44024 Federal Register / Vol. 86, No. 152 / Wednesday, August 11, 2021 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Annual 

responses per 

respondent 

Average 

burden hours 

per response 

Annual 

burden hours 

COVID–19 Verbal Screening and Temperature Check .................................. 15,000 260 .033 128,700 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: 6 U.S.C. 279. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2021–17255 Filed 8–9–21; 4:15 pm] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0008] 

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 September 27, 2021, for 

vacancies listed in this notice. 

Concurrently, nomination materials for 

prospective candidates should be sent to 

FDA (see ADDRESSES) by September 27, 

2021. Nominations will be accepted for 

current vacancies and for those that will 

or may occur through December 31, 

2021. 

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

Contact person Committee/panel 

Rakesh Raghuwanshi, Office of the Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3309, Silver 

Spring, MD 20993–0002, 301–796–4769, Rakesh.Raghuwanshi@

fda.hhs.gov. 

FDA Science Board Advisory Committee. 

Christina Vert, Center for Biologics Evaluation and Research, Food and 

Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 

6268, Silver Spring, MD 20993–0002, 240–402–8054, 

Christina.Vert@fda.hhs.gov. 

Blood Products Advisory Committee. 

Jarrod Collier, Center for Biologics Evaluation and Research, Food and 

Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Silver 

Spring, MD 20993–0002, 202–906–0043, Jarrod.Collier@

fda.hhs.gov. 

Cellular, Tissue and Gene Therapies Advisory Committee. 


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TABLE 1—ADVISORY COMMITTEE CONTACTS—Continued 

Contact person Committee/panel 

Kathleen Hayes, Center for Biologics Evaluation and Research, Food 

and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 

6307C, Silver Spring, MD 20993–0002, 301–796–7864, 

Kathleen.Hayes@fda.hhs.gov. 

Allergenics Products Advisory Committee, Vaccines and Related Biological Products Advisory Committee. 

Yvette Waples, Center for Drugs Evaluation and Research, Food and 

Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 

2510, Silver Spring, MD 20993–0002, 301–796–9034, 

Yvette.Waples@fda.hhs.gov. 

Gastrointestinal Drugs Advisory Committee, Pharmaceutical Science 

and Clinical Pharmacology Advisory Committee, 

Psychopharmacologic Drugs Advisory Committee. 

James Swink, Center for Devices and Radiological Health, Food and 

Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 

5211, Silver Spring, MD 20993–0002, 301–796–6313, 

James.Swink@fda.hhs.gov. 

Anesthesiology and Respiratory Therapy Devices Panel, Circulatory 

Systems Devices Panel, Dental Products Devices Panel, General 

Hospital and Personal Use Devices Panel, Hematology and Pathology Devices Panel, Radiological Devices Panel. 

Patricio Garcia, Center for Devices and Radiological Health, Food and 

Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 

5216, 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, General and Plastic Surgery 

Devices Panel, Obstetrics and Gynecology Devices Panel. 

Aden Asefa, Center for Devices and Radiological Health, Food and 

Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 

5214, Silver Spring, MD 20993–0002, 301–796–0400, Aden.Asefa@

fda.hhs.gov. 

Immunology Devices Panel, Microbiology Devices Panel, Molecular 

and Clinical Genetics Devices Panel, Neurological Devices Panel. 

Aden Asefa, Center for Devices and Radiological Health, Food and 

Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 

5214, Silver Spring, MD 20993–0002, 301–796–0400, Aden.Asefa@

fda.hhs.gov. 

National Mammography Quality Assurance Advisory Committee. 

Letise Williams, Center for Devices and Radiological Health, Food and 

Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 

5407, Silver Spring, MD 20993–0002, 301–796–8398, 

Letise.Williams@fda.hhs.gov. 

Patient Engagement Advisory Committee. 

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 

FDA Science Board Advisory Committee—The Science Board provides advice to the Commissioner of 

Food and Drugs (Commissioner) and other appropriate officials on specific complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board provides advice that supports the Agency in keeping pace with 

technical and scientific developments, including in regulatory science; and input into the Agency’s research agenda, and on upgrading its scientific and research facilities and training opportunities. It also 

provides, where requested, expert review of Agency-sponsored intramural and extramural scientific research programs. 

1—Voting ....... Immediately. 

Blood Products Advisory Committee—Knowledgeable in the fields of clinical and administrative medicine, 

hematology, immunology, blood banking, surgery, internal medicine, biochemistry, engineering, biological and physical sciences, biotechnology, computer technology, statistics, epidemiology, sociology/ethics, and other related professions. 

1—Voting ....... October 1, 2021. 

Cellular, Tissue and Gene Therapies Advisory Committee—Knowledgeable in the fields of cellular therapies, tissue transplantation, gene transfer therapies and xenotransplantation (biostatistics, bioethics, 

hematology/oncology, human tissues and transplantation, reproductive medicine, general medicine, 

and various medical specialties, including surgery and oncology, immunology, virology, molecular biology, cell biology, developmental biology, tumor biology, biochemistry, rDNA technology, nuclear medicine, gene therapy, infectious diseases, and cellular kinetics). 

1—Voting ....... Immediately. 

Allergenics Products Advisory Committee—Knowledgeable in the fields of allergy, immunology, pediatrics, internal medicine, biochemistry, and related specialties. 1—Voting ....... September 1, 2021. 

Vaccines and Related Biologic Advisory Committee—Knowledgeable in the fields of immunology, molecular biology, rDNA, virology, bacteriology, epidemiology or biostatistics, allergy, preventive medicine, 

infectious diseases, pediatrics, microbiology, and biochemistry. 

1—Voting ....... Immediately. 

Gastrointestinal Drugs Advisory Committee—Knowledgeable in the fields of gastroenterology, endocrinology, surgery, clinical pharmacology, physiology, pathology, liver function, motility, esophagitis, and 

statistics. 

1—Voting ....... July 1, 2021. 

Pharmaceutical Science and Clinical Pharmacology Advisory Committee—Knowledgeable in the fields of 

pharmaceutical manufacturing, clinical pharmacology, pharmacokinetics, bioavailability and bioequivalence research, the design and evaluation of clinical trials, laboratory analytical techniques, pharmaceutical chemistry, physiochemistry, biochemistry, biostatistics, and related biomedical and pharmacological specialties. 

1—Voting ....... November 1, 2021. 


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

NEEDED—Continued 

Committee/panel/areas of expertise needed Type of 

vacancy 

Approximate date 

needed 

Psychopharmacologic Drugs Advisory Committee—Knowledgeable in the fields of psychopharmacology, 

psychiatry, epidemiology or statistics, and related specialties. 

1—Voting ....... Immediately. 

Anesthesiology and Respiratory Therapy Devices Panel—Anesthesiologists, pulmonary medicine specialists, or other experts who have specialized interests in ventilator support, pharmacology, physiology, or 

the effects and complications of anesthesia. 

1—Nonvoting December 1, 2021. 

Circulatory Systems Devices Panel—Interventional cardiologists, electrophysiologists, invasive (vascular) 

radiologists, vascular and cardiothoracic surgeons, and cardiologists with special interest in congestive 

heart failure. 

1—Nonvoting Immediately. 

Dental Products Devices Panel—Dentists, engineers, and scientists who have expertise in the areas of 

dental implants, dental materials, periodontology, tissue engineering, and dental anatomy. 

1—Nonvoting Immediately. 

General Hospital and Personal Use Devices Panel—Internists, pediatricians, neonatologists, 

endocrinologists, gerontologists, nurses, biomedical engineers, or microbiologists/infection control practitioners or experts. 

1—Nonvoting Immediately. 

Hematology and Pathology Devices Panel—Hematologists (benign and/or malignant hematology), 

hematopathologists (general and special hematology, coagulation and hemostasis, and hematological 

oncology), gynecologists with special interests in gynecological oncology, cytopathologists, and molecular pathologists with special interests in development of predictive biomarkers. 

1—Nonvoting Immediately. 

Radiological 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. 

Clinical Chemistry and Clinical Toxicology 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. 1—Nonvoting Immediately. 

Gastroenterology and Urology Devices Panel—Gastroenterologists, urologists, and nephrologists. 1—Nonvoting Immediately. 

General and Plastic Surgery Devices Panel—Surgeons (general, plastic, reconstructive, pediatric, thoracic, abdominal, pelvic, and endoscopic); dermatologists; experts in biomaterials, lasers, wound healing, and quality of life; and biostatisticians. 1—Nonvoting Immediately. 

Obstetrics and Gynecology Devices Panel—Experts in perinatology, embryology, reproductive endocrinology, pediatric gynecology, gynecological oncology, operative hysteroscopy, pelviscopy, 

electrosurgery, 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. 

1—Nonvoting Immediately. 

Immunology Devices Panel—Persons with experience in medical, surgical, or clinical oncology, internal 

medicine, clinical immunology, allergy, molecular diagnostics, or clinical laboratory medicine. 

1—Nonvoting Immediately. 

Microbiology Devices Panel—Clinicians 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. 

1—Nonvoting Immediately. 

Molecular and Clinical Genetics Devices Panel—Experts in human genetics and in the clinical management of patients with genetic disorders, e.g., pediatricians, obstetricians, neonatologists. The Agency is 

also interested in considering candidates with training in inborn errors of metabolism, biochemical and/ 

or molecular genetics, population genetics, epidemiology, and related statistical training. Additionally, 

individuals with experience in genetic counseling, medical ethics, as well as ancillary fields of study will 

be considered. 

1—Nonvoting Immediately. 

Neurological Devices Panel—Neurosurgeons (cerebrovascular and pediatric), neurologists (stroke, pediatric, pain management, and movement disorders), interventional neuroradiologists, psychiatrists, and 

biostatisticians. 

1—Nonvoting December 1, 2021. 

National Mammography Quality Assurance Advisory Committee—Physician, practitioner, or other health 

professional whose clinical practice, research specialization, or professional expertise includes a significant focus on mammography. 

4—Voting ....... Immediately. 

Patient Engagement Advisory Committee—Experts who are knowledgeable in areas such as clinical research, primary care patient experience, and healthcare needs of patient groups in the United States. 

Selected Committee members may also be experienced in the work of patient and health professional 

organizations; methodologies for eliciting patient preferences; and strategies for communicating benefits, risks, and clinical outcomes to patients and research subjects. 

1—Voting ....... Immediately. 

I. Functions and General Description of 

the Committee Duties 

A. FDA Science Board Advisory 

Committee 

The Science Board Advisory 

Committee (Science Board) provides 

advice to the Commissioner of Food and 

Drugs (Commissioner) and other 

appropriate officials on specific 

complex scientific and technical issues 

important to FDA and its mission, 

including emerging issues within the 

scientific community. Additionally, the 

Science Board provides advice that 

supports the Agency in keeping pace 

with technical and scientific 

developments, including in regulatory 

science, and input into the Agency’s 

research agenda and on upgrading its 

scientific and research facilities and 

training opportunities. It also provides, 

where requested, expert review of 


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Agency-sponsored intramural and 

extramural scientific research programs. 

B. Blood Products Advisory Committee 

The Blood Products Advisory 

Committee reviews and evaluates 

available data concerning the safety, 

effectiveness, and appropriate use of 

blood products derived from blood and 

serum or biotechnology. The Committee 

reviews and evaluates these products or 

biotechnology which are also intended 

for use in the diagnosis, prevention, or 

treatment of human diseases, as well as 

the safety, effectiveness, and labeling of 

the products, on clinical and laboratory 

studies involving such products, on the 

affirmation or revocation of biological 

product licenses. The Committee also 

reviews and evaluates the quality and 

relevance of FDA’s research program 

that provides the scientific support for 

regulating these products. 

C. Cellular, Tissue, and Gene Therapies 

Advisory Committee 

The Cellular, Tissue, and Gene 

Therapies Advisory Committee reviews 

and evaluates available data relating to 

the safety, effectiveness, and 

appropriate use of human cells, human 

tissues, gene transfer therapies and 

xenotransplantation products that are 

intended for transplantation, 

implantation, infusion and transfer in 

the prevention and treatment of a broad 

spectrum of human diseases, and in the 

reconstruction, repair, or replacement of 

tissues for various conditions. The 

Committee also considers the quality 

and relevance of FDA’s research 

program that provides scientific support 

for the regulation of these products. 

D. Allergenics 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. 

E. Vaccines and Related Biologic 

Products Advisory Committee 

The Vaccines and Related Biologic 

Products Advisory Committee reviews 

and evaluates data concerning the 

safety, effectiveness, and appropriate 

use of vaccines and related biological 

products that are intended for use in the 

prevention, treatment, or diagnosis of 

human diseases, as well as considers the 

quality and relevance of FDA’s research 

program that provides scientific support 

for the regulation of these products. 

F. Gastrointestinal Drugs Advisory 

Committee 

The Gastrointestinal 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 gastrointestinal 

diseases. 

G. Pharmaceutical Science and Clinical 

Pharmacology Advisory Committee 

The Pharmaceutical Science and 

Clinical Pharmacology Advisory 

Committee provides advice on scientific 

and technical issues concerning the 

safety and effectiveness of human 

generic drug products for use in the 

treatment of a broad spectrum of human 

diseases and as required, any other 

product for which FDA has regulatory 

responsibility. The Committee may also 

review Agency-sponsored intramural 

and extramural biomedical research 

programs in support of FDA’s generic 

drug regulatory responsibilities. 

H. Psychopharmacologic Drugs 

Advisory Committee 

The 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. 

I. Certain Panels of the Medical Devices 

Advisory Committee 

The Medical Devices Advisory 

Committee has established certain 

panels to review and evaluate data on 

the safety and effectiveness of marketed 

and investigational devices and make 

recommendations for their regulation. 

With the exception of the Medical 

Devices Dispute Resolution Panel, each 

panel, according to its specialty area: (1) 

Advises on the classification or 

reclassification of devices into one of 

three regulatory categories and advises 

on any possible risks to health 

associated with the use of devices; (2) 

advises on formulation of product 

development protocols; (3) reviews 

premarket approval applications for 

medical devices; (4) reviews guidelines 

and guidance documents; (5) 

recommends exemption of certain 

devices from the application of portions 

of the Federal Food, Drug, and Cosmetic 

Act; (6) advises on the necessity to ban 

a device; and (7) 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 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. 

J. National Mammography Quality 

Assurance Advisory Committee 

The National Mammography Quality 

Assurance Advisory Committee advises 

the Agency on the following: 

Development of appropriate quality 

standards and regulations for 

mammography facilities; standards and 

regulations for bodies accrediting 

mammography facilities under this 

program; regulations with respect to 

sanctions; procedures for monitoring 

compliance with standards; establishing 

a mechanism to investigate consumer 

complaints; and reporting new 

developments concerning breast 

imaging that should be considered in 

the oversight of mammography 

facilities. The Committee also advises 

the Agency on determining whether 

there exists a shortage of mammography 

facilities in rural and health 

professional shortage areas and 

determining the effects of personnel on 

access to the services of such facilities 

in such areas; determining whether 

there exist a sufficient number of 


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44028 Federal Register / Vol. 86, No. 152 / Wednesday, August 11, 2021 / Notices 

medical physicists; and determining the 

costs and benefits of compliance with 

these requirements. 

K. Patient Engagement Advisory 

Committee 

The Patient Engagement Advisory 

Committee advises the Agency on 

complex issues relating to medical 

devices, the regulation of devices, and 

their use by patients. The Committee 

may consider topics such as Agency 

guidance and policies, clinical trial or 

registry design, patient preference study 

design, benefit-risk determinations, 

device labeling, unmet clinical needs, 

available alternatives, patient reported 

outcomes and device-related quality of 

life or health status issues, and other 

patient-related topics. The Committee 

will provide relevant skills and 

perspectives to improve communication 

of benefits, risks, and clinical outcomes 

and increase integration of patient 

perspectives into the regulatory process 

for medical devices. The Committee will 

perform its duties by discussing and 

providing advice and recommendation 

in ways such as identifying new 

approaches, promoting innovation, 

recognizing unforeseen risks or barriers, 

and identifying unintended 

consequences that could result from 

FDA policy. 

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 re ́sume ́. 

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 

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 of 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: August 5, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–17066 Filed 8–10–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0008] 

Patient Engagement Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

forthcoming public advisory committee 

meeting of the Patient Engagement 

Advisory Committee. The general 

function of the committee is to provide 

advice to the Commissioner of Food and 

Drugs, or designee, on complex 

scientific issues relating to medical 

devices, the regulation of devices, and 

their use by patients. The meeting will 

be open to the public. 

DATES: The meeting will take place 

virtually on October 6, 2021, from 10 

a.m. to 5 p.m. Eastern Time. 

ADDRESSES: Please note that due to the 

impact of this COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. 

Answers to commonly asked questions 

about FDA advisory committee meetings 

may be accessed at: https://

www.fda.gov/AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

Information on how to access the 

webcast will be made available no later 

than 2 business days prior to the 

meeting at https://www.fdalive.com/ 

peac. 

FOR FURTHER INFORMATION CONTACT: 

Letise Williams, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5441, Silver Spring, 

MD 20993–0002, letise.williams@


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