[Federal Register Volume 85, Number 131 (Wednesday, July 8, 2020)]
[Notices]
[Pages 41050-41053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14715]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2256]


Request for Nominations for Individuals and Consumer 
Organizations for Advisory Committees

AGENCY: Food and Drug Administration, HHS.

[[Page 41051]]


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.

DATES: Any consumer organization interested in participating in the 
selection of an appropriate voting or nonvoting member to represent 
consumer interests on an FDA advisory committee or panel may send a 
letter or email stating that interest to FDA (see ADDRESSES) by August 
7, 2020, for vacancies listed in this notice. Concurrently, nomination 
materials for prospective candidates should be sent to FDA (see 
ADDRESSES) by August 7, 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 or by mail to 
Advisory Committee Oversight and Management Staff, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver 
Spring, MD 20993-0002.
    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 or by mail to Advisory Committee Oversight and 
Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver 
Spring, MD 20993-0002. 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, 301-796-8220, 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,
 Kathleen.Hayses@fda.hhs.gov.
LaTonya 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 20992-0002, 301-796-
 2855, Latoya.Bonner@fda.hhs.gov.
Philip Bautista, Center for Drugs Evaluation   Drug Safety and Risk
 and Research, Food and Drug Administration,    Advisory Committee.
 10903 New Hampshire Ave., Bldg. 31, Rm.
 2430, Silver Spring, MD 20992-0002, 240-762-
 8729, Philip.Bautista@fda.hhs.gov.
Kalyani Bhatt, Center for Drugs Evaluation     Psychopharmacologic Drugs
 and Research, Food and Drug Administration,    Advisory Committee.
 10903 New Hampshire Ave., Bldg. 31, Rm.
 2438, Silver Spring, MD 20993-0002, 301-796-
 9005, Kalyani.Bhatt@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. 5216, Silver Spring, MD 20993-   Gastroenterology and
 0002, 301-796-6875,                            Urology Devices Panel,
 Patricio.Garcia@fda.hhs.gov.                   Obstetrics and
                                                Gynecology Devices
                                                Panel.
James Swink, Center for Devices and            Circulatory Systems
 Radiological Health, Food and Drug             Devices Panel, Dental
 Administration, 10903 New Hampshire Ave.,      Products Devices Panel,
 Bldg. 66, Rm. 5211 Silver Spring, MD 20993-    National Mammography
 0002, 301-796-7047, James.Swink@fda.hhs.gov.   Advisory Committee,
                                                Radiological Devices
                                                Panel.
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. 5214, Silver Spring, MD 20993-
 0002, 301-796-0400, Aden.Asefa@fda.hhs.gov.
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SUPPLEMENTARY INFORMATION: 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.
    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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Allergenics Advisory Committee--Knowledgeable   1--Voting......................  August 2020.
 in the fields of allergy, immunology,
 pediatrics, internal medicine, biochemistry,
 and related specialties.
Dermatologic and Ophthalmic Advisory            1--Voting......................  Immediately.
 Committee--Knowledgeable in the fields of
 dermatology, ophthalmology, internal
 medicine, pathology, immunology, epidemiology
 or statistics, and other related professions.

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Drug Safety and Risk Management Advisory        1--Voting......................  Immediately.
 Committee--Knowledgeable in risk
 communication, risk management, drug safety,
 medical, behavioral, and biological sciences
 as they apply to risk management, and drug
 abuse.
Psychopharmacologic Drugs Advisory Committee--  1--Voting......................  Immediately.
 Knowledgeable in the fields of
 psychopharmacology, psychiatry, epidemiology
 or statistics, and related specialties.
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 Panel--    1--Non-Voting..................  Immediately.
 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.
National Mammography Advisory Committee--       1--Non-Voting..................  Immediately.
 Physician, practitioner, or other health
 professional whose clinical practice,
 research specialization, or professional
 expertise includes a significant focus on
 mammography.
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.
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 with an  1--Non-Voting..................  Immediately.
 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. Allergenics 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. 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.

C. 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 product 
for which FDA has regulatory responsibility. Scientific and medical 
evaluation of all information gathered by the Department of Health and 
Human Services (HHS) 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 HHS with regard to the marketing, 
investigation, and control of such drugs or other substances.

D. Psychopharmacologic Drugs Advisory Committee

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

E. 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,

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

II. Criteria for Members

    Persons nominated for membership as consumer representatives on 
committees or panels should meet the following criteria: (1) 
Demonstrate an affiliation with and/or active participation in consumer 
or community-based organizations, (2) be able to analyze technical 
data, (3) understand research design, (4) discuss benefits and risks, 
and (5) evaluate the safety and efficacy of products under review. The 
consumer representative should be able to represent the consumer 
perspective on issues and actions before the advisory committee; serve 
as a liaison between the committee and interested consumers, 
associations, coalitions, and consumer organizations; and facilitate 
dialogue with the advisory committees on scientific issues that affect 
consumers.

III. Selection Procedures

    Selection of members representing consumer interests is conducted 
through procedures that include the use of organizations representing 
the public interest and public advocacy groups. These organizations 
recommend nominees for the Agency's selection. Representatives from the 
consumer health branches of Federal, State, and local governments also 
may participate in the selection process. Any consumer organization 
interested in participating in the selection of an appropriate voting 
or nonvoting member to represent consumer interests should send a 
letter stating that interest to FDA (see ADDRESSES) within 30 days of 
publication of this document.
    Within the subsequent 30 days, FDA will compile a list of consumer 
organizations that will participate in the selection process and will 
forward to each such organization a ballot listing at least two 
qualified nominees selected by the Agency based on the nominations 
received, together with each nominee's current curriculum vitae or 
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 
Committee Nomination Portal (see ADDRESSES), and a list of consumer or 
community-based organizations for which the candidate can demonstrate 
active participation.
    Nominations must also specify the advisory committee(s) or panel(s) 
for which the nominee is recommended. In addition, nominations must 
also acknowledge that the nominee is aware of the nomination unless 
self-nominated. FDA will ask potential candidates to provide detailed 
information concerning such matters as financial holdings, employment, 
and research grants and/or contracts to permit evaluation of possible 
sources of conflicts of interest. Members will be invited to serve for 
terms up to 4 years.
    FDA will review all nominations received within the specified 
timeframes and prepare a ballot containing the names of qualified 
nominees. Names not selected will remain on a list of eligible nominees 
and be reviewed periodically by FDA to determine continued interest. 
Upon selecting qualified nominees for the ballot, FDA will provide 
those consumer organizations that are participating in the selection 
process with the opportunity to vote on the listed nominees. Only 
organizations vote in the selection process. Persons who nominate 
themselves to serve as voting or nonvoting consumer representatives 
will not participate in the selection process.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: July 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14715 Filed 7-7-20; 8:45 am]
BILLING CODE 4164-01-P


