Submission for Office of Management and Budget Review; Objective Work Plan/On-Going Progress Report (Office of Management and Budget #0970-0452), 51321-51322 [2023-16588]
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Federal Register / Vol. 88, No. 148 / Thursday, August 3, 2023 / Notices
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number:__, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, please access the CMS PRA
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
ddrumheller on DSK120RN23PROD with NOTICES1
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10146 Notice of Denial of
Medicare Prescription Drug Coverage
Under the 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.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires Federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Notice of Denial
of Medicare Prescription Drug Coverage;
Use: Part D plan sponsors are required
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17:35 Aug 02, 2023
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to issue the Notice of Denial of Medicare
Prescription Drug Coverage notice when
a request for a prescription drug or
payment is denied, in whole or in part.
The written notice must include a
statement, in understandable language,
the reasons for the denial and a
description of the appeals process.
The purpose of this notice is to
provide information to enrollees when
prescription drug coverage has been
denied, in whole or in part, by their Part
D plans. The notice must be readable,
understandable, and state the specific
reasons for the denial. The notice must
also remind enrollees about their rights
and protections related to requests for
prescription drug coverage and include
an explanation of both the standard and
expedited redetermination processes
and the rest of the appeal process. Form
Number: CMS–10146 (OMB control
number 0938–0976); Frequency: Daily;
Affected Public: Private sector (Business
or other for-profits); Number of
Respondents: 743; Total Annual
Responses: 2,631,728; Total Annual
Hours: 657,932. (For policy questions
regarding this collection contact: Coretta
Edmondson at 410–786–0512.)
Dated: July 31, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–16549 Filed 8–2–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for Office of Management
and Budget Review; Objective Work
Plan/On-Going Progress Report (Office
of Management and Budget #0970–
0452)
Administration for Native
Americans, Administration for Children
and Families, United States 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
SUMMARY:
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
51321
(OMB) #0970–0452, expiration
September 30, 2023). There are no
changes requested to the forms.
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.
DATES:
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 infocollection@
acf.hhs.gov. Identify all emailed
requests by the title of the information
collection.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
Description: There are no changes
proposed to the OPR or OWP.
The OPR information collection is
conducted in accordance with section
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 information in the
OPR is collected on a semi-annual basis
to monitor the performance of grantees
and better gauge grantee progress.
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 section 806 [42 U.S.C. 2991-d 1](a)(1).
The information in the OWP is collected
at time of application to detail the
project goal, objectives, activities and
outputs.
Respondents: Federally and state
recognized tribes, Native Pacific
Islanders, tribal Colleges and
Universities, Native non-profits, and
consortia.
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51322
Federal Register / Vol. 88, No. 148 / Thursday, August 3, 2023 / Notices
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
Objective work plan .............................................................
On-Going Progress Report ..................................................
[FR Doc. 2023–16588 Filed 8–2–23; 8:45 am]
BILLING CODE 4184–24–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–1635]
Prescription Drug User Fee Act
Waivers, Reductions, and Refunds for
Fixed-Combinations and Single-Entity
Versions of Previously Approved
Antiretrovirals Under the President’s
Emergency Plan for Acquired
Immunodeficiency Syndrome Relief;
Draft Guidance for Industry;
Availability
Food and Drug Administration,
HHS.
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘PDUFA
Waivers, Reductions, and Refunds for
Fixed-Combinations and Single-Entity
Versions of Previously Approved
Antiretrovirals under PEPFAR.’’ The
draft guidance describes circumstances
under which an applicant may be
eligible for a barrier-to-innovation
waiver under the Prescription Drug User
Fee Act (PDUFA) for certain new drug
applications (NDAs) for single-entity
(SE) antiretroviral (ARV) and fixedcombination (FC) ARV drug products
for the treatment or prevention of
human immunodeficiency virus-one
(HIV–1). The draft guidance is also
intended to help applicants request a
barrier-to-innovation waiver under
those circumstances.
DATES: Submit either electronic or
written comments on the draft guidance
by October 2, 2023 to ensure that the
Agency considers your comment on this
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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17:35 Aug 02, 2023
Jkt 259001
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–
2018–D–1635 for ‘‘PDUFA Waivers,
Reductions, and Refunds for FixedCombinations and Single-Entity
Versions of Previously Approved
PO 00000
Frm 00064
Fmt 4703
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Average
burden hours
per response
1
2
Electronic Submissions
Mary B. Jones,
ACF/OPRE Certifying Officer.
ACTION:
300
200
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Estimated Total Annual Burden
Hours: 433.
Authority: Section 806 [42 U.S.C.
2991d–1](a)(1) and sec. 811 [42 U.S.C.
2992].
AGENCY:
Total
number of
responses per
respondent
3
1
Total
burden hours
900
400
Annual
burden hours
300
133
Antiretrovirals under PEPFAR.’’
Received comments 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
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.
E:\FR\FM\03AUN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 148 (Thursday, August 3, 2023)]
[Notices]
[Pages 51321-51322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16588]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for Office of Management and Budget Review; Objective
Work Plan/On-Going Progress Report (Office of Management and Budget
#0970-0452)
AGENCY: Administration for Native Americans, Administration for
Children and Families, United States 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 (OMB) #0970-0452,
expiration September 30, 2023). There are no changes requested to the
forms.
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 emailed requests by
the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: There are no changes proposed to the OPR or OWP.
The OPR information collection is conducted in accordance with
section 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 information in the OPR is collected on a semi-annual
basis to monitor the performance of grantees and better gauge grantee
progress.
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 section 806 [42 U.S.C.
2991-d 1](a)(1). The information in the OWP is collected at time of
application to detail the project goal, objectives, activities and
outputs.
Respondents: Federally and state recognized tribes, Native Pacific
Islanders, tribal Colleges and Universities, Native non-profits, and
consortia.
[[Page 51322]]
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Total number
Total number of responses Average Total burden Annual burden
Instrument of per burden hours hours hours
respondents respondent per response
----------------------------------------------------------------------------------------------------------------
Objective work plan............. 300 1 3 900 300
On-Going Progress Report........ 200 2 1 400 133
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 433.
Authority: Section 806 [42 U.S.C. 2991d-1](a)(1) and sec. 811 [42
U.S.C. 2992].
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2023-16588 Filed 8-2-23; 8:45 am]
BILLING CODE 4184-24-P
