Proposed Information Collection Activity; Objective Work Plan/On-Going Progress Report (Office of Management and Budget #0970-0452), 89645-89646 [2024-26230]
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89645
Federal Register / Vol. 89, No. 219 / Wednesday, November 13, 2024 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN FOR THE 2025–2027 MEPS–IC
Number of
respondents
Form name
Total burden
hours
Average
hourly wage
rate *
Total cost
burden
Prescreener Questionnaire ....................................................................................
Establishment Questionnaire .................................................................................
Plan Questionnaire ................................................................................................
18,900
21,900
18,900
1,575
7,300
7,970
38.76
38.76
38.76
$61,047
282,948
308,898
Total ................................................................................................................
59,700
16,845
n/a
652,893
* Based upon the mean hourly wage for Compensation, Benefits, and Job Analysis Specialists occupation code 13–1141, at https://
www.bls.gov/oes/current/oes131141.htm (U.S. Department of Labor, Bureau of Labor Statistics.)
Request for Comments
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3520,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) whether the
proposed collection of information is
necessary for the proper performance of
AHRQ’s health care research and health
care information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: November 5, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024–26207 Filed 11–12–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Objective Work Plan/OnGoing Progress Report (Office of
Management and Budget #0970–0452)
Administration for Native
Americans, Administration for Children
and Families, U.S. Department of Health
and Human Services.
ACTION: Request for public comments.
AGENCY:
The Administration for
Children and Families’ (ACF)
Administration for Native Americans
(ANA) is requesting a 3-year extension
to the Ongoing Progress Report (OPR)
and the Objective Work Plan (OWP)
(Office of Management and Budget
#0970–0452, expiration September 30,
2026). Changes are proposed only to the
report.
DATES: Comments due January 13, 2025.
In compliance with the requirements of
the Paperwork Reduction Act of 1995,
ACF is soliciting public comment on the
specific aspects of the information
collection described above.
ADDRESSES: You can obtain copies of the
proposed collection of information and
submit comments by emailing
infocollection@acf.hhs.gov. Identify all
SUMMARY:
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: The information in the
OPR is collected on a semi-annual basis
to monitor the performance of grantees
and better gauge grantee progress.
The OPR information collection is
conducted in accordance with sec. 811
[42 U.S.C. 2992] of the Native American
Programs Act and will allow ANA to
report quantifiable results across all
program areas. It also provides grantees
with parameters for reporting their
progress and helps ANA better monitor
and determine the effectiveness of their
projects.
The OWP information collection is
conducted in accordance with 42 U.S.C.
of the Native American Programs Act of
1972, as amended. This collection is
necessary to evaluate applications for
financial assistance and determine the
relative merits of the projects for which
such assistance is requested, as set forth
in sec. 806 [42 U.S.C. 2991–d 1](a)(1).
The report was revised based on a
review by ANA and feedback from
grantees, which identified some data
elements that could be eliminated and
areas that could be clarified.
Respondents: Federally and state
recognized tribes, Native Pacific
Islanders, Tribal Colleges and
Universities, native non-profits, and
consortia.
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
lotter on DSK11XQN23PROD with NOTICES1
Objective Work Plan ................................................................
On-Going Progress Report ......................................................
Estimated Total Annual Burden
Hours: 433.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
VerDate Sep<11>2014
17:40 Nov 12, 2024
Jkt 265001
Total
number of
responses per
respondent
300
200
1
2
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
Average
burden
hours per
response
Total
burden
hours
3
1
Annual
burden
hours
900
400
300
133
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
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89646
Federal Register / Vol. 89, No. 219 / Wednesday, November 13, 2024 / Notices
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: Sec. 806 [42 U.S.C. 2991d–
1](a)(1) and Sec. 811 [42 U.S.C. 2992].
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–26230 Filed 11–12–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–5057]
Public Workshop on Optimizing the
Use of Real-World Evidence in
Regulatory Decision-Making for Drugs
and Biological Products—Looking
Forward; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing a public workshop titled
‘‘Optimizing the Use of Real-World
Evidence in Regulatory DecisionMaking for Drugs and Biological
Products—Looking Forward.’’ The
purpose of the public workshop is to
provide interested parties with an
update on FDA’s current activities
related to real-world evidence (RWE)
and to share accomplishments, ongoing
challenges, and future opportunities.
The public workshop will discuss
potential next steps to promote the
continued evolution and consistent
application of real-world data (RWD) in
drug development. This public
workshop will be convened and
supported by a cooperative agreement
between FDA and the Duke University,
Duke-Margolis Institute for Health
Policy.
DATES: The public workshop will be
held on December 12, 2024, from 12:30
p.m. to 5 p.m., Eastern Time. Either
electronic or written comments on this
public workshop must be submitted by
January 13, 2025. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will
be held in-person at the Bethesda North
Marriott & Conference Center, 5701
Marinelli Rd., North Bethesda, MD
20852 and virtually using the Zoom
platform.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
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The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 13, 2025.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are received on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2024–N–5057 for ‘‘Optimizing the Use
of Real-World Evidence in Regulatory
Decision-Making for Drugs and
Biological Products—Looking Forward.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
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Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Dianne Paraoan, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 301–796–3161,
Dianne.Paraoan@fda.hhs.gov or CDERRWE@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The volume and complexity of RWD
available to support drug development
have increased substantially over the
past several decades. This increase,
combined with enhanced computing
power and emerging technologies, is
transforming how drugs are developed.
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[Federal Register Volume 89, Number 219 (Wednesday, November 13, 2024)]
[Notices]
[Pages 89645-89646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-26230]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Objective Work Plan/On-
Going Progress Report (Office of Management and Budget #0970-0452)
AGENCY: Administration for Native Americans, Administration for
Children and Families, U.S. Department of Health and Human Services.
ACTION: Request for public comments.
-----------------------------------------------------------------------
SUMMARY: The Administration for Children and Families' (ACF)
Administration for Native Americans (ANA) is requesting a 3-year
extension to the Ongoing Progress Report (OPR) and the Objective Work
Plan (OWP) (Office of Management and Budget #0970-0452, expiration
September 30, 2026). Changes are proposed only to the report.
DATES: Comments due January 13, 2025. In compliance with the
requirements of the Paperwork Reduction Act of 1995, ACF is soliciting
public comment on the specific aspects of the information collection
described above.
ADDRESSES: You can obtain copies of the proposed collection of
information and submit comments by emailing [email protected].
Identify all requests by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: The information in the OPR is collected on a semi-
annual basis to monitor the performance of grantees and better gauge
grantee progress.
The OPR information collection is conducted in accordance with sec.
811 [42 U.S.C. 2992] of the Native American Programs Act and will allow
ANA to report quantifiable results across all program areas. It also
provides grantees with parameters for reporting their progress and
helps ANA better monitor and determine the effectiveness of their
projects.
The OWP information collection is conducted in accordance with 42
U.S.C. of the Native American Programs Act of 1972, as amended. This
collection is necessary to evaluate applications for financial
assistance and determine the relative merits of the projects for which
such assistance is requested, as set forth in sec. 806 [42 U.S.C. 2991-
d 1](a)(1).
The report was revised based on a review by ANA and feedback from
grantees, which identified some data elements that could be eliminated
and areas that could be clarified.
Respondents: Federally and state recognized tribes, Native Pacific
Islanders, Tribal Colleges and Universities, native non-profits, and
consortia.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Average
Total Total number burden Total burden Annual burden
Instrument number of of responses hours per hours hours
respondents per respondent response
----------------------------------------------------------------------------------------------------------------
Objective Work Plan................. 300 1 3 900 300
On-Going Progress Report............ 200 2 1 400 133
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 433.
Comments: The Department specifically requests comments on (a)
whether the proposed collection of information is necessary for the
proper performance of the functions of the agency, including whether
the information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden of the collection
of information on respondents, including through the use of automated
collection techniques or other forms of information
[[Page 89646]]
technology. Consideration will be given to comments and suggestions
submitted within 60 days of this publication.
Authority: Sec. 806 [42 U.S.C. 2991d-1](a)(1) and Sec. 811 [42
U.S.C. 2992].
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024-26230 Filed 11-12-24; 8:45 am]
BILLING CODE 4184-34-P
