
[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Notices]
[Pages 7803-7806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03010]


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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 March 
17, 2016, for vacancies listed in this notice. Concurrently, nomination 
materials for prospective candidates should be sent to FDA (see 
ADDRESSES) by March 17, 2016. Nominations will be accepted for current 
vacancies and for those that will or may occur through March 31, 2016.

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: 301-847-8640.
    Consumer Representative nominations should be submitted 
electronically by logging into the FDA Advisory Committee Membership 
Nomination Portal: 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 selection process: Kimberly Hamilton, Advisory 
Committee Oversight and Management Staff (ACOMS), Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32., Rm. 5117, Silver 
Spring, MD 20993-0002, 301-796-8224, 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
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               Contact person                      Committee/panel
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Janie Kim, Center for Biologics Evaluation   Cellular, Tissue and Gene
 and Research, Food and Drug                  Therapies.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 71, Rm. 6129, Silver Spring, MD
 20993-0002, Phone: 301-796-9016, Email:
 Janie.Kim@fda.hhs.gov.
Philip Bautista, Center for Drugs            Drug Safety and Risk
 Evaluation and Research, Food and Drug       Management Advisory
 Administration, 10903 New Hampshire Ave.,    Committee.
 Bldg. 31, Rm. 2410, Silver Spring, MD
 20993-0002, Phone: 301-796-9006, Email:
 Philip.Bautista@fda.hhs.gov.
Natasha Facey, Center for Devices and        Immunology Devices Panel.
 Radiological Health, Food and Drug
 Administration, 10903 New Hampshire Ave.,
 Bldg. 66, Rm. 1552, Silver Spring, MD
 20993-0002, Phone: 301-796-5290, Email:
 Natasha.Facey@fda.hhs.gov.

[[Page 7804]]

 
Terri Crescenzi, Office of the               Pediatrics Advisory
 Commissioner, Food and Drug                  Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 32, Rm. 5152, Silver Spring, MD
 20993-0002, Phone: 301-796-8646, Email:
 Terrie.Crescenzi@fda.hhs.gov.
Donna Mendrick, National Center for          Science Advisory Board to
 Toxicological Research, Food and Drug        National Center for
 Administration, 10903 New Hampshire Ave.,    Toxicological Research
 Bldg. 32, Rm. 2208, Silver Spring, MD        (NCTR).
 20993-0002, Phone: 301-796-8892, Email:
 Donna.Mendrick@fda.hhs.gov.
Bryan Emery, Center for Biologics            Transmissible Spongiform
 Evaluation and Research, Food and Drug       Encephalopathies Advisory
 Administration, 10903 New Hampshire Ave.,    Committee.
 Bldg. 71, Rm. 6132, Silver Spring, MD
 20993-0002, Phone: 240-402-8054, Email:
 Bryan.Emery@fda.hhs.gov.
Sujata Vijh, Center for Biologics            Vaccines and Related
 Evaluation and Research, Food and Drug       Biological Products
 Administration, 10903 New Hampshire Ave.,    Advisory Committee.
 Bldg. 71, Rm. 6128, Silver Spring, MD
 20993-0002, Phone: 240-402-7107, Email:
 Sujata.Vijh@fda.hhs.gov.
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    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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Cellular, Tissue and Gene Therapies Advisory        1-Voting.....................  3/31/2016.
 Committee--Knowledgeable in the fields of
 cellular therapies, tissue transplantation, gene
 transfer therapies and xenotransplantation
 (biostatistics, bioethics, hematology/oncology,
 human tissues and transplantation, reproductive
 medicine, general medicine and various medical
 specialties including surgery and oncology,
 immunology, virology, molecular biology, cell
 biology, developmental biology, tumor biology,
 biochemistry, rDNA technology, nuclear medicine,
 gene therapy, infectious diseases, and cellular
 kinetics.
Drug Safety and Risk Management Advisory            1-Voting.....................  Immediately.
 Committee--Knowledgeable in risk communication,
 risk management, drug safety, medical,
 behavioral, and biological sciences as they apply
 to risk management, and drug abuse.
Immunology Devices Panel--Persons with experience   1-Non-Voting.................  2/28/2016.
 in medical, surgical, or clinical oncology,
 internal medicine, clinical immunology, allergy,
 molecular diagnostics, or clinical laboratory
 medicine.
Pediatrics Advisory Committee--Knowledgeable in     1-Voting.....................  Immediately.
 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.
Science Advisory Board to the NCTR--Knowledgeable   1-Voting.....................  Immediately.
 in the fields related to toxicological research.
Transmissible Spongiform Encephalopathies Advisory  1-Voting.....................  Immediately.
 Committee--Knowledgeable in the fields of
 clinical and administrative medicine, hematology,
 virology, neurovirology, neurology, infectious
 diseases, immunology, transfusion medicine,
 surgery, internal medicine, biochemistry,
 biostatistics, epidemiology, biological and
 physical sciences, sociology/ethics, and other
 related professions.
Vaccines and Related Biological Products Advisory   1-Voting.....................  Immediately.
 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. Cellular, Tissue, and Gene Therapies Advisory Committee

    Reviews and evaluates available data relating to the safety, 
effectiveness, and appropriate use of human cells, human tissues, gene 
transfer 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, as well as considers the quality and relevance of FDA's 
research program which provides scientific support for the regulation 
of these products.

B. Drug Safety and Risk Management Advisory Committee

    Risk management, risk communication, and quantitative evaluation of 
spontaneous reports for drugs for human use and for any other product 
for which the FDA has regulatory responsibility. Scientific and medical 
evaluation of all information gathered by the Department of Health and 
Human Service (DHHS) and the Department of Justice with regard to 
safety, efficacy, and abuse potential of drugs or other substances, and 
recommends actions to be taken by DHHS with regard to the marketing, 
investigation, and control of such drugs or other substances.

C. Certain Panels of the Medical Devices Advisory Committee

    The committee reviews and evaluates data on the safety and 
effectiveness of marketed and investigational devices and makes 
recommendations for their regulation. The panels engage in a number of 
activities to fulfill the functions the Federal Food, Drug, and 
Cosmetic Act (the act) envisions for device advisory panels. With the 
exception of the Medical Devices Dispute Resolution Panel, each panel, 
according to its specialty area, advises

[[Page 7805]]

the Commissioner of Food and Drugs (the Commissioner) regarding 
recommended classification or reclassification of devices into one of 
three regulatory categories, advises on any possible risks to health 
associated with the use of devices, advises on formulation of product 
development protocols, reviews premarket approval applications for 
medical devices, reviews guidelines and guidance documents, 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. 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 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.

D. 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 DHHS.

E. Science Advisory Board to the National Center for Toxicological 
Research

    Reviews and advises the Agency on the establishment, implementation 
and evaluation of the research programs and regulatory responsibilities 
as it relates to NCTR. The Board will also provide an extra-agency 
review in ensuring that the research programs at NCTR are 
scientifically sound and pertinent.

F. Transmissible Spongiform Encephalopathies Advisory Committee

    Reviews and evaluates available scientific data concerning the 
safety of products which may be at risk for transmission of spongiform 
encephalopathies having an impact on the public health, as well as 
considers the quality and relevance of FDA's research program which 
provides scientific support for the regulation of these products.

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 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 with the opportunity to vote on the

[[Page 7806]]

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: February 8, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-03010 Filed 2-12-16; 8:45 am]
 BILLING CODE 4164-01-P


