Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 47151 [2023-15456]
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47151
Federal Register / Vol. 88, No. 139 / Friday, July 21, 2023 / Notices
Dated: July 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
ACTION:
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
SUMMARY:
[FR Doc. 2023–15458 Filed 7–20–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2018–D–4417, FDA–
2013–N–1619, FDA–2018–D–2613, FDA–
2021–N–0341, FDA–2016–N–2066, FDA–
2022–N–0862, and FDA–2022–N–1874]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Notice.
Food and Drug Administration,
HHS.
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs;
GMP for Finished Pharmaceuticals (Including Medical Gases and Active Pharmaceutical Ingredients) ...........
Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements ........................................................................................................................................................
Prescription Drug Advertisements ...........................................................................................................................
Federal-State Food Regulatory Program Standards ...............................................................................................
Certification of Identity for Freedom of Information and Privacy Act Requests ......................................................
The Real Cost Campaign Outcomes Evaluation Study: Cohort 3 (Outcomes Study) ...........................................
Perceptions of Prescription Drug Products with Medication Tracking Capabilities ................................................
Dated: July 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
[FR Doc. 2023–15456 Filed 7–20–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Mpox Vaccine Distribution
Request Forms, OMB No. 0915–xxxx–
New
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
ddrumheller on DSK120RN23PROD with NOTICES1
AGENCY:
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
SUMMARY:
VerDate Sep<11>2014
19:06 Jul 20, 2023
Jkt 259001
Comments on this ICR should be
received no later than August 21, 2023.
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 Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email
Samantha Miller, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 443–
3093.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Mpox Vaccine Distribution Request
Forms, OMB No. 0915–xxxx–New.
DATES:
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
Date approval
expires
0910–0139
6/30/2026
0910–0606
0910–0686
0910–0760
0910–0832
0910–0915
0910–0916
6/30/2026
6/30/2026
6/30/2026
6/30/2026
6/30/2026
6/30/2026
Abstract: On August 4, 2022, the
mpox outbreak was declared a public
health emergency (PHE) in the United
States. From the outset, HRSA engaged
with federal partners across HHS to
provide resources to combat the spread
of mpox; assist health care providers
who are treating people who have
mpox; and ensure those who are most
at risk are the focus of vaccine response
efforts.
HHS authorized HRSA to receive
allotments of the JYNNEOS vaccine for
mpox for rapid distribution to Ryan
White HIV/AIDS Program (RWHAP)
recipients. HRSA was identified as a
distribution partner due to the health
care services provided to individuals
with HIV and the number of uninsured
and underinsured persons seen in
RWHAP and Health Center Programs.
The allotments were meant to
supplement, not replace, vaccine efforts
at jurisdictional levels.
To expedite dispensing of the vaccine,
HRSA provided the vaccine to dually
funded RWHAP Part C and Health
Center providers that care for at-risk
populations. Most of the identified
providers already had access to the
Health Partner Ordering Portal (HPOP),
E:\FR\FM\21JYN1.SGM
21JYN1
]]>Agencies
[Federal Register Volume 88, Number 139 (Friday, July 21, 2023)]
[Notices]
[Page 47151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15456]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2018-D-4417, FDA-2013-N-1619, FDA-2018-D-2613, FDA-
2021-N-0341, FDA-2016-N-2066, FDA-2022-N-0862, and FDA-2022-N-1874]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Current Good Manufacturing Practice 0910-0139 6/30/2026
(CGMP): Manufacturing, Processing,
Packing, and Holding of Drugs; GMP for
Finished Pharmaceuticals (Including
Medical Gases and Active Pharmaceutical
Ingredients)...........................
Current Good Manufacturing Practice in 0910-0606 6/30/2026
Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary
Supplements............................
Prescription Drug Advertisements........ 0910-0686 6/30/2026
Federal-State Food Regulatory Program 0910-0760 6/30/2026
Standards..............................
Certification of Identity for Freedom of 0910-0832 6/30/2026
Information and Privacy Act Requests...
The Real Cost Campaign Outcomes 0910-0915 6/30/2026
Evaluation Study: Cohort 3 (Outcomes
Study).................................
Perceptions of Prescription Drug 0910-0916 6/30/2026
Products with Medication Tracking
Capabilities...........................
------------------------------------------------------------------------
Dated: July 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15456 Filed 7-20-23; 8:45 am]
BILLING CODE 4164-01-P
