September 16, 2016 – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of 147
Notice of Realty Action: Application for Conveyance of Federally Owned Mineral Interests in Escambia County, FL
The Bureau of Land Management (BLM) is processing an application under the Federal Land Policy and Management Act of October 21, 1976 (FLPMA) to convey the undivided mineral interest owned by the United States in 70 acres located in Escambia County, Florida, to the surface owner, Airway Development, LLC. Publication of this notice temporarily segregates the federally owned mineral interests in the land covered by the application from all forms of appropriation under the public land laws, including the mining laws, for up to 2 years while the BLM processes the application.
Indiana Disaster #IN-00059
This is a notice of an Administrative declaration of a disaster for the State of Indiana dated 09/08/2016. Incident: Tornadoes and High Winds. Incident Period: 08/24/2016. Effective Date: 09/08/2016. Physical Loan Application Deadline Date: 11/07/2016. Economic Injury (EIDL) Loan Application Deadline Date: 06/08/2017.
Sixteenth RTCA SC-209 Working Session and Plenary Session Joint With EUROCAE WG 49, WG 51, and RTCA SC-186
The FAA is issuing this notice to advise the public of a meeting of Sixteenth RTCA SC-209 Working Session and Plenary Session joint with EUROCAE WG 49, WG 51, and RTCA SC-186.
Approval of California Air Plan Revisions, South Coast Air Quality Management District
The Environmental Protection Agency (EPA) is proposing to approve revisions to the South Coast Air Quality Management District (SCAQMD) portion of the California State Implementation Plan (SIP). These revisions concern emissions of oxides of nitrogen (NOX) from ovens, dryers, dehydrators, heaters, kilns, calciners, furnaces, crematories, incinerators, heated pots, cookers, roasters, smokers, fryers, closed and open heated tanks and evaporators, distillation units, afterburners, degassing units, vapor incinerators, catalytic or thermal oxidizers, soil and water remediation units, and other combustion equipment. We are proposing to approve local rules to regulate these emission sources under the Clean Air Act (CAA or the Act). We are taking comments on this proposal and plan to follow with a final action.
Entergy Nuclear Operations, Inc., Indian Point Nuclear Generating Unit Nos. 2 and 3
The U.S. Nuclear Regulatory Commission (NRC) is giving notice that by petition dated June 30, 2016, Mr. David A. Lochbaum of the Union of Concerned Scientists (the petitioner) requested that the NRC take action with regard to Indian Point Nuclear Generating Unit Nos. 2 and 3. The petitioner's requests are included in the SUPPLEMENTARY INFORMATION section of this document.
Culturally Significant Objects Imported for Exhibition Determinations: “Word and Image: Martin Luther's Reformation” Exhibition
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257 of April 15, 2003), I hereby determine that the objects to be included in the exhibition ``Word and Image: Martin Luther's Reformation,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at The Morgan Library & Museum, New York, New York, from on or about October 7, 2016, until on or about January 22, 2017, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these Determinations be published in the Federal Register.
Use of Outer Continental Shelf (OCS) Sand Resources for the Mississippi Coastal Improvements Program (MsCIP) Comprehensive Barrier Island Restoration in Hancock, Harrison, and Jackson Counties, Mississippi
BOEM is announcing the availability of the ROD that documents BOEM's decision to authorize the use of OCS sand resources by the U.S. Army Corps of Engineers (USACE) Mobile District in the MsCIP Comprehensive Barrier Island Restoration Project (Project) in Hancock, Harrison, and Jackson Counties, Mississippi. The ROD is available at BOEM's Web site at https://www.boem.gov/Non-Energy-Minerals/Marine- Minerals-Program.aspx. BOEM will enter into a Memorandum of Agreement (MOA) with the USACE and make available OCS sand for use in the MsCIP Comprehensive Barrier Island Restoration Project.
Culturally Significant Objects Imported for Exhibition Determinations: “The Rama Epic: Hero, Heroine, Ally, Foe” Exhibition
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257 of April 15, 2003), I hereby determine that the objects to be included in the exhibition ``The Rama Epic: Hero, Heroine, Ally, Foe,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the Asian Art Museum of San Francisco, San Francisco, California, from on or about October 21, 2016, until on or about January 15, 2017, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these Determinations be published in the Federal Register.
Culturally Significant Objects Imported for Exhibition Determinations: “The Art of Alchemy” Exhibition
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257 of April 15, 2003), I hereby determine that the objects to be included in the exhibition ``The Art of Alchemy,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the Getty Research Institute at the Getty Center, Los Angeles, California, from on or about October 11, 2016, until on or about February 12, 2017, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these Determinations be published in the Federal Register.
60-Day Notice of Proposed Information Collection: Multifamily Project Construction Change
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
60-Day Notice of Proposed Information Collection: Final Endorsement of Credit Instrument
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Ammonium Persulfate; Exemption From the Requirement of a Tolerance
This regulation establishes an exemption from the requirement of a tolerance for residues of ammonium persulfate (CAS Reg. No.7727- 54-0) when used as an inert ingredient (preservative) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest, etc.) at a concentration not to exceed 0.05% by weight. Exponent, Inc., on behalf of Becker Underwood, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of ammonium persulfate under the approved conditions.
Visas: Diversity Immigrants
This final rule is promulgated to clarify that photographs submitted as part of a diversity visa lottery entry package must have been taken no more than six months before the date the entry is made and prohibit applicants from wearing eyeglasses in photographs.
Agency Information Collection Activities: African Growth and Opportunity Act Certificate of Origin
U.S. Customs and Border Protection (CBP) of the Department of Homeland Security will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: African Growth and Opportunity Act Certificate of Origin (AGOA). CBP is proposing that this information collection be extended with a change to the burden hours. There is no change to the information collected. This document is published to obtain comments from the public and affected agencies.
TRICARE; Mental Health and Substance Use Disorder Treatment
On September 2, 2016, the Department of Defense published a final rule (81 FR 61068-61098) titled TRICARE; Mental Health and Substance Use Disorder Treatment. DoD is making a technical amendment due to the discovery of two errors. We noted in the preamble of the final rule that we had removed the requirements regarding capacity (30 percent) and length of time licensed and at full operational status (6 months) for substance use disorder rehabilitation facilities (SUDRFs). However, we did not remove the necessary sentence in the regulatory text. In a response to a public comment in the preamble of the final rule, we said that TRICARE will require opioid treatment programs (OTPs) to be licensed and operate in substantial compliance with state and federal regulations. However, we did not make the necessary change in the regulatory text. This technical amendment corrects those errors.
Implementing Public Safety Broadband Provisions of the Middle Class Tax Relief and Job Creation Act of 2012
In this document, the Federal Communications Commission (Commission) addresses the 758-769/788-799 MHz band, which the Commission licensed to the First Responder Network Authority (FirstNet) on a nationwide basis pursuant to the provisions of the Middle Class Tax Relief and Job Creation Act of 2012. We provide a mechanism to facilitate the relocation of the public safety narrowband incumbents currently operating on FirstNet's spectrum. We also affirmatively decline at this time to impose specific build-out requirements on FirstNet as a condition of renewal of its license.
Federal Property Suitable as Facilities To Assist the Homeless
This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for use to assist the homeless.
Notice of Information Collection Under OMB Emergency Review: Affidavit of Relationship (AOR) for Minors Who Are Nationals of El Salvador, Guatemala, or Honduras
The Department of State has submitted the information collection request described below to the Office of Management and Budget (OMB) for review and approval in accordance with the emergency review procedures of the Paperwork Reduction Act of 1995 (5 CFR 1320.13). The purpose of this notice is to allow for public comment from all interested individuals and organizations. Emergency review and approval of this collection has been requested from OMB by September 30, 2016. If granted, the emergency approval will only be valid for a maximum of 180 days. The Department plans to follow this emergency request with a submission for a three year approval through OMB's normal PRA clearance process (5 CFR 1320.10).
Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G; Temporary Exemptions From the Requirement of a Tolerance
This regulation establishes temporary exemptions from the requirement of a tolerance for residues of Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G in or on the food and feed commodities of corn, field; corn, pop; and corn, sweet when used in accordance with the terms of Experimental Use Permit (EUP) No. 91163-EUP-1. Interregional Research Project Number 4 (IR-4) submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting these temporary tolerance exemptions. This regulation eliminates the need under FFDCA to establish a maximum permissible level for residues of Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G when used under the terms of EUP No. 91163-EUP-1. The temporary tolerance exemptions expire on June 30, 2020.
Special Local Regulations; Ironman 70.3 Augusta Triathlon, Savannah River
The Coast Guard will enforce the Ironman 70.3 Augusta Triathlon, Savannah River, Special Local Regulation from 7 a.m. through 11 a.m. on September 25, 2016. This action is necessary to ensure safety of life on navigable waterways of the United States during this event. During the enforcement period, and in accordance with previously issued special local regulations, vessels may not enter, transit through, anchor in, remain within the designated area unless authorized by the Captain of the Port (COTP) Savannah or a designated representative.
Information Collection: General Oil and Gas and Sulphur and Production Requirements in the Outer Continental Shelf; Proposed Collection for OMB Review; Comment Request
To comply with the Paperwork Reduction Act of 1995 (PRA), the Bureau of Ocean Energy Management (BOEM) is inviting comments on a collection of information that we will submit to the Office of Management and Budget (OMB) for review and approval. The information collection request (ICR) concerns the paperwork requirements in the regulations under 30 CFR 550, Subparts A, General; and K, and Oil and Gas Production Requirements, as well as the associated forms. The Office of Management and Budget (OMB) has assigned control number 1010- 0114 to this information collection.
60-Day Notice of Proposed Information Collection: Request for Advisory Opinion
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.
Recommendations for Microbial Vectors Used for Gene Therapy; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Recommendations for Microbial Vectors Used for Gene Therapy; Guidance for Industry.'' The guidance document provides investigational new drug application (IND) sponsors, with recommendations concerning IND submissions for microbial vectors used for gene therapy (MVGTs) in early phase clinical trials. The guidance focuses on the chemistry, manufacturing, and control (CMC) information that sponsors should submit in an IND for MVGTs and provides an overview of preclinical and clinical considerations for these products. The guidance announced in this notice finalizes the draft guidance of the same title dated October 2015 and supplements the guidance entitled ``Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs),'' dated April 2008.
Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices
The Food and Drug Administration (FDA or Agency) is announcing a public workshop regarding ``Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices (ASTs).'' This public workshop is intended to facilitate discussion between drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs or ASTs and who wish to coordinate development of these products, such that the AST device could be cleared either at the time of new drug approval or shortly thereafter. The input from this public workshop will also help in developing topics for future discussion.
National Historic Landmarks Committee of the National Park System Advisory Board Meeting
Notice is hereby given in accordance with the Federal Advisory Committee Act (5 U.S.C. Appendix 1-16), and Part 65 of title 36 of the Code of Federal Regulations, that a meeting of the National Historic Landmarks Committee of the National Park System Advisory Board will be held beginning at 10:00 a.m. on October 18, 2016, at the Charles Sumner School Museum and Archives. The meeting will continue beginning at 9:30 a.m. on October 19, 2016.
Notice of Open Public Meetings for the National Park Service Alaska Region Subsistence Resource Commission Program
As required by the Federal Advisory Committee Act (16 U.S.C. Appendix 1-16), the National Park Service (NPS) is hereby giving notice that the Lake Clark National Park Subsistence Resource Commission (SRC), Aniakchak National Monument SRC, Wrangell-St. Elias National Park SRC, Cape Krusenstern National Monument SRC, Kobuk Valley National Park SRC, and Gates of the Arctic National Park SRC will hold public meetings to develop and continue work on NPS subsistence program recommendations, and other related regulatory proposals and resource management issues. The NPS SRC program is authorized under Section 808 of the Alaska National Interest Lands Conservation Act (16 U.S.C. 3118), title VIII. Lake Clark National Park SRC Meeting/Teleconference Date and Location: The Lake Clark National Park SRC will meet from 1:00 a.m. to 5:00 p.m. or until business is completed on Wednesday, September 28, 2016, at the Community Hall in Nondalton, AK. Teleconference participants must call the National Park Service office at (907) 644- 3648, prior to the meeting to receive teleconference passcode information. For more detailed information regarding this meeting, or if you are interested in applying for SRC membership, contact Designated Federal Official Margaret L. Goodro, Superintendent, at (907) 644-3627, or via email at margaret_goodro@nps.gov, or Liza Rupp, Subsistence Manager, at (907) 644-3648, or via email at liza_rupp@nps.gov or Clarence Summers, Subsistence Manager, at (907) 644-3603 or via email at clarence_summers@nps.gov. Aniakchak National Monument SRC Meeting/Teleconference Date and Location: The Aniakchak National Monument SRC will meet from 2:00 p.m. to 7:30 p.m. or until business is completed on Friday, September 30, 2016, at the Subsistence Building in Chignik Lagoon, AK. Teleconference participants must call the National Park Service at (907) 246-2154 or (907) 246-3305, prior to the meeting for teleconference call in information. For more detailed information regarding this meeting, or if you are interested in applying for SRC membership, contact Linda Chisholm, Subsistence Coordinator, at (907) 246-2154, or via email linda_chisholm@nps.gov, or Clarence Summers, Subsistence Manager, at (907) 644-3603, or via email clarence_summers@nps.gov. Wrangell-St. Elias National Park SRC Meeting Dates and Locations: The Wrangell-St. Elias National Park SRC will meet from 10:00 a.m. to 5:00 p.m. or until business is completed on Wednesday, October 12, 2016, at the Northway Village Hall in Northway, AK. On Thursday, October 13, 2016, the Wrangell-St. Elias National Park SRC will meet from 9:00 a.m. to 5:00 p.m. or until business is completed at the Musher's Hall in Tok, AK. For more detailed information regarding these meetings, or if you are interested in applying for SRC membership, contact Barbara Cellarius, Subsistence Coordinator, at (907) 822-7236 or by email at barbara_cellarius@nps.gov or Clarence Summers, Subsistence Manager, at (907) 644-3603 or via email at clarence_summers@nps.gov. Gates of The Arctic National Park SRC Meeting Date and Location: The Gates of the Arctic National Park SRC will meet from 9:00 a.m. to 5:00 p.m. or until business is completed on Tuesday, November 15, 2016, and Wednesday, November 16, 2016, at the Gates of the Arctic National Park and Preserve office in Fairbanks, AK. For more detailed information regarding this meeting, or if you are interested in applying for SRC membership, contact Designated Federal Official Greg Dudgeon, Superintendent, at (907) 457-5752, or via email at greg_dudgeon@nps.gov or Marcy Okada, Subsistence Coordinator, at (907) 455-0639 or via email at marcy_okada@nps.gov or Clarence Summers, Subsistence Manager, at (907) 644-3603, or via email at clarence_summers@nps.gov. Cape Krusenstern National Monument SRC Meeting Date and Location: The Cape Krusenstern National Monument SRC will meet from 1:00 p.m. to 5:00 p.m. or until business is completed on Tuesday, November 8, 2016, and from 9:00 a.m. to 12:00 p.m. on November 9, 2016, at the Northwest Arctic Heritage Center in Kotzebue, AK. For more detailed information regarding this meeting or if you are interested in applying for SRC membership, contact Hannah Atkinson, Cultural Resource Specialist at the Cape Krusenstern National Monument office at (907) 442-4342, or via email at hannah_atkinson, or Clarence Summers, Subsistence Manager, at (907) 644-3603 or via email at clarence_summers@nps.gov. Kobuk Valley National Park SRC Meeting Date and Location: The Kobuk Valley National Park SRC will meet from 1:00 p.m. to 5:00 p.m. or until business is completed on Thursday, November 10, 2016, and from 9:00 a.m. to 12:00 p.m. on Friday, November 11, 2016, at the Northwest Arctic Heritage Center in Kotzebue, AK. For more detailed information regarding this meeting or if you are interested in applying for SRC membership, contact Hannah Atkinson, Cultural Resource Specialist at the Kobuk Valley National Park office at (907) 442-4342, or via email at hannah_atkinson, or Clarence Summers, Subsistence Manager, at (907) 644-3603 or via email at clarence_summers@nps.gov. Proposed Meeting Agenda: The agenda may change to accommodate SRC business. The proposed meeting agenda for each meeting includes the following:
Notice of November 17-18, 2016, Meeting of the National Park System Advisory Board
Notice is hereby given in accordance with the Federal Advisory Committee Act, 5 U.S.C. Appendix 1-16, and part 62 of title 36 of the Code of Federal Regulations that the National Park System Advisory Board will meet November 17-18, 2016, in Philadelphia, Pennsylvania. The agenda will include the review of proposed actions regarding the National Historic Landmarks Program. Interested parties are encouraged to submit written comments and recommendations that will be presented to the Board. Interested parties also may attend the board meeting and upon request may address the Board concerning an area's national significance.
Clinical Investigator Training Course
The Food and Drug Administration (FDA), in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), is announcing a 3-day training course for clinical investigators on the scientific, ethical, and regulatory aspects of clinical trials for medical products. This training course is intended to provide clinical investigators, such as clinicians, nurses, pharmacists, and other health care providers involved in conducting clinical trials, with expertise in the design, conduct, and analysis of clinical trials; to improve the quality of clinical trials; and to enhance the safety of trial participants. Senior FDA staff, along with other experts, will present on issues critical for successful conduct of clinical research.
Qualification of Biomarker-Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Qualification of BiomarkerTotal Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease.'' This guidance provides a qualified context of use (COU) for total kidney volume (TKV), measured at baseline, to be used as a prognostic enrichment biomarker to select patients with autosomal dominant polycystic kidney disease (ADPKD) at high risk for a ``progressive decline'' in renal function, defined as a confirmed 30 percent decline in the patient's estimated glomerular filtration rate (eGFR), for inclusion in interventional clinical trials. This guidance also describes the experimental conditions and constraints for which this biomarker is qualified through the Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program. This biomarker can be used by drug developers for the qualified COU in submissions of investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs)without the relevant CDER review group reconsidering and reconfirming the suitability of the biomarker.
Determination of Regulatory Review Period for Purposes of Patent Extension; LUMASON
The Food and Drug Administration (FDA) has determined the regulatory review period for LUMASON and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; ENTYVIO
The Food and Drug Administration (FDA) has determined the regulatory review period for ENTYVIO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patents and Trademarks Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; RESQCPR SYSTEM
The Food and Drug Administration (FDA) has determined the regulatory review period for RESQCPR SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: The necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities; Proposed Collection; Comment Request; Unique Device Identification System
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with the Unique Device Identification System.
Waivers From the Requirement To Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles; Draft Revised Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft revised guidance for industry (GFI) #171 entitled ``Waivers from the Requirement to Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles.'' This draft revised guidance document describes how the Center for Veterinary Medicine (CVM) intends to evaluate requests for waiving the requirement for submitting data demonstrating the bioequivalence of animal drugs in soluble powder oral dosage form products and Type A medicated articles. It expands upon CVM's Bioequivalence Guidance,\1\ particularly the section on Criteria for Waiver of In Vivo Bioequivalence Study. This guidance is applicable to generic investigational new animal drug (JINAD) files and abbreviated new animal drug applications (ANADAs). Although the recommendations in this guidance reference generic drug applications, the general principles described may also be applicable to new animal drug applications (NADAs), investigational new animal drug (INAD) files, and supplemental NADAs.
Fisheries of the Exclusive Economic Zone Off Alaska; Exchange of Flatfish in the Bering Sea and Aleutian Islands Management Area
NMFS is exchanging allocations of Amendment 80 cooperative quota (CQ) for Amendment 80 acceptable biological catch (ABC) reserves. This action is necessary to allow the 2016 total allowable catch of flathead sole, rock sole, and yellowfin sole in the Bering Sea and Aleutian Islands management area to be harvested.
Menu Labeling Public Workshop; Public Meeting
The Food and Drug Administration (FDA or we) is announcing a third public meeting to discuss menu labeling requirements. We announced the first two public meetings in a separate Federal Register notice earlier this year. The purpose of the public meetings is to help the regulated industry comply with the requirements of the menu labeling final rule.
Withdrawal of Notice of Intent To Prepare a Supplemental Environmental Impact Statement for the Raritan Bay and Sandy Hook Bay, New Jersey Feasibility Report for Hurricane and Storm Damage Reduction Union Beach, New Jersey Final Feasibility Report
The U.S. Army Corps of Engineers, New York District (NY District), is withdrawing its intent to prepare a Draft Supplemental Environmental Impact Statement (SEIS) for the Study. The Notice of Intent to prepare the SEIS was published in the Friday, January 24, 2014, issue of the Federal Register (79 FR 4155).
New England Fishery Management Council; Public Meeting
The New England Fishery Management Council (Council) is scheduling a public meeting of its Groundfish Committee 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.
Agenda and Notice of Public Meeting of the Maine Advisory Committee
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the Maine State Advisory Committee to the Commission will convene by conference call at 1:30 p.m. (EST) a planning meeting on the following dates: Tuesday, October 18, 2016; Tuesday, November 15, 2016; Tuesday, December 20, 2016; Tuesday, January, 17, 2017 and Tuesday, February 21, 2017. The purpose of each planning meeting is to discuss project planning as the Committee moves to selecting a topic as its civil rights project and once the project is selected to continue working on the project. The Committee may also select additional officers, as necessary.
Gulf of Mexico Fishery Management Council; Public Meeting
The Gulf of Mexico Fishery Management Council will hold a meeting of its Reef Fish Advisory Panel (AP).
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