January 13, 2017 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2017-01-13-ReaderAids
Type: Reader Aids
Date: 2017-01-13
Sunshine Act Meeting Notice
Document Number: 2017-00875
Type: Notice
Date: 2017-01-13
Agency: Nuclear Regulatory Commission, Agencies and Commissions
Sunshine Act Meeting Notice
Document Number: 2017-00799
Type: Notice
Date: 2017-01-13
Agency: Consumer Product Safety Commission, Agencies and Commissions
Cardiovascular Devices
Document Number: 2017-00796
Type: Rule
Date: 2017-01-13
Agency: Food and Drug Administration, Department of Health and Human Services
Notice of Availability of the Record of Decision for the Dominguez-Escalante National Conservation Area Resource Management Plan and Final Environmental Impact Statement, Colorado
Document Number: 2017-00772
Type: Notice
Date: 2017-01-13
Agency: Department of the Interior, Bureau of Land Management
The Bureau of Land Management (BLM) announces the availability of the Record of Decision (ROD) for the Approved Resource Management Plan (RMP) and Final Environmental Impact Statement for the Dominguez- Escalante National Conservation Area (NCA) located in Mesa, Delta and Montrose counties, Colorado. The Colorado State Director signed the ROD on January 9, 2017, which constitutes the final decision of the BLM and makes the Approved RMP effective immediately.
Notice of Temporary Closures and Restrictions of Public Lands in La Paz County, AZ
Document Number: 2017-00771
Type: Notice
Date: 2017-01-13
Agency: Department of the Interior, Bureau of Land Management
Notice is hereby given that closures and restrictions will be in effect on public lands administered by the Bureau of Land Management (BLM), Lake Havasu Field Office. This action is being taken to protect public safety and resources within and adjacent to the permitted operations of the Best in the Desert (BITD) Racing Association ``GMZ Utility Terrain Vehicle Winter Nationals Parker 250'' and ``BlueWater Resort Parker 425'' off-highway vehicle (OHV) events.
Public Land Order No. 7859; Withdrawal of National Forest System and Bureau of Land Management Public Lands in Southwestern Oregon; Oregon
Document Number: 2017-00770
Type: Notice
Date: 2017-01-13
Agency: Department of the Interior, Bureau of Land Management
This order withdraws, subject to valid existing rights, approximately 5,216.18 acres of public domain and Revested Oregon and California Railroad lands and 95,805.53 acres of National Forest System lands from settlement, sale, location, and entry under the public land laws; location and entry under the United States mining laws; and operation of the mineral and geothermal leasing laws for a period of 20 years while Congress considers legislation to permanently withdraw those areas and to protect the Southwestern Oregon watershed from possible adverse effects of mineral development.
Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
Document Number: 2017-00766
Type: Notice
Date: 2017-01-13
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) considered a proposal to conduct research involving the deliberate transfer of a chloramphenicol resistance trait to Rickettsia typhi, conorii, rickettsii, and felis. The acquisition of this antibiotic resistance trait could possibly compromise the use of a class of antibiotics for the treatment of Rickettsia infections in humans. Under the NIH Guidelines (http://www.osp.od.nih.gov/sites/default/files/ NIH_Guidelines.html), these experiments can proceed only after they are reviewed by the NIH Recombinant DNA Advisory Committee (RAC) and specifically approved by the NIH Director as Major Actions. This proposal was discussed at the December 4, 2015, RAC meeting. The proposal was published in the Federal Register on December 29, 2015, (80 FR 81346) with a request for public comment; one comment was received. This notice announces the final NIH action regarding this proposal.
National Emission Standards for Hazardous Air Pollutants: Nutritional Yeast Manufacturing Risk and Technology Review
Document Number: 2017-00762
Type: Proposed Rule
Date: 2017-01-13
Agency: Environmental Protection Agency
On December 28, 2016, the Environmental Protection Agency (EPA) published a notice to announce its proposed amendments to the National Emission Standards for Hazardous Air Pollutants for the Manufacturing of Nutritional Yeast source category. The notice also requested public comment on the proposed amendments. The EPA is announcing that a public hearing will be held. In addition, the EPA is extending the public comment period.
Renewal of Approved Information Collection; OMB Control No. 1004-0196
Document Number: 2017-00759
Type: Notice
Date: 2017-01-13
Agency: Department of the Interior, Bureau of Land Management
In compliance with the Paperwork Reduction Act, the Bureau of Land Management (BLM) invites public comments on, and plans to request approval to continue, the collection of information from participants in the oil and gas leasing program within the National Petroleum ReserveAlaska (NPRA). The Office of Management and Budget (OMB) has assigned control number 1004-0196 to this information collection.
Renewal of Approved Information Collection; OMB Control No. 1004-0042
Document Number: 2017-00757
Type: Notice
Date: 2017-01-13
Agency: Department of the Interior, Bureau of Land Management
The Bureau of Land Management (BLM) has submitted an information collection request to the Office of Management and Budget (OMB) to continue the collection of information from those who wish to adopt and obtain title to wild horses and burros. The OMB previously approved this information collection activity, and assigned it control number 1004-0042.
Notice of Intent to Grant Exclusive License
Document Number: 2017-00746
Type: Notice
Date: 2017-01-13
Agency: Agricultural Research Service, Department of Agriculture
Notice is hereby given that the U.S. Department of Agriculture, Agricultural Research Service, intends to grant to Huvepharma, Inc. of Peachtree City, Georgia, an exclusive license to U.S. Patent Application Serial No. 15/108,725, ``MUTATED SALMONELLA ENTERIACA'', filed on June 28, 2016.
Environmental Laboratory Advisory Board (ELAB) Meeting Dates and Agenda
Document Number: 2017-00745
Type: Notice
Date: 2017-01-13
Agency: Environmental Protection Agency
Approval of Expansion of Subzone 100D; Thor Industries, Inc.; Jackson Center, Ohio
Document Number: 2017-00741
Type: Notice
Date: 2017-01-13
Agency: Department of Commerce, Foreign-Trade Zones Board
Caribbean Fishery Management Council; Public Meetings
Document Number: 2017-00738
Type: Notice
Date: 2017-01-13
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Caribbean Fishery Management Council's Scientific and Statistical Committee (SSC) will hold a five-day meeting in San Juan, Puerto Rico.
Mid-Atlantic Fishery Management Council (MAFMC); Public Meetings
Document Number: 2017-00737
Type: Notice
Date: 2017-01-13
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Mid-Atlantic Fishery Management Council (Council) will hold public meetings of the Council and its Committees.
Granular Polytetrafluoroethylene Resin From Italy: Rescission of Antidumping Duty Administrative Review; 2015-2016
Document Number: 2017-00736
Type: Notice
Date: 2017-01-13
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (the Department) is rescinding the administrative review of the antidumping duty order on granular polytetrafluoroethylene (PTFE) resin from Italy, for the period of review (POR) August 1, 2015, through July 18, 2016, based on the timely withdrawal of request for review by Polis S.r.l., (Polis).
Government-Owned Inventions; Availability for Licensing
Document Number: 2017-00735
Type: Notice
Date: 2017-01-13
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Institute of Allergy and Infectious Diseases Notice of Closed Meetings
Document Number: 2017-00734
Type: Notice
Date: 2017-01-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2017-00733
Type: Notice
Date: 2017-01-13
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meetings
Document Number: 2017-00732
Type: Notice
Date: 2017-01-13
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-00731
Type: Notice
Date: 2017-01-13
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-00730
Type: Notice
Date: 2017-01-13
Agency: Department of Health and Human Services, National Institutes of Health
Award Management Requirements: Availability of Final Circular
Document Number: 2017-00728
Type: Notice
Date: 2017-01-13
Agency: Federal Transit Administration, Department of Transportation
The Federal Transit Administration (FTA) has placed in the docket and on its Web site guidance in the form of FTA Circular 5010.1E, ``Award Management Requirements,'' to facilitate implementation of FTA's assistance programs. The final Circular updates the ``Grant Management Requirements'' Circular 5010.1D to reflect various changes in the law, as well as FTA's transition to a new electronic award management system.
Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request For Scientific Data, Information, and Comments; Reopening of Comment Period
Document Number: 2017-00725
Type: Notice
Date: 2017-01-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is reopening the comment period for the document requesting scientific data, information, and comments entitled ``Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates'' that appeared in the Federal Register of November 23, 2016 (81 FR 84595). In the document, we requested scientific data, information, and comments to help us determine whether a particular isolated or synthetic non-digestible carbohydrate should be added to our definition of ``dietary fiber'' for purposes of being declared as dietary fiber on a Nutrition Facts or Supplement Facts label. We also announced in the document the availability for comment of a scientific literature review document that we conducted that summarizes clinical studies associated with 26 specific isolated or synthetic non- digestible carbohydrates. We are taking this action in response to requests to allow interested persons additional time to submit comments.
Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition; Draft Guidance for Industry; Extension of Comment Period
Document Number: 2017-00724
Type: Proposed Rule
Date: 2017-01-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the comment period for the notice of availability of a draft guidance entitled ``Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition'' that appeared in the Federal Register of November 23, 2016. The draft guidance, when finalized, will describe our views on the scientific evidence needed and the approach to evaluating the scientific evidence on the physiological effects of isolated or synthetic non-digestible carbohydrates that are added to foods that are beneficial to human health. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities; Final Guidance for Industry; Availability
Document Number: 2017-00723
Type: Notice
Date: 2017-01-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled ``Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.'' This guidance describes the conditions under which FDA does not intend to take action for violations of certain provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), when a State-licensed pharmacy, a Federal facility, or an outsourcing facility repackages certain human drug products.
Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Revised Draft Guidance For Industry; Availability
Document Number: 2017-00722
Type: Notice
Date: 2017-01-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance for industry entitled ``Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.'' This revised draft guidance describes the conditions under which FDA does not intend to take action against a State-licensed pharmacy, a Federal facility, or an outsourcing facility that mixes, dilutes, or repackages certain biological products outside the scope of an approved biologics license application (BLA). It also describes the conditions under which FDA does not intend to take action when a State-licensed pharmacy, a Federal facility, an outsourcing facility, or a physician prepares prescription sets of allergenic extracts for subcutaneous immunotherapy. This revised draft guidance for industry replaces the draft guidance for industry of the same title issued in February 2015.
Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders; Availability
Document Number: 2017-00721
Type: Notice
Date: 2017-01-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry and other stakeholders entitled ``Emergency Use Authorization of Medical Products and Related Authorities.'' The purpose of this guidance is to explain FDA's current thinking on the authorization of the emergency use of certain medical products under certain sections of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended or added by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA). The provisions in PAHPRA include key legal authorities to sustain and strengthen national preparedness for public health, military, and domestic emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents, including emerging infectious disease threats.
The Benefits, Challenges, and Potential Roles for the Government in Fostering the Advancement of the Internet of Things
Document Number: 2017-00720
Type: Notice
Date: 2017-01-13
Agency: Department of Commerce, National Telecommunications and Information Administration
Recognizing the vital importance of the Internet to U.S. innovation, prosperity, education, and civic and cultural life, the Department of Commerce (Department) has made it a top priority to encourage growth of the digital economy and ensure that the Internet remains an open platform for innovation. Thus, as part of the Department's Digital Economy Agenda, the National Telecommunications and Information Administration (NTIA) issued a green paper ``Fostering the Advancement of the Internet of Things'' that lays out an approach and areas of engagement for the Department's possible future work on the Internet of Things (IoT). Through this Notice, NTIA seeks broad input from all interested stakeholdersincluding the private industry, researchers, academia, and civil societyon the issues and proposed approach, current initiatives, and next steps laid out in this paper. These comments will help inform Department leadership on possible future Department action regarding IoT.
Environmental Impact Statements; Notice of Availability
Document Number: 2017-00716
Type: Notice
Date: 2017-01-13
Agency: Environmental Protection Agency
Affirmatively Furthering Fair Housing: Announcement of Renewal of Approval of the Assessment Tool for Local Governments
Document Number: 2017-00714
Type: Notice
Date: 2017-01-13
Agency: Department of Housing and Urban Development
This notice announces that the Office of Management and Budget (OMB) has approved HUD's request to renew for approval under the Paperwork Reduction Act (PRA), the Assessment Tool developed by HUD for use by local governments that receive Community Development Block Grants (CDBG), HOME Investment Partnerships Program (HOME), Emergency Solutions Grants (ESG), or Housing Opportunities for Persons with AIDS (HOPWA) formula funding from HUD when conducting and submitting their own Assessment of Fair Housing (AFH). This Assessment Tool, referred to as the Local Government Assessment Tool, is used for AFHs conducted by joint and regional collaborations between: (1) Such local governments; (2) one or more such local governments with one or more public housing agency (PHA) partners, including qualified PHAs (QPHAs); and (3) other collaborations in which such a local government is designated as the lead for the collaboration. Through the notice and comment process required by the PRA, HUD did make changes to the Local Government Assessment Tool approved by OMB in 2015. HUD's Web page at https:// www.hudexchange.info/programs/affh/ highlights the differences between the 2015 Local Government Assessment Tool and this 2016 Local Government Assessment Tool. This notice also highlights significant issues raised by commenters on the 30-day notice published in the Federal Register on August 23, 2016.
Affirmatively Furthering Fair Housing Assessment Tool for Public Housing Agencies: Announcement of Final Approved Document
Document Number: 2017-00713
Type: Notice
Date: 2017-01-13
Agency: Department of Housing and Urban Development
This notice announces that the Assessment Tool developed by HUD for use by Public Housing Agencies receiving assistance under the United States Housing Act of 1937 has completed the notice and comment process required by the Paperwork Reduction Act (PRA), been reviewed by the Office of Management and Budget and approved. While this Assessment Tool has been approved, this Notice does not trigger the obligation of PHAs to conduct and submit an AFH in accordance with 24 CFR 5.160, as HUD has not yet provided PHAs with the data they will need. As HUD makes data available for certain PHAs, HUD will publish, in the Federal Register, a Notice announcing the availability of data for certain PHAs, triggering their obligation to conduct and submit an AFH, and will post such Notice on the HUD Exchange. HUD also anticipates that, at that time, the online User Interface will be available for use by PHAs. Until such time that PHAs are required to conduct and submit an AFH, HUD notes that PHAs must continue to comply with existing fair housing and civil rights requirements. This Assessment Tool, referred to as the PHA Assessment Tool, was modeled on the Local Government Assessment Tool, first approved by OMB on December 31, 2015 but with modifications to address the different public housing and Housing Choice Voucher operations that PHAs have compared to local governments, and how fair housing planning may be undertaken by PHAs in a meaningful manner. As with the Local Government Assessment Tool, the PHA Assessment Tool allows for collaboration with other PHAs. To reduce burden for PHAs, HUD has increased the threshold for the insert from QPHAs that have 550 units or less to PHAs with 1,250 or fewer combined public housing and HCV units. HUD has also committed to developing an additional Assessment Tool specifically for use by Qualified PHAs (QPHAs) who conduct and submit an individual AFH or collaborate with other QPHAs to conduct and submit a joint AFH to be issued in 2017. Therefore, this PHA Assessment Tool will be for use by PHAs submitting AFHs individually or jointly, and for collaborations among PHAs with 1,250 or fewer units and with PHAs with more than 1,250 units. In addition, to reduce burden further, this Assessment Tool includes an insert with streamlined questions for PHAs with 1,250 or fewer units to use if jointly submitting with PHA with more than 1,250 units. In addition, this Assessment Tool includes revised instructions based on public comments received during the 30-day PRA review that provide more guidance to PHAs in conducting the AFH, including how the regional analysis is to be prepared based on the location of a PHA's geographic region and program type. Through the notice and comment process required by the PRA, HUD made changes to the PHA Assessment Tool from the 30-day notice published in the Federal Register on August 23, 2016.
Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company
Document Number: 2017-00711
Type: Notice
Date: 2017-01-13
Agency: Federal Reserve System, Agencies and Commissions
Committee on Equal Opportunities in Science and Engineering; Notice of Meeting
Document Number: 2017-00705
Type: Notice
Date: 2017-01-13
Agency: National Science Foundation, Agencies and Commissions
North Carolina Disaster Number NC-00086
Document Number: 2017-00704
Type: Notice
Date: 2017-01-13
Agency: Small Business Administration, Agencies and Commissions
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of North Carolina (FEMA-4285-DR), dated 11/10/2016. Incident: Hurricane Matthew. Incident Period: 10/04/2016 through 10/24/2016. Effective Date: 01/04/2017. Physical Loan Application Deadline Date: 01/09/2017. Economic Injury (EIDL) Loan Application Deadline Date: 08/10/2017.
Reservation Proclamations
Document Number: 2017-00703
Type: Notice
Date: 2017-01-13
Agency: Department of the Interior, Bureau of Indian Affairs
The Bureau of Indian Affairs (BIA) has updated its Fee-to- Trust Handbook to include procedural guidance for its employees on processing reservation proclamations, including simultaneous requests for trust acquisition and reservation proclamations.
Tenth RTCA SC-229 406 MHz ELT Plenary Joint With WG-98; Correction
Document Number: 2017-00699
Type: Notice
Date: 2017-01-13
Agency: Federal Aviation Administration, Department of Transportation
The Federal Aviation Administration published a document in the Federal Register of January 9, 2017, concerning the Tenth RTCA SC- 229 406 MHz ELT Plenary Joint with WG-98. The document contained the incorrect location.
Agency Information Collection Activities; Proposed Collection; Comment Request; Information Collection for Importation of On-Highway Vehicles and Motorcycles and Nonroad Engines, Vehicles, and Equipment
Document Number: 2017-00698
Type: Notice
Date: 2017-01-13
Agency: Environmental Protection Agency
The Environmental Protection Agency has submitted an information collection request (ICR), ``Importation of On-highway Vehicles and Motorcycles and Nonroad Engines, Vehicles, and Equipment'' EPA ICR Number 2583.01, OMB Control Number 2060-NEW to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This new ICR is the consolidation of two individual ICRS that are currently approved by OMB. EPA currently has an approved collection that covers the information requirements for importation of on-highway vehicles which expires on February 28, 2017 (OMB Control Number 2060-0095, ICR Number 0010.14). EPA also has an approved collection for information requirements for importation of nonroad engines and recreational vehicles (OMB Control Number 2060-0320, ICR Number 1723.07), which expires February 28, 2017. Public comments were requested via the Federal Register on September 16, 2016 (81 FR 63758) during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. 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.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Performance Evaluation Studies on Wastewater Laboratories (Renewal)
Document Number: 2017-00697
Type: Notice
Date: 2017-01-13
Agency: Environmental Protection Agency
The Environmental Protection Agency has submitted an information collection request (ICR), ``Performance Evaluation Studies on Wastewater Laboratories (Renewal)'' (EPA ICR No. 0234.12, OMB Control No. 2080-0021) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through March 31, 2017. Public comments were previously requested via the Federal Register (81 FR 44017) on July 6, 2016 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. 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.
Safety zone; Tennessee River, Mile 446.0 to 454.5
Document Number: 2017-00696
Type: Proposed Rule
Date: 2017-01-13
Agency: Coast Guard, Department of Homeland Security
The Coast Guard proposes to establish a safety zone for all waters of the Tennessee River, beginning at mile marker 446.0 and ending at mile marker 454.5 during periods of high water flow. High water flow is determined by flow rates that have reached or exceeded 100,000 cubic feet per second at Chickamauga lock and dam on the Tennessee River at mile marker 471.0. This proposed safety zone is necessary to provide safety for mariners transiting on the Tennessee River during periods of high water flow. Entry into this area will be prohibited unless specifically authorized by the Captain of the Port Ohio Valley or designated representative. We invite your comments on this proposed rulemaking.