Submission for OMB Review; Sexual Risk Avoidance Education National Evaluation: Nationwide Study of the National Descriptive Study (New Collection), 54699-54700 [2022-19231]
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54699
Federal Register / Vol. 87, No. 172 / Wednesday, September 7, 2022 / Notices
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2022–19256 Filed 9–6–22; 8:45 am]
BILLING CODE 4184–83–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review; Sexual
Risk Avoidance Education National
Evaluation: Nationwide Study of the
National Descriptive Study (New
Collection)
Office of Planning, Research
and Evaluation, Administration for
Children and Families, HHS.
ACTION: Request for public comments.
AGENCY:
The Office of Planning,
Research and Evaluation (OPRE),
Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS),
proposes survey and focus group data
collection activities for the Sexual Risk
Avoidance Education National
Evaluation (SRAENE) Nationwide Study
(NWS) of the National Descriptive Study
(NDS).
DATES: Comments due within 30 days of
publication. OMB must make a decision
about the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
SUMMARY:
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review-Open
for Public Comments’’ or by using the
search function. You can also obtain
copies of the proposed collection of
information by emailing
OPREinfocollection@acf.hhs.gov.
Identify all requests by the title of the
information collection.
SUPPLEMENTARY INFORMATION:
Description: OPRE/ACF/HHS
proposes to conduct the NWS, a substudy under the NDS of the SRAENE, to
learn about Sexual Risk Avoidance
Education (SRAE) program
implementation experiences and
outcomes of the SRAE grant program.
The NWS builds on the Early
Implementation Study, the first substudy of the NDS, which was designed
to tell the story about SRAE grant
program plans (OMB Control #0970–
0530). The NWS, which responds to
Congress’s reauthorization in February
2018 of title V, section 510 of the Social
Security Act (Pub. L. 115–123),
extended by the CARES ACT of 2020
(Pub. L. 116–136), will use a mixedmethods approach of surveys and focus
groups to tell the story of the SRAE
grant program, collecting detailed
information on grantee program
implementation experiences from grant
recipients, SRAE program providers and
facilitators, and youth program
recipients. The NWS will also make use
of extant data from grant-recipient
performance measures on program
outputs and outcomes. Combined with
data on program implementation, the
NWS will examine associations between
implementation, outputs, and outcomes.
The survey and focus group data are key
to fully understanding program
implementation experiences from all
levels that bring the SRAE programs to
youth-from grant administrators to
program supervisors to the facilitators
who interact directly with the youth
themselves.
The study is being undertaken by ACF
and its contractor Mathematica. The
study research questions driving the
need for data collection are as follows:
1. What are grant recipients’ and
providers’ experiences with delivering
SRAE curricular content? What are
youth’s experiences with receiving the
SRAE curricular content?
2. How did grant recipients and
providers interpret, understand, and
address the A to F topics in the SRAE
legislation?
3. Are some features of
implementation more strongly
associated with youth outcomes than
others?
4. What provider characteristics are
associated with a greater number of
youth served and with youth outcomes?
To support these efforts, ACF
proposes the following data collection
activities: (1) a web-based survey of all
grant recipient Directors who are not
also providers, (2) a web-based survey of
all SRAE program providers, (3) a webbased survey of all SRAE program
facilitators, and (4) in-person (or virtual
if necessary) focus groups with youth
recipients of SRAE programming across
five geographic regions of the United
States.
Respondents: Respondents to the
surveys will be SRAE program grant
Directors, SRAE program providers, and
SRAE program facilitators. Focus group
participants will be youth recipients of
SRAE programming. The focus group
participants will be recruited from
middle and high school across five U.S.
Geographic regions: West, Midwest,
Southwest, Southeast, and Northeast.
ANNUAL BURDEN ESTIMATES
Number of
respondents
(total over
request period)
Instrument
lotter on DSK11XQN23PROD with NOTICES1
(1)
(2)
(3)
(4)
Number of
responses per
respondent
(total over
request period)
Avg. burden
per response
(in hours)
Total/annual
burden
(in hours)
NWS Grantee Survey ........................................................................
NWS Provider Survey ........................................................................
NWS Facilitator Survey ......................................................................
SRAE Program Youth Focus Group Discussion Guide .....................
40
500
1,600
200
1
1
1
1
.17
.75
.75
* .83
7
375
1,200
166
Estimated Total Annual Burden Hours: ............................................
............................
............................
........................
1,748
* Average burden per response includes 5 minutes to complete the consent and assent forms.
Authority: The Title V Competitive
SRAE Program was authorized and
funded by section 510 of the Social
Security Act (42 U.S.C. 710), as
VerDate Sep<11>2014
17:50 Sep 06, 2022
Jkt 256001
amended by section 50502 of the
Bipartisan Budget Act of 2018 (Public
Law 115–123) and extended by the
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
CARES Act of 2020 (Public Law 116–
136).
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54700
Federal Register / Vol. 87, No. 172 / Wednesday, September 7, 2022 / Notices
See https://www.ssa.gov/OP_Home/
ssact/title05/0510.htm.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Mary B. Jones,
ACF/OPRE Certifying Officer.
Food and Drug Administration
[Docket No. FDA–2018–N–1262]
[FR Doc. 2022–19231 Filed 9–6–22; 8:45 am]
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Proposal To Withdraw Approval of
MAKENA; Hearing; Correction
Food and Drug Administration,
HHS.
ACTION:
Notice of hearing; correction.
The Food and Drug
Administration (FDA) is correcting a
notice entitled ‘‘Proposal To Withdraw
Approval of MAKENA; Hearing’’ that
appeared in the Federal Register of
August 17, 2022. The document
announced the hearing on the Center for
Drug Evaluation and Research’s
proposal to withdraw approval of
MAKENA (hydroxyprogesterone
caproate injection, 250 milligrams per
milliliter, once weekly), new drug
application 021945, held by Covis
Pharma Group/Covis Pharma GmbH.
The document was published with an
incorrect deadline. This document
corrects that error.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Rachael Vieder Linowes, Office of
Scientific Integrity, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4206, Silver Spring,
MD 20993, 240–402–5931,
rachael.linowes@fda.hhs.gov.
In the
Federal Register of August 17, 2022 (87
FR 50626), in FR Doc. 2022–17715, on
page 50628, the following correction is
made:
1. On page 50628, in the last
paragraph of the second column, in the
first sentence, ‘‘September 6, 2022’’ is
corrected to ‘‘September 14, 2022.’’
lotter on DSK11XQN23PROD with NOTICES1
SUPPLEMENTARY INFORMATION:
Dated: September 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–19293 Filed 9–6–22; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
17:50 Sep 06, 2022
Jkt 256001
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
amended by the Food and Drug
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA is required to publish notice of the
award of the priority review voucher.
FDA has determined that ZTALMY
(ganaxolone), manufactured by Marinus
Pharmaceuticals, Inc., meets the criteria
for a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Cathryn Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–1394, email: Cathryn.Lee@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), which was
added by FDASIA, FDA will award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA has determined that ZTALMY
(ganaxolone), manufactured by Marinus
Pharmaceuticals, Inc., meets the criteria
for a priority review voucher. ZTALMY
(ganaxolone) is indicated to treat
seizures associated with cyclindependent kinase-like 5 (CDKL5)
deficiency disorder in patients 2 years
of age and older.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about ZTALMY
(ganaxolone), go to the ‘‘Drugs@FDA’’
website at https://www.accessdata.
fda.gov/scripts/cder/daf/.
PO 00000
Frm 00031
Fmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice.
SUMMARY:
[Docket No. FDA–2020–N–2029]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
[FR Doc. 2022–19276 Filed 9–6–22; 8:45 am]
BILLING CODE 4164–01–P
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
BILLING CODE 4184–83–P
Dated: August 31, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
Sfmt 4703
Solicitation of Nominations for
Membership To Serve on the Advisory
Commission on Childhood Vaccines
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Request for nominations.
AGENCY:
HRSA is seeking nominations
of qualified candidates for consideration
for appointment as members of the
Advisory Commission on Childhood
Vaccines (ACCV). The ACCV advises
the Secretary of HHS (Secretary) on
issues related to implementation of the
National Vaccine Injury Compensation
Program (VICP). HRSA is seeking
nominations of qualified candidates to
fill vacancies on the ACCV.
DATES: Written nominations for
membership on the ACCV will be
received on a continuous basis.
ADDRESSES: Nomination packages must
be submitted to the Director, Division of
Injury Compensation Programs, Health
Systems Bureau, HRSA, 5600 Fishers
Lane, Room 08N146B, Rockville,
Maryland 20857. Candidates can submit
electronic nomination packages by
email to Pita Gomez at ACCV@hrsa.gov.
FOR FURTHER INFORMATION CONTACT: Pita
Gomez, Principal Staff Liaison, Division
of Injury Compensation Programs,
Health Systems Bureau, HRSA at (301)
945–9386 or email at ACCV@hrsa.gov. A
copy of the ACCV charter and list of the
current membership is available on the
ACCV website at https://www.hrsa.gov/
advisory-committees/vaccines/
index.html.
SUMMARY:
The ACCV
was established by Title XXI of the
Public Health Service Act (the Act) and
advises the Secretary on issues related
to implementation of the VICP. The
ACCV meets at least four times each
calendar year.
Nominations: HRSA is requesting
nominations for voting members to
serve as Special Government Employees
(SGEs) on the ACCV to fill open
positions. The Secretary appoints
members with the expertise needed to
fulfill the duties of the ACCV. The
SUPPLEMENTARY INFORMATION:
E:\FR\FM\07SEN1.SGM
07SEN1
]]>Agencies
[Federal Register Volume 87, Number 172 (Wednesday, September 7, 2022)]
[Notices]
[Pages 54699-54700]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19231]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Sexual Risk Avoidance Education
National Evaluation: Nationwide Study of the National Descriptive Study
(New Collection)
AGENCY: Office of Planning, Research and Evaluation, Administration for
Children and Families, HHS.
ACTION: Request for public comments.
-----------------------------------------------------------------------
SUMMARY: The Office of Planning, Research and Evaluation (OPRE),
Administration for Children and Families (ACF), U.S. Department of
Health and Human Services (HHS), proposes survey and focus group data
collection activities for the Sexual Risk Avoidance Education National
Evaluation (SRAENE) Nationwide Study (NWS) of the National Descriptive
Study (NDS).
DATES: Comments due within 30 days of publication. OMB must make a
decision about the collection of information between 30 and 60 days
after publication of this document in the Federal Register. Therefore,
a comment is best assured of having its full effect if OMB receives it
within 30 days of publication.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review-
Open for Public Comments'' or by using the search function. You can
also obtain copies of the proposed collection of information by
emailing [email protected]. Identify all requests by the
title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: OPRE/ACF/HHS proposes to conduct the NWS, a sub-study
under the NDS of the SRAENE, to learn about Sexual Risk Avoidance
Education (SRAE) program implementation experiences and outcomes of the
SRAE grant program. The NWS builds on the Early Implementation Study,
the first sub-study of the NDS, which was designed to tell the story
about SRAE grant program plans (OMB Control #0970-0530). The NWS, which
responds to Congress's reauthorization in February 2018 of title V,
section 510 of the Social Security Act (Pub. L. 115-123), extended by
the CARES ACT of 2020 (Pub. L. 116-136), will use a mixed-methods
approach of surveys and focus groups to tell the story of the SRAE
grant program, collecting detailed information on grantee program
implementation experiences from grant recipients, SRAE program
providers and facilitators, and youth program recipients. The NWS will
also make use of extant data from grant-recipient performance measures
on program outputs and outcomes. Combined with data on program
implementation, the NWS will examine associations between
implementation, outputs, and outcomes. The survey and focus group data
are key to fully understanding program implementation experiences from
all levels that bring the SRAE programs to youth-from grant
administrators to program supervisors to the facilitators who interact
directly with the youth themselves.
The study is being undertaken by ACF and its contractor
Mathematica. The study research questions driving the need for data
collection are as follows:
1. What are grant recipients' and providers' experiences with
delivering SRAE curricular content? What are youth's experiences with
receiving the SRAE curricular content?
2. How did grant recipients and providers interpret, understand,
and address the A to F topics in the SRAE legislation?
3. Are some features of implementation more strongly associated
with youth outcomes than others?
4. What provider characteristics are associated with a greater
number of youth served and with youth outcomes?
To support these efforts, ACF proposes the following data
collection activities: (1) a web-based survey of all grant recipient
Directors who are not also providers, (2) a web-based survey of all
SRAE program providers, (3) a web-based survey of all SRAE program
facilitators, and (4) in-person (or virtual if necessary) focus groups
with youth recipients of SRAE programming across five geographic
regions of the United States.
Respondents: Respondents to the surveys will be SRAE program grant
Directors, SRAE program providers, and SRAE program facilitators. Focus
group participants will be youth recipients of SRAE programming. The
focus group participants will be recruited from middle and high school
across five U.S. Geographic regions: West, Midwest, Southwest,
Southeast, and Northeast.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses per Avg. burden Total/annual
Instrument respondents respondent per response burden (in
(total over (total over (in hours) hours)
request period) request period)
----------------------------------------------------------------------------------------------------------------
(1) NWS Grantee Survey...................... 40 1 .17 7
(2) NWS Provider Survey..................... 500 1 .75 375
(3) NWS Facilitator Survey.................. 1,600 1 .75 1,200
(4) SRAE Program Youth Focus Group 200 1 * .83 166
Discussion Guide...........................
-------------------------------------------------------------------
Estimated Total Annual Burden Hours:.... ................ ................ .............. 1,748
----------------------------------------------------------------------------------------------------------------
* Average burden per response includes 5 minutes to complete the consent and assent forms.
Authority: The Title V Competitive SRAE Program was authorized and
funded by section 510 of the Social Security Act (42 U.S.C. 710), as
amended by section 50502 of the Bipartisan Budget Act of 2018 (Public
Law 115-123) and extended by the CARES Act of 2020 (Public Law 116-
136).
[[Page 54700]]
See https://www.ssa.gov/OP_Home/ssact/title05/0510.htm.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2022-19231 Filed 9-6-22; 8:45 am]
BILLING CODE 4184-83-P
