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Document Number: 2016-10453
Type: Proposed Rule
Date: 2016-05-04
Agency: Coast Guard, Department of Homeland Security
The Coast Guard proposes to create safety zones around each tall ship visiting the Great Lakes during the Tall Ships Challenge 2016 race series. These safety zones will provide for the regulation of vessel traffic in the vicinity of each tall ship in the navigable waters of the United States. The Coast Guard is taking this action to safeguard participants and spectators from the hazards associated with the limited maneuverability of these tall ships and to ensure public safety during tall ships events. We invite your comments on this proposed rulemaking.
Document Number: 2016-10450
Type: Notice
Date: 2016-05-04
Agency: Department of Housing and Urban Development
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
Document Number: 2016-10449
Type: Notice
Date: 2016-05-04
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Assistant Regional Administrator for Sustainable Fisheries, Greater Atlantic Region, NMFS, has made a preliminary determination that an Exempted Fishing Permit application contains all of the required information and warrants further consideration. This Exempted Fishing Permit would allow eight commercial fishing vessels to fish outside of the limited access sea scallop regulations in support of a study on seasonal bycatch distribution and optimal scallop meat yield on Georges Bank. Regulations under the Magnuson-Stevens Fishery Conservation and Management Act require publication of this notification to provide interested parties the opportunity to comment on applications for proposed Exempted Fishing Permits.
Document Number: 2016-10448
Type: Notice
Date: 2016-05-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on an information collection concerning CMS' Healthy Indiana Program (HIP) 2.0 Beneficiaries Survey. We are also announcing that the proposed information collection had been submitted to OMB and was approved under control number 0938-1300 through September 30, 2016. In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA) we requested emergency review under 5 CFR 1320.13(a)(2)(i) because public harm is reasonably likely to result if the regular clearance procedures were followed. More specifically, the regular PRA clearance process would jeopardize the timely completion of CMS' evaluation of the State's upcoming non-emergency medical transportation (NEMT) waiver and other important waivers. Most importantly, it would potentially cause significant harm by depriving Medicaid beneficiariesespecially those affected by the NEMT waiverof appropriate medical services and needed care. Although we have already received OMB approval to test/develop the survey instruments, we are now soliciting public comment for 30-days prior to implementing the survey in order to meet the conditions of OMB's Terms of Clearance that were issued on March 21, 2016. Under the PRA, federal agencies are required to publish notice in the Federal Register concerning each proposed information collection request (ICR). Interested persons are invited to send comments regarding our burden estimates or any other aspect of this ICR, including any of the following subjects: (1) The necessity and utility of the proposed ICR for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Document Number: 2016-10447
Type: Notice
Date: 2016-05-04
Agency: Postal Regulatory Commission, Agencies and Commissions
The Commission is noticing a recent Postal Service filing concerning notice to enter into an additional Global Expedited Package Services 3 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Document Number: 2016-10446
Type: Notice
Date: 2016-05-04
Agency: Department of Housing and Urban Development
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
Document Number: 2016-10445
Type: Notice
Date: 2016-05-04
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS has requested the Center for Independent Experts (CIE) to conduct a peer review of the agency's stock assessment of Eastern Bering Sea walleye pollock (Theragra chalcogramma). The CIE is a group affiliated with the University of Miami that provides independent peer reviews of NMFS science nationwide, including reviews of stock assessments for fish and marine mammals. The Eastern Bering Sea pollock stock assessment is reviewed annually by the Alaska Fisheries Science Center, the North Pacific Fishery Management Council (NPFMC) Plan Team, and the NPFMC Scientific and Statistical Committee. The CIE review will examine whether the assessment incorporates the best available scientific information and provides a reasonable approach to understanding the population dynamics and stock status of Eastern Bering Sea pollock. The public is invited to attend and observe the presentations and discussions between the CIE panel and the NMFS scientists who collected and processed the data, and designed the underlying model.
Document Number: 2016-10444
Type: Rule
Date: 2016-05-04
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is prohibiting directed fishing for species that comprise the deep-water species fishery by vessels using trawl gear in the Gulf of Alaska (GOA). This action is necessary because the second seasonal apportionment of the Pacific halibut bycatch allowance specified for the deep-water species fishery in the GOA has been reached.
Document Number: 2016-10440
Type: Rule
Date: 2016-05-04
Agency: Federal Aviation Administration, Department of Transportation
These special conditions are issued for the Gulfstream Aerospace Corporation (Gulfstream) Model GVII-G500 airplane. This airplane will have a novel or unusual design feature associated with side-facing seats. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Document Number: 2016-10439
Type: Rule
Date: 2016-05-04
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS approves and implements through regulations the measures included in Framework Adjustment 27 to the Atlantic Sea Scallop Fishery Management Plan, which the New England Fishery Management Council adopted and submitted to NMFS for approval. The purpose of Framework 27 is to prevent overfishing, improve yield-per-recruit, and improve the overall management of the Atlantic sea scallop fishery. Framework 27 sets specifications for the scallop fishery for fishing year 2016, including days-at-sea allocations, individual fishing quotas, and sea scallop access area trip allocations; creates a new rotational closed area south of Closed Area 2 to protect small scallops; opens the northern portion of the Nantucket Lightship Access Area to the Limited Access General Category fleet; transfers 19 percent of the Limited Access General Category access area trips from the Mid-Atlantic Access Area to the northern portion of the Nantucket Lightship Access Area; and implements an accountability measure to the fishing year 2016 Northern Gulf of Maine Total Allowable Catch as a result of a fishing year 2015 catch overage.
Document Number: 2016-10438
Type: Notice
Date: 2016-05-04
Agency: Securities and Exchange Commission, Agencies and Commissions
Applicant, a closed-end investment company, seeks an order declaring that it has ceased to be an investment company. Applicant has never made a public offering of its securities and does not propose to make a public offering or engage in business of any kind. Filing Dates: The application was filed on March 21, 2016 and amended on March 28, 2016. Applicant's Address: 71 South Wacker Drive, Chicago, Illinois 60606.
Document Number: 2016-10435
Type: Notice
Date: 2016-05-04
Agency: Federal Maritime Commission, Agencies and Commissions
Document Number: 2016-10434
Type: Notice
Date: 2016-05-04
Agency: Department of Health and Human Services, National Institutes of Health
The Kidney Interagency Coordinating Committee (KICC) will hold a meeting on June 17, 2016, on improving access to kidney transplantation. The meeting is open to the public.
Document Number: 2016-10433
Type: Notice
Date: 2016-05-04
Agency: Federal Reserve System, Agencies and Commissions
Document Number: 2016-10432
Type: Notice
Date: 2016-05-04
Agency: Federal Reserve System, Agencies and Commissions
Document Number: 2016-10430
Type: Notice
Date: 2016-05-04
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Preparedness and Response Science Board (NPRSB) will be holding a public teleconference.
Document Number: 2016-10429
Type: Notice
Date: 2016-05-04
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft environmental assessment (EA) prepared under the National Environmental Policy Act of 1969 (NEPA) and NRC regulations. This EA summarizes the results of the NRC staff's environmental review, which evaluates the potential environmental impacts of issuing license amendments and granting regulatory exemptions in response to a request from STP Nuclear Operating Company (STPNOC, the licensee) for Facility Operating License Nos. NPF-76 and NPF-80, for South Texas Project (STP), Units 1 and 2, respectively. The license amendments and regulatory exemptions would allow STPNOC to make changes to the STP licensing basis to incorporate the use of both a deterministic and a risk-informed approach to address safety issues discussed in Generic Safety Issue (GSI)-191 and to close Generic Letter (GL) 2004-02.
Document Number: 2016-10428
Type: Notice
Date: 2016-05-04
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is giving notice once each week for four consecutive weeks of the North Anna Unit 3 combined license (COL) application from Dominion Virginia Power (Dominion).
Document Number: 2016-10427
Type: Proposed Rule
Date: 2016-05-04
Agency: Department of Energy
On March 24, 2016, the U.S. Department of Energy (DOE) published in the Federal Register a notice of proposed rulemaking (NOPR) for commercial packaged boiler energy conservation standards. This document announces an extension of the public comment period for submitting comments on the NOPR or any other aspect of the rulemaking for commercial packaged boilers. The comment period is extended to June 22, 2016.
Document Number: 2016-10426
Type: Notice
Date: 2016-05-04
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Pursuant to the National Environmental Policy Act (NEPA), this notice announces that NMFS intends to obtain information necessary to prepare an Environmental Impact Statement (EIS) for 10 Hatchery and Genetic Management Plans (HGMPs) for salmon and steelhead hatchery programs jointly submitted by the Washington Department of Fish and Wildlife (WDFW) with the Muckleshoot Indian Tribe and the Suquamish Tribe (referred to as the co-managers), for NMFS's evaluation and determination under Limit 6 of the Endangered Species Act (ESA) 4(d) Rule for threatened salmon and steelhead. The HGMPs specify the propagation of salmon and steelhead in the Duwamish-Green River basin in Washington State. NMFS provides this notice to advise other agencies and the public of its plans to analyze effects related to the action, and obtain suggestions and information that may be useful to the scope of issues and alternatives to include in the EIS.
Document Number: 2016-10425
Type: Notice
Date: 2016-05-04
Agency: Department of Energy, Office of Energy Efficiency and Renewable Energy
In this notice, DOE is extending the completion schedule for its H2 Refuel H-Prize competition. On October 28, 2014, the Department of Energy (DOE) announced the $1 million competition in the Federal Register, allowing teams from across the United States to compete to develop systems that generate and dispense hydrogen from resources commonly available to residences (electricity or natural gas) for use in homes, community centers, businesses or similar locations, to supplement the current infrastructure roll-out and reduce barriers to using hydrogen fuel cell electric vehicles. These Guidelines were updated in a September 3, 2015, Federal Register notice. Both the original and updated guidelines included a competition schedule. A delay in announcing the finalist selection significantly reduced the period for system construction before the start of the originally planned testing period. The announcement was originally planned for December 2015 to provide seven months for the system build as described by the guidelines. However, the announcement was delayed until January 29, 2016. Therefore, DOE is updating the completion schedule to allow a reasonable construction period.
Document Number: 2016-10423
Type: Notice
Date: 2016-05-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2016-10422
Type: Notice
Date: 2016-05-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This document corrects a notice that was published in the Federal Register on April 21, 2016, Volume 81, Number 77, page 23497. This meeting is cancelled in its entirety. Contact Person for More Information: Brenda Colley Gilbert, Ph.D., M.S.P.H., Director, Extramural Research Program Operations and Services, CDC, 4770 Buford Highway NE., Mailstop F-80, Atlanta, Georgia 30341, Telephone: (770) 488-6295, BJC4@cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.
Document Number: 2016-10421
Type: Notice
Date: 2016-05-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2016-10420
Type: Notice
Date: 2016-05-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2016-10419
Type: Notice
Date: 2016-05-04
Agency: Department of Agriculture, Rural Utility Service
Document Number: 2016-10417
Type: Notice
Date: 2016-05-04
Agency: International Trade Commission, Agencies and Commissions
Document Number: 2016-10416
Type: Notice
Date: 2016-05-04
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces that Daimler Trucks North America (Daimler) has requested a five-year exemption for one of its employees from the Federal requirement to hold a U.S. commercial driver's license (CDL). Mr. Henning Oeltjenbruns, general manager of the Daimler Truck Plant in Cleveland, NC, holds a valid German commercial license and wants to test drive Daimler vehicles on U.S. roads to better understand product requirements in ``real world'' environments, and verify results. Daimler believes the requirements for a German commercial license ensure that operation under the exemption will likely achieve a level of safety equivalent to or greater than the level that would be obtained in the absence of the exemption.
Document Number: 2016-10415
Type: Notice
Date: 2016-05-04
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces that Daimler Trucks North America (Daimler) has requested a five-year exemption for one of its employees from the Federal requirement to hold a U.S. commercial driver's license (CDL). Mr. Sebastian Boehm, a project engineer, holds a valid German commercial license and wants to test drive Daimler vehicles on U.S. roads to better understand product requirements in ``real world'' environments, and verify results. Daimler believes the requirements for a German commercial license ensure that operation under the exemption will likely achieve a level of safety equivalent to or greater than the level that would be obtained in the absence of the exemption.
Document Number: 2016-10414
Type: Notice
Date: 2016-05-04
Agency: Department of Education
This meeting notice is an update to the previous notice published in the Federal Register (81 FR 14846) on March 18, 2016, and sets forth the time and location for the June 22-24, 2016 meeting of the National Advisory Committee on Institutional Quality and Integrity (NACIQI). The notice of this meeting is required under Section 10(a)(2) of the Federal Advisory Committee Act (FACA) and Section 114(d)(1)(B) of the Higher Education Act of 1965 (HEA), as amended.
Document Number: 2016-10411
Type: Notice
Date: 2016-05-04
Agency: Department of Energy, Federal Energy Regulatory Commission
Document Number: 2016-10409
Type: Rule
Date: 2016-05-04
Agency: Department of the Interior, Bureau of Indian Affairs
The Bureau of Indian Affairs (BIA) is confirming the interim final rule published on March 1, 2016, extending the deadline for filing an application for burial assistance to 180 days to address hardships resulting from the current short timeframe. The Department of the Interior (Department) did not receive any significant adverse comments during the public comment period on the interim final rule, and therefore confirms the rule without change.
Document Number: 2016-10408
Type: Notice
Date: 2016-05-04
Agency: Department of the Interior, Bureau of Indian Affairs
This notice publishes the current list of 567 Tribal entities recognized and eligible for funding and services from the Bureau of Indian Affairs (BIA) by virtue of their status as Indian Tribes. The list is updated from the notice published on January 29, 2016 (81 FR 5019).
Document Number: 2016-10406
Type: Notice
Date: 2016-05-04
Agency: Securities and Exchange Commission, Agencies and Commissions
The Securities and Exchange Commission Advisory Committee on Small and Emerging Companies is providing notice that it will hold a public meeting on Wednesday, May 18, 2016, in Multi-Purpose Room LL-006 at the Commission's headquarters, 100 F Street NE., Washington, DC. The meeting will begin at 9:30 a.m. (EDT) and will be open to the public. The meeting will be webcast on the Commission's Web site at www.sec.gov. Persons needing special accommodations to take part because of a disability should notify the contact person listed below. The public is invited to submit written statements to the Committee. The agenda for the meeting includes matters relating to rules and regulations affecting small and emerging companies under the federal securities laws.
Document Number: 2016-10403
Type: Notice
Date: 2016-05-04
Agency: National Science Foundation, Agencies and Commissions
The National Science Foundation (NSF) is requesting renewal of the Generic Clearance of the National Center for Science & Engineering Statistics' Survey Improvement Projects (3145-0174), and has submitted an information collection requirement to OMB for review and clearance. In accordance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (Pub. L. 104-13), this is the second notice for public comment; the first was published in the Federal Register at 81 FR 7833; no comments were received. NSF is forwarding the proposed renewal submission to the Office of Management and Budget (OMB) for clearance simultaneously with the publication of this second notice. The full submission may be found at http://www.reginfo.gov/ public/do/PRAMain. Comments: Comments are invited on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the NSF, including whether the information shall have practical utility; (b) the accuracy of the NSF's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, use, and clarity of the information on respondents, including through the use of automated collection techniques or other forms of information technology; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Document Number: 2016-10401
Type: Notice
Date: 2016-05-04
Agency: Department of Defense, Department of the Air Force
The United States Air Force (Air Force) is issuing this notice to advise the public of its intent to prepare an Environmental Impact Statement (EIS) for the Presidential Aircraft Recapitalization (PAR) Program at Joint Base Andrews-Naval Air Facility, Washington, Maryland (JBA). The EIS will assess the potential environmental consequences of the proposal to beddown versions of the Boeing 747-8 passenger aircraft at JBA as replacements to the two existing VC-25A aircraft currently used to transport the President of the United States (POTUS).
Document Number: 2016-10400
Type: Notice
Date: 2016-05-04
Agency: Department of the Interior, Bureau of Land Management
In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management (BLM) Idaho Falls District Resource Advisory Council (RAC), will meet as indicated below.
Document Number: 2016-10399
Type: Notice
Date: 2016-05-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 project entitled ``Community-Based Organization Outcome Monitoring Projects for CBO HIV Prevention Services Clients''.
Document Number: 2016-10398
Type: Notice
Date: 2016-05-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of FDA's Office of Orphan Products Development (OOPD) Natural History Grants Program. The goal of the Orphan Products Natural History Grants Program is to support studies that advance rare disease medical product development through characterization of the natural history of rare diseases/conditions, identification of genotypic and phenotypic subpopulations, and development and/or validation of clinical outcome measures, biomarkers and/or companion diagnostics. The ultimate goal of these natural history studies is to support clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA provides grants for natural history studies that will either assist or substantially contribute to market approval of these products. Applicants must include in the application's Background and Significance section documentation to support that the estimated prevalence of the orphan disease or condition in the United States is less than 200,000 (or in the case of a vaccine or diagnostic, information to support that the product will be administered to fewer than 200,000 people in the United States per year), and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.
Document Number: 2016-10397
Type: Notice
Date: 2016-05-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (CERSI), is announcing a public workshop entitled ``Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics.'' The objective of the workshop is to discuss quantitative and qualitative approaches for verifying assumptions pertaining to disease and therapeutic response similarity between adults and children. The workshop will also provide a forum for discussion on the use of modeling and simulation for systematic assessment of extrapolation assumptions.
Document Number: 2016-10396
Type: Notice
Date: 2016-05-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Document Number: 2016-10395
Type: Notice
Date: 2016-05-04
Agency: Securities and Exchange Commission, Agencies and Commissions
Document Number: 2016-10391
Type: Notice
Date: 2016-05-04
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 draft guidance for industry entitled ``Special Protocol Assessment.'' This draft guidance provides information about the procedures and general policies adopted by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for special protocol assessment (SPA). This draft guidance is intended to improve the quality of Requests for SPAs and accompanying submission materials, and the quality of the resulting interaction between sponsors and FDA. This draft guidance revises the guidance for industry entitled ``Special Protocol Assessment'' issued May 17, 2002.
Document Number: 2016-10390
Type: Notice
Date: 2016-05-04
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 draft guidance for industry entitled ``Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in all phases of development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C. This draft guidance revises the draft guidance of the same name that was issued on October 23, 2013.
Document Number: 2016-10389
Type: Rule
Date: 2016-05-04
Agency: Environmental Protection Agency
This regulation establishes tolerances for residues of mefenoxam in or on rapeseed subgroup 20A. Syngenta Crop Protection, LLC., requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Document Number: 2016-10388
Type: Notice
Date: 2016-05-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that it has received a petition requesting exemption from the premarket notification requirements for a method, metallic reduction, glucose (urinary, non-quantitative) test system in a reagent tablet format that is intended to measure glucosuria (glucose in urine). Method, metallic reduction, glucose (urinary, non-quantitative) test systems in a reagent tablet format are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this notice to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
Document Number: 2016-10387
Type: Notice
Date: 2016-05-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Document Number: 2016-10386
Type: Proposed Rule
Date: 2016-05-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency or we) is proposing to amend the general biological products standards relating to dating periods and also to remove certain standards relating to standard preparations and limits of potency. FDA is proposing this action to update outdated requirements, and accommodate new and evolving technology and testing capabilities, without diminishing public health protections. This proposed action is part of FDA's retrospective review of its regulations in response to an Executive order.