39526 Federal Register / Vol. 87, No. 126 / Friday, July 1, 2022 / Notices 

provide information to a third party. 

The PRA requires Federal agencies to 

provide a 60-day notice in the Federal 

Register concerning each proposed 

collection of information, including 

each proposed extension of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, ACL is publishing a notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, ACL invites 

comments on our burden estimates or 

any other aspect of this collection of 

information, including: 

(1) whether the proposed collection of 

information is necessary for the proper 

performance of ACL’s functions, 

including whether the information will 

have practical utility; 

(2) the accuracy of ACL’s estimate of 

the burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used 

to determine burden estimates; 

(3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and 

(4) ways to minimize the burden of 

the collection of information on 

respondents, including through the use 

of automated collection techniques 

when appropriate, and other forms of 

information technology. 

The Administration for Community 

Living (ACL) is currently engaged in an 

effort to better understand how ACL 

programs support grantees to apply 

CLAS Standards and related diversity, 

equity, and inclusion (DEI) priorities in 

their programming. While the previous 

research effort focused on the 

perspective of ACL staff and national 

associations and advocacy 

organizations; this new IC will focus on 

a broader scope of respondents. In this 

IC, ACL will be reaching out to ACLfunded grantees. By capturing the 

perspectives of these grantees, this 

research aims to build on both our 

current knowledge of the CLAS 

Standards and DEI landscape at ACL, as 

well as to enhance our understanding of 

how to support the aging and disability 

networks to strengthen their CLAS 

Standards and DEI practices and 

priorities. 

The IC, as well as analyses of 

available NSOAAP, Annual 

Performance data or other ACL data, 

would help address the following key 

research questions: 

1. Who does ACL serve? 

a. How do ACL clients differ by 

demographic characteristics and/or 

social determinants of health (e.g., 

language, culture, race/ethnicity, age, 

disability status)? 

b. Are there any gaps in the types of 

people (or clients) served? 

2. How are ACL program grantees 

meeting the needs of these diverse 

people (or clients)? 

a. What data do they collect that 

would help ensure they meet diverse 

client needs? 

b. What resources do grantee 

organizations need to support the 

cultural and linguistic needs of their 

clients? 

Five focus groups with ACL grantees, 

comprised of 8–10 participants each 

(with each participant representing one 

grantee entity), would be conducted to 

help ACL better understand the current 

service provider grantee landscape 

related to cultural and linguistic needs 

and other DEI activities. Data gathered 

from these focus groups would also help 

refine a web-based survey that would be 

administered to a minimum of 400 

service provider grantees. The survey 

would allow for broader reach to help 

ACL understand both how provider 

grantees address diverse client needs 

and what additional resources provider 

grantee organizations may need to 

support the cultural, linguistic, and DEI 

needs of the people they serve. 

Together, these data will help ACL 

better understand how grantees are 

meeting the needs of their clients, as 

well as the extent of unmet CLAS/DEI 

needs that exist for clients and the 

extent to which those unmet needs may 

limit service access. The proposed data 

collection tools may be found on the 

ACL website for review at: https://

www.acl.gov/about-acl/public-input. 

Estimated Program Burden: ACL 

estimates the burden of this collection 

of information as follows: 

The grantee focus groups will include 

no more than 50 individuals 

representing grantee organizations 

across the US. The burden for their 

participation is estimated at 1.5 hours 

per participant, for a total of 75 hours. 

A minimum of 400 grantees are 

expected to respond to the web-based 

survey. The approximate burden for 

survey completion may be ten minutes 

per respondent for a total estimate of 

4,000 minutes. The estimated survey 

completion burden includes time to 

review the instructions, read the 

questions and complete the responses. 

IC BURDEN CHART

Respondent/data collection activity Number of 

respondents 

Responses 

per 

respondent 

Hours per 

response 

Annual 

burden hours 

Grantee focus groups ...................................................................................... 50 1 1.50 75.00 

Web-based grantee survey ............................................................................. 400 1 0.16 66.67 

Total .......................................................................................................... 480 1 1.66 141.67 

Dated: June 27, 2022. 

Alison Barkoff, 

Acting Administrator and Assistant Secretary 

for Aging. 

[FR Doc. 2022–14078 Filed 6–30–22; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–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 


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Federal Register / Vol. 87, No. 126 / Friday, July 1, 2022 / Notices 39527 

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 individuals on 

its advisory committee regardless of 

their gender identification, religious 

affiliation, racial and ethnic 

identification, or disability status and, 

therefore, encourages nominations of 

appropriately qualified candidates from 

all 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 15, 2022, for 

vacancies listed in this notice. 

Concurrently, nomination materials for 

prospective candidates should be sent to 

FDA (see ADDRESSES) by August 15, 

2022. Nominations will be accepted for 

current vacancies and for those that will 

or may occur through December 31, 

2023. 

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. 

Prabhakara Atreya, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1226, Silver Spring, MD 20993–0002, 240– 

402–8006, Prabhakara.Atreya@fda.hhs.gov.

Allergenics Products Advisory Committee. 

Moon Hee Choi, Center for Drugs 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 Advisory Committee, Non-Prescription Drugs Advisory 

Committee. 

She-Chia Chen, Center for Dugs Evaluation and Research, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 31 Rm. 2438, Silver Spring, MD 20993–0002, 240–402– 

5343, She-Chia.Chen@fda.hhs.gov.

Antimicrobial Drugs Advisory Committee. 

Jessica Seo, Center for Drugs Evaluation and Research, Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 31, Rm. 2412, Silver Spring, MD 20993–0002, 301–796–7699, 

Jessica.Seo@fda.hhs.gov.

Arthritis Drugs Advisory Committee, Peripheral 

and Central Nervous System Drugs Advisory 

Committee. 

Joyce Yu, Center for Drugs Evaluation Research, Food and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2438, Silver Spring, MD 20993–0002, 301–837–7126, 

Joyce.Yu@fda.hhs.gov.

Cardiovascular Drugs Advisory Committee, 

Medical Imaging Drugs Advisory Committee. 

LaToya Bonner, Center for Drugs Evaluation and Research, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 31, Rm. 2428, Silver Spring, MD 20993–0002, 301–796– 

2855, LaToya.Bonner@fda.hhs.gov.

Endocrinologic and Metabolic Drugs Advisory 

Committee. 

Takyiah Stevenson, Center for Drugs Evaluation Research, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 31, Rm. 2406, Silver Spring, MD 20993–0002, 240–402– 

2507, Takyiah.Stevenson@fda.hhs.gov.

Pharmacy Compounding Drugs Advisory Committee. 

Joyce Frimpong, Center for Drugs Evaluation and Research, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 31, Rm. 2462, Silver Spring, MD 20993–0002, 301–796– 

7973, Joyce.Frimpong@fda.hhs.gov.

Psychopharmacologic Drugs Advisory Committee. 

Candace Nalls, Center for Devices and Radiological Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, Rm. 5211, Silver Spring, MD 20993–0002, 301–636– 

0510, Candace.Nalls@fda.hhs.gov.

Anesthesiology and Respiratory Therapy Devices Panel, Clinical Chemistry and Clinical 

Toxicology Devices Panel, Ear, Nose and 

Throat Devices Panel, Gastroenterology and 

Urology Devices Panel, General and Plastic 

Surgery Devices Panel. 

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.

Circulatory System Devices Panel, Immunology Devices Panel, Microbiology Devices 

Panel. 

Akinola Awojope, Center for Devices and Radiological Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993–0002, 301–636– 

0512, Akinola.Awojope@fda.hhs.gov.

Dental Products Devices Panel, Obstetrics and 

Gynecology Devices Panel, Orthopaedic and 

Rehabilitation Devices Panel. 

Jarrod Collier, Center for Devices and Radiological Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, Rm. 5211, Silver Spring, MD 20993–0002, 240–672– 

5763, Jarrod.Collier@fda.hhs.gov.

General Hospital and Personal Use Devices 

Panel, Hematology and Pathology Devices 

Panel, Molecular and Clinical Genetics Devices Panel, Ophthalmic Devices Panel, Radiology Devices Panel. 


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TABLE 1—ADVISORY COMMITTEE CONTACTS—Continued 

Contact person Committee/panel 

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.

National Mammography Quality Assurance 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 Administration (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. 

Allergenics Products Advisory Committee—Knowledgeable in the fields of allergy, 

immunology, pediatrics, internal medicine, biochemistry, and related specialties.

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

Anesthetic and Analgesic Drug Products Advisory Committee—Knowledgeable in 

the fields of anesthesiology, surgery, epidemiology or statistics, and related specialties.

1—Voting ............................ April 1, 2023. 

Non-Prescription Drugs Advisory Committee—Knowledgeable in the fields of internal 

medicine, family practice, clinical toxicology, clinical pharmacology, pharmacy, 

dentistry, and related specialties.

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

Antimicrobial Drugs Advisory Committee—Knowledgeable in the fields of infectious 

disease, internal medicine, microbiology, pediatrics, epidemiology or statistics, and 

related specialties.

1—Voting ............................ May 1, 2023. 

Arthritis Drugs Advisory Committee—Knowledgeable in the fields of arthritis, 

rheumatology, orthopedics, epidemiology or statistics, analgesics, and related specialties.

1—Voting ............................ December 1, 2023. 

Peripheral and Central Nervous Systems Drugs Advisory Committee—Knowledgeable in the fields of neurology, neuropharmacology, neuropathology, otolaryngology, epidemiology or statistics, and related specialties.1—Voting ............................ February 1, 2023. 

Cardiovascular Drugs Advisory Committee—Knowledgeable in the fields of cardiology, hypertension, arrhythmia, angina, congestive heart failure, diuresis, and 

biostatistics.

1—Voting ............................ July 1, 2023. 

Medical Imaging Drugs Advisory Committee—Knowledgeable in the fields of nuclear 

medicine, radiology, epidemiology, statistics, and related specialties.

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

Endocrinologic and Metabolic Drugs Advisory Committee—Knowledgeable in the 

fields of endocrinology, metabolism, epidemiology or statistics, and related specialties.

1—Voting ............................ July 1, 2022. 

Pharmacy Compounding Drugs Advisory Committee—Knowledgeable in the fields of 

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

1—Voting ............................ October 1, 2023. 

Psychopharmacologic Drugs Advisory Committee—Knowledgeable in the fields of 

psychopharmacology, psychiatry, epidemiology or statistics, and related specialties.

1—Voting ............................ July 1, 2022. 

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 ...................... 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. 

Ear, Nose and Throat Devices Panel—Otologists, neurotologists, audiologists .......... 1—Nonvoting ...................... November 1, 2023. 

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. 

Circulatory System Devices Panel—Interventional cardiologists, electrophysiologists, 

invasive (vascular) radiologists, vascular and cardiothoracic surgeons, and cardiologists with special interest in congestive heart failure.

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


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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 

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. 

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. 

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. 

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. 

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. 

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. 

Ophthalmic Devices Panel—Ophthalmologists with expertise in corneal-external disease, vitreo-retinal surgery, glaucoma, ocular immunology, ocular pathology; optometrists; vision scientists; and ophthalmic professionals with expertise in clinical 

trial design, quality of life assessment, electrophysiology, low vision rehabilitation, 

and biostatistics.

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. 

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.

3—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 

Agency-sponsored intramural and 

extramural scientific research programs. 

B. Allergenics Drugs 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 


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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. 

C. Anesthetic and Analgesic Drugs 

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. 

D. Nonprescription Drugs Advisory 

Committee 

Review and evaluate available data 

concerning the safety and effectiveness 

of over-the-counter (nonprescription) 

human drug products, or any other 

FDA-regulated product, for use in the 

treatment of a broad spectrum of human 

symptoms and diseases and advise the 

Commissioner either on the 

promulgation of monographs 

establishing conditions under which 

these drugs are generally recognized as 

safe and effective and not misbranded or 

on the approval of new drug 

applications for such drugs. The 

Committee will serve as a forum for the 

exchange of views regarding the 

prescription and nonprescription status, 

including switches from one status to 

another, of these various drug products 

and combinations thereof. The 

Committee may also conduct peer 

review of Agency-sponsored intramural 

and extramural scientific biomedical 

programs in support of FDA’s mission 

and regulatory responsibilities. 

E. Antimicrobial 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 infectious diseases and disorders. 

F. Arthritis Drugs Advisory Committee 

Reviews and evaluates data 

concerning the safety and effectiveness 

of marketed and investigational human 

drug products for use in the treatment 

of arthritis, rheumatism, and related 

diseases. 

G. Peripheral and Central Nervous 

System Drugs Advisory Committee 

Reviews and evaluates data 

concerning the safety and effectiveness 

of marketed and investigational human 

drug products for use in the treatment 

of neurologic diseases. 

H. Cardiovascular 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. 

I. Medical Imaging Drugs 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. 

J. Endocrinologic and Metabolic Drugs 

Advisory Committee 

Reviews and evaluates data 

concerning the safety and effectiveness 

of marketed and investigational human 

drug products for use in the treatment 

of endocrine and metabolic disorders. 

K. Pharmacy Compounding 

Provides advice on scientific, 

technical, and medical issues 

concerning drug compounding by 

pharmacists and licensed practitioners. 

L. 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. 

M. Medical Devices Panels 

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. Except for 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 Devices 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. 

N. National Mammography Quality 

Assurance Advisory Committee 

Advise 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 

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 will exist 

enough medical physicists after October 

1, 1999; and determining the costs and 

benefits of compliance with these 

requirements. 

II. Criteria for Members 

Persons nominated for membership as 

consumer representatives on 

committees or panels should meet the 

following criteria: (1) demonstrate an 


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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 45 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 section of this document), 

and a list of consumer or communitybased 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. After 

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: June 24, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14135 Filed 6–30–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2021–E–0452; FDA– 

2021–E–0453] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; IMCIVREE 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for IMCIVREE and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of applications to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see the 

SUPPLEMENTARY INFORMATION section) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by August 30, 2022. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

December 28, 2022. See ‘‘Petitions’’ in 

the SUPPLEMENTARY INFORMATION section 

for more information. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

August 30, 2022. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are postmarked or the 

delivery service acceptance receipt is on 

or before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 


khammond on DSKJM1Z7X2PROD with NOTICES