[Federal Register Volume 75, Number 248 (Tuesday, December 28, 2010)]
[Notices]
[Pages 81618-81622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-32624]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]


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

-----------------------------------------------------------------------

[[Page 81619]]

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 December 2011.

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 
January 27, 2011, for vacancies listed in this document. Concurrently, 
nomination materials for prospective candidates should be sent to FDA 
(see ADDRESSES) by January 27, 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 
[email protected], 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 GENERAL 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, e-mail: [email protected].
    For questions relating to specific advisory committees or panels, 
contact the following persons listed in table 1 of this document:

                                 Table 1
------------------------------------------------------------------------
              Contact person                       Committee/panel
------------------------------------------------------------------------
Walter Ellenberg, 10903 New Hampshire       Pediatrics Advisory
 Ave., Bldg. 32, rm. 5488, Silver Spring,    Committee.
 MD 20993-0002; phone: 301-796-3873; e-
 mail: [email protected].
Martha Monser, 10903 New Hampshire Ave.,    Science Board.
 Bldg. 32, rm. 4286, Silver Spring, MD
 20993-0002; phone: 301-796-4627; e-mail:
 [email protected].
Yvette Waples (Acting), 10903 New           Advisory Committee for
 Hampshire Ave., Bldg. 31, rm. 2410,         Pharmaceutical Science and
 Silver Spring, MD 20993-0002; phone: 301-   Clinical Pharmacology
 796-9034; e-mail:                           Dermatologic, Ophthalmic
 [email protected].                  Drugs and
                                             Psychopharmacologic Drugs.
Minh Doan, 10903 New Hampshire Ave., Bldg.  Arthritis Drugs.
 31, rm. 2432, Silver Spring, MD 20993-
 0002; phone: 301-796-9009; e-mail:
 [email protected].
Kalyani Bhatt, 10903 New Hampshire Ave.,    Anesthetic & Life Support
 Bldg. 31, rm. 3438, Silver Spring, MD       Drugs.
 20993-0002; phone: 301-796-9005; e-mail:
 [email protected].
Paul Tran, 10903 New Hampshire Ave., Bldg.  Anti-Viral Drugs
 31, rm. 2404, Silver Spring, MD 20993-
 0002; phone: 301-796-9029; e-mail:
 [email protected].
Caleb Briggs, 10903 New Hampshire Ave.,     Oncologic Drugs.
 Bldg. 31, rm. 2428, Silver Spring, MD
 20993-0002; phone: 301-796-9022; e-mail:
 [email protected].
Bryan Emery, Rockwall Building (HFM-71),    Blood Products and
 5515 Security Lane, rm. 1312, Rockville,    Transmissible Spongiform
 MD 20852; phone: 301-827-1277; e-mail:      Encephalopathies
 [email protected].
Margaret Miller, 10903 New Hampshire Ave.,  Science Advisory Board to
 Bldg. 32, rm. 2208, Silver Spring, MD       the National Center of
 20993-0002; phone: 301-796-8890; e-mail:    Toxicological Research.
 [email protected].
Shanika Craig, 10903 New Hampshire Ave.,    Anesthesiology and
 Bldg. 66, rm. 1613, Silver Spring, MD       Respiratory Therapy Devices
 20993-0002; phone: 301-796-6639; e-mail:    Panel and General Hospital
 [email protected].                  and Personal Use Devices
                                             Panel.
Margaret McCabe-Janicki, 10903 New          Gastroenterology and Urology
 Hampshire Ave., Bldg. 66, rm. 1535,         General Plastic Surgery.
 Silver Spring, MD 20993-0002; phone: 301-
 796-7029; e-mail: [email protected].
Olga Claudio, 10903 New Hampshire Ave.,     Immunology Devices Panel,
 Bldg. 66, rm. 1611, Silver Spring, MD       Dental Products Devices
 20993-0002; phone: 301-796-7608; e-mail:    Panel and National
 [email protected].                   Mammography Quality
                                             Assurance Advisory
                                             Committee.
James Swink, 10903 New Hampshire Ave.,      Molecular and Clinical
 Bldg. 66, rm. 1609, Silver Spring, MD       Genetics.
 20993-0002; phone: 301-796-6313; e-mail:
 [email protected].
James Engles, 10903 New Hampshire Ave.,     Neurological Devices Panel
 Bldg. 66, rm. 1566, Silver Spring, MD       and Ophthalmic Devices
 20993-0002; phone: 301-796-7543; e-mail:    Panel.
 [email protected].
------------------------------------------------------------------------


SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting 
and/or nonvoting consumer representatives for the vacancies listed in 
table 2 of this document:

                                 Table 2
------------------------------------------------------------------------
    Committee/panel/areas of          Current and      Approximate date
        expertise needed          upcoming vacancies        needed
------------------------------------------------------------------------
Pediatrics Advisory Committee:    1-Voting..........  immediately.
 Knowledgeable in pediatric
 research, pediatric
 subspecialties, statistics, and/
 or biomedical ethics.

[[Page 81620]]

 
Science Board: Knowledgeable in   1-Voting..........  immediately.
 the fields of food safety,
 nutrition, chemistry,
 pharmacology, toxicology,
 clinical research of systems
 biology, healthcare devices,
 nanotechnology, medical
 imaging, robotics, cell and
 tissue based products,
 regenerative medicine and
 combination products.
Blood Products: Knowledgeable in  1-Voting..........  immediately.
 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.
Transmissible Spongiform          1-Voting..........  immediately.
 Encephalopathies: 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.
Anesthetic and Life Support:      1-Voting..........  04/01/11.
 Knowledgeable in the fields of
 anesthesiology, surgery,
 epidemiology or statistics, and
 related specialties.
Antiviral Drugs: Knowledgeable    1-Voting..........  11/01/11.
 in the fields of clinical
 pharmacology, internal
 medicine, infectious diseases,
 microbiology, virology,
 psychiatry, statistics,
 epidemiology, ophthalmology,
 immunology, pediatrics,
 hematology, and related
 specialties.
Arthritis Drugs: Knowledgeable    1-Voting..........  immediately.
 in the fields of arthritis,
 rheumatology, orthopedics,
 epidemiology or statistics,
 analgesics, and related
 specialties.
Dermatologic and Ophthalmic       1-Voting..........  09/01/11.
 Drugs: Knowledgeable in the
 fields of dermatology,
 ophthalmology, internal
 medicine, pathology,
 immunology, epidemiology or
 statistics, and other related
 professions.
Oncologic Drugs: Knowledgeable    1-Voting..........  07/01/11.
 in the fields of general
 oncology, pediatric oncology,
 hematologic oncology,
 immunologic oncology,
 biostatistics, and other
 related professions.
Pharmaceutical Science and        1-Voting..........  11/01/11.
 Clinical 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.
Psychopharmacologic Drugs:        1-Voting..........  07/30/11.
 Knowledgeable in the fields of
 psychopharmacology, psychiatry,
 epidemiology or statistics, and
 related specialties.
Veterinary Advisory:              1-Voting..........  immediately.
 Knowledgeable in the fields of
 companion animal medicine, food
 animal medicine, avian
 medicine, microbiology,
 biometrics, toxicology,
 pathology, pharmacology, animal
 science, chemistry, public
 health/epidemiology and minor
 species/minor use veterinary
 medicine.
Science Board to the National     1-Voting..........  immediately.
 Center for Toxicology:
 Knowledgeable in the fields
 related to toxicological
 research.
National Mammography Quality      2-Voting..........  Immediately.
 Assurance Advisory Committee:
 Knowledgeable in clinical
 practice, research
 specialization, or professional
 work that has a significant
 focus on mammography.
------------------------------------------------------------------------
        Certain Panels of the Medical Devices Advisory Committee
------------------------------------------------------------------------
Anesthesiology and Respiratory    1-Nonvoting.......  12/01/10.
 Therapy Devices: Knowledgeable
 in anesthesiology and pulmonary
 medicine or others who have
 specialized interests in
 ventilator support,
 pharmacology, physiology, or
 the effects and complications
 of anesthesia.
Dental Products Panel:            1-Nonvoting.......  immediately.
 Knowledgeable in the areas of
 dental implants, dental
 materials, periodontology,
 tissue engineering, and dental
 anatomy.
Gastroenterology and Urology      1-Nonvoting.......  01/01/12.
 Devices: Knowledgeable in the
 area of gastroenterology,
 urology, and nephrology.
General Hospital and Personal     1-Nonvoting.......  01/01/11.
 Use Devices: Nurses, biomedical
 engineers, microbiologists/
 infection control
 practitioners, or experts
 knowledgeable in the area of
 hospital and personal use
 devices.
Immunology Devices:               1-Nonvoting.......  immediately.
 Knowledgeable in medical,
 surgical, or clinical oncology,
 internal medicine, clinical
 immunology, allergy, molecular
 diagnostics, or clinical
 laboratory medicine.

[[Page 81621]]

 
Molecular and Clinical Genetics   1-Nonvoting.......  immediately.
 Panel: Knowledgeable in human
 genetics and in the clinical
 management of patients with
 genetic disorders, e.g.,
 candidates with training in
 inborn errors of metabolism,
 biochemical and/or molecular
 genetics, population genetics,
 epidemiology and related
 statistical training.
 Additionally, individuals with
 experience in genetic
 counseling, medical ethics as
 well as ancillary fields of
 study will be considered.
Neurological Devices:             1-Nonvoting.......  immediately.
 Knowledgeable in neurologic
 diseases and devices used to
 treat neurologic disorders.
Ophthalmic Devices:               1-Nonvoting.......  immediately.
 Knowledgeable in corneal-
 external disease, vitreo-
 retinal surgery, glaucoma,
 ocular immunology, ocular
 pathology; optometrists; vision
 scientists; ophthalmic
 professionals quality of life
 assessment, electrophysiology,
 low vision rehabilitation.
------------------------------------------------------------------------

I. Functions

A. Pediatric Advisory Committee

    Advises and makes recommendations 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.

B. Science Board

    Provides advice primarily to the Commissioner of Food and Drugs and 
other appropriate officials on specific complex and technical issues as 
well as emerging issues in the scientific community, industry, and 
academia. Additionally, the Board will provide advice to the Agency on 
keeping pace with technical and scientific evolutions in the fields of 
regulatory science, on formulating an appropriate research agenda, and 
on upgrading its scientific and research facilities to keep pace with 
these changes. It will also provide the means for critical review of 
Agency sponsored intramural and extramural scientific research 
programs.

C. Blood Products

    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.

D. Transmissible Spongiform Encephalopathies

    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.

E. Anesthetic and Life Support Drugs

    Reviews and evaluates available data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in anesthesiology and surgery.

F. Antiviral Drugs

    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.

G. Arthritis Drugs

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational human drug products for use in the 
treatment of arthritis, rheumatism, and related diseases.

H. Oncologic Drugs

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational human drug products for use in the 
treatment of cancer.

I. Pharmaceutical Science & Clinical Pharmacology

    Provides advice on scientific and technical issues concerning the 
safety, 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 the 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.

J. Psychopharmacologic Drugs

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational human drug products for use in the 
practice of psychiatry and related fields.

K. Veterinary Medicine

    Reviews and evaluates available data concerning the safety and 
effectiveness of marketed and investigational new animal drugs, feeds, 
and devices for use in the treatment and prevention of animal diseases 
and increased animal production.

L. Technical Electronic Product Radiation Standards Advisory Committee

    Reviews and evaluates the technical feasibility, reasonableness, 
and practicability of performance standards for electronic products to 
control the emission of radiation from such products, and may recommend 
electronic product radiation safety standards.

M. 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 that meet 
current and future scientific needs of the Agency. The Board also 
provides

[[Page 81622]]

an extra-agency review in ensuring that the research programs at NCTR 
are scientifically sound and relevant to the regulatory needs of the 
Agency.

N. National Mammography Quality Assurance Advisory Committee

    Advises the Agency on 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; and establishing a mechanism to investigate 
consumer complaints; reporting new developments concerning breast 
imaging which should be considered in the oversight of mammography 
facilities. Also determines whether there exists a shortage of 
mammography facilities in rural and health professional shortage areas 
and determines 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.

O. 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, 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 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.

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 home or office 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 three to five 
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.

    Dated: December 22, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-32624 Filed 12-27-10; 8:45 am]
BILLING CODE 4160-01-P