1510 Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices 

Programming Interface (API). 

Instructions for navigating the report, 

accessing and using the API, and 

definitions of the report contents are 

found at https://www.fda.gov/safety/ 

enforcement-reports/enforcementreport-information-and-definitions.com. 

We estimate the burden of the 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity; 21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

Firm initiated recall; § 7.46 ................................................... 2,779 1 2,779 25 69,475 

Termination of recall; § 7.55 ................................................ 2,095 1 2,095 10 20,950 

Recall status reports; § 7.53 ................................................ 2,779 13 36,127 10 361,270 

Total .............................................................................. ........................ ........................ 41,001 ........................ 451,695 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

A review of Agency data shows that 

8,337 recalls were conducted during 

fiscal years 2017 through 2019, for an 

average of 2,779 recalls annually. We 

assume an average of 25 hours is needed 

to submit the requisite notification to 

FDA, for a total annual burden of 69,475 

hours. Similarly, during the same 

period, 6,287 recalls were terminated, 

for an average of 2,095 recall 

terminations annually, and we assume 

an average of 10 hours is needed for the 

corresponding information collection 

activity. To determine burden 

associated with recall status reports we 

divided the average number of annual 

submissions (36,127) by the average 

number of annual respondents (2,779) 

and assume 10 hours is necessary for 

the corresponding information 

collection, resulting in 361,270 hours 

annually. 

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity; 21 CFR part Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total 

annual 

disclosures 

Average burden per 

disclosure Total hours 

Recall communications; 

§ 7.49.

2,779 ........................... 445 1,236,655 .................... 0.05 (3 minutes) .......... 61,832.75 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

To determine burden associated with 

recall communication disclosures 

described in § 7.49, we calculated an 

average of 445 disclosures per recall and 

attribute 3 minutes for each disclosure, 

resulting in 61,832.75 burden hours 

annually. 

These estimates reflect an overall 

decrease in the average number of 

annual responses by 245,846 and a 

decrease in the average number of 

annual burden hours by 70,949.25 since 

our last submission for OMB review and 

approval of the information collection. 

Dated: January 4, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–00125 Filed 1–7–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–0008] 

Request for Nominations for 

Individuals and Consumer 

Organizations for Advisory 

Committees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

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 January 29, 2021, for 

vacancies listed in this notice. 

Concurrently, nomination materials for 

prospective candidates should be sent to 

FDA (see ADDRESSES) by February 8, 

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, by 


tkelley on DSKBCP9HB2PROD with NOTICES
Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices 1511 

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, 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. Additional information about 

becoming a member of an FDA advisory 

committee can also be obtained by 

visiting FDA’s website at http://

www.fda.gov/AdvisoryCommittees/ 

default.htm. 

FOR FURTHER INFORMATION CONTACT: For 

questions relating to participation in the 

selection process: Kimberly Hamilton, 

Advisory Committee Oversight and 

Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5122, Silver Spring, 

MD 20993–0002, 301–796–8220, email: 

kimberly.hamilton@fda.hhs.gov. 

For questions relating to specific 

advisory committees or panels, contact 

the appropriate Contact Person listed in 

table 1. 

TABLE 1—ADVISORY COMMITTEE CONTACTS

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, email: 

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, email: Christina.Vert@fda.hhs.gov.

Blood Products Advisory Committee. 

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, email: Kathleen.Hayes@fda.hhs.gov.

Cellular, Tissue and Gene Therapies Advisory 

Committee, Vaccines and Related Biological 

Products Advisory Committee. 

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

10903 New Hampshire Ave., Bldg. 31, Rm. 2428, Silver Spring, MD 20992–0002, 301–796– 

2855, email: Latoya.Bonner@fda.hhs.gov.

Dermatologic and Ophthalmic Drugs Advisory 

Committee. 

Yinghua Wang, Center for Drugs Evaluation and Research, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 31, Rm. 2412, Silver Spring, MD 20992–002, 301–796– 

9033, email: Yinghua.Wang@fda.hhs.gov.

Gastrointestinal Drugs Advisory Committee, 

Pharmaceutical Science and Clinical Pharmacology 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, email: Yvette.Waples@fda.hhs.gov.

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, email: 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, email: 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, 

email: 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, 

email: 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, email: 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 shall provide advice to the 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 will provide 

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 will also provide, where requested, expert review of Agency 

sponsored intramural and extramural scientific research programs 

1—Voting ....... January 1, 

2021. 


tkelley on DSKBCP9HB2PROD with NOTICES
1512 Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices 

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 

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 ....... April 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 ....... September 1, 

2021. 

Dermatologic and Ophthalmic Drugs Advisory Committee—Knowledgeable in the fields of dermatology, ophthalmology, internal medicine, pathology, immunology, epidemiology or statistics, and other related professions 1—Voting ....... September 1, 

2021. 

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. 

Psychopharmacologic Drugs Advisory Committee—Knowledgeable in the fields of psychopharmacology, psychiatry, epidemiology or statistics, and related specialties 1—Voting ....... 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—Non-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—Non-Voting 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—Non-Voting 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—Non-Voting Immediately. 

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

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

1—Non-Voting 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—Non-Voting March 1, 2021. 

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—Non-Voting 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—Non-Voting Immediately. 

Gastroenterology and Urology Devices Panel—Gastroenterologists, urologists and nephrologists 1—Non-Voting 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—Non-Voting Immediately. 

Obstetrics and Gynecology Devices Panel—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 

1—Non-Voting 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—Non-Voting 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—Non-Voting Immediately. 


tkelley on DSKBCP9HB2PROD with NOTICES
Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices 1513 

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 

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—Non-Voting June 1, 2021. 

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—Non-Voting Immediately. 

Neurological Devices Panel—Neurosurgeons (cerebrovascular and pediatric), neurologists (stroke, pediatric, 

pain management, and movement disorders), interventional neuroradiologists, psychiatrists, and biostatisticians 

1—Non-Voting 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 ....... 2—Immediately 

2—February 1, 

2021. 

Patient Engagement Advisory Committee—Experts who are knowledgeable in areas such as clinical research, 

primary care patient experience, and health care 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 ....... May 1, 2021. 

I. Functions and General Description of 

the Committee Duties 

A. FDA Science Board Advisory 

Committee 

The Science Board shall provide 

advice to the 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 will provide 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 will also 

provide, where requested, expert review 

of Agency sponsored intramural and 

extramural scientific research programs. 

B. 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 which are 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, and on the quality and 

relevance of FDA’s research program 

which provides the scientific support 

for regulating these products. 

C. 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 which 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, as well as 

considers the quality and relevance of 

FDA’s research program which provides 

scientific support for the regulation of 

these products. 

D. Vaccines and Related Biologic 

Products Advisory Committee 

Reviews and evaluates data 

concerning the safety, effectiveness, and 

appropriate use of vaccines and related 

biological products which 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 which provides 

scientific support for the regulation of 

these products. 

E. 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. 

F. 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 

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 

the 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 

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 

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 


tkelley on DSKBCP9HB2PROD with NOTICES
1514 Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices 

any possible risks to health associated 

with the use of devices; advises on 

formulation of product development 

protocols; reviews premarket approval 

applications for medical devices; 

reviews guidelines and guidance 

documents; recommends exemption of 

certain devices from the application of 

portions of the Federal Food, Drug, and 

Cosmetic Act; advises on the necessity 

to ban a device; and responds to 

requests from the Agency to review and 

make recommendations on specific 

issues or problems concerning the safety 

and effectiveness of devices. With the 

exception of the Medical Devices 

Dispute Resolution Panel, each panel, 

according to its specialty area, may also 

make appropriate recommendations to 

the Commissioner of Food and Drugs 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 

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; reporting new 

developments concerning breast 

imaging which should be considered in 

the oversight of mammography 

facilities. As well as 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 a sufficient number of 

medical physicists after October 1, 1999; 

and determining the costs and benefits 

of compliance with these requirements. 

K. 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, benefitrisk determinations, device labeling, 

unmet clinical needs, available 

alternatives, patient reported outcomes 

and device-related quality of life or 

health status issues, and other patientrelated topics. The Committee will 

provide relevant skills and perspectives, 

in order to improve communication of 

benefits, risks, clinical outcomes, and 

increase integration of patient 

perspectives into the regulatory process 

for medical devices. It 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 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 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 


tkelley on DSKBCP9HB2PROD with NOTICES
Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices 1515 

consumer organizations that are 

participating in the selection process 

with the opportunity to vote on the 

listed nominees. Only organizations 

vote in the selection process. Persons 

who nominate themselves to serve as 

voting or nonvoting consumer 

representatives will not participate in 

the selection process. 

This notice is issued under the 

Federal Advisory Committee Act (5 

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

relating to advisory committees. 

Dated: January 4, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–00124 Filed 1–7–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3240] 

List of Bulk Drug Substances for 

Which There Is a Clinical Need Under 

Section 503B of the Federal Food, 

Drug, and Cosmetic Act; Reopening of 

the Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; reopening of the 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

reopening the comment period for a 

notice that appeared in the Federal 

Register of July 31, 2020, in which FDA 

identified certain bulk drug substances 

(active pharmaceutical ingredients) that 

FDA has considered and proposes to 

include or not include on the list of bulk 

drug substances for which there is a 

clinical need (the 503B Bulks List). The 

Agency is taking this action in response 

to a request received during the initial 

comment period, which asked the 

Agency to allow interested persons 

additional time to submit comments. 

DATES: FDA is reopening the comment 

period on the notice published on July 

31, 2020 (85 FR 46126). Submit either 

electronic or written comments by 

February 8, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before February 8, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of February 8, 2021. 

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’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–N–3240 for ‘‘List of Bulk Drug 

Substances for Which There is a Clinical 

Need Under Section 503B of the Federal 

Food, Drug, and Cosmetic Act.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Dominic Markwordt, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 5104, 

Silver Spring, MD 20993, 301–796– 

9349. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of July 31, 2020 (85 FR 

46126), FDA published a notice that 

identified four bulk drug substances that 

FDA considered and proposed to 

include on the 503B Bulks List: 

diphenylcyclopropenone (DPCP), 

glycolic acid, squaric acid dibutyl ester 

(SADBE), and trichloroacetic acid 

(TCA). The July 31, 2020, notice also 

identified 19 bulk drug substances that 

FDA considered and proposed not to 

include on the 503B Bulks List: 

Diazepam, dobutamine hydrochloride 


tkelley on DSKBCP9HB2PROD with NOTICES