Proposed Information Collection Activity; Operation Allies Welcome Afghan Supplement Survey (New Collection), 17577-17578 [2023-05980]
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17577
Federal Register / Vol. 88, No. 56 / Thursday, March 23, 2023 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Number of
respondents
(total over
request
period)
Instrument
Number of
responses per
respondent
(total over
request
period)
Average
burden per
response
(in hours)
Total burden
(in hours)
Annual burden
(in hours)
Instrument 4: Subrecipient Data Collection and Reporting Form
SPREP subrecipients ...........................................................
TPREP subrecipients ...........................................................
CPREP subrecipients ..........................................................
PREIS subrecipients ............................................................
Estimated Total Annual Burden
Hours: 41,052.
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
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: Sec. 50503, Pub. L. 115–
123.
John M. Sweet, Jr.,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–05992 Filed 3–22–23; 8:45 am]
BILLING CODE 4184–37–P
259
27
54
20
6
6
6
6
21,756
2,268
3,888
1,440
7,252
756
1,296
480
You can obtain copies of the
proposed collection of information and
submit comments by emailing
infocollection@acf.hhs.gov. Identify all
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: Under the Afghanistan
Supplemental Appropriations Act,
2022, and Additional Afghanistan
Supplemental Appropriations Act,
2022, Congress authorized ORR to
provide resettlement assistance and
other benefits available to refugees to
specific Afghan populations in response
to their emergency evacuation and
resettlement. The OAW Afghan
Supplement Survey is a sample survey
of Afghan households entering the
United States under OAW, collecting
both household- and individual-level
information. It will generate nationally
representative data on OAW Afghans’
well-being, integration outcomes, and
progress towards self-sufficiency. Data
collected will help ORR and service
providers better understand the impact
of services and on-going service needs
of OAW Afghan populations.
Respondents: OAW Afghan
populations.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Operation Allies Welcome
Afghan Supplement Survey (New
Collection)
Office of Refugee Resettlement,
Administration for Children and
Families, U.S. Department of Health and
Human Services.
AGENCY:
ACTION:
14
14
12
12
Request for public comments.
The Office of Refugee
Resettlement (ORR), Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services is proposing to collect data for
a new Operation Allies Welcome (OAW)
Afghan Supplement Survey.
SUMMARY:
Comments due within 60 days of
publication. 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.
DATES:
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
OAW Afghan Supplement Survey Contact Update Requests ........................
OAW Afghan Supplement Survey ...................................................................
Total number
of responses
per
respondent
1,100
1,100
1
1
Average
burden hours
per response
0.05
0.92
Total/annual
burden
hours *
55
1,012
ddrumheller on DSK120RN23PROD with NOTICES1
* Survey is one-time and will be completed within the 1st year.
Estimated Total Annual Burden
Hours: 1,067.
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;
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19:23 Mar 22, 2023
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(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
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technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: Division C, Title III, Public
Law 117–43, 135 Stat. 374; Division B,
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17578
Federal Register / Vol. 88, No. 56 / Thursday, March 23, 2023 / Notices
Title III, Public Law 117–70, 1102 Stat.
4.
John M. Sweet, Jr.,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–05980 Filed 3–22–23; 8:45 am]
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0573]
Changes to Third-Party Vendors for
Risk Evaluation and Mitigation
Strategies; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the establishment of a
docket to solicit comments on factors
that generally should be considered by
the Secretary of Health and Human
Services (Secretary) when reviewing
modification requests from sponsors of
drugs subject to risk evaluation and
mitigation strategies (REMS) related to
changes in third-party vendors engaged
by sponsors to aid in implementation
and management of the strategies.
DATES: Submit either electronic or
written comments by July 21, 2023. See
the SUPPLEMENTARY INFORMATION section
for registration date and information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
July 21, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
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
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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–
2023–N–0573 for ‘‘Proposed Changes to
Third-Party Vendors Establishment of a
Public Docket; Request for Comments.’’
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
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
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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:
Marcus Cato, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 4475, 301–796–
2380, OSE.PMKTREGS@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 505–1 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 355–1), authorizes FDA to
require a REMS if FDA determines that
a REMS is necessary to ensure that the
benefits of the drug outweigh its risks.
A REMS is a required risk management
strategy that employs tools beyond
prescribing information to ensure that
the benefits of a drug outweigh its risks.
A REMS may require a Medication
Guide (or patient package insert) to
provide risk information to patients, a
communication plan to disseminate risk
information to healthcare providers, and
certain packaging and safe disposal
systems for drugs that pose a serious
risk of abuse or overdose. FDA may also
require certain elements to assure safe
use (ETASU) when such elements are
necessary to mitigate a specific serious
risk listed in the labeling of the drug.
ETASU may include, for example,
requirements that healthcare providers
who prescribe the drug have particular
training or experience, that patients
using the drug be monitored, or that the
drug be dispensed to patients with
evidence or other documentation of
safe-use conditions. Certain REMS with
ETASU may also include an
implementation system through which
the applicant is able to monitor and
evaluate implementation of the ETASU
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]]>Agencies
[Federal Register Volume 88, Number 56 (Thursday, March 23, 2023)]
[Notices]
[Pages 17577-17578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05980]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Operation Allies
Welcome Afghan Supplement Survey (New Collection)
AGENCY: Office of Refugee Resettlement, Administration for Children and
Families, U.S. Department of Health and Human Services.
ACTION: Request for public comments.
-----------------------------------------------------------------------
SUMMARY: The Office of Refugee Resettlement (ORR), Administration for
Children and Families (ACF), U.S. Department of Health and Human
Services is proposing to collect data for a new Operation Allies
Welcome (OAW) Afghan Supplement Survey.
DATES: Comments due within 60 days of publication. 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: Under the Afghanistan Supplemental Appropriations Act,
2022, and Additional Afghanistan Supplemental Appropriations Act, 2022,
Congress authorized ORR to provide resettlement assistance and other
benefits available to refugees to specific Afghan populations in
response to their emergency evacuation and resettlement. The OAW Afghan
Supplement Survey is a sample survey of Afghan households entering the
United States under OAW, collecting both household- and individual-
level information. It will generate nationally representative data on
OAW Afghans' well-being, integration outcomes, and progress towards
self-sufficiency. Data collected will help ORR and service providers
better understand the impact of services and on-going service needs of
OAW Afghan populations.
Respondents: OAW Afghan populations.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Total number Average burden
Instrument Total number of responses hours per Total/annual
of respondents per respondent response burden hours *
----------------------------------------------------------------------------------------------------------------
OAW Afghan Supplement Survey Contact Update 1,100 1 0.05 55
Requests.......................................
OAW Afghan Supplement Survey.................... 1,100 1 0.92 1,012
----------------------------------------------------------------------------------------------------------------
* Survey is one-time and will be completed within the 1st year.
Estimated Total Annual Burden Hours: 1,067.
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 technology.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Authority: Division C, Title III, Public Law 117-43, 135 Stat. 374;
Division B,
[[Page 17578]]
Title III, Public Law 117-70, 1102 Stat. 4.
John M. Sweet, Jr.,
ACF/OPRE Certifying Officer.
[FR Doc. 2023-05980 Filed 3-22-23; 8:45 am]
BILLING CODE 4184-45-P
