January 13, 2017 – Federal Register Recent Federal Regulation Documents

Results 51 - 100 of 159
Multiple Endpoints in Clinical Trials; Draft Guidance for Industry; Availability
Document Number: 2017-00695
Type: Notice
Date: 2017-01-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Multiple Endpoints in Clinical Trials.'' This draft guidance provides sponsors and review staff with the Agency's thinking about the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in clinical trials for human drugs, including drugs subject to licensing as biological products. Most clinical trials performed in drug development contain multiple endpoints to assess the effects of the drug and to document the ability of the drug to favorably affect one or more disease characteristics. The purpose of this guidance is to describe various strategies for grouping and ordering endpoints for analysis and applying some well- recognized statistical methods for managing multiplicity within a study to control the chance of making erroneous conclusions about a drug's effects.
Nonproprietary Naming of Biological Products; Guidance for Industry; Availability
Document Number: 2017-00694
Type: Notice
Date: 2017-01-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Nonproprietary Naming of Biological Products.'' The guidance describes our current thinking on the need for biological products previously and newly licensed under the Public Health Service Act (PHS Act) to bear nonproprietary names that include FDA-designated suffixes. Accordingly, we intend to designate nonproprietary names for originator biological products, related biological products, or biosimilar products which will include a core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters. This guidance finalizes the draft guidance issued on August 28, 2015. FDA is also 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.
Petition for Waiver of Compliance
Document Number: 2017-00693
Type: Notice
Date: 2017-01-13
Agency: Federal Railroad Administration, Department of Transportation
Petition for Waiver of Compliance
Document Number: 2017-00692
Type: Notice
Date: 2017-01-13
Agency: Federal Railroad Administration, Department of Transportation
Establishment of an Emergency Relief Docket for Calendar Year 2017
Document Number: 2017-00691
Type: Notice
Date: 2017-01-13
Agency: Federal Railroad Administration, Department of Transportation
This Notice announces the establishment of FRA's emergency relief docket (ERD) for calendar year 2017. The designated ERD for calendar year 2017 is Docket Number FRA-2017-0001.
Certain Magnesia Carbon Bricks From the People's Republic of China: Rescission of Countervailing Duty Administrative Review; 2014
Document Number: 2017-00689
Type: Notice
Date: 2017-01-13
Agency: Department of Commerce, International Trade Administration
On September 13, 2016, the Department of Commerce (the Department) published the preliminary results of the administrative review of the countervailing duty (CVD) order on certain chemically- bonded magnesia carbon bricks (MCBs) from the People's Republic of China (PRC). The period of review (POR) is January 1, 2014, through December 31, 2014. The Department preliminarily found no evidence of any reviewable entries and received no comments on the preliminary results. Therefore, the Department is rescinding the administrative review of the CVD order on MCBs from the PRC.
Procurement List; Additions and Deletions
Document Number: 2017-00688
Type: Notice
Date: 2017-01-13
Agency: Committee for Purchase From People Who Are Blind or Severely Disabled, Agencies and Commissions
This action adds products and a service to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes products and a service from the Procurement List previously furnished by such agencies.
General Services Administration Acquisition Regulation; Information Collection; Industrial Funding Fee and Sales Reporting
Document Number: 2017-00687
Type: Notice
Date: 2017-01-13
Agency: General Services Administration, Agencies and Commissions
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division is submitting a request to the Office of Management and Budget (OMB) to review and approve an extension of a previously approved information collection associated with General Services Administration Acquisition Regulation clause 552.238-74, Industrial Funding Fee and Sales Reporting. GSA uses this information to collect the Industrial Funding Fee and administer the Federal Supply Schedule (FSS) program.
Duke Energy Progress; Combined License Applications for Shearon Harris Nuclear Plant Units 2 and 3
Document Number: 2017-00685
Type: Notice
Date: 2017-01-13
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is issuing an exemption in response to an October 13, 2016, letter from Duke Energy Progress (DEP). On May 2, 2013, DEP requested that the NRC suspend review of its combined license (COL) application until further notice. On October 13, 2016, DEP requested an exemption from certain regulatory requirements which, if granted, would allow them to revise their COL application for Shearon Harris Nuclear Plant (Harris) Units 2 and 3 in order to address enhancements to the Emergency Preparedness (EP) rules by December 31, 2019, rather than by December 31, 2016, as the regulations currently require. The NRC staff reviewed this request and determined that it is appropriate to grant the exemption to the EP update requirements until December 31, 2019, but stipulated that the updates to the Final Safety Analysis Report must be submitted prior to requesting the NRC resume its review of the COL application, or by December 31, 2019, whichever comes first.
Notice of Initiating the Assessment Phase of the Forest Plan Revision for the Salmon-Challis National Forest
Document Number: 2017-00684
Type: Notice
Date: 2017-01-13
Agency: Department of Agriculture, Forest Service
The Salmon-Challis National Forest, located in east central Idaho, is initiating the first phase of the forest planning process pursuant to the 2012 National Forest System Land Management Planning rule. This process will result in a revised forest land management plan (Forest Plan) which describes the strategic direction for management of forest resources on the Salmon-Challis National Forest for the next ten to fifteen years. The planning process encompasses three-stages: assessment, plan revision, and monitoring. The first stage of the planning process involves assessing ecological, social, and economic conditions of the planning area, which is documented in an assessment report. The Forest is inviting the public to contribute in the development of the Assessment. The Forest will be hosting public forums near the end of February into early March 2017 with a second set of meetings forthcoming in June 2017. We will invite the public to share information relevant to the assessment including existing information, current trends, and local knowledge. Public engagement opportunities associated with the development of the Assessment will be announced on the Web site cited below.
Southern Nuclear Operating Company, Inc., Vogtle Electric Generating Plant, Units 3 and 4; Debris Screen Related Dimensions
Document Number: 2017-00683
Type: Notice
Date: 2017-01-13
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is granting an exemption to allow a departure from the certification information of Tier 1 of the generic design control document (DCD) and is issuing License Amendment No. 63 to Combined Licenses (COL), NPF-91 and NPF-92. The COLs were issued to Southern Nuclear Operating Company, Inc., and Georgia Power Company, Oglethorpe Power Corporation, MEAG Power SPVM, LLC, MEAG Power SPVJ, LLC, MEAG Power SPVP, LLC, Authority of Georgia, and the City of Dalton, Georgia (the licensee); for construction and operation of the Vogtle Electric Generating Plant (VEGP) Units 3 and 4, located in Burke County, Georgia. The granting of the exemption allows the changes to Tier 1 information asked for in the amendment. Because the acceptability of the exemption was determined in part by the acceptability of the amendment, the exemption and amendment are being issued concurrently.
Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, From the People's Republic of China: Rescission, in Part, of Antidumping Duty Administrative Review; 2015-2016
Document Number: 2017-00682
Type: Notice
Date: 2017-01-13
Agency: Department of Commerce, International Trade Administration
On August 11, 2016, the Department of Commerce (Department) initiated an administrative review of the antidumping duty order on tapered roller bearings and parts thereof, finished and unfinished (TRBs) from the People's Republic of China (PRC) for eight companies. Based on timely withdrawal of requests for review, we are now rescinding this administrative review with respect to two of these companies, Changshan Peer Bearing Co. Ltd. (CPZ/SKF) and GGB Bearing Technology (Suzhou) Co., Ltd. (GGB).
Procurement List; Proposed Additions and Deletions
Document Number: 2017-00675
Type: Notice
Date: 2017-01-13
Agency: Committee for Purchase from People Who Are
The Committee is proposing to add products and a service to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes products previously furnished by such agencies.
Initiation of Antidumping and Countervailing Duty Administrative Reviews
Document Number: 2017-00674
Type: Notice
Date: 2017-01-13
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (``the Department'') has received requests to conduct administrative reviews of various antidumping and countervailing duty orders and findings with November anniversary dates. In accordance with the Department's regulations, we are initiating those administrative reviews.
Agency Information Collection Activities: Proposed Collection; Comment Request; National Flood Insurance Program Claims Forms
Document Number: 2017-00673
Type: Notice
Date: 2017-01-13
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 revision of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning the collection of information related to the flood insurance claims process.
Reopening of the Period for Comments on a Preliminary Draft Convention on the Recognition and Enforcement of Foreign Judgments Currently Being Negotiated at The Hague Conference on Private International Law
Document Number: 2017-00671
Type: Notice
Date: 2017-01-13
Agency: Department of Commerce, Patent and Trademark Office
The United States Patent and Trademark Office is publishing this notice to reopen the comment period provided in its notice of November 18, 2016, entitled Request for Comments and Notice of Public Meeting on a Preliminary Draft Convention on the Recognition and Enforcement of Foreign Judgments Currently Being Negotiated at the Hague Conference on Private International Law. The new deadline for public comments is January 18, 2017.
Request for Public Comment on Draft Consent-Based Siting Process for Consolidated Storage and Disposal Facilities for Spent Nuclear Fuel and High-Level Radioactive Wastes
Document Number: 2017-00670
Type: Notice
Date: 2017-01-13
Agency: Department of Energy
The U.S. Department of Energy (DOE) is designing a consent- based siting process to establish an integrated waste management system to transport, store, and dispose of commercial spent nuclear fuel and high-level radioactive waste. In a consent-based siting approach, DOE will work with communities, tribal governments and states across the country that express interest in hosting federal consolidated interim storage facilities and disposal facilities for spent nuclear fuel and high-level radioactive waste as part of an integrated waste management system. The Department is seeking input on the Draft Consent-Based Siting Process for Consolidated Storage and Disposal Facilities for Spent Nuclear Fuel and High-Level Radioactive Wastes.
Circular Welded Carbon Quality Steel Pipe From the People's Republic of China: Rescission of Antidumping Duty Administrative Review; 2015-2016
Document Number: 2017-00668
Type: Notice
Date: 2017-01-13
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (``the Department'') is rescinding the administrative review of the antidumping duty order on circular welded carbon quality steel pipe from the People's Republic of China (``PRC'') for the period July 1, 2015, through June 30, 2016.
Steel Wire Garment Hangers From the People's Republic of China; 2015-2016; Partial Rescission of the Eighth Antidumping Duty Administrative Review
Document Number: 2017-00667
Type: Notice
Date: 2017-01-13
Agency: Department of Commerce, International Trade Administration
On December 16, 2016, the Department of Commerce (``Department'') published a notice of initiation of an administrative review of the antidumping duty order on steel wire garment hangers from the People's Republic of China (``PRC''). Based on M&B Metal Products Co., Ltd.'s (``Petitioner'') timely withdrawal of the requests for review of certain companies, we are now rescinding this administrative review with respect to 42 companies.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; EDFacts Data Collection School Years 2016-17, 2017-18, and 2018-19
Document Number: 2017-00666
Type: Notice
Date: 2017-01-13
Agency: Department of Education
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.
30-Day Notice of Proposed Information Collection: Request for Determination of Possible Loss of United States Citizenship
Document Number: 2017-00665
Type: Notice
Date: 2017-01-13
Agency: Department of State
The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. 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 30 days for public comment.
Innovative Pathways Funding Opportunity Announcement
Document Number: 2017-00664
Type: Notice
Date: 2017-01-13
Agency: Department of Energy, Office of Energy Efficiency and Renewable Energy
The U.S. Department of Energy's (DOE) Office of Energy Efficiency and Renewable Energy's (EERE) Technology-to-Market (T2M) team is issuing a Funding Opportunity Announcement (DE-FOA-0001703) entitled Innovative Pathways. This FOA is seeking to surface new testable and scalable ways to alleviate common structural challenges facing promising new energy technologies on the pathway to market.
Endangered and Threatened Wildlife and Plants; Permit Applications
Document Number: 2017-00663
Type: Notice
Date: 2017-01-13
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications for a permit to conduct activities intended to enhance the survival of endangered or threatened species. Federal law prohibits certain activities with endangered species unless a permit is obtained.
Notice of Statute of Limitations on Claims; Final Federal Agency Actions on Proposed Highway in California
Document Number: 2017-00662
Type: Notice
Date: 2017-01-13
Agency: Federal Highway Administration, Department of Transportation
The FHWA, on behalf of Caltrans, is issuing this notice to announce actions taken by Caltrans, USFWS and USACE, that are final within the meaning of 23 U.S.C. 139(l)(1). The actions relate to a proposed highway project, United States (US) 101/State Route (SR) 84 interchange in the City of Redwood City, along 1.9 miles on US 101 and 0.4 mile on SR 84 in the County of San Mateo, State of California. Those actions grant licenses, permits, and approvals for the project.
Notice of Public Meetings for the John Day-Snake Resource Advisory Council
Document Number: 2017-00661
Type: Notice
Date: 2017-01-13
Agency: Department of the Interior, Bureau of Land Management
In accordance with the Federal Land Policy and Management Act and the Federal Advisory Committee Act of 1972, and the U.S. Department of the Interior, Bureau of Land Management (BLM), the John Day-Snake Resource Advisory Council (RAC) will meet as indicated below.
Notice of Public Meeting For the Southeast Oregon Resource Advisory Council
Document Number: 2017-00659
Type: Notice
Date: 2017-01-13
Agency: Department of the Interior, Bureau of Land Management
In accordance with the Federal Land Policy and Management Act and the Federal Advisory Committee Act of 1972, and the U.S. Department of the Interior, Bureau of Land Management (BLM), the Southeast Oregon Resource Advisory Council (RAC) will meet as indicated below:
Notice of Grand Staircase-Escalante National Monument Advisory Committee Meeting
Document Number: 2017-00657
Type: Notice
Date: 2017-01-13
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 Department of the Interior, Bureau of Land Management (BLM), Grand Staircase-Escalante National Monument Advisory Committee (GSENMAC) will meet as indicated below.
Endangered and Threatened Wildlife and Plants; Status Review of the Northern Rocky Mountain Distinct Population Segment of the Fisher
Document Number: 2017-00656
Type: Notice
Date: 2017-01-13
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service (Service), announce the opening of an information gathering period regarding the status of the fisher (Pekania pennanti) throughout the range of its northern Rocky Mountain distinct population segment (DPS) in the United States. The status review will include analysis of whether the northern Rocky Mountain DPS of the fisher warrants listing as an endangered or a threatened species under the Endangered Species Act of 1973, as amended (Act). We encourage all interested parties to provide us information regarding the status of, and any potential threats to, the northern Rocky Mountain DPS of the fisher.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2017-00655
Type: Notice
Date: 2017-01-13
Agency: Department of Health and Human Services, Administration for Children and Families
Statement of Organizations, Functions, and Delegations of Authority. The Administration for Children and Families (ACF) and the National Treasury Employees Union (NTEU) have renewed the ACF Labor Management Committee Charter.
Certain Pasta From Italy: Final Results of Antidumping and Countervailing Duty Changed Circumstances Reviews
Document Number: 2017-00654
Type: Notice
Date: 2017-01-13
Agency: Department of Commerce, International Trade Administration
On June 22, 2016, the Department of Commerce (the Department) published its initiation and preliminary results in these changed circumstances reviews. Based on our analysis of the comments submitted by interested parties, our final results remain unchanged from the preliminary results.
Increase of Controls: Infrared Detection Items
Document Number: 2017-00652
Type: Notice
Date: 2017-01-13
Agency: Department of Commerce, Bureau of Industry and Security
On October 12, 2016, the Bureau of Industry and Security (BIS) published a final rule entitled ``Revisions to the Export Administration Regulations (EAR): Control of Fire Control, Laser, Imaging, and Guidance Equipment the President Determines No Longer Warrant Control Under the United States Munitions List (USML).'' This notice of inquiry is published to request comments from the public on the impact of further increasing certain controls implemented by that final rule.
Notice of Inquiry; Request for Comments Regarding United States Munitions List Category XII
Document Number: 2017-00651
Type: Proposed Rule
Date: 2017-01-13
Agency: Department of State
The Department of State requests comments from the public regarding recent revisions to Category XII of the United States Munitions List (USML). In light of the ongoing transition of the USML to a more ``positive list'' pursuant to the President's Export Control Reform (ECR) initiative, the Department requests that the public comment on (1) alternatives to controls on certain items when ``specially designed for a military end user,'' (2) the scope of the control in paragraph (b)(1), and (3) certain technical parameters that the Department is evaluating to replace ``specially designed'' controls.
Information Collection Request; General Program Administration
Document Number: 2017-00650
Type: Notice
Date: 2017-01-13
Agency: Department of Agriculture, Farm Service Agency
In accordance with the Paperwork Reduction Act of 1995, the Farm Service Agency (FSA) is requesting comments from all interested individuals and organizations on an extension with a revision of a currently approved information collection associated with FSA's Farm Loan Programs (FLP) General Program Administration. The information collected is used to ensure that applicants meet statutory eligibility requirements, loan funds are used for authorized purposes, and the Government's interest in security is adequately protected.
Community Development Advisory Board Meeting
Document Number: 2017-00649
Type: Notice
Date: 2017-01-13
Agency: Community Development Financial Institutions Fund, Department of Treasury, Department of the Treasury
This notice announces the next meeting of the Community Development Advisory Board (the Advisory Board), which provides advice to the Director of the Community Development Financial Institutions Fund (the CDFI Fund). The meeting will be conducted via telephone conference call.
Chemical Transportation Advisory Committee
Document Number: 2017-00648
Type: Notice
Date: 2017-01-13
Agency: Coast Guard, Department of Homeland Security
The Chemical Transportation Advisory Committee will meet on February 28, March 1, and March 2, 2017, in Houston, TX to discuss committee matters relating to the safe and secure marine transportation of hazardous materials. These meeting will be open to the public.
Sanctions Actions Pursuant To The Cuban Assets Control Regulations
Document Number: 2017-00647
Type: Notice
Date: 2017-01-13
Agency: Department of the Treasury, Office of Foreign Assets Control
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of 10 individuals and 14 entities whose names have been removed from the list of Specially Designated Nationals and Blocked Persons (SDN List) pursuant to the Cuban Assets Control Regulations.
Suggestions, Recommendations, and Comments for Topics That May Be Considered by the Food and Drug Administration Combination Product Policy Council; Establishment of a Docket
Document Number: 2017-00646
Type: Notice
Date: 2017-01-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is establishing a docket to receive suggestions, recommendations, and comments for topics from interested parties, including academic institutions, regulated industry, patient representatives, and other interested organizations, on policy issues that may be considered by the FDA Combination Product Policy Council (Council). These comments will help the Agency identify and address combination product policy issues that need clarification through guidance, notice and comment procedures, or other means.
Agency Information Collection Activities; Proposed eCollection eComments Requested; [Notice of Firearms Manufactured or Imported (ATF Form 2 (5320.2)]
Document Number: 2017-00642
Type: Notice
Date: 2017-01-13
Agency: Department of Justice
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the Federal Register 81 FR 73140, on October 24, 2016, allowing for a 60-day comment period.
Submission for OMB Review; Comment Request
Document Number: 2017-00641
Type: Notice
Date: 2017-01-13
Agency: Department of Agriculture
Certain Liquid Crystal Ewriters and Components Thereof; Institution of Investigation
Document Number: 2017-00640
Type: Notice
Date: 2017-01-13
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on December 8, 2016, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Kent Displays, Inc. of Kent, Ohio. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain liquid crystal eWriters and components thereof by reason of infringement of certain claims of U.S. Patent Nos. 7,351,506 (``the '506 patent'') and 8,947,604 (``the '604 patent''). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
Softwood Lumber Products From Canada; Determinations
Document Number: 2017-00639
Type: Notice
Date: 2017-01-13
Agency: International Trade Commission, Agencies and Commissions
Solid Urea From Russia and Ukraine; Termination of Five-Year Reviews
Document Number: 2017-00638
Type: Notice
Date: 2017-01-13
Agency: International Trade Commission, Agencies and Commissions
The Commission instituted the subject five-year reviews in November 2016 to determine whether revocation of the antidumping duty orders on solid urea from Russia and Ukraine would be likely to lead to continuation or recurrence of material injury. On December 30, 2016, the Department of Commerce published notice that it was revoking the orders effective December 20, 2016, because the domestic interested parties did not participate in its sunset reviews (81 FR 96434). Accordingly, the subject reviews are terminated.
Advisory Committee for Cyberinfrastructure; Notice of Meeting
Document Number: 2017-00635
Type: Notice
Date: 2017-01-13
Agency: National Science Foundation, Agencies and Commissions
Alan T. Waterman Award Committee; Notice of Meeting
Document Number: 2017-00634
Type: Notice
Date: 2017-01-13
Agency: National Science Foundation, Agencies and Commissions
Advisory Committee for Mathematical and Physical Sciences; Notice of Meeting
Document Number: 2017-00633
Type: Notice
Date: 2017-01-13
Agency: National Science Foundation, Agencies and Commissions
Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Rapid Response Surveys (Generic Clearance)
Document Number: 2017-00632
Type: Notice
Date: 2017-01-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing 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 the use of rapid response surveys to obtain data on safety information to support quick turnaround decisionmaking about potential safety problems or risk management solutions from health care professionals, hospitals, and other user facilities (e.g., nursing homes, etc.); consumers; manufacturers of biologics, drugs, and medical devices; distributors; and importers, when FDA must quickly determine whether or not a problem with a biologic, drug, or medical device impacts the public health.
180-Day Exclusivity: Questions and Answers; Draft Guidance for Industry; Availability
Document Number: 2017-00631
Type: Notice
Date: 2017-01-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``180-Day Exclusivity: Questions and Answers.'' This draft guidance is intended to address questions that have been raised about the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that relate to generic drug exclusivity, which commonly is known as ``180-day exclusivity'' for generic drug products. As a general matter, FDA has implemented these statutory provisions within the context of application-specific decisions. Some FDA decisions have been made publicly available (e.g., in FDA citizen petition responses and documents released in litigation). FDA believes that a guidance for industry that provides answers to commonly asked questions about 180-day exclusivity would enhance transparency and facilitate the development, approval, and timely marketing of generic drug products. FDA intends to update this guidance to include additional questions and answers as appropriate.
How To Prepare a Pre-Request for Designation; Draft Guidance for Industry; Availability
Document Number: 2017-00629
Type: Notice
Date: 2017-01-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``How to Prepare a Pre-Request for Designation (Pre-RFD).'' The purpose of this guidance is to explain the Pre-RFD process at the FDA Office of Combination Products (OCP), describe and help a sponsor understand the type of information that the sponsor should include in a Pre-RFD, and assist sponsors in obtaining a preliminary assessment from FDA through the Pre-RFD process. The Pre-RFD process is available to provide informal, non-binding feedback regarding the regulatory identity or classification of a human medical product as a drug, device, biological product, or combination product. In addition, this informal process provides information about a non-combination or combination product's assignment to the appropriate Agency Center (Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), or Center for Biologics Evaluation and Research (CBER)) for premarket review and regulation. This draft guidance is not final nor is it in effect at this time.
Guardian Variable Products Trust and Park Avenue Institutional Advisers LLC; Notice of Application
Document Number: 2017-00628
Type: Notice
Date: 2017-01-13
Agency: Securities and Exchange Commission, Agencies and Commissions