Latest Federal Register Notices

DEVICES

Comments Extended on GMPs for Hearing Aids
Federal Register Notice: FDA is extending the comment period to 6/30 for the document entitled “Streamlining Regulations for Good Manufacturing Practices for Hearing Aids; Public Workshop,” that appeared in the 1/7 Federal Register. FDA requested comments on the appropriate level of good manufacturing practices regulation to ensure the safety and effectiveness of air-conduction hearing aid devices. To view this notice, click here.

Technical Guidance on 3-D Printed Devices
Federal Register Notice: FDA is making available a draft guidance entitled Technical Considerations for Additive Manufactured Devices. The agency has developed this draft leapfrog guidance to provide its initial thoughts on technical considerations specific to devices using additive manufacturing, the broad category of manufacturing encompassing 3-dimensional (3D) printing. To download this guidance, clickhere. To view this notice, click here.

Guidance on Infectious Disease Diagnostics
Federal Register Notice: FDA is making available a draft guidance entitled Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers. It provides recommendations to assist industry in designing studies to establish the analytical and clinical performance characteristics of infectious disease next generation sequencing- based diagnostic devices for microbial identification and detection of antimicrobial resistance and virulence markers. To download this draft guidance, click here. To view this notice, click here.

HUMAN DRUGS

Anesthetic & Analgesic Drug Panel Renewed
Federal Register Notice: The FDA commissioner is renewing the Anesthetic and Analgesic Drug Products Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 5/1/18. To view this notice, click here.

Workshop on Malaria Drug Development
Federal Register Notice: FDA plans a public workshop 6/30 on clinical trial design considerations for malaria drug development. It is intended to provide information for and gain perspective from health care providers, other U.S. government agencies, public health organizations, academic experts, and industry on various aspects of the design of clinical trials evaluating new drugs to treat malaria. The workshop will be held from 8:30 a.m. to 4 p.m. at FDA’s White Oak campus, 10903 New Hampshire Ave., Bldg. 31 Great Rm., Silver Spring, MD. Contact Lori Benner and/or Jessica Barnes, (30) 796-1300. To view this notice, click here.

Public Meeting on User Fees for OTC Monograph Drugs
Federal Register Notice: FDA will hold a public meeting 6/10 to gather stakeholder input on the potential development of a user-fee program for nonprescription (over-the-counter or OTC) monograph drugs. A user-fee program would provide funding to supplement congressional non-user-fee appropriations, and would support timely and efficient FDA review of the efficacy and safety of ingredients included in or proposed for inclusion in a monograph. The agency invites public comment on a potential OTC monograph user-fee program and also invites suggestions regarding the features such a user-fee program should include. The meeting will be held from 9 a.m. to 5 p.m. EDT at FDA’s White Oak Campus, Bldg. 31 Conference Center, 10903 New Hampshire Ave., the Great Room (Rm. 1503A), Silver Spring, MD. Contact Amy Bertha, (301) 796-1647, email: OTCMonographUserFeeProgram@fda.hhs.gov. To view this notice, click here.

FDA Renews Pulmonary-Allergy Drugs Panel
Federal Register Notice: The FDA commissioner renews that charter of the Pulmonary-Allergy Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 5/30/18. To view this notice, click here.

TOBACCO

Guidance on Tobacco Product Master Files
Federal Register Notice: FDA is making available a guidance for industry entitled Tobacco Product Master Files. It provides recommendations to industry on tobacco product master files (TPMF), which are voluntary submissions used to permit the person that owns the TPMF to authorize other parties to rely on information in the TPMF to support a submission to FDA without the TPMF owner having to disclose that information to the authorized parties. Parties that obtain a right of reference from a TPMF owner may reference information in a TPMF that the TPMF owner does not want to make public, but that the other party would otherwise need to develop on its own to make a complete submission to FDA. To download this guidance, click here. To view this notice, click here.

Guidance on Tobacco Packages and Ads
Federal Register Notice: FDA is making available a guidance for industry entitled FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements; Small Entity Compliance Guide. It is intended to set forth in plain language the requirements of the deeming regulation and to help small businesses understand and comply with the regulation. To download this guide, click here. To view this notice, click here.

Guidance on Electronic Nicotine Delivery Systems
Federal Register Notice: FDA is making available a draft guidance for industry entitled Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems. Given the relatively new presence of electronic nicotine delivery systems (ENDS) on the U.S. market and FDA’s final rule deeming these products to be subject to the tobacco product authorities, the agency expects to receive premarket tobacco product application (PMTA) submissions from manufacturers of ENDS. This draft guidance is intended to assist persons with their PMTA submissions for ENDS products. To download this guidance, click here. To view this notice, click here.

Guide on User Fees for Tobacco Products
Federal Register Notice: FDA is making available a revised guidance for industry entitled Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products; Small Entity Compliance Guide' for the final user fees rule published 7/10/14 and for the new user fees regulation. It replaces the SECG of the same name published on 7/16/14. To download the guide, click here. To view this notice, click here.

Tobacco Manufacturers/Importers Must Submit User Fee Info
Federal Register Final rule: FDA is issuing a final rule that requires domestic manufacturers and importers of cigars and pipe tobacco to submit information needed to calculate the amount of user fees assessed under the Federal Food, Drug, and Cosmetic Act. To view this notice, click here.

FDA Deems Tobacco Product Subject to FD&C Act
Federal Register Final rule: FDA is issuing this final rule to deem products meeting the statutory definition of “tobacco product,” except accessories of the newly deemed tobacco products, to be subject to the FD&C Act, as amended the Tobacco Control Act. This final rule also prohibits the sale of “covered tobacco products” to individuals under the age of 18 and requires the display of health warnings on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements. To view this final rule, click here.

VETERINARY

Comments Sought on ANADA Info Collection
Federal Register Notice: FDA is seeking public comment on the information collection provisions of abbreviated new animal drug applications (ANADA). The information required to be submitted as part of an ANADA is described in FDCA 512(n)(1). Among other things, an ANADA is required to contain information to show that the proposed generic drug is bioequivalent to, and has the same labeling as, the approved new animal drug. Comments should be submitted by 7/11. To view this notice, click here.

FDA Requires Antimicrobial Report from Animal Drug Sponsors
Federal Register Final rule: FDA is issuing a final rule to require that the sponsor of each approved or conditionally approved new animal drug product that contains an antimicrobial active ingredient submit an annual report to the agency. This report would include the amount of each such ingredient in the drug product that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. To view this final rule, click here.

GENERAL

FDA Sends Info on Supplement Notification to OMB
Federal Register Notice: FDA’s proposed collection of information, “Food Labeling; Notification Procedures for Statements on Dietary Supplements — 21 CFR 101.93,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. FDCA 403(r)(6) and its implementing regulation, 21 CFR 101.93, require that FDA is notified by the manufacturer, packer, or distributor of a dietary supplement that it is marketing a dietary supplement product that bears on its label or in its labeling a statement provided for in FDCA 403(r)(6). To view this notice, click here.

FAQ Guidance on Medical Foods
Federal Register Notice: FDA is making available a guidance for industry entitled Frequently Asked Questions About Medical Foods; Second Edition. This guidance provides responses to additional questions on the definition and labeling of medical foods and updates some prior responses. To download this guidance, click here. To view this notice, click here.