Advisory Committee on Automation in Transportation Meeting Notice
The Department of Transportation is publishing this notice to announce the following Federal advisory committee meeting of the Advisory Committee on Automation in Transportation (ACAT). The meeting is open to the public.
U.S.-Nigeria Commercial and Investment Dialogue
The U.S. Department of Commerce is currently seeking applications for members of the U.S. private sector to participate in the newly established U.S.-Nigeria Commercial and Investment Dialogue (CID). The purpose of the CID is to deepen the trade and investment ties between the U.S. and Nigeria and to foster sustained engagement between our governments on concrete issues of importance to our private sectors.
Notice of Public Meeting, BLM Alaska Resource Advisory Council
In accordance with the Federal Land Policy and Management Act of 1976 as amended (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the Bureau of Land Management (BLM) Alaska Resource Advisory Council (RAC) will meet as indicated below.
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements; Corrections
This document corrects technical and typographical errors that appeared in the final rule published in the November 15, 2016 Federal Register (81 FR 80170). That rule is entitled, ``Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements.''
Notice of Public Meeting for the Steens Mountain Advisory Council
In accordance with the Federal Land Policy and Management Act and the Federal Advisory Committee Act of 1972, and the U.S. Department of the Interior, Bureau of Land Management (BLM), the Steens Mountain Advisory Council (SMAC) will meet as indicated below:
Endangered Species; Recovery Permit Applications
We, the U.S. Fish and Wildlife Service, invite the public to comment on applications for recovery permits to conduct activities with the purpose of enhancing the survival of endangered species. With some exceptions, the Endangered Species Act of 1973, as amended (Act), prohibits certain activities with endangered species unless a Federal permit allows such activity. The Act also requires that we invite public comment before issuing these permits.
California State Motor Vehicle Pollution Control Standards; Greenhouse Gas Emissions From 2014 and Subsequent Model Year Medium- and Heavy-Duty Engines and Vehicles; Notice of Decision
The Environmental Protection Agency (EPA) is granting the California Air Resources Board's (``CARB's'') request for a waiver of Clean Air Act preemption for its greenhouse gas (``GHG'') emission regulation for the new 2014 and subsequent model year on-road medium- and heavy-duty engines and vehicles (``California Phase 1 GHG Regulation'') adopted in 2011. This regulation establishes requirements applicable to new motor vehicles with a gross vehicle weight rating exceeding 8,500 pounds and engines that power such motor vehicles, except for medium-duty passenger vehicles that are subject to California's Low Emission Vehicle Program. This regulation generally aligns California's GHG emission standards and test procedures with the federal GHG emission standards and test procedures that EPA adopted in 2011. A deemed-to-comply provision is included in CARB's regulation whereby manufacturers may demonstrate compliance with California's Phase 1 GHG Regulation by complying with EPA's Phase 1 regulation. This decision is issued under the authority of the Clean Air Act (``CAA'' or ``the Act'').
Human Studies Review Board; Notification of Public Meetings
The Environmental Protection Agency (EPA) Office of the Science Advisor announces two separate public meetings of the Human Studies Review Board (HSRB) to advise the Agency on the ethical and scientific review of research involving human subjects.
Clean Air Act Operating Permit Program; Petition for Objection to State Operating Permit for Piedmont Green Power (Lamar County, Georgia)
The EPA Administrator signed an Order, dated December 13, 2016, granting in part and denying in part the petition to object to Clean Air Act (CAA) title V operating permit issued by the Georgia Environmental Protection Division (Georgia EPD) to the Piedmont Green Power (PGP) facility located in Barnesville, Lamar County, Georgia. This Order constitutes a final action on the petition submitted by the Partnership for Policy Integrity (Petitioner) and received by EPA on May 26, 2015.
Agency Information Collection Activities; Proposed Renewal of an Existing Collection (EPA ICR No. 2472.02 and OMB Control No. 2070-0191); Comment Request
In compliance with the Paperwork Reduction Act (PRA), this document announces that EPA is planning to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). The ICR, entitled: ``Pesticide Spray Drift Reduction Technologies'' and identified by EPA ICR No. 2472.02 and OMB Control No. 2070-0191, represents the renewal of an existing ICR that is scheduled to expire on August 31, 2017. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection that is summarized in this document. The ICR and accompanying material are available in the docket for public review and comment.
Notice of Availability of the BLM Draft Presumed To Conform List of Actions Under General Conformity-Upper Green River Basin, Wyoming
In accordance with the Clean Air Act, Clean Air Act Amendments of 1990, and U.S. Environmental Protection Agency's (EPA) regulations, the Bureau of Land Management (BLM) has developed a Draft Presumed to Conform List of Actions under General Conformity for the Upper Green River Basin (UGRB) ozone nonattainment area and by this notice is announcing the opening of the comment period.
Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-Based Products; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-based Products.'' The purpose of the public workshop is to have a scientific discussion of the current methods available for identifying and characterizing infectious disease risks associated with human cells, tissues, and cellular and tissue-based products (HCT/Ps).
Botanical Drug Development; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Botanical Drug Development.'' This guidance describes FDA's current thinking on appropriate development plans for botanical drugs to be submitted in new drug applications (NDAs) and specific recommendations for submitting investigational new drug applications (INDs) to support future NDA submissions for botanical drugs. In addition, this guidance provides general information on the over-the-counter (OTC) drug monograph system for botanical drugs. Although this guidance does not intend to provide recommendations specific to botanical drugs to be marketed under biologics license applications (BLAs), many scientific principles described in this guidance may also apply to these products. This guidance replaces the guidance for industry entitled ``Botanical Drug Products'' issued in June 2004 and finalizes the August 2015 draft guidance entitled ``Botanical Drug Development.''
Providing Regulatory Submissions in Electronic Format-Submission of Manufacturing Establishment Information; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatSubmission of Manufacturing Establishment Information.'' This guidance discusses the requirements for a valid electronic submission of manufacturing establishment information (MEI) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action will streamline the review of all manufacturing establishments involved in the preparation of a drug or biological product by consolidating information in one location and eliminating the inclusion of erroneous and/or outdated information from other Agency files.
Abbott Laboratories, et al.; Withdrawal of Approval of Four New Drug Applications and Two Abbreviated New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of four new drug applications (NDAs) and two abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Magnuson-Stevens Act Provisions; Fisheries Off West Coast States; Pacific Coast Groundfish Fishery; Trawl Rationalization Program; 2017 Cost Recovery
This action provides participants in the Pacific coast groundfish trawl rationalization program with the 2017 fee percentages and ``MS pricing'' needed to calculate the required payments for trawl rationalization program cost recovery fees due in 2017. It also provides a redetermination of previous years' fees. For calendar year 2017, NMFS announces the following fee percentages by sector: 3.0 percent for the Shorebased Individual Fishing Quota (IFQ) Program, 0 percent for the MS Coop Program, 0 percent for the Catcher/Processer (C/P) Coop Program. For 2017, the MS pricing to be used as a proxy by the C/P Coop Program is: $0.08/lb for Pacific whiting.
Newspapers Used for Publication of Legal Notices in the Pacific Northwest Region Which Includes Washington and Oregon
This notice provides the list of newspapers that will be used by the Pacific Northwest Region to publish legal notices required under 36 CFR part 218 and 36 CFR part 219. The intended effect of this action is to inform interested members of the public which newspapers will be used by the Forest Service to publish legal notices for public comment, notices for draft decisions and the opportunity to file an administrative review on USDA Forest Service proposals.
U.S. Extractive Industries Transparency Initiative Multi-Stakeholder Group (USEITI MSG) Advisory Committee Meeting Notice
This notice announces the next three meetings of the United States Extractive Industries Transparency Initiative (USEITI) Multi- Stakeholder Group (MSG) Advisory Committee.
Filing of Plats of Survey: Oregon/Washington
The plats of survey of the following described lands are scheduled to be officially filed in the Bureau of Land Management, Oregon State Office, Portland, Oregon, 30 days from the date of this publication.
Proposed Information Collection; Comment Request; Nautical Discrepancy Reporting System
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.
Electronic Tax Administration Advisory Committee (ETAAC)
The charter for the Electronic Tax Administration Advisory Committee (ETAAC) was amended on December 13, 2016, in accordance with the Federal Advisory Committee Act (FACA).
New England Fishery Management Council; Public Meeting
The New England Fishery Management Council (Council) is scheduling a public meeting of its Scientific and Statistical Committee (SSC) to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
Proposed Collection; Comment Request for Form 4422
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 4422, Application for Certificate Discharging Property Subject to Estate Tax Lien.
Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled ``Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act.'' This guidance sets forth FDA's policy concerning certain prescription requirements for compounding human drug products for identified individual patients under section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). It addresses compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of a prescription for an identified individual patient (anticipatory compounding), and compounding for office use.
Proposed Collection; Comment Request
In compliance with the Paperwork Reduction Act of 1995, the Department of the Army announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: 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; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, 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. This notice invites comment on a proposed information collection entitled ``Test Predictability of Falls Screening Tools.'' CDC will use the information collected to evaluate current screening tools and potentially design a new screening tool for health care practitioners to identify community-dwelling adults 65 and older at risk for falls.
Acceptance of Commercial-Grade Design and Analysis Computer Programs for Nuclear Power Plants
The U.S. Nuclear Regulatory Commission (NRC) is issuing Revision 0 to Regulatory Guide (RG) 1.231, ``Acceptance of Commercial- Grade Design and Analysis Computer Programs for Nuclear Power Plants.'' This RG describes methods that the NRC considers acceptable in meeting regulatory requirements for acceptance and dedication of commercial- grade design and analysis computer programs used in safety-related applications for nuclear power plants.
South Carolina Electric & Gas Company, South Carolina Public Service Authority; Virgil C. Summer Nuclear Station, Units 2 and 3; Radiologically Controlled Area Ventilation System
The U.S. Nuclear Regulatory Commission (NRC) is issuing an exemption to allow a departure from the certification information of Tier 1 of the generic design control document (DCD) and is issuing License Amendment No. 53 to Combined Licenses (COLs), NPF-93 and NPF- 94. The COLs were issued to South Carolina Electric & Gas Company, (the licensee); for construction and operation of the Virgil C. Summer Nuclear Station (VCSNS) Units 2 and 3, located in Fairfield County, South Carolina. The issuance of the exemption allows the changes to Tier 1 information requested in the amendment. Because the acceptability of the exemption was determined in part by the acceptability of the amendment, the exemption and amendment are being issued concurrently.
Fisheries of the Northeastern United States; Atlantic Herring Fishery; Adjustment to the Atlantic Herring Management Area 1A Annual Catch Limit
NMFS adjusts the 2016 fishing year annual catch limit for Atlantic Herring Management Area 1A due to an underharvest in the New Brunswick weir fishery. This action is necessary to comply with the 2016-2018 specifications and management measures for the Atlantic Herring Fishery Management Plan and to ensure that accounting of the annual catch limit is accurate for fishing year 2016.
Listing of Ingredients in Tobacco Products; Revised Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a revised guidance for industry entitled ``Listing of Ingredients in Tobacco Products.'' The revised guidance document is intended to assist persons making tobacco product ingredient submissions to FDA as required by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). We received several comments to the draft guidance, and those comments were considered as the guidance was finalized.
Submission of Warning Plans for Cigars; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Submission of Warning Plans for Cigars.'' The guidance will help those involved in the manufacture, distribution, and sale of cigars in the United States understand the new cigar warning plan requirements under FDA's final rule deeming these products to be subject to the tobacco product authorities in the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The guidance reiterates the health warning statements and display and distribution requirements that should be provided in cigar warning plans and will help persons determine who should submit a warning plan, when a plan must be submitted, and what information should be included when submitting a plan.
Information Collection Request Sent to the Office of Management and Budget (OMB) for Approval; Federal Fish and Wildlife Permit Applications and Reports-Law Enforcement
We (U.S. Fish and Wildlife Service) have sent an Information Collection Request (ICR) to OMB for review and approval. We summarize the ICR below and describe the nature of the collection and the estimated burden and cost. This information collection is scheduled to expire on December 31, 2016. We 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. However, under OMB regulations, we may continue to conduct or sponsor this information collection while it is pending at OMB.
Notice of Funds Availability (NOFA); Farm-to-Fleet Feedstock Program Biofuel Production Incentive (BPI)
In support and for the purposes of the Farm-to-Fleet Program, the U.S. Department of Agriculture (USDA) Commodity Credit Corporation (CCC) is announcing that funding is available to pay a BPI to companies that are refining biofuel in the United States from certain domestically grown feedstocks converted to drop-in biofuel. If eligibility requirements are met, subject to availability of funds, the USDA Farm Service Agency (FSA) will use CCC funds to pay a per gallon incentive amount for JP-5 and F-76 blended biofuels produced from eligible feedstocks and delivered to the U.S. Department of Navy (U.S. Navy). Up to $50 million of CCC funds is available for obligation through fiscal year (FY) 2018. USDA does not expect funding to be a constraint through FY 2018; however, should there be a demand in excess of $50 million, USDA would consider requesting additional funds be made available for BPI payments. As explained in this NOFA, the BPI payment rate will range between 8.335 to 25 cents per blended gallon of biofuel depending on the blended rate; the payment rate will not be based on which eligible feedstock is used to produce the biofuel. The total BPI payment will be determined by multiplying the payment rate by the number of gallons of qualifying biofuel blend delivered under a Defense Logistics Agency (DLA) Energy contract. Biofuel vendors that deliver blended biofuel under a DLA Energy contract on behalf of the U.S. Navy that was refined in the United States and was produced from a domestically grown eligible feedstock are referred to in this NOFA as ``claimants'' for the BPI payment. As further specified in the Background of this NOFA and subject to the availability of funds, FSA will make a BPI payment to the claimant upon receipt of the following information: Quantity of delivered biofuel blend, identification of the U.S. produced feedstock from which the biofuel was produced, and the blend rate.
Defense Innovation Board: Notice of Federal Advisory Committee Meeting
The DoD is publishing this notice to announce the following Federal Advisory Committee Meeting of the Defense Innovation Board (``the Board''). This meeting is partially closed to the public.
Proposed Information Collection; Comment Request
The Corporation for National and Community Service (CNCS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirement on respondents can be properly assessed. Currently, CNCS is soliciting comments concerning its proposed renewal of the President's Higher Education Community Service Honor Roll. The President's Higher Education Community Service Honor Roll recognizes higher education institutions that reflect the values of exemplary community service and achieve meaningful outcomes in their communities. The Honor Roll is part of the Corporation for National and Community Service's strategic commitment to engage millions of college students in service and celebrate the critical role of higher education in strengthening communities. This information collection does not result in grant funding from the Corporation for National and Community Service or other federal agencies. Copies of the information collection request can be obtained by contacting the office listed in the Addresses section of this notice.
Okanogan-Wenatchee National Forest; Okanogan, Chelan and Skagit Counties, Washington; Pack Stock Outfitter Guide Special Use Permits Supplemental Environmental Impact Statement
The Okanogan-Wenatchee National Forest is issuing this notice to advise the public of a 30-day extension to the public comment period on the Pack and Saddle Stock Outfitter Guide Special Use Permit Issuance Draft Supplemental Environmental Impact Statement (SEIS). The initial Notice of Availability was published in the Federal Register on November 25, 2016, and established a public comment period from November 25, 2016 through January 9, 2017. The Okanogan-Wenatchee National Forest is hereby extending the deadline for submitting public comments on this matter to February 8, 2017.
National Estuarine Research Reserve System
Notice is hereby given that the Stewardship Division, Office for Coastal Management, National Ocean Service, National Oceanic and Atmospheric Administration, U.S. Department of Commerce is announcing a thirty-day public comment period for the Weeks Bay National Estuarine Research Reserve Management Plan revision. Pursuant to 15 CFR Section 921.33(c), the revised plan will bring the reserve into compliance. The Weeks Bay Reserve revised plan will replace the plan approved in 2007. The revised management plan outlines the administrative structure; the research/monitoring, stewardship, education, and training programs of the reserve; and the plans for future land acquisition and facility development to support reserve operations. The Weeks Bay Reserve takes an integrated approach to management, linking research, education, coastal training, and stewardship functions. The Alabama Department of Conservation and Natural Resources has outlined how it will administer the Reserve and its core programs by providing detailed actions that will enable it to accomplish specific goals and objectives. Since the last management plan, the Reserve has built out its core programs and monitoring infrastructure; constructed several facilities including a Resource Center that supports education, training, and outreach events; participated in more than 35 research projects and conducted over 100 coastal training program events; convened a permanent Restoration Advisory Board; and built new partnerships with organizations within the Mobile Bay of Alabama. With the approval of this management plan, the Weeks Bay Reserve will increase their total acreage from, 6,594 acres to 9,317. The change is attributable to the recent acquisitions of several parcels by the Reserve, totaling 933 acres, as well as the incorporation of 1,790 acres of water bottoms adjacent to the newly acquired land. These parcels have high ecological value and will enhance the Reserve's ability to provide increased opportunities for research, education, and stewardship. The revised management plan will serve as the guiding document for the expanded 9,317 acre Weeks Bay Reserve for the next five years. View the Weeks Bay Reserve Management Plan revision at (http:// www.weeksbayreserve.com) and provide comments to the Reserve's Manager, LG Adams (LG.Adams@dcnr.alabama.gov).