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, 45579-45582 [2011-19066]

Download as PDF Federal Register / Vol. 76, No. 146 / Friday, July 29, 2011 / Notices Nominations should be received before September 27, 2011. ADDRESSES: All nominations for membership, except for consumernominated members and industry representatives members, should be sent to Minh Doan (see FOR FURTHER INFORMATION CONTACT). FOR FURTHER INFORMATION CONTACT: Minh Doan, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg. 31, rm. 2417, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796– 9001, Fax: 301–847–8533, E-mail: MIDAC@fda.hhs.gov. DATES: FDA is requesting nominations for voting members on the Medical Imaging Drugs Advisory Committee (the Committee). (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 nonvoting industry representatives, and a request for nominations of voting and nonvoting consumer representatives.) SUPPLEMENTARY INFORMATION: mstockstill on DSK4VPTVN1PROD with NOTICES I. Function The Committee advises the Commissioner of Food and Drugs or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility. The Committee also 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. II. Criteria for Members Persons nominated for membership on the Committee must have adequately diversified research and/or clinical experience appropriate to the work of the committee in such fields as nuclear medicine, radiology, epidemiology or statistics, and related specialties. The specialized training and experience necessary to qualify the nominee as an expert suitable for appointment is subject to review, but may include experience in medical practice, teaching, research, and/or public service relevant to the field of VerDate Mar<15>2010 16:17 Jul 28, 2011 Jkt 223001 activity of the committee. The term of office is up to 4 years. III. Nomination Procedure Any interested person may nominate one or more qualified persons for membership on the Committee. Selfnominations are also accepted. Nominations must include a current, complete resume or curriculum vitae for each nominee, current business and/or home address, telephone number, and email address if available. Nominations must specify the advisory committee for which the nominee is recommended. Nominations must also acknowledge that the nominee is aware of the nomination, unless self-nominated. 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. This document is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: July 22, 2011. David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget. [FR Doc. 2011–19067 Filed 7–28–11; 8:45 am] BILLING CODE 4160–01–P 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. 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 SUMMARY: PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 45579 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 selfnominated 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. 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. DATES: 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 https://www.fda.gov/ AdvisoryCommittees/default.htm. ADDRESSES: 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. FDA is requesting nominations for voting and/ or nonvoting consumer representatives for the vacancies listed in table 1 of this document: SUPPLEMENTARY INFORMATION: E:\FR\FM\29JYN1.SGM 29JYN1 45580 Federal Register / Vol. 76, No. 146 / Friday, July 29, 2011 / Notices TABLE 1 Current & upcoming vacancies Committee/panel/areas of expertise needed Drug Safety and Risk Communication—Knowledgeable in 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 of gastroenterology, endocrinology, surgery, clinical pharmacology, physiology, pathology, liver function, motility, esophagitis, and statistics. Medical Imaging—Knowledgeable in the fields of nuclear medicine, radiology, epidemiology or statistics, and related specialties. Blood Products—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. Cellular Tissue and Gene Therapies—Knowledgeable in 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—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—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 diagnostic and therapeutic radiological and nuclear medical devices, engineering and operating mechanisms of radiologic devices. 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. mstockstill on DSK4VPTVN1PROD with NOTICES 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 VerDate Mar<15>2010 18:53 Jul 28, 2011 Jkt 223001 Approximate date needed 1-Voting ................. 5/31/12 1-Voting ................. 6/30/12 1-Voting ................. immediately 1-Voting ................. immediately 1-Voting ................. 3/31/12 1-Voting ................. immediately 1-Voting ................. 3/31/12 1-Non voting ......... 1/31/12 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.) 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. D. Blood Products F. Transmissible Spongiform Encephalopathies 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 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 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 E:\FR\FM\29JYN1.SGM 29JYN1 45581 Federal Register / Vol. 76, No. 146 / Friday, July 29, 2011 / Notices 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 mstockstill on DSK4VPTVN1PROD with NOTICES Contact person Committee/panel Kristina Toliver, Center for Drug Evaluation and Research, Food and Drug Administration, White 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 Research, Food and Drug Administration, White 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 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. VerDate Mar<15>2010 16:17 Jul 28, 2011 Jkt 223001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\29JYN1.SGM Drug Safety and Risk Management. Gastrointestinal Drugs. Medical Imaging Drugs. 29JYN1 45582 Federal Register / Vol. 76, No. 146 / Friday, July 29, 2011 / Notices TABLE 2—Continued Contact person Committee/panel Bryan Emery, Center for Biologics Evaluation & Research, Food and Drug Administration, 1401 Rockville Pike (HFM–71), Rockville, MD 20852, Phone: 301–827–1277, Fax: 301–827–0294, E-mail: bryan.emery@fda.hhs.gov. Gail Dapolito, Center for Biologics Evaluation & Research, Food and Drug Administration, 1401 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 & Research, Food and Drug Administration, 1401 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 Health, Food and Drug 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. Blood Products and Transmissible Spongiform Encephalopathies. 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on Public Advisory Committees AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on its public advisory committees for the Center for Drug Evaluation and Research (CDER) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on CDER’s public advisory committees. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice. DATES: Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating that interest to the FDA by August 29, 2011, for vacancies listed in this notice. Concurrently, nomination materials for mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:17 Jul 28, 2011 Jkt 223001 prospective candidates should be sent to FDA by August 29, 2011. ADDRESSES: All letters of interest and nominations should be submitted in writing to Cicely Reese (see FOR FURTHER INFORMATION CONTACT). FOR FURTHER INFORMATION CONTACT: Cicely Reese, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002. 301–796–9001, e-mail: Cicely.Reese@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Section 120 of the FDA Modernization Act of 1997 (FDAMA) (21 U.S.C. 355) requires that newly formed FDA advisory committees include representatives from the drug manufacturing industries. Although not required for committees existing prior to the passage of FDAMA, to keep within the spirit of FDAMA, the Agency has added nonvoting industry representatives to CDER advisory committees identified in the following paragraphs. I. CDER Advisory Committees A. Advisory Committee for Pharmaceutical Science and Clinical Pharmacology Advises 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. B. Advisory Committee for Reproductive Health Drugs Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in obstetrics, gynecology, and contraception. C. Anesthetic and Life Support Drugs Advisory Committee Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 Cellular Tissue and Gene Therapy. Vaccines and Related Biological Products. Radiological Devices Panel. drug products for use in anesthesiology and surgery. D. Anti-Infective 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 infectious diseases and disorders. E. Antiviral 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 acquired immune deficiency syndrome (AIDS), HIV-related illnesses, and other viral, fungal, and mycobacterial infections. F. Arthritis 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 arthritis, rheumatism, and related diseases. G. Cardiovascular and Renal 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 cardiovascular and renal disorders. H. Dermatologic and Ophthalmic 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 dermatologic and ophthalmic disorders. I. Drug Safety and Risk Management Advisory Committee Advises the Commissioner of Food and Drugs (the Commissioner) regarding the scientific and medical evaluation of all information gathered by the E:\FR\FM\29JYN1.SGM 29JYN1

Agencies

[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]

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

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.

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

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 https://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
----------------------------------------------------------------------------------------------------------------
Current & upcoming
Committee/panel/areas of expertise needed vacancies Approximate date needed
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------

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
------------------------------------------------------------------------
Contact person Committee/panel
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

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

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