Latest Federal Register Notices

BIOLOGICS

Comments Sought on BLAs, Postmarketing Reports
Federal Register Notice: FDA is seeking public comment on the collection of information relating to general licensing provisions for BLAs, changes to an approved application, labeling, revocation and suspension, postmarketing studies status reports, and Form FDA 356h. Form 356h is the “Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use” and was developed to harmonize application procedures between CBER and CDER. The application form serves primarily as a checklist for firms to gather and submit certain information to FDA. Comments should be submitted by 9/9. To view this notice, click here.

FDA Removes Obsolete References in Biological Reclassification Rule
Federal Register Final rule: FDA is amending its regulations by removing certain ones that include obsolete references. In the 2/12 Federal Register (81 FR 7445), FDA published a final rule entitled “Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972.” FDA, in part, removed Sec. 601.25 (21 CFR 601.25), which prescribed procedures for FDA’s review of biological products licensed before 7/1/72. Under Sec. 14.1(a)(2) specific provisions are provided for a matter that is subject to a hearing before an advisory committee. In the 2/2016 final rule, FDA inadvertently did not remove these sections (Sec. Sec. 14.1(a)(2)(v) and 20.100(c)(22)) that referenced Sec. 601.25. To view this final rule, click here.

DEVICES

Comments Sought on 3rd Party Device Review
Federal Register Notice: FDA is seeking comments on the information collection associated with medical devices third-party review under the Food and Drug Administration Modernization Act. Comments should be submitted by 9/6. To view this notice, click here.

FDA Issues EUA for Biocartis Ebola Diagnostic
Federal Register Notice: FDA is issuing an Emergency Use Authorization for an in vitro diagnostic device for detecting the Ebola Zaire virus in response to the Ebola virus outbreak in West Africa. FDA issued this authorization under the Federal Food, Drug, and Cosmetic Act, as requested by Biocartis NV. It contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. To view this notice, click here.

FDA Issues Emergency Use for Hologic Zika Diagnostic
Federal Register Notice: FDA is issuing an Emergency Use Authorization for a Hologic Inc. in vitro diagnostic device for detecting the Zika virus in response to the Zika virus outbreak in the Americas. The authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. To view this notice, click here.

Guidance on Genetic Databases to Support NGS Diagnostics
Federal Register Notice: FDA is making available a draft guidance entitled Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics. It describes how publicly accessible databases of human genetic variants can serve as sources of valid scientific evidence to support the clinical validity of genotype-phenotype relationships in FDA’s regulatory review of NGS-based tests. It also outlines the process by which administrators of genetic variant databases could voluntarily apply to FDA for recognition, and how the agency would review such applications and periodically reevaluate recognized databases. To download this guidance, click here. To view this notice, click here.

Guidance on Next-Generation Sequencing-IVDs for Germline Diseases
Federal Register Notice: FDA is making available a draft guidance entitled Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases. As part of the White House’s Precision Medicine Initiative, FDA is providing its proposed approach on the content and possible use of standards in providing oversight for targeted and whole exome human DNA sequencing NGS-based tests intended to aid in diagnosing individuals with suspected germline diseases or other conditions. The guidance provides recommendations for designing, developing, and validating NGS-based tests for germline diseases, and also discusses possible use of FDA-recognized standards for regulatory oversight of these tests. To download this guidance, click here. To view this notice, click here.

Workshop on Elemental Impurities
Federal Register Notice: FDA will hold a public workshop 8/22-23 entitled: “Regional Public Workshop on ICH Q3D Implementation of Guideline for Elemental Impurities.” Its purpose is to elaborate key aspects of the ICH Guideline Q3D: Guideline on Elemental Impurities in order to facilitate a harmonized interpretation and implementation by industry and regulators. It is not intended to provide additional guidance beyond the scope of Q3D. The meeting will take place on the FDA campus at 10903 New Hampshire Ave., Bldg. 31, Rm. 1503B/C, Silver Spring, MD and also be broadcast on the Web. Contact Amanda Roache, (301)-796-4548, email: Amanda.Roache@fda.hhs.gov. To view this notice, click here.

FDA Posts List of OMB-Approved Info Collections
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. These lists include information on MDUFMA Small Business Qualification Certification, Hearing, Aging, and Direct-to-Consumer Television Advertisements, and Electronic Submission of Medical Device Registration and Listing. To view this notice, click here.

Guidance on Electromagnetic Compatibility of Electric Devices
Federal Register Notice of availability: FDA is making available a guidance entitled Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Device. It describes the types of information that should be provided to support a claim of EMC in a premarket submission for an electrically powered medical device. Electromagnetic disturbance is electronic product radiation that may interfere with the performance of an electrically powered medical device in its intended environment (i.e., cause an electromagnetic interference). To download this guidance, click here. To view this notice, click here.

Workshop on Myopia and Future Medical Devices
Federal Register Notice: FDA will co-sponsor a public workshop 9/30 entitled “Controlling the Progression of Myopia: Contact Lenses and Future Medical Devices.” Its purpose is to discuss the increasing prevalence of myopia, as well as suggested clinical trial design attributes for studies using contact lenses or other medical devices to control the progression of myopia. The workshop will be held from 8 a.m. to 6 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 Michelle Tarver (301) 796-6884. To view this notice, click here.

Insomnia Device Goes into Class 2
Federal Register Final order: FDA is classifying the thermal system for insomnia into Class 2 (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the thermal system for insomnia's classification. To view this final order, click here.

Biliary Stent System into Class 2
Federal Register Final order: FDA is classifying the metallic biliary stent system for benign strictures into Class 2 (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the metallic biliary stent system for benign strictures’ classification. To view this final order, click here.

Guidance on Codeveloping IVDs with Therapeutic Products
Federal Register Notice: FDA is making available a draft guidance entitled Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product. It is intended to be a practical guide to assist therapeutic product sponsors and in vitro diagnostic device (IVD) sponsors in developing a therapeutic product with an accompanying IVD companion diagnostic, a process referred to as codevelopment. To download this guidance, click here. To view this notice, click here.

HUMAN DRUGS

Info on PET Drugs GMPs Sent to OMB
Federal Register Notice: FDA’s proposed collection of information, “Current Good Manufacturing Practice for Positron Emission Tomography Drugs,” 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 Compounded Copies of Approved Drugs
Federal Register Notice: FDA is making available a draft guidance for industry entitled Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act. For a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the FD&C Act, it must not be essentially a copy of one or more approved drug products and must meet the other conditions in section 503B. To download this guidance, click here. To view this notice, click here.

Guidance on Compounded Copies of Commercially Available Drugs
Federal Register Notice: FDA is announcing the availability of a draft guidance for industry entitled Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act. To qualify for exemptions under section 503A of the FD&C Act, a drug product must be compounded by a licensed pharmacist or physician who does not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product. To download this guidance, click here. To view this notice, click here.

Guidance on ANDA Labeling After RLD is Withdrawn
Federal Register Notice: FDA is making available a draft guidance for industry entitled Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn. It describes a process for updating labeling for ANDAs in cases where FDA has withdrawn approval of the NDA for the ANDA’s reference listed drug for reasons other than safety or effectiveness. To download this guidance, click here. To view this notice, click here.

Parafon Forte DSC Not Withdrawn for S&E
Federal Register Notice: FDA has determined that Parafon Forte DSC (chlorzoxazone) tablets, 500 mg were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow the agency to continue to approve ANDAs for chlorzoxane tablets, 500 mg, if all other legal and regulatory requirements are met. To view this notice, click  here.

Guidance on Developing Drugs for Bacterial Vaginosis
Federal Register Notice: FDA is making available a draft guidance for industry entitled Bacterial Vaginosis: Developing Drugs for Treatment. Its purpose is to assist sponsors in the clinical development of drugs for treating bacterial vaginosis (BV). It helps define enrollment criteria for BV trials and recommends that such trials be superiority trials. The draft guidance reflects recent developments in scientific information that pertain to drugs being developed for treating BV, including the characterization of the primary efficacy endpoint. To download this guidance, click here. To view this notice, click here.

TOBACCO

Guidance for Tobacco Registration/Product Listing
Federal Register Notice: FDA is making available a revised guidance for industry entitled Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments. It is intended to assist persons making tobacco product establishment registration and product listing submissions to FDA. To download this guidance, clickhere. To view this notice, click here.

Selectors, Nominations Sought for Tobacco Panel
Federal Register Notice: FDA is requesting that any industry organizations interested in participating in selecting a nonvoting industry representative of the tobacco manufacturing industry to serve on the Tobacco Products Scientific Advisory, notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative and an alternate to this representative. Any industry organization interested in participating in the selection process should send a letter to FDA by 8/15 and nomination materials for prospective candidates should also be sent by 8/15. To view this notice, click here.

VETERINARY

FDA Releases Food and Veterinary Strategic Plan
Federal Register Notice: FDA is making available the “Foods and Veterinary Medicine Program’s Strategic Plan for Fiscal Years 2016-2025” that covers activities of the Office of Foods and Veterinary Medicine, the Center for Food Safety and Applied Nutrition, and the Center for Veterinary Medicine as related efforts by the Office of Global Regulatory Operations and Policy and the Office of Regulatory Affairs. The strategic plan includes goals and objectives for the next 10 years including a mission to implement the FDA Food Safety Modernization Act enacted in 2011 and details on goals to protect and enhance the health of people and animals. To view this notice, click here.