[Federal Register Volume 77, Number 194 (Friday, October 5, 2012)]
[Notices]
[Pages 61004-61006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-24554]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


Request for Nominations for Voting Members on Public Advisory 
Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting 
nominations for voting members to serve on the Allergenic Products 
Advisory Committee, Blood Products Advisory Committee, Cellular, Tissue 
and Gene Therapies Advisory Committee, and Transmissible Spongiform and 
Encephalopathies Advisory Committee, Center for Biologics Evaluation 
and Research. Nominations will be accepted for vacancies that will or 
may occur through December 31, 2013.
    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: Because scheduled vacancies occur on various dates throughout 
each year, no cutoff date is established for the receipt of 
nominations. However, when possible, nominations should be received at 
least 6 months before the date of scheduled vacancies for each year, as 
indicated in this notice.

ADDRESSES: All nominations for membership should be sent electronically 
to [email protected], or by mail to Advisory Committee Oversight and 
Management Staff, 10903 New Hampshire Ave., Bldg. 32, rm. 5103, Silver 
Spring, MD 20993-0002. Information about becoming a member on a 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 specific Committee questions, 
contact the following persons listed in Table 1 of this document:

                                 Table 1
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                Contact person                         Committee
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Donald Jehn, Center for Biologics Evaluation   Allergenic Products
 and Research, Food and Drug Administration,    Advisory Committee.
 1401 Rockville Pike, HFM-71, Rockville, MD
 20852, 301-827-1293; email:
 [email protected].
Bryan Emery, Center for Biologics Evaluation   Blood Products Advisory
 and Research, Food and Drug Administration,    Committee and
 1401 Rockville Pike, HFM-71, Rockville, MD     Transmissible Spongiform
 20852, 301-827-1277, email:                    Encephalopathies
 [email protected].                       Advisory Committee.
Gail Dapolito, Center for Biologics            Cellular, Tissue and Gene
 Evaluation and Research, Food and Drug         Therapies Advisory
 Administration, 1401 Rockville Pike, HFM-71,   Committee.
 Rockville, MD 20852, 301-827-1289, email:
 [email protected].
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SUPPLEMENTARY INFORMATION: 

I. Vacancies

    FDA is requesting nominations of voting members for vacancies 
listed as follows:

                                 Table 2
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                                 Upcoming
 Committee expertise needed      vacancies      Approximate date needed
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Allergenic Products Advisory               3  September 1, 2013.
 Committee--individuals
 knowledgeable in clinical
 immunology/allergy.
Blood Products Advisory                    4  October 1, 2013.
 Committee--individuals
 knowledgeable in surgery/
 trauma, pediatric
 hematology/oncology,
 hematology, medical
 epidemiology.
Cellular, Tissue and Gene                  2  April 2, 2013.
 Therapies Advisory
 Committee--individuals
 knowledgeable in tissue
 engineering/regenerative
 medicine, orthopedic
 oncology.

[[Page 61005]]

 
Transmissible Spongiform                   2  February 1, 2013.
 Encephalopathies Advisory
 Committee--individuals
 knowledgeable in veterinary
 medicine, prion molecular
 biology.
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II. Functions

A. Allergenic Products Advisory Committee

    The Committee reviews and evaluates available data concerning the 
safety, effectiveness, and adequacy of labeling of marketed and 
investigational allergenic biological products or materials that are 
administered to humans for the diagnosis, prevention, or treatment of 
allergies and allergic disease, and makes appropriate recommendations 
to the Commissioner of Food and Drugs of its findings regarding the 
affirmation or revocation of biological product licenses, on the 
safety, effectiveness, and labeling of the products, on clinical and 
laboratory studies of such products, on amendments or revisions to 
regulations governing the manufacture, testing and licensing of 
allergenic biological products, and on the quality and relevance of 
FDA's research programs which provide the scientific support for 
regulating these agents.

B. Blood Products Committee

    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, and, as 
required, any other product for which the Food and Drug Administration 
has regulatory responsibility, and advises the Commissioner of Food and 
Drugs of its findings regarding the safety, effectiveness, screening 
and testing (to determine eligibility) of donors 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 agents. The Committee will 
function at times as a medical device panel under the Federal Food, 
Drug, and Cosmetic Act Medical Device Amendments of 1976. As such, the 
Committee recommends classification of devices subject to its review 
into regulatory categories; recommends the assignment of a priority for 
the application of regulatory requirements for devices classified in 
the standards or premarket approval category; advises on formulation of 
product development protocols and reviews premarket approval 
applications for those devices to recommend changes in classification 
as appropriate; 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.

C. Cellular, Tissue and Gene Therapies Advisory Committee

    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 of Food and Drugs.

D. Transmissible Spongiform Encephalopathies Advisory Committee

    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 
determined by the Commissioner of Food and Drugs. The Committee will 
make recommendations to the Commissioner regarding the regulations of 
such products.

III. Qualifications

A. Allergenic Products Advisory Committee

    Persons nominated for membership should be authorities 
knowledgeable in the fields of allergy, immunology, pediatrics, 
internal medicine, biochemistry, and related specialties. The 
particular needs at this time for this committee are listed in section 
I of this document. The term of office is up to 4 years, depending on 
the appointment date.

B. Blood Products Advisory Committee

    Persons nominated for membership should be authorities 
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. The particular needs 
at this time for this committee are listed in section I of this 
document. The term of office is up to 4 years, depending on the 
appointment date.

C. Cellular, Tissue and Gene Therapies Advisory Committee

    Persons nominated for membership should be authorities 
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). The particular needs at 
this time for this committee are listed in section I of this document. 
The term of office is up to 4 years, depending on the appointment date.

D. Transmissible Spongiform Encephalopathies Advisory Committee

    Persons nominated for membership should be authorities 
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.

[[Page 61006]]

IV. Nomination Procedures

    Any interested person may nominate one or more qualified persons 
for membership on one or more of the advisory panels or advisory 
committees. Self-nominations are also accepted. Nominations must 
include a current, complete resume or curriculum vitae for each 
nominee, and their current business address and/or home address, 
telephone number, and email address if available. Nominations must 
specify the advisory committee(s) for which the nominee is recommended. 
Nominations must also acknowledge that the nominee is aware of the 
nomination unless self-nominated. FDA will ask potential candidates to 
provide detailed information concerning such matters related to 
financial holdings, employment, and research grants and/or contracts to 
permit evaluation of possible sources of conflict of interest.
    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: September 25, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-24554 Filed 10-4-12; 8:45 am]
BILLING CODE 4160-01-P