AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
DATES:
Any consumer organization interested in participating in the selection of an appropriate voting or nonvoting member to represent consumer interests on an FDA advisory committee or panel may send a letter or email stating that interest to FDA (see ADDRESSES) by September 1, 2016, for vacancies listed in this notice. Concurrently, nomination materials for prospective candidates should be sent to FDA (see ADDRESSES) by September 1, 2016. Nominations will be accepted for current vacancies and for those that will or may occur through January 31, 2017.
ADDRESSES:
All statements of interest from consumer organizations interested in participating in the selection process and consumer representative nominations should be submitted electronically to kimberly.hamilton@fda.hhs.gov, by mail to Advisory Committee Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002, or by FAX at: 301-847-8640.
Consumer representative nominations should be submitted electronically by logging into the FDA Advisory Committee Membership Nomination Portal at: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm,, by mail to Advisory Committee Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002, or by FAX at: 301-847-8640. Additional information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA's Web site at: http://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT:
For questions relating to participation in the selection process: Kimberly Hamilton, Advisory Committee Oversight and Management Staff (ACOMS), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002, 301-796-8220, email: kimberly.hamilton@fda.hhs.gov.
For questions relating to specific advisory committees or panels, contact the appropriate Contact Person listed in table 1 in the SUPPLEMENTARY INFORMATION section.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing (see table 1 for Contact Person).
Table 1—Advisory Committee Contacts
| Contact person | Committee/panel |
|---|---|
| Bryan Emery, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6132, Silver Spring, MD 20993-0002, phone: 240-402-8054, email: Bryan.Emery@fda.hhs.gov | Blood Products Advisory Committee. |
| Evella Washington, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1535, Silver Spring, MD 20993-0002, phone: 301-796-6683, email: Evella.Washington@fda.hhs.gov | Ear, Nose and Throat Devices Panel. |
| Cindy Hong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2430, Silver Spring, MD 20993-0002, phone: 301-796-0889, email: Cindy.Hong@fda.hhs.gov | Gastrointestinal Drugs Advisory Committee. |
| Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2434, Silver Spring, MD 20993-0002, phone: 301-796-4043, email: Jennifer.Shepherd@fda.hhs.gov | Medical Imaging Advisory Committee. |
| Sara Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1643, Silver Spring, MD 20993-0002, phone: 301-796-0889, email: Sara.Anderson@fda.hhs.gov | National Mammography Quality Assurance Advisory Committee. |
| Moon Hee Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2434, Silver Spring, MD 20993-0002, phone: 301-796-2894, email: MoonHee.Choi@fda.hhs.gov | Peripheral & Central Nervous Systems Advisory Committee. |
| Sujata Vijh, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6128, Silver Spring, MD 20993-0002, phone: 240-4020-7107, email: Sujata.Vijh@fda.hhs.gov | Vaccine and Related Biologic Products Advisory Committee. |
Table 2—Committee Descriptions, Type of Consumer Representative Vacancy, and Approximate Date Needed
| Committee/panel/areas of expertise needed | Type of vacancy | Approximate date needed |
|---|---|---|
| Blood Products Advisory Committee—Knowledgeable in the fields of clinical and administrative medicine, hematology, immunology, blood banking, surgery, internal medicine, biochemistry, engineering, biological and physical sciences, biotechnology, computer technology, statistics, epidemiology, sociology/ethics, and other related professions | 1—Voting | Immediately. |
| Ear, Nose and Throat Devices Panel—Experts in otology, neurology, and audiology | 1—Nonvoting | Immediately. |
| Gastrointestinal Drugs Advisory Committee—Knowledgeable in the fields of gastroenterology, endocrinology, surgery, clinical pharmacology, physiology, pathology, liver function, motility, esophagitis, and statistics | 1—Voting | Immediately. |
| Medical Imaging Advisory Committee—Knowledgeable in the fields of nuclear medicine, radiology, epidemiology, statistics, and related specialties | 1—Voting | Immediately. |
| National Mammography Quality Assurance Advisory Committee—Physician, practitioner, or other health professional whose clinical practice, research specialization, or professional expertise includes a significant focus on mammography | 1—Nonvoting | January 31, 2017. |
| Peripheral and Central Nervous System Drugs Advisory Committee—Knowledgeable in the fields of neurology, neuropharmacology, neuropathology, otolaryngology, epidemiology or statistics, and related specialties | 1—Voting | January 31, 2017. |
| Vaccines and Related Biological Products Advisory Committee—Knowledgeable in the fields of immunology, molecular biology, rDNA, virology, bacteriology, epidemiology or biostatistics, allergy, preventive medicine, infectious diseases, pediatrics, microbiology, and biochemistry | 1—Voting | Immediately. |
II. Functions and General Description of the Committee Duties
A. Blood Products Advisory 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 as well as the safety, effectiveness, and labeling of the products, on clinical and laboratory studies involving such products, on the affirmation or revocation of biological product licenses, and on the quality and relevance of FDA's research program which provides the scientific support for regulating these products.
B. Certain Panels of the Medical Devices Advisory Committee
Reviews and evaluates data on the safety and effectiveness of marketed and investigational devices and makes 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; (2) advises on any possible risks to health associated with the use of devices; (3) advises on formulation of product development protocols; (4) reviews premarket approval applications for medical devices; (5) reviews guidelines and guidance documents; (6) recommends exemption of certain devices from the application of portions of the Federal Food, Drug, and Cosmetic Act; (7) advises on the necessity to ban a device; and (8) 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 of Food and Drugs (the Commissioner) on issues relating to the design of clinical studies regarding the safety and effectiveness of marketed and investigational devices.
The Dental Products Panel also functions at times as a dental drug panel. The functions of the dental drug panel are to evaluate and recommend whether various prescription drug products should be changed to over-the-counter status and to evaluate data and make recommendations concerning the approval of new dental drug products for human use.
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.
C. Gastrointestinal Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of gastrointestinal diseases.
D. Medical Imaging Advisory Committee
Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in diagnostic and therapeutic procedures using radioactive pharmaceuticals and contrast media used in diagnostic radiology.
E. National Mammography Quality Assurance Advisory Committee
Advises the Agency on the following: (1) Development of appropriate quality standards and regulations for mammography facilities; (2) standards and regulations for bodies accrediting mammography facilities under this program; regulations with respect to sanctions; (3) procedures for monitoring compliance with standards; (4) establishing a mechanism to investigate consumer complaints; (5) reporting new developments concerning breast imaging which should be considered in the oversight of mammography facilities; (6) determining whether there exists a shortage of mammography facilities in rural and health professional shortage areas and determining the effects of personnel on access to the services of such facilities in such areas; (7) determining whether there will exist a sufficient number of medical physicists after October 1, 1999; and (8) determining the costs and benefits of compliance with these requirements.
F. Peripheral and Central Nervous System Advisory 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.
G. Vaccines and Related Biological Products Advisory Committee
Reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, as well as considers the quality and relevance of FDA's research program which provides scientific support for the regulation of these products.
III. Criteria for Members
Persons nominated for membership as consumer representatives on committees or panels should meet the following criteria: (1) Demonstrate ties to consumer and community-based organizations, (2) be able to analyze technical data, (3) understand research design, (4) discuss 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.
IV. 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 interests should send a letter stating that interest to FDA (see ADDRESSES) within 30 days of publication of this document.
Within the subsequent 30 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 resume. 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.
V. 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 should include a cover letter and current curriculum vitae or resume for each nominee, including a current business and/or home address, telephone number, and email address if available, and a list of consumer or community-based organizations for which the candidate can demonstrate active participation.
Nominations should also specify the advisory committee(s) or panel(s) for which the nominee is recommended. In addition, nominations should include confirmation 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 up to 4 years.
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. Upon 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. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: July 27, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-18216 Filed 8-1-16; 8:45 am]
BILLING CODE 4164-01-P