41474 Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–21–1235 Docket No. CDC–2021– 

0076] 

Proposed Data Collection Submitted 

for Public Comment and 

Recommendations 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), as part of 

its continuing effort to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other Federal 

agencies the opportunity to comment on 

a continuing information collection, as 

required by the Paperwork Reduction 

Act of 1995. This notice invites 

comment on a continued information 

collection project titled ‘‘Assessments to 

Inform Program Refinement for HIV, 

other STD, and Pregnancy Prevention 

among Middle and High-School Aged 

Youth.’’ This is a generic information 

collection package that supports 

qualitative and quantitative data 

collection from adolescents (ages 11–19) 

and their parents/caregivers for the 

purpose of needs assessment and 

program refinement for programs and 

services designed to prevent HIV, other 

sexually transmitted diseases (STDs), 

and pregnancy among middle and high 

school aged adolescents. 

DATES: CDC must receive written 

comments on or before October 1, 2021. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2021– 

0076 by any of the following methods: 

• Federal eRulemaking Portal: 

Regulations.gov. Follow the instructions 

for submitting comments. 

• Mail: Jeffrey M. Zirger, Information 

Collection Review Office, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE, MS–D74, Atlanta, 

Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. CDC will post, without 

change, all relevant comments to 

Regulations.gov. 

Please note:Submit all comments 

through the Federal eRulemaking portal 

regulations.gov) or by U.S. mail to the 

address listed above. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the information collection plan and 

instruments, contact Jeffrey M. Zirger, 

Information Collection Review Office, 

Centers for Disease Control and 

Prevention, 1600 Clifton Road NE, MS– 

D74, Atlanta, Georgia 30329; phone: 

404–639–7118; Email: omb@cdc.gov. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), Federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. In addition, the PRA also 

requires Federal agencies to provide a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each new 

proposed collection, each proposed 

extension of existing collection of 

information, and each reinstatement of 

previously approved information 

collection before submitting the 

collection to the OMB for approval. To 

comply with this requirement, we are 

publishing this notice of a proposed 

data collection as described below. 

The OMB is particularly interested in 

comments that will help: 

1. Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

2. Evaluate the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

3. Enhance the quality, utility, and 

clarity of the information to be 

collected; 

4. Minimize the burden of the 

collection of information on those who 

are to respond, including using 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology, e.g., permitting 

electronic submissions of responses; 

and 

5. Assess information collection costs. 

Proposed Project 

Assessments to Inform Program 

Refinement for HIV, other STD, and 

Pregnancy Prevention among Middle 

and High-School Aged Youth (OMB 

Control No. 0920–1235, Exp. 05/31/ 

2022)—Extension—National Center for 

HIV/AIDS, Viral Hepatitis, STD, TB 

Prevention (NCHHSTP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

The Centers for Disease Control and 

Prevention (CDC) requests three-year 

OMB approval for the extension of a 

Generic information collection package 

(OMB Control No. #0920–1235, Exp. 05/ 

31/2022) that supports collection of 

quantitative and qualitative information 

from adolescents (ages 11–19) and their 

parents/caregivers for the purpose of 

needs assessment and program 

refinement for programs and services to 

prevent HIV, other sexually transmitted 

diseases (STDs), and pregnancy among 

middle and high school aged 

adolescents. 

NCHHSTP conducts behavioral and 

health service assessments and research 

projects as part of its response to the 

domestic HIV/AIDS epidemic, STD 

prevention, TB elimination and viral 

hepatitis control with national, state, 

and local partners. Adolescents are a 

population with specific developmental, 

health and social, and resource needs, 

and their health risk factors and access 

to health care are addressed as a 

primary mission by the Division of 

Adolescent and School Health (DASH), 

and adolescents are a population of 

interest for several other NCHHSTP 

divisions. The assessment and research 

conducted by NCHHSTP is one pillar 

upon which recommendations and 

guidelines are revised and updated. 

Recommendations and guidelines for 

adolescent sexual risk reduction require 

that foundation of scientific evidence. 

Assessment of programmatic practices 

for adolescents helps to assure effective 

and evidence-based sexual risk 

reduction practices and efficient use of 

resources. Such assessments also help to 

improve programs through better 

identification of strategies relevant to 

adolescents as a population as well as 

specific sub-groups of adolescents at 

highest risk for HIV and other STDs so 

that programs can be better tailored for 

them. 

The information collection requests 

under this generic package are intended 

to allow for data collection with two 

types of respondents: 

• Adolescents (11–19 years old) of 

middle and high school age; and 

• Parents and/or caregivers of 

adolescents of middle and high school 

age. For the purposes of this generic 

package, parents/caregivers include the 

adult primary caregiver(s) for a child’s 

basic needs (e.g., food, shelter, and 

safety). This includes biological parents; 

other biological relatives such as 

grandparents, aunts, uncles, or siblings; 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices 41475 

and non-biological parents such as 

adoptive, foster, or stepparents. 

The types of information collection 

activities included in this generic 

package are: 

(1) Quantitative data collection 

through electronic, telephone, or paper 

questionnaires to gather information 

about programmatic and service 

activities related to the prevention of 

HIV and other STDs among adolescents 

of middle- and high-school age. 

(2) Qualitative data collection through 

electronic, telephone, or paper means to 

gather information about programmatic 

and service activities related to the 

prevention of HIV and other STDs 

among adolescents of middle- and highschool age. Qualitative data collection 

may involve focus groups and in-depth 

interviewing through group interviews, 

and cognitive interviewing. 

For adolescents, data collection 

instruments will include questions on 

demographic characteristics; 

experiences with programs and services 

to reduce the risk of HIV and other STD 

transmission; and knowledge, attitudes, 

behaviors, and skills related to sexual 

risk and protective factors on the 

individual, interpersonal, and 

community levels. 

For parents and caregivers, data 

collection instruments will include 

questions on demographic 

characteristics as well as parents’/ 

caregivers’ (1) perceptions about 

programs and services provided to 

adolescents; (2) knowledge, attitudes, 

and perceptions about their adolescents’ 

health risk and protective behaviors; 

and (3) parenting knowledge, attitudes, 

behaviors, and skills. 

Any data collection request put 

forward under this generic clearance 

will identify the programs and/or 

services to be informed or refined, and 

will include a cross-walk of data 

elements to the aspects of the program 

the project team seeks to inform or 

refine. Because this request includes a 

wide range of possible data collection 

instruments, specific requests will 

include items of information to be 

collected and copies of data collection 

instruments. It is expected that all data 

collection instruments will be pilottested, and will be culturally, 

developmentally, and age appropriate 

for the adolescent populations included. 

Similarly, parent data collection 

instruments will be pilot-tested, and the 

data collection instruments will reflect 

the culture, developmental stage, and 

age of the parents’ adolescent children. 

All data collection procedures will 

receive review and approval by an 

Institutional Review Board for the 

Protection of Human Subjects and 

follow appropriate consent and assent 

procedures as outlined in the IRBapproved protocols. These will be 

described in the individual information 

collection requests put forward under 

this Generic package. 

The table below provides the 

estimated annualized response burden 

for up to 15 individual data collections 

per year under this generic clearance at 

57,584 hours. Participation of 

respondents is voluntary. There is no 

cost to participants other than their 

time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Middle and High School Age Adolescents.Youth Questionnaire ........................ 20,000 1 50/60 16,667 

Middle and High School Age Adolescents.Pre/Post youth questionnaire ........... 10,000 2 50/60 16,667 

Middle and High School Age Adolescents.Youth interview/focus group guide ... 3,000 2 90/60 9,000 

Parents/caregivers of adolescents .... Parent/Caregiver questionnaire ....... 7,500 2 25/60 6,250 

Parents/caregivers of adolescents .... Parent/Caregiver interview/focus 

group guide.

3,000 2 90/60 9,000 

Total ........................................... ........................................................... ........................ ........................ ........................ 57,584 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2021–16376 Filed 7–30–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0758] 

Antimicrobial Drugs Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Antimicrobial Drugs 

Advisory Committee. The general 

function of the committee is to provide 

advice and recommendations to FDA on 

regulatory issues. The meeting will be 

open to the public. FDA is establishing 

a docket for public comment on this 

document. 

DATES: The meeting will be held on 

October 7, 2021, from 9 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. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2021–N–0758. 

The docket will close on October 6, 

2021. Submit either electronic or 

written comments on this public 

meeting by October 6, 2021. Please note 

that late, untimely filed comments will 

not be considered. Electronic comments 

must be submitted on or before October 

6, 2021. The https://

www.regulations.gov electronic filing 


khammond on DSKJM1Z7X2PROD with NOTICES