SUPPLEMENTARY INFORMATION:

FDA is requesting nominations for voting and/or nonvoting consumer representatives for the vacancies listed in the table below:

I. Functions and General Description of the Committee Duties

A. FDA Science Board Advisory Committee

The Committee reviews and evaluates data concerning specific complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Committee will provide advice that supports the Agency in keeping pace with technical and scientific developments, including regulatory science; and input into the Agency's research agenda; and on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agency-sponsored intramural and extramural scientific research programs.

B. Pediatrics Advisory Committee

The Committee reviews, evaluates, and makes recommendations to the Commissioner of Food and Drugs (the Commissioner) regarding (1) pediatric research conducted under sections 351, 409I, and 499 of the Public Health Service Act (42 U.S.C. 262, 284m, and 290b) and sections 501,502, 505, 505A, 505B, 510(k), 515, and 520(m) of the Federal Food, Drug, and Cosmetic Act ( printed page 62525) (FD&C Act) (21 U.S.C. 351, 352, 355, 355a, 355c, 360(k), 360e, and 360j(m)); (2) identification of research priorities related to pediatric therapeutics (including drugs and biological products) and medical devices for pediatric populations and the need for additional diagnostics and treatments of specific pediatric diseases or conditions; (3) the ethics, design, and analysis of clinical trials related to pediatric therapeutics (including drugs and biological products) and medical devices; (4) pediatric labeling disputes as specified in Public Law 107-109, Public Law 110-85, and Public Law 112-144; (5) pediatric labeling changes as specified in Public Law 107-109, Public Law 110-85, and Public Law 112-144; (6) adverse event reports for drugs studied under Public Law 107-109, Public Law 110-85, and Public Law 112-144; (7) any safety issues that may occur as specified in Public Law 107-109, Public Law 110-85, and Public Law 112-144; (8) any other pediatric issue or pediatric labeling dispute involving FDA-regulated products; (9) pediatric ethical issues including research involving children as subjects as specified in 21 CFR 50.54; (10) advise and make recommendations to the Secretary of Health and Human Services (the Secretary) (HHS) on the development of countermeasures for pediatric populations in H.R. 307, Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5); and (11) any other matter involving pediatrics for which FDA has regulatory responsibility.

The Committee also advises and makes recommendations to the Secretary directly or to the Secretary through the Commissioner on research involving children as subjects that is conducted or supported by HHS as specified in 45 CFR 46.407.

C. Blood Products Advisory Committee

The Committee reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of blood, products derived from blood and serum or biotechnology which are intended for use in the diagnosis, prevention, or treatment of human diseases, and as required, any other products for which FDA has regulatory responsibility. The Committee also advises the Commissioner of its findings regarding screening and testing (to determine eligibility) of donors and labeling of the products, on clinical and laboratory studies involving such products, on the affirmation or revocation of biological products licenses. The Committee may consider the quality and relevance of FDA's research program, which provides scientific support for the regulation of these products, and makes appropriate recommendations to the Commissioner.

The Committee will function at times as a medical device panel under the Federal Food, Drug, and Cosmetic Act Medical Device Amendments of 1976. As such, the Committee recommends classification of devices subject to its review into regulatory categories; recommends the assignment of a priority for the application of regulatory requirements for devices classified in the standards or premarket approval category; advises on formulation of product development protocols and reviews premarket approval applications for those devices to recommend changes in classification as appropriate; recommends exemption of certain devices from the application of portions of the Act; advises on the necessity to ban a device; and responds to requests from the Agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices.

D. Cellular, Tissue and Gene Therapies

The Committee reviews and evaluates available data relating to the safety, effectiveness, and appropriate use of human cells, human tissues, gene therapies, and xenotransplantation products which are intended for transplantation, implantation, infusion, and transfer in the prevention and treatment of a broad spectrum of human diseases and in the reconstruction, repair, or replacement of tissues for various conditions. The Committee also considers the quality and relevance of FDA's research program, which provides scientific support for the regulation of these products, and makes appropriate recommendations to the Commissioner.

E. Vaccines and Related Biological Products

The Committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines, allergenics, and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and as required, any other products for which FDA has regulatory responsibility. The Committee may consider the quality and relevance of FDA's research program, which provides scientific support for the regulation of these products, and makes appropriate recommendations to the Commissioner.

F. Anesthetic and Analgesic Drug Products Advisory Committee

The Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products including analgesics, e.g., abuse-deterrent opioids, novel analgesics, and issues related to opioid abuse, and those for use in anesthesiology and makes appropriate recommendations to the Commissioner.

G. Antimicrobial Drugs Advisory Committee

The Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of infectious diseases and disorders and makes appropriate recommendations to the Commissioner.

H. Cardiovascular and Renal Drugs Advisory Committee

The Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cardiovascular and kidney diseases and makes appropriate recommendations to the Commissioner.

I. Dermatologic and Ophthalmic Drugs Advisory Committee

The Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of dermatologic and ophthalmic disorders and makes appropriate recommendations to the Commissioner.

J. Drug Safety and Risk Management Advisory Committee

The Committee reviews and evaluates information on risk management, risk communication, and quantitative evaluation of spontaneous reports for drugs for human use and for any other product for which FDA has regulatory responsibility. The Committee also advises the Commissioner regarding the scientific and medical evaluation of information gathered by HHS and the Department of Justice with regard to safety, efficacy, and abuse potential of drugs or other substances, and makes recommendations as appropriate to be taken by HHS with regard to the marketing, investigation, and control of such drugs or other substances. The Committee may consider the quality and relevance of FDA's research program, which provides scientific support for the regulation of these products, and ( printed page 62526) makes appropriate recommendations to the Commissioner.

K. Endocrinologic and Metabolic Drugs Advisory Committee

The Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of endocrine and metabolic disorders and makes appropriate recommendations to the Commissioner.

L. Genetic Metabolic Disease Advisory Committee

The Committee reviews and evaluates data on the safety and effectiveness of marketed and investigational human drug and biologic products for use in the treatment of genetic metabolic diseases and makes appropriate recommendations to the Commissioner. The Committee may consider the quality and relevance of FDA's research program, which provides scientific support for the regulation of these products, and makes appropriate recommendations to the Commissioner.

M. Nonprescription Drugs Advisory Committee

The Committee reviews and evaluates available data concerning the safety and effectiveness of over-the-counter (nonprescription) human drug products, or any other FDA-regulated product, for use in the treatment of broad spectrum of human symptoms and diseases and advises the Commissioner either on promulgation of monographs establishing conditions under which these drugs are generally recognized as safe and effective and not misbranded or on the approval of new drug applications for such drugs. The Committee serves as a forum for the exchange of views regarding the prescription and nonprescription status, including switches from one status to another, of these various drug products and combinations thereof. The Committee may also conduct peer review of Agency sponsored intramural and extramural scientific biomedical programs in support of FDA's mission and regulatory responsibilities.

N. Obstetrics, Reproductive and Urologic Products Advisory Committee

The Committee reviews and evaluates data on the safety and effectiveness of marketed and investigational human drug products for use in the practice of obstetrics, gynecology, urology and related specialties, and makes appropriate recommendations to the Commissioner. The Committee may consider the quality and relevance of FDA's research program, which provides scientific support for the regulation of these products and makes appropriate recommendations to the Commissioner.

O. Oncologic Drugs Advisory Committee

The Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes appropriate recommendations to the Commissioner.

P. Peripheral and Central Nervous Systems Drugs Advisory Committee

The Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of neurologic diseases and makes appropriate recommendations to the Commissioner.

Q. Pharmacy Compounding Advisory Committee

The Committee reviews and evaluates scientific, technical, and medical issues concerning drug compounding under sections 503A and 503B of the FD&C Act (21 U.S.C. 353a and 353b) and, as required, any other product for which FDA has regulatory responsibility, and makes appropriate recommendations to the Commissioner. The Committee may consider the quality and relevance of FDA's research program, which provides scientific support for the regulation of these products and makes appropriate recommendations to the Commissioner.

R. Psychopharmacologic Drugs Advisory Committee

The Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the practice of psychiatry and related specialties. The Committee may consider the quality and relevance of FDA's research program, which provides scientific support for the regulation of these products, and makes appropriate recommendations to the Commissioner.

S. Pulmonary-Allergy Drugs Advisory Committee

The Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of pulmonary disease and diseases with allergic and/or immunologic mechanisms. The Committee may consider the quality and relevance of FDA's research program, which provides scientific support for the regulation of these products, and makes appropriate recommendations to the Commissioner.

T. Medical Devices Advisory Committee Panels

The Medical Devices Advisory Committee has established certain panels to review and evaluate data on the safety and effectiveness of marketed and investigational devices and make recommendations for their regulation. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area: (1) advises on the classification or reclassification of devices into one of three regulatory categories and advises on any possible risks to health associated with the use of devices; (2) advises on formulation of product development protocols; (3) reviews premarket approval applications for medical devices; (4) reviews guidelines and guidance documents; (5) recommends exemption of certain devices from the application of portions of the FD&C Act; (6) advises on the necessity to ban a device; and (7) responds to requests from the Agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, may also make appropriate recommendations to the Commissioner on issues relating to the design of clinical studies regarding the safety and effectiveness of marketed and investigational devices.

The Medical Devices Dispute Resolution Panel provides advice to the Commissioner on complex or contested scientific issues between FDA and medical device sponsors, applicants, or manufacturers relating to specific products, marketing applications, regulatory decisions and actions by FDA, and Agency guidance and policies. The Panel makes recommendations on issues that are lacking resolution, are highly complex in nature, or result from challenges to regular advisory panel proceedings or Agency decisions or actions.

II. Criteria for Members

Persons nominated for membership as consumer representatives on committees or panels should meet the following criteria: (1) demonstrate an affiliation with and/or active participation in consumer or community-based organizations, (2) be able to analyze technical data, (3) understand research design, (4) discuss ( printed page 62527) benefits and risks, and (5) evaluate the safety and efficacy of products under review. The consumer representative should be able to represent the consumer perspective on issues and actions before the advisory committee; serve as a liaison between the committee and interested consumers, associations, coalitions, and consumer organizations; and facilitate dialogue with the advisory committees on scientific issues that affect consumers.

III. Selection Procedures

Selection of members representing consumer interests is conducted through procedures that include the use of organizations representing the public interest and public advocacy groups. These organizations recommend nominees for the Agency's selection. Representatives from the consumer health branches of Federal, State, and local governments also may participate in the selection process. Any consumer organization interested in participating in the selection of an appropriate voting or nonvoting member to represent consumer interest should send a letter stating that interest to FDA (see ADDRESSES ) within 30 days of publication of this document.

Within the subsequent 45 days, FDA will compile a list of consumer organizations that will participate in the selection process and will forward to each such organization a ballot listing at least two qualified nominees selected by the Agency based on the nominations received, together with each nominee's current curriculum vitae or résumé. Ballots are to be filled out and returned to FDA within 30 days. The nominee receiving the highest number of votes ordinarily will be selected to serve as the member representing consumer interests for that particular advisory committee or panel.

IV. Nomination Procedures

Any interested person or organization may nominate one or more qualified persons to represent consumer interests on the Agency's advisory committees or panels. Self-nominations are also accepted. Nominations must include a current, complete résumé or curriculum vitae for each nominee and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Nomination Portal (see ADDRESSES ), and a list of consumer or community-based organizations for which the candidate can demonstrate active participation.

Nominations must also specify the advisory committee(s) or panel(s) for which the nominee is recommended. In addition, nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will ask potential candidates to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflicts of interest. Members will be invited to serve for terms of up to 4 years, or for less time at the discretion of the Commissioner or designee.

FDA will review all nominations received within the specified timeframes and prepare a ballot containing the names of qualified nominees. Names not selected will remain on a list of eligible nominees and be reviewed periodically by FDA to determine continued interest. After selecting qualified nominees for the ballot, FDA will provide those consumer organizations that are participating in the selection process with the opportunity to vote on the listed nominees. Only organizations vote in the selection process. Persons who nominate themselves to serve as voting or nonvoting consumer representatives will not participate in the selection process.

This notice is issued under the Federal Advisory Committee Act (5 U.S.C. 1001 et seq.) and 21 CFR part 14, relating to advisory committees.

91 FR 62522