83 FR 36605 - Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 146 (July 30, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 146 (July 30, 2018)
| Page Range | 36605-36607 | |
| FR Document | 2018-16161 |
[Federal Register Volume 83, Number 146 (Monday, July 30, 2018)] [Notices] [Pages 36605-36607] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-16161] [[Page 36605]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-1095] 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 August 29, 2018, for vacancies listed in this notice. Concurrently, nomination materials for prospective candidates should be sent to FDA (see ADDRESSES) by August 29, 2018. Nominations will be accepted for current vacancies and for those that will or may occur through September 30, 2018. 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: 301-847-8640. Consumer representative nominations should be submitted electronically by logging into the FDA Advisory Committee Membership Nomination Portal: 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: 301-847-8640. Additional information about becoming a member of an FDA advisory committee can also be obtained by visiting FDA's website 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 protected]. For questions relating to specific advisory committees or panels, contact the appropriate contact person listed in table 1. Table 1--Advisory Committee Contacts ------------------------------------------------------------------------ Contact person Committee/panel ------------------------------------------------------------------------ Moon Hee V. Choi, Center for Drug Anesthetic and Analgesic Drug Evaluation and Research, Food and Drug Products Advisory Committee. Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2434, Silver Spring, MD 20993-0002, 301-796-2894, [email protected]. Lauren Tesh, Center for Drug Evaluation Antimicrobial Advisory and Research, Food and Drug Committee. Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2426, Silver Spring, MD 20993-0002, 301-796-2721, [email protected]. Kalyani Bhatt, Center for Drug Bone, Reproductive, and Evaluation and Research, Food and Drug Urological Drugs Advisory Administration, 10903 New Hampshire Committee. Ave., Bldg. 31, Rm. 2438, Silver Spring, MD 20993-0002, 301-796-9005, [email protected]. Jennifer Shepherd, Center for Drug Cardiovascular and Renal Drugs Evaluation and Research, Food and Drug Advisory Committee; Medical Administration, 10903 New Hampshire Imaging Advisory Committee. Ave., Bldg. 31, Rm. 2434, Silver Spring, MD 20993-0002, 301-796-4043, [email protected]. Cindy Chee, Center for Drug Evaluation Pharmacy Compounding Advisory and Research, Food and Drug Committee. Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2430, Silver Spring, MD 20993-0002, 301-796-0889, [email protected]. Patricio Garcia, Center for Devices and Clinical Chemistry and Radiological Health, Food and Drug Clinical Toxicology Devices Administration, 10903 New Hampshire Panel; Gastroenterology and Ave., Bldg. 66, Rm. G610, Silver Urology Devices Panel. Spring, MD 20993-0002, 301-796-6875, [email protected]. Evella Washington, Center for Devices Ear, Nose, and Throat Devices and Radiological Health, Food and Drug Panel. Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G640, Silver Spring, MD 20993-0002, 301-796-6683, [email protected]. Pamela Scott, Center for Devices and Medical Devices Dispute Radiological Health, Food and Drug Resolution Panel. Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5572, Silver Spring, MD 20993-0002, 301-796-5433, [email protected]. Aden Asefa, Center for Devices and Microbiology Devices Panel; Radiological Health, Food and Drug Radiology Devices Panel. Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G642, Silver Spring, MD 20993-0002, 301-796-0400, [email protected]. Sara Anderson, Center for Devices and Orthopaedic and Rehabilitation Radiological Health, Food and Drug Devices Panel. Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G616, Silver Spring, MD 20993-0002, 301-796-7047, [email protected]. ------------------------------------------------------------------------ [[Page 36606]] SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting and/or nonvoting consumer representatives for the vacancies listed in table 2: Table 2--Committee Descriptions, Type of Consumer Representative Vacancy, and Approximate Date Needed ---------------------------------------------------------------------------------------------------------------- Committee/panel/areas of expertise needed Type of vacancy Approximate date needed ---------------------------------------------------------------------------------------------------------------- Anesthetic and Analgesic Drug Products 1--Voting.......................... Immediately. Advisory Committee--Knowledgeable in the fields of anesthesiology, surgery, epidemiology or statistics, and related specialties.. Antimicrobial Advisory Committee-- 1--Voting.......................... Immediately. Knowledgeable in the fields of infectious disease, internal medicine, microbiology, pediatrics, epidemiology or statistics, and related specialties. Bone, Reproductive, and Urological 1--Voting.......................... Immediately. Drugs Advisory Committee-- Knowledgeable in the fields of obstetrics, gynecology, endocrinology, pediatrics, epidemiology or statistics, and related specialties. Cardiovascular and Renal Drugs 1--Voting.......................... Immediately. Advisory Committee--Knowledgeable in the fields of cardiology, hypertension, arrhythmia, angina, congestive heart failure, diuresis, and biostatistics. Medical Imaging Advisory Committee-- 1--Voting.......................... Immediately. Knowledgeable in the fields of nuclear medicine, radiology, epidemiology, statistics, and related specialties. Pharmacy Compounding Advisory 1--Voting.......................... September 30, 2018. Committee--Knowledgeable in the fields of pharmaceutical compounding, pharmaceutical manufacturing pharmacy, medicine, and other related specialties. Clinical Chemistry and Clinical 1--Nonvoting....................... Immediately. Toxicology Devices Panel--Doctors of medicine or philosophy with experience in clinical chemistry (e.g., cardiac markers), clinical toxicology, clinical pathology, clinical laboratory medicine, and endocrinology. Gastroenterology and Urology Devices 1--Nonvoting....................... Immediately. Panel--Gastroenterologists, urologists, and nephrologists. Radiology Devices Panel--Physicians 1--Nonvoting....................... Immediately. with experience in general radiology, mammography, ultrasound, magnetic resonance, computed tomography, other radiological subspecialties and radiation oncology; scientists with experience in diagnostic devices, radiation physics, statistical analysis, digital imaging, and image analysis. Ear, Nose and Throat Devices Panel-- 1--Nonvoting....................... Immediately. Experts in otology, neurology, and audiology. Medical Devices Dispute Resolution-- 1--Nonvoting....................... Immediately. Experts with broad, cross-cutting scientific, clinical, analytical, or mediation skills. Microbiology Devices Panel--Clinicians 1--Nonvoting....................... Immediately. with expertise in infectious disease, e.g., pulmonary disease specialists, sexually transmitted disease specialists, pediatric infectious disease specialists, experts in tropical medicine and emerging infectious diseases, mycologists; clinical microbiologists and virologists; clinical virology and microbiology laboratory directors, with expertise in clinical diagnosis and in vitro diagnostic assays, e.g., hepatologists; molecular biologists. Orthopaedic and Rehabilitation Devices 1--Nonvoting....................... Immediately. Panel--Orthopedic surgeons (joint spine, trauma, and pediatric); rheumatologists; engineers (biomedical, biomaterials, and biomechanical); experts in rehabilitation medicine, sports medicine, and connective tissue engineering; and biostatisticians.. ---------------------------------------------------------------------------------------------------------------- I. Functions and General Description of the Committee Duties A. Anesthetic and Analgesic Drug Products Advisory Committee Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in anesthesiology and surgery. B. Antimicrobial 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. C. Bone, Reproductive, and Urological Drugs Advisory Committee Reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in the practice of obstetrics, gynecology, and related specialties. D. 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. E. 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. F. Pharmacy Compounding Advisory Committee Provides advice on scientific, technical, and medical issues concerning drug compounding by pharmacists and licensed practitioners. G. Certain Panels of the Medical Devices Advisory Committee Reviews and evaluates data on the safety and effectiveness of marketed and investigational devices and makes recommendations for their regulation. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, advises on the classification or reclassification of devices into one of three regulatory categories; advises on any possible risks to health associated with the use of devices; advises on formulation of product development protocols; reviews premarket approval applications for medical devices; reviews guidelines and guidance documents; recommends exemption of certain devices from the application of portions of the Federal Food, Drug, and Cosmetic Act; advises on the necessity to ban a device; and responds to requests from the Agency to review and [[Page 36607]] make recommendations on specific issues or problems concerning the safety and effectiveness of devices. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, may also make appropriate recommendations to the Commissioner of Food and Drugs on issues relating to the design of clinical studies regarding the safety and effectiveness of marketed and investigational devices. The Dental Products Panel also functions at times as a dental drug panel. The functions of the dental drug panel are to evaluate and recommend whether various prescription drug products should be changed to over-the-counter status and to evaluate data and make recommendations concerning the approval of new dental drug products for human use. 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. II. Criteria for Members Persons nominated for membership as consumer representatives on committees or panels should meet the following criteria: (1) Demonstrate an affiliation with and/or active participation in consumer or 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 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. 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. Nominations must include a current, complete resume or curriculum vitae for each nominee and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Nomination Portal (see ADDRESSES), and a list of consumer or community-based organizations for which the candidate can demonstrate active participation. Nominations must also specify the advisory committee(s) or panel(s) for which the nominee is recommended. In addition, nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will ask potential candidates to provide detailed information concerning such matters 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 24, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-16161 Filed 7-27-18; 8:45 am] BILLING CODE 4164-01-P
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DEPARTMENT OF HEALTH AND FDA seeks to include the views of 32, Rm. 5103, Silver Spring, MD 20993–
HUMAN SERVICES women and men, members of all racial 0002, or by Fax: 301–847–8640.
and ethnic groups, and individuals with Consumer representative nominations
Food and Drug Administration and without disabilities on its advisory should be submitted electronically by
committees and, therefore, encourages logging into the FDA Advisory
[Docket No. FDA–2018–N–1095] nominations of appropriately qualified Committee Membership Nomination
candidates from these groups. Portal: https://www.accessdata.fda.gov/
Request for Nominations for scripts/FACTRSPortal/FACTRS/
Individuals and Consumer DATES: Any consumer organization index.cfm, by mail to Advisory
Organizations for Advisory interested in participating in the Committee Oversight and Management
Committees selection of an appropriate voting or Staff, 10903 New Hampshire Ave., Bldg.
nonvoting member to represent 32, Rm. 5103, Silver Spring, MD 20993–
AGENCY: Food and Drug Administration, consumer interests on an FDA advisory 0002, or by Fax: 301–847–8640.
HHS. committee or panel may send a letter or Additional information about becoming
ACTION: Notice. email stating that interest to FDA (see a member of an FDA advisory
ADDRESSES) by August 29, 2018, for committee can also be obtained by
SUMMARY: The Food and Drug vacancies listed in this notice.
Administration (FDA) is requesting that visiting FDA’s website at https://
Concurrently, nomination materials for www.fda.gov/AdvisoryCommittees/
any consumer organizations interested prospective candidates should be sent to
in participating in the selection of default.htm.
FDA (see ADDRESSES) by August 29,
voting and/or nonvoting consumer 2018. Nominations will be accepted for FOR FURTHER INFORMATION CONTACT: For
representatives to serve on its advisory current vacancies and for those that will questions relating to participation in the
committees or panels notify FDA in or may occur through September 30, selection process: Kimberly Hamilton,
writing. FDA is also requesting 2018. Advisory Committee Oversight and
nominations for voting and/or Management Staff (ACOMS), Food and
nonvoting consumer representatives to ADDRESSES: All statements of interest Drug Administration, 10903 New
serve on advisory committees and/or from consumer organizations interested Hampshire Ave., Bldg. 32, Rm. 5103,
panels for which vacancies currently in participating in the selection process Silver Spring, MD 20993–0002, 301–
exist or are expected to occur in the near and consumer representative 796–8220, kimberly.hamilton@
future. Nominees recommended to serve nominations should be submitted fda.hhs.gov.
as a voting or nonvoting consumer electronically to ACOMSSubmissions@ For questions relating to specific
representative may be self-nominated or fda.hhs.gov, by mail to Advisory advisory committees or panels, contact
may be nominated by a consumer Committee Oversight and Management the appropriate contact person listed in
organization. Staff, 10903 New Hampshire Ave., Bldg. table 1.
TABLE 1—ADVISORY COMMITTEE CONTACTS
Contact person Committee/panel
Moon Hee V. Choi, Center for Drug Evaluation and Research, Food and Drug Admin- Anesthetic and Analgesic Drug Products Advisory Com-
istration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2434, Silver Spring, MD mittee.
20993–0002, 301–796–2894, MoonHee.Choi@fda.hhs.gov.
Lauren Tesh, Center for Drug Evaluation and Research, Food and Drug Administra- Antimicrobial Advisory Committee.
tion, 10903 New Hampshire Ave., Bldg. 31, Rm. 2426, Silver Spring, MD 20993–
0002, 301–796–2721, Lauren.Tesh@fda.hhs.gov.
Kalyani Bhatt, Center for Drug Evaluation and Research, Food and Drug Administra- Bone, Reproductive, and Urological Drugs Advisory
tion, 10903 New Hampshire Ave., Bldg. 31, Rm. 2438, Silver Spring, MD 20993– Committee.
0002, 301–796–9005, Kalyani.Bhatt@fda.hhs.gov.
Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug Admin- Cardiovascular and Renal Drugs Advisory Committee;
istration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2434, Silver Spring, MD Medical Imaging Advisory Committee.
20993–0002, 301–796–4043, Jennifer.Shepherd@fda.hhs.gov.
Cindy Chee, Center for Drug Evaluation and Research, Food and Drug Administra- Pharmacy Compounding Advisory Committee.
tion, 10903 New Hampshire Ave., Bldg. 31, Rm. 2430, Silver Spring, MD 20993–
0002, 301–796–0889, Cindy.Chee@fda.hhs.gov.
Patricio Garcia, Center for Devices and Radiological Health, Food and Drug Adminis- Clinical Chemistry and Clinical Toxicology Devices
tration, 10903 New Hampshire Ave., Bldg. 66, Rm. G610, Silver Spring, MD Panel; Gastroenterology and Urology Devices Panel.
20993–0002, 301–796–6875, Patricio.Garcia@fda.hhs.gov.
Evella Washington, Center for Devices and Radiological Health, Food and Drug Ad- Ear, Nose, and Throat Devices Panel.
ministration, 10903 New Hampshire Ave., Bldg. 66, Rm. G640, Silver Spring, MD
20993–0002, 301–796–6683, Evella.Washington@fda.hhs.gov.
Pamela Scott, Center for Devices and Radiological Health, Food and Drug Adminis- Medical Devices Dispute Resolution Panel.
tration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5572, Silver Spring, MD 20993–
0002, 301–796–5433, Pamela.Scott@fda.hhs.gov.
Aden Asefa, Center for Devices and Radiological Health, Food and Drug Administra- Microbiology Devices Panel; Radiology Devices Panel.
tion, 10903 New Hampshire Ave., Bldg. 66, Rm. G642, Silver Spring, MD 20993–
daltland on DSKBBV9HB2PROD with NOTICES
0002, 301–796–0400, Aden.Asefa@fda.hhs.gov.
Sara Anderson, Center for Devices and Radiological Health, Food and Drug Adminis- Orthopaedic and Rehabilitation Devices Panel.
tration, 10903 New Hampshire Ave., Bldg. 66, Rm. G616, Silver Spring, MD
20993–0002, 301–796–7047, Sara.Anderson@fda.hhs.gov.
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![Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices 36607
make recommendations on specific Representatives from the consumer participating in the selection process
issues or problems concerning the safety health branches of Federal, State, and with the opportunity to vote on the
and effectiveness of devices. With the local governments also may participate listed nominees. Only organizations
exception of the Medical Devices in the selection process. Any consumer vote in the selection process. Persons
Dispute Resolution Panel, each panel, organization interested in participating who nominate themselves to serve as
according to its specialty area, may also in the selection of an appropriate voting voting or nonvoting consumer
make appropriate recommendations to or nonvoting member to represent representatives will not participate in
the Commissioner of Food and Drugs on consumer interests should send a letter the selection process.
issues relating to the design of clinical stating that interest to FDA (see This notice is issued under the
studies regarding the safety and ADDRESSES) within 30 days of Federal Advisory Committee Act (5
effectiveness of marketed and publication of this document. U.S.C. app. 2) and 21 CFR part 14,
investigational devices. Within the subsequent 30 days, FDA relating to advisory committees.
The Dental Products Panel also will compile a list of consumer
Dated: July 24, 2018.
functions at times as a dental drug organizations that will participate in the
selection process and will forward to Leslie Kux,
panel. The functions of the dental drug
panel are to evaluate and recommend each such organization a ballot listing at Associate Commissioner for Policy.
whether various prescription drug least two qualified nominees selected by [FR Doc. 2018–16161 Filed 7–27–18; 8:45 am]
products should be changed to over-the- the Agency based on the nominations BILLING CODE 4164–01–P
counter status and to evaluate data and received, together with each nominee’s
make recommendations concerning the current curriculum vitae or resume.
approval of new dental drug products Ballots are to be filled out and returned DEPARTMENT OF HEALTH AND
for human use. to FDA within 30 days. The nominee HUMAN SERVICES
The Medical Devices Dispute receiving the highest number of votes
Resolution Panel provides advice to the ordinarily will be selected to serve as Food and Drug Administration
Commissioner on complex or contested the member representing consumer
scientific issues between FDA and interests for that particular advisory [Docket Nos. FDA–2014–N–1069; FDA–
medical device sponsors, applicants, or committee or panel. 2017–N–6931; FDA–2011–N–0362; FDA–
manufacturers relating to specific 2011–N–0279; FDA–2011–N–0672; FDA–
IV. Nomination Procedures 2014–N–0913; FDA–2017–N–0493; and
products, marketing applications, FDA–2011–N–0781]
regulatory decisions and actions by Any interested person or organization
FDA, and Agency guidance and may nominate one or more qualified
Agency Information Collection
policies. The Panel makes persons to represent consumer interests
Activities; Announcement of Office of
recommendations on issues that are on the Agency’s advisory committees or
Management and Budget Approvals
lacking resolution, are highly complex panels. Self-nominations are also
in nature, or result from challenges to accepted. Nominations must include a AGENCY: Food and Drug Administration,
regular advisory panel proceedings or current, complete resume or curriculum HHS.
Agency decisions or actions. vitae for each nominee and a signed ACTION: Notice.
copy of the Acknowledgement and
II. Criteria for Members Consent form available at the FDA SUMMARY: The Food and Drug
Persons nominated for membership as Advisory Nomination Portal (see Administration (FDA) is publishing a
consumer representatives on ADDRESSES), and a list of consumer or list of information collections that have
committees or panels should meet the community-based organizations for been approved by the Office of
following criteria: (1) Demonstrate an which the candidate can demonstrate Management and Budget (OMB) under
affiliation with and/or active active participation. the Paperwork Reduction Act of 1995.
participation in consumer or Nominations must also specify the
FOR FURTHER INFORMATION CONTACT: Ila
community-based organizations, (2) be advisory committee(s) or panel(s) for
S. Mizrachi, Office of Operations, Food
able to analyze technical data, (3) which the nominee is recommended. In
and Drug Administration, Three White
understand research design, (4) discuss addition, nominations must also
Flint North, 10A–12M, 11601
benefits and risks, and (5) evaluate the acknowledge that the nominee is aware
Landsdown St., North Bethesda, MD
safety and efficacy of products under of the nomination unless self-
20852, 301–796–7726, PRAStaff@
review. The consumer representative nominated. FDA will ask potential
fda.hhs.gov.
should be able to represent the candidates to provide detailed
consumer perspective on issues and information concerning such matters as SUPPLEMENTARY INFORMATION: The
actions before the advisory committee; financial holdings, employment, and following is a list of FDA information
serve as a liaison between the research grants and/or contracts to collections recently approved by OMB
committee and interested consumers, permit evaluation of possible sources of under section 3507 of the Paperwork
associations, coalitions, and consumer conflicts of interest. Members will be Reduction Act of 1995 (44 U.S.C. 3507).
organizations; and facilitate dialogue invited to serve for terms up to 4 years. The OMB control number and
with the advisory committees on FDA will review all nominations expiration date of OMB approval for
scientific issues that affect consumers. received within the specified each information collection are shown
timeframes and prepare a ballot in table 1. Copies of the supporting
III. Selection Procedures containing the names of qualified statements for the information
daltland on DSKBBV9HB2PROD with NOTICES
Selection of members representing nominees. Names not selected will collections are available on the internet
consumer interests is conducted remain on a list of eligible nominees at https://www.reginfo.gov/public/do/
through procedures that include the use and be reviewed periodically by FDA to PRAMain. An Agency may not conduct
of organizations representing the public determine continued interest. Upon or sponsor, and a person is not required
interest and public advocacy groups. selecting qualified nominees for the to respond to, a collection of
These organizations recommend ballot, FDA will provide those information unless it displays a
nominees for the Agency’s selection. consumer organizations that are currently valid OMB control number.
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Document Created: 2018-07-28 01:44:13
Document Modified: 2018-07-28 01:44:13
| 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 protected] | |
| FR Citation | 83 FR 36605 |
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