Proposed Data Collection Submitted for Public Comment and Recommendations, 41474-41475 [2021-16376]
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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices
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.
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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
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
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SUMMARY:
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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.
SUPPLEMENTARY INFORMATION:
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:
Proposed Project
• Adolescents (11–19 years old) of
middle and high school age; and
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).
• 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;
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41475
Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices
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,
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.
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
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Form name
Middle and High School Age Adolescents.
Middle and High School Age Adolescents.
Middle and High School Age Adolescents.
Parents/caregivers of adolescents ....
Parents/caregivers of adolescents ....
Youth Questionnaire ........................
20,000
1
50/60
16,667
Pre/Post youth questionnaire ...........
10,000
2
50/60
16,667
Youth interview/focus group guide ...
3,000
2
90/60
9,000
Parent/Caregiver questionnaire .......
Parent/Caregiver
interview/focus
group guide.
7,500
3,000
2
2
25/60
90/60
6,250
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
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
respondents
Type of respondents
[Docket No. FDA–2021–N–0758]
Antimicrobial Drugs Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
VerDate Sep<11>2014
17:21 Jul 30, 2021
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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.
SUMMARY:
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
DATES:
Food and Drug Administration,
Health and Human Services (HHS).
AGENCY:
Notice; establishment of a
public docket; request for comments.
ACTION:
PO 00000
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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
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]]>Agencies
[Federal Register Volume 86, Number 145 (Monday, August 2, 2021)]
[Notices]
[Pages 41474-41475]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16376]
[[Page 41474]]
-----------------------------------------------------------------------
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:
[email protected].
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;
[[Page 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 high-school 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 pilot-tested, 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
IRB-approved 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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
Middle and High School Age Youth 20,000 1 50/60 16,667
Adolescents. Questionnaire.
Middle and High School Age Pre/Post youth 10,000 2 50/60 16,667
Adolescents. questionnaire.
Middle and High School Age Youth interview/ 3,000 2 90/60 9,000
Adolescents. focus group
guide.
Parents/caregivers of Parent/Caregiver 7,500 2 25/60 6,250
adolescents. questionnaire.
Parents/caregivers of Parent/Caregiver 3,000 2 90/60 9,000
adolescents. interview/focus
group guide.
---------------------------------------------------------------
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
