83 FR 57734 - 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 222 (November 16, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 222 (November 16, 2018)
| Page Range | 57734-57737 | |
| FR Document | 2018-25076 |
[Federal Register Volume 83, Number 222 (Friday, November 16, 2018)] [Notices] [Pages 57734-57737] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-25076] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3789] 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 or Agency) 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 December 17, 2018, for vacancies listed in this notice. Concurrently, nomination materials for prospective candidates should be sent to FDA (see ADDRESSES) by December 17, 2018. Nominations will be accepted for current vacancies and for those that will or may occur through December 30, 2018. ADDRESSES: All statements of interest from consumer organizations interested in participating in the selection process should be submitted electronically to [email protected], by mail to Advisory Committee Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993-0002, or by Fax: 301- 847-8640. Consumer representative nominations should be submitted electronically by [[Page 57735]] 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. 5122, 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, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993- 0002, Phone: 301-796-6319, [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 ------------------------------------------------------------------------ Lauren Tesh, Center for Drug Evaluation and Antimicrobial Advisory Research, Food and Drug Administration, Committee. 10903 New Hampshire Ave., Bldg. 31, Rm. 2426, Silver Spring, MD 20993-0002, Phone: 301-796-2721, [email protected]. Kalyani Bhatt, Center for Drugs Evaluation Bone Reproductive and and Research, Food and Drug Urological Drugs Advisory Administration, 10903 New Hampshire Ave., Committee. Bldg. 31, Rm. 2438, Silver Spring, MD 20993-0002, Phone: 301-796-9005, [email protected]. Jennifer Shepherd, Center for Drugs Cardiovascular and Renal Evaluation and Research, Food and Drug Drugs Advisory Committee, Administration, 10903 New Hampshire Ave., Medical Imaging Advisory Bldg. 31, Rm. 2434, Silver Spring, MD Committee. 20993-0002, Phone: 301-796-4043, [email protected]. Cindy Chee, Center for Drug Evaluation and Pharmacy Compounding 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 protected]. Patricio Garcia, Center for Devices and Clinical Chemistry and Radiological Health, Food and Drug Clinical Toxicology Administration, 10903 New Hampshire Ave., Devices Panel, Bldg. 66, Rm. G610, Silver Spring, MD Gastroenterology and 20993-0002, Phone: 301-796-6875, Urology Devices Panel. [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. G640, Silver Spring, MD 20993-0002, Phone: 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. 2647, Silver Spring, MD 20993-0002, Phone: 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, Phone: 301-796-0400, [email protected]. Sara Anderson, Center for Devices and Orthopaedic and Radiological Health, Food and Drug Rehabilitation Devices Administration, 10903 New Hampshire Ave., Panel. Bldg. 66, Rm. G616m Silver Spring, MD 20993-0002, Phone: 301-796-7047, [email protected]. ------------------------------------------------------------------------ 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/area of Approximate date expertise needed Type of vacancy needed ------------------------------------------------------------------------ Antimicrobial Advisory 1--Voting......... Immediately. Committee--Knowledgeable in the fields of infectious disease, internal medicine, microbiology, pediatrics, epidemiology or statistics, and related specialties. Bone, Reproductive, and 1--Voting......... Immediately. Urological 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 1--Voting......... Immediately. Committee--Knowledgeable in the fields of nuclear medicine, radiology, epidemiology, statistics, and related specialties. Pharmacy Compounding Advisory 1--Voting......... Immediately. 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. [[Page 57736]] Gastroenterology and Urology 1--Nonvoting...... Immediately. Devices Panel-- Gastroenterologists, urologists and nephrologists. Radiology Devices Panel-- 1--Nonvoting...... Immediately. Physicians 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 1--Nonvoting...... Immediately. Panel--Experts in otology, neurology, and audiology. Medical Devices Dispute 1--Nonvoting...... Immediately. Resolution--Experts with broad, cross-cutting scientific, clinical, analytical, or mediation skills. Microbiology Devices Panel-- 1--Nonvoting...... Immediately. Clinicians 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 1--Nonvoting...... Immediately. Devices 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. 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. B. 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. C. 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. 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. Pharmacy Compounding Advisory Committee Provides advice on scientific, technical, and medical issues concerning drug compounding by pharmacists and licensed practitioners. F. Certain Panels of the Medical Devices Advisory Committee Reviews and evaluates data on the safety and effectiveness of marketed and investigational devices and makes recommendations for their regulation. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, advises on the classification or reclassification of devices into one of three regulatory categories; advises on any possible risks to health associated with the use of devices; advises on formulation of product development protocols; reviews premarket approval applications for medical devices; reviews guidelines and guidance documents; recommends exemption of certain devices from the application of portions of the Federal Food, Drug, and Cosmetic Act; advises on the necessity to ban a device; and responds to requests from the Agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, may also make appropriate recommendations to the Commissioner of Food and Drugs on issues relating to the design of clinical studies regarding the safety and effectiveness of marketed and investigational devices. The Dental Products Panel also functions at times as a dental drug panel. The functions of the dental drug panel are to evaluate and recommend whether various prescription drug products should be changed to over-the-counter status and to evaluate data and make recommendations concerning the approval of new dental drug products for human use. 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 [[Page 57737]] 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 r[eacute]sum[eacute] 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: November 13, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-25076 Filed 11-15-18; 8:45 am] BILLING CODE 4164-01-P
![57734 Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Notices
above topics may be discussed in each selected for presentation, any DEPARTMENT OF HEALTH AND
meeting. FDA will consider all presentation materials must be emailed HUMAN SERVICES
comments made at these public to eprompt@fda.hhs.gov no later than
meetings or received through the docket 11:59 p.m. Eastern Time on January 18, Food and Drug Administration
(see ADDRESSES). 2019, for the first meeting, July 10, 2019, [Docket No. FDA–2018–N–3789]
III. Participating in the Public Meeting for the second meeting, and February
12, 2020, for the third meeting. Persons Request for Nominations for
Registration: To register for the public Individuals and Consumer
registered to speak should check in
meetings, please visit the following Organizations for Advisory
website to register: https:// before the meeting and are encouraged
to arrive early to ensure their designated Committees
fdae2br3.eventbrite.com by December
20, 2018, for the first meeting, June 14, order of presentation. Participants who AGENCY: Food and Drug Administration,
2019, for the second meeting, and are not present when called may not be HHS.
January 17, 2020, for the third meeting. permitted to speak at a later time. No ACTION: Notice.
Please provide complete contact commercial or promotional material
information for each attendee, including will be permitted to be presented or SUMMARY: The Food and Drug
name, title, affiliation, address, email, distributed at the public meeting. An Administration (FDA or Agency) is
telephone, and method of attendance agenda will be made available at least 3 requesting that any consumer
(in-person or web conference). days before each public meeting at organizations interested in participating
Registration is free and based on https://www.fda.gov/Drugs/NewsEvents/ in the selection of voting and/or
space availability, with priority given to ucm621215.htm. nonvoting consumer representatives to
early registrants. Persons interested in serve on its advisory committees or
Streaming Webcast of the Public
attending the public meetings must panels notify FDA in writing. FDA is
register by 11:59 p.m. Eastern Time on Meetings and Video of the Public
also requesting nominations for voting
December 20, 2018, for the first meeting, Meetings: These public meetings will and/or nonvoting consumer
June 14, 2019, for the second meeting, also be webcast; the URL will be posted representatives to serve on advisory
and January 17, 2020, for the third at https://www.fda.gov/Drugs/ committees and/or panels for which
meeting. Early registration is NewsEvents/ucm621215.htm at least 1 vacancies currently exist or are expected
recommended because seating is day before each meeting. A video record to occur in the near future. Nominees
limited; therefore, FDA may limit the of the public workshops will be recommended to serve as a voting or
number of participants from each available at the same website address for nonvoting consumer representative may
organization. Registrants will receive 1 year. be self-nominated or may be nominated
confirmation when they have been If you have never attended a Connect by a consumer organization.
accepted. If time and space permit, Pro event before, test your connection at FDA seeks to include the views of
onsite registration on the day of the https://collaboration.fda.gov/common/ women and men, members of all racial
public meeting/public workshop will be and ethnic groups, and individuals with
help/en/support/meeting_test.htm. To
provided beginning at 8 a.m. and without disabilities on its advisory
If you need special accommodations get a quick overview of the Connect Pro
program, visit https://www.adobe.com/ committees and, therefore, encourages
due to a disability, please contact nominations of appropriately qualified
Chenoa Conley, 301–796–0035, email: go/connectpro_overview. FDA has
verified the website addresses in this candidates from these groups.
Chenoa.Conley@fda.hhs.gov, at least 7
document, as of the date this document DATES: Any consumer organization
days before each meeting.
Request for Oral Presentations: During publishes in the Federal Register, but interested in participating in the
online registration you may indicate if websites are subject to change over time. selection of an appropriate voting or
you wish to present during the public nonvoting member to represent
Transcripts: Please be advised that as consumer interests on an FDA advisory
comment session. All requests to make soon as a transcript of the public
oral presentations must be received by committee or panel may send a letter or
meeting is available, it will be accessible email stating that interest to FDA (see
the close of registration at 11:59 p.m. at https://www.regulations.gov. It may ADDRESSES) by December 17, 2018, for
Eastern Time on December 20, 2018, for be viewed at the Dockets Management
the first meeting, June 14, 2019, for the vacancies listed in this notice.
Staff (see ADDRESSES). A link to the Concurrently, nomination materials for
second meeting, and January 17, 2020,
transcript will also be available on the prospective candidates should be sent to
for the third meeting. We will do our
best to accommodate requests to make internet at https://www.fda.gov/Drugs/ FDA (see ADDRESSES) by December 17,
public comments. Individuals and GuidanceComplianceRegulatory 2018. Nominations will be accepted for
organizations with common interests are Information/Surveillance/AdverseDrug current vacancies and for those that will
urged to consolidate or coordinate their Effects/ucm115894.htm. or may occur through December 30,
presentations and request time for a Dated: November 8, 2018.
2018.
joint presentation. Following the close Leslie Kux, ADDRESSES: All statements of interest
of registration, we will determine the Associate Commissioner for Policy.
from consumer organizations interested
amount of time allotted to each in participating in the selection process
[FR Doc. 2018–25063 Filed 11–15–18; 8:45 am]
presenter and the approximate time should be submitted electronically to
each oral presentation is to begin and BILLING CODE 4164–01–P
ACOMSSubmissions@fda.hhs.gov, by
amozie on DSK3GDR082PROD with NOTICES
will select and notify participants by mail to Advisory Committee Oversight
11:59 p.m. Eastern Time on January 4, and Management Staff, 10903 New
2019, for the first meeting, June 26, Hampshire Ave., Bldg. 32, Rm. 5122,
2019, for the second meeting, and Silver Spring, MD 20993–0002, or by
January 30, 2020, for the third meeting. Fax: 301–847–8640.
FDA will notify registered presenters of Consumer representative nominations
their scheduled presentation time. If should be submitted electronically by
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![Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Notices 57737
consumer perspective on issues and information concerning such matters as administered in the U.S. territories and
actions before the advisory committee; financial holdings, employment, and jurisdictions (excluding the District of
serve as a liaison between the research grants and/or contracts to Columbia) for purposes of collecting
committee and interested consumers, permit evaluation of possible sources of information related to the well-being of
associations, coalitions, and consumer conflicts of interest. Members will be all mothers, children, and their families.
organizations; and facilitate dialogue invited to serve for terms up to 4 years. DATES: Comments on this ICR must be
with the advisory committees on FDA will review all nominations received no later than January 15, 2019.
scientific issues that affect consumers. received within the specified ADDRESSES: Submit your comments to
timeframes and prepare a ballot paperwork@hrsa.gov or mail the HRSA
III. Selection Procedures
containing the names of qualified Information Collection Clearance
Selection of members representing nominees. Names not selected will Officer, Room 14N136B, 5600 Fishers
consumer interests is conducted remain on a list of eligible nominees Lane, Rockville, MD 20857.
through procedures that include the use and be reviewed periodically by FDA to FOR FURTHER INFORMATION CONTACT: To
of organizations representing the public determine continued interest. Upon
interest and public advocacy groups. request more information on the
selecting qualified nominees for the proposed project or to obtain a copy of
These organizations recommend ballot, FDA will provide those
nominees for the Agency’s selection. the data collection plans and draft
consumer organizations that are instruments, email paperwork@hrsa.gov
Representatives from the consumer participating in the selection process
health branches of Federal, State, and or call Lisa Wright-Solomon, the HRSA
with the opportunity to vote on the Information Collection Clearance Officer
local governments also may participate listed nominees. Only organizations
in the selection process. Any consumer at (301) 443–1984.
vote in the selection process. Persons
organization interested in participating SUPPLEMENTARY INFORMATION: When
who nominate themselves to serve as
in the selection of an appropriate voting submitting comments or requesting
voting or nonvoting consumer
or nonvoting member to represent information, please include the
representatives will not participate in
consumer interests should send a letter information request collection title for
the selection process.
stating that interest to FDA (see This notice is issued under the reference.
ADDRESSES) within 30 days of Information Collection Request Title:
Federal Advisory Committee Act (5
publication of this document. MCH Jurisdictional Survey Instrument
U.S.C. app. 2) and 21 CFR part 14,
Within the subsequent 30 days, FDA for the Title V MCH Block Grant
relating to advisory committees.
will compile a list of consumer Program, OMB No. 0906–XXXX New.
organizations that will participate in the Dated: November 13, 2018. Abstract: The purpose of the Title V
selection process and will forward to Leslie Kux, MCH Block Grant is to improve the
each such organization a ballot listing at Associate Commissioner for Policy. health of the nation’s mothers, infants,
least two qualified nominees selected by [FR Doc. 2018–25076 Filed 11–15–18; 8:45 am] children, including children with
the Agency based on the nominations BILLING CODE 4164–01–P special health care needs, and their
received, together with each nominee’s families by creating federal/state
current curriculum vitae or resume. partnerships that provide each state/
Ballots are to be filled out and returned DEPARTMENT OF HEALTH AND jurisdiction with needed flexibility to
to FDA within 30 days. The nominee HUMAN SERVICES respond to its individual MCH
receiving the highest number of votes population needs. Unique to the MCH
ordinarily will be selected to serve as Health Resources and Services Block Grant is a commitment to
the member representing consumer Administration performance accountability, while
interests for that particular advisory assuring state flexibility. Utilizing a
Agency Information Collection three-tiered national performance
committee or panel. Activities: Proposed Collection: Public measure framework, which includes
IV. Nomination Procedures Comment Request; Information National Outcome Measures (NOMs),
Any interested person or organization Collection Request Title: MCH National Performance Measures (NPMs),
may nominate one or more qualified Jurisdictional Survey Instrument for and Evidence-Based and Evidence-
persons to represent consumer interests the Title V MCH Block Grant Program, Informed Strategy Measures, State Title
on the Agency’s advisory committees or OMB No. 0906–XXXX, New V programs report annually on their
panels. Self-nominations are also AGENCY: Health Resources and Services performance relative to the selected
accepted. Nominations must include a Administration (HRSA), Department of national performance and outcome
current, complete résumé or curriculum Health and Human Services. measures. Such reporting enables the
vitae for each nominee and a signed ACTION: Notice. state and federal program offices to
copy of the Acknowledgement and assess the progress achieved in key
Consent form available at the FDA SUMMARY: In compliance with the MCH priority areas and to document
Advisory Nomination Portal (see requirement of the Paperwork Title V program accomplishments.
ADDRESSES), and a list of consumer or Reduction Act of 1995 for opportunity By legislation (Section 505(a) of Title
community-based organizations for for public comment on proposed data V of the Social Security Act), the MCH
which the candidate can demonstrate collection projects, HRSA announces Block Grant Application/Annual Report
active participation. plans to submit an Information must be developed by, or in
Nominations must also specify the Collection Request (ICR), described consultation with, the State MCH Health
amozie on DSK3GDR082PROD with NOTICES
advisory committee(s) or panel(s) for below, to the Office of Management and agency. In establishing state reporting
which the nominee is recommended. In Budget (OMB). Prior to submitting the requirements, HRSA’s Maternal and
addition, nominations must also ICR to OMB, HRSA seeks comments Child Health Bureau (MCHB) considers
acknowledge that the nominee is aware from the public regarding the burden the availability of national data from
of the nomination unless self- estimate, or any other aspect of the ICR other federal agencies. Data for the
nominated. FDA will ask potential related to the Maternal and Child Health national performance and outcome
candidates to provide detailed (MCH) Jurisdictional Survey that is to be measures are pre-populated for states in
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Document Created: 2018-11-16 07:22:57
Document Modified: 2018-11-16 07:22:57
| 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, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993- 0002, Phone: 301-796-6319, [email protected] | |
| FR Citation | 83 FR 57734 |
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