Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Mpox Vaccine Distribution Request Forms, OMB No. 0915-xxxx-New, 47151-47152 [2023-15463]
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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
47152
Federal Register / Vol. 88, No. 139 / Friday, July 21, 2023 / Notices
a system HHS uses to quickly distribute
vaccines to HHS health partners. For
providers who elected to receive the
vaccine but did not have access to
HPOP, HRSA registered them in the
HPOP system. HRSA made 73
shipments to 57 (53 dually funded and
four Part C only) RWHAP recipients
who elected to receive and distribute
the mpox vaccine.
RWHAP recipients that receive
shipments of the JYNNEOS vaccine are
required to upload administration and
inventory/wastage data into HPOP on a
weekly basis. The information collected
includes federal or state PIN, contact, lot
number, description, number of vials,
expiration date, courses/doses/bottles
administered, bottles available, wastage,
reason, and date reported.
RWHAP recipients who accept
JYNNEOS vaccine from HRSA are also
asked to submit data with information
necessary for HRSA to assess the
quantity of mpox vaccines requested
and their distribution status. The
information collected includes grant
number; recipient name, point of
contact, and phone number; shipping
address; shipping point of contact,
email address, and phone number; and
number of boxes of mpox vaccine
requested.
As a result of the PHE for mpox, the
Assistant Secretary for Planning and
Evaluation issued a Paperwork
Reduction Act waiver for collection of
these data. Since the PHE ended on
January 31, 2023, HRSA is proposing to
continue collecting these data until
December 31, 2025. This action will
help to improve HRSA’s ability to
provide additional resources and
assistance to RWHAP recipients, which
may result in increased prevention of
mpox among RWHAP clients.
A 60-day notice was published in the
Federal Register on May 9, 2023, vol.
88, no. 89, pp. 29909–10. There was one
comment received. There are no
changes made to the information
collection since the comment received
is outside the scope of this information
request.
Need and Proposed Use of the
Information: HRSA will use the
information collected to (1) assess and
improve its response to the mpox
outbreak and (2) improve HRSA’s ability
to provide resources and assistance to
RWHAP recipients in future public
health emergencies.
Likely Respondents: Dually funded
RWHAP Part C and Health Center
recipients who accepted at least one
shipment of mpox vaccine from HRSA.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Vaccine Distribution Report .................................................
Wastage Upload Report ......................................................
Therapeutic Courses (Administered and Available) ............
57
57
57
1
52
52
57
2,964
2,964
0.20
0.23
0.23
11.40
681.72
681.72
Total ..............................................................................
171
........................
........................
........................
1,374.84
Maria G. Button,
Director, Executive Secretariat.
practice the inventions embodied in the
Patents and Patent Applications listed
in the SUPPLEMENTARY INFORMATION
section of this Notice to Elgia
Therapeutics Inc. (‘‘Elgia’’),
headquartered in La Jolla, CA.
[FR Doc. 2023–15463 Filed 7–20–23; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Only written comments and/or
applications for a license which are
received by the National Center for
Advancing Translational Sciences’
Office of Strategic Alliances on or before
August 7, 2023 will be considered.
DATES:
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Development and
Commercialization of Caspase
Inhibitors
AGENCY:
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
responses per
respondent
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Center for
Advancing Translational Sciences, an
institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Patent License to
SUMMARY:
VerDate Sep<11>2014
19:06 Jul 20, 2023
Jkt 259001
Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Sury Vepa, Ph.D., J.D.,
Senior Licensing and Patenting
Manager, Office of Strategic Alliances,
Telephone: (301) 642–0460; Email:
sury.vepa@nih.gov.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Intellectual Property
1. U.S. Provisional Application No.
61/299,790, filed January 29, 2010
which is entitled ‘‘Caspase Inhibitors’’
(HHS Ref. No. E–308–2009–0–US–01);
2. International Patent Application
No. PCT/US2011/02274 filed on January
27, 2011 which is entitled ‘‘Caspase
Inhibitors’’ (HHS Ref. No. E–308–2009–
0–PCT–02); and
3. US Patent Application No. 13/
575,273 filed on July 25, 2012 which is
entitled ‘‘Caspase Inhibitors’’ and issued
as U.S. Patent No. 9,365,612 (HHS Ref.
No. E–308–2009–0–US–03).
The patent rights in these inventions
have been either assigned and/or
exclusively licensed to the government
of the United States of America.
The prospective exclusive license
territory may be worldwide, and the
field of use may be limited to the
following:
‘‘Development, manufacture, use and
commercialization of Caspase Inhibitors
E:\FR\FM\21JYN1.SGM
21JYN1
]]>Agencies
[Federal Register Volume 88, Number 139 (Friday, July 21, 2023)]
[Notices]
[Pages 47151-47152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15463]
-----------------------------------------------------------------------
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
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 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.
DATES: 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 [email protected] or call
(301) 443-3093.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Mpox Vaccine Distribution
Request Forms, OMB No. 0915-xxxx-New.
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),
[[Page 47152]]
a system HHS uses to quickly distribute vaccines to HHS health
partners. For providers who elected to receive the vaccine but did not
have access to HPOP, HRSA registered them in the HPOP system. HRSA made
73 shipments to 57 (53 dually funded and four Part C only) RWHAP
recipients who elected to receive and distribute the mpox vaccine.
RWHAP recipients that receive shipments of the JYNNEOS vaccine are
required to upload administration and inventory/wastage data into HPOP
on a weekly basis. The information collected includes federal or state
PIN, contact, lot number, description, number of vials, expiration
date, courses/doses/bottles administered, bottles available, wastage,
reason, and date reported.
RWHAP recipients who accept JYNNEOS vaccine from HRSA are also
asked to submit data with information necessary for HRSA to assess the
quantity of mpox vaccines requested and their distribution status. The
information collected includes grant number; recipient name, point of
contact, and phone number; shipping address; shipping point of contact,
email address, and phone number; and number of boxes of mpox vaccine
requested.
As a result of the PHE for mpox, the Assistant Secretary for
Planning and Evaluation issued a Paperwork Reduction Act waiver for
collection of these data. Since the PHE ended on January 31, 2023, HRSA
is proposing to continue collecting these data until December 31, 2025.
This action will help to improve HRSA's ability to provide additional
resources and assistance to RWHAP recipients, which may result in
increased prevention of mpox among RWHAP clients.
A 60-day notice was published in the Federal Register on May 9,
2023, vol. 88, no. 89, pp. 29909-10. There was one comment received.
There are no changes made to the information collection since the
comment received is outside the scope of this information request.
Need and Proposed Use of the Information: HRSA will use the
information collected to (1) assess and improve its response to the
mpox outbreak and (2) improve HRSA's ability to provide resources and
assistance to RWHAP recipients in future public health emergencies.
Likely Respondents: Dually funded RWHAP Part C and Health Center
recipients who accepted at least one shipment of mpox vaccine from
HRSA.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose, or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Vaccine Distribution Report..... 57 1 57 0.20 11.40
Wastage Upload Report........... 57 52 2,964 0.23 681.72
Therapeutic Courses 57 52 2,964 0.23 681.72
(Administered and Available)...
-------------------------------------------------------------------------------
Total....................... 171 .............. .............. .............. 1,374.84
----------------------------------------------------------------------------------------------------------------
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023-15463 Filed 7-20-23; 8:45 am]
BILLING CODE 4165-15-P
