Latest Federal Register Notices

BIOLOGICS

Panel to Discuss Dynavax Hepatitis B Vaccine
Federal Register Notice: FDA will hold a meeting of the Vaccines and Related Biological Products Advisory Committee11/16, from 8:30 a.m. to 2:30 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 Sujata Vijh or Rosanna Harvey, (240) 402-7107, sujata.vijh@fda.hhs.gov and (240) 402-8072, rosanna.harvey@fda.hhs.gov. The committee will meet in open session to discuss and make recommendations on the safety and efficacy of a hepatitis B vaccine manufactured by Dynavax. To view this notice, click here.

Guidance on Reducing Zika Transmission by Blood/Blood Components
Federal Register Notice: FDA is making available a guidance, Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry. The document is notifying blood establishments that collect whole blood and blood components, that FDA has determined Zika virus (ZIKV) to be a relevant transfusion-transmitted infection and provides the agency’s assessment and recommendations to reduce the risk of transmission. It applies to the collection of whole blood and blood components and not the collection of source plasma. The guidance supersedes the February document entitled, Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus: Guidance for Industry and the March document entitled, Questions and Answers Regarding ‘Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus: Guidance for Industry’ no later than 12 weeks after the date of the issuance of this guidance. To download the revised guidance, click here. To view this notice, click here.

FDA Plans Workshop on Immunization Monitoring
Federal Register Notice: FDA will hold a workshop 12/7 entitled “The Sentinel Post-Licensure Rapid Immunization Safety Monitoring (PRISM) Program.” Its purpose is to describe the Sentinel Initiative and PRISM program, illustrate how PRISM is used by FDA for regulatory responsibilities (including how it has been integrated into FDA’s regulatory review process and case examples), and discuss the future direction of PRISM in terms of expansion and further integration into the regulatory review process. The workshop will be held from 8:30 a.m. to 5 p.m. at the National Institutes of Health, 8600 Rockville Pike, Lister Hill Center Auditorium, Building 38A, Bethesda, MD. Contact Chris Nguyen or Cynthia Whitmarsh, email: CBERPublicEvents@fda.hhs.gov (Subject Line: Sentinel PRISM Workshop). To view this notice, click here.

DEVICES

Guidance on Enforcement of NHRIC/NDC Device Codes
Federal Register Notice: FDA is making available a guidance entitled, Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices. It describes the agency’s intent to refrain from enforcing the prohibition against providing National Health Related Item Code or National Drug Code numbers on device labels and device packages, with respect to finished devices that are manufactured and labeled prior to 9/24/21. Also, the guidance describes FDA’s intent to continue considering requests for continued use of FDA labeler codes under a system for the issuance of unique device identifiers that are submitted before 9/24/21. To download this guidance, click here. To view this notice, click here.

Microbiology Devices Panel to Meet
Federal Register Notice: FDA will hold a meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee 10/5. During session I, the panel will discuss reclassification of quantitative Cytomegalovirus viral load devices from Class 3 to Class 2. During session II, the topics to be addressed include appropriate initial classification for qualitative or quantitative viral load devices for Epstein-Barr virus, BK virus, JC virus, Human Herpesvirus 6, and Adenovirus infections. FDA is seeking expert recommendations to assess the potential risks and benefits of these devices when used in patients following solid-organ or stem cell transplantation. The meeting will be held from 8 a.m. to 6 p.m. at Gaithersburg Holiday Inn, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD. Contact Aden Asefa, aden.asefa@fda.hhs.gov, (301) 796-0400. To view this notice, click here.

HUMAN DRUGS

Guidance on BE Recommendations for Risperidone
Federal Register Notice: FDA is making available a revised draft guidance for industry on generic risperidone injection, entitled Bioequivalence Recommendations for Risperidone. It provides specific guidance on the design of bioequivalence studies to support ANDAs for risperidone injection. To download this guidance, click here. To view this notice, click here.

Panel to Discuss 2 NDAs for Pneumonia
Federal Register Notice: FDA will hold a meeting of the Antimicrobial Drugs Advisory Committee 11/4, from 8:30 a.m. to 5 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will discuss Cempra Pharmaceutical NDAs for solithromycin capsules and solithromycin for injection for treating community-acquired bacterial pneumonia. Contact Lauren D. Tesh, (301) 796-9001. To view this notice, click here.

FDA Renews Cardiovascular and Renal Drugs Advisory Panel
Federal Register Notice: The FDA commissioner is renewing the Cardiovascular and Renal Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 8/27/18. To view this notice, click here.

FDA Renews Endocrinologic and Metabolic Panel
Federal Register Notice: The FDA commissioner renews the charter of the Endocrinologic and Metabolic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 8/27/18. To view this notice, click here.

TOBACCO

Guidance on Cigar Warning Plans
Federal Register Notice: FDA is making available a draft guidance, Submission of Warning Plans for Cigars. When finalized, it will help those involved in the manufacture, distribution, and sale of cigars in the U.S. understand the new cigar warning plan requirements under FDA’s final rule deeming these products to be subject to the tobacco product authorities in the FD&C Act. The draft guidance reiterates the required health warning statements and the requirements for random display and distribution that should be provided in cigar warning plans, and, when finalized, will help persons determine who should submit a warning plan, when a plan must be submitted, and what information should be included when submitting a plan. To download this guidance, click here. To view this notice, click here.

VETERINARY

FDA Amends Animal Drug Regs to Post May/June Approvals
Federal Register Final rule: FDA is amending the animal drug regulations to reflect application-related actions for NADAs and ANADAs during May and June including Elanco Animal Health’s Inteprity, Aratana Therapeutics’ Entyce, Elanco U.S.’s Onsior tablets for dogs, and Med-Pharmex’ Mometavet,. 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, changes of sponsors’ names and addresses, and the voluntary withdrawals of approval of applications. To view this final rule, click here.

FDA Withdraws 8 Elanco NADAs
Federal Register Notification of withdrawal: FDA is withdrawing approval of eight new animal drug applications at the sponsor’s request because these products are no longer manufactured or marketed. Elanco Animal Health has requested that FDA withdraw approval of the NADAs such as Tylosin/Hygromix, Tylan TM Type A medicated article, Tylan/Hygromix, and Tylan TM/Bio-Cox. To view this notice, click here.

GENERAL

FDA Plans Small Business Device/Drug Education Conference
Federal Register Notice: CDER and CDRH are sponsoring a two day conference entitled “FDA Small Business and Industry Assistance Regulatory Education for Industry (REdI) Fall Conference.” Its goal is to provide direct, relevant, and helpful information on the key aspects of drug and device regulations. The primary audience is that of small manufacturers of drug and/or device medical products who want to learn about how FDA approaches the regulation of drugs and devices, but anyone involved in the pharmaceutical and/device industry may attend. The conference will be held 9/27-28, from 8:15 a.m. to 4:15 p.m. The conference will be held at the Sheraton Silver Spring Hotel, 8777 Georgia Ave., Cypress and Magnolia Ballrooms (4th floor), Silver Spring, MD. Contact Brenda Stodart, (301) 796-6707, cdersbia@fda.hhs.gov; or Elias Mallis, (301) 796-7100, DICE@fda.hhs.gov. To view this notice, click here.

FDA Amends Drug Registration/Listing Regulations
Federal Register Final rule: FDA is amending its regulations governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule requires electronic submission, unless waived in certain circumstances, of registration and listing information. This rulemaking pertains to finished drug products and to active pharmaceutical ingredients alone or together with one or more other ingredients. This rule is effective on 11/29. To view this notice, click here.

Hearing on Communications on Unapproved Uses
Federal Register Notice: FDA will hold a public hearing 11/9-10 to obtain input on issues related to communications by manufacturers, packers, and distributors, including their representatives for FDA-regulated drugs and medical devices for humans, including those that are licensed as biological products, and animal drugs. FDA is engaged in a comprehensive review of its regulations and policies governing firms’ communications about unapproved uses of approved/cleared medical products, and the input from this meeting will inform agency policy development in this area. The hearing will be held from 9 a.m. to 5 p.m. and may be extended or end early depending on the level of public participation. It will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. To view this notice, click here.