Latest Federal Register Notices

BIOLOGICS

Guidance on Blood Donors for Autologous Use
Federal Register Notice: FDA is making available a document entitled Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use — Compliance Policy; Guidance for Industry. This guidance addresses the regulatory requirements for determining donor eligibility that apply to establishments that collect blood and blood components intended solely for autologous use. FDA has developed this guidance in response to questions from blood establishments on the applicability of the donor eligibility rule to autologous donations. It explains the conditions under which the agency does not intend to take regulatory action for a blood establishment’s failure to comply with certain donor eligibility determination requirements in collecting blood and blood components intended solely for autologous use. To download this guidance, click here. To view this notice, click here.

CBER Panel to Hear Research Updates
Federal Register Notice: FDA will hold a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee 9/7 from 1 p.m. to 4 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will meet by teleconference. In open session, it will hear updates of research programs in CBER’s Gene Transfer and Immunogenicity Branch, Division of Cellular and Gene Therapies, Office of Cellular, Tissue, and Gene Therapies.Contact Janie Kim or Denise Royster (301) 796-9016 or (240) 402-8158, Janie.kim@fda.hhs.gov or Denise.royster@fda.hhs.gov. To view this notice, click here.

DEVICES

Info on Device Sterilization Sent to OMB
Federal Register Notice: FDA’s proposed collection of information, “Agreement for Shipment of Devices for Sterilization — 21 CFR 801.150,” 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 X-Ray Imaging Devices
Federal Register Notice: FDA is making available a draft guidance entitled Medical X-Ray Imaging Devices Conformance With IEC Standards. It describes FDA’s policy on regulating medical x-ray imaging equipment that is subject to requirements in the FD&C Act and the agency’s regulations that apply to medical devices and electronic products. The guidance also provides recommendations to industry on how to comply with the applicable requirements. To download this draft guidance, click here. To view this notice, click here.

FDA Posts List of Approved PMAs
Federal Register Notice: FDA is publishing a list of premarket approval applications (PMAs) that have been approved. This list includes NuMed, Inc.’s Cheatham Platinum Stent System, Abiomed’s Impella Left Ventricular Support System, and Medtronic Minimed’s iPro2 Continuous Glucose Monitoring System With Enlite Sensor. The agency is informing the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and FDA’s Division of Dockets Management. To view this notice, click here. 

HUMAN DRUGS

FDA Sets Fees for Drug Compounders Registered as Outsourcing Facilities
Federal Register Notice: FDA is announcing the fiscal year (FY) 2017 rates for the establishment and re-inspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the FD&C Act. This document establishes the FY 2017 rates for the small business establishment fee ($5,279), the non-small business establishment fee ($16,852), and the re-inspection fee ($15,837) for outsourcing facilities; provides information on how the fees for FY 2017 were determined; and describes the payment procedures outsourcing facilities should follow. To view this notice, click here.

Info on E-Reporting for Compounding Outsourcing Sent to OMB
Federal Register Notice: FDA’s proposed collection of information, “Guidance for Industry: Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act,” 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.

Samsca Not Withdrawn for S&E
Federal Register Notice: FDA has determined that Samsca (tolvaptan) tablets, 60 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow the agency to approve abbreviated new drug applications (ANDAs) for tolvaptan tablets, 60 mg, if all other legal and regulatory requirements are met. To view this notice, click here.

Guidance on Compounding Facilities Insanitary Conditions
Federal Register Notice: FDA is making available a draft guidance for industry entitled Insanitary Conditions at Compounding Facilities. FDA is issuing this draft guidance to assist compounding facilities in identifying insanitary conditions so that they can implement appropriate corrective actions, and to assist state regulatory agencies in understanding some examples of what FDA considers to be insanitary conditions. To download this guidance, click here. To view this notice, click here.

Workshop Planned on Pediatric Master Protocols
Federal Register Notice: FDA in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation will hold a public workshop 9/23 entitled, “Pediatric Master Protocols.” Its objective is to discuss regulatory and scientific concerns related to pediatric master protocols and clinical trial design considerations for these protocols. In addition, applications of pediatric master protocols to specific pediatric therapeutic areas will be presented. The workshop will be held from 8:30 a.m. to 4:30 p.m. at FDA’s White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. Contact Audrey Thomas, (301) 796-3520, Audrey.Thomas@fda.hhs.gov. To view this notice, click here.

TOBACCO

Info on Tobacco Training Programs Guidance Sent to OMB
Federal Register Notice: FDA’s proposed collection of information, “Guidance for Tobacco Retailers on Tobacco Retailer Training Programs,” 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.

FDA Seeks Selectors, Nominations for Tobacco Panel
Federal Register Notice: FDA is requesting that any industry organizations interested in participating in selecting a nonvoting member to represent the interests of tobacco growers to serve on the Tobacco Products Scientific Advisory Committee, notify the agency in writing. FDA is also requesting nominations for a nonvoting member to represent the interests of tobacco growers to serve on the Tobacco Products Scientific Advisory Committee, and an alternate to this representative. To view this notice, click here.

GENERAL

Guidance on IRB Written Procedures
Federal Register Notice: The Office for Human Research Protections, Office of the Assistant Secretary for Health, and FDA are making available a draft guidance entitled Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs. Its purpose is to assist IRB administrators, IRB chairpersons, and other institutional officials responsible for preparing and maintaining written procedures for IRBs. It is intended for IRBs and institutions responsible for review and oversight of human subject research under the HHS or FDA regulations, or both. To download this guidance, click here. To view this notice, click here.

FDA Seeks for Advisory Panel Selectors, Nominations from Consumer Organizations
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.

Info on DTC Advertising Survey Sent to OMB
Federal Register Notice: FDA has submitted a proposed collection of information entitled, “National Direct-to-Consumer Advertising Survey,” to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. The purpose of the survey is to collect updated insights on consumer experiences with and attitudes towards DTC promotion of prescription drugs. FDA last surveyed patients about their experiences with DTC advertising in 2002 and numerous changes have occurred including declines in print readership, the rise in online prescription drug promotion, and self-imposed industry guidelines for DTC advertising. To view this notice, click here.

Comments Sought on FOIA Certification
Federal Register Notice: FDA is seeking public comment on a proposed collection of information on “Certification of Identity for Freedom of Information Act and Privacy Act Requests.” Comments should be submitted by 10/3. To view this notice, click here.

Mammography QA Committee to Meet
Federal Register Notice: FDA will hold meeting 9/15 of the National Mammography Quality Assurance Advisory Committee. It will be held from 8:30 a.m. to 4:30 p.m. at Hilton Washington, DC North/Gaithersburg, Salons A, B, C and D, 620 Perry Pkwy, Gaithersburg, MD. The committee will discuss and make recommendations on compliance analysis. This presentation will be focused on Mammography Quality Standards Act current compliance trends, such as how most compliance cases originate. The panel will also seek input from the committee on any trends seen in the analysis, why the trends may be occurring, and possible actions. Contact S.J. Anderson, Sara.Anderson@fda.hhs.gov, (301) 796-7047. To view this notice, click here.