Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices 36605 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1095] 

Request for Nominations for 

Individuals and Consumer 

Organizations for Advisory 

Committees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting that 

any consumer organizations interested 

in participating in the selection of 

voting and/or nonvoting consumer 

representatives to serve on its advisory 

committees or panels notify FDA in 

writing. FDA is also requesting 

nominations for voting and/or 

nonvoting consumer representatives to 

serve on advisory committees and/or 

panels for which vacancies currently 

exist or are expected to occur in the near 

future. Nominees recommended to serve 

as a voting or nonvoting consumer 

representative may be self-nominated or 

may be nominated by a consumer 

organization. 

FDA seeks to include the views of 

women and men, members of all racial 

and ethnic groups, and individuals with 

and without disabilities on its advisory 

committees and, therefore, encourages 

nominations of appropriately qualified 

candidates from these groups. 

DATES: Any consumer organization 

interested in participating in the 

selection of an appropriate voting or 

nonvoting member to represent 

consumer interests on an FDA advisory 

committee or panel may send a letter or 

email stating that interest to FDA (see 

ADDRESSES) by August 29, 2018, for 

vacancies listed in this notice. 

Concurrently, nomination materials for 

prospective candidates should be sent to 

FDA (see ADDRESSES) by August 29, 

2018. Nominations will be accepted for 

current vacancies and for those that will 

or may occur through September 30, 

2018. 

ADDRESSES: All statements of interest 

from consumer organizations interested 

in participating in the selection process 

and consumer representative 

nominations should be submitted 

electronically to ACOMSSubmissions@

fda.hhs.gov, by mail to Advisory 

Committee Oversight and Management 

Staff, 10903 New Hampshire Ave., Bldg. 

32, Rm. 5103, Silver Spring, MD 20993– 

0002, or by Fax: 301–847–8640. 

Consumer representative nominations 

should be submitted electronically by 

logging into the FDA Advisory 

Committee Membership Nomination 

Portal: https://www.accessdata.fda.gov/ 

scripts/FACTRSPortal/FACTRS/ 

index.cfm, by mail to Advisory 

Committee Oversight and Management 

Staff, 10903 New Hampshire Ave., Bldg. 

32, Rm. 5103, Silver Spring, MD 20993– 

0002, or by Fax: 301–847–8640. 

Additional information about becoming 

a member of an FDA advisory 

committee can also be obtained by 

visiting FDA’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm. 

FOR FURTHER INFORMATION CONTACT: For 

questions relating to participation in the 

selection process: Kimberly Hamilton, 

Advisory Committee Oversight and 

Management Staff (ACOMS), Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, Rm. 5103, 

Silver Spring, MD 20993–0002, 301– 

796–8220, 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 

Moon Hee V. Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2434, Silver Spring, MD 

20993–0002, 301–796–2894, MoonHee.Choi@fda.hhs.gov.

Anesthetic and Analgesic Drug Products Advisory Committee. 

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, 301–796–2721, Lauren.Tesh@fda.hhs.gov.

Antimicrobial Advisory Committee. 

Kalyani Bhatt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2438, Silver Spring, MD 20993– 

0002, 301–796–9005, Kalyani.Bhatt@fda.hhs.gov.

Bone, Reproductive, and Urological Drugs Advisory 

Committee. 

Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2434, Silver Spring, MD 

20993–0002, 301–796–4043, Jennifer.Shepherd@fda.hhs.gov.

Cardiovascular and Renal Drugs Advisory Committee; 

Medical Imaging Advisory Committee. 

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, 301–796–0889, Cindy.Chee@fda.hhs.gov.

Pharmacy Compounding Advisory Committee. 

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, 301–796–6875, Patricio.Garcia@fda.hhs.gov.

Clinical Chemistry and Clinical Toxicology Devices 

Panel; Gastroenterology and Urology Devices Panel. 

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, 301–796–6683, Evella.Washington@fda.hhs.gov.

Ear, Nose, and Throat Devices Panel. 

Pamela Scott, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5572, Silver Spring, MD 20993– 

0002, 301–796–5433, Pamela.Scott@fda.hhs.gov.

Medical Devices Dispute Resolution Panel. 

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, 301–796–0400, Aden.Asefa@fda.hhs.gov.

Microbiology Devices Panel; Radiology Devices Panel. 

Sara Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G616, Silver Spring, MD 

20993–0002, 301–796–7047, Sara.Anderson@fda.hhs.gov.

Orthopaedic and Rehabilitation Devices Panel. 


daltland on DSKBBV9HB2PROD with NOTICES
36606 Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nominations for voting and/ 

or nonvoting consumer representatives 

for the vacancies listed in table 2: 

TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE

NEEDED

Committee/panel/areas of expertise needed Type of vacancy Approximate date 

needed 

Anesthetic and Analgesic Drug Products Advisory Committee—Knowledgeable in the fields of 

anesthesiology, surgery, epidemiology or statistics, and related specialties..

1—Voting ................... Immediately. 

Antimicrobial Advisory Committee—Knowledgeable in the fields of infectious disease, internal 

medicine, microbiology, pediatrics, epidemiology or statistics, and related specialties.

1—Voting ................... Immediately. 

Bone, Reproductive, and Urological Drugs Advisory Committee—Knowledgeable in the fields of 

obstetrics, gynecology, endocrinology, pediatrics, epidemiology or statistics, and related specialties.

1—Voting ................... Immediately. 

Cardiovascular and Renal Drugs Advisory Committee—Knowledgeable in the fields of cardiology, hypertension, arrhythmia, angina, congestive heart failure, diuresis, and biostatistics.1—Voting ................... Immediately. 

Medical Imaging Advisory Committee—Knowledgeable in the fields of nuclear medicine, radiology, epidemiology, statistics, and related specialties.1—Voting ................... Immediately. 

Pharmacy Compounding Advisory Committee—Knowledgeable in the fields of pharmaceutical 

compounding, pharmaceutical manufacturing pharmacy, medicine, and other related specialties.

1—Voting ................... September 30, 2018. 

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—Nonvoting ............. Immediately. 

Gastroenterology and Urology Devices Panel—Gastroenterologists, urologists, and 

nephrologists.

1—Nonvoting ............. Immediately. 

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.

1—Nonvoting ............. Immediately. 

Ear, Nose and Throat Devices Panel—Experts in otology, neurology, and audiology .................. 1—Nonvoting ............. Immediately. 

Medical Devices Dispute Resolution—Experts with broad, cross-cutting scientific, clinical, analytical, or mediation skills.1—Nonvoting ............. Immediately. 

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.

1—Nonvoting ............. Immediately. 

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. 

I. Functions and General Description of 

the Committee Duties 

A. Anesthetic and Analgesic Drug 

Products Advisory Committee 

Reviews and evaluates available data 

concerning the safety and effectiveness 

of marketed and investigational human 

drug products for use in anesthesiology 

and surgery. 

B. Antimicrobial Advisory Committee 

Reviews and evaluates available data 

concerning the safety and effectiveness 

of marketed and investigational human 

drug products for use in the treatment 

of infectious diseases and disorders. 

C. Bone, Reproductive, and Urological 

Drugs Advisory Committee 

Reviews and evaluates data on the 

safety and effectiveness of marketed and 

investigational human drugs for use in 

the practice of obstetrics, gynecology, 

and related specialties. 

D. Cardiovascular and Renal Drugs 

Advisory Committee 

Reviews and evaluates available data 

concerning the safety and effectiveness 

of marketed and investigational human 

drug products for use in the treatment 

of cardiovascular and renal disorders. 

E. Medical Imaging Advisory Committee 

Reviews and evaluates data 

concerning the safety and effectiveness 

of marketed and investigational human 

drug products for use in diagnostic and 

therapeutic procedures using 

radioactive pharmaceuticals and 

contrast media used in diagnostic 

radiology. 

F. Pharmacy Compounding Advisory 

Committee 

Provides advice on scientific, 

technical, and medical issues 

concerning drug compounding by 

pharmacists and licensed practitioners. 

G. Certain Panels of the Medical Devices 

Advisory Committee 

Reviews and evaluates data on the 

safety and effectiveness of marketed and 

investigational devices and makes 

recommendations for their regulation. 

With the exception of the Medical 

Devices Dispute Resolution Panel, each 

panel, according to its specialty area, 

advises on the classification or 

reclassification of devices into one of 

three regulatory categories; advises on 

any possible risks to health associated 

with the use of devices; advises on 

formulation of product development 

protocols; reviews premarket approval 

applications for medical devices; 

reviews guidelines and guidance 

documents; recommends exemption of 

certain devices from the application of 

portions of the Federal Food, Drug, and 

Cosmetic Act; advises on the necessity 

to ban a device; and responds to 

requests from the Agency to review and 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices 36607 

make recommendations on specific 

issues or problems concerning the safety 

and effectiveness of devices. With the 

exception of the Medical Devices 

Dispute Resolution Panel, each panel, 

according to its specialty area, may also 

make appropriate recommendations to 

the Commissioner of Food and Drugs on 

issues relating to the design of clinical 

studies regarding the safety and 

effectiveness of marketed and 

investigational devices. 

The Dental Products Panel also 

functions at times as a dental drug 

panel. The functions of the dental drug 

panel are to evaluate and recommend 

whether various prescription drug 

products should be changed to over-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 

consumer perspective on issues and 

actions before the advisory committee; 

serve as a liaison between the 

committee and interested consumers, 

associations, coalitions, and consumer 

organizations; and facilitate dialogue 

with the advisory committees on 

scientific issues that affect consumers. 

III. Selection Procedures 

Selection of members representing 

consumer interests is conducted 

through procedures that include the use 

of organizations representing the public 

interest and public advocacy groups. 

These organizations recommend 

nominees for the Agency’s selection. 

Representatives from the consumer 

health branches of Federal, State, and 

local governments also may participate 

in the selection process. Any consumer 

organization interested in participating 

in the selection of an appropriate voting 

or nonvoting member to represent 

consumer interests should send a letter 

stating that interest to FDA (see 

ADDRESSES) within 30 days of 

publication of this document. 

Within the subsequent 30 days, FDA 

will compile a list of consumer 

organizations that will participate in the 

selection process and will forward to 

each such organization a ballot listing at 

least two qualified nominees selected by 

the Agency based on the nominations 

received, together with each nominee’s 

current curriculum vitae or resume. 

Ballots are to be filled out and returned 

to FDA within 30 days. The nominee 

receiving the highest number of votes 

ordinarily will be selected to serve as 

the member representing consumer 

interests for that particular advisory 

committee or panel. 

IV. Nomination Procedures 

Any interested person or organization 

may nominate one or more qualified 

persons to represent consumer interests 

on the Agency’s advisory committees or 

panels. Self-nominations are also 

accepted. Nominations must include a 

current, complete resume or curriculum 

vitae for each nominee and a signed 

copy of the Acknowledgement and 

Consent form available at the FDA 

Advisory Nomination Portal (see 

ADDRESSES), and a list of consumer or 

community-based organizations for 

which the candidate can demonstrate 

active participation. 

Nominations must also specify the 

advisory committee(s) or panel(s) for 

which the nominee is recommended. In 

addition, nominations must also 

acknowledge that the nominee is aware 

of the nomination unless selfnominated. FDA will ask potential 

candidates to provide detailed 

information concerning such matters as 

financial holdings, employment, and 

research grants and/or contracts to 

permit evaluation of possible sources of 

conflicts of interest. Members will be 

invited to serve for terms up to 4 years. 

FDA will review all nominations 

received within the specified 

timeframes and prepare a ballot 

containing the names of qualified 

nominees. Names not selected will 

remain on a list of eligible nominees 

and be reviewed periodically by FDA to 

determine continued interest. Upon 

selecting qualified nominees for the 

ballot, FDA will provide those 

consumer organizations that are 

participating in the selection process 

with the opportunity to vote on the 

listed nominees. Only organizations 

vote in the selection process. Persons 

who nominate themselves to serve as 

voting or nonvoting consumer 

representatives will not participate in 

the selection process. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: July 24, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16161 Filed 7–27–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2014–N–1069; FDA– 

2017–N–6931; FDA–2011–N–0362; FDA– 

2011–N–0279; FDA–2011–N–0672; FDA– 

2014–N–0913; FDA–2017–N–0493; and 

FDA–2011–N–0781] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approvals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of information collections that have 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

following is a list of FDA information 

collections recently approved by OMB 

under section 3507 of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507). 

The OMB control number and 

expiration date of OMB approval for 

each information collection are shown 

in table 1. Copies of the supporting 

statements for the information 

collections are available on the internet 

at https://www.reginfo.gov/public/do/ 

PRAMain. An Agency may not conduct 

or sponsor, and a person is not required 

to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 


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