Page Range | 58333-58532 | |
FR Document |
Page and Subject | |
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82 FR 58531 - National Pearl Harbor Remembrance Day, 2017 | |
82 FR 58383 - Service Contract Inventory for Fiscal Year (FY) 2016 | |
82 FR 58480 - Notice of Opportunity for Public Comment on a Land Use Change From Aeronautical to Non-Aeronautical Use for 22.1 Acres of Airport Land for Solar Farm Use at Brunswick Executive Airport, Brunswick, ME | |
82 FR 58479 - Notice of Opportunity for Public Comment on a Land Use Change From Aeronautical to Non-Aeronautical Use for 419 Acres of Airport Land for Solar Farm Use at Sanford Seacoast Regional Airport, Sanford, ME | |
82 FR 58480 - Notice of Opportunity for Public Comment on a Land Swap Between the Northern Maine Regional Airport and the Presque Isle Industrial Council, Presque Isle, ME | |
82 FR 58446 - Agency Information Collection Activities: Submission to the Office of Management and Budget for Review and Approval; Fee Collection and Coal Production Reporting and Form OSM-1, Coal Reclamation Fee Report | |
82 FR 58452 - National Space Council Users' Advisory Group; Establishment | |
82 FR 58397 - Production of Rates Based on Data for Repurchase Agreements | |
82 FR 58400 - Medicare Program; Extension of Prior Authorization for Repetitive Scheduled Non-Emergent Ambulance Transports | |
82 FR 58482 - Agency Information Collection Activity Under OMB Review: Department of Veterans Affairs Acquisition Regulation (VAAR), Special Notes | |
82 FR 58481 - Agency Information Collection Activity Under OMB Review: Information Regarding Apportionment of Beneficiary's Award | |
82 FR 58482 - Agency Information Collection Activity: Request for Approval of School Attendance and School Attendance Report | |
82 FR 58483 - Agency Information Collection Activity: Veterans Mortgage Life Insurance Change of Address Statement | |
82 FR 58481 - Agency Information Collection Activity Under OMB Review: Agency Information Collection Activity: VetBiz Vendor Information Pages Verification Program | |
82 FR 58477 - Privacy Act of 1974; System of Records | |
82 FR 58475 - Privacy Act of 1974; System of Records | |
82 FR 58455 - In the Matter of MP Mine Operations LLC; Order Approving Direct Transfers of Control of Licenses | |
82 FR 58383 - Hydrogen and Fuel Cell Technical Advisory Committee (HTAC) | |
82 FR 58387 - Notice of Authorization for Continued Project Operation; Pelzer Hydro Company, LLC, Consolidated Hydro Southeast, LLC | |
82 FR 58384 - Notice of Intent To Prepare an Environmental Assessment for the Proposed TX-LA Markets Project and Request for Comments on Environmental Issues; Enbridge-Texas Eastern Transmission, L.P. | |
82 FR 58387 - Combined Notice of Filings | |
82 FR 58386 - Combined Notice of Filings #2 | |
82 FR 58386 - Combined Notice of Filings #1 | |
82 FR 58431 - Meeting of the Chronic Fatigue Syndrome Advisory Committee; Amendment | |
82 FR 58431 - Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria | |
82 FR 58447 - Proposed Collection, Comment Request | |
82 FR 58333 - Highly Erodible Land Conservation and Wetland Conservation; Conforming Amendment | |
82 FR 58454 - Arts Advisory Panel Meetings | |
82 FR 58374 - Fisheries of the Exclusive Economic Zone Off Alaska; Halibut Bycatch Management in the Groundfish Fisheries of the Bering Sea and Aleutian Islands | |
82 FR 58348 - Federal Civil Penalties Adjustments | |
82 FR 58396 - Federal Advisory Committee Act; Communications Security, Reliability, and Interoperability Council | |
82 FR 58393 - Information Collection Being Submitted for Review and Approval to the Office of Management and Budget | |
82 FR 58388 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority | |
82 FR 58394 - Information Collection Being Reviewed by the Federal Communications Commission | |
82 FR 58374 - Petitions for Reconsideration of Action in Rulemaking Proceeding | |
82 FR 58458 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Granting an Extension to Limited Exemption From Rule 612(c) of Regulation NMS In Connection With the Exchange's Retail Liquidity Program Until June 30, 2018 | |
82 FR 58378 - Proposed Information Collection; Comment Request; The American Community Survey | |
82 FR 58421 - Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements; Guidance for Industry; Availability | |
82 FR 58381 - Availability of Elizabeth River and Southern Branch Navigation Improvements Draft General Reevaluation Report/Environmental Assessment | |
82 FR 58382 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Evaluation of the ESEA Title VI Indian Education LEA Grants Program | |
82 FR 58429 - Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2018 Proposed Guidance Development | |
82 FR 58457 - New Postal Products | |
82 FR 58448 - Safe + Sound Campaign; Office of Management and Budget's (OMB) Approval of Information Collection (Paperwork) Requirements | |
82 FR 58454 - Notice of Intent To Seek Approval To Establish an Information Collection | |
82 FR 58381 - Submission for OMB Review; Comment Request | |
82 FR 58350 - Department of State Acquisition Regulation; Technical Amendment | |
82 FR 58351 - Department of State Acquisition Regulation | |
82 FR 58396 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB | |
82 FR 58378 - Submission for OMB Review; Comment Request | |
82 FR 58411 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion | |
82 FR 58432 - National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting | |
82 FR 58433 - Intent To Request Revision From OMB of One Current Public Collection of Information: Flight Crew Self-Defense Training-Registration and Evaluation | |
82 FR 58456 - Submission for OMB Review; Comments Request | |
82 FR 58469 - Calvert Research and Management and Calvert ETF Trust | |
82 FR 58335 - Streamlining Administrative Regulations for Multifamily Housing Programs and Implementing Family Income Reviews Under the Fixing America's Surface Transportation (FAST) Act | |
82 FR 58434 - Family Self-Sufficiency Performance Measurement System (“Composite Score”) | |
82 FR 58439 - Notice for Suspension of Small Area Fair Market Rent (Small Area FMR) Designations; Solicitation of Comment | |
82 FR 58452 - Records Schedules; Availability and Request for Comments | |
82 FR 58421 - Determination That NOROXIN (Norfloxacin) Tablets, 400 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | |
82 FR 58410 - Refusal of Inspection by a Foreign Food Establishment or Foreign Government; Draft Guidance for Industry; Availability | |
82 FR 58407 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food Allergen Labeling and Reporting | |
82 FR 58470 - Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Applicable to Its Equity Options Platform | |
82 FR 58462 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the NYSE Arca Options Fees and Charges and the NYSE Arca Equities Fees and Charges To Modify the Fees Related to Four Bundles of Co-Location Services in Connection With the Exchange's Co-Location Services | |
82 FR 58473 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing of Proposed Rule Change Amending the NYSE Listed Company Manual To Modify Its Requirements With Respect to Delivery of Proxy Materials to the Exchange | |
82 FR 58465 - Self-Regulatory Organizations; NYSE American LLC; Notice of Filing and Immediate Effectiveness of Proposed Change To Amend the NYSE American Equities Price List and the NYSE American Options Fee Schedule To Modify the Fees Related to Four Bundles of Co-Location Services in Connection With the Exchange's Co-Location Services | |
82 FR 58459 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Exchange's Price List To Modify the Fees Related to Four Bundles of Co-Location Services in Connection With the Exchange's Co-Location Services | |
82 FR 58441 - Advanced Notice of EnVision Center Demonstration | |
82 FR 58458 - Actuarial Advisory Committee With Respect to the Railroad Retirement Account; Notice of Public Meeting | |
82 FR 58480 - Petitions for Exemptions; Summary of Petition Received; Extension of Comments | |
82 FR 58389 - Information Collections Being Submitted for Review and Approval to the Office of Management and Budget | |
82 FR 58391 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority | |
82 FR 58392 - Information Collection Being Submitted for Review and Approval to the Office of Management and Budget | |
82 FR 58365 - FCC Form 325 Data Collection; Modernization of Media Regulation Initiative | |
82 FR 58446 - Agency Information Collection Activities; Comment Request; DOL-Only Performance Accountability, Information, and Reporting System | |
82 FR 58450 - Minnesota State Plan; Changes in Level of Federal Enforcement: Employment on Indian Reservations and Twin Cities Army Ammunition Plant, and Coverage Clarifications | |
82 FR 58450 - Excavations (Design of Cave-in Protection Systems); Extension of the Office of Management and Budget's (OMB) Approval of Information Collection (Paperwork) Requirements | |
82 FR 58479 - Release of Waybill Data | |
82 FR 58432 - Agency Information Collection Activities: 287(g) Needs Assessment; New Collection | |
82 FR 58425 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Calorie Labeling of Articles of Food in Vending Machines | |
82 FR 58468 - Proposed Collection; Comment Request | |
82 FR 58403 - Agency Information Collection Activities: Submission for Office of Management and Budget Review; Comment Request; Applications for Food and Drug Administration Approval To Market a New Drug | |
82 FR 58424 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Products Development; Food and Drug Administration Orphan Drug Designation Request Form and The Common European Medicines Agency/Food and Drug Administration Form for Orphan Medicinal Product Designation | |
82 FR 58347 - Approval and Promulgation of Implementation Plans; New Mexico; Albuquerque and Bernalillo County; Regional Haze Progress Report State Implementation Plan | |
82 FR 58342 - Approval and Promulgation of Implementation Plans; New York; Reasonably Available Control Technology for the 2008 8-Hour Ozone National Ambient Air Quality Standards | |
82 FR 58334 - Amendment of Class E Airspace, Stevens Point, WI | |
82 FR 58362 - Airworthiness Directives; Gulfstream Aerospace Corporation Airplanes | |
82 FR 58486 - Renewable Fuel Standard Program: Standards for 2018 and Biomass-Based Diesel Volume for 2019 | |
82 FR 58364 - Periodic Reviews of the Renewable Fuel Standard Program | |
82 FR 58341 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Removal of Clean Air Interstate Rule Trading Programs Replaced by Cross-State Air Pollution Rule Trading Programs; Withdrawal of Direct Final Rule | |
82 FR 58354 - Public Availability of Information | |
82 FR 58444 - Endangered and Threatened Wildlife and Plants; Draft Supplement to the Grizzly Bear Recovery Plan: Habitat-Based Recovery Criteria for the Northern Continental Divide Ecosystem |
Census Bureau
National Oceanic and Atmospheric Administration
Defense Acquisition Regulations System
Engineers Corps
Federal Energy Regulatory Commission
Centers for Medicare & Medicaid Services
Food and Drug Administration
National Institutes of Health
Transportation Security Administration
U.S. Immigration and Customs Enforcement
Fish and Wildlife Service
Surface Mining Reclamation and Enforcement Office
Employment and Training Administration
Labor Statistics Bureau
Occupational Safety and Health Administration
National Endowment for the Arts
Federal Aviation Administration
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
Office of the Secretary and Federal Crop Insurance Corporation, USDA.
Final rule.
This final rule amends the United States Department of Agriculture regulations to conform to the changes regarding conservation compliance made by the Federal Crop Insurance Corporation (FCIC) to its regulations in Catastrophic Risk Protection Endorsement; Area Risk Protection Insurance Basic Provisions; and Common Crop Insurance Policy Basic Provisions. These changes will provide more flexibility for conservation compliance determinations; reduce burdens on policyholders; and will allow the conservation compliance certification process for crop insurance to be administered more consistently with the practices of the Farm Service Agency (FSA).
This rule is effective December 12, 2017.
Tim Hoffmann, Risk Management Agency, telephone (816) 926-7730; Joe Fuchtman, Farm Service Agency, telephone (202) 260-9146; or Jason Outlaw, Natural Resource Conservation Service, telephone (202) 720-7838.
Recently, FCIC published a final rule in the
USDA is amending the Highly Erodible Land Conservation and Wetland Conservation provisions to conform to the changes to the Catastrophic Risk Protection Endorsement, the Area Risk Protection Insurance Basic Provisions, and the Common Crop Insurance Policy Basic Provisions regarding conservation compliance.
The specific changes to the Highly Erodible Land Conservation and Wetland Conservation regulation include removing the date of June 1 from the conservation compliance provisions and adding a reference to the premium billing date. Because the June 1 date is being removed, USDA is also revising the exception for farmers who began farming after June 1 to instead refer to producers who meet the Risk Management Agency's conditions for farmers who are new to farming, new to crop insurance, a new entity, or have not previously been required to file form AD-1026.
These changes will provide more flexibility for FSA conservation compliance determinations, reduce burdens on policyholders and will allow the conservation compliance certification process for crop insurance to be administered more consistently with the way it is administered for other USDA programs while maintaining conformance to the Conservation Compliance provisions mandated by the Congress in the Agricultural Act of 2014.
Executive Order 12866, “Regulatory Planning and Review,” and Executive Order 13563, “Improving Regulation and Regulatory Review,” 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). Executive Order 13563 emphasized the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The Office of Management and Budget (OMB) designated this rule as not significant under Executive Order 12866, “Regulatory Planning and Review,” and therefore, OMB has not reviewed this rule. The rule is not subject to Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs.”
Pursuant to the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35, subchapter I), the collections of information in this rule have been approved by OMB under control number 0563-0053.
USDA is committed to complying with the E-Government Act of 2002, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. This rule contains no Federal mandates (under the regulatory provisions of title II of the UMRA) for State, local, and tribal governments or the private sector. Therefore, this rule is not subject to the requirements of sections 202 and 205 of UMRA.
It has been determined under section 1(a) of Executive Order 13132, Federalism, that this rule does not have sufficient implications to warrant consultation with the States. The provisions contained in this rule will not have a substantial direct effect on States, or 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 rule has been reviewed in accordance with the requirements of Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments.” Executive Order 13175 requires Federal agencies to consult and coordinate with tribes on a government-to-government basis on policies that have tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that 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.
USDA has assessed the impact of this rule on Indian tribes and determined that this rule does not, to our knowledge, have tribal implications that require tribal consultation under E.O. 13175. If a Tribe requests consultation, USDA will work with the Office of Tribal Relations to ensure meaningful consultation is provided where changes, additions and modifications identified herein are not expressly mandated by Congress.
USDA certifies that this regulation will not have a significant economic impact on a substantial number of small entities. This regulation is a conforming amendment to a final rule published by FCIC that states the Federal crop insurance program is the same for all producers regardless of the size of their farming operation. For instance, all producers are required to file an AD-1026 with FSA to be eligible for premium subsidy. Whether a producer has 10 acres or 1,000 acres, there is no difference in the kind of information collected. To ensure crop insurance is available to small entities, the Federal Crop Insurance Act (FCIA) authorizes FCIC to waive collection of administrative fees from limited resource farmers. FCIC believes this waiver helps to ensure that small entities are given the same opportunities as large entities to manage their risks through the use of crop insurance. A Regulatory Flexibility Analysis has not been prepared since this regulation does not have a significant impact on a substantial number of small entities, and, therefore, this regulation is exempt from the provisions of the Regulatory Flexibility Act (5 U.S.C. 605).
This program is listed in the Catalog of Federal Domestic Assistance under No. 10.450.
This program is not subject to the provisions of Executive Order 12372, which require intergovernmental consultation with State and local officials. See 2 CFR part 415, subpart C.
This rule has been reviewed in accordance with Executive Order 12988 on civil justice reform. The provisions of this rule will not have a retroactive effect. The provisions of this rule will preempt State and local laws to the extent such State and local laws are inconsistent herewith.
This action is not expected to have a significant economic impact on the quality of the human environment, health, or safety. Therefore, neither an Environmental Assessment nor an Environmental Impact Statement is needed.
Crop insurance, Reporting and recordkeeping requirements, Soil conservation.
Accordingly, as set forth in the preamble, USDA amends 7 CFR part 12 as follows:
16 U.S.C. 3801, 3811-12, 3812a, 3813-3814, and 3821-3824.
(b)
(1) A Form AD-1026, or successor form, for the person must be filed with FSA for the reinsurance year in order for the person to be eligible for any Federal crop insurance premium subsidies for the reinsurance year. Persons will be ineligible for Federal crop insurance premium subsidy on their crop insurance policy if form AD-1026, or successor form, has not been filed with FSA for the reinsurance year by the premium billing date for their Federally-reinsured crop insurance policy.
(2) A person that has not filed an AD-1026 for the reinsurance year by the premium billing date may be eligible for premium subsidy for the reinsurance year if they provide information necessary for the person's filing of a Form AD-1026 if the person:
(i) Is unable to file a Form AD-1026 due to circumstances beyond the person's control, as determined by FSA; or
(ii) Files a Form AD-1026 in good faith and FSA subsequently determines that additional information is needed, but the person is unable to comply due to circumstances beyond the control of the person.
(3) A person who does not have Form AD-1026, or successor form, on file with FSA for the reinsurance year may be eligible for Federal crop insurance premium subsidy for the initial reinsurance year if the person can demonstrate they meet RMA's conditions for new to farming, new to crop insurance, a new entity, or have not previously been required to file form AD-1026.
Federal Aviation Administration (FAA), DOT.
Final rule, correction.
This action corrects a final rule published in the
Effective 0901 UTC, February 1, 2018. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
Walter Tweedy, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5900.
The FAA published a final rule in the
Subsequent to publication, the FAA found that the geographic coordinates for the airport were incorrect. This action amends the latitude coordinate in the airspace designation.
Class E airspace designations are published in paragraph 6005, respectively, of FAA Order 7400.11B, dated August 2, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
Accordingly, pursuant to the authority delegated to me, in the
Office of the Deputy Secretary, HUD.
Interim final rule.
HUD published a final rule on March 8, 2016, containing changes to streamline regulatory requirements pertaining to certain elements of the Housing Choice Voucher (HCV), Public Housing (PH), and various multifamily housing (MFH) rental assistance programs. The goal of the final rule was to reduce the administrative burden on public housing agencies (PHAs) and MFH owners, including changes pertaining to annual income reviews in the HCV, PH, and Section 8 Project-Based Rental Assistance (PBRA) programs for families with sources of fixed income. On December 4, 2015, the President signed the Fixing America's Surface Transportation Act (FAST Act) into law. The law contained language that allowed PHAs and owners to conduct full income recertification for families with 90 percent or more of their income from fixed-income every 3 years instead of annually. This interim final rule amends the regulatory language to implement the FAST Act and to align the current regulatory flexibilities with those provided in the FAST Act. In addition, this interim final rule seeks to extend to certain MFH programs some of the streamlining changes that were proposed for and made only to the HCV and PH programs.
Interested persons are invited to submit comments regarding this interim final rule. All communications must refer to the above docket number and title. There are two methods for submitting public comments.
1.
2.
To receive consideration as public comments, comments must be submitted through one of the two methods specified above. Again, all submissions must refer to the docket number and title of the rule.
For questions, please contact the following people (the phone numbers are not toll-free):
Persons with hearing or speech impairments may access this number through TTY by calling the Federal Relay Service at 800-877-8339 (this is a toll-free number). The above-listed contacts may also be reached by mail at the following address: U.S. Department of Housing and Urban Development; 451 7th Street SW, Washington, DC 20410.
On January 6, 2015, at 80 FR 423, HUD issued a proposed rule to implement several statutory changes made in the Department of Housing and Urban Development Appropriations Act, 2014 and also make multiple administrative streamlining changes across several HUD programs. In that proposed rule, some of these additional streamlining changes applied only to the HCV and PH programs, not MFH programs. Given feedback on the rule, HUD is issuing this interim final rule to expand some of the flexibilities—namely, flexibilities related to utility reimbursements and asset declarations that were finalized for the HCV and PH programs in a March 8, 2016, final rule, at 81 FR 12354—to housing assisted under the following MFH programs, while seeking public feedback on that expansion:
(1) Section 8 Project-Based Rental Assistance (PBRA), including projects undergoing Mark-to Market debt restructuring under the Multifamily Assisted Housing Reform and Affordability Housing Act.
(2) Section 202 of the Housing Act of 1959 (both before and after section 202 was amended by section 801 of the Cranston-Gonzalez National Affordable Housing Act).
(3) Section 811 of the Cranston-Gonzalez National Affordable Housing Act.
In addition, another of the provisions in the March 8, 2016, final rule, which applied to the HCV, PH, and above-listed MFH programs, allowed PHAs and multifamily owners to streamline income recertification procedures for families with income that comes from fixed-income sources. The new regulatory provision allowed PHAs and owners to only require third-party documentation for fixed-income sources every 3 years. In the intermediate years the PHA or owner could apply a previously determined or verified cost of living adjustment (COLA) or interest rate adjustment specific to each source of fixed income.
Prior to the issuance of the final rule, on December 4, 2015, the President signed the FAST Act (Pub. L. 114-94). While primarily a transportation law, section 78001 of the FAST Act also amended the United States Housing Act of 1937 to allow PHAs and owners in the HCV, PH, and PBRA programs to eliminate annual income reviews in some years by applying a COLA determined by the Secretary to fixed-income sources for families with incomes that are made up of at least 90 percent fixed income. The PHA or owner is not required to verify non-fixed income amounts in years where no fixed-income review is required, but is still required to use third-party documentation for a full income recertification every 3 years.
This interim final rule not only implements the statutory provisions of the FAST Act, but it also modifies the earlier streamlining regulations so that the procedures for families meeting the 90 percent fixed-income threshold of the FAST Act are as similar as possible to those for families who receive some, but less than 90 percent, of their income from fixed-income sources.
Under this interim final rule, during years 2 and 3 after a full income review, PHAs and owners in the HCV, PH, and PBRA programs may determine a family's fixed income by using a verified COLA or rate of interest on the individual sources of fixed income. In the case of a family with at least 90 percent of the family's unadjusted income from fixed income, a PHA or owner using streamlined income verification may, but is not required to, adjust the non-fixed income. For families with at least one source of fixed income, but for which less than 90 percent of the family's income is from fixed sources, PHAs and owners must verify and adjust non-fixed sources annually.
This interim final rule does not change the requirement that the PHA or owner must undertake a full recertification every 3 years. Nor does it alter the requirement, applicable under the current regulations, that families certify that all the information they submit for income verification, including the sources of income, is accurate.
As required by § 5.632 of the current PBRA regulations, where tenants pay for their utility usage, owners must reimburse tenants if the utility allowance exceeds the total tenant payment, but they do not specify how frequently such reimbursement must be made. Such silence may have led owners to the assumption that reimbursements must be monthly, causing them to process small monthly checks and expend postage to mail them to voucher holders, which may constitute an administrative and financial burden.
This interim final rule explicitly allows owners to make reimbursements of $45 or less (per quarter) on a quarterly basis, in order to eliminate the burdensome process of processing and mailing monthly reimbursement checks. In the event a family leaves the program in advance of its next quarterly reimbursement, the owner would be required to reimburse the family for a prorated share of the applicable reimbursement. Owners exercising this option will be required to have a policy in place to assist tenants for whom the quarterly reimbursements will pose a financial hardship.
For the Section 202 and Section 811 programs, the regulations do not contain the requirements around utility reimbursements, in general, leaving such requirements in the assistance contracts. Therefore, HUD is not including regulatory text to implement these new flexibilities in this interim final rule, but rather would be open to amending the assistance contracts of any owners looking to take advantage of the flexibilities.
Families in the PBRA program are required to report all assets annually. The amount of interest earned on those assets is included as income used to calculate the tenant's rent obligation. Tenants with assets below $5,000 typically generate minimal income from these assets, which results in small changes, if any, to tenant rental payments. Owners spend significant time verifying such assets.
This rule amends the regulations so that, for a family that has net assets equal to or less than $5,000, an owner, at recertification, may accept a family's declaration that it has net assets equal to or less than $5,000, without annually taking additional steps to verify the accuracy of the declaration. Third-party verification of all family assets will be required every 3 years.
The regulations allow owners in the Section 202 and Section 811 programs to require tenants to provide the same certification of assets allowed in the HCV, PH, and PBRA programs.
In the March 8, 2016, final rule, the provisions related to utility allowance reimbursements and asset certification applied to the HCV and PH programs only. HUD is currently expanding the same policies to the MFH programs through this interim final rule. However, comments on this interim final rule may lead us to reconsider those policies as they apply to the HCV and PH programs, in the interest of aligning policies across HUD programs.
In general, HUD publishes a rule for public comment before issuing a rule for effect, in accordance with its own regulations on rulemaking, 24 CFR part 10. Part 10, however, provides for exceptions from that general rule where the Department finds good cause to omit advance notice and public participation. The good cause requirement is satisfied when the prior public procedure is “impracticable, unnecessary, or contrary to the public interest.”
The Department finds that good cause exists to publish this interim rule for effect on the basis that the streamlining changes made to utility reimbursement and declaration of assets in this interim rule were included in HUD's January 6, 2015, proposed rule. Although these provisions were not presented as streamlining changes for adoption in HUD's MFH programs, commenters responding to the solicitation of comment in the January 6, 2015, proposed rule requested HUD consideration of extending the applicability of these provisions to HUD's MFH programs.
The language implementing the FAST Act is implementing statutory language that provides an option for PHAs and owners. While the statute does not mandate that PHAs or owners use the streamlined reexamination, it does require HUD to give PHAs and owners the option. In addition, this interim final rule builds upon proposals that already underwent public comment, resulting in HUD's March 8, 2016, final rule. The specific use of the Social Security Administration's COLA was not issued for prior public comment, but the use of a single COLA, unless requested otherwise by the family, will provide PHAs and owners with additional streamlining benefits.
Although HUD is issuing this rule for effect, HUD has delayed the effective date for a period of 90 days, allowing participants in HUD's MFH programs and other interested parties to submit comment during the first 30-day period following publication of this interim rule. HUD will take any comments received into consideration and determine whether any further changes should be made before implementing the streamlining changes for the MFH programs.
While HUD welcomes comments on all aspects of this interim final rule, HUD is seeking specific comment on the following question:
The language in this interim final rule proposes a policy on utility reimbursements and asset certification identical to that applying to the HCV and PH programs contained in the March 8, 2016, final rule. Comments on this interim final rule may lead us to reconsider those policies as they apply to the HCV and PH programs, in the interest of aligning policies across HUD programs. Are there program-specific or unintended impacts in the HCV, PH, or MFH programs that should be considered in aligning these policies across programs? Would any difference cause a burden to entities administering these forms of assistance or to the tenants receiving the assistance?
Under Executive Order 12866 (Regulatory Planning and Review), a determination must be made whether a regulatory action is significant and therefore, subject to review by the Office of Management and Budget (OMB) in accordance with the requirements of the order. Executive Order 13563 (Improving Regulations and Regulatory Review) directs executive agencies to analyze regulations that are “outmoded, ineffective, insufficient, or excessively burdensome,” and to modify, streamline, expand, or repeal them in accordance with what has been learned. Executive Order 13563 also directs that, where relevant, feasible, and consistent with regulatory objectives, and to the extent permitted by law, agencies are to identify and consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public. This rule was not determined to be a “significant regulatory action” as defined in section 3(f) of the Executive order.
As discussed, this interim final rule furthers HUD's efforts to streamline administrative requirements for owners receiving subsidies under the HCV, PH, PBRA, Section 202 and Section 811 programs. Specifically, this interim rule gives PHAs and owners greater flexibilities in determining tenant families' income and assets, and in issuing utility reimbursements. The rule provides PHAs and owners with the discretion to implement these regulations. Some may choose the status quo; others will choose the streamlining alternative. By allowing voluntary implementation, HUD enables participants to choose their desired method of administration, which in many cases will presumably be the least-cost method. Aggregate savings are expected to be approximately $31.2 million.
The most significant savings come from reduced time devoted to administrative tasks related to certifying income. HUD expects that this streamlining interim rule will, in some cases, reduce the time required for income recertification, but it is difficult to know by how much, given the voluntary nature of the regulatory changes. To monetize the cost savings, we make assumptions concerning the proportion of PHAs and owners that will adopt the streamlining practices and what the time savings will be.
We assume that administrative costs for PH and PBRA, are similar to those for the HCV program. A HUD study of administrative costs in the HCV program found that, on average, 13.8 hours are required per voucher per year to run a high-performing program.
Based on this study, we estimate that the savings per household per year are 30 minutes (or approximately 12 percent of the total average reexamination time of 232 minutes).
Current regulations in the HCV, PH, and PBRA programs apply streamlined income verification practices to all households with any income coming from fixed-income sources (60 percent of households in these programs).
For these 2.5 million households, a PHA or owner using streamlined income verification may, but is not required to, adjust the non-fixed income. It is reasonable to expect that streamlining will be applied to no more than half of those eligible (or that the savings will be noticeable for no more than half). Thus, we assume that assistance providers realize average administrative efficiencies of $20 across 1.25 million households for aggregate savings of $25 million. The aggregate efficiencies realized would be correspondingly higher (lower) if applied to more (fewer) households or if opportunity costs were higher (lower). Given anecdotal evidence from streamlining regulations, HUD expects the lower-end estimates to be more representative of the impact of the changes. If the impact ranges from 0 percent to 75 percent of the point estimate, we could expect administrative efficiencies of from $0 to $37.5 million.
In addition to the savings seen by streamlining annual certification of income, self-certification by households of assets is expected to reduce administrative burdens on PHAs and owners in the PBRA, Section 202, and Section 811 programs. This interim final rule applies to the 95 percent of PBRA-, Section 202-, and Section 811-assisted households that have assets with a cash value of less than $5,000 but would only reduce costs for the 43 percent of households in these programs that have assets worth less than $5,000 but more than zero. Of the 589,000 estimated eligible households (43 percent of 1.378 million), we assume that the streamlining savings will be realized for half of them. Applying the same logic as for income recertification and assuming that the average savings per household from streamlining is $20, the aggregate savings will be $5.9 million.
Further savings come from allowing quarterly utility reimbursements when such quarterly amounts are $45 or less. The Tenant Rental Assistance Certification System (TRACS) database which contains data on multifamily owners, contracts, and tenants, reports that as of March 2017, 82,000 households assisted by the PBRA, Section 202 and Section 811 programs (of approximately 1.37 million) received utility reimbursements. Of these households, 30,000 received a monthly utility reimbursement less than $45. If administrators choose quarterly reimbursements as opposed to monthly, then doing so would save some time and expense by eliminating the costs of sending eight letters every year to eligible households. Because it is a minor activity, information to estimate time spent on utility reimbursements is not available. We assume that processing and mailing costs $3 per letter. Over 1 year, the savings amount to $24 (8 months × $3) per affected household. If only half choose the streamlining, then total savings will be $0.36 million.
By allowing voluntary implementation, HUD enables participants to choose their desired method of administration, which in many cases will presumably be the least-cost method. It is difficult to estimate the savings with precision given that an unknown number of PHAs and owners may choose the status quo. Based on the aforementioned assumptions, aggregate savings are expected to be approximately $31.2 million ($24.9 million from income verification + $0.6 million from utility reimbursement + $5.9 million from asset verification).
All of the regulatory changes included in this interim final rule are intended to provide additional options and flexibilities to PHAs and owners, not to mandate new actions. Therefore, HUD expects that PHAs and owners will not adopt any new procedures that add costs to their operations.
There may be a small transfer resulting from the change to the income streamlining regulations due to foregone tenant rent increases that would otherwise be owed by an unknown portion of the 2.5 million tenants affected by the new 90 percent fixed-income cutoff; there is no incentive to report an increase in income if regulations do not require doing so. Those households who realize a positive transfer from HUD is the subset who experience increases in non-fixed income during years 2 and 3 of the streamlined recertification cycle.
Of those households who receive 90 percent of income from fixed sources, the
There may also be a small cost to the tenant from temporarily withholding utility reimbursements for quarterly reimbursements. However, given the short time span and low amount, the maximum opportunity cost for a household would range from $0.44 (at a 3 percent annual discount rate) to $1.04 (at a 7 percent annual discount rate.
Any associated risk of lost revenue to PHAs, owners, or HUD resulting from errors in imputed asset income is expected to be negligible. HUD's Quality Control Study (QC Study) reports that 34.5 percent of all households in HUD-assisted housing programs reported some errors in their income reporting. Of the group with income reporting errors, only 3 percent were found to have erroneously reported their annual asset income (by $800 on average).
A potential administrative inefficiency is that the frequency and size of reporting error would increase if certifications are required every 3 years. Examination of quality control data from 2014 reveals that the net error in rent payments is more positive (indicating a tenant is overpaying) and varies less when asset income is the largest source of the rent error. For those with assets less than $5,000, the estimated annual net error is only $8 in cases where asset income is the largest source of error (representing an overpayment). It is not clear what the impact of the rule would be on the level of the net error; however, we could expect greater variability with less accurate data. From the quality control data, we estimate that 1 percent of all households are those with assets less than $5,000 for which errors originate from miscalculation of asset income (or 132,500 of 1.325 million households in multifamily housing). Even if the net error doubled because of the rule, the transfer to or from tenants would amount to no more than $1 million per year 2 out of every 3 years. Finally, streamlining would allow staff to more rigorously control tenant information that is a greater source of error (such as earned income).
The information collection requirements contained in this interim final rule have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) and assigned OMB control number 2502-0204. In accordance with the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless the collection displays a currently valid OMB control number.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) establishes requirements for federal agencies to assess the effects of their regulatory actions on state, local, and tribal governments and the private sector. This interim final rule will not impose any federal mandates on any state, local, or tribal governments or the private sector within the meaning of UMRA.
This interim final rule involves external administrative requirements and procedures related to calculation of HUD rental assistance that do not constitute a development decision affecting the physical condition of specific project areas or building sites. Accordingly, under 24 CFR 50.19(c)(6), this interim final rule is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601
Notwithstanding HUD's belief that this interim final rule will not have a significant effect on a substantial number of small entities, HUD specifically invites comments regarding any less burdensome alternatives to this interim final rule that will meet HUD's objectives as described in this preamble.
Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial direct compliance costs on state and local governments and is not required by statute, or the rule preempts state law, unless the agency meets the consultation and funding requirements of section 6 of the Executive order. This interim final rule does not have federalism implications and does not impose substantial direct compliance costs on state and local governments nor preempt state law within the meaning of the Executive order.
The Catalog of Federal Domestic Assistance numbers applicable to the program affected by this interim final rule are 14.157, 14.181, 14.195, 14.850, and 14.871.
Administrative practice and procedure, Aged, Claims, Crime, Government contracts, Grant programs—housing and community development, Individuals with disabilities, Intergovernmental relations, Loan programs—housing and community development, Low and moderate income housing, Mortgage insurance, Penalties, Pets, Public housing, Rent subsidies, Reporting and recordkeeping requirements, Social security, Unemployment compensation.
Aged, Grant programs—housing and community development, Individuals with disabilities, Loan programs—housing and community development, Rent subsidies, Reporting and recordkeeping requirements.
Aged, Grant programs—housing and community development, Individuals with disabilities, Pets, Public housing.
Grant programs—housing and community development, Grant programs—Indians, Indians, Public housing, Rent subsidies, Reporting and recordkeeping requirements.
Accordingly, for the reasons stated in the preamble, HUD is amending 24 CFR parts 5, 891, 960, and 982 as follows:
12 U.S.C. 1701x; 42 U.S.C. 1437a, 1437c, 1437d, 1437f, 1437n, 3535(d); Sec. 327, Pub. L. 109-115, 119 Stat. 2936; Sec. 607, Pub. L. 109-162, 119 Stat. 3051 (42 U.S.C. 14043e
(b) * * *
(1) * * * The responsible entity has the option of making utility reimbursement payments not less than once per calendar-year quarter, for reimbursements totaling $45 or less per quarter. In the event a family leaves the program in advance of its next quarterly reimbursement, the responsible entity must reimburse the family for a prorated share of the applicable reimbursement. PHAs and owners exercising this option must have a hardship policy in place for tenants.
(d)
(2)
(i) Social Security, Supplemental Security Income, Supplemental Disability Insurance.
(ii) Federal, state, local, or private pension plans.
(iii) Annuities or other retirement benefit programs, insurance policies, disability or death benefits, or other similar types of periodic receipts.
(iv) Any other source of income subject to adjustment by a verifiable COLA or current rate of interest.
(3)
(i) When 90 percent or more of a family's unadjusted income consists of fixed income, owners using streamlined income determinations must apply a COLA or COLAs to the family's fixed-income sources, provided that the family certifies both that 90 percent or more of their unadjusted income is fixed income and that their sources of fixed income have not changed from the previous year. For non-fixed income, owners may choose, but are not required, to make appropriate adjustments pursuant to paragraph (b) of this section.
(ii) When less than 90 percent of a family's unadjusted income consists of fixed income, owners using streamlined income determinations must apply a COLA to each of the family's sources of fixed income. Owners must determine all other income pursuant to paragraph (b) of this section.
(4)
(5)
(d)
(e)
(1) The declaration must state the amount of income the family expects to receive from such assets; this amount must be included in the family's income.
(2) An owner must obtain third-party verification of all family assets every 3 years.
12 U.S.C. 1701q; 42 U.S.C. 1437f, 3535(d), and 8013.
(a) * * *
(2) Supply such certification, release of information, consent, completed forms or documentation as the Owner (or Borrower, as applicable) or HUD determines necessary, including information and documentation relating to the disclosure and verification of Social Security Numbers, as provided by 24 CFR part 5, subpart B; the signing and submission of consent forms for the obtaining of wage and claim information from State Wage Information Collection Agencies, as provided by 24 CFR part 5, subpart B; and any certification of family net assets, as provided by 24 CFR 5.659(e);
42 U.S.C. 1437a, 1437c, 1437d, 1437n, 1437z-3, and 3535(d).
(c)
(2)
(i) Social Security, Supplemental Security Income, Supplemental Disability Insurance.
(ii) Federal, state, local, or private pension plans.
(iii) Annuities or other retirement benefit programs, insurance policies, disability or death benefits, or other similar types of periodic receipts.
(iv) Any other source of income subject to adjustment by a verifiable COLA or current rate of interest.
(3)
(i) When 90 percent or more of a family's unadjusted income consists of
(ii) When less than 90 percent of a family's unadjusted income consists of fixed income, PHAs using streamlined income determinations must apply a COLA to each of the family's sources of fixed income individually. The PHA must determine all other income pursuant to paragraph (a) of this section.
(4)
(5)
42 U.S.C. 1437f and 3535(d).
(b)
(2)
(i) Social Security, Supplemental Security Income, Supplemental Disability Insurance.
(ii) Federal, state, local, or private pension plans.
(iii) Annuities or other retirement benefit programs, insurance policies, disability or death benefits, or other similar types of periodic receipts.
(iv) Any other source of income subject to adjustment by a verifiable COLA or current rate of interest.
(3)
(i) When 90 percent or more of a family's unadjusted income consists of fixed income, PHAs using streamlined income determinations must apply a COLA or COLAs to the family's fixed-income sources, provided that the family certifies both that 90 percent or more of their unadjusted income is fixed income and that their sources of fixed income have not changed from the previous year. For non-fixed income, the PHA may choose, but is not required, to make appropriate adjustments pursuant to paragraph (a) of this section
(ii) When less than 90 percent of a family's unadjusted income consists of fixed income, PHAs using streamlined income determinations must apply a COLA to each of the family's sources of fixed income individually. The PHA must determine all other income pursuant to paragraph (a) of this section.
(4)
(5)
Environmental Protection Agency (EPA).
Withdrawal of direct final rule.
Due to receipt of an adverse comment, the Environmental Protection Agency (EPA) is withdrawing the September 25, 2017 direct final rule that approved two state implementation plan (SIP) revisions submitted by the State of West Virginia removing the Clean Air Interstate Rule (CAIR) annual nitrogen oxide (NO
The direct final rule published at 82 FR 44525 on September 25, 2017 is withdrawn as of December 12, 2017.
Marilyn Powers, (215) 814-2308, or by email at
On July 13, 2016, the State of West Virginia, through the West Virginia Department of Environmental Protection (WVDEP), submitted three SIP revisions requesting that EPA remove from its SIP three regulations that implemented the CAIR (70 FR 25162, May 12, 2005) trading programs: Regulation 45CSR39—
Because an adverse comment was received, EPA is withdrawing the direct final rule approving the revisions to the West Virginia SIP that remove the CAIR annual trading programs for NO
Environmental protection, Air pollution control, Incorporation by reference, Nitrogen oxides, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides.
Environmental Protection Agency.
Final rule.
The Environmental Protection Agency (EPA) is conditionally approving a State Implementation Plan (SIP) submitted by the State of New York for purposes of implementing Reasonably Available Control Technology (RACT) for the 2008 8-hour ozone National Ambient Air Quality Standard (NAAQS) related to control of volatile organic compounds (VOCs) from industrial cleaning solvents. The EPA is approving New York's Ozone Transport Region RACT SIP as it applies to non-control technique guideline major sources of VOCs and major sources of oxides of nitrogen. The EPA is also approving the State of New York's state-wide non-attainment new source review certification as sufficient for purposes of satisfying the 2008 8-hour ozone NAAQS. The EPA is approving New York's certification that there are no sources within the State for the following CTGs: Manufacture of Vegetable Oils and Application of Agricultural Pesticides. This action is being taken in accordance with the requirements of the Clean Air Act.
This final rule is effective on January 11, 2018.
The EPA has established a docket for this action under Docket ID Number EPA-R02-OAR-2017-0459. All documents in the docket are listed on the
Anthony (Ted) Gardella, Environmental Protection Agency, 290 Broadway, New York, New York 10007-1866, at (212) 637-3892, or by email at
The
On September 14, 2017 (82 FR 43209), the EPA published a Notice of Proposed Rulemaking that proposed to conditionally approve the State of New York's December 22, 2014 State Implementation Plan (SIP) submittal,
The proposed approval was conditioned on New York finalizing revisions to RACT requirements related sources subject to the industrial cleaning solvents control techniques guidelines (CTG). As the SIP submittal indicates, the RACT requirements for the 2008 ozone NAAQS have been fulfilled with the exception of sources subject to the industrial cleaning solvents CTG. In the SIP submittal, New York committed to address sources subject to this CTG through a timely revision to Title 6 of the New York Codes, Rules and Regulations Part 226 entitled, “Solvent Metal Cleaning Processes” (6 NYCRR Part 226). Therefore, consistent with section 110(k)(4) of the Clean Air Act (CAA), the EPA's September 14, 2017 rulemaking, signed September 6, 2017 and published September 14, 2017, proposed to conditionally approve New York's December 2014 SIP submittal. On September 6, 2017, New York supplemented its SIP submittal with a letter to the EPA committing to fulfill the requirements of the industrial cleaning solvents CTG by finalizing revisions to Part 226 by November 30, 2018. Therefore, based on the State's September 6, 2017 commitment letter, the EPA is conditionally approving New York's December 2014 SIP submittal, as it applies to CTG requirements for VOC major sources, for purposes of implementing RACT statewide for the 2008 8-hour ozone NAAQS.
The specific details of New York's December 2014 SIP submittal and the rationale for the EPA's approval action are explained in the EPA's proposed rulemaking and are not restated in this
In response to the EPA's September 14, 2017 proposed rulemaking on New York's December 2014 SIP submittal, the EPA received the following four comments summarized below. The specific comments may be viewed under Docket ID Number EPA-R02-OAR-2017-0459 on the
The commenter states that he had prepared comments and analyses that support his recommendation to do further modeling before implementing any further controls. The commenter states that he had compared NO
The commenter concludes his letter by stating that there are complex meteorological conditions during ozone episodes downwind of New York (land and sea breezes, elevated terrain concerns, and the nocturnal boundary layer structure along the coast) that need to be incorporated into regional ozone modeling analyses. The commenter states that if regional ozone modeling analyses that use post-2015 emissions data and incorporate complex meteorology are not used then New York runs the risk of implementing a control program that cannot succeed. Concluding, the commenter states, “Given the level of effort and time doing the modeling right it might be necessary to delay implementation of further SIP control requirements.”
The Alliance expresses concern that the imposition of emission limits needs to be balanced with the need to maintain reliable electricity service to New York. While the Alliance supports New York's and the EPA's efforts to reach attainment of the ozone NAAQS, the Alliance suggests that the need to reduce emissions in the NYMA and the Alliance's requirement to maintain reliable service to its customers is a more complex issue than simply imposing more stringent emission limits. The Alliance comments that there are over 100 peaking turbines (about 3000 megawatts (MW)) in the NYMA to maintain system reliability and support renewables. The Alliance states that with the impending closure of 2000 MW of nuclear generation, the combined effect of the peaking unit regulation changes and retirements suggests any new rule implementation should proceed with flexibility and caution.
The Alliance states that it has worked cooperatively with New York to develop an approach to replace, repower, or retrofit controls of existing peaking units. The Alliance's October 16, 2017 comment letter includes as an attachment a September 8, 2017 letter commenting on New York's July 25, 2017 pre-proposal entitled “Combustion Turbine (Peaking Unit) Pre-Proposal Outline” which outlines, according to the Alliance, New York's efforts to achieve attainment of the ozone NAAQS in the NYMA as it relates to peaking units. In its September 2017 letter to New York, the Alliance expresses the hope to collectively design cost-effective solutions compatible with the need to maintain reliable service to ratepayers. In addition, in its September 2017 letter, the Alliance provides detailed comments and recommendations related to the following issues: the compliance schedule, emission limits, performance of control options, potential for collateral increase in carbon monoxide, system averaging, emission limits for dual-fueled units, compliance requirements during the interim period before unit retirement, and alternative approaches to NO
These extensive and detailed comments concerning the connection between reliability of the electric grid and the development and implementation of NO
1. Adopt rules that reduce NO
2. Adopt rules that reduce NO
3. Assess lightering operations in the New York harbor that emit VOC from crude oil, gasoline, and other volatile product transfers.
As part of the State's October 10, 2017 comment letter, NJDEP attached its August 20, 2014 comment letter to New York at the time New York proposed its RACT SIP in 2014. NJDEP's August 2014 comment letter to New York provides NJDEP's detailed arguments as to why New York needs to address the above mentioned three source categories as RACT sources. NJDEP states that the first two source categories are subject to the New Jersey's RACT regulation but not the third source category since there are no lightering operations in New Jersey waters. NJDEP comments that New York, in finalizing its 2014 RACT SIP, did not adequately address the same three source categories since New York responded that the three source categories did not meet their definition of RACT. NJDEP comments that it believes these source categories should be covered under RACT requirements because they are existing, major stationary sources for which reasonably available control technology exists. NJDEP comments that the lightering activities can be considered a major stationary source, similar to the EPA's treatment of some airports for emissions inventory, since the activities are occurring within established areas of New York Harbor. NJDEP further comments that the State of Delaware has had regulations addressing lightering activities since 2007 thus establishing reasonably available control technology.
As stated in our proposed rule dated September 14, 2017 (82 FR 43209), New York's December 22, 2014 SIP submittal included a response to a comment that “once the NYMA is reclassified to moderate nonattainment for the 2008 ozone NAAQS and an attainment SIP is required, DEC [New York] will undertake a review of its many NO
In response to NJDEP's August 2014 letter, New York issued a document entitled “Assessment of Public Comments New York State Implementation Plan for 8-hour Ozone: Reasonably Available Control Technology” (Assessment) which is included in the docket for this action. In its Assessment, New York responded to the three source category comments from NJDEP as summarized below.
For peaking turbines, New York responded that peaking generating units that exceed major source emission threshold are subject to the State's NO
In response to New Jersey's comment, the EPA finds that New York's OTR NO
The EPA, however, encourages New York to evaluate whether NO
For stationary engines used for demand-side management, New York responded in its Assessment that the majority of combustion engines used for demand-side management are minor sources based on NO
In response to New Jersey's comment, the EPA herein responds that we concur with New York's logic, as articulated in its Assessment (see preceding paragraph) regarding RACT applicability for sources considered minor and major. EPA nonetheless encourages New York to consider a more stringent NO
For lightering operations in the New York harbor, New York, in its Assessment, responded that they do not consider tank vessels or service vessels to be stationary sources; such vessels are considered mobile sources and are not permitted under the Title V stationary source permitting program. New York concluded that it is not appropriate to address lightering operations in the New York SIP. In response to New Jersey's comment, the EPA finds that New York's OTR VOC RACT SIP submittal is approvable given New York's current treatment of tank vessels and service vessels.
The EPA recognizes that, as New Jersey indicates in its comment, the State of Delaware regulates lightering operations in the State's “Regulation No. 1124—Control of Volatile Organic Compound Emissions (formally Regulation No. 24), section 46 entitled, Crude Oil Lightering Operations.” The EPA approved Delaware's VOC RACT Regulation 1124, section 46, Crude Oil Lightering Operations, into the SIP on September 13, 2007 (72 FR 52285). As discussed above, in response to a comment received by the State during its RACT rulemaking process, New York states that, if the NYMA is reclassified to moderate nonattainment, “New York will investigate the need and appropriateness for additional emission reductions and evaluate lightering controls and/or other emission reductions strategies in order to determine the most effective manner in which to attain the ozone NAAQS.” Therefore, the EPA recommends that New York review the lightering operations in New York's harbor for possible applicability to RACT as it relates to New York's future submittal of its attainment SIP for the NYMA nonattainment area.
To summarize, since the NYMA has been reclassified from marginal to a moderate nonattainment area, New York is required to submit a new RACT determination as part of the State's attainment demonstration for the 2008 ozone standard for the NYMA moderate nonattainment area. New York should include an evaluation of the three source categories suggested by NJDEP, as well as the other recommendations discussed by the EPA as in the September 14, 2017 proposal, in its RACT evaluation as part of the State's attainment demonstration for the 2008 ozone standard.
The EPA is conditionally approving New York's statewide RACT submittal dated December 22, 2014, as supplemented on September 6, 2017, for purposes of satisfying the 2008 8-hour ozone standard RACT requirement, as it applies to CTG requirements for VOC major sources. New York must meet its commitment to adopt a revised Part 226 by November 30, 2018.
The EPA is approving the remainder of New York's OTR RACT SIP submittal, as it applies to non-CTG major sources of VOCs and to major sources of NO
The EPA is also approving New York's non-attainment new source review certification, state-wide, as sufficient for purposes of the 2008 ozone NAAQS. Finally, the EPA is approving New York's certification that there are no sources within the State for the following CTGs: (a) Manufacture of Vegetable Oils and (b) Application of Agricultural Pesticides.
Under section 110(k) of the CAA, the EPA may conditionally approve a plan revision based on a commitment by the State to adopt specific enforceable measures by a date certain but not later than one year after the date of approval of the plan revision. If New York meets its commitment within the applicable time frame, the conditionally approved submission will remain as part of the SIP until the EPA takes final action approving or disapproving the SIP requirement in question. If New York fails to meet its commitment within the specified time period, the conditional approval will, by operation of law, become a disapproval. If the conditional approval becomes a disapproval, this commitment will no longer be a part of the approved SIP for New York, and an 18-month clock for sanctions under CAA section 179(a)(2) and a two-year clock for a federal implementation plan (FIP) under CAA section 110(c)(1) would commence. The EPA subsequently will publish a document in the
The Act provides for the imposition of sanctions and the promulgation of a FIP if States fail to correct any deficiencies identified by the EPA in a final disapproval action within certain timeframes.
If the EPA disapproves a required SIP submittal or component of a SIP submittal, section 179(a) provides for the imposition of sanctions unless the deficiency is corrected within 18 months of the final disapproval. The first sanction would apply 18 months after the EPA disapproves the SIP submittal or if the State fails to make the required submittal. Under the EPA's sanctions regulations, 40 CFR 52.31, the first sanction would be 2:1 offsets for sources subject to the new source review requirements under section 173 of the Act. If the State has still failed to submit a SIP 6 months after the first sanction is imposed, the second sanction will apply. The second sanction is a limitation on the receipt of Federal highway funds. The EPA also has authority under section 110(m) to sanction a broader area.
In addition to sanctions, if the EPA finds that a State failed to submit the required SIP revision or disapproves the required SIP revision, or a portion thereof, the EPA must promulgate a FIP no later than 2 years from the date of the finding if the deficiency has not been corrected.
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;
• Does not impose an information collection burden under the provisions
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 12, 2018. 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, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
(e) * * *
(b) * * *
(2) Manufacture of Vegetable Oils.
(3) Application of Agricultural Pesticides.
(p)(1) The December 22, 2014 New York reasonably available control technology (RACT) analysis plan, as supplemented on September 6, 2017, submitted pursuant to the 2008 8-hour ozone national ambient air quality standard (NAAQS), which applies to the entire State, including the New York portion of the New York-Northern New Jersey-Long Island (NY-NJ-CT) and the Jamestown 8-hour ozone marginal nonattainment areas, is conditionally approved as it applies to the Clean Air Act control techniques guidelines (CTG)
(2) The remainder of New York's December 22, 2014 RACT analysis plan, pursuant to the 2008 8-hour ozone NAAQS as applied to the entire State, including the New York portion of the NY-NJ-CT and the Jamestown 8-hour ozone marginal nonattainment areas, and as it applies to non-CTG major sources of VOCs and to major sources of oxides of nitrogen (NO
(3) The December 22, 2014 New York plan submittal providing a nonattainment new source review (NNSR) certification as sufficient for purposes of the state-wide 2008 8-hour ozone NAAQS, including the New York portion of the NY-NJ-CT and the Jamestown 8-hour ozone nonattainment areas, is approved.
Environmental Protection Agency (EPA).
Final rule.
Pursuant to the Federal Clean Air Act (CAA or the Act), the Environmental Protection Agency (EPA) is approving a revision to a State Implementation Plan (SIP) for the City of Albuquerque and Bernalillo County, New Mexico (the County) submitted by the Governor on June 24, 2016. The SIP revision addresses requirements of the Act and the EPA's rules that require the County to submit a periodic report assessing reasonable progress goals (RPGs) for regional haze with a determination of the adequacy of the existing regional haze SIP.
This rule is effective on January 11, 2018.
The EPA has established a docket for this action under Docket ID No. EPA-R06-OAR-2016-0406. All documents in the docket are listed at the
James E. Grady, (214) 665-6745;
Throughout this document “we,” “us,” or “our” each mean “the EPA.”
The background for this action is discussed in detail in the October 2, 2017 proposal (82 FR 45762). In that document the EPA proposed to approve the County's regional haze progress report SIP revision (submitted on June 24, 2016) as meeting the applicable regional haze requirements set forth in 40 CFR 51.309(d)(10). In addition, the EPA proposed to approve the County's determination that the current regional haze SIP is adequate to meet the State's 2018 RPGs for the first planning period and does not require further substantive revision to achieve the established regional haze goals. The public comment period for the proposal closed on November 1, 2017. The EPA did not receive any comments regarding the proposal during its public comment period.
The EPA is approving the County's regional haze progress report SIP revision (submitted on June 24, 2016) as meeting the applicable regional haze requirements set forth in 40 CFR 51.309(d)(10)(i)(A) through (G). The EPA is also approving the County's determination that the current regional haze SIP requires no further substantive revision at this time in order to achieve the established 2018 RPGs for visibility improvement and emission reduction (40 CFR 51.309(d)(10)(ii)). This action is being taken under section 110 of the Act.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
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 12, 2018. 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, Best available retrofit technology, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Regional haze, Reporting and recordkeeping requirements, Sulfur dioxide, Visibility, Volatile organic compounds.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
(e) * * *
National Endowment for the Arts, National Foundation for the Arts And Humanities.
Final rule.
The National Endowment for the Arts (NEA) is adjusting the maximum civil monetary penalties that may be imposed for violations of the Program Fraud Civil Remedies Act (PFCRA) and the NEA's Restrictions on Lobbying to reflect the requirements of the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act). The 2015 Act further amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act) to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect. This final rule finalizes the catch-up inflation adjustment interim final rule required by the Inflation Adjustment Act.
Aswathi Zachariah, Assistant General Counsel, National Endowment for the Arts, 400 7th St. SW, Washington, DC 20506, Telephone: 202-682-5418.
On June 15, 2017 the NEA issued an interim final rule entitled “Implementing the Federal Civil Penalties Adjustment Act Improvements Act of 2015” (the IFR) to implement the required catch-up and annual adjustments to the NEA's civil monetary penalties. (
The 2015 Act requires agencies to: (1) Adjust the level of civil monetary penalties with an initial “catch-up” adjustment through an interim final rulemaking; and (2) make subsequent annual adjustments for inflation. Inflation adjustments will be based on the percent change in the Consumer Price Index for all Urban Consumers (CPI-U) for the month of October preceding the date of the adjustment, relative to the October CPI-U in the year of the previous adjustment.
The Office of Management and Budget has issued two memoranda, providing guidance on implementing and calculating adjustments.
In the IFR, the NEA identified two civil penalties in its regulations that require adjustment: (1) The penalty associated with Restrictions on Lobbying (45 CFR 1158.400; 45 CFR part 1158, app. A) and (2) the penalty associated with the Program Fraud Civil Remedies Act (45 CFR 1149.9). The NEA received no comments in response to the IFR and the proposed adjustments and therefore will continue to publish subsequent annual adjustments in
The 2015 Act requires agencies to make annual adjustments to civil penalty amounts no later than January 15 of each year following the adjustments contained in this final rule. For subsequent annual adjustments made in accordance with the 2015 Act, the amount of the adjustment will have the same basis as the annual adjustments previously described in the IFR (the percent increase between the CPI-U for the month of October preceding the date of the adjustment and the CPI-U for the October one year prior to the October immediately preceding the date of the adjustment). If there is no increase, there is no adjustment of civil penalties. Therefore, if the NEA adjusts penalties in January 2018, the adjustment will be calculated based on the percent change between the CPI-U for October 2017 (the October immediately preceding the date of adjustment) and October 2016 (the October one year prior to October 2017). The NEA will publish the amount of these annual inflation adjustments in the
Section 553 of the Administrative Procedure Act requires agencies to provide an opportunity for notice and comment on rulemaking and also requires agencies to delay a rule's effective date for 30 days following the date of publication in the
Even if the 2015 Act did not except this rulemaking from section 553 of the APA, the NEA has good cause to dispense with notice and comment. Section 553(b)(B), authorizes agencies to dispense with notice and comment procedures for rulemaking if the agency finds good cause that notice and comment are impracticable, unnecessary, or contrary to public interest. The annual adjustments to civil penalties for inflation and the method of calculating those adjustments are established by section 5 of the FCPIAA, as amended, leaving no discretion for the NEA. Accordingly, public comment would be impracticable because the NEA would be unable to consider such comments in the rulemaking process.
Executive Order 12866 (E.O. 12866) established a process for review of rules by the Office of Information and Regulatory Affairs, which is within the Office of Management and Budget (OMB). Only “significant” proposed and final rules are subject to review under this Executive Order. “Significant,” as used in E.O. 12866, means “economically significant.” It refers to rules with (1) an impact on the economy of $100 million; or that (2) were inconsistent or interfered with an action taken or planned by another agency; (3) materially altered the budgetary impact of entitlements, grants, user fees, or loan programs; or (4) raised novel legal or policy issues.
This final rule would not be a significant policy change and OMB has not reviewed this final rule under E.O. 12866. We have made the assessments required by E.O. 12866 and determined that this rule: (1) Will not have an effect of $100 million or more on the economy; (2) will not adversely affect in a material way the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities; (3) will not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (4) does not alter the budgetary effects of entitlements, grants, user fees, or loan programs or the rights or obligations of their recipients; and (5) does not raise novel legal or policy issues.
Executive Order 13771 section 5 requires that agencies, in most circumstances, remove or rescind two regulations for every regulation promulgated unless they request and are specifically exempted from that order's requirements by the Director of the Office of Management and Budget.
This rule is not subject to the requirements of Executive Order 13771 because this rule is not significant under Executive Order 12866. Furthermore, the NEA has requested and has received an exemption from the requirement that the agency rescind two regulations for every regulation it promulgate from the Director of the Office of Management and Budget.
This rulemaking does not have Federalism implications, as set forth in E.O. 13132. As used in this order, Federalism implications mean “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.” The NEA has determined that this rulemaking will not have Federalism implications within the meaning of E.O. 13132.
This rulemaking meets the applicable standards set forth in section 3(a) and 3(b)(2) of E.O. 12988. Specifically, this final rule is written in clear language designed to help reduce litigation.
Under the criteria in E.O. 13175, we have evaluated this final rule and determined that it would have no potential effects on Federally recognized Indian Tribes.
Under the criteria in E.O. 12630, this rulemaking does not have significant takings implications. Therefore, a takings implication assessment is not required.
This rulemaking will not have a significant adverse impact on a substantial number of small entities, including small businesses, small governmental jurisdictions, or certain small not-for-profit organizations.
This rulemaking will not impose any “information collection” requirements under the Paperwork Reduction Act. Under the act, information collection means the obtaining or disclosure of facts or opinions by or for an agency by 10 or more nonfederal persons.
This rulemaking does not contain a Federal mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year.
The final rule will not have significant effect on the human environment.
This final rule would not be a major rule as defined in section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This final rule will not result in an annual effect on the economy of $100,000,000 or more, a major increase in costs or prices, significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign based companies in domestic and export markets.
Section 206 of the E-Government Act requires agencies, to the extent practicable, to ensure that all information about that agency required to be published in the
Finally, the E-Government Act requires, to the extent practicable, that agencies ensure that a publicly accessible Federal Government Website contains electronic dockets for rulemakings under the Administrative Procedure Act of 1946 (5 U.S.C. 551
Under this Act, the term “plain writing” means writing that is clear, concise, well-organized, and follows other best practices appropriate to the subject or field and intended audience. To ensure that this rule has been written in plain and clear language so that it can be used and understood by the public, the NEA has modeled the language of this rule on the Federal Plain Language Guidelines.
The NEA has written this final rule in compliance with E.O. 13563 by ensuring its accessibility, consistency, simplicity of language, and overall comprehensibility. In addition, the public participation goals of this order are also satisfied by the NEA's participation in a process in which its views and information are made public to the extent feasible, and before any decisions are actually made. This will allow the public the opportunity to react to the comments, arguments, and information of others during the rulemaking process. The NEA initiates its participation in an open exchange by posting the regulation and its rulemaking docket on
Finally, Section 2 of E.O. 13563 directs agencies, where feasible and appropriate, to seek the views of those who are likely to be affected by rulemaking. This provision emphasizes the importance of prior consultation with “those who are likely to benefit from and those who are potentially subject to such rulemaking.” One goal is to solicit ideas about alternatives, relevant costs and benefits (both quantitative and qualitative), and potential flexibilities. The NEA reaches out to interested and affected parties by soliciting comments.
Administrative practice and procedure, Government contracts, Grant programs, Loan programs, Lobbying, Penalties.
Department of State.
Final rule.
The Department of State (DOS) is amending the Department of State Acquisition Regulation (DOSAR) to add notice that the Department has an agreement with the Defense Contract Audit Agency, and to provide a procedural correction.
This final rule is effective on January 11, 2018.
Ms. Colleen Kosar, Policy Division, Office of the Procurement Executive, A/OPE, 2201 C Street NW, Suite 1060, State Annex Number 15, Washington, DC 20520. Telephone: 703-516-1685. email:
This document adds a new subpart 642.1, including section 642.101(b), to provide notice of the Department's agreement with the Defense Contract Audit Agency on the conduct of incurred cost audits for the Department's cost-reimbursement contracts. In addition, part 604 is amended to specify the office through which audits are coordinated, from the Office of the Inspector General to the Audit Team in the Office of Acquisitions Management's Quality Assurance Branch.
The Department is publishing this rule as a final rule, as a rule of agency procedure or practice.
The Department of State, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation and, by approving it, certifies that this rule will not have a significant economic impact on a substantial number of small entities. This determination was based on the fact that the amendment in this rule will not have any cost or administrative impact on offerors or contractors. This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year and it will not
The Department of State does not consider this rule to be an “economically significant” regulatory action under E.O. 12866. The Department has reviewed the regulation to ensure its consistency with the regulatory philosophy and principles set forth in Executive Orders 12866 and 13563 and finds that the benefits of updating this rule outweigh any costs, which the Department assesses to be minimal. This final rule is not subject to the requirements of Executive Order 13771 because this final rule is related to agency organization, management or personnel, and has been determined to be non-significant within the meaning of Executive Order 12866.
This rule 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. The Department has determined that this rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not pre-empt tribal law.
The rule imposes no new or revised information collections under the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).
Government procurement.
For the reasons stated in the preamble, the Department of State amends 48 CFR chapter 6 as follows:
22 U.S.C. 2651a, 40 U.S.C. 121(c) and 48 CFR chapter 1.
(d) * * *
(3) * * * Requests for audits, normally by the Defense Contract Audit Agency (DCAA) in accordance with the agreement DOS has with DCAA to conduct incurred cost audits, shall be submitted through the A/LM/AQM/BOD/QA Audit Team (see 642.101(b)). * * *
(b) The Department has an interagency agreement with the Defense Contract Audit Agency (DCAA) to perform incurred cost audits on cost-reimbursement contracts. DCAA audits are requested through the A/LM/AQM/BOD/QA Audit Team.
Department of State.
Interim final rule.
The Department of State (DOS) is amending the Department of State Acquisition Regulation (DOSAR) to provide new guidance prescribing more stringent safety requirements for certain overseas construction and services projects.
You may submit comments by any of the following methods:
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• Persons with access to the internet may view this interim rule and submit comments by visiting:
Ms. Colleen Kosar, Policy Division, Office of the Procurement Executive, A/OPE, 2201 C Street NW, Suite 1060, State Annex Number 15, Washington, DC 20520. Telephone 703-516-1685.
The purpose of this interim rule is to update 48 CFR part 636, section 636.513, Accident Prevention; 48 CFR part 637; and 48 CFR part 652, section 652.236-70, Accident Prevention. The Department of State (DOS) is rescinding the class deviation that authorized the substitution of DOSAR 652.236-70, Accident Prevention, for FAR 52.236-13 Accident Prevention, thus reinstating the requirement for use of FAR 52.236-13. Additionally, a new clause, “Additional Safety Measures,” is added to replace DOSAR 652.236-70. Specifically, the interim rule:
• Amends section 636.513 to reinstate the use of FAR 52.236-13, Accident Prevention, together with its Alternate I, and to prescribe the use of DOSAR clause 652.236-70, Additional Safety Measures.
• Amends part 637, to add a new section 637.102-71 to provide a cross-reference to 636.513 for services contracts.
• Amend section 652.236-70 to replace the current clause (“Accident Prevention”) with a new clause (“Additional Safety Measures”).
In accordance with 5 U.S.C. 553(a)(2), which exempts from the Administrative Procedure Act matters relating to contracts, the Department is publishing this rulemaking as an interim final rule, but is inviting public comment.
This rulemaking is not a “rule” as defined by the Regulatory Flexibility Act (5 U.S.C. 601
This interim rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Act of 1995.
This rule is not a major rule as defined by the Small Business Regulatory Enforcement Act of 1996 (5 U.S.C. 801
Executive Orders (E.O.) 12866 and 13563 direct agencies to assess 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. The Department of State does not consider this interim rule to be an “economically significant regulatory action” under Executive Order 12866.
The Department has reviewed the regulation to ensure its consistency with the regulatory philosophy and principles set forth in the Executive Orders and finds that the benefits of this rule outweigh any costs, which the Department assesses to be minimal. This interim final rule is not subject to the requirements of Executive Order 13771 because this final rule has been determined to be non-significant within the meaning of the Executive Order 12866.
This interim rule 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. Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this interim rule does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement.
The Department has determined that this interim rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not pre-empt tribal law. Accordingly, the requirements of Executive Order 13175 do not apply to this interim rulemaking.
The interim rule removes a data collection requirement from Department of State Acquisition Regulation (DOSAR) information collection under OMB Control Number 1405-0050. The data collection requirement removed is DOSAR 652.236-70, Accident Prevention, which requires construction contractors to submit a written accident prevention plan. The removal of this requirement will reduce the total burden hours of this information collection under the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) by 150 hours.
This information collection renewal was approved by OMB on February 23, 2016. The removal of the data collection will not affect any other data collection requirements within this information collection.
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this document is to allow 60 days for public comment preceding submission of the collection to OMB.
Submit comments to the Office of Management and Budget (OMB) and Department of State, Office of the Procurement Executive, up to
Direct comments to the Department of State Desk Officer in the Office of Information and Regulatory Affairs at the Office of Management and Budget (OMB). You may submit comments by the following methods:
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Direct requests for additional information regarding the collection listed in this document, including requests for copies of the proposed collection instrument and supporting documents, to Ms. Colleen Kosar, U.S. Department of State, Office of the Procurement Executive, 2201 C Street NW, Suite 1060, State Annex Number 15, Washington, DC 20520; who may be reached on (703) 516-1685.
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden for
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
Government procurement.
For the reasons stated in the preamble, the Department of State amends 48 CFR chapter 6 as follows:
22 U.S.C. 2651a, 40 U.S.C. 121(c) and 48 CFR chapter 1.
(a) The contracting officer shall insert the clause at 652.236-70, Additional Safety Measures in all solicitations and contracts that include FAR 52.236-13, Accident Prevention, Alternate I,
(1) When a fixed-price construction contract or a fixed-price dismantling, demolition, or removal of improvements contract is contemplated and the contract amount is expected to exceed the simplified acquisition threshold and the contract will involve work of a long duration or hazardous nature; or
(2) When a contract for services to be performed at Government facilities (see FAR part 37) is contemplated, and technical representatives advise that special precautions are appropriate, such as contracts for building maintenance, building operations or infrastructure repair.
(b) The contracting officer shall confer with OBO/OM/SHEM if there are any questions on any factors listed in paragraph (a) of the clause, or if the contracting officer has any questions regarding safety issues.
When contracting for services to be performed overseas, always consider 636.513(b) and FAR 36.513(b), and consult with technical representatives to determine whether special precautions are appropriate, such as when the services are for building operations, building maintenance or infrastructure repairs.
As prescribed in 636.513, insert the following clause.
In addition to the safety/accident prevention requirements of FAR 52.236-13, Accident Prevention Alternate I, the contractor shall comply with the following additional safety measures.
(a)
(1) Scaffolding;
(2) Work at heights above 1.8 meters;
(3) Trenching or other excavation greater than one (1) meter in depth;
(4) Earth-moving equipment and other large vehicles;
(5) Cranes and rigging;
(6) Welding or cutting and other hot work;
(7) Partial or total demolition of a structure;
(8) Temporary wiring, use of portable electric tools, or other recognized electrical hazards. Temporary wiring and portable electric tools require the use of a ground fault circuit interrupter (GFCI) in the affected circuits; other electrical hazards may also require the use of a GFCI;
(9) Work in confined spaces (limited exits, potential for oxygen less than 19.5 percent or combustible atmosphere, potential for solid or liquid engulfment, or other hazards considered to be immediately dangerous to life or health such as water tanks, transformer vaults, sewers, cisterns, etc.);
(10) Hazardous materials—a material with a physical or health hazard including but not limited to, flammable, explosive, corrosive, toxic, reactive or unstable, or any operations, which creates any kind of contamination inside an occupied building such as dust from demolition activities, paints, solvents, etc.; or
(11) Hazardous noise levels as required in EM 385-1 Section 5B or local standards if more restrictive.
(b)
(c)
(d)
(e)
(f)
(1) The SSHP shall be submitted at least 10 working days prior to commencing any activity at the site.
(2) The plan must address developing activity hazard analyses (AHAs) for specific tasks. The AHAs shall define the activities being performed and identify the work sequences, the specific anticipated hazards, site conditions, equipment, materials, and the control measures to be implemented to eliminate or reduce each hazard to an acceptable level of risk. Work shall not begin until the AHA for the work activity has been accepted by the COR and discussed with all engaged in the activity, including the Contractor, subcontractor(s), and Government on-site representatives.
(3) The names of the Competent/Qualified Person(s) required for a particular activity (for example, excavations, scaffolding, fall protection, other activities as specified by EM 385-1-1) shall be identified and included in the AHA. Proof of their competency/qualification shall be submitted to the contracting officer or COR for acceptance prior to the start of that work activity. The AHA shall be reviewed and modified as necessary to address changing site conditions, operations, or change of competent/qualified person(s).
National Transportation Safety Board (NTSB).
Interim final rule.
The NTSB is issuing an interim final rule that revises 49 CFR part 801, “Public Availability of Information,” to implement the substantive and procedural changes to the Freedom of Information Act (FOIA), identified in the Open Government Act of 2007, December 31, 2007, the Open FOIA Act of 2009, October 28, 2009, and the FOIA Improvement Act of 2016, June 30, 2016. These revisions to the NTSB FOIA regulation are being issued as an interim final rule to ensure that an updated regulation is in place as soon as practicable to implement the Acts referenced above.
This interim final rule is effective on December 12, 2017. The NTSB will accept written comments on this interim final rule on or before February 12, 2018.
A copy of this interim final rule, published in the
You may send comments identified by Docket ID Number NTSB-GC-2017-0004 using any of the following methods:
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Kathleen Silbaugh, General Counsel, (202) 314-6016.
The FOIA provides that any person has a right, enforceable in federal court, to obtain access to federal agency records, except to the extent that any portions of such records are protected from public disclosure by one of nine exemptions or by one of three special law enforcement record exclusions. The FOIA also sets forth the process for obtaining federal agency records and requires agencies to promulgate regulations addressing the requirements for making initial requests and appeals, the fees an agency may charge, and the standards and procedures for regular and expedited processing of requests.
Since the NTSB last revised 49 CFR part 801 on April 16, 2007, 72 FR 18914, the FOIA was amended three times: In the Open Government Act of 2007, Public Law 110-175, 121 Stat. 2524, December 31, 2007 (hereinafter “2007 Act”), the Open FOIA Act of 2009, Public Law 111-83, 123 Stat. 2142, October 28, 2009 (hereinafter “2009 Act”), and the FOIA Improvement Act of 2016, Public Law 114-185, 130 Stat. 538, June 30, 2016 (hereinafter “2016 Act”). The 2016 Act specifically requires all agencies to review and update their FOIA regulations in accordance with its provisions. The NTSB is revising part 801 to (1) implement the 2007, 2009, and 2016 statutory amendments, and (2) update and clarify the regulation pursuant to the NTSB's plan to review and revise all of its regulations.
The NTSB is issuing this regulation as an interim final rule to ensure that the agency implements the 2016 Act as soon as practicable. In the revised regulation, the NTSB has adopted, where appropriate, the template for agency FOIA regulations released by the Office of Information Policy at the Department of Justice.
The NTSB has concluded that good cause exists, under the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(B) and (d)(3), to waive the APA's notice-and-comment and delayed-effective-date requirements and to issue this regulation as an interim final rule. The amendments to part 801 primarily address how the NTSB will implement the 2007, 2009, and 2016 Acts, and make clarifying and general updates to the existing regulation but do not fundamentally alter or change the regulation's nature or scope. Further, in light of the significant need for immediate guidance regarding the changes made under the 2016 Act, the NTSB has determined that notice-and-comment rulemaking is impracticable and unnecessary. The revisions are noncontroversial, and no opposition or significant adverse comments are expected. Nevertheless, the NTSB is providing the public a 60-day period following publication of the interim final rule to submit comments. The NTSB will consider comments received during the comment period, and will alter the issued final rule if the comments warrant alteration.
The revisions add to § 801.10, “General,” a list of proactive disclosures pursuant to 5 U.S.C. 552(a)(2), (a)(5), (e)(3), and (g). Pursuant to the 2016 Act, § 801.10 explains that the proactive disclosures are available on the NTSB's Website, and specifies the categories of agency records that must be made available in its electronic reference room and its public reference room at NTSB headquarters. These proactively disclosed records include records that have been disclosed pursuant to a FOIA request and have been requested at least three times.
Throughout part 801, pursuant to the 2016 Act, the revisions emphasize information that is available on the NTSB's Website. Section 801.10 also explains that the NTSB maintains a public access link for requesters to submit and track FOIA requests electronically.
Pursuant to the 2007 Act, the definition of “record” in § 801.3 specifies that agency records include information maintained in an electronic format and information maintained by contractors.
Section 801.20 provides definitions and procedures for deciding requests for expedited processing. Sections 801.21 and 801.23 clarify the circumstances in which the NTSB may extend the time to make an initial determination, and the procedures to follow when extending the time. Pursuant to the 2016 Act, section 801.22 extends the time to appeal an initial determination to the NTSB Managing Director from 20 days to 90 days.
Pursuant to the 2007 Act, as amended by the 2016 Act, sections 801.21-.23 and 801.60 permit requesters to seek dispute resolution services from the NTSB FOIA Public Liaison, or the Office of Government Information Services (OGIS) in the National Archives and Records Administration, in connection with initial and final determinations, time extensions, and fee assessments. Sections 801.20 and 801.23 also allow a requester to modify a request to qualify for faster processing.
Pursuant to the 2007 Act, as amended by the 2016 Act, section 801.60 prohibits the NTSB from charging search fees, or for some requesters, duplication fees, if the NTSB fails to comply with the time limits, including extensions, for processing a request. If the NTSB fails to comply with a time limit for processing a request, it may assess search fees only if unusual circumstances exist, the request involves more than 5,000 responsive pages; and the NTSB has attempted in good faith to work with the requester to limit the scope of the request.
Section 801.60 also prohibits the NTSB from requiring advance payment of fees unless the requester has previously failed to pay or the fee is expected to exceed $250;
Pursuant to the 2016 Act, the NTSB will withhold records under a FOIA exemption only if the NTSB reasonably foresees that disclosure would harm an interest protected by the exemption. The NTSB will partially disclose a record if a releasable portion of the record is reasonably segregable from a portion that is being withheld.
Also, pursuant to the 2016 Act, section 801.55, which implements the interagency and intra-agency exchanges exemption under 5 U.S.C. 552(b)(5), provides that the deliberative process privilege does not apply to records created 25 years or more before the FOIA request.
Pursuant to the 2009 Act, section 801.53, which implements the FOIA exemption at 5 U.S.C. 552(b)(3) for records exempt by statute from disclosure, provides that, to exempt information from disclosure under the FOIA, statutes enacted after the 2009 Act must specifically cite to section 552(b).
This rule does not require an assessment of its potential costs and benefits under section 6(a)(3) of E.O. 12866,
In addition, under the Regulatory Flexibility Act, 5 U.S.C. 601-12, the NTSB has considered whether this rule would have a significant economic impact on a substantial number of small entities. The NTSB certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities. Moreover, in accordance with 5 U.S.C. 605(b), the NTSB will submit this certification to the Chief Counsel for Advocacy at the Small Business Administration.
The NTSB does not anticipate this rule will have a substantial, direct effect on state or local governments or will preempt state law; as such, this rule does not have implications for federalism under E.O. 13132,
This rule also complies with all applicable standards in sections 3(a) and 3(b)(2) of E.O. 12988,
NTSB has evaluated this rule under: E.O. 12630,
The NTSB invites comments relating to any of the foregoing determinations and notes the most helpful comments reference a specific portion of this interim final rule, explain the reason for any recommended change, and include supporting data.
Archives and records; Freedom of information.
Accordingly, for the reasons stated in the Preamble, the NTSB is revising 49 CFR part 801 to read as follows:
49 U.S.C. 1113(f); 5 U.S.C. 552; 18 U.S.C. 641, 2071; 31 U.S.C. 3717, 9701; 44 U.S.C. Chapters 21, 29, 31, and 33.
(a) This part contains the rules that the National Transportation Safety Board (NTSB) follows in processing requests for records under the Freedom of Information Act, as amended (FOIA), 5 U.S.C. 552. These rules should be read together with the FOIA, which provides additional information about public access to records maintained by the NTSB.
(b) This part also provides for document services and the fees for such services, pursuant to 31 U.S.C. 9701.
(c) This part applies only to records existing when the request for the information is made. The NTSB is not required to create records for the sole purpose of responding to a FOIA request.
(d) Subpart F of this part describes records that are exempt from public disclosure.
(a) In implementing the FOIA, it is the policy of the NTSB to make information available to the public to the greatest extent possible, consistent with the mission of the NTSB. The NTSB will withhold records under the FOIA only when the NTSB reasonably foresees that disclosure would harm an interest protected by a FOIA exemption or is prohibited by law. Whenever the NTSB determines that full disclosure of a requested record is not possible, the NTSB will consider whether partial disclosure is possible and will take reasonable steps to segregate and release nonexempt material. Information the NTSB routinely provides to the public as part of a regular NTSB activity (such as press releases and information disclosed on the NTSB's public Website) may be provided to the public without compliance with this part.
(b) The NTSB will release on its website a “public docket” containing documentation that the agency deemed pertinent to the investigation. Requesters may access these public dockets without submitting a FOIA request. The NTSB encourages all requesters to review the public docket materials before submitting a FOIA request.
The following definitions apply in this part:
(1) Any writing, drawing, map, recording, tape, film, photo, or other documentary material by which information is preserved. In this part, “document” and “record” have the same meaning;
(2) Any information that would be an agency record subject to the requirements of this section when maintained by the NTSB in any format, including an electronic format; and
(3) Any information described under subparagraphs (1) or (2) that is maintained for the NTSB by an entity under Government contract, for the purposes of records management.
(a) The NTSB's Chief FOIA Officer provides high level oversight and support to NTSB's FOIA programs, and recommends adjustments to agency practices, personnel, and funding as may be necessary to improve FOIA administration. The Chief FOIA Officer is responsible for the initial determination of whether to release records within the 20-working-day time limit, or the extension, specified in the Freedom of Information Act. The Chief FOIA Officer is also responsible for designating one or more FOIA Public Liaisons.
(b) The NTSB's Chief, Records Management Division:
(1) Is responsible for the custody and control of all NTSB records required to be preserved under the Federal Records Act, 44 U.S.C. Chapters 21, 29, 31, and 33.
(2) Maintains a public reference room and an electronic reading room in
(3) Maintains a public access link on the NTSB's FOIA Website for requesters to electronically submit a FOIA request and track the status of the request.
(c) The NTSB maintains in its electronic reading room and makes available for public inspection in its public reference room:
(1) Records that have been provided pursuant to a FOIA request, and
(i) Have been requested at least three times or
(ii) Are likely to be the subject of repeat requests.
(2) A general index of the records in paragraph (c)(1) of this section;
(3) Final opinions, including concurring and dissenting opinions, as well as orders, made in the adjudication of appeals under parts 821 and 825 of this chapter.
(4) Statements of policy and interpretations which have been adopted by the agency and are not published in the
(5) Administrative staff manuals and instructions to staff that affect a member of the public;
(6)(i) The annual report submitted to the Attorney General and the Office of Government Information Services in the National Archives and Records Administration (OGIS), under 5 U.S.C. 552(e)(1); and
(ii) The raw statistical data used in the annual report in an aggregate, searchable, and downloadable format, provided without charge, license, or registration requirement;
(7) A guide for requesting records or information from the NTSB that includes an index of the agency's major information systems, major information and record locator systems, concise descriptions of FOIA exemptions, and general categories of NTSB records to which the exemptions apply; and
(8) A record of the votes of each Member in NTSB proceedings.
(d) FOIA requests for records or information not publicly available on the NTSB Website may be submitted electronically by email or through the public access link, or in writing to: National Transportation Safety Board, Attention: FOIA Requester Service Center, CIO-40, 490 L'Enfant Plaza SW, Washington, DC 20594-003. All requests must reasonably identify the record requested and contain the name, address, email address, and telephone number of the person making the request. A requester must inform the NTSB of changes to the requester's contact information. Requests mailed to the NTSB must prominently display the letters “FOIA” to distinguish the FOIA request from other types of document requests. For requests regarding an investigation of a particular accident, requesters should include the date and location of the accident, as well as the NTSB investigation number.
(e) In response to broad requests for records regarding a particular investigation, the FOIA Office will notify the requester that a public docket has been or will be opened for the investigation, and attempt to clarify whether the information in the docket satisfies the request.
(f) The NTSB will not release records originally generated by other agencies or entities. Instead, the NTSB will refer such requests for other agencies' records to the appropriate agency, which will make a release determination upon receiving and processing the referred request.
(g) Where a requester seeks a record on behalf of another person, and the record contains that person's personal information protected by 5 U.S.C. 552(b)(6) and § 801.56, the personal information will not be provided to the requester unless the requester submits a notarized statement of consent from the person whose personal information is contained in the record.
(h) In general, the NTSB will deny requests for records concerning a pending investigation, pursuant to appropriate exemptions under the FOIA. The FOIA Office will notify the requester of this denial in accordance with § 801.21(b), and provide the requester additional information regarding how the requester may receive information on the investigation once the investigation is complete.
The initial decision of the FOIA Officer will include a determination of segregability. If it is reasonable to do so, the exempt portions of a record will be segregated and, where necessary, redacted, and the nonexempt portions will be sent to the requester.
No person may, without permission, remove from the place where it is made available any record made available for inspection or copying under § 801.10(c). Removing, concealing, altering, mutilating, obliterating, or destroying, in whole or in part, such a record is deemed a criminal offense pursuant to 18 U.S.C. 641, 2071(a).
(a)
(1) Track 1: Requests that meet the criteria for expedited processing, or requests that seek records that have been produced in response to a prior request.
(2) Track 2: Requests that do not involve voluminous records or lengthy consultations with other entities.
(3) Track 3: Requests that involve voluminous records and for which lengthy or numerous consultations are required, or those requests which may involve sensitive records.
(b)
(2) In this section, “compelling need” means:
(i) That a failure to expedite the request could reasonably be expected to pose an imminent threat to the life or physical safety of an individual; or
(ii) With respect to a request made by a person primarily engaged in disseminating information, urgency to inform the public concerning actual or alleged Federal Government activity.
(3) The requester may appeal the FOIA Office's decision regarding expedited processing to the Managing Director within 90 calendar days. The Managing Director will decide the appeal on an expedited basis, and no later than 20 days (excluding Saturdays, Sundays, and legal public holidays) after receipt of the appeal. The final determination will notify the requester of the statutory right to seek judicial review of the determination pursuant to 5 U.S.C. 552(a)(6)(E)(iii), and will inform the requester of the dispute resolution services offered by OGIS.
(a) The NTSB FOIA Officer will make an initial determination as to whether to comply with the request within 20 days (excluding Saturdays, Sundays, and legal public holidays) after the request is received.
(b) Upon the FOIA Office's receipt of a FOIA request, the time limit is tolled while the FOIA Office seeks reasonable information from the requester:
(1) About the scope of the request, such as whether docket items and other publicly available information on the NTSB website satisfy the request; and
(2) Necessary to resolve fee assessment issues.
(c) If unusual circumstances exist, this time limit may be extended up to 10 additional days (excluding Saturdays, Sundays, and legal public holidays) in accordance with § 801.23. The requester will be notified immediately of an extension in accordance with § 801.23. If a determination is made to release the requested record(s), such record(s) will be made available promptly.
(d) If the FOIA Officer determines not to release the record(s), the FOIA Office will notify the requester of:
(1) The reason for the determination;
(2) The right to appeal the determination to the Managing Director within 90 calendar days;
(3) The name and title or positions of each person responsible for the denial of the request;
(4) The right to seek dispute resolution services from the NTSB's FOIA Public Liaison or OGIS.
Requesters seeking an appeal of the FOIA Officer's initial determination must send a written appeal to the NTSB's Managing Director within 90 calendar days. The NTSB's Managing Director will determine whether to grant or deny any appeal within 20 days (excluding Saturdays, Sundays, and legal public holidays) after receipt of such appeal, except that this time limit may be extended by as many as 10 additional days (excluding Saturdays, Sundays, and legal public holidays), in accordance with § 801.23. The final determination will notify the requester of the statutory right to seek judicial review of the determination pursuant to 5 U.S.C. 552(a)(4)(B), and will inform the requester of the dispute resolution services offered by OGIS.
(a) In unusual circumstances as specified in this section, the time limits prescribed in either § 801.21 or § 801.22 may be extended by no more than 10 days (excluding Saturdays, Sunday, and legal public holidays) by providing written notice to the requester setting forth the reasons for the extension and the date on which a determination is expected to be dispatched.
(b) If the request cannot be processed within the extended time limit specified in paragraph (a) of this section, the requester will be:
(1) Notified in writing;
(2) Given an opportunity to limit the scope of the request so that it may be processed within that time limit, or an opportunity to arrange with the agency an alternative time frame for processing the request or a modified request; and
(3) Advised of the requester's right to seek assistance from the NTSB's FOIA Public Liaison and seek dispute resolution services from OGIS.
(c) As used in this paragraph (c), “unusual circumstances,” as they relate to any delay that is reasonably necessary to the proper processing of the particular request, means:
(1) The need to search for and collect the requested records from field facilities or other establishments that are separate from the office processing the request;
(2) The need to search for, collect, and appropriately examine and process a voluminous amount of separate and distinct records which are the subject of a single request; or
(3) The need to consult with another agency that has a substantial interest in the disposition of the request or with two or more components of the agency having substantial subject-matter interest therein.
Upon completion of an accident investigation, the NTSB will compile a public docket containing investigators' factual reports, and documents and exhibits that the agency deemed pertinent to the investigation. The Chief, Records Management Division, will then make the docket available on the NTSB Website and available for public inspection and copying in the NTSB's public reference room.
Within approximately four (4) weeks after a public investigative hearing conducted in accordance with part 845, subpart A, of this chapter, the Chief, Records Management Division, will make the hearing transcript available in the electronic reading room and the public reference room. On or before the date of the hearing, the Chief, Records Management Division, will make the exhibits introduced at the hearing available on the NTSB Website and available for public inspection and copying in the NTSB's public reference room.
(a) The NTSB will report the facts, conditions, circumstances, and its determination of the probable causes of U.S. civil transportation accidents, in accordance with 49 U.S.C. 1131(e).
(b) These reports will be made available on the NTSB Website and available for public inspection and copying in the NTSB's public reference room.
The NTSB's rules are published in the Code of Federal Regulations, Title 49, Chapter VIII.
The NTSB submits its annual report to Congress, in accordance with 49 U.S.C. 1117. The report will be available on the NTSB's website, found at
Title 5 U.S.C. 552(a) and (b) exempt certain records from public disclosure. Examples of records given in this subpart included within a particular statutory exemption are not necessarily illustrative of all types of records covered by the applicable exemption.
Pursuant to 5 U.S.C. 552(b)(1), national defense and foreign policy secrets established by Executive Order, as well as properly classified documents, are exempt from public disclosure. Requests to the NTSB for such records will be transferred to the source agency as appropriate, where such classified records are identified. (See,
Pursuant to 5 U.S.C. 552(b)(2), the following records are exempt from disclosure under FOIA:
(a) Records relating solely to internal personnel rules and practices, including memoranda pertaining to personnel matters such as staffing policies, and procedures for the hiring, training,
(b) Records regarding:
(1) Internal matters of a relatively trivial nature that have no significant public interest, and
(2) Predominantly internal matters, the release of which would risk circumvention of a statute or agency regulation.
Pursuant to 5 U.S.C. 552(b)(3), the NTSB will not disclose records specifically exempted from disclosure by statute (other than 5 U.S.C. 552(b)), provided that such statute:
(a)(1) Requires that the matters be withheld from the public in such manner as to leave no discretion on the issue, or
(2) Establishes particular criteria for withholding or refers to particular types of matters to be withheld; and
(b) If enacted after the date of enactment of the Open FOIA Act of 2009, Public Law 111-83, Title V, section 564, 123 Stat. 2142, Oct. 28, 2009, specifically cites to 5 U.S.C. 552(b)(3).
Pursuant to 5 U.S.C. 552(b)(4), trade secrets and items containing commercial or financial information that are obtained from a person and are privileged or confidential are exempt from public disclosure.
(a) Pursuant to 5 U.S.C. 552(b)(5), any record prepared by an NTSB employee for internal Government use is exempt from public disclosure to the extent that it contains—
(1) Opinions made in the course of developing official action by the NTSB but not actually made a part of that official action, or
(2) Information concerning any pending NTSB proceeding, or similar matter, including any claim or other dispute to be resolved before a court of law, administrative board, hearing officer, or contracting officer.
(b) The purpose of this section is to protect the full and frank exchange of ideas, views, and opinions necessary for the effective functioning of the NTSB. These resources must be fully and readily available to those officials upon whom the responsibility rests to take official NTSB action. Its purpose is also to protect against the premature disclosure of material that is in the developmental stage, if premature disclosure would be detrimental to the authorized and appropriate purposes for which the material is being used, or if, because of its tentative nature, the material is likely to be revised or modified before it is officially presented to the public.
(c) Examples of materials covered by this section include, but are not limited to, staff papers containing advice, opinions, or suggestions preliminary to a decision or action; preliminary notes; advance information on such things as proposed plans to procure, lease, or otherwise hire and dispose of materials, real estate, or facilities; documents exchanged in preparation for anticipated legal proceedings; material intended for public release at a specified future time, if premature disclosure would be detrimental to orderly processes of the NTSB; records of inspections, investigations, and surveys pertaining to internal management of the NTSB; and matters that would not be routinely disclosed in litigation but which are likely to be the subject of litigation.
(d) The deliberative process privilege does not apply to records created 25 years or more before the date on which the records were requested.
Pursuant to 5 U.S.C. 552(b)(6), any personal, medical, or similar file is exempt from public disclosure if its disclosure would harm the individual concerned or would be a clearly unwarranted invasion of the person's personal privacy.
Pursuant to 5 U.S.C. 552(b)(7), any records compiled for law or regulatory enforcement are exempt from public disclosure to the extent that disclosure would interfere with enforcement, would be an unwarranted invasion of privacy, would disclose the identity of a confidential source, would disclose investigative procedures and practices, or would endanger the life or security of law enforcement personnel.
Pursuant to 5 U.S.C. 552(b)(8), records compiled for agencies regulating or supervising financial institutions are exempt from public disclosure.
Pursuant to 5 U.S.C. 552(b)(9), records concerning geological wells are exempt from public disclosure.
(a)
(b)
(c)
(1)
(ii) In searching for and retrieving records, the NTSB will charge $4.00 for each quarter of an hour spent by administrative personnel, $7.00 for each quarter of an hour spent by professional personnel, and $10.25 for each quarter of an hour spent by management personnel.
(2)
(ii) The NTSB will charge $0.10 per page for the duplication of a standard-size paper record. For other forms of duplication, the NTSB will charge the direct costs of the duplication.
(iii) Where the NTSB certifies records upon request, the NTSB will charge the direct cost of certification.
(3)
(d)
(i) If the NTSB determines there are unusual circumstances, as defined by 5 U.S.C. 552(a)(6)(B)(iii) and § 801.23(c), and more than 5,000 pages are responsive to the request, the FOIA Office may charge fees if timely written notice of the unusual circumstances has been provided to the requester and the FOIA Office has discussed with the requestor (or made not less than three good-faith attempts to do so) how the requester could limit the scope of the request.
(ii) If a court determines there are exceptional circumstances, as defined by 5 U.S.C. 552(a)(6)(C), a failure to comply with the time limits will be excused for the length of time provided by the court order.
(2) The NTSB will not charge a fee for notices, decisions, orders, etc. provided to persons acting as parties in the investigation under the procedures set forth in part 831 of this chapter, or where required by law to be served on a party to any proceeding or matter before the NTSB. Likewise, the NTSB will not charge fees for requests made by family members of accident victims, when the NTSB has investigated the accident that is the subject of the FOIA request.
(3) The NTSB will not charge a search fee or review fee for a quarter-hour period unless more than half of that period is required for search or review.
(4) Except for requesters seeking records for commercial use, the NTSB will provide the following items without charge:
(i) The first 100 pages of duplication (or the cost equivalent) of a record; and
(ii) The first two hours of search (or the cost equivalent) for a record.
(5) Whenever the total fee calculated under paragraph (c) of this section is $14.00 or less for any request, the NTSB will not charge a fee.
(6) The NTSB will not charge fees for ordinary packaging and mailing costs.
(7) When the FOIA Office determines or estimates that fees to be charged under this section will amount to more than $25.00, the Office will notify the requester of the actual or estimated amount of the fees, including a breakdown of the fees for the search, review or duplication, unless the requester has indicated a willingness to pay fees as high as those anticipated. If the FOIA Office is able to estimate only a portion of the expected fee, the FOIA Office will advise the requester that the estimated fee may be only a portion of the total fee. Where the FOIA Office notifies a requester that the actual or estimated fees will exceed $25.00, the NTSB will not expend additional agency resources on the request until the requester agrees in writing to pay the anticipated total fee. The NTSB does not accept payments in installments.
(8) In circumstances involving a total fee that will exceed $250.00, or if the requester has previously failed to pay fees in a timely fashion, the NTSB may require the requester to make an advance payment or deposit of a specific amount before beginning to process the request. If the requester does not pay the advance payment within 30 calendar dates after the date of the FOIA Office's fee determination, the request will be closed.
(9) The NTSB may charge interest on any unpaid bill starting on the 31st day following the date of billing the requester. Interest charges will be assessed at the rate provided at 31 U.S.C. 3717 and will accrue from the date of the billing until the NTSB receives payment. The NTSB will follow the provisions of the Debt Collection Act of 1982, Public Law 97-365, 96 Stat. 1749, as amended, and its administrative procedures, including the use of consumer reporting agencies, collection agencies, and offset.
(10) Where the NTSB reasonably believes that a requester or group of requesters acting together is attempting to divide a request into a series of requests for the purpose of avoiding fees, the NTSB may aggregate those requests and charge accordingly.
(11) The NTSB will make the FOIA Public Liaison available to assist the requester in reformulating a request to meet the requester's needs at a lower cost.
(e)
(i) Disclosure of the requested information is in the public interest because it is likely to contribute significantly to public understanding of the operations of activities of the government; and
(ii) Disclosure of the requested information is not primarily in the commercial interest or for the commercial use of the requester.
(2) In determining whether disclosure of the requested information is in the public interest, the NTSB will consider the following factors:
(i) Whether the subject of the requested records concerns identifiable operations or activities of the Federal Government, with a connection that is direct and clear, and not remote or attenuated. In this regard, the NTSB will consider whether a requester's use of the documents would enhance transportation safety or contribute to the NTSB's programs.
(ii) Whether the portions of a record subject to disclosure are meaningfully informative about government operations or activities. The disclosure of information already in the public domain, in either a duplicative or substantially identical form, would not be as likely to contribute to such understanding where nothing new would be added to the public's understanding.
(iii) Whether disclosure of the requested information would contribute to the understanding of a reasonably broad audience of persons interested in the subject, as opposed to the individual understanding of the requester. The NTSB will consider a requester's expertise in the subject area and ability to effectively convey information to the public.
(iv) Whether the disclosure is likely to enhance the public's understanding of government operations or activities.
(3) The NTSB's decision to designate the FOIA request as commercial will be made on a case-by-case basis based on the NTSB's review of the requester's intended use of the information. The NTSB will provide the requester with a reasonable opportunity to submit further clarification. In determining whether the request is primarily in the commercial interest of the requester, the NTSB will consider the following factors:
(i) The existence and magnitude of any commercial interest the requester may have, or of any person on whose behalf the requester may be acting. The NTSB will provide requesters with an opportunity in the administrative process to submit explanatory information regarding this consideration.
(ii) Whether the commercial interest is greater in magnitude than any public interest in disclosure.
(4) Additionally, the NTSB may, at its discretion, waive search, duplication, and review fees for qualifying foreign countries, international organizations, nonprofit public safety entities, state and federal transportation agencies, and colleges and universities, after approval by the Chief, Records Management Division.
(5) Where only some of the records to be released satisfy the requirements for a waiver of fees, the NTSB will grant a waiver for those particular records.
(6) Requests for the waiver or reduction of fees should address the factors listed in paragraphs (e)(2) and (3) of this section, insofar as they apply to each request. The NTSB will exercise its discretion to consider the cost-effectiveness of its use of administrative resources in determining whether to grant waivers or reductions of fees.
(f)
(i) Press releases;
(ii) NTSB regulations (Chapter VIII of Title 49, Code of Federal Regulations);
(iii) Indexes to initial decisions, Board orders, opinion and orders, and staff manuals and instructions;
(iv) Safety recommendations; and
(v) NTSB Annual Reports.
(2) The NTSB public Website,
Requesters seeking an appeal of the FOIA Office's fee or fee waiver determination must send a written appeal to the Managing Director within 90 calendar days. The Managing Director will determine whether to grant or deny any appeal made pursuant to § 801.21 within 20 days (excluding Saturdays, Sundays, and legal public holidays) after receipt of such appeal, except that this time limit may be extended for as many as 10 additional days (excluding Saturdays, Sundays, and legal public holidays), in accordance with § 801.23.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Gulfstream Aerospace Corporation Models G-IV and GIV-X airplanes. This proposed AD was prompted by the potential for fatigue cracks developing in the main landing gear actuator attachment fitting that had a certain repair incorporated. This proposed AD would require incorporating new revisions into the Instructions for Continued Airworthiness of the Limitations section of the FAA-approved maintenance program (
We must receive comments on this proposed AD by January 26, 2018.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Gulfstream Aerospace Corporation, P.O. Box 2206, Savannah, Georgia 31402-2206; telephone: (800) 810-4853; fax 912-965-3520; email:
You may examine the AD docket on the internet at
William O. Herderich, Aerospace Engineer, Atlanta ACO Branch, FAA, 1701 Columbia Avenue, College Park, Georgia 30337; phone: (404) 474-5547; fax: (404) 474-5605; email:
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We were notified that fatigue cracking in the main landing gear (MLG) actuator attachment fitting could occur on certain Gulfstream Aerospace Corporation (Gulfstream) Models G-IV and GIV-X airplanes that are Maintenance Steering Group “MSG-3” compliant and have had repair SE05732102 incorporated.
It has been determined that incorrect fracture toughness was used in calculating repetitive inspection intervals based on damage tolerances. Repair SE05732102 for the MLG side brace fitting was issued without Instructions for Continued Airworthiness (ICA). Gulfstream has developed new ICA to address this issue.
This condition, if not corrected, could result in failure of the MLG actuator attachment, which could compromise the lateral support of the MLG during ground maneuvers, possibly leading to collapse of the affected MLG with consequent loss of control. In addition, this condition could also cause the MLG side brace to fail, which could result in penetration of the wing fuel tank and cause an uncontained fire.
We reviewed Gulfstream G350 Customer Bulletin Number 192A, dated June 15, 2017, including Appendix A, Gulfstream Document GIV-SGER-553, Revision A, Instructions for Continued Airworthiness for Gulfstream Repair Drawing SE05732102, dated December 14, 2016; Gulfstream G450 Customer Bulletin 192A, dated June 15, 2017, including Appendix A, Gulfstream Document GIV-SGER-553, Revision A, Instructions for Continued Airworthiness for Gulfstream Repair Drawing SE05732102, dated December 14, 2016; Gulfstream IV Customer Bulletin Number 238A, dated June 15, 2017, including Appendix A, Gulfstream Document GIV-SGER-553, Revision A, Instructions for Continued Airworthiness for Gulfstream Repair Drawing SE05732102, dated December 14, 2016; Gulfstream G300 Customer Bulletin Number 238A, dated June 15, 2017, including Appendix A, Gulfstream Document GIV-SGER-553,
We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This proposed AD would require accomplishing the actions specified in the service information described previously.
We estimate that this proposed AD affects 709 airplanes of U.S. registry.
We estimate the following costs to comply with this proposed AD:
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This proposed AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to small airplanes and domestic business jet transport airplanes to the Director of the Policy and Innovation Division.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect 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.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by January 26, 2018.
None.
This AD applies to the following Gulfstream Aerospace Corporation model airplanes that are certificated in any category:
(1) Model G-IV, serial numbers (S/Ns) 1000 through 1399 having Aircraft Service Change (ASC) 416A (MSG-3) incorporated; and S/Ns 1400 through 1535; and
(2) Model GIV-X, S/Ns 4001 through 4355.
Joint Aircraft System Component (JASC)/Air Transport Association (ATA) of America Code 32, Landing Gear.
This AD was prompted by the potential for fatigue cracks in the main landing gear (MLG) actuator attachment fitting that had a certain repair incorporated. We are issuing this AD to prevent failure of the MLG actuator attachment. The unsafe condition, if not
Within the next 100 hours time-in-service after the effective date of this AD, comply with the actions in paragraphs (g) through (i) of this AD, unless already done.
Inspect the airplane maintenance records to determine if repair SE05732102 for the MLG side brace fitting has been incorporated. To do this inspection, use the Accomplishment Instructions in Gulfstream G350 Customer Bulletin Number 192A; Gulfstream G450 Customer Bulletin 192A; Gulfstream IV Customer Bulletin Number 238A; Gulfstream G300 Customer Bulletin Number 238A; and Gulfstream G400 Customer Bulletin Number 238A; all dated June 15, 2017, as applicable. The service information referenced in this paragraph specifies sending a service reply card back to Gulfstream Aerospace Corporation if repair SE05732102 for the MLG side brace fitting has been not been incorporated. This action is not required in this AD.
If it is determined during the maintenance records inspection required in paragraph (g) of this AD that repair SE05732102 for the MLG side brace fitting has been incorporated, determine the initial and repetitive inspection requirements using the Accomplishment Instructions of the service information identified in paragraph (g) of this AD along with the following documents, as applicable. Comply with the inspection requirements as determined.
(1) Appendix A, Gulfstream Document GIV-SGER-553, Revision A, Instructions for Continued Airworthiness for Gulfstream Repair Drawing SE05732102, dated December 14, 2016, to Gulfstream G350 Customer Bulletin No. 192A, dated June 15, 2017;
(2) Appendix A, Gulfstream Document GIV-SGER-553, Revision A, Instructions for Continued Airworthiness for Gulfstream Repair Drawing SE05732102, dated December 14, 2016, to Gulfstream G450 Customer Bulletin No. 192A, dated June 15, 2017;
(3) Appendix A, Gulfstream Document GIV-SGER-553, Revision A, Instructions for Continued Airworthiness for Gulfstream Repair Drawing SE05732102, dated December 14, 2016, to Gulfstream IV Customer Bulletin No. 283A, dated June 15, 2017;
(4) Appendix A, Gulfstream Document GIV-SGER-553, Revision A, Instructions for Continued Airworthiness for Gulfstream Repair Drawing SE05732102, dated December 14, 2016, to Gulfstream G300 Customer Bulletin No. 283A, dated June 15, 2017; and
(5) Appendix A, Gulfstream Document GIV-SGER-553, Revision A, Instructions for Continued Airworthiness for Gulfstream Repair Drawing SE05732102, dated December 14, 2016, to Gulfstream G400 Customer Bulletin No. 283A, dated June 15, 2017.
Insert the documents listed in paragraphs (h)(1) through (5) of this AD into the Instructions for Continued Airworthiness of the Limitations section of the FAA-approved maintenance program (
(1) The Manager, Atlanta ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (k)(1) of this AD.
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (g) through (i) of this AD apply.
(i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. An AMOC is required for any deviations to RC steps, including substeps and identified figures.
(ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.
(1) For more information about this AD, contact William O. Herderich, Aerospace Engineer, Atlanta ACO Branch, FAA, 1701 Columbia Avenue, College Park, Georgia 30337; phone: (404) 474-5547; fax: (404) 474-5605; email:
(2) For service information identified in this AD, contact Gulfstream Aerospace Corporation, P.O. Box 2206, Savannah, Georgia 31402-2206; telephone: (800) 810-4853; fax 912-965-3520; email:
Environmental Protection Agency (EPA).
Notification of availability.
The Environmental Protection Agency (EPA) is required to conduct periodic reviews of certain aspects of the Renewable Fuel Standard (RFS) program under the Clean Air Act. This Notification of Availability (NOA) announces the availability of a document titled “Periodic Reviews for the Renewable Fuel Standard Program.” The document describes EPA's interpretation of the statutory requirement to conduct periodic reviews, and prior actions that EPA has taken to fulfill its obligations to conduct such reviews.
December 12, 2017.
Julia MacAllister, Office of Transportation and Air Quality, Assessment and Standards Division, Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI 48105; telephone number: 734-214-4131; email address:
EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2017-0627. Publicly available docket materials are available either electronically through
You may access this
Under section 211(o)(11) of the Clean Air Act, EPA is required to conduct certain periodic reviews. A separate document entitled, “Periodic Reviews for the Renewable Fuel Standard Program” explains our interpretation of the statutory text, including both ambiguities and unintelligible aspects of subparagraph (C) of CAA section 211(o)(11). That document also describes our fulfillment of the obligation to conduct periodic reviews notwithstanding the interpretive issues, and the contexts in which we have used the results of those periodic reviews. That document, and other supporting documents, are available in the docket.
Federal Communications Commission.
Proposed rule.
In this document, the Federal Communications Commission (Commission) seeks comment on whether to eliminate Form 325, Annual Report of Cable Television Systems, or, in the alternative, on ways to modernize and streamline the form.
Comments are due on or before February 12, 2018; reply comments are due on or before February 26, 2018.
You may submit comments, identified by MB Docket Nos. 17-290, 17-105, by any of the following methods:
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For additional information on this proceeding, contact Maria Mullarkey of the Policy Division, Media Bureau at
This is a summary of the Commission's Notice of Proposed Rulemaking, FCC 17-157, adopted and released on November 16, 2017. The full text of this document is available electronically via the FCC's Electronic Document Management System (EDOCS) website at
1. This Notice of Proposed Rulemaking (NPRM) seeks comment on whether to eliminate Form 325, Annual Report of Cable Television Systems, or, in the alternative, on ways to modernize and streamline the form. Form 325 collects operational information from cable television systems nationwide, including their network structure, system-wide capacity, programming, and number of subscribers. There have been significant changes in the multichannel video programming distributor (MVPD) marketplace and in the way cable systems operate since the Commission last examined the requirement to file Form 325 almost two decades ago. Given these transformations in the industry, and the commercial availability of cable operator-related data, we think it is appropriate to take a fresh look at the form and to evaluate the continued need for the Form 325 information collection. We also note that, as part of the record in the Commission's Modernization of Media Regulation Initiative proceeding, some industry commenters request that the Commission reevaluate the requirement for cable systems to file Form 325 and consider whether the form should be eliminated to reduce burdens on the cable industry.
2. Form 325 collects operational information from cable television systems nationwide, including data about subscriber numbers, equipment, plant information, frequency and signal distribution information, and programming.
3. The Commission first developed the form for use in 1966
4. The Commission's last significant modification of the Form 325 data collection was in 1999.
5. Today, industry commenters argue that Form 325 is burdensome for cable systems and has outlived its usefulness, given the availability of information about the cable industry from alternative sources and the changes in the MVPD marketplace. In the 2017 Modernization of Media Regulation Initiative proceeding, NCTA—The Internet and Television Association (NCTA), the American Cable Association (ACA), Verizon, and ITTA—The Voice of America's Broadband Providers (ITTA) each assert that the Commission should eliminate the Form 325 requirement. NCTA argues that the routine collection of information does not make sense in today's competitive video marketplace, particularly where there is no similar requirement applicable to non-cable MVPDs or online video distributors.
6. We seek comment on the continued utility of collecting Form 325 data and whether the Commission should eliminate the form entirely. Given the substantial changes in the MVPD marketplace and in the operations of cable systems since the Commission last considered the utility and effectiveness of the Form 325 data collection almost two decades ago, including the transition to digital television and the development of new technologies and ways to deliver video programming to consumers, we believe it is appropriate to consider whether the form continues to be useful to the agency's regulatory and adjudicatory functions with respect to the cable industry and whether the information collected therein is available from alternative sources. We also seek comment on the costs of this requirement for cable systems and on whether the benefits of the information outweigh the costs.
7. We seek comment on whether changes in the MVPD marketplace or other factors since the Commission last considered the utility and effectiveness of the Form 325 data collection almost two decades ago should lead the Commission to a different conclusion regarding the need for the Commission to collect the data required by the form. To what extent do the changes in the industry and regulatory environment since 1999 obviate or reduce the need for this information? For example, in the
8. We also seek comment on the burden for cable operators to file Form 325 each year and, in particular, on the amount of time and resources it takes to complete the filing for each cable system. Do the benefits and uses of the information collected via Form 325 outweigh the burdens and costs on cable systems to file the form? To the extent the Commission might in the future need discrete information, would it be more cost effective for the Commission to undertake targeted information collections to obtain it?
9. We also seek comment on whether and to what extent Form 325 merely duplicates information that the Commission can obtain from commercial sources. For example, the Commission routinely cites data from SNL Kagan, BIA/Kelsey, The Nielsen Company, and Warren Communications Television and Cable Factbook.
10. Are there other external uses of the Form 325 data collection of which the Commission should take account?
11. If the Commission decides to retain the Form 325 data collection, we seek comment on ways to improve and modernize the form. The cable television industry has experienced many changes since Form 325 was last updated, most notably the ongoing transition to digital technology and the introduction of video programming delivered via internet protocol (IPTV). These changes may render some data collected by the form no longer necessary and raise new information needs not met by the current form. If the Commission decides to retain the Form 325 data collection, we seek to minimize the administrative burden on cable television systems and improve the quality and usefulness of Form 325 data to reflect technological and other pertinent industry changes. We also seek to ensure that the data we collect are closely aligned with the uses to which they will be put by the Commission.
12. In addition, to the extent the form is retained, we propose to upgrade the current COALS filing system to minimize the filing burden for cable systems. An upgraded filing system would be able to pre-fill much of the data that does not change from year to year using other filings, such as community registrations, online public inspection files (OPIF), and previous Form 325 submissions. Cable operators will only have to verify the continued accuracy of any pre-filled information, and update those fields only if necessary.
13. Currently, Form 325 is organized into five parts: (1) Operator information; (2) general information; (3) frequency and signal distribution information; (4) channel line-up; and (5) certification.
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18. We seek comment on whether there is a continued need to collect information on frequency and signal distribution to the extent the form is retained, and, if not, whether we should eliminate this section of the form. We seek comment on the uses of this data and whether we can obtain it from other sources. We also seek comment on how the Commission can modernize the questions about a cable system's technical capabilities, capacity, and potential for growth, including its ability to offer sophisticated services, if it decides to retain this section of the
19. We tentatively conclude that we should eliminate the collection of channel line-up information to the extent the form is retained. We note that information about a cable system's programming is available from online sources, including on cable operator websites and from third-party guide services. Given the availability of this information from other public sources, we tentatively conclude that it is not necessary to continue to collect it from the cable operators via Form 325. We seek comment on this tentative conclusion. If, on the other hand, the Commission ultimately decides that this information collection is necessary and useful, are there ways for the Commission to streamline this section of Form 325 to reduce the burden on cable systems to input their entire channel lineup? For example, should we reduce the types of program channels that must be reported?
20.
21. We seek specific comment on the burden imposed by the Form 325 filing requirement on smaller cable systems. In its media modernization proceeding comments, ACA contends that, should the Commission decide to retain Form 325, it should no longer require cable systems with fewer than 20,000 subscribers to complete the form.
22. We tentatively conclude that, at a minimum, the Commission should exempt systems that serve fewer than 5,000 subscribers and are not affiliated with a larger operator from filing Form 325, if the form is retained. We seek comment on this tentative conclusion. Given the relative burdens and benefits, should we also exempt other smaller systems from having to complete the form? In addition, for those small cable systems that may still be required to file, should the Commission maintain the current approach of requiring only a sample of these systems to file Form 325 each year? Instead of randomly sampling smaller systems annually, should we require smaller systems to file the report every two, three, or five years, or some other time period? How should we define small systems for such purposes? For example, we could require systems that serve between 5,000 and 20,000 subscribers and are not affiliated with a larger operator (serving more than 2 percent of all MVPD subscribers
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25. The NPRM may result in revised information collection requirements. If the Commission adopts any revised information collection requirement, the Commission will publish a notice in the
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Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.
All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th Street SW, TW-A325, Washington, DC 20554. The filing hours are 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of
Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701.
U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW, Washington, DC 20554.
28. Availability of Documents. Comments, reply comments, and
29. People with Disabilities. To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to
30. For additional information on this proceeding, contact Maria Mullarkey of the Policy Division, Media Bureau, at
31. As required by the Regulatory Flexibility Act of 1980, as amended (RFA),
32. Form 325 collects operational information from cable television systems nationwide, including their network structure, system-wide capacity, programming, and number of subscribers, which is used to inform the Commission's policymaking and enforcement activities on matters related to the cable industry. The NPRM seeks comment on the utility of collecting Form 325 data and whether the Commission should continue to require this annual filing by cable television systems. The NPRM also seeks comment on ways to modernize and streamline Form 325 to minimize the administrative burden on cable systems while ensuring that the most pertinent information about cable television systems is collected, if the Commission decides to retain the Form 325 data collection. Further, the NPRM seeks comment on the impact of the Form 325 filing requirement on smaller cable systems and on whether the annual Form 325 filing requirement should continue to apply to a random sampling of cable systems that serve fewer than 20,000 subscribers.
33. The proposed action is authorized pursuant to sections 4(i), 4(j), 303, and 628 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 154(j), 303, and 548.
34. The RFA directs agencies to provide a description of, and where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted.
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39. As indicated above, the NPRM seeks comment on the utility of collecting Form 325 data and on whether the Commission should eliminate the Form 325 data collection entirely. The NPRM also seeks comment on ways to improve and modernize the form, if the Commission decides to retain the Form 325 data collection. With respect to each section of Form 325, the NPRM seeks comment on whether there is a continued need to collect the information solicited therein to the extent the form is retained, and, if not, whether the Commission should eliminate that particular section of the form; on the uses of the data and whether such data can be obtained from other sources; and on how the Commission can update or modernize the questions, if it decides to retain that particular section of the form. In order to evaluate any new or modified reporting, recordkeeping, or other compliance requirements that may result from the actions proposed in this NPRM, the Commission has sought input from the parties on various matters. For example, the NPRM seeks comment on the burden imposed by the Form 325 filing requirement on smaller cable systems; which data, if any, is particularly burdensome on smaller systems to provide; and whether the burden on smaller systems to file Form 325 will be significantly reduced if the form is streamlined and modernized as proposed in the NPRM. The NPRM tentatively concludes that, at a minimum, the Commission should exempt systems that serve fewer than 5,000 subscribers and are not affiliated with a larger operator from filing Form 325, if the form is retained. The NPRM also seeks comment on whether to exempt other smaller systems from having to complete the form or whether to maintain the current approach of requiring a sample of smaller cable systems to file the Form 325 each year. Through this NPRM, the Commission seeks to minimize the administrative burden on cable television systems, including smaller cable systems, improve the quality and usefulness of Form 325 data to reflect technological and other pertinent industry changes, and to ensure that the data collected are closely aligned with the uses to which they will be put by the Commission, if the Commission retains the form. We anticipate that the removal or modification of Form 325 reporting requirements will lead to a long-term reduction in reporting, recordkeeping, or other compliance requirements on all cable systems, including small entities.
40. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): “(1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities; (3) the use of performance, rather than design standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.”
41. The Commission expects to more fully consider the economic impact on small entities following its review of comments filed in response to the NPRM and this IRFA. Generally, the NPRM seeks comment on the burden for cable operators to file Form 325 each year and on the amount of time and resources it takes to complete the filing for each cable system. The NPRM also asks whether the benefits and uses of the information collected via Form 325 outweigh the burdens and costs on cable systems to file the form. The NPRM also seeks specific comment on the burden imposed by the Form 325 filing requirement on smaller cable systems. The NPRM inquires as to which data is particularly burdensome on smaller systems to provide and on whether the burden on small systems to file Form 325 would be significantly reduced if the Commission streamlines and modernizes the form as discussed in the NPRM, if it decides to retain the form. The NPRM tentatively concludes that, at a minimum, the Commission should exempt systems that serve fewer than 5,000 subscribers and are not affiliated with a larger operator from filing Form 325, if the form is retained. The NPRM asks whether the Commission should exempt other smaller cable systems from having to complete the form or on any alternative approaches to alleviate the filing burden on smaller systems,
42. None.
43. Accordingly, it is ordered that, pursuant to the authority found in sections 4(i), 4(j), 303, and 628 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 154(j), 303, and 548, this Notice of Proposed Rulemaking is adopted.
44. It is further ordered that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of this Notice of Proposed Rulemaking, including the Initial Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.
Cable television operators.
Federal Communications Commission.
Petitions for Reconsideration.
Petitions for Reconsideration (Petition) have been filed in the Commission's rulemaking proceeding by Charles S. Farlow, on behalf of Medtronic, Inc., Chuck Powers on behalf of Motorola Solutions, Inc., and Michael E. Williams, on behalf of Cobra Electronics Corporation.
Oppositions to the Petition must be filed on or before December 27, 2017. Replies to an opposition must be filed on or before January 8, 2018.
Federal Communications Commission, 445 12th Street SW, Washington, DC 20554.
Thomas Derenge, email:
This is a summary of the Commission's document, Report No. 3082, released December 01, 2017. The full text of the Petitions is available for viewing and copying at the FCC Reference Information Center, 445 12th Street SW, Room CY-A257, Washington, DC 20554. It also may be accessed online via the Commission's Electronic Comment Filing System at:
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of intent to prepare an environmental impact statement; request for written comments.
NMFS, in consultation with the North Pacific Fishery Management Council (Council), announces its intent to prepare an Environmental Impact Statement (EIS) on a new halibut bycatch management program for groundfish fisheries in the Bering Sea and Aleutian Islands (BSAI), in accordance with the National Environmental Policy Act of 1969 (NEPA). The proposed action would create a new method of managing halibut bycatch that links halibut prohibited species catch (PSC) limits for the groundfish fisheries to data on halibut abundance. The proposed action is intended to provide a responsive approach for managing halibut bycatch at varying levels of halibut abundance. The new program would minimize halibut bycatch to the extent practicable while achieving, on a continuing basis, optimum yield from the groundfish fisheries. The new management program also could provide additional opportunity for the directed halibut fishery at low levels of halibut abundance compared to the status quo and promote conservation of the halibut spawning stock biomass, particularly at low levels of abundance. The EIS will analyze the impacts to the human environment resulting from the proposed bycatch management program. NMFS will accept written comments from the public to identify the issues of concern and assist the Council in determining the appropriate range of management alternatives for the EIS.
Written comments will be accepted through February 16, 2018.
You may submit comments on this document, identified by NOAA-NMFS-2017-0144, by any of the following methods:
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Glenn Merrill, (907) 586-7228 or email
Under the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), the United States has exclusive fishery management authority over all living marine resources found within the exclusive economic zone (EEZ). The management of these marine resources, with the exception of marine mammals and birds, is vested in the Secretary of Commerce. The Council has the responsibility to prepare fishery management plans for the fishery resources that require conservation and management in the EEZ off Alaska. Management of the Federal groundfish fisheries in the BSAI is carried out under the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP). The FMP, its amendments, and implementing regulations (found at 50 CFR part 679) are developed in accordance with the requirements of the Magnuson-Stevens Act and other applicable Federal laws and executive orders, notably the National Environmental Policy Act (NEPA) and the Endangered Species Act (ESA).
The Pacific halibut (
The International Pacific Halibut Commission (IPHC) and NMFS manage Pacific halibut fisheries through regulations established under the authority of the Northern Pacific Halibut Act of 1982 (Halibut Act) (16 U.S.C. 773-773k). The IPHC adopts regulations governing the target fishery for Pacific halibut under the Convention between the United States and Canada for the Preservation of the Halibut Fishery of the North Pacific Ocean and Bering Sea (Convention), signed at Ottawa, Ontario, on March 2, 1953, as amended by a Protocol Amending the Convention (signed at Washington, DC, on March 29, 1979). For the United States, regulations governing the fishery for Pacific halibut developed by the IPHC are subject to acceptance by the Secretary of State with concurrence from the Secretary of Commerce. After acceptance by the Secretary of State and the Secretary of Commerce, NMFS publishes the IPHC regulations in the
Section 773c(c) of the Halibut Act also provides the Council with authority to develop regulations that are in addition to, and not in conflict with, approved IPHC regulations. The Council has exercised this authority in the development of Federal regulations for the halibut fishery such as (1) subsistence halibut fishery management measures, codified at § 300.65; (2) the limited access program for charter vessels in the guided sport fishery, codified at § 300.67; and (3) the Individual Fishing Quota (IFQ) Program for the commercial halibut and sablefish fisheries, codified at 50 CFR part 679, under the authority of section 773 of the Halibut Act and section 303(b) of the Magnuson-Stevens Act.
The Council is examining abundance-based approaches for halibut PSC limits in the BSAI groundfish fisheries. Currently, halibut PSC limits are a fixed amount of halibut mortality in metric tons. When halibut abundance declines, halibut PSC becomes a larger proportion of total halibut removals and can result in lower catch limits for directed halibut fisheries. Both the Council and the IPHC have expressed concern about the impacts of lower catch limits on directed halibut fisheries at low levels of halibut abundance under the status quo. The Council identified abundance-based halibut PSC limits as a potential management approach to address this concern by linking halibut PSC limits to halibut abundance and potentially providing additional opportunity for the directed halibut fisheries compared to the status quo at low levels of halibut abundance.
NMFS and the Council have determined the preparation of an EIS may be required for this action because abundance-based halibut PSC limits may have effects on target and bycatch species and their users that are uncertain or unknown and may result in significant impacts on the human environment not previously analyzed. Thus, NMFS and the Council are initiating scoping for an EIS in the event an EIS is needed.
NMFS and the Council are seeking information from the public through the EIS scoping process on the range of alternatives to be analyzed, and on the environmental, social, and economic issues to be considered in the analysis. Written comments generated during this scoping process will be provided to the Council and incorporated into the EIS for the proposed action.
The Magnuson-Stevens Act authorizes the Council and NMFS to manage groundfish fisheries in the Alaska EEZ that take halibut as bycatch. The groundfish fisheries cannot be prosecuted without some level of halibut bycatch because groundfish and halibut occur in the same areas at the same times, and no fishing gear or technique has been developed that can avoid all halibut bycatch. However, the Council and NMFS have taken a number of management actions over the past several decades to minimize halibut bycatch in the BSAI groundfish fisheries. Most importantly, the Council has designated Pacific halibut and several other species (herring, salmon and steelhead, king crab, and Tanner crab) as “prohibited species” (Section 3.6.1 of the FMP). By regulation, the operator of any vessel fishing for groundfish in the BSAI must minimize the catch of prohibited species (§ 679.21(b)(2)(i)).
Although halibut is taken as bycatch by vessels using all types of gear (trawl, hook-and-line, pot, and jig gear), halibut bycatch primarily occurs in the trawl and hook-and-line groundfish fisheries. NMFS manages halibut bycatch in the BSAI by (1) establishing halibut PSC limits for trawl and non-trawl fisheries; (2) apportioning those halibut PSC limits to groundfish sectors, fishery categories, and seasons; and (3) managing groundfish fisheries to prevent PSC from exceeding the established limits.
Consistent with National Standard 1 and National Standard 9 of the
In 2015, the Council revised halibut PSC management in the BSAI groundfish fisheries by recommending Amendment 111 to the FMP. Amendment 111 reduced halibut PSC limits for the BSAI groundfish fisheries by 21 percent. NMFS implemented Amendment 111 on May 27, 2016 (81 FR 24714). In February 2015, in conjunction with review of the analysis prepared for Amendment 111, the Council also requested an initial evaluation of possible approaches to link BSAI halibut PSC limits to data or model-based abundance estimates of halibut. The Council reviewed this initial evaluation at its December 2015 meeting and requested additional information on appropriate indices for use in indexing halibut abundance to PSC limits in the BSAI.
In April 2016, the Council reviewed additional information on abundance-based approaches for halibut PSC limits and unanimously adopted a purpose and need statement to establish abundance-based halibut PSC limits for the BSAI groundfish fisheries. The Council refined the purpose and need statement at subsequent meetings in 2016 and 2017:
The current fixed yield based halibut PSC caps are inconsistent with management of the directed halibut fisheries and Council management of groundfish fisheries, which are managed based on abundance. When halibut abundance declines, PSC becomes a larger proportion of total halibut removals and thereby further reduces the proportion and amount of halibut available for harvest in directed halibut fisheries. Conversely, if halibut abundance increases, halibut PSC limits could be unnecessarily constraining. The Council is considering linking PSC limits to halibut abundance to provide a responsive management approach at varying levels of halibut abundance. The Council is considering abundance-based PSC limits to control total halibut mortality, provide an opportunity for the directed halibut fishery, and protect the halibut spawning stock biomass, particularly at low levels of abundance. The Council recognizes that abundance-based halibut PSC limits may increase and decrease with changes in halibut abundance.
In October 2016, the Council identified the following objectives for establishing abundance-based halibut PSC limits to guide the development of appropriate management measures and the tradeoffs among them:
1. Halibut PSC limits should be indexed to halibut abundance.
2. Halibut spawning stock biomass should be protected especially at lower levels of abundance.
3. There should be flexibility provided to avoid unnecessarily constraining the groundfish fishery particularly when halibut abundance is high.
4. Provide for directed halibut fishing operations in the Bering Sea.
5. Provide for some stability in PSC limits on an inter-annual basis.
In October 2017, the Council requested a preliminary analysis using specific elements and options it intends to consider in developing alternatives for abundance-based halibut PSC limits. The Council and NMFS also agreed to initiate scoping to prepare an EIS for the proposed action to establish abundance-based halibut PSC limits in the BSAI groundfish fisheries. Additional information on the Council's development of abundance-based halibut PSC limits is available on the Council's website at
The EIS will analyze the proposed action to establish halibut PSC limits for the BSAI groundfish fisheries that can vary with changes in halibut abundance. Abundance-based halibut PSC limits would replace current PSC limits that establish a fixed amount of halibut PSC as the limit for each groundfish sector in the BSAI. The proposed action would apply to participants in Federal groundfish fisheries prosecuted in the BSAI using trawl and non-trawl (fixed) gear. This area is defined at § 679.2 and shown in Figure 1 to 50 CFR part 679.
NMFS, in coordination with the Council, will evaluate a range of alternative methods for establishing abundance-based halibut annual PSC limits for the groundfish fisheries in the BSAI. NMFS and the Council recognize that implementation of abundance-based halibut PSC limits could result in substantial changes to many of the current management measures for halibut PSC in the groundfish fisheries. The EIS will analyze these changes and the likely impacts of those changes on groundfish stocks and participants in the groundfish fisheries. The EIS also will analyze the likely impacts of an abundance-based halibut PSC limits on the halibut stock and on participants in directed halibut fisheries. Alternatives may be formulated based on two elements critical to establishing abundance-based halibut PSC limits: (1) A halibut abundance index, and (2) a control rule informed by abundance index data that results in a halibut PSC limit for the trawl and fixed gear groundfish fisheries in the BSAI. The Council has identified the following index and control rule options for preliminary analysis.
Possible alternatives for the abundance-based halibut PSC management program could be constructed from one or more of the following options, in addition to those developed through the public scoping and Council processes:
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Scoping is an early and open process for determining the scope of issues to be addressed in an EIS and for identifying the significant issues related to the proposed action. A principal objective of the scoping and public involvement process is to identify a range of reasonable management alternatives that, with adequate analysis, will delineate critical issues and provide a clear basis for distinguishing among those alternatives and selecting a preferred alternative. Through this document, NMFS is notifying the public that an EIS and decision-making process for this proposed action have been initiated so that interested or affected people may participate and contribute to the final decision.
NMFS is seeking written public comments on the scope of issues, including potential impacts, and alternatives that should be considered to establish abundance-based halibut PSC limits for the groundfish fisheries in the BSAI. Written comments should be as specific as possible to be the most helpful. Written comments received during the scoping process, including the names and addresses of those submitting them, will be considered part of the public record of this proposal and will be available for public inspection. Written comments will be accepted at the address above (see
The public is invited to participate and provide input at Council meetings where the latest scientific information regarding the BSAI groundfish fisheries is reviewed and alternatives for abundance-based halibut PSC limits are developed and evaluated. Notice of future Council meetings will be published in the
16 U.S.C. 1801
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden 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 those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments regarding this information collection received by January 11, 2018 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW, Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to:
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
U.S. Census Bureau, Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
To ensure consideration, written comments must be submitted on or before February 12, 2018.
Please direct all written comments 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 or copies of the information collection instrument(s) and instructions should be directed to Robin A. Pennington, Rm. 2H465, U.S. Census Bureau, Decennial Census Management Division, Washington, DC 20233 or via email to
Since the founding of the nation, the U.S. Census has mediated between the demands of a growing country for information about its economy and people, and the people's privacy and respondent burden. Beginning with the 1810 Census, Congress added questions to support a range of public concerns and uses, and over the course of a century questions were added about agriculture, industry, and commerce, as well as occupation, ancestry, marital status, disabilities, and other topics. In 1940, the U.S. Census Bureau introduced the long form and, since then, the more detailed questions were only asked of a sample of the public.
The American Community Survey (ACS), launched in 2005, is the current embodiment of the long form of the census and is asked each year of a sample of the U.S. population in order to provide current data needed more often than once every ten years.
The content of the proposed 2019 ACS questionnaire and data collection instruments for both Housing Unit and Group Quarters operations reflects changes to content and instructions that were proposed as a result of the 2016 ACS Content Test. The Census Bureau periodically conducts tests of new and improved survey content to ensure the ACS is meeting the data needs of its stakeholders. The primary objective of content tests is to test whether changes to question wording, response categories, and definitions of underlying constructs improve the quality of data collected.
The ACS is one of the Department of Commerce's most valuable data products, used extensively by businesses, non-governmental organizations (NGOs), local governments, and many federal agencies. In conducting this survey, the Census Bureau's top priority is respecting the time and privacy of the people providing information while preserving the survey's value to the public. The 2019 survey content changes cover several topics:
The rise of cellphone and smartphone usage, and other complex and varied telephone services and equipment, has changed how people view and use telephones in a household. Research also suggests that some respondents, or in some cases interviewers, may not fully understand the current wording of the survey question on Telephone Service, the additional instructions that accompany the question, or what the question is intending to capture. To make the intent of the Telephone Service question easier to understand by respondents and interviewers, the question was made a stand-alone question and additional instructions are provided on the types of telephones and equipment respondents should include when answering the question. Currently, telephone service is asked as part of a broader question on housing characteristics.
A question on health insurance premiums and subsidies will be introduced to the ACS immediately following the current question on health insurance coverage. The question on premiums and subsidies asks if a person pays a health insurance premium, and if so, if he or she received a subsidy to help pay the premium. This question will provide more accurate information about coverage categories than available from the existing ACS question on current coverage alone. These data will enhance the ability of HHS and the states to administer Medicaid, CHIP, and the exchanges, and monitor private insurance coverage.
Changes to the Commute Mode question were motivated by changes in public transportation infrastructure across the United States, particularly the increased prevalence of light rail systems and the need to update and clarify the terminology used to refer to commute modes that appear as categories on the ACS. To improve the Commute Mode question, some of the public transportation modes were modified. The category “Streetcar or trolley car” was changed to “Light rail, street car, or trolley,” “Subway or elevated” was changed to “Subway or Elevated Rail,” and “Railroad” was changed to “Long-distance train or commuter rail.” These three rail-related categories were also slightly reordered so that “Subway or elevated rail,” the most prevalent rail mode, is listed first. The phrase “trolley bus” was dropped and the phrase “work at home” was changed to “work from home.” The subheading of instructions was simplified to read “Mark ONE box for the method of transportation used for most of the distance.” The Time of Departure question has historically raised concerns about privacy because of the reference to the time a person leaves home. To phrase the question in a less intrusive way, the question was changed to ask what time the person's trip to work began and to remove the word “home.”
The changes to the question on the number of weeks worked were made to allow the Census Bureau to provide high-quality, continuous measures for the number of weeks worked, such as means, medians, and aggregates. In addition, the changes enable additional specificity for weeks worked, particularly with hours worked, income, and occupation. Part A of the question regarding the time period of interest was rephrased from working “50 or more weeks” to “EVERY week” and additional information is provided in the second sentence. The original instruction of “Count paid time off as work” was changed to “Count paid vacation, paid sick leave, and military service as work.” For part B of the question, the response option was changed to a write-in response, the reference period (“the PAST 12 MONTHS”) is repeated, and new guidance clarifies what to count as work.
Changes to the Class of Worker question improve overall question clarity, refine the definition of unpaid family workers, explicitly define a category for Active Duty military, improve question wording and categories, and improve the layout of the question. Response categories were grouped under three general headings. “Active Duty” was added as one of the response categories in the government section, and the “Active Duty” checkbox was dropped from the Employer Name question. Question and response category wording were revised for clarity. To signal that all six employment characteristics questions refer to the same job (including industry and occupation), the series was renumbered from separate questions to a single series with sub-questions. Lastly, the instructional text and heading for the series immediately preceding the Class of Worker question was simplified.
Ongoing research of the Industry and Occupation question write-in responses has demonstrated that the questions were unclear and confusing to respondents, who were unable to answer at all or answer with sufficient clarity to provide useful data. To increase clarity and improve occupational specificity, these questions were revised to include new and consistent examples, in terms of content and length, and include modified question wording. The number of
Over the last 40 years, defined contribution retirement plans have become increasingly common while defined benefit plans (such as pensions) have become less so. Federal surveys have lagged in addressing these newer forms of retirement income and subsequently underreport retirement income. The Retirement, Survivor, and Disability Income question was changed to improve income reporting, increase item response rates, reduce reporting errors, and update questions on retirement income and the income generated from retirement accounts and all other assets in order to better measure retirement income data. The question was expanded to ask about “
For several years, the Census Bureau has been testing revised Relationship questions to improve the estimates of coupled households. The 1990 Census first introduced “Unmarried Partner” as a response category to the Relationship to Householder question. The 2000 and 2010 Censuses built upon this work, changing the processing of responses to the Relationship question to more accurately represent same-sex couples. The Census Bureau discovered a statistical error in the 2010 Census data that resulted from opposite-sex couples mismarking their sex. This error has the potential to inflate the estimates of same-sex, married-couple households from the 2010 Census. The Census Bureau released a set of modified state-level, same-sex household estimates from the 2010 Census because of this error, and also began new research efforts to improve the Relationship question.
The Relationship question has been revised to improve measurement of same-sex couples. The existing “Husband or wife” and “Unmarried partner” response categories were each split into two versions: “Opposite-sex husband/wife/spouse,” “Opposite-sex unmarried partner,” “Same-sex husband/wife/spouse,” and “Same-sex unmarried partner.” Additionally, the two unmarried partner categories were moved from near the end of the list of response options to near the beginning, immediately after the “Husband/wife/spouse” options. An automated relationship/sex consistency check will be included in electronic instruments to provide respondents an opportunity to change their sex or relationship responses when there is an inconsistency in the reported sex of an individual and whether their relationship was reported as “Opposite-sex” or “Same-sex” husband/wife/spouse or unmarried partner. This check reduces the inconsistency in responses for a given household and improves the quality of the relationship data. The category “Roomer or boarder” has been dropped from the Relationship question.
The 2016 ACS Content Test served as an operational test of the race and ethnicity questions that were previously tested on the 2015 National Content Test (NCT). While recommendations about the race and ethnicity questions adopted for the 2020 Census and production ACS will be based on the results of the census tests and decisions made in consultation with the Office of Management and Budget (OMB), the 2016 ACS Content Test provided an opportunity to test data collection modes and examine other data not available in the 2015 NCT. The 2016 ACS Content Test evaluated interviewer-administered collection modes, assessed the race and ethnicity questions against demographic and socioeconomic data, and separately compared the race and ethnicity results to data from the ancestry question. In 2020 or later, the ACS will adopt the final version of the race and Hispanic origin questions that are implemented for the 2020 Census.
In August 2012, the OMB in conjunction with the Census Bureau established a Subcommittee of the Interagency Council on Statistical Policy (ICSP) to address ACS matters. The ICSP Subcommittee on the ACS exists to advise the Chief Statistician at OMB and the Director of the Census Bureau on how the ACS can best fulfill its role in the portfolio of Federal household surveys and provide the most useful information with the least amount of burden. It may also advise Census Bureau technical staff on issues they request the subcommittee to examine or that otherwise arise in discussions. The ICSP Subcommittee on the ACS reviewed the proposed 2019 ACS content changes and recommended their approval to the OMB and the Census Bureau. For the 2016 ACS Content Test, initial versions of the new and revised questions were proposed by federal agencies participating in the OMB Interagency Committee for the ACS. The initial proposals contained a justification for each change and described any previous testing of the question wording, the expected impact of revisions to the time series and the single-year as well as five-year estimates, and the estimated net impact on respondent burden for the proposed revision. For proposed new questions, the justification also described the need for the new data, whether federal law or regulation required the data for small areas or small population groups, if other data sources were currently available to provide the information (and why any alternate sources were insufficient), how policy needs or emerging data needs would be addressed through the new question, an explanation of why the data were needed with the geographic precision and frequency provided by the ACS, and whether other testing or production surveys had evaluated the use of the proposed questions.
The Census Bureau and the OMB, as well as the ICSP Subcommittee, reviewed these proposals for the ACS. The OMB determined which proposals moved forward into cognitive testing. After OMB approval of the proposals, topical subcommittees were formed from the OMB Interagency Committee on the ACS, which included all interested federal agencies that use the data from the proposed questions. These subcommittees further refined the specific proposed wording in preparation for cognitive testing.
The Census Bureau contracted with Westat, an internationally recognized organization with expertise in statistical research and survey methods, to conduct three rounds of cognitive testing. The results of the first two rounds of cognitive testing informed decisions on specific revisions to the proposed content for the stateside 2016 ACS Content Test. The proposed changes, identified through cognitive testing for each question topic, were reviewed by the Census Bureau, the corresponding topical subcommittee, and the ICSP Subcommittee for the ACS. The OMB then provided final overall approval of the proposed wording for field testing.
The public is invited to comment on all questions on the ACS; however, the Census Bureau is particularly interested in comments on the wording changes to the nine ACS questions listed above, which are proposed to be changed based
Title 13 U.S.C. Sections 141 and 193.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
Notice.
The Department of Defense has submitted to OMB, for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by January 11, 2018.
Written comments and recommendations on the proposed information collection should be sent to Ms. Seehra at the Office of Management and Budget, Desk Officer for DoD, Room 10236, New Executive Office Building, Washington, DC 20503.
You may also submit comments, identified by docket number and title, by the following method:
Department of the Army, U.S. Army Corps of Engineers, DoD.
Notice of availability.
The U.S. Army Corps of Engineers (USACE) in association with the nonfederal sponsor, the Virginia Port Authority, an agent of the Commonwealth of Virginia, announces the availability of the Elizabeth River and Southern Branch Navigation Improvements Draft General Reevaluation Report/Environmental Assessment (GRR/EA) for public review and comment. The purpose of this Draft GRR/EA is to evaluate alternatives that have the potential to improve the current and future operational efficiency of commercial vessels currently using the Norfolk Harbor federal channel in the Elizabeth River. Channel deepening alternatives were evaluated as well as
The Draft GRR/EA is available for a 30-day review period. Written comments, pursuant to the NEPA, will be accepted until the close of public review at the close of business on January 15, 2018.
Written comments or questions from the public may be submitted to the U.S. Army Corps of Engineers, Norfolk District, ATTN: Mr. David Schulte, Planning Branch, Environmental Analysis Section (CENAO-WR-PE), 803 Front Street, Norfolk, VA 23510 or via email to
Mr. David Schulte, 757-201-7007.
The document is available at the following locations: (1) Elizabeth River and Southern Branch Navigation Improvements website:
The Action Alternative consists of constructing and maintaining the following features:
• Deepening the channel from Lamberts Bend to Perdue Farms (Segment 1a) from a required depth of 40 feet to 45 feet deep in Segment 1a, and deepening the channel from Perdue Farms to the Norfolk Southern Lift Bridge (Segment 1b) from a required depth of 40 feet to 42 feet.
• Deepening the channel from the Norfolk Southern Lift Bridge to the Gilmerton Bridge (Segment 2), from a required depth of 35 feet to 39 feet deep; and
• Continuing to maintain the channel from the Gilmerton Bridge to the Chesapeake Extension to a required depth of 35 feet (Segment 3).
This study is authorized under Section 216 of the Flood Control Act of 1970 (Pub. L. 91-611), which authorizes the review of completed projects in the interest of navigation and related purposes to determine the feasibility of further port deepening.
Office of Planning, Evaluation and Policy Development (OPEPD), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a new information collection.
Interested persons are invited to submit comments on or before January 11, 2018.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Joanne Bogart, 202-205-7855.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in
Office of the Chief Financial Officer, Department of Education.
Notice of availability—FY 2016 service contract inventory.
Through this notice, the Secretary announces the availability of the Department of Education's service contract inventory on its website, at
Camille Manuel, U.S. Department of Education, 400 Maryland Avenue SW, Washington, DC 20202. Telephone: 202-245-6658 or by email:
If you use a telecommunications device for the deaf or a text telephone, call the Federal Relay Service, toll free, at 1-800-877-8339.
Section 743 of Division C of the Consolidated Appropriations Act of 2010, Public Law 111-117, requires civilian agencies, other than the Department of Defense, that are required to submit an inventory in accordance with the Federal Activities Inventory Reform Act of 1998 (Pub. L. 105-270, 31 U.S.C. 501 note) to submit their inventories to the Office of Federal Procurement Policy in the Office of Management and Budget by December 31, 2016. In addition, section 743 requires these agencies, which include the Department of Education, to (1) make the inventory available to the public, and (2) publish in the
Through this notice, the Department announces the availability of its inventory on the following website:
You may also access documents of the Department published in the
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notice of open meeting.
This notice announces an open meeting of the Hydrogen and Fuel Cell Technical Advisory Committee (HTAC). The Federal Advisory Committee Act requires notice of the meeting be announced in the
Tuesday, February 13, 2018, 8:30 a.m.-5:45 p.m.
Wednesday, February 14, 2018, 8:00 a.m.-12:00 p.m.
National Renewable Energy Laboratory, 901 D Street SW, Suite 930, Washington, DC 20024.
Email:
The staff of the Federal Energy Regulatory Commission (FERC or Commission) will prepare an environmental assessment (EA) that will discuss the environmental impacts of the TX-LA Markets Project involving construction and operation of facilities by Enbridge—Texas Eastern Transmission, L.P. (Texas Eastern) in Beauregard Parish, Louisiana. The Commission will use this EA in its decision-making process to determine whether the project is in the public convenience and necessity.
This notice announces the opening of the scoping process the Commission will use to gather input from the public and interested agencies on the project. You can make a difference by providing us with your specific comments or concerns about the project. Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. Your input will help the Commission staff determine what issues they need to evaluate in the EA. To ensure that your comments are timely and properly recorded, please send your comments so that the Commission receives them in Washington, DC on or before January 5, 2018.
If you sent comments on this project to the Commission before the opening of this docket on October 19, 2017, you will need to file those comments in Docket No. CP18-10-000 to ensure they are considered as part of this proceeding. This notice is being sent to the Commission's current environmental mailing list for this project. State and local government representatives should notify their constituents of this proposed project and encourage them to comment on their areas of concern.
Texas Eastern provided landowners with a fact sheet prepared by the FERC entitled “An Interstate Natural Gas Facility On My Land? What Do I Need To Know?” This fact sheet addresses a number of typically asked questions, including the use of eminent domain and how to participate in the Commission's proceedings. It is also available for viewing on the FERC website (
For your convenience, there are three methods you can use to submit your comments to the Commission. The Commission encourages electronic filing of comments and has expert staff available to assist you at (202) 502-8258 or
(1) You can file your comments electronically using the
(2) You can file your comments electronically by using the
(3) You can file a paper copy of your comments by mailing them to the following address. Be sure to reference the project docket number (CP18-10-000) with your submission: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Texas Eastern proposes to modify its existing Gillis Compressor Station in Beauregard Parish, Louisiana. The TX-LA Markets Project would provide about 157,500 dekatherms of natural gas per day to Entergy Louisiana, LLC and Natgasoline LLC.
The TX-LA Markets Project would consist of the following modifications at the existing Gills Compressor Station:
• Installation of two gas cooling bays; and
• installation of two new impellers
The general location of the project facilities is shown in appendix 1.
Construction of the proposed facilities would disturb about 39 acres of land for the aboveground facilities. All areas affected are owned by Texas Eastern. Texas Eastern would not require any additional acres for permanent operation of the project's facilities.
The National Environmental Policy Act (NEPA) requires the Commission to take into account the environmental impacts that could result from an action whenever it considers the issuance of a Certificate of Public Convenience and Necessity. NEPA also requires us
In the EA we will discuss impacts that could occur as a result of the construction and operation of the proposed project under these general headings:
• Geology and soils;
• land use;
• water resources, fisheries, and wetlands;
• cultural resources;
• vegetation and wildlife;
• air quality and noise;
• endangered and threatened species;
• public safety; and
• cumulative impacts.
We will also evaluate reasonable alternatives to the proposed project or portions of the project, and make recommendations on how to lessen or avoid impacts on the various resource areas.
The EA will present our independent analysis of the issues. The EA will be available in the public record through eLibrary. Depending on the comments received during the scoping process, we may also publish and distribute the EA to the public for an allotted comment period. We will consider all comments on the EA before making our recommendations to the Commission. To ensure we have the opportunity to consider and address your comments, please carefully follow the instructions in the Public Participation section, beginning on page 2.
With this notice, we are asking agencies with jurisdiction by law and/or special expertise with respect to the environmental issues of this project to formally cooperate with us in the preparation of the EA.
In accordance with the Advisory Council on Historic Preservation's implementing regulations for section 106 of the National Historic Preservation Act, we are using this notice to initiate consultation with the applicable State Historic Preservation Office (SHPO), and to solicit their views and those of other government agencies, interested Indian tribes, and the public on the project's potential effects on historic properties.
The environmental mailing list includes federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American Tribes; other interested parties; and local libraries and newspapers. This list also includes all affected landowners (as defined in the Commission's regulations) who are potential right-of-way grantors, whose property may be used temporarily for project purposes, or who own homes within certain distances of aboveground facilities, and anyone who submits comments on the project. We will update the environmental mailing list as the analysis proceeds to ensure that we send the information related to this environmental review to all individuals, organizations, and government entities interested in and/or potentially affected by the proposed project.
If we publish and distribute the EA, copies of the EA will be sent to the environmental mailing list for public review and comment. If you would prefer to receive a paper copy of the document instead of the CD version or would like to remove your name from the mailing list, please return the attached Information Request (appendix 2).
In addition to involvement in the EA scoping process, you may want to become an “intervenor” which is an official party to the Commission's proceeding. Intervenors play a more formal role in the process and are able to file briefs, appear at hearings, and be heard by the courts if they choose to appeal the Commission's final ruling. An intervenor formally participates in the proceeding by filing a request to intervene. Instructions for becoming an intervenor are in the “Document-less Intervention Guide” under the “e-filing” link on the Commission's website. Motions to intervene are more fully described at
Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website at
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
Finally, public sessions or site visits will be posted on the Commission's
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
On November 30, 2015 Pelzer Hydro Company, LLC and Consolidated Hydro Southeast, LLC, licensee(s) for the Lower Pelzer Hydroelectric Project, filed an Application for a New License pursuant to the Federal Power Act (FPA) and the Commission's regulations thereunder. The Lower Pelzer Hydroelectric project facilities are located on the Saluda River in Anderson and Greenville Counties, South Carolina.
The license for Project No. 10253 was issued for a period ending November 30, 2017. Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1), requires the Commission, at the expiration of a license term, to issue from year-to-year an annual license to the then licensee under the terms and conditions of the prior license until a new license is issued, or the project is otherwise disposed of as provided in section 15 or any other applicable section of the FPA. If the project's prior license waived the applicability of section 15 of the FPA, then, based on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c), and as set forth at 18 CFR 16.21(a), if the licensee of such project has filed an application for a subsequent license, the licensee may continue to operate the project in accordance with the terms and conditions of the license after the minor or minor part license expires, until the Commission acts on its application. If the licensee of such a project has not filed an application for a subsequent license, then it may be required, pursuant to 18 CFR 16.21(b), to continue project operations until the Commission issues someone else a license for the project or otherwise orders disposition of the project.
If the project is subject to section 15 of the FPA, notice is hereby given that an annual license for Project No. 10253 is issued to the licensee(s) for a period effective December 1, 2017 through November 30, 2018 or until the issuance of a new license for the project or other disposition under the FPA, whichever comes first. If issuance of a new license (or other disposition) does not take place on or before November 30, 2018, notice is hereby given that, pursuant to 18 CFR 16.18(c), an annual license under section 15(a)(1) of the FPA is renewed automatically without further order or notice by the Commission, unless the Commission orders otherwise.
If the project is not subject to section 15 of the FPA, notice is hereby given that the licensee(s), Pelzer Hydro Company, LLC and Consolidated Hydro Southeast, LLC, are authorized to continue operation of the Lower Pelzer Hydroelectric Project, until such time as the Commission acts on its application for a subsequent license.
On November 30, 2015 Pelzer Hydro Company, LLC and Consolidated Hydro Southeast, LLC, licensee(s) for the Upper Pelzer Hydroelectric Project, filed an Application for a New License pursuant to the Federal Power Act (FPA) and the Commission's regulations thereunder. The Upper Pelzer Hydroelectric project facilities are located on the Saluda River in Anderson and Greenville Counties, South Carolina.
The license for Project No. 10254 was issued for a period ending November 30, 2017. Section 15(a) (1) of the FPA, 16 U.S.C. 808(a)(1), requires the Commission, at the expiration of a license term, to issue from year-to-year an annual license to the then licensee under the terms and conditions of the prior license until a new license is issued, or the project is otherwise disposed of as provided in section 15 or any other applicable section of the FPA. If the project's prior license waived the applicability of section 15 of the FPA, then, based on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c), and as set forth at 18 CFR 16.21(a), if the licensee of such project has filed an application for a subsequent license, the licensee may continue to operate the project in accordance with the terms and conditions of the license after the minor or minor part license expires, until the Commission acts on its application. If the licensee of such a project has not filed an application for a subsequent license, then it may be required, pursuant to 18 CFR 16.21(b), to continue project operations until the Commission issues someone else a license for the project or otherwise orders disposition of the project.
If the project is subject to section 15 of the FPA, notice is hereby given that an annual license for Project No. 10254 is issued to the licensee(s) for a period effective December 1, 2017 through November 30, 2018 or until the issuance of a new license for the project or other disposition under the FPA, whichever comes first. If issuance of a new license (or other disposition) does not take place on or before November 30, 2018, notice is hereby given that, pursuant to 18 CFR 16.18(c), an annual license under section 15(a)(1) of the FPA is renewed automatically without further order or notice by the Commission, unless the Commission orders otherwise.
If the project is not subject to section 15 of the FPA, notice is hereby given that the licensee(s), Pelzer Hydro Company, LLC and Consolidated Hydro Southeast, LLC, are authorized to continue operation of the Upper Pelzer Hydroelectric Project, until such time as the Commission acts on its application for a subsequent license.
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before February 12, 2018. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email:
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
As part of its continuing effort to reduce paperwork burdens, and as required by the PRA, 44 U.S.C. 3501-3520, the FCC invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The Federal Communications Commission (“Commission”) plans to implement and release to the public an “Application for Renewal of an International Broadcast Station License (FCC Form 422-IB).” The form has not been implemented yet due to a lack of budget resources and technical staff. After the FCC Form 422-IB has been implemented and the Commission receives final approval from OMB, applicants will complete the FCC Form 422-IB in lieu of the “Application for Renewal of an International or Experimental Broadcast Station License,” (FCC Form 311). In the interim, applicants will continue to file the FCC Form 311 with the Commission. (Note: The OMB approved the FCC Form 311 under OMB Control No. 3060-1035).
The Commission stated previously that the FCC Form 422-IB will be available to applicants in the International Bureau Filing System (“IBFS”) after it is implemented. However, the Commission plans to develop a new licensing system within the next five years that will replace IBFS. Therefore, the FCC Form 422-IB will be made available to the public in CLS instead of IBFS.
The information collected pursuant to the rules set forth in 47 CFR part 73, subpart F, is used by the Commission to assign frequencies for use by international broadcast stations, to grant authority to operate such stations and to determine if interference or adverse propagation conditions exist that may impact the operation of such stations. If the Commission did not collect this information, it would not be in a position to effectively coordinate spectrum for international broadcasters or to act for entities in times of frequency interference or adverse propagation conditions. The orderly nature of the provision of international broadcast service would be in jeopardy without the Commission's involvement.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before January 11, 2018. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts listed below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, OMB, via email
For additional information or copies of the information collection, contact Nicole Ongele at (202) 418-2991. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the web page
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
Total Annual Burden: 144,000 hours.
Section 2.955 describes for each equipment device subject to verification, the responsible party, as shown in 47 CFR 2.909 shall maintain the records listed as follows:
(1) A record of the original design drawings and specifications and all changes that have been made that may affect compliance with the requirements of § 2.953.
(2) A record of the procedures used for production inspection and testing (if tests were performed) to insure the conformance required by § 2.953. (Statistical production line emission testing is not required.)
(3) A record of the measurements made on an appropriate test site that demonstrates compliance with the applicable regulations in this chapter. The record shall:
(i) Indicate the actual date all testing was performed;
(ii) State the name of the test laboratory, company, or individual performing the verification testing. The Commission may request additional information regarding the test site, the test equipment or the qualifications of the company or individual performing the verification tests;
(iii) Contain a description of how the device was actually tested, identifying the measurement procedure and test equipment that was used;
(iv) Contain a description of the equipment under test (EUT) and support equipment connected to, or installed within, the EUT;
(v) Identify the EUT and support equipment by trade name and model number and, if appropriate, by FCC Identifier and serial number;
(vi) Indicate the types and lengths of connecting cables used and how they were arranged or moved during testing;
(vii) Contain at least two drawings or photographs showing the test set-up for the highest line conducted emission and showing the test set-up for the highest radiated emission. These drawings or photographs must show enough detail to confirm other information contained in the test report. Any photographs used must be focused originals without glare or dark spots and must clearly show the test configuration used;
(viii) List all modifications, if any, made to the EUT by the testing company or individual to achieve compliance with the regulations in this chapter;
(ix) Include all of the data required to show compliance with the appropriate regulations in this chapter; and
(x) Contain, on the test report, the signature of the individual responsible for testing the product along with the name and signature of an official of the responsible party, as designated in § 2.909.
(4) For equipment subject to the provisions in part 15 of this chapter, the records shall indicate if the equipment was verified pursuant to the transition provisions contained in § 15.37 of this chapter.
(b) The records listed in paragraph (a) of this section shall be retained for two years after the manufacture of said equipment item has been permanently discontinued, or until the conclusion of an investigation or a proceeding if the manufacturer or importer is officially notified that an investigation or any other administrative proceeding involving his equipment has been instituted.
The Commission needs and requires the information under FCC Rules at 47 CFR parts 15 and 18, that RF equipment manufacturers (respondents) `self-determine” their responsibility for adherence to these rules, as guided by the following criteria:
(a) Whether the RF equipment device that is being marketed complies with the applicable Commission Rules; and
(b) If the operation of the equipment is consistent with the initially documented test results, as reported to the Commission.
The information collection is essential to controlling potential interference to radio communications.
(a) Companies that manufacture RF equipment are the anticipated respondents to this information collection.
(b) This respondent “public” generally remains the same, although the types of equipment devices that they manufacture may change in response to changing technologies and to new spectrum allocations made by the Commission.
(c) In addition, the Commission may establish new technical operating standards in response to these changing technologies and in allocation spectrum, which these RF equipment manufacturers must meet to receive their equipment authorization from the FCC.
(d) However, the process that RF equipment manufacturers must follow to verify their compliance, as mandated by 47 CFR 2.955 of FCC Rules, will not change despite new technical standards established for specific equipment.
This information collection, therefore, applies to a variety of equipment, which is currently manufactured in the future, and that operates under varying technical standards.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before February 12, 2018. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email:
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
As part of its continuing effort to reduce paperwork burdens, and as required by the PRA, 44 U.S.C. 3501-3520, the FCC invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before January 11, 2018. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts listed below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, OMB, via email
For additional information or copies of the information collection, contact Nicole Ongele at (202) 418-2991. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the web page <
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
This information collection addresses the requirement that certain carriers with high cost reporting obligations must file information about their locations which meet their broadband deployment public interest obligations via an electronic portal (“portal”).
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before January 11, 2018. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts listed below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, OMB, via email
For additional information or copies of the information collection, contact Cathy Williams at (202) 418-2918. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the web page
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
After the challenge window closes, the USAC system will use an automated challenge validation process developed by USAC to validate a challenger's evidence and will determine which challenged areas pass validation and which fail. Once all valid challenges have been identified, a challenged party that chooses to respond to any valid challenge(s) will have a response window within which to submit additional data via the online USAC portal. A challenged party may submit technical information that is probative regarding the validity of a challenger's speed tests (
In conjunction with the qualified 4G LTE data separately collected pursuant to OMB 3060-1242 that will be used to create the map of areas presumptively eligible for MF-II support, the information collected under this new MF-II challenge process collection will enable the Commission to efficiently resolve disputes concerning the eligibility or ineligibility of an area initially deemed ineligible for MF-II support and establish the final map of areas eligible for such support, thereby furthering the Commission's goal of targeting MF-II support to areas that lack adequate mobile voice and broadband coverage absent subsidies through a transparent process.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before February 12, 2018. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email:
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
As part of its continuing effort to reduce paperwork burdens, and as required by the PRA, 44 U.S.C. 3501-3520, the FCC invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The current title of OMB Control No. 3060-0686 is “International Section 214 Process and Tariff Requirements—47 CFR Sections 63.10, 63.11, 63.13, 63.18, 63.19, 63.21, 63.24, 63.25 and 1.1311”. The Commission would like to change the title to “International Section 214 Process and Tariff Requirements—47 CFR Sections 63.10, 63.11, 63.13, 63.18, 63.19, 63.21, 63.22, 63.24, 63.25 and 1.1311” to reflect the addition of 47 CFR 63.22(h) to the information collection.
The information will be used by the Commission staff in carrying out its duties under the Communications Act. The information collections pertaining to Part 63 are necessary largely to determine the qualifications of applicants to provide common carrier international telecommunications service under section 214 of the Communications Act, 47 U.S.C. 214, including applicants that are, or are affiliated with, foreign carriers, and to determine whether and under what conditions the authorizations are in the public interest, convenience, and necessity. The information collections are also necessary to maintain effective oversight of U.S. international carriers generally.
The frequency of filing applications pursuant to Sections 214 will be determined largely by the applicant seeking to provide U.S international common carrier service under section 214 of the Communications Act, 47 U.S.C. 214. Carriers will also determine largely the frequency of filing under the other rules included in this collection, with the exception of the quarterly reports required of certain carriers under 47 CFR 63.10(c) and the list of routes for which a facilities-based international service provider must make a one-time filing and update as necessary under 47 CFR 63.22(h). If the collections are not conducted or are conducted less frequently, applicants will not obtain the authorizations necessary to provide telecommunications services, and the Commission will be unable to carry out its mandate under the Communications Act of 1934. In addition, without the information collections, the United States would jeopardize its ability to fulfill the U.S. obligations as negotiated under the World Telecommunications Organization (WTO) Basic Telecom Agreement because these collections are imperative to detecting and deterring anticompetitive conduct. They are also necessary to preserve the Executive Branch agencies' and the Commission's ability to review foreign investments for national security, law enforcement, foreign policy, and trade concerns. Regarding 47 CFR 63.11, carriers determine largely when to notify the Commission of planned investments by or in foreign carriers. If the information is not collected by the Commission, we will not be able to prevent carriers that control bottleneck facilities in foreign countries from using those bottlenecks to discriminate against unaffiliated U.S. carriers.
Federal Communications Commission.
Notice.
In accordance with the Federal Advisory Committee Act, this document advises interested persons that the Federal Communications Commission's (FCC or Commission) Communications Security, Reliability, and Interoperability Council (CSRIC) VI will hold its third meeting.
December 12, 2017.
Federal Communications Commission, Room TW-C305 (Commission Meeting Room), 445 12th Street SW, Washington, DC 20554.
Jeffery Goldthorp, Designated Federal Officer, (202) 418-1096 (voice) or
The notice of this meeting was first published in the
In addition, it is not possible at this time to schedule a half-day meeting in the FCC's Commission Meeting Room for any date within one month of December 12, 2017. As the December 2017 meeting date was announced at the October 2017 public meeting of the Council, the meeting has now been broadly announced to the public more than once.
The December 5, 2017,
Additional information regarding the CSRIC can be found at:
Board of Governors of the Federal Reserve System.
The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to extend for three years, without revision, the Quarterly Savings and Loan Holding Company Report.
Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.
OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-6974.
On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
Final approval under OMB delegated authority of the extension for three years, without revision, of the following report:
The Board also has determined that data items C572, C573, and C574 (line items 24, 25, and 26) may be protected from disclosure under exemption 4 of the Freedom of Information Act (FOIA). Commercial or financial information may be protected from disclosure under exemption 4 if disclosure of such information is likely to cause substantial competitive harm to the provider of the information. (5 U.S.C. 552(b)(4)). The data items listed above pertain to new or changed pledges, or capital stock of any subsidiary savings association that secures short-term or long-term debt or other borrowings of the SLHC; changes to any class of securities of the SLHC or any of its subsidiaries that would negatively impact investors; and defaults of the SLHC or any of its subsidiaries during the quarter. Disclosure of this type of information is likely to cause substantial competitive harm to the SLHC providing the information and thus this information may be protected from disclosure under FOIA exemption 4.
With regard to the remaining data items on the FR 2320, the Board has determined that institutions may request confidential treatment for any FR 2320 data item or for all FR 2320 data items, and that confidential treatment will be reviewed on a case-by-case basis.
Board of Governors of the Federal Reserve System.
Notice.
The Board of Governors of the Federal Reserve System (Board) is announcing the production and publication of three rates by the Federal Reserve Bank of New York (FRBNY), in coordination with the U.S. Office of Financial Research (OFR), based on data for overnight repurchase agreement transactions on Treasury securities.
FRBNY intends to begin publishing the three rates during the second quarter of 2018.
David Bowman, Associate Director, (202-452-2334), Division of International Finance; or Christopher W. Clubb, Special Counsel (202-452-3904), Evan Winerman, Counsel (202-872-7578), Legal Division; for users of Telecommunications Device for the Deaf (TDD) only, contact (202-263-4869).
On August 30, 2017, the Board published a notice and request for public comment (Request for Information) on the proposal that FRBNY, in coordination with OFR, produce and publish three rates based on overnight repurchase agreement (repo) transactions on U.S. Treasury securities (Treasury repo).
The Request for Information indicated that this rate would be a measure of rates on overnight, specific-counterparty tri-party Treasury general collateral (GC) repo. This rate would be calculated based on transaction-level tri-party repo data collected from the Bank of New York Mellon (BNYM) under the Board's supervisory authority. The rate would exclude General Collateral Finance (GCF) Repo® cleared by the Fixed Income Clearing Corporation (FICC) and transactions in which a Federal Reserve Bank is a counterparty.
The Request for Information indicated that this rate would provide a broad measure of rates on overnight Treasury GC repo transactions. The rate would be calculated based on the same transaction-level tri-party repo data collected from BNYM as in the TGCR plus GCF Repo data obtained from DTCC Solutions LLC (DTCC Solutions), an affiliate of the Depository Trust & Clearing Corporation (DTCC).
The Request for Information indicated that this rate would provide a broad measure of the general cost of financing Treasury securities overnight. The rate would be calculated based on the tri-party data from BNYM and GCF Repo data from DTCC Solutions used to calculate the BGCR, plus bilateral Treasury repo transactions cleared through FICC's Delivery-versus-Payment (DVP) service, filtered to remove some (but not all) transactions considered “specials.”
The Request for Information stated that FRBNY would use a volume-weighted median as the central tendency measure for each of the three Treasury repo rates described above. FRBNY would publish summary statistics to accompany the daily publication of the rate, which would consist of the 1st, 25th, 75th and 99th volume-weighted percentile rates, as well as volumes.
The Request for Information included a target publication time of 8:30 a.m. ET. The Request for Information stated that the rates would be revised only on a same-day basis, and only if the revision would result in a shift in the volume-weighted median by more than one
For each rate, the Request for Information stated that FRBNY would exclude trades between affiliated entities when relevant and when the data to make such exclusions is available. To the extent possible, “open” trades for which pricing resets daily (making such transactions economically similar to overnight transactions) would be included in the calculation of the rates.
Finally, the Request for Information stated that each of the rates could be modified in the future in response to market evolution or to incorporate additional market segments if data become available.
The Board received twelve comments on the Request for Information from financial institutions and industry associations. Certain commenters focused on possible uses of the proposed rates, including the possibility that the proposed rates (particularly SOFR) could serve as reference rates for financial contracts. Other commenters focused on the calculation, publication, and governance of the proposed rates.
Commenters suggested that the proposed rates would be useful because they would provide a comprehensive view of pricing in the Treasury repo market, would provide a good proxy for a risk-free rate, would provide useful information regarding overnight demand and supply for funding, and could facilitate the creation of futures contracts that would allow market participants to hedge Treasury repos and spot-market Treasury purchases. Most commenters who expressed a view on the potential uses of the proposed rates suggested that SOFR would be more useful than the other rates because SOFR would provide a broader measure of pricing in the Treasury repo market.
Other commenters raised concerns regarding the possible use of SOFR as a replacement for the London Interbank Offered Rate (LIBOR) in financial contracts. For example, a number of commenters believed that U.S. dollar LIBOR should be replaced with term reference rates or rates that reflect bank credit risk in ways that are similar to U.S. dollar LIBOR. Some commenters also noted difficulties in amending certain existing contracts (
Based on public comments, the Board believes that market participants could use the proposed Treasury repo rates in a variety of ways. The Board recognizes that the proposed rates could be used as reference rates in financial contracts, and that the Alternative Reference Rates Committee (ARRC) has selected SOFR as its recommended alternative to U.S. Dollar LIBOR.
The Board received a number of comments on the calculation, publication, and governance of the proposed rates. Commenters discussed the types of data that FRBNY will include in the rates, FRBNY's calculation methodology, and various issues related to publication and governance of the rates.
Three commenters suggested that the Federal Reserve and OFR should consider including additional Treasury repo activity in the proposed rates (
A commenter asked the Board to provide more information regarding FRBNY's contract to acquire data from DTCC Solutions, stating that additional information would help market participants evaluate potential risks related to loss of access to data. The Federal Reserve and OFR are confident that the combination of the relevant provisions of the contract with DTCC Solutions and the data collection authorities of the OFR and Federal Reserve will ensure that they will be able to continue to produce robust rates under a variety of circumstances. In this regard, the Board notes that OFR informed the Financial Stability Oversight Council on November 16, 2017, that it intends to propose an information collection in the first half of 2018 to collect data regarding cleared repo transactions.
Finally, a commenter suggested that the Board should use its supervisory authority to ensure that BNYM conducts its tri-party operations properly, including appropriate business continuity and other risk contingency planning. BNYM is a State member bank and is subject to comprehensive supervision by the Federal Reserve.
Two commenters supported the proposal to calculate the Treasury repo
Multiple commenters asked the Board to clarify how FRBNY will trim specials from the proposed rates. One commenter supported exclusion of all bilateral transactions below the 25th volume-weighted percentile rate, while two commenters stated that they would need more data to evaluate whether this approach is sensible. Another commenter suggested other possible techniques for excluding outlier transactions. Federal Reserve and OFR staff considered several techniques for trimming specials activity, including removing all transactions collateralized by on-the-run and first-off-the-run securities.
A commenter requested more information about how FRBNY will include “open” trades in the proposed rates. Open transactions are transactions with no specific maturity date for which the interest rate is periodically reset upon agreement by both borrower and lender. Although there are many forms of open transactions with different reset periods, those with daily rate resets are economically very similar to overnight transactions. On January 24, 2017, the Treasury Market Practices Group recommended a new best practice in the recording of daily-resetting open trades, which is expected to make daily-resetting trades easier to differentiate from open trades with different reset periods.
Two commenters noted that SOFR tends to spike at quarter-ends and suggested that FRBNY apply a “smoothing” mechanism to minimize volatility of the proposed rates. The Board recognizes that rates in some segments of the Treasury repo market currently tend to increase at quarter-ends, but FRBNY will not apply a smoothing mechanism to the Treasury repo rates because doing so would provide an inaccurate view of that day's pricing in the Treasury repo market.
Finally, one commenter suggested that, even though the proposed rates would exclude transactions in which a Federal Reserve Bank is a counterparty, Federal Reserve activity in repo markets might distort rates in Treasury repos that do not involve a Federal Reserve Bank. The Federal Reserve implements monetary policy through multiple types of financial transactions, including repos. These open market operations affect all money market rates. The Board nevertheless believes that the Treasury repo rates will provide market participants with a transparent and comprehensive view of pricing in the Treasury repo market.
One commenter stated that the proposed 8:30 a.m. ET publication time was appropriate. Another commenter asked the Federal Reserve to consider carefully whether publishing the rates at 8:30 a.m. would impact efficient market functioning. Three commenters believed that the proposed rates should be published earlier, explaining that 8:30 a.m. publication would be too late for some foreign financial markets and on certain days would coincide with some U.S. economic data releases. FRBNY will shift the publication time at least as early as 8:00 a.m. ET to avoid coincident release with key U.S. economic data. The Board and FRBNY will consider whether FRBNY can publish Treasury repo rates even earlier, but operational constraints—for example, constraints on the ability of FRBNY's data providers to produce and deliver data overnight and the time required for FRBNY to perform data validation and quality assurance processes—may prevent earlier publication.
A commenter asked for an explanation of how FRBNY would publish the proposed rates. FRBNY will publish the Treasury repo rates on its public website, similar to the manner in which FRBNY currently publishes the effective federal funds rate (EFFR) and the overnight bank funding rate (OBFR).
Four commenters supported the proposal to publish summary statistics. One of these commenters suggested, however, that publishing statistics from the 1st and 99th percentiles would not be informative, and that FRBNY should instead publish summary statistics for percentiles
Three commenters requested that FRBNY publish historical data for SOFR. Commenters believed that historical data would serve a number of purposes—for example, commenters suggested that historical data would help market participants determine
Two commenters suggested that the proposed threshold of “greater than one basis point” for revising the proposed rates was too sensitive. Another commenter explained that its members had not achieved consensus on the threshold at which FRBNY should revise errors, but the commenter emphasized that FRBNY should articulate a clear rationale for its revision policy. The Board notes that, because FRBNY will round the Treasury repo rates to the nearest whole basis point, the threshold is effectively two basis points. The Board also notes that this is the same threshold employed for EFFR and OBFR, for which revisions are very rare. The Federal Reserve will periodically review the revision threshold to ensure that revisions are very rare and do not impose undue operational costs on users of the Treasury repo rates.
A commenter asked whether FRBNY would publish the proposed rates if relevant data sources were unavailable and, if so, whether FRBNY would correct such rates retroactively when data becomes available. Another commenter suggested that FRBNY should provide more information regarding the back-up repo market survey it would conduct if standard data sources are unavailable. As noted in the Request for Information, in the event that data sources are unavailable, the Treasury repo rates would be calculated based upon back-up repo market survey data collected from FRBNY's primary dealer counterparties. FRBNY currently collects repo data from primary dealers each morning. Going forward, FRBNY will also collect data each afternoon. The afternoon survey will capture that day's activity by primary dealers and will be available as a contingency data source for the following morning's publication of the Treasury repo rates. The survey will request aggregated primary dealer activity in each of the market segments captured in the Treasury repo rates: Overnight tri-party Treasury repo transactions, overnight Treasury repo transactions in the GCF market, and FICC-cleared bilateral Treasury repo transactions. For each of these market segments, each dealer will report its aggregate borrowing activity (excluding, to the extent possible, transactions between affiliated entities and transactions in which the Federal Reserve is a counterparty), along with the weighted-average rate of its borrowing. If FRBNY publishes Treasury repo rates that use survey data and subsequently receives updated data, FRBNY would issue same-day revisions at or around 2:30 p.m. ET if the use of updated data would result in the published rate changing by more than one basis point.
Finally, two commenters asked that FRBNY begin publishing the Treasury repo rates as soon as possible. FRBNY intends to begin publishing the Treasury repo rates in the second quarter of 2018.
A commenter suggested that governance arrangements for the Treasury repo rates should align with the
After considering public comments, the Board concludes that the public would benefit if FRBNY publishes the three Treasury repo rates as proposed, with certain modifications described above.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3506; 5 CFR part 1320, Appendix A.1), the Board reviewed the Request for Information and this final notice under the authority delegated to the Board by the Office of Management and Budget. For purposes of calculating burden under the Paperwork Reduction Act, a “collection of information” involves 10 or more respondents. As noted above, the data to be used to produce the rates will be obtained solely from (1) BNYM with respect to tri-party GC repo data and (2) DTCC Solutions with respect to GCF repo data and DVP bilateral repo data. Therefore, producing the rates will not involve a collection of information pursuant to the Paperwork Reduction Act.
The Regulatory Flexibility Act (5 U.S.C. 601
The Board did not receive any comments regarding the Paperwork Reduction Act or the RFA.
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice.
This notice announces a 1-year extension of the Medicare Prior Authorization Model for Repetitive Scheduled Non-Emergent Ambulance Transport. The extension of this model is applicable to the following states and the District of Columbia: Delaware, Maryland, New Jersey, North Carolina, Pennsylvania, South Carolina, Virginia, and West Virginia.
This extension began on December 5, 2017 and ends on December 1, 2018. However, prior authorization is available upon provider, supplier, or beneficiary request for dates of service between December 2, 2017 and December 4, 2017.
Angela Gaston, (410) 786-7409. Questions regarding the Medicare Prior Authorization Model Extension for Repetitive Scheduled Non-Emergent
Medicare may cover ambulance services, including air ambulance (fixed-wing and rotary-wing) services, if the ambulance service is furnished to a beneficiary whose medical condition is such that other means of transportation are contraindicated. The beneficiary's condition must require both the ambulance transportation itself and the level of service provided in order for the billed service to be considered medically necessary.
Non-emergent transportation by ambulance is appropriate if either the—(1) beneficiary is bed-confined and it is documented that the beneficiary's condition is such that other methods of transportation are contraindicated; or (2) beneficiary's medical condition, regardless of bed confinement, is such that transportation by ambulance is medically required. Thus, bed confinement is not the sole criterion in determining the medical necessity of non-emergent ambulance transportation; rather, it is one factor that is considered in medical necessity determinations.
A repetitive ambulance service is defined as medically necessary ambulance transportation that is furnished in 3 or more round trips during a 10-day period, or at least 1 round trip per week for at least 3 weeks.
Medicare may cover repetitive, scheduled non-emergent transportation by ambulance if the—(1) medical necessity requirements described previously are met; and (2) ambulance provider/supplier, before furnishing the service to the beneficiary, obtains a written order from the beneficiary's attending physician certifying that the medical necessity requirements are met (see 42 CFR 410.40(d)(1) and (2)).
In addition to the medical necessity requirements, the service must meet all other Medicare coverage and payment requirements, including requirements relating to the origin and destination of the transportation, vehicle and staff, and billing and reporting. Additional information about Medicare coverage of ambulance services can be found in 42 CFR 410.40, 410.41, and in the Medicare Benefit Policy Manual (Pub. L. 100-02), Chapter 10, at
According to a study published by the Government Accountability Office in October 2012, entitled “Costs and Medicare Margins Varied Widely; Transports of Beneficiaries Have Increased,”
Section 1115A of the Social Security Act (the Act) authorizes the Secretary to test innovative payment and service delivery models to reduce program expenditures, while preserving or enhancing the quality of care furnished to Medicare, Medicaid, and Children's Health Insurance Program beneficiaries. Section 1115A(d)(1) of the Act authorizes the Secretary to waive such requirements of Titles XI and XVIII, as well as sections 1902(a)(1), 1902(a)(13), 1903(m)(2)(A)(iii), and 1934 (other than subsections (b)(1)(A) and (c)(5)) of the Act as may be necessary solely for purposes of carrying out section 1115A of the Act with respect to testing models described in section 1115A(b) of the Act. Consistent with this standard, we will continue to waive the same provisions for the extension of this model as have been waived for the initial three years of the model. Additionally, we have determined that the implementation of this model does not require the waiver of any fraud and abuse law, including sections 1128A, 1128B, and 1877 of the Act. Thus providers and suppliers affected by this model must comply with all applicable fraud and abuse laws.
In the November 14, 2014
In the October 23, 2015
This notice announces that the Medicare Prior Authorization Model for Repetitive Scheduled Non-Emergent Ambulance Transport is being extended in the current model states of Delaware, the District of Columbia, Maryland, New Jersey, North Carolina, Pennsylvania, South Carolina, Virginia, and West Virginia, effective December 5, 2017, for an additional year to allow for additional evaluation of the model. Repetitive, scheduled non-emergent ambulance transport claims with dates of service of December 2, 2017 through December 4, 2017 will not be stopped for prepayment review if prior authorization is not requested before the fourth round trip in a 30-day period; however, providers, suppliers, and beneficiaries may request prior authorization for these dates of service. The model will now end in all states on December 1, 2018. Prior authorization will not be available for repetitive
We will continue to test whether prior authorization helps reduce expenditures, while maintaining or improving quality of care, using the established prior authorization process for repetitive, scheduled non-emergent ambulance transport to reduce utilization of services that do not comply with Medicare policy.
We will continue to use this prior authorization process to help ensure that all relevant clinical or medical documentation requirements are met before services are furnished to beneficiaries and before claims are submitted for payment. This prior authorization process further helps to ensure that payment complies with Medicare documentation, coverage, payment, and coding rules.
The use of prior authorization does not create new clinical documentation requirements. Instead, it requires the same information that is already required to support Medicare payment, just earlier in the process. Prior authorization allows providers and suppliers to address coverage issues prior to furnishing services.
The prior authorization process under this model will continue to apply in the nine states listed previously for the following codes for Medicare payment:
• A0426 Ambulance service, advanced life support, non-emergency transport, Level 1 (ALS1).
• A0428 Ambulance service, BLS, non-emergency transport.
While prior authorization is not needed for the mileage code, A0425, a prior authorization decision for an A0426 or A0428 code will automatically include the associated mileage code.
We have conducted and will continue to conduct outreach and education to ambulance providers/suppliers, as well as beneficiaries, through such methods as updating the operational guide, frequently asked questions (FAQs) on our website, a physician letter explaining the ambulance providers/suppliers' need for the proper documentation, and educational events and materials issued by the Medicare Administrative Contractors (MACs). We are also working to implement a new process that will help identify alternate transportation resources for beneficiaries who receive non-affirmative decisions. Additional information about the implementation of the prior authorization model is available on the CMS website at
Under this model, submitting a prior authorization request is voluntary. However, an ambulance provider/supplier or beneficiary is encouraged to submit to the MAC a request for prior authorization along with all relevant documentation to support Medicare coverage of a repetitive, scheduled non-emergent ambulance transport. If prior authorization has not been requested by the fourth round trip in a 30-day period, the subsequent claims will be stopped for prepayment review.
In order for a prior authorization request to be provisionally affirmed, the request for prior authorization must meet all applicable rules and policies, including any local coverage determination (LCD) requirements for ambulance transport claims. A provisional affirmation is a preliminary finding that a future claim submitted to Medicare for the service likely meets Medicare's coverage, coding, and payment requirements. After receipt of all relevant documentation, the MACs will make every effort to conduct a review and postmark the notification of their decision on a prior authorization request within 10 business days for an initial submission. Notification will be provided to the ambulance provider/supplier and to the beneficiary. If a subsequent prior authorization request is submitted after a non-affirmative decision on an initial prior authorization request, the MACs will make every effort to conduct a review and postmark the notification of their decision on the resubmitted request within 20 business days.
An ambulance provider/supplier or beneficiary may request an expedited review when the standard timeframe for making a prior authorization decision could jeopardize the life or health of the beneficiary. If the MAC agrees that the standard review timeframe would put the beneficiary at risk, the MAC will make reasonable efforts to communicate a decision within 2 business days of receipt of all applicable Medicare-required documentation. As this model is for non-emergent services only, we expect requests for expedited reviews to be extremely rare.
A provisional affirmative prior authorization decision may affirm a specified number of trips within a specific amount of time. The prior authorization decision, justified by the beneficiary's condition, may affirm up to 40 round trips (which equates to 80 one-way trips) per prior authorization request in a 60-day period. Alternatively, a provisional affirmative decision may affirm less than 40 round trips in a 60-day period, or may affirm a request that seeks to provide a specified number of transports (40 round trips or less) in less than a 60-day period. A provisional affirmative decision can be for all or part of the requested number of trips. Transports exceeding 40 round trips (or 80 one-way trips) in a 60-day period require an additional prior authorization request.
The following describes examples of various prior authorization scenarios:
•
•
•
•
++ If the claim is determined to be for services that were not medically necessary or for which there was insufficient documentation, the claim will be denied, and all current policies and procedures regarding liability for payment will apply. The ambulance provider/supplier or the beneficiary, or both, can appeal the claim denial if they believe the denial was inappropriate.
++ If the claim is determined to be payable, it will be paid.
Under the model, we will work to limit any adverse impact on beneficiaries and to educate beneficiaries about the process. If a prior authorization request is non-affirmed, and the claim is still submitted by the ambulance provider/supplier, the claim will be denied, but beneficiaries will continue to have all applicable administrative appeal rights. We will also work to implement a process that will help identify alternate transportation resources for beneficiaries who receive non-affirmative decisions.
Only one prior authorization request per beneficiary per designated time period can be provisionally affirmed. If the initial ambulance provider/supplier cannot complete the total number of prior authorized transports (for example, the initial ambulance company closes or no longer services that area), the initial request is cancelled. In this situation, a subsequent prior authorization request may be submitted for the same beneficiary and must include the required documentation in the submission. If multiple ambulance providers/suppliers are providing transports to the beneficiary during the same or overlapping time period, the prior authorization decision will only cover the ambulance provider/supplier indicated in the provisionally affirmed prior authorization request. Any ambulance provider/supplier submitting claims for repetitive, scheduled non-emergent ambulance transports for which no prior authorization request is submitted by the fourth round trip in a 30-day period will be subject to 100 percent prepayment medical review of those claims.
Additional information is available on the CMS website at
Section 1115A(d)(3) of the Act states that chapter 35 of title 44, United States Code (the Paperwork Reduction Act of 1995), shall not apply to the testing and evaluation of models or expansion of such models under this section. Consequently, this document need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995.
This document announces a 1-year extension of the Medicare Prior Authorization Model for Repetitive Scheduled Non-Emergent Ambulance Transport. Therefore, there are no regulatory impact implications associated with this notice.
Section 1115A of the Social Security Act.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by January 11, 2018.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(a)), a new drug may not be commercially marketed in the United States, imported, or exported from the United States, unless an approval of an application filed with FDA under section 505(b) or (j) of the FD&C Act is effective with respect to such drug. The Agency has codified regulations regarding applications for FDA approval to market a new drug under 21 CFR part 314. This collection of information supports the regulatory requirements found in those regulations. The collection of information is necessary for FDA to make a scientific and technical determination whether the product is safe and effective for use, and is summarized as follows:
Section 314.50(a) requires that an application form (Form FDA 356h) be submitted that includes information about the applicant, the submission, and a checklist of enclosures.
Section 314.50(b) requires that an index be submitted with the archival copy of the application and that it reference certain sections of the application.
Section 314.50(c) requires that a summary of the application be submitted that presents a good general synopsis of all the technical sections and other information in the application.
Section 314.50(d) requires that the new drug application (NDA) contain the following technical sections about the new drug: Chemistry, manufacturing,
Section 314.50(e) requires the applicant to submit samples of the drug if requested by FDA. In addition, the archival copy of the application must include copies of the label and all labeling for the drug.
Section 314.50(f) requires that case report forms and tabulations be submitted with the archival copy.
Section 314.50(h) requires that patent information, as described under § 314.53, be submitted with the application. However, burden hours for § 314.50(h) are approved under OMB control numbers 0910-0513 (Patent Certification Forms FDA 3542 and FDA 3542a) and 0910-0786 (Abbreviated New Drug Applications (ANDAs) and 505(b)(2) Applications), and are therefore not included among the estimates found in table 1.
Section 314.50(i) requires that patent certification information be submitted in section 505(b)(2) applications for patents claiming the drug substance, drug product, or method of use. Sections 314.50(i)(1)(i)(C) and 314.54(i) and (j) require that patent certification information be submitted for each patent listed in the “Approved Drug Products with Therapeutic Equivalence Evaluations” (the Orange Book) for a drug product approved in an NDA that is pharmaceutically equivalent to the proposed drug product in the original 505(b)(2) application and was submitted and was approved before the original 505(b)(2) application was submitted. Burden for these provisions is included under OMB control number 0910-0786.
Section 314.50(j) requires that applicants who request a period of marketing exclusivity submit certain information with the application.
Section 314.50(k) requires that the application contain a financial certification or disclosure statement or both.
Section 314.50(
Section 314.52 requires that any notice of certification of invalidity, unenforceability, or non-infringement of a patent to each patent owner and the NDA holder be sent by a section 505(b)(2) applicant that relies on a listed drug. A 505(b)(2) applicant is required to amend the application at the time notice is provided to include a statement certifying that the required notice has been provided. A 505(b)(2) applicant also is required to amend the application to document receipt of the required notice. Burden hours for these provisions are included in OMB control number 0910-0786.
Section 314.53 sets forth the patent information requirements for applicants who submit applications or amendments to the application filed under section 505(b)(2) of the FD&C Act or supplements to the approved 505(b)(2) application. Burden hours for these collections are approved in OMB control number 0910-0786.
Section 314.54 sets forth the content requirements for applications filed under section 505(b)(2) of the FD&C Act. The burden estimate for 505(b)(2) applications is included in table 1 under the estimates for § 314.50(a) through (g) and (i) through (
Section 314.55 sets forth the assessment requirements for each application. The burden estimate for 505(b)(2) applications is included in table 1 under the estimates for § 314.50(a) through (g) and (i) through (
Section 314.60 sets forth reporting requirements and patent certification requirements for sponsors who amend an unapproved 505(b)(2) application. Burden hours for the § 314.60(f) collections are approved under OMB control number 0910-0786.
Section 314.65 states that the sponsor must notify FDA when withdrawing an unapproved application.
Sections 314.70 and 314.71 require that supplements be submitted to FDA for certain changes to an approved application.
Section 314.72 requires sponsors to report to FDA any transfer of ownership of an application.
Section 314.80(c)(1) and (2) set forth requirements for expedited adverse drug experience postmarketing reports and followup reports, as well as for periodic adverse drug experience postmarketing reports (Form FDA 3500A).
Section 314.80(i) establishes recordkeeping requirements for reports of postmarketing adverse drug experiences. The burden hours for § 314.80(i) are approved under OMB control numbers 0910-0230 (Adverse Drug Experience Reporting) and 0910-0291 (MedWatch: FDA's Medical Reporting Program), and therefore burden estimates are not included in table 1.
Section 314.81(b)(1) requires that NDA and ANDA field alert reports be submitted to FDA (Forms FDA 3331 and Form FDA 3331a).
Section 314.81(b)(2) requires that annual reports be submitted to FDA (Form FDA 2252).
Section 314.81(b)(3)(i) requires that drug advertisements and promotional labeling be submitted to FDA (Form FDA 2253).
Section 314.81(b)(3)(iii) sets forth reporting requirements for sponsors who withdraw an approved drug product from sale. The burden hours for § 314.81(b)(3)(iii) are approved under OMB control number 0910-0045 (Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution), and therefore are not included in table 1.
Section 314.90 sets forth requirements for sponsors who request waivers from FDA for compliance with §§ 314.50 through 314.81. The information collection burden estimate for NDA waiver requests is included in table 1 under the estimates for each section that is in part 314, subpart B.
Section 314.93 sets forth requirements for submitting a suitability petition to request a change from a listed drug in accordance with § 10.20 (21 CFR 10.20) and § 10.30. The burden hours for § 314.93 are approved under OMB control number 0910-0191 (Administrative Practices and Procedures; Formal Evidentiary Public Hearing) and are not included in table 1.
Section 314.94(a) through (d) require that an ANDA contain the following information: Application form; table of contents; basis for ANDA submission; conditions of use; active ingredients; route of administration, dosage form, and strength; bioequivalence; labeling; chemistry, manufacturing, and controls; samples; and patent certification.
Section 314.95 requires that any notice of certification of invalidity or non-infringement of a patent to each patent owner and the NDA holder be sent by ANDA applicants.
Section 314.96 sets forth requirements for amendments to an unapproved ANDA.
Section 314.97 sets forth requirements for submitting supplements to an approved ANDA for certain changes to the application. Approval of burden hours for information collections for §§ 314.95 through 314.97 are covered under OMB control number 0910-0786.
Section 314.98(a) sets forth postmarketing adverse drug experience reporting and recordkeeping requirements for ANDAs. The burden hours for § 314.98(a) are approved under OMB control numbers 0910-0230 and 0910-0291 and are not included in table 1 of this document.
Section 314.98(b) requires other postmarketing reports for ANDAs: Field alert reports (Form FDA 3331a), annual reports (Form FDA 2252), and
Section 314.99(a) requires that sponsors comply with certain reporting requirements for withdrawing an unapproved ANDA and for a change in ownership of an ANDA.
Section 314.99(b) sets forth requirements for sponsors who request waivers from FDA for compliance with §§ 314.92 through 314.99. (The information collection burden estimate for ANDA waiver requests is included in table 1 of this document under the estimates for each section that is in part 314, subpart C.)
Section 314.101(a) states that if FDA refuses to file an application, the applicant may request an informal conference with FDA and request that the application be filed over protest.
Section 314.102 covers communications between FDA and applicants, including requests for meetings.
Section 314.103 covers specified dispute resolution. To assist respondents with certain aspects of this requirement, we have issued draft guidance entitled “Requests for Reconsideration at the Division Level Under GDUFA [the Generic Drug User Fee Act]; Guidance for Industry.”
Section 314.107(c) requires notice to FDA by the first applicant to submit a substantially complete ANDA containing a certification that a relevant patent is invalid, unenforceable, or will not be infringed of the date of first commercial marketing. The burden estimate for § 314.107(c) is included in table 1 under the estimates for § 314.50(a) through (g) and (i) through (
Section 314.107(e) requires that an applicant submit a copy of the entry of the order or judgment to FDA within 10 working days of a final judgment. The burden estimate for § 314.107(e) applications is included in table 1 under the estimates for § 314.50(a) through (g) and (i) through (
Section 314.107(f) requires that ANDA or section 505(b)(2) applicants notify FDA immediately of the filing of any legal action filed within 45 days of receipt of the notice of certification. A patent owner must also notify FDA of the filing of any legal action for patent infringement. If the patent owner or approved application holder who is an exclusive patent licensee waives its opportunity to file a legal action for patent infringement within the 45-day period, the patent owner or approved application holder may submit to FDA a waiver in the specified format. The burden estimate for § 314.107(f) is included in table 1 under the estimates for § 314.50 (a) through (g) and (i) through (
Section 314.110(b)(3) states that, after receipt of an FDA complete response letter, an applicant must either: (1) Resubmit the application addressing all the deficiencies identified in the complete response letter; (2) withdraw the application; or (3) request an opportunity for a hearing on the question of whether there are grounds for denying approval of the application. The burden hours for § 314.110(b)(3) are included under parts 10 through 16 (21 CFR parts 10 through 16, OMB control number 0910-0191) hearing regulations, in accordance with § 314.201, and are not included in table 1.
Section 314.122(a) requires that an ANDA or a suitability petition that relies on a listed drug that has been voluntarily withdrawn from sale must be accompanied by a petition seeking a determination whether the drug was withdrawn for safety or effectiveness reasons. The burden hours for § 314.122(a) are approved under OMB control number 0910-0191 and therefore are not included in table 1.
Section 314.122(d) sets forth requirements for relisting petitions for unlisted discontinued products. The burden hours for § 314.122(d) are approved under OMB control number 0910-0191 and therefore are not included in table 1.
Sections 314.125 and 314.127 state that FDA may refuse to approve an NDA or an ANDA and will provide the applicant written notice of an opportunity for a hearing under § 314.200 along with the reason for refusal to approve the application, including lack of a patent certification or statement with respect to each listed patent for an approved drug product that is pharmaceutically equivalent to the drug product for which the original 505(b)(2) application is submitted and was approved before the original 505(b)(2) was submitted. The burden hours for §§ 314.125 and 314.127 (refuse to approve an ANDA) are included under parts 10 through 16 hearing regulations (in accordance with § 314.201) and approved under OMB control number 0910-0191, and therefore are not included in table 1.
Section 314.126(c) sets forth requirements for a petition to waive criteria for adequate and well-controlled studies. The burden hours for § 314.126(c) are approved under OMB control number 0910-0191 and therefore are not included in table 1.
Sections 314.150(a) and (b) and 314.151(a) and (b) set forth requirements for the withdrawal of approval of an NDA or ANDA and the applicant's opportunity for a hearing and submission of comments. The burden hours for § 314.151(a) and (b) are included under parts 10 through 16 hearing regulations, in accordance with § 314.201, and approved under OMB control number 0910-0191 and therefore are not included in table 1.
Section 314.151(c) sets forth the requirements for withdrawal of approval of an ANDA and the applicant's opportunity to submit written objections and participate in a limited oral hearing. The burden hours for § 314.151(c) are included under parts 10 through 16 hearing regulations, in accordance with § 314.201, approved under OMB control number 0910-0191, and therefore are not included in table 1.
Section 314.153(b) sets forth the requirements for suspension of an ANDA when the listed drug is voluntarily withdrawn for safety and effectiveness reasons, and the applicant's opportunity to present comments and participate in a limited oral hearing. The burden hours for § 314.152(b) are included under parts 10 through 16 hearing regulations, in accordance with § 314.201, approved under OMB control number 0910-0191, and therefore are not included in table 1.
Section 314.161(b) and (e) sets forth the requirements for submitting a petition to determine whether a listed drug was voluntarily withdrawn from sale for safety or effectiveness reasons. The burden hours for § 314.161(b) and (e) are approved under OMB control number 0910-0191 and therefore are not included in table 1.
Section 314.200(c), (d), and (e) requires that applicants or others subject to a notice of opportunity for a hearing who wish to participate in a hearing file a written notice of participation and request for a hearing as well as the studies, data, and so forth, relied on. Other interested persons may also submit comments on the notice. This section also sets forth the content and format requirements for the applicants' submission in response to notice of opportunity for hearing. The burden hours for § 314.200(c), (d), and (e) are included under parts 10 through 16 hearing regulations, in accordance with
Section 314.200(f) states that participants in a hearing may make a motion to the presiding officer for the inclusion of certain issues in the hearing. The burden hours for § 314.200(f) are included under parts 10 through 16 hearing regulations, in accordance with § 314.201, are approved under OMB control number 0910-0191, and therefore are not included in table 1.
Section 314.200(g) states that a person who responds to a proposed order from FDA denying a request for a hearing provide sufficient data, information, and analysis to demonstrate that there is a genuine and substantial issue of fact, which justifies a hearing. The burden hours for § 314.200(g) are included under parts 10 through 16 hearing regulations, in accordance with § 314.201, are approved under OMB control number 0910-0191, and therefore are not included in table 1.
Section 314.420 states that an applicant may submit to FDA a drug master file in support of an application, in accordance with certain content and format requirements.
Section 314.430 states that data and information in an application are disclosable under certain conditions, unless the applicant shows that extraordinary circumstances exist. The burden hours for § 314.430 are included under parts 10 through 16 hearing regulations, in accordance with § 314.201, are approved under OMB control number 0910-0191, and therefore are not included in table 1.
Section 314.530(c) and (e) states that if FDA withdraws approval of a drug approved under the accelerated approval procedures, the applicant has the opportunity to request a hearing and submit data and information. The burden hours for § 314.530(c) and (e) are included under parts 10 through 16 hearing regulations, in accordance with § 314.201, are approved under OMB control number 0910-0191, and therefore are not included in table 1.
Section 314.530(f) requires that an applicant first submit a petition for stay of action before requesting an order from a court for a stay of action pending review. The burden hours for § 314.530(f) are approved under OMB control number 0910-0191, and therefore are not included in table 1.
Section 314.550 requires an applicant with a new drug product being considered for accelerated approval to submit copies of all promotional materials to FDA during the preapproval and post-approval periods.
Section 314.610(b)(1) requires that applicants include a plan or approach to postmarketing study commitments in applications for approval of new drugs when human efficacy studies are not ethical or feasible, and provide status reports of postmarketing study commitments. The burden estimate for § 314.610(b)(1) is included in table 1 under the estimates for §§ 314.50(a) through (f), (k), and (
Section 314.610(b)(3) requires that applicants propose labeling to be provided to patient recipients in applications for approval of new drugs when human efficacy studies are not ethical or feasible. The burden estimate for § 314.610(b)(3) is included in table 1 under the estimates for § 314.50(e).
Section 314.630 requires that applicants provide postmarketing safety reporting for applications for approval of new drugs when human efficacy studies are not ethical or feasible. The burden hours for § 314.630 are approved under OMB control numbers 0910-0230 and 0910-0291, and therefore not included in table 1.
Section 314.640 requires that applicants provide promotional materials for applications for approval of new drugs when human efficacy studies are not ethical or feasible. The burden estimate for § 314.640 is included in table 1 under the estimates for § 314.81(b)(3)(i)).
In the
Accordingly, we estimate the burden for this collection of information as follows:
We retain the currently approved burden estimate for the information collection associated with the provisions identified above. At the same time, we have added burden estimate associated with § 314.103, although in an effort to reduce burden, we have issued associated guidance to assist respondents with the relevant information collection.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, the Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by February 12, 2018.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 12, 2018. The
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 Dockets Management Staff, 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.” The Agency will review this copy, including the claimed confidential information, in its 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
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (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, FDA invites 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.
This information collection supports the reporting associated with the submission of petitions and notifications seeking exemptions from the labeling requirements for ingredients derived from major food allergens, and the Agency's associated guidance document.
The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (Title II, Pub. L. 108-282) amended the FD&C Act by defining the term “major food allergen” and stating that foods regulated under the FD&C Act are misbranded unless they declare the presence of each major food allergen on the product label using the name of the food source from which the major food allergen is derived. Section 403(w)(1) of the FD&C Act (21 U.S.C. 343(w)(1)) sets forth the requirements for declaring the presence of each major food allergen on the product label. Section 201(qq) of the FD&C Act (21 U.S.C. 321(qq)) defines a major food allergen as “[m]ilk, egg, fish (
In some cases, the production of an ingredient derived from a major food allergen may alter or eliminate the allergenic proteins in that derived ingredient to such an extent that it does not contain allergenic protein. In addition, a major food allergen may be used as an ingredient or as a component of an ingredient such that the level of allergenic protein in finished food products does not cause an allergic response that poses a risk to human health. Therefore, FALCPA provides two mechanisms through which such ingredients may become exempt from the labeling requirement of section 403(w)(1) of the FD&C Act. An ingredient may obtain an exemption through submission and approval of a petition containing scientific evidence that demonstrates that the ingredient “does not cause an allergic response that poses a risk to human health” (section 403(w)(6) of the FD&C Act). Alternately, an ingredient may become exempt through submission of a notification containing scientific evidence showing that the ingredient “does not contain allergenic protein” or that there has been a previous determination through a premarket approval process under section 409 of the FD&C Act (21 U.S.C. 348) that the ingredient “does not cause an allergic response that poses a risk to human health” (section 403(w)(7) of the FD&C Act).
The labeling requirements of section 403(w)(1) of the FD&C Act apply to all packaged foods sold in the United States that are regulated under the FD&C Act, including both domestically manufactured and imported foods. As noted, section 403(w)(1) of the FD&C Act requires that the label of a food product declare the presence of each major food allergen. We estimate the information collection burden of the third-party disclosure associated with food allergen labeling under section 403(w)(1) of the FD&C Act as the time needed for a manufacturer to review the labels of new or reformulated products for compliance with the requirements of section 403(w)(1) of the FD&C Act and the time needed to make any needed modifications to the labels of those products. The allergen information disclosed on the label or labeling of a food product benefits consumers who purchases that food product. Because even small exposure to a food allergen can potentially cause an adverse reaction, consumers use food labeling information to help determine their product choices.
FDA estimates the third-party disclosure burden of the collection of information as follows:
We have retained the currently approved burden estimate associated with the information collection. Based on our experience with the information collection since it was established 3 years ago, we estimate that there are approximately 690,000 Universal Product Codes (UPCs) of FDA-regulated foods and approximately 85,000 UPCs of FDA-regulated dietary supplements for a total of 775,000 UPCs (Ref. 1). Using the labeling cost model, we estimate the entry rate of new UPCs to be 8 percent per year. Based on the entry rate of new UPCs, we estimate the rate of new or reformulated UPCs to be approximately 10 percent per year, or 77,500 products (775,000 × 10 percent). Thus, we estimate that, annually, 77,500 new or reformulated products are sold in the United States. Assuming an association of one respondent to each of the 77,500 new or reformulated products, we estimate that 77,500 respondents will each review the label of one of the 77,500 new or reformulated products. We estimate an average of 1 hour for the review of labels for compliance with the food allergen labeling requirements under section 403(w)(1) of the FD&C Act, for a total of 77,500 hours annually, as reflected in table 1, row 1.
We have no data on how many label reviews would identify the need to redesign the label. For purposes of this analysis, therefore, we estimate 5 percent, or 3,875 labels (77,500 × 5 percent) will be redesigned to comply with the requirements of section 403(w)(1) of the FD&C Act. Assuming an association of one respondent to each of the 3,875 redesigned labels and averaging 16 hours to complete the label redesign, we estimate a total of 62,000 hours annually for this activity, as reflected in table 1, row 2.
Under sections 403(w)(6) and (7) of the FD&C Act, respondents may request from us a determination that an ingredient is exempt from the labeling requirement of section 403(w)(1) of the FD&C Act. An ingredient may obtain an exemption through submission and approval of a petition containing scientific evidence that demonstrates that the ingredient “does not cause an allergic response that poses a risk to human health” (section 403(w)(6) of the FD&C Act). This section also states that “the burden shall be on the petitioner to provide scientific evidence (including the analytical method used to produce the evidence) that demonstrates that such food ingredient, as derived by the method specified in the petition, does not cause an allergic response that poses a risk to human health.” Alternately, an ingredient may become exempt through submission of a notification containing scientific evidence showing that the ingredient “does not contain allergenic protein” or that there has been a previous determination through a premarket approval process under section 409 of the FD&C Act that the ingredient “does not cause an allergic response that poses a risk to human health” (section 403(w)(7) of the FD&C Act).
The guidance document entitled, “Food Allergen Labeling Exemption Petitions and Notifications: Guidance for Industry,” sets forth our recommendations with regard to the information that respondents should submit in such a petition or notification. The guidance states that to evaluate these petitions and notifications, we will consider scientific evidence that describes: (1) The identity or composition of the ingredient; (2) the methods used to produce the ingredient; (3) the methods used to characterize the ingredient; (4) the intended use of the ingredient in food; and (5) either (a) for a petition—data and information, including the expected level of consumer exposure to the ingredient, that demonstrate that the ingredient, when manufactured and used as described, does not cause an allergic response that poses a risk to human health; or (b) for a notification, data and information that demonstrate that the ingredient, when manufactured as described, does not contain allergenic protein, or documentation of a previous determination under a process under section 409 of the FD&C Act that the ingredient does not cause an allergic response that poses a risk to human health. We use the information submitted in the petition or notification to determine whether the ingredient satisfies the criteria of section 403(w)(6) and (7) of the FD&C Act for granting the exemption.
We estimate the reporting burden associated with the collection of information as follows:
Based on our experience with the collection thus far, we retain the currently approved burden estimate. Accordingly, we estimate that we will receive an average of five petitions and five notifications annually over the next 3 years. Assuming an association of one respondent to each petition or notification, we estimate that five respondents will each submit one petition and five respondents will each submit one notification. We estimate a petition takes, on average, 100 hours to develop and submit (Ref. 2). Therefore, we estimate the total burden associated with petitions will be 500 hours annually (5 petitions × 100 hours per petition).
The burden of a notification involves collecting documentation that a food ingredient does not pose an allergen risk. Either we can make a determination that the ingredient does not cause an allergic response that poses a risk to human health under a premarket approval or notification program under section 409 of the FD&C Act, or the respondent submits scientific evidence demonstrating that the ingredient when manufactured as described does not contain allergenic protein. We estimate it takes a respondent 20 hours to prepare and submit a notification based on our determination under a process under section 409 of the FD&C Act that the ingredient does not cause an allergic response. We estimate respondents may spend 100 hours to prepare a notification submitting scientific evidence (including the analytical method used) that demonstrates that the food ingredient (as derived by the method specified in the notification, where applicable) does not contain allergenic protein. We have no data on how many notifications would be based on our determination that the ingredient does not cause an allergic response or based on scientific evidence that demonstrates that the food ingredient does not contain allergenic protein. Therefore, we estimate that three of the five notifications would be based on scientific evidence, and two of the five notifications would be based on our determination. The average time per notification is then estimated to be 68 hours (2 × 20 hours + 3 × 100 hours)/5). Therefore, we estimate that the burden associated with notifications will be 340 hours annually (5 notifications × 68 hours per notification), as reflected in table 2.
The following references are on display in the Dockets Management Staff (see
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “Refusal of Inspection by a Foreign Food Establishment or Foreign Government.” This draft guidance, when finalized, will provide information for foreign food establishments subject to our inspection, as well as foreign governments, on when we may consider that a foreign food establishment or a government of a foreign country has refused to permit an inspection by us as provided in the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Submit either electronic or written comments on the draft guidance by February 26, 2018 to ensure that the Agency considers your comment on the draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time 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 Dockets Management Staff, 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.”
•
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the draft guidance to the Compliance Policy Staff/Office of Compliance, Center for Food Safety and Applied Nutrition (HFS-605), 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
Mischelle B. Ledet, Center for Food Safety and Applied Nutrition (HFS-605), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-701-5986, or Eric Nelson, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5642, or Tyler Scandalios, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857, 240-402-4552.
We are announcing the availability of a draft guidance for industry entitled “Refusal of Inspection by a Foreign Food Establishment or Foreign Government.” 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 the 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 alternate approach if it satisfies the requirements of the applicable statutes and regulations. The guidance is not subject to Executive Order 12866.
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), enacted on January 4, 2011, amended the FD&C Act to expand and enhance our ability to ensure that imported food products meet U.S. standards and are safe for consumers. Among the FSMA changes to the FD&C Act, we now must refuse admission of a food into the United States if it is from a foreign factory, warehouse, or other establishment of which the owner, operator, or agent in charge, or the government of the foreign country, refuses to permit entry of United States inspectors or other individuals duly designated by the Secretary of Health and Human Services, upon request, to inspect such factory, warehouse, or other establishment (section 807(b) of the FD&C Act (21 U.S.C. 384c(b))). In addition, the FD&C Act, at section 807(b), states that an owner, operator, or agent in charge is considered to have refused an inspection if the owner, operator, or agent in charge does not permit an inspection of a factory, warehouse, or other establishment during the 24-hour period after we submit an inspection request, or after such other time period, as agreed upon by FDA and the foreign factory, warehouse, or other establishment.
This draft guidance, when finalized, will provide information for foreign food establishments subject to our inspection, as well as foreign governments, on when we may consider that a foreign food establishment or a government of a foreign country has refused to permit an inspection by us as provided in section 807(b) of the FD&C Act.
Persons with access to the internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).
Fax written comments on the collection of information by January 11, 2018.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying out the provisions of the FD&C Act. Under the FD&C Act and implementing regulations, promotional labeling and advertising about prescription drugs are generally required to be truthful, non-misleading, and to reveal facts material to the presentations made about the product being promoted (see FD&C Act sections 201(n) and 502(a) and (n) (21 U.S.C. 321(n) and 352(a) and (n)); see also 21 CFR 202.1).
Prescription drug promotion sometimes includes false or misleading (collectively, deceptive
The ability of consumers and HCPs to identify deceptive prescription drug promotion has important public health implications. If unable to identify deceptive promotion, consumers may ask their HCPs to prescribe specific drugs that they would not otherwise request. Likewise, HCPs who are unable to identify deceptive promotion may prescribe specific drugs that they would not otherwise prescribe. On the other hand, if consumers and HCPs are able to identify deceptive promotion, they may appropriately discount or disregard such information in their medication decisions, and perhaps even report deceptive promotion to appropriate government regulators who can take corrective action.
Reports of deceptive promotion are useful to FDA because they allow investigators to focus their efforts in an era where the amount of promotion far exceeds the resources available to review everything. The FDA Bad Ad program, for example, encourages HCPs to report deceptive prescription drug promotion (Ref. 5), a goal which requires that HCPs successfully identify such promotion when it appears in the course of their duties. Likewise, similar programs could be implemented for consumers to report deceptive prescription drug promotion to FDA.
The mission of the Office of Prescription Drug Promotion (OPDP) within FDA is to protect the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated, and to guard against deceptive promotion through comprehensive surveillance, enforcement, and educational programs. As part of this mission, it is critical that OPDP adequately understand the capacity of consumers and HCPs to detect false and misleading claims as well as these populations' processing of such claims. This understanding will help OPDP to identify best practices for addressing false and misleading claims in prescription drug promotion. The research described here will provide evidence to inform consideration of the approaches best suited to fulfill OPDP's mission to protect the public from deceptive promotion.
The proposed project involves two studies examining volunteer participants' ability to detect and report deceptive presentations in prescription drug promotion. The studies will be conducted concurrently and will focus on different health conditions. Each study will be administered to two separate populations (
The purpose of Study 1 is to assess consumer and HCP response to promotional websites with varying levels of false or misleading presentations. In Study 1, degree of deception will be manipulated over three levels by altering the number of deceptive claims (none, fewer, more). It is possible that consumers and HCPs are only able to identify ads as deceptive when they include a greater number of violations, whereas ads with few violations may not be identified as deceptive. The experimental stimuli will be in the form of a web page for a fictitious drug targeted toward consumers who have chronic pain or toward HCPs. The deceptive websites will contain various types of violations. The website with fewer violations will contain a subset of the deceptive claims, imagery, or other presentations included in the website with more violations. For example, if the fewer-violations website includes two violations, then the more-violations website will include the same two violations plus two or three additional violations (in the form of claims and/or graphics).
Study 1 will help FDA address several key questions:
• What proportion of consumers and HCPs correctly identify a promotional piece as deceptive? Does the ability to identify deceptive promotion vary depending on the number of deceptive claims in a promotional piece?
• Does the degree of deception affect consumers' and HCPs' attitudes and behavioral intentions toward the promoted drug, including intended reporting to regulatory authorities?
• Is the effect of deceptive promotional pieces mediated by a person's ability to identify a promotional piece as deceptive (that is, do people who recognize a piece as deceptive discount the information in the piece, thereby adjusting their attitudes and intentions toward the product)?
Whereas Study 1 focuses on the
As with Study 1, we envision a pair of one-way factorial experiments, one conducted with a sample of consumers and the other with HCPs. Similar to Study 1, Study 2 will investigate how misleading implicit claims and explicitly false claims in prescription drug promotional pieces influence a person's ability to detect and respond appropriately to deception. The experimental stimuli will be in the form of a mockup of a pharmaceutical website targeted toward the relevant experimental population, obese consumers or HCPs who treat obese patients. As with study 1, the drug profile, including indication, risks, and logo branding will be fictitious. For the implicit misleading claim manipulations, we are interested in whether people infer false beliefs from the implicit communications.
Study 2 will help FDA address several key questions:
• What proportion of consumers and HCPs correctly identify a promotional piece as deceptive? Does the ability to identify deceptive promotion vary depending on whether deceptive claims in a promotional piece are explicit versus implicit?
• Does the type of deception affect consumers' and HCPs' attitudes and behavioral intentions toward the promoted drug, including intended reporting to regulatory authorities?
• Is the effect of deceptive promotional pieces mediated by a person's ability to identify a promotional piece as deceptive (that is, do people who recognize a piece as deceptive discount the information in the piece, thereby adjusting their attitudes and intentions toward the product)?
In the
(Comment 1)
We are supportive of the study, but have the following recommendations.
We propose that additional study arms be included that explore various scenarios/websites which test both the number of deceptive claims in conjunction with the degree of deception. Currently, the study is structured to measure the impact of the number of deceptions in a promotional website (Study 1) separately from the degree of the deception (explicit vs implicit, in Study 2). However, it would also be beneficial to measure other combinations to see which factor or combination of factors had the greatest impact on HCPs and Consumers' overall perception of the website. For example, a single explicit lie may be more impactful than 15 implied deceptions. The current study will not be able to draw any conclusions regarding that scenario. Testing additional combinations of the number of deceptions in a website along with deceptive claims of varying severity would enable a better comparison and understanding of what ultimately drives HCPs and Consumers' perception of deceptive prescription promotion.
(Response) We thank the commenter for their support and for this suggestion. While certainly a viable research idea, cost implications of creating and testing additional stimuli for this purpose bar us from pursuing it. We encourage researchers to pursue this idea in future research.
(Comment 2)
a. Given the stated purpose of the pretests, sample size can be substantially reduced, and revised to a qualitative approach.
(Response) In addition to the quantitative pretest, we have already conducted a qualitative test of stimuli and questionnaire materials via cognitive interviews. Changes based on cognitive interviews are reflected in our updated survey materials. In regard to sample size, the number of pretest participants per experimental condition (n = 50) was chosen based on a power analysis, and is considered to be the minimum effective size to allow for assessment of the quantitative outcomes specified in the 60-day FRN. Examples of quantitative outcomes include assessment of response rates and timing of the survey.
b. To reduce bias, add a screening question to exclude respondents who are opposed to taking prescription medicines.
(Response) The survey length does not allow for a full exploration of attitudes toward prescription drug use. However, to assess opposition to prescription drug use more generally, we added one item to the survey that has been used successfully in previous FDA surveys. This item will be used in the pretest survey as a potential covariate and may or may not be retained in the main study survey depending on its performance.
The item reads: “In what situations would you consider taking prescription drugs?”
• I would never take them.
• I would take them only for serious health conditions.
• I would take them for moderate and serious health conditions.
• I would take them for most health conditions, including minor problems.
c. Consider revising item scales to include a mid-point to allow respondents to express neutral views (unless objective is to force a selection).
(Response) Given the focus of the questions, we believe that offering a neutral response option is not necessary to measure opinions and attitudes accurately. Consequently, our objective is to force a selection and have participants make at least a weak commitment in either a positive or negative direction. Of concern is that offering a neutral midpoint could potentially encourage “satisficing”—cuing participants to choose a neutral response because it is offered (Ref. 8). Additionally, providing a midpoint leads to the loss of information regarding the direction in which people lean (Ref. 9). Research has found that neither format (either with or without a neutral point) is necessarily better or produces more valid or reliable results (Ref. 10). Instead, it should be left to the researcher to determine the goals of the study. During cognitive testing, a majority of participants were satisfied with the response options and all participants felt comfortable choosing a response in the absence of a midpoint. Use of a midpoint is an issue we have examined in previous studies and we determined that we achieve valid and reliable responses without a midpoint. To increase consistency with measures used in previous studies, and in support of the arguments presented above, we are opting to exclude a midpoint. Finally, if a participant does not feel that they can choose a response because of a lack of a neutral option, they will be able to skip the question.
d. In Study 1, remove Q21 and Q30 due to potentially leading nature of items.
(Response) To avoid redundancy, we dropped Q21. In Q30, we ask participants to click on anything they think is misleading, and we note that if they do not think anything is misleading, they can click “none.” Consequently, we are not strongly presupposing there are misleading claims. To address some of the wording concerns for this item, we changed the question to ask about inaccurate information instead of misleading information and we moved the “None” response to be more prominent above the image.
(Comment 3)
The commenter expresses concern about the practical utility of the research, reasons for which are covered by comments 3a through 3e. In the case that FDA continues with the research, the commenter makes several recommendations which are covered by comments 3f through 3cc. Comments 3f through 3h concern the study stimuli, comment 3i pertains to subject recruitment, and comments 3j through 3cc concern the study questionnaires.
a. The identification of deceptive promotion is FDA's assigned
(Response) As discussed above, the mission of OPDP within FDA is to protect the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated, and to guard against false and misleading promotion through comprehensive surveillance, enforcement, and educational programs. As part of this mission, it is critical that OPDP adequately understand the capacity of consumers and HCPs to detect false and misleading claims as well as these populations' processing of such claims. This understanding will help FDA/OPDP to identify best practices for addressing deceptive claims in prescription drug promotion. Moreover, we note that sponsors are not generally required to submit promotional pieces to FDA prior to dissemination, and limited resources prevent OPDP from reviewing all promotional materials in the marketplace. Voluntary HCP and consumer reporting of false and misleading promotional pieces contribute to the accomplishment of FDA/OPDP's mission.
b. Deceptive drug promotion is not a prevalent issue that requires further studying.
(Response) Numerous studies have examined the prevalence of false or misleading claims and presentations in DTC advertising, and FDA frequently issues compliance letters addressing false and misleading claims and presentations (Refs. 1 and 2). Consequently, FDA disagrees with this assertion.
c. FDA's proposed studies fail to acknowledge the role of the HCP as the “learned intermediary.”
(Response) The present research takes into consideration both consumer and HCP responses to false or misleading promotion. Consumers often wish to participate in shared decision making with HCPs when selecting prescription drugs and may request specific prescription drugs from their HCPs based on promotions they have seen in the marketplace. Because information consumers receive through DTC prescription drug promotion can impact these requests, it is important to investigate consumers' ability to assess prescription drug product efficacy and risks as conveyed in promotional pieces. And although HCPs have medical training and clinical expertise, we are not aware of research that investigates whether such training and expertise translates into an ability to detect false or misleading promotion in the marketplace. Consequently, the present research investigates both consumer and HCP ability to identify and discount deceptive prescription drug promotion.
d. The proposed studies are duplicative of recent FDA research concerning HCP willingness to report deceptive promotion.
The commenter suggests that if FDA wishes to investigate consumer reporting, the Agency should create two separate studies. The first should gauge consumer aptitude in identifying false or misleading prescription drug promotion. Depending on the results of the first study, the Agency could potentially undertake a second study, surveying subject willingness to report false or misleading drug promotion. This approach would avoid potential error associated with influence of earlier questions regarding deception on later questions regarding reporting.
(Response) FDA conducted a survey of HCPs in 2013 in which respondents were asked about their familiarity with the Bad Ad program and willingness to report misleading advertising (Ref. 5). The current study is quite different in scope from the previous research. The current study consists of an experimental design that will enable us to determine whether HCPs can detect misleading advertising, not just whether they are willing to report it. We do include questions at the end of the survey asking similar questions as those in the 2013 survey, but the purpose here is in connection to HCP ability to detect misleading advertising. Moreover, our use of similar questions here reflects a well-established technique in scientific research, used to determine whether previous findings can be replicated or not.
In response to the second comment recommending division of this project into two separate studies, we believe that proposal to be an inefficient use of resources. Regarding concerns about the order of questions affecting subsequent responses, we chose to distribute deception-related items throughout the survey, rather than ask all deception items first and then other outcome measures second. Also, we include “masking” items on the same screen as deception-related items to mask the intent of the questions. The results from cognitive interviews confirm that this approach was successful. Consequently, we have no evidence to suggest that earlier questions related to deception will influence subsequent questions related to reporting.
e. FDA already has created and implemented consumer programs to report deceptive promotion.
(Response) The proposed research can inform program needs at present, whether such needs involve reevaluation of past programs such as EthicAd, or extensions of existing programs such as the Bad Ad program or other actions.
f. Validating Stimuli. It is not clear how the Agency will determine that a study stimulus is deceptive. FDA notes in the PRA Notice that the “term deceptive is not meant to imply equivalence (or lack thereof) with use of the same term by the U.S. Federal Trade Commission.” It seems unrealistic for FDA to conduct research with primary care physicians (PCPs) and consumers who do not understand the Agency's standards or have access to the training and resources of an FDA reviewer.
Further, except for literal falsity, whether a particular communication is false or misleading must be based on empirical evidence. Promotional pieces do not exist in a vacuum. These communications interact with the overall health information ecosystem, including the internet. FDA needs to first validate that the study stimuli are indeed deceptive before including the stimuli in either proposed study with the presumption that they are deceptive.
(Response) Our reference to the Federal Trade Commission's (FTC) definition of the term “deceptive” was offered as a point of clarification for our use of the same term as shorthand within the FRN for the longer phrase “false or misleading.” In other words, by using “deceptive” as a term of art in this narrow context, we are not evoking the specific meaning and interpretation of the same term used by the FTC.
We disagree with the suggestion that participants need to have access to the training and resources of an FDA reviewer before FDA can evaluate their ability to identify deceptive promotion. As further explained below, FDA is not asking participants to determine whether nuanced text meets the regulatory standards for deceptive promotion; instead, we are presenting material that meets both the regulatory standard for a deceptive promotion and could be identified as such by consumers or healthcare providers with no prior experience with the regulations.
We agree with the second point about the need to validate that the study stimuli are deceptive, and we are doing this in several ways for this study. For example, some of the specific claims used in our experimental manipulations are established as being factually incorrect because the promoted drug is a member of a class of drugs for which the claim could not be true (
Further, it is important to note that we included a control condition in both studies, which will enable us to compare responses to a website that has no violations. The control conditions serve as a baseline for perceived deception, which will also allow us to examine how consumers and providers perceive websites with no violations.
g. Media. The Agency proposes using websites as the only stimuli. FDA should consider testing additional non-electronic media, including DTC and HCP print promotional materials. The Agency should also base the promotional stimuli on realistic “mock” package insert (PI) documents. The commenter requests that FDA make available for public comment these materials.
(Response) Previous research on DTC and HCP-directed prescription drug promotional materials has, to varying extents, included all available media formats, and assessment of outcomes using these formats has proven useful. We agree that investigating recognition of misleading prescription drug information in multiple formats—including print, television, web, and other modes—would be valuable. However, we also recognize that no single study can effectively examine all promotional formats or presentations, and we chose to focus on branded drug websites for several reasons. First, websites, while not necessarily more or less useful than any other format, are arguably quite prevalent and important in today's technological age where a large segment of the consumer population is connected to the internet and known to seek information regarding prescription drugs using the internet. For example, online promotion is the fastest growing category of DTC drug marketing, and branded websites account for the largest share of this category (Ref. 11). Second, almost all print and television ads for prescription drugs encourage viewers to visit branded websites for more information, making these sites an important extension of promotion in other formats (Ref. 12). Third, FDA has issued multiple warning and notice of violation letters for branded drug websites that incorrectly communicate information to visitors, suggesting that there may be a problem with a proportion of such sites presenting misleading information. Fourth, websites serve as a fairly newer format for promotion relative to television and print promotion, and by consequence warrant further study. There has been significantly less research on consumer and provider interpretation of branded drug websites than other promotional formats (Ref. 13), and the extant research suggests that some websites still do not present a fair balance of risk and benefit information (Ref. 14).
Based on these considerations, we believe that focusing this study on branded drug websites will be the most effective use of FDA's limited resources. The fictitious websites included in this study were modeled on real products (including the package insert) to ensure realism and relevance.
In response to the request to share stimuli, we generally do not share stimuli before the study has been conducted to avoid possible inadvertent publication and therefore contamination of the subject pool, which would compromise the research.
h. Disease States. The Agency's two studies propose testing stimuli concerning chronic pain or obesity. The commenter suggests that FDA instead consider testing stimuli featuring a fictitious product for a disease state which involves more complex safety information. Such stimuli would be more reflective of the current healthcare environment, where product labeling is increasingly complex.
(Response) The fictitious websites used in this research do include complex safety information, which reflect the risks for real chronic pain and obesity products in the marketplace. For example, one of the fictitious products includes a black box warning, and the other includes severe and complex safety information, such as potential drug interactions and contraindications.
i. Study 1 Stimuli. In Study 1, the “degree of deception will be manipulated over three levels by altering the number of deceptive claims (none, fewer, more).” FDA states that the deceptive claims will include “various types of violations.” Under the potential design, the most egregious deceptive claim(s) might only be contained in the “more” level. This could potentially skew study results, as subjects would be more likely to identify such egregious claims. FDA should develop a scale that is used to determine the egregiousness of the deception. The scale should include specific examples of egregiousness by category.
(Response) Although some claims do not overlap between the “fewer violations” and “more violations” conditions, we strategically manipulated the stimuli so that one of the more “egregiously” deceptive claims (which appears in a callout bubble) is present in both conditions. There is also overlap in those two conditions for another manipulated element, where we minimized the prominence of the Important Safety Information. Additionally, we included an item (Q30) that would provide participants the opportunity to click on anything they think may be inaccurate. Using this question, we would expect that the more egregious claims will be chosen more often. In this way, this item would serve as a proxy measure of egregiousness. Further, our various questions that ask about perceived deceptiveness of the websites will provide an initial assessment of the degree of deception—with higher scores representing greater perceived deception. Because of space constraints on the survey, we are unable to ask participants to rate the egregiousness of the violative claims. Although we appreciate the value that developing a scale to determine the egregiousness of each of the deceptive claims would add, adopting this suggestion in the present research would be outside of the scope of this study and would have an impact on overall cost considerations.
j. FDA proposes that the HCP samples for both studies will only include physician subjects. The commenter believes the samples should include other types of HCPs, including nurse practitioners, physician assistants, and pharmacists. As the Agency's recent research showed, “Nurse practitioners and physician assistants tended to see the [Bad Ad] program as more useful than [PCPs] and specialists. They also reported a greater likelihood of reporting false or misleading advertising in the future.” Given these findings, it would be helpful also to investigate the ability of other HCPs independently to identify false or misleading promotion.
Additionally, during the recruiting process, FDA should ensure enrollment of a diversity of subjects across demographic categories. Previous research indicates that certain demographic groups respond to drug promotion in different manners. Uneven representation within certain categories could potentially skew study results.
(Response) FDA acknowledges and agrees with the assertion that including other types of HCPs in this research would provide value. Yet, sampling from these additional groups requires funding that may not be justified in this initial investigation of the topic area. Nonetheless, we do intend to strive for diversity in both our HCP and consumer samples. HCPs and consumers will vary in terms of age, race, and ethnicity, and consumers will additionally vary in terms of their education level.
k. Leading Questions. The overall format of the questionnaires is quite leading. As previously mentioned, questions asking whether sample advertisements are “deceptive,” “misleading,” “bad,” and “not believable” could easily pollute data from later questions inquiring whether a subject would potentially report such promotion to FDA. The Agency should state all questions in an objective manner.
(Response) Leading questions are those that “suggest a possible answer or make some responses seem more acceptable than others” (Ref. 15). In keeping with standard practice for balancing the valence of attitudinal questions, we have included a mix of positive and negative statements in the questionnaire. In fact, there are presently more positively framed items than negatively framed items. Moreover, the slider questions referenced by the commenter are semantic differentials, which show both a negatively framed word and its positive counterpart on opposite ends of the response scale (
(Response) Q1-Q2 of Study 1 measure risk recall and risk recognition. These are important outcome measures for our study because we vary how the risks are presented in the different experimental conditions, minimizing them (in terms of size and format) in the violative conditions. Including these risk recall and recognition measures allow us to test whether minimizing the risks influences participants' ability to remember them. Further, because minimization of risk is a misleading violation in its own right, reduced risk recall or recognition among participants in the violative conditions would provide relevant context for interpreting more direct measures of deception. Q4 of Study 2 will enable us to determine if participants can recall seeing the
(Response) The use of multiple items to tap into a singular construct is considered a best practice in social science research, particularly when assessing complex psychological constructs like those in this survey. Our intent is to combine responses to these items into a single composite score. Our cognitive interviewing of these items suggests that they have slightly different meanings for many participants and thus are not viewed as completely redundant. Further, there is no evidence to suggest that the use of multiple items to assess this construct led participants to believe that the promotional material was actually false or misleading or that this series of questions was designed to capture whether they thought the website was misleading. Consequently, we successfully masked the true intent of this item by including other bipolar response options unrelated to misleadingness.
We dropped Q21 to reduce redundancy across items.
(Response) Sophisticated medical terminology will only be used in the HCP survey. To use the example of “hepatic failure,” consumers will instead see “decreased liver function.” We have verified in cognitive interviews that preceded this study (and in our previous scale development efforts) that the terminology used is generally well understood by our participant sample.
(Response) Use of a sliding scale allows for greater precision and variation in response, as opposed to a “Yes-No-Don't Know” format. Research suggests that scales with five to seven points are more valid and reliable than those with only two to three categories (Ref. 16). Additionally, we tested the sliding-scale format in previous cognitive interviews and found that it worked well; participants had little difficulty understanding this format. Further, as noted in the response to Comment 2c, we want to avoid leading participants to choose a “Don't know” response; providing this option may cue participants to select this response and avoid deeper thinking on the topic. Regarding the use of an even numbered scale rather than odd numbered scale, please see our response to Comment 2c.
(Response) Consistent with previous surveys, we added a category to exclude
(Response) We did not restrict people to be diagnosed with chronic pain because the prevalence was too small, which would increase the costs of the study. Using our current screening questions, we achieve an 11 percent prevalence rate (Ref. 6). The objective of our sampling plan is to target people that would be in the audience for the ads; being diagnosed is not a criterion.
(Response) Assessing whether participants currently experience chronic pain helps to ensure a motivated sample for which the fictitious medication would potentially be of interest. Originally, we included participants that reported suffering from chronic pain in the past, but we did not require that they are currently suffering from chronic pain (although we had an item that asked “Do you still have this chronic or long-lasting pain?”). After further consideration, we opted to revise the screener so that participants remain eligible if (a) they say “Yes” I still have chronic pain, or (b) they say “No” (or remain silent) about still having chronic pain
(Response) We appreciate how these additional questions could provide valuable context and propose adding new items to our pretest survey (see below). We have found, in past work, that HCPs often have difficulty recalling precise information about their practice. Consequently, our approach is to assess this information more generally. However, to include some additional context, we included two additional items:
• Rate your current knowledge about prescription drugs for [weight loss/chronic pain] on a scale of 0 to 10, where 0 means knowing nothing and 10 means knowing everything you could possibly know about the topic.
• [If “chronic pain”] Approximately what proportion of your current patients do you treat for chronic pain? (None or very few have chronic pain; a small proportion have chronic pain; about one-half have chronic pain; a large proportion have chronic pain; almost all have chronic pain).
(Response) In cognitive interviews, very few people chose this response option. Moreover, in previous research, because so few people chose this response option, we often end up collapsing this response option with the response indicating that the referent was not mentioned in the website.
(Response) These items help to mask the overall intent of the other items in this series (
(Response) The intent of this item is to assess information-seeking more broadly, which can include, but is not limited to, asking one's doctor about a drug. While assessing how consumers access information from various sources (doctor, family members, etc.) is of interest, our survey does not have room to ask about each source individually. Given that there are multiple sources of information a consumer might consult for more information on a drug, we decided to address information-seeking more broadly with one question, rather than attempting to list all possible options.
(Response) To avoid redundancy, we dropped Q21. We retained Q19 to ensure assessment of a critical construct. Because deception is a complicated construct to measure, we included a variety of items to capture the various dimensions of this construct. Based on a review of the literature, we recommend using a variety of relatively sensitive measures of ability to detect misleading advertisements to ensure we capture potentially meaningful variance. The inclusion of Q19 and Q21 were based on findings from the literature review that included measures that tapped into third-person perception (Ref. 17)—which is among the most widely replicated phenomena across media contents (Ref. 18), such as DTC prescription drug advertising (Ref. 19). By including an item that taps into third-person effects, we will be able to explore if consumers are more likely to think that others will be misled, even if they do not think they are susceptible to being misled by the website.
(Response) To avoid bias, the most critical questions should appear as up front as possible in the surveys. Although current question ordering may bias responses to the attention item, this outcome is less consequential and we chose instead to prioritize the key dependent variables (putting those measures that rely on memory at the start of the survey). Consequently, we intend to retain the current order of questions in the survey.
Q30a: Did you notice anything on the website that is false or misleading?
1. Yes (go to question 30b).
2. No (go to question 31).
Q30b: What information was false or misleading? [open box comment]
(Response) A programming note was missing in the original survey draft. The current survey programming reflects the approach suggested by the commenter.
(Response) We have adopted this recommendation in the revised survey.
Footnote 21 reads: For example, FDA completed a HCP study incorporating information asked at Q34, Q41, and Q42 of Study 1. It is not clear why the Agency is undertaking another study focusing on such questions. These questions should be eliminated.
(Response) Please see our response to Comment 3d.
(Response) For this study, our intent was to target people that would be in the audience for these ads, and being diagnosed is not a requirement for personal relevance. The target audience is consumers with a body mass index greater than or equal to 30.
(Response) We have adopted this recommendation.
(Comment 4)
a. The commenter expressed concern about the practical utility of the consumer-oriented arms of the research. Namely, if consumers are unfamiliar with the prescribing information for the product, it is unclear on which basis they can determine a claim to be deceptive.
(Response) Please see our response to Comment 3f, which addresses a similar theme and may provide useful context. The concern addressed by the commenter is framed as a limitation of the study and appears to question the relevance of examining consumers' ability to detect deception in prescription drug promotion. We believe the opposite is correct: The merit of conducting the study is reinforced by the observation that it is unclear how consumers can determine a claim to be deceptive if they lack relevant background information or knowledge about an advertised drug. While prescription drug promotions are required to present truthful and non-misleading information, some prescription drug promotion nevertheless includes false or misleading claims, images, or presentations. DTC prescription drug promotion can help provide consumers with truthful information about drugs. When it does so, it can help consumers to make well-informed decisions when determining whether to explore treatment options and when making ultimate treatment choices, and it can provide useful and actionable information about a product's efficacy and risks to consumers already on treatment, among other outcomes. Yet, because the information in prescription drug promotion is not always truthful, consumers must make judgments about whether it is true, misleading, or false. And the same background knowledge that a consumer might rely on to identify a claim as deceptive would also be used to decide that a claim is true. As the commenter points out, this background information may be incomplete or inadequate for the task, and yet some presume that consumers (and, for that matter, healthcare providers) are typically able to distinguish between true claims and those that are false or misleading. Concerns like the one voiced here and the empirical literature on the topic suggest there is reason to doubt this presumption, thus warranting the proposed study.
b. The commenter expressed concern that the varied causes of obesity will result in a heterogeneous population which could potentially confound the results of the study.
(Response) We consider diversity within this illness population to be an asset. Also, random assignment will help to control extraneous influences because it will create groups that, on average, are probabilistically similar to each other. Because randomization eliminates most other sources of systematic variation, researchers can be reasonably confident that any effect that is found is the result of the intervention and not some preexisting differences between the groups (Ref. 20). Consequently, the varied causes of obesity should not impact the results. The primary intention of the research is to empirically examine consumer and HCP ability to detect and report deceptive prescription drug promotion, but we have to choose stimuli (and by extension, an illness population) in order to empirically test our research questions. By choosing illness conditions with diverse patient populations, we can better grasp how consumers and HCPs from all walks of life react to deceptive prescription drug promotion. Also see response to comment 3j.
(Comment 5)
We strongly support FDA's proposed project as part of the Agency's broader research efforts to better understand the impact of prescription drug promotion and direct-to-consumer advertising (DTC). Research regarding deceptive advertising is becoming increasingly important as DTC continues to grow at unprecedented rates. One analysis estimated DTC spending in 2015 at $5.2 billion—a growth of over 60 percent in just 4 years. Five drugs—HUMIRA, LYRICA, ELIQUIS, CIALIS, and XELJANZ—accounted for one-quarter of this $5.2 billion. Importantly, these figures are an underestimate, as they do not account for spending on digital ads and social media.
The risks and benefits of DTC have been well noted and debated. DTC may promote patient dialogue with healthcare providers and remove the stigma associated with certain diseases. However, there are also significant concerns that DTC may be misleading, overemphasize a drug's benefits as compared to risks, and lead to inappropriate prescribing and overutilization.
Again, we applaud the FDA's efforts in this important area. The need to better understand the ability of consumers and healthcare professionals to detect and report misleading DTC is critical as the use of DTC continues to
(Response) FDA appreciates this support.
FDA estimates the burden of this collection of information as follows:
The following references are on display in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers 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
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) has determined that NOROXIN (norfloxacin) tablets, 400 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for norfloxacin tablets, 400 mg, if all other legal and regulatory requirements are met.
Darren Eicken, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD 20993-0002, 240-402-0978.
In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.
NOROXIN (norfloxacin) tablets, 400 mg, is the subject of NDA 019384, held by Merck & Company, Inc. (Merck), and initially approved on October 31, 1986. NOROXIN is indicated for the treatment of adults with the following infections caused by susceptible strains of certain designated microorganisms: Uncomplicated urinary tract infections (including cystitis), uncomplicated urethral and cervical gonorrhea, and prostatitis.
In a letter dated October 13, 2015, Merck notified FDA that NOROXIN (norfloxacin) tablets, 400 mg, was being discontinued, and FDA moved the drug product to the “Discontinued Drug Product List” section of the Orange Book. In the
Jubilant Generics Ltd. submitted a citizen petition dated April 27, 2017 (Docket No. FDA-2017-P-2659), under 21 CFR 10.30, requesting that the Agency determine whether NOROXIN (norfloxacin) tablets, 400 mg, was withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that NOROXIN (norfloxacin) tablets, 400 mg, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that NOROXIN (norfloxacin) tablets, 400 mg, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of NOROXIN (norfloxacin) tablets, 400 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that this drug product was not withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list NOROXIN (norfloxacin) tablets, 400 mg, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to NOROXIN (norfloxacin) tablets, 400 mg, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised, the Agency will advise ANDA applicants to submit such labeling.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements.” The guidance clarifies the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertisements for human prescription drugs, including prescription biological products, and for animal prescription
FDA is also announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).
The announcement of the guidance is published in the
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
You may submit either electronic or written comments on Agency guidances at any time as follows:
Submit electronic comments in the following way:
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• 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.” The Agency will review this copy, including the claimed confidential information, in its 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
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the
FDA is announcing the availability of a guidance for industry entitled “Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements.” This guidance clarifies the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertisements for human prescription drugs, including prescription biological products, and for animal prescription drugs. The disclosure of the product
The placement, size, prominence, and frequency of the proprietary and established names for human prescription drugs, including prescription biological products, and for prescription animal drugs are specified in labeling and advertising regulations (21 CFR 201.10(g) and (h) and 202.1(b), (c), and (d)).
The recommendations in this guidance pertain to product names in traditional print promotional labeling and advertisements (
In the
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements.” 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. This guidance is not subject to Executive Order 12866.
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. The information collection requests in support of the guidance are discussed below. Specifically, the guidance discusses the requirement in FDA's regulations for prescription drug promotional labeling and advertisements to include the established name in conjunction with the proprietary name, and explains FDA recommendations that:
• Firms should include the established name at least once per page or spread where the proprietary name most prominently appears.
• The established name should be placed either directly beside or below the proprietary name without any intervening matter.
• The size of the established name should be at least half the size of the presentation of the proprietary name wherever the established name is required.
• For superimposed text that is equivalent to a headline or tagline, the established name should be presented alongside the most prominent presentation of the proprietary name in audiovisual promotional materials (promotional labeling and broadcast advertisements).
• For electronic and computer-based promotion, the established name should accompany the proprietary name at least once per Web page, and this should generally be where the proprietary name most prominently appears on the Web page.
Thus, the guidance recommends that firms disclose certain information to others to fulfill the product name placement requirements found in FDA's regulations. This “third-party disclosure” constitutes a “collection of information” under the PRA. Disclosures in advertising pursuant to 21 CFR 202.1 are covered by an existing information collection (OMB control number 0910-0686), so this information collection request covers only disclosures in labeling in accordance with 21 CFR 201.10(g) and (h).
In the
As reflected in table 1, we provide an estimate of the annual third-party disclosure burden associated with this collection of information. The placement, size, prominence, and frequency of the proprietary and established names for human prescription drugs, including prescription biological products, and animal prescription drugs are specified in labeling and advertising regulations (21 CFR 201.10(g) and (h); 202.1(b), (c) and (d); and 610.62). Using calendar year 2015 data, FDA estimates that, for prescription human and animal drugs and biological products, approximately 407 firms disseminate approximately 104,358 advertisements and promotional pieces each year. We further estimate that the burden hours associated with the regulatory requirements would be approximately 3 hours per disclosure.
FDA is issuing this final guidance subject to OMB approval of the information collection. Before implementing the information collection provisions of the guidance, FDA will publish a notice in the
This guidance also refers to previously approved collections of information found in FDA regulations. The collections of information associated with 21 CFR 202.1 have been approved under OMB control number 0910-0686.
Persons with access to the internet may obtain the guidance at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by January 11, 2018.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Sections 525 through 528 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360aa-360dd) give FDA statutory authority to do the following: (1) Provide recommendations on investigations required for approval of marketing applications for orphan drugs, (2) designate eligible drugs as orphan drugs, (3) set forth conditions under which a sponsor of an approved orphan drug obtains exclusive approval, and (4) encourage sponsors to make orphan drugs available for treatment on an “open protocol” basis before the drug has been approved for general marketing. The implementing regulations for these statutory requirements have been codified under part 316 (21 CFR part 316) and specify procedures that sponsors of orphan drugs use in availing themselves of the incentives provided for orphan drugs in the FD&C Act and sets forth procedures FDA will use in administering the FD&C Act with regard to orphan drugs.
Section 316.10 specifies the content and format of a request for written recommendations concerning the nonclinical laboratory studies and clinical investigations necessary for approval of marketing applications. Section 316.12 provides that, before providing such recommendations, FDA may require results of studies to be submitted for review. Section 316.14 contains provisions permitting FDA to refuse to provide written recommendations under certain circumstances. Within 90 days of any refusal, a sponsor may submit additional information specified by FDA. Based on past experience, FDA estimates that there will be one respondent to §§ 316.10, 316.12, and 316.14 requiring 50 hours of human resources annually.
Section 316.20 specifies the content and format of an orphan drug application which includes requirements that an applicant document that the disease is rare (affects fewer than 200,000 persons in the United States annually) or that the sponsor of the drug has no reasonable expectation of recovering costs of research and development of the drug. Section 316.21 specifies content of a request for orphan drug designation required for verification of orphan-drug status. Section 316.26 allows an applicant to amend the applications under certain circumstances. Based on past experience, FDA estimates 496 respondents to §§ 316.20, 316.21, and 316.26, requiring 83,700 hours of human resources annually.
The Common EMEA/FDA Application for Orphan Medicinal Product Designation form for orphan designation of drugs intended for rare diseases or conditions (Form FDA 3671) is intended to benefit sponsors who desire to seek orphan designation of drugs intended for rare diseases or conditions from both the European Commission and FDA by reducing the burden of preparing separate applications to meet the regulatory requirements in each jurisdiction. It highlights the regulatory cooperation between the United States and the European Union mandated by the Transatlantic Economic Council. The FDA Orphan Drug Designation Request Form (Form FDA 4035) is intended to benefit sponsors who desire to seek orphan designation of drugs intended for rare diseases or conditions from only FDA. The form is a simplified method for sponsors to provide only information required by 21 CFR 316.20 for FDA to make a decision. Based on past experience, FDA estimates there will be 496 respondents using the form requiring 19,840 hours of human resources annually.
Section 316.22 specifies requirement of a permanent resident agent for foreign sponsors. Based on past experience, FDA estimates 70 respondents requiring 140 hours of human resources annually.
Section 316.27 specifies content of a change in ownership of orphan-drug designation. Based on past experience, FDA estimates 63 respondents requiring 315 hours of human resources annually. Section 316.30 requires submission of annual reports, including progress reports on studies, a description of the investigational plan, and a discussion of changes that may affect orphan status. Based on number of orphan-drug designations, the number of respondents is estimated as 744 requiring 2,232 hours of human resources annually. Finally, § 316.36 describes information required of sponsor when there is insufficient quantity of approved orphan drug. Based on past experience, FDA estimates two respondents requiring 90 hours of human resources annually.
The information requested will provide the basis for an FDA determination that the drug is for a rare disease or condition and satisfies the requirements for obtaining orphan drug status. Secondly, the information will describe the medical and regulatory history of the drug. The respondents to this collection of information are biotechnology firms, drug companies, and academic clinical researchers.
In the
FDA estimates the burden of this collection of information as follows:
FDA has experienced increases in: (1) The number of submissions to change ownership of orphan-drug designation (§ 316.27), (2) the number of annual reports (§ 316.30), and (3) assurances of the availability of sufficient quantities of the orphan drug and the holder's consent for the approval of other marketing applications for the same drug (§ 316.36).
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by February 12, 2018.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 12, 2018. The
Submit electronic comments in the following way:
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• 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 Dockets Management Staff, 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.” The Agency will review this copy, including the claimed confidential information, in its 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
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (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, FDA invites 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.
This information collection supports FDA regulations under § 101.8 (21 CFR 101.8) and Form FDA 3757. Under § 101.8(d) vending machine operators not subject to the requirements of section 403(q)(5)(H)(viii) (21 U.S.C. 343(q)(5)(H)(viii)) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) may, through an authorized official, voluntarily register with FDA to be subject to those requirements. Those who do voluntarily register must provide FDA with contact information, the address of the location of each vending machine owned or operated by the vending machine operator that is being registered, the preferred mailing address (if different from the vending machine operator address) for purposes of receiving correspondence, and certification that the information submitted is true and accurate, that the person or firm submitting the information is authorized to do so, and that each registered vending machine will be subject to the requirements of § 101.8(c)(2). We have developed Form FDA 3757 entitled, “DHHS/FDA Menu and Vending Machine Labeling Voluntary Registration,” to assist respondents in this regard. To keep the establishment's registration active, the authorized official of the vending machine operator must register every other year within 60 days prior to the expiration of the vending machine operator's current registration with
It should be noted that an article of food sold from a vending machine whose operator has voluntarily registered with FDA under the regulations is not required to provide calorie declarations for articles of food sold from a vending machine that permits the prospective purchaser to examine the Nutrition Facts label before purchasing the article as provided in § 101.8(b)(1), or otherwise provides visible nutrition information at the point of purchase as provided in § 101.8(b)(2).
FDA estimates the burden of the collection of information as follows:
As reflected in table 1, we retain the currently approved reporting burden estimate for the information collection. At this time, we lack comprehensive data on the number of vending machine operators with fewer than 20 machines that might voluntarily register to comply with the regulations and, as indicated in our final rule of December 1, 2014 (79 FR 71259) establishing the information collection, no vending machine operators have voluntarily registered with FDA. Therefore, while we expect relatively few submissions, we have provided a conservative estimate of the burden respondents may encounter.
We estimate there are approximately 757 vending machine operators with fewer than 20 machines; this number is based on the mean estimate of the low and high counts of firms with less than $50,000 in annual revenue. We estimate that 5 percent of vending machine operators with fewer than 20 machines may voluntarily register to become subject to the final requirements, or 38 operators. We estimate a burden of approximately 2 hours per initial registration, which yields a total burden of 76 hours (38 total operators × 2 hours per response). Annualizing this number over 3 years yields a rounded 13 respondents per year (5 percent × 757 operators/3 years). With an annualized estimate of 13 vending machine operators and one registration per vending machine operator at 2 hours per registration, we estimate the initial hourly burden for these operators is 26 hours.
We expect that renewal registrations after the first year will require substantially less time because operators are expected to be able to affirm or update the existing information in an online account in a way similar to other FDA firm registration systems. Therefore, we estimate that re-registration will take 0.5 hours for each registrant. This indicates that biennial registration would impose a burden of 19 hours (38 operators × 0.5 hours) every 2 years, or 9.5 hours every year (19 operators every year × 0.5 hours).
We have omitted providing a burden estimate associated with generating, providing, or maintaining records associated with calorie analysis and recording because the regulations do not require vending machine operators to maintain such records. However, we have considered the “time, effort, or financial resources” expended by covered vending machine operators to declare calories for covered vending machine food and have included the burden in table 2 as part of the third-party disclosure burden. We are particularly interested in hearing from respondents to the information collection regarding calorie declaration signage.
As reflected in table 2, we have retained the currently approved third-party burden estimate for the information collection.
Under the regulations, we calculate three types of third party disclosure burden. The first burden estimate reflects the time and effort we believe necessary for vending machine operators to determine the calorie content of covered vending machine food for the required calorie declarations as described in § 101.8(c)(2)(i). We refer to this as a “calorie analysis.” A calorie analysis entails the burden of determining calorie content for covered vending machine food. Most foods sold from vending machines provide the nutrition labeling required by section 403(q) of the FD&C Act and 21 CFR 101.9, including calorie content information, which means that calorie content for many covered vending machine foods is
We estimate the mean number of vending machine operators that need calorie analysis to be 847. Annualizing this estimate over 3 years yields 282 operators. We also estimate the range of products available in a typical machine for each of the three most commonly sold product categories that are likely to require a calorie analysis, or 3 percent of food items, 5 percent of hot beverages, and 1 percent of cold cup beverages. We estimate that food machines typically offer between 10 and 25 different items, and both hot beverage and cold cup beverage machines typically offer between 5 and 10 items. From this, we estimate each vending machine operator will require a calorie analysis for 11 items, on average. These estimates are based upon conversations with vending machine operators and our survey of various vending machine models that vend these types of food and beverage, as discussed in our final rule. Based on available data, we estimate the time needed to determine the calorie content of each covered vending machine food to be approximately 1 hour. Our estimate for the burden hours required for new calorie analysis is then 9,317 hours (847 operators × 11 products needing analysis × 1 hour per analysis). Annualizing this value over 3 years yields 3,102 hours (847 operators/3 years × 11 products needing analysis × 4 hours per analysis). (847 operators/3 years = 282 operators per year.) This is reflected in table 2, row 1.
The second burden estimate reflects burden associated with calorie declaration signage as described in § 101.8(c)(2)(ii). Covered vending machine operators with 20 or more vending machines and vending machine operators that voluntarily register to become subject to the Federal requirements must disclose calorie information by providing calorie declaration signs in, on, or adjacent to their vending machines to a third party who will most often be the prospective purchaser or consumer.
We estimate there is an average of 9,838 (9,800 covered non-bulk + 38 voluntary) vending machine operators subject to the regulations (9,838/3 = 3,279 annualized). Our estimate for the average number of non-bulk vending machines that will require declaration signage is based upon data relied upon in our final rule (see references 1, 6 to 8 under Docket No. FDA-2011-F-0171). We estimate there is an average of 5.61 million non-bulk vending machines. Digital signage is an emerging technology, and according to available sources, approximately 0.1 percent of all vending machines in operation currently have electronic video displays capable of providing calorie information, or approximately 4,014 to 5,670 vending machines. Subtracting the number of vending machines with the electronic video from the total machine count yields an average of 5.61 million vending machines that will need signage. We expect the number of vending machines that will require signage to decline over time as manufacturers continue to add the required calorie information to the principal display panel of the package as part of “front of package labeling,” and because we anticipate greater use of electronic video displays on vending machines. In addition, to the extent that covered vending machines sell foods that permit prospective purchasers to examine the Nutrition Facts label before purchase or otherwise provide visible nutrition information at the point of purchase in accordance with section 403(q)(5)(H)(viii)(I)(aa) of the FD&C Act and § 101.8(b), this analysis may overestimate the burden estimate for calorie declaration signs.
Vending machine operators can create one sign that contains all of the information for the products offered in the vending machine, and do not have to create individual signs for each item. The number of templates a given firm would need to design to produce signs that comply with the regulations may vary based upon the number of different types of products the firm purveys. In our estimate, we have considered the time it takes for template design, sign creation, sign installation, updates, replacement, and bulk machine signage. Cumulatively we estimate that those 3,279 (annualized) vending machine operators subject to the regulations will expend a total 1,494,403 hours to fulfill the requirements under § 101.8(c)(2)(ii) regarding signage for calorie declarations. This is reflected in table 2 row 2. We note that while we previously provided burden estimates for individual disclosure activities found under § 101.8(c)(2)(ii) in our final rule of December 1, 2014 (79 FR 71259 at 71286), we have consolidated them here into one entry. Because this is the first extension request for this information collection and we have limited available data, we are specifically interested in respondents' experience with the third-party burden associated with the requirements under § 101.8(c)(2)(ii).
Finally, we have provided a burden estimate associated with § 101.8(e)(1) requiring a vending machine operator subject to section 403(q)(5)(H)(viii) of the FD&C Act or a vending machine operator that voluntarily registers to provide contact information. We assume that venders that do not already have a sign or label with their contact information will add their contact information into the initial sign design. We estimate the time it takes to include contact information is 1.5 minutes (0.025 hours) for each sign. We estimate the total initial burden for including contact information on the predesigned templates to be 30,744 hours (9,838 operators × 125 sign formats × 0.025 hours per sign). Annualized over 3 years, this burden becomes 10,248 hours (9,838 operators/3 years × 125 signs × 0.025 hours per sign). (Some States have licensing requirements for vending machine operators, and some of these licensing requirements already require the vending machine operator's license or contact information to be displayed on the vending machine.) If the contact information displayed on a vending machine due to State or local requirements includes some but not all of the contact information required under § 101.8(e)(1), the vending machine operator is required to display the remaining contact information required under § 101.8(e)(1) in a manner specified under § 101.8(e)(1). We do not have an estimate of the number of machines already in compliance; to the extent that some operators are already in compliance, we overestimate the associated burden for third-party disclosure.) This is reflected in table 2, row 3.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) is announcing the website location where the Agency will post two lists of guidance documents that CDRH (or the Center) intends to publish in fiscal year (FY) 2018. In addition, FDA has established a docket where interested persons may comment on the priority of topics for guidance, provide comments and/or propose draft language for those topics, suggest topics for new or different guidance documents, comment on the applicability of guidance documents that have issued previously, and provide any other comments that could benefit the CDRH guidance program and its engagement with stakeholders. This feedback is critical to the CDRH guidance program to ensure that we meet stakeholder needs.
Submit either electronic or written comments by February 12, 2018.
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 Dockets Management Staff, 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.” The Agency will review this copy, including the claimed confidential information, in its 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
Erica Takai, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002, 301-796-6353.
During negotiations on the Medical Device User Fee Amendments of 2012 (MDUFA III), Title II, Food and Drug Administration Safety and Innovation Act (Pub. L. 112-114), FDA agreed to meet a variety of quantitative and qualitative goals intended to help get safe and effective medical devices to market more quickly. Among these commitments included:
• Annually posting a list of priority medical device guidance documents that the Agency intends to publish within 12 months of the date this list is published each fiscal year (the “A-list”), and
• Annually posting a list of device guidance documents that the Agency intends to publish, as the Agency's guidance-development resources permit each fiscal year (the “B-list”).
The Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA Reauthorization Act of 2017 (Pub. L. 115-52) maintained these commitments.
FDA welcomes comments on any or all of the guidance documents on the lists as explained in 21 CFR 10.115(f)(5). FDA has established Docket No. FDA-2012-N-1021 where comments on the FY 2018 lists, draft language for guidance documents on those topics, suggestions for new or different guidances, and relative priority of guidance documents may be submitted and shared with the public (see
In addition to posting the lists of prioritized device guidance documents,
Fulfillment of these commitments will be reflected through the issuance of updated guidance on existing topics, removal of guidances that no longer reflect FDA's current thinking on a particular topic, and annual updates to the A-list and B-list announced in this notice.
CDRH has identified as a priority, and has devoted resources to, finalization of draft guidance documents. To assure the timely completion or re-issuance of draft guidances, in FY 2015 CDRH committed to performance goals for current and future draft guidance documents. For draft guidance documents issued after October 1, 2014, CDRH committed to finalize, withdraw, re-open the comment period, or issue new draft guidance on the topic for 80 percent of the documents within 3 years of the close of the comment period and for the remaining 20 percent, within 5 years. As part of MDUFA IV commitments, FDA reaffirmed this commitment, as resources permit. In addition, in FY 2017, CDRH withdrew 4 of 8 draft guidances issued prior to October 1, 2011, and has been continuing to work towards taking an action on the remaining draft guidances. Looking forward, in FY 2018, CDRH will strive to finalize, withdraw, or re-open the comment period for 50 percent of existing draft guidances issued prior to October 1, 2012.
CDRH has received feedback that stakeholders desire earlier involvement in the guidance process and has taken steps to create a mechanism to address this request. In FY 2016, in anticipation of guidance documents expected to be developed, CDRH sought stakeholder input regarding electromagnetic compatibility of electrically powered medical devices and regarding utilizing animal studies to evaluate the safety of organ preservation devices and solutions. FDA appreciated the feedback received and considered it in the development of these guidances. Demonstrating commitment to incorporating stakeholder input, CDRH issued a draft guidance in FY17 on utilizing animal studies to evaluate the safety of organ preservation devices, and is progressing toward issuance of draft policies reflecting early stakeholder input as appropriate.
FDA also welcomes any additional feedback for improving the guidance program and the quality of CDRH guidance documents.
CDRH has issued over 600 final guidance documents to provide stakeholders with the Agency's thinking on numerous topics. Each guidance reflected the Agency's current position at the time that it was issued. However, the guidance program has issued these guidances over a period of 30 years, raising the question of how current previously issued final guidances remain. CDRH has resolved to address this concern through a staged review of previously issued final guidances in collaboration with stakeholders. At the website where CDRH has posted the “A-list” and “B-list” for FY 2018, CDRH has also posted a list of final guidance documents that issued in 2008, 1998, 1988, and 1978.
In FY 2017, CDRH received comments regarding guidances issued in 2007, 1997, and 1987, and has withdrawn 32 guidance documents in response to comments received and because these guidance documents were determined to no longer represent the Agency's current thinking. The revision of several guidance documents is also being considered as resources permit.
Consistent with the Good Guidance Practices regulation at 21 CFR 10.115(f)(4), CDRH would appreciate suggestions that CDRH revise or withdraw an already existing guidance document. We request that the suggestion clearly explain why the guidance document should be revised or withdrawn and, if applicable, how it should be revised. While we are requesting feedback on the list of previously issued final guidances located in the annual agenda website, feedback on any guidance is appreciated and will be considered.
This notice announces the website location of the document that provides the A and B lists of guidance documents, which CDRH is intending to publish during FY 2018. To access these two lists, visit FDA's website at
Stakeholder feedback on guidance priorities is important to ensure that the CDRH guidance program meets the needs of stakeholders. The feedback received on the FY 2017 list was mostly in agreement, and CDRH continued to work toward issuing the guidances on this list. In FY 2017, CDRH issued 9 of 27 guidances on the FY 2017 list (6 from the A-list, 3 from the B-list). At this time, CDRH has decided not to pursue several guidances that were on the FY 2017 A or B list, due to factors including feedback from industry.
Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.
Notice; amendment.
A notice was published in the
CDR Gustavo Ceinos, 202-690-7650; Email address:
Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.
Notice.
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held on January 24, 2018, of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council). The meeting will be open to the public; a public comment session will be held during the meeting. Pre-registration is required for members of the public who wish to attend the meeting and who wish to participate in the public comment session. Individuals who wish to attend the meeting and/or send in their public comment via email should send an email to
The meeting is scheduled to be held on January 24, 2018, from 9:00 a.m. to 5:00 p.m. ET (times are tentative and subject to change). The confirmed times and agenda items for the meeting will be posted on the website for the Advisory Council at
U.S. Department of Health and Human Services, Hubert H. Humphrey Building, Great Hall, 200 Independence Avenue SW, Washington, DC 20201.
The meeting can also be accessed through a live webcast on the day of the meeting. For more information, visit
Jomana Musmar, Acting Designated Federal Officer, Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services, Hubert H. Humphrey Building, 200 Independence Avenue SW, Room 715H, Washington, DC 20201. Phone: (202) 690-5566; email:
Under Executive Order 13676, dated September 18, 2014, authority was given to the Secretary of HHS to establish the Advisory Council, in consultation with the Secretaries of Defense and Agriculture. Activities of the Advisory Council are governed by the provisions of Public Law 92-463, as amended (5 U.S.C. App.), which sets forth standards for the formation and use of federal advisory committees.
The Advisory Council will provide advice, information, and recommendations to the Secretary of HHS regarding programs and policies intended to support and evaluate the implementation of Executive Order 13676, including the National Strategy for Combating Antibiotic-Resistant Bacteria and the National Action Plan for Combating Antibiotic-Resistant Bacteria. The Advisory Council shall function solely for advisory purposes.
In carrying out its mission, the Advisory Council will provide advice, information, and recommendations to the Secretary regarding programs and policies intended to preserve the effectiveness of antibiotics by optimizing their use; advance research to develop improved methods for combating antibiotic resistance and conducting antibiotic stewardship; strengthen surveillance of antibiotic-resistant bacterial infections; prevent the transmission of antibiotic-resistant bacterial infections; advance the development of rapid point-of-care and agricultural diagnostics; further research on new treatments for bacterial infections; develop alternatives to antibiotics for agricultural purposes; maximize the dissemination of up-to-date information on the appropriate and proper use of antibiotics to the general public and human and animal healthcare providers; and improve international coordination of efforts to combat antibiotic resistance.
The public meeting will be dedicated to two main activities. The Advisory Council will deliberate and vote on a letter drafted by the Immediate Action Subcommittee. The remainder of the day will be focused on the topic of antibiotic stewardship in food and companion animals. The meeting agenda will be posted on the Advisory Council website at
Public attendance at the meeting is limited to the available space. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Advisory Council at the address/telephone number listed above at least one week prior to the meeting. For those unable to attend in person, a
Members of the public will have the opportunity to provide comments prior to the Advisory Council meeting by emailing
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to timing limitations imposed by the review and funding schedule.
U.S. Immigration and Customs Enforcement, Department of Homeland Security.
30-day notice.
The Department of Homeland Security (DHS), U.S. Immigration and Customs Enforcement (USICE) is submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the
Written comments and/or suggestions regarding the items contained in this notice, especially regarding the estimated public burden and associated response time, must be directed to the OMB Desk Officer for U.S. Immigration and Customs Enforcement, Department of Homeland Security and sent via electronic mail to
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Transportation Security Administration, DHS.
60-Day notice.
The Transportation Security Administration (TSA) invites public comment on one currently approved Information Collection Request (ICR), Office of Management and Budget (OMB) control number 1652-0028, abstracted below, that we will submit to OMB for revision in compliance with the Paperwork Reduction Act (PRA). The ICR describes the nature of the information collection and its expected burden. The collection involves requesting information from flight and cabin crew members of air carriers to verify employment status to confirm eligibility to participate in voluntary advanced self-defense training provided by TSA. Each crew member will also be required to complete an electronic Injury Waiver Form. Additionally, each participant is asked to complete an anonymous course evaluation at the conclusion of the training.
Send your comments by February 12, 2018.
Comments may be emailed to
Christina A. Walsh at the above address, or by telephone (571) 227-2062.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
(1) Evaluate whether the proposed information requirement is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Consistent with the requirements of Executive Order (EO) 13771, Reducing Regulation and Controlling Regulatory Costs, and EO 13777, Enforcing the Regulatory Reform Agenda, TSA is also requesting comments on the extent to which this request for information could be modified to reduce the burden on respondents.
TSA must collect specific information in order to provide the program to eligible participants as well as assess training quality. This information includes limited biographical information from flight and cabin crew members to confirm their eligibility to participate in this training. TSA uses the information to confirm the eligibility of the participant by contacting the participant's employer.
TSA currently collects the following information at the time of registration online: Name of the crew member, airline affiliation, position, crew member airline identification (ID) number, crew member contact information (home mailing address, last four digits of the crew member's social security number (SSN), home telephone number and/or email address), and the city and state of the TSA Office of Law Enforcement/Federal Air Marshals Service (OLE/FAMS) field office where the course will be taken. Upon attending class, crew members are asked to show ID to verify their identity against registration records and to sign the class attendance roster. TSA also asks trainees to complete a voluntary TSA training evaluation form. Trainees are not required to identify themselves on the evaluation form.
TSA is revising this information collection to no longer include the collection of the last four digits of the SSN from crew members. TSA is also revising this information collection to include an electronic Injury Waiver Form. Each crew member will be asked to complete an Injury Waiver Form during the registration process, or before the training is conducted. The Injury Waiver Form requests the employee's airline, airline ID number, signature, and date, and is intended to limit any liability to TSA or its facilities should a crew member become injured during the training. Further, TSA is revising the information collection to update the attendance roster to add a “training complete” column. Finally, TSA is revising the information collection to replace the evaluation form with an electronic feedback tab. At the completion of the course, participants may assess the quality of the training off-site, on their own time, by clicking on the electronic feedback link, located on the registration site, to provide their anonymous and voluntary comments. This revision is necessary so that TSA may continue to provide the program to eligible participants as well as assess training quality.
The estimated number of annual respondents is 3,400 and estimated annual burden is 595 hours. TSA plans to graduate at least 1,700 crew members during each year of the program, an increase of 700 from the 2015 ICR submission. TSA estimates, the online registration requires five (5) minutes and the injury waiver and class roster sign-in process requires one (1) minute per crew member. This amounts to 311.67 hours [(3,400 crew members × 5 minutes) + (1,700 crew members × 1 minute)]. Although utilizing the course Feedback tab is strictly voluntary, TSA estimates ten (10) minutes per crew member for those who complete the evaluation. Assuming everyone participates, this amounts to a total of 283.33 hours (1,700 crew members × 10 minutes). TSA estimates the total annual hours for this information collection to be 595 hours (311.67 + 283.33).
Office of Public and Indian Housing, HUD.
Notice of Proposed New Performance Measurement System (“Composite Score”) for the Family Self-Sufficiency Program.
This Notice describes and requests comment on a performance measurement system that HUD plans to implement for Public Housing Agencies (PHAs) that receive HUD Family Self-Sufficiency (FSS) program coordinator grants. The Notice also requests comment on whether and, if so, how to develop a performance measurement system for FSS programs that do not receive HUD FSS coordinator funding. The desired effect of this notice is to notify and solicit comments from public housing agencies regarding new proposed criteria for evaluating FSS programs.
HUD invites interested persons to submit comments regarding the proposed FSS Performance Measurement System to the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 Seventh Street SW, Room 10276, Washington, DC 20410-0001. Communications must refer to the above docket number and title and should contain the information specified in the “Request for Comments” section. There are two methods for submitting public comments.
1.
2.
To receive consideration as public comments, comments must be submitted through one of the two methods specified above. Again, all submissions must refer to the docket number and title of the notice.
Questions on this notice may be addressed to
This Notice sets forth a new performance measurement system for evaluating the efficacy of FSS programs, requests comment on that performance measurement system, and asks additional questions regarding these proposed changes.
In pursuit of advancing HUD's ability to evaluate the effectiveness of the FSS program, per statutory mandate (Section 23(i)(2) of the Housing Act of 1937), HUD has developed a new FSS performance measurement system to provide HUD, Congress, and public housing agencies (PHAs) with information on the performance of individual FSS programs. The information will help PHAs determine the extent to which PHAs are administering effective and impactful FSS programs that help participants to successfully graduate from the program and make progress toward economic security. The information will also help HUD understand the extent to which individual FSS program performance, and the performance of all FSS programs receiving HUD FSS coordinator funding as a group, improves or declines over time.
HUD plans to use the performance measures to identify high performing and troubled FSS programs. In the future, HUD will likely consider the FSS performance score of an FSS program in determining FSS funding awards. HUD may also use the rating system to identify PHAs that could benefit from technical assistance to improve their programs. At this time, HUD does not envision using this performance measurement system for tribes/TDHEs, who do not report into Public and Indian Housing Information Center (PIC), or for PHAs with a Moving to Work (MTW) designation, as they report differently into PIC, using Form HUD-50058-MTW. However, HUD is presently exploring a change to the reporting processes for MTW agencies in order to include them in the FSS performance scoring process.
HUD developed the approach described in this Notice based in part on feedback received on an earlier performance measurement approach proposed in the FY 2014 FSS Notice of Funding Availability (NOFA). In the FY 2014 NOFA, HUD proposed evaluating FSS programs based on the share of FSS participants that experience an increase in earned income (also known as “earnings growth”) over a specified time period. Among other feedback, commentators expressed concern that this approach did not adequately account for differences in local economic conditions and differences in the approach of local FSS programs.
Under the planned performance measurement system, at least once per year, HUD will analyze data collected through the PIC to calculate FSS performance scores for each FSS program for which sufficient data are available to calculate the score. A PHA's FSS performance score will be calculated based on three measures, weighted as follows:
HUD has selected these measures because they are important indicators of program performance and are verifiable using the data HUD collects through the PIC data system. No outside or additional reporting will be required, ensuring the system does not increase the reporting burden of PHAs. No new Paperwork Reduction Act (PRA) Information Collection will be required for the scoring, as proposed.
As described below, the Earnings Performance Measure represents the difference between the earnings growth of FSS participants and the earnings growth of other similar households within the PHA within a specified time frame. This approach helps to control for variations in local economic conditions. Earnings growth is one of the primary outcomes desired from FSS; the FSS performance score therefore assigns the Earnings Performance Measure a high weight. HUD has assigned the next highest weight to the Graduation Rate indicator—which represents the rate of FSS participants who successfully “graduate” from the program—to encourage PHAs to work closely with individual FSS participants to increase graduation rates. (To graduate from FSS, a participant must be employed, be independent of welfare assistance for at least one year, and achieve the other goals set forth in the participant's contract of participation.) Finally, the FSS performance score looks at Participation Rate, which reflects the extent to which a PHA exceeds the minimum number of households that HUD requires the PHA to serve as a condition of receiving an FSS grant. PHAs with higher Participation Rates are serving more households than required, which is a desired output, provided the PHAs are serving those households effectively. Because the Earnings Performance Measure is weighted more heavily than the Participation Rate, however, PHAs should be careful not to execute more Contracts of Participation than they can serve effectively, because doing so would likely reduce their scores on the Earnings Performance Measure.
Together, the Earnings Performance Measure, Graduation Rate, and Participation Rate provide a balanced measurement of the performance of an individual FSS program. The three measures are calculated as follows:
The Earnings Performance Measure gauges the extent to which the earnings
To accommodate these different factors and control for variations among FSS programs, HUD calculates the Earnings Performance Measure for each FSS program using the process outlined below. HUD applies this process to the population of FSS participants who enrolled in the FSS program 3.5 to 7.5 years prior to the end of the most recent quarter of data available through PIC to calculate the latest FSS performance scores.
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• Selects three comparison households for each FSS household based on the extent to which the comparison households are similar to the FSS household on the following characteristics: Earnings as of the time of the FSS household's entry into FSS, age of head of household, length of time in the voucher or public housing program, number of adults in the household and number of children under age 5.
• Calculates the earnings growth for all of the comparison households using the same approach used to calculate the earnings growth for FSS households, with the FSS household's enrollment date being applied to its comparison households for purposes of calculating the comparison households' initial earnings.
• Calculates the difference between the average earnings growth for all FSS participants and the average earnings growth for all comparison households at each PHA. The difference between the two represents the PHA's earnings performance measure.
HUD applies this measure to all FSS participants with a head of household who is neither elderly nor a person with disabilities who joined FSS between 3.5 and 7.5 years prior to the end of the quarter of the PIC extract used to calculate the score. For example, if the most recent PIC data extract ended in March 31, 2017, HUD's calculation of earnings performance measures would focus on FSS participants who joined the FSS program between October 1, 2009 and September 30, 2013. This methodology aggregates information for four years of FSS entrants in order to generate a large enough sample to analyze. The methodology does not examine data for participants that have entered the FSS program more recently than 3.5 years ago to allow sufficient time to have passed for FSS participants to have benefitted from the program. At the same time, the methodology does not focus only on an older sample of FSS participants to ensure that the results reflect recent FSS program performance to the maximum extent practicable.
This measure examines the share of FSS participants at each PHA who have “graduated” from the FSS program. It is calculated based on the graduation rate of FSS participants who entered each PHA's FSS program 5 to 8 years before the end of the most recent quarter of available PIC data. The methodology focuses on these households to allow sufficient time for most of the FSS participants who will graduate to have done so. HUD considered focusing on an older cohort to capture 100 percent of the FSS participants who will graduate, but HUD determined that it was more advantageous for the period analyzed to include more recent performance by the PHA.
The Participation Rate is the ratio of the number of FSS participants being served to the minimum number expected to be served under the standards used for awarding funding under the FSS NOFA. Agencies that exactly meet the standard will have a ratio of 1.0. Agencies that serve more than the required number will have a ratio above 1.0. Agencies that serve fewer than the required number will have a ratio below 1.0.
To calculate the Participation Rate, HUD first calculates the minimum number of FSS participants that HUD expects each PHA to serve for each of the most recent three (3) fiscal years for which both funding award and number served data are available. HUD calculates this number based on the guidelines in the NOFA and the number of coordinators funded in each agency during each year. HUD then sums the number of FSS participants actually served in each of the three years based on PIC data. Finally, HUD divides the total number of FSS participants served in each PHA by the total minimum number expected for the PHA's HUD-funded coordinator positions to determine the participation rate. If funding is only awarded to the PHA in one or two of the three years, the measure only uses data for the years for which funding was awarded. Note that this metric, while similar, is different from the “number of participants served,” which has been used in NOFA competitions and assesses only the most recent period of performance.
As calculated using the procedures described above, the participation rate is higher if the PHA has served more participants relative to its funding level. The ratio required in the NOFA is 25 for one full-time coordinator and 50 for each additional full-time coordinator. For example, a PHA with 1 funded full-time coordinator is expected to serve at least 25 participants during the year, while a PHA with 3 funded full-time coordinators is expected to serve at least
PHAs that receive funding jointly with other PHAs are evaluated together in calculating the participation rate. HUD sums the number of FSS participants served by each of the jointly-funded agencies and the minimum number of participants the agencies are jointly expected to serve and provides the same participation score for each of the PHAs.
After making the calculations described above, HUD will develop an FSS Performance Score for each PHA using a two-step process.
In Step One, HUD will assign a score of 0 to 10 to each PHA's FSS program for each of the three measures. Scores will be assigned using the procedures described below. The ranges for awarding points between two values include those values as well as all intermediary values.
For each of the three measures, HUD has selected criteria for evaluating PHA performance. For each measure, the highest performers are assigned a score of 10, the next-highest performers are assigned a score of 7.5, and low performers are assigned a score of 0. HUD will award a score of 5 to PHAs whose performance does not satisfy the criteria for highest, next-highest, or low performance for that measure.
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As described above, a PHA's earnings performance measure represents the difference between: (a) The average earnings growth for FSS participants and (b) the average earnings growth for comparison households at the same PHA. A PHA's earnings performance measure is not simply a measure of the extent to which FSS participants increased their earnings. Instead, a PHA's earnings performance measure reflects the relative growth of FSS participants relative to a matched set of non-participants at that PHA. HUD assigns a higher score to FSS programs that achieve a higher earnings performance score.
In addition to focusing on the size of the earnings performance measure, the scoring for this measure applies a one-tailed test of statistical significance, designed to protect FSS programs from being scored “low performer” due to random variation and low sample size. For example, without this protection, an individual FSS program may include several anomalous participants or control households that skew research results. The statistical test measures the likelihood that a PHA's earnings performance measure is significantly lower than the median measure. The lower the p-value, the less likely it is that a PHA received a below-median earnings performance measure due to random variation. To receive 0 points, a PHA must not only have an earnings performance measure below $1,500 but also a p-value on this test of less than .10, which means there is at least a 90 percent probability that the earnings performance measure is truly below the median value of $3,418.
While a similar statistical test could theoretically be applied to help identify high performing programs, such a test would make it harder for small FSS programs to qualify. To avoid disadvantaging smaller FSS programs, p-values are not considered in determining whether to award 10 or 7.5 points.
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Under this approach, a higher graduation rate results in a higher score.
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Under this approach, a higher participation rate results in a higher score.
After computing individual scores for each of the three measures, HUD aggregates each PHA's scores using the weights noted above to develop a final FSS Performance Score from 0 to 10. Based on this score, HUD assigns the following ranking to the PHA's performance:
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The thresholds for converting the three performance measures into scores in step one are fixed and will now apply to all future years until HUD revises the methodology. These thresholds were selected by applying the FSS Performance Score methodology to PIC data from the quarter ending December 31, 2016. The thresholds were selected as follows:
• The threshold for awarding a score of 10 points (an earnings performance measure of $6,400) represents approximately the 80th percentile of the distribution of results of the earnings performance measure for PHAs whose measures have a p value >.10 on a statistical test measuring the likelihood that the earnings performance measure is different from $0. HUD calculated the distribution using agencies that receive a p value below .10 on this test to reduce the likelihood that the results would be affected by random variation.
• The threshold for awarding a score of 7.5 points ($4,750) represents approximately the 60th percentile of the distribution of results of the earnings performance measure for PHAs whose measures have a p value <.10 on the statistical test described above.
• The threshold for awarding a score of 0 points ($1,500) represents approximately the 20th percentile of the distribution of results of the earnings performance measure for all PHAs.
• The threshold for awarding a score of 10 points represents approximately the 80th percentile of the distribution of graduation rates.
• The threshold for awarding a score of 7.5 points represents approximately the 60th percentile of the distribution of graduation rates.
• The threshold for awarding a score of 0 points represents approximately the 20th percentile of the distribution of graduation rates.
• The threshold for awarding a score of 10 points represents approximately the 80th percentile of the distribution of participation rates.
• The threshold for awarding a score of 7.5 points represents approximately the 60th percentile of the distribution of participation rates.
• The threshold for awarding a score of 0 points is 0.95, which falls below the minimum standard established by HUD. A PHA serving the minimum number of FSS participants required to obtain FSS funding would normally have a participation rate of 1.0. However, this methodology uses a score of 0.95 to give PHAs the benefit of the doubt and account for any temporary vacancies in the FSS program.
• The threshold for awarding a ranking of Excellent represents approximately the 80th percentile of the distribution of FSS Performance Scores.
• The range for awarding a ranking of Low represents approximately the 10th through the 20th percentiles in the distribution of FSS Performance Scores.
• Programs falling below approximately the 10th percentile in the distribution of FSS Performance Scores are classified as Troubled.
• All other FSS programs are classified as “Standard” performers. The range for awarding a ranking of Standard represents approximately the 20th through the 80th percentiles of the distribution of FSS Performance Scores.
As noted above, all thresholds are now fixed and will not be recalculated each year. This will facilitate tracking individual PHA progress as well as that of all FSS programs over time. Further, this framework does not limit how many programs can receive any particular ranking. The thresholds are absolute, not relative.
The following is additional information about how HUD calculates FSS performance scores:
1. For households entering FSS more than one time during the analysis period, the methodology focuses only on the FSS Contract of Participation that began 5 to 8 years before the end of the most recent quarter of available PIC data to calculate the FSS performance score. This facilitates appropriate evaluation of each program's graduation rate, which focuses on the same group of households. If a participant entered more than once during that period, the methodology focuses on the older entry.
2. FSS performance scores are calculated for any PHA that has sufficient data in PIC to calculate at least one of the three measures used to calculate the score. If there are insufficient data to calculate one or two of the measures, that PHA will receive a middle (standard) score of “5” for the missing measure(s) before calculating the FSS performance score.
3. A PHA for which none of the three scores are available will not receive a score.
4. Because the earnings performance measure and the graduation rate are calculated using data that spans a range of years, it will take time for a PHA to improve its FSS Performance Score through improvements in earnings and graduation outcomes. However, improvements in these areas will eventually become apparent in a PHA's FSS Performance Score. It is important for PHAs with low scores to begin implementing improvements as quickly as possible. PHAs with participation rates below 0.95 can quickly improve their FSS Performance Scores by increasing participation rates to meet HUD's minimum requirements.
HUD is interested in evaluating the performance of all FSS programs administered by PHAs, including programs that do not receive funding from HUD. However, there are several concerns with applying the methodology described above to the evaluation of the performance of non-funded agencies. First, the participation rate cannot be calculated using the methodology described in this notice because there are no set expectations for program size. Second, such programs tend to be smaller than NOFA-funded programs, which means their results are more subject to random variation due to the participation of individuals with idiosyncratic features. Third, these program participants tend to receive less personal attention from FSS coordinators due to the lack of dedicated funding from HUD for FSS.
HUD will continue studying options for measuring the performance of such agencies to determine if an approach can be developed for evaluating the quality of their FSS programs. To inform HUD's analysis of this issue, HUD requests comments on the following questions:
1. Should HUD evaluate FSS programs that do not receive funding from HUD?
2. Should the performance of an unfunded FSS program be considered by HUD in determining whether to award funding? If not, what factors should be used in determining whether to award funding to a currently unfunded agency?
3. Should the FSS performance score of an unfunded PHA be compared solely with that of other unfunded PHAs or also against the performance of funded agencies?
4. How should the procedures for evaluating the performance of funded FSS programs be adapted for purposes of measuring the performance of FSS programs that do not receive funding?
5. Should HUD calculate a participation rate for unfunded FSS programs in evaluating their performance and if so, how should it be calculated?
6. In addition to, or instead of a participation rate, should HUD limit the evaluation of non-funded agencies to FSS programs over a certain size, such as 15 or 25 participants? Focusing only on FSS programs of a certain minimum size should help to improve the reliability of the evaluation results while also focusing the evaluation (and any corresponding preference for funding) on PHAs that demonstrate a threshold level of commitment to the FSS program.
In addition to the questions noted above, HUD requests feedback on the following questions:
1. Has HUD assigned the appropriate weight to each of the three measures? The proposed system uses the following weights: Earnings performance measure (50 percent); Graduation rate (30 percent); and Participation rate (20 percent).
2. In evaluating earnings growth, HUD focuses on the average of the earnings growth of individual households at a PHA, rather than median growth. HUD
3. Has HUD adequately accounted for variations in local economic conditions? If not, what further adjustments should be made? The earnings performance measure accounts for local economic conditions by comparing the earnings growth for FSS participants at a PHA to the earnings growth for non-FSS participants at the same PHA with similar characteristics. The assumption underlying this approach is that earnings growth for non-FSS participants will be higher in areas with stronger job markets than in areas with weaker job markets. To attain the same earnings performance measure, a PHA in an area with a strong job market would thus need to demonstrate a higher level of earnings growth among FSS participants than would a PHA in an area with a weaker job market. After calculating the difference between earnings growth for FSS and non-FSS participants at a PHA, the proposed system makes no further adjustments. Should HUD further adjust its system to account for variations in local economic conditions, and if so, how should HUD make this adjustment? For example, HUD could divide the earnings performance measure by the average starting earnings for a PHA's FSS participants and then compare the resulting percentages across PHAs. Further, HUD could adjust the earnings performance measures by an index that accounts for local economic conditions.
4. HUD currently allows a PHA to count FSS participants living in multifamily FSS programs toward the minimum number of participants required to be served in order to qualify for FSS funding. The PIC data system, however, does not capture information on multifamily FSS participants. HUD requests suggestions on how best to capture information on multifamily FSS participants being served by a PHA's FSS coordinator to determine a PHA's participation rate.
5. HUD currently permits, and funds, FSS programs in Tribes and Tribally Designated Housing Entities (TDHEs). However, Tribes and TDHEs do not report into the PIC data system. HUD requests suggestions on how to best capture information on tribal FSS participants to determine a score.
6. HUD currently permits, and funds, FSS programs at MTW agencies. However, MTW agencies are only required to report select FSS data fields into the PIC system. HUD requests suggestions on how to best capture information on MTW FSS participants to determine a score.
7. How should HUD evaluate FSS programs offered by HUD-assisted multifamily properties with Section 8 contracts? These programs are very new and currently submit quarterly spreadsheets rather than an FSS addendum integrated into a HUD data reporting system.
This notice does not direct, provide for assistance or loan and mortgage insurance for, or otherwise govern or regulate, real property acquisition, disposition, leasing, rehabilitation, alteration, demolition, or new construction, or establish, revise or provide for standards for construction or construction materials, manufactured housing, or occupancy. Accordingly, under 24 CFR 50.19(c)(1), this notice is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).
Office of Public and Indian Housing, HUD.
Notice; solicitation of comment.
On August 10, 2017, pursuant to the authority provided in regulation, HUD suspended for two years the designation for the mandatory use of Small Area Fair Market Rents (Small Area FMRs) for certain metropolitan areas that had previously been designated for Small Area FMR use (Suspension). After HUD provided notice of this suspension, interested persons requested an opportunity to review and comment on the Suspension. While HUD is not required to post the Suspension for public comment, this notice solicits comment for a period of 30 days. At the expiration of the 30-day period, HUD will review the comments and consider if any further changes to the Suspension are necessary.
Comment Due Date: January 11, 2018.
Interested persons are invited to submit comments regarding this notice, and HUD's temporary suspension of the use of Small Area FMRs, to the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street SW, Room 10276, Washington, DC 20410-0500. Communications must refer to the above docket number and title. There are two methods for submitting public comments. All submissions must refer to the above docket number and title.
To receive consideration as public comments, comments must be submitted through one of the two methods specified above. Again, all submissions must refer to the docket number and title of the notice.
Todd M. Richardson, Deputy Assistant Secretary, Office of Policy Development, Office of Policy Development and Research, Department of Housing and Urban Development, 451 7th Street SW, Room 4130, Washington, DC 20410, 202-708-1537, ext. 5706 (this is not a toll-free number).
Since October 2011, all Public Housing Agencies (PHAs) operating the Housing Choice Voucher (HCV) program in the Dallas, TX HUD Metro FMR Area have been using Small Area Fair Market Rents (Small Area FMRs). The use of Small Area FMRs was intended to give HCV families access to areas of high opportunity and lower poverty by providing a subsidy that is adequate to cover rents in those areas, thereby reducing the number of voucher families that reside in areas of high poverty concentration. The PHAs in Dallas began using Small Area FMRs as the result of a legal settlement.
HUD announced the commencement of the Small Area FMR demonstration in November 2012. Five PHAs participated voluntarily in this demonstration, which sought to assess the effect on families of using FMRs published at the U.S. Postal Service ZIP code level (
In 2015, HUD awarded a cooperative agreement to Abt Associates to evaluate the use of Small Area FMRs by the five PHAs that voluntarily participated in the demonstration, as well as two PHAs operating the voucher program in the Dallas, TX HUD Metro FMR Area. Abt was charged with examining whether and to what extent providing higher subsidies in ZIP code areas where rents are higher, and lower subsidies in ZIP code areas where rents are lower, helps HCV families to better access areas of opportunity. HUD also requested that the evaluation examine how the transition from metropolitan-wide to Small Area FMRs affected families and landlords, and the impact of Small Area FMRs on HCV subsidy and administrative costs.
On November 16, 2016, HUD published its “Establishing a More Effective Fair Market Rent System; Using Small Area Fair Market Rents in the Housing Choice Voucher Program Instead of the Current 50th Percentile FMR” final rule (81 FR 80567). This final rule required the use of Small Area FMRs in certain metropolitan areas instead of the 50th percentile rent previously used. On the same day, HUD published a notice listing areas in which the use of Small Area FMRs is mandatory beginning on October 1, 2017 (81 FR 80678).
On April 26, 2017, HUD received Abt's Small Area Fair Market Rent Demonstration Evaluation Interim Report.
On August 10, 2017, pursuant to the authority provided in regulation, HUD suspended the designation for the mandatory use of Small Area FMRs for 23 of the 24 metropolitan areas that would become subject to the requirement on October 1, 2017 (Suspension).
HUD will designate Small Area FMR areas at the beginning of a Federal fiscal year, such designations will be permanent, and [HUD] will make new area designations thereafter as new data becomes available. HUD may suspend a Small Area FMR designation from a metropolitan area, or may temporarily exempt a PHA in a Small Area FMR metropolitan area from use of the Small Area FMRs, when HUD by notice makes a documented determination that such action is warranted. Actions that may serve as the basis of a suspension of Small Area FMRs are:
i. A Presidentially declared disaster area that results in the loss of a substantial number of housing units;
ii. A sudden influx of displaced households needing permanent housing; or
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Based on the findings in Abt's Small Area Fair Market Rent Demonstration Evaluation Interim Report, summarized above, HUD has concerns that the mandatory use of Small Area FMRs, without sufficient preparation and mitigation of potential unintended consequences, could put some PHAs at risk of causing an adverse rental housing market condition. Accordingly, after careful consideration, HUD issued the Suspension of the Small Area FMR designation for 23 of the 24 metropolitan areas that had previously been designated for mandatory Small Area FMR use. The Suspension was for two Federal fiscal years (FYs), becoming effective at the beginning of FY 2020 (October 1, 2019) instead of FY 2018. To provide notice to affected PHAs, HUD sent letters to more than 200 PHAs in the 23 metropolitan areas noted in the Suspension. Additionally, HUD posted an article regarding the Suspension on its website.
The delayed implementation of mandatory Small Area FMR adoption will provide HUD with reasonable time to analyze the final findings of the demonstration and determine what measures are necessary to mitigate negative effects, if possible. For example, the delay may allow HUD to develop guidance and technical assistance that is informed by the lessons learned from the demonstration.
Notwithstanding the exercise of this authority, the Small Area FMR Rule permits any PHA that voluntarily seeks to adopt SAFMRs to do so. The program regulations at 24 CFR 888.113(c)(3) provide that a PHA administering an HCV program in a metropolitan area not subject to the mandatory application of Small Area FMRs may opt to use Small Area FMRs by seeking approval from HUD's Office of Public and Indian Housing (PIH) through written request to PIH. In light of the findings of Abt's Small Area Fair Market Rent Demonstration Evaluation Interim Report referenced above, should HUD receive a request under this provision, HUD will consider in its approval determination a PHA's ability to provide reasonable assurance that adoption of Small Area FMRs will not result in an adverse housing market condition.
With this notice, HUD seeks public comment on the Suspension. While
Office of the Secretary, HUD.
Notice.
Through this notice, HUD solicits comment on a demonstration designed to test the effectiveness of collaborative efforts by government, industry, and nonprofit organizations to accelerate economic mobility of low-income households in communities that include HUD-assisted housing through EnVision Centers, centralized hubs for supportive services focusing on the four pillars of Economic Empowerment, Educational Advancement, Health and Wellness, and Character and Leadership. Approximately 10 communities, selected from across the country, are anticipated to participate in the demonstration. The purpose of the demonstration is to explore the potential of a new service-delivery mechanism to provide HUD-assisted households the ability to benefit from life-changing opportunities that the advancement of the four pillars affords.
Comment Due Date: February 12, 2018.
Interested persons are invited to submit comments responsive to this notice to the Office of General Counsel, Regulations Division, Department of Housing and Urban Development, 451 7th Street SW, Room 10276, Washington, DC 20410-0001. All submissions should refer to the above docket number and title. Submission of public comments may be carried out by hard copy or electronic submission.
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Ariel Pereira, Associate General Counsel for Legislation and Regulations, Office of General Counsel, Department of Housing and Urban Development, 451 Seventh Street SW, Room 10282, Washington, DC 20410-7000, telephone number 202-402-5132 (this is not a toll-free number). Persons with hearing or speech impairments may access this number through TTY by calling the Federal Relay Service at 800-877-8339 (this is a toll-free number).
Under the leadership of President Donald J. Trump, the Administration is committed to reforming government services and expanding opportunities for more Americans to become self-sufficient. The EnVision Center demonstration focuses on empowering people to leave HUD-assisted housing through self-sufficiency to become responsible homeowners and renters in the private market. By doing so, HUD will be able to make those resources available to others and help more Americans.
The EnVision Centers demonstration is premised on the notion that financial support alone is insufficient to solve the problem of poverty. Intentional and collective efforts across a diverse set of organizations are needed to implement a holistic approach to foster long-lasting self-sufficiency. EnVision Centers will provide communities with a centralized hub for support in the following four pillars: (1) Economic Empowerment, (2) Educational Advancement, (3) Health and Wellness, and (4) Character and Leadership. The Economic Empowerment pillar is designed to improve the economic sustainability of individuals residing in HUD-assisted housing by empowering them with opportunities to improve their economic outlook. The Education pillar seeks to bring educational opportunities directly to HUD-assisted housing and includes partnering with public and private organizations that approach education in non-traditional ways on non-traditional platforms. The Health and Wellness pillar is designed to improve access to health outcomes by individuals and families living in HUD-assisted housing. The Character and Leadership pillar is designed to enable all individuals and families residing in HUD-assisted housing, especially young people, to reach their full potential as productive, caring, responsible citizens by encouraging participation in volunteer and mentoring opportunities.
Through results-driven partnerships with federal agencies, state and local governments, non-profits, faith-based organizations, corporations, public housing authorities (PHAs), tribal designated housing entities (TDHEs) and housing finance agencies, EnVision Centers will leverage public and private
A January 2011 report from the Government Accountability Office (GAO) that focused on Temporary Assistance for Needy Families, Employment Services and Workforce Investment Act Adult employment programs funded by the U.S. Departments of Labor, Education, and Health and Human Services, found that while it would be a challenge, efficiencies in offering government services could be achieved by co-locating services and consolidating administrative structures.
Every resident living in public or assisted housing should have access to the opportunities economic mobility can provide. This demonstration is designed to encourage and create a platform for communities to collaborate with community supportive service providers, other businesses, foundations, nonprofit organizations, educational leaders, job training and workforce development organizations, and others to advance economic mobility in their communities and to test the effectiveness of a collaborative set of actions that address all barriers to economic sufficiency. The demonstration will build upon existing partnerships and continue collaborative work to improve the lives of residents housed with HUD assistance by providing a forum by which cross-sector organizations can come together to design and implement local interventions to advance economic mobility.
HUD's goal is to identify a sample of diverse communities from different geographies and of varying sizes that have the capacity to effectively and expediently implement the demonstration to serve HUD-assisted families. HUD seeks the interest of communities where local leadership has already taken steps to support the goals of the demonstration, as measured by both the community's participation in other complementary Federal initiatives supporting economic mobility, as well as local plans and strategies for addressing the four pillars.
Participation in the demonstration by these communities will build upon existing efforts already underway to expand economic mobility, thereby building the comprehensive and coordinated set of resources that will result in the long-term, sustainable employment that places individuals and families on track to become self-sufficient.
As part of this demonstration, HUD will provide technical assistance, evaluation and monitoring, access to online resources such as the EnVision Center mobile application, access to stakeholder offerings made available to participating communities and a network of support from HUD's departments to ensure that all relevant HUD knowledge resources are made available to participating communities. HUD believes that communities participating in the EnVision Center demonstration will benefit from the collaboration made possible under this demonstration with: Local, state and federal government services, community based organization services, non-profit mission based organization services and faith based organization services that will lead to the development of economic self-sufficiency and ultimately, greater economic mobility for those most in need within these communities.
HUD will use the following criteria to assess communities that have expressed an interest in participating in the demonstration:
(1) The mayor or equivalent executive elected official of the community, and the PHA's or TDHE's executive leader, must formally announce a commitment to enhance economic mobility and in so doing identify skills gaps that exist in their community among distinct neighborhoods and demographics, the resolution of which will support long-term, sustainable employment that places individuals and families in HUD-assisted housing on track to become self-sufficient.
(2) Communities should commit to developing and implementing a plan to promote and expand economic mobility. The development of this plan will serve as a vehicle for bringing various stakeholders together and providing them with a tangible path for achieving the goals of the demonstration. As an example, the plan could specify and formalize the participation of community stakeholders, describe gaps in current service delivery models, identify a physical location(s) which can act as a shared services site to house the EnVision Center, and/or outline specific benchmarks and goals for the EnVision center. Communities' participation plans will be expected to describe the goals of the community's participation in the demonstration and provide, to the extent possible, objective goals regarding the number of partnerships established with state and local government, non-profits, faith based organizations, and private and philanthropic organizations.
(3) To ensure the presence of local support and leverage HUD infrastructure for implementation of this demonstration, communities should be currently participating in one or more Federal place-based initiatives, such as: The Promise Zones program; PHAs participating in the Moving to Work Demonstration, the Byrne Criminal Justice Innovation program; the Strong Cities, Strong Communities program; the JobsPlus program; the Family Self-Sufficiency program and the Resident Opportunities and Self-Sufficiency (ROSS) program; the ConnectHome program; existing Neighborhood Networks sites; existing Family Investment sites; the ROSS for Education Program; the Energy and Economic Development program (SEED); or the Building Neighborhood Capacity program.
(4) Communities should be broadly committed to realizing the Office of American Innovation
(5) As a condition of participation, selected entities are required to cooperate in full with HUD staff and/or any contractors affiliated with HUD, in the implementation and evaluation of this program.
(6) After selection, HUD will finalize a set of measurement tools to evaluate the program's impact and effectiveness. Selected respondents will be required to keep records to document how the Demonstration is being implemented, cooperate with the evaluation, and
These criteria are meant to create optimal conditions to accelerate the adoption and use of the EnVision Center model. However, the criteria may be applied with reasonable flexibility to ensure that a diverse set of communities are considered for participation in this demonstration. Approximately 10 communities are anticipated to initially participate in the demonstration. As the demonstration proceeds, HUD will assess expressions of interest from communities and the availability of HUD staffing resources to support additional participation. Additionally, as the demonstration proceeds, HUD will assess the effectiveness of the participation criteria on an ongoing basis. As a result of these assessments, HUD may expand the number of participating communities, revise the participation criteria, or both to reflect HUD's experience in implementing the demonstration.
In advance of commencement of the demonstration, HUD will sponsor or co-sponsor one or more meetings of communities, cross-sector entities, and other stakeholders to facilitate the sharing of information and identify communities interested in participation in the demonstration. HUD will reach out to communities that have formally declared a commitment to advance economic mobility and otherwise meet the criteria described above to participate in those meetings. HUD also invites interested communities to reach out to HUD to note their interest and request attendance at a stakeholder meeting. HUD therefore encourages interested communities to take the necessary steps to meet the criteria as quickly as possible in order to be best positioned to realize the benefits of these discussions.
HUD may partner with an existing entity that has a national organizational presence sufficient to provide a strong coordinating function across communities, government, and the private and nonprofit sectors. The entity should have significant expertise in community services, economic mobility and the four pillars. It should possess strong existing relationships with industry, foundations, universities, and nonprofit and non-governmental agencies. Finally, it should have community project experience, including educational and outreach activities in underserved populations.
Communities interested in participating in this demonstration must submit a written commitment by the mayor or equivalent executive elected official of the community (municipality, county, tribal nation or state), and the PHA or TDHE executive leader, to advancing economic mobility and empowering HUD-assisted households to become self-sufficient. This commitment, must also respond to the items outlined in Section II.1. above, as well as identification of the Federal place-based initiatives in which it is involved, as requested by Section II.1.(3.) above. In addition, HUD will require submission of an EnVision Center plan that outlines specific benchmarks and goals for the EnVision Center as outlined in Section II of this notice. Communities seeking to participate in this demonstration must submit this information to
The information collection requirements contained for the EnVision Center Demonstration will be submitted to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). In accordance with the Paperwork Reduction Act, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection displays a currently valid OMB control number.
In accordance with 5 CFR 1320.8(d)(1), HUD is soliciting comments from members of the public and affected agencies concerning this collection of information to:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated collection techniques or other forms of information technology,
Interested persons are invited to submit comments regarding the information collection requirements in this notice. Comments must refer to the proposal by name and docket number (FR-6069) and must be sent to:
HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503, Fax: (202) 395-6947, and, Office of Legislation and Regulations, Office of General Counsel, Department of Housing and Urban Development, Room 10282, 451 7th Street SW, Washington, DC 20410.
Interested persons may submit comments regarding the information collection requirements electronically through the Federal eRulemaking Portal at
HUD will work with entities across the government and the broader research community to rigorously measure outcomes associated with the
In accordance with section 470 of the Housing and Urban-Rural Recovery Act of 1983 (42 U.S.C. 3542), HUD is seeking comment on the demonstration. Section 470 provides that HUD may not begin a demonstration program not expressly authorized by statute until a description of the demonstration program is published in the
While HUD welcomes comments on the entirety of the demonstration, it asks that commenters consider the following specific questions:
(1) In administering and evaluating the demonstration, how should HUD define “economic mobility”?
(2) How can HUD tailor the Economic Empowerment Pillar of the Demonstration to identify and focus on families and individuals residing in HUD-assisted housing that are able to work, and not those who are elderly or include persons with disabilities;
(3) How can HUD and identified partners (state and local entities, private sector, philanthropic, non-profit and other entities) best maximize existing programs and efforts across agencies in a coordinated and holistic approach?
(4) What impediments exist for achieving the four pillars, including institutional, organizational, legal or statutory, and behavioral impediments? Is it necessary to the success of the demonstration that communities link all four pillars, and if not, would it be sufficient for a community to identify in its participation plan the barriers to including a specific pillar? Are there additional pillars that contribute to self-sufficiency and economic mobility that should be made part of the demonstration?
(5) What incentives and programs have worked in the past to achieve the four pillars?
(6) What elements and level of detail should HUD require in a community's participation plan?
(7) How should HUD define and measure economic mobility over time and space? How should HUD measure quality of life for residents that remain in assisted housing?
(8) What data sources or data linkage is needed to develop outcome metrics such as, return on investment, involvement of local institutions of higher learning, employment and economic opportunities for Section 3 residents and businesses, and a public process for reviewing outcomes and lessons learned?
Fish and Wildlife Service, Interior.
Notice of document availability; request for comments; notice of public workshop.
We, the U.S. Fish and Wildlife Service (Service), announce the availability of a draft Supplement to the Grizzly Bear Recovery Plan: Habitat-Based Recovery Criteria for the Northern Continental Divide Ecosystem (NCDE). The draft supplement, which will be appended to the Grizzly Bear Recovery Plan upon finalization, proposes to establish habitat-based recovery criteria for the NCDE grizzly bear population. In addition, the Service hereby gives notice that a public workshop will be held to review the habitat-based recovery criteria for the grizzly bear in the NCDE. The workshop will allow scientists and the public to submit oral and written comments. The Service solicits review and comment from the public on this draft supplement.
(1)
(2)
Hilary Cooley, Grizzly Bear Recovery Office (see
We, the U.S. Fish and Wildlife Service (Service), announce the availability of a draft Supplement to the Grizzly Bear Recovery Plan: Habitat-Based Recovery Criteria for the Northern Continental Divide Ecosystem (NCDE). The draft supplement, which will be appended to the Grizzly Bear Recovery Plan upon finalization, proposes to establish habitat-based recovery criteria for the NCDE grizzly bear population. In addition, the Service hereby gives notice that a public workshop will be held to review the habitat-based recovery criteria for the grizzly bear in the NCDE. The workshop will allow scientists and the public to submit oral and written comments. The Service solicits review
Restoring an endangered or threatened animal or plant to the point where it is again a secure, self-sustaining member of its ecosystem is a primary goal of the Service's endangered species program. To help guide the recovery effort, the Service prepares recovery plans for the federally listed species native to the United States where a plan will promote the conservation of the species. Recovery plans describe site-specific actions necessary for the conservation of the species; establish objective, measurable criteria which, when met, may result in a determination that the species no longer needs the protection of the ESA; and provide estimates of the time and cost for implementing the needed recovery measures (16 U.S.C. 1533(f)(1)(B)).
We approved the first Grizzly Bear Recovery Plan for grizzly bears in the lower 48 States on January 29, 1982 (U.S. Fish and Wildlife Service 1982). In 1993, we approved a revision to the Grizzly Bear Recovery Plan (U.S. Fish and Wildlife Service 1993), which included additional tasks and new information that increased the focus and effectiveness of recovery efforts. The 1993 Recovery Plan identifies distinct Recovery Zones and unique recovery criteria for six different grizzly bear populations, including the NCDE, with the intent that these individual populations would be delisted as they each achieve recovery (U.S. Fish and Wildlife Service 1993, pp. ii, 33-34). Supplements to the Recovery Plan were approved in 1997, 1998, 2007, and 2017 (U.S. Fish and Wildlife Service 1997, 1998, 2007a, 2007b, 2017).
Under the ESA, recovery plans must include objective, measurable recovery criteria, including habitat-based recovery standards (16 U.S.C. 1533(f)(1)(B)(ii)). A Grizzly Bear Recovery Plan Task Force also recommended further consideration of this issue, stating that we should work to “establish a threshold of minimal habitat values to be maintained within each Cumulative Effects Analysis Unit in order to ensure that sufficient habitat is available to support a viable population” (U.S. Fish and Wildlife Service 1993, p. 76). The draft habitat-based recovery criteria were developed in part by taking into account the oral and written comments received at the habitat-based recovery criteria workshop, which was held on July 7, 2016, in Missoula, Montana (81 FR 29295, May 11, 2016), and during the public comment period that followed the workshop. The Service has decided to hold a second habitat-based recovery criteria workshop.
The ESA requires the Service to provide public notice and opportunity for public review and comment on recovery plans prior to final approval (16 U.S.C. 1533(f)(4)). The Service will consider all information received during a public comment period when preparing each new or revised recovery plan for approval. The Service and other Federal agencies also will take these comments into consideration in the course of implementing approved recovery plans. It is our policy to request peer review of recovery plans. Comments received at the upcoming workshop announced in this
As described above, the Service will hold a public workshop seeking input and ideas on objective, measurable habitat-based recovery criteria available at
All information and comments received at the workshop or during the public comment period will be considered in finalizing the habitat-based recovery criteria for the NCDE.
The Service solicits public comments on a draft Supplement to the Grizzly Bear Recovery Plan. Specifically, this supplement proposes to append habitat-based recovery criteria for the Northern Continental Divide Ecosystem to the Grizzly Bear Recovery Plan. All comments received by the date specified in
If you submit information via
A list of the references cited in this notice may be found at
The authority for this action is section 4(f) of the Endangered Species Act, 16 U.S.C. 1533(f).
Office of Surface Mining Reclamation and Enforcement, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Office of Surface Mining Reclamation and Enforcement (OSMRE) are proposing to renew an information collection relating to the Abandoned Mine Reclamation Fund—Fee Collection and Coal Production Reporting.
Interested persons are invited to submit comments on or before January 11, 2018.
Send written comments on this information collection request (ICR) to the Office of Management and Budget's Desk Officer for the Department of the Interior by email at
To request additional information about this ICR, contact John Trelease by email at
In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provides the requested data in the desired format.
A
We are again soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of OSMRE; (2) is the estimate of burden accurate; (3) how might OSMRE enhance the quality, utility, and clarity of the information to be collected; and (4) how might OSMRE minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq).
Employment and Training Administration (ETA), Labor.
Notice of availability; request for comments.
The Department of Labor (DOL or Department) is soliciting comments concerning the measures of performance for the Senior Community Service Employment Program (SCSEP). The Older Americans Act Reauthorization Act of 2016 (OAA-2016) amended the measures of performance for SCSEP to align them with the performance measures under the Workforce Innovation and Opportunity Act (WIOA). The Department added performance information collection requirements for SCSEP to the information collection request (ICR) titled, “DOL-Only Performance Accountability, Information, and Reporting System.” This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA).
Submit written comments to the office listed in the addresses section below on or before February 12, 2018.
Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at
Comments submitted in response to this comment request will become a matter of public record and will be summarized and included in the request for Office of Management and Budget (OMB) approval of the information collection request. In addition, comments, regardless of the delivery method, will be posted without change on the
Herman L. Quilloin III by telephone at 202-693-3994 (this is not a toll-free number) or by email at
The DOL, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation process to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information before submitting them to the OMB for final approval. This process helps ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements can be properly assessed.
The DOL-Only ICR was developed based on the requirements in WIOA Sec. 116. The Department amended the information collection by adding the performance-related reporting requirements for SCSEP to the
The Department requires grantees to certify and submit the ETA (Program) Performance Report to ETA on a quarterly basis. ETA will aggregate the information the grantees submit through the PIRL to populate the ETA (Program) Performance Report and grantees will confirm their accuracy.
The OAA-2016 amended the SCSEP core indicators of performance and requires the amended measures to be implemented by regulation by December 31, 2017. SCSEP will retain its current ICR (under OMB Control Number 1205-0040) for data elements not contained in the revised DOL-Only Performance Accountability, Information and Reporting System. This ICR incorporates the SCSEP Interim Final Rule citations, as required by 5 CFR 1320.11(h). Those citations are sections 20 CFR parts: 641.700, 641.710, 641.720, 641.730, 641.740, and 641.750.
The OAA amended the measures of performance for SCSEP in large part to align SCSEP performance measures with the three employment outcome indicators mandated for WIOA core programs under WIOA sec. 116(b)(2)(A)(i)(I)-(III). In addition to these three WIOA employment outcome indicators of performance, SCSEP has three measures related to participation in the program: Service level, hours of community service, and service to the most-in-need.
The Department proposes to amend the information collection by adding the regulatory citations from the SCSEP Interim Final Rule to comply with the PRA. The Department plans to review and analyze any comments received in response to this
The Department is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology (
Notice.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95). This program helps to ensure
Written comments must be submitted to the office listed in the
Send comments to Erin Good, BLS Clearance Officer, Division of Management Systems, Bureau of Labor Statistics, Room 4080, 2 Massachusetts Avenue NE, Washington, DC 20212. Written comments also may be transmitted by fax to 202-691-5111 (this is not a toll free number).
Erin Good, BLS Clearance Officer, 202-691-7763 (this is not a toll free number). (See
The Bureau of Labor Statistics (BLS) awards funds to State agencies in the 50 States, the District of Columbia, Puerto Rico, Guam, and the Virgin Islands, hereinafter referred to as the “States”) in order to jointly conduct BLS/State Labor Market Information and Occupational Safety and Health Statistics cooperative statistical programs, which themselves have been approved by OMB separately, as follows:
To ensure the timely flow of information and to be able to evaluate and improve the BLS/State cooperative programs' management and operations, it is necessary to conduct ongoing communications between the BLS and its State partners. Whether information requests deal with program deliverables, program enhancements, operations, or administrative issues, questions and dialogue are crucial to the successful implementation of these programs.
Office of Management and Budget clearance is being sought for the General Inquiries to State Agency Contacts. Information collected under this clearance is used to support the administrative and programmatic needs of jointly conducted BLS/State Labor Market Information and Occupational Safety and Health Statistics cooperative statistical programs.
The Bureau of Labor Statistics is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility.
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they also will become a matter of public record.
Occupational Safety and Health Administration, Labor.
Request for public comment.
OSHA solicits public comments concerning its proposal to the Office of Management and Budget's (OMB) approval of the information collection requirements specified in the Safe + Sound Campaign.
Comments must be submitted (postmarked, sent, or received) by February 12, 2018.
Theda Kenney or Charles McCormick, Directorate of Standards and Guidance, OSHA, U.S. Department of Labor; telephone (202) 693-2222.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent (
In 2016, OSHA established the Safe + Sound Campaign, a voluntary effort to support the implementation of safety and health programs in businesses throughout the United States. Outside stakeholders, including safety and health professional organizations, trade and industry associations, academic institutions, and state and federal government agencies, collaborate with the Agency on the Campaign. The Campaign includes periodic activities and events, ranging from regular email updates to quarterly national webinars to local meetings to an annual national stand down (
OSHA has a particular interest in comments on the following issues:
• Whether the proposed information collection requirements are necessary for the proper performance of the Agency's functions, including whether the information is useful;
• The accuracy of OSHA's estimate of the burden (time and costs) of the information collection requirements, including the validity of the methodology and assumptions used;
• The quality, utility, and clarity of the information collected; and
• Ways to minimize the burden on employers who must comply. For example, by using automated or other technological information collection and transmission techniques.
OSHA is requesting that OMB approve the information collection associated with Safe + Sound Campaign activities. This voluntary information collection will include event registration and customer feedback surveys for activities throughout the year (
You may submit comments in response to this document as follows: (1) Electronically at
Because of security procedures, the use of regular mail may cause a significant delay in the receipt of comments. For information about security procedures concerning the delivery of materials by hand, express delivery, messenger, or courier service, please contact the OSHA Docket Office at (202) 693-2350, (TTY (877) 889-5627).
Comments and submissions are posted without change at
Loren Sweatt, Deputy Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506
Occupational Safety and Health Administration (OSHA), Department of Labor.
Notice.
This document gives notice of OSHA's approval of changes to the State of Minnesota's Occupational Safety and Health State Plan that specify that non-Indian private- sector employment within an Indian reservation or on lands held in trust by the Federal Government, and employment on land formerly occupied by the Twin Cities Army Ammunition Plant, are included in its State Plan, and that make other minor coverage clarifications.
Applicable Date: December 12, 2017.
For press inquiries, contact Francis Meilinger, Director, OSHA Office of Communications, U.S. Department of Labor; telephone: (202) 693-1999; email:
For general and technical information, contact Douglas J. Kalinowski, Director, OSHA Directorate of Cooperative and State Programs, U.S. Department of Labor; telephone: (202) 693-2200; email:
Section 18 of the Occupational Safety and Health Act of 1970, 29 U.S.C. 667 (OSH Act), provides that States that wish to assume responsibility for developing and enforcing their own occupational safety and health standards may do so by submitting and obtaining federal approval of a State Plan. State Plan approval occurs in stages that include initial approval under Section 18(c) of the Act and, ultimately, final approval under Section 18(e).
The Minnesota State Plan was initially approved under Section 18(b) of the OSHA Act. 38 FR 15077 (June 8, 1973). The State Plan later received final approval. 50 FR 30832 (July 30, 1985). The Minnesota State Plan is administered by the Minnesota Department of Labor and Industry, Minnesota Occupational Safety and Health Administration (MNOSHA). Under the Plan, MNOSHA covers state and local government employers and private-sector employers with certain exceptions. Originally, one of the exceptions was employment at the Twin Cities Army Ammunition Plant, which Federal OSHA covered because the United States had exclusive federal jurisdiction over the site. 50 FR 30832 (July 30, 1985). Later, another exception was added for tribal and private-sector employment within any Indian reservation in the State, which Federal OSHA also covered. 61 FR 36824 (July 15, 1996).
With the decommissioning and removal of the Twin Cities Army Ammunition Plant, MNOSHA requested that the exception to the State Plan's coverage for the plant be eliminated. The land on which the plant stood was transferred to the county and as such, private-sector employment on this land would fall under the State Plan's area of coverage. However, Federal OSHA continues to cover employment on land adjacent to the land transferred to the county because that adjacent land continues to be under exclusive federal jurisdiction. Federal OSHA granted this request.
MNOSHA also requested that the exception to the State Plan for tribal and private-sector employment on Indian reservations and lands held in trust by the Federal Government be changed so that MNOSHA could cover non-Indian private-sector employment in these areas. Federal OSHA continues to cover establishments owned or operated by Indian tribes or by enrolled members of Indian tribes. This approach to coverage is consistent with case law on federal and state authority over Indian lands. Federal OSHA granted this request.
These changes are reflected on the Federal OSHA web page for MNOSHA,
Loren Sweatt, Deputy Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, authorized the preparation of this notice. OSHA is issuing this notice under the authority specified by section 18 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 667), Secretary of Labor's Order No. 1-2012 (77 FR 3912), and 29 CFR parts 1902 and 1953.
Occupational Safety and Health Administration (OSHA), Labor.
Request for public comments.
OSHA solicits public comments concerning its proposal to extend OMB approval of the information collection requirements contained in the Standard on Excavations (Design of Cave-in Protection Systems).
Comments must be submitted (postmarked, sent, or received) by February 12, 2018.
Charles McCormick or Theda Kenney, Directorate of Standards and Guidance, OSHA, U.S. Department of Labor, (202) 693-2222.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent (
Paragraphs (b) and (c) of § 1926.652 (“Requirements for Protective Systems;” the “Standard”) contain paperwork requirements that impose burden hours or costs on employers. These paragraphs require employers to use protective systems to prevent cave-ins during excavation work; these systems include sloping the side of the trench, benching the soil away from the excavation, or using a support system or shield (such as a trench box). The Standard specifies allowable configurations and slopes for excavations, and provides appendices to assist employers in designing protective systems. However, paragraphs (b)(3) and (b)(4) of the Standard permit employers to design sloping or benching systems based on tabulated data (Option 3), or to use a design approved by a registered professional engineer (Option 4).
Under Option 3, employers must provide the tabulated data in a written form that also identifies the registered professional engineer who approved the data and the parameters used to select the sloping or benching system drawn from the data, as well as the limitations of the data (including the magnitude and configuration of slopes determined to be safe). The document must also provide any explanatory information necessary to select the correct benching system based on the data. Option 2 requires employers to develop a written design approved by a registered professional engineer. The design information must include the magnitude and configuration of the slopes determined to be safe, and the identity of the registered professional engineer who approved the design.
Paragraph (c)(2)(iii) allows employers to use manufacturer's tabulated data or to deviate from the data provided. The manufacturer's specification, recommendations, and limitations as well as the manufacturer's approval to deviate from these items shall be in writing. Paragraphs (c)(3) and (c)(4) allow employers to design support systems, shield systems, and other protective systems based on tabulated data provided by a system manufacturer (Option 3) or obtained from other sources including a registered professional engineer and approved by a registered professional engineer (Option 4).
Each of these provisions requires employers to maintain a copy of the documents described in these options at the jobsite during construction. After construction is completed, employers may store the documents off-site provided they make them available to an OSHA compliance officer on request. These documents provide both the employer and the compliance officer with information needed to determine if the selection and design of a protective system are appropriate to the excavation work, thereby assuring workers maximum protection against cave-ins.
OSHA has a particular interest in comments on the following issues:
• Whether the proposed information collection requirements are necessary for the proper performance of the Agency's functions, including whether the information is useful;
• The accuracy of OSHA's estimate of the burden (time and costs) of the information collection requirements, including the validity of the methodology and assumptions used;
• The quality, utility, and clarity of the information collected; and
• Ways to minimize the burden on employers who must comply; for example, by using automated or other technological information collection and transmission techniques.
The Agency is requesting that OMB extend its approval of the information collection requirements contained in the Standard on Excavations (Design of Cave-in Protection Systems). An increase in the number of construction from 761,873 to 931,009 projects/sites has resulted in an adjustment increase in burden hours from 14,266 to 17,262—a total increase of 2,996 burden hours. OSHA increased the number of apartment and non-residential construction sites that would use outside contractor engineering services for the required protective system design approval from 2,038 to 2,466. There was an increase in hourly wage for a civil engineer from $53.17 to $63.16, which increased the overall cost from $216,721 to $311,505, a difference of $94,784.
The Agency will summarize any comments submitted in response to this notice and will include this summary in
You may submit comments in response to this document as follows: (1) Electronically at
Because of security procedures, the use of regular mail may cause a significant delay in the receipt of comments. For information about security procedures concerning the delivery of materials by hand, express delivery, messenger, or courier service, please contact the OSHA Docket Office at (202) 693-2350, TTY (877) 889-5627.
Comments and submissions are posted without change at
Loren Sweatt, Deputy Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506
National Aeronautics and Space Administration (NASA).
Notice of establishment of the National Space Council Users' Advisory Group.
Pursuant to the NASA Authorization Act of 1991 (Pub. L. 101-611, Section 121), and Executive Order 13803 (“Reviving The National Space Council”), Section 6, signed by the President on June 30, 2017, NASA has established the National Space Council Users' Advisory Group (UAG). The UAG is a non-discretionary statutory Federal advisory committee under the Federal Advisory Committee Act (FACA) (Pub. L. 92-463, as amended). NASA is sponsoring and managing the operations of the UAG on behalf of the National Space Council, Executive Office of the President. This determination follows consultation with the Committee Management Secretariat of the U.S. General Services Administration.
Dr. Jeff Waksman, Designated Federal Officer/Executive Secretary, NASA Headquarters, 300 E Street SW, Washington, DC 20546, phone: 202-358-3758 or email:
National Archives and Records Administration (NARA)
Notice of availability of proposed records schedules; request for comments.
The National Archives and Records Administration (NARA) publishes notice at least once monthly of certain Federal agency requests for records disposition authority (records schedules). Once approved by NARA, records schedules provide mandatory instructions on what happens to records when agencies no longer need them for current Government business. The records schedules authorize agencies to preserve records of continuing value in the National Archives of the United States and to destroy, after a specified
NARA must receive requests for copies in writing by January 11, 2018. Once NARA finishes appraising the records, we will send you a copy of the schedule you requested. We usually prepare appraisal memoranda that contain additional information concerning the records covered by a proposed schedule. You may also request these. If you do, we will also provide them once we have completed the appraisal. You have 30 days after we send to you these requested documents in which to submit comments.
You may request a copy of any records schedule identified in this notice by contacting Records Appraisal and Agency Assistance (ACRA) using one of the following means:
You must cite the control number, which appears in parentheses after the name of the agency that submitted the schedule, and a mailing address. If you would like an appraisal report, please include that in your request.
Margaret Hawkins, Director, by mail at Records Appraisal and Agency Assistance (ACRA); National Archives and Records Administration; 8601 Adelphi Road; College Park, MD 20740-6001, by phone at 301-837-1799, or by email at
NARA publishes notice in the
Each year, Federal agencies create billions of records on paper, film, magnetic tape, and other media. To control this accumulation, agency records managers prepare schedules proposing records retention periods and submit these schedules for NARA's approval. These schedules provide for timely transfer into the National Archives of historically valuable records and authorize the agency to dispose of all other records after the agency no longer needs them to conduct its business. Some schedules are comprehensive and cover all the records of an agency or one of its major subdivisions. Most schedules, however, cover records of only one office or program or a few series of records. Many of these update previously approved schedules, and some include records proposed as permanent.
The schedules listed in this notice are media neutral unless otherwise specified. An item in a schedule is media neutral when an agency may apply the disposition instructions to records regardless of the medium in which it creates or maintains the records. Items included in schedules submitted to NARA on or after December 17, 2007, are media neutral unless the item is expressly limited to a specific medium. (See 36 CFR 1225.12(e).)
Agencies may not destroy Federal records without Archivist of the United States' approval. The Archivist approves destruction only after thoroughly considering the records' administrative use by the agency of origin, the rights of the Government and of private people directly affected by the Government's activities, and whether or not the records have historical or other value.
In addition to identifying the Federal agencies and any subdivisions requesting disposition authority, this notice lists the organizational unit(s) accumulating the records (or notes that the schedule has agency-wide applicability when schedules cover records that may be accumulated throughout an agency); provides the control number assigned to each schedule, the total number of schedule items, and the number of temporary items (the records proposed for destruction); and includes a brief description of the temporary records. The records schedule itself contains a full description of the records at the file unit level as well as their disposition. If NARA staff has prepared an appraisal memorandum for the schedule, it also includes information about the records. You may request additional information about the disposition process at the addresses above.
1. Department of Agriculture, Rural Development Agency (DAA-0572-2017-0006, 15 items, 15 temporary items). Records documenting the Electric Program, including routine correspondence, loan and borrower information, field activity reports, loan applications, and routine studies. Also included is information on rural community loans used for wastewater management assistance.
2. Department of Energy, Office of Energy Efficiency & Renewable Energy (DAA-0434-2017-0012, 1 item, 1 temporary item). Records of an electronic information system designed to promote energy efficient buildings including best practices, networking information, summaries of meetings, and related documents.
3. Department of Homeland Security, United States Citizenship and Immigration Services (DAA-0566-2017-0008, 14 items, 14 temporary items). Forms and supporting documentation for non-adjudicative actions on pending and previously approved cases and arrival/departure document replacement requests.
4. Department of Homeland Security, United States Citizenship and Immigration Services (DAA-0566-2017-0034, 1 item, 1 temporary item). Master files of an electronic information system used to track and process requests from other government agencies and foreign partners for information contained in Alien Files.
5. Corporation for National and Community Service, Office of the National Service Trust (DAA-0362-2018-0003, 9 items, 9 temporary items). Records related to education awards and student loan payment benefits, including institutional registration, and requests for payment, forbearance, benefit transfer, and extension.
6. National Labor Relations Board, Agency-wide (DAA-0025-2017-0001, 22 items, 15 temporary items). Records of an electronic case management system, including undocketed correspondence, electronic submissions of representation case documentation, paper submissions of showing of interest documentation, paper submissions of other representation case documentation, back pay administration, court mediation working files, non-court settlement working files, submitted documentation, misconduct by attorneys or party representatives files where no action is taken, all other misconduct cases, drafts and informal background material, electronic case tracking data, case records unit tracking records, statistical reports, and working papers, transitory, and duplicative case file documentation. Proposed for permanent retention are official case files, advisory opinions and declaratory orders case files, sub-panel notes, panel notes, board agenda records, research publications and electronic databases, and special litigation case files.
National Endowment for the Arts, National Foundation on the Arts and Humanities.
Notice of meetings.
Pursuant to the Federal Advisory Committee Act, as amended, notice is hereby given that 18 meetings of the Arts Advisory Panel to the National Council on the Arts will be held by teleconference unless otherwise noted.
See the
National Endowment for the Arts, Constitution Center, 400 7th St. SW, Washington, DC 20506.
Further information with reference to these meetings can be obtained from Ms. Sherry P. Hale, Office of Guidelines & Panel Operations, National Endowment for the Arts, Washington, DC 20506;
The closed portions of meetings are for the purpose of Panel review, discussion, evaluation, and recommendations on financial assistance under the National Foundation on the Arts and the Humanities Act of 1965, as amended, including information given in confidence to the agency. In accordance with the determination of the Chairman of July 5, 2016, these sessions will be closed to the public pursuant to subsection (c)(6) of section 552b of title 5, United States Code.
The upcoming meetings are:
National Science Foundation.
Notice and request for comments.
The National Science Foundation (NSF) is announcing plans to request approval for the Hispanic-Serving Institutions (HSI) Certification Form. In accordance with the requirements of the Paperwork Reduction Act of 1995, we are providing opportunity for public comment on this action. After obtaining and considering public comment, NSF will prepare the submission requesting that OMB approve clearance of this collection for no longer than 3 years.
Written comments on this notice must be received by February 12, 2018 to be assured of consideration. Comments received after that date will be considered to the extent practicable.
Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation, 2415 Eisenhower Avenue, Room W 18000, Alexandria, Virginia 22314; or send email to
Comments are invited on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the NSF, including whether the information shall have practical utility; (b) the accuracy of the NSF's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information on respondents, including through the use of automated collection techniques or other forms of information technology; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological
Nuclear Regulatory Commission.
Order; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is issuing an Order approving a request, submitted by Molycorp Minerals LLC (Molycorp), seeking the NRC's consent to the direct transfers of control of Export Licenses XSOU8707 and XSOU8827. In addition, Molycorp requested approval of conforming license amendments to reflect the new name of the holder of the license from Molycorp Minerals LLC, to MP Mine Operations (MPMO).
The Order was issued on November 27, 2017.
Please refer to Docket IDs 11004455 and 11005966 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this document using any of the following methods:
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•
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Andrea R. Jones, Office of International Programs, telephone: 301-287-9072, email:
The text of the Order is attached.
For the Nuclear Regulatory Commission.
Molycorp, the original Licensee, previously held export licenses nos. XSOU8707 and XSOU8827. The Licensee address included on these export licenses was the Mountain Pass rare earth mine and processing facility. After Molycorp filed for bankruptcy, MP Mine Operations LLC (MPMO) purchased the Mountain Pass rare earth mine and processing facility from Molycorp pursuant to an asset purchase agreement dated June 19, 2017, (Agencywide Documents Access and Management System [ADAMS] Accession No. ML17297B230). Although the “purchased assets” covered by this agreement included “all Permits . . . to the extent transferable,” the export licenses held by Molycorp were not transferred to MPMO at that time (see sections 2.1(b)(viii) and 2.7(a) of the asset purchase agreement). MPMO, a Delaware limited liability company, is controlled by two U.S. investment funds, JHL Capital Group Holdings Fund Two and QVT Financial LP, which combined have a 90.01 percent economic stake and own 100 percent of the voting common units for MPMO. Shenghe Resources Holding Co., Ltd., through its subsidiary Leshan Shenghe Rare Earth Co., Ltd., owns a 9.99 percent non-voting preferred stake for MPMO, and has no voting rights in MPMO. Both Shenghe Resources Holding Co., Ltd. and Leshan Shenghe Rare Earth Co., Ltd. are foreign companies.
By letter dated August 14, 2017 (ADAMS Accession Nos. ML17236A034 and ML17236A039), as supplemented by letter dated October 5, 2017, (ADAMS Accession No. ML17297A131) and revised applications dated October 19, 2017, (ADAMS Accession Nos. ML17296A544 and ML17296A693), MPMO requested approval from the U.S. Nuclear Regulatory Commission (NRC) to transfer control of export licenses nos. XSOU8707 and XSOU8827 from Molycorp to MPMO. This request was made pursuant to Section 184 of the Atomic Energy Act of 1954, as amended (AEA) (42 U.S.C. 2234) and Title 10 of the
The revised applications dated October 19, 2017, were made publicly available in ADAMS on October 23, 2017. No requests for hearing or comments were received.
Pursuant to Section 184 of the AEA, no license granted under 10 CFR part 110 shall be transferred, assigned, or in any manner disposed of, directly or indirectly, through transfer of control of any license to any person unless the NRC, after securing full information, finds that the transfer is in accordance with the provisions of the AEA, and gives its consent in writing. Pursuant to 10 CFR 110.50(d), a specific license granted under 10 CFR part 110 may be transferred, disposed of, or assigned to another person only with the approval of the NRC by license amendment.
After review of the information in the revised applications dated October 19, 2017, and relying on statements and representations contained in the supplemental information dated October 5, 2017, the NRC staff has determined that the proposed transferee is qualified to hold the licenses and that the direct transfers of control are consistent with the applicable provisions of the AEA, regulations, and orders issued by the Commission. MPMO stated that (1) there will be no change in personnel, duties, or location; (2) all manufacturing data and information, operating instructions, documentation, operating records, files, and data were included in the asset purchase agreement and have been maintained; and (3) MPMO will abide by all constraints, conditions, and requirements of the licensed program, including the regulations in 10 CFR 110.53. The NRC staff has further determined that the request for the proposed conforming license amendments complies with the standards and requirements of the AEA, and the NRC regulations in 10 CFR part 110. The transfers of control of the licenses and issuance of the conforming license amendments will not be inimical to the common defense and security, or to the health and safety of the public, and all applicable requirements have been satisfied.
Accordingly, pursuant to Section 184 of the AEA and 10 CFR 110.50(d), IT IS HEREBY ORDERED that the direct transfer of the licenses from Molycorp to MPMO, as described herein, is approved.
This Order is effective upon issuance.
For further details with respect to this Order, see the revised applications dated October 19, 2017, and associated supplemental materials dated October 5, 2017. These documents are available for public inspection at the Commission Public Document Room (PDR), located at One White Flint North, Room O1-F21, 1155 Rockville Pike (first floor), Rockville, MD 20852, and available online in the ADAMS Public Documents collection at
For the Nuclear Regulatory Commission.
Overseas Private Investment Corporation (OPIC).
Notice and request for comments.
Under the provisions of the Paperwork Reduction Act, agencies are required to publish a Notice in the
Comments must be received within sixty (60) calendar days of publication of this Notice.
Mail all comments and requests for copies of the subject form to OPIC's Agency Submitting Officer: James Bobbitt, Overseas Private Investment Corporation, 1100 New York Avenue NW, Washington, DC 20527. See
OPIC Agency Submitting Officer: James Bobbitt, (202)336-8558.
All mailed comments and requests for copies of the subject form should include form number OPIC-256 on both the envelope and in the subject line of the letter. Electronic comments and requests for copies of the subject form may be sent to
Overseas Private Investment Corporation (OPIC).
Notice and request for comments.
Under the provisions of the Paperwork Reduction Act, agencies are required to publish a Notice in the
Comments must be received within sixty (60) calendar days of publication of this Notice.
Mail all comments and requests for copies of the subject form to OPIC's Agency Submitting Officer: James Bobbitt, Overseas Private Investment Corporation, 1100 New York Avenue NW, Washington, DC 20527. See
OPIC Agency Submitting Officer: James Bobbitt, (202) 336-8558.
All mailed comments and requests for copies of the subject form should include form number OPIC-115 on both the envelope and in the subject line of the letter. Electronic comments and requests for copies of the subject form may be sent to
Postal Regulatory Commission.
Notice.
The Commission is noticing recent Postal Service filings for the Commission's consideration concerning negotiated service agreements. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the market dominant or the competitive product list, or the modification of an existing product currently appearing on the market dominant or the competitive product list.
Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.
The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern market dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3010, and 39 CFR part 3020, subpart B. For request(s) that the Postal Service states concern competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comment deadline(s) for each request appear in section II.
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2.
3.
4.
This notice will be published in the
Notice is hereby given in accordance with Public Law 92-463 that the Actuarial Advisory Committee will hold a meeting on December 20, 2017 at 10:00 a.m. at the office of the Chief Actuary of the U. S. Railroad Retirement Board, 844 North Rush Street, Chicago, Illinois, on the conduct of the 27th Actuarial Valuation of the Railroad Retirement System. The agenda for this meeting will include a discussion of the assumptions to be used in the 27th Actuarial Valuation. A report containing recommended assumptions and the experience on which the recommendations are based will have been sent by the Chief Actuary to the Committee before the meeting.
The meeting will be open to the public. Persons wishing to submit written statements or make oral presentations should address their communications or notices to the Actuarial Advisory Committee, c/o Chief Actuary, U.S. Railroad Retirement Board, 844 North Rush Street, Chicago, Illinois 60611-1275.
For the Board.
On July 3, 2012, the Securities and Exchange Commission (“Commission”) issued an order pursuant to its authority under Rule 612(c) of Regulation NMS (“Sub-Penny Rule”)
The Exchange now seeks to further extend the exemption until June 30, 2018.
The limited and temporary exemption extended by this Order are subject to modification or revocation if at any time the Commission determines that such action is necessary or appropriate in furtherance of the purposes of the Securities Exchange Act of 1934.
Responsibility for compliance with any applicable provisions of the Federal securities laws must rest with the persons relying on the exemptions that are the subject of this Order.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend the Exchange's Price List to modify the fees related to four bundles of co-location services (“Partial Cabinet Solution bundles”) in connection with the Exchange's co-location services. The Exchange proposes to implement the fee changes effective January 1, 2018. The proposed rule change is available on the Exchange's website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend the Exchange's Price List to modify the fees related to Partial Cabinet Solution bundles in connection with the Exchange's co-location services.
The Exchange offers the four Partial Cabinet Solution bundles in order to attract smaller Users, including those with minimal power or cabinet space demands or those for which the costs attendant with having a dedicated cabinet or greater network connection bandwidth are too burdensome.
Currently, the Exchange offers Users
• Extend the 50% reduction to those Users that purchase a Partial Cabinet Solution bundle on or before December 31, 2018; and
• increase the duration of the reduction from 12 months to 24 months.
The Exchange also proposes that Users that already purchased a Partial Cabinet Solution bundle have the duration of their 50% reduction increased from 12 months to 24 months as well.
The Exchange proposes to implement the fee changes effective January 1, 2018.
Specifically, the Exchange proposes to modify its Price List so that it reads as follows:
The Exchange is not proposing any other changes to the Partial Cabinet Solution bundles.
As is the case with all Exchange co-location arrangements, (i) neither a User nor any of the User's customers would be permitted to submit orders directly to the Exchange unless such User or customer is a member organization, a Sponsored Participant or an agent thereof (
The Exchange believes that the proposed rule changes are consistent with Section 6(b) of the Act,
The Exchange believes that the proposed rule changes provide for the equitable allocation of reasonable dues, fees, and other charges among its members, issuers and other persons using its facilities, and are not designed to permit unfair discrimination between customers, issuers, brokers, or dealers, because the Exchange proposes to offer the 50% reduction in the MRC, and the increase in the duration of the reduction from 12 months to 24 months, to all Users equally. As is currently the case, the purchase of any colocation service (including Partial Cabinet Solution bundles) is completely voluntary. All Users that order a bundle on or before December 31, 2018 would have their MRC reduced by 50% for the first 24 months.
The Exchange believes that extending the 50% reduction in the MRC for Partial Cabinet Solution bundles, and increasing the duration of the reduction, is not designed to permit unfair discrimination between customers, issuers, brokers, or dealers because the Partial Cabinet Solution bundles would continue to offer four different Partial Cabinet Solution bundles with options with respect to cabinet footprint and network connections. Users that require other sizes or combinations of cabinets, network connections and cross connects could still request them.
In addition, the Exchange believes that its proposal would remove impediments to, and perfects the mechanisms of, a free and open market and a national market system and, in general, protects investors and the public interest because the proposed extension of the 50% reduction in MRC and the proposed increase in the duration of the reduction would continue to make it more cost effective for Users to utilize co-location by creating a convenient way to create a colocation environment, through four Partial Cabinet Solution bundles with options with respect to cabinet footprint and network connections. The Exchange expects that such Users would include those with minimal power or cabinet space demands and Users for which the costs attendant with having a dedicated cabinet or greater network connection bandwidth are too burdensome.
The Exchange believes that the proposed change to have Users that already purchased a Partial Cabinet Solution bundle have the duration of their 50% reduction increased from 12 months to 24 months is designed to prevent fraudulent and manipulative
The Exchange also believes that the proposed rule changes are consistent with Section 6(b)(4) of the Act,
The Exchange believes that it is reasonable that Users that order a Partial Cabinet Solution bundle on or before December 31, 2018 would have their MRC reduced by 50% for the first 24 months because it is reasonable to continue to offer such reduction as an incentive to Users to utilize the service, including both new and past Users of bundles. As noted above, the Exchange anticipates that Users of the Partial Cabinet Solution bundles would include those with minimum power or cabinet space demands and Users for which the costs attendant with having a dedicated cabinet or greater network connection bandwidth are too burdensome.
For the reasons above, the proposed changes do not unfairly discriminate between or among market participants that are otherwise capable of satisfying any applicable co-location fees, requirements, terms and conditions established from time to time by the Exchange.
Finally, the Exchange believes that it is subject to significant competitive forces, as described below in the Exchange's statement regarding the burden on competition.
For these reasons, the Exchange believes that the proposal is consistent with the Act.
In accordance with Section 6(b)(8) of the Act,
The Exchange believes that extending the 50% reduction in the MRC and increasing the duration of the reduction will not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act because such access will continue to satisfy User demand for cost effective options for smaller Users that choose to utilize co-location. All Users that order a bundle on or before December 31, 2018 would have their MRC reduced by 50% for the first 24 months. The Exchange believes that the proposed change to have Users that already purchased a Partial Cabinet Solution bundle have the duration of their 50% reduction increased from 12 months to 24 months would ensure that all Users that purchase a Partial Cabinet Solution bundle prior to December 31, 2018 benefit from the 50% reduction for a total of 24 months.
The proposed changes will also enhance competition by making it more cost effective for Users that purchase a Partial Cabinet Solution bundle to utilize co-location by creating a convenient way to create a colocation environment, through Partial Cabinet Solution bundles with options with respect to cabinet footprint and network connections at a reduced MRC for the first 24 months. Such Users may choose to pass on such cost savings to their customers.
The Exchange operates in a highly competitive market in which exchanges offer co-location services as a means to facilitate the trading and other market activities of those market participants who believe that co-location enhances the efficiency of their operations. Accordingly, fees charged for co-location services are constrained by the active competition for the order flow of, and other business from, such market participants. If a particular exchange charges excessive fees for co-location services, affected market participants will opt to terminate their co-location arrangements with that exchange, and adopt a possible range of alternative strategies, including placing their servers in a physically proximate location outside the exchange's data center (which could be a competing exchange), or pursuing strategies less dependent upon the lower exchange-to-participant latency associated with co-location. Accordingly, the exchange charging excessive fees would stand to lose not only co-location revenues but also the liquidity of the formerly co-located trading firms, which could have additional follow-on effects on the market share and revenue of the affected exchange. In such an environment, the Exchange must continually review, and consider adjusting, its services and related fees and credits to remain competitive with other exchanges.
For the reasons described above, the Exchange believes that the proposed rule changes reflect this competitive environment.
No written comments were solicited or received with respect to the proposed rule change.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act.
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend the NYSE Arca Options Fees and Charges (the “Options Fee Schedule”) and the NYSE Arca Equities Fees and Charges (the “Equities Fee Schedule” and, together with the Options Fee Schedule, the “Fee Schedules”) to modify the fees related to four bundles of co-location services (“Partial Cabinet Solution bundles”) in connection with the Exchange's co-location services. The Exchange proposes to implement the fee changes effective January 1, 2018. The proposed rule change is available on the Exchange's website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend the Exchange's Fee Schedules to modify the fees related to Partial Cabinet Solution bundles in connection with the Exchange's co-location services.
The Exchange offers the four Partial Cabinet Solution bundles in order to attract smaller Users, including those with minimal power or cabinet space demands or those for which the costs attendant with having a dedicated cabinet or greater network connection bandwidth are too burdensome.
Currently, the Exchange offers Users
• Extend the 50% reduction to those Users that purchase a Partial Cabinet Solution bundle on or before December 31, 2018; and
• increase the duration of the reduction from 12 months to 24 months.
The Exchange also proposes that Users that already purchased a Partial Cabinet Solution bundle have the
The Exchange proposes to implement the fee changes effective January 1, 2018.
Specifically, the Exchange proposes to modify its Fee Schedules so that they read as follows:
The Exchange is not proposing any other changes to the Partial Cabinet Solution bundles.
As is the case with all Exchange co-location arrangements, (i) neither a User nor any of the User's customers would be permitted to submit orders directly to the Exchange unless such User or customer is a member organization, a Sponsored Participant or an agent thereof (
The Exchange believes that the proposed rule changes are consistent with Section 6(b) of the Act,
The Exchange believes that the proposed rule changes provide for the equitable allocation of reasonable dues, fees, and other charges among its members, issuers and other persons using its facilities, and are not designed to permit unfair discrimination between customers, issuers, brokers, or dealers, because the Exchange proposes to offer the 50% reduction in the MRC, and the increase in the duration of the reduction from 12 months to 24 months, to all Users equally. As is currently the case, the purchase of any co-location service (including Partial Cabinet Solution
The Exchange believes that extending the 50% reduction in the MRC for Partial Cabinet Solution bundles, and increasing the duration of the reduction, is not designed to permit unfair discrimination between customers, issuers, brokers, or dealers because the Partial Cabinet Solution bundles would continue to offer four different Partial Cabinet Solution bundles with options with respect to cabinet footprint and network connections. Users that require other sizes or combinations of cabinets, network connections and cross connects could still request them.
In addition, the Exchange believes that its proposal would remove impediments to, and perfects the mechanisms of, a free and open market and a national market system and, in general, protects investors and the public interest because the proposed extension of the 50% reduction in MRC and the proposed increase in the duration of the reduction would continue to make it more cost effective for Users to utilize co-location by creating a convenient way to create a co-location environment, through four Partial Cabinet Solution bundles with options with respect to cabinet footprint and network connections. The Exchange expects that such Users would include those with minimal power or cabinet space demands and Users for which the costs attendant with having a dedicated cabinet or greater network connection bandwidth are too burdensome.
The Exchange believes that the proposed change to have Users that already purchased a Partial Cabinet Solution bundle have the duration of their 50% reduction increased from 12 months to 24 months is designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in regulating, clearing, settling, processing information with respect to, and facilitating transactions in securities, to remove impediments to, and perfect the mechanisms of, a free and open market and a national market system and, in general, to protect investors and the public interest and because it is not designed to permit unfair discrimination between customers, issuers, brokers, or dealers, because it would ensure that all Users that purchase a Partial Cabinet Solution bundle prior to December 31, 2018 benefit from the 50% reduction for a total of 24 months.
The Exchange also believes that the proposed rule changes are consistent with Section 6(b)(4) of the Act,
The Exchange believes that it is reasonable that Users that order a Partial Cabinet Solution bundle on or before December 31, 2018 would have their MRC reduced by 50% for the first 24 months because it is reasonable to continue to offer such reduction as an incentive to Users to utilize the service, including both new and past Users of bundles. As noted above, the Exchange anticipates that Users of the Partial Cabinet Solution bundles would include those with minimum power or cabinet space demands and Users for which the costs attendant with having a dedicated cabinet or greater network connection bandwidth are too burdensome.
For the reasons above, the proposed changes do not unfairly discriminate between or among market participants that are otherwise capable of satisfying any applicable co-location fees, requirements, terms and conditions established from time to time by the Exchange.
Finally, the Exchange believes that it is subject to significant competitive forces, as described below in the Exchange's statement regarding the burden on competition.
For these reasons, the Exchange believes that the proposal is consistent with the Act.
In accordance with Section 6(b)(8) of the Act,
The Exchange believes that extending the 50% reduction in the MRC and increasing the duration of the reduction will not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act because such access will continue to satisfy User demand for cost effective options for smaller Users that choose to utilize co-location. All Users that order a bundle on or before December 31, 2018 would have their MRC reduced by 50% for the first 24 months. The Exchange believes that the proposed change to have Users that already purchased a Partial Cabinet Solution bundle have the duration of their 50% reduction increased from 12 months to 24 months would ensure that all Users that purchase a Partial Cabinet Solution bundle prior to December 31, 2018 benefit from the 50% reduction for a total of 24 months.
The proposed changes will also enhance competition by making it more cost effective for Users that purchase a Partial Cabinet Solution bundle to utilize co-location by creating a convenient way to create a co-location environment, through Partial Cabinet Solution bundles with options with respect to cabinet footprint and network connections at a reduced MRC for the first 24 months. Such Users may choose to pass on such cost savings to their customers.
The Exchange operates in a highly competitive market in which exchanges offer co-location services as a means to facilitate the trading and other market activities of those market participants who believe that co-location enhances the efficiency of their operations. Accordingly, fees charged for co-location services are constrained by the active competition for the order flow of, and other business from, such market participants. If a particular exchange charges excessive fees for co-location services, affected market participants will opt to terminate their co-location arrangements with that exchange, and adopt a possible range of alternative strategies, including placing their servers in a physically proximate location outside the exchange's data center (which could be a competing exchange), or pursuing strategies less dependent upon the lower exchange-to-participant latency associated with co-location. Accordingly, the exchange charging excessive fees would stand to lose not only co-location revenues but also the liquidity of the formerly co-located trading firms, which could have additional follow-on effects on the market share and revenue of the affected exchange. In such an environment, the Exchange must continually review, and consider adjusting, its services and related fees and credits to remain competitive with other exchanges.
For the reasons described above, the Exchange believes that the proposed
No written comments were solicited or received with respect to the proposed rule change.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend the NYSE American Equities Price List (“Price List”) and the NYSE American Options Fee Schedule (“Fee Schedule”) to modify the fees related to four bundles of co-location services (“Partial Cabinet Solution bundles”) in connection with the Exchange's co-location services. The Exchange proposes to implement the fee changes effective January 1, 2018. The proposed change is available on the Exchange's website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend the Exchange's Price List and Fee Schedule to modify the fees related to Partial Cabinet Solution bundles in connection with the Exchange's co-location services.
The Exchange offers the four Partial Cabinet Solution bundles in order to attract smaller Users, including those with minimal power or cabinet space demands or those for which the costs attendant with having a dedicated cabinet or greater network connection bandwidth are too burdensome.
Currently, the Exchange offers Users
• extend the 50% reduction to those Users that purchase a Partial Cabinet Solution bundle on or before December 31, 2018; and
• increase the duration of the reduction from 12 months to 24 months.
The Exchange also proposes that Users that already purchased a Partial Cabinet Solution bundle have the duration of their 50% reduction increased from 12 months to 24 months as well.
The Exchange proposes to implement the fee changes effective January 1, 2018.
Specifically, the Exchange proposes to modify its Price List and Fee Schedule so that they read as follows:
The Exchange is not proposing any other changes to the Partial Cabinet Solution bundles.
As is the case with all Exchange co-location arrangements, (i) neither a User nor any of the User's customers would be permitted to submit orders directly to the Exchange unless such User or customer is a member organization, a Sponsored Participant or an agent thereof (
The Exchange believes that the proposed rule changes are consistent with Section 6(b) of the Act,
The Exchange believes that the proposed rule changes provide for the equitable allocation of reasonable dues, fees, and other charges among its members, issuers and other persons using its facilities, and are not designed to permit unfair discrimination between customers, issuers, brokers, or dealers, because the Exchange proposes to offer the 50% reduction in the MRC, and the increase in the duration of the reduction from 12 months to 24 months, to all Users equally. As is currently the case, the purchase of any colocation service (including Partial Cabinet Solution bundles) is completely voluntary. All Users that order a bundle on or before December 31, 2018 would have their MRC reduced by 50% for the first 24 months.
The Exchange believes that extending the 50% reduction in the MRC for Partial Cabinet Solution bundles, and increasing the duration of the reduction, is not designed to permit unfair discrimination between customers, issuers, brokers, or dealers because the Partial Cabinet Solution bundles would continue to offer four different Partial Cabinet Solution bundles with options with respect to cabinet footprint and network connections. Users that require other sizes or combinations of cabinets, network connections and cross connects could still request them.
In addition, the Exchange believes that its proposal would remove impediments to, and perfects the mechanisms of, a free and open market and a national market system and, in general, protects investors and the public interest because the proposed extension of the 50% reduction in MRC and the proposed increase in the duration of the reduction would continue to make it more cost effective for Users to utilize co-location by creating a convenient way to create a colocation environment, through four Partial Cabinet Solution bundles with options with respect to cabinet footprint and network connections. The Exchange expects that such Users would include those with minimal power or cabinet space demands and Users for which the costs attendant with having a dedicated cabinet or greater network connection bandwidth are too burdensome.
The Exchange believes that the proposed change to have Users that already purchased a Partial Cabinet Solution bundle have the duration of their 50% reduction increased from 12 months to 24 months is designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in regulating, clearing, settling, processing information with respect to, and facilitating transactions in securities, to remove impediments to, and perfect the mechanisms of, a free and open market and a national market system and, in general, to protect investors and the public interest and because it is not designed to permit unfair discrimination between customers, issuers, brokers, or dealers, because it would ensure that all Users that purchase a Partial Cabinet Solution bundle prior to December 31, 2018 benefit from the 50% reduction for a total of 24 months.
The Exchange also believes that the proposed rule changes are consistent with Section 6(b)(4) of the Act,
The Exchange believes that it is reasonable that Users that order a Partial Cabinet Solution bundle on or before December 31, 2018 would have their MRC reduced by 50% for the first 24 months because it is reasonable to continue to offer such reduction as an incentive to Users to utilize the service, including both new and past Users of bundles. As noted above, the Exchange anticipates that Users of the Partial Cabinet Solution bundles would include those with minimum power or cabinet space demands and Users for which the costs attendant with having a dedicated cabinet or greater network connection bandwidth are too burdensome.
For the reasons above, the proposed changes do not unfairly discriminate between or among market participants that are otherwise capable of satisfying any applicable co-location fees, requirements, terms and conditions established from time to time by the Exchange.
Finally, the Exchange believes that it is subject to significant competitive forces, as described below in the Exchange's statement regarding the burden on competition.
For these reasons, the Exchange believes that the proposal is consistent with the Act.
In accordance with Section 6(b)(8) of the Act,
The Exchange believes that extending the 50% reduction in the MRC and increasing the duration of the reduction will not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act because such access will continue to satisfy User demand for cost effective options for smaller Users that choose to utilize co-location. All Users that order a bundle on or before December 31, 2018 would have their MRC reduced by 50% for the first 24 months. The Exchange believes that the proposed change to have Users that already purchased a Partial Cabinet Solution bundle have the duration of their 50% reduction increased from 12 months to 24 months would ensure that all Users that purchase a Partial Cabinet Solution bundle prior to December 31, 2018 benefit from the 50% reduction for a total of 24 months.
The proposed changes will also enhance competition by making it more cost effective for Users that purchase a Partial Cabinet Solution bundle to utilize co-location by creating a convenient way to create a colocation environment, through Partial Cabinet Solution bundles with options with respect to cabinet footprint and network connections at a reduced MRC for the first 24 months. Such Users may choose to pass on such cost savings to their customers.
The Exchange operates in a highly competitive market in which exchanges offer co-location services as a means to facilitate the trading and other market activities of those market participants who believe that co-location enhances the efficiency of their operations. Accordingly, fees charged for co-location services are constrained by the active competition for the order flow of, and other business from, such market participants. If a particular exchange charges excessive fees for co-location services, affected market participants will opt to terminate their co-location arrangements with that exchange, and adopt a possible range of alternative strategies, including placing their servers in a physically proximate location outside the exchange's data center (which could be a competing exchange), or pursuing strategies less dependent upon the lower exchange-to-participant latency associated with co-location. Accordingly, the exchange charging excessive fees would stand to lose not only co-location revenues but also the liquidity of the formerly co-located trading firms, which could have additional follow-on effects on the market share and revenue of the affected exchange. In such an environment, the Exchange must continually review, and consider adjusting, its services and related fees and credits to remain competitive with other exchanges.
For the reasons described above, the Exchange believes that the proposed rule changes reflect this competitive environment.
No written comments were solicited or received with respect to the proposed rule change.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 609 (17 CFR 230.609) under the Securities Act of 1933 (15 U.S.C. 77a
There has not been a Form 2-E filing since calendar year 2010, when there was one filing of Form 2-E by one respondent. The Commission has previously estimated that the total annual burden associated with information collection and Form 2-E preparation and submission is four hours per filing. Although there have been no filings made under this rule since 2010, we are requesting one annual response and an annual burden of one hour for administrative purposes.
Estimates of average burden hours are made solely for the purposes of the Paperwork Reduction Act and are not derived from a comprehensive or even representative survey or study of the costs of Commission rules and forms. The collection of information under rule 609 and Form 2-E is mandatory. The information provided under rule 609 and Form 2-E will not be kept confidential. 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.
Written comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
Please direct your written comments to Pamela Dyson, Director/Chief Information Officer, Securities and Exchange Commission, C/O Remi Pavlik-Simon, 100 F Street NE, Washington, DC 20549; or send an email to:
Securities and Exchange Commission (“Commission”).
Notice.
Notice of an application for an order under section 6(c) of the Investment Company Act of 1940 (the “Act”) for an exemption from sections 2(a)(32), 5(a)(1), 22(d), and 22(e) of the Act and rule 22c-1 under the Act, under sections 6(c) and 17(b) of the Act for an exemption from sections 17(a)(1) and 17(a)(2) of the Act, and under section 12(d)(1)(J) for an exemption from sections 12(d)(1)(A) and 12(d)(1)(B) of the Act. The requested order would permit (a) index-based series of certain open-end management investment companies (“Funds”) to issue shares redeemable in large aggregations only (“Creation Units”); (b) secondary market transactions in Fund shares to occur at negotiated market prices rather than at net asset value (“NAV”); (c) certain Funds to pay redemption proceeds, under certain circumstances, more than seven days after the tender of shares for redemption; (d) certain affiliated persons of a Fund to deposit securities into, and receive securities from, the Fund in connection with the purchase and redemption of Creation Units; and (e) certain registered management investment companies and unit investment trusts outside of the same group of investment companies as the Funds (“Funds of Funds”) to acquire shares of the Funds.
Calvert Research and Management (the “Initial Adviser”), a Massachusetts business trust, that is registered as an investment adviser under the Investment Advisers Act of 1940 and Calvert ETF Trust (the “Trust”), a Massachusetts business trust that intends to register under the Act as an open-end management investment company with multiple series.
The application was filed on September 20, 2017 and amended on November 14, 2017.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicants with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on January 2, 2018, and should be accompanied by proof of service on applicants, in the form of an affidavit, or for lawyers, a certificate of service. Pursuant to rule 0-5 under the Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.
Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090; Applicants: 1825 Connecticut Avenue NW, Suite 400, Washington, DC 20009.
Courtney S. Thornton, Senior Counsel, at (202) 551-6821, or Robert H. Shapiro, Branch Chief, at (202) 551-6821 (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete application may be obtained via the Commission's website by searching for the file number, or for an applicant using the Company name box, at
1. Applicants request an order that would allow Funds to operate as index exchange traded funds (“ETFs”).
2. Each Fund will hold investment positions selected to correspond generally to the performance of an Underlying Index. Certain of the Funds will track an Underlying Index that is compiled, created, sponsored, or maintained by an affiliated person, as defined in section 2(a)(3) of the Act (“Affiliated Person”), or an affiliated person of an Affiliated Person (“Second-Tier Affiliate”), of the Trust or a Fund, of the Adviser, of any sub-adviser to or promoter of a Fund, or of the Distributor (each a “Self-Indexing Fund”).
3. Shares will be purchased and redeemed in Creation Units and generally on an in-kind basis. Except where the purchase or redemption will include cash under the limited circumstances specified in the application, purchasers will be required to purchase Creation Units by depositing specified instruments (“Deposit Instruments”), and shareholders redeeming their shares will receive specified instruments (“Redemption Instruments”). The Deposit Instruments and the Redemption Instruments will each correspond pro rata to the positions in the Fund's portfolio (including cash positions) except as specified in the application.
4. Because shares will not be individually redeemable, applicants request an exemption from section 5(a)(1) and section 2(a)(32) of the Act that would permit the Funds to register as open-end management investment companies and issue shares that are redeemable in Creation Units only.
5. Applicants also request an exemption from section 22(d) of the Act and rule 22c-1 under the Act as secondary market trading in shares will take place at negotiated prices, not at a current offering price described in a Fund's prospectus, and not at a price based on NAV. Applicants state that (a) secondary market trading in shares does not involve a Fund as a party and will not result in dilution of an investment in shares, and (b) to the extent different prices exist during a given trading day, or from day to day, such variances occur as a result of third-party market forces, such as supply and demand. Therefore, applicants assert that secondary market transactions in shares will not lead to discrimination or preferential treatment among purchasers. Finally, applicants represent that share market prices will be disciplined by arbitrage opportunities, which should prevent shares from trading at a material discount or premium from NAV.
6. With respect to Funds that effect creations and redemptions of Creation Units in kind and that are based on certain Underlying Indexes that include foreign securities, applicants request relief from the requirement imposed by section 22(e) in order to allow such Funds to pay redemption proceeds within fifteen calendar days following the tender of Creation Units for redemption. Applicants assert that the requested relief would not be inconsistent with the spirit and intent of section 22(e) to prevent unreasonable, undisclosed or unforeseen delays in the actual payment of redemption proceeds.
7. Applicants request an exemption to permit Funds of Funds to acquire Fund shares beyond the limits of section 12(d)(1)(A) of the Act; and the Funds, and any principal underwriter for the Funds, and/or any broker or dealer registered under the Exchange Act, to sell shares to Funds of Funds beyond the limits of section 12(d)(1)(B) of the Act. The application's terms and conditions are designed to, among other things, help prevent any potential (i) undue influence over a Fund through control or voting power, or in connection with certain services, transactions, and underwritings, (ii) excessive layering of fees, and (iii) overly complex fund structures, which are the concerns underlying the limits in sections 12(d)(1)(A) and (B) of the Act.
8. Applicants request an exemption from sections 17(a)(1) and 17(a)(2) of the Act to permit persons that are Affiliated Persons, or Second Tier Affiliates, of the Funds, solely by virtue of certain ownership interests, to effectuate purchases and redemptions in-kind. The deposit procedures for in-kind purchases of Creation Units and the redemption procedures for in-kind redemptions of Creation Units will be the same for all purchases and redemptions and Deposit Instruments and Redemption Instruments will be valued in the same manner as those investment positions currently held by the Funds. Applicants also seek relief from the prohibitions on affiliated transactions in section 17(a) to permit a Fund to sell its shares to and redeem its shares from a Fund of Funds, and to engage in the accompanying in-kind transactions with the Fund of Funds.
9. Section 6(c) of the Act permits the Commission to exempt any persons or transactions from any provision of the Act if such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act. Section 12(d)(1)(J) of the Act provides that the Commission may exempt any person, security, or transaction, or any class or classes of persons, securities, or transactions, from any provision of section 12(d)(1) if the exemption is consistent with the public interest and the protection of investors. Section 17(b) of the Act authorizes the Commission to grant an order permitting a transaction otherwise prohibited by section 17(a) if it finds that (a) the terms of the proposed transaction are fair and reasonable and do not involve overreaching on the part of any person concerned; (b) the proposed transaction is consistent with the policies of each registered investment company involved; and (c) the proposed transaction is consistent with the general purposes of the Act.
For the Commission, by the Division of Investment Management, under delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
The Exchange filed a proposal to amend the Market Data section of its fee schedule applicable to its equity options platform (“BZX Options”) to adopt fees for receipt of historical market data.
The text of the proposed rule change is available at the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend the Market Data section of its BZX Options fee schedule to adopt fees for historical market data. The Exchange proposes to begin providing historical data to data recipients upon request for a fee. The Exchange currently provides historical data upon request on an ad hoc basis, but proposes to begin charging a fee due to the infrastructure costs of storing and providing such data. Similar to what it does today, the Exchange proposes to provide a data recipient with the requested historical data on an external hard drive provided by the Exchange. As an alternative means to obtain historical data, the Exchange provides market participants with access to a database from which they can download data that is up to 3 months old. As proposed, the Exchange will offer historical data from the Exchange's PITCH data feed for a fee of $500 per month of data accessed by any individual user. The Exchange's databases will contain up to 90 days of data at any point in time. For data that the Exchange provides on an external hard drive to a market participant the proposed cost is $2,500 per 1 terabyte (TB) drive generated by the Exchange. Historical data would be provided to data recipients for internal use only, and thus, no redistribution will be permitted. The proposed rates are identical to the rates it charges for historical data on its equity trading platform (“BZX Equities”).
Historical data provided by the Exchange can be used for a variety of purposes. For instance, data recipients may use historical data to back-test certain trading strategies. As another example, data recipients that provide market information through public websites or develop dynamic stock tickers, portfolio trackers, price/time graphs and other visual systems can use historical data for such purposes.
The Exchange proposes to implement the proposed change to its fee schedule on January 2, 2018.
The Exchange believes that the proposed rule change is consistent with the objectives of Section 6 of the Act,
The Exchange also believes that the proposed rule change is consistent with Section 11(A) of the Act
In addition, the proposed fees would not permit unfair discrimination because all of the Exchange's customers and market data vendors will be subject to the proposed fees on an equivalent basis. Historical data is distributed and purchased on a voluntary basis, in that neither the Exchange nor market data distributors are required by any rule or regulation to make this data available. Accordingly, Distributors and Users can discontinue use at any time and for any reason, including due to an assessment of the reasonableness of fees charged. Firms have a wide variety of alternative market data products from which to choose, such as similar proprietary data products offered by other exchanges and consolidated data. Moreover, the Exchange is not required to make any
In addition, the fees that are the subject of this rule filing are constrained by competition. As explained below in the Exchange's Statement on Burden on Competition, the existence of alternatives to historical data further ensures that the Exchange cannot set unreasonable fees, or fees that are unreasonably discriminatory, when vendors and subscribers can elect such alternatives. That is, the Exchange competes with other exchanges (and their affiliates) that provide similar market data products. If another exchange (or its affiliate) were to charge less to distribute its similar product than the Exchange charges to distribute historical data, prospective Users likely would not subscribe to, or would cease subscribing to, the Exchange's historical data.
The Exchange notes that the Commission is not required to undertake a cost-of-service or rate-making approach. The Exchange believes that, even if it were possible as a matter of economic theory, cost-based pricing for non-core market data would be so complicated that it could not be done practically.
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended. The Exchange's ability to price historical data is constrained by: (i) Competition among exchanges, other trading platforms, and Trade Reporting Facilities (“TRF”) that compete with each other in a variety of dimensions; (ii) the existence of inexpensive real-time consolidated data and market-specific data and free delayed data; and (iii) the inherent contestability of the market for proprietary data.
The Exchange and its market data products are subject to significant competitive forces and the proposed fees represent responses to that competition. To start, the Exchange competes intensely for order flow. It competes with the other national securities exchanges that currently trade equities, with electronic communication networks, with quotes posted in FINRA's Alternative Display Facility, with alternative trading systems, and with securities firms that primarily trade as principal with their customer order flow.
The availability of a variety of alternative sources of information imposes significant competitive pressures on Exchange data products and the Exchange's compelling need to attract order flow imposes significant competitive pressure on the Exchange to act equitably, fairly, and reasonably in setting the proposed data product fees. The proposed data product fees are, in part, responses to that pressure. The Exchange believes that the proposed fees would reflect an equitable allocation of its overall costs to users of its facilities.
In addition, when establishing the proposed fees, the Exchange considered the competitiveness of the market for proprietary data and all of the implications of that competition. The Exchange believes that it has considered all relevant factors and has not considered irrelevant factors in order to establish fair, reasonable, and not unreasonably discriminatory fees and an equitable allocation of fees among all Users. The existence of alternatives to historical data, including existing similar feeds by other exchanges, consolidated data, and proprietary data from other sources, ensures that the Exchange cannot set unreasonable fees, or fees that are unreasonably discriminatory, when vendors and subscribers can elect these alternatives or choose not to purchase a specific proprietary data product if its cost to purchase is not justified by the returns any particular vendor or subscriber would achieve through the purchase.
The Exchange has neither solicited nor received written comments on the proposed rule change.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend the NYSE Listed Company Manual (the “Manual”) to modify its requirements with respect to delivery of proxy materials to the Exchange. The proposed rule change is available on the Exchange's website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend the Manual to modify its requirements with respect to delivery of proxy materials to the Exchange.
The Manual currently includes two provisions requiring listed companies to provide physical copies of proxy materials to the Exchange. Section 204.00(B) requires listed companies to provide six hard copies of proxy materials not later than the date on which the material is physically or electronically delivered to shareholders. Section 402.01 requires listed companies to provide three definitive copies of the proxy material (together with proxy card) not later than the date on which such material is sent, or given, to any security holders.
The Exchange proposes to delete from Section 204.00(B) a provision stating that listed companies are required to file hard copies of certain SEC reports and other material (such as proxies) with the Exchange, as this provision is inconsistent with the Exchange's proposed revised approach to the review of SEC filings. To that end, the Exchange proposes to modify Section 204.00(B) so as to require companies to send hard copy proxy materials to the Exchange only (i) in the circumstances specified by Section 402.01 in its proposed amended form and (ii) one hard copy of any filing that is not required to be filed through EDGAR, including pursuant to a hardship exemption granted by the SEC.
In addition, the Exchange proposes to amend Section 402.01 to provide that listed companies will not be required to provide proxy materials to the Exchange in physical form, provided such proxy materials are included in an SEC filing available on the SEC's EDGAR filing system. Any listed company whose proxy materials are available on EDGAR but not filed pursuant to Schedule 14A under the Act will be required to provide to the Exchange information sufficient to identify such filing (by one of the means specified in Section 204.00(A)) not later than the date on which such material is sent, or given, to any security holders. Notwithstanding the foregoing, any listed company whose proxy materials are not included in their entirety (together with proxy card) in an SEC filing available on EDGAR will continue to be required to provide three physical copies of any proxy material not available on EDGAR to the Exchange not later than the date on which such material is sent, or given, to any security holders, consistent with the requirements of Rule 14a-6(b) under the Act.
The Exchange notes that almost all U.S. domestic listed companies are subject to the SEC's proxy rules. Those companies are required to file their proxy materials on the SEC's EDGAR system and the relevant filings are readily identifiable as being filed under Schedule 14A under the U.S. proxy rules. Exchange staff receives alerts when filings are submitted to the SEC and generally reviews proxy materials on EDGAR shortly after filing. This review has generally been completed long before the Exchange receives hard copies of proxy materials and the Exchange therefore has no real need to receive hard copies.
Listed foreign private issuers are not required to comply with the U.S. proxy rules, although the NYSE does require these companies to solicit proxies. However, many foreign private issuers furnish and submit their proxy materials to the SEC as part of a Form 6-K (or, in the case of foreign private issuers that voluntarily submit periodic reports applicable to domestic companies, proxy materials may instead be included in a Form 8-K). As foreign
The Exchange's proposed approach would ensure that the Exchange staff will continue to be able to review all listed company proxy material in a timely manner and without disruption of existing review procedures. The proposal also has the benefit of eliminating a significant amount of unnecessary use of paper and of resources devoted to processing unneeded materials received through the mail.
The Exchange recognizes that Rule 14a-6(b) under the Act requires listed companies that are subject to the U.S. proxy rules to deliver hard copies of proxy materials to their listing exchange. In this regard, the Exchange notes that it has previously been granted no action relief by the SEC staff in relation to the obligation of listed companies to provide hard copy material to the Exchange of materials filed with the SEC via EDGAR, including proxy materials.
The Exchange believes that the proposed rule change is consistent with Section 6(b)
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Act. The Exchange does not believe that the proposed amendments will impose any burden on competition, as their purpose is to eliminate unnecessary deliveries of physical proxy materials to the Exchange.
No written comments were solicited or received with respect to the proposed rule change.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove the proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Department of State.
Notice of a Modified System of Records.
This System of Records compiles information about Department of State user accounts to monitor and control access to Department of State networks and computer systems.
In accordance with 5 U.S.C. 552a(e)(4) and (11), this system of records takes effect upon publication, with the exception of the routine uses (a) and (b) that are subject to a 30-day period during which interested persons may submit comments to the Department. Please submit any comments by January 11, 2018.
Questions can be submitted by mail or email. If mail, please write to: U.S. Department of State; Office of Global Information Systems, Privacy Staff; A/GIS/PRV; SA-2, Suite 8100; Washington, DC 20522-0208. If email, please address the email to the Chief Privacy Officer, Margaret P. Grafeld, at
Margaret P. Grafeld, Chief Privacy Officer; U.S. Department of State; Office of Global Information Services, A/GIS/PRV; SA-2, Suite 8100; Washington, DC 20522-0208 or 202-261-8300.
The purpose of this modification is to make substantive and administrative changes to the previously published notice. This notice modifies the following sections of State-56, Network User Account Records: System Location, Categories of Individuals, Routine Uses, Storage, Safeguards. In addition, this notice makes administrative updates to the following sections: Policies and Procedures for Retrieval of Records, Record Access Procedures, Notification Procedures, and History. These changes reflect the Department's move to cloud storage, new OMB guidance, access by contractors, updated contact information, and a notice publication history.
Network User Account Records, State-56.
Unclassified.
Department of State (“Department”), located at 2201 C Street NW, Washington, DC 20520, and within a government cloud provided, implemented, and overseen by the Department's Enterprise Server Operations Center (ESOC), 2201 C Street NW, Washington, DC 20520.
Chief Information Officer, Bureau of Information Resource Management, Department of State, 2201 C Street, NW, Washington, DC 20520 and can be reached at either
5 U.S.C. 301; 44 U.S.C. 3544.
To administer Department network user accounts; to help document and/or control access to computer systems, platforms, services, applications, and databases within a Department network and Department-authorized cloud services and applications; to monitor security of computer systems; to investigate and make referrals for disciplinary or other actions if unauthorized access or inappropriate usage is suspected or detected; and to identify the need for training programs.
Department of State employees and other organizational users (examples include eligible family members, locally employed staff, contractors, and personal services contractors) who have access to Department of State computer networks and access to cloud computing applications that are authorized for processing Department information. The Privacy Act defines an individual at 5 U.S.C.552a(a)(2) as a United States citizen or lawful permanent resident.
This system of records consists of the network and application user account records that Department information technology systems, applications, and services compile and maintain about users of a network and application. These records include user data such as the user's name, system-assigned username; email address; employee or other user identification number; organization code; job title; business affiliation; work contact information; systems, applications, or services to which the individual has access; systems, applications, or services used; dates, times, and durations of use; profile photo; user profile; and IP address of access. The records also include system usage files and directories when they contain information about specific users.
Individuals about whom the network user account record is maintained; information technology systems, applications, and services within a Department network that record usage by individuals assigned a user account on that network.
Records may be disclosed:
(a) To appropriate agencies, entities, and persons when (1) the Department of State suspects or has confirmed that there has been a breach of the system of records; (2) the Department of State has determined that as a result of the suspected or confirmed breach there is a risk of harm to individuals, the Department of State (including its information systems, programs, and operations), the Federal Government, or national security; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Department of State efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.
(b) To another Federal agency or Federal entity, when the Department of State determines that information from this system of records is reasonably necessary to assist the recipient agency or entity in (1) responding to a suspected or confirmed breach or (2) preventing, minimizing, or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, programs, and operations), the Federal Government, or national security, resulting from a suspected or confirmed breach.
The Department of State periodically publishes in the
Records are stored both in hard copy and on electronic media. A description of standard Department of State policies concerning storage of electronic records is found in the Department's Foreign Affairs Manual (
Records are indexed by the name; system-assigned username; email address; or other searchable data fields or codes.
Records maintained in this system of records are generally destroyed three to six years after the user account is terminated. These records are retired and destroyed in accordance with published Department of State Records Disposition Schedules as approved by the National Archives and Records Administration (NARA), and a complete list of the Department's schedules can be found on our Freedom of Information Act (FOIA) program's website (
All users are given cyber security awareness training that covers the procedures for handling Sensitive but Unclassified information, including personally identifiable information (PII). Annual refresher training is mandatory. In addition, all Foreign Service and Civil Service employees and those Locally Engaged Staff who handle PII are required to take the Foreign Service Institute distance learning course instructing employees on privacy and security requirements, including the rules of behavior for handling PII and the potential consequences if it is handled improperly.
Access to the Department of State, its annexes and posts abroad is controlled by security guards and admission is limited to those individuals possessing a valid identification card or individuals under proper escort. While the majority of records covered in the Network User Account Records are electronic, all paper records containing personal information are maintained in secured file cabinets in restricted areas, access to which is limited to authorized personnel. Access to computerized files is password-protected and under the direct supervision of the system manager. The system manager has the capability of printing audit trails of access from the computer media, thereby permitting regular and ad hoc monitoring of computer usage. When it is determined that a user no longer needs access, the user account is disabled.
Before being granted access to Network User Account Records, a user must first be granted access to the Department of State computer system. Remote access to the Department of State network from non-Department owned systems is authorized only through a Department approved access program. Remote access to the network is configured with the authentication requirements contained in the Office of Management and Budget Circular Memorandum A-130. All Department of State employees and contractors with authorized access have undergone a background security investigation.
The Department of State will store records maintained in this system of records in cloud systems. All cloud systems that provide IT services and process Department of State information must be authorized to operate by the Department of State Authorizing Official and Senior Agency Official for Privacy. Only information that conforms with Department-specific definitions for FISMA low or moderate categorization are permissible for cloud usage unless specifically authorized by the Department's Cloud Computing Governance Board. Prior to operation, all Cloud systems must comply with applicable security measures that are outlined in FISMA, FedRAMP, OMB guidance, NIST Federal Information Processing Standards (FIPS) and Special Publications, and Department of State policy and standards.
Individuals who wish to gain access to or to amend records pertaining to themselves should write to U.S. Department of State; Director, Office of Information Programs and Services; A/GIS/IPS; SA-2, Suite 8100; Washington, DC 20522-0208. The individual must specify that he or she wishes the Network User Account Records to be checked. At a minimum, the individual must include: Full name (including maiden name, if appropriate) and any other names used; current mailing address and zip code; date and place of birth; notarized signature or statement under penalty of perjury; a brief description of the circumstances that caused the creation of the record (including the city and/or country and the approximate dates) which gives the individual cause to believe that the Network User Account Records include records pertaining to him or her. Detailed instructions on Department of State procedures for accessing and amending records can be found at the Department's FOIA website (
Individuals who wish to contest record procedures should write to U.S. Department of State; Director, Office of Information Programs and Services; A/
Individuals who have reason to believe that this system of records may contain information pertaining to them may write to U.S. Department of State; Director, Office of Information Programs and Services; A/GIS/IPS; SA-2, Suite 8100; Washington, DC 20522-0208. The individual must specify that he or she wishes the Network User Account Records to be checked. At a minimum, the individual must include: Full name (including maiden name, if appropriate) and any other names used; current mailing address and zip code; date and place of birth; notarized signature or statement under penalty of perjury; a brief description of the circumstances that caused the creation of the record (including the city and/or country and the approximate dates) which gives the individual cause to believe that the Network User Account Records include records pertaining to him or her.
None.
This SORN was previously published at 75 FR 7210.
Department of State.
Notice of a New System of Records.
The purpose of the Email Archive Management Records system is to capture all emails and attachments that interact with a Department of State email account and to store them in a secure repository that allows for search, retrieval, and view when necessary.
In accordance with 5 U.S.C. 552a(e)(4) and (11), this system of records takes effect upon publication, with the exception of the routine uses that are subject to a 30-day period during which interested persons may submit comments to the Department. Please submit any comments by January 11, 2018.
Comments can be submitted by mail or email. If mail, please write to: U.S. Department of State; Office of Global Information Systems, Privacy Staff; A/GIS/PRV; SA-2, Suite 8100; Washington, DC 20522-0208. If email, please address the email to the Chief Privacy Officer, Margaret P. Grafeld, at
Margaret P. Grafeld, Chief Privacy Officer; U.S. Department of State; Office of Global Information Services, A/GIS/PRV; SA-2, Suite 8100; Washington, DC 20522-0208 or 202-261-8300.
None.
Email Archive Management Records, State-01.
Unclassified and Classified.
Department of State (“Department'), located at 2201 C Street NW, Washington, DC 20520; Department of State annexes, U.S. Embassies, U.S. Consulates General, and U.S. Consulates. Information may also be stored within a government-certified cloud, implemented, and overseen by the Department's Messaging Systems Office (MSO), 2025 E. St. NW, Washington, DC 20006.
Division Chief, Office of Information Resource Management, Messaging Systems Office, Messaging Design Division; U.S. Department of State, 7049 Newington Rd; Lorton, VA 22079. The System Manager can be reached at (703) 746-2113.
(a) 5 U.S.C. 301
(b) Federal Records Act, 44 U.S.C. Ch. 31;
(c) Freedom of Information Act, 5 U.S.C. 552.
(d) Privacy Act of 1974, 5 U.S.C.552a(d).
(e) 22 CFR part 171.
The purpose of the system is to capture all emails and attachments that interact with a Department of State email account and to store them in a secure repository that allows for search, retrieval, and view when necessary.
Individuals who maintain a Department of State email account that is archived in the system. The system may also include information about individuals who interact with a Department of State email account, as well as individuals who are mentioned in a Department of State email message or attachment. The Privacy Act defines an individual at 5 U.S.C.552a(a)(2) as a United States citizen or lawful permanent resident.
The records in this system include email messages and attachments associated with a Department of State email account, including any information that may be included in such messages or attachments. The system may also include biographic and contact information of individuals who maintain a Department of State email account, including name, address, email address, and phone number.
These records contain information obtained from individuals who maintain a Department of State email account, as well as those who interact with such individuals.
The information in the system may be shared with:
(a) Other federal agencies, foreign governments, and private entities where relevant and necessary for them to review or consult on documents that implicate their equities;
(b) a contractor of the Department having need for the information in the performance of the contract, but not operating a system of records within the meaning of 5 U.S.C. 552a(m).
(c) appropriate agencies, entities, and persons when (1) the Department of State suspects or has confirmed that there has been a breach of the system of records; (2) the Department of State has determined that as a result of the suspected or confirmed breach there is a risk of harm to individuals, the Department of State (including its information systems, programs, and operations), the Federal Government, or national security; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Department of State efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.
(d) another Federal agency or Federal entity, when the Department of State determines that information from this system of records is reasonably necessary to assist the recipient agency
(e) an agency, whether federal, state, local or foreign, where a record indicates a violation or potential violation of law, whether civil, criminal or regulatory in nature, and whether arising by general statute or particular program statute, or by regulation, rule or order issued pursuant thereto, so that the recipient agency can fulfill its responsibility to investigate or prosecute such violation or enforce or implement the statute, rule, regulation, or order.
(f) the Federal Bureau of Investigation, the Department of Homeland Security, the National Counter-Terrorism Center (NCTC), the Terrorist Screening Center (TSC), or other appropriate federal agencies, for the integration and use of such information to protect against terrorism, if that record is about one or more individuals known, or suspected, to be or to have been involved in activities constituting, in preparation for, in aid of, or related to terrorism. Such information may be further disseminated by recipient agencies to Federal, State, local, territorial, tribal, and foreign government authorities, and to support private sector processes as contemplated in Homeland Security Presidential Directive/HSPD-6 and other relevant laws and directives, for terrorist screening, threat-protection and other homeland security purposes.
(g) a congressional office from the record of an individual in response to an inquiry from the Congressional office made at the request of that individual.
(h) a court, adjudicative body, or administrative body before which the Department is authorized to appear when (a) the Department; (b) any employee of the Department in his or her official capacity; (c) any employee of the Department in his or her individual capacity where the U.S. Department of Justice (“DOJ”) or the Department has agreed to represent the employee; or (d) the Government of the United States, when the Department determines that litigation is likely to affect the Department, is a party to litigation or has an interest in such litigation, and the use of such records by the Department is deemed to be relevant and necessary to the litigation or administrative proceeding.
(i) the Department of Justice (“DOJ”) for its use in providing legal advice to the Department or in representing the Department in a proceeding before a court, adjudicative body, or other administrative body before which the Department is authorized to appear, where the Department deems DOJ's use of such information relevant and necessary to the litigation, and such proceeding names as a party or interests:
(a) The Department or any component of it;
(b) Any employee of the Department in his or her official capacity;
(c) Any employee of the Department in his or her individual capacity where DOJ has agreed to represent the employee; or
(d) The Government of the United States, where the Department determines that litigation is likely to affect the Department or any of its components.
(j) the National Archives and Records Administration and the General Services Administration: For records management inspections, surveys and studies; following transfer to a Federal records center for storage; and to determine whether such records have sufficient historical or other value to warrant accessioning into the National Archives of the United States.
Records are stored on electronic media. A description of standard Department of State policies concerning storage of electronic records is found here
By individual name or other personal identifier, if available.
The Department of State is in the process of finalizing a retention schedule for these records. Once the schedule is approved by the National Archives and Records Administration, the Records will be retired in accordance with the published Department of State Records Disposition Schedule that shall be published here:
All users are given cyber security awareness training which covers the procedures for handling Sensitive But Unclassified information, including personally identifiable information (PII). Annual refresher training is mandatory. In addition, all Foreign Service and Civil Service employees and those Locally Employed Staff who handle PII are required to take a distance learning course instructing employees on privacy and security requirements, including the rules of behavior for handling PII and the potential consequences if it is handled improperly. Before being granted access to Email Archive Management Records, a user must first be granted access to the Department of State computer system.
Remote access to the Department of State network from non-Department-owned systems is authorized only to unclassified systems and through a Department-approved access program. Remote access to the network is configured with the authentication requirements contained in the Office of Management and Budget Circular Memorandum A-130.
All Department of State employees and contractors with authorized access have undergone a thorough background security investigation. Access to the Department of State, its annexes and posts abroad is controlled by security guards, and admission is limited to those individuals possessing a valid identification card or individuals under proper escort. Access to Department of State workstations/networks requires a valid PKI identification card protected by a user's PIN that must first be entered before accessing the Department of State network. Access to computerized files is password-protected and under the direct supervision of the system manager. The system manager has the capability of printing audit trails of access from the computer media, thereby permitting regular and ad hoc monitoring of computer usage. When it is determined that a user no longer needs access, the user account is disabled.
The safeguards in the following paragraphs apply only to records that are maintained in cloud systems. All cloud systems that provide IT services and process Department of State information must be specifically authorized by the Department of State Authorizing Official and Senior Agency Official for Privacy.
Information that conforms with Department-specific definitions for FISMA low, moderate, or high categorization are permissible for cloud usage and must specifically be authorized by the Cloud Computing Governance Board. Specific security measures and safeguards will depend on
All data stored in cloud environments categorized above a low FISMA impact risk level must be encrypted at rest and in-transit using a federally-approved encryption mechanism. The encryption keys shall be generated, maintained, and controlled in a Department data center by the Department key management authority. Deviations from these encryption requirements must be approved in writing by the Authorizing Official. Data in Email Archive Management Records categorized at a high FISMA impact risk level will additionally be subject to continual auditing and monitoring, multifactor authentication mechanisms utilizing PKI, NIST 800-53 controls concerning virtualization, servers, storage and networking as well as stringent measures to sanitize data from the cloud service once the contract is terminated.
Individuals who wish to gain access to or to amend records pertaining to themselves should write to U.S. Department of State; Director, Office of Information Programs and Services; A/GIS/IPS; SA-2, Suite 8100; Washington, DC 20522-0208. The individual must specify that he or she wishes the Email Archive Management Records to be checked. At a minimum, the individual must include: Full name (including maiden name, if appropriate) and any other names used; current mailing address and zip code; date and place of birth; notarized signature or statement under penalty of perjury; a brief description of the circumstances that caused the creation of the record (including the city and/or country and the approximate dates) which gives the individual cause to believe that the Email Archive Management Records include records pertaining to him or her. Detailed instructions on Department of State procedures for accessing and amending records can be found at
Individuals who wish to contest record procedures should write to U.S. Department of State; Director, Office of Information Programs and Services; A/GIS/IPS; SA-2, Suite 8100; Washington, DC 20522-0208.
Individuals who have reason to believe that this system of records may contain information pertaining to them may write to U.S. Department of State; Director, Office of Information Programs and Services; A/GIS/IPS; SA-2, Suite 8100; Washington, DC 20522-0208. The individual must specify that he or she wishes the Email Archive Management Records to be checked. At a minimum, the individual must include: Full name (including maiden name, if appropriate) and any other names used; current mailing address and zip code; date and place of birth; notarized signature or statement under penalty of perjury; a brief description of the circumstances that caused the creation of the record (including the city and/or country and the approximate dates) which gives the individual cause to believe that the Email Archive Management Records include records pertaining to him or her.
Pursuant to 5 U.S.C. 552a (j)(2), records in this system may be exempted from subsections (c)(3) and (4), (d), (e)(1), (2), (3), and (e)(4)(G), (H), and (I), and (f) of the Privacy Act.
Pursuant to 5 U.S.C. 552a (k)(1), (k)(2), (k)(3), (k)(4), (k)(5), (k)(6), and (k)(7), records in this system may be exempted from subsections (c)(3), (d)(1), (d)(2), (d)(3), (d)(4), (d)(5), (e)(1), (e)(4)(G), (e)(4)(H), (e)(4)(I), (f)(1), (f)(2), (f)(3), (f)(4), and (f)(5).
Any other exempt records from other agencies' systems of records that are recompiled into this system are also considered exempt to the extent they are claimed as such in the original systems.
None.
The Surface Transportation Board has received a request from Neville Peterson LLP on behalf of Trinity Industries, Inc. (WB17-51—12/05/17) for permission to use certain data from the Board's 2016 Carload Waybill Sample. A copy of this request may be obtained from the Office of Economics.
The waybill sample contains confidential railroad and shipper data; therefore, if any parties object to these requests, they should file their objections with the Director of the Board's Office of Economics within 14 calendar days of the date of this notice. The rules for release of waybill data are codified at 49 CFR 1244.9.
Federal Aviation Administration (FAA), DOT.
Request for public comments.
Notice is being given that the FAA is considering a request from the Sanford Seacoast Regional Airport, to change the current land use from aeronautical use to non-aeronautical use of 419 acres of land. The parcels are located along the southwesterly side of Runway 07/25, the northerly end of Runway 25 and in a portion of the infield area between Runway 07/25 and Runway 14/32. There is adequate developable area on the airport to meet the future twenty year need for projected activity and the Airport Layout Plan was updated with a Pen and Ink change to designate the parcels for non-aeronautical use. The airport will obtain fair market value for the lease of the land and the income derived from this lease will be placed in the airport's operation and maintenance funds for the facility.
Comments must be received on or before January 11, 2018.
You may send comments using any of the following methods:
•
•
•
•
Interested persons may inspect the request and supporting documents by contacting the FAA at the address listed under
Mr. Jorge E. Panteli, Compliance and Land Use Specialist, Federal Aviation Administration New England Region Airports Division, 1200 District Avenue, Burlington, Massachusetts, 01803. Telephone: 781-238-7618.
Federal Aviation Administration (FAA), DOT.
Request for public comments.
Notice is being given that the FAA is considering a request from the Midcoast Regional Redevelopment Authority (MRRA), to change the current land use from aeronautical use to non-aeronautical use of a 22.1-acre parcel of land. The parcel is located in the northern quadrant of the airport adjacent, but separate from the airside area. The Airport Layout Plan was updated with a Pen and Ink Change to designate the parcel for non-aeronautical use. The airport will obtain fair market value for the lease of the land. The income derived from this lease will be placed in the airport's operation and maintenance funds for the facility.
Comments must be received on or before January 11, 2018.
You may send comments using any of the following methods:
•
•
•
•
Interested persons may inspect the request and supporting documents by contacting the FAA at the address listed under
Mr. Jorge E. Panteli, Compliance and Land Use Specialist, Federal Aviation Administration New England Region Airports Division, 1200 District Avenue, Burlington, Massachusetts, 01803. Telephone: 781-238-7618.
Federal Aviation Administration (FAA), DOT.
Request for public comments.
Notice is being given that the FAA is considering a request from the Northern Maine Regional Airport, for a land swap with the Presque Isle Industrial Council. The on-airport land, currently in use as non-aeronautical development, is to be swapped with four parcels of land along the northern ramp area of airport and land within the northern approach. The land swap will further enhance the protection of the northern approach area while also providing developable land for aeronautical uses.
Comments must be received on or before January 11, 2018.
You may send comments using any of the following methods:
•
•
•
•
Interested persons may inspect the request and supporting documents by contacting the FAA at the address listed under
Mr. Jorge E. Panteli, Compliance and Land Use Specialist, Federal Aviation Administration New England Region Airports Division, 1200 District Avenue, Burlington, Massachusetts, 01803. Telephone: 781-238-7618.
Federal Aviation Administration (FAA), DOT.
Notice: Extension.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to extend the comment period to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number involved and must be received on or before January 5, 2018.
Send comments identified by docket number FAA-2017-1046 using any of the following methods:
•
•
•
•
Lynette Mitterer, AIR673, Federal Aviation Administration, 1601 Lind Avenue SW, Renton, WA 98057-3356, email
This notice is published pursuant to 14 CFR 11.85.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Comments must be submitted on or before January 11, 2018.
Submit written comments on the collection of information through
Cynthia Harvey-Pryor, Enterprise Records Service (005R1B), Department of Veterans Affairs, 811 Vermont Avenue NW, Washington, DC 20420, (202) 461-5870 or email
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The
By direction of the Secretary.
Center for Verification and Evaluation, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Center for Verification and Evaluation, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Comments must be submitted on or before January 11, 2018.
Submit written comments on the collection of information through
Cynthia Harvey-Pryor, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-5870 or email
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
Veterans Benefits Administration, Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before February 12, 2018.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Cynthia Harvey-Pryor at (202) 461-5870.
Under the PRA of 1995, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
a. 15 minutes for VA Forms 21-674 and 21-674c.
b. 5 minutes for VA Form 21-674b.
By direction of the Secretary.
Office of Acquisition and Logistics, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Office of Acquisition and Logistics, Department of Veterans Affairs, will
Comments must be submitted on or before January 11, 2018.
Submit written comments on the collection of information through
Cynthia Harvey-Pryor, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-5870 or email
44 U.S.C. 3501-21.
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
a. VAAR Clause 852.236-91 for Qualified Data—.5 hour.
b. VAAR Clause 852.236-91 for Weather Data—1 hour.
a. VAAR Clause 852.236-91 for Qualified Data—1516.
b. VAAR Clause 852.236-91 for Weather Data—20.
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
Veterans Benefits Administrations, Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before February 12, 2018.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Cynthia Harvey-Pryor at (202) 461-5870.
Under the PRA of 1995, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Environmental Protection Agency (EPA).
Final rule.
Under section 211 of the Clean Air Act, the Environmental Protection Agency (EPA) is required to set renewable fuel percentage standards every year. This action establishes the annual percentage standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel that apply to gasoline and diesel transportation fuel produced or imported in the year 2018. Relying on statutory waiver authority that is available when projected cellulosic biofuel production volumes are less than the applicable volume specified in the statute, the EPA is establishing volume requirements for cellulosic biofuel, advanced biofuel, and total renewable fuel that are below the statutory volume targets. In this action, we are also establishing the applicable volume of biomass-based diesel for 2019.
This final rule is effective on February 12, 2018.
The EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2017-0091. All documents in the docket are listed on the
Julia MacAllister, Office of Transportation and Air Quality, Assessment and Standards Division, Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI 48105; telephone number: 734-214-4131; email address:
Entities potentially affected by this final rule are those involved with the production, distribution, and sale of transportation fuels, including gasoline and diesel fuel or renewable fuels such as ethanol, biodiesel, renewable diesel, and biogas. 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 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 would be regulated by this action, you should carefully examine the applicability criteria in 40 CFR part 80. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed in the
The Renewable Fuel Standard (RFS) program began in 2006 pursuant to the requirements in Clean Air Act (CAA) section 211(o) that were added through the Energy Policy Act of 2005 (EPAct). The statutory requirements for the RFS program were subsequently modified through the Energy Independence and Security Act of 2007 (EISA), leading to the publication of major revisions to the regulatory requirements on March 26, 2010.
The statute includes annual volume targets, and requires EPA to translate those volume targets (or alternative volume requirements established by EPA in accordance with statutory waiver authorities) into compliance obligations that obligated parties must meet every year. In this action, we are establishing the annual percentage standards for cellulosic biofuel, biomass-based diesel (BBD), advanced biofuel, and total renewable fuel that would apply to all gasoline and diesel produced or imported in 2018. We are also establishing the applicable volume of BBD for 2019.
Real-world challenges, in particular the slower-than-expected development of the cellulosic biofuel industry, has slowed progress towards meeting Congressional goals for renewable fuels. Given the nested nature of the standards, the shortfall in cellulosic biofuels has made the volume targets established by Congress for 2018 for advanced biofuels and total renewable fuels beyond reach. On July 21, 2017, EPA published a proposed rulemaking, containing proposed volume requirements for the RFS Program's four categories of renewable fuels that would apply in 2018 (and 2019 for BBD).
In this action, we are finalizing volume requirements for cellulosic biofuel at the level we project to be available for 2018. We are using the “cellulosic waiver authority” provided by the statute to finalize volume requirements for advanced biofuel and total renewable fuel that are lower than the statutory targets by the same magnitude as the reduction in the cellulosic biofuel reduction (
The final volume requirements for 2018 are shown in Table I-1 below. Relative to the levels finalized for 2017, the 2018 volume requirements for advanced biofuel and total renewable fuel are higher by 10 million gallons. EPA is reducing the advanced biofuel and total renewable fuel statutory volumes by the same amount as we are reducing the cellulosic biofuel volume. These reductions effectively preserve the implied statutory volumes for conventional renewable fuel and non-cellulosic advanced biofuels. We are establishing the volume requirement for BBD for 2019 at the proposed volume of 2.1 billion gallons.
The national volume targets of renewable fuel that are intended to be achieved under the RFS program each year (absent an adjustment or waiver by EPA) are specified in CAA section 211(o)(2). The statutory volume targets for 2018 are shown in Table I.A-1, along with the 2017 targets for comparison. The cellulosic biofuel and BBD categories are nested within the advanced biofuel category, which is itself nested within the total renewable fuel category. This means, for example, that each gallon of cellulosic biofuel or BBD that is used to satisfy the individual volume requirements for those fuel types can also be used to satisfy the requirements for advanced biofuel and total renewable fuel.
Under the RFS program, EPA is required to determine and publish annual percentage standards for each compliance year. The percentage standards are calculated to ensure use in transportation fuel of the national “applicable volumes” of the four types of biofuel (cellulosic biofuel, BBD, advanced biofuel, and total renewable fuel) that are set forth in the statute or established by EPA in accordance with the Act's requirements. The percentage standards are used by obligated parties (generally, producers and importers of gasoline and diesel fuel) to calculate their individual compliance obligations. Each of the four percentage standards is applied to the volume of non-renewable gasoline and diesel that each obligated party produces or imports during the specified calendar year to determine their individual volume obligations with respect to the four renewable fuel types. The individual volume obligations determine the number of Renewable Identification Numbers (RINs) of each renewable fuel type that each obligated party must acquire and retire to demonstrate compliance.
EPA is establishing the annual applicable volume requirements for cellulosic biofuel, advanced biofuel, and total renewable fuel for 2018, and for BBD for 2019.
As shown in Table I.A-2, the statutory authorities allowing EPA to modify or set the applicable volumes differ for the four categories of renewable fuel. Under the statute, EPA must annually determine the projected volume of cellulosic biofuel production for the following year. If the projected volume of cellulosic biofuel production is less than the applicable volume specified in CAA section 211(o)(2)(B)(i)(III) of the statute, EPA must lower the applicable volume used to set the annual cellulosic biofuel percentage standard to the projected production volume. In Section III of this final rule, we present our analysis of cellulosic biofuel production and the applicable volume for 2018. This analysis is based primarily on the estimate of cellulosic biofuel production for 2018 conducted by the Energy Information Administration (EIA),
With regard to BBD, CAA section 211(o)(2)(B) specifies the applicable volumes of BBD to be used in the RFS program only through year 2012. For subsequent years the statute sets a minimum volume of 1 billion gallons, and directs EPA, in coordination with the U.S. Departments of Agriculture (USDA) and Energy (DOE), to determine the required volume after review of implementation of the renewable fuels program and consideration of a number of factors. The BBD volume requirement must be established 14 months before the year in which it will apply. In the 2017 final rule we established the BBD volume for 2018. In Section VI of this preamble we discuss our assessment of statutory and other relevant factors and our final volume requirement for BBD for 2019, which has been developed in coordination with USDA and DOE. We are establishing an applicable volume of 2.1 billion gallons of BBD for use in deriving the BBD percentage standard in 2019. This volume is equal to the applicable volume of BBD established in a prior rulemaking for 2018, and would provide continued support to an industry that is a significant contributor to the pool of advanced biofuel, while at the same time setting the volume requirement in a manner anticipated to provide a continued incentive for the development of other types of advanced biofuel.
Regarding advanced biofuel and total renewable fuel, Congress provided several mechanisms through which the statutory targets could be reduced if necessary. If we reduce the applicable volume of cellulosic biofuel below the volume specified in CAA section 211(o)(2)(B)(i)(III), we also have the authority to reduce the applicable volumes of advanced biofuel and total renewable fuel by the same or a lesser amount. We refer to this as the “cellulosic waiver authority.” We may also reduce the applicable volumes of any of the four renewable fuel types using the “general waiver authority” provided in CAA section 211(o)(7)(A) if EPA, in consultation with USDA and DOE, finds that implementation of the statutory volumes would severely harm the economy or environment of a State, region, or the U.S., or if there is inadequate domestic supply. We are also authorized under CAA section 211(o)(7)(E) to reduce the applicable volume of BBD established for 2018, and to make equal or lesser reductions in the 2018 applicable volumes of advanced biofuel and total renewable fuel, if we determine that there is a significant renewable feedstock disruption or other market circumstance that would make the price of BBD increase significantly. Sections II and IV of this final rule describe our use of the cellulosic waiver authority alone to derive the volumes of advanced biofuel and total renewable fuel that are below the statutory target volumes, and our assessment that the resulting volumes can be met. We believe that reductions in the statutory targets for cellulosic biofuel, advanced biofuel and total renewable fuel for 2018 are necessary. However, in light of our review of available information, we are making those reductions under the cellulosic waiver authority alone and are not reducing them further under other waiver authorities. Thus, the reductions in both the advanced and total
This section briefly summarizes the major provisions of this final rule. We are establishing applicable volume requirements and associated percentage standards for cellulosic biofuel, advanced biofuel, and total renewable fuel for 2018; for BBD we are establishing the percentage standard for 2018 and the applicable volume requirement for 2019.
The approach we have taken in this final rule of using the cellulosic waiver authority to reduce advanced biofuel and total renewable fuel by the same amount as the reduction in the required volume of cellulosic biofuel is the same approach as in our proposed rule, but is a departure from our approach to using the cellulosic biofuel waiver authority in previous years. In previous years we have used the cellulosic waiver authority to reduce the advanced biofuel and total renewable fuel volume requirements by a lesser amount than the reduction in the cellulosic biofuel volume requirement to allow reasonably attainable volumes of advanced biofuels to partially backfill for missing cellulosic biofuel volumes. However, the approach we have taken for 2018 does not result in a reduction in the volume requirement for non-cellulosic advanced biofuel. While the implied statutory volume for non-cellulosic advanced biofuel increased by 500 million gallons from 2017 to 2018, through our 2017 action we effectively required early use of approximately 0.5 billion gallons of non-cellulosic advanced volume that Congress envisioned would be first used in 2018.
Section II provides a general description of our approach to setting volume requirements in today's rule, including a review of the statutory waiver authorities and our consideration of carryover RINs. Section III provides our assessment of the 2018 cellulosic biofuel volume, based on a projection of production that reflects a neutral aim at accuracy. Sections IV and V describe our assessments of advanced biofuel and total renewable fuel, and consideration of the general and biomass-based diesel waiver authorities. Finally, Section VI provides our determination regarding the 2019 BBD volume requirement, and reflects an analysis of a set of factors stipulated in CAA section 211(o)(2)(B)(ii).
In the past several years the cellulosic biofuel industry has continued to make progress towards increased commercial scale production. Cellulosic biofuel production reached record levels in 2016 and has continued to grow throughout 2017, driven largely by compressed natural gas (CNG) and liquefied natural gas (LNG) derived from biogas. Liquid cellulosic biofuels, while produced in much smaller quantities than CNG/LNG derived from biogas, have been produced at steady but relatively small volumes throughout 2017. In this rule we are establishing a cellulosic biofuel volume requirement of 288 million ethanol-equivalent gallons for 2018 based on our production projection. Our projection reflects consideration of a production estimate from EIA, RIN generation data available to EPA through EMTS, comments we received on the proposed rule, the information we have received regarding individual facilities' capacities, production start dates and biofuel production plans, a review of cellulosic biofuel production relative to EPA's projections in previous annual rules, and EPA's own engineering judgment. To project cellulosic biofuel production for 2018 we used the same basic methodology described in the proposed rule. However, we have used updated data to derive percentile values used in our production projection for liquid cellulosic biofuels and to derive the year-over-year change in the rate of production of CNG/LNG derived from biogas that is used in the projection for CNG/LNG. (See Section III for further detail on the methodology used to project cellulosic biofuel production.)
In estimating the volume of liquid cellulosic biofuel that will be made available in the U.S. in 2018, we considered all potential production sources by company and facility. This included facilities still in the commissioning or start-up phases, as well as facilities already producing some volume of cellulosic biofuel.
For 2018, we are using an industry wide, rather than a facility-by-facility approach to project the production of CNG/LNG derived from biogas. We believe this approach is appropriate due to the mature state of this technology, the large number of facilities that are registered to produce cellulosic biofuel RINs for these fuels, and the fact that their volumes are likely to be affected more by market wide factors than individual company situations. Further discussion on our projection of cellulosic biofuel production in 2018, including the factors considered and the way these factors were used to determine our final cellulosic biofuel projection, can be found in Section III.
We are finalizing required advanced biofuel requirements using the same approach used in the July proposed rulemaking. As was the case at the time of proposal, the conditions that compelled us to reduce the 2017 volume requirement for advanced biofuel below the statutory target remain relevant in 2018. As for 2017, we investigated the ability of volumes of non-cellulosic advanced biofuels to backfill unavailable volumes of cellulosic biofuel in 2018. We took into account the various constraints on the ability of the market to make advanced biofuels available, the ability of the standards we set to bring about market changes in the time available, the potential impacts associated with diverting biofuels and/or biofuel feedstocks from current use to the production of advanced biofuel used in the U.S., the fact that the biodiesel tax credit is currently not available for 2018, the proposed countervailing duties on imports of biodiesel from Argentina and Indonesia, as well as the cost of advanced biofuels. Based on these considerations we have decided to reduce the applicable volume of advanced biofuel by the same amount as we are reducing the applicable volume of cellulosic biofuels. This results in an advanced biofuel volume for 2018 that is 10 million gallons higher than the advanced biofuel volume for 2017. Although we determined that a small amount of reasonably attainable volumes of advanced biofuel could be used to backfill a portion of the missing cellulosic biofuel, for reasons described in Section IV, we are not exercising the discretion provided under the cellulosic waiver authority in a manner that would lead to that result.
As mentioned above, we are exercising our cellulosic waiver authority to reduce the statutory applicable volume of advanced biofuel to a volume requirement of 4.29 billion gallons for 2018. This applicable volume for 2018 is 10 million gallons higher than the applicable volume for advanced biofuel for 2017.
Following our determination of the appropriate volume reduction for advanced biofuel for 2018 using the cellulosic waiver authority, we calculated what the total renewable fuel volume would be if we provide the same level of reduction using the cellulosic waiver authority. The resulting volume is 19.29 billion gallons.
We have evaluated whether additional reductions in cellulosic biofuel, biomass-based diesel, advanced biofuel, or total renewable fuel are warranted for 2018 using either the general waiver authority or the BBD waiver authority and have determined that additional reductions are not warranted at this time.
In EISA, Congress specified increasing applicable volumes of BBD through 2012. Beyond 2012 Congress stipulated that EPA, in coordination with DOE and USDA, was to establish the BBD volume taking into consideration implementation of the program to date and various specified factors, providing that the required volume for BBD could not be less than 1.0 billion gallons. For 2013, EPA established an applicable volume of 1.28 billion gallons. For 2014 and 2015 we established the BBD volume requirement to reflect the actual volume for each of these years of 1.63 and 1.73 billion gallons.
Given current and recent market conditions, the advanced biofuel volume requirement is driving the production and use of biodiesel and renewable diesel volumes over and above volumes required through the separate BBD standard, and we expect this to continue. For 2019, EPA continues to believe that it would still be appropriate to provide a floor above the statutory minimum of 1 billion gallons to provide a guaranteed level of support for the continued production and use of BBD. However, we also believe that the volume of BBD supplied in previous years demonstrates that the advanced biofuel standard is capable of incentivizing additional supply of these fuels above the volume required by the BBD standard. Thus, based on a review of the implementation of the program to date and all the factors required under the statute, and in coordination with USDA and DOE, we are finalizing an applicable volume of BBD for 2019 at the proposed volume of 2.1 billion gallons.
The renewable fuel standards are expressed as a volume percentage and are used by each producer and importer of fossil-based gasoline or diesel to determine their renewable fuel volume obligations.
Four separate percentage standards are required under the RFS program, corresponding to the four separate renewable fuel categories shown in Table I.A-1. The specific formulas we use in calculating the renewable fuel percentage standards are contained in the regulations at 40 CFR 80.1405. The percentage standards represent the ratio of the national applicable volume of renewable fuel volume to the national projected non-renewable gasoline and diesel volume less any gasoline and diesel attributable to small refineries granted an exemption prior to the date that the standards are set. The volume of transportation gasoline and diesel used to calculate the percentage standards was based on a letter provided to the EPA by EIA, as required by statute.
By November 30 of each year we are required to assess the status of the aggregate compliance approach to land use restrictions under the definition of renewable biomass for both the U.S. and Canada. In today's action we are providing the final announcements for these administrative actions. As described in Section VIII.A, based on data provided by the USDA and using the methodology in place since 2014, we have estimated that U.S. agricultural land totaled approximately 376 million acres in 2017 and thus did not exceed the 2007 baseline acreage. This assessment means that the aggregate compliance provision can continue to be used in the U.S. for calendar year 2018.
On September 29, 2011, EPA approved the use of a similar aggregate compliance approach for planted crops and crop residue grown in Canada. As
The CAA provides EPA with the authority to enact volume requirements below the applicable volume targets specified in the statute under specific circumstances. This section discusses those authorities.
In CAA section 211(o)(2), Congress specified increasing annual volume targets for total renewable fuel, advanced biofuel, and cellulosic biofuel for each year through 2022, and for BBD through 2012, and authorized EPA to set volume requirements for subsequent years in coordination with USDA and DOE, and after consideration of specified factors. However, Congress also recognized that under certain circumstances it would be appropriate for EPA to set volume requirements at a lower level than reflected in the statutory volume targets, and thus provided waiver provisions in CAA section 211(o)(7).
Section 211(o)(7)(D)(i) of the CAA provides that if EPA determines that the projected volume of cellulosic biofuel production for a given year is less than the applicable volume specified in the statute, that EPA must reduce the applicable volume of cellulosic biofuel required to the projected production volume for that calendar year. In making this projection, EPA may not “adopt a methodology in which the risk of overestimation is set deliberately to outweigh the risk of underestimation” and must make a projection that “aims at accuracy.”
CAA section 211(o)(7)(D)(i) also provides EPA with the authority to reduce the applicable volume of total renewable fuel and advanced biofuel in years when it reduces the applicable volume of cellulosic biofuel under that provision. The reduction must be less than or equal to the reduction in cellulosic biofuel. For 2018, we are also reducing the applicable volumes of advanced biofuel and total renewable fuel under this authority.
The cellulosic waiver authority is discussed in detail in the preamble to the 2017 final rule and that discussion is incorporated by reference.
In
In this action we are reducing the statutory volume targets for advanced biofuels and total renewable fuel by equal amounts, as was our approach in using the cellulosic waiver authority in setting the 2014-2017 standards. EPA's reasoning for an equal reduction is explained in the 2017 final rule.
Section 211(o)(7)(A) of the CAA provides that EPA, in consultation with the Secretary of Agriculture and the Secretary of Energy, may waive the applicable volumes specified in the Act in whole or in part based on a petition by one or more States, by any person subject to the requirements of the Act, or by the EPA Administrator on his own motion. Such a waiver must be based on a determination by the Administrator, after public notice and opportunity for comment that: (1) Implementation of the requirement would severely harm the
In the October 4 document, EPA sought comment on the possible use of the general waiver authority to reduce volumes of advanced biofuel and total renewable fuel for the 2018 standards below the levels proposed in the 2018 NPRM.
Based on an evaluation of supply and potential economic impact of the volumes of advanced and total renewable fuel that result after use of the cellulosic waiver authority, comments from stakeholders, and as further discussed in Section V, EPA is not using the general waiver authority on the basis of severe economic or environmental harm or inadequate domestic supply to further reduce those volumes for 2018. EPA's response to comments addressing possible use of the general waiver authority are provided in a memorandum to the docket
Section 211(o)(7)(E)(ii) of the CAA provides that if EPA determines that there is a significant renewable feedstock disruption or other market circumstance that would make the price of BBD increase significantly, EPA shall, in consultation with the Secretary of Energy, and the Secretary of Agriculture, issue an order to reduce, for up to a 60-day period, the annual volume requirement for BBD by an appropriate quantity that does not exceed 15 percent. The statute also stipulates that EPA is authorized to reduce applicable volumes of advanced biofuel and total renewable fuel by the same or a lesser volume than the reduction in BBD.
In the October 4 document, EPA sought comment on potential interpretations of this authority, as well as the potential use of the BBD waiver authority to reduce the 2018 volume requirement for BBD by as much as 315 million gallons, and to concurrently reduce the advanced biofuel and total renewable fuel volume requirements by as much as 473 million gallons. The notice provided information on the price of biodiesel in light of the expiration of the federal tax credit, and the potential imposition of new duties on imports of biodiesel from Argentina and Indonesia.
As described in the RTC document, EPA has determined that it would not be appropriate at this time to use the BBD waiver authority. Based on information provided in comments, as well its own analysis discussed in Section V, EPA believes that there is an insufficient basis to support a finding that the biomass based diesel prices currently in the marketplace, or reasonably anticipated in the immediate future, represent a “significant” increase in prices that would justify use of this waiver authority.
Consistent with our approach in the 2013, 2014-16, and 2017 final rules, we have also considered the availability and role of carryover RINs in evaluating whether we should exercise our discretion to use the cellulosic waiver authority in setting the cellulosic, advanced, and total volume requirements for 2018. Neither the statute nor EPA regulations specify how or whether EPA should consider the availability of carryover RINs in exercising the cellulosic waiver authority.
In the 2018 NPRM, EPA estimated that the size of the carryover RIN bank was then approximately 2.06 billion carryover RINs (including all D codes).
Based on currently available information, our estimate of the carryover RIN bank has increased to 2.22 billion RINs, an increase of 160 million RINs from the previous estimate of 2.06 billion carryover RINs in the 2018 NPRM.
The carryover RIN volume is 11.5 percent of the total renewable fuel volume requirement that EPA is finalizing for 2018, which is less than the 20 percent maximum limit permitted by the regulations to be carried over for use in complying with the 2018 standards.
EPA has decided to maintain the proposed approach, and not set the volume requirements in the final rule with the intention or expectation of drawing down the current bank of carryover RINs. In addition, we do not believe that the availability of carryover RINs, together with the potential supply of renewable fuel in volumes higher than we are requiring though this final rule, should lead us to increase the volume requirements. In finalizing this approach, we carefully considered the comments received, including on the role of carryover RINs under our waiver authorities and the policy implications of our decision. While we have not assumed an intentional drawdown in the overall bank of carryover RINs owned by obligated parties collectively in establishing the volume requirements for 2018, we understand that some obligated parties may choose to sell or use all or part of their individual banks of carryover RINs. To the extent that they do, other obligated parties would be in a position to bank carryover RINs by using available renewable fuel or purchasing RINs representing such fuel, with the expected net result that the standards adopted in this action will have no effect on the size of the overall bank of carryover RINs that is owned collectively by obligated parties.
We believe that a balanced consideration of the possible role of carryover RINs in achieving the statutory volume objectives for advanced and total renewable fuels, versus maintaining an adequate bank of carryover RINs for important programmatic functions, is appropriate when EPA exercises its discretion under the cellulosic waiver authority, and that the statute does not specify the extent to which EPA should require a drawdown in the bank of carryover RINs when it exercises this authority.
An adequate RIN bank serves to make the RIN market liquid. Just as the economy as a whole functions best when individuals and businesses prudently plan for unforeseen events by maintaining inventories and reserve money accounts, we believe that the RFS program functions best when sufficient carryover RINs are held in reserve for potential use by the RIN holders themselves, or for possible sale to others that may not have established their own carryover RIN reserves. Were there to be no RINs in reserve, then even minor disruptions causing shortfalls in renewable fuel production or distribution, or higher than expected transportation fuel demand (requiring greater volumes of renewable fuel to comply with the percentage standards that apply to all volumes of transportation fuel, including the unexpected volumes) could lead to the need for a new waiver of the standards, undermining the market certainty so critical to the RFS program. However, a significant drawdown of the carryover RIN bank leading to a scarcity of RINs may stop the market from functioning in an efficient manner (
Therefore, for the reasons noted above, and consistent with the approach we took in the 2014-2016 and 2017 final rules, we are making a determination that, under current circumstances, an intentional drawdown of the carryover RIN bank should not be assumed in establishing the 2018 volume requirements. In addition, we do not believe that the
In the past several years the cellulosic biofuel industry has continued to make progress towards increased commercial-scale production. Cellulosic biofuel production reached record levels in 2016, driven largely by CNG and LNG derived from biogas. Production volumes have continued to increase in 2017.
In the July NPRM, EPA proposed cellulosic volumes based on a methodology that differed in a couple of important ways from the approach we used in 2017. We proposed changes to the percentile values used to project liquid cellulosic biofuel production and a new industry-wide methodology for projecting the production of CNG/LNG derived from biogas. For this action, we are finalizing volumes for 2018 based on an approach that is similar, but not identical, to what we proposed. We discuss the changes we made from proposal to final below. In our RTC document, we respond to the multiple comments EPA received on the changes to the cellulosic projection methodology we proposed in July.
In order to project the volume of cellulosic biofuel production in 2018 we considered EIA's projection of cellulosic biofuel production,
After a brief description of the statutory requirements in Section III.A, we discuss the companies the EPA reviewed in the process of projecting qualifying cellulosic biofuel production in the U.S. in 2018 in Section III.B. Section III.C discusses the projection of cellulosic biofuel production provided to EPA by EIA, and Section III.D discusses the methodologies used by EPA to project cellulosic biofuel production in 2018 and the resulting projection of 288 million ethanol-equivalent gallons.
The volumes of renewable fuel to be produced and used as transportation fuel under the RFS program each year (absent an adjustment or waiver by EPA) are specified in CAA section 211(o)(2)(B)(i)(III). The volume of cellulosic biofuel specified in the statute for 2018 is 7.0 billion gallons. The statute provides that if EPA determines, based on a letter provided to the EPA by EIA, that the projected volume of cellulosic biofuel production in a given year is less than the statutory volume, then EPA shall reduce the applicable volume of cellulosic biofuel to the projected volume available during that calendar year.
In addition, if EPA reduces the required volume of cellulosic biofuel below the level specified in the statute, the Act also indicates that we may reduce the applicable volumes of advanced biofuels and total renewable fuel by the same or a lesser volume, and we are required to make cellulosic waiver credits available.
In order to project cellulosic biofuel production for 2018, we have tracked the progress of several dozen potential cellulosic biofuel production facilities. As we have done in previous years, we have focused on facilities with the potential to produce commercial-scale volumes of cellulosic biofuel rather than small research and development (R&D) or pilot-scale facilities. Larger commercial-scale facilities are much more likely to generate RINs for the fuel they produce and the volumes they produce will have a far greater impact on the cellulosic biofuel standard for 2018. The volume of cellulosic biofuel produced from R&D and pilot-scale facilities is quite small in relation to that expected from the commercial-scale facilities. R&D and demonstration-scale facilities have also generally not generated RINs for the fuel they have produced in the past. Their focus is on developing and demonstrating the technology, not producing commercial volumes. RIN generation from R&D and pilot-scale facilities in previous years has not contributed significantly to the overall number of cellulosic RINs generated.
From this list of commercial-scale facilities we used information from EMTS, publicly available information (including press releases and news reports), comments on the 2018 NPRM, information from EIA, and information provided by representatives of potential cellulosic biofuel producers, to make a determination of which facilities are most likely to produce liquid cellulosic biofuel and generate cellulosic biofuel RINs in 2018. Each of these companies was investigated further in order to determine the current status of its facilities and its likely cellulosic biofuel production and RIN generation volumes for 2018. Both in our discussions with representatives of individual companies and as part of our internal evaluation process we gathered and analyzed information including, but not limited to, the funding status of these facilities, current status of the production technologies, anticipated construction and production ramp-up periods, facility registration status, and annual fuel production and RIN generation targets.
As an initial matter, it is useful to review the success of EPA's recent cellulosic biofuel projections. EPA used a consistent methodology to project cellulosic biofuel production in the final three months of 2015 and in 2016 and 2017.
EPA's projections of liquid cellulosic biofuel were higher than the actual volume of liquid cellulosic biofuel produced in both 2015 and 2016, and appear likely to be higher than actual liquid cellulosic biofuel production in 2017. We believe this recent data warrants a change to the percentile values used to project liquid cellulosic biofuel from the percentile values used in prior years in an effort to take into account the most recent data available and make the projections for 2018 more accurate. We are therefore adjusting the percentile values used to project liquid cellulosic biofuel production based on actual liquid cellulosic biofuel production in 2016 and through September 2017. Use of this updated data also results in different percentile values than we proposed to use for 2018. We believe that the use of the methodology (described in the 2018 NPRM and in Section III.D.1 below), with the adjusted approach to developing the percentile values used to project production volumes for liquid cellulosic biofuels, results in a projection that reflects a neutral aim at accuracy since it accounts for expected growth in the near future by using historical data that is free of any subjective bias.
In previous years, we used the same general methodology for CNG/LNG derived from biogas as for liquid cellulosic biofuel, but used different percentile values to project CNG/LNG derived from biogas and liquid cellulosic biofuels, reflecting the more established nature of the CNG/LNG industry relative to liquid cellulosic biofuel production. For 2018, EPA proposed using an industry-wide approach, rather than an approach that projects volumes for individual companies or facilities, to project the production of CNG/LNG derived from biogas. This updated approach reflects the fact that this industry is far more mature than the liquid cellulosic biofuel industry, and that there are a large number of facilities registered to generate cellulosic biofuel RINs from biogas, rendering a facility-by-facility analysis difficult and unnecessary for purposes of accuracy.
The remainder of this section discusses the companies and facilities EPA expects to be in a position to produce commercial-scale volumes of cellulosic biofuel by the end of 2018 and describes in more detail the methodology EPA is using to project cellulosic biofuel production in 2018 (including a review of cellulosic biofuel production and the accuracy of the projection methodology in previous years).
There are a number of companies and facilities
In addition to the potential sources of cellulosic biofuel located in the U.S., there are several foreign cellulosic biofuel companies that may produce cellulosic biofuel in 2018. These include facilities owned and operated by Beta Renewables, Enerkem, Ensyn, GranBio, and Raizen. All of these facilities use fuel production pathways that have been approved by EPA for cellulosic RIN generation provided eligible sources of renewable feedstock are used and other regulatory requirements are satisfied. These companies would therefore be eligible to register their facilities under the RFS program and generate RINs for any qualifying fuel imported into the U.S. While these facilities may be able to generate RINs for any volumes of cellulosic biofuel they import into the U.S., demand for the cellulosic biofuels they produce is expected to be high in their own local markets.
EPA is charged with projecting the volume of cellulosic biofuel that will be produced or imported into the U.S.
Cellulosic biofuel produced at four foreign facilities (Ensyn's Renfrew facility, GranBio's Brazilian facility, and the CNG/LNG facilities Complexe Enviro Progressive Ltee and Saint-Thomas Biomethane Plant) generated cellulosic biofuel RINs for fuel exported to the U.S. in 2017; projected volumes from each of these facilities are included in our projection of available volumes for 2018. EPA has also included projected volume from two foreign facilities (Enerkem's Canadian facility and Ensyn's Port-Cartier, Quebec facility) that are not currently registered to generate cellulosic biofuel RINs under the RFS program. We believe that it is appropriate to include volume from these facilities in light of their proximity to the U.S., the proven technology used by these facilities, the volumes of cellulosic biofuel exported to the U.S. by the company in previous years (in the case of Ensyn), and the company's stated intentions to market fuel produced at these facilities to qualifying markets in the U.S. One additional foreign facility (Raizen's Costa Pinto) has registered as a cellulosic biofuel producer, but has not yet generated any cellulosic RINs. EPA attempted to contact representatives from this facility to inquire about their intentions to export cellulosic biofuel to the U.S. in 2018, but received no response. We have therefore not projected any cellulosic biofuel exports from this facility to the U.S. in 2018. All of the facilities included in EPA's cellulosic biofuel projection for 2018 are listed in Table III.B.3-1 below.
General information on each of the cellulosic biofuel producers (or group of producers in the case of producers of CNG/LNG derived from biogas and liquid cellulosic biofuel facilities using Edeniq's technology) that factored into our projection of cellulosic biofuel production for 2018 is shown in Table III.B.3-1. This table includes both facilities that have already generated cellulosic RINs, as well as those that have not yet generated cellulosic RINs, but are projected to do so by the end of 2018. As discussed above, we have focused on commercial-scale cellulosic biofuel production facilities. Each of these facilities (or group of facilities) is discussed further in a memorandum to the docket.
Section 211(o)(3)(A) of the CAA requires EIA to “. . . provide to the Administrator of the Environmental Protection Agency an estimate, with respect to the following calendar year, of the volumes of transportation fuel, biomass-based diesel, and cellulosic biofuel projected to be sold or introduced into commerce in the U.S.” EIA provided these estimates to EPA on October 11, 2017.
In their letter, EIA did not identify the facilities on which their estimate of cellulosic biofuel production was based. EIA did, however, indicate in their letter that they included neither estimates of cellulosic biofuel produced by foreign entities and imported into the U.S., nor estimates of cellulosic heating oil or CNG/LNG produced from biogas, which together represent approximately 96 percent of our projected cellulosic biofuel volume for 2017. When limiting the scope of our projection to the companies assessed by EIA, we note that while our volume projections are not identical, they are very similar. EPA projects approximately 10 million gallons of liquid cellulosic biofuel will be produced domestically in 2017 (when excluding heating oil, as EIA did in their estimate of cellulosic biofuel production). EIA did not provide detail on the basis of their projections, so we cannot say precisely why EPA and EIA's projections differ. We further note that if we used EIA's projections for domestic liquid cellulosic biofuel production without modification in place of our own assessment of these facilities the impact on the cellulosic biofuel standard overall for 2018 would be approximately 1%.
For our 2018 liquid cellulosic biofuel projection, we use the same general approach as we have in projecting these volumes in previous years. We begin by first categorizing potential liquid cellulosic biofuel producers in 2018 according to whether or not they have achieved consistent commercial scale production of cellulosic biofuel to date. Next we define a range of likely production volumes for 2018 for each group of companies. Finally, we use a percentile value to project from the established range a single projected production volume for each group of
Consistent with our approach in previous years, we separated the list of potential producers of cellulosic biofuel (listed in Table III.B.3-1) into two groups according to whether or not the facilities have achieved consistent commercial-scale production and cellulosic biofuel RIN generation. We next defined a range of likely production volumes for each group of potential cellulosic biofuel producers. The low end of the range for each group of producers reflects actual RIN generation data over the last 12 months for which data are available at the time our technical assessment was completed (October 2016-September 2017). For potential producers that have not yet generated any cellulosic RINs, the low end of the range is zero. For the high end of the range of production volumes for companies expected to produce liquid cellulosic biofuel we considered a variety of factors, including the expected start-up date and ramp-up period,
After defining likely production ranges for each group of companies we next considered the percentile values to use in projecting a production volume for each group of companies. In the proposed rule, we used the 1st and 43rd percentile to project production from facilities that had not yet achieved consistent commercial scale production of liquid cellulosic biofuels and those that had, respectively, based on data indicating what percentile of production from within the 2016 projected range facilities included in our 2016 cellulosic biofuel projection actually achieved. However, for this final rule we are adjusting the percentile values used to project liquid cellulosic biofuel production from within the range of projected production values, by using data on actual liquid cellulosic biofuel production from both 2016 and 2017 (through September). We believe an adjustment to the percentile values used to generate a projected production volume from the range of potential production volumes for each group of facilities is warranted. EPA's estimates for liquid cellulosic biofuel exceeded actual production of liquid cellulosic biofuel in both 2015 and 2016.
The projected ranges for liquid cellulosic biofuel production in 2016, along with the percentile values used to project a production volume within the calculated ranges the actual number of cellulosic RINs generated in 2016 that are available for compliance, and the percentile values that would have resulted in a projection equal to the actual production volume are shown in Table III.D.1-3 below.
Since the actual production in 2016 was lower than the projected production for both new facilities and consistent producers, we determined that for the purposes of our proposed rule it would be appropriate to adjust the percentiles to attempt to make them more accurate. To this end, EPA calculated the percentile values that would have resulted in accurate production projections in 2016 based on the actual number of cellulosic biofuel RINs generated for liquid cellulosic biofuels and available for compliance in 2016. These calculated percentile values are the 1st percentile for new facilities (replacing in the NPRM the 25th percentile used for 2016 and 2017) and the 43rd percentile for consistent producers (replacing in the NPRM the 50th percentile used for 2016 and 2017). These percentile values, however, do not reflect the updated production data EPA has from liquid cellulosic biofuel producers in 2017.
EPA currently only has data on cellulosic biofuel production in 2017 through the end of September. While we believe that any final assessment of the accuracy of a projection method cannot be made until complete data for the year are available, we nevertheless believe it is appropriate to consider data from 2017 and adjust the percentile values used in the final rule as appropriate. To calculate the percentile values that would have resulted in a projection equal to the actual production volume for 2017 we first need to project the volume of cellulosic biofuel that will be produced in the 4th quarter of 2017 for each group of facilities.
The liquid cellulosic biofuel
Finally, we used these percentile values, together with the ranges determined for each group of companies discussed above, to project a volume for each group of companies in 2018. These calculations are summarized in Table III.D.1-6 below.
EPA also considered whether it would be appropriate to modify other individual components of the past methodology for projecting liquid cellulosic biofuel based on a narrow consideration of each factor, but we do not believe that such changes are warranted. Making the adjustment to the percentile values used in the methodology while keeping other components of the methodology constant should, we believe, provide an appropriate refinement of the methodology that reflects recent experience. We acknowledge, however, that using the calculated percentile values from previous years to project liquid cellulosic biofuel production in future years does not eliminate the possibility that actual production will differ from our projections. This is especially true for the liquid cellulosic biofuel industry, which is currently in the early stages of commercialization. Nevertheless, based on the record before us, we believe the ranges of projected production volumes for each company (or group of companies for those using the Edeniq technology) are reasonable, and that projecting overall production in 2018 in the manner described above results in a neutral estimate (neither biased to produce a projection that is too high or too low) of likely liquid cellulosic biofuel production in 2018 (14 million gallons).
For 2018, EPA is using a new methodology to project production of CNG/LNG derived from biogas used as transportation fuel. We believe a new
EPA received many comments on our proposed approach to projecting production of CNG/LNG derived from biogas in 2018. Some commenters critiqued EPA's calculation of a year-over-year rate of growth based on production during the first five months of 2017 (relative to production in the first five months of 2016) and suggested that EPA use updated production data in the final rule, or that EPA calculate the annual rate of growth based on comparisons of time periods no less than 12 months. Many commenters characterized EPA's proposed approach as inappropriately “backwards looking,” and claimed that while this approach may adequately project production from facilities that are currently producing CNG/LNG derived from biogas it did not adequately consider the new facilities the industry expects will begin production in 2018. Many of these commenters provided facility specific information on facilities capable of producing CNG/LNG derived from biogas in 2018 for both facilities that are currently producing CNG/LNG and those that expect to begin producing in 2018.
In this final rule EPA has used updated data in projecting the production of CNG/LNG derived from biogas, consistent with our stated intentions in the proposed rule and as requested by several commenters. At the time the analyses were performed for this final rule, EPA had data available through the end of September 2017. EPA has adjusted our calculated year-over-year rate of growth based on this new data. EPA also agrees with commenters who stated that it is more appropriate to calculate a year-over-year rate of growth using a full year's (12 months) worth of data, as this captures any seasonality and would (in future years) minimize the opportunity for producers of CNG/LNG derived from biogas to attempt to influence the projected growth rate for the next year by intentionally shifting production to particular months of the year.
For this final rule, EPA has calculated the year-over-year growth rate in CNG/LNG derived from biogas by comparing RIN generation from October 2016-September 2017 (the most recent 12 months for which data are available) to RIN generation in the 12 months that immediately precede this time period (October 2015-September 2016). These RIN generation volumes are shown in Table III.C.2-1 below.
EPA then applied this 21.6 percent year-over-year growth rate to the total number of 2016 cellulosic RINs generated for CNG/LNG that were available for compliance (185.14 million) to project the production of cellulosic RINs from these fuels in 2017, and then repeated the calculation to arrive at a projection for 2018. This methodology results in a projection of 273.6 million gallons of CNG/LNG derived from biogas in 2018.
EPA disagrees with commenters who claimed that a facility-by-facility approach to projecting cellulosic RIN generation for CNG/LNG derived from biogas would necessarily result in a more accurate projection than an industry-wide projection methodology. We continue to believe that in case of nascent industries with a small number of participants, such as the liquid cellulosic biofuel industry, industry wide projection methodologies may be inappropriate as they do not capture the specific circumstances that may impact each participant. In industries where the number of participants is small, failing to adequately assess each individual participant can have a significant impact on the overall accuracy of industry projections. However, as the number of market participants grows the impact of any single participant on the overall performance of the industry decreases. In these cases, industry-wide projection methods are more accurate than a more individualized approach, especially as macro market and economic factors become more influential on total production than the success or challenges at any single facility.
Further, the accuracy of a facility by facility approach to projecting production is heavily dependent on the accuracy of the information available to EPA on the projected RIN generation volumes of each of the potential production facilities for 2018. Conversely, the market wide approach used by EPA in this final rule relies on actual RIN generation data, rather than individual company projections for 2018, to calculate a demonstrated rate of growth. As the number of potential production facilities increases, EPA's ability to verify the accuracy of the information we receive, and make a determination about the likelihood that the producers will produce CNG/LNG derived from biogas at the projected levels decreases. This is especially challenging in situations where there are a large number of potential producers that have previously overestimated the actual production from their facilities. In our 2017 final rule, EPA projected that 26 new facilities would begin producing CNG/LNG derived from biogas in 2017, largely based on information we received from the renewable CNG/LNG industry through the Coalition for Renewable Natural Gas. While we currently only have data available for the first 9 months of 2017, to date only two new facilities have generated cellulosic RINs for CNG/LNG derived from biogas in 2017. While additional new facilities may generate cellulosic RINs for CNG/LNG derived from biogas in the final 3 months of 2017, many projected that they would be producing cellulosic RINs by this point in the year, and it is highly unlikely that all 26 of these facilities will successfully generate cellulosic RINs by the end of 2017. The failure of these new facilities to generate cellulosic RINs in 2017, together with the over-projection by many of the facilities that have generated cellulosic RINs in 2017 resulted in the facility specific approach recommended by many commenters appearing to have significantly over-estimated the production of CNG/LNG in 2017. EPA has therefore used an alternative methodology based on actual production data in previous years, rather than production projections by individual facilities, to project production of CNG/LNG derived from biogas in this final rule. We believe the production of CNG/LNG derived from biogas has matured to a point where an industry wide projection methodology is more appropriate than a facility by facility approach, and is likely to result in a more accurate projection. We will monitor the success of this new approach, and will make appropriate modifications in the future if warranted.
We also disagree with commenters who claim that our proposed projection methodology does not appropriately account for new facilities expected to begin producing CNG/LNG derived from biogas in 2018. The methodology used by EPA in this final rule compared the total projection of CNG/LNG derived from biogas from October 2016-September 2017 to production in the 12 months that immediately precede this time period (October 2015-September 2016). The production increases observed in October 2016-September 2017, as compared to the preceding 12 months, were the result of both increased production from facilities that had previously produced CNG/LNG derived from biogas as well as production from facilities that had not previously produced this fuel. For example, from October 2015-September 2016 a total of 34 facilities generated cellulosic RINs for CNG/LNG derived from biogas. From October 2016-September 2017 the number of facilities that produced cellulosic RINs for CNG/LNG derived from biogas increased to 41. We believe, therefore, that while our projection methodology uses a growth rate based on historical data it adequately anticipates higher production volumes in future years, including both increased production from existing facilities as well as production from new facilities. In this way it is a forward, rather than backward looking methodology that satisfies our charge to project future cellulosic biofuel production in a reasonable manner, and with neutrality.
After projecting production of cellulosic biofuel from liquid cellulosic biofuel production facilities and producers of CNG/LNG derived from biogas, EPA combined these projections to project total cellulosic biofuel production for 2018. These projections are shown in Table III.D.3-1. Using the methodologies described in this section, we project that 288 million ethanol-equivalent gallons of cellulosic biofuel will be produced in 2018. We believe that projecting overall production in 2018 in the manner described above results in a neutral estimate (neither biased to produce a projection that is too high nor too low) of likely cellulosic biofuel production in 2018.
Further discussion of the individual companies we believe will produce cellulosic biofuel and make it commercially available in 2018 can be found in a memorandum to the docket.
The national volume targets for advanced biofuel and total renewable fuel to be used under the RFS program each year through 2022 are specified in CAA section 211(o)(2)(B)(i)(I) and (II). Congress set annual renewable fuel volume targets that envisioned growth at a pace that far exceeded historical growth and, for years after 2011, prioritized that growth as occurring principally in advanced biofuels (contrary to previous growth patterns where most growth was in conventional renewable fuel, principally corn-ethanol). Congressional intent is evident in the fact that the portion of the total renewable fuel volume target in the statutory volume tables that is not required to be advanced biofuel is 15 billion gallons for all years after 2014, while the advanced volumes, driven by growth in cellulosic volumes, continue to grow through 2022 to a total of 21 billion gallons.
In this Section we discuss our use of the discretion afforded by the cellulosic waiver authority at CAA section 211(o)(7)(D)(i) to reduce volumes of advanced biofuel and total renewable fuel. We first discuss our assessment of advanced biofuel and the considerations, including comments received in response to the proposal and October 4 document, which have led us to conclude that the advanced biofuel volume target in the statute should be reduced by the full amount permitted under the cellulosic waiver authority. We then address total renewable fuel in the context of our interpretation, articulated in previous annual rulemakings, that advanced biofuel and total renewable fuel should be reduced by the same amount under the cellulosic waiver authority. In Section V we discuss our consideration of additional reductions for both advanced biofuel and total renewable fuel beyond those permitted under the cellulosic waiver authority, using other waiver authorities provided by the statute.
To begin, we have evaluated the capabilities of the market and are making a finding that the 11.0 billion gallons specified in the statute for advanced biofuel cannot be reached in 2018. This is primarily due to the expected continued shortfall in cellulosic biofuel; production of this fuel type has consistently fallen short of the statutory targets by 95 percent or more, and as described in Section III, we project that it will fall far short of the statutory target of 7.0 billion gallons again in 2018. In addition, although for the 2016 and 2017 standards we determined that the projected reasonably attainable supply of non-cellulosic advanced biofuel and other considerations justified establishing standards that included a partial backfill of the shortfall in cellulosic biofuel with advanced biofuel, for reasons described in this section we are reducing the advanced biofuel applicable volume by the full amount of the shortfall in cellulosic biofuel for 2018.
In previous years when exercising the cellulosic waiver authority to determine the required volume of advanced biofuel, we have taken into account the availability of advanced biofuels, their energy security and GHG impacts, and the apparent intent of Congress as reflected in the statutory volumes tables to substantially increase the use of advanced biofuels over time, as well as factors such as increased costs associated with the use of advanced biofuels and the environmental and food competition concerns raised by some commenters. In considering these factors, in those years, we have concluded that it was appropriate to set the advanced biofuel standard in a manner that would allow the partial backfilling of missing cellulosic volumes with non-cellulosic advanced biofuels. For purposes of this final rule we have again taken these factors into consideration, but rely more heavily on consideration of cost as a result of a stronger policy focus on the economic impacts of the RFS program to conclude that such backfilling with non-cellulosic advanced biofuel volumes should not be required in 2018. In other words, we are reducing the statutory volume target for advanced biofuel by the same amount as the reduction in cellulosic biofuel. This results in the non-cellulosic component of the advanced biofuel volume requirement being equal to the implied statutory volume of 4.00 billion gallons. We believe this new approach to balancing relevant considerations and exercising our discretion under the cellulosic waiver authority is permissible under the statute, and consistent with the principles articulated in
We note that the predominant non-cellulosic advanced biofuels available in the near term are advanced biodiesel and renewable diesel.
Furthermore, two other factors have added uncertainty regarding advanced biofuel volumes that are reasonably attainable and appropriate. The first is the fact that the tax credit for biodiesel has not been renewed, and if renewed could be in the form of a producer's tax credit rather than a blender's tax credit.
We believe that the factors and considerations noted above are all appropriately considered in our exercise of the broad discretion provided under the cellulosic waiver authority, and that a comprehensive consideration of these factors supports our use of the authority. Some of the considerations discussed in this final rule are related to the availability of non-cellulosic advanced biofuels (
The net impact of our exercise of the cellulosic waiver authority is that after waiving the cellulosic biofuel volume down to the projected available level, and applying the same volume reduction to the statutory volume target for advanced biofuel, the resulting volume requirement for advanced biofuel for 2018 is 10 million gallons more than the applicable volume used to derive the 2017 percentage standard. Furthermore, after applying the same reduction to the statutory volume target for total renewable fuel, the volume requirement for total renewable fuel is also 10 million gallons more than the applicable volume used to derive the 2017 percentage standard. The remainder of this section provides our justification for this approach to the determination of the volume requirements for advanced biofuel and total renewable fuel. Section V discusses our consideration of further reductions in either advanced biofuel or total renewable fuel using either the general waiver authority or the BBD waiver authority, and our justification for not applying such further reductions.
As described in Section II.A, when making reductions in advanced biofuel and total renewable fuel under the cellulosic waiver authority, the statute limits those reductions to no more than the reduction in cellulosic biofuel. As described in Section III.D, we are establishing a 2018 applicable volume for cellulosic biofuel of 288 million gallons, representing a reduction of 6,712 million gallons from the statutory target of 7,000 million gallons. As a result, 6,711 million gallons is the maximum volume reduction for advanced biofuel and total renewable fuel that is permissible using the cellulosic waiver authority. Use of the cellulosic waiver authority to this maximum extent would result in volumes of 4.29 and 19.29 billion gallons for advanced biofuel and total renewable fuel, respectively.
We are authorized under the cellulosic waiver authority to reduce the advanced biofuel and total renewable fuel volumes “by the same or a lesser” amount as the reduction in the cellulosic biofuel volume. As discussed in Section II.A, EPA has broad discretion in using the cellulosic waiver authority in instances where its use is authorized under the statute, since Congress did not specify factors that EPA must consider in determining whether to use the authority or what the appropriate volume reductions (within the range permitted by statute) should be. This broad discretion was affirmed in both
It is appropriate to consider the availability of advanced biofuel, both to inform our exercise of the cellulosic waiver authority and to ascertain whether there might be an “inadequate domestic supply” justifying use of the general waiver authority. As the Court noted in
In
As noted above, a higher advanced biofuel volume requirement has a greater potential to increase the incentive for switching advanced biofuel feedstocks from existing uses to biofuel production. Such market reactions could cause disruptions and/or price increases in the non-biofuel markets that currently use these feedstocks. Increasing the required volumes of advanced biofuels without giving the market adequate time to adjust by increasing supplies could also result in diversion of advanced biofuels from foreign countries to the U.S. without increasing total global volumes. We believe it is likely that the parties that formerly used advanced biofuel feedstocks would seek to replace the advanced biofuel feedstocks with the cheapest alternatives, likely products derived from palm oil or petroleum, rather than forgoing the use of oil-based products. Increasing volumes of advanced biofuels used in the U.S. in this way (by shifting the end use of advanced feedstocks to biofuel production and satisfying the current markets for these advanced feedstocks with non-qualifying or petroleum based feedstocks, or by simply shifting advanced biodiesel or renewable diesel from foreign to domestic use—referred to for simplicity as “feedstock/fuel diversions”) would therefore likely not produce the GHG benefits that would otherwise be expected. We have decided not to set the advanced biofuel volume requirement at a level that would require such feedstock/fuel diversions. Our individual assessments of reasonably attainable volumes of advanced biofuels reflect this approach. That is, while we refer to them as “reasonably attainable” volumes for convenience, they represent those volumes that are not likely to lead to feedstock/fuel diversions. Greater volumes could likely be made available if such diversions were not of concern.
The predominant available source of advanced biofuel other than cellulosic biofuel and BBD is imported sugarcane ethanol. In setting both the 2016 and 2017 standards, we determined that 200 million gallons of imported sugarcane ethanol would be reasonably attainable. In deriving this estimate of sugarcane ethanol, we attempted to balance indications of lower potential imports from recent data with indications that higher volumes were possible based on older data. We also pointed to the high variability in ethanol import volumes in the past (including of Brazilian sugarcane ethanol, the predominant form of imported ethanol, and the only significant source of imported advanced ethanol), increasing gasoline consumption in Brazil, and variability in Brazilian production of sugar as reasons that it would be inappropriate to assume that sugarcane ethanol imports would reach the much higher levels suggested by some stakeholders.
The data on 2016 ethanol imports suggests that we overestimated the volume of sugarcane ethanol imports for that year. Despite the fact that the applicable standards for 2016 were set prior to the beginning of 2016, and despite suggestions from UNICA
Available data for imports in 2017 similarly suggests that imports are again likely to fall well below the 200 million gallons that we assumed when setting the 2017 standards; for January through August of 2017, total imports of sugarcane ethanol were 75 million gallons; by the end of 2017, total imports of sugarcane ethanol might be about 100 million gallons.
We note that the future projection of imports of sugarcane ethanol is inherently imprecise, and that actual imports in 2018 could be lower or higher than 100 million gallons. Factors that could result in import volumes below 100 million gallons include weather and harvests in Brazil, world ethanol demand and prices, and constraints associated with the E10 blendwall in the U.S. Also, global sugar consumption has continued to increase steadily, while production has decreased. If the trend continues, Brazilian production of sugar could increase, with a concurrent reduction in production of ethanol.
With regard to biodiesel and renewable diesel, there are many different factors that could potentially influence the
However, the primary considerations in our determination of the reasonably attainable volumes of
The volume of advanced biodiesel and renewable diesel projected to be available based on a consideration of these factors is less than the maximum volume of biodiesel and renewable diesel we believe could be produced (based solely on an assessment of the available production capacity) or consumed (based on an assessment of the ability of the market to distribute and use biodiesel and renewable diesel). Production capacity and the ability for the market to distribute and use biodiesel and renewable diesel are therefore not constraining factors in our assessment of the reasonably attainable volume of advanced biodiesel and renewable diesel in 2018.
Before considering the projected growth in the production of qualifying feedstocks that could be used to produce advanced biodiesel and renewable diesel, it is helpful to review the volumes of biodiesel and renewable diesel that have been used in the U.S. in recent years. While historic data and trends alone are insufficient to project the volumes of biodiesel and renewable diesel that could be provided in future years, historic data can serve as a useful frame of reference in considering future volumes. Past experience suggests that a high percentage of the biodiesel and renewable diesel used in the U.S. (from both domestic production and imports) qualifies as advanced biofuel.
Since 2011 the year-over-year changes in the volume of advanced biodiesel and renewable diesel in the U.S. have varied greatly, from a low of negative 61 million gallons from 2011 to 2012 to a high of 779 million gallons from 2015 to 2016. These changes were likely influenced by a number of factors such as the cost of biodiesel feedstocks and petroleum diesel, the status of the biodiesel blenders tax credit, growth in marketing of biodiesel at high volume truck stops and centrally fueled fleet locations, demand for biodiesel and renewable diesel in other countries, biofuel policies in both the U.S. and foreign countries, and the volumes of renewable fuels (particularly advanced biofuels) required by the RFS. This historical information does not indicate that the maximum previously observed increase of 779 million gallons of advanced biodiesel and renewable diesel would be reasonable to expect from 2017 to 2018, nor does it indicate that the low growth rates observed in other years represent the limit of potential growth in 2018. Rather, these data illustrate both the magnitude of the increases in advanced biodiesel and renewable diesel in previous years and the significant variability in these increases.
The historic data indicates that the biodiesel tax policy in the U.S. can have a significant impact on the supply of biodiesel and renewable diesel in any given year. While the biodiesel blenders tax credit has applied in each year from 2010-2016, it has only been in effect during the calendar year in 2011, 2013 and 2016, while other years it has been applied retroactively. The biodiesel blenders tax credit expired at the end of 2009 and was re-instated in December 2010 to apply retroactively in 2010 and extend through the end of 2011. Similarly, after expiring at the end of 2011, 2013, and 2014 the tax credit was re-instated in January 2013 (for 2012 and 2013), December 2014 (for 2014), and December 2015 (for 2015 and 2016). Each of the years in which the biodiesel blenders tax credit was in effect during the calendar year (2013 and 2016) resulted in significant increases in the supply of advanced biodiesel and renewable diesel over the previous year (653 million gallons and 779 million gallons respectively). However, following this large increase in 2013, the increase in the supply of advanced biodiesel and renewable diesel in 2014 and 2015 was minimal, only 33 million gallons from 2013 to 2015. This pattern is likely the result of both accelerated production and/or importation of biodiesel and renewable diesel in the final few months of 2013 to take advantage of the expiring tax credit as well as relatively lower volumes of biodiesel and renewable diesel production and import in 2014 and 2015 than would have occurred if the tax credit had been in place.
We believe it is reasonable to anticipate a similar production pattern in 2016 through 2018 as observed in 2013 through 2015; that increases in the volumes of advanced biodiesel and renewable diesel will be modest in 2017 and 2018, following the significant increase in 2016. In 2013 the tax credit was in place through the entire year. This was followed by two years (2014 and 2015) in which the tax credit was not in place, but was eventually reinstated retroactively. Similarly, the tax credit in place through 2016, but at the time of this rulemaking not applicable to 2017 or 2018.
After reviewing the historical supply of advanced biodiesel and renewable diesel and consideration of the possible impact of the expiration of the biodiesel tax credit (discussed above), EPA next considered the expected increase in the availability of advanced biodiesel and renewable diesel feedstocks in 2018. We acknowledge that an increase in the required use of advanced biodiesel and renewable diesel could be realized through a diversion of advanced feedstocks from other uses, or a diversion of advanced biodiesel and renewable diesel from existing markets in other countries. We perceive the net benefits associated with such increased advanced biofuel and renewable fuel volumes to be significantly less than the net benefits associated with the production of additional advanced biodiesel and renewable diesel with the use of newly-available advanced feedstocks due to the likelihood that parties that previously used advanced biofuel feedstocks will replace them with low cost palm or petroleum derived products. This is both because of the potential disruption and associated cost impacts to other industries resulting from feedstock switching, and a reduced GHG reduction benefit related to use of feedstocks for biofuel production that would have been used for other purposes and which must then be backfilled with other feedstocks with potentially greater GHG emissions. Similarly, increasing the supply of biodiesel and renewable diesel to the U.S. by diverting fuel that would otherwise have been used in other countries results in lesser GHG benefits than if the supply of these fuels was increased through additional biofuel production, especially if this diversion results in increased consumption of petroleum fuels in the countries that would have otherwise consumed the biodiesel or renewable diesel. By focusing our assessment of the potential growth in the reasonably attainable volume of biodiesel and renewable diesel on the expected growth in the production of advanced feedstocks (rather than the total supply of these feedstocks in 2018, which would include feedstocks currently being used for non-biofuel purposes), we are attempting to minimize the incentives for the RFS program to increase the supply of advanced biodiesel and renewable diesel through feedstock switching or diverting biodiesel and renewable diesel from foreign market to the U.S.
Advanced biodiesel and renewable diesel feedstocks include both waste oils, fats and greases and oils from planted crops. While we believe a small increase in supply of waste oils, fats, and greases may be possible in 2018, we believe this increase is limited as most of these oils, fats, and greases are already being recovered and used in biodiesel and renewable diesel production or for other purposes. Many of the planted crops that supply vegetable oil for advanced biodiesel and renewable diesel production are primarily grown for purposes other than providing feedstocks for biodiesel and renewable diesel, such as for livestock feed with the oil that is used as feedstock for renewable fuel production a co-product or by-product.
Increasing the demand for advanced biodiesel and renewable diesel beyond the volumes that could be made from the projected increase in the feedstocks used to produce these fuels would likely require diverting volumes of advanced biodiesel and renewable diesel (or the feedstocks used to produce these fuels) from existing markets to be used to produce biofuels supplied to the U.S. Increasing the short-term supply of advanced biodiesel and renewable diesel to the U.S. in this manner (simply shifting the end use of advanced feedstocks to biodiesel and renewable diesel production and meeting non-biofuel demand for these feedstocks with conventional renewable and/or petroleum based feedstocks or diverting advanced biodiesel and renewable diesel from foreign markets to the U.S.) may not advance the full GHG or energy security goals of the RFS program. In a worst case scenario, higher standards could cause supply disruptions to a number of markets as biodiesel and renewable diesel producers seek additional supplies of advanced feedstocks and the parties that previously used these feedstocks, both within and outside of the fuels marketplace, seek out alternative feedstocks. Similarly, advanced biodiesel and renewable diesel could be diverted to the U.S. from foreign countries and displaced with petroleum fuels. These actions could result in significant cost increases, for both biodiesel and renewable diesel as well as other products produced from renewable oils, with reduced GHG benefits.
We believe the most reliable source for projecting the expected increase in vegetable oils in the U.S. is USDA's World Agricultural Supply and Demand Estimates (WASDE). According to the September 2017 WASDE report, domestic vegetable oil production is expected to increase by 0.33 million metric tons in 2018, from 11.42 million metric tons in the 2016/2017 agricultural marketing year to 11.75 million metric tons in the 2017/2018 agricultural marketing year.
In addition to virgin vegetable oils, we also expect increasing volumes of distillers corn oil
We have also considered the expected increase in the imports of advanced biodiesel and renewable diesel produced in other countries. In previous years, significant volumes of foreign produced advanced biodiesel and renewable diesel have been supplied to markets in the U.S. (see Table IV.B.2-1 above). These significant imports were likely the result of a strong U.S. demand for advanced biodiesel and renewable diesel, supported by the RFS standards, the LCFS in California, the biodiesel blenders tax credit, and the opportunity for imported biodiesel and renewable diesel to realize these incentives. At this time the impact of the expiration of the biodiesel blenders tax credit on the volumes of foreign-produced biodiesel and renewable diesel imported into the U.S., is highly uncertain. Additionally, in August 2017 the Department of Commerce announced a preliminary determination that it would be appropriate to place countervailing duties of 41 percent to 68 percent on biodiesel imported from Argentina and Indonesia. According to data from EIA, biodiesel imports from Argentina were 10,679 thousand barrels in 2016 (approximately 449 million gallons) and 5,601 billion barrels (approximately 235
After a careful consideration of the factors discussed above, EPA has determined, for the purposes of this final rule, that approximately 2.55 billion gallons of advanced biodiesel and renewable diesel is reasonably attainable for use in our determination of the appropriate applicable volume of advanced biofuel to require for 2018. This volume is 150 million gallons higher than the volume of advanced biodiesel and renewable diesel determined to be reasonably attainable and appropriate for the purposes of deriving the advanced biofuel standard in 2017.
The 150 million gallon increase in advanced biodiesel and renewable diesel that we project will be reasonably attainable for 2018 represents a smaller annual increase in advanced biodiesel and renewable diesel than we assumed in deriving the 2017 advanced biofuel standard (approximately 300 million gallons over 2016 levels). We believe that this reflects that the circumstances presented with respect to 2018 are different from those we anticipated for 2017. The primary differences are a smaller projected increase in advanced feedstock production in the U.S., the continued absence of the biodiesel tax credit, and the preliminary determination placing duties on biodiesel imported from Argentina and Indonesia.
In addition to cellulosic biofuel, imported sugarcane ethanol, and advanced biodiesel and renewable diesel, there are other advanced biofuels that can be counted in the determination of reasonably attainable volumes of advanced biofuel for 2018. These other advanced biofuels include biogas, naphtha, heating oil, butanol, jet fuel, and domestically-produced advanced ethanol.
The downward trend over time in biogas as advanced biofuel with a D code of 5 is due to the re-categorization in 2014 of landfill biogas from advanced (D code 5) to cellulosic (D code 3).
We recognize that the potential exists for additional volumes of advanced biofuel from sources such as jet fuel, liquefied petroleum gas (LPG), and liquefied natural gas (as distinct from compressed natural gas), as well as non-cellulosic biogas such as from digesters. However, since they have been produced in only de minimis and sporadic amounts in the past, we do not have a basis for projecting substantial volumes from these sources in 2018.
The total volume of advanced biofuel that we believe is reasonably attainable in 2018 is the combination of cellulosic biofuel and the sources described above: imported sugarcane ethanol, biodiesel and renewable diesel which qualifies as BBD, and other advanced biofuels such as advanced biogas that does not qualify as cellulosic biofuel, heating oil, naphtha, domestic advanced ethanol, and advanced renewable diesel that does not qualify as BBD. Our assessment of the reasonably attainable volumes of these sources, discussed in the preceding sections, is summarized below. We note that the reasonably attainable volumes of each of these advanced biofuels cannot themselves be viewed as volume requirements. The volumes for each advanced biofuel type represent one significant factor that is considered in the analysis used to determine the reasonably attainable volumes of advanced biofuel. As discussed in more detail in a memorandum to the docket, there are many ways that the market could respond to the percentage standards we establish, including use of higher or lower volumes of these fuel types than
Based on the information presented above, we believe that 4.40 billion gallons of advanced biofuel would be reasonably attainable in 2018. This volume is 110 million gallons higher than the 4.29 billion gallons that would result from reducing the applicable volume of advanced biofuel by the same amount as the reduction to the statutory applicable volume of cellulosic biofuel (see Section III for a discussion of the cellulosic biofuel volume requirement for 2018). In exercising the cellulosic waiver authority in past years, we determined it was appropriate to require a partial backfilling of missing cellulosic volumes with volumes of non-cellulosic advanced biofuel we determined to be reasonably attainable and appropriate, notwithstanding the increase in costs associated with this decision.
In Section IV.E we present illustrative cost projections for sugarcane ethanol and soybean biodiesel in 2018, the two advanced biofuels that would be most likely to provide the marginal increase in volumes of advanced biofuel in 2018 in comparison to 2017. Sugarcane ethanol results in a cost increase compared to gasoline that ranges from $0.61-$1.56 per ethanol-equivalent gallon.
Based on consideration of the volumes that may be reasonably attainable in 2018, along with a balancing of the costs and benefits associated with the option of setting the advanced biofuel standard at a level that would require use of all volumes that we have estimated could be reasonably attainable, we are exercising our cellulosic waiver authority to reduce advanced biofuel volumes to 4.29 billion gallons for 2018.
It should be noted that by exercising the full cellulosic waiver authority for advanced biofuel, the implied statutory volume target for non-cellulosic advanced biofuel of 4.0 billion gallons in 2018 is maintained. Although the implied volume for non-cellulosic advanced biofuel in the statute increases from 3.5 billion gallons in 2017 to 4.0 billion gallons in 2018, the applicable volume requirements for 2017 as finalized by EPA included an allowance for 4.0 billion gallons of non-cellulosic advanced biofuel, one year before envisioned by the statute. Through our 2017 action, we effectively required early use of the 0.5 billion gallon increment of non-cellulosic advanced volume that Congress envisioned would be first used in 2018. The net result of our action for 2018, after deciding that no further reductions beyond those obtained by exercise of the cellulosic waiver authority are appropriate (see Section V), is that the advanced biofuel volume requirement for 2018 is 10 million gallons higher than the advanced biofuel volume requirement for 2017, but the portion of this volume requirement that may be satisfied with non-cellulosic biofuels remains constant.
As discussed in Section II.A.1, we believe that the cellulosic waiver provision is best interpreted to provide equal reductions in advanced biofuel and total renewable fuel. We have consistently articulated this interpretation.
Applying an equal reduction of 6.71 billion gallons to both the statutory target for advanced biofuel and the statutory target for total renewable fuel results in a total renewable fuel volume of 19.29 billion gallons as shown in Table IV.A-1.
In this section, EPA presents its assessment of the illustrative costs of the final 2018 RFS rule. It is important to note that these illustrative costs do not attempt to capture the full impacts of this final rule. These estimates are provided solely for the purpose of showing how the cost to produce a gallon of a “representative” renewable fuel compares to the cost of petroleum fuel. There are a significant number of caveats that must be considered when interpreting these cost estimates. There are a number of different feedstocks that could be used to produce biofuels, and there is a significant amount of heterogeneity in the costs associated with these different feedstocks and fuels. Some renewable fuels may be cost competitive with the petroleum fuel they replace; however, we do not have cost data on every type of feedstock and every type of fuel. Therefore, we do not attempt to capture this range of potential costs in our illustrative estimates.
The annual standard-setting process encourages consideration of the RFS program on a piecemeal (
To provide an illustrative estimate of the cost of the 2018 cellulosic biofuel requirements, EPA has compared the 2018 cellulosic biofuel volume requirements to the statutory volume that would be required absent the exercise of our cellulosic waiver authority under CAA section 211(o)(7)(D)(i).
To estimate the overall cost savings from waiving the cellulosic biofuel volumes, EPA has taken the following steps. First, EPA determined the magnitude of the volume reduction of cellulosic biofuel we are establishing in this rule, relative to the statutory volume. In this rule we are reducing the required volume of cellulosic biofuel by 6.71 billion gallons, with corresponding reductions in the advanced biofuel and total renewable fuel standards. Second, we estimated the per-gallon costs of producing cellulosic ethanol derived from corn kernel fiber that would be expected in complying with the standards. Third, the per-gallon costs of cellulosic biofuel from corn fiber were multiplied by 6.71 billion gallons.
While there may be growth in other cellulosic biofuel sources, for this exercise we believe it is appropriate to use corn kernel fiber as the representative cellulosic biofuel. The majority of liquid cellulosic biofuel in 2018 is expected to be produced using this technology, and application of this technology in the future could result in significant incremental volumes of cellulosic biofuel. In addition, as explained in Section III.D.2, we believe that production of the major alternative cellulosic biofuel—CNG/LNG derived from biogas—is limited to approximately 580 million gallons due to a limitation in the number of vehicles capable of using this form of fuel.
EPA uses a “bottom-up” engineering cost analysis to quantify the costs of producing a gallon of cellulosic ethanol derived from corn kernel fiber. There are multiple processes that could yield cellulosic ethanol from corn kernel fiber. EPA assumes a cellulosic ethanol production process that generates biofuel using distiller's grains, a co-product of generating corn starch ethanol that is commonly dried and sold into the feed market as distillers dried grains with solubles (DDGS), as the renewable biomass feedstock. We assume an enzymatic hydrolysis process with cellulosic enzymes to break down the cellulosic components of the distiller's grains. This process for generating cellulosic ethanol is similar to approaches currently used by industry to generate cellulosic ethanol at a commercial scale, and we believe these costs estimates are likely representative of the range of different technology options being developed to produce ethanol from corn kernel fiber. We then compare the per-gallon wholesale costs of the cellulosic ethanol to the petroleum fuels that would be replaced.
These cost estimates do not consider taxes, retail margins, or other costs or transfers that occur at or after the point of blending (transfers are payments within society and are not additional costs). We do not attempt to estimate potential cost savings related to avoided infrastructure costs (
Table IV.E.1-1 below presents the cost savings associated with this final rule that are estimated using this approach.
We recognize that
EPA is providing an illustrative cost analysis for the increase in the overall advanced biofuel volume of 10 million ethanol equivalent gallons (as compared to 2017 volumes) using four different scenarios, assuming this increase in advanced biofuel volumes is comprised of: (1) cellulosic biofuel from CNG/LNG, (2) cellulosic biofuel from corn kernel fiber, (3) soybean oil BBD, or (4) sugarcane ethanol from Brazil. Showing the illustrative costs of soybean oil BBD and sugarcane ethanol is consistent with the methodology EPA developed for previous rulemakings. However, this discussion should not be interpreted as suggesting that the various renewable fuel types discussed are necessarily available in the marketplace. The availability of different types of renewable fuel is discussed in other sections of this preamble; in this section we assess costs as if the different fuel types are available, without intending to suggest that they are.
In previous annual RFS rules, EPA provided an illustrative cost estimate for the entire change in the total renewable fuel volume standard assuming it was satisfied with conventional (
As described earlier, we are focusing on the wholesale level in our cost scenarios, and do not consider taxes, retail margins, additional infrastructure, or other costs or transfers that occur at or after the point of blending. More background information on this section, including details of the data sources used and assumptions made for each of the scenarios, can be found in a memorandum available in the docket.
Table IV.E.2-1 below presents estimates of per energy-equivalent gallon costs for producing soybean biodiesel, Brazilian sugarcane ethanol, CNG/LNG derived from landfill biogas, and cellulosic ethanol derived from corn fiber relative to the petroleum fuels they replace at the wholesale level. For each of the four scenarios, these per-gallon costs are then multiplied by the 10 million ethanol-equivalent gallon increase in the 2018 advanced standard relative to the previous 2017 standard to obtain an overall cost estimate.
Based
As discussed in previous sections, we are reducing the statutory volume target for cellulosic biofuel to reflect the projected production volume of that fuel type in 2018, and we are reducing both advanced biofuel and total renewable fuel by the maximum permissible amount authorized under the cellulosic waiver authority in CAA section 211(o)(7)(D)(i).
We have also considered whether it would be appropriate to provide further reductions for these renewable fuel categories pursuant to the general waiver authority in CAA section 211(o)(7)(A), or for these renewable fuel categories and the 2018 BBD using the BBD waiver authority in CAA section 211(o)(7)(E). We have concluded that further reductions in volumes using any of these other waiver authorities are not warranted. We note that in the October 4
As a result, we are finalizing advanced biofuel and total renewable fuel volume requirements resulting from the exercise of the cellulosic biofuel waiver authority alone, and we are not modifying the 2018 BBD applicable volume of 2.1 billion gallons established through a prior rulemaking. The implied volume for conventional renewable fuel (calculated by subtracting the advanced volume from the total volume) will be 15.0 billion gallons, consistent with the statutory target provided in the statute for 2018.
On July 21, 2017, we proposed to reduce the 2018 statutory volume targets for advanced biofuel and total renewable fuel by the maximum permissible amount using the cellulosic waiver authority, and not to reduce these volumes further using other authorities. However, we requested comment on the possible additional use of the general waiver authority or other authorities to provide further reductions in the proposed volume requirements.
In Section III we discussed our projection that 288 million gallons of cellulosic biofuel will be made available in 2018. In Section IV we described our assessment that about 4.40 billion gallons of advanced biofuel would be reasonably attainable in 2018 from both domestic production and imports but that, after considering a number of factors, such as the potential for feedstock/fuel diversions and cost of advanced biofuel, we would exercise our discretion to use the full cellulosic waiver authority to reduce the applicable volume to 4.29 billion gallons.
Having determined that there will not be an inadequate domestic supply of advanced biofuel, we further considered whether there may be an inadequate domestic supply to satisfy the portion of the total renewable fuel volume requirement that can be satisfied with non-advanced (conventional) renewable fuel. After application of the full cellulosic waiver authority to the advanced biofuel and total renewable
In the October 4 document, we discussed comments on the proposal suggesting that EPA should interpret the undefined term “domestic” in the phrase “inadequate domestic supply” to account for only volumes of renewable fuel that are produced domestically. If EPA were to adopt this interpretation, we could exclude potential imports of renewable fuel in our assessment of domestic supply but, even if we found domestic supply to be inadequate, could take factors such as potential imports and the availability of carryover RINs into account in determining the extent to which we should exercise our discretion to grant a waiver on the basis of inadequate domestic supply.
In light of the fact that the domestic production capacity of conventional biofuel volumes is in excess of 15 billion gallons, whether we were to exclude imported biofuels from our consideration of domestic supply would primarily impact our assessment of the supply of cellulosic biofuel and advanced biofuel volumes, not conventional renewable fuel. With respect to cellulosic biofuel, we note that the vast majority of the supply in 2018 is expected to come from domestic sources. In fact, if EPA excluded consideration of projected cellulosic biofuel imports, our projection of the available volume of cellulosic biofuel in 2018 would be reduced by only 2 million gallons or less than 1 percent of our projection that 288 million cellulosic biofuel gallons will be made available in 2018. Given the importance that Congress placed on the growth of cellulosic biofuel volumes, our projection that compliance with a 288 million gallon requirement is feasible using RINs generated in 2018, and the availability of carryover cellulosic biofuel RINs and cellulosic waiver credits for additional compliance flexibility, EPA would not exercise its discretion to lower the 288 million gallon projected cellulosic biofuel volume by 2 million gallons even if EPA were to interpret the term “domestic supply” to exclude imported volumes.
With respect to the available supply of advanced biofuel in 2018 in the context of an interpretation of inadequate domestic supply that excludes imports, several commenters noted the data provided by EPA in the October 4 document indicating that a significant portion of the advanced biofuel available in previous years has been from imported biofuels, particularly imported biodiesel and renewable diesel. Some commenters pointed to total domestic production capacity and feedstock availability to argue that domestic producers are capable of compensating for volumes that would not be provided through imports, so that even under an interpretation of “domestic supply” that excluded imports, EPA would not be justified in reducing volumes on the basis of inadequate domestic supply to a level below what was proposed. Others suggested that, without imported volumes, the domestic industry could not ramp up production quickly enough to compensate for the exclusion of imports from our analysis and provide a “domestic supply” equal to the proposed 2018 volume requirements.
The proposal and October 4 document requested comment on the possibility of further reductions in the proposed volume requirements, including on the basis of a severe economic harm. We received comments from stakeholders both in support of, and opposed to, further reductions in the advanced biofuel and/or total renewable fuel volume requirements based on a finding of severe economic harm. For instance, several obligated parties stated that the purchase of RINs to comply with the applicable standards represents a significant economic burden to their companies. Some also indicated that they are considering filing for bankruptcy. However, these commenters did not provide sufficient evidence that the purchase of RINs, as opposed to other market factors, is responsible for the company's difficult economic circumstances, or why they cannot recoup the cost of RINs through higher prices of their products, or the arguments presented were unconvincing.
In addition to reviewing comments on the proposed rule and the October 4 document, EPA also reviewed market data from 2017 and previous years to see if there was evidence that the RFS standards are currently causing severe economic harm, or would be likely to cause severe economic harm in 2018. Given that the 2018 volumes generated through the maximum reduction permitted under the cellulosic waiver authority are nearly the same as the volume requirements for 2017, we considered:
1. Whether severe economic harm has occurred to date or is likely to occur in 2017, and
2. whether the economic conditions in 2018 might be expected to be substantially different than those in 2017.
To determine whether severe economic harm has occurred to date or is likely to occur in in 2017, we investigated several possible indicators. These included RIN generation for 2017 relative to 2016, refinery closures, retail fuel prices, and corn and soybean prices. Based on our investigation, we do not believe that severe economic harm has occurred thus far in 2017 to any State, region, or the U.S. as a result of the 2017 standards, or is likely occur by the end of 2017. Details of this investigation can be found in a memorandum to the docket.
To determine whether the economic conditions in 2018 might be expected to be substantially different than those in 2017 in ways that could affect the economic impact of compliance with the RFS program, we investigated projections of two primary drivers of the cost of compliance: Crop-based feedstock futures prices, and projected gasoline demand. We also investigated the potential market impacts of the final 2018 standards, most specifically in terms of ethanol and biodiesel consumption.
Based on the record before us, we do not believe that there is sufficient evidence to conclude that severe economic harm is occurring currently in 2017 in any State, region, or the United States, and we do not believe that market conditions in 2018 are likely to cause compliance with the applicable standards to be more economically challenging than it is in 2017. Given that the 2018 standards are very similar to the 2017 standards, then, we do not believe that further reductions in the 2018 volume requirements on the basis of severe economic harm are warranted.
EPA received comments in response to the proposal asserting that there are negative environmental impacts that may be associated with the RFS program. A significant portion of these concerns center on feedstock production. Although we are authorized to reduce the statutory volume targets on the basis of a finding that the requirements would “severely harm the . . . environment of a State, region, or the United States,” commenters have not presented evidence sufficient to support a determination to make a reduction on this basis for 2018. EPA is not making reductions on this basis for 2018. EPA's response to comments related to perceived environmental harms of the RFS program is set forth in the RTC document accompanying this rule.
The BBD waiver authority in CAA section 211(o)(7)(E)(ii) provides that if EPA determines that there is a significant renewable feedstock disruption or other market circumstance that would make the price of BBD increase significantly, then EPA shall, in consultation with the Secretary of Energy and the Secretary of Agriculture, issue an order to reduce, for up to a 60-day period, the annual volume requirement for BBD by an appropriate quantity that does not exceed 15 percent. If EPA reduces the annual volume requirement for BBD using this waiver authority, we may also reduce the applicable volume of advanced biofuel and total renewable fuel by an equal or lesser volume than the reduction in BBD. In the October 4 document we requested comment on the expected impact on the price of BBD of the expiration of the biodiesel blenders tax credit, proposed import duties on biodiesel from Argentina and Indonesia, or any other factors. We further requested comment on whether any expected impacts should be considered significant for the purposes of the BBD waiver authority.
To investigate whether a reduction in the 2018 BBD volume requirement would be warranted under CAA section 211(o)(7)(E)(ii), we considered current and historical prices of unblended biodiesel (B100), the price of blended biodiesel (in particular, B20), and BBD (D4) RIN prices. The results of this investigation are described in a memorandum to the docket.
Based on the information before us, including the results of our investigation and information and comments submitted in response to the October 4 document, we have concluded that there is not sufficient evidence of a significant increase to the price of BBD due to feedstock disruption or other relevant market circumstances to justify reductions to the 2018 BBD volume requirement using the biomass-based diesel waiver authority.
In this section we discuss the BBD applicable volume for 2019. We are establishing this volume in advance of those for other renewable fuel categories in light of the statutory requirement in CAA section 211(o)(2)(B)(ii) to establish the applicable volume of BBD for years after 2012 no later than 14 months before the applicable volume will apply. We are not at this time establishing the BBD percentage standards that would apply to obligated parties in 2019 but
The statute establishes applicable volume targets for years through 2022 for cellulosic biofuel, advanced biofuel, and total renewable fuel. For BBD, applicable volume targets are specified in the statute only through 2012. For years after those for which volumes are specified in the statute, EPA is required under CAA section 211(o)(2)(B)(ii) to determine the applicable volume of BBD, in coordination with the Secretary of Energy and the Secretary of Agriculture, based on a review of the implementation of the program during calendar years for which the statute specifies the volumes and an analysis of the following factors:
1. The impact of the production and use of renewable fuels on the environment, including on air quality, climate change, conversion of wetlands, ecosystems, wildlife habitat, water quality, and water supply;
2. The impact of renewable fuels on the energy security of the United States;
3. The expected annual rate of future commercial production of renewable fuels, including advanced biofuels in each category (cellulosic biofuel and BBD);
4. The impact of renewable fuels on the infrastructure of the United States, including deliverability of materials, goods, and products other than renewable fuel, and the sufficiency of infrastructure to deliver and use renewable fuel;
5. The impact of the use of renewable fuels on the cost to consumers of transportation fuel and on the cost to transport goods; and
6. The impact of the use of renewable fuels on other factors, including job creation, the price and supply of agricultural commodities, rural economic development, and food prices.
The statute also specifies that the volume requirement for BBD cannot be less than the applicable volume specified in the statute for calendar year 2012, which is 1.0 billion gallons. The statute does not, however, establish any other numeric criteria, or provide any guidance on how the EPA should weigh the importance of the often competing factors, and the overarching goals of the statute when the EPA sets the applicable volumes of BBD in years after those for which the statute specifies such volumes. In the period 2013-2022, the statute specifies increasing applicable volumes of cellulosic biofuel, advanced biofuel, and total renewable fuel, but provides no guidance, beyond the 1.0 billion gallon minimum, on the level at which BBD volumes should be set.
In establishing the BBD and cellulosic standards as nested within the advanced biofuel standard, Congress clearly intended to support development of BBD and especially cellulosic biofuels, while also providing an incentive for the growth of other non-specified types of advanced biofuels. That is, the advanced biofuel standard provides an opportunity for other advanced biofuels (advanced biofuels that do not qualify as cellulosic biofuel or BBD) to compete with cellulosic biofuel and BBD to satisfy the advanced biofuel standard after the cellulosic biofuel and BBD standards have been met.
One of the primary considerations in determining the BBD volume for 2019 is a review of the implementation of the program to date, as it affects BBD. This review is required by the CAA, and also provides insight into the capabilities of the industry to produce, import, export, and distribute BBD. It also helps us to understand what factors, beyond the BBD standard, may incentivize the production and import of BBD. The number of BBD RINs generated, along with the number of RINs retired due to export or for reasons other than compliance with the annual BBD standards from 2011-2018 are shown in Table VI.B.1-1 below.
In reviewing historical BBD RIN generation and use, we see that the number of RINs available for compliance purposes exceeded the volume required to meet the BBD standard in 2011, 2012, 2013, and 2016. Additional production and use of biodiesel was likely driven by a number of factors, including demand to satisfy the advanced biofuel and total renewable fuels standards, the biodiesel tax credit,
The prices paid for advanced biofuel and BBD RINs beginning in early 2013 through the end of 2016 also support the conclusion that advanced biofuel and/or total renewable fuel standards provide a sufficient incentive for additional biodiesel volume beyond what is required by the BBD standard. Because the BBD standard is nested within the advanced biofuel and total renewable fuel standards, and therefore can help to satisfy three RVOs, we would expect the price of BBD RINs to exceed that of advanced and conventional renewable RINs.
When examining RIN price data from 2012 through September 2017, shown in Figure VI.B.2-1 below, we see that beginning in early 2013 and through September 2017 the advanced RIN price and BBD RIN prices were approximately equal. Similarly, from early 2013 through late 2016 the conventional renewable fuel and BBD RIN prices were approximately equal. This suggests that the advanced biofuel standard and/or total renewable fuel standard are capable of incentivizing increased BBD volumes beyond the BBD standard, and operated in this manner starting in 2013.
In raising the 2013 BBD volume above the 1 billion gallon minimum mandated by Congress, the EPA sought to “create greater certainty for both producers of BBD and obligated parties” while also acknowledging that, “the potential for somewhat increased costs is appropriate in light of the additional certainty of GHG reductions and enhanced energy security provided by the advanced biofuel volume requirement of 2.75 billion gallons.”
The only advanced biofuel other than BBD available in appreciable quantities in 2012 and 2013 was advanced ethanol, the vast majority of which was imported sugarcane ethanol. EPA had significant concerns as to whether or not the supply of advanced ethanol could increase this significantly (750 million gallons) in a single year. These concerns were heightened by the approaching E10 blendwall, which increased the challenges associated with supplying increasing volumes of ethanol to the U.S. If neither BBD volumes nor advanced ethanol volumes increased sufficiently, EPA was concerned that some obligated parties might be unable to acquire the advanced biofuel RINs necessary to demonstrate compliance with their RVOs in 2013. Therefore, as discussed above, EPA increased the volume requirement for BBD in 2013 to help create greater certainty for BBD producers (by ensuring demand for their product above the 1.0 billion gallon statutory minimum) and obligated parties (by ensuring that sufficient RINs would be available to satisfy their advanced biofuel RVOs). Since 2013, however, EPA has gained significant experience implementing the RFS program. As discussed above, RIN generation data has consistently demonstrated that the advanced biofuel volume requirement, and to a lesser degree the total renewable fuel volume requirement, are capable of incentivizing the supply of BBD above and beyond the BBD volume requirement.
Finally, we note that the BBD industry in the U.S and abroad has matured since EPA first increased the required volume of BBD beyond the statutory minimum in 2013. To assess the maturity of the biodiesel industry, EPA compared information on BBD RIN generation by company from 2012 and 2016 (the most recent year for which complete RIN generation is available). In 2012, the annual average RIN generation per company producing BBD was about 11 million RINs (about 7.3 million gallons) with approximately 50 percent of companies producing less the 1 million gallons of BBD a year. The agency heard from multiple commenters during the 2012 and 2013 rulemakings that higher volume requirements for BBD would provide greater certainty for the emerging BBD industry and encourage further investment. Since that time, the BBD industry has matured in a number of critical areas, including growth in the size of companies, the consolidation of the industry, and more stable funding and access to capital. In 2012, the BBD industry was characterized by smaller companies with dispersed market share. By 2016, the average BBD RIN generation per company had climbed to almost 33 million RINs (22 million gallons) annually, a 3-fold increase. Only 27 percent of the companies produced less than 1 million gallons of BBD.
We are conscious of public comments claiming that BBD volume requirements that are a significant portion of the
With the considerations discussed above and in Section IV.B.2 in mind, as well as our analysis of the factors specified in the statute, we are setting the applicable volume of BBD at 2.1 billion gallons for 2019. We believe this volume sets the appropriate floor for BBD, and that the volume of advanced biodiesel and renewable diesel actually used in 2019 will be driven by the level of the advanced biofuel and total renewable fuel standards that the Agency will establish for 2019. We have considered the required statutory factors in reaching our decision, as summarized in Section C, below, and in a memorandum to the docket (the “2019 BBD docket memorandum”).
We believe our final 2019 BBD volume requirement strikes the appropriate balance between providing a market environment where the development of other advanced biofuels is incentivized, while also maintaining support for the BBD industry. Based on our review of the data, and the nested nature of the BBD standard within the advanced standard, we conclude that the advance standard continues to drive the ultimate volume of BBD supplied. Given the success of the industry in the past few years, as well as the substantial increases in the BBD volume being driven by the advanced standard, we have determined that a volume requirement greater than 2.1 billion gallons for BBD in 2019 is not necessary to provide support for the BBD industry. Setting the BBD standard in this manner continues to allow a considerable portion of the advanced biofuel volume to be satisfied by either additional gallons of BBD or by other unspecified and potentially less costly types of qualifying advanced biofuels.
As noted earlier in Section IV.B., the BBD volume requirement is nested within the advanced biofuel requirement and the advanced biofuel requirement is, in turn, nested within the total renewable fuel volume requirement. This means that any BBD produced beyond the mandated BBD volume can be used to satisfy both these other applicable volume requirements. The result is that in considering the statutory factors we must consider the potential impacts of increasing or decreasing BBD in comparison to other advanced biofuels.
Consistent with our approach in setting the final BBD volume requirement for 2018, EPA's primary assessment of the statutory factors for the 2019 BBD applicable volume is that because the BBD requirement is nested within the advanced biofuel volume requirement, we expect that the 2019 advanced volume requirement, when set next year, will determine the level of BBD production and imports that occur in 2019.
As an additional supplementary assessment, we have considered the potential impacts of selecting an applicable volume of BBD other than 2.1 billion gallons in 2019. Setting a requirement higher or lower than 2.1 billion gallons in 2019 would only be expected to impact BBD volumes on the margin, protecting to a greater or lesser degree BBD from competition with other potential advanced biofuels. In this supplementary assessment we have considered all of the statutory factors found in CAA section 211(2)(B)(ii), and as described in the 2019 BBD docket memorandum, our assessment does not appear, based on available information, to provide a reasonable basis for setting a higher or lower volume requirement for BBD than 2.1 billion gallons for 2019.
Overall and as described in the 2019 BBD docket memorandum, we have determined that both the primary assessment and the supplemental assessment of the statutory factors specified in CAA section 211(o)(2)(B)(ii)(I)-(VI) for the year 2019 does not provide significant support for setting the BBD standard at a level higher or lower than 2.1 billion gallons in 2019.
The renewable fuel standards are expressed as volume percentages and are used by each obligated party to determine their Renewable Volume Obligations (RVOs). Since there are four separate standards under the RFS program, there are likewise four separate RVOs applicable to each obligated party. Each standard applies to the sum of all non-renewable gasoline and diesel produced or imported. The percentage standards are set so that if every obligated party meets the percentages by acquiring and retiring an appropriate number of RINs, then the amount of renewable fuel, cellulosic biofuel, BBD, and advanced biofuel used will meet the applicable volume requirements on a nationwide basis.
Sections III through V provide our rationale and basis for the volume requirements for 2018.
For the purposes of converting these volumes into percentage standards, we generally use two decimal places to be consistent with the volume targets as given in the statute, and similarly two decimal places in the percentage standards. However, for cellulosic biofuel we use three decimal places in both the volume requirement and percentage standards to more precisely capture the smaller volume projections and the unique methodology that in some cases results in estimates of only a few million gallons for a single producer.
To calculate the percentage standards, we are following the same methodology for 2018 as we have in all prior years. The formulas used to calculate the percentage standards applicable to producers and importers of gasoline and diesel are provided in 40 CFR 80.1405. The formulas rely on estimates of the volumes of gasoline and diesel fuel, for both highway and nonroad uses, which are projected to be used in the year in which the standards will apply. The projected gasoline and diesel volumes are provided by EIA, and include projections of ethanol and biodiesel used in transportation fuel. Since the percentage standards apply only to the non-renewable gasoline and diesel produced or imported, the volumes of ethanol and biodiesel are subtracted out of the EIA projections of gasoline and diesel.
Transportation fuels other than gasoline or diesel, such as natural gas, propane, and electricity from fossil fuels, are not currently subject to the standards, and volumes of such fuels are not used in calculating the annual percentage standards. Since under the regulations the standards apply only to producers and importers of gasoline and diesel, these are the transportation fuels used to set the percentage standards, as well as to determine the annual volume obligations of an individual gasoline or diesel producer or importer.
As specified in the RFS2 final rule,
In CAA section 211(o)(9), enacted as part of the Energy Policy Act of 2005, and amended by the Energy Independence and Security Act of 2007, Congress provided a temporary exemption to small refineries
EPA has granted exemptions pursuant to this process in the past. However, at this time no exemptions have been approved for 2018, and therefore we have calculated the percentage standards for 2018 without any adjustment for exempted volumes. EPA is maintaining its approach that any exemptions for 2018 that are granted after the final rule is released will not be reflected in the percentage standards that apply to all gasoline and diesel produced or imported in 2018.
The formulas in 40 CFR 80.1405 for the calculation of the percentage standards require the specification of a total of 14 variables covering factors such as the renewable fuel volume requirements, projected gasoline and diesel demand for all states and territories where the RFS program applies, renewable fuels projected by EIA to be included in the gasoline and diesel demand, and exemptions for small refineries. The values of all the variables used for this final rule are shown in Table VII.C-1.
Projected
Using the volumes shown in Table VII.C-1, we have calculated the percentage standards for 2018 as shown in Table VII.C-2.
The RFS regulations specify an “aggregate compliance” approach for demonstrating that planted crops and crop residue from the U.S. complies with the “renewable biomass” requirements that address lands from which qualifying feedstocks may be harvested.
In the 2010 RFS2 rulemaking, EPA committed to make an annual finding concerning whether the 2007 baseline amount of U.S. agricultural land has been exceeded in a given year. If the baseline is found to have been exceeded, then producers using U.S. planted crops and crop residue as feedstocks for renewable fuel production would be required to comply with individual recordkeeping and reporting requirements to verify that their feedstocks are renewable biomass.
The Aggregate Compliance methodology provided for the exclusion of acreage enrolled in the Grassland Reserve Program (GRP) and the Wetlands Reserve Program (WRP) from the estimated total U.S. agricultural land. However, the 2014 Farm Bill terminated the GRP and WRP as of 2013 and USDA established the Agriculture Conservation Easement Program (ACEP) with wetlands and land easement components. The ACEP is a voluntary program that provides financial and technical assistance to help conserve agricultural lands and wetlands and their related benefits. Under the Agricultural Land Easements (ACEP-ALE) component, USDA helps Indian tribes, state and local governments, and non-governmental organizations protect working agricultural lands and limit non-agricultural uses of the land. Under the Wetlands Reserve Easements (ACEP-WRE) component, USDA helps to restore, protect and enhance enrolled wetlands. The WRP was a voluntary program that offered landowners the opportunity to protect, restore, and enhance wetlands on their property. The GRP was a voluntary conservation program that emphasized support for working grazing operations, enhancement of plant and animal biodiversity, and protection of grassland under threat of conversion to other uses.
USDA and EPA concur that the ACEP-WRE and ACEP-ALE represent a continuation in basic objectives and goals of the original WRP and GRP. Therefore, in preparing this year's assessment of the total U.S. acres of agricultural land, the acreage enrolled in the ACEP-WRE and ACEP-ALE was excluded.
Based on data provided by the USDA Farm Service Agency (FSA) and Natural Resources Conservation Service (NRCS), we have estimated that U.S. agricultural land reached approximately 376 million acres in 2017, and thus did not exceed the 2007 baseline acreage. This acreage estimate is based on the same methodology used to set the 2007 baseline acreage for U.S. agricultural land in the RFS2 final rulemaking, with the GRP and WRP substitution as noted above. Specifically, we started with FSA crop history data for 2017, from which we derived a total estimated acreage of 379,220,752 acres. We then subtracted the ACEP-ALE and ACEP-WRE enrolled areas by the end of Fiscal Year 2017, 2,777,887 acres, to yield an estimate of 376,442,865 acres or approximately 376 million acres of U.S. agricultural land in 2017. The USDA data used to make this derivation can be found in the docket to this rule.
The RFS regulations specify a petition process through which EPA may approve the use of an aggregate compliance approach for planted crops and crop residue from foreign countries.
The total agricultural land in Canada in 2017 is estimated at 117.8 million acres. This total agricultural land area includes 95.5 million acres of cropland and summer fallow, 12.5 million acres of pastureland and 9.8 million acres of agricultural land under conservation practices. This acreage estimate is based on the same methodology used to set the 2007 baseline acreage for Canadian agricultural land in EPA's response to Canada's petition. The data used to make this calculation can be found in the docket to this rule.
Some stakeholders have expressed concerns that the current regulatory provisions related to RIN trading render the RFS program vulnerable to market manipulation. The EPA takes such issues seriously. The RIN system was originally designed with an open trading market in order to maximize its liquidity and ensure a robust marketplace for RINs. However, the EPA is interested in assessing whether and how the current trading structure provides an opportunity for market manipulation. To that effect, the EPA sought comment and input on this issue, including on potential changes to the RIN trading system that might help address these concerns. We received comments from stakeholders suggesting a number changes to the RIN trading system. While EPA received many comments that are helpful to highlight opportunities for improvement to the RIN system, we are not in a position to make significant changes to the RIN system at this time. However, we intend to explore these suggested changes and are open to suggestions for making changes in the future that are within our authority and would help to improve the function and liquidity of the RIN system.
Separate from evaluating the RIN trading options in the RFS program, the EPA is working with appropriate market regulators to analyze targeted concerns of some stakeholders. Although the EPA has not seen evidence of manipulation in the RIN market, the EPA is not a commodity market regulatory agency, and thus we do not have expertise in this field. Claims of market manipulation prompted the EPA to execute a memorandum of understanding (MOU) with the U.S. Commodity Futures Trading Commission (CFTC), which has the authority and expertise to investigate such claims.
In the meantime, the EPA has continued to explore additional ways to increase program transparency in order to support the program and share data with all stakeholders. The EPA already publishes RFS program data on our Web site, including data related to RIN generation, sales and holdings, and annual compliance.
Many interested parties participated in the rulemaking process that culminates with this final rule. This process provided opportunity for submitting written public comments following the proposal that we published on July 21, 2017 (82 FR 34206), and we also held a public hearing on August 1, 2017, at which many parties provided both verbal and written testimony. All comments received, both verbal and written, are available in Docket ID No. EPA-HQ-OAR-2017-0091 and we considered these comments in developing the final rule. Public comments and EPA responses are discussed throughout this preamble and in the accompanying Response to Comment document, which is available in the docket for this action.
This action is an economically significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review. Any changes made in response to OMB recommendations have been documented in the docket. The EPA prepared an analysis of illustrative costs associated with this action. This analysis is presented in Section IV.E of this preamble.
This action is considered an Executive Order 13771 regulatory action. Details on the estimated costs of this final rule can be found in EPA's analysis of the illustrative costs associated with this action. This analysis is presented in Section IV.E of this preamble.
This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control numbers 2060-0637 and 2060-0640. The final standards will not impose new or different reporting requirements on regulated parties than already exist for the RFS program.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden, or otherwise has a positive economic effect on the small entities subject to the rule.
The small entities directly regulated by the RFS program are small refiners, which are defined at 13 CFR 121.201. We have evaluated the impacts of this final rule on small entities from two perspectives: As if the 2018 standards
When evaluating the standards as if they were a standalone action separate and apart from the original rulemaking which established the RFS2 program, then the standards could be viewed as increasing the advanced and total renewable fuel volumes required of obligated parties by 10 million gallons between 2017 and 2018. To evaluate the impacts of the volume requirements on small entities relative to 2017, EPA has conducted a screening analysis
While the screening analysis described above supports a certification that this rule would not have a significant economic impact on small refiners, we continue to believe that it is more appropriate to consider the standards as a part of ongoing implementation of the overall RFS program. When considered this way, the impacts of the RFS program as a whole on small entities were addressed in the RFS2 final rule (75 FR 14670, March 26, 2010), which was the rule that implemented the entire program required by the Energy Independence and Security Act of 2007 (EISA 2007). As such, the Small Business Regulatory Enforcement Fairness Act (SBREFA) panel process that took place prior to the 2010 rule was also for the entire RFS program and looked at impacts on small refiners through 2022.
For the SBREFA process for the RFS2 final rule, EPA conducted outreach, fact-finding, and analysis of the potential impacts of the program on small refiners, which are all described in the Final Regulatory Flexibility Analysis, located in the rulemaking docket (EPA-HQ-OAR-2005-0161). This analysis looked at impacts to all refiners, including small refiners, through the year 2022 and found that the program would not have a significant economic impact on a substantial number of small entities, and that this impact was expected to decrease over time, even as the standards increased. For gasoline and/or diesel small refiners subject to the standards, the analysis included a cost-to-sales ratio test, a ratio of the estimated annualized compliance costs to the value of sales per company. From this test, it was estimated that all directly regulated small entities would have compliance costs that are less than one percent of their sales over the life of the program (75 FR 14862, March 26, 2010).
We have determined that this final rule will not impose any additional requirements on small entities beyond those already analyzed, since the impacts of this rule are not greater or fundamentally different than those already considered in the analysis for the RFS2 final rule assuming full implementation of the RFS program. This rule establishes the 2018 advanced and total renewable fuel volume requirements at levels 10 million gallons higher than the 2017 volume requirements, and significantly below the statutory volume targets. This exercise of EPA's waiver authority reduces burdens on small entities, as compared to the burdens that would be imposed under the volumes specified in the Clean Air Act in the absence of waivers—which are the volumes that we assessed in the screening analysis that we prepared for implementation of the full program. Regarding the BBD standard, we are maintaining the volume requirement for 2019 at the same level as 2018. While this volume is an increase over the statutory minimum value of 1 billion gallons, the BBD standard is a nested standard within the advanced biofuel category, which we are significantly reducing from the statutory volume targets. As discussed in Section VI, we are setting the 2019 BBD volume requirement at a level below what is anticipated will be produced and used to satisfy the reduced advanced biofuel requirement. The net result of the standards being established in this action is a reduction in burden as compared to implementation of the statutory volume targets, as was assumed in the RFS2 final rule analysis.
While the rule will not have a significant economic impact on a substantial number of small entities, there are compliance flexibilities in the program that can help to reduce impacts on small entities. These flexibilities include being able to comply through RIN trading rather than renewable fuel blending, 20 percent RIN rollover allowance (up to 20 percent of an obligated party's RVO can be met using previous-year RINs), and deficit carry-forward (the ability to carry over a deficit from a given year into the following year, providing that the deficit is satisfied together with the next year's RVO). In the RFS2 final rule, we discussed other potential small entity flexibilities that had been suggested by the SBREFA panel or through comments, but we did not adopt them, in part because we had serious concerns regarding our authority to do so.
Additionally, as we realize that there may be cases in which a small entity may be in a difficult financial situation and the level of assistance afforded by the program flexibilities is insufficient. For such circumstances, the program provides hardship relief provisions for small entities (small refiners), as well as for small refineries.
Given that this final rule would not impose additional requirements on small entities, would decrease burden via a reduction in required volumes as compared to statutory volume targets, would not change the compliance flexibilities currently offered to small entities under the RFS program (including the small refinery hardship provisions we continue to successfully implement), and available information shows that the impact on small entities from implementation of this rule would not be significant viewed either from the perspective of it being a standalone action or a part of the overall RFS program, we have therefore concluded that this action would have no net regulatory burden for directly regulated small entities.
This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action implements mandates specifically and explicitly set forth in CAA section 211(o) and we believe that this action represents the least costly, most cost-effective approach to achieve the statutory requirements of the rule.
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 final rule will be implemented at the Federal level and affects transportation fuel refiners, blenders, marketers, distributors, importers, exporters, and renewable fuel producers and importers. Tribal governments would be affected only to the extent they produce, purchase, and use regulated fuels. Thus, Executive Order 13175 does not apply to this action.
The 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 implements specific standards established by Congress in statutes (CAA section 211(o)) and does not concern an environmental health risk or safety risk.
This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. This action establishes the required renewable fuel content of the transportation fuel supply for 2018, consistent with the CAA and waiver authorities provided therein. The RFS program and this rule are designed to achieve positive effects on the nation's transportation fuel supply, by increasing energy independence and lowering lifecycle GHG emissions of transportation fuel.
This rulemaking does not involve technical standards.
The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations, and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). This final rule does not affect the level of protection provided to human health or the environment by applicable air quality standards. This action does not relax the control measures on sources regulated by the RFS regulations and therefore will not cause emissions increases from these sources.
This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is a “major rule” as defined by 5 U.S.C. 804(2).
Statutory authority for this action comes from section 211 of the Clean Air Act, 42 U.S.C. 7545. Additional support for the procedural and compliance related aspects of this final rule comes from sections 114, 208, and 301(a) of the Clean Air Act, 42 U.S.C. 7414, 7542, and 7601(a).
Environmental protection, Administrative practice and procedure, Air pollution control, Diesel fuel, Fuel additives, Gasoline, Imports, Oil imports, Petroleum, Renewable fuel.
For the reasons set forth in the preamble, EPA amends 40 CFR part 80 as follows:
42 U.S.C. 7414, 7521, 7542, 7545, and 7601(a).
(a) * * *
(9)
(i) The value of the cellulosic biofuel standard for 2018 shall be 0.159 percent.
(ii) The value of the biomass-based diesel standard for 2018 shall be 1.74 percent.
(iii) The value of the advanced biofuel standard for 2018 shall be 2.37 percent.
(iv) The value of the renewable fuel standard for 2018 shall be 10.67 percent.
Category | Regulatory Information | |
Collection | Federal Register | |
sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
Publisher | Office of the Federal Register, National Archives and Records Administration |