setting I have seen patients advised to delay in securing Medicare.” Another employee at a dialysis facility relayed the story of a mother seeking a transplant for her daughter but being told by a dialysis facility not to enroll in Medicare. A transplant facility employee explained “In some circumstances, the patient has been encouraged to drop their MediCal (Medicaid) coverage in favor of the individual market plan, without having a full understanding of the personal financial impact of doing so.”
• Patients are unaware that a dialysis facility is seeking to enroll them in the individual market and are not informed of this fact by their health care providers. As one commenter said, “In numerous instances, these patients were already admitted at these facilities, and interviews have found that many were unaware they had insurance, let alone who was providing it.”
• Patients are not informed about how their third party premium support is linked to continued receipt of dialysis. For example, one comment explained, “People receiving assistance don't realize that if they want a transplant the premiums will no longer get paid.”
• Facilities retaliate against social workers who attempt to disclose additional information to consumers. One commenter explained that they were “reported to upper management of [dialysis corporations] for voicing my concerns of the impact this [enrollment in the individual market] will have on patients after transplant.”
• Social workers are concerned that patients' trust in health care providers is being manipulated to facilitate individual market enrollment. For example, comments explained that insurance counselors “meet often with the patients establishing a relationship of trust” before pursuing individual market enrollment. A commenter said, “Most of us, who have some sophistication in health care coverage, are aware of how confusing it is to negotiate the information and reach the best decisions. Dialysis patients who may be less sophisticated and already highly stressed are vulnerable to being steered.” Another commenter vividly explained, “Patients . . . are in a vulnerable position when they come to a dialysis facility. I hope those of you reviewing these comments realize the power disequilibrium which exists when a patient is hooked up with needles in their arm, lifeblood running through their arms attached to a machine.”
In addition, HHS's own data and information submitted in response to the RFI suggest that this inappropriate steering of patients may be accelerating over time. Insurance industry commenters stated that the number of enrollees in individual market plans receiving dialysis increased 2 to 5 fold in recent years. Based on concerns raised in the public comments in response to the RFI, we have reviewed administrative data on enrollment of patients with ESRD. Information available from the risk adjustment program in the individual market show that between 2014 and 2015, the number of individual market enrollees with an ESRD diagnosis more than doubled.
In the face of harms like those above, which go to essential patient safety and care in life-threatening circumstances, HHS is taking immediate regulatory action to prevent harms to patients. As described in more detail below, we are establishing new Conditions for Coverage standards (CfCs) for dialysis facilities. This standard applies to any dialysis facility that makes payments of premiums for individual market health plans (in any amount), whether directly, through a parent organization (such as a dialysis corporation), or through another entity (including by providing contributions to entities that make such payments). Dialysis facilities subject to the new standard will be required to make patients aware of potential coverage options and educate them about the benefits of each to improve transparency for consumers. Further, in order to ensure that patients' coverage is not disrupted mid-year, facilities must ensure that issuers are informed of and have agreed to accept the payments.
This action is consistent with comments from dialysis facilities, non-profits, social workers, and issuers that generally emphasized disclosure and transparency as important components of a potential rulemaking. By focusing on transparency, we believe we can promote patients' best interests. CMS remains concerned, however, about the extent of the abuses reported. We are considering whether it would be appropriate to prohibit third party premium payments for individual market coverage completely for people with alternative public coverage. Given the magnitude of the potential financial conflict of interest and the abusive practices described above, we are unsure if disclosure standards will be sufficient to protect patients. We seek comments from stakeholders on whether patients would be better off if premium payments in this context were more strictly limited. We also seek comment on alternative options where
Through this Interim Final Rule with comment (IFC) we are implementing a number of disclosure requirements for dialysis facilities that make payments of premiums for individual market health plans, whether directly, through a parent organization, or through another entity, to ensure proper protections for those patients. These requirements are intended to ensure that patients are able to make insurance coverage decisions based on full and accurate information.
As described in more detail below, we are establishing new CfC standards for dialysis facilities. New standards apply to any dialysis facility that makes payments of premiums for individual market health plans (in any amount), whether directly, through a parent organization (such as a dialysis corporation), or through another entity (including by providing contributions to entities that make such payments). While we remain concerned about any type of financial assistance that could be used to influence patients' coverage decisions, we believe these individual market premium payments are particularly prone to abuse because they are so closely tied to the type of coverage an individual selects. Further, as described above, such third party payments in the individual market uniquely put patients at risk of mid-year coverage disruption if their issuer discovers and rejects such payments. Dialysis facilities subject to the new standards will be required to make patients aware of potential coverage options and educate them about certain benefits and risks of each. Further, in order to ensure that patients' coverage is not disrupted mid-year, dialysis facilities must ensure that issuers are informed of and have agreed to accept such payments for the duration of the plan year.
In order to increase awareness of health coverage options for individuals receiving maintenance dialysis in Medicare-certified dialysis facilities, we are establishing a new patient rights standard under the CfCs at 42 CFR 494.70(c). This new standard applies only to those facilities that make payments of premiums for individual market health plans (in any amount), whether directly, through a parent organization (such as a dialysis corporation), or through another entity (including by providing contributions to entities that make such payments).
Dialysis facilities that do not make premium payments, and do not make financial contributions to other entities that make such payments, are not subject to the new requirements.
At § 494.70(c)(1), we detail the health insurance information that must be provided to all patients served by applicable facilities. These requirements establish that such information must cover how plans in the individual market will affect the patient's access to and costs for the providers and suppliers, services, and prescription drugs that are currently within the individual's care plan, as well as those likely to result from other documented health care needs. This must include an overview of the health-related and financial risks and benefits of the individual market plans available to the patient (including plans offered through and outside the Exchange). This information must reflect local, current plans, and thus would need to be updated at least annually to reflect changes to individual market plans. We expect that applicable dialysis facilities will meet this requirement by providing the required information upon an individual's admittance to the facility, and annually thereafter, on a timely basis for each plan year.
While current costs to the patient are important, information about potential future costs related to the current health plan selection must also be addressed. In particular, we are requiring that coverage of transplantation and associated transplant costs must be included in information provided to patients. For example, some plans may not cover all costs typically covered by Medicare, such as necessary medical expenses for living donors. Kidney transplant patients who want Medicare to cover immunosuppressive drugs must have Part A at the time of the kidney transplant. Upon enrolling in Part B, Medicare will generally cover the immunosuppressive drugs. Therefore, the beneficiary must file for Part A no later than the 12th month after the month of the kidney transplant. Entitlement to Part A and Part B based on a kidney transplant terminates 36 months after the transplant. However, a beneficiary who establishes Part A entitlement effective with the month of the transplant is eligible for immunosuppressive drug coverage when subsequent entitlement to Part B is based on age or disability. Facilities must provide information regarding enrollment in Medicare, and clearly explain Medicare's benefits to the patient. Facilities must also provide individuals with information about Medicaid, including State eligibility requirements, and if there is any reason to believe the patient may be eligible, clearly explain the State's Medicaid benefits, including the Medicare Savings Programs.
For other potential future effects, the facilities must provide information about penalties associated with late enrollment (or re-enrollment) in Medicare Part B or Part D for those that have Medicare Part A as well as potential delays or gaps in coverage. Section 1839(b) of the Act outlines the Medicare premium—Part A (for those who are not eligible for premium-free Part A) and Part B late enrollment penalty. Individuals who do not enroll in Medicare premium—Part A or Medicare Part B when first eligible (that is, during their Initial Enrollment Period) will have to pay a late enrollment penalty should they decide to enroll at a later time. There are certain circumstances in which individuals are exempt from the late enrollment penalty, such as those who are eligible for Medicare based on Age or Disability, and did not enroll when first eligible because they had or have group health plan coverage based on their own or spouse's (or a family
Although an ESRD diagnosis may establish eligibility for Medicare regardless of age, it does not make individuals eligible for a Medicare Special Enrollment Period or provide relief from the late enrollment penalty. Thus, if an individual enrolls in Medicare Part A but does not enroll in Part B, or later drops Part B coverage, that individual will pay a Part B (and Part D) late enrollment penalty when ultimately enrolling, or reenrolling, in Medicare Part B (and Part D). Additionally, that individual will need to wait until the Medicare General Enrollment Period to apply for Medicare Part B. The General Enrollment Period runs from January 1 to March 31 each year, and Part B coverage becomes effective July 1 of the same year. Thus, individuals could face significant gaps in coverage while waiting for their Medicare Part B coverage to become effective. We note that late enrollment penalties and statutory enrollment periods do not apply to premium-free Part A.
Information about potential costs to the patient is vitally important for patients considering individual market coverage. An individual may benefit in the short term by selecting a private health plan instead of enrolling in Medicare, but patients must be informed that those plans, or the particular costs and benefits of those plans, may only exist for a given plan year, and that the individual may be at a disadvantage (that is, late enrollment penalties for those that are enrolled in Medicare Part A) should they choose to enroll in Medicare Part B (or Part D) at a later date.
At § 494.70(c)(2) and (3), we require that applicable facilities provide information to all patients about available premium payments for individual market plans and the nature of the facility's or parent organization's contributions to such efforts and programs. This information must include, but is not limited to, limits on financial assistance and other information important for the patient to make an informed decision, including the reimbursements for services rendered that the facility would receive from each coverage option. For example, if premium payments are not guaranteed for an entire plan year, or funding is capped at a certain dollar amount, patients must be informed of such limits. Facilities also must inform patients if the premium payments are contingent on continued use of dialysis services or use of a particular facility, and would therefore be terminated in the event that the patient receives a successful kidney transplant or transfers to a different dialysis facility. Further, facilities must disclose to patients all aggregate amounts that support enrollment in individual market health plans provided to patients directly, to issuers directly, through the facility's parent organization, or through third parties.
As with all patient rights standards for dialysis facilities, the information and disclosures required in § 494.70(c) must be provided to all patients of applicable facilities, not just those new to a facility who have not yet enrolled in Medicare or Medicaid. This ensures that all patients are treated fairly and appropriately, and not treated differently based on their health care payer, as required by CMS regulations at 42 CFR 489.53(a)(2).
In conjunction with these requirements for patient information and disclosures, we establish at § 494.180(k), a new standard that requires facilities that make payments of premiums for individual market health plans, whether directly, through a parent organization, or through another entity to ensure that issuers are informed of and have agreed to accept the third party payments. Facilities should develop reasonable procedures for communicating with health insurance issuers in the individual market, and for obtaining and documenting that the issuer has agreed to accept such payments. If an issuer does not agree to accept the payments for the duration of the plan year, the facility shall not make payments of premiums and shall take reasonable steps to ensure that such payments are not made by any third parties to which the facility contributes.
These requirements are intended to protect ESRD patients from avoidable interruptions in health insurance coverage mid-year by ensuring that they have access to full, accurate information about health coverage options. We intend to outline expectations for compliance in subsequent guidance. This rule does not alter the legal obligations or requirements placed on issuers, including with respect to the guaranteed availability and renewability requirements of the Public Health Service Act and non-discrimination-related regulations issued pursuant to the Affordable Care Act.
Because we are concerned that patients face risks that are not disclosed to them, and that they may be at risk of disruptions in coverage on an ongoing basis, we are taking action to ensure greater disclosure to consumers and to provide for smooth and continuous access to stable coverage when these rules are fully implemented. At the same time, we are mindful of the need for dialysis facilities that make payments of premiums for individual market health plans, whether directly, through a parent organization, or through another entity, to develop new procedures to comply with the standards established in this rule. Therefore, the requirements in this rule will become effective beginning January 13, 2017.
We note that, in specific circumstances, individuals may not be eligible to enroll in Medicare Part A or Part B except during the General Enrollment Period, which runs from January 1 to March 31 and after which coverage becomes effective on July 1. These individuals may experience a temporary disruption in coverage between the effective date of the rule and the time when Medicare Part A and/or Part B coverage becomes effective. In light of these circumstances, while the standards under § 494.180(k) will be effective beginning January 13, 2017, if a facility is aware of a patient who is not eligible for Medicaid and is not eligible to enroll in Medicare Part A and/or Part B except during the General Enrollment Period, and the facility is aware that the patient intends to enroll in Medicare Part A and/or Part B during that period, the standards under § 494.180(k) will not apply until July 1, 2017, with respect to payments made for that patient.
We ordinarily publish a notice of proposed rulemaking in the
HHS has determined that issuing this regulation as a proposed rulemaking, such that it would not become effective until after public comments are submitted, considered and responded to in a final rule, would be contrary to the public interest and would cause harm to patients. Based on the newly available evidence discussed in section I of this rule, that is, the responses to the August 2016 RFI, HHS has determined that the widespread practice of third parties making payments of premiums for individual market coverage places dialysis patients at significant risk of three kinds of harms: Having their ability to be determined ready for a kidney transplant negatively affected, being exposed to additional costs for health care services, and being exposed to a significant risk of a mid-year disruption in health care coverage. We believe these are unacceptable risks to patient health that will be greatly mitigated by this rulemaking, and that the delay caused by notice and comment rulemaking would continue to put patient health at risk. Given the risk of patient harm, notice and comment rulemaking would be contrary to the public interest. Therefore, we find good cause to waive notice and comment rulemaking and to issue this interim final rule with comment. We are providing a 30-day public comment period.
In addition, we ordinarily provide a 60-day delay in the effective date of the provisions of a rule in accordance with the APA (5 U.S.C. 553(d)), which requires a 30-day delayed effective date, and the Congressional Review Act (5 U.S.C. 801(a)(3)), which requires a 60-day delayed effective date for major rules. However, we can waive the delay in the effective date if the Secretary finds, for good cause, that the delay is impracticable, unnecessary, or contrary to the public interest, and incorporates a statement of the finding and the reasons in the rule issued (5 U.S.C. 553(d)(3).
In addition, the Congressional Review Act (5 U.S.C. 801(a)(3)) requires a 60-day delayed effective date for major rules. However, we can determine the effective date of the rule if the Secretary finds, for good cause, that notice and public procedure is impracticable, unnecessary, or contrary to the public interest, and incorporates a statement of the finding and the reasons in the rule issued (5 U.S.C. 808(2)).
As noted above, for good cause, we have found that notice and public procedure is contrary to the public interest. Accordingly, we have determined that it is appropriate to issue this regulation with an effective date 30 days from the date of publication. As described above, we believe patients are currently at risk of harm. Health-related and financial risks are not fully disclosed to them, and they may have their transplant readiness delayed or face additional financial consequences because of coverage decisions that are not fully explained. Further, consumers are at risk of mid-year coverage disruptions. This is the time of year when patients often make enrollment decisions, with Open Enrollment in the individual market ongoing and General Enrollment Period for certain new enrollees in Medicare about to begin on January 1. We have therefore determined that the rule will become effective on January 13, 2017 to best protect consumers.
Under the Paperwork Reduction Act of 1995, we are required to provide 30-day notice in the
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our estimate of the information collection burden.
• The quality, utility, and clarity of the information to be collected.
• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
We are soliciting public comment on each of these issues for the following sections of the interim final rule with comment that contain ICRs. We generally used data from the Bureau of Labor Statistics to derive average labor costs (including a 100 percent increase for fringe benefits and overhead) for estimating the burden associated with the ICRs.
Under § 494.70(c), HHS implements a number of requirements and establishes a new patient rights standard for Medicare-certified dialysis facilities that make payments of premiums for individual market health plans, whether directly, through a parent organization, or through another entity, to ensure proper protections for those patients. Those applicable facilities will be required, on an annual basis, to inform patients of health coverage options available to them, including Medicare and Medicaid and locally available individual market plans; enrollment periods for both Medicare and the individual market; the effects each option will have on the patients access to, and costs for the providers and suppliers, services, and prescription drugs that are currently within the individual's ESRD plan of care and other documented health care needs; coverage and anticipated costs for transplant services, including pre- and post-transplant care; any funds available to the patient for enrollment in an individual market health plan, including but not limited to limitations and any associated risks of such assistance; and current information about the facility's, or its parent organization's premium payments for patients, or to other third parties that make such premium payments to individual market health plans for individuals on dialysis.
We assume that each applicable facility will develop a system to educate and inform each ESRD patient of their options and the effects of these options. For our purposes, we assume that each facility will develop a pamphlet containing information that compares the benefits and costs for each locally available individual market plan, Medicare, and Medicaid, and display it prominently in their facility. In addition, it is assumed that a facility staff such as a health care social worker will review the required information with the patient and answer any questions.
There are 6,737 Medicare-certified dialysis facilities. As explained later in the regulatory impact analysis section, we estimate that approximately 90 percent, or 6,064, facilities make payments of premiums for individual market health plans, whether directly, through a parent organization, or through another entity, and therefore, will need to comply with these disclosure requirements. We estimate
In addition to providing a copy of the pamphlet to the patients, it is assumed that a health care social worker or other patient assistance personnel at each facility will review the information with the patients and obtain a signed acknowledgement form stating that the patient has received this information. We estimate that a lawyer (at an hourly rate of $131.02) will take 30 minutes to develop an acknowledgement form confirming that the required information was provided to be signed by the ESRD patient. The total burden for all 6,064 facilities to develop the acknowledgement form in the initial year only will be 3,032 hours (0.5 hours × 6,064 facilities) with an equivalent cost of approximately $397,253 (($131.02 hourly rate × 0.5 hours) × 6,064 facilities).
We estimate that a health care social worker (at an hourly rate of $51.94) will take an average of 45 minutes to further educate each patient about their coverage options. The social worker will also obtain the patient's signature on the acknowledgement form and save a copy of the signed form for recordkeeping, incurring a materials and printing cost of $0.05 per form. The total annual burden for each facility will be 54.75 hours (0.75 hours × 73 patients) with an equivalent cost of approximately $2,844 ($51.94 hourly rate × 54.75 hours), and approximately $4 in printing and materials cost. The total annual burden for all 6,064 facilities will be 332,004 hours 54.75 hours × 6,064 facilities) with an equivalent cost of approximately $17,244,288 ($2,843.72 annual burden cost × 6,064 facilities), and approximately $22,134 in printing and materials cost.
We will revise the information collection currently approved under OMB Control Number 0938-0386 to account for this additional burden.
Under § 494.180(k), HHS is implementing a requirement for those dialysis facilities that make payments of premiums for individual market health plans, whether directly, through a parent organization, or through another entity, must ensure issuers are informed of and have agreed to accept the payments for the duration of the plan year.
Based on comments received in response to the RFI, it is assumed that approximately 7,000 patients that receive such payments are enrolled in individual market plans. Therefore, we estimate that 6,064 facilities will be required to send approximately 7,000 notices. It is assumed that these notices will be sent and returned electronically at minimal cost. We estimate that, for each facility during the initial year, it will take a lawyer one hour (at an hourly rate of $131.02) to draft a letter template notifying the issuer of third party payments and requesting assurance of acceptance for such payments. The total annual burden for all facilities during the initial year will be 6,064 hours with an equivalent cost of approximately $794,505 ($131.02 × 6,064 facilities). This is likely to be an overestimation since parent organizations will probably develop a single template for all individual facilities they own. We further estimate that it will require an administrative assistant approximately 30 minutes (at an hourly rate of $37.86) to insert customized information and email the notification to the issuer, send any follow-up communication, and then save copies of the responses for recordkeeping. The total annual burden for all facilities for sending the notifications will be 3,500 hours (7,000 notifications x 0.5 hours) with an equivalent cost of $132,510 ($37.86 hourly rate × 3,500 hours).
There are an estimated 468 issuers in the individual market. It is assumed that the approximately 7,000 patients are uniformly distributed between these issuers. Issuers will incur a burden if they respond to the notifications from dialysis facilities and inform them whether or not they will accept third party payments. It is estimated that it will take a lawyer 30 minutes (at an hourly rate of $131.02) to review the notification and an administrative manager 30 minutes (at an hourly rate of $91.20) to approve or deny the request and respond to any follow-up communication. It will further take an administrative assistant approximately 30 minutes (at an hourly rate of $37.86) to respond electronically to the initial notification and any follow-up communications. The total annual burden for all issuers to respond to 7,000 notifications will be 10,500 hours (1.5 hours × 7,000 notifications) with an equivalent cost of $910,280 (10,500 hours × $86.69 average hourly rate per notification per issuer).
We will revise the information collection currently approved under OMB Control Number 0938-0386 to account for this additional burden.
If you comment on these information collection requirements, please do either of the following:
1. Submit your comments electronically as specified in the
2. Submit your comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: CMS Desk Officer, CMS-3337-IFC. Fax: (202) 395-6974; or Email:
This interim final rule with comment implements a number of requirements for Medicare-certified dialysis facilities that make payments of premiums for individual market health plans, whether directly, through a parent organization, or through another entity. It establishes a new patient rights standard applicable only to such facilities that they must provide patients with information on available health insurance options, including locally available individual market plans, Medicare, Medicaid, and CHIP coverage. This information must include the effects each option will have on the patient's access to, and costs for the providers and suppliers, services, and prescription drugs that are currently within the individual's ESRD plan of care as well as those likely to result from other documented health care needs. This must include an overview of the health-related and financial risks and benefits of the individual market plans available to the patient (including plans offered through and outside the Exchange). Patients must also receive information about all available financial assistance for enrollment in an individual market health plan and the limitations and associated risks of such assistance; including any and all current information about the facility's, or its parent organization's contributions to patients or third parties that subsidize enrollment in individual market health plans for individuals on dialysis.
In addition, the interim final rule with comment establishes a new standard requiring dialysis facilities that make payments of premiums for individual market health plans, whether directly, through a parent organization, or through another entity, to disclose these payments to applicable issuers and requiring the contributing facility to obtain assurance from the issuer that the issuer will accept such payments for the duration of the plan year.
These requirements are intended to ensure that patients are able to make coverage decisions based on full, accurate information, and are not inappropriately influenced by financial interests of dialysis facilities and suppliers, and to minimize the likelihood that coverage is interrupted midyear for these vulnerable patients.
This interim final rule with comment addresses concerns raised by commenters and by HHS regarding the inappropriate steering of patients with ESRD, especially those eligible for Medicare and Medicaid, into individual market health plans that offer significantly higher reimbursement rates compared to Medicare and Medicaid, without regard to the potential risks incurred by the patient. As discussed previously in the preamble, public comments received in response to the August 2016 RFI indicated that dialysis facilities may be encouraging patients to move from one type of coverage into another based solely on the financial benefit to the dialysis facility, and without transparency about the potential consequences for the patient, in circumstances where these actions may result in harm to the individual.
This interim final rule with comment addresses these issues by implementing a number of requirements that will provide patients with the information they need to make informed decisions about their coverage and will help to ensure that their care is not at risk of disruptions, gaps in coverage, limited access to necessary treatment, or undermined by the providers' or suppliers' financial interests.
We have examined the effects of this rule as required by Executive Order 12866 (58 FR 51735, September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), Executive Order 13132 on Federalism, and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Order 12866 (58 FR 51735) directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects; distributive impacts; and equity). Executive Order 13563 (76 FR 3821, January 21, 2011) is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in Executive Order 12866.
Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule—(1) having an annual effect on the economy of $100 million or more in any one year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as “economically significant”); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year. We estimate that this rulemaking is “economically significant” as measured by the $100 million threshold, and hence also a major rule under the Congressional Review Act. Accordingly, we have prepared an RIA that to the best of our ability presents the costs and benefits of the rulemaking.
In accordance with OMB Circular A-4, Table 3 below depicts an accounting statement summarizing HHS' assessment of the benefits, costs, and transfers associated with this regulatory action. The period covered by the RIA is 2017 through 2026.
HHS anticipates that the provisions of this interim final rule with comment will enhance patient protections and enable patients with ESRD to choose health insurance coverage that best suits their needs and improve their health outcomes. Providing patients with accurate information will help to ensure that patients are able to obtain necessary health care, reduce the likelihood of coverage gaps, as well as provide financial protection. Dialysis facilities and issuers will incur costs to comply with these requirements. If patients covered through individual market plans opt to move to (or return to) Medicare and Medicaid, then there will be a transfer of patient care costs to the Medicare and Medicaid programs. For those patients covered through individual market plans who chose to apply for and enroll in Medicare, there would be a transfer of premium payments from individual market issuers to the Medicare program. In accordance with Executive Order 12866, HHS believes that the benefits of this regulatory action justify the costs.
There are 6,737 dialysis facilities across the country that are certified by Medicare, and an estimated 495,000 patients on dialysis. Based on USRDS data for recent years, we estimated that approximately 99.3 percent or 491,500 patients receive services at Medicare-certified facilities. Therefore, each Medicare-certified facility is providing services to approximately 73 patients on average annually. As mentioned previously, data indicates that about 88 percent of ESRD patients receiving hemodialysis were covered by Medicare (as primary or secondary payer) in 2014. Data from the CMS risk adjustment program in the individual market (both on and off exchange) suggest that the number of enrollees with an ESRD diagnosis in the individual market more than doubled between 2014 and 2015. Although some of the increase could be due to increases in coding intensity and cross-year claims, the gross number is still significant and concerning. Comments received in response to the RFI suggest that the inappropriate steering of patients may be accelerating over time. Insurance industry commenters stated that the number of patients in individual market plans receiving dialysis increased 2 to 5 fold in recent years. We will continue to analyze these data to better understand trends in ESRD diagnoses as well as the extent to which individuals may be enrolled in both Medicare and individual market plans and implications for the anti-duplication provision outlined in section 1882(d)(3) of the Act.
There is no data on how many dialysis facilities make payments of premiums for individual market health plans, whether directly, through a parent organization, or through another entity. We believe that these practices are likely concentrated within large dialysis chains that together operate approximately 90 percent of dialysis facilities, and therefore estimate that approximately 6,064 facilities make payments of premiums for individual market health plans, whether directly, through a parent organization, or through another entity.
This interim final rule with comment implements a number of requirements for Medicare-certified dialysis facilities (as defined in 42 CFR 494.10) that make payments of premiums for individual market health plans (in any amount), whether directly, through a parent organization (such as a dialysis corporation), or through another entity (including by providing contributions to entities that make such payments). Such facilities must provide patients with information on available health coverage options, including local, current individual market plans, Medicare, Medicaid, and CHIP coverage. This information must include; the effects each coverage option will have on the patient's access to, and costs for, the providers and suppliers, services, and prescription drugs that are currently within the individual's ESRD plan of care as well as those likely to result from other documented health care needs. This must include an overview of the health-related and financial risks and benefits of the individual market plans available to the patient (including plans offered through and outside the Exchange). Information on coverage of transplant-associated costs must also be provided to patients, including pre- and post-transplant care. In addition, facilities must provide information about penalties associated with late enrollment in Medicare. Patients must also receive information about available financial assistance for enrollment in an individual market health plan and limitations and associated risks of such assistance; the financial benefit to the facility of enrolling the individual in an individual market plan as opposed to public plans; and current information about the facility's, or its parent organization's contributions to patients or third parties that make payments of premiums for individual market plans for individuals on dialysis.
These requirements are intended to ensure that patients are able to make insurance coverage decisions based on full, accurate information, and not based on misleading, inaccurate, or incomplete information that prioritizes providers and suppliers' financial interests. It is likely that some patients will elect to apply for and enroll in Medicare and Medicaid (if eligible) instead of individual market plans once they are provided all the information as required. As previously discussed, Medicare (and Medicaid) enrollment will provide health benefits by reducing the likelihood of disruption of care, gaps in coverage, limited access to necessary treatment, denial of access to kidney transplants or delay in transplant readiness, and denial of post-surgical care. By enrolling in Medicare (and Medicaid), many individuals can avoid potential financial loss due to Medicare late enrollment penalties; higher cost-sharing, especially for out-of-network services; higher deductibles; and coverage limits in individual market plans. This is particularly true for the individuals eligible for Medicare based on ESRD who are also eligible for
In addition, this interim final rule with comment establishes a new standard, applicable only to facilities that make payments of premiums for individual market health plans, whether directly, through a parent organization (such as a dialysis corporation), or through another entity (including by providing contributions to entities that make such payments), requiring that the facility disclose such payments to applicable issuers and obtain assurance from the issuer that they will accept such payments for the duration of the plan year. This will lead to improved health outcomes for patients by ensuring that coverage is not interrupted midyear for these vulnerable patients, leaving them in medical or financial jeopardy.
Dialysis facilities that make premium payments for patients as discussed above will incur costs to comply with the provisions of this rule. The administrative costs related to the disclosure requirements have been estimated in the previous section.
If patients elect to apply for and enroll in Medicare and Medicaid (if eligible) instead of individual market plans, the cost of their coverage will be transferred from the patients and the individual market issuers to the Medicare and Medicaid programs (if the patient is eligible for both). This will lead to increased spending for these programs. For the purpose of this analysis, we assume that approximately 50 percent of patients enrolled in individual market plans that receive third party premium payments will elect to apply for and enroll in Medicare. USRDS data show that for individuals with ESRD enrolled in Medicare receiving hemodialysis, total health care spending averaged $91,000 per person in 2014, including dialysis and non-dialysis services. Therefore, if 3,500 patients switch to Medicare, the total transfer from individual market issuers to the Medicare program will be approximately $318,500,000. We assume that about 50 percent of patients that opt to enroll in Medicare will also be eligible for Medicaid and will have negligible or zero cost-sharing, rather than the maximum out-of-pocket cost of $7,150, which will be a transfer from the patients to the Medicare and Medicaid programs. Therefore, for 1,750 dual eligible patients, the total transfer is estimated to be $12,512,500. For those patients covered through individual market plans who choose to enroll in Medicare there will also be a transfer of premium payments from the individual market issuers to the Medicare program. Assuming that patients will pay the standard Part B premium amount, which will be $134 in 2017, and an average Part D premium of $42.17,
Under the Executive Order, HHS is required to consider alternatives to issuing rules and alternative regulatory approaches. HHS considered not requiring any additional disclosures to patients. Providing complex information regarding available coverage options may not always help patients make the best decisions. In addition, disclosure requirements may not be as effective where financial conflicts of interest remain for the dialysis facilities. We also considered prohibiting outright contributions from dialysis suppliers to patients or third parties for individual market plan premiums, but determined that we wanted to have additional data before implementing additional restrictions. A ban could potentially cause financial hardship for some patients. On the other hand, dialysis facilities would not be able to use these contributions to steer patients towards individual market plans that are more in the financial interests of dialysis facilities rather than those of the patient. In the absence of additional data, it is not possible to estimate the costs, benefits and transfers associated with such a ban, whether the benefits would outweigh the costs, and whether it would be more effective in ending the practice of steering.
HHS believes, however, that patients will benefit from having complete and accurate information regarding their options, especially information on Medicare and Medicaid and the financial and medical/coverage consequences of each option. In addition, CMS can ensure compliance with the disclosure requirements through the survey and certification process. CMS plans to issue interpretive guidance and a survey protocol for the enforcement of the new standards by state surveyors to ensure that the facilities share appropriate information with patients.
We also considered requiring issuers to accept all third party premium payments. However, requiring issuers to accept such payments could skew the individual market risk pool, a position CMS has consistently articulated since 2013, when we expressly discouraged issuers from accepting these premium payments from providers. We also received comments from issuers, social workers, and others in response to the RFI indicating that inappropriate steering practices could have the effect of skewing the insurance risk pool. The underlying policy considerations have not changed and therefore CMS is seeking to prevent mid-year disruption by requiring facilities to disclose payments and assure acceptance. In light of the comments received regarding dialysis facilities' practices in particular, and the unique health needs and coverage options available to this population, we are at this time imposing disclosure-related obligations only on the ESRD facilities themselves. This rule does not change the legal obligations or requirements placed on issuers.
In addition, to determine whether further action is warranted, we seek comments from stakeholders on whether patients would be better off on balance if premium assistance originating from health care providers and suppliers were more strictly limited and disclosed. We also seek comment on alternative options where payments would be limited absent a showing that the individual market coverage was in the individual's best interest, and we seek comment on what such a showing would require and how it could prevent mid-year disruptions in coverage.
The Regulatory Flexibility Act (5 U.S.C. 601
The RFA generally defines a “small entity” as (1) a proprietary firm meeting the size standards of the Small Business Administration (SBA) (13 CFR 121.201); (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 to 5 percent.
Because this provision is issued as a final rule without being preceded by a general notice of proposed rulemaking, a final regulatory analysis under section 604 of the Regulatory Flexibility Act (94 Stat. 1167) is not required. Nevertheless, HHS estimates that approximately 10 percent of Medicare-certified dialysis facilities are not part of a large chain and may qualify as small entities. It is not clear how many of these facilities make payments of premiums for individual market health plans, whether directly, through a parent organization, or through another entity. To the extent that they do so, these facilities will incur costs to comply with the provisions of this interim final rule with comment and experience a reduction in reimbursements if patients transfer from individual market coverage to Medicare. However, HHS believes that very few small entities, if any, make such payments. Therefore, HHS expects that this interim final rule with comment will not affect a substantial number of small entities. Accordingly, the Secretary certifies that a regulatory flexibility analysis is not required.
In addition, section 1102(b) of the Social Security Act requires agencies to prepare a regulatory impact analysis if a rule may have a significant economic impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. This interim final rule with comment will not affect small rural hospitals. Therefore, HHS has determined that this regulation will not have a significant impact on the operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act (UMRA) 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.
UMRA does not address the total cost of a 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.
This interim final rule with comment includes no mandates on state, local, or tribal governments. Thus, this rule does not impose an unfunded mandate on state, local or tribal governments. As discussed previously, dialysis facilities that wish to make payments of premiums for individual market health plans (in any amount), whether directly, through a parent organization (such as a dialysis corporation), or through another entity (including by providing contributions to entities that make such payments), will incur administrative costs in order to comply with the provisions of this interim final rule with comment. Issuers will incur some administrative costs as well. However, consistent with policy embodied in UMRA, this interim final rule with comment has been designed to be the least burdensome alternative for state, local and tribal governments, and the private sector.
Executive Order 13132 outlines fundamental principles of federalism. It requires adherence to specific criteria by Federal agencies in formulating and implementing policies that have “substantial direct effects” on the states, the relationship between the national government and states, or on the distribution of power and responsibilities among the various levels of government.
This rule does not have direct effects on the states, the relationship between the Federal government and states, or on the distribution of power and responsibilities among various levels of government.
This interim final rule with comment is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801
In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
Health facilities, Incorporation by reference, Kidney diseases, Medicare, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR Chapter IV as follows:
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
(1) Be informed annually, on a timely basis for each plan year, of all available health coverage options, including but not limited to Medicare, Medicaid, CHIP and individual market plans. This must include information on:
(i) How plans in the individual market will affect the patient's access to, and costs for the providers and suppliers, services, and prescription
(ii) Medicare and Medicaid/Children's Health Insurance Coverage (CHIP) coverage, including Medicare Savings Programs, and how enrollment in those programs will affect the patient's access to and costs for health care providers, services, and prescription drugs that are currently within the individual's plan of care.
(iii) Each option's coverage and anticipated costs associated with transplantation, including patient and living donor costs for pre- and post-transplant care.
(2) Receive current information from the facility about premium assistance for enrollment in an individual market health plan that may be available to the patient from the facility, its parent organization, or third parties, including but not limited to limitations and any associated risks of such assistance.
(3) Receive current information about the facility's, or its parent organization's, contributions to patients or third parties that subsidize the individual's enrollment in individual market health plans for individuals on dialysis, including the reimbursements for services rendered that the facility receives as a result of subsidizing such enrollment.
(i) Disclose to the applicable issuer each policy for which a third party payment described in this paragraph (k) will be made, and
(ii) Obtain assurance from the issuer that the issuer will accept such payments for the duration of the plan year. If such assurances are not provided, the facility shall not make payments of premiums and shall take reasonable steps to ensure such payments are not made by the facility or by third parties to which the facility contributes as described in this paragraph (k).
(2) If a facility is aware that a patient is not eligible for Medicaid and is not eligible to enroll in Medicare Part A and/or Part B except during the General Enrollment Period, and the facility is aware that the patient intends to enroll in Medicare Part A and/or Part B during that period, the standards under this paragraph (k) will not apply with respect to payments for that patient until July 1, 2017.
National Aeronautics and Space Administration.
NASA has adopted as final, without change, an interim rule amending the NASA Federal Acquisition Regulation Supplement (NFS) to implement revisions to the voucher submittal and payment process.
Mr. John J. Lopez, telephone 202-358-3740.
NASA published an interim rule in the
There were no public comments submitted in response to the interim rule. The interim rule has been converted to a final rule, without change.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
NASA does not expect this final rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
The purpose of this rule is to implement revisions to the NASA voucher submittal and payment process. These revisions are necessary due to section 893 of the National Defense Authorization Act for Fiscal Year 2016 (Pub. L. 114-92) prohibiting DCAA from performing audit work for non-Defense Agencies. This rule removes an outdated NFS payment clause and its associated prescription relative to the NASA voucher submittal and payment process and replaces it with a new clause that revises NASA's current cost voucher submission and payment process to ensure the continued prompt payment to its suppliers.
No comments were received in response to the initial regulatory flexibility analysis.
This rule applies to contractors requesting payment under cost reimbursement contracts. An analysis of data in the Federal Procurement Data System (FPDS) revealed that cost reimbursement contracts are primarily awarded to large businesses. FPDS data compiled over the past three fiscal years (FY 2013 through FY 2015) showed an average of 311 active cost reimbursement NASA contracts, of which 141 (approximately 45%) were awarded to small businesses. However, there is no significant economic or administrative cost impact to small or
There are no new reporting requirements or recordkeeping requirements associated with this rule. Further, there are no significant alternatives that could further minimize the already minimal impact on businesses, small or large.
The rule contains information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35); however, these changes to the NFS do not impose additional information collection requirements to the paperwork burden previously approved under OMB Control Number 9000-0070, entitled Payments—FAR Sections Affected: 52.232-1 thru 52.232-4 and 52.232-6 thru 52.232-11.
Surface Transportation Board.
The Surface Transportation Board (Board or STB) is adopting final rules for investigations conducted on the Board's own initiative pursuant to Section 12 of the Surface Transportation Board Reauthorization Act of 2015.
These rules are effective on January 13, 2017.
Information or questions regarding these final rules should reference Docket No. EP 731 and be in writing addressed to Chief, Section of Administration, Office of Proceedings, Surface Transportation Board, 395 E Street SW., Washington, DC 20423-0001.
Scott M. Zimmerman at (202) 245-0386. [Assistance for the hearing impaired is available through the Federal Information Relay Service (FIRS) at 1-800-877-8339.]
Section 12 of the Surface Transportation Board Reauthorization Act of 2015, Public Law 114-110, 129 Stat. 2228 (2015) (
By decision served on May 16, 2016, the Board issued a Notice of Proposed Rulemaking (NPRM) in which the Board proposed rules for investigations conducted on the Board's own initiative pursuant to Section 12 of the
After consideration of parties' comments, the Board is adopting final rules, to be set forth at 49 CFR part 1122, that establish the procedures for Board investigations conducted pursuant to Section 12 of the
Within 30 days after initiating an investigation, the Board must provide notice to parties under investigation stating the basis for such investigation. The Board may only investigate issues that are of national or regional significance. Parties under investigation have a right to file a written statement describing all or any facts and circumstances concerning a matter under investigation. The Board should separate the investigative and decisionmaking functions of Board staff to the extent practicable.
Investigations must be dismissed if they are not concluded with administrative finality within one year after commencement.
In the NPRM, the Board proposed a three-stage process, consisting of (1) Preliminary Fact-Finding, (2) Board-Initiated Investigations, and (3) Formal Board Proceedings. Having considered the comments, the Board will adopt this three-stage process in the final rules, subject to certain modifications from what was proposed in the NPRM. Below we address the comments received in response to the NPRM pertaining to each stage, as well as other related issues, and the Board's responses, including modifications from the NPRM. The final rules are below.
As proposed in the NPRM, Preliminary Fact-Finding refers to the process in which Board staff would conduct, at their discretion, an initial, informal, nonpublic inquiry regarding an issue. The purpose of the Preliminary Fact-Finding would be to determine if there is enough information to warrant
In particular, AAR asserts that the one-year time limit for investigations should apply to Preliminary Fact-Finding because an “open-ended, limitless Preliminary Fact-Finding phase” would undermine the “purpose of the statutory scheme” and would force parties to “endure the burdens and uncertainty of an open-ended inquiry that could last for years.”
NSR asserts two arguments in support of including Preliminary Fact-Finding in the one-year time limit. First, NSR states that the plain language of the statute “expressly provides that the Board has one year to conclude any `investigation' with administrative finality.” Therefore, the Board's proposed “Preliminary Fact-Finding phase is a blatant attempt to buy itself more time to conduct an investigation than afforded” by Section 12 of the
NGFA and NITL disagree with including Preliminary Fact-Finding in the statutorily-mandated one-year time limit for investigations, but argue that the Board should instead impose a reasonable time limit on Preliminary Fact-Finding. NGFA supports the Board imposing a time limit of 60 days. (NGFA Reply 5.) NITL supports a 45-day deadline for Preliminary Fact-Finding. (NITL Comment 2.)
SMART-TD argues that “there is always `preliminary' work” before an “official” agency action and, therefore, the Board should delete the provision for Preliminary Fact-Finding from the final rules. (SMART-TD Comment 11.)
Although 49 U.S.C. 11701 requires that the Board dismiss any investigation that is not concluded with administrative finality within one year, Preliminary Fact-Finding does not constitute part of an investigation; rather, it is the Board's informal process of determining
Although there is no limitation in the statute as to how long Preliminary Fact-Finding should occur, the Board understands the concern from the parties that the Board not allow the Preliminary Fact-Finding phase to continue “indefinitely.” The final rules, accordingly, require that Preliminary Fact-Finding be concluded within a reasonable period of time. As a matter of policy, we determine “a reasonable period of time” to be approximately 60 days from the date the Board notifies the party subject to Preliminary Fact-Finding that Preliminary-Fact Finding has commenced.
Jersey City requests that the Board publish notice of commencement of Preliminary Fact-Finding in the
AAR opposes making Preliminary Fact-Finding public, stating that to do so would make parties “reluctant to volunteer information” and subject to “unwarranted reputational damage or other harm.” (
The Board will adopt the proposal in the NPRM to keep the Preliminary Fact-Finding confidential, subject to certain limited exceptions (discussed below). Having considered the parties' arguments, we are not convinced the potential benefits of making Preliminary Fact-Finding public outweigh the risks. During Preliminary Fact-Finding, Board staff would only be ascertaining whether a matter warrants an investigation by the Board. Preliminary Fact-Finding would not be a formal, evidence-gathering process, and, if the Board were to make Preliminary Fact-Finding public, parties subject to Preliminary Fact-Finding could possibly be subject to unwarranted reputational damage or other harm. NGFA suggests that concerns about confidentiality could be avoided by redacting the parties' names, but even a general description of the issues subject to Preliminary Fact-Finding might effectively disclose the identity of involved parties, regardless of whether the name(s) of the parties were redacted. Therefore, the final rules presume that Preliminary Fact-Finding would be nonpublic and confidential, unless the Board otherwise finds it necessary to make certain information related to, or the fact of, Preliminary Fact-Finding public.
As previously proposed in the NPRM, the final rules would continue to allow the Board to make aspects of Preliminary Fact-Finding public.
First, AAR asserts that the Board or the Director of the Office of Proceedings, as opposed to Board staff, should approve commencement of Preliminary Fact-Finding, “given the potentially significant consequences on regulated parties” from Preliminary Fact-Finding, or from a Board-Initiated Investigation or Formal Board Proceeding opened as a result of Preliminary Fact-Finding. (AAR Comment 6.) We decline to incorporate the suggestion that the Board or the Director of the Office of Proceedings should approve commencement of Preliminary Fact-Finding. The Board must gather information concerning potentially qualifying violations to determine whether it should commence a Board-Initiated Investigation. For the reasons discussed earlier,
Second, AAR suggests that the Board should notify parties subject to Preliminary Fact-Finding that Preliminary Fact-Finding has commenced. AAR argues that, without such notice, railroads may not be willing to coordinate and share information with the Board's Office of Public Assistance, Governmental Affairs, and Compliance (OPAGAC) out of concern that such information could be used by Board staff in Preliminary Fact-Finding against them. (AAR Comment 7-8.) To address AAR's concerns regarding OPAGAC, we are modifying section 1122.3 to include a requirement that Board staff notify parties subject to Preliminary Fact-Finding that Preliminary Fact-Finding has commenced.
Third, AAR argues that section 1122.3 should use the terminology “warranted” or “not warranted” (instead of “appropriate” or “not appropriate”), as both the NPRM's preamble and the statute use the word “warranted.” (AAR Comment 9 n.3.) The final rules incorporate this suggestion, adopting the terminology of “warranted” or “not warranted,” instead of “appropriate” or “not appropriate.”
AAR seeks clarification that (1) the production of documents during Preliminary Fact-Finding is voluntary, (2) the requirement to certify a production of documents applies to Preliminary Fact-Finding, (3) the Board retains its right to demand to inspect and copy any record of a rail carrier pursuant to 49 U.S.C. 11144(b) during Preliminary Fact-Finding, and (4) the information submitted during Preliminary Fact-Finding will be “subject to disclosure in any subsequent Board-Initiated Investigation on the same terms as other materials gathered during Board-Initiated Investigations.” (AAR Comment 5, 7-8.)
In response to AAR's comments, the Board provides the following clarifications. First, the production of documents during Preliminary Fact-Finding would be voluntary.
NITL and NGFA state that the Board should provide staff the “appropriate tools” to obtain information needed during Preliminary Fact-Finding. (NITL Comment 2; NGFA Reply 5-6.) NGFA also suggests that the Board should adopt deadlines for a party subject to Preliminary Fact-Finding to submit evidence to the Board. (NGFA Reply 6.)
The Board declines to give Board staff additional authority to obtain information during Preliminary Fact-Finding. As previously noted, Preliminary Fact-Finding is an initial, informal inquiry to determine whether a Board-Initiated Investigation is warranted. The Board, thus, has intentionally limited Board staff's authority to collect evidence in order to prevent undue burden on anyone. However, during Preliminary Fact-Finding, Board staff would be able to request that parties produce information and documents on a voluntary basis and request that any evidence submitted be provided by a certain deadline. Although Board staff would not be able to issue subpoenas to compel the production of evidence during Preliminary Fact-Finding, parties would have an incentive to provide information or documents to show that a Board-Initiated Investigation is not warranted. For these reasons, the Board declines to grant Board staff any further authority to obtain information during Preliminary Fact-Finding.
As proposed in the NPRM, Board-Initiated Investigation refers to an investigation, conducted in accordance with Section 12 of the
In this section, we address parties' comments on (1) the standard for opening a Board-Initiated Investigation, (2) the definition of “national or regional significance,” (3) timing of providing the Order of Investigation to parties under investigation, (4) confidentiality of Board-Initiated Investigations, (5) parties' requests for the right to intervene in Board-Initiated Investigations, (6) railroads' request for access to exculpatory evidence, (7) parties' comments relating to the collection of information and documentation, and (8) the process for providing Board staff's recommendations and summary of findings to a party under investigation.
In comments, AAR asks the Board to clarify the standard for commencing a Board-Initiated Investigation and require that (1) “the issue [be] of national or regional significance” and (2) “there [be]
AAR further asks that the Board require that any Order of Investigation issued state that “the matter at issue `is' of national or regional significance” (instead of “may be” of national or regional significance). (AAR Comment 9.) Relatedly, NSR asks that the Board clarify that any issue subject to a Board-Initiated Investigation must “remain of national or regional significance throughout the Board-Initiated Investigation and related Formal Board Proceeding.” (NSR Comment 3.)
The final rules will continue to require that an alleged violation subject to a Board-Initiated Investigation be of national or regional significance.
In particular, AAR states that the Board should define “national or regional significance” as “widespread and significant effects on transportation service or markets in a region or across the nation.” AAR also asks that the Board clarify that issues of national or regional significance do not include individual rate disputes or disputes involving a single shipper. (AAR Comment 10.) Similarly, Jersey City states that the Board should define “national or regional significance” in order to avoid litigation on jurisdictional issues stemming from this phrase. (Jersey City Comment 11-12.)
We decline to adopt a definition of “national or regional significance.” The Board finds that AAR's proposed definition does not provide significantly more insight than the phrase itself as to what constitutes a matter “of national or regional significance.” In addition, there is no need to expressly exclude rate disputes in these rules—such disputes are not subject to Board-Initiated Investigation under the statute (whether or not they are of national or regional significance). Section 11701(a) of Title 49 of the United States Code states that the Board may begin an investigation on its own initiative, “[e]xcept as otherwise provided in this part.” Rate disputes are governed by 49 U.S.C. 10704, which specifically states that rate disputes may only be commenced “on complaint.” 49 U.S.C. 10704(b). Therefore, rate disputes fall outside the purview of the investigatory authority conferred to the Board under Section 12 of the
As to disputes involving a single shipper, the Board declines to adopt a blanket approach as to whether such issues are of national or regional significance. Such a determination would be fact-dependent and require the Board to make a determination based on the specific situation and various factors (such as the dispute's impact on national or regional rail traffic), which are discussed further below.
NSR and NGFA also ask that the Board provide clarification related to the definition of “national or regional significance.” Specifically, NSR asks the Board to explain how it “intends to apply the jurisdictional standard of `national or regional significance.' ” (NSR Comment 3.) NGFA requests that the Board “provide a discussion of the types of rail practices or issues the Board would consider to be of national or regional significance.” (NGFA Comment 3-4; NGFA Reply 6.)
Under the final rules, the Board would apply the jurisdictional standard of national or regional significance on a case-by-case basis, considering, for instance, the extent of the impacts of the potential violation on national or regional rail traffic, customers, or third parties, or the geographic scope of the alleged violation. Examples of recent matters that the Board might consider to be of national or regional significance include (but are not limited to): Fertilizer shipment delays; rail car supply issues that impact grain shipments; or extensive congestion at strategic interchange points such as Chicago, Ill.
In comments, NGFA asks that the Board publish Orders of Investigation in the
We find that the risks of making Board-Initiated Investigations public outweigh the potential benefits, absent extraordinary circumstances.
With respect to confidentiality, AAR asks that the Board clarify that it is “not claiming unbounded discretion to make confidential
The Board will grant these requests to clarify that parties will be given notice and the ability to respond to the potential disclosure of confidential commercial information prior to its release. Specifically, the final rules at
In its comments, AAR asks that the Board instead provide a copy of the Order of Investigation to the parties under investigation within 10 days of its issuance. (AAR Comment 12.) Similarly, NGFA asks that the Board provide a copy of the Order of Investigation to the public within 10 or 15 days of its issuance. (NGFA Reply 7.)
Under 49 U.S.C. 11701(d)(1), the Board is required to provide written notice to the parties under investigation by not later than 30 days after initiating the investigation. Although in practice the Board intends to provide copies of the Order of Investigation to parties within a shorter timeframe as requested by AAR and NGFA, the Board declines to adopt regulations that are stricter than the requirements of Section 12 of the
We decline to permit third parties to intervene or participate as a matter of right in Board-Initiated Investigations. Although NGFA and Jersey City argue that interventions could increase transparency and assist Investigative Officers in developing a more complete record and determining whether a qualifying violation occurred, a final, binding determination in that regard is not made during a Board-Initiated Investigation. (
Finally, we disagree with Jersey City's argument that 28 U.S.C. 2323 grants interested “[c]ommunities, associations, firms, and individuals” a right to intervene in any Board-Initiated Investigation. As AAR points out, section 2323 applies only to federal court proceedings arising from challenges to Board rulemakings or attempts to enforce Board orders. (AAR Reply 9.) For these reasons, the final rules continue to prohibit intervention or participation by third parties in any Board-Initiated Investigation.
In response to AAR and NSR's comments pertaining to transcripts, the Board declines to always require a transcript of investigative testimony, but will require that witnesses be given access to any transcript of their investigative testimony—either by receiving a copy of the transcript or by inspecting the transcript. Specifically, the final rules now provide that “[a] witness who has given testimony pursuant to [part 1122 of the regulations] shall be entitled, upon written request, to procure a transcript of the witness' own testimony or, upon proper identification, shall have the right to inspect the official transcript of the witness' own testimony.”
As to Investigating Officers' right to request documents, we will adopt AAR's suggestion that Investigating Officers be limited to request documents that are likely to be directly relevant to the investigation. (AAR Comment 15.) Thus, we have modified the language of section 1122.9 to state that Investigating Officer(s) may interview or depose witnesses, inspect property and facilities, and request and require the production of any information, documents, books, papers, correspondence, memoranda, agreements, or other records, in any form or media, “that are likely to be directly relevant to the issues of the Board-Initiated Investigation.” This change also sufficiently addresses NSR's concern that Investigating Officers' requests for evidence be “limited in scope, specific in directive, and in good faith.” (NSR Comment 4.) The Board declines to otherwise limit the Investigating Officers' right to request evidence.
AAR and NSR also ask that the Board provide parties under investigation the right to seek discovery.
Finally, AAR and NSR request that the Board eliminate or add certain other provisions related to the Board's collection of information and documentation during a Board-Initiated Investigation. First, AAR asks that the Board entirely eliminate the proposed regulation (proposed in the NPRM as 49 CFR 1122.11) titled “Certifications and false statements,” including subparagraph (b), which requires a party from whom documents are sought to submit a list of all documents withheld due to privilege, and subparagraph (c), which sets forth the criminal penalty for perjury. (AAR Comment 16-17.) Alternatively, AAR asks the Board to revise the “Certifications and false statements” provision to “require the person [producing documents] to confirm that it produced all responsive, non-privileged documents located after reasonable search and subject to any agreed-upon protocols regarding reduction of duplicative documents.” (AAR Comment 16.) AAR claims its language would allow a party to only have to produce one copy of a document, even if duplicative digital versions exist. Its language would also require a party to perform a “reasonable” search, rather than a “diligent” search, as proposed in the NPRM. Additionally, AAR asks that the Board adopt a “witness rights” provision in accordance with other agencies' practices. (AAR Comment 17.) NGFA opposes AAR's request to remove the “Certifications and false statements” provision. (NGFA Reply 8.)
We decline to eliminate the “Certifications and false statements” provision in its entirety, or its subparagraph (b) relating to the privilege log requirements. Subparagraphs (a) and (b) are necessary, as they would be the Investigating Officers' primary means of ensuring that parties under investigation have conducted their due diligence and provided the Board with the information requested. However, we will grant AAR's request regarding agreed-upon protocols for duplicative documents. Accordingly, the final rules now expressly subject the “Certifications and false statements” provision to any search protocols that the Investigating Officer(s) and producing parties may agree upon.
Second, AAR and NSR request that the Board remove the attorney disqualification provision, proposed in the NPRM as section 1122.9(b), in which the Board would have the authority to exclude a particular attorney from further participation in any Board-Initiated Investigation in which the attorney is obstructing the Board-Initiated Investigation. (AAR Comment 18; NSR Comment 26-27.) After considering the comments, we will remove the attorney disqualification provision from the final rules, as the Board's current rules governing attorney conduct sufficiently protect the integrity of any investigation.
The Board recognizes the merits of the Brady Rule and expects to employ the practice of disclosing exculpatory evidence if the Board were to open a Formal Board Proceeding following the conclusion of a Board-Initiated Investigation involving any criminal provisions of 49 U.S.C. Subtitle IV, Part A. However, because (1) most Board-Initiated Investigations will not likely involve any such criminal provisions, (2) Board-Initiated Investigations only determine if the Board should open a Formal Board Proceeding, and (3) any remedy that may result from an investigation must be prospective only, the Brady Rule does not appear directly applicable, and the Board will not codify it in the final rules adopted here.
The NPRM also provided an optional process whereby Investigating Officer(s), in their discretion and time permitting, could present (orally or in writing) their recommendations and/or summary of findings to parties under investigation
In response, AAR and NSR request that the Board make this optional process mandatory.
The Board intends that Investigating Officer(s), when possible, will utilize the optional process of presenting their recommendations and summary of findings to parties under investigation prior to submitting them to the Board Members. However, given the one-year deadline for concluding Board-Initiated Investigations, the Board will not make this process mandatory, as there may be circumstances in which Investigating Officer(s) cannot complete their recommendations and summary of findings sufficiently in advance of the one-year deadline to allow them to be presented to the party under investigation prior to submission to the Board. In such cases, the Investigating Officer(s) will provide their recommendations and summary of findings to parties at the same time they are submitted to the Board Members. This is provided for in the final rules at section 1122.5(c), which states that the Investigating Officer(s) must submit their recommendations and summary of findings to the Board and parties under investigation within 275 days.
With respect to parties' responses to Investigating Officers' recommendations and summary of findings, AAR also requests that the Board clarify that parties have the right to submit arguments in their response to Board staff's recommendations and summary of findings. AAR also argues that the Board should increase the 15-page limit for parties' responses to Board staff's recommendations and summary of findings, but if not, then clarify that the party's supporting data, evidence, and verified statements would not count towards the 15-page limit. We will grant AAR's requests, as they would provide the Board with more information in determining whether further action is warranted following a Board-Initiated Investigation. The final rules now provide that: parties have the right to submit arguments in their response to Board staff's recommendations and summary of findings; supporting data, evidence, and verified statements do not count towards the page limit of such responses; and parties may submit written statements responding to the Investigating Officers' recommendations and summary of findings of up to 20 pages.
As proposed in the NPRM, the Formal Board Proceeding refers to a public proceeding that may be instituted by the Board pursuant to an Order to Show Cause after a Board-Initiated Investigation has been conducted. With respect to the Formal Board Proceeding phase, commenters express concerns relating to (1) the duration of the Formal Board Proceeding, (2) the standard for commencing a Formal Board Proceeding, and (3) the Order to Show Cause.
According to NSR, because 49 U.S.C. 11701(d)(6) states that the Board must “dismiss any investigation that is not concluded by the Board with administrative finality within 1 year after the date on which it was commenced,” the Board must either dismiss the Board-Initiated Investigation or decide on the merits of the Formal Board Proceeding within one year of opening the Board-Initiated Investigation. (NSR Comment 6-7.) However, such an interpretation directly contradicts the Senate Report for the
The requirement to dismiss any investigation that is not concluded within 1 year after the date on which it was commenced would only include the time period needed to generate recommendations and summary of findings. The time period needed to complete a proceeding, after receipt of the recommendations and summary of findings, would not be included in the 1 year timeline for investigations.
NSR nonetheless states that the Senate Report “is trumped by the unambiguous new section 11701(d)(6),” arguing that “administrative finality” is “a known term of art with a specific definition, thus precluding any need to rely on legislative history.” As support, NSR, among other cases, compares the Board's proposed investigation process to
Moreover, under 49 U.S.C. 11701(d)(7), which immediately follows the requirement that the Board conclude a Board-Initiated Investigation with administrative finality within one year, the Board's options for concluding the Board-Initiated Investigation, and thus
Additionally, NSR states that “other provisions of the Board's governing statute reinforce that administrative finality occurs only with [a] Board decision.” (NSR Comment 8.) Specifically, NSR cites 49 U.S.C. 11701(e)(7), which “permits judicial review upon conclusion of the Formal Board Proceeding,” and 49 U.S.C. 722(d),
Additionally, NSR asks that the Board require that the Order to Show Cause state the issues to be considered in the Formal Board Proceeding. (NSR Comment 4, 30-32.) We find this request to be reasonable, as a party subject to a Formal Board Proceeding should have notice as to the issues that will be publicly considered by the Board. Based on NSR's comment, the final rules include a requirement that the Order to Show Cause state the issues to be considered during the Formal Board Proceeding.
The NPRM's proposed language expressly tracked 49 U.S.C. 11701(d)(5), which states that in any investigation commenced on the Board's own initiative, the Board must “to the extent practicable, separate the investigative and decisionmaking functions of staff.” Although AAR argues that this is insufficient, as it is merely a “ritualistic incantation of [the] statutory language,” the NPRM also proposed that the Order of Investigation would identify the Investigating Officer(s) and provided that parties subject to investigation could submit written materials to the Board Members at any time. As a result, parties that feel that the investigative and decisionmaking functions of staff are not properly separated may express their concerns in writing directly to the Board during the course of a Board-Initiated Investigation or Formal Board Proceeding.
AAR further asks that the Board explain “any instances where it may not be practicable to separate these functions.” AAR also requests that the Board include in the final rules provisions ensuring the separation of investigatory and decisionmaking functions, such as requirements that the Board “[i]dentify all staff who work in an investigation, not just the Investigating Officers” and “[n]otify Board Members, decisional staff within the Board, and parties subject to investigation who has been designated investigation staff for any particular Board-Initiated Investigation.” (AAR Comment 11-12.)
The Board declines to describe instances where it may not be practicable to separate these functions. Based on AAR's comment, however, we clarify that our intent is that
Jersey City and NSR ask the Board to revise the NPRM's approach to ex parte communications. First, Jersey City asks that the Board remove the NPRM's provision allowing any party subject to a Board-Initiated Investigation to submit to the Board written statements at any time during the Board-Initiated Investigation. (Jersey City Comment 16.) Second, NSR requests that the Board restrict ex parte communications between Investigating Officers and Board staff conducting Preliminary-Fact Finding and other Board staff, as well as Board Members involved in the Formal Board Proceeding. Finally, NSR states that, should such communications occur, Section 5 and Section 12 of the
The Board declines to adopt Jersey City's and NSR's proposals regarding ex parte communications. As explained above, the final rules require the Board to identify in the Order of Investigation (which would be voted on by the Board Members) all Board staff conducting a Board-Initiated Investigation. Therefore, Board Members and their staffs would know with whom to restrict their communications to avoid ex parte issues. Additionally, the final rules continue to provide parties under investigation with the ability to notify the Board in writing of any facts or circumstances relating to the investigation, including potentially prohibited ex parte communications.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, generally requires a description and analysis of new rules that would have a significant economic impact on a substantial number of small entities. In drafting a rule, an agency is required to: (1) Assess the effect that its regulation will have on small entities; (2) analyze effective alternatives that may minimize a regulation's impact; and (3) make the analysis available for public comment. 5 U.S.C. 601-604. Under section 605(b), an agency is not required to perform an initial or final regulatory flexibility analysis if it certifies that the proposed or final rules will not have a “significant impact on a substantial number of small entities.”
Because the goal of the RFA is to reduce the cost to small entities of complying with federal regulations, the RFA requires an agency to perform a regulatory flexibility analysis of small entity impacts only when a rule directly regulates those entities. In other words, the impact must be a direct impact on small entities “whose conduct is circumscribed or mandate” by the proposed rule.
In the NPRM, the Board certified under 5 U.S.C. 605(b) that the proposed rule would not have a significant economic impact on a substantial number of small entities within the meaning of the RFA. The Board explained that the proposed rule would not place any additional burden on small entities, but rather clarify an existing obligation. The Board further explained that, even assuming for the sake of argument that the proposed regulation were to create an impact on small entities, which it would not, the number of small entities so affected would not be substantial. No parties submitted comments on this issue. A copy of the NPRM was served on the U.S. Small Business Administration (SBA).
The final rule adopted here revises the rules proposed in the NPRM. However, the same basis for the Board's certification of the proposed rule applies to the final rules adopted here. The final rules would not create a significant impact on a substantial number of small entities, as the regulations would only specify procedures related to investigations of matters of regional or national significance conducted on the Board's own initiative and do not mandate or circumscribe the conduct of small entities. Therefore, the Board certifies under 5 U.S.C. 605(b) that the final rules will not have a significant economic impact on a substantial number of small entities within the meaning of the RFA. A copy of this decision will be served upon the Chief Counsel for Advocacy, Office of Advocacy, U.S. Small Business Administration, Washington, DC 20416.
1. The final rules set forth below are adopted and will be effective on January 13, 2017.
2. A copy of this decision will be served upon the Chief Counsel for Advocacy, Office of Advocacy, U.S. Small Business Administration.
3. This decision is effective on January 13, 2017.
By the Board, Chairman Elliott, Vice Chairman Miller, and Commissioner Begeman.
49 U.S.C. 1321, 11144, 11701.
This part applies only to matters subject to Section 12 of the Surface Transportation Board Reauthorization Act of 2015, 49 U.S.C. 11701.
The Board staff may, in its discretion, conduct nonpublic Preliminary Fact-Finding, subject to the provisions of § 1122.6, to determine if a matter presents an alleged violation that could be of national or regional significance and subject to the Board's jurisdiction under 49 U.S.C. Subtitle IV, Part A, and warrants a Board-Initiated Investigation. Board staff shall inform the subject of Preliminary Fact-Finding that Preliminary Fact-Finding has commenced. Where it appears from Preliminary Fact-Finding that a Board-Initiated Investigation is warranted, staff shall so recommend to the Board. Where it appears from the Preliminary Fact-Finding that a Board-Initiated Investigation is not warranted, staff shall conclude its Preliminary Fact-Finding and notify any parties involved that the process has been terminated.
The Board may, in its discretion, commence a nonpublic Board-Initiated Investigation of any matter of national or regional significance that is subject to the jurisdiction of the Board under 49 U.S.C. Subtitle IV, Part A, subject to the provisions of § 1122.6, by issuing an Order of Investigation. Orders of Investigation shall state the basis for the Board-Initiated Investigation and identify all Board staff who are authorized to conduct the investigation as Investigating Officer(s). The Board may add or remove Investigating Officer(s) during the course of a Board-Initiated Investigation. To the extent practicable, an Investigating Officer shall not participate in any decisionmaking functions in any Formal Board Proceeding(s) opened as a result of any Board-Initiated Investigation(s) that he or she conducted.
(a) After notifying the party subject to Preliminary Fact-Finding that Preliminary Fact-Finding has commenced, the Board staff shall, within a reasonable period of time, either:
(1) Conclude Preliminary Fact-Finding and notify any parties involved that the process has been terminated; or
(2) Recommend to the Board that a Board-Initiated Investigation is warranted.
(b) Not later than 30 days after commencing a Board-Initiated Investigation, the Investigating Officer(s) shall provide the parties under investigation a copy of the Order of Investigation. If the Board adds or removes Investigating Officer(s) during the course of the Board-Initiated Investigation, it shall provide written notification to the parties under investigation.
(c) Not later than 275 days after issuance of the Order of Investigation, the Investigating Officer(s) shall submit to the Board and the parties under investigation:
(1) Any recommendations made as a result of the Board-Initiated Investigation; and
(2) A summary of the findings that support such recommendations.
(d) Not later than 90 days after receiving the recommendations and summary of findings, the Board shall decide whether to dismiss the Board-Initiated Investigation if no further action is warranted or initiate a Formal Board Proceeding to determine whether any provision of 49 U.S.C. Subtitle IV, Part A, has been violated in accordance with section 12 of the Surface Transportation Board Reauthorization Act of 2015. The Board shall dismiss any Board-Initiated Investigation that is not concluded with administrative finality within one year after the date on which it was commenced.
(e) A Formal Board Proceeding commences upon issuance of a public Order to Show Cause. The Order to Show Cause shall state the basis for, and the issues to be considered during, the Formal Board Proceeding and set forth a procedural schedule.
(a) All information and documents obtained under § 1122.3 or § 1122.4, whether or not obtained pursuant to a Board request or subpoena, and all activities conducted by the Board under this part prior to the opening of a Formal Board Proceeding, shall be treated as nonpublic by the Board and its staff except to the extent that:
(1) The Board, in accordance with 49 CFR 1001.4(c), (d), and (e), directs or authorizes the public disclosure of activities conducted under this part prior to the opening of a Formal Board Proceeding. If any of the activities being publicly disclosed implicate records claimed to be confidential commercial information, the Board shall notify the submitter prior to disclosure in accordance with 49 CFR 1001.4(b) and provide an opportunity to object to disclosure in accordance with 49 CFR 1001.4(d);
(2) The information or documents are made a matter of public record during the course of an administrative proceeding; or
(3) Disclosure is required by the Freedom of Information Act, 5 U.S.C. 552 or other relevant provision of law.
(b) Procedures by which persons submitting information to the Board pursuant to this part of title 49, chapter X, subchapter B, of the Code of Federal Regulations may specifically seek confidential treatment of information for purposes of the Freedom of Information Act disclosure are set forth in § 1122.7. A request for confidential treatment of information for purposes of Freedom of Information Act disclosure shall not, however, prevent disclosure for law
Any person that produces documents to the Board pursuant to § 1122.3 or § 1122.4 may claim that some or all of the information contained in a particular document or documents is exempt from the mandatory public disclosure requirements of the Freedom of Information Act (FOIA), 5 U.S.C. 552, is information referred to in 18 U.S.C. 1905, or is otherwise exempt by law from public disclosure. In such case, the person making such a claim shall, at the time the person produces the document to the Board, indicate on the document that a request for confidential treatment is being made for some or all of the information in the document. In such case, the person making such a claim also shall file a brief statement specifying the specific statutory justification for non-disclosure of the information in the document for which confidential treatment is claimed. If the person states that the information comes within the exception in 5 U.S.C. 552(b)(4) for trade secrets and commercial or financial information, and the information is responsive to a subsequent FOIA request to the Board, 49 CFR 1001.4 shall apply.
No party who is not the subject of a Board-Initiated Investigation may intervene or participate as a matter of right in any such Board-Initiated Investigation under this part.
The Investigating Officer(s), in connection with any Board-Initiated Investigation, may interview or depose witnesses, inspect property and facilities, and request and require the production of any information, documents, books, papers, correspondence, memoranda, agreements, or other records, in any form or media, that are likely to be directly relevant to the issues of the Board-Initiated Investigation. The Investigating Officer(s), in connection with a Board-Initiated Investigation, also may issue subpoenas, in accordance with 49 U.S.C. 1321, to compel the attendance of witnesses, the production of any of the records and other documentary evidence listed above, and access to property and facilities.
Transcripts, if any, of investigative testimony shall be recorded solely by the official reporter or other person or by means authorized by the Board or by the Investigating Officer(s). A witness who has given testimony pursuant to this part shall be entitled, upon written request, to procure a transcript of the witness' own testimony or, upon proper identification, shall have the right to inspect the official transcript of the witness' own testimony.
(a) Any person who is compelled or requested to furnish documentary evidence or testimony in a Board-Initiated Investigation shall, upon request, be shown the Order of Investigation. Copies of Orders of Investigation shall not be furnished, for their retention, to such persons requesting the same except with the express approval of the Chairman.
(b) Any person compelled to appear, or who appears in person at a Board-Initiated Investigation by request or permission of the Investigating Officer may be accompanied, represented, and advised by counsel, as provided by the Board's regulations.
(c) The right to be accompanied, represented, and advised by counsel shall mean the right of a person testifying to have an attorney present with him during any aspect of a Board-Initiated Investigation and to have this attorney advise his client before, during and after the conclusion of such examination.
(a) When producing documents under § 1122.4, the producing party shall submit a statement certifying that such person has made a reasonable search for the responsive documents and is producing all the documents called for by the Investigating Officer(s), subject to any search protocols agreed to by the Investigating Officer(s) and producing parties. If any responsive document(s) are not produced for any reason, the producing party shall state the reason therefor.
(b) If any responsive documents are withheld because of a claim of the attorney-client privilege, work product privilege, or other applicable privilege, the producing party shall submit a list of such documents which shall, for each document, identify the attorney involved, the client involved, the date of the document, the person(s) shown on the document to have prepared and/or sent the document, and the person(s) shown on the document to have received copies of the document.
Any party subject to a Board-Initiated Investigation may, at any time during the course of a Board-Initiated Investigation, submit to the Board written statements of facts or circumstances, with any relevant supporting evidence, concerning the subject of that investigation.
(a) After conducting sufficient investigation and prior to submitting recommendations and a summary of findings to the Board, the Investigating Officer, in his or her discretion, may inform the parties under investigation (orally or in writing) of the proposed recommendations and summary of findings that may be submitted to the Board. If the Investigating Officer so chooses, he or she shall also advise the parties under investigation that they may submit a written statement, as explained below, to the Investigating Officer prior to the consideration by the Board of the recommendations and summary of findings. This optional process is in addition to, and does not limit in any way, the rights of parties under investigation otherwise provided for in this part.
(b) Unless otherwise provided for by the Investigating Officer, parties under investigation may submit a written statement, as described above, within 14 days after of being informed by the Investigating Officer of the proposed recommendation(s) and summary of findings. Such statements shall be no more than 20 pages, not including any supporting data, evidence, and verified statements that may be attached to the written statement, double spaced on 8
(c) Such written statements, if the parties under investigation choose to submit, shall be submitted to the Investigating Officer. The Investigating Officer shall provide any written statement(s) from the parties under investigation to the Board at the same time that he or she submits his or her recommendations and summary of findings to the Board.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
This final rule establishes a commercial retention limit of eight blacknose sharks for all Atlantic shark limited access permit holders in the Atlantic region south of 34°00′ N. latitude. NMFS manages four small coastal shark (SCS) species in the Atlantic: Blacknose, Atlantic sharpnose, finetooth, and bonnethead. All of these species except blacknose sharks are managed in a management group called the “non-blacknose SCS.” This action is being taken to reduce discards of non-blacknose small coastal sharks (SCS) while increasing the utilization of available Atlantic non-blacknose SCS quota and aid in rebuilding and ending overfishing of Atlantic blacknose sharks. The final action affects fishermen who fish in the Atlantic region and who hold commercial shark limited access permits. In addition, this final rule implements two small, unrelated administrative changes to existing regulatory text to remove cross-references to an unrelated section and a section that does not exist. These two changes are administrative in nature, and are not expected to result in any impacts to the environment or current fishing operations.
Effective on January 13, 2017.
Copies of the supporting documents—the Final Environmental Assessment (EA) for this final action, the 2006 Consolidated Highly Migratory Species (HMS) Fishery Management Plan (FMP) and its amendments, and the annual HMS Stock Assessment and Fishery Evaluation (SAFE) Reports—are available from the HMS Management Division Web site at
Guý DuBeck, Larry Redd, Cliff Hutt, or Karyl Brewster-Geisz by telephone at 301-427-8503.
Atlantic sharks are directly managed under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), and the authority to issue regulations has been delegated from the Secretary of Commerce to the Assistant Administrator (AA) for Fisheries, NOAA. NMFS published in the
NMFS published a proposed rule on August 3, 2016 (81 FR 51165), outlining the alternatives analyzed in the Draft EA, identifying the preferred alternative, and soliciting public comments on the measures, which would impact the blacknose shark and non-blacknose SCS fisheries in the Atlantic region. Specifically, the proposed rule proposed establishing a commercial retention limit of eight blacknose sharks in the Atlantic region south of 34°00′ N. latitude but also considered alternatives that would establish a commercial retention limit of non-blacknose SCS for shark directed access permit holders in the Atlantic region south of 34°00′ N. latitude once the blacknose shark quota is reached, as well as two other alternatives regarding potential commercial retention limits for blacknose sharks. The full description of the management and conservation measures considered is included in both the Final EA and the proposed rule and is not repeated here. The comment period for the Draft EA and proposed rule ended on September 20, 2016. The comments received, and responses to those comments, are summarized below under the heading labeled Response to Comments.
This final rule establishes a commercial retention limit of eight blacknose sharks for all Atlantic shark limited access permit holders in the Atlantic region south of 34°00′ N. latitude. This rulemaking only focuses on the Atlantic region south of 34°00′ N. latitude since NMFS prohibited the retention and landings of blacknose sharks in the Gulf of Mexico and north of 34°00′ N. latitude in 2015. This final action should reduce discards of non-blacknose SCS while increasing the utilization of available Atlantic non-blacknose SCS quota and aid in rebuilding and ending overfishing of Atlantic blacknose sharks.
Finally, this rule makes administrative changes to existing regulatory text. Specifically, in two locations in § 635.24(a), the regulations make reference to paragraphs (a)(4)(iv) through (vi); those cross-references are unnecessary because the Commercial Caribbean Small Boat permit under (a)(4)(iv) is a separate permit from the shark limited access permits and there is no (a)(4)(v) and (a)(4)(vi) regulations. This final rule implements changes to the regulations in 50 CFR part 635 to correct those regulatory cross-references.
During the proposed rule stage, NMFS received 15 written and oral comments. NMFS also received feedback from: The HMS Advisory Panel on September 8, 2016; constituents who attended the conference call/webinar held on August 16, 2016; and constituents who attended the public hearing on August 24, 2016, in Cocoa Beach, FL. Additionally, NMFS consulted with the South Atlantic Fishery Management Council on September 15, 2016. A summary of the comments received on the proposed rule during the public comment period is provided below with NMFS' responses. All written comments submitted during the comment period can be found at
The NMFS Assistant Administrator has determined that the final rule is necessary for the conservation and management of the Atlantic shark fisheries and that it is consistent with the Magnuson-Stevens Act and other applicable laws.
This final action has been determined to be not significant for purposes of Executive Order 12866.
A Final Regulatory Flexibility Analysis (FRFA) was prepared for this rule pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 604 (c)(1)-(4)). The FRFA incorporates the Initial Regulatory Flexibility Analysis (IRFA), a summary of the significant issues raised by the public comments in response to the IRFA, NMFS responses to those comments, and a summary of the analyses completed to support the action. The full FRFA and analysis of economic and ecological impacts are available from NMFS (see
Under Section 604(a)(1) of the RFA, the management goals and objectives of the preferred alternative are to provide for the sustainable management of SCS species under authority of the Secretary consistent with the requirements of the Magnuson-Stevens Act and other statutes which may apply to such management, including the Endangered Species Act, Marine Mammal Protection Act, and Atlantic Tunas Convention Act. The Magnuson-Stevens Act mandates that the Secretary provide for the conservation and management of HMS through development of an FMP for species identified for management and to implement the FMP with necessary regulations. In addition, the Magnuson-Stevens Act directs the Secretary, in managing HMS, to prevent overfishing of species while providing for their optimum yield on a continuing basis and to rebuild fish stocks that are considered overfished. The management objective of the preferred alternative is to implement management measures for the Atlantic SCS fishery that will further the objective of preventing overfishing while achieving (on a continuing basis) optimum yield, and aid in rebuilding overfished shark stocks.
Section 604(a)(2) of the RFA requires a summary of the significant issues raised by the public comments in response to the IRFA, a summary of the Agency's assessment of such issues, and a statement of any changes made in the rule as a result of such comments. NMFS received several comments on the proposed rule and Draft EA during the public comment period. Summarized public comments and NMFS' responses to them are included in Appendix A of this document. Section 604(a)(3) of the RFA requires the Agency to respond to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration (SBA) in response to the proposed rule, and a detailed statement of any change made in the rule as a result of such comments. NMFS did not receive any comments from the Chief Counsel for Advocacy of the SBA nor the public in response to this document.
Section 604(a)(3) of the RFA requires agencies to provide an estimate of the number of small entities to which the rule would apply. The Small Business Administration (SBA) has established size criteria for all major industry sectors in the United States, including fish harvesters. Provision is made under SBA's regulations for an agency to develop its own industry-specific size standards after consultation with Advocacy and an opportunity for public comment (see 13 CFR 121.903(c)). Under this provision, NMFS may establish size standards that differ from those established by the SBA Office of Size Standards, but only for use by NMFS and only for the purpose of conducting an analysis of economic effects in fulfillment of the agency's obligations under the RFA. To utilize this provision, NMFS must publish such size standards in the
This final rule would apply to the 499 commercial shark permit holders in the Atlantic shark fishery, based on an analysis of permit holders as of November 2015. Of these permit holders, 224 have directed shark permits and 275 hold incidental shark permits. Not all permit holders are active in the fishery in any given year. Active directed permit holders are defined as those with valid permits that landed one shark based on 2015 HMS electronic dealer reports. Of the 499 permit holders, only 27 permit holders landed SCS in the Atlantic region and of those only 13 landed blacknose sharks. NMFS has determined that the final rule would not likely affect any small governmental jurisdictions.
Section 604(a)(4) of the RFA requires Agencies to describe any new reporting, record-keeping and other compliance requirements. The action does not contain any new collection of information, reporting, or record-keeping requirements. The alternatives considered would adjust the commercial retention limits for the SCS fisheries, which would mean new compliance requirements for the shark fishery participants in the Atlantic region south of 34°00′ N. latitude, but which are similar to other compliance requirements the fishermen already follow.
Section 604(a)(5) of the RFA requires a description of the steps the Agency has taken to minimize any significant economic impact on small entities consistent with the stated objectives of applicable statutes. Additionally, the RFA lists four general categories of “significant” alternatives that would assist an agency in the development of significant alternatives. These categories of alternatives are: (1) Establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) Clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities; (3) Use of performance rather than design standards; and (4) Exemptions from coverage of the rule, or any part thereof, for small entities.
In order to meet the objectives of this final rule, consistent with the Magnuson-Stevens Act and the Endangered Species Act, NMFS cannot establish differing compliance requirements for small entities or exempt small entities from compliance requirements. Thus, there are no alternatives discussed that fall under the first and fourth categories described above. NMFS does not know of any performance or design standards that would satisfy the aforementioned objectives of this rulemaking while, concurrently, complying with the Magnuson-Stevens Act. As described below, NMFS analyzed several different alternatives in this final rulemaking and provides rationales for identifying the preferred alternatives to achieve the desired objectives.
The alternatives considered and analyzed are described below. The FRFA assumes that each vessel will have similar catch and gross revenues to show the relative impact of the final action on vessels.
Alternative 1, the No Action alternative, would not implement any new retention limits for blacknose sharks or non-blacknose SCS in the Atlantic region south of 34°00′ N. latitude beyond those already in effect for current Atlantic shark limited access permit holders. NMFS would continue to allow fishermen with a direct limited access permit to land unlimited sharks per trip and allow fishermen with an incidental permit to land 16 combined SCS and pelagic sharks per vessel per trip. In 2010, Amendment 3 to the 2006
Alternative 2a would remove the quota linkage to blacknose sharks for shark directed limited access permit holders in the Atlantic region south of 34°00′ N. latitude once the blacknose shark quota is reached and would implement a commercial retention limit of 50 non-blacknose SCS per trip at that point. Additionally, this alternative would adjust the blacknose shark quota to 15.0 mt dw (33,069 lb dw) assuming a 5 lb dw carcass, or 11.8 mt dw (26,089 lb dw) assuming a 12 lb dw carcass. Reduction of the blacknose shark quota would result in an average ex-vessel revenue loss of $5,275 for the fishery assuming a 5 lb dw carcass, or $12,660 assuming a 12 lb dw carcass. Conversely, increased landings of non-blacknose SCS would result in an overall estimated average ex-vessel revenue gain of $34,470 for the fishery. NMFS estimates that this bycatch retention limit would result in a net gain of $21,810 to $29,195 in average ex-vessel revenue for the fishery per year depending on the average carcass weight of blacknose sharks, or $808 to $1,081 per vessel for the 27 vessels that targeted non-blacknose SCS in 2015.
Alternative 2b would remove the quota linkage to blacknose sharks for shark directed limited access permit holders in the Atlantic region south of 34°00′ N. latitude once the blacknose shark quota is reached and would implement a commercial retention limit of 150 non-blacknose SCS per trip at that point. Additionally, this alternative would adjust the blacknose shark quota to 10.5 mt dw (23,148 lb dw) assuming a 5 lb dw carcass, or 1.1 mt dw (2,521 lb dw) assuming a 12 lb dw carcass. Reduction of the blacknose shark quota would result in an average ex-vessel revenue loss of $15,783 for the fishery assuming a 5 lb dw carcass, or $37,878 assuming a 12 lb dw carcass. Conversely, increased landings of non-blacknose SCS would result in an overall estimated average ex-vessel revenue gain of $65,139 for the fishery. NMFS estimates that this bycatch retention limit would result in a net gain of $27,261 to $49,357 in average ex-vessel revenue for the fishery per year depending on the average carcass weight of blacknose sharks, or approximately $1,010 to $1,828 per vessel for the 27 vessels that targeted non-blacknose SCS in 2015.
Alternative 2c would remove the quota linkage to blacknose sharks for shark directed limited access permit holders in the Atlantic region south of 34°00′ N. latitude once the blacknose shark quota is reached and would implement a commercial retention limit of 250 non-blacknose SCS per trip at that point. This alternative would also adjust the blacknose shark quota to 6.1 mt dw (13,448 lb dw) assuming a 5 lb dw carcass, or 0.0 mt dw (0.0 lb dw) assuming a 12 lb dw carcass. Reduction of the blacknose shark quota would result in an average ex-vessel revenue loss of $26,295 for the fishery assuming a 5 lb dw carcass, or $40,575 assuming a 12 lb dw carcass. Conversely, increased landings of non-blacknose SCS would result in an estimated average ex-vessel revenue gain of $80,339 for the fishery. NMFS estimates that this bycatch retention limit would result in a net gain of $39,764 to $54,044 in average ex-vessel revenue for the fishery per year depending on the average carcass weight of blacknose sharks, or approximately $1,473 to $2,002 per vessel for the 27 vessels that targeted non-blacknose SCS in 2015.
Alternative 3a would establish a commercial retention limit of 50 blacknose sharks per trip for shark directed limited access permit holders in the Atlantic region south of 34°00′ N. latitude and maintain the quota linkage between blacknose sharks and non-blacknose SCS. This alternative would have minor beneficial to neutral economic impacts as a retention limit of this size would allow an average of 250 to 600 lb dw blacknose sharks per trip and would take an estimated 63 to 152 trips for fishermen to land the full blacknose shark quota. This alternative will prevent targeted take of blacknose sharks as the per trip value of 50 blacknose sharks would range between $270 ($218 for meat and $52 for fins) assuming an average weight of 5 lb dw per blacknose shark, and $642 ($522 for meat and $120 for fins) assuming an average weight of 12 lb dw for the estimated 13 vessels that land blacknose sharks in the Atlantic. Based on 2015 eDealer reports, 106 trips landed blacknose sharks, and between 14 and 33 percent landed blacknose sharks in excess of a commercial retention limit of 50 blacknose sharks depending on the average trip weight used in the calculations (250-600 lb dw). This alternative would likely increase the number of trips needed to fill the blacknose shark quota when compared to the average from 2010 through 2015 under Alternative 1. A retention limit of 50 blacknose sharks could potentially cause the SCS fisheries to close as early as June or July if every trip landing blacknose sharks landed the full retention limit but, since few fishermen land that many blacknose sharks per trip now, NMFS believes a change in behavior as a result of this alternative is unlikely.
Alternative 3b would establish a commercial retention limit of 16 blacknose sharks per trip for all Atlantic shark limited access permit holders in the Atlantic region south of 34°00′ N. latitude and maintain the quota linkage between blacknose sharks and non-blacknose SCS. This alternative would have minor beneficial economic impacts as a retention limit of this size would allow an average of 80 to 192 lb dw blacknose sharks per trip and would take an estimated 198 to 474 trips for fishermen to land the full blacknose shark quota. Based on 2015 eDealer reports, 38 to 55 percent of the overall number of trips landed blacknose sharks in excess of a commercial retention limit of 16 blacknose sharks depending on the average trip weight used in the calculations (80-192 lb dw). This alternative would dramatically increase the number of trips needed to fill the blacknose shark quota when compared to the yearly averages under Alternative 1. Currently, the linkage between the blacknose shark quota and the non-blacknose SCS quota causes the closure of both fisheries once the lower blacknose shark quota is attained. NMFS expects that, under this alternative, the blacknose shark quota would not be filled and the SCS fisheries in the South Atlantic region
Alternative 3c, the preferred alternative, would establish a commercial retention limit of eight blacknose sharks per trip for all Atlantic shark limited access permit holders in the Atlantic region south of 34°00′ N. latitude and maintain the quota linkage between blacknose sharks and non-blacknose SCS. Because this retention limit would be less than the current retention limit for shark incidental limited access permit holders, the retention limit for shark incidental limited access permit holders would need to change slightly. The adjusted retention limit for incidental permit holders would still allow fishermen to land a total of 16 pelagic or small coastal sharks per trip but, of those sharks, no more than eight could be blacknose sharks. This alternative would have moderate beneficial economic impacts as a retention limit of this size would allow an average of 40 to 96 lb dw blacknose sharks per trip and would take an estimated 395 to 948 trips to land the full blacknose shark quota. Based on 2015 eDealer reports, 55 to 70 percent of the overall number of trips landed blacknose sharks in excess of the commercial retention limit of eight blacknose sharks depending on the average trip weight used in the calculations (40-96 lb dw). This alternative would dramatically increase the number of trips needed to fill the blacknose shark quota when compared to the yearly averages under Alternative 1. Currently, the linkage between the blacknose shark quota and the non-blacknose SCS quota causes the closure of both fisheries once the lower blacknose shark quota is attained. NMFS expects that, under this alternative, the blacknose shark quota would not be filled and the SCS fisheries in the South Atlantic region would not close early. Thus, this would have moderate beneficial economic impacts as the fishermen would still be allowed to land blacknose sharks and the fishery would remain open for a longer period of time, significantly increasing non-blacknose SCS revenues by as much as $298,583 a year on average if the non-blacknose SCS quota is fully utilized. However, given current monthly trip rates in the Atlantic the non-blacknose SCS quota is likely to remain underutilized. Using calculations based on observed trip and landings rates of non-blacknose SCS in 2015, a more likely result of this alternative would be additional landings of 104,962 lb dw of non-blacknose SCS valued at $98,664, or approximately $3,654 per vessel for the 27 vessels that participated in the fishery in 2015. Any financial losses due to underutilization of the blacknose shark quota would be minimal in comparison.
Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rulemaking process, a listserv notice to permit holders that also serves as small entity compliance guide (the guide) was prepared. Copies of this final rule are available from the HMS Management Division (see
Fisheries, Fishing, Fishing vessels, Foreign relations, Imports, Penalties, Reporting and recordkeeping requirements, Treaties.
For the reasons set out in the preamble, 50 CFR part 635 is amended as follows:
16 U.S.C. 971
(a) * * *
(2) The commercial retention limit for LCS other than sandbar sharks for a person who owns or operates a vessel that has been issued a directed LAP for sharks and does not have a valid shark research permit, or a person who owns or operates a vessel that has been issued a directed LAP for sharks and that has been issued a shark research permit but does not have a NMFS-approved observer on board, may range between zero and 55 LCS other than sandbar sharks per vessel per trip if the respective LCS management group(s) is open per §§ 635.27 and 635.28. Such persons may not retain, possess, or land sandbar sharks. At the start of each fishing year, the default commercial retention limit is 45 LCS other than sandbar sharks per vessel per trip unless NMFS determines otherwise and files with the Office of the Federal Register for publication notification of an inseason adjustment. During the fishing year, NMFS may adjust the retention limit per the inseason trip limit adjustment criteria listed in paragraph (a)(8) of this section.
(3) A person who owns or operates a vessel that has been issued an incidental LAP for sharks and does not have a valid shark research permit, or a person who owns or operates a vessel that has been issued an incidental LAP for sharks and that has been issued a valid shark research permit but does not have a NMFS-approved observer on board, may retain, possess, or land no more than 3 LCS other than sandbar sharks per vessel per trip if the respective LCS management group(s) is open per §§ 635.27 and 635.28. Such persons may not retain, possess, or land sandbar sharks.
(4) * * *
(ii) A person who owns or operates a vessel that has been issued a shark LAP and is operating south of 34°00′ N. lat. in the Atlantic region, as defined at § 635.27(b)(1), may retain, possess, land, or sell blacknose and non-blacknose SCS if the respective blacknose and non-blacknose SCS management groups are open per §§ 635.27 and 635.28. Such
(iii) Consistent with paragraph (a)(4)(ii) of this section, a person who owns or operates a vessel that has been issued an incidental shark LAP may retain, possess, land, or sell no more than 16 SCS and pelagic sharks, combined, per vessel per trip, if the respective fishery is open per §§ 635.27 and 635.28. Of those 16 SCS and pelagic sharks per vessel per trip, no more than 8 shall be blacknose sharks.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
This final rule implements regulations in Amendment 16 to the Atlantic Mackerel, Squid, and Butterfish Fishery Management Plan. Amendment 16 protects deep-sea corals from the effects of commercial fishing gear in the Mid-Atlantic. The management measures implemented in this rule are intended to protect deep-sea coral and deep-sea coral habitat while promoting the sustainable utilization and conservation of several different marine resources managed under the authority of the Mid-Atlantic Fishery Management Council.
Effective January 13, 2017.
Copies of supporting documents used by the Mid-Atlantic Fishery Management Council, including the Environmental Assessment (EA) and Regulatory Impact Review (RIR)/Initial Regulatory Flexibility Analysis (IRFA), are available from: Dr. Christopher M. Moore, Executive Director, Mid-Atlantic Fishery Management Council, 800 North State Street, Suite 201, Dover, DE 19901, telephone (302) 674-2331. The EA/RIR/IRFA is also accessible online at
Peter Christopher, Supervisory Fishery Policy Analyst, (978) 281-9288, fax (978) 281-9135.
On January 16, 2013, the Council published a Notice of Intent (NOI) to prepare an Environmental Impact Statement (78 FR 3401) for Amendment 16 to the Atlantic Mackerel, Squid, and Butterfish Fishery Management Plan (FMP) to consider measures to protect deep-sea corals from the impacts of commercial fishing gear in the Mid-Atlantic. The Council conducted scoping meetings during February 2013 to gather public comments on these issues. Following further development of Amendment 16 through 2013 and 2014, the Council conducted public hearings in January 2015. Following public hearings, and with disagreement about the boundaries of the various alternatives, the Council held a workshop with various stakeholders on April 29-30, 2015, to further refine the deep-sea coral area boundaries. The workshop was an example of effective collaboration among fishery managers, the fishing industry, environmental organizations, and the public to develop management recommendations with widespread support. The Council adopted Amendment 16 on June 10, 2015, and submitted Amendment 16 on August 15, 2016, for final review by NMFS, acting on behalf of the Secretary of Commerce. NMFS published a Notice of Availability (NOA) announcing its review of Amendment 16 on September 2, 2016 (81 FR 60666), and a proposed rule including implementing regulations on September 27, 2016 (81 FR 66245). The public comment period for both the NOA and proposed rule ended on November 1, 2016.
The Council developed the action, and the measures described in this notice, under the discretionary provisions for deep-sea coral protection in section 303(b) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). This provision gives the Regional Fishery Management Councils the authority to:
(A) Designate zones where, and periods when, fishing shall be limited, or shall not be permitted, or shall be permitted only by specified types of fishing vessels or with specified types and quantities of fishing gear;
(B) Designate such zones in areas where deep-sea corals are identified under section 408 (this section describes the deep-sea coral research and technology program), to protect deep-sea corals from physical damage from fishing gear or to prevent loss or damage to such fishing gear from interactions with deep-sea corals, after considering long-term sustainable uses of fishery resources in such areas; and
(C) With respect to any closure of an area under the Magnuson-Stevens Act that prohibits all fishing, ensure that such closure:
(i) Is based on the best scientific information available;
(ii) Includes criteria to assess the conservation benefit of the closed area;
(iii) Establishes a timetable for review of the closed area's performance that is consistent with the purposes of the closed area; and
(iv) Is based on an assessment of the benefits and impacts of the closure, including its size, in relation to other management measures (either alone or in combination with such measures), including the benefits and impacts of limiting access to: Users of the area, overall fishing activity, fishery science, and fishery and marine conservation.
Consistent with these provisions, the Council recommended the measures in Amendment 16 to balance the impacts of measures implemented under this discretionary authority with the management objectives of the Mackerel, Squid, and Butterfish FMP and the value of potentially affected commercial fisheries.
This final rule creates a deep-sea coral protection area in Mid-Atlantic waters. It consists of a broad zone that starts at a depth contour of approximately 450 meters (m) and extends to the U.S. Exclusive Economic Zone (EEZ) boundary, and to the north and south to the boundaries of the Mid-Atlantic waters (as defined in the Magnuson-Stevens Act). In addition, the deep-sea coral protection area includes 15 discrete zones that outline deep-sea canyons on the continental shelf in Mid-Atlantic waters. The deep-sea coral area, including both broad and discrete zones, is one continuous area.
The broad coral zone is precautionary in nature and is intended to freeze the footprint of fishing to protect corals from future expansion of fishing effort into deeper waters. The broad coral zone has a landward boundary drawn between the 400 m and 500 m contours with the intention to approximate the 450 m depth contour as closely as possible, minimizing the number of vertices in the boundary line. In areas where there is conflict or overlap between this broad zone and any designated discrete zone boundaries, the discrete zone boundaries are prioritized. From the landward boundary, the broad zone boundaries extends along the northern and southern boundaries of the Mid-Atlantic management region, and to the edge of the EEZ as the eastward boundary.
The discrete coral zones are specific submarine canyons and slope areas located in Mid-Atlantic waters. The boundaries were developed collaboratively by participants at the Council's April 29-30, 2015, Deep-sea Corals Workshop in Linthicum, MD. Participants included the Council's Squid, Mackerel, and Butterfish Advisory Panel, the Ecosystems and Ocean Planning Advisory Panel, members of the Deep-sea Corals Fishery Management Action Team, invited deep-sea coral experts, additional fishing industry representatives, and other interested stakeholders. The canyons and slope areas were identified as areas with observed coral presence or highly likely coral presence indicated by modeled suitable habitat. Therefore, prohibiting bottom-tending fishing gear in these areas prevents interaction with and damage to deep-sea corals that either are known through observation to live in these areas or that are likely to live there. The discrete coral zones are: Block Canyon; Ryan and McMaster Canyons; Emery and Uchupi Canyons; Jones and Babylon Canyons; Hudson Canyon; Mey-Lindenkohl Slope; Spencer Canyon; Wilmington Canyon; North Heyes and South Wilmington Canyons; South Vries Canyon; Baltimore Canyon; Warr and Phoenix Canyon Complex; Accomac and Leonard Canyons; Washington Canyon; and Norfolk Canyon.
This action prohibits the use of bottom-tending commercial fishing gear within the designated deep-sea coral area, including: Bottom-tending otter trawls; bottom-tending beam trawls; hydraulic dredges; non-hydraulic dredges; bottom-tending seines; bottom-tending longlines; sink or anchored gill nets; and pots and traps except those used to fish for red crab and American lobster. The prohibition on these gears will protect deep-sea corals from interaction with and damage from bottom-tending fishing gear.
Vessels can transit the deep-sea coral area protection area provided the vessels bring bottom-tending fishing gear onboard the vessel, and reel bottom-tending trawl gear onto the net reel. The Council proposed these slightly less restrictive transiting provisions because the majority of transiting will be through the very narrow canyon heads (
Vessels issued an
This action expands the framework adjustment provisions in the FMP to facilitate future modifications to the deep-sea coral protection measures. The framework measures include:
• Modifications to coral zone boundaries via framework action;
• Modifications to the boundaries of broad or discrete deep-sea coral zones through a framework action;
• Modification of management measures within deep-sea coral protection areas. This provides the Council the option to modify fishing restrictions, exemptions, monitoring requirements, and other management measures within deep-sea coral zones through a framework action. It includes measures directed at gear and species not currently addressed in the FMP to further the FMP's goal of protecting deep-sea corals from physical damage from fishing gear or to prevent loss or damage to such fishing gear from interactions with deep-sea corals. This would also include the ability to add a prohibition on anchoring in deep-sea coral protection areas;
• Addition of discrete coral zones; and
• Implementation of special access program for deep-sea coral protection area. This provides the Council the option to design and implement a special access program for commercial fishery operations in deep-sea coral zones through a framework action.
The Council recommended that the deep-sea coral protection area should be named in honor of the late Senator Frank R. Lautenberg. Senator Lautenberg was responsible for several important pieces of ocean conservation legislation and authored several provisions included in the most recent reauthorized Magnuson-Stevens Act (2007), including the discretionary provision for corals. Therefore, this final rule implements the deep-sea coral protection area as the “Frank R. Lautenberg Deep-Sea Coral Protection Area.”
We received 10 comments on the proposed rule and NOA (8 in general support of the action and 2 against the action), including letters from five individuals, the Garden State Seafood Association, the Maryland Department of Natural Resources, and the Wildlife Conservation Society's New York Aquarium. We also received a joint comment from Oceana, Wildlife Conservation Society's New York Aquarium, Conservation Law Foundation, Earthjustice, Great Egg Harbor Watershed Association, Natural Resource Defense Council, Pew Charitable Trusts, Tycoon Tackle Inc., and Wild Oceans. Supporting this joint comment was a comment the PEW Charitable Trust submitted to the Council prior to final action on Amendment 16. This comment was included to convey the strong and broad public support for the protection of deep-sea corals (including 12,201 signatures). The comment specific to the Amendment 16 proposed rule was supportive of the action. The following summarizes the issues raised in the comments and NMFS's responses.
There are no changes from the proposed rule.
Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this final rule is consistent with the FMP, other provisions of the Magnuson-Stevens Act, and other applicable law.
The Office of Management and Budget (OMB) has determined that this final rule is not significant according to Executive Order (E.O.) 12866.
This final rule does not contain policies with federalism or “takings” implications, as those terms are defined in E.O. 13132 and E.O. 12630, respectively.
This action does not contain any collection-of-information requirements subject the Paperwork Reduction Act (PRA).
NMFS, pursuant to section 604 of the Regulatory Flexibility Act (RFA), has completed a final regulatory flexibility analysis (FRFA) in support of Amendment 16 in this final rule. The FRFA incorporates the IRFA, a summary of the significant issues raised by the public comments in response to the IRFA, NMFS responses to those comments, a summary of the analyses completed in the Amendment 16 EA, and this portion of the preamble. A summary of the IRFA was published in the proposed rule for this action and is not repeated here. A description of why this action was considered, the objectives of, and the legal basis for this rule is contained in Amendment 16 and in the preamble to the proposed and this final rule, and is not repeated here. All of the documents that constitute the FRFA are available from NMFS and a copy of the IRFA, the Regulatory Impact Review (RIR), and the EA are available upon request (see
There were no specific comments on the IRFA. The Comments and Responses section summarizes the comments that highlight concerns about the economic impacts and implications of impacts on small businesses (
On December 29, 2015, NMFS issued a final rule establishing a small business size standard of $11 million in annual gross receipts for all businesses primarily engaged in the commercial fishing industry (NAICS 11411) for RFA compliance purposes only (80 FR 81194; December 29, 2015). The $11 million standard became effective on July 1, 2016, and is to be used in place of the U.S. Small Business Administration's (SBA) current standards of $20.5 million, $5.5 million, and $7.5 million for the finfish (NAICS 114111), shellfish (NAICS 114112), and other marine fishing (NAICS 114119) sectors of the U.S. commercial fishing industry in all NMFS rules subject to the RFA after July 1, 2016 (Id. at 81194).
The Council prepared the IRFA under the SBA standards and submitted the action for initial NMFS review in March 2016, prior to the July 1, 2016, effective date of NMFS' new size standard for commercial fishing businesses, under the assumption that the proposed rule would also publish prior to the July 1, 2016, effective date. However, NMFS has reviewed the analyses prepared for this regulatory action in light of the new size standard. The new size standard could result in some of the large businesses being considered small, but, as explained below, this does not affect the conclusions of the analysis. The following summarizes the IRFA using the SBA definitions of small businesses.
The deep-sea coral zones measures in association with other management measures within the coral zones could affect any business entity that has an active Federal fishing permit and fishes in the zone/gear restricted areas. In order to identify firms, vessel ownership data, which have been added to the permit database, were used to identify all the individuals who own fishing vessels. With this information, vessels were grouped together according to common owners. The resulting groupings were then treated as a fishing business (firm, affiliate, or entity), for purposes of identifying small and large firms. According to the ownership database, a total of 113 finfish firms (all small entities) fished in the Council's preferred broad and discrete zones during 2014. Also in 2014, there were 184 small and 16 large shellfish entities. The ownership database shows that small finfish firms that operated in the Council's preferred broad and discrete zones generated average revenues that ranged from $18,344 (in 2013) to $21,055 (in 2014). The ownership database shows that small shellfish firms that operated in the Council's preferred broad and discrete zones generated average revenues that ranged from $35,276 (in 2014) to $58,723 (in 2012). The ownership database shows that large shellfish firms that operated in the Council's preferred broad and discrete zones generated average revenues that ranged from $146,901 (in 2013) to $314,223 (in 2012).
This action contains no new collection-of-information requirements subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA). This action requires
During the development of Amendment 16, the Council considered several alternatives to the deep-sea coral protection measures it ultimately recommended. While some alternatives would have closed less area (smaller discrete zone areas and broad zone area starting at a deeper depth) and other alternatives would have allowed more fishing (an exemption for tilefish gear), NMFS has does not have the authority to implement measures that were not recommended by the Council as part of its preferred action. Rather, NMFS can only approve or disapprove Council recommendations in an amendment. NMFS, therefore, is implementing the Council's preferred action, but the action includes some measures that reduce the economic impact inherent in closing areas to fishing. Specifically, this final rule exempts red crab pot gear from the prohibition on fishing with bottom-tending fishing gear in the deep-sea coral protection area. The red crab fishery exists entirely within the boundaries of the deep-sea coral protection area in the Mid-Atlantic. The exemption allows the fishery to continue to operate in the Mid-Atlantic and gain revenue from its catch. In addition, vessels are allowed to transit the deep-sea coral protection area, which is particularly important at the heads of the discrete zone canyons (where the boundaries come to a point). Because vessels fish with bottom-tending gear along the edges of the canyons, they would have to transit around them to fish on both sides of the canyon. This would cost fuel and could ultimately impact trip duration and catch if vessel operators would have had to spend time transiting around the canyon heads rather than across them. Both the red crab pot gear exemption and the transiting provision therefore reduces cost and time and minimizes the economic impact of the measures implemented under this final rule.
Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a final regulatory flexibility analysis, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. The preamble to the proposed rule (81 FR 66245, September 27, 2016) and the preamble to this final rule serve as the small entity compliance guide. This final rule does not require any additional compliance from small entities that is not described in the preamble to the proposed rule and this final rule. Copies of the proposed rule and this final rule are available from NMFS at the following Web site:
Fisheries, Fishing, Recordkeeping and reporting requirements.
For the reasons set out in the preamble, 50 CFR part 648 is amended as follows:
16 U.S.C. 1801
(b) * * *
(11) Vessels issued an
(b) * * *
(10) Fish with bottom-tending gear within the Frank R. Lautenberg Deep-sea Coral Protection Area described at § 648.27, unless transiting pursuant to § 648.27(d), fishing lobster trap gear in accordance with § 697.21 of this chapter, or fishing red crab trap gear in accordance with § 648.264. Bottom-tending gear includes but is not limited to bottom-tending otter trawls, bottom-tending beam trawls, hydraulic dredges, non-hydraulic dredges, bottom-tending seines, bottom longlines, pots and traps, and sink or anchored gill nets.
(g) * * *
(2) * * *
The revisions and addition read as follows:
(a) * * *
(i) Adjustments within existing ABC control rule levels;
(ii) Adjustments to the existing MAFMC risk policy;
(iii) Introduction of new AMs, including sub-ACTs;
(iv) Minimum and maximum fish size;
(v) Gear restrictions, gear requirements or prohibitions;
(vi) Permitting restrictions;
(vii) Recreational possession limit, recreational seasons, and recreational harvest limit;
(viii) Closed areas;
(ix) Commercial seasons, commercial trip limits, commercial quota system, including commercial quota allocation procedure and possible quota set-asides to mitigate bycatch;
(x) Annual specification quota setting process;
(xi) FMP Monitoring Committee composition and process;
(xii) Description and identification of EFH (and fishing gear management measures that impact EFH);
(xiii) Description and identification of habitat areas of particular concern;
(xiv) Overfishing definition and related thresholds and targets;
(xv) Regional gear restrictions, regional season restrictions (including option to split seasons), regional management;
(xvi) Restrictions on vessel size (LOA and GRT) or shaft horsepower;
(xvii) Changes to the SBRM, including the CV-based performance standard, the means by which discard data are collected/obtained, fishery stratification, the process for prioritizing observer sea-day allocations, reports, and/or industry-funded observers or observer set aside programs;
(xviii) Set aside quota for scientific research;
(xix) Process for inseason adjustment to the annual specification;
(xx) Mortality caps for river herring and shad species, time/area management for river herring and shad species, and provisions for river herring and shad incidental catch avoidance program, including adjustments to the mechanism and process for tracking fleet activity, reporting incidental catch events, compiling data, and notifying the fleet of changes to the area(s);
(xxi) The definition/duration of `test tows,' if test tows would be utilized to determine the extent of river herring incidental catch in a particular area(s);
(xxii) The threshold for river herring incidental catch that would trigger the need for vessels to be alerted and move out of the area(s), the distance that vessels would be required to move from the area(s), and the time that vessels would be required to remain out of the area(s);
(xxiii) Modifications to the broad and discrete deep-sea coral zone boundaries and the addition of discrete deep-sea coral zones;
(xxiv) Modifications to the management measures within the Frank R. Lautenberg Deep-sea Coral Protection Area and implementation of special access programs to the Frank R. Lautenberg Deep-sea Coral Protection Area; and
(xxv) Any other management measures currently included in the FMP.
(2) Measures contained within this list that require significant departures from previously contemplated measures or that are otherwise introducing new concepts may require amendment of the FMP instead of a framework adjustment.
(a) No vessel may fish with bottom-tending gear within the Frank R. Lautenberg Deep-Sea Coral Protection Area described in this section, unless transiting pursuant to paragraph (d) of this section, fishing lobster trap gear in accordance with § 697.21 of this chapter, or fishing red crab trap gear in accordance with § 648.264. Bottom-tending gear includes but is not limited to bottom-tending otter trawls, bottom-tending beam trawls, hydraulic dredges, non-hydraulic dredges, bottom-tending seines, bottom longlines, pots and traps, and sink or anchored gillnets. The Frank R. Lautenberg Deep-Sea Coral Protection Area consists of the Broad and Discrete Deep-Sea Coral Zones defined in paragraphs (b) and (c) of this section.
Agricultural Marketing Service, USDA.
The U. S. Department of Agriculture (USDA), Agricultural Marketing Service (AMS), is proposing to amend the regulations under the Perishable Agricultural Commodities Act (PACA or Act) to enhance clarity and improve the administration and enforcement of the PACA. The proposed revisions to the regulations would provide greater direction to the industry of how growers and other principals that employ selling agents may preserve their PACA trust rights. The proposed revisions would further provide greater direction to the industry on the definition of “written notification” and the jurisdiction of USDA to investigate alleged PACA violations.
Written or electronic comments received by February 13, 2017 will be considered prior to issuance of a final rule.
You may submit written or electronic comments to “PACA Regulatory Enhancements,” AMS, Specialty Crops Program, PACA Division, 1400 Independence Avenue SW., Room 1510-S, Stop 0242, Washington, DC 20250-0242; Internet:
Josephine E. Jenkins, Chief, Investigative Enforcement Branch, 202-720-6873; or
The Perishable Agricultural Commodities Act (PACA) was enacted in 1930 to promote fair-trading in the marketing of fresh and frozen fruits and vegetables in interstate and foreign commerce. It protects growers, shippers, distributors, and retailers dealing in those commodities by prohibiting unfair and fraudulent trade practices. The PACA also provides a forum to adjudicate or mediate commercial disputes. Licensees who violate the PACA may have their license suspended or revoked, and individuals determined to be responsibly connected to such licensees are restricted from being employed or operating in the produce industry for a period.
Growing, harvesting, packing, and shipping perishables involve risk: Costs are high; capital is tied up in farmland and machinery; and returns are delayed until the crop is sold. Because of the highly perishable nature of the commodities and distance from selling markets, produce trading is fast moving and often informal. Transactions are often consummated in a matter of minutes, frequently while the commodities are in route to their destination. Under such conditions, it is often difficult to check the credit rating of the buyer.
Congress examined the sufficiency of the PACA fifty years after its inception and determined that prevalent financing practices in the perishable agricultural commodities industry were placing the industry in jeopardy. Particularly, Congress focused on the increase in the number of buyers who failed to pay, or were slow in paying their suppliers, and the impact of such payment practices on small suppliers who could not withstand a significant loss or delay in receipt of monies owed. Congress was also troubled by the common practice of produce buyers granting liens on their inventories to their lenders, which covered all proceeds and receivables from the sales of perishable agricultural commodities, while produce suppliers remained unpaid. This practice elevated the lenders to a secured creditor position in the case of the buyer's insolvency, while the sellers of perishable agricultural commodities remained unsecured creditors with little or no legal protection or means of recovery in a suit for damages.
Deeming this situation a “burden on commerce,” Congress amended the PACA in 1984 to include a statutory trust provision, which provides increased credit security in the absence of prompt payment for perishable agricultural commodities. The 1984 amendment to the PACA states in relevant part:
It is hereby found that a burden on commerce in perishable agricultural commodities is caused by financing arrangements under which commission merchants, dealers, or brokers, who have not made payment for perishable agricultural commodities purchased, contracted to be purchased, or otherwise handled by them on behalf of another person, encumber or give lenders a security interest in such commodities, or on inventories of food or other products derived from such commodities, and any receivables or proceeds from the sale of such commodities or products, and that such arrangements are contrary to the public interest. This subsection is intended to remedy such burden on commerce in perishable agricultural commodities and to protect the public interest.
Under the 1984 amendment, perishable agricultural commodities, inventories of food or other derivative products, and any receivables or proceeds from the sale of such commodities or products are to be held in a non-segregated floating trust for the benefit of unpaid sellers. This trust is created by operation of law upon the purchase of such goods, and the produce buyer is the statutory trustee for the benefit of the produce seller. To preserve its trust benefits, the unpaid supplier, seller, or agent must give the buyer written notice of intent to preserve its rights under the trust within 30 calendar days after payment was due. Alternatively, as provided in the 1995 amendments to the PACA (Pub. L. 104-48), a PACA licensee may provide notice of intent to preserve its trust rights by including specific language as part of its ordinary and usual billing or invoice statements.
The trust is a non-segregated “floating trust” made up of all of a buyer's commodity-related assets, under which there may be a commingling of trust assets. There is no need to identify specific trust assets through each step of
Perishable agricultural commodities received by a commission merchant, dealer, or broker in all transactions, and all inventories of food or other products derived from perishable agricultural commodities, and any receivables or proceeds from the sale of such commodities or products, shall be held by such commission merchant, dealer, or broker in trust for the benefit of all unpaid suppliers or sellers of such commodities or agents involved in the transaction, until full payment of the sums owing in connection with such transactions has been received by such unpaid suppliers, sellers, or agents.
Thus, trust participants remain trust beneficiaries until they have been paid in full.
Under the statute, the District Courts of the United States are vested with jurisdiction to entertain actions by trust beneficiaries to enforce payment from the trust. (7 U.S.C. 499e(c)(5)).
Thus, in the event of a business failure, produce creditors may enforce their trust rights by suing the buyer in federal district court. It is common in this type of trust enforcement action for unpaid sellers to seek a temporary restraining order (TRO) that freezes the bank accounts of a buyer until the trust creditors are paid. Many unpaid sellers have found this to be a very effective tool to recover payment for produce. Often, a trust enforcement action with a TRO will be the defining moment for the future of a buyer-debtor firm. Since the TRO freezes the bank accounts of the buyer, the buyer must either pay the trust creditors or attempt to operate a business without access to its bank accounts. This aggressive course of action by unpaid sellers is generally pursued when the sellers are concerned that trust assets are being dissipated.
In the event of a bankruptcy by a produce buyer, that is, the produce “debtor,” the debtor's trust assets are not property of the bankruptcy estate and are not available for distribution to secured lenders and other creditors until all valid PACA trust claims have been satisfied. The trust creditors can petition the court for the turnover of the debtor's trust-related assets or alternatively request that the court oversee the liquidation of the inventory and collection of the receivables and disburse the trust proceeds to qualified PACA trust creditors.
Because of the statutory trust provision, produce creditors, including sellers outside the United States, have a far greater chance of recovering money owed them when a buyer goes out of business. However, because attorney's fees are incurred in trust enforcement cases, it is not always practical to pursue small claims that remain unpaid. Nonetheless, because of the PACA trust provisions, unpaid sellers, including those outside the United States, have recovered hundreds of millions of dollars that most likely would not otherwise have been collected.
The PACA trust provisions protect not only growers, but also other firms trading in fruits and vegetables since each buyer in the marketing chain becomes a seller in its own turn and can preserve its own trust eligibility accordingly. Because each creditor that buys produce can preserve trust rights for the benefit of its own suppliers, any money recovered from a buyer that goes out of business is passed back through preceding sellers until ultimately the grower also realizes the financial benefits of the trust provisions. This is particularly important in the produce industry due to the highly perishable nature of the commodities as well as the many hands such commodities customarily pass through to the end customer.
In 1995, Congress amended the PACA (Pub. L. 104-48), changing several requirements of the PACA trust. Changes include no longer requiring sellers or suppliers to file notices of intent to preserve trust benefits with USDA, and allowing PACA licensees to have their invoices or other billing documents serve as the trust notice. The primary reason for removing the notice filing requirement was to reduce the paperwork burden on sellers and suppliers and eliminate USDA's expense in processing trust notices and administrating the provision.
To preserve trust protection under the PACA, the law offers two approaches to unpaid sellers, suppliers, and agents. One option allows PACA licensees to declare at the time of sale that the produce is sold subject to the PACA trust, providing protection in the event that payment is late or the payment instrument is not honored. This option allows PACA licensees to protect their trust rights by including the following language on invoices or other billing statements:
The second option for a PACA licensee to preserve its trust rights, and the sole method for all non-licensed sellers requires the seller to provide a separate, independent notice to the buyer of its intent to preserve its trust benefits. The notice must include sufficient details to identify each transaction and be received by the buyer within 30 days after payment becomes due.
Under current 7 CFR 46.46(e)(2), only transactions with payment terms of 30 days from receipt and acceptance, or less, are eligible for trust protection. Section 46.46(e)(1) of the regulations (7 CFR 46.46(e)(1)) requires that any payment terms beyond “prompt” payment as defined by the regulations, usually 10 days after receipt and acceptance in a customary purchase and sale transaction, must be expressly agreed to in writing before entering into the transaction. A copy of the agreement must be retained in the files of each party and the payment due date must be disclosed on the invoice or billing statement.
Since 1984, the district courts have had jurisdiction to entertain actions by trust beneficiaries to enforce payment from the trust. Recent court decisions have invalidated the trust claims of unpaid growers against their growers' agent because the growers did not file a trust notice directly with the growers' agent. Growers' agents sell and distribute produce for or on behalf of growers and may provide such services as financing, planting, harvesting, grading, packing, labor, seed, and containers. The growers have argued that it is not necessary to file a trust notice with their growers' agent because growers' agents are required to preserve the growers' rights as a trust beneficiary against the buyer (7 CFR 46.46(d)(2)). Some courts have ruled that while the growers' agent is required to preserve the growers' trust benefits with the buyer of the produce, the grower has the responsibility to preserve its trust benefits with the growers' agent.
AMS proposes that section 46.46 of the regulations be amended by revising paragraphs (d)(1) and (d)(2), redesignating paragraph (d)(2) as (d)(3), adding a new paragraph (d)(2) and revising (f)(1)(iv). These amendments
If licensed under the PACA, the grower may choose to preserve its trust rights by invoicing the growers' agent based on shipping and/or billing documents. The shipping and/or billing documents must include the requisite trust language provided in section 5(c)4 of the PACA. Non-licensed growers may choose to preserve their trust rights by issuing a notice of intent to preserve trust benefits as outlined under section 46.46 of the PACA regulations.
The PACA was amended in 1995 to require written notification as a precursor to investigations of alleged violations of the PACA. Within recent years, produce entities have challenged the USDA's jurisdiction to conduct investigations based their narrow reading of the definition of “written notification” stated in section 46.49 of the Regulations (7 CFR 46.49). The proposed amendment of section 46.49 is needed to make clear that public filings such as bankruptcy petitions, civil trust actions, and judgments constitute written notification. Moreover, AMS proposes to clarify that the filing of a written notification with USDA may be accomplished by myriad means, including, but not limited to, delivery by: Regular or commercial mail service, hand delivery, or electronic means such as email, text, or facsimile message. Furthermore, a written notification published in any public forum, including, but not limited to, a newspaper or internet Web site, will be considered filed with USDA upon its visual inspection by any office or official of USDA responsible for administering the Act. Clarification of the meaning of “written notification” would ensure that PACA licensees and entities operating subject to the PACA understand the breadth of documentation that could trigger USDA's authority to initiate an investigation of alleged PACA violations.
Section 46.49 would be amended by revising paragraphs (a), (b), (c) and (d) to clarify the meaning of “written notification” as the term is used in section 6(b) of the PACA. Further, to reflect current industry practices and advancements in electronic communication, section 46.49(d) would be amended to allow the Secretary to serve a notice or response, as it relates to paragraph (d), by any electronic means such as registered email that provides proof of receipt to the electronic mail address or phone number of the subject of the investigation.
The proposed rule has been reviewed under Executive Order 12866 supplemented by Executive Order 13563 and it has been determined that this proposed rule is not considered a significant regulatory action under section 3(f) of Executive Order 12866 and, therefore, it was not reviewed by the Office of Management and Budget.
This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform, and is not intended to have retroactive effect. This proposed rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule. There are no administrative procedures that must be exhausted prior to any judicial challenge to the provisions of this proposed rule.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C.
The Agricultural Marketing Service (AMS) believes that the proposed amendments to the PACA regulations would help growers and other sellers and suppliers of produce protect their rights under the PACA trust, and the potential recovery of millions of dollars in unpaid produce debt. Moreover, AMS believes that the proposed amendments more accurately reflect the intent of Congress when it amended the PACA to require written notification as a precursor to investigations by the Secretary of Agriculture. The proposed revisions include language that clarifies a grower's responsibility to preserve its benefits under the PACA trust, as well as language that clarifies what constitutes “written notification” for purposes of investigating alleged violations of the PACA.
AMS believes the proposed revisions would increase the clarity of the PACA regulations and improve AMS's enforcement of the PACA. AMS believes that this proposed rule would not have a significant economic impact on a substantial number of small entities.
This proposed rule has been reviewed in accordance with the requirements of Executive Order 13175, consultation and Coordination with Indian Tribal governments. The review reveals that this proposed regulation will not have substantial and direct effects on Tribal governments and will not have significant Tribal implications.
In accordance with OMB regulations (5 CFR part 1320) that implement the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the information collection and recordkeeping requirements that are covered by this proposed rule are currently approved under OMB number 0581-0031.
USDA is committed to complying with the E-Government Act, which requires Government agencies in general to provide the public the option of submitting information or transacting business electronically to the maximum extent possible. Forms are available on our PACA Web site at
Agricultural commodities, Brokers, Penalties, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, AMS proposes to amend 7 CFR part 46 as follows:
7 U.S.C. 499a-499t.
(2) Principals, including growers, who employ agents to sell perishable agricultural commodities on their behalf are “suppliers” and/or “sellers” as those words are used in section 5(c)(2) and (3) of the Act (7 U.S.C. 499e(c)(2) and (3)) and therefore must preserve their trust rights against their agents by filing a notice of intent to preserve trust rights with their agents as set forth in paragraph (f) of this section.
(3) Agents who sell perishable agricultural commodities on behalf of their principals must preserve their principals' trust benefits against the buyers by filing a notice of intent to preserve trust rights with the buyers. Any act or omission which is inconsistent with this responsibility, including failure to give timely notice of intent to preserve trust benefits, is unlawful and in violation of section 2 of the Act (7 U.S.C. 499b).
(f) * * *
(1) * * *
(iv) The amount past due and unpaid; except that if a supplier, seller or agent engages a commission merchant or growers' agent to sell or market their produce, the supplier, seller or agent that has not received a final accounting from the commission merchant or growers' agent shall only be required to provide information in sufficient detail to identify the transaction subject to the trust.
(a) Written notification, as used in section 6(b) of the Act (7 U.S.C. 499f (b)), means:
(1) Any written statement reporting or complaining of a violation of the Act made by any officer or agency of any State or Territory having jurisdiction over licensees or persons subject to license, or a person filing a complaint under section 6(a), or any other interested person who has knowledge of or information regarding a possible violation of the Act, other than an employee of an agency of USDA administering the Act;
(2) Any written notice of intent to preserve the benefits of, or any claim for payment from, the trust established under section 5 of the Act (7 U.S.C. 499e);
(3) Any official certificate(s) of the United States Government or States or Territories of the United States; or
(4) Any public legal filing or other published document describing or alleging a violation of the Act.
(b) Any written notification may be filed by delivering the written notification to any office of USDA or any official of USDA responsible for administering the Act. Any written notification published in any public forum, including, but not limited to, a newspaper or an internet Web site shall be deemed filed upon visual inspection by any office of USDA or any official of USDA responsible for administering the Act. A written notification which is so filed, or any expansion of an investigation resulting from any indication of additional violations of the Act found as a consequence of an investigation based on written notification or complaint, also shall be deemed to constitute a complaint under section 13(a) of the Act (7 U.S.C. 499m(a)).
(c) Upon becoming aware of a complaint under section 6(a) or written notification under 6(b) of the Act (7 U.S.C. 499f (a) or (b)) by means described in paragraph (a) and (b) of this section, the Secretary will determine if reasonable grounds exist to conduct an investigation of such complaint or written notification for disciplinary action. If the investigation substantiates the existence of violations of the Act, a formal disciplinary complaint may be issued by the Secretary as described in section 6(c)(2) of the Act (7 U.S.C. 499f(c)(2)).
(d) Whenever an investigation, initiated as described in section 6(c) of the Act (7 U.S.C. 499f(c)(2)), is commenced, or expanded to include new violations of the Act, notice shall be given by the Secretary to the subject of the investigation within thirty (30) days of the commencement or expansion of the investigation. Within one hundred and eighty (180) days after giving initial notice, the Secretary shall provide the subject of the investigation with notice of the status of the investigation, including whether the Secretary intends to issue a complaint under section 6(c)(2) of the Act (7 U.S.C. 499f(e)(2)), terminate the investigation, or continue or expand the investigation. Thereafter, the subject of the investigation may request in writing, no more frequently than every ninety (90) days, a status report from the Director of the PACA Division who shall respond to the written request within fourteen (14) days of receiving the request. When an investigation is terminated, the Secretary shall, within fourteen (14) days, notify the subject of the termination of the investigation. In every case in which notice or response is required under this paragraph, such notice or response shall be accomplished by personal service; or by posting the notice or response by certified or registered mail, or commercial or private delivery service to the last known address of the subject of the investigation; or by sending the notice or response by any electronic means such as registered email, that provides proof of receipt to the electronic mail address or phone number of the subject of the investigation.
Office of the Secretary (OST), Department of Transportation (DOT).
Notice of Proposed Rulemaking (NPRM).
The Department of Transportation (DOT or the Department) is proposing to protect airline
Comments should be filed by February 13, 2017. Late-filed comments will be considered to the extent practicable.
You may file comments identified by the docket number DOT-OST-2014-0002 by any of the following methods:
Robert Gorman, Senior Trial Attorney, or Blane A. Workie, Assistant General Counsel, Office of Aviation Enforcement and Proceedings, U.S. Department of Transportation, 1200 New Jersey Ave. SE., Washington, DC 20590, 202-366-9342, 202-366-7152 (fax),
The purpose of this action is to propose a method for regulating voice calls on passengers' mobile wireless devices on flights to, from, and within the United States. Permitting passengers to make voice calls onboard aircraft may create an environment that is unfair and deceptive to those passengers. While the Federal Communications Commission (FCC) currently prohibits the use of certain commercial mobile bands onboard aircraft, that ban does not cover Wi-Fi and other means by which it is possible to make voice calls. Moreover, in 2013, the FCC proposed lifting its existing ban, so long as certain conditions are met, as described in detail below. As technologies advance, the cost of making voice calls may decrease and the quality of voice call service may increase, leading to a higher prevalence of voice calls and greater risk of passenger harm.
For these reasons, the Department proposes to require sellers of air transportation to provide adequate advance notice to passengers if the carrier operating the flight allows passengers to make voice calls using mobile wireless devices. Under this proposed rule, carriers would be free to set their own voice call policies, to the extent otherwise permitted by law, so long as carriers provide adequate advance notice when voice calls will be allowed. The requirement for airlines to provide advance notice when voice calls are allowed would not apply to small airlines (
The Department takes this action under its authority to prohibit unfair and deceptive practices in air transportation or the sale of air transportation, and under its authority to ensure adequate air transportation, as further described herein.
The proposed rule would require airlines and ticket agents that are not small entities to disclose the airline's voice call policy if the airline chooses to permit voice calls. The Department's Preliminary Regulatory Impact Analysis (PRIA), found in the docket, examined the costs that ticket agents and airlines would incur to implement any disclosure requirements that would arise from allowing voice calls. For the period of 2017-2026, the PRIA estimated the cost to carriers to be $41 million and the cost to ticket agent costs to be $46 million. The PRIA found qualitative benefits to passengers in the form of improved information for those who wish to avoid (or make) voice calls. These costs and benefits are summarized in the chart below.
On February 24, 2014, the Department issued an Advance Notice of Proposed Rulemaking (ANPRM) in Docket DOT-OST-2014-0002 titled “Use of Mobile Wireless Devices for Voice Calls on Aircraft.” The ANPRM was published in the
Currently, FCC rules restrict airborne use of mobile devices that can operate on certain commercial mobile frequencies.
The FCC's proposal is technology-neutral, in that it does not intend to limit the use of mobile communications to non-voice applications. The FCC states that any modifications to the AAS would be at the discretion of individual airlines, in addition to any rules or guidelines adopted by the DOT.
In the Department's ANPRM, we explained that DOT and the FCC have distinct areas of responsibilities with respect to the use of cell phones or other mobile devices for voice calls on aircraft. The FCC has authority over various technical issues (as described above); the FAA, a component of DOT, has authority over safety issues; and DOT's OST has authority over aviation consumer protection issues.
The FAA, pursuant to its aviation safety oversight authority in 49 U.S.C. 106(f) and 44701(a), has authority to determine whether portable electronic devices (PEDs)
Many U.S. airlines currently offer Wi-Fi connectivity to passengers' mobile devices using FAA-approved in-flight connectivity systems. Like Airborne Access Systems, airborne Wi-Fi systems receive signals from passengers' mobile devices and relay those signals to satellites or dedicated ground towers. Wi-Fi spectrum is capable of transmitting voice calls as well as other types of data, such as video and text messages. The FCC does not prohibit voice calls over Wi-Fi; the FCC's current ban relates to the use of certain commercial mobile spectrum bands.
To summarize, the current proposed rulemaking would regulate voice calls onboard aircraft as a matter of consumer protection, rather than as a matter of ensuring aviation safety or preventing cellular interference with ground networks. Moreover, it would apply to voice calls on passenger-supplied cellular telephones and other passenger-supplied mobile wireless devices, regardless of whether the call is made on a commercial mobile frequency, Wi-Fi, or other means. Under this proposal, the Department would not prohibit voice calls (although we seek further comment on that issue), but airlines would remain subject to any technical, safety, or security rules that do prohibit or restrict voice calls. Airlines would be required to disclose their voice call policies to the extent that they permit voice calls; those policies, in turn, will be based both on the airline's own choices and on any existing rules affecting such calls.
The DOT sought comment in the February 2014 ANPRM on whether permitting voice calls on aircraft constitutes an unfair practice to consumers pursuant to 49 U.S.C. 41712, and/or is inconsistent with adequate air transportation pursuant to 49 U.S.C. 41702, and if so, whether such calls should be banned. More specifically, it solicited comment on a number of questions, including, but not limited to: (1) Whether the Department should refrain from rulemaking and allow the airlines to develop their own policies; (2) whether a voice call ban should apply to all mobile wireless devices; (3) whether any proposed ban on voice calls should be extended to foreign air carriers; and (4) whether exceptions should apply for emergencies, certain areas of the aircraft, certain types of flights, or certain individuals (such as flight attendants and air marshals). It did not seek comment on the technical or safety aspects of voice calls, because those fall under the regulatory authority of the FCC and the FAA, respectively.
The comment period was open from February 24, 2014, to March 26, 2014. During that time, the Department received over 1,700 comments from individuals. The vast majority of commenters, 96%, favored a ban on voice calls. An additional 2% favored bans on voice calls, but indicated that they would be open to exceptions, such as for (unspecified) “emergencies.” Most commenters used strong language to express the view that voice calls in the presence of others are disturbing in general, and even more so in a confined space. Individuals also commented that voice calls would create “air rage” incidents by disgruntled passengers, place additional strains on flight attendants, and intrude upon privacy and opportunities to sleep. Only 2% of individuals opposed a voice call ban. These commenters generally took the position that airlines should be able to set their own policies.
Consumer advocacy organizations (Consumers Union and the Global Business Travel Association) stated that they favored a ban on voice calls, for the same reasons identified by the majority of individuals. Global Business Travel Association favored a ban on voice calls and stated that “quiet sections” are not feasible on aircraft.
Unions (the Air Line Pilots Association (ALPA), the Association of Professional Flight Attendants (APFA), the Association of Flight Attendants—CWA (AFA-CWA), the Teamsters, and the Transportation Trades Department) expressed safety concerns arising from permitting voice calls on aircraft, including an increased number of “air rage” incidents and a decrease in the ability to hear crewmember instructions. These organizations also cited security concerns, such as the possibility that voice call capability could be exploited by terrorists.
In contrast, the major airline organizations, Airlines for America (A4A) and the International Air Transport Association (IATA), expressed the view that airlines should be permitted to develop their own policies on voice calls. They recognized that their member airlines may take differing positions on whether they would allow voice calls on their flights. A4A and IATA stressed, however, that each airline should be free to respond to its own consumers' demand. They also argued that the Department lacks the statutory authority under 49 U.S.C. 41702 or 41712 to ban voice calls. Finally, these organizations contended that a voice call ban would stifle innovation in this area.
One U.S. airline, Spirit Airlines, Inc., echoed IATA's free-market position, but added that the Department would have the authority to require airlines to disclose their voice call policies.
Certain foreign airlines (Emirates and Virgin Atlantic), along with suppliers of onboard voice call equipment (Panasonic, OnAir Switzerland, and the Telecommunications Industry Association/Information Technology Industry Council), commented that foreign airlines increasingly permit voice calls, with few reports of consumer complaints. They stated that voice calls are rarely placed, and are of short duration because they are quite expensive (several dollars per minute, akin to “roaming” charges). They also note that voice calls may be easily disabled at any time during flight by one of the pilots. Finally, they report that crewmembers are adequately trained to handle any incidents that may arise as a result of voice calls.
One commenter, the Business Travel Coalition, suggested that the Department should permit voice calls in an “inbound, listen-only” mode for participating passively in conference calls. Another commenter, GoGo, Inc., suggested that any ban on voice calls should apply to regularly-scheduled commercial flights, and not to private aircraft or charter flights.
First, we recognize the safety and security concerns expressed by pilots' and flight attendants' unions. Without discounting those concerns in any way, we note that the proposed rule is not based on considerations of safety or security. Nevertheless the Department is actively coordinating this proposed rulemaking with all relevant Federal authorities that have jurisdiction over aviation safety and security.
Next, we understand the significant concerns expressed by individual commenters about the degree of hardship that may arise from an enclosed airline cabin environment in which voice calls are unrestricted. Under the proposed rule, airlines remain free to respond to those concerns by banning voice calls as a matter of policy, allowing voice calls only on certain flights (such as those frequently used by business travelers) or only
We recognize that certain foreign airlines permit voice calls when outside U.S. airspace, and that these airlines have reported few consumer complaints. This experience of foreign airlines suggests that voice calls do not, at present, create a significant degree of consumer harm. Our review of the individual comments to the ANPRM suggests, however, that U.S. consumers have come to expect a voice-call-free cabin environment and that they may generally hold a different view from foreign consumers on the issue of voice calls. Moreover, as we note in the regulatory evaluation to the proposed rule, the Department anticipates that airlines' technical capacity to allow voice calls will increase significantly in the near future, with corresponding potential reductions in the price of individual voice calls. These factors could result in an environment in which voice calls increase in both number and length, raising passenger discomfort to a degree that passengers on foreign airlines do not currently experience. As such, this proposal would require sellers of air transportation that are not small entities to provide adequate notice to passengers if voice calls are permitted on a “flight within, to, or from the United States.” We recognize that a “flight to or from the United States” may be a continuous journey including one flight segment beginning or ending in the United States (
The Department appreciates the comments we received from business travelers, some of whom have advocated for the ability to participate in “listen-only” calls, such as lengthy conference calls, on airplanes. This NPRM does not propose a ban on voice calls on aircraft, although we seek further comment on that issue. As a result, airlines would be free, under this proposal, to develop policies to prohibit, restrict or allow voice calls, and airlines would have the flexibility to provide these types of “listen-only” or other exceptions if they so choose. With that being said, DOT continues to seek comment on whether a ban on voice calls would be the more appropriate regulatory approach and whether any exceptions, such as a “listen-only” exception, should apply.
With respect to GoGo's comment that any ban on voice calls should apply to regularly-scheduled commercial flights, and not to private aircraft or charter flights, we again note that we are not proposing to ban voice calls at this time.
Finally, we agree with Spirit Airlines' comment that the Department has the authority to require carriers to disclose their voice-call policies, if the airline does allow them. While the major airline organizations did not comment on the disclosure approach, we believe that it is a well-established means of regulation that falls squarely within the Department's authority under 49 U.S.C. 41712. At this point in time, the Department is proposing this method of regulation, which is structured similarly to the Department's existing code-share disclosure rule. This proposed rule would require airlines that permit voice calls to provide early notice to consumers so that they may know prior to purchasing a ticket that a particular flight permits voice calls. This proposal provides a means of regulating voice calls without banning them outright.
On October 29, 2014, the sixth meeting of the Secretary's Advisory Committee on Aviation Consumer Protection (ACACP) convened to discuss a number of issues, including regulation of voice calls on aircraft.
After reviewing the comments, the Department finds that allowing the use of mobile wireless devices for voice calls without providing adequate notice to all passengers is an “unfair” and “deceptive” practice in air transportation under 49 U.S.C. 41712. A practice is unfair if it causes or is likely to cause substantial injury to consumers which cannot be reasonably avoided and which is not outweighed by countervailing benefits to consumers or competition that the practice produces. The Department relied upon 49 U.S.C. 41712 when promulgating the “Tarmac Delay Rule” (14 CFR 259.4), in which the Department addressed the harm to consumers when aircraft sit for hours on the airport tarmac without an opportunity for passengers to deplane.
We also believe that permitting voice calls on aircraft without adequate disclosure is a deceptive practice. A practice is deceptive if it misleads or is likely to mislead a consumer acting reasonably under the circumstances with respect to a material issue (
A number of individuals and organizations expressed significant concern over the many safety and security issues that arise from permitting voice calls on aircraft. Recognizing the multi-jurisdictional scope of the voice call issue, numerous members of Congress
Before discussing the proposed rule text, we note that we seek further comment on whether the Department should ban voice calls on domestic and/or international flights. We recognize that we have already received considerable feedback on this topic during the comment period to the ANPRM; individuals and organizations need not re-submit those same comments during the comment period to this NPRM. Here, we particularly solicit comment on whether there is any market failure or other reason to support a Federal ban on voice calls during flights, as well as the costs and benefits of any such ban. For example, is there evidence of a market failure or other problems based on the experience of countries that permit carriers to allow passengers to make voice calls during flights? What are the different types of policies and practices being used by carriers that permit some degree of voice calls? Will the price of voice calls go down as technology improves, and if so, will the volume of voice calls increase? What would be the costs and benefits of any such increase in voice call usage? What are the quantifiable benefits to consumers from being able to make a voice call onboard an aircraft? What are the quantifiable benefits of being able to listen to a conference call on a “listen-only” call? Would carriers and/or consumers benefit from airlines offering either “voice call zones” or “voice call free zones” onboard aircraft? Would carriers charge a specific fee for being able to make voice calls, or would the fee for voice calls be bundled with the general charges for Wi-Fi, and/or in-flight entertainment? Would carriers have an economic incentive to provide electronic devices to passengers independent of the portable electronic devices that passengers themselves already bring onboard the aircraft? What are the quantifiable costs to consumers from being exposed to unwanted voice calls onboard aircraft? What is the proper method of measuring such costs? Is a voice call ban justified even if the Department requires disclosure of a carrier's voice call policy? Should any such ban apply to international as well as domestic flights? Should any such ban apply to small carriers, air taxis, or charter operations? In general, are market forces sufficient or insufficient to moderate voice call use without Departmental regulation? Are there alternative regulatory approaches, in addition to disclosure and bans, that the Department should consider?
In the NPRM, we define “mobile wireless device” to mean any portable wireless telecommunications device not provided by the covered airline that is used for the transmission or reception of voice calls. The term includes, but is not limited to, passengers' cellular telephones, computers, tablets, and other portable electronic devices using radio frequency (RF) signals, including Voice over Internet Protocol (VoIP) via aircraft Wi-Fi. We define “voice call” to mean an oral communication made or received by a passenger using a mobile wireless device. The Department seeks comment on the proposed definitions of “mobile wireless device” and “voice call.”
The proposed rule applies to passenger flights in scheduled or charter air transportation by U.S. and foreign air carriers that are not small entities (
Under this proposed rule, if an airline permits voice calls on a specific flight that is offered to a prospective consumer, then the seller of the air transportation (
The proposed rule is modeled on the code-share disclosure rule, 14 CFR 257.5. Code-sharing is an arrangement whereby a flight is operated by a carrier other than the airline whose designator code or identity is used in schedules and on tickets. Based on the statutory prohibition against unfair and deceptive practices in the sale of air transportation, 49 U.S.C. 41712, the purpose of the disclosure requirement in section 257.5 is to ensure that consumers are aware of the identity of the airline actually operating their flight in code-sharing and long-term wet lease arrangements in domestic and international air transportation.
Similarly, the Department believes that a carrier's voice call policy is an important factor that may affect consumers' purchasing decisions. Prospective consumers should be aware, from the beginning of a prospective purchase, whether a carrier permits voice calls on its flights. As noted above, the comments to the ANPRM reflected an overwhelmingly negative public reaction to the prospect of permitting voice calls on aircraft. Based on these comments, the Department believes that consumers should be informed, from the beginning of the process, whether a carrier permits voice calls. Similarly, the Department believes that consumers would be unfairly surprised and harmed if they learned only after the purchase of a ticket (or, worse, after boarding the aircraft) that the carrier permits voice calls on its flights. While some carriers or ticket agents may voluntarily or sporadically provide notice of a carrier's voice call policy in the absence of regulation, the Department believes that the systematic and comprehensive notice requirements of proposed Part 260 provide the most effective means of avoiding consumer harm.
The Department proposes that disclosure take place under Part 260 only if the carrier
As proposed, the rule would exempt carriers that operate exclusively with aircraft having a designed seating capacity of less than 60 seats and ticket agents defined as “small businesses” (
The specific notice requirements are set forth in section 260.9. Section 260.9 requires disclosure in two areas: flight itinerary and schedule displays, and oral communications.
Subsection (a) would require voice call disclosure on flight itinerary and schedule displays, including on the Web sites and mobile applications of both carriers and ticket agents with respect to flights in, to, or from the United States. The inclusion of ticket agents reflects the fact that, through the growth and development of the internet and related technologies, more and more ticket agents, especially online travel agencies (OTAs), are able to provide flight schedules and itinerary search functions to the public. Also, we view any ticket agent that markets and is compensated for the sale of air transportation to consumers in the United States, either from a brick-and-mortar office located in the United States or via an internet Web site that is marketed towards consumers in the United States, as “doing business in the United States.” This interpretation would cover any travel agent or ticket agent that does not have a physical presence in the United States but has a Web site that is marketed to consumers in the United States for purchasing tickets for flights within, to, or from the United States. We also note that with the usage of mobile devices gaining popularity among consumers, our voice call disclosure requirement with respect to flight schedule and itinerary displays covers not only conventional internet Web sites under the control of carriers and ticket agents, but also those Web sites and applications specifically designed for mobile devices, such as mobile phones and tablets.
Furthermore, the text of section 260.9(a) states that voice call policies (
Our proposal reflects the requirement of 49 U.S.C. 41712(c)(2) on Internet offers, which requires that on a Web site fare/schedule search engine, code-share disclosure must appear on the first display following an itinerary search. Further, section 41712(c)(2) requires that the disclosure on a Web site must be “in a format that is easily visible to a viewer.” Similarly, we are proposing that the voice call policy disclosure must appear in text format immediately adjacent to each flight where voice calls are permitted, in response to an itinerary request by a consumer. We ask whether the proposed voice-call disclosure format would be clear and prominent to the passenger. As an alternative to the proposed standard, we ask whether a voice call disclosure appearing immediately adjacent to the entire itinerary as opposed to appearing immediately adjacent to each flight would be clear and prominent to the passenger. We also ask whether a symbol, such a picture of cell phone, would be sufficient, rather than disclosure in text format.
With regard to flight schedules provided to the public (whether the schedules are in paper or electronic format), we propose that the voice call disclosure be provided by an asterisk or other identifiable mark that clearly indicates the existence of a voice call policy and directs the reader's attention to another prominent location on the same page indicating in words that the carrier permits voice calls. We seek public comment on whether we should impose the same standard for flight schedules as for flight itineraries provided on the internet in response to an itinerary search,
Proposed section 260.9(b) requires that in any direct oral communication in the United States with a prospective consumer, and in any telephone call placed from the United States by a prospective consumer, concerning a flight within, to, or from the United States where voice calls are permitted, a ticket agent doing business in the United States or a carrier shall inform the consumer, the first time that such a flight is offered to the consumer, that voice calls are permitted. This rule requires carriers and ticket agents to disclose the voice call policy the first time the carrier or ticket agent offers a flight where voice calls are allowed, or, if no such offer was made, the first time a consumer inquires about such a flight. As with the remaining subsections of section 260.9, the purpose of this subsection is to ensure that a prospective consumer understands that voice calls would be permitted on a flight from the beginning of the decisionmaking process, and regardless of whether the consumer ultimately makes a reservation. Because carriers are already required to provide code-share disclosure, the Department believes that there is only a small additional burden to requiring disclosure of voice call policies as well. Subsection (b) requires disclosure only the first time that such a flight is offered to the consumer; the agent need not repeat the voice call policy at every mention of the flight, but should be prepared to repeat the voice call disclosure information upon request. The rule also requires disclosure if no such offer was made, the first time a consumer inquires about such a flight.
The phrase “ticket agent doing business in the United States” is used in the same manner as described in the discussion of that phrase in section 260.9(a) above. Consequently, a ticket agent that sells air transportation via a Web site marketed toward U.S. consumers (or that distributes other marketing material in the United States) is covered by section 260.9(b) even if the agent does not have a physical location in the United States, and such an agent must provide the disclosure required by section 260.9(b) during a telephone call placed from the United States even if the call is to the agent's foreign location.
While the Department has proposed a disclosure that is based on the code-share disclosure model, we seek comment on other approaches, including whether and to what extent it should require disclosure of voice call policies to consumers. For example, should the Department require airlines that permit voice calls on aircraft to disclose that fact on their general Web site, outside of the booking path? What information may need to be moved or deleted to make room for this disclosure? Should ticket agents be required to identify airlines that permit voice calls and disclose that information on their Web site? If so, where on the Web site should such disclosure appear? Would a general link to a policy be sufficient, or should disclosure take place on the screen where passengers construct itineraries and/or purchase tickets? Should disclosure take place during telephone reservation and inquiry calls? At all points of sale? Should such disclosure be provided on itinerary or e-ticket documents? If a passenger wishes to learn the full extent of a carrier's voice call policy, beyond the mere disclosure that calls “are permitted,” should carriers or ticket agents be required to provide that information on request? If so, how? The Department specifically seeks comments on the costs and benefits of all of these approaches.
The Department proposes that the rule becomes effective 30 days after publication in the
This action has been determined to be significant under Executive Order 12866 and the Department of Transportation's Regulatory Policies and Procedures. A copy of the Preliminary Regulatory Impact Analysis (PRIA) has been placed in the docket.
The PRIA found qualitative consumer benefits in the form of having readily-available flight-specific information regarding a carrier's voice call policy before making air travel purchase decisions. The PRIA did not quantify this benefit. The PRIA estimated aggregate costs for compliance with the proposed rule for 2017-2026 (including costs for revising Web sites and for training personnel) to be $41 million for carriers and $46 million for ticket agents. A summary of these findings is set forth below.
The Regulatory Flexibility Act (5 U.S.C. 601
The Department does not expect this rule to have a significant economic impact on a substantial number of small entities. The proposed rule contains an exemption for small carriers and small ticket agents. On the basis of the analysis provided in the PRIA and IRFA, I hereby certify that this rulemaking will not have a significant economic impact on a substantial number of small entities.
This rulemaking has been analyzed in accordance with the principles and criteria contained in Executive Order 13132 (“Federalism”). This rulemaking does not include any provision that: (1) Has substantial direct effects on the States, the relationship between the national government and the States, or the distribution of power and responsibility among the various levels of government; (2) imposes substantial direct compliance costs on State and local governments; or (3) preempts State law. States are already preempted from regulating in this area by the Airline Deregulation Act, 49 U.S.C. 41713. Therefore, the consultation and funding requirements of Executive Order 13132 do not apply.
This rulemaking has been analyzed in accordance with the principles and criteria contained in Executive Order 13084 (“Consultation and Coordination with Indian Tribal Governments”). Because this rulemaking does not significantly or uniquely affect the communities of the Indian Tribal governments or impose substantial direct compliance costs on them, the funding and consultation requirements of Executive Order 13084 do not apply.
The Department has determined that this proposed rule is subject to the requirements of the Paperwork Reduction Act (PRA) because it adopts new information gathering requirements on airlines and ticket agents. The Department will publish a separate 30 day and 60 day notice in the
The Department has determined that the requirements of Title II of the Unfunded Mandates Reform Act of 1995 do not apply to this rule.
The Department has analyzed the environmental impacts of this proposed action pursuant to the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321
Air carriers, Foreign air carriers, Ticket agents, Voice calls, Mobile wireless devices, Consumer protection. Disclosure when voice calls are permitted.
49 U.S.C. 41712.
The purpose of this part is to ensure that ticket agents doing business in the United States, air carriers, and foreign air carriers inform consumers clearly when the air transportation they are buying or considering buying permits passengers to use their mobile wireless devices for voice calls onboard the flight.
Except as noted in § 260.11, this part applies to the following:
(a) U.S. and foreign air carriers marketing scheduled or charter air transportation where voice calls are permitted onboard flights; and
(b) Ticket agents doing business in the United States that market scheduled or charter air transportation where voice calls are permitted onboard flights.
As used in this part:
The holding out or sale of scheduled or charter passenger air transportation is prohibited as unfair and deceptive in violation of 49 U.S.C. 41712 unless, in conjunction with such holding out or sale, carriers and ticket agents follow the requirements of this part.
(1) In flight schedule information provided to U.S. consumers on desktop browser-based or mobile browser-based internet Web sites or applications in response to any requested itinerary search, for each flight on which voice calls are permitted, notice that voice calls are permitted must appear prominently in text format on the first display following the input of a search query, immediately adjacent to each flight in that search-results list. Roll-over, pop-up and linked disclosures do not comply with this paragraph.
(2) For static written schedules, each flight in passenger air transportation where voice calls are permitted shall be identified by an asterisk or other easily identifiable mark that leads to disclosure of notification that voice calls are permitted.
(c) Each air carrier and foreign air carrier that permits voice calls via passenger devices shall provide notification to all ticket agents that receive and distribute the U.S. or foreign carrier's fare, schedule, and availability information of the fact that voice calls via passenger devices are permitted during the flight. This notification shall be useable, current, and accurate, and suitable for providing the notices to prospective air travelers required by paragraphs (a) and (b) of this section.
This Part does not apply to:
(a) Air carriers or foreign air carriers providing air transportation only with aircraft having a designed passenger capacity of less than 60 seats.
(b) Ticket agents with $20.5 million or less in annual revenues, or that qualify as a small business pursuant to 13 CFR part 121.
Food and Drug Administration, HHS.
Notification of availability.
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “Fruit Juice and Vegetable Juice as Color Additives in Food.” The draft guidance, when finalized, will help manufacturers determine whether a color additive derived from a plant material meets the specifications under certain FDA color additive regulations.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 13, 2017.
You may submit comments as follows:
Submit electronic comments in the following way:
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Submit written requests for single copies of the draft guidance to the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the
We are announcing the availability of a draft guidance for industry entitled “Fruit Juice and Vegetable Juice as Color Additives in Food.” We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
When a food substance, including plant material, is deliberately used as a color, it is a color additive (see 21 CFR 70.3(f)). We have a statutory obligation to ensure that authorized (or listed) color additives are suitable and safe for their intended use. FDA has authorized the use of the color additive “fruit juice,” under § 73.250 (21 CFR 73.250), that is prepared either by expressing the juice from mature varieties of fresh, edible fruits, or by the water infusion of the dried fruit. Similarly, § 73.260 establishes that the color additive “vegetable juice” is prepared either by expressing the juice from mature varieties of fresh, edible vegetables or by the water infusion of the dried vegetable. The underlying premise of §§ 73.250 and 73.260 is that the safety of fruit juice and vegetable juice as color additives for use in food is assured by the fact that the fruit or vegetable from which the color additive is derived has been safely consumed as food, such that there would not be safety concerns in using the juice or water soluble color components from the fruit or vegetable as a color additive. The fact that plant material can be eaten does not necessarily mean that juice from such plant material meets the specifications of these regulations. We also note that, in addition to the color additive regulations for fruit juice in § 73.250 and vegetable juice in § 73.260, we have authorized color additives derived from plant materials in separate color additive regulations, including § 73.169 (grape skin extract) and § 73.500 (saffron).
The draft guidance, when finalized, is intended to help manufacturers determine whether a color additive derived from a plant material meets the specifications for fruit juice under § 73.250 or vegetable juice under § 73.260. The draft guidance, including our interpretation of the terms used in §§ 73.250 and 73.260, is limited to these color additive regulations. The draft guidance does not address the use of fruit- or vegetable-derived color additives that are authorized under different color additive regulations or that are the subject of a color additive petition.
Since we issued the color additive regulations for fruit juice and vegetable juice, we have received inquiries from industry regarding whether certain plant materials are covered by these color additive regulations. The draft guidance provides the criteria that should be used to determine if a plant material is a mature, fresh, edible fruit or a mature, fresh, edible vegetable under §§ 73.250 and 73.260. The draft guidance also encourages firms to consult us if they are unsure of the regulatory status of a substance that they propose to derive from plant materials for use as a color additive for food. Separately, we have posted on our Web site a summary table of the informal opinions that we have issued in response to the specific inquiries we have received regarding the applicability of §§ 73.250 and 73.260. The draft guidance document contains the Web site link to the summary table.
The draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of
The draft guidance also refers to new collections of information found in FDA regulations. Under the PRA, Federal Agencies must obtain approval from OMB for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, we invite comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (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 respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
The draft guidance, when finalized, will help manufacturers determine whether a color additive derived from a plant material meets the specifications for fruit juice under § 73.250 or vegetable juice under § 73.260. Information in the draft guidance regarding submission of a color additive petition has been previously approved by OMB in accordance with the PRA under OMB control number 0910-0016.
The proposed new information collection provides manufacturers the opportunity to request a meeting with FDA if they are unsure whether a color additive that is derived from plant material and that is intended for use in food meets the identity for fruit juice or vegetable juice in § 73.250 or § 73.260. When manufacturers request a meeting, the draft guidance suggests that they provide the scientific name, common name(s), origin, cultivation state, and life-stage of the plant material from which they wish to derive the color additive, and which plant structure will be declared the mature, fresh, edible fruit or vegetable, as well as a complete description of the manufacturing process for the color additive. Manufacturers also may provide information to us to verify that the plant material can be consumed for its taste, aroma, or nutrient properties in its fresh state and to document the amount and frequency of consumption and the history of safe consumption. If we determine that a proposed color additive does not meet the specifications for fruit juice or vegetable juice under § 73.250 or § 73.260, the manufacturer may submit a color additive petition, the collection of information for which has been approved under OMB control number 0910-0016.
FDA estimates the burden of this collection of information as follows:
FDA's estimate of the number of respondents and number of responses in table 1 is based on the average number of meetings that are expected to be requested annually by manufacturers over the next 3 years. Based on past experience, we expect the request for a meeting and the submission of fruit juice or vegetable juice information can be completed by a qualified plant taxonomist in less than 1 hour. We also expect that some manufacturers may want to provide research supporting the plant material as a consumable food, the amount and frequency of consumption, and the history of safe consumption of the mature fruit or vegetable by humans. We estimate that, in these cases, it would take a qualified toxicologist up to 3 days (24 working hours) to perform a thorough literature and plant database search. This estimate includes the time we expect it would take for a submitter to compile the information for submission to FDA.
To be conservative, the total number of annual burden hours, therefore, would be 125 hours, which would include 5 hours to complete the initial request for a meeting and of the submission of associated information to FDA, and 120 hours to complete a literature and database search and to present this information for submission to FDA.
Before the proposed information collection provisions contained in the draft guidance become effective, we will publish a notice in the
Persons with access to the Internet may obtain the draft guidance at either
Department of the Army, DoD.
The Department of the Army proposes to amend its regulation concerning policies and procedures for release of official information and testimony of Army witnesses in federal and state courts where the Army or Department of Defense (DoD) has an interest in the matter. This regulation was last published in the
Consideration will be given to all comments received by: February 13, 2017.
You may submit comments, identified by 32 CFR part 516, Docket No. USA-2015-0016 and or RIN 0702-AA69, by any of the following methods:
Major Thomas S. Hong, (703) 693-1093;
The rule discusses departmental responsibilities, procedures for service of process, procedures for government officials sued in their official capacities, and procedures for requests for release of official information, to include witness testimony. The rule also discusses the release of official information and the appearance of present and former Army personnel as witnesses in response to requests for interviews, notices of depositions, subpoenas, and other requests or orders related to judicial or quasi-judicial proceedings.
For the purposes of this rule, Army personnel include the following:
• Present, former and retired Army military personnel, including the U.S. Army Reserve, regardless of current status.
• Present, former and retired civilian employees of the U.S. Army, regardless of current status.
• Soldiers of the Army National Guard of the United States (Title 10, U.S.C.) and, when specified by statute or where a Federal interest is involved, Soldiers in the Army National Guard (Title 32, U.S.C.).
• Technicians under 32 U.S.C. 709.
• USMA cadets.
• Nonappropriated fund employees.
• Foreign nationals who perform services for the Army overseas.
• Other individuals hired by or for the Army, including individuals hired through contractual agreements by or on behalf of the Army.
This regulation was most recently published in the
Authorities for this rulemaking include the following:
• The Freedom of Information Act at 5 U.S.C. 552 which provides the public with a right to request access to federal agency records or information, except to the extent the records are protected from disclosure by any of nine exemptions or by one of three special law enforcement record exclusions.
• The Privacy Act of 1974 at 5 U.S.C. 552a, which establishes a code of fair information practices that governs the collection, maintenance, use, and dissemination of information about individuals that is maintained in systems of records by federal agencies.
• Confidentiality of records at 42 U.S.C. 290 which requires certain medical records shall be confidential and disclosed only for authorized purposes.
• Executive Order No. 12988, Civil Justice Reform (add a link to the E.O.) which establishes several requirements on Federal agencies involved in litigation or contemplating filing an action on behalf of the United States.
The proposed revisions benefit the Department of the Army agencies, Army support to the Department of Justice, and interaction with state courts in affirmative and defensive litigation information. With the updates to the CFR for statutory and other changes since the document was published in 1994, Army's support of federal litigation and response to requests to support state and private litigation will be improved.
Although no formal study or collection of data are available, a review of the closed Touhy requests for FY 2016 shows that hundreds of hours were expended by Army personnel responding to these requests. Similar to costs in Freedom of Information Act processing, there are substantial costs for searching, reviewing, and producing Army records and personnel for depositions and trial.
This rule will be included in DoD's retrospective plan, completed in August 2011, and will be reported in future
The Department of the Army has determined that the Regulatory Flexibility Act does not apply because the proposed rule does not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601-612.
The Department of the Army has determined that the Unfunded Mandates Reform Act does not apply because the proposed rule does not include a mandate that may result in estimated costs to State, local or tribal governments in the aggregate, or the private sector, of $100 million or more.
The Department of the Army has determined that the National Environmental Policy Act does not apply because the proposed rule does not have an adverse impact on the environment.
This proposed rule does not impose any new recordkeeping, reporting, or other information collection requirements on the public. The proposed rule sets forth procedures by which litigants may serve summonses, complaints, subpoenas, and other legal process, demands, and requests upon the DA. The proposed rule imposes special procedural requirements for those who seek to serve third-party subpoenas upon the DA in accordance with
The Department of the Army has determined that Executive Order 12630 does not apply because the proposed rule does not impair private property rights.
The Department of the Army has determined that, although this rule is not “economically significant” because it does not have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, it is “other significant” for raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in these Executive Orders. For that reason, it has been reviewed by the Office of Management and Budget (OMB).
The Department of the Army has determined that according to the criteria defined in Executive Order 13045. This proposed rule does not apply since it does not implement or require actions impacting environmental health or safety risks to children.
The Department of the Army has determined that according to the criteria defined in Executive Order 13132 this proposed rule does not apply because it will not have a substantial effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among various levels of government.
Litigation, Service of process, Witnesses, Official information, Discovery requests, Expert testimony.
5 U.S.C. 552; 5 U.S.C. 552a; 42 U.S.C. 290; Executive Order No. 12988.
(A) Supervising litigation in which the Army has an interest, except as outlined in paragraphs (a)(1)(A)(ii)-(iv) of this section.
(B) Acting for The Judge Advocate General (TJAG) and the Secretary of the Army on litigation issues, including the authority to settle or compromise cases.
(C) Delegating responsibility for cases if appropriate.
(D) Serving as primary contact with the Department of Justice (DOJ) on litigation.
(E) Accepting service of process for the Department of the Army (DA) and for the Secretary of the Army in his or her official capacity. (See 32 CFR 257.5.)
(F) Approval of the appointment of Special Assistant United States Attorneys (SAUSAs) and DOJ special trial attorneys to represent the Army and DOD in civil litigation.
(ii) Chief, Contract and Fiscal Law Division, USALSA, is responsible for supervising Armed Services Board of Contract Appeals (ASBCA) and Government Accountability Office (GAO) litigation. The Chief Trial Attorney, attorneys assigned to the Contract and Fiscal Law Division, and attorneys designated by the Chief Trial Attorney, will represent DA before the ASBCA for contract appeals. They also represent DA before the GAO for bid protests in cases not falling under the purview of either the U.S. Army Corps of Engineers (USACE) or Army Materiel Command. They will maintain direct liaison with DOJ and represent DA in appeals from ASBCA decisions. The Chief Trial Attorney has designated USACE attorneys to act as trial attorneys in connection with USACE contract appeals.
(iii) Chief, Environmental Law Division, USALSA, is responsible for the following:
(A) Supervising defensive environmental civil litigation and administrative proceedings involving missions and functions of DA, its major and subordinate commands, and
(B) Supervising affirmative cost recovery actions, brought pursuant to Federal or State environmental laws, in which the Army has an interest.
(C) Acting for TJAG and the Secretary of the Army on the assertion and defense of Army water rights, and environmental litigation and affirmative cost recovery issues, including the authority to settle or compromise cases.
(D) Delegating responsibility for cases as appropriate.
(E) Serving as primary contact with DOJ on environmental litigation and cost recovery.
(iv) Chief, Regulatory Law and Intellectual Property (RL & IP) Division, USALSA, is responsible for the following:
(A) Supervising the attorneys assigned to the Regulatory Law and Intellectual Property Division (RL & IP) and other attorneys designated by the Chief, RL & IP, who represent DA consumer interests in regulatory matters before State and Federal administrative agencies and commissions, including but not limited to proceedings involving rates and conditions for the purchase of services for communications (except long-distance telephone), transportation, and utilities (gas, electric, water and sewer). Those attorneys will maintain direct liaison with DOJ for communications, transportation, and utilities litigation as authorized by the Chief, RL & IP.
(B) Supervising attorneys assigned to the RL & IP Division, and other attorneys designated by the Chief RL & IP who represent DA in matters pertaining to patents, copyrights, and trademarks. Those attorneys will maintain direct liaison with DOJ and represent the DA in intellectual property issues as authorized by the Chief, RL & IP.
(v) Chief, Procurement Fraud Division (PFD), is responsible for supervising all attorneys designated to represent the DA in all procurement fraud and corruption matters before the Army suspension and debarment authority and before any civil fraud recovery administrative body. Those attorneys will maintain liaison and coordinate remedies with DOJ and other agencies in matters of procurement fraud and corruption.
(vi) Legal Representatives of the Chief of Engineers. The U.S. Army Corps of Engineers (USACE) Office of Chief Counsel, attorneys assigned thereto, and other attorneys designated by the Chief Counsel will maintain direct liaison with DOJ and represent DA in litigation and administrative proceedings arising from the navigation, civil works, Clean Water Act 404 permit authority, environmental response activities, real property functions of the (USACE).
(2) This part does not apply to releasing official information or testimony by Army personnel in the following situations:
(i) Before courts-martial convened by military departments or in administrative proceedings conducted by or on behalf of a DOD component.
(ii) In administrative proceedings for:
(A) The Equal Employment Opportunity Commission.
(B) The Merit Systems Protection Board.
(C) The Federal Labor Relations Authority.
(D) A negotiated grievance procedure under a collective bargaining agreement to which the government is a party.
(iii) In response to requests by Federal Government counsel in litigation conducted on behalf of the United States.
(iv) Pursuant to disclosure of information to Federal, State, and local prosecuting and law enforcement authorities, in conjunction with an investigation conducted by a DoD criminal investigative organization.
(i) Classified or sensitive information of any kind;
(ii) Privileged information of any kind;
(iii) The acquisition, funding, construction, operation, maintenance, physical condition or readiness, as applicable, of DOD, Army, or other Federal government programs, systems, properties, facilities, equipment, data management systems or personnel;
(iv) Unit records, training records, individual personnel or medical records, investigative reports of any kind, scientific or financial data, official Army publications, and records
(v) Army personnel, their family members, contractors, and other related third parties.
(i) Responses to discovery requests, depositions, and other pretrial proceedings.
(ii) Responses to formal or informal requests by attorneys or others in existing or reasonably anticipated litigation matters.
(ii) In which the Army has an interest. In cases where the Army is not a named party, the Army may still have an interest. These may include: Cases where the Army may incur costs as a result of the litigation; cases where Army operations or policies are implicated; cases which could impact Army property or water rights; disclosure of information harmful to national security or otherwise protected from disclosure; litigation involving Army contractors or manufacturers of Army equipment and property; incidents arising from Department of Defense or Army activities; litigation involving the personal injury of Army personnel or family members, or the personal injury of third parties by Army personnel; the foreign or civilian criminal prosecution of Army personnel, family members, contractors, or manufacturers of Army equipment or property; or civil or family law litigation which may overlap or relate to the foreign or civilian criminal prosecution of Army personnel or family members. If an SJA or legal advisor cannot clearly determine whether Army interests are implicated in a particular case, consult with the appropriate litigating division.
(i) Present, former and retired Army military personnel, including the U.S. Army Reserve, regardless of current status.
(ii) Present, former and retired civilian employees of the U.S. Army, regardless of current status.
(iii) Soldiers of the Army National Guard of the United States (title 10 U.S.C.) and, when specified by statute or where a Federal interest is involved, Soldiers in the Army National Guard (title 32, U.S.C.). It also includes technicians under 32 U.S.C. 709.
(iv) USMA cadets.
(v) Nonappropriated fund employees.
(vi) Foreign nationals who perform services for DA overseas.
(vii) Other individuals hired by or for the Army, including individuals hired through contractual agreements by or on behalf of the Army.
(5) Demand. Subpoena, order, or other demand of a court of competent jurisdiction, or other specific authority, to produce, disclose, or release official Army information (or other official federal agency information subject to release under this chapter) or which require that DA Personnel testify or appear as witnesses.
(1) United States is a party or has an interest. The appropriate litigating division is the release authority for all official, unclassified Army information in cases in which the United States is a party or has a direct interest; they also make all such release decisions for cases in which the information could be used in a claim or litigation against the United States. If uncertainty exists as to whether a given situation constitutes private litigation, forward the request to the appropriate litigating division (See § 516.1(d)).
(2) Non-classified information where the United States has no interest. SJAs and legal advisors are the release authorities for official, unclassified factual information held by their respective commands or organizations in cases of private litigation.
(3) Classified information. Litigation Division is the release authority for official information or appearance of DA personnel as witnesses in litigation involving terrorism, espionage, nuclear weapons, intelligence sources and methods, or involving records otherwise privileged from release, including classified information. Refer any requests involving such information to the General Litigation Branch, Litigation Division.
(4) Medical treatment records. Army Medical Center or Command Judge Advocates or supporting SJAs are the release authorities for official, unclassified factual information in private litigation which involves the release of medical and other records and information within the custody, control or knowledge of the Center or Command Judge Advocates' or supporting SJAs'permanent station hospital and its personnel. Medical records may only be released in compliance with the Health Insurance Portability and Accountability Act (HIPAA) regulations published at 45 CFR parts 160, 162, and 164. Upon court order or subpoena, if appropriate under §§ 516.3-4 (Release Determination and Requestor Responsibilities), and if compliant under the HIPAA regulations, Center or Command Judge Advocates, SJAs and legal advisors may furnish to the attorney for the injured party or the tortfeasor's attorney or insurance company a copy of the narrative summary of medical care that relates to a claim initiated by the United States for recovery of costs for medical care or property claims, pursuant to the Federal Medical Care Recovery Act (42 U.S.C. 2651), the Federal Claims Collection Act (31 U.S.C. 3711), the Third Party Collection Program (10 U.S.C. 1095), or Executive Order No. 12988, Civil Justice Reform. If additional medical records are requested by subpoena or court order, only those that are relevant and necessary to the litigation or pending action will be furnished. If furnishing copies of medical records would prejudice the cause of action, the matter will be reported to Litigation Division.
(5) Substance abuse treatment records. Subpoenas for alcohol abuse or drug abuse treatment records must be processed under 42 U.S.C. 290dd-3 and 290ee-3, and Public Health Service regulations published at 42 CFR 2.1-2.67.
(6) Armed Services Board of Contract Appeals cases. Contracting officers, in consultation with the appropriate servicing SJA, are authorized to release official information to be used in litigation before the Armed Services Board of Contract Appeals, per the Federal Acquisition Regulation (FAR), subpart 5.4., and applicable DOD directives and Army instructions.
(1) Cases where the United States has an interest. The appropriate litigating division, as identified in § 516.1, is the approval authority for personnel who may appear and testify as witnesses in contemplated or pending litigation where the United States is a party or has an interest.
(2) Classified, sensitive, or privileged information. Litigation Division is the approval authority for the appearance of DA personnel as witnesses in litigation involving terrorism, espionage, nuclear weapons, intelligence sources and methods, or involving records otherwise privileged from release, including classified information. (See § 516.1(b)). Refer any requests involving such information to the General Litigation Branch, Litigation Division.
(3) Non-classified Information where the United States has no interest. SJAs, Chief Counsel, or their equivalent, are the approval authorities for individuals within their organizations or commands who may appear for witness testimony, depositions, or interviews or make declarations on factual matters within their personal knowledge when it involves private litigation where the United States has no interest.
(4) Medical Information. Commanders of Medical Commands, in consultation with their legal advisors, are the approval authorities for medical providers and other hospital personnel assigned to their command. This includes witness testimony, depositions, interviews or declarations on factual matters within their personal knowledge when it involves private litigation where the United States has no interest.
(5) Expert testimony. Litigation Division is the approval authority for expert testimony. (See § 516.10).
(6) Former and Retired DA Personnel. The appropriate litigating division is the approval authority for witness testimony relating to official information. (See § 516.2).
(ii) Refer matters concerning patents, copyrights, trade secrets, or trademarks to the Regulatory Law and Intellectual Property Division.
(iii) Refer taxation matters to the Contract and Fiscal Law Division.
(iv) Refer matters concerning communication, transportation, or utility service proceedings to the Regulatory Law and Intellectual Property Division.
(v) Refer environmental matters, to include water rights and affirmative environmental cost recovery to the Environmental Law Division.
(vi) Refer matters arising from the navigation, civil works, Clean Water Act 404 permit authority, environmental response activities, and real property functions of the U.S. Army Corps of Engineers (USACE) Office of Chief Counsel.
(vii) Refer all bid protests, and contract appeals cases before the ASBCA and GAO to the Contract and Fiscal Law Division.
(viii) Refer procurement fraud matters, including
(ix) Refer all other matters to the General Litigation Branch, Litigation Division.
(2) Information to Submit with Referrals. Provide the following data when referring matters pursuant to § 516.2(c):
(i) Copy of the request for official information and all available relevant pleadings (
(ii) Parties (named or prospective) to the proceeding, their attorneys, and case number.
(iii) Party making the request (if a subpoena, indicate moving party) and his or her attorney.
(iv) Name of tribunal in which the proceeding is pending.
(v) Nature of the proceeding.
(vi) Date of receipt of request or date and place of service of subpoena.
(vii) Name, grade, position, and organization of person receiving request or served with subpoena.
(viii) Date, time, and place designated in request or subpoena for production of information or appearance of witness.
(xi) Nature of information sought or document requested, and place where document is maintained.
(x) A copy of each document requested. Contact the appropriate litigating division if this would be burdensome and unnecessary to a decision whether to release, redact, or withhold a particular document.
(xi) Name of requested witness, expected testimony, requested appearance time and date, and whether witness is reasonably available.
(xii) Analysis of the request with recommendations.
(a) Release authorities must ensure requestors state in writing the nature and relevance of the official information they want and include the documentation required by § 516.4. The appropriate release authority should evaluate the request in light of 32 CFR part 97 and
(1) Whether the request is unduly burdensome, inappropriate under the applicable court rules or otherwise irrelevant. Considerations include the size and scope of the request; amount of preparation and transportation time for the witness; mission impact of requiring the witness to be pulled away from current duties to participate; mission impact of requiring responding office personnel to be pulled away from their current assignments to respond to document search, review and production requests; and the potential cumulative burden upon the agency in granting similar requests.
(2) Whether the disclosure is inappropriate under the rules of procedure governing the matter in which the request arose.
(3) Whether the disclosure violates a statute, executive order, regulation, or directive.
(4) Whether the disclosure (including release
(5) Whether the disclosure reveals information properly classified pursuant to the DOD Information Security Program under AR 380-5, unclassified technical data withheld from public release pursuant to 32 CFR 250 and DOD Directive 5230.25 or other sensitive or privileged information exempt from disclosure.
(6) Whether the disclosure would interfere with ongoing enforcement proceedings, compromise constitutional rights, reveal the identity of an intelligence source or confidential informant, disclose trade secrets or confidential, commercial, or financial information, or would otherwise be inappropriate under the circumstances.
(7) Whether disclosure violates any person's expectation of confidentiality or privacy.
(8) Whether any other factor or consideration relevant to the circumstances warrants approving or denying the request.
(a) Individuals seeking official information must submit, at least 14 days before the desired date of production, a detailed written request setting forth the nature and relevance to the litigation or proceeding of the official information sought. Requests for official information involving an employee's appearance and/or production of documents must comply with 32 CFR part 97 and this part. At a minimum, requests must include:
(1) Copy of the complaint or criminal charges and relevant pleadings;
(2) Date of the requested appearance or production;
(3) Party for whom the request is made;
(4) Reason why official information sought is relevant and necessary to requestor and litigation;
(5) For witness requests, name, grade, position, and organization of the witness if known, and substance of the expected testimony. Requestors should not contact potential witnesses without first coordinating with the witness' SJA or legal advisor, or the appropriate litigating division.
(b) Requests from DOJ for DA personnel as witnesses need not follow the requirements above. See § 516.6 for the witness request procedures for DOJ.
(1) Privacy Act (5 U.S.C. 552a) records include any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, his education, financial transactions, medical history, and criminal or employment history and that contains his name, or the identifying number, symbol, or other identifying particular assigned to the individual, such as a finger or voice print or a photograph.
(2) A demand (see definition in
(3) In connection with discovery in federal or state litigation, Privacy Act records will only be released with consent of the individual or under a court order specifically signed by a judge or magistrate of a court of competent jurisdiction. (
(i) Release by Court Order. The court order must state that the court finds that the law authorizes release of the records and the records should be released. If the order or subpoena does not contain these findings the release authority may release the records to a clerk of the court empowered by local statute or practice to receive the records under seal subject to the release authority's request that the clerk of court withhold the records from the parties until the court issues an order determining that the records should be released.
(ii) Release to the Requestor. Privacy Act records may be released to the requestor if a valid Privacy Act consent waiver from the individual to whom the record(s) pertain is submitted with the request. Otherwise, Privacy Act records should only be released pursuant to court order as set forth in (i) above.
(1) Litigation Division and the USACRC Command Judge Advocate will consult with the appropriate United States Attorney's Office regarding assertion of appropriate privileges. To assess the appropriate privilege, safety reports and records will be provided to Litigation Division in complete unredacted form along with a separate copy reflecting identification of all privileged portions.
(2) When requested, contact information for safety personnel witnesses and technical experts will be provided to Litigation Division. As needed, Litigation Division will provide safety records, information, and witness contact information to the U.S. Attorney's Office for evaluation.
(3) Providing safety records, information, and access to safety personnel to Litigation Division or the U.S. Attorney's Office is not considered a “release,” under DOD safety regulations.
(4) All parties handling privileged safety information are obligated to observe confidentiality, protected safety-use requirements, and all other privileges against public disclosure. Privileged safety reports, records, information, or testimony will not be used in litigation without appropriate disclosure safeguards, such as a protective order, agreement, or order to seal.
In routine cases where the Department of the Army is neither a party nor has an interest in the litigation, SJAs may release unclassified and unprivileged official information to DOJ or the U.S. Attorney's Office on request. In connection with any such release, DOJ or the U.S. Attorney's Office must be provided sufficient information to determine whether the requested information is classified, privileged or protected by the Privacy Act or other applicable confidentiality laws, to ensure for its proper handling. DOJ or U.S. Attorney requests for classified information will be coordinated through Litigation Division prior to action. Prior to pursuing declassification of official information, Litigation Division will coordinate with the requesting DOJ attorney to determine whether declassification of the information is appropriate or advisable under the circumstances.
(a) Request or demand for official information and witness testimony will be resolved by the SJA or legal advisor pursuant to this subpart. The appropriate litigating division will be
(b) Local SJAs and command legal advisors will assist DA personnel within their commands and in their geographic area regarding compliance with subpoenas for official information and witness testimony. Such assistance should include providing advice and attending interviews, depositions, and trial testimony.
(c) Where an immediate response is required. A demand, including a subpoena or court order, should never be ignored. If a response to a subpoena or court order is required before a release determination can be made, the SJA or legal advisor will do the following:
(1) Attempt to resolve the issue through informal efforts. Inform the requestor that the demand is under review and, if applicable, that the requestor must provide additional information in accordance with this part in order for a release determination to be made. Seek additional time to respond to the demand and to have the requestor voluntarily withdraw the subpoena or stay the court order.
(2) If informal efforts to resolve the issue are unsuccessful or if time does not permit attempting informal efforts, contact the appropriate litigating division. When the appropriate litigating division is not available, contact the appropriate USAO directly. Request that the USAO seek to stay the subpoena or court order pending the requestor's compliance with this part.
(3) If efforts to stay the subpoena or court order are unsuccessful, seek to quash the subpoena or court order through coordination with the appropriate litigating division or USAO.
(4) If the USAO is challenging the subpoena or court order, the SJA or legal advisor will direct the affected personnel to respectfully decline to comply with the subpoena or court order pending resolution of the challenge.
(d) Subpoenas seeking protected or privileged information. When privilege, statute, or regulation prohibits releasing the subpoenaed information, the SJA or legal advisor should attempt to resolve the matter with the requestor, or, after consultation with the appropriate litigating division and with the assistance of the local U.S. Attorney's Office, appear through counsel and explain the matter to the court. To resolve the matter, SJAs or legal advisors should:
(1) Communicate with the counsel requesting the subpoena. (See sample letter at fig 7-3).
(2) Explain the restrictions on release.
(3) Provide any releasable information.
(4) Suggest withdrawing the subpoena.
(e) Coordination with the US Attorney concerning subpoenas for protected or privileged information. If informal efforts to resolve the situation are unsuccessful, the appropriate litigating division may ask the local U.S. Attorney's Office to file a motion to quash or a motion for a protective order or other appropriate legal recourse. The records privileged or otherwise protected from release should be retained by the custodian pending the court's ruling.
(f) Release of Information through Witness Testimony. If the approval authority determines that the official information may be released, DA personnel may be interviewed, deposed, or appear as a witness in court provided such interview or appearance is consistent with the requirements of this subpart. An Army attorney should ordinarily be present, as the legal representative of the Army, during any interview or testimony. If a question seeks information not previously authorized for release, the legal representative will advise the witness not to answer. If necessary to avoid release of the information, the legal representative will advise the witness to terminate the interview or deposition, or by the Assistant U.S. Attorney in the case of testimony in court, advise the judge that DOD directives and Army regulations preclude the witness from answering without approval from the appropriate litigating division. Every effort should be made, however, to substitute releasable information and to continue the interview or testimony.
(1) If the absence of a witness from duty will interfere seriously with the accomplishment of a military mission, the SJA or legal advisor will advise the requesting party and attempt to make alternative arrangements. If these efforts fail, the SJA or legal advisor will consult on the matter with appropriate litigating division.
(2) When requested by the U.S. Attorney's Office, the SJA or legal advisor will ensure that no witnesses involved in litigation are reassigned from the judicial district without first advising the U.S. Attorney's Office. If this is not feasible, or if a satisfactory arrangement cannot be reached with the U.S. Attorney's Office, the SJA or legal advisor should notify the Litigation Division.
(g) Release of Records. If the Release Authority, after considering the factors set forth in § 516.3, determines that all or part of requested official records are releasable, copies of the records should be furnished to the requestor. In absence of a protective order issued by a court of competent jurisdiction, records protected by the Privacy Act should only be released to the court issuing the applicable subpoena or order, or pursuant to a signed Privacy Act Waiver from the individual to whom the records pertain. (See § 516.5(b))
(h) Authenticating Records. Records custodians should authenticate official Army documents for civil litigation through written certification, rather than personally appearing and testifying. DA personnel will submit authenticated copies rather than originals of documents or records for use in legal proceedings, unless directed otherwise by the appropriate litigating division (See 28 U.S.C. 1733.) The DA Form 4, Department of the Army Certification for Authentication of Records is used to authenticate Army records or documents. (See Figure 5). Documents attached to a properly prepared and sealed DA Form 4 are self-authenticating. (See Fed. R. Evid. 902). A DA Form 4 need not be prepared until the trial attorney presenting the Government's case identifies documents maintained at the installation level that he or she will need at trial. Once documents are identified, the custodian of the documents will execute his or her portion of the DA Form 4. The custodian certifies that the documents attached to the DA Form 4 are true copies of official documents. Documents attached to each form should be identified generally; each document need not be mentioned specifically. Only the upper portion of the form should be executed at the local level. Upon receipt of the DA Form 4 with documents attached thereto, HQDA will affix a ribbon and seal and deliver it to The Office of The Administrative Assistant to The Secretary of the Army or the Chief, Litigation Division. Either The Office of The Administrative Assistant to The Secretary of the Army or the Chief, Litigation Division will place the official Army seal on the packet. Use the simplest authentication procedure permissible, including any suitable alternative suggested by the court.
(i) SJAs or legal advisors should promptly report any subpoenas from foreign courts requiring records, files, or documents to Litigation Division, and comply with the guidance in § 516.7.
(i) They testify regarding their official duties or produce official records on behalf of the U.S.; or
(ii) They testify on matters that relate to their official duties or produce official records on behalf of a party other than the U.S.
(iii) They produce official records on behalf of a party other than the government.
(1) DA personnel are entitled to government funded travel expenses when testifying in an official capacity on behalf of the U.S.
(2) DA personnel are entitled to government funded travel expenses when testifying in an unofficial capacity on behalf of the U.S.
(3) DA uniformed personnel are entitled to government funded travel expenses when testifying in an official capacity for non-federal government agencies when:
(i) The case is directly related to an agency or agency employee, and
(ii) The case is one in which the agency has a particularly strong, compelling and genuine interest.
(4) DA personnel are not entitled to government funded travel expenses when testifying in an official or unofficial capacity on behalf of a party other than the U.S.
(5) See the JTR for exceptions to these general guidelines and for current guidance regarding funding responsibilities for witness travel.
(a) Department of Justice request for DA personnel as witnesses must be coordinated through the General Litigation Branch, Litigation Division. DA personnel receiving a subpoena or witness request from DOJ should contact the General Litigation Branch for assistance.
(b) Cases in which the Army is a party to the litigation. When DOJ requests current DA personnel to appear as witnesses and in cases involving an activity connected to their employment, the travel expenses are payable by the employing command or activity. (See 28 CFR 21.2).
(1) DOJ initiates a witness request by sending a subpoena and a Request for Personnel to Testify as Government Witness form to the General Litigation Branch. The notice should include the witness' name, social security number, residence or duty station address, phone number, email address or fax number, the location, hour and date of appearance, and number of days needed. DOJ should also include the purpose of the testimony.
(2) The General Litigation Branch will notify the witness and the SJA or legal advisor at the employing command or activity and provide them with travel instructions. If the case does not involve the employee's command or activity, the command or activity represented in the litigation will fund the travel expenses, issue a travel authorization/order for the required travel, and provide the necessary line of accounting. (28 CFR 21.2(d)(1) (JTR C4975-C4H-2)).
(c) Cases in which the Army is not a party to the litigation. When DOJ requests current DA personnel to appear as a witness on behalf of the U.S. in an unofficial capacity, the employee's travel expenses are payable by DOJ. The General Litigation Branch will coordinate with the witness and the witness' command or activity to provide travel instructions and DOJ's line of accounting.
(1) DOJ initiates a witness request by sending a subpoena and a Request for Personnel to Testify as Government Witness form to the General Litigation Branch. The notice should include the witnesses' name, social security number, residence or duty station address, phone number, email address or fax number, the location, hour and date of appearance, and number of days needed. The requestor should also include the purpose of the testimony.
(2) The General Litigation Branch will notify the witness and the SJA or legal advisor at the employing command or activity and provide them with travel instructions and a DOJ line of accounting. The witnesses' command prepares travel orders. Upon completion of the travel the witness will seek reimbursement from DOJ.
(1) The litigation involves patients they have treated, investigations they have made, laboratory tests they have conducted, or other actions they have taken in the regular course of their duties; and
(2) Written authorization is obtained under § 516.1(b). AMEDD personnel must limit their testimony to factual matters such as: Their observations of the patient or other operative facts; the treatment prescribed or corrective action taken; course of recovery or steps required for repair of damage suffered; and, contemplated future treatment; and
(3) Their testimony may not extend to expert or opinion testimony, to hypothetical questions, or to a prognosis not formed at the time of examination or treatment.
(1) Whether a consideration listed in §§ 516.3 (a)(1)-(7) above applies.
(2) Whether the information requested is releasable under the principles established in this subpart.
(3) Whether the approval of the American Embassy should be obtained because the person is attached to the Embassy staff or a question of diplomatic immunity may be involved.
(4) Whether coordination with OTJAG International Law office is necessary to respond to the request.
News media inquiries regarding litigation or potential litigation will be referred to the appropriate public affairs office. DA personnel will not comment on any matter currently or potentially in litigation without proper clearance. Local public affairs officers will refer press inquiries to HQDA (SAPA-OSR), WASHINGTON, DC 20310-1500, with appropriate recommendations for review and approval by the Office of the Chief of Public Affairs. All releases of information regarding actual or potential litigation will be coordinated with Litigation Division prior to release. Normally, DOJ is responsible for responding to media inquiries regarding cases in federal litigation.
For the Judge Advocate General.
U.S. Army Corps of Engineers, DoD.
Notice of proposed rulemaking and request for comments.
The U.S. Army Corps of Engineers (Corps) is proposing to revise the existing regulations for a danger zone at the Naval Special Warfare Center (NSWC) N31 Branch within the acoustic buffer of the John C. Stennis Space Center on the East Pearl River, in Hancock County, Mississippi. The Navy requested establishment of a danger zone on waterways and tributaries of the
Written comments must be submitted on or before January 13, 2017.
You may submit comments, identified by docket number COE-2016-0014, by any of the following methods:
Mr. David Olson, Headquarters, Operations and Regulatory Community of Practice, Washington, DC at 202-761-4922 or Ms. Kristi Hall, U.S. Army Corps of Engineers, Vicksburg District, Regulatory Branch at 601-631-7528.
Pursuant to its authorities in Section 7 of the Rivers and Harbors Act of 1917 (40 Stat 266; 33 U.S.C. 1) and Chapter XIX of the Army Appropriations Act of 1919 (40 Stat 892; 33 U.S.C. 3) the Corps is proposing to revise the regulations at 33 CFR part 334 by establishing a danger zone along the East Pearl River. The amendment to this regulation will allow the Commanding Officer of the Naval Construction Battalion Center, Gulfport, MS to restrict passage of persons, watercraft, and vessels in the waters within the danger zone during Department of Defense training for conducting coastal and riverine special operations in support of global military missions. This area is referred to as a danger zone due to the use of short-range tactical ammunition within riverine areas.
Danger zones, Navigation (water), Restricted areas, Waterways.
For the reasons set out in the preamble, the Corps proposes to amend 33 CFR part 334 as follows:
40 Stat. 266 (33 U.S.C. 1) and 40 Stat. 892 (33 U.S.C. 3).
(2) The danger zone, or a portion or portions thereof, will be closed, for riverine, weapons, or other dangerous naval training, by placement of Government picket boats at the northern and southern boundaries in the East Pearl River, or at such other location(s) within the danger zone as may be determined to be sufficient to protect the public. Prior to closure, picket boats will transit the area(s) to be closed, to ensure that no persons, vessels, or other watercraft are present. Once the danger zone, or location(s) within the zone, has been cleared, picket boats will remain in position, upstream and downstream, until it is safe to re-open the area(s) to public access.
(3) Riverine, weapons, and other dangerous naval training may occur on any day of the week, typically, but not exclusively, in periods of two to eight hours, between 6 a.m. and 6 p.m. Training may occur at night, in darkness.
Environmental Protection Agency (EPA).
Notice of data availability.
This Notice provides an opportunity to comment on new information that pertains to the proposed provisions for ethanol flex fuel contained in the Renewables Enhancement and Growth Support (REGS) rule which was published in the
Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2016-0041, to the
Julia MacAllister, Assessment and Standards Division, Office of Transportation and Air Quality, Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI 48105; telephone number: (734) 214-4131; email address:
This action relates to provisions in a previously promulgated Proposed Rule that would potentially affect companies involved with the production, distribution, and sale of blends of ethanol and gasoline. Potentially regulated categories include:
This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that the EPA is now aware could potentially be regulated by this action. Other types of entities not listed in the table could also be regulated. To determine whether your entity is regulated by this action, you should carefully examine the applicability criteria in the referenced regulations. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed in the
This action is issued under the authority of CAA sections 208, 211 and 301.
In the Renewables Enhancement and Growth Support (REGS) Rule,
To support the use of natural gasoline as an EFF blendstock while meeting the EPA's evaporative emission control and public health protection goals, the EPA proposed that a fuel volatility compliance tool could be used to demonstrate compliance with the proposed volatility standards for EFF. The proposed compliance tool was based on a fuel volatility model that was developed using data on the volatility of gasoline—ethanol fuel blends.
Centers for Disease Control and Prevention, HHS.
Denial of petition for addition of a health condition.
On April 11, 2016, the Administrator of the World Trade Center (WTC) Health Program received two petitions (combined into Petition 012) to add atherosclerosis to the List of WTC-Related Health Conditions (List). The Program conducted a literature search for the term in response to the Petition and found no relevant studies regarding atherosclerosis among 9/11-exposed populations. Accordingly, the Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a
The Administrator of the WTC Health Program is denying this petition for the addition of a health condition as of December 14, 2016.
Rachel Weiss, Program Analyst, 1090 Tusculum Avenue, MS: C-46, Cincinnati, OH 45226; telephone (855) 818-1629 (this is a toll-free number); email
Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347, as amended by Pub. L. 114-113), added Title XXXIII to the Public Health Service (PHS) Act,
All references to the Administrator of the WTC Health Program (Administrator) in this notice mean the Director of the National Institute for Occupational Safety and Health (NIOSH) or his or her designee.
Pursuant to section 3312(a)(6)(B) of the PHS Act, interested parties may petition the Administrator to add a health condition to the List in 42 CFR 88.1. Within 90 days after receipt of a petition to add a condition to the List, the Administrator must take one of the following four actions described in section 3312(a)(6)(B) and 42 CFR 88.17: (1) Request a recommendation of the STAC; (2) publish a proposed rule in the
In addition to the regulatory provisions, the WTC Health Program has developed policies to guide the review of submissions and petitions
On April 11, 2016, the Administrator received a petition from a New York City Police Department (NYPD) responder who worked at Ground Zero, and a second, related petition which requested the addition of “atherosclerosis (plaque in arteries),” and “atherosclerosis—arterial plaque,” respectively, to the List; the petitions provided references to the same medical basis, a study by Mani
In accordance with WTC Health Program policy, the medical basis for a potential addition to the List may be demonstrated by reference to a peer-reviewed, published, epidemiologic study about the health condition among 9/11-exposed populations or to clinical case reports of health conditions in WTC responders or survivors.
In response to Petition 012, and pursuant to Program policy,
Since the literature review did not identify any relevant studies of atherosclerosis in the 9/11-exposed population, in accordance with the Program policy discussed above, the Program was unable to further evaluate Petition 012.
Finding no relevant studies with regard to Petition 012, the Administrator has accordingly determined that insufficient evidence is available to take further action at this time, including either proposing the addition of atherosclerosis to the List (pursuant to PHS Act, sec. 3312(a)(6)(B)(ii) and 42 CFR 88.17(a)(2)(ii)) or publishing a determination not to publish a proposed rule in the
For the reasons discussed above, the request made in Petition 012 to add atherosclerosis to the List of WTC-Related Health Conditions is denied.
Studies have not yet demonstrated whether 9/11 exposures, including inhalational dust/debris exposures or psychological exposures of the duration and magnitude experienced on and in the aftermath of September 11, 2001, could cause the development of atherosclerosis in an individual WTC responder or survivor several years later. The Administrator looks forward to more definitive studies that directly evaluate the causal association between 9/11 exposures, especially inhalational dust exposures, and atherosclerosis.
The Secretary, HHS, or her designee, the Director, Centers for Disease Control and Prevention (CDC) and Administrator, Agency for Toxic Substances and Disease Registry (ATSDR), authorized the undersigned, the Administrator of the WTC Health Program, to sign and submit the document to the Office of the Federal Register for publication as an official document of the WTC Health Program. Thomas R. Frieden, M.D., M.P.H., Director, CDC, and Administrator, ATSDR, approved this document for publication on December 2, 2016.
Fish and Wildlife Service, Interior.
We, the U.S. Fish and Wildlife Service (Service), announce a proposal to list the following five tarantula species under the Endangered Species Act of 1973, as amended (Act):
We will accept comments received or postmarked on or before February 13, 2017. Comments submitted electronically using the Federal eRulemaking Portal (see
You may submit comments by one of the following methods:
Janine Van Norman, Chief, Branch of Foreign Species, Ecological Services, U.S. Fish and Wildlife Service, MS: ES, 5275 Leesburg Pike, Falls Church, VA 22041-3803; telephone, 703-358-2171; facsimile, 703-358-1735. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 800-877-8339.
This document proposes the listing of the tarantula species
Our intent, as required by the Act, is to use the best available scientific and commercial data as the foundation for all endangered and threatened species classification decisions. Further, we want any final rule resulting from this proposal to be as accurate and effective as possible. Therefore, we invite the range country, tribal and governmental agencies, the scientific community, industry, and other interested parties to submit comments regarding this Proposed Rule. Comments should be as specific as possible.
Before issuing a final rule to implement this proposed action, we will take into account all comments and any additional relevant information we receive. Such communications may lead to a final rule that differs from our proposal. For example, new information provided may lead to a threatened status instead of an endangered status for some or all of the species addressed in this proposed rule, or we may determine that one or more of these species do not warrant listing based on the best available information when we make our determination. All comments, including commenters' names and addresses, if provided to us, will become part of the administrative record. For each of the five species, we particularly seek comments concerning:
(1) The species' biology, ranges, and population trends, including:
(a) Biological or ecological requirements of the species, including habitat requirements for feeding, breeding, and sheltering;
(b) Genetics and taxonomy;
(c) Historical and current range including distribution patterns;
(d) Historical and current population levels, and current and projected trends; and
(e) Past and ongoing conservation measures for the species, its habitat or both.
(2) Factors that may affect the continued existence of the species, which may include habitat modification or destruction, overutilization, disease, predation, the inadequacy of existing regulatory mechanisms, or other natural or manmade factors.
(3) Biological, commercial trade, or other relevant data concerning any threats (or lack thereof) to the species and existing regulations that may be addressing those threats.
(4) Additional information concerning the historical and current status, range, distribution, and population size of the species, including the locations of any additional populations of the species.
Please include sufficient information with your submission (such as scientific journal articles or other publications) to allow us to verify any scientific or commercial information you include.
Please note that submissions merely stating support for or opposition to the action under consideration without providing supporting information, although noted, will not be considered in making a determination, as section 4(b)(1)(A) of the Act directs that determinations as to whether any species is a threatened or endangered species must be made “solely on the basis of the best scientific and commercial data available.”
You may submit your comments and materials concerning this proposed rule by one of the methods listed in
If you submit information via
Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on
Section 4(b)(5) of the Act provides for one or more public hearings on this
In accordance with our joint policy on peer review published in the
We received a petition, dated October 29, 2010, from WildEarth Guardians requesting that the following 11 tarantula species in the genus
The World Spider Catalog (2016, unpaginated) currently recognizes 14 species of
The primary characteristics used to distinguish
Tarantulas possess life-history traits markedly different from most spiders and other arthropods (Bond
Tarantulas are primarily nocturnal and typically lead a hidden life, spending much of their time concealed inside burrows or crevices (retreats) that provide protection from predators and the elements (Foelix 2011, p. 14; Molur
The lifestyle of adult male tarantulas differs from that of adult females and juveniles. Females and juveniles are sedentary, spending most of their time in or near their retreat. Adult females are also long-lived, and continue to grow, molt, and reproduce for several years after reaching maturity (Ferreti
When a male locates a receptive female, the two will mate in or near the entrance to the female's retreat. After mating, the female returns to her retreat where she eventually lays eggs within an egg-sac and tends the eggs until they hatch. Spiderlings reach maturity in one or more years (Gallon 2000, unpaginated).
Limited information is available on
We are not aware of any information regarding the reproductive success of wild
Time to maturity in
Unlike most tarantulas, which are solitary, most
Sri Lanka is an island nation about 65,610 square kilometers (km
Sri Lanka consists of a mountainous region (central highlands), reaching 2,500 m in elevation, in the south-central part of the island surrounded by broad lowland plains (GOSL 2012, p. 2a-3-141) (Fig. 2). The country has a tropical climate characterized by two major monsoon periods: The southwest monsoon from May to September and the northeast monsoon from December to February (GOSL 2012, pp. 7-8).
Sri Lanka's central highlands create a rain shadow effect that gives rise to two pronounced climate zones—the wet zone and dry zone—and a less extensive intermediate zone between the two (Ministry of Environment—Sri Lanka (MOE) 2010, pp. 21-22) (Fig. 2). Small arid zones also occur on the northwestern and southeastern ends of the country (Nanayakkara 2014a, p. 22). Annual rainfall ranges from less than 1,000 millimeters (mm) (39.4 inches (in)) in the arid zone to over 5,000 mm (197 in) in the central highlands (Jayatillake
The wet zone is located in the southwestern quarter of the island, where high annual rainfall is maintained throughout the year by rain received during both monsoons and during inter-monsoonal periods (MOE 2010, pp. 21-22) (Fig. 2). The wet zone is divided into low, mid, and montane regions based on altitude (Table 2). The dry zone, in which most of the land area of Sri Lanka occurs, is spread over much of the lowland plains and is subjected to several months of drought (MOE 2010, pp. 21-22) (Table 2) (Fig. 2). Most of the rain in this zone comes from the northeast monsoon and inter-monsoonal rains (MOE 2010, pp. 21-22; Malgrem 2003, p. 1236). Characteristic forest types occur within each of the different climate zones (Table 2).
Each of the five petitioned species addressed in this finding is endemic to Sri Lanka and has a range restricted to a particular region and one or two of Sri Lanka's climate zones (Nanayakkara 2014a, pp. 84-85) (Fig. 1, Fig. 2). Due to their secretive and nocturnal habits, sensitivity to vibrations, and their occurrence in structurally complex habitat (forest),
Historical ranges for the five petitioned Sri Lankan species are unknown. Further, population information is not available on any of the five petitioned Sri Lankan species; therefore, population trends are unknown. However, experts believe populations are declining, and that these species are very likely to go extinct within the next two or three decades (Nanayakkara and Adikaram 2013, p. 54). We are not aware of any existing conservation programs for these species. All five species are categorized on the National Red List of Sri Lanka as Endangered or Critically Endangered based on their area of occupancy (Critically Endangered: Less than 10 km
For locations discussed in species-specific information below, see Fig. 1. For locations of the ranges of the different species, see Fig. 2.
The only detailed record of the species' occurrence in a coconut plantation is provided by Smith
During recent surveys,
During recent surveys,
The Act directs us to determine whether any species is an endangered species or a threatened species because of any one or more of five factors or the cumulative effects thereof: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) Overutilization for commercial, recreational, scientific, or educational purposes; (C) Disease or predation; (D) The inadequacy of existing regulatory mechanisms; or (E) Other natural or manmade factors affecting its continued existence. In this section, we summarize the biological condition of the species and its resources, and the influences on such to assess the species' overall viability and the risks to that viability.
Habitat loss and degradation are considered primary factors negatively affecting
Natural forests covered almost the entire island of Sri Lanka a few centuries ago (Mattsson
The extent of past deforestation differed in the three climate zones of the country. The impacts of anthropogenic factors on forests in the wetter regions of the island have been more extensive due to the higher density of the human population in these regions. The human population density in the wet zone is 650 people per km
Recent information on forest cover in the different climate zones is provided in GOSL 2015, GOSL 2012, and FAO 2015a, all of which provide information from the Forest Department of Sri Lanka. The GOSL 2015 report provides a map of the change in forest cover between 1992 and 2010 and a qualitative assessment of these changes. The GOSL 2012 and FAO 2015a reports provide quantitative information on the area of forest cover by forest type for 1992, 1999, and 2010 and contain identical data from the Forest Department. The relevant forest cover information in these two reports is provided in Table 4. However, the Forest Department of Sri Lanka used different rainfall criteria to separate dry and intermediate zone forests, and different altitude criteria to separate montane and submontane forests, in different years (see climate zone and forest definitions in FAO 2015a, p. 6; GOSL 2012, p. 51; FAO 2005, p. 7; FAO 2001, pp. 16, 53). Therefore, we combine the information on intermediate and dry zone forests, and the information on montane and submontane forests in Table 4. We discuss the information on forest cover from the various sources by climate zone below.
Very little wet zone forest remains in Sri Lanka. Currently, the area of montane and submontane forests combined is only about 733 km
The area of lowland wet zone forests (lowland rainforest) declined from 1992 to 2010 (Table 4). Remaining lowland rainforests are severely fragmented, exist primarily as small, isolated patches, and declined by 182 km
Dry and intermediate zone forests, which include most open-canopy forest (Mattsson
Sri Lanka has taken several steps in recent decades to conserve its forests, and these efforts have contributed to the slowing of deforestation in the country (GOSL 2012, pp. 54-55). In 1990 the country imposed a moratorium, which is still in effect, on logging in all natural forests, has marked most forest and wildlife reserve boundaries to stem encroachments, and prepared and implemented management plans for forest and wildlife reserves, which became legal requirements under the Forest Ordinance Amendment Act No. 65 of 2009 and the Fauna and Flora Ordinance Amendment Act No. 22 of 2009 (GOSL 2014, p. 26). The government also encourages community participation in forest and protected area management, has implemented programs to engage residents in community forestry to reduce encroachment of cash crops and tea in the wet zone and slash-and-burn agriculture in the dry zone, and encourages use of non-forest lands and private woodlots for meeting the demands for wood and wood products (GOSL 2014, p. 26). In addition to these efforts, between 12 percent (GOSL 2015, unpaginated) and 28 percent (GOSL 2014, pp. xvi, 23) of the country's land area is reported to be under protected area status.
Although considerable efforts have been undertaken in Sri Lanka in recent years to stop deforestation and forest degradation, these processes are ongoing (see Current and Future Forest Trends). The assessment of the status of natural forests during the Species Red List assessments in 2012 indicate that, despite advances in forest conservation in the country, many existing threats continue to impact forest habitats (GOSL 2014, p. 26). While laws and regulations are in place to address deforestation, issues exist regarding their implementation (GOSL 2012, pp. 55, 2a-3-148-150). For instance, lack of financial assistance for protected area management, increasing demand for land, and regularization of land encroachments, result in further loss of the forest habitat of the five species addressed in this finding (GOSL 2014, p. 22; GOSL 2011, unpaginated). Also, there is poor coordination between government agencies with respect to forest conservation—conservation agencies are not always adequately consulted on initiatives to develop forested land (GOSL 2014, p. 22; MOE 2010, p. 31). In addition, many protected areas within the wet zone are small, degraded, and isolated (GOSL 2014, p. 31).
The current drivers of deforestation and forest degradation in Sri Lanka include a variety of factors such as small-scale encroachments, illicit timber harvesting, forest fires, destructive mining practices, and clearing of forest for developments, settlements, and agriculture (GOSL 2012, p. 12). These are exacerbated by a large, dense human population that is projected to increase from 20.7 million in 2015 to 21.5 million in 2030 (United Nations 2015, p. 22). While the majority of forested areas are protected areas, further population growth is likely to result in reduction of forested areas because (1) Sri Lanka already has a very high human density (329 people per km
The current drivers of deforestation and forest degradation are also exacerbated by high economic returns
Overall, deforestation and forest degradation in Sri Lanka are ongoing, although recent rates of deforestation are much lower than during the mid- to late- 20th century—the rate of deforestation during 1992-2010 was 71 km
Coconut is grown throughout Sri Lanka. Most (57 percent) of the area under coconut cultivation is in the intermediate and wet zones north of Colombo (MOE 2011, p. 14), which overlaps with the southern portion of the range of
The aerial extent of coconut cultivation in Sri Lanka has varied between about 3,630 and 4,200 km
Sri Lanka has lost most of its forest cover due to a variety of factors over the past several decades. Very little (1,966 km
Tarantulas have sedentary habits, limited dispersal ability, and highly structured populations. Therefore, loss of habitat has likely resulted in direct loss of individuals or populations and, consequently, a reduction in the distribution and genetic diversity of these species. The distribution of these species is already limited—each currently occupies less than 500 km
Pesticides are identified as a threat to
There are over 100 pesticide (herbicide, fungicide, and insecticide) active ingredients registered for use in Sri Lanka. Among the most commonly used insecticides are carbofuran, diazinon, and chloropyrifos (Padmajani
The use of pesticides in Sri Lanka has been increasing steadily since the 1950s (Selvarajah and Thiruchelvam 2007, p. 381). Pesticide imports into Sri Lanka increased by 50 percent in 2011 compared to 2006 (Padmajani
The susceptibility of spiders to the direct effects of different pesticides varies with pesticide type and formulation, spider species, development stage, sex, and abiotic and biotic conditions at the time of pesticide application (Pekar 2013, pp. 416-417). Further, different classes of pesticides can cause different sub-lethal effects. For instance, activities such as movement, prey capture, reproduction, development, and defense are particularly disrupted by neurotoxic formulations because they are governed by complex neural interactions. However, spiders can potentially recover from sub-lethal effects over several days (Pekar 2013, p. 417), although the effects are complicated by the potential for cumulative effects of multiple applications across a season (Nash
We are not aware of any information on the population level effects of pesticides on
The Intergovernmental Panel on Climate Change (IPCC) concluded that warming of the climate system is unequivocal (IPCC 2013, p. 4). Numerous long-term climate changes have been observed including changes in land surface temperatures, precipitation patterns, ocean temperature and salinity, sea ice extent, and sea level (IPCC 2013, pp. 4-12). Various types of changes in climate can have direct or indirect effects on species. These effects may be positive, neutral, or negative and they may change over time, depending on the species and other relevant considerations, such as the effects of interactions of climate with other variables (
Maintenance of body temperature and water relations by spiders is critical to their survival. All spiders, including
Tropical ectotherms evolved in an environment of relatively low inter- and intra-annual climate variability, and already live near their upper thermal limits (Settele
While observed and projected changes in temperature and precipitation could potentially be within the tolerance limits of the
The general trend in temperature in Sri Lanka over the past several decades is that of increasing temperature, though with considerable variation between locations in rates and magnitudes of change (De Costa 2008, p. 87; De Silva
Studies show a decreasing trend in rainfall in Sri Lanka over the past several decades (see De Costa 2008, p. 87; De Silva
Rainfall in Sri Lanka is highly variable from year to year, across seasons and across locations within any given year (Jayatillake
While at least one of the species addressed in this finding appears to be vulnerable to drought, the responses of the five petitioned
Collection of species from the wild for trade often begins when a new species is described or when a rare species has been rediscovered. Alerted to a new or novel species, collectors arrive at the reported location and set out collecting the species from the wild (Molur
All five of the petitioned endemic Sri Lankan species are bred by hobbyists and vendors and are available in the pet trade as captive-bred individuals in the United States, Europe, and elsewhere (see Herndon 2014,
Sri Lanka prohibits the commercial collection and exportation of all
In sum, individuals of at least some of these species are currently being collected from the wild. However, the extent to which this activity is occurring is unknown, as is the extent to which these species have been, or are being, affected by collection. Based on the available information on U.S. imports, a small amount of trade occurs in wild specimens of these species. However, it is likely that more wild specimens enter Europe or Asia than the United States due to the closer proximity of Sri Lanka to Europe and Asia and consequent increased ease of travel and transport of specimens. Further, even small amounts of collection of species with small populations can have a negative impact on the species. Given that evidence indicates that low levels of collection of at least some of these species from the wild continues to occur, it is likely that collection for trade is exacerbating population effects of other factors negatively impacting these species, such as habitat loss and degradation, and stochastic processes.
We are not aware of any information on the number of individuals of the petitioned species that are intentionally killed by people. However, in areas where these species occur, higher human densities are likely to result in higher human contact with these species and, consequently, higher numbers of spiders killed. The human population density in Sri Lanka is much higher in the wet zone (see
Species endemic to small regions, or known from few, widely dispersed locations, are inherently more vulnerable to extinction than widespread species because of the higher risks from localized stochastic (random) events and processes, such as floods, fire, landslides, and drought (Brooks
Section 4 of the Act (16 U.S.C. 1533), and its implementing regulations at 50 CFR part 424, set forth the procedures for adding species to the Federal Lists of Endangered and Threatened Wildlife and Plants. Under section 4(a)(1) of the Act, we may list a species based on (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) Overutilization for commercial, recreational, scientific, or educational purposes; (C) Disease or predation; (D) The inadequacy of existing regulatory mechanisms; or (E) Other natural or manmade factors affecting its continued existence. Listing
We have carefully assessed the best scientific and commercial information available on
All five of the petitioned Sri Lankan species have restricted ranges within specific regions and climates of Sri Lanka and are currently estimated to occupy areas of less than 500 km
Therefore, for the following reasons we conclude that these species' resiliency, redundancy, and representation have been and continue to be significantly reduced to the extent that the viability of each of these five species is significantly compromised:
(1) These species are closely tied to their habitats, little of their forest habitat remains, deforestation is ongoing in these habitats, and these species are vulnerable to habitat loss;
(2) these species' have poor dispersal ability, are unlikely to be able to escape changing climate conditions via range shifts, and Sri Lanka's climate is changing at increasing rates;
(3) the cumulative effects of climate change, intentional killing, pesticides, capture for the pet trade, and stochastic processes are likely significantly exacerbating the effects of habitat loss; and
The Act defines an endangered species in section 3(6) of the Act as any species that is “in danger of extinction throughout all or a significant portion of its range” and a threatened species in section 3(20) of the Act as any species that is “likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.” We find that
Based on the factors described above and their impacts on
Under the Act and our implementing regulations, a species may warrant listing if it is endangered or threatened throughout all or a significant portion of its range. Because we have determined that
Conservation measures provided to species listed as endangered or threatened under the Act include recognition of conservation status, requirements for Federal protection, and prohibitions against certain practices. Recognition through listing encourages and results in public awareness and conservation actions by Federal and State governments in the United States, foreign governments, private agencies and groups, and individuals.
Section 7(a) of the Act, as amended, and as implemented by regulations at 50 CFR part 402, requires Federal agencies to evaluate their actions that are to be conducted within the United States or upon the high seas, with respect to any species that is proposed to be listed or is listed as endangered or threatened. Because
Section 8(a) of the Act authorizes the provision of limited financial assistance for the development and management of
Section 9 of the Act and our implementing regulations at 50 CFR 17.21 set forth a series of general prohibitions that apply to all endangered wildlife. These prohibitions, in part, make it illegal for any person subject to the jurisdiction of the United States to “take” (which includes harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect; or to attempt any of these) endangered wildlife within the United States or upon the high seas. It is also illegal to possess, sell, deliver, carry, transport, or ship any such wildlife that has been taken illegally. In addition, it is illegal for any person subject to the jurisdiction of the United States to import; export; deliver, receive, carry, transport, or ship in interstate or foreign commerce, by any means whatsoever and in the course of commercial activity; or sell or offer for sale in interstate or foreign commerce any listed species. Certain exceptions apply to employees of the Service, the National Marine Fisheries Service, other Federal land management agencies, and State conservation agencies.
We may issue permits to carry out otherwise prohibited activities involving endangered wildlife under certain circumstances. Regulations governing permits for endangered species are codified at 50 CFR 17.22. With regard to endangered wildlife, a permit may be issued for the following purposes: for scientific purposes, to enhance the propagation or survival of the species, and for incidental take in connection with otherwise lawful activities. There are also certain statutory exemptions from the prohibitions, which are found in sections 9 and 10 of the Act.
We are required by Executive Orders 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:
(1) Be logically organized;
(2) Use the active voice to address readers directly;
(3) Use clear language rather than jargon;
(4) Be divided into short sections and sentences; and
(5) Use lists and tables wherever possible.
If you feel that we have not met these requirements, send us comments by one of the methods listed in
We have determined that environmental assessments and environmental impact statements, as defined under the authority of the National Environmental Policy Act (NEPA; 42 U.S.C. 4321
A complete list of references cited in this rulemaking is available on the Internet at
The primary authors of this proposed rule are the staff members of the Branch of Foreign Species, Ecological Services, Falls Church, VA.
Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation.
Accordingly, we propose to amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:
16 U.S.C. 1361-1407; 1531-1544; and 4201-4245; unless otherwise noted.
(h) * * *
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of availability; request for comments.
The South Atlantic Fishery Management Council (South Atlantic Council) and Gulf of Mexico Fishery Management Council (Gulf Council) have jointly submitted Amendment 26 to the Fishery Management Plan for the Coastal Migratory Pelagics Fishery of the Gulf of Mexico and Atlantic Region (FMP) for review, approval, and implementation by NMFS. Amendment 26 would adjust the management boundary for the Gulf of Mexico (Gulf) and Atlantic migratory groups of king mackerel; revise management reference points, stock and sector annual catch limits (ACLs), commercial quotas, and recreational annual catch targets (ACTs) for Atlantic migratory group king mackerel; allow limited retention and sale of Atlantic migratory group king mackerel incidentally caught in the shark gillnet fishery; establish a commercial split season for Atlantic migratory group king mackerel in the Atlantic southern zone; establish a commercial trip limit system for Atlantic migratory group king mackerel in the Atlantic southern zone; revise reference points and stock and sector ACLs for Gulf migratory group king mackerel; revise commercial zone quotas for Gulf migratory group king mackerel; and modify the recreational bag limit for Gulf migratory group king mackerel. The purpose of Amendment 26 is to ensure that king mackerel management is based on the best scientific information available, while increasing the social and economic benefits of the fishery.
Written comments must be received on or before February 13, 2017.
You may submit comments on Amendment 26 identified by “NOAA-NMFS-2016-0120,” by either of the following methods:
Electronic copies of Amendment 26 may be obtained from the Southeast Regional Office Web site at
Karla Gore, telephone: 727-551-5753, or email:
The Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) requires each regional fishery management council to submit any FMP or FMP amendment to NMFS for review and approval, partial approval, or disapproval. The Magnuson-Stevens Act also requires that NMFS, upon receiving a plan or amendment, publish an announcement in the
The FMP being revised by Amendment 26 was prepared jointly by the South Atlantic and the Gulf Councils (Councils) and implemented through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Act.
In September of 2014, the Southeast Data, Assessment, and Review 38 stock assessment (SEDAR 38) was completed for both the Gulf migratory group and Atlantic migratory group of king mackerel. SEDAR 38 determined that both the Gulf migratory group and Atlantic migratory group of king mackerel are not overfished and are not undergoing overfishing. The Gulf Council's and South Atlantic Council's Scientific and Statistical Committees (SSCs) reviewed the assessment and concluded that SEDAR 38 should form the basis for revisions to reference points such as the overfishing limit (OFL) and acceptable biological catch (ABC), and the ACLs for the two migratory groups of king mackerel. SEDAR 38 also provided genetic information on king mackerel, which indicated that the winter mixing zone for the two migratory groups was smaller than previously thought and that the management boundary for these migratory groups should be revised.
Amendment 26 includes actions to adjust the management boundary of the Gulf and Atlantic migratory groups of king mackerel; revise reference points, stock and sector ACLs, commercial quotas, and recreational ACTs for Atlantic migratory group king mackerel; allow limited retention and sale of Atlantic migratory group king mackerel incidentally caught in the shark gillnet fishery; establish a commercial split season for Atlantic migratory group king mackerel in the Atlantic southern zone; establish a commercial trip limit system for Atlantic migratory group king mackerel in the Atlantic southern zone; establish a commercial trip limit system for Atlantic migratory group king mackerel in the Atlantic southern zone;
Currently management boundaries change seasonally for the Gulf and Atlantic migratory groups of king mackerel based on the historical understanding that the two migratory groups mixed seasonally off the east coast of Florida and in Monroe County, Florida. However, in 2014, SEDAR 38 determined the mixing zone between the two migratory groups now exists only in the portion of the EEZ off Monroe County, Florida, south of the Florida Keys. Amendment 26 would set a single year-round regulatory boundary (Gulf/Atlantic group boundary) separating management of the two migratory groups of king mackerel, based on the genetic analysis used in SEDAR 38. This new year-round Gulf/Atlantic group boundary would be set at a line extending east of the Miami-Dade/Monroe County, FL boundary, to better represent the area where the two migratory groups primarily exist. The newly defined mixing zone off of the Florida Keys would be included in the Gulf migratory group and managed by the Gulf Council.
Through Amendment 26, the Gulf migratory group's current eastern zone-northern subzone and eastern zone-southern subzone would be renamed the northern zone and southern zone, respectively. The southern zone would include the new mixing zone, extending east to the new Gulf/Atlantic group boundary. The name and dimensions of the Gulf migratory group's western zone would remain the same. The Atlantic migratory group's northern zone would also remain unchanged. The southern boundary of the Atlantic migratory group's southern zone would shift to the new Gulf/Atlantic group boundary. Due to this shift, the current Florida east coast subzone would no longer exist under Amendment 26. Instead, that area would be included in the Atlantic migratory group's southern zone year-round.
This action would not change the current Federal fishing permits requirements for fishing for king mackerel in the Gulf and Atlantic areas as defined in Federal regulations.
Amendment 18 to the FMP established reference points, ACLs, and accountability measures for both migratory groups of king mackerel (76 FR 82058, December 29, 2011). The current ABC of 10.46 million lb (4.74 million kg) for the Atlantic migratory group king mackerel was set in Amendment 18. In Amendment 26, the Councils chose revisions of the OFLs and ABCs for Atlantic migratory group king mackerel based on SEDAR 38 and the South Atlantic Council's SSC ABC recommendation based on a high recruitment scenario. The Atlantic migratory group ABC would gradually decrease from 17.4 million lb (7.89 million kg) in the 2016-2017 fishing year to 12.7 million lb (5.76 million kg) in the 2019-2020 fishing year.
Amendment 26 would also set the stock ACL equal to OY and the ABC. The Atlantic migratory group's sector allocation (37.1 percent of the ACL to the commercial sector and 62.9 percent of the ACL to the recreational sector) will not change through Amendment 26. Amendment 26 would revise the commercial ACLs for Atlantic migratory group king mackerel to be 6.5 million lb (2.9 million kg) for the 2016-2017 fishing year, 5.9 million lb (2.7 million kg) for the 2017-2018 fishing year, 5.2 million lb (2.4 million kg) for the 2018-2019 fishing year, and 4.7 million lb (2.1 million kg) for the 2019-2020 fishing year and subsequent fishing years. The recreational ACLs for Atlantic migratory group king mackerel would be set at 10.9 million lb (4.9 million kg) for the 2016-2017 fishing year, 9.9 million lb (4.5 million kg) for the 2017-2018 fishing year, 8.9 million lb (4.0 million kg) for the 2018-2019 fishing year, and 8.0 million lb (3.6 million kg) for the 2019-2020 fishing year and subsequent fishing years. The recreational sector ACTs for Atlantic migratory group kind mackerel would be set at 10.1 million lb (4.6 million kg) for the 2016-2017 fishing year, 9.2 million lb (4.2 million kg) for the 2017-2018 fishing year, 8.3 million lb (3.8 million kg) for the 2018-2019 fishing year and 7.4 million lb (3.4 million kg) for the 2019-2020 fishing year and subsequent fishing years.
The commercial ACLs for Atlantic migratory group king mackerel would be divided each fishing year between the northern zone (23.04 percent) and the southern zone (76.96 percent) into their respective commercial quotas. The proposed commercial quotas for the Atlantic northern zone would be 1,497,600 lb (679,300 kg) for the 2016-2017 fishing year, 1,259,360 lb (616,595 kg) for the 2017-2018 fishing year, 1,198,080 lb (543,440 kg) for the 2018-2019 fishing year, and 1,082,880 lb (491,186 kg) for the 2019-2020 fishing year and subsequent years. Proposed commercial quotas for the Atlantic southern zone would be 5,002,400 lb (2,269,050 kg) for the 2016-2017 fishing year, 4,540,640 lb (2,059,600 kg) for the 2017-2018 fishing year, 4,001,920 lb (1,815,240 kg) for the 2018-2019 fishing year, and 3,617,120 lb (1,640,698 kg) for the 2019-2020 fishing year and subsequent fishing years.
Amendment 20A to the FMP prohibited recreational bag limit sales of king mackerel by commercially permitted king mackerel fishers in South Atlantic Council jurisdictional waters, which included king mackerel incidentally caught on directed commercial shark trips (79 FR 34246, June 16, 2014).
In Amendment 26, the Councils determined that, as a result of the mesh size used and the nature of the shark gillnet fishery, most king mackerel are already dead when the shark gillnets are retrieved. The Councils decided that some incidental catch of Atlantic migratory group king mackerel should be allowed for retention and sale if it is incidentally caught in the commercial shark gillnet fishery on vessels with a Federal king mackerel commercial permit.
If Amendment 26 is approved and implemented, a vessel in the Atlantic Exclusive Economic Zone that is engaged in directed shark fishing with gillnets, and that has both a valid Federal shark directed commercial permit and a valid Federal king mackerel commercial permit, would be allowed to retain and sell a limited number of king mackerel. In the Atlantic northern zone, no more than three king mackerel per crew member could be retained or sold per trip. In the Atlantic southern zone, no more than two king mackerel per crew member could be retained or sold per trip. The incidental catch allowance would not apply to commercial shark trips that are using an authorized gillnet for Atlantic migratory group king mackerel north of Cape Lookout Light. In that area the existing commercial trip limit of 3,500 lb (1,588 kg) would apply. No type of gillnet is an allowable gear for Atlantic migratory group king mackerel south of Cape Lookout Light. These incidentally caught king mackerel would have to be retained or sold to a dealer with a valid
Currently, the commercial fishing year for Atlantic migratory group king mackerel is March 1 through the end of February, and the commercial ACLs for the Atlantic northern zone and southern zone are allocated for the entire fishing year. Amendment 26 would divide the annual Atlantic migratory group kind mackerel commercial quota for the Atlantic southern zone into two commercial seasons. The Atlantic northern zone quota would not be split. Amendment 26 would divide the commercial quotas for the Atlantic southern zone by allocating 60 percent to the first season of March 1 through September 30, and 40 percent to the second season of October 1 through the end of February. This commercial split season for the Atlantic southern zone quota is intended to ensure that a portion of the southern zone's quota is available in later months of the fishing year, which will allow for increased fishing opportunities during more of the fishing year.
The proposed seasonal commercial quotas for the first season of March 1 through September 30 each fishing year in the southern zone would be: 3,001,440 lb (1,361,430 kg) for the 2016-2017 fishing year, 2,724,384 lb (1,235,760 kg) for the 2017-2018 fishing year, 2,401,152 lb (1,089,144 kg) for the 2018-2019 fishing year, and 2,170,272 lb (984,419 kg) for the 2019-2020 fishing year and subsequent fishing years. The proposed seasonal commercial quotas for the second season of October 1 through the end of February each fishing year in the southern zone would be: 2,000,960 lb (907,620 kg) for the 2016-2017 fishing year, 1,816,256 lb (823,840 kg) for the 2017-2018 fishing year, 1,600,768 lb (726,096 kg) for the 2018-2019 fishing year, and 1,446,848 lb (656,279 kg) for the 2019-2020 fishing year and subsequent years.
Commercial trip limits for Atlantic migratory group king mackerel are limits on the amount of that species that may be possessed on board or landed, purchased or sold from a federally permitted king mackerel vessel per day. Several commercial trip limits currently exist in the Atlantic southern zone. North of 29°25′ N. lat., which is a line directly east from the Flagler/Volusia County, FL, boundary, the trip limit for Atlantic migratory group king mackerel is 3,500 lb (1,588 kg) year-round. In the area between the Flagler/Volusia County, FL, boundary (29°25′ N. lat.) and 28°47.8′ N. lat., which is a line extending directly east from the Volusia/Brevard County, FL, boundary, the trip limit is 3,500 lb (1,588 kg) from April 1 through October 31. In the area between the Volusia/Brevard County, FL, boundary (28°47.8′ N. lat.) and 25°20.4′ N. lat., which is a line directly east from the Miami-Dade/Monroe County, FL boundary, the trip limit is 75 fish from April 1 through October 31. In the area between the Miami-Dade/Monroe County, FL, boundary, and 25°48″ N. lat., which is a line directly west from Monroe/Collier County, FL, boundary, the trip limit is 1,250 lb (567 kg) from April 1 through October 31.
Amendment 26 would revise the commercial trip limits for Atlantic migratory group king mackerel in the Atlantic southern zone, based on the revised management boundary and split commercial season. During the first commercial season (March 1 through September 30), in the area between the Flagler/Volusia County, FL, boundary (29°25′ N. lat.), and the Miami-Dade/Monroe County, FL boundary (25°20.24″ N. lat.), the trip limit would be 50 fish during March. From April 1 through September 30, the trip limit would be 75 fish, unless NMFS determines that 75 percent or more of the Atlantic southern zone quota for the first season has been landed, then the trip limit would be 50 fish. During the second commercial season (October 1 through the end of February), the trip limit would be 50 fish for the area between the Flagler/Volusia County, FL, boundary, and the the Miami-Dade/Monroe County, FL boundary. During the month of February, the trip limit would remain 50 fish, unless NMFS determines that less than 70 percent of the commercial quota for the southern zone's second season has been landed, then the trip limit would be 75 fish.
Amendment 26 would not revise the 3,500 lb (1,588 kg) year-round trip limit for Atlantic migratory group king mackerel, north of the Flagler/Volusia County, FL boundary.
In Amendment 26, the Councils determined that these changes to the commercial season and commercial trip limits for the Atlantic southern zone would ensure the longest possible commercial fishing season for Atlantic migratory group king mackerel.
The current ABC and total ACL for Gulf migratory group king mackerel is 10.8 million lb (4.89 million kg). Based on its review of SEDAR 38, the Gulf Council's SSC recommended OFLs and ABCs for Gulf migratory group king mackerel for the 2015-2016 through 2019-2020 fishing years that decrease over time. The Gulf migratory group king mackerel ABCs in Amendment 26 are lower than the current ABC and total ACL, because the geographical area for which the new ABCs apply is smaller than the current area for which they apply, as a result of the proposed zone revisions in the Gulf and Atlantic.
Because Gulf migratory group king mackerel is not overfished or undergoing overfishing, the Gulf Council recommended that ACL remain equal to OY and to ABC. Therefore, in Amendment 26, the total ACLs for the Gulf migratory group of king mackerel are the same values as the ABCs recommended by the Gulf SSC: 9.21 million lb (4.18 million kg) for the 2016-2017 fishing year, 8.88 million lb (4.03 million kg) for the 2017-2018 fishing year, 8.71 million lb (3.95 million kg) for the 2018-2019 fishing year, and 8.55 million lb (3.88 million kg) for the 2019-2020 fishing year.
Amendment 26 would not revise the current Gulf migratory group king mackerel allocations (68 percent of the total ACL to the recreational sector and 32 percent to the commercial sector). Based on the existing allocations, the commercial ACLs proposed for Gulf migratory group king mackerel are: 2.95 million lb (1.34 million kg) for the 2016-2017 fishing year, 2.84 million lb (1.29 million kg) for the 2017-2018 fishing year, 2.79 million lb (1.27 million kg) for the 2018-2019 fishing year, and 2.74 million lb (1.24 million kg) for the 2019-2020 fishing year and subsequent fishing years.
The Gulf migratory group commercial ACLs would be further divided each fishing year into gear-specific commercial ACLs for hook-and-line gear and for vessels fishing with run-around gillnet gear. The hook-and-line component commercial ACLs (which applies to the entire Gulf) would be: 2,330,500 lb (1,057,097 kg) for the 2016-2017 fishing year, 2,243,600 lb (1,017,680 kg) for the 2017-2018 fishing year, 2,204,100 lb (999,763 kg) for the 2018-2019 fishing year, and 2,164,600 lb (981,846 kg) for the 2019-2020 fishing year and subsequent years. The run-around gillnet component
The proposed recreational ACLs for Gulf migratory group king mackerel would be: 6.26 million lb (2.84 million kg) for the 2016-2017 fishing year, 6.04 million lb (2.74 million kg) for the 2017-2018 fishing year, 5.92 million lb (2.69 million kg) for the 2018-2019 fishing year, and 5.81 million lb (2.64 million kg) for the 2019-2020 fishing year and subsequent fishing years.
Amendment 26 would revise the Gulf migratory group commercial zone quotas, because of the proposed changes to the Councils' jurisdictional boundaries and resultant zone revisions. The current allocation of the commercial ACL for Gulf migratory group king mackerel by zones is: 31 percent in the western zone, 5.17 percent in the northern zone, 15.96 percent for the southern zone using hook-and-line gear, 15.96 percent for the southern zone using gillnet gear, and 31.91 percent for the Florida east coast subzone. However, under Amendment 26, the Florida east coast subzone would no longer exist and the quota associated with that zone would be re-allocated to the remaining zones. The revised allocation of commercial zone quotas for Gulf migratory group king mackerel would be: 40 percent in the western zone, 18 percent in the northern zone, 21 percent for the southern zone using hook-and-line gear, and 21 percent for the southern zone using gillnet gear.
The proposed commercial quotas for the Gulf western zone would be: 1,180,000 lb (535,239 kg) for the 2016-2017 fishing year, 1,136,000 lb (515,281 kg) for the 2017-2018 fishing year, 1,116,000 lb (506,209 kg) for the 2018-2019 fishing year, and 1,096,000 lb (497,137 kg) for the 2019-20 fishing year and subsequent fishing years.
The proposed commercial quotas for the Gulf northern zone would be: 531,000 lb (240,858 kg) for the 2016-2017 fishing year, 511,200 lb (231,876 kg) for the 2017-18 fishing year, 502,200 lb (227,794 kg) for the 2018-2019 fishing year, and 493,200 lb (223,712 kg) for the 2019-2010 fishing year and subsequent fishing years.
The proposed commercial hook-and-line and commercial run-around gillnet component quotas in the southern zone would be equal to each other for each fishing year and would be: 619,500 lb (281,000 kg) for the 2016-2017 fishing year, 596,400 lb (270,522 kg) for the 2017-2018 fishing year, 585,900 lb (265,760 kg) for the 2018-2019 fishing year, and 575,400 lb (260,997 kg) for the 2019-2020 fishing year and subsequent fishing years.
From the 2002-2003 fishing year through the 2013-2014 fishing year, the recreational sector's landings of the Gulf migratory group of king mackerel were consistently less than 50 percent of the recreational ACL, while the commercial sector's landings were consistently 90 percent or more of the commercial ACL. In Amendment 26, the Councils considered but rejected, the possibility of reallocating from the recreational ACL to the commercial ACL and instead proposed an increase in the recreational bag limit for Gulf migratory group king mackerel from 2 fish per person per trip to 3 fish per person per trip. The Councils determined that this increased recreational bag limit would allow more opportunities for recreational anglers to harvest the recreational sector ACL.
A proposed rule that would implement Amendment 26 has been drafted. In accordance with the Magnuson-Stevens Act, NMFS is evaluating the proposed rule to determine whether it is consistent with the FMP, the Magnuson-Stevens Act, and other applicable law. If that determination is affirmative, NMFS will publish a proposed rule in the
The Councils have submitted Amendment 26 for Secretarial review, approval, and implementation. Comments on Amendment 26 must be received by February 13, 2017. Comments received during the respective comment periods, whether specifically directed to the amendment or the proposed rule, will be considered by NMFS in its decision to approve, disapprove, or partially approve Amendment 26.
All comments received by NMFS on the amendment or the proposed rule during their respective comment periods will be addressed in the final rule.
16 U.S.C 1801
Office of the Deputy Under Secretary for Food Safety, USDA.
Notice of public meeting and request for comments.
The Office of the Deputy Under Secretary for Food Safety, U.S. Department of Agriculture (USDA) and the Agricultural Marketing Service (AMS), are sponsoring a public meeting on January 17, 2017. The objective of the meeting is to provide information and receive public comments on agenda items and draft United States (U.S.) positions to be discussed at the 3rd Session of the Codex Committee on Spices and Culinary Herbs (CCSCH) of the Codex Alimentarius Commission (Codex), taking place in Chennai, India, February 6-10,2017. The Deputy Under Secretary for Food Safety and AMS recognize the importance of providing interested parties the opportunity to obtain background information on the 3rd Session of the CCSCH and to address items on the agenda.
The public meeting is scheduled for Tuesday, January 17, 2017 from 2:00 p.m.-4:00 p.m.
The public meeting will take place at the USDA, Jamie L. Whitten Building, Room 107-A, 1400 Independence Avenue SW., Washington, DC 20250.
Documents related to the 3rd Session of the CCSCH will be accessible via the Internet at the following address:
Dorian LaFond, U.S. Delegate to the 3rd Session of the CCSCH, invites U.S. interested parties to submit their comments electronically to the following email address:
If you wish to participate in the public meeting for the 3rd Session of the CCSCH by conference call, please use the call-in-number below:
The participant code will be posted on the following Web page:
Attendees may register to attend the public meeting by emailing
Dorian LaFond, Agricultural Marketing Service, Fruits and Vegetables Division, Mail Stop 0235, Room 2086, USDA, 1400 Independence Avenue SW., Washington, DC 20250. Telephone: (202) 690-4944, Fax: (202) 720-0016, email:
Marie Maratos, U.S. Codex Office, 1400 Independence Avenue SW., Room 4861, Washington, DC 20250. Telephone: (202) 205-7760, Fax: (202) 720-3157, email:
The Codex was established in 1963 by two United Nations organizations, the Food and Agriculture Organization and the World Health Organization. Through adoption of food standards, codes of practice, and other guidelines developed by its committees, and by promoting their adoption and implementation by governments, the Codex seeks to protect the health of consumers and ensure that fair practices are used in trade.
The CCSCH is responsible for elaborating worldwide standards for spices and culinary herbs in their dried and dehydrated state in whole, ground, and cracked or crushed form. The CCSCH consults as necessary with other international organizations in the standards development process to avoid duplication.
The CCSCH is hosted by India.
The following items on the Agenda for the 3rd Session of the CCSCH will be discussed during the public meeting:
• Matters Referred by the Codex Alimentarius Commission and its Subsidiary bodies;
• Activities of International Organizations relevant to the Work of CCSCH;
• Draft Standard for Cumin;
• Draft Standard for Thyme;
• Proposed draft Standard for Black, White and Green Pepper;
• Proposed draft Standard for Oregano;
• Sampling plans for cumin and thyme;
• Further work on grouping of spices and culinary herbs;
• Discussion paper on glossary of terms for spices and culinary herbs;
• Discussion paper on further processing (in the context of spices and culinary herbs);
• Proposal for new work (replies to CL 2015/27-SCH); and
• Other business.
Each issue listed will be fully described in documents distributed, or to be distributed, by the Secretariat before the Meeting. Members of the public may access or request copies of these documents (see
At the January 17, 2017, public meeting, draft U.S. positions on the agenda items will be described and discussed. Attendees will have the opportunity to pose questions and offer comments. Written comments may be offered at the meeting or sent to the U.S. Delegates for the 3rd Session of the CCSCH,(see
Public awareness of all segments of rulemaking and policy development is
FSIS also will make copies of this publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations,
No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.
To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at
Send your completed complaint form or letter to USDA by mail, fax, or email:
Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.), should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).
Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the Virginia State Advisory Committee to the Commission (MD State Advisory Committee) will convene by conference call at 12:00 p.m. (EDT) on Thursday, January 5, 2017. The purpose of each planning meeting is to discuss project planning and eventually select topic(s) for the Committee's civil rights review. At its last meeting, the Committee decided to have a proposal on hate crimes presented and considered among other potential topics.
The meeting will be held on Thursday, January 5, 2017, at 12:00 p.m. EST.
Public call information: Dial: 888-601-3861, Conference ID: 417838
Ivy L. Davis, at
Interested members of the public may listen to the discussion by calling the following toll-free conference call-in number: 1-888-601-3861 and conference ID: 417838. Please be advised that before being placed into the conference call, you will be prompted to provide your name, organizational affiliation (if any), and email address (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free conference call-in number.
Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-800-977-8339 and providing the operator with the toll-free conference call-in number: 1-888-601-3861 and conference call ID: 417838.
Members of the public are invited to submit written comments; the comments must be received in the regional office approximately 30 days after each scheduled meeting. Written comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, faxed to (202) 376-7548, or emailed to Evelyn Bohor at
Records and documents discussed during the meeting will be available for public viewing as they become available at
U.S. Census Bureau, Department of Commerce.
Notice of revision of the confidentiality pledge under Title 13 United States Code, Section 9.
Under 44 U.S.C. 3506(e) and 13 U.S.C. Section 9, the U.S. Census Bureau is announcing revisions to the confidentiality pledge it provides to its respondents under Title 13, United States Code, Section 9. These revisions are required by the passage and
These revisions become effective upon publication of this notice in the
Questions about this notice should be addressed to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Requests for additional information should be directed to Robin J. Bachman, Policy Coordination Office, Census Bureau, HQ-8H028, Washington, DC 20233; 301-763-6440 (or via email at
Federal statistics provide key information that the Nation uses to measure its performance and make informed choices about budgets, employment, health, investments, taxes, and a host of other significant topics. The overwhelming majority of Federal surveys are conducted on a voluntary basis. Respondents, ranging from businesses to households to institutions, may choose whether or not to provide the requested information. Many of the most valuable Federal statistics come from surveys that ask for highly sensitive information such as proprietary business data from companies or particularly personal information or practices from individuals. Strong and trusted confidentiality and exclusively statistical use pledges under Title 13, U.S.C. and similar statistical confidentiality pledges are effective and necessary in honoring the trust that businesses, individuals, and institutions, by their responses, place in statistical agencies.
Under the authority of Title 13, U.S.C. and similar statistical confidentiality protection statutes, many Federal statistical agencies make statutory pledges that the information respondents provide will be seen only by statistical agency personnel or their sworn agents, and will be used only for statistical purposes. Title 13, U.S.C. and similar statutes protect the confidentiality of information that agencies collect solely for statistical purposes and under a pledge of confidentiality. These acts protect such statistical information from administrative, law enforcement, taxation, regulatory, or any other non-statistical use and immunize the information submitted to statistical agencies from legal process. Moreover, many of these statutes carry criminal penalties of a Class E felony (fines up to $250,000, or up to five years in prison, or both) for conviction of a knowing and willful unauthorized disclosure of covered information.
As part of the Consolidated Appropriations Act for Fiscal Year 2016 signed on December 17, 2015, the Congress included the Federal Cybersecurity Enhancement Act of 2015 (H.R. 2029, Division N, Title II, Subtitle B, Sec. 223). This Act, among other provisions, permits and requires the Secretary of Homeland Security to provide Federal civilian agencies' information technology systems with cybersecurity protection for their Internet traffic. The technology currently used to provide this protection against cyber malware is known as Einstein 3A; it electronically searches Internet traffic in and out of Federal civilian agencies in real time for malware signatures.
When such a signature is found, the Internet packets that contain the malware signature are shunted aside for further inspection by Department of Homeland Security (DHS) personnel. Since it is possible that such packets entering or leaving a statistical agency's information technology system may contain a small portion of confidential statistical data, statistical agencies can no longer promise their respondents that their responses will be seen only by statistical agency personnel or their sworn agents. However, they can promise, in accordance with provisions of the Federal Cybersecurity Enhancement Act of 2015, that such monitoring can be used only to protect information and information systems from cybersecurity risks, thereby, in effect, providing stronger protection to the integrity of the respondents' submissions.
Consequently, with the passage of the Federal Cybersecurity Enhancement Act of 2015, the Federal statistical community has an opportunity to welcome the further protection of its confidential data offered by DHS' Einstein 3A cybersecurity protection program. The DHS cybersecurity program's objective is to protect Federal civilian information systems from malicious malware attacks. The Federal statistical system's objective is to ensure that the DHS Secretary performs those essential duties in a manner that honors the Government's statutory promises to the public to protect their confidential data. Given that the Department of Homeland Security is not a Federal statistical agency, both DHS and the Federal statistical system have been successfully engaged in finding a way to balance both objectives and achieve these mutually reinforcing objectives.
Accordingly, DHS and Federal statistical agencies, in cooperation with their parent departments, have developed a Memorandum of Agreement for the installation of Einstein 3A cybersecurity protection technology to monitor their Internet traffic and have incorporated an associated Addendum on Highly Sensitive Agency Information that provides additional protection and enhanced security handling of confidential statistical data.
However, many current Title 13, U.S.C. and similar statistical confidentiality pledges promise that respondents' data will be seen only by statistical agency personnel or their sworn agents. Since it is possible that DHS personnel could see some portion of those confidential data in the course of examining the suspicious Internet packets identified by Einstein 3A sensors, statistical agencies need to revise their confidentiality pledges to reflect this process change. Therefore, the U.S. Census Bureau is providing this notice to alert the public to the confidentiality pledge revisions in an efficient and coordinated fashion.
The following is the revised statistical confidentiality pledge for the Census Bureau's data collections:
The U.S. Census Bureau is required by law to protect your information. The Census Bureau is not permitted to publicly release your responses in a way that could identify you. Per the Federal Cybersecurity Enhancement Act of 2015, your data are protected from cybersecurity risks through screening of the systems that transmit your data.
The following listing includes Census Bureau information collections which are confidential under 13 U.S.C. Section 9, as well as information collections that the Census Bureau conducts on behalf of other agencies which are confidential under 13 U.S.C. Section 9 and for which
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the “Department”) is conducting the fifth administrative review of the antidumping duty order on seamless refined copper pipe and tube from the People's Republic of China (“PRC”), covering the period November 1, 2014 through October 31, 2015. The Department preliminarily finds that, during the period of review (“POR”), the Hailiang Single Entity sold subject merchandise in the United States at less than normal value. Additionally, the Department preliminarily finds that the GD Single Entity did not sell subject merchandise in the United States at less than normal value. Interested parties are invited to comment on these preliminary results.
Effective December 14, 2016.
Drew Jackson or Stephen Bailey, AD/CVD Operations, Office IV, Enforcement & Compliance, International Trade Administration, Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: 482-4406, and 482-0193, respectively.
On November 22, 2010, the Department published in the
The merchandise subject to the order is seamless refined copper pipe and tube. The product is currently classified under Harmonized Tariff Schedule of the United States (“HTSUS”) item numbers 7411.10.1030 and 7411.10.1090. Products subject to this order may also enter under HTSUS item numbers 7407.10.1500, 7419.99.5050, 8415.90.8065, and 8415.90.8085. Although the HTSUS numbers are provided for convenience and customs purposes, the written description of the scope of this order remains dispositive.
On July 12, 2016, the Department extended the time period for issuing the preliminary results of this review until December 5, 2016.
Based on record evidence in this review, as well as the Department's affiliation determination in the 2013-2014 administrative review,
Moreover, based on the information presented in this review, we preliminarily find that Golden Dragon and its group of affiliated companies should be treated as a single entity and Hailiang and its group of affiliated companies should be treated as a single entity for purposes of this review pursuant to 19 CFR 351.401(f). Specifically, pursuant to 19 CFR 351.401(f)(1), the Department preliminarily found that the Golden Dragon companies are affiliated, have production facilities for producing similar or identical products that would not require substantial retooling of their respective facilities in order to restructure manufacturing priorities, and there is a significant potential for manipulation of price or production. The Department reached a similar preliminarily decision with respect to Hailiang and its affiliated companies. Additionally, the Department preliminarily finds that among the Golden Dragon companies and among the Hailiang companies, a significant potential for manipulation exists pursuant to 19 CFR 351.401(f)(2). For additional information,
In the Initiation Notice, we informed parties of the opportunity to request a separate rate.
In this review, nine companies for which a review was requested and which remain under review did not submit separate-rate information to rebut the presumption that they are subject to government control. These companies are: Zhejiang Jiahe Pipes Inc., Sinochem Ningbo Ltd., Sinochem Ningbo Import & Export Co., Ltd., Ningbo Jintian Copper Tube Co., Ltd., Zhejiang Naile Copper Co., Ltd., Guilin Lijia Metals Co., Ltd., Foshan Hua Hong Copper Tube Co., Ltd., Hong Kong Hailiang Metal, and Taicang City Jinxin Copper Tube Co., Ltd. As further discussed in the Preliminary Decision Memorandum,
The Department preliminarily finds that information placed on the record by the GD Single Entity
The Department's change in policy regarding conditional review of the PRC-wide entity applies to this administrative review.
The Department is conducting this review in accordance with section 751(a)(1)(B) of the Act. The Department calculated export prices and constructed export prices in accordance with section 772 of the Act. Because the PRC is a non-market economy country, within the meaning of section 771(18) of the Act, the Department calculated normal value in accordance with section 773(c) of the Act. For a full description of the methodology underlying the preliminary results of this review,
The Preliminary Decision Memorandum is a public document and is made available to the public
The Department preliminarily finds that the following weighted-average dumping margins exist for the POR:
The Department intends to disclose to parties the calculations performed for these preliminary results of review within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). Interested parties may submit case briefs no later than 30 days after the date of publication of these preliminary results of review.
Interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice.
All submissions, with limited exceptions, must be filed electronically using ACCESS.
Unless otherwise extended, the Department intends to issue the final results of this administrative review, which will include the results of its analysis of issues raised in any briefs, within 120 days of publication of these preliminary results, pursuant to section 751(a)(3)(A) of the Act.
Upon issuance of the final results of this review, the Department will determine, and Customs and Border Protection (“CBP”) shall assess, a