[Federal Register Volume 81, Number 148 (Tuesday, August 2, 2016)]
[Notices]
[Pages 50706-50708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18216]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Request for Nominations for Individuals and Consumer 
Organizations for Advisory Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 
[email protected], 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: 
[email protected].
    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
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               Contact person                      Committee/panel
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Bryan Emery, Center for Biologics            Blood Products Advisory
 Evaluation and Research, Food and Drug       Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 71, Rm. 6132, Silver Spring, MD
 20993-0002, phone: 240-402-8054, email:
 [email protected].
Evella Washington, Center for Devices and    Ear, Nose and Throat
 Radiological Health, Food and Drug           Devices Panel.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 66, Rm. 1535, Silver Spring, MD
 20993-0002, phone: 301-796-6683, email:
 [email protected].
Cindy Hong, Center for Drug Evaluation and   Gastrointestinal Drugs
 Research, Food and Drug Administration,      Advisory Committee.
 10903 New Hampshire Ave., Bldg. 31, Rm.
 2430, Silver Spring, MD 20993-0002, phone:
 301-796-0889, email:
 [email protected].
Jennifer Shepherd, Center for Drug           Medical Imaging Advisory
 Evaluation and Research, Food and Drug       Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 31, Rm. 2434, Silver Spring, MD
 20993-0002, phone: 301-796-4043, email:
 [email protected].
Sara Anderson, Center for Devices and        National Mammography
 Radiological Health, Food and Drug           Quality Assurance Advisory
 Administration, 10903 New Hampshire Ave.,    Committee.
 Bldg. 66, Rm. 1643, Silver Spring, MD
 20993-0002, phone: 301-796-0889, email:
 [email protected].

[[Page 50707]]

 
Moon Hee Choi, Center for Drug Evaluation    Peripheral & Central
 and Research, Food and Drug                  Nervous Systems Advisory
 Administration, 10903 New Hampshire Ave.,    Committee.
 Bldg. 31, Rm. 2434, Silver Spring, MD
 20993-0002, phone: 301-796-2894, email:
 [email protected].
Sujata Vijh, Center for Biologics            Vaccine and Related
 Evaluation and Research, Food and Drug       Biologic Products Advisory
 Administration, 10903 New Hampshire Ave.,    Committee.
 Bldg. 71, Rm. 6128, Silver Spring, MD
 20993-0002, phone: 240-4020-7107, email:
 [email protected].
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    Table 2--Committee Descriptions, Type of Consumer Representative
                  Vacancy, and Approximate Date Needed
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    Committee/panel/areas of                           Approximate date
        expertise needed            Type of vacancy         needed
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Blood Products Advisory           1--Voting.........  Immediately.
 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.
Ear, Nose and Throat Devices      1--Nonvoting......  Immediately.
 Panel--Experts in otology,
 neurology, and audiology.
Gastrointestinal Drugs Advisory   1--Voting.........  Immediately.
 Committee--Knowledgeable in the
 fields of gastroenterology,
 endocrinology, surgery,
 clinical pharmacology,
 physiology, pathology, liver
 function, motility,
 esophagitis, and statistics.
Medical Imaging Advisory          1--Voting.........  Immediately.
 Committee--Knowledgeable in the
 fields of nuclear medicine,
 radiology, epidemiology,
 statistics, and related
 specialties.
National Mammography Quality      1--Nonvoting......  January 31, 2017.
 Assurance Advisory Committee--
 Physician, practitioner, or
 other health professional whose
 clinical practice, research
 specialization, or professional
 expertise includes a
 significant focus on
 mammography.
Peripheral and Central Nervous    1--Voting.........  January 31, 2017.
 System Drugs Advisory
 Committee--Knowledgeable in the
 fields of neurology,
 neuropharmacology,
 neuropathology, otolaryngology,
 epidemiology or statistics, and
 related specialties.
Vaccines and Related Biological   1--Voting.........  Immediately.
 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.
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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

[[Page 50708]]

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