Request for Nominations for Individuals and Consumer Organizations for Advisory Committees, 50706-50708 [2016-18216]

Download as PDF 50706 Federal Register / Vol. 81, No. 148 / Tuesday, August 2, 2016 / Notices In recent years, a new kind of transportation service provider, known as Transportation Network Companies (TNCs), have begun operations across the United States and the world. TNCs connect paying passengers with driversfor-hire via Web sites and mobile apps. TNCs are a form of special conveyance for purposes of the Federal Travel Regulation (FTR), and may be an efficient and cost effective alternative to taxis or rental cars. This bulletin provides guidance to agencies subject to FTR to clarify that they may authorize and reimburse employees for use of TNC for official business away from the employee’s official station in accordance with internal agency policy and when permissible under local laws and ordinances. Pursuant to the authority of 5 U.S.C. 5702(a) this bulletin applies only to employees on temporary duty travel. FTR Bulletin 16– 05 and all other FTR Bulletins can be found at www.gsa.gov/ftrbulletin. SUPPLEMENTARY INFORMATION: Dated: July 28, 2016. Troy Cribb, Associate Administrator, Office of Government-wide Policy. [FR Doc. 2016–18279 Filed 8–1–16; 8:45 am] BILLING CODE 6820–14–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0001] Request for Nominations for Individuals and Consumer Organizations for Advisory Committees AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups. DATES: Any consumer organization interested in participating in the selection of an appropriate voting or nonvoting member to represent consumer interests on an FDA advisory committee or panel may send a letter or email stating that interest to FDA (see ADDRESSES) by September 1, 2016, for vacancies listed in this notice. Concurrently, nomination materials for prospective candidates should be sent to FDA (see ADDRESSES) by September 1, 2016. Nominations will be accepted for current vacancies and for those that will or may occur through January 31, 2017. ADDRESSES: All statements of interest from consumer organizations interested in participating in the selection process and consumer representative nominations should be submitted electronically to kimberly.hamilton@ SUMMARY: fda.hhs.gov, by mail to Advisory Committee Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993– 0002, or by FAX at: 301–847–8640. Consumer representative nominations should be submitted electronically by logging into the FDA Advisory Committee Membership Nomination Portal at: https:// www.accessdata.fda.gov/scripts/ FACTRSPortal/FACTRS/index.cfm, by mail to Advisory Committee Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993–0002, or by FAX at: 301–847–8640. Additional information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA’s Web site at: https://www.fda.gov/ AdvisoryCommittees/default.htm. FOR FURTHER INFORMATION CONTACT: For questions relating to participation in the selection process: Kimberly Hamilton, Advisory Committee Oversight and Management Staff (ACOMS), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993–0002, 301– 796–8220, email: kimberly.hamilton@ fda.hhs.gov. For questions relating to specific advisory committees or panels, contact the appropriate Contact Person listed in table 1 in the SUPPLEMENTARY INFORMATION section. SUPPLEMENTARY INFORMATION: I. Background FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing (see table 1 for Contact Person). TABLE 1—ADVISORY COMMITTEE CONTACTS mstockstill on DSK3G9T082PROD with NOTICES Contact person Committee/panel Bryan Emery, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6132, Silver Spring, MD 20993–0002, phone: 240–402–8054, email: Bryan.Emery@fda.hhs.gov. Evella Washington, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1535, Silver Spring, MD 20993–0002, phone: 301–796–6683, email: Evella.Washington@fda.hhs.gov. Cindy Hong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2430, Silver Spring, MD 20993–0002, phone: 301–796–0889, email: Cindy.Hong@fda.hhs.gov. Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2434, Silver Spring, MD 20993–0002, phone: 301–796–4043, email: Jennifer.Shepherd@fda.hhs.gov. Sara Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1643, Silver Spring, MD 20993–0002, phone: 301–796–0889, email: Sara.Anderson@fda.hhs.gov. VerDate Sep<11>2014 18:35 Aug 01, 2016 Jkt 238001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\02AUN1.SGM Blood Products mittee. Advisory Com- Ear, Nose and Throat Devices Panel. Gastrointestinal Committee. Drugs Advisory Medical Imaging Advisory Committee. National Mammography Quality Assurance Advisory Committee. 02AUN1 50707 Federal Register / Vol. 81, No. 148 / Tuesday, August 2, 2016 / Notices TABLE 1—ADVISORY COMMITTEE CONTACTS—Continued Contact person Committee/panel Moon Hee Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2434, Silver Spring, MD 20993–0002, phone: 301–796–2894, email: MoonHee.Choi@fda.hhs.gov. Sujata Vijh, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6128, Silver Spring, MD 20993–0002, phone: 240–4020–7107, email: Sujata.Vijh@fda.hhs.gov. Peripheral & Central Nervous Systems Advisory Committee. Vaccine and Related Biologic Products Advisory Committee. TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE NEEDED Committee/panel/areas of expertise needed Type of vacancy Blood Products Advisory Committee—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. Ear, Nose and Throat Devices Panel—Experts in otology, neurology, and audiology. Gastrointestinal Drugs Advisory Committee—Knowledgeable in the fields of gastroenterology, endocrinology, surgery, clinical pharmacology, physiology, pathology, liver function, motility, esophagitis, and statistics. Medical Imaging Advisory Committee—Knowledgeable in the fields of nuclear medicine, radiology, epidemiology, statistics, and related specialties. National Mammography Quality Assurance Advisory Committee—Physician, practitioner, or other health professional whose clinical practice, research specialization, or professional expertise includes a significant focus on mammography. Peripheral and Central Nervous System Drugs Advisory Committee—Knowledgeable in the fields of neurology, neuropharmacology, neuropathology, otolaryngology, epidemiology or statistics, and related specialties. Vaccines and Related Biological Products Advisory Committee—Knowledgeable in the fields of immunology, molecular biology, rDNA, virology, bacteriology, epidemiology or biostatistics, allergy, preventive medicine, infectious diseases, pediatrics, microbiology, and biochemistry. 1—Voting ............................ Immediately. 1—Nonvoting ...................... Immediately. 1—Voting ............................ Immediately. 1—Voting ............................ Immediately. 1—Nonvoting ...................... January 31, 2017. 1—Voting ............................ January 31, 2017. 1—Voting ............................ Immediately. II. Functions and General Description of the Committee Duties mstockstill on DSK3G9T082PROD with NOTICES A. Blood Products Advisory 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. B. 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: (1) Advises on the classification or VerDate Sep<11>2014 18:35 Aug 01, 2016 Jkt 238001 reclassification of devices into one of three regulatory categories; (2) advises on any possible risks to health associated with the use of devices; (3) advises on formulation of product development protocols; (4) reviews premarket approval applications for medical devices; (5) reviews guidelines and guidance documents; (6) recommends exemption of certain devices from the application of portions of the Federal Food, Drug, and Cosmetic Act; (7) advises on the necessity to ban a device; and (8) 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 (the Commissioner) on issues relating to the design of clinical studies regarding the safety and effectiveness of marketed and investigational devices. The Dental Products Panel also functions at times as a dental drug PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 Approximate date needed panel. The functions of the dental drug panel are to evaluate and recommend whether various prescription drug products should be changed to over-thecounter status and to evaluate data and make recommendations concerning the approval of new dental drug products for human use. The Medical Devices Dispute Resolution Panel provides advice to the Commissioner on complex or contested scientific issues between FDA and medical device sponsors, applicants, or manufacturers relating to specific products, marketing applications, regulatory decisions and actions by FDA, and Agency guidance and policies. The Panel makes recommendations on issues that are lacking resolution, are highly complex in nature, or result from challenges to regular advisory panel proceedings or Agency decisions or actions. C. Gastrointestinal Drugs Advisory Committee Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human E:\FR\FM\02AUN1.SGM 02AUN1 50708 Federal Register / Vol. 81, No. 148 / Tuesday, August 2, 2016 / Notices drug products for use in the treatment of gastrointestinal diseases. D. Medical Imaging Advisory 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. E. National Mammography Quality Assurance Advisory Committee Advises the Agency on the following: (1) Development of appropriate quality standards and regulations for mammography facilities; (2) standards and regulations for bodies accrediting mammography facilities under this program; regulations with respect to sanctions; (3) procedures for monitoring compliance with standards; (4) establishing a mechanism to investigate consumer complaints; (5) reporting new developments concerning breast imaging which should be considered in the oversight of mammography facilities; (6) determining whether there exists a shortage of mammography facilities in rural and health professional shortage areas and determining the effects of personnel on access to the services of such facilities in such areas; (7) determining whether there will exist a sufficient number of medical physicists after October 1, 1999; and (8) determining the costs and benefits of compliance with these requirements. mstockstill on DSK3G9T082PROD with NOTICES F. Peripheral and Central Nervous System Advisory Committee Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of neurologic diseases. G. Vaccines and Related Biological Products Advisory Committee Reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, as well as considers the quality and relevance of FDA’s research program which provides scientific support for the regulation of these products. III. Criteria for Members Persons nominated for membership as consumer representatives on committees or panels should meet the following criteria: (1) Demonstrate ties to consumer and community-based VerDate Sep<11>2014 18:35 Aug 01, 2016 Jkt 238001 organizations, (2) be able to analyze technical data, (3) understand research design, (4) discuss benefits and risks, and (5) evaluate the safety and efficacy of products under review. The consumer representative should be able to represent the consumer perspective on issues and actions before the advisory committee; serve as a liaison between the committee and interested consumers, associations, coalitions, and consumer organizations; and facilitate dialogue with the advisory committees on scientific issues that affect consumers. IV. Selection Procedures Selection of members representing consumer interests is conducted through procedures that include the use of organizations representing the public interest and public advocacy groups. These organizations recommend nominees for the Agency’s selection. Representatives from the consumer health branches of Federal, State, and local governments also may participate in the selection process. Any consumer organization interested in participating in the selection of an appropriate voting or nonvoting member to represent consumer interests should send a letter stating that interest to FDA (see ADDRESSES) within 30 days of publication of this document. Within the subsequent 30 days, FDA will compile a list of consumer organizations that will participate in the selection process and will forward to each such organization a ballot listing at least two qualified nominees selected by the Agency based on the nominations received, together with each nominee’s current curriculum vitae or resume. Ballots are to be filled out and returned to FDA within 30 days. The nominee receiving the highest number of votes ordinarily will be selected to serve as the member representing consumer interests for that particular advisory committee or panel. V. Nomination Procedures Any interested person or organization may nominate one or more qualified persons to represent consumer interests on the Agency’s advisory committees or panels. Self-nominations are also accepted. Nominations should include a cover letter and current curriculum vitae or resume for each nominee, including a current business and/or home address, telephone number, and email address if available, and a list of consumer or community-based organizations for which the candidate can demonstrate active participation. Nominations should also specify the advisory committee(s) or panel(s) for PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 which the nominee is recommended. In addition, nominations should include confirmation that the nominee is aware of the nomination, unless selfnominated. FDA will ask potential candidates to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflicts of interest. Members will be invited to serve for terms up to 4 years. FDA will review all nominations received within the specified timeframes and prepare a ballot containing the names of qualified nominees. Names not selected will remain on a list of eligible nominees and be reviewed periodically by FDA to determine continued interest. Upon selecting qualified nominees for the ballot, FDA will provide those consumer organizations that are participating in the selection process with the opportunity to vote on the listed nominees. Only organizations vote in the selection process. Persons who nominate themselves to serve as voting or nonvoting consumer representatives will not participate in the selection process. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: July 27, 2016. Janice M. Soreth, Acting Associate Commissioner, Special Medical Programs. [FR Doc. 2016–18216 Filed 8–1–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–D–2071] Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use—Compliance Policy; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency or we) is announcing the availability of a document titled ‘‘Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use—Compliance Policy; Guidance for Industry.’’ This guidance addresses the regulatory requirements for determining donor SUMMARY: E:\FR\FM\02AUN1.SGM 02AUN1

Agencies

[Federal Register Volume 81, Number 148 (Tuesday, August 2, 2016)]
[Notices]
[Pages 50706-50708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18216]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Request for Nominations for Individuals and Consumer
Organizations for Advisory Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting that any
consumer organizations interested in participating in the selection of
voting and/or nonvoting consumer representatives to serve on its
advisory committees or panels notify FDA in writing. FDA is also
requesting nominations for voting and/or nonvoting consumer
representatives to serve on advisory committees and/or panels for which
vacancies currently exist or are expected to occur in the near future.
Nominees recommended to serve as a voting or nonvoting consumer
representative may be self-nominated or may be nominated by a consumer
organization. FDA seeks to include the views of women and men, members
of all racial and ethnic groups, and individuals with and without
disabilities on its advisory committees and, therefore, encourages
nominations of appropriately qualified candidates from these groups.

DATES: Any consumer organization interested in participating in the
selection of an appropriate voting or nonvoting member to represent
consumer interests on an FDA advisory committee or panel may send a
letter or email stating that interest to FDA (see ADDRESSES) by
September 1, 2016, for vacancies listed in this notice. Concurrently,
nomination materials for prospective candidates should be sent to FDA
(see ADDRESSES) by September 1, 2016. Nominations will be accepted for
current vacancies and for those that will or may occur through January
31, 2017.

ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process and consumer
representative nominations should be submitted electronically to
kimberly.hamilton@fda.hhs.gov, by mail to Advisory Committee Oversight
and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993-0002, or by FAX at: 301-847-8640.
Consumer representative nominations should be submitted
electronically by logging into the FDA Advisory Committee Membership
Nomination Portal at: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, by mail to Advisory Committee Oversight
and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993-0002, or by FAX at: 301-847-8640. Additional
information about becoming a member on an FDA advisory committee can
also be obtained by visiting FDA's Web site at: https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: For questions relating to
participation in the selection process: Kimberly Hamilton, Advisory
Committee Oversight and Management Staff (ACOMS), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver
Spring, MD 20993-0002, 301-796-8220, email:
kimberly.hamilton@fda.hhs.gov.
For questions relating to specific advisory committees or panels,
contact the appropriate Contact Person listed in table 1 in the
SUPPLEMENTARY INFORMATION section.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is requesting that any consumer organizations interested in
participating in the selection of voting and/or nonvoting consumer
representatives to serve on its advisory committees or panels notify
FDA in writing (see table 1 for Contact Person).

Table 1--Advisory Committee Contacts
------------------------------------------------------------------------
Contact person Committee/panel
------------------------------------------------------------------------
Bryan Emery, Center for Biologics Blood Products Advisory
Evaluation and Research, Food and Drug Committee.
Administration, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 6132, Silver Spring, MD
20993-0002, phone: 240-402-8054, email:
Bryan.Emery@fda.hhs.gov.
Evella Washington, Center for Devices and Ear, Nose and Throat
Radiological Health, Food and Drug Devices Panel.
Administration, 10903 New Hampshire Ave.,
Bldg. 66, Rm. 1535, Silver Spring, MD
20993-0002, phone: 301-796-6683, email:
Evella.Washington@fda.hhs.gov.
Cindy Hong, Center for Drug Evaluation and Gastrointestinal Drugs
Research, Food and Drug Administration, Advisory Committee.
10903 New Hampshire Ave., Bldg. 31, Rm.
2430, Silver Spring, MD 20993-0002, phone:
301-796-0889, email:
Cindy.Hong@fda.hhs.gov.
Jennifer Shepherd, Center for Drug Medical Imaging Advisory
Evaluation and Research, Food and Drug Committee.
Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2434, Silver Spring, MD
20993-0002, phone: 301-796-4043, email:
Jennifer.Shepherd@fda.hhs.gov.
Sara Anderson, Center for Devices and National Mammography
Radiological Health, Food and Drug Quality Assurance Advisory
Administration, 10903 New Hampshire Ave., Committee.
Bldg. 66, Rm. 1643, Silver Spring, MD
20993-0002, phone: 301-796-0889, email:
Sara.Anderson@fda.hhs.gov.

[[Page 50707]]

Moon Hee Choi, Center for Drug Evaluation Peripheral & Central
and Research, Food and Drug Nervous Systems Advisory
Administration, 10903 New Hampshire Ave., Committee.
Bldg. 31, Rm. 2434, Silver Spring, MD
20993-0002, phone: 301-796-2894, email:
MoonHee.Choi@fda.hhs.gov.
Sujata Vijh, Center for Biologics Vaccine and Related
Evaluation and Research, Food and Drug Biologic Products Advisory
Administration, 10903 New Hampshire Ave., Committee.
Bldg. 71, Rm. 6128, Silver Spring, MD
20993-0002, phone: 240-4020-7107, email:
Sujata.Vijh@fda.hhs.gov.
------------------------------------------------------------------------

Table 2--Committee Descriptions, Type of Consumer Representative
Vacancy, and Approximate Date Needed
------------------------------------------------------------------------
Committee/panel/areas of Approximate date
expertise needed Type of vacancy needed
------------------------------------------------------------------------
Blood Products Advisory 1--Voting......... Immediately.
Committee--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.
Ear, Nose and Throat Devices 1--Nonvoting...... Immediately.
Panel--Experts in otology,
neurology, and audiology.
Gastrointestinal Drugs Advisory 1--Voting......... Immediately.
Committee--Knowledgeable in the
fields of gastroenterology,
endocrinology, surgery,
clinical pharmacology,
physiology, pathology, liver
function, motility,
esophagitis, and statistics.
Medical Imaging Advisory 1--Voting......... Immediately.
Committee--Knowledgeable in the
fields of nuclear medicine,
radiology, epidemiology,
statistics, and related
specialties.
National Mammography Quality 1--Nonvoting...... January 31, 2017.
Assurance Advisory Committee--
Physician, practitioner, or
other health professional whose
clinical practice, research
specialization, or professional
expertise includes a
significant focus on
mammography.
Peripheral and Central Nervous 1--Voting......... January 31, 2017.
System Drugs Advisory
Committee--Knowledgeable in the
fields of neurology,
neuropharmacology,
neuropathology, otolaryngology,
epidemiology or statistics, and
related specialties.
Vaccines and Related Biological 1--Voting......... Immediately.
Products Advisory Committee--
Knowledgeable in the fields of
immunology, molecular biology,
rDNA, virology, bacteriology,
epidemiology or biostatistics,
allergy, preventive medicine,
infectious diseases,
pediatrics, microbiology, and
biochemistry.
------------------------------------------------------------------------

II. Functions and General Description of the Committee Duties

A. Blood Products Advisory 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.

B. 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: (1)
Advises on the classification or reclassification of devices into one
of three regulatory categories; (2) advises on any possible risks to
health associated with the use of devices; (3) advises on formulation
of product development protocols; (4) reviews premarket approval
applications for medical devices; (5) reviews guidelines and guidance
documents; (6) recommends exemption of certain devices from the
application of portions of the Federal Food, Drug, and Cosmetic Act;
(7) advises on the necessity to ban a device; and (8) 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 (the
Commissioner) on issues relating to the design of clinical studies
regarding the safety and effectiveness of marketed and investigational
devices.
The Dental Products Panel also functions at times as a dental drug
panel. The functions of the dental drug panel are to evaluate and
recommend whether various prescription drug products should be changed
to over-the-counter status and to evaluate data and make
recommendations concerning the approval of new dental drug products for
human use.
The Medical Devices Dispute Resolution Panel provides advice to the
Commissioner on complex or contested scientific issues between FDA and
medical device sponsors, applicants, or manufacturers relating to
specific products, marketing applications, regulatory decisions and
actions by FDA, and Agency guidance and policies. The Panel makes
recommendations on issues that are lacking resolution, are highly
complex in nature, or result from challenges to regular advisory panel
proceedings or Agency decisions or actions.

C. Gastrointestinal Drugs Advisory Committee

Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human

[[Page 50708]]

drug products for use in the treatment of gastrointestinal diseases.

D. Medical Imaging Advisory 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.

E. National Mammography Quality Assurance Advisory Committee

Advises the Agency on the following: (1) Development of appropriate
quality standards and regulations for mammography facilities; (2)
standards and regulations for bodies accrediting mammography facilities
under this program; regulations with respect to sanctions; (3)
procedures for monitoring compliance with standards; (4) establishing a
mechanism to investigate consumer complaints; (5) reporting new
developments concerning breast imaging which should be considered in
the oversight of mammography facilities; (6) determining whether there
exists a shortage of mammography facilities in rural and health
professional shortage areas and determining the effects of personnel on
access to the services of such facilities in such areas; (7)
determining whether there will exist a sufficient number of medical
physicists after October 1, 1999; and (8) determining the costs and
benefits of compliance with these requirements.

F. Peripheral and Central Nervous System Advisory Committee

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

G. Vaccines and Related Biological Products Advisory Committee

Reviews and evaluates data concerning the safety, effectiveness,
and appropriate use of vaccines and related biological products which
are intended for use in the prevention, treatment, or diagnosis of
human diseases, as well as considers the quality and relevance of FDA's
research program which provides scientific support for the regulation
of these products.

III. Criteria for Members

Persons nominated for membership as consumer representatives on
committees or panels should meet the following criteria: (1)
Demonstrate ties to consumer and community-based organizations, (2) be
able to analyze technical data, (3) understand research design, (4)
discuss benefits and risks, and (5) evaluate the safety and efficacy of
products under review. The consumer representative should be able to
represent the consumer perspective on issues and actions before the
advisory committee; serve as a liaison between the committee and
interested consumers, associations, coalitions, and consumer
organizations; and facilitate dialogue with the advisory committees on
scientific issues that affect consumers.

IV. Selection Procedures

Selection of members representing consumer interests is conducted
through procedures that include the use of organizations representing
the public interest and public advocacy groups. These organizations
recommend nominees for the Agency's selection. Representatives from the
consumer health branches of Federal, State, and local governments also
may participate in the selection process. Any consumer organization
interested in participating in the selection of an appropriate voting
or nonvoting member to represent consumer interests should send a
letter stating that interest to FDA (see ADDRESSES) within 30 days of
publication of this document.
Within the subsequent 30 days, FDA will compile a list of consumer
organizations that will participate in the selection process and will
forward to each such organization a ballot listing at least two
qualified nominees selected by the Agency based on the nominations
received, together with each nominee's current curriculum vitae or
resume. Ballots are to be filled out and returned to FDA within 30
days. The nominee receiving the highest number of votes ordinarily will
be selected to serve as the member representing consumer interests for
that particular advisory committee or panel.

V. Nomination Procedures

Any interested person or organization may nominate one or more
qualified persons to represent consumer interests on the Agency's
advisory committees or panels. Self-nominations are also accepted.
Nominations should include a cover letter and current curriculum vitae
or resume for each nominee, including a current business and/or home
address, telephone number, and email address if available, and a list
of consumer or community-based organizations for which the candidate
can demonstrate active participation.
Nominations should also specify the advisory committee(s) or
panel(s) for which the nominee is recommended. In addition, nominations
should include confirmation that the nominee is aware of the
nomination, unless self-nominated. FDA will ask potential candidates to
provide detailed information concerning such matters as financial
holdings, employment, and research grants and/or contracts to permit
evaluation of possible sources of conflicts of interest. Members will
be invited to serve for terms up to 4 years.
FDA will review all nominations received within the specified
timeframes and prepare a ballot containing the names of qualified
nominees. Names not selected will remain on a list of eligible nominees
and be reviewed periodically by FDA to determine continued interest.
Upon selecting qualified nominees for the ballot, FDA will provide
those consumer organizations that are participating in the selection
process with the opportunity to vote on the listed nominees. Only
organizations vote in the selection process. Persons who nominate
themselves to serve as voting or nonvoting consumer representatives
will not participate in the selection process.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

Dated: July 27, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-18216 Filed 8-1-16; 8:45 am]
BILLING CODE 4164-01-P

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