Agency Information Collection Request; 30-Day Public Comment Request, 5217-5218 [2020-01573]
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5217
Federal Register / Vol. 85, No. 19 / Wednesday, January 29, 2020 / Notices
II. References
The following references marked with
an asterisk (*) are on display at the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852) and are available for viewing by
interested persons between 9 a.m. and 4
p.m., Monday through Friday; they also
are available electronically at https://
www.regulations.gov. References
without asterisks are not on public
display at https://www.regulations.gov
because they have copyright restriction.
Some may be available at the website
address, if listed. References without
asterisks are available for viewing only
at the Dockets Management Staff. FDA
has verified the website addresses, as of
the date this document publishes in the
Federal Register, but websites are
subject to change over time.
1. Kim, J., J. Gao, L. Amiri-Kordestani, et
al., ‘‘Patient-Friendly Language to Facilitate
Treatment Choice for Patients with Cancer.’’
The Oncologist, 10.1634/theoncologist.2018–
0761, 2019. Available from: https://
www.ncbi.nlm.nih.gov/pmc/articles/
PMC6693727/.
2. Aikin, K.J., A.C. O’Donoghue, C.M.
Squire, et al., ‘‘An Empirical Examination of
the FDAAA-Mandated Toll-Free Statement
for Consumer Reporting of Side Effects in
Direct-to-Consumer Television
Advertisements.’’ Journal of Public Policy &
Marketing, 35(1):108–123, 2016.
3. Sullivan, H.W., V. Boudewyns, A.C.
O’Donoghue, et al., ‘‘Attention to and
Distraction from Risk Information in
Prescription Drug Advertising: An EyeTracking Study.’’ Journal of Public Policy &
Marketing, 36(2):236–245, 2017.
4. 21 U.S.C. 321(n).
Dated: January 23, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–01555 Filed 1–28–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–new]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
lotter on DSKBCFDHB2PROD with NOTICES
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before February 28, 2020.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
0990-New-30D and project title for
reference.
SUMMARY:
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Health
Evaluation of Pregnancy Prevention
Program Replications for High Risk and
Hard to Reach Youth.
Type of Collection: OMB No. 0990–
NEW.
Abstract: The Office of the Assistant
Secretary for Health (OASH), U.S.
Department of Health and Human
Services (HHS), is requesting approval
by OMB of a new information collection
request. OASH seeks to collect
information to understand whether
previously proven adolescent pregnancy
programs have similar effects on
knowledge, attitudes, beliefs, intentions,
and behaviors related to sexual activity
and health among different youth in
different locations, especially among
understudied and hard-to-reach youth.
We propose to collect both qualitative
and quantitative information in a quasiexperimental design with a matched
SUPPLEMENTARY INFORMATION:
Max number
of respondents
Respondents
Form name
Youth Program Participants ............................
Baseline survey and youth assent .................
First follow-up survey .....................................
3-month follow-up survey ...............................
Focus group assent .......................................
VerDate Sep<11>2014
17:27 Jan 28, 2020
Jkt 250001
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
comparison group. Eight organizations
implementing a broad range of
previously proven-effective pregnancy
prevention programs (including sexual
health education, sexual risk avoidance,
and youth development programs) will
recruit hard to reach or high-risk youth.
Youth will complete surveys at baseline,
immediately following the intervention,
and at three months follow-up, yielding
quantitative data about youth
knowledge, attitudes, beliefs, intentions,
and behaviors related to sexual health.
Surveys will last for about 50 minutes.
Focus groups yielding qualitative data
about youth perspectives about
adolescent pregnancy prevention
programs will occur after the
interventions are complete and will last
for approximately 90 minutes.
Need and Proposed Use of the
Information: Rates of pregnancy among
hard-to-reach, high-risk, vulnerable, or
understudied youth are significantly
higher than the general population.
However, there have been few
evaluations assessing whether programs
that have been previously proven
successful can be delivered successfully
to these youth. Hence, this evaluation is
intended to help fill the evidence gap
about the efficacy and effectiveness of
existing pregnancy prevention programs
among high-risk, vulnerable, or
understudied youth. To enhance the
rigor of the evaluation, a matched
comparison group will be identified
from select implementing organizations
and their communities. OASH plans to
use the findings of this evaluation to
inform guidance to HHS grantees and
prospective grantees on approaches for
replication of pregnancy prevention
programs for hard-to-reach and
underserved youth.
Likely respondents: Respondents will
include youth aged 12–16 years old, and
their parents/guardians. Respondents
will also include youth in a matched
comparison group (‘‘comparison
youth’’).
Burden: Exhibit 1 summarizes the
total annual burden hours estimated for
this ICR. This hour-burden estimate
includes time spent by program youth,
comparison group youth, and parents/
guardians of both groups to complete
data collection for the ICR.
E:\FR\FM\29JAN1.SGM
1,216
730
438
474
29JAN1
Average
burden
per response
(hours)
1.00
0.83
0.83
0.25
Total max
burden
(hours)
1,216
608
365
119
5218
Federal Register / Vol. 85, No. 19 / Wednesday, January 29, 2020 / Notices
Respondents
Max number
of respondents
Form name
Average
burden
per response
(hours)
Total max
burden
(hours)
Parents/Guardians ..........................................
Focus group protocol .....................................
Baseline survey and youth assent .................
First follow-up survey .....................................
3-month follow-up survey ...............................
Parental consent ............................................
285
2,946
730
438
4,163
1.50
1.00
0.83
0.83
0.25
428
2,946
608
365
1,041
Total .........................................................
.........................................................................
........................
........................
7,696
Youth Comparison Group Participants ...........
Please Note: No. Responses per Respondent is 1. Each form is completed one time.
Terry Clark,
Office of the Secretary, Asst Paperwork
Reduction Act Reports Clearance Officer.
[FR Doc. 2020–01573 Filed 1–28–20; 8:45 am]
BILLING CODE 4150–34–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Meetings
lotter on DSKBCFDHB2PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of
meetings of the National Diabetes and
Digestive and Kidney Diseases Advisory
Council.
The meetings will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meetings will be closed to the
public in accordance with the
provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended.
The grant applications and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Diabetes and
Digestive and Kidney Diseases Advisory
Council.
Date: May 12–13, 2020.
Open: May 12, 2020, 8:30 a.m. to 12:00
p.m.
Agenda: To Present the Director’s Report
and other Scientific Presentations.
Place: Porter Neuroscience Research
Center, Building 35A, Conference Room 610–
640, 35 Convent Drive, Bethesda, MD 20892.
VerDate Sep<11>2014
17:27 Jan 28, 2020
Jkt 250001
Closed: May 12, 2020, 1:00 p.m. to 4:30
p.m.
Agenda: To review and evaluate grant
applications.
Place: Porter Neuroscience Research
Center, Building 35A, Conference Room 610–
640, 35 Convent Drive, Bethesda, MD 20892.
Contact Person: Karl F. Malik, Ph.D.,
Director, Division of Extramural Activities,
National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy
Boulevard, Room 7329, MSC 5452, Bethesda,
MD 20892, (301) 594–4757, malikk@
niddk.nih.gov.
Name of Committee: National Diabetes and
Digestive and Kidney Diseases Advisory
Council; Digestive Diseases and Nutrition.
Date: May 12–13, 2020.
Open: May 12, 2020, 1:00 p.m. to 2:00 p.m.
Agenda: To review the Division’s scientific
and planning activities.
Place: Porter Neuroscience Research
Center, Building 35A, Conference Room 610–
640, 35 Convent Drive, Bethesda, MD 20892.
Closed: May 12, 2020, 2:15 p.m. to 3:15
p.m.
Agenda: To review and evaluate grant
applications.
Place: Porter Neuroscience Research
Center, Building 35A, Conference Room 610–
640, 35 Convent Drive, Bethesda, MD 20892.
Contact Person: Karl F. Malik, Ph.D.,
Director, Division of Extramural Activities,
National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy
Boulevard, Room 7329, MSC 5452, Bethesda,
MD 20892, (301) 594–4757, malikk@
niddk.nih.gov.
Name of Committee: National Diabetes and
Digestive and Kidney Diseases Advisory
Council; Diabetes, Endocrinology, and
Metabolic Diseases.
Date: May 12–13, 2020.
Open: May 12, 2020, 1:00 p.m. to 2:00 p.m.
Agenda: To review the Division’s scientific
and planning activities.
Place: Porter Neuroscience Research
Center, Building 35A, Conference Room 610–
640, 35 Convent Drive, Bethesda, MD 20892.
Closed: May 12, 2020, 2:15 p.m. to 3:45
p.m.
Agenda: To review and evaluate grant
applications.
Place: Porter Neuroscience Research
Center, Building 35A, Conference Room 610–
640, 35 Convent Drive, Bethesda, MD 20892.
Contact Person: Karl F. Malik, Ph.D.,
Director, Division of Extramural Activities,
National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
Boulevard, Room 7329, MSC 5452, Bethesda,
MD 20892, (301) 594–4757, malikk@
niddk.nih.gov.
Name of Committee: National Diabetes and
Digestive and Kidney Diseases Advisory
Council; Kidney, Urologic, and Hematologic
Diseases.
Date: May 12–13, 2020.
Open: May 12, 2020, 1:00 p.m. to 2:45 p.m.
Agenda: To review the Division’s scientific
and planning activities.
Place: Porter Neuroscience Research
Center, Building 35A, Conference Room 610–
640, 35 Convent Drive, Bethesda, MD 20892.
Closed: May 12, 2020, 2:45 p.m. to 3:45
p.m.
Agenda: To review and evaluate grant
applications.
Place: Porter Neuroscience Research
Center, Building 35A, Conference Room 610–
640, 35 Convent Drive, Bethesda, MD 20892.
Contact Person: Karl F. Malik, Ph.D.,
Director, Division of Extramural Activities,
National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy
Boulevard, Room 7329, MSC 5452, Bethesda,
MD 20892, (301) 594–4757, malikk@
niddk.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
stringent procedures for entrance into NIH
federal property. Visitors will be asked to
show one form of identification (for example,
a government-issued photo ID, driver’s
license, or passport) and to state the purpose
of their visit.
Information is also available on the
Institute’s/Center’s home page:
www.niddk.nih.gov/fund/divisions/DEA/
Council/coundesc.htm, where an agenda and
any additional information for the meeting
will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
E:\FR\FM\29JAN1.SGM
29JAN1
]]>Agencies
[Federal Register Volume 85, Number 19 (Wednesday, January 29, 2020)]
[Notices]
[Pages 5217-5218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01573]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-new]
Agency Information Collection Request; 30-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the Office of the Secretary (OS), Department of Health and
Human Services, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before February 28,
2020.
ADDRESSES: Submit your comments to [email protected] or via
facsimile to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected]
or (202) 795-7714. When submitting comments or requesting information,
please include the document identifier 0990-New-30D and project title
for reference.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
Title of the Collection: Health Evaluation of Pregnancy Prevention
Program Replications for High Risk and Hard to Reach Youth.
Type of Collection: OMB No. 0990-NEW.
Abstract: The Office of the Assistant Secretary for Health (OASH),
U.S. Department of Health and Human Services (HHS), is requesting
approval by OMB of a new information collection request. OASH seeks to
collect information to understand whether previously proven adolescent
pregnancy programs have similar effects on knowledge, attitudes,
beliefs, intentions, and behaviors related to sexual activity and
health among different youth in different locations, especially among
understudied and hard-to-reach youth. We propose to collect both
qualitative and quantitative information in a quasi-experimental design
with a matched comparison group. Eight organizations implementing a
broad range of previously proven-effective pregnancy prevention
programs (including sexual health education, sexual risk avoidance, and
youth development programs) will recruit hard to reach or high-risk
youth. Youth will complete surveys at baseline, immediately following
the intervention, and at three months follow-up, yielding quantitative
data about youth knowledge, attitudes, beliefs, intentions, and
behaviors related to sexual health. Surveys will last for about 50
minutes. Focus groups yielding qualitative data about youth
perspectives about adolescent pregnancy prevention programs will occur
after the interventions are complete and will last for approximately 90
minutes.
Need and Proposed Use of the Information: Rates of pregnancy among
hard-to-reach, high-risk, vulnerable, or understudied youth are
significantly higher than the general population. However, there have
been few evaluations assessing whether programs that have been
previously proven successful can be delivered successfully to these
youth. Hence, this evaluation is intended to help fill the evidence gap
about the efficacy and effectiveness of existing pregnancy prevention
programs among high-risk, vulnerable, or understudied youth. To enhance
the rigor of the evaluation, a matched comparison group will be
identified from select implementing organizations and their
communities. OASH plans to use the findings of this evaluation to
inform guidance to HHS grantees and prospective grantees on approaches
for replication of pregnancy prevention programs for hard-to-reach and
underserved youth.
Likely respondents: Respondents will include youth aged 12-16 years
old, and their parents/guardians. Respondents will also include youth
in a matched comparison group (``comparison youth'').
Burden: Exhibit 1 summarizes the total annual burden hours
estimated for this ICR. This hour-burden estimate includes time spent
by program youth, comparison group youth, and parents/guardians of both
groups to complete data collection for the ICR.
----------------------------------------------------------------------------------------------------------------
Average
Max number of burden per Total max
Respondents Form name respondents response burden (hours)
(hours)
----------------------------------------------------------------------------------------------------------------
Youth Program Participants......... Baseline survey and youth 1,216 1.00 1,216
assent.
First follow-up survey..... 730 0.83 608
3-month follow-up survey... 438 0.83 365
Focus group assent......... 474 0.25 119
[[Page 5218]]
Focus group protocol....... 285 1.50 428
Youth Comparison Group Participants Baseline survey and youth 2,946 1.00 2,946
assent.
First follow-up survey..... 730 0.83 608
3-month follow-up survey... 438 0.83 365
Parents/Guardians.................. Parental consent........... 4,163 0.25 1,041
-----------------------------------------------
Total.......................... ........................... .............. .............. 7,696
----------------------------------------------------------------------------------------------------------------
Please Note: No. Responses per Respondent is 1. Each form is completed one time.
Terry Clark,
Office of the Secretary, Asst Paperwork Reduction Act Reports Clearance
Officer.
[FR Doc. 2020-01573 Filed 1-28-20; 8:45 am]
BILLING CODE 4150-34-P
