Latest Federal Register Notices

BIOLOGICS

Guidance on Donor Screening to Reduce Zika Virus
Federal Register Notice: FDA is making available a guidance: Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus. The document provides blood establishments that collect blood and blood components with recommendations for donor screening, donor deferral, and product management to reduce the risk of transfusion-transmitted Zika virus. The document applies to the collection of whole blood and blood components intended for transfusion, but not to the collection of source plasma. To download this guidance, click here. To view this notice, click here.

DEVICES

Workshop on National Device Evaluation System
Federal Register Notice: FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation will hold a public workshop 3/24 entitled “Building the National Evaluation System for Medical Devices: Using Real-World Evidence to Improve Device Safety and Effectiveness.” Its objective is to discuss the scientific progress being made in harnessing evidence generated from the real-world use of medical devices to improve device safety and effectiveness. A national evaluation system for medical devices, which leverages real-world evidence, can help FDA more efficiently strike the right balance between premarket and postmarket data collection, facilitate access to medical devices, and more quickly and robustly identify safety signals that may arise in the postmarket period. The workshop will be held from 8:30 a.m. to 4:30 p.m. at the University of Maryland, Pharmacy Hall, 20 North Pine St., Baltimore, MD 21201. Contact Ann Anonsen, University of Maryland, (301) 405-0285. To view this notice, click here.

FDA Seeks Nominations, Selectors for Device Panels
Federal Register Notice: FDA is requesting that any industry organizations interested in participating in the selecting nonvoting industry representatives to serve on certain panels of the Medical Devices Advisory Committee in CDRH notify FDA in writing. The agency is also requesting nominations for nonvoting industry representatives to serve on certain device panels. To view this notice, click here.

FDA Requires PMA/PDP for Metal Hip Joint Prosthesis
Federal Register Final order: FDA is issuing a final order to require the filing of a PMA or a notice of completion of a product development protocol for the hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis. To view this notice, click here.

Workshop on Devices for Monitoring Warfarin Therapy
Federal Register Notice: FDA will hold a public workshop 3/18 entitled “Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy.” Its purpose is to discuss approaches to the analytical and clinical validation of point of care (POC) Prothrombin Time/International Normalized Ratio (PT/INR) in vitro diagnostic devices for improved clinical management of warfarin therapy. Also, the workshop will describe FDA’s process for facilitating the development of safe and effective POC and patient self-testing PT/INR devices. The workshop had been scheduled for 1/25 and was postponed due to unanticipated weather conditions. It will be held from 8 a.m. to 5 p.m. at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, Rm. 1503 (the Great Room), Silver Spring, MD. Contact Rachel Goehe, 240-402-6565, email: Rachel.Goehe@fda.hhs.gov. To view this notice, click here.

HUMAN DRUGS

BE Guidance on Ophthalmic Cyclosporine
Federal Register Notice: FDA is making available a draft guidance for industry on cyclosporine ophthalmic emulsion entitled Draft Guidance on Cyclosporine. The recommendations provide specific guidance on the design of bioequivalence studies to support ANDAs for cyclosporine ophthalmic emulsion. To download this guidance, click here. To view this notice, click here.

Guidance on Drugs for Nonallergic Rhinitis
Federal Register Notice: FDA is making available a draft guidance for industry entitled Nonallergic Rhinitis: Developing Drug Products for Treatment. The purpose of this draft guidance is to assist applicants in the development of drug and biological products for treating nonallergic rhinitis. To download this guidance, click here. To view this notice, click here.

Guidance on Drug Development for Anthrax
Federal Register Notice: FDA is making available a draft guidance for industry entitled Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax. Its purpose is to assist sponsors in the development of new drugs for the prophylaxis of inhalational anthrax. This draft guidance supersedes the draft guidance entitled Inhalational Anthrax (Post-Exposure) — Developing Antimicrobial Drugs issued in 3/2002. To download this guidance, click here. To view this notice, click here.

Guidance on Drug Master Files for Type 2 APIs
Federal Register Notice: FDA is making available a guidance entitled Completeness Assessments for Type II API DMFs Under GDUFA. It finalizes the draft guidance entitled Initial Completeness Assessments for Type II API DMFs Under GDUFA, which published 10/2/12. This guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an ANDA, an amendment to an ANDA, a prior approval supplement (PAS) to an ANDA, or an amendment to a PAS (generic drug submissions). To download this guidance, click here. To view this notice, click here.

Guidance on Drugs for Allergic Rhinitis
Federal Register Notice: FDA is making available a draft guidance: Allergic Rhinitis: Developing Drug Products for Treatment. Its purpose is to assist sponsors in the development of drug products for the treatment of seasonal allergic rhinitis and perennial allergic rhinitis. It revises the draft guidance for industry entitled Allergic Rhinitis: Clinical Development Programs for Drug Products issued 4/2000. To download this guidance, click here. To view this notice, click here.

Workshop on Drug Supply Chain Pilot
Federal Register Notice: FDA will hold a public workshop 4/5 entitled “Proposed Pilot Project(s) under the Drug Supply Chain Security Act (DSCSA).” It will provide a forum for discussing proposed design objectives of pilot projects that will explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. FDA would like to obtain information and input from interested pharmaceutical distribution supply chain members about issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying the system attributes that are necessary to implement the requirements established under the DSCSA. The workshop will be held 4/5, from 9 a.m. to 5 p.m. and 4/6, from 9 a.m. to 12:15 p.m. Contact Daniel Bellingham, (301) 796-3130. To view this notice, click here.

Panel to Discuss Clovis NDA for Lung Cancer
Federal Register Notice: FDA’s Oncologic Drugs Advisory Committee will meet 4/12 from 8:30 a.m. to 1 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will discuss a Clovis Oncology NDA for rociletinib tablets for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation as detected by an FDA approved test. Contact Lauren D. Tesh, (301) 796-9001. To view this notice, click here.

FDA Science Board to Discuss Opioids
Federal Register Notice: The Science Board to the FDA will meet 3/1, from 8:30 a.m. until 5 p.m. at FDA’s White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503, Section A), Silver Spring, MD. For those unable to attend in person, the meeting will also be webcast at https://collaboration.fda.gov/scienceboard0316/. The Science Board will hear about and discuss: (1) The role of opioids in pain management; (2) scientific challenges facing FDA in supporting the development of pain medications, including opioids, that have reduced risks of being abused; (3) scientific challenges facing FDA in seeking to understand the real-world use of opioids to treat pain, including the impact of opioids with potentially less risk for abuse; (4) the role that FDA plays as a part of a larger federal, state, and local response to the challenges of providing appropriate pain treatment while reducing opioid abuse; and (5) postmarket surveillance activities related to opioids. The Science Board will also receive a final report from the Centers of Excellence in Regulatory Science and Innovation Program Evaluation Subcommittee. Contact Rakesh Raghuwanshi, (301) 796-4769, rakesh.raghuwanshi@fda.hhs.gov. To view this notice, click here.

Guidance on Low Molecular Weight Heparin
Federal Register Notice: FDA is making available a guidance for industry entitled Immunogenicity-Related Considerations for Low Molecular Weight Heparin. It discusses how applicants for low molecular weight heparin products should provide information on impurities and their potential impact on immunogenicity. To download this guidance, click here. To view this notice, click here.

FDA Sends Info to OMB on Non-Rx Human Drug Products
Federal Register Notice: FDA’s proposed collection of information, “Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.

Guidance on Safety Data for Late-Stage Trials
Federal Register Notice: FDA is making available a guidance for industry entitled Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations. It is intended to help sponsors determine the amounts and types of safety data to collect based on what is already known about a drug’s safety profile. FDA believes that selective safety data collection may be possible for some late-stage premarket and postapproval clinical investigations because certain aspects of a drug’s safety profile will be sufficiently well-established and comprehensive data collection is not needed. This guidance finalizes the draft guidance issued 2/2012. To download this guidance, click here. To view this notice, click here.

Advisory Panels to Discuss Opioids for Pediatric Patients
Federal Register Notice: FDA’s Anesthetic and Analgesic Drug Products Advisory Committee, the Drug Safety and Risk Management Advisory Committee, and the Pediatric Advisory Committee will meet 9/15-16 to discuss the appropriate development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients, including obtaining pharmacokinetic data and the use of extrapolation. The meeting will be held 9/15 from 8 a.m. to 5 p.m. and 9/16 from 8 a.m. to 5 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The docket number is FDA-2016-N-0584. Contact Stephanie L. Begansky, (301) 796-9001. To view this notice, click here. 

TOBACCO

FDA Seeks Participants for Tobacco E-submissions Pilot
Federal Register Notice: FDA’s Center for Tobacco Products (CTP) is soliciting applications from regulated tobacco product manufacturers to participate in a voluntary pilot program to help CTP evaluate a potential new portal, the CTP eSubmissions Portal (CTP Portal), that is being designed to improve the process in connection with providing certain regulatory submissions electronically to CTP. The Center plans to accept up to six participants for the pilot program, which is intended to provide CTP regulatory review staff with an opportunity to evaluate the CTP Portal, including its capability for sending and receiving secure messages and providing information as to the documents submitted to it (for example, receipt date and tracking number). Interested parties should submit an electronic application to participate in this pilot program by 3/2. To view this notice, click here.

Comments Sought on Smokeless Tobacco Labels
Federal Register Notice: FDA is seeking public comment on submission of rotational plans for health warning label statements for smokeless tobacco products. Comments should be submitted by 4/19. To view this notice, click here.

Comments Sought on FDA Youth Tobacco Prevention Campaign
Federal Register Notice: FDA seeks comments on (1) an extension of the study conducted with the original longitudinal youth cohort developed and surveyed for the outcome evaluation of FDA’s General Market Youth Tobacco Prevention Campaign, (2) the development of a second longitudinal cohort for the purpose of continuing the evaluation, (3) an extension of the time period for the outcome evaluation of the Rural Male Youth Smokeless Tobacco Campaign, (4) and an extension of the media tracking survey. Comments should be submitted by 4/19. To view this notice, click here.

GENERAL

FDA Plans Workshop on Clinical Trial Requirements
Federal Register Notice: FDA will hold a public workshop 3/9-10 entitled “Educational Conference Co-Sponsored With the Society of Clinical Research Associates (SOCRA).” The workshop on FDA’s clinical trial requirements is designed to aid the Clinical Research Professional’s understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among FDA, clinical trial staff, investigators, and institutional review boards (IRBs). Individual FDA representatives will discuss the informed consent process and informed consent documents; regulations relating to drugs, devices, and biologics; as well as inspections of clinical investigators, of IRBs, and of research sponsors. The workshop will be held on both days from 8 a.m. to 5 p.m. at the Holiday Inn San Diego Bayside, 4875 North Harbor Dr., San Diego, CA. Contact Jane Kreis (510) 287-2708 or Society of Clinical Research Associates (800) 762-7292 or (215) 822-8644. To view this notice, click here.

Workshop on Drugs/Biologics Used During Lactation
Federal Register Notice: FDA is planning a public workshop 4/27-28 entitled “Evaluation of the Safety of Drugs and Biological Products used during Lactation.” Attendees will discuss the current state and future directions of the collection of data on the potential risks to breastfed infants with maternal use of medications during lactation. The workshop will review current approaches to the collection of data when drugs are used or expected to be used during lactation. It will also discuss and consider novel approaches to improve the quality and quantity of data, to inform of the potential risks of medication use during lactation, and to raise awareness and engage stakeholders about communication of safety information related to maternal use of medications during lactation. The workshop will be held 4/27, from 8 a.m. to 5 p.m.; and 4/28, from 8 a.m. to 1 p.m. at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD. To view this notice, click here.

FDA Seeks Consumer Reps for Advisory Panels
Federal Register Notice: FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify the agency in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. To view this notice, click here.

FDA Submits Info on GRAS Notification to OMB
Federal Register Notice: FDA’s proposed collection of information, “Substances Generally Recognized as Safe: Notification Procedure — 21 CFR 170.36 and 570.36,” has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.

Patient Participation Summary Report Available
Federal Register Notice: FDA is making available the summary report of the public comments received during the open period from 11/4-12/4/14, on FDA activities under the Food and Drug Administration Safety and Innovation Act, Patient Participation in Medical Product Discussions. An electronic copy of the summary report is available at http://www.fda.gov/ForPatients/About/ucm483931.htm. The summary report is also available in Docket No. FDA-2014-N-1698. To view this notice, click here.

Pediatric Panel to Discuss Safety Reviews
Federal Register Notice: FDA’s Pediatric Advisory Committee will meet 4/12 to discuss pediatric-focused safety reviews of 17 products, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. The meeting will be held from 8 a.m. to 5:30 p.m. at the Double Tree by Hilton Hotel, 8727 Colesville Rd., Silver Spring, MD. Contact Marieann Brill, (240) 402-3838, email: marieann.brill@fda.hhs.gov. To view this notice, click here.