Latest Federal Register Notices

BIOLOGICS

FDA Confirms Date for Updated Biological Standards
Federal Register Direct final rule: FDA is confirming the effective date of 9/16 for the 5/4 final rule that amends the general biological products standards relating to dating periods and removes certain standards relating to standard preparations and limits of potency. The agency aims to update outdated requirements, and accommodate new and evolving technology and testing capabilities. To view this notice, click here.

DEVICES

Guidance on Submitting 510(k) for Device Software Change
Federal Register Notice: FDA is making available the draft guidance entitled Deciding When to Submit a 510(k) for a Software Change to an Existing Device. It is aiming to clarify when a software change in a legally marketed medical device would require that a manufacturer submit a premarket notification (510(k)) to FDA. To download this guidance, click here. To view this notice, click here.

Guidance on 510(k)s for Changes to Existing Device
Federal Register Notice: FDA is making available a draft guidance entitled Deciding When to Submit a 510(k) for a Change to an Existing Device. FDA intends to clarify when a change in a legally marketed medical device would require that a manufacturer submit a premarket notification (510(k)) to FDA. When finalized, this document will supersede Deciding When to Submit a 510(k) for a Change to an Existing Device'' issued January 10, 1997. To download this guidance, click here. To view this notice, click here.

CDRH Reaches Goal on Pre vs. Postmarket Device Data Collection
Federal Register Notice: FDA is completing the target of the goal established to address CDRH’s 2014-2015 Strategic Priority “Strike the Right Balance Between Premarket and Postmarket Data Collection.” To achieve this strategic priority, CDRH established a goal to facilitate and expedite the development and review of medical devices, in particular high-risk devices of public health importance. The agency established a target date of 12/31/15, by which to review 100% of product codes subject to a PMA that are legally marketed and were approved prior to 2010 to determine, for each such product code, whether or not, to reduce premarket data collection by relying more on postmarket controls, and whether to shift some premarket data collection to the postmarket setting or to pursue down-classification. To view this notice, click here.

Panel to Discuss Wound Care Product Dressing
Federal Register Notice: FDA will hold a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee 9/20-21, from 8 a.m. to 6 p.m. at Hilton Washington, DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD. The committee will discuss and make recommendations on the classification of certain wound care products containing antimicrobials and other drugs as part of the routine process for device classification. These products are regulated under product code FRO, “Dressing, Wound, Drug,” and are considered “pre-amendments” because they were in commercial distribution prior to 5/28/76, when the Medical Devices Amendments were enacted, and have not yet been classified under section 513 of the Federal Food, Drug, and Cosmetic Act. Contact Evella Washington, (301) 796-6683, Evella.Washington@fda.hhs.gov. To view this notice, click here.

Comments Extended on Diagnostics for Antimicrobial Resistance
Federal Register Notice: FDA is extending the comment period until 9/12 for the document entitled “Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers; Draft Guidance for Industry and Food and Drug Administration Staff,” that appeared in the 5/13 Federal Register. In the document, FDA requested comments on its recommendations to assist industry in designing studies to establish the analytical and clinical performance characteristics of the diagnostic devices. To view this notice, click here.

FDA Corrects Regs on Device Bans
Federal Register Final rule: FDA is amending its regulations to correct an error in the lists of statutory and regulatory provisions that provide an opportunity for an informal hearing in connection with a ban of a device. In the list of statutory provisions at Sec. 16.1(b)(1), the agency is adding a reference to subsection (b) of section 516 of the FD&C Act (21 U.S.C. 360f), which provides for a reasonable opportunity for an informal hearing when FDA proposes a medical device ban with a special effective date. The list of regulatory provisions at Sec. 16.1(b)(2) does not include any reference to part 895 and FDA is correcting this by adding a reference to Sec. 895.30(c), which provides for an opportunity for an informal hearing under 21 CFR part 16 when FDA proposes a medical device ban with a special effective date. To view this notice, click here.

HUMAN DRUGS

Drug Products Not Withdrawn for S&E
Federal Register Notice: FDA has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. The products are: Bentyl, Neptazane, Inderal, Avandamet, Axid, Garamycin, Aristocort, Aristocort A, and Kenalog. To view this notice, click here.

Guidance on Ulcerative Colitis Trial Endpoints
Federal Register Notice: FDA is making available a draft guidance for industry entitled Ulcerative Colitis: Clinical Trial Endpoints. It aims to assist sponsors in the clinical development of drugs for treating ulcerative colitis (UC) in adult and pediatric patients and addresses FDA’s current thinking on efficacy endpoints for UC clinical trials. To download this guidance, click here. To view this notice, click here.

Comments on OTC Drug User Fees Reopened
Federal Register Notice: FDA is reopening the comment period on the potential development of a user-fee program for nonprescription (over-the-counter) monograph drugs. The agency sought comments in the 5/11 Federal Register that announced a 6/10 public meeting on the topic. FDA will hold a Webinar 9/6 from 10:30 a.m.-12 p.m. as a follow-up to the public meeting and also to provide stakeholders with a status update on the process of FDA and industry discussions that began in July. Comments should be submitted by 10/6. To view this notice, click here.

Panels to Discuss Naloxone Products
Federal Register Notice: FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet 10/5 from 8 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. The committees will be asked to discuss naloxone products intended for use in the community especially the most appropriate dose or doses of naloxone to reverse the effects of life-threatening opioid overdose in all ages, and the role of having multiple doses available in this setting. The committees will also be asked to discuss the criteria prescribers will use to select the most appropriate dose in advance of an opioid overdose event and the labeling to inform this decision, if multiple doses are available.Contact Jennifer Shepherd, (301) 796-9001. To view this notice, click here.

TOBACCO

FDA Proposes Refusal of Insufficient Tobacco Product Applications
Federal Register Proposed rule/direct final rule: FDA is issuing a proposed rule describing when it would refuse to accept a tobacco product submission (or application) because the application has not met a minimum threshold for acceptability for agency review. Under the proposed rule, FDA would refuse to accept a tobacco product submission, for example, that is not in English, does not pertain to a tobacco product, or does not identify the type of submission. Comments should be submitted by 10/24. To view this notice, click here.

VETERINARY

FDA Corrects Regs on NADA Hearing Procedures
Federal Register Final rule: FDA is making technical corrections to its regulations for hearing procedures for denial of approval or withdrawal of approval of new animal drug applications. FDA is revising Sec. 514.200 to make its language and terminology consistent with the language and terminology of the procedural regulations for hearings in part 12. The agency is changing the references to “administrative law judge” in current Sec. 514.200 to the term “presiding officer.” FDA is also updating the language in current Sec. 514.200 from “written appearance” to “objections and request for a hearing” since the latter terminology is used throughout part 12. Finally, FDA is updating the language in Sec. 514.200 on the contents of the objections and request for hearing and the contents of the Commissioner’s notice granting a hearing to match the language of part 12 and to make clear what is required. All of these corrections are nonsubstantive, technical amendments designed to harmonize the language and terminology of Sec. 514.200. To view this final rule, click here.

GENERAL

Info on Commissioner’s Fellowship Program Sent to OMB
Federal Register Notice: FDA’s proposed collection of information, “Survey of Alumni Commissioner's Fellowship Program Fellows,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. The information from Alumni CFP Fellows will allow FDA’s Office of the Commissioner to easily and efficiently elicit and review program feedback. The online survey will assist FDA in promoting and protecting the public health by encouraging outside persons to share their experience with the FDA while a Commissioner’s Fellow. The surveys include questions to assess the following measures: Post-fellowship employment (e.g., employment type); number of awards; number of contributions while a CFP fellow (e.g., number of publications, guidances authored or co-authored); and contributions in their field (e.g., list of publications). To view this notice, click here.

FDA Posts OMB Approvals
Federal Register Notice: FDA is publishing a list of information collections that have been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995 including information on dispute resolutions, SPF labeling, and generic drug user fee cover sheets. To view this notice, click here.

Guidance on Dietary Ingredient Notifications for Supplements
Federal Register Notice: FDA is issuing a revised draft guidance for industry entitled Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. It supersedes a 7/2011 draft guidance on the same topic. The revised draft guidance, when finalized, will help industry in evaluating whether to submit a premarket safety notification for a new dietary ingredient (NDI), or for a dietary supplement containing an NDI, and in preparing such premarket safety notifications (also referred to as NDI notifications). To download this guidance, click here. To view this notice, click here.