Latest Federal Register Notices

BIOLOGICS

CBER Seeks Participants for Site Training Program
Federal Register Notice: CBER is inviting biologics facilities to contact the Center for more information on participating in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities to allow CBER staff to directly observe routine manufacturing practices and to give a better understanding of the biologics industry, including its challenges and operations. To view this notice, click here.

OMB OKs Info on Biosimilar Licensing
Federal Register Notice: FDA’s collection of information entitled “General Licensing Provisions; Section 351(k) Biosimilar Applications” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To view this notice, click here.

OMB OKs Info on Biosimilar User Fee Cover Sheet
Federal Register Notice: FDA’s collection of information entitled “Biosimilar User Fee Cover Sheet; Form FDA 3792,” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.

DEVICES

Guidance on Human Factors Data for Devices
Federal Register Notice: FDA is making available a draft guidance entitled List of Highest Priority Devices for Human Factors Review. The agency aims to inform medical device manufacturers on which device types should have human factors data included in premarket submissions. FDA believes these device types have clear potential for serious harm resulting from use error and that review of human factors data in premarket submissions will help it evaluate the safety and effectiveness and substantial equivalence of these devices. To download this guidance, click here. To view this notice, click here.

Guidance on National Drug Code Numbers for Devices
Federal Register Notice: FDA makes available a draft guidance for industry and FDA staff entitled Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices. It will describe the agency’s intent not to enforce, before 9/24/21, the prohibition against providing National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers on device labels and device packages, with respect to certain finished devices manufactured and labeled prior to 9/24/18. Also, it will describe FDA’s intent to continue considering requests for continued use of FDA labeler codes under a system for the issuance of unique device identifiers (UDIs) until 9/24/18. To download this guidance, click here. To view this notice, click here.

Guidance on Applying Human Factors to Devices
Federal Register Notice: FDA is making available a guidance entitled Applying Human Factors and Usability Engineering to Medical Devices. Its purpose is to assist industry in following appropriate human factors and usability engineering processes to maximize the likelihood that new medical devices will be safe and effective for the intended users, uses, and use environments. The recommendations in this guidance are intended to support manufacturers in improving the design of medical devices to minimize potential use errors and resulting harm. To download this guidance, click here. To view this notice, click here.

HUMAN DRUGS

Panel to Discuss Acadia NDA for Nuplazid
Federal Register Notice: FDA’s Psychopharmacologic Drugs Advisory Committee will meet 3/29 from 8 a.m. to 5 p.m. at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will discuss the specific risk-benefit profile for an Acadia Pharmaceuticals NDA for Nuplazid (pimavanserin) 17 mg immediate-release, film-coated oral tablets, for the proposed treatment of psychosis associated with Parkinson’s disease. Contact Kalyani Bhatt, (301) 796-9001. To view this notice, click here.

Comments Sought on Patent Info Requirements
Federal Register Notice: FDA seeks comments on the reporting requirements for submission and listing of patent information associated with a new drug application, an amendment, or a supplement. Comments should be submitted by 4/4. To view this notice, click here.

OMB OKs Info on Drug Supply Chain Security
Federal Register Notice: FDA’s collection of information entitled “Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.

FDA Plans Workshop on Osteoarthritis Clinical Trials
Federal Register Notice: CDER and the Arthritis Foundation will co-sponsor a workshop 2/24-25 entitled, “Accelerating OA Clinical Trials Workshop.” Its purpose is to discuss recommendations from the international Arthritis Foundation Accelerating Osteoarthritis Clinical Trial workgroup and identify next steps in forging new approaches to osteoarthritis clinical trials that may improve the likelihood of successful conduct and outcomes of these trials and lead to the development of safe and effective treatments for osteoarthritis. The workshop will be held 2/24, from 8 a.m. to 5:30 p.m., and 2/25, from 8 a.m. to 2 p.m. at the Atlanta Airport Hilton, 1031 Virginia Ave., Atlanta, GA. Contact Sarah Yim, sarah.yim@fda.hhs.gov. To view this notice, click here.

Info on Postmarketing Adverse Drug Reporting Sent to OMB
Federal Register Notice: FDA’s collection of information entitled “Postmarketing Adverse Drug Experience Reporting” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.

OMB OKs Info on Non-Rx Drug Adverse Event Reporting
Federal Register Notice: FDA’s collection of information entitled “Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application,” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.

TOBACCO

OMB OKs Info on Modified Risk Tobacco Products
Federal Register Notice: FDA’s proposed collection of information, “Experimental Studies on Consumer Perceptions of Modified Risk Tobacco Products,” 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 Tobacco Product Research Sent to OMB
Federal Register Notice: FDA’s proposed collection of information, “Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products,” 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.

GENERAL

OMB OKs Info on Data Monitoring Committees
Federal Register Notice: FDA’s collection of information entitled “Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.

Guidance on Human Factor Studies for Combo Products
Federal Register Notice: FDA is making available a draft guidance for industry and FDA staff entitled Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development. It provides guidance on the underlying principles of human factors studies during the development of combination products. To download this draft guidance, click here. To view this notice, click here.