Latest Federal Register Notices
BIOLOGICS
CBER Workshop on Developing HCT/Ps
Federal Register Notice: CBER announcing a public workshop 9/8 entitled “Scientific Evidence in Development of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Subject to Premarket Approval.” Its purpose is to identify and discuss scientific considerations and challenges to help inform the development of HCT/Ps subject to premarket approval, including stem cell-based products. The workshop will be held from 8:30 a.m. to 5 p.m. at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room, Silver Spring, MD. Contact Lori Jo Churchyard, (240) 402-7911. To view this notice, click here.
Hearing on HCT/P Draft Guidances
Federal Register Notice: FDA will hold a two-day public hearing 9/12-13 to obtain input on four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The draft guidances are: Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception, Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products, Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations, and Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products.The hearing will be held from 9 a.m. to 5 p.m. on both days, but the 9/13 hearing on may be extended or end early depending on the number of speakers scheduled. Persons (including FDA employees) seeking to view the hearing via a live Webcast are not required to register. The hearing will be held at the National Institutes of Health, 9000 Rockville Pike, Bldg. 10, Masur Auditorium, Bethesda, MD. Contact Lori Jo Churchyard, (240) 402-7911, lori.olsenchurchyard@fda,hhs.gov. To view this notice, click here.
FDA Extends Comments on 4 HCT/P Guidances
Federal Register Notice: FDA is extending the comment period for the draft guidance documents entitled Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Human Cells, Tissues, and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory Considerations; and Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products. To view this notice, click here.
DEVICES
FDA Sends Info on Device Inspections to OMB
Federal Register Notice: FDA’s proposed collection of information, “Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002,” 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 Radiation Biodosimetry Countermeasure Devices
Federal Register Notice: FDA is making available a guidance entitled Radiation Biodosimetry Medical Countermeasure Devices. It has been developed to provide industry and agency staff with recommendations for the types of information that should be submitted to support marketing authorization for radiation biodosimetry medical countermeasure devices. To download this guidance, click here. To view this notice, click here.
EPPG Devices and Pacing System Analyzers into Class 2
Federal Register Final order: FDA is issuing a final order to reclassify external pacemaker pulse generator (EPPG) devices, which are currently preamendments Class 3 devices (regulated under product code DTE), into Class 2 (special controls) and to reclassify pacing system analyzers (PSAs) into Class 2 based on new information and subject to premarket notification. This final order also creates a separate classification regulation for PSAs and places single and dual chamber PSAs, which are currently classified with EPPG devices, and triple chamber PSAs (TCPSAs), which are currently postamendments Class 3 devices, into that new classification regulation. To view this notice, click here.
Comments Sought on Info on Nonsterile Devices
Federal Register Notice: FDA is seeking comments on information collection requirements relating to shipment of nonsterile devices that are to be sterilized elsewhere or are shipped to other establishments for further processing, labeling, or repacking. Comments should be submitted by 6/20. To view this notice, click here.
Guidance on Whole Slide Imaging Devices
Federal Register Notice: FDA is making available a guidance entitled Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices. It provides industry and agency staff with suggestions on how to best characterize the technical aspects that are relevant to whole slide imaging performance for their intended use and determine any possible limitations that might affect their safety and effectiveness. To download this guidance, click here. To view this notice, click here.
Comments Sought on Unapproved Device Exportation
Federal Register Notice: FDA is seeking public comments on reporting requirements for firms that intend to export certain unapproved medical devices. Comments should be submitted by 6/21. To view this notice, click here.
FDA Issues EUA for 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. The authorization was requested by OraSure Technologies and contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. To view this notice, click here.
FDA Issues EUA for Zika Diagnostic
Federal Register Notice: FDA is issuing an Emergency Use Authorization for an in vitro diagnostic device for detecting Zika virus in response to the Zika virus outbreak in the Americas. It contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. To view this notice, click here.
HUMAN DRUGS
Guidance on Hospital/Health System Compounding
Federal Register Notice: FDA is making available a draft guidance for industry entitled Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act. It describes how FDA intends to apply the FD&C Act to drugs compounded by licensed pharmacists or physicians in state-licensed hospital or health system pharmacies. To download this guidance, click here. To view this notice, click here.
Guidance on Definition of Outsourcing Facility
Federal Register Notice: FDA is making available a draft guidance for industry entitled Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act. Section 503B defines an outsourcing facility, in part, as “a facility at one geographic location or address.” FDA has received questions from outsourcing facilities and other stakeholders about the meaning of this term, such as whether multiple suites used for compounding human drugs at a single street address constitute one or multiple facilities, or whether a single location where human drugs are compounded can be subdivided into separate operations compounding under different standards. FDA is issuing this draft guidance to answer these questions. To download this draft guidance, click here. To view this notice, click here.
Guidance on Prescription Requirement for Compounded Drugs
Federal Register Notice: FDA is making available a draft guidance for industry entitled Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act. It describes the agency’s policy on certain prescription requirements for compounding human drug products for identified individual patients under section FDCA 503A. It addresses compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of a prescription for an identified individual patient (anticipatory compounding), and compounding for office use. To download this draft guidance, click here. To view this notice, click here.
Patient-Focused Drug Development Meeting for Neuropathic Pain
Federal Register Notice: FDA will hold a public meeting 6/10 and is making an opportunity for public comment on Patient-Focused Drug Development for neuropathic pain associated with peripheral neuropathies. The public meeting is intended to allow FDA to obtain patient perspectives on the impact of neuropathic pain associated with peripheral neuropathies, patient views on treatment approaches, and decision factors taken into account when selecting a treatment. The meeting will be held from 10 a.m. to 4 p.m. Registration to attend the meeting must be received by 6/3. To view this notice, click here.
Public Meeting to Discuss ICH Meetings in Lisbon
Federal Register Notice: FDA is announcing a regional public meeting entitled “U.S. Food and Drug Administration and Health Canada Joint Public Consultation on International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).” The meeting will take place on the FDA campus and also be broadcast on the Internet. Its goal is to provide information and receive comments on the ICH and the upcoming ICH meetings in Lisbon, Portugal in June. The public meeting will be held 5/6, from 9 a.m. to 12 p.m., EST. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center (Rm. 1503A), Silver Spring, MD. Registration to attend the Webcast and requests for oral presentations must be received by 5/4. Contact Amanda Roache, (301) 796-4548, Amanda.Roache@fda.hhs.gov. To view this notice, click here.
FDA Withdraws Abbvie’s Advicor, Simcor
Federal Register Notice: FDA is withdrawing approval of two AbbVie NDAs for Advicor (niacin extended-release and lovastatin) tablets and Simcor (niacin ER and simvastatin) tablets. The company has requested the withdrawal and has waived its opportunity for a hearing. The agency has also determined that Advicor and Simcor were withdrawn from sale for reasons of safety and effectiveness, and FDA will not accept or approve ANDAs that reference the two drugs. To view this notice, click here.
FDA Withdraws Statin and Niacin ER/Fenobric DR Co-administration
Federal Register Notice: FDA is withdrawing approval of the indications related to the co-administration with a statin for niacin extended-release tablets and fenofibric acid delayed-release capsules. Affected applications include one NDA and seven ANDAs for niacin ER tablets, and one NDA and three ANDAs for fenofibric acid DR capsules. The holders of these applications have requested that FDA withdraw approval of the indications and have waived their opportunities for a hearing. To view this notice, click here.
FDA Reopens Comments on Fixed-Combo/Co-packaged Drugs
Federal Register Proposed rule: FDA is reopening the comment period for the proposed rule, published in the 12/23/15 Federal Register revising its regulations on prescription and nonprescription fixed-combination and co-packaged drugs and on combinations of active ingredients under consideration for inclusion in an over-the-counter monograph. Comments should be submitted by 5/18/16. To view this notice, click here.
Review Period Set for Luzu
Federal Register Notice: FDA has determined the regulatory review period for Nihon Nohyaku Co.’s Luzu is 2,242 days for extending a patent which claims the human drug product. Luzu is indicated for topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Tricophyton rubrum and Epidermophyton floccosum in patients 18 years of age and older. To view this notice, click here.
TOBACCO
FDA Seeks Tobacco Farms for Site Tours
Federal Register Notice: FDA’s Center for Tobacco Products is inviting participants for its voluntary Tobacco Farm Site Tours Program. This program is intended to give staff an opportunity to visit farms that grow tobacco for sale to tobacco product manufacturers in order to gain a better understanding of tobacco farming and the processes involved in curing and preparing tobacco intended for sale to tobacco product manufacturers. It is not an FDA regulatory inspection, and tobacco farms are not regulated entities unless they are also a tobacco product manufacturer or controlled by a tobacco product manufacturer. Those interested should submit either an electronic or written request for participation in this program by 6/17. To view this notice, click here.
VETERINARY
Animal Drug Regs Reflect January, February Actions
Federal Register Final rule: FDA is amending the animal drug regulations to reflect application-related actions for NADAs and ANADAs during January and February. The agency is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications from Bayer to Huvepharma AD and Strategic Veterinary Pharmaceuticals to Phibro Animal Health Corp. that occurred in January and February. To view this notice, click here.
Guidance on Animal Drug Distributor Labeling
Federal Register Notice: FDA is making available guidance for industry entitled Distributor Labeling for New Animal Drugs. It discusses FDA’s current thinking on the factors it considers in determining whether to take regulatory action against distributor labeling for a new animal drug that differs from the labeling approved as part of a new animal drug application or abbreviated new animal drug application in ways other than those permitted by regulation. To download this guidance, click here. To view this notice, click here.
FDA Seeks Info on Animal Generic Drug User Fee Meetings
Federal Register Notice: FDA is requesting that public stakeholders notify the agency of their intent to participate in periodic consultation meetings on reauthorization of the Animal Generic Drug User Fee Act (AGDUFA). The statutory authority for AGDUFA expires 9/30/18. The FD&C Act requires that FDA consult with a range of stakeholders, including patient and consumer advocacy groups, veterinary professionals, and scientific and academic experts, in developing recommendations for the next AGDUFA program, and hold discussions with these stakeholders at least once every four months during FDA’s negotiations with the regulated industry. To view this notice, click here.
FDA Seeks Participants for Animal Drug User Fee Meetings
Federal Register Notice: FDA is issuing this notice to request that public stakeholders notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Animal Drug User Fee Act (ADUFA). The statutory authority for ADUFA expires 9/30/18. To view this notice, click here.
FDA Plans Animal Generic Drug User Fee Meeting
Federal Register Notice: FDA will hold a public meeting 5/16 on the Animal Generic Drug User Fee Act (AGDUFA) from 1 p.m. to 4 p.m. at FDA, 7519 Standish Pl., 3rd floor, Rm. A, Rockville, MD. FDA invites public comment by 5/4 on the AGDUFA program and suggestions on features FDA should propose for the next AGDUFA program. Contact Cassie Ravo, (240) 402-6866. To view this notice, click here.
Meeting on Animal Drug User Fee Act
Federal Register Notice: FDA plans a public meeting 5/16 from 9 a.m. to 12 p.m. at FDA, 7519 Standish Pl., 3rd floor, Rm. A, Rockville, MD on the Animal Drug User Fee Act (ADUFA). FDA invites public comment on the ADUFA program and suggestions on the features FDA should propose for the next ADUFA program. To view this notice, click here.
FDA Corrects Notice on Carbadox in Swine Feed
Federal Register Notice: FDA is correcting a 4/12 Federal Register notice announcing an opportunity for a hearing on the Center for Veterinary Medicine’s proposal to withdraw approval of all new animal drug applications providing for use of carbadox in medicated swine feed. The telephone number and address for Phibro Animal Health were incorrect. On page 21560, in the second column, in the FOR FURTHER INFORMATION CONTACT paragraph, the telephone number is corrected to read “240-402-7001”. On page 21560, in the third column, in the first paragraph, the address for Phibro Animal Health Corp. is corrected to read “GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666”. On page 21572, in the first column, in the third paragraph, the address for Phibro is also corrected. To view this notice, click here.
GENERAL
Guidance on Drug/Biologic Comparability Protocols & CMC Info
Federal Register Notice: FDA is making available a draft guidance for industry entitled Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information. This document is a revised version of a draft guidance that published in 2/2003 entitled “Comparability Protocols: Chemistry, Manufacturing, and Controls Information.” A related draft guidance entitled Comparability Protocols — Protein Drug Products and Biological Products — Chemistry, Manufacturing, and Controls Information, that published in 9/2003 was withdrawn on 5/6/15. The revised draft guidance provides recommendations to human drug and biologics manufacturers on implementing a chemistry, manufacturing, and controls postapproval change(s) through the use of a comparability protocol. To download this guidance, click here. To view this notice, click here.