Request for Nominations for Individuals and Consumer Organizations for Advisory Committees, 57734-57737 [2018-25076]

Download as PDF 57734 Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Notices selected for presentation, any presentation materials must be emailed to eprompt@fda.hhs.gov no later than 11:59 p.m. Eastern Time on January 18, 2019, for the first meeting, July 10, 2019, for the second meeting, and February III. Participating in the Public Meeting 12, 2020, for the third meeting. Persons Registration: To register for the public registered to speak should check in meetings, please visit the following before the meeting and are encouraged website to register: https:// to arrive early to ensure their designated fdae2br3.eventbrite.com by December order of presentation. Participants who 20, 2018, for the first meeting, June 14, are not present when called may not be 2019, for the second meeting, and permitted to speak at a later time. No January 17, 2020, for the third meeting. commercial or promotional material Please provide complete contact information for each attendee, including will be permitted to be presented or distributed at the public meeting. An name, title, affiliation, address, email, agenda will be made available at least 3 telephone, and method of attendance (in-person or web conference). days before each public meeting at Registration is free and based on https://www.fda.gov/Drugs/NewsEvents/ space availability, with priority given to ucm621215.htm. early registrants. Persons interested in Streaming Webcast of the Public attending the public meetings must Meetings and Video of the Public register by 11:59 p.m. Eastern Time on December 20, 2018, for the first meeting, Meetings: These public meetings will also be webcast; the URL will be posted June 14, 2019, for the second meeting, at https://www.fda.gov/Drugs/ and January 17, 2020, for the third NewsEvents/ucm621215.htm at least 1 meeting. Early registration is day before each meeting. A video record recommended because seating is of the public workshops will be limited; therefore, FDA may limit the available at the same website address for number of participants from each 1 year. organization. Registrants will receive confirmation when they have been If you have never attended a Connect accepted. If time and space permit, Pro event before, test your connection at onsite registration on the day of the https://collaboration.fda.gov/common/ public meeting/public workshop will be help/en/support/meeting_test.htm. To provided beginning at 8 a.m. get a quick overview of the Connect Pro If you need special accommodations program, visit https://www.adobe.com/ due to a disability, please contact go/connectpro_overview. FDA has Chenoa Conley, 301–796–0035, email: verified the website addresses in this Chenoa.Conley@fda.hhs.gov, at least 7 document, as of the date this document days before each meeting. Request for Oral Presentations: During publishes in the Federal Register, but websites are subject to change over time. online registration you may indicate if you wish to present during the public Transcripts: Please be advised that as comment session. All requests to make soon as a transcript of the public oral presentations must be received by meeting is available, it will be accessible the close of registration at 11:59 p.m. at https://www.regulations.gov. It may Eastern Time on December 20, 2018, for be viewed at the Dockets Management the first meeting, June 14, 2019, for the Staff (see ADDRESSES). A link to the second meeting, and January 17, 2020, transcript will also be available on the for the third meeting. We will do our internet at https://www.fda.gov/Drugs/ best to accommodate requests to make GuidanceComplianceRegulatory public comments. Individuals and organizations with common interests are Information/Surveillance/AdverseDrug Effects/ucm115894.htm. urged to consolidate or coordinate their presentations and request time for a Dated: November 8, 2018. joint presentation. Following the close Leslie Kux, of registration, we will determine the Associate Commissioner for Policy. amount of time allotted to each [FR Doc. 2018–25063 Filed 11–15–18; 8:45 am] presenter and the approximate time BILLING CODE 4164–01–P each oral presentation is to begin and will select and notify participants by 11:59 p.m. Eastern Time on January 4, 2019, for the first meeting, June 26, 2019, for the second meeting, and January 30, 2020, for the third meeting. FDA will notify registered presenters of their scheduled presentation time. If amozie on DSK3GDR082PROD with NOTICES above topics may be discussed in each meeting. FDA will consider all comments made at these public meetings or received through the docket (see ADDRESSES). VerDate Sep<11>2014 17:19 Nov 15, 2018 Jkt 247001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 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. 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. SUMMARY: All statements of interest from consumer organizations interested in participating in the selection process should be submitted electronically to ACOMSSubmissions@fda.hhs.gov, 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 ADDRESSES: E:\FR\FM\16NON1.SGM 16NON1 Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Notices 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 questions relating to participation in the selection process: Kimberly Hamilton, Advisory Committee Oversight and FOR FURTHER INFORMATION CONTACT: 57735 Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993–0002, Phone: 301–796–6319, kimberly.hamilton@fda.hhs.gov. 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 Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2426, Silver Spring, MD 20993–0002, Phone: 301–796–2721, Lauren.Tesh@ fda.hhs.gov. Kalyani Bhatt, Center for Drugs Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2438, Silver Spring, MD 20993–0002, Phone: 301–796–9005, Kalyani.Bhatt@fda.hhs.gov. Jennifer Shepherd, Center for Drugs Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2434, Silver Spring, MD 20993–0002, Phone: 301–796–4043, Jenifer.Shepherd@fda.hhs.gov. Cindy Chee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2430, Silver Spring, MD 20993–0002, Phone: 301–796–0889, Cindy.Chee@ fda.hhs.gov. Patricio Garcia, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G610, Silver Spring, MD 20993–0002, Phone: 301–796–6875, Patricio.Garcia@fda.hhs.gov. Evella Washington, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G640, Silver Spring, MD 20993–0002, Phone: 301–796–6683, Evella.Washington@fda.hhs.gov. Pamela Scott, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2647, Silver Spring, MD 20993–0002, Phone: 301–796–5433, Pamela.Scott@fda.hhs.gov. Aden Asefa, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G642, Silver Spring, MD 20993–0002, Phone: 301–796–0400, Aden.Asefa@fda.hhs.gov. Sara Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G616m Silver Spring, MD 20993–0002, Phone: 301–796–7047, Sara.Anderson@fda.hhs.gov. FDA is requesting nominations for voting and/ SUPPLEMENTARY INFORMATION: Antimicrobial Advisory Committee. Bone Reproductive and Urological Drugs Advisory Committee. Cardiovascular and Renal Drugs Advisory Committee, Medical Imaging Advisory Committee. Pharmacy Compounding Advisory Committee. Clinical Chemistry and Clinical Toxicology Devices Panel, Gastroenterology and Urology Devices Panel. Ear, Nose and Throat Devices Panel. Medical Devices Dispute Resolution Panel. Microbiology Devices Panel, Radiology Devices Panel. Orthopaedic and Rehabilitation Devices Panel. or nonvoting consumer representatives for the vacancies listed in table 2: amozie on DSK3GDR082PROD with NOTICES TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE NEEDED Committee/panel/area of expertise needed Type of vacancy Antimicrobial Advisory Committee—Knowledgeable in the fields of infectious disease, internal medicine, microbiology, pediatrics, epidemiology or statistics, and related specialties. Bone, Reproductive, and Urological Drugs Advisory Committee— Knowledgeable in the fields of obstetrics, gynecology, endocrinology, pediatrics, epidemiology or statistics and related specialties. Cardiovascular and Renal Drugs Advisory Committee—Knowledgeable in the fields of cardiology, hypertension, arrhythmia, angina, congestive heart failure, diuresis, and biostatistics. Medical Imaging Advisory Committee—Knowledgeable in the fields of nuclear medicine, radiology, epidemiology, statistics, and related specialties. Pharmacy Compounding Advisory Committee—Knowledgeable in the fields of pharmaceutical compounding, pharmaceutical manufacturing pharmacy, medicine, and other related specialties. Clinical Chemistry and Clinical 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. 1—Voting ....................................... Immediately. 1—Voting ....................................... Immediately. 1—Voting ....................................... Immediately. 1—Voting ....................................... Immediately. 1—Voting ....................................... Immediately. 1—Nonvoting ................................. Immediately. VerDate Sep<11>2014 17:19 Nov 15, 2018 Jkt 247001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\FR\FM\16NON1.SGM Approximate date needed 16NON1 57736 Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Notices TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE NEEDED—Continued Committee/panel/area of expertise needed Type of vacancy Gastroenterology and Urology Devices Panel—Gastroenterologists, urologists and nephrologists. Radiology Devices Panel—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 Panel—Experts in otology, neurology, and audiology. Medical Devices Dispute Resolution—Experts with broad, cross-cutting scientific, clinical, analytical, or mediation skills. Microbiology Devices Panel—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 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. 1—Nonvoting ................................. Immediately. 1—Nonvoting ................................. Immediately. 1—Nonvoting ................................. Immediately. 1—Nonvoting ................................. Immediately. 1—Nonvoting ................................. Immediately. 1—Nonvoting ................................. Immediately. I. Functions and General Description of the Committee Duties concerning drug compounding by pharmacists and licensed practitioners. A. Antimicrobial Advisory Committee F. Certain Panels of the Medical Devices 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. amozie on DSK3GDR082PROD with NOTICES 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 VerDate Sep<11>2014 17:19 Nov 15, 2018 Jkt 247001 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. PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 Approximate date needed 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-thecounter status and to evaluate data and make recommendations concerning the approval of new dental drug products for human use. The Medical Devices Dispute Resolution Panel provides advice to the Commissioner on complex or contested scientific issues between FDA and medical device sponsors, applicants, or manufacturers relating to specific products, marketing applications, regulatory decisions and actions by FDA, and Agency guidance and policies. The Panel makes recommendations on issues that are lacking resolution, are highly complex in nature, or result from challenges to regular advisory panel proceedings or Agency decisions or actions. 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 E:\FR\FM\16NON1.SGM 16NON1 Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Notices 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. amozie on DSK3GDR082PROD with NOTICES 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 re´sume´ 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 selfnominated. FDA will ask potential candidates to provide detailed VerDate Sep<11>2014 17:19 Nov 15, 2018 Jkt 247001 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: MCH Jurisdictional Survey Instrument for the Title V MCH Block Grant Program, OMB No. 0906–XXXX, New Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with the requirement of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, or any other aspect of the ICR related to the Maternal and Child Health (MCH) Jurisdictional Survey that is to be SUMMARY: PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 57737 administered in the U.S. territories and jurisdictions (excluding the District of Columbia) for purposes of collecting information related to the well-being of all mothers, children, and their families. DATES: Comments on this ICR must be received no later than January 15, 2019. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 14N136B, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at (301) 443–1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: MCH Jurisdictional Survey Instrument for the Title V MCH Block Grant Program, OMB No. 0906–XXXX New. Abstract: The purpose of the Title V MCH Block Grant is to improve the health of the nation’s mothers, infants, children, including children with special health care needs, and their families by creating federal/state partnerships that provide each state/ jurisdiction with needed flexibility to respond to its individual MCH population needs. Unique to the MCH Block Grant is a commitment to performance accountability, while assuring state flexibility. Utilizing a three-tiered national performance measure framework, which includes National Outcome Measures (NOMs), National Performance Measures (NPMs), and Evidence-Based and EvidenceInformed Strategy Measures, State Title V programs report annually on their performance relative to the selected national performance and outcome measures. Such reporting enables the state and federal program offices to assess the progress achieved in key MCH priority areas and to document Title V program accomplishments. By legislation (Section 505(a) of Title V of the Social Security Act), the MCH Block Grant Application/Annual Report must be developed by, or in consultation with, the State MCH Health agency. In establishing state reporting requirements, HRSA’s Maternal and Child Health Bureau (MCHB) considers the availability of national data from other federal agencies. Data for the national performance and outcome measures are pre-populated for states in E:\FR\FM\16NON1.SGM 16NON1

Agencies

[Federal Register Volume 83, Number 222 (Friday, November 16, 2018)]
[Notices]
[Pages 57734-57737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.
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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

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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

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