Latest Federal Register Notices

DEVICES

FDA Corrects Notice on FY ’16 CDRH Guidances
Federal Register Notice: FDA is correcting a notice entitled “Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2016 Proposed Guidance Development,” that appeared in the 12/29/15 Federal Register. It announced the Web site location where the agency will post two lists of guidance documents that CDRH intends to publish in fiscal year 2016. The document was published with the incorrect number of years in which CDRH committed to finalize, withdraw, re-open the comment period, or issue another draft guidance on the topic for 80% of the documents. On page 81336, in the third column, in the 13th sentence of the second paragraph under section II. CDRH Guidance Development Initiative, “2 years” is corrected to read “3 years.” To view this notice, click here.
 

Workshop on Next-Generation Sequencing-Based Tests
Federal Register Notice: FDA will hold a public workshop 9/23 entitled “Adapting Regulatory Oversight of Next Generation Sequencing-Based Tests” to obtain feedback on two FDA draft guidances, Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases and Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics that describes new approaches to regulate NGS-based tests. The workshop will be held from 9 a.m. to 3 p.m. in Masur Auditorium at the NIH Campus, 9000 Rockville Pike, Bldg. 10, Bethesda, MD. Contact David Litwack, 301-796-6206, ernest.litwack@fda.hhs.gov. To view this notice, click here.
 

Guidance on Device Patient Preference Info
Federal Register Notice: FDA is making available a guidance entitled Patient Preference Information — Voluntary Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling. This document explains the principal concepts that sponsors and other stakeholders should consider when choosing to collect patient preference information, which may inform FDA’s benefit-risk determinations in the premarket review of PMAs, HDE applications, and de novo classification requests. It also discusses FDA’s inclusion of patient preference information in its decision summaries and provides recommendations for including such information in device labeling for certain devices. FDA is also issuing a Level 2 updated version of the guidance document entitled Factors To Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications, originally issued on 3/28/12, that has been edited to be consistent with this guidance document. To download this guidance, click here. To view this notice, click here.

HUMAN DRUGS

Guidance on Fidaxomicin Bioequivalence Studies
Federal Register Notice: FDA is making available a draft guidance for industry entitled Draft Guidance on Fidaxomicin. The recommendations provide specific guidance on the design of bioequivalence studies to support ANDAs for fidaxomicin tablets. To download this guidance, click here. To view this notice, click here.

Guidance on Refuse to Receive ANDAs for Lack of Impurity Info
Federal Register Notice: FDA is making available a guidance for industry entitled Abbreviated New Drug Application Submissions — Refuse to Receive for Lack of Justification of Impurity Limits. It is intended to assist applicants preparing to submit to FDA ANDAs and prior approval supplements for which the applicant is seeking approval of a new strength of the drug product. The guidance highlights deficiencies about impurity information that may cause FDA to refuse to receive an ANDA. To download this guidance, click here. To view this notice, click here.

Guidance on Systemic Antibacterial Drugs Data
Federal Register Notice: FDA is making available a guidance for industry entitled Microbiology Data for Systemic Antibacterial Drugs — Development, Analysis, and Presentation. Its purpose is to assist sponsors in the development, analysis, and presentation of microbiology data during antibacterial drug development. This guidance finalizes the draft guidance of the same name issued on 9/17/09. To download this guidance, click here. To view this notice, click here.

VETERINARY

Comments Sought on Minor Use/Species Animal Drugs
Federal Register Notice: FDA is seeking comment on a proposed collection of information entitled: “Reporting Associated With Designated New Animal Drugs for Minor Use and Minor Species; 21 CFR Part 516.” Comments should be submitted by 10/21. To view this notice, click here.

FDA Proposes to Expand Animal Drug Investigator Ineligibility
Federal Register Proposed rule: FDA is proposing to amend the regulations for new animal drugs for investigational use to expand the scope of clinical investigator disqualification to include ineligibility to conduct nonclinical laboratory studies. Currently, when the FDA commissioner determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also is ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. Under this proposal, the investigator also will be ineligible to conduct any nonclinical study intended to support an application for a research or marketing permit for a new animal drug. To view this proposed rule, click here.

FDA to Revise Categories for Animal Drugs in Feed
Federal Register Proposed rule/direct final rule: FDA proposes to amend the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. The proposed revision will preserve the availability of medicated feeds intended for therapeutic use in minor animal species and prevent a significant disincentive for future development of additional minor species therapies. To view this notice, click here.

Guidance on Food for Animals CGMPs
Federal Register Notice: FDA is making available a draft guidance for industry entitled Current Good Manufacturing Practice Requirements for Food for Animals. The document helps domestic and foreign facilities that are required to register as food facilities under the FD&C Act determine whether and how they need to comply with the current good manufacturing practice requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule. To download this guidance, click here. To view this notice, click here.

Guidance on Human Food By-products Used for Animal Food
Federal Register Notice: FDA is making available a draft guidance for industry entitled Human Food By-Products For Use As Animal Food. It helps domestic and foreign facilities that are required to register as food facilities under the FD&C Act, because they manufacture, process, pack, or hold human food for consumption in the U.S., determine what requirements to follow for their human food by-products for use as animal food and provides examples and recommendations for how to meet those requirements. To download this guidance, click here. To view this notice, click here.

GENERAL

FDA Amends Mammography Meeting Notice
Federal Register Notice: FDA is amending the 8/5 notice of meeting of the National Mammography Quality Assurance Advisory Committee to reflect a change in the ADDRESSES portion of the document. On page 51919, in the first column, it is changed to read as follows: Gaithersburg Holiday Inn Grand Ballroom, 2 Montgomery Village Ave., Gaithersburg, MD 20878. The hotel’s telephone number is 301-948-8900. To view this notice, click here.

FDA Proposes Quality System Approach to Nonclinical Lab Studies
Federal Register Proposed rule: FDA is proposing to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach, referred to as a GLP Quality System, when safety and toxicity studies support or are intended to support applications or submissions for products regulated by FDA. FDA is proposing additional management responsibilities and standard operating procedures consistent with the proposed requirement for a GLP Quality System. The agency also proposes to revise the testing facility definition to reflect current practices for the conduct of nonclinical laboratory studies, particularly multi-site studies. To view this proposed rule, click here.

Comments Sought on Import Trade Communication
Federal Register Notice: FDA is seeking public comment on the collection of information required to implement user account management function in FDA’s Import Trade Auxiliary Communication System (ITACS). Secure user accounts will allow import trade users to receive Notices of FDA Action and requests for specific information via email or via download within ITACS. Comments should be submitted by 10/25. To view this notice, click here.