81 FR 50706 - Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 148 (August 2, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 148 (August 2, 2016)
| Page Range | 50706-50708 | |
| FR Document | 2016-18216 |
[Federal Register Volume 81, Number 148 (Tuesday, August 2, 2016)] [Notices] [Pages 50706-50708] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-18216] ======================================================================= ----------------------------------------------------------------------- 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 [email protected], 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: http://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: [email protected]. 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: [email protected]. 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: [email protected]. 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: [email protected]. 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: [email protected]. 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: [email protected]. [[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: [email protected]. 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: [email protected]. ------------------------------------------------------------------------ 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
![50706 Federal Register / Vol. 81, No. 148 / Tuesday, August 2, 2016 / Notices
SUPPLEMENTARY INFORMATION: In recent ACTION: Notice. fda.hhs.gov, by mail to Advisory
years, a new kind of transportation Committee Oversight and Management
service provider, known as SUMMARY: The Food and Drug Staff, 10903 New Hampshire Ave., Bldg.
Transportation Network Companies Administration (FDA) is requesting that 32, Rm. 5103, Silver Spring, MD 20993–
(TNCs), have begun operations across any consumer organizations interested 0002, or by FAX at: 301–847–8640.
the United States and the world. TNCs in participating in the selection of
Consumer representative nominations
connect paying passengers with drivers- voting and/or nonvoting consumer
should be submitted electronically by
for-hire via Web sites and mobile apps. representatives to serve on its advisory
logging into the FDA Advisory
TNCs are a form of special conveyance committees or panels notify FDA in
Committee Membership Nomination
for purposes of the Federal Travel writing. FDA is also requesting
Portal at: https://
Regulation (FTR), and may be an nominations for voting and/or
www.accessdata.fda.gov/scripts/
nonvoting consumer representatives to
efficient and cost effective alternative to FACTRSPortal/FACTRS/index.cfm, by
serve on advisory committees and/or
taxis or rental cars. This bulletin mail to Advisory Committee Oversight
panels for which vacancies currently
provides guidance to agencies subject to and Management Staff, 10903 New
exist or are expected to occur in the near
FTR to clarify that they may authorize Hampshire Ave., Bldg. 32, Rm. 5103,
future. Nominees recommended to serve
and reimburse employees for use of Silver Spring, MD 20993–0002, or by
as a voting or nonvoting consumer
TNC for official business away from the FAX at: 301–847–8640. Additional
representative may be self-nominated or
employee’s official station in information about becoming a member
may be nominated by a consumer
accordance with internal agency policy on an FDA advisory committee can also
organization. FDA seeks to include the
and when permissible under local laws be obtained by visiting FDA’s Web site
views of women and men, members of
and ordinances. Pursuant to the all racial and ethnic groups, and at: http://www.fda.gov/
authority of 5 U.S.C. 5702(a) this individuals with and without AdvisoryCommittees/default.htm.
bulletin applies only to employees on disabilities on its advisory committees FOR FURTHER INFORMATION CONTACT: For
temporary duty travel. FTR Bulletin 16– and, therefore, encourages nominations questions relating to participation in the
05 and all other FTR Bulletins can be of appropriately qualified candidates selection process: Kimberly Hamilton,
found at www.gsa.gov/ftrbulletin. from these groups. Advisory Committee Oversight and
Dated: July 28, 2016. DATES: Any consumer organization Management Staff (ACOMS), Food and
Troy Cribb, interested in participating in the Drug Administration, 10903 New
Associate Administrator, Office of selection of an appropriate voting or Hampshire Ave., Bldg. 32, Rm. 5103,
Government-wide Policy. nonvoting member to represent Silver Spring, MD 20993–0002, 301–
[FR Doc. 2016–18279 Filed 8–1–16; 8:45 am] consumer interests on an FDA advisory 796–8220, email: kimberly.hamilton@
BILLING CODE 6820–14–P committee or panel may send a letter or fda.hhs.gov.
email stating that interest to FDA (see For questions relating to specific
ADDRESSES) by September 1, 2016, for advisory committees or panels, contact
DEPARTMENT OF HEALTH AND vacancies listed in this notice. the appropriate Contact Person listed in
HUMAN SERVICES Concurrently, nomination materials for table 1 in the SUPPLEMENTARY
prospective candidates should be sent to INFORMATION section.
Food and Drug Administration FDA (see ADDRESSES) by September 1, SUPPLEMENTARY INFORMATION:
2016. Nominations will be accepted for
[Docket No. FDA–2016–N–0001] current vacancies and for those that will I. Background
or may occur through January 31, 2017. FDA is requesting that any consumer
Request for Nominations for
ADDRESSES: All statements of interest organizations interested in participating
Individuals and Consumer
Organizations for Advisory from consumer organizations interested in the selection of voting and/or
Committees in participating in the selection process nonvoting consumer representatives to
and consumer representative serve on its advisory committees or
AGENCY: Food and Drug Administration, nominations should be submitted panels notify FDA in writing (see table
HHS. electronically to kimberly.hamilton@ 1 for Contact Person).
TABLE 1—ADVISORY COMMITTEE CONTACTS
Contact person Committee/panel
Bryan Emery, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Blood Products Advisory Com-
Hampshire Ave., Bldg. 71, Rm. 6132, Silver Spring, MD 20993–0002, phone: 240–402–8054, email: mittee.
Bryan.Emery@fda.hhs.gov.
Evella Washington, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Ear, Nose and Throat Devices
Hampshire Ave., Bldg. 66, Rm. 1535, Silver Spring, MD 20993–0002, phone: 301–796–6683, email: Panel.
Evella.Washington@fda.hhs.gov.
Cindy Hong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hamp- Gastrointestinal Drugs Advisory
shire Ave., Bldg. 31, Rm. 2430, Silver Spring, MD 20993–0002, phone: 301–796–0889, email: Committee.
Cindy.Hong@fda.hhs.gov.
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Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Medical Imaging Advisory Com-
Hampshire Ave., Bldg. 31, Rm. 2434, Silver Spring, MD 20993–0002, phone: 301–796–4043, email: Jen- mittee.
nifer.Shepherd@fda.hhs.gov.
Sara Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New National Mammography Quality As-
Hampshire Ave., Bldg. 66, Rm. 1643, Silver Spring, MD 20993–0002, phone: 301–796–0889, email: surance Advisory Committee.
Sara.Anderson@fda.hhs.gov.
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![50708 Federal Register / Vol. 81, No. 148 / Tuesday, August 2, 2016 / Notices
drug products for use in the treatment organizations, (2) be able to analyze which the nominee is recommended. In
of gastrointestinal diseases. technical data, (3) understand research addition, nominations should include
design, (4) discuss benefits and risks, confirmation that the nominee is aware
D. Medical Imaging Advisory Committee
and (5) evaluate the safety and efficacy of the nomination, unless self-
Reviews and evaluates data of products under review. The nominated. FDA will ask potential
concerning the safety and effectiveness consumer representative should be able candidates to provide detailed
of marketed and investigational human to represent the consumer perspective information concerning such matters as
drug products for use in diagnostic and on issues and actions before the financial holdings, employment, and
therapeutic procedures using advisory committee; serve as a liaison research grants and/or contracts to
radioactive pharmaceuticals and between the committee and interested permit evaluation of possible sources of
contrast media used in diagnostic consumers, associations, coalitions, and conflicts of interest. Members will be
radiology. consumer organizations; and facilitate invited to serve for terms up to 4 years.
dialogue with the advisory committees FDA will review all nominations
E. National Mammography Quality
on scientific issues that affect received within the specified
Assurance Advisory Committee timeframes and prepare a ballot
consumers.
Advises the Agency on the following: containing the names of qualified
(1) Development of appropriate quality IV. Selection Procedures nominees. Names not selected will
standards and regulations for Selection of members representing remain on a list of eligible nominees
mammography facilities; (2) standards consumer interests is conducted and be reviewed periodically by FDA to
and regulations for bodies accrediting through procedures that include the use determine continued interest. Upon
mammography facilities under this of organizations representing the public selecting qualified nominees for the
program; regulations with respect to interest and public advocacy groups. ballot, FDA will provide those
sanctions; (3) procedures for monitoring These organizations recommend consumer organizations that are
compliance with standards; (4) nominees for the Agency’s selection. participating in the selection process
establishing a mechanism to investigate Representatives from the consumer with the opportunity to vote on the
consumer complaints; (5) reporting new health branches of Federal, State, and listed nominees. Only organizations
developments concerning breast local governments also may participate vote in the selection process. Persons
imaging which should be considered in in the selection process. Any consumer who nominate themselves to serve as
the oversight of mammography organization interested in participating voting or nonvoting consumer
facilities; (6) determining whether there in the selection of an appropriate voting representatives will not participate in
exists a shortage of mammography or nonvoting member to represent the selection process.
facilities in rural and health consumer interests should send a letter This notice is issued under the
professional shortage areas and stating that interest to FDA (see Federal Advisory Committee Act (5
determining the effects of personnel on ADDRESSES) within 30 days of U.S.C. app. 2) and 21 CFR part 14,
access to the services of such facilities publication of this document. relating to advisory committees.
in such areas; (7) determining whether Within the subsequent 30 days, FDA Dated: July 27, 2016.
there will exist a sufficient number of will compile a list of consumer
Janice M. Soreth,
medical physicists after October 1, 1999; organizations that will participate in the
Acting Associate Commissioner, Special
and (8) determining the costs and selection process and will forward to
Medical Programs.
benefits of compliance with these each such organization a ballot listing at
[FR Doc. 2016–18216 Filed 8–1–16; 8:45 am]
requirements. least two qualified nominees selected by
BILLING CODE 4164–01–P
the Agency based on the nominations
F. Peripheral and Central Nervous received, together with each nominee’s
System Advisory Committee current curriculum vitae or resume.
DEPARTMENT OF HEALTH AND
Reviews and evaluates data Ballots are to be filled out and returned
HUMAN SERVICES
concerning the safety and effectiveness to FDA within 30 days. The nominee
of marketed and investigational human receiving the highest number of votes Food and Drug Administration
drug products for use in the treatment ordinarily will be selected to serve as
of neurologic diseases. the member representing consumer [Docket No. FDA–2016–D–2071]
interests for that particular advisory
G. Vaccines and Related Biological Determining Donor Eligibility for
committee or panel.
Products Advisory Committee Autologous Donors of Blood and
Reviews and evaluates data V. Nomination Procedures Blood Components Intended Solely for
concerning the safety, effectiveness, and Any interested person or organization Autologous Use—Compliance Policy;
appropriate use of vaccines and related may nominate one or more qualified Guidance for Industry; Availability
biological products which are intended persons to represent consumer interests AGENCY: Food and Drug Administration,
for use in the prevention, treatment, or on the Agency’s advisory committees or HHS.
diagnosis of human diseases, as well as panels. Self-nominations are also ACTION: Notice of availability.
considers the quality and relevance of accepted. Nominations should include a
FDA’s research program which provides cover letter and current curriculum SUMMARY: The Food and Drug
scientific support for the regulation of vitae or resume for each nominee, Administration (FDA or Agency or we)
including a current business and/or is announcing the availability of a
mstockstill on DSK3G9T082PROD with NOTICES
these products.
home address, telephone number, and document titled ‘‘Determining Donor
III. Criteria for Members email address if available, and a list of Eligibility for Autologous Donors of
Persons nominated for membership as consumer or community-based Blood and Blood Components Intended
consumer representatives on organizations for which the candidate Solely for Autologous Use—Compliance
committees or panels should meet the can demonstrate active participation. Policy; Guidance for Industry.’’ This
following criteria: (1) Demonstrate ties Nominations should also specify the guidance addresses the regulatory
to consumer and community-based advisory committee(s) or panel(s) for requirements for determining donor
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Document Created: 2016-08-02 01:47:51
Document Modified: 2016-08-02 01:47:51
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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 | |
| 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: [email protected] | |
| FR Citation | 81 FR 50706 |
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