[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27497-27501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12352]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-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 July 
17, 2017, for vacancies listed in this notice. Concurrently, nomination 
materials for prospective candidates should be sent to FDA (see 
ADDRESSES) by July 17, 2017. Nominations will be accepted for current 
vacancies and for those that will or may occur through November 30, 
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: 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: 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

[[Page 27498]]

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.

                  Table 1--Advisory Committee Contacts
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                Contact person                      Committee/panel
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Lauren Tesh, Center for Drug Evaluation and    Antimicrobial Advisory
 Research, Food and Drug Administration,        Committee.
 10903 New Hampshire Ave., Bldg. 31, Rm.
 2426, Silver Spring, MD 20993-0002, phone:
 301-796-2721, email:
 [email protected]..
Patricio Garcia, Center for Devices and        Clinical Chemistry and
 Radiological Health, Food and Drug             Clinical Toxicology
 Administration, 10903 New Hampshire Ave.,      Devices Panel.
 Bldg. 66, Rm. G610, Silver Spring, MD 20993-
 0002, phone: 301-796-6875, 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.,      Immunology Devices
 Bldg. 66, Rm. 1535, Silver Spring, MD 20993-   Panel.
 0002, phone: 301-796-6683, email:
 [email protected]..
Pamela Scott, Center for Devices and           Medical Devices Dispute
 Radiological Health, Food and Drug             Resolution.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 66, Rm. 5572, Silver Spring, MD 20993-
 0002, phone: 301-796-5433, email:
 [email protected]..
Aden Asefa, Center for Devices and             Neurological Devices
 Radiological Health, Food and Drug             Panel.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 66, Rm. 2648, Silver Spring, MD 20993-
 0002, phone: 301-796-0400, email:
 [email protected]..
LaToya Bonner, Center for Drug Evaluation and  Endocrinologic and
 Research, Food and Drug Administration,        Metabolic Drugs Advisory
 10903 New Hampshire Ave., Bldg. 31, Rm.        Committee.
 2428, Silver Spring, MD 20993-0002, phone:
 301-796-2855, email:
 [email protected]..
Karen Strambler, Center for Food Safety and    Foods Advisory Committee.
 Nutrition, Food and Drug Administration, FDA
 College Park, CPK1, Rm. 1C008, College Park,
 MD 20740, phone: 240-402-2589, 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.        Pulmonary-Allergy Drugs
 2430, Silver Spring, MD 20993-0002, phone:     Advisory Committee.
 301-796-0889, email: [email protected]..
Jennifer Shepherd, Center for Drug Evaluation  Medical Imaging Advisory
 and Research, Food and Drug Administration,    Committee,
 10903 New Hampshire Ave., Bldg. 31, Rm.        Pharmaceutical Science
 2434, Silver Spring, MD 20993-0002, phone:     and Clinical
 301-796-4043, email:                           Pharmacology.
 [email protected]..
Sara Anderson, Center for Devices and          National Mammography
 Radiological Health, Food and Drug             Quality Assurance
 Administration, 10903 New Hampshire Ave.,      Advisory Committee.
 Bldg. 66, Rm. 1643, Silver Spring, MD 20993-
 0002, phone: 301-796-0889, email:
 [email protected]..
Moon Hee Choi, Center for Drug Evaluation and  Non-Prescription Drugs
 Research, Food and Drug Administration,        Advisory Committee,
 10903 New Hampshire Ave., Bldg. 31, Rm.        Peripheral & Central
 2434, Silver Spring, MD 20993-0002, phone:     Nervous Systems Advisory
 301-796-2894, email:                           Committee.
 [email protected]..
Marie ann Brill, Office of the Commissioner,   Pediatrics Advisory
 Office of Medical Products and Tobacco, Food   Committee.
 and Drug Administration, 10903 New Hampshire
 Ave., Bldg. 32, Rm. 5154, Silver Spring, MD
 20993-0002, phone: 240-402-3838, email:
 [email protected]..
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SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting 
and/or nonvoting consumer representatives for the vacancies listed in 
table 2.

      Table 2--Committee Descriptions, Type of Consumer Representative Vacancy, and Approximate Date Needed
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Committee/panel/areas of expertise needed           Type of vacancy                Approximate date needed
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Antimicrobial Advisory Committee--         1--Voting.......................  November 30, 2017.
 Knowledgeable in the fields of
 infectious disease, internal medicine,
 microbiology, pediatrics, epidemiology
 or statistics, and related specialties.
Clinical Chemistry and Clinical            1--Non-Voting...................  February 28, 2017.
 Toxicology Devices Panel--Doctors of
 medicine or philosophy with experience
 in clinical chemistry (e.g., cardiac
 markers), clinical toxicology, clinical
 pathology, clinical laboratory medicine,
 and endocrinology.
Ear, Nose and Throat Devices Panel--       1--Non-Voting...................  Immediately.
 Otologists, neurologists, audiologists.
Immunology Devices--Persons with           1--Non-Voting...................  Immediately.
 experience in medical, surgical, or
 clinical oncology, internal medicine,
 clinical immunology, allergy, molecular
 diagnostics, or clinical laboratory
 medicine.
Medical Devices Dispute Resolution--       1--Non-Voting...................  Immediately.
 Experts with broad, cross-cutting
 scientific, clinical, analytical, or
 mediation skills.
Neurological Devices Panel--Neurosurgeons  1--Non-Voting...................  Immediately.
 (cerebrovascular and pediatric),
 neurologists (stroke, pediatric, pain
 management, and movement disorders),
 interventional neuroradiologists,
 psychiatrists, and biostatisticians.
Endocrinologic and Metabolic Drugs         1--Voting.......................  June 30, 2017.
 Advisory Committee--Knowledgeable in the
 fields of endocrinology, metabolism,
 epidemiology or statistics, and related
 specialties.
Foods Advisory Committee--Knowledgeable    1--Voting.......................  June 30, 2017.
 in the fields of physical sciences,
 biological and life sciences, food
 science, risk assessment, nutrition,
 food technology, molecular biology, and
 other relevant scientific and technical
 disciplines.
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.
Pulmonary-Allergy Drugs Advisory           1--Voting.......................  May 31, 2017.
 Committee--Knowledgeable in the fields
 of pulmonary medicine, allergy, clinical
 immunology, and epidemiology or
 statistics.

[[Page 27499]]

 
Medical Imaging Advisory Committee--       1--Voting.......................  Immediately.
 Knowledgeable in the fields of nuclear
 medicine, radiology, epidemiology,
 statistics, and related specialties.
Pharmaceutical Science and Clinical        1--Voting.......................  Immediately.
 Pharmacology--Knowledgeable in the
 fields of pharmaceutical manufacturing,
 clinical pharmacology, pharmacokinetics,
 bioavailability and bioequivalence
 research, the design and evaluation of
 clinical trials, laboratory analytical
 techniques, pharmaceutical chemistry,
 physiochemistry, biochemistry,
 biostatistics, and related biomedical
 and pharmacological specialties.
National Mammography Quality Assurance     1--Non-Voting...................  Immediately.
 Advisory Committee--Physician,
 practitioner, or other health
 professional whose clinical practice,
 research specialization, or professional
 expertise includes a significant focus
 on mammography.
Non-Prescription Drugs Advisory            1--Voting.......................  May 31, 2017.
 Committee--Knowledgeable in the fields
 of internal medicine, family practice,
 clinical toxicology, clinical
 pharmacology, pharmacy, dentistry, and
 related specialties.
Peripheral and Central Nervous System      1--Voting.......................  Immediately.
 Drugs Advisory Committee--Knowledgeable
 in the fields of neurology,
 neuropharmacology, neuropathology,
 otolaryngology, epidemiology or
 statistics, and related specialties.
Pediatrics Advisory Committee--            1--Voting.......................  Immediately.
 Knowledgeable in pediatric research,
 pediatric subspecialties, statistics,
 and/or biomedical ethics. The core of
 voting members shall also include one
 representative from a pediatric health
 organization and one representative from
 a relevant patient or patient-family
 organization and may include one
 technically qualified member, selected
 by the Commissioner or designee, who is
 identified with consumer interests and
 is recommended by either a consortium of
 consumer-oriented organizations or other
 interested persons. In addition to the
 voting members, the Committee may
 include one non-voting member who is
 identified with industry interests.
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I. Functions and General Description of the Committee Duties

A. Antimicrobial 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 infectious diseases and disorders.

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 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. Endocrinologic and Metabolic Drugs Advisory 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.

D. Food Advisory Committee

    Make recommendations on emerging food safety, food science, 
nutrition, and other food-related health issues that FDA considers of 
primary importance for its food and cosmetics programs. Reviewing and 
evaluating available data and making recommendations on matters such as 
those relating to: (1) Broad scientific and technical food or cosmetic 
related issues; (2) the safety of new foods and food ingredients; (3) 
labeling of foods and cosmetics; (4) nutrient needs and nutritional 
adequacy; and (5) safe exposure limits for food contaminants. The 
Committee may also be asked to provide advice and make recommendations 
on ways of communicating to the public the potential risks associated 
with these issues and on approaches that might be considered for 
addressing the issues.

E. 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.

F. Pulmonary-Allergy 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 pulmonary disease and diseases with allergic 
and/or immunologic mechanisms.

G. Medical Imaging Drugs 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.

H. Pharmaceutical Science and Clinical Pharmacology Advisory Committee

    Provide advice on scientific and technical issues concerning the 
safety,

[[Page 27500]]

and effectiveness of human generic drug products for use in the 
treatment of a broad spectrum of human diseases, and as required, any 
other product for which FDA has regulatory responsibility. The 
committee may also review Agency sponsored intramural and extramural 
biomedical research programs in support of FDA's generic drug 
regulatory responsibilities.

I. National Mammography Quality Assurance Advisory Committee

    Advise the Agency on the following development of appropriate 
quality standards and regulations for mammography facilities; standards 
and regulations for bodies accrediting mammography facilities under 
this program; regulations with respect to sanctions; procedures for 
monitoring compliance with standards; establishing a mechanism to 
investigate consumer complaints; reporting new developments concerning 
breast imaging which should be considered in the oversight of 
mammography facilities. As well as 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; determining whether 
there will exist a sufficient number of medical physicists after 
October 1, 1999; and determining the costs and benefits of compliance 
with these requirements.

J. Non-Prescription Drugs Advisory Committee

    Review and evaluate 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 a broad spectrum of human symptoms and diseases and advise the 
Commissioner either on the 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 will serve 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.

K. 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.

L. Pediatrics Advisory Committee

    The Committee advises and makes recommendations to the Commissioner 
of Food and Drugs regarding: (1) Pediatric research; (2) identification 
of research priorities related to pediatric therapeutics and the need 
for additional treatments of specific pediatric diseases or conditions, 
(3) the ethics, design, and analysis of clinical trials related to 
pediatric therapeutics, (4) pediatric labeling disputes, (5) pediatric 
labeling changes, (6) adverse event reports for drugs granted pediatric 
exclusivity and any safety issues that may occur, (7) any other 
pediatric issue or pediatric labeling dispute involving FDA regulated 
products, (8) research involving children as subjects, and (9) 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 the Department of Health and Human Services.

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 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 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 
r[eacute]sum[eacute]. 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 should include a cover letter and current curriculum vitae 
or r[eacute]sum[eacute] 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

[[Page 27501]]

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: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation and Analysis.
[FR Doc. 2017-12352 Filed 6-14-17; 8:45 am]
BILLING CODE 4164-01-P