[Federal Register Volume 76, Number 146 (Friday, July 29, 2011)]
[Notices]
[Pages 45579-45582]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19066]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]


Request for Notification From Consumer Organizations Interested 
in Participating in the Selection Process for Nominations for Voting 
and/or Nonvoting Consumer Representatives and Request for Nominations 
for Voting and/or Nonvoting Consumer Representatives on Public Advisory 
Committees or Panels

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 either be self-nominated or may be nominated by a 
consumer organization. Nominations will be accepted for current 
vacancies and for those that will or may occur through June 2012.

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 e-mail stating that interest to FDA (see ADDRESSES) by August 
29, 2011, for vacancies listed in this notice. Concurrently, nomination 
materials for prospective candidates should be sent to FDA (see 
ADDRESSES) by August 29, 2011.

ADDRESSES: All statements of interest from consumer organizations 
interested in participating in the selection process and consumer 
representative nominations should be sent electronically to 
CV@OC.FDA.GOV, by mail to Advisory Committee Oversight and Management 
Staff, 10903 New Hampshire Ave., Bldg. 32, rm. 5129, Silver Spring MD 
20993-0002, or by fax to 301-847-8640. Information about becoming a 
member of an FDA advisory committee can be obtained by visiting FDA's 
Web site at http://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Doreen Brandes, Advisory Committee 
Oversight and Management Staff, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, rm. 5122, Silver Spring, MD 20993-0002, 301-
796-8858, or e-mail: Doreen.Brandes@fda.hhs.gov.
    For questions relating to specific advisory committees or panels, 
contact the persons listed in table 2 in the SUPPLEMENTARY INFORMATION 
section of this document.

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting 
and/or nonvoting consumer representatives for the vacancies listed in 
table 1 of this document:

[[Page 45580]]



                                                     Table 1
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                                                            Current &  upcoming
      Committee/panel/areas of expertise needed                  vacancies             Approximate date needed
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Drug Safety and Risk Communication--Knowledgeable in   1-Voting....................  5/31/12
 risk communication, risk management, drug safety,
 medical, behavioral, and biological sciences as they
 apply to risk management, and drug abuse.
Gastrointestinal Drugs--Knowledgeable in the fields    1-Voting....................  6/30/12
 of gastroenterology, endocrinology, surgery,
 clinical pharmacology, physiology, pathology, liver
 function, motility, esophagitis, and statistics.
Medical Imaging--Knowledgeable in the fields of        1-Voting....................  immediately
 nuclear medicine, radiology, epidemiology or
 statistics, and related specialties.
Blood Products--Knowledgeable in the fields of         1-Voting....................  immediately
 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.
Cellular Tissue and Gene Therapies--Knowledgeable in   1-Voting....................  3/31/12
 the fields of cellular therapies, tissue
 transplantation, gene transfer therapies and
 xenotransplantation including 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.
Transmissible Spongiform Encephalopathies--            1-Voting....................  immediately
 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--             1-Voting....................  3/31/12
 Knowledgeable in the fields of immunology, molecular
 biology, rDNA, virology, bacteriology, epidemiology
 or biostatistics, allergy, preventive medicine,
 infectious diseases, pediatrics, microbiology, and
 biochemistry.
Radiological Device Panel--Knowledgeable in            1-Non voting................  1/31/12
 diagnostic and therapeutic radiological and nuclear
 medical devices, engineering and operating
 mechanisms of radiologic devices.
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I. Functions

A. Drug Safety and Risk Management

    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 
of Food and Drugs (the Commissioner) regarding the scientific and 
medical evaluation of all information gathered by the Department of 
Health and Human Services 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 the Department of Health and Human 
Services with regard to the marketing, investigation, and control of 
such drugs or other substances.

B. Gastrointestinal Drugs

    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 gastrointestinal diseases and 
makes appropriate recommendations to the Commissioner.

C. Medical Imaging Drugs

    The 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. 
(Elsewhere in this issue of the Federal Register is a final rule adding 
the Medical Imaging Drugs Advisory Committee to the list of FDA 
standing advisory committees in 21 CFR 14.100, as well as a request for 
nominations of voting members and a request for nominations of 
nonvoting industry representative members.)

D. Blood Products

    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 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.

E. Cellular Tissue and Gene Therapy

    The 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. 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.

F. Transmissible Spongiform Encephalopathies

    The 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 Biologic Products

    The 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, and, as required, any other product for 
which FDA has regulatory responsibility. The Committee also considers 
the quality

[[Page 45581]]

and relevance of FDA's research program which provides scientific 
support for the regulation of these products and makes appropriate 
recommendations to the Commissioner.

H. 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. With the exception of the Medical 
Devices Dispute Resolution Panel, each panel, according to its 
specialty area, advises on the 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 Federal Food, Drug, and Cosmetic 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.

II. Criteria for Members

    Persons nominated for membership as consumer representatives on the 
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.

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 three to five 
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.

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. 
Potential candidates will be required 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.
    All nominations should include: A cover letter; a curriculum vitae 
or resume that includes the nominee's address, telephone number, and e-
mail address; and a list of consumer or community-based organizations 
for which the candidate can demonstrate active participation.
    Nominations also should 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 
and is willing to serve as a member of the advisory committee or panel 
if selected. The term of office is up to 4 years.
    FDA will review all nominations received within the specified 
timeframes and prepare a ballot containing the names of 3 to 5 
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.
    FDA has a special interest in ensuring that women, minority groups, 
and individuals with physical disabilities are adequately represented 
on its advisory committees and panels and, therefore, encourages 
nominations for appropriately qualified candidates from these groups.
    For questions relating to specific advisory committees or panels, 
contact the following persons listed in table 2 of this document:

                                 Table 2
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                 Contact person                       Committee/panel
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Kristina Toliver, Center for Drug Evaluation and  Drug Safety and Risk
 Research, Food and Drug Administration, White     Management.
 Oak Bldg. 31, 10903 New Hampshire Ave., Silver
 Spring, MD 20993-0002, Phone: 301-796-0063,
 Fax: 301-847-8533, E-mail:
 Kristina.Toliver@fda.hhs.gov.
Kristine T. Khuc, Center for Drug Evaluation and  Gastrointestinal
 Research, Food and Drug Administration, White     Drugs.
 Oak Bldg. 31, 10903 New Hampshire Ave., Silver
 Spring, MD 20993-0002, Phone: 301-796-9005,
 Fax: 301-847-8533, E-mail:
 Kristine.Khuc@fda.hhs.gov.
Minh Doan, Center for Drug Evaluation and         Medical Imaging Drugs.
 Research, Food and Drug Administration, White
 Oak Bldg. 31, 10903 New Hampshire Ave., Silver
 Spring, MD 20993-0002, Phone: 301-796-9009,
 Fax: 301-847-8533, E-mail:
 ming.doan@fda.hhs.gov.

[[Page 45582]]

 
Bryan Emery, Center for Biologics Evaluation &    Blood Products and
 Research, Food and Drug Administration, 1401      Transmissible
 Rockville Pike (HFM-71), Rockville, MD 20852,     Spongiform
 Phone: 301-827-1277, Fax: 301-827-0294, E-mail:   Encephalopathies.
 bryan.emery@fda.hhs.gov.
Gail Dapolito, Center for Biologics Evaluation &  Cellular Tissue and
 Research, Food and Drug Administration, 1401      Gene Therapy.
 Rockville Pike (HFM-71), Rockville, MD 20852-
 1448, Phone: 301-827-1289, Fax: 301-827-0294, E-
 mail: gail.dapolito@fda.hhs.gov.
Donald Jehn, Center for Biologics Evaluation &    Vaccines and Related
 Research, Food and Drug Administration, 1401      Biological Products.
 Rockville Pike (HFM-71), Rockville, MD 20852,
 Phone: 301-827-1293, Fax: 301-827-0294, E-mail:
 donald.jehn@fda.hhs.gov.
Shanika Craig, Center for Devices and             Radiological Devices
 Radiological Health, Food and Drug                Panel.
 Administration, White Oak Bldg. 66, rm. 1613,
 10903 New Hampshire Ave., Silver Spring, MD
 20993-0002, Phone: 301-796-6639, E-mail:
 Shanika.Craig@fda.hhs.gov.
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    Dated: July 22, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-19066 Filed 7-28-11; 8:45 am]
BILLING CODE 4160-01-P