Latest Federal Register Notices

BIOLOGICS

CBER Releases eSubmitter Program for Vaccine AERS
Federal Register Notice: CBER is making available a Vaccine Adverse Event Reporting System (VAERS) eSubmitter program for the electronic submission of postmarketing individual case safety reports (ICSRs) and ICSR attachments of adverse events for human vaccine products. It is a free software program for voluntary use that is intended to help persons subject to mandatory postmarketing requirements for vaccines including applicants, manufacturers, packagers, and distributors to electronically submit ICSRs and attachments as required by the final rule entitled “Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements.” To view this notice, click here.

DEVICES

Comments Extended on Device Refurbishing
Federal Register Notice: FDA is extending the comment period for the document entitled “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers” in the 3/4 Federal Register. FDA requested comments about the quality, safety, and continued effectiveness of medical devices that have been subject to one or more of these activities that are performed by both original equipment manufacturers and third parties, including health care establishments. Comments should be submitted by 6/3. To view this notice, click here.

FDA Propose Ban on Behavioral Electrical Stimulation Devices
Federal Register Proposed rule: FDA is proposing to ban electrical stimulation devices used to treat aggressive or self-injurious behavior. The agency has determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. This proposal includes both new devices and devices already in distribution and use. To view this notice, click here.

Comments Sought on In Vitro Diagnostic Test Categorization
Federal Register Notice: FDA is seeking public comments on requests for Clinical Laboratory Improvement Amendments of 1998 (CLIA) categorization of in vitro diagnostic tests when a premarket review is not needed. Comments should be submitted by 6/27. To view this notice, click here.

Comments Sought on Device Surveillance Info
Federal Register Notice: FDA seeks comments on information collection requirements for postmarket surveillance of medical devices. Comments should be submitted by 6/27. To view this notice, click here.

Comments Reopened on Liquid Chromatography-Spectrometry IVDs
Federal Register Notice: FDA is reopening the comment period for a 3/9 Federal Register notice of a public workshop on the use of liquid chromatography/mass-spectrometry (LC/MS)-based in vitro diagnostic devices (IVDs) in the clinical laboratory. Comments should be submitted by 6/2. To view this notice, click here.

HUMAN DRUGS

Thalitone Not Withdrawn for S&E
Federal Register Notice: FDA has determined that Thalitone (chlorthalidone USP) tablets, 15 mg were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve ANDAs for chlorthalidone USP tablets, 15 mg, if all other legal and regulatory requirements are met. To view this notice, click here.

Guidance on Assays for Therapeutic Protein Products
Federal Register Notice: FDA is making available a revised draft guidance for industry entitled Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products. It provides recommendations to facilitate industry’s development and validation of immune assays for assessing the immunogenicity of therapeutic protein products during clinical trials. It applies to assays for detecting anti-drug antibodies and includes screening, confirmatory, titering, and neutralization assays. The document revises a 12/2009 draft guidance entitled Assay Development for Immunogenicity Testing of Therapeutic Proteins. To download this guidance, click here. To view this notice, click here.

Meeting on Patient-Focused Drugs for Organ Transplant Patients
Federal Register Notice: FDA will hold a public meeting 9/27 on patient-focused drug development for patients who have received an organ transplant. The meeting is intended to allow the agency to obtain patient perspectives on the impact of receiving an organ transplant on daily life and patient views on treatment approaches. FDA is also interested in discussing issues related to scientific challenges in developing drugs to manage organ transplantation. In the afternoon, FDA will hold a workshop and provide information for and gain perspective from patients and patient advocacy organizations, health care providers, academic experts, and industry on various aspects of clinical development of drug products intended to manage organ transplantation. The meeting will be held from 9 a.m. to 5 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm.1503), Silver Spring, MD. Contact Graham Thompson, (301) 796-5003 or graham.thompson@fda.hhs.gov. To view this notice, click here.

CDER’s Office of Medical Policy Changes Structure
Federal Register Notice: FDA’s Office of Medical Products and Tobacco, CDER, Office of Medical Policy has modified its organizational structure. The Office of Medical Policy is headed by the Director, Office of Medical Policy and includes the following organizational units: Office of Medical Policy, Office of Prescription Drug Promotion, Division of Advertising and Promotion Review I, and Division of Advertising and Promotion Review II. To view this notice, click here.

VETERINARY

FDA Corrects Errors in Animal Drug Notice
Federal Register Final rule: FDA published a document in the 4/18 Federal Register amending the animal drug regulations to reflect application-related actions for NADAs and ANADAs during January and February. That rule included two amendatory instructions that cited incorrect sections of 21 CFR part 524: “Ophthalmic and Topical Dosage Form New Animal Drugs.” In paragraph (b)(2) of Sec. 524.1193, remove “000859'' and in its place add “016592”. In Sec. 524.1484k, revise the section heading to read: Neomycin and prednisolone suspension. To view this final rule, click here.

Comments Reopened on Combo Drug Medicated Animal Feeds
Federal Register Notice: FDA is reopening the comment period and requesting public input on possible modifications to the current review processes for new animal drug applications for the use of multiple new animal drugs in combination drug medicated feeds. FDA is also making available a Center for Veterinary Medicine recommendations document for the animal drug user fee negotiating committee. Comments should be submitted by 7/29. To view this notice, click here.