October 28, 2015 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2015-10-28-ReaderAids
Type: Reader Aids
Date: 2015-10-28
Sunshine Act Notice
Document Number: 2015-27618
Type: Notice
Date: 2015-10-28
Agency: Federal Election Commission, Agencies and Commissions
Product Change-Priority Mail Negotiated Service Agreement
Document Number: 2015-27501
Type: Notice
Date: 2015-10-28
Agency: Postal Service, Agencies and Commissions
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Pacific Gas and Electric Company; Diablo Canyon Power Plant, Units 1 and 2, and Diablo Canyon Independent Spent Fuel Storage Installation
Document Number: 2015-27484
Type: Notice
Date: 2015-10-28
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft environmental assessment (EA) and finding of no significant impact (FONSI) related to a request to amend the Facility Operating License Nos. DPR-80, DPR-82, and SNM-2511 issued to Pacific Gas and Electric Company (PG&E), for operation of the Diablo Canyon Power Plant, Units 1 and 2, including the specific-license Independent Spent Fuel Storage Installation (hereinafter DCPP or the facility), located in San Luis Obispo County, California. The requested amendments would permit licensee security personnel to use certain firearms and ammunition feeding devices not previously permitted, notwithstanding State, local, and certain Federal firearms laws or regulations that otherwise prohibit such actions.
Strata Energy, Inc.
Document Number: 2015-27483
Type: Notice
Date: 2015-10-28
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is issuing a temporary exemption from certain NRC financial assurance requirements to Strata Energy, Inc. (Strata), in response to its annual financial assurance update for its Ross In-Situ Recovery (ISR) project. Issuance of this temporary exemption will not remove the requirement for Strata to provide adequate financial assurance through an approved mechanism, but will allow the NRC staff to further evaluate whether the State of Wyoming's separate account provision for financial assurance instruments it holds is consistent with the NRC's requirement for a standby trust agreement.
Washington; Major Disaster and Related Determinations
Document Number: 2015-27477
Type: Notice
Date: 2015-10-28
Agency: Federal Emergency Management Agency, Department of Homeland Security
This is a notice of the Presidential declaration of a major disaster for the State of Washington (FEMA-4242-DR), dated October 15, 2015, and related determinations.
Agency Information Collection Activities: Proposed Collection; Comment Request; Individual & Community Preparedness Division (ICPD) Annual Youth Preparedness Council (YPC) Application Form
Document Number: 2015-27476
Type: Notice
Date: 2015-10-28
Agency: Federal Emergency Management Agency, Department of Homeland Security
The Federal Emergency Management Agency, 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 a new information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning the Individual & Community Preparedness Division (ICPD) Annual Youth Preparedness Council (YPC) Application Form.
Proposed Flood Hazard Determinations
Document Number: 2015-27475
Type: Notice
Date: 2015-10-28
Agency: Federal Emergency Management Agency, Department of Homeland Security
On August 19, 2015, FEMA published in the Federal Register a proposed flood hazard determination notice that contained an erroneous table. This notice provides corrections to that table, to be used in lieu of the information published at 80 FR 50307-50308. The table provided here represents the proposed flood hazard determinations and communities affected for Lower Suwannee Watershed.
Extension of Public Comment Period for the Revision of Certain Federal Water Quality Criteria Applicable to Washington
Document Number: 2015-27474
Type: Proposed Rule
Date: 2015-10-28
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is extending the comment period for the proposed rule, ``Revision of Certain Federal Water Quality Criteria Applicable to Washington.'' In response to stakeholder requests, EPA is extending the comment period for an additional 45 days, from November 13, 2015, to December 28, 2015. EPA will offer virtual public hearings on the proposed rule via the Internet in December 2015.
Changes in Flood Hazard Determinations
Document Number: 2015-27472
Type: Notice
Date: 2015-10-28
Agency: Federal Emergency Management Agency, Department of Homeland Security
New or modified Base (1-percent annual chance) Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, and/or regulatory floodways (hereinafter referred to as flood hazard determinations) as shown on the indicated Letter of Map Revision (LOMR) for each of the communities listed in the table below are finalized. Each LOMR revises the Flood Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance Study (FIS) reports, currently in effect for the listed communities. The flood hazard determinations modified by each LOMR will be used to calculate flood insurance premium rates for new buildings and their contents.
Agency Information Collection Activities; Proposed Renewal of the Collection under OMB Control No. 2070-0030, EPA ICR No. 0795.15; Comment Request
Document Number: 2015-27470
Type: Notice
Date: 2015-10-28
Agency: Environmental Protection Agency
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: ``Notification of Chemical ExportsTSCA Section 12(b)'' and identified by EPA ICR No. 0795.15 and OMB Control No. 2070- 0030, represents the renewal of an existing ICR that is scheduled to expire on August 31, 2016. 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.
Final Flood Elevation Determinations
Document Number: 2015-27469
Type: Rule
Date: 2015-10-28
Agency: Federal Emergency Management Agency, Department of Homeland Security
Base (1% annual-chance) Flood Elevations (BFEs) and modified BFEs are made final for the communities listed below. The BFEs and modified BFEs are the basis for the floodplain management measures that each community is required either to adopt or to show evidence of being already in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
Board of Scientific Counselors Safe and Sustainable Water Resources Subcommittee; Notification of Public Teleconference Meeting and Public Comment
Document Number: 2015-27468
Type: Notice
Date: 2015-10-28
Agency: Environmental Protection Agency
Pursuant to the Federal Advisory Committee Act, Public Law 92- 463, the U.S. Environmental Protection Agency, Office of Research and Development (ORD), gives notice of a public teleconference meeting of the Board of Scientific Counselors (BOSC) Safe and Sustainable Water Resources Subcommittee.
South Carolina; Amendment No. 6 to Notice of a Major Disaster Declaration
Document Number: 2015-27466
Type: Notice
Date: 2015-10-28
Agency: Federal Emergency Management Agency, Department of Homeland Security
This notice amends the notice of a major disaster declaration for the State of South Carolina (FEMA-4241-DR), dated October 5, 2015, and related determinations.
Agency Information Collection Activities; Proposed Collection; Comment Request; General Hazardous Waste Facility Standards.
Document Number: 2015-27465
Type: Notice
Date: 2015-10-28
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), General Hazardous Waste Facility Standards (EPA ICR No. 1571.11, OMB Control No. 2050-0120) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.). Before doing so, the EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through February 29, 2016. 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.
Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Specific Release Form
Document Number: 2015-27462
Type: Notice
Date: 2015-10-28
Agency: Federal Aviation Administration, Department of Transportation
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The information garnered from a Specific Release form will be used by FAA Special Agents to obtain information related to a specific investigation. That information is then provided to the FAA decision making authority to make FAA employment and/or pilot certification/revocation determinations.
Methoxyfenozide; Pesticide Tolerances
Document Number: 2015-27461
Type: Rule
Date: 2015-10-28
Agency: Environmental Protection Agency
This regulation establishes tolerances for residues of methoxyfenozide in or on multiple commodities which are identified and discussed later in this document. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Application(s) for Duty-Free Entry of Scientific Instruments
Document Number: 2015-27459
Type: Notice
Date: 2015-10-28
Agency: Department of Commerce, International Trade Administration
Certain Pasta From Italy: Notice of Final Results of Antidumping Duty Changed Circumstances Review
Document Number: 2015-27458
Type: Notice
Date: 2015-10-28
Agency: Department of Commerce, International Trade Administration
On June 23, 2015, the Department of Commerce (Department) published the preliminary results of the changed circumstances review of the antidumping duty order on certain pasta from Italy and preliminarily determined that La Molisana S.p.A. (La Molisana) was not the successor-in-interest to La Molisana Industrie Alimentari, S.p.A. (LMI), a respondent in the investigation and several administrative reviews.\1\ We received comments from interested parties. Based on our analysis, for the final results, the Department continues to find that La Molisana is not the successor-in-interest to LMI.
Determination
Document Number: 2015-27456
Type: Notice
Date: 2015-10-28
Agency: Department of State
Notice of Agreements Filed
Document Number: 2015-27455
Type: Notice
Date: 2015-10-28
Agency: Federal Maritime Commission, Agencies and Commissions
Prospective Grant of Exclusive License: Development of Therapeutics To Treat Obesity, Type 2 Diabetes, Fatty Liver Disease, and Liver Fibrosis in Humans
Document Number: 2015-27454
Type: Notice
Date: 2015-10-28
Agency: Department of Health and Human Services, National Institutes of Health
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the following inventions embodied in the following patent applications, entitled ``CB1 receptor mediating compounds'':
Investigations Regarding Eligibility To Apply for Worker Adjustment Assistance
Document Number: 2015-27453
Type: Notice
Date: 2015-10-28
Agency: Employment and Training Administration, Department of Labor
Notice of Determinations Regarding Eligibility To Apply for Worker Adjustment Assistance
Document Number: 2015-27452
Type: Notice
Date: 2015-10-28
Agency: Employment and Training Administration, Department of Labor
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; 2016-2017 Federal Student Aid Application
Document Number: 2015-27451
Type: Notice
Date: 2015-10-28
Agency: Department of Education
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a revision of an existing information collection.
Council for Native American Farming and Ranching Meeting
Document Number: 2015-27450
Type: Notice
Date: 2015-10-28
This notice announces a forthcoming meeting of The Council for Native American Farming and Ranching (CNAFR), a public advisory committee of the Office of Tribal Relations (OTR). Notice of the meetings are provided in accordance with section 10(a)(2) of the Federal Advisory Committee Act, as amended, (5 U.S.C. Appendix 2). This will be the first meeting held during fiscal year 2016 and will consist of, but not be limited to: Hearing public comments, update of USDA programs and activities, and discussion of committee priorities. This meeting will be open to the public.
Hardwood Lumber and Hardwood Plywood Promotion, Research and Information Order; Termination of Rulemaking Proceeding
Document Number: 2015-27448
Type: Proposed Rule
Date: 2015-10-28
Agency: Agricultural Marketing Service, Department of Agriculture
This action terminates a rulemaking proceeding that proposed to establish a Hardwood Lumber and Hardwood Plywood Promotion, Research and Information Order (Order) under authority in the Commodity Promotion, Research and Information Act of 1996 (1996 Act). The Order was proposed by the proponent group, the Blue Ribbon Committee (BRC), and would have authorized a national research and promotion program for hardwood lumber and hardwood plywood. USDA issued a supplemental notice of proposed rulemaking in response to the extensive comments received. Based on comments received, outstanding substantive questions and significant proposed modifications from stakeholders, USDA is terminating the proceeding. Termination of this proceeding will remove ex parte communication prohibitions and allow USDA to engage fully with all interested parties to discuss and consider the evolving needs of the industry going forward.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Extension
Document Number: 2015-27446
Type: Notice
Date: 2015-10-28
Agency: Federal Trade Commission, Agencies and Commissions
The FTC intends to ask the Office of Management and Budget (``OMB'') to extend for an additional three years the current Paperwork Reduction Act (``PRA'') clearance \1\ for the FTC's shared enforcement with the Consumer Financial Protection Bureau (``CFPB'') of the disclosure requirements in subpart N of Regulation V (``Rule''). That clearance expires on December 31, 2015.
Announcement of Chronicling America: Historic American Newspapers
Document Number: 2015-27445
Type: Notice
Date: 2015-10-28
Agency: National Foundation on the Arts and the Humanities, Agencies and Commissions
The National Endowment for the Humanities (NEH) announces the Chronicling America: Historic American Newspapers Data Challenge under Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-358). This challenge encourages the creation of web-based tools, data visualizations, and other creative uses of the information found in the Chronicling America historic newspaper database.
Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest
Document Number: 2015-27444
Type: Notice
Date: 2015-10-28
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that the U.S. International Trade Commission has received an amended complaint entitled Certain Woven Textile Fabrics and Products Containing Same, DN 3088; the Commission is soliciting comments on any public interest issues raised by the amended complaint or complainant's filing under section 210.8(b) of the Commission's Rules of Practice and Procedure (19 CFR 210.8(b)).
Grant Guideline, Notice
Document Number: 2015-27443
Type: Notice
Date: 2015-10-28
Agency: State Justice Institute, Agencies and Commissions
This Guideline sets forth the administrative, programmatic, and financial requirements attendant to Fiscal Year 2016 State Justice Institute grants, cooperative agreements, and contracts.
Amendments to Existing Validated End-User Authorizations in the People's Republic of China
Document Number: 2015-27442
Type: Rule
Date: 2015-10-28
Agency: Department of Commerce, Bureau of Industry and Security
In this rule, the Bureau of Industry and Security (BIS) amends the Export Administration Regulations (EAR) to revise the existing authorizations for Validated End Users Advanced Micro-Fabrication Equipment, Inc., China (AMEC) and Applied Materials (China), Inc. (AMC) in the People's Republic of China (PRC). Specifically, BIS amends Supplement No. 7 to Part 748 of the EAR to add one item to AMEC's list of eligible items that may be exported, reexported or transferred (in country) to the company's eligible facility in the PRC, and to add a facility and an item to Validated End User AMC's list of eligible destinations and eligible items.
Quarterly IRS Interest Rates Used in Calculating Interest on Overdue Accounts and Refunds on Customs Duties
Document Number: 2015-27437
Type: Notice
Date: 2015-10-28
Agency: Department of Homeland Security, U.S. Customs and Border Protection
This notice advises the public of the quarterly Internal Revenue Service interest rates used to calculate interest on overdue accounts (underpayments) and refunds (overpayments) of customs duties remains unchanged from the previous quarter. For the calendar quarter beginning October 1, 2015, the interest rates for overpayments will be 2 percent for corporations and 3 percent for non-corporations, and the interest rate for underpayments will be 3 percent for both corporations and non-corporations. This notice is published for the convenience of the importing public and U.S. Customs and Border Protection personnel.
World Trade Center Health Program; Petition 009-Autoimmune Diseases; Finding of Insufficient Evidence
Document Number: 2015-27435
Type: Proposed Rule
Date: 2015-10-28
Agency: Department of Health and Human Services
On September 14, 2015, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 009) to add the autoimmune disease multiple sclerosis to the List of WTC-Related Health Conditions (List). Upon reviewing the information provided by the petitioner, the Administrator has determined that Petition 009 is not substantially different from Petitions 007 and 008, which also requested the addition of autoimmune diseases. The Administrator recently published responses to both Petition 007 and Petition 008 in the Federal Register and has determined that Petition 009 does not provide additional evidence of a causal relationship between 9/11 exposures and autoimmune diseases. Accordingly, the Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
Solicitation of Nominations for Appointment to the Advisory Committee on Cemeteries and Memorials.
Document Number: 2015-27433
Type: Notice
Date: 2015-10-28
Agency: Department of Veterans Affairs
The Department of Veterans Affairs (VA), National Cemetery Administration (NCA), is seeking nominations of qualified candidates to be considered for appointment as a member of the Advisory Committee on Cemeteries and Memorials (herein-after in this section referred to as ``the Committee''). The Committee was established pursuant to 38 U.S.C. 2401 to advise the Secretary of VA with respect to the administration of VA national cemeteries, soldiers' lots and plots, which are the responsibility of the Secretary, the erection of appropriate memorials and the adequacy of Federal burial benefits. Nominations of qualified candidates are being sought to fill upcoming vacancies on the Committee.
Information Collection; Payment to Small Business Subcontractors
Document Number: 2015-27432
Type: Notice
Date: 2015-10-28
Agency: Department of Defense, General Services Administration, Agencies and Commissions
The notice, OMB Control No. 9000-00XX, Payment to Small Business Subcontractors, published in the Federal Register, is being withdrawn and is no longer accepting comments.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2015-27431
Type: Notice
Date: 2015-10-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Marine Fisheries Advisory Committee
Document Number: 2015-27430
Type: Notice
Date: 2015-10-28
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
This notice sets forth the schedule and proposed agenda of a forthcoming meeting of the Marine Fisheries Advisory Committee (MAFAC). The members will discuss and provide advice on issues outlined in the agenda below.
Fisheries of the Exclusive Economic Zone Off Alaska; Reallocation of Pacific Cod in the Bering Sea and Aleutian Islands Management Area
Document Number: 2015-27429
Type: Rule
Date: 2015-10-28
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is reallocating the projected unused amounts of Pacific cod from catcher vessels greater than 60 feet (18.3 meters (m)) length overall (LOA) using pot gear, American Fisheries Act (AFA) trawl catcher processors (C/Ps), and catcher vessels using trawl gear to Amendment 80 (A80) C/Ps, C/Ps using hook-and-line gear, and C/Ps using pot gear in the Bering Sea and Aleutian Islands management area. This action is necessary to allow the 2015 total allowable catch of Pacific cod to be harvested.
Certain Consumer Electronics and Display Devices With Graphics Processing and Graphics Processing Units Therein; Notice of Request for Statements on the Public Interest
Document Number: 2015-27428
Type: Notice
Date: 2015-10-28
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that the presiding administrative law judge (``ALJ'') has issued an Initial Determination and Recommended Determination on Remedy and Bonding. The ALJ found no violation of section 337. Should the Commission, however, find a violation of section 337, the ALJ recommends that the Commission issue a limited exclusion order directed to Samsung's Accused Products and a cease and desist order against Samsung. The Commission is soliciting comments on public interest issues raised by the recommended determination. This notice is soliciting public interest comments from the public only. Parties are to file public interest submissions pursuant to 19 CFR 210.50(a)(4).
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2015-27427
Type: Notice
Date: 2015-10-28
Agency: Department of Health and Human Services, National Institutes of Health
Privacy Act of 1974, Altered System of Records
Document Number: 2015-27426
Type: Notice
Date: 2015-10-28
Agency: Department of Commerce
The Department of Commerce publishes this notice to announce the effective date of a Privacy Act System of Records notice entitled Notice of Proposed Amendment to COMMERCE/NOAA-14, Dr. Nancy Foster Scholarship Program.
National Estuarine Research Reserve System
Document Number: 2015-27425
Type: Notice
Date: 2015-10-28
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
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 approves the Apalachicola, Florida National Estuarine Research Reserve Management Plan revision. The revised management plan outlines the administrative structure; the research & monitoring, education, training, and stewardship goals of the reserve; and the plans for future land acquisition and facility development to support reserve operations. The Apalachicola Reserve revised plan will replace the plan approved in 2003. The Apalachicola Reserve management plan emphasizes a fully integrated approach that links ongoing research, education, training and stewardship programs together. This integrated approach, in coordination with strategic partnerships addresses high priority reserve issues including public use and access, changing land use patterns, the loss of cultural resources, impacts of global and regional processes on ecosystems and communities, engagement with local communities, and changes in reserve habitats. Since the last management plan, the reserve has expanded its monitoring and geographic information system programs; increased staff resources; completed a site profile, established a Coastal Training Program; expanded educational programs; and constructed a new nature center and headquarters complex in the town of Eastpoint that includes laboratories, offices, classrooms, interpretative areas, and are planning interpretive trails. There is a boundary change associated with this management plan revision that will decrease their total acreage from 246,766 acres to 234,715. The change is attributable to accuracy adjustments based on improved geographic information for the site. The revised management plan will serve as the guiding document for the 234,715 acre Apalachicola Reserve for the next five years. View the Apalachicola, Florida Reserve Management Plan revision at (https:// www.dep.state.fl.us/coastal/sites/apalachicola/publications.h tm).
SJI Board of Directors Meeting, Notice
Document Number: 2015-27424
Type: Notice
Date: 2015-10-28
Agency: State Justice Institute, Agencies and Commissions
The SJI Board of Directors will be meeting on Monday, November 16, 2015 at 1:00 p.m. The meeting will be held at the Supreme Court of Louisiana in New Orleans, Louisiana. The purpose of this meeting is to consider grant applications for the 1st quarter of FY 2016, and other business. All portions of this meeting are open to the public.
Trustees of the Cincinnati Southern Railway Company-Abandonment Exemption, Scott County, TN
Document Number: 2015-27422
Type: Notice
Date: 2015-10-28
Agency: Surface Transportation Board, Department of Transportation
Snapper-Grouper Fishery of the South Atlantic; 2015 Commercial Accountability Measure and Closure for South Atlantic Yellowtail Snapper
Document Number: 2015-27421
Type: Rule
Date: 2015-10-28
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS implements accountability measures (AMs) for the yellowtail snapper commercial sector in the exclusive economic zone (EEZ) of the South Atlantic for the 2015 fishing year through this temporary rule. Commercial landings for yellowtail snapper, as estimated by the Science and Research Director, are projected to reach the commercial annual catch limit (ACL) on October 31, 2015. Therefore, NMFS closes the yellowtail snapper commercial sector on October 31, 2015, through the remainder of the fishing year in the South Atlantic EEZ. This closure is necessary to protect the South Atlantic yellowtail snapper resource.
Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records
Document Number: 2015-27420
Type: Notice
Date: 2015-10-28
Agency: Food and Drug Administration, Department of Health and Human Services
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 investigational device exemptions reports and records.
National Offshore Safety Advisory Committee
Document Number: 2015-27419
Type: Notice
Date: 2015-10-28
Agency: Coast Guard, Department of Homeland Security
The National Offshore Safety Advisory Committee and its Subcommittee will hold a public meeting in Katy, TX to discuss the safety of operations and other matters affecting the offshore oil and gas industry. These meetings are open to the public.
Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route; Guidance for Industry and Review Staff; Availability
Document Number: 2015-27418
Type: Notice
Date: 2015-10-28
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 review staff entitled ``Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route.'' The guidance provides recommendations concerning the evaluation of the nonclinical safety of reformulated drug products or products being used by an alternate route. It is intended for use by interested individuals in industry and reviewers within the Center for Drug Evaluation and Research (CDER). The goals of this guidance are to foster and expedite the development of reformulated drug products or the use of previously approved drugs by alternate routes, communicate to industry current CDER thoughts pertaining to safety data needed to support these drug products, and increase uniformity within CDER on expectations for the nonclinical development of reformulated drug products or products being used by an alternate route. This guidance finalizes the draft guidance of the same name published on March 7, 2008.
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