Latest Federal Register Notices
BIOLOGICS
Workshop on Pre-clinical Evaluation of Red Blood Cells
Federal Register Notice: FDA will hold a public workshop 10/6-7 entitled “Pre-Clinical Evaluation of Red Blood Cells for Transfusion.” Its purpose is to discuss new methodologies for pre-clinical evaluation of the safety and efficacy of red blood cell transfusion products. The workshop has been planned in partnership with the National Heart, Lung, and Blood Institute; National Institutes of Health; the Department of Defense; and the Office of the Assistant Secretary for Health, HHS. The workshop will include presentations and panel discussions by experts from academic institutions, industry, and government agencies. It will be held 10/6, from 8 a.m. to 5 p.m. and 10/7, from 9 a.m. to 1 p.m. at the Ruth Kirschstein Auditorium, Natcher Conference Center, Bldg. 45, National Institutes of Health Campus, 9000 Rockville Pike, Bethesda, MD. Contact Matthew Morrison, (240) 402-8126, Matthew.D.Morrison@fda.hhs.gov. To view this notice, click here.
DEVICE
Workshop on 3rd Party Medical Device Refurbishing
Federal Register Notice: FDA will hold a public workshop 10/27-28: “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers.” The workshop will discuss the current regulatory environment for these activities, the definitions of the various terms FDA proposed in the prior Federal Register notice on this subject, and whether these activities should appropriately be regulated by FDA or a non-governmental organization. The workshop will be held 10/27, from 8:30 a.m. to 5 p.m. and 10/28, from 8:30 a.m. to 4 p.m. at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. Contact Felicia Brayboy, (301) 796-8086, Felicia.Brayboy@fda.hhs.gov. To view this notice, click here.
HUMAN DRUGS
2 ICH Guidances on Periodic Benefit-Risk Evaluation
Federal Register Notice: FDA is making available two guidances for industry entitled E2C(R2) Periodic Benefit-Risk Evaluation (E2C(R2) guidance) and E2C(R2) Periodic Benefit-Risk Evaluation Report — Questions and Answers (E2C(R2) Q&A guidance). These guidances were prepared under the auspices of the International Council for Harmonization (ICH). The E2C(R2) draft guidance, issued 4/11/12, updated and combined two ICH guidances, E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (E2C guidance) and Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (addendum to the E2C guidance). The E2C(R2) guidance is intended to describe the format, content, and timing of a Periodic Benefit-Risk Evaluation Report for an approved drug or biologic, and it finalizes the draft guidance. The E2C(R2) Q&A guidance is a supplementary guidance that is intended to clarify key issues in the E2C(R2) guidance. To download the E2C(R2) guidance, click here. To download the E2C(R2) Q&A guidance, click here. To view this notice, click here.
Public Meeting on Reauthorizing PDUFA
Federal Register Notice: FDA is holding a public meeting 8/15 to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years 2018 through 2022. The meeting will be held from 9 a.m. to 2 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503, Section A), Silver Spring, MD. To view this notice, click here.
FDA Corrects Notice on Workshop
Federal Register Notice: FDA is correcting a Web link in a 6/16 Federal Register notice announcing a “Pediatric Clinical Investigator Training” workshop. To view this notice, click here.
Review Period Set for Qutenza
Federal Register Notice: FDA has determined the regulatory review period for NeurogesX, Inc.’s Qutenza (capsaicin) is 2,944 days for extending a patent that claims the human drug product. Qutenza is indicated for managing neuropathic pain associated with postherpetic neuralgia. To view this notice, click here.
VETERINARY
Guidance on Human Food Safety of New Animal Drugs
Federal Register Notice: FDA is making available a draft revised guidance for industry entitled General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in Food-Producing Animals. It is intended to inform sponsors of the scientific data and/or information that may provide an acceptable basis to determine that the residue of a new animal drug in or on food, when consumed, presents a reasonable certainty of no harm to humans. CVM acknowledges that alternate approaches also may be appropriate and encourages sponsors to discuss with CVM whether an alternate approach may be appropriate for specific new animal drugs. To download this guidance, click here. To view this notice, click here.
GENERAL
Info on CLIA Waivers Sent to OMB
Federal Register Notice: FDA’s proposed collection of information “CLIA Waiver Applications,” 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.
Comments Sought on Human Subject Protection Info
Federal Register Notice: FDA is seeking public comment on the collection of information related to certain regulations that provide protection for human subjects of clinical investigations conducted in support of applications or submissions to FDA for FDA-regulated products. The regulations provide protection of the rights, safety, and welfare of human subjects involved in research activities within FDA’s jurisdiction. Comments should be submitted by 9/19. To view this notice, click here.
Info on Bar Code Labels for Drug/Blood Products Sent to OMB
Federal Register Notice: FDA’s proposed collection of information, “Bar Code Label Requirement for Human Drug Products and Blood,” 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.
Info on Review Transparency for New Molecular Entities Sent to OMB
Federal Register Notice: FDA’s proposed collection of information, “Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Acts,” 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.
Science Board Renewed
Federal Register Notice: The FDA commissioner is renewing the Science Board to the FDA for an additional two years beyond the charter expiration date. The new charter will be in effect until 6/26/18. TO view this notice, click here.
FDA Confirms Effective Date on IRB Compliance
Federal Register Direct final rule: FDA is confirming the effective date of 8/17 for the direct final rule that appeared in the 4/4 Federal Register amending the regulations describing lesser administrative actions that may be imposed on an Institutional Review Board that has failed to comply with applicable regulations. To view this direct final rule, click here.