12486 Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices 

IRB shall determine whether adequate 

provisions are made for soliciting 

assent. Generally, assent requires 

securing the signature of a minor 

potentially participating in the research 

on a separate assent form, in addition to 

the consent form the parent or legal 

guardian signs. An assent document 

should: (1) Contain an explanation of 

the study; (2) a description of what is 

required of the subject (e.g., what he or 

she will experience (whether the minor 

will be in the hospital, whether the 

minor’s parents will be with him or her, 

etc.)); (3) an explanation of any risks 

and pain associated with the study; (4) 

an explanation of any anticipated 

change in the minor’s appearance; and 

(5) an explanation of the benefits to the 

minor or others. 

FDA plans to use the data collected 

under the generic clearance to inform 

the following information for education, 

interventions, outcomes, regulatory 

science programs, materials and 

resources, and disease prevention and 

treatment. FDA expects the data to 

guide the formulation of the Agency’s 

educational and public health objectives 

on FDA-regulated products and support 

development of subsequent research 

efforts. The data will not be used to 

make policy or regulatory decisions. 

Rather, these data will: (1) Inform FDA’s 

public education campaigns and other 

educational/interventional materials 

directed to informing consumers, 

patients, caregivers, and public health 

professionals about human and animal 

health issues; and (2) provide 

information on the safety, efficacy, and 

usage of FDA-regulated products. 

If these conditions are not met, FDA 

will submit an information collection 

request to OMB for approval through the 

normal PRA process. 

To obtain approval for a collection 

that meets the conditions of this generic 

clearance, an abbreviated supporting 

statement will be submitted to OMB, 

along with supporting documentation 

(e.g., a copy of the interview or 

moderator guide, screening 

questionnaire). 

FDA will submit individual 

qualitative and quantitative collections 

under this generic clearance to the 

OMB. Individual collections will also 

undergo review by FDA’s IRB, senior 

leadership for the primary investigator’s 

respective offices, and PRA specialists. 

Description of Respondents: The 

respondents to this collection of 

information are all FDA stakeholders, 

including general population 

individuals, as well as consumers of 

certain products, patients and their 

caregivers, academic/scientific experts, 

individuals from specific target labor 

groups, such as physicians, medical 

specialists, pharmacists, dentists, 

nurses, veterinarians, dietitians, and 

other public health professionals. 

In the Federal Register of July 7, 2020 

(85 FR 40655), FDA published a 60-day 

notice requesting public comment on 

the proposed collection of information. 

Although five comments were received, 

they were not responsive to the four 

collection of information topics 

solicited and, therefore, will not be 

discussed in this document. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Interviews/Surveys/Focus Groups ................................. 2,520 14.6 36,792 0.25 (15 minutes) 9,198 

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

This is a new collection of 

information whose total estimated 

annual reporting burden is 9,198 hours. 

The number of participants to be 

included in each individual generic 

submission under this collection of 

information will vary, depending on the 

nature of the compliance efforts and the 

target audience. 

Dated: February 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–04407 Filed 3–2–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Arthritis and 

Musculoskeletal and Skin Diseases; 

Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the Board of Scientific 

Counselors, NIAMS. 

The meeting will be closed to the 

public as indicated below in accordance 

with the provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended for the review, discussion, 

and evaluation of individual intramural 

programs and projects conducted by the 

NATIONAL INSTITUTE OF ARTHRITIS 

AND MUSCULOSKELETAL AND SKIN 

DISEASES, including consideration of 

personnel qualifications and 

performance, and the competence of 

individual investigators, the disclosure 

of which would constitute a clearly 

unwarranted invasion of personal 

privacy. 

Name of Committee: Board of Scientific 

Counselors, NIAMS. 

Date: April 27–28, 2021. 

Time: April 27, 2021, 12:30 p.m. to 4:45 

p.m. 

Agenda: To review and evaluate personnel 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institutes of Health, 10 

Center Drive, Bethesda, MD 20892, (Virtual 

Meeting). 

Time: April 28, 2021, 12:00 p.m. to 4:15 

p.m. 

Agenda: To review and evaluate personnel 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institutes of Health, 10 

Center Drive, Bethesda, MD 20892, (Virtual 

Meeting). 

Contact Person: John J. O’Shea, MD, Ph.D., 

Scientific Director, National Institute of 

Arthritis & Musculoskeletal and Skin 

Diseases, Building 10, Room 6N204, 

Bethesda, MD 20892, (301) 496–2612, 

osheajo@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.846, Arthritis, 

Musculoskeletal and Skin Diseases Research, 

National Institutes of Health, HHS) 

Dated: _February 25, 2021. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–04366 Filed 3–2–21; 8:45 am] 

BILLING CODE 4140–01–P 


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