[Federal Register Volume 85, Number 13 (Tuesday, January 21, 2020)]
[Notices]
[Pages 3386-3388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00869]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0008]


Request for Nominations for Individuals and Consumer 
Organizations for Advisory Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 
February 20, 2020, for vacancies listed in this notice. Concurrently, 
nomination materials for prospective candidates should be sent to FDA 
(see ADDRESSES) by February 20, 2020. Nominations will be accepted for 
current vacancies and for those that will or may occur through December 
31, 2020.

ADDRESSES: 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 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 http://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: For questions relating to 
participation in the selection process: Kimberly Hamilton, Advisory 
Committee Oversight and Management Staff, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993-
0002, 301-796-8220, email kimberly.hamilton@fda.hhs.gov.
    For questions relating to specific advisory committees or panels, 
contact the appropriate contact person listed in table 1.

                  Table 1--Advisory Committee Contacts
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                Contact person                      Committee/panel
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Kathleen Hayes, Center for Biologics           Allergenic Products
 Evaluation and Research, Food and Drug         Advisory Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 71, Rm. 6307C, Silver Spring, MD 20993-
 0002, 301-796-7864, email:
 Kathleen.Hayses@fda.hhs.gov.
Kalyani Bhatt, Center for Drugs Evaluation     Bone, Reproductive and
 and Research, Food and Drug Administration,    Urological Drugs
 10903 New Hampshire Ave., Bldg. 31, Rm.        Advisory Committee,
 2438, Silver Spring, MD 20993-0002, 301-796-   Psychopharmacologic
 9005, email: Kalyani.Bhatt@fda.hhs.gov.        Drugs Advisory
                                                Committee.
LaToya Bonner, Center for Drugs Evaluation     Dermatologic and
 and Research, Food and Drug Administration,    Ophthalmic Drugs
 10903 New Hampshire Ave., Bldg. 31, Rm.        Advisory Committee.
 2428, Silver Spring, MD 20993-0002, 301-796-
 2855, email: LaToya.Bonner@fda.hhs.gov.
Philip Bautista, Center for Drugs Evaluation   Drug Safety and Risk
 and Research, Food and Drug Administration,    Management Advisory
 10903 New Hampshire Ave., Bldg. 31, Rm.        Committee.
 2430, Silver Spring, MD 20993-0002, 240-762-
 8729, email: Philip.Bautista@fda.hhs.gov.
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 20993-   Gastroenterology and
 0002, 301-796-6875, email:                     Urology Devices Panel,
 Patricio.Garcia@fda.hhs.gov.                   Obstetrics and
                                                Gynecology Devices
                                                Panel.
Sara Anderson, Center for Devices and          Dental Products Devices
 Radiological Health, Food and Drug             Panel.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 66, Rm. G616, Silver Spring, MD 20993-
 0002, 301-796-7047, email:
 Sara.Anderson@fda.hhs.gov.
Evella Washington, Center for Devices and      Circulatory Systems
 Radiological Health, Food and Drug             Devices Panel.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 66, Rm. G640, Silver Spring, MD 20993-
 0002, 301-796-6683, email:
 Evella.Washington@fda.hhs.gov.
Joannie Adams-White, Center for Devices and    Medical Devices Dispute
 Radiological Health, Food and Drug             Resolution Panel.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 66, Rm. 5519, Silver Spring, MD 20993-
 0002, 301-796-5421, email: Joannie.Adams-White@fda.hhs.gov.
Aden Asefa, Center for Devices and             Immunology Devices Panel;
 Radiological Health, Food and Drug             Microbiology Devices
 Administration, 10903 New Hampshire Ave.,      Panel.
 Bldg. 66, Rm. G642, Silver Spring, MD 20993-
 0002, 301-796-0400, email:
 Aden.Asefa@fda.hhs.gov.
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[[Page 3387]]


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
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 Committee/panel/areas of expertise needed           Type of vacancy                Approximate date needed
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Allergenic Products Advisory Committee--    1-Voting.........................  August 31, 2020.
 Knowledgeable in the fields of allergy,
 immunology, pediatrics, internal
 medicine, biochemistry, and related
 specialties.
Bone, Reproductive and Urological Drugs     1-Voting.........................  Immediately.
 Advisory Committee--Knowledgeable in the
 fields of osteoporosis and metabolic bone
 disease, obstetrics, gynecology, urology,
 pediatrics, epidemiology, or statistics
 and related specialties.
Psychopharmacologic Drugs Advisory          1-Voting.........................  Immediately.
 Committee--Knowledgeable in the fields of
 psychopharmacology, psychiatry,
 epidemiology or statistics, and related
 specialties.
Dermatologic and Ophthalmic Drugs Advisory  1-Voting.........................  August 31, 2020.
 Committee--Knowledgeable in the fields of
 dermatology, ophthalmology, internal
 medicine, pathology, immunology,
 epidemiology or statistics, and other
 related professions.
Drug Safety and Risk Management Advisory    1-Voting.........................  May 31, 2020.
 Committee--Knowledgeable in risk
 communication, risk management, drug
 safety, medical, behavioral, and
 biological sciences as they apply to risk
 management, and drug abuse.
Clinical Chemistry and Clinical Toxicology  1-Non-Voting.....................  Immediately.
 Devices Panel--Doctor 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-Non-Voting.....................  Immediately.
 Panel--Gastroenterologists, urologists
 and nephrologists.
Obstetrics and Gynecology Devices Panel--   1-Non-Voting.....................  Immediately.
 Experts in perinatology, embryology,
 reproductive endocrinology, pediatric
 gynecology, gynecological oncology,
 operative hysteroscopy, pelviscopy,
 electro-surgery, laser surgery, assisted
 reproductive technologies, contraception,
 postoperative adhesions, and cervical
 cancer and colposcopy; biostatisticians
 and engineers with experience in
 obstetrics/gynecology devices;
 urogynecologists; experts in breast care;
 experts in gynecology in the older
 patient; experts in diagnostic (optical)
 spectroscopy; experts in midwifery; labor
 and delivery nursing.
Dental Products Device Panel--Dentists,     1-Non-Voting.....................  Immediately.
 engineers and scientists who have
 expertise in the areas of dental
 implants, dental materials,
 periodontology, tissue engineering, and
 dental anatomy.
Circulatory Systems Devices Panel--         1-Non-Voting.....................  Immediately.
 Interventional cardiologists,
 electrophysiologists, invasive (vascular)
 radiologists, vascular and cardiothoracic
 surgeons, and cardiologists with special
 interest in congestive heart failure.
Medical Devices Dispute Resolution--        1-Non-Voting.....................  Immediately.
 Experts with broad, cross-cutting
 scientific, clinical, analytical or
 mediation skills.
Immunology Devices Panel--Persons with      1-Non-Voting.....................  Immediately.
 experience in medical, surgical, or
 clinical oncology, internal medicine,
 clinical immunology, allergy, molecular
 diagnostics, or clinical laboratory
 medicine.
Microbiology Devices Panel--Clinicians      1-Non-Voting.....................  Immediately.
 with an 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.
Radiology Devices Panel--Physicians with    1-Non-Voting.....................  Immediately.
 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.
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I. Functions and General Description of the Committee Duties

A. Allergenic Products Advisory Committee

    Reviews and evaluates available data concerning the safety, 
effectiveness, and adequacy of labeling of marketed and investigational 
allergenic biological products or materials that are administered to 
humans for the diagnosis, prevention, or treatment of allergies and 
allergic disease as well as the affirmation or revocation of biological 
product licenses, on the safety, effectiveness, and labeling of the 
products, on clinical and laboratory studies of such products, on 
amendments or revisions to regulations governing the manufacture, 
testing and licensing of allergenic biological products, and on the 
quality and relevance of FDA's research programs.

B. Bone, Reproductive and Urologic Drugs Advisory Committee

    Reviews and evaluates data on the safety and effectiveness of 
marketed and investigational human drugs for use in the practice of 
osteoporosis and metabolic bone disease, obstetrics, gynecology, 
urology, and related specialties.

C. Psychopharmacologic Drugs Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational human drug products for use in the 
practice of psychiatry and related fields.

D. Dermatologic and Ophthalmic 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 dermatologic and ophthalmic disorders.

E. Drug Safety and Risk Management Advisory Committee

    Risk management, risk communication, and quantitative evaluation of 
spontaneous reports for drugs for human use and for any other

[[Page 3388]]

product for which the FDA has regulatory responsibility. Scientific and 
medical evaluation of all information gathered by the Department of 
Health and Human Services (DHHS) and the Department of Justice with 
regard to safety, efficacy, and abuse potential of drugs or other 
substances, and recommends actions to be taken by the DHHS with regard 
to the marketing, investigation, and control of such drugs or other 
substances.

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 (the Commissioner) on issues relating to the design of 
clinical studies regarding the safety and effectiveness of marketed and 
investigational devices.
    The Dental Products Panel also functions at times as a dental drug 
panel. The functions of the dental drug panel are to evaluate and 
recommend whether various prescription drug products should be changed 
to over-the-counter status and to evaluate data and make 
recommendations concerning the approval of new dental drug products for 
human use.
    The Medical Devices Dispute Resolution Panel provides advice to the 
Commissioner on complex or contested scientific issues between FDA and 
medical device sponsors, applicants, or manufacturers relating to 
specific products, marketing applications, regulatory decisions and 
actions by FDA, and Agency guidance and policies. The Panel makes 
recommendations on issues that are lacking resolution, are highly 
complex in nature, or result from challenges to regular advisory panel 
proceedings or Agency decisions or actions.

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) be able to understand research design, (4) be able to discuss 
benefits and risks, and (5) be able to 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 
r[eacute]sum[eacute]. 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: January 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00869 Filed 1-17-20; 8:45 am]
 BILLING CODE 4164-01-P


