Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Implement Maternal, Infant, and Early Childhood Home Visiting Program 2022 Legislative Changes: Assessment of Administrative Burden, 46141-46142 [2024-11563]
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Federal Register / Vol. 89, No. 103 / Tuesday, May 28, 2024 / Notices
46141
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TABLE 1—APPROVED NDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED
Application No.
Drug
Holder
NDA 004652 ........................
NDA 013268 ........................
ORETON (testosterone) Pellets for Subcutaneous Implantations, 75 milligrams (mg).
WINSTEROID (stanozolol) Tablets, 2 mg ......................
NDA 017455 ........................
Copper T Model TCu 200B (copper) Intrauterine Device
NDA 205003 ........................
PRESTALIA (amlodipine besylate/perindopril arginine)
Tablets, equivalent to (EQ) 2.5 mg base/3.5mg, EQ 5
mg base/7 mg, and EQ 10 mg base/14 mg.
Progynon Associates, 9300 Wilshire Blvd., Beverly
Hills, CA 90212.
Sterling Winthrop Inc., 90 Park Ave., New York, NY
10016.
Duramed Research, Inc., 425 Privet Rd., Horsham, PA
19044.
Adhera Therapeutics, Inc., 224 Holding Ave., Wake
Forest, NC 27588.
Therefore, notice is given to the
holders of the approved NDAs listed in
table 1 and to all other interested
persons that the Director of CDER
proposes to issue an order, under
section 505(e) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(e)), withdrawing approval of the
NDAs and all amendments and
supplements thereto on the grounds that
the NDA holders have failed to submit
reports required under § 314.81.
In accordance with section 505 of the
FD&C Act and part 314 (21 CFR part
314), the NDA holders are hereby
provided an opportunity for a hearing to
show why the approval of the NDAs
listed previously should not be
withdrawn and an opportunity to raise,
for administrative determination, all
issues relating to the legal status of the
drug products covered by these NDAs.
An NDA holder who decides to seek
a hearing must file the following: (1) A
written notice of participation and
request for a hearing (see DATES and
ADDRESSES) and (2) the data,
information, and analyses relied on to
demonstrate that there is a genuine and
substantial issue of fact that requires a
hearing (see DATES and ADDRESSES). Any
other interested person may also submit
comments on this notice. The
procedures and requirements governing
this notice of opportunity for a hearing,
notice of participation and request for a
hearing, the information and analyses to
justify a hearing, other comments, and
a grant or denial of a hearing are
contained in § 314.200 and in 21 CFR
part 12.
The failure of an NDA holder to file
a timely written notice of participation
and request for a hearing, as required by
§ 314.200, constitutes an election by that
NDA holder not to avail itself of the
opportunity for a hearing concerning
CDER’s proposal to withdraw approval
of the NDAs and constitutes a waiver of
any contentions concerning the legal
status of the drug products. FDA will
then withdraw approval of the NDAs,
and the drug products may not
thereafter be lawfully introduced or
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18:43 May 24, 2024
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delivered for introduction into interstate
commerce. Any new drug product
introduced or delivered for introduction
into interstate commerce without an
approved NDA is subject to regulatory
action at any time.
A request for a hearing may not rest
upon mere allegations or denials but
must present specific facts showing that
there is a genuine and substantial issue
of fact that requires a hearing. If a
request for a hearing is not complete or
is not supported, the Commissioner of
Food and Drugs will enter summary
judgment against the person who
requests the hearing, making findings
and conclusions, and denying a hearing.
All submissions under this notice of
opportunity for a hearing must be filed
in two copies. Except for data and
information prohibited from public
disclosure under 21 U.S.C. 331(j) or 18
U.S.C. 1905, the submissions may be
seen at the Dockets Management Staff
(see ADDRESSES) between 9 a.m. and 4
p.m., Monday through Friday, and will
be posted to the docket at https://
www.regulations.gov.
This notice is issued under section
505(e) of the FD&C Act and under
authority delegated to the Director of
CDER by the Commissioner of Food and
Drugs.
Dated: May 17, 2024.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation
and Research.
[FR Doc. 2024–11609 Filed 5–24–24; 8:45 am]
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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; Implement Maternal, Infant,
and Early Childhood Home Visiting
Program 2022 Legislative Changes:
Assessment of Administrative Burden
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with 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.
SUMMARY:
Comments on this ICR should be
received no later than June 27, 2024.
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
Joella Roland, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 443–
3983.
SUPPLEMENTARY INFORMATION:
DATES:
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46142
Federal Register / Vol. 89, No. 103 / Tuesday, May 28, 2024 / Notices
Information Collection Request Title:
Implement Maternal, Infant, and Early
Childhood Home Visiting Program 2022
Legislative Changes: Assessment of
Administrative Burden
OMB No. 0915-xxxx—[NEW]
Abstract: The Consolidated
Appropriations Act, 2023, Public Law
117–328, section 6101, the Jackie
Walorski Maternal and Child Home
Visiting Reauthorization Act of 2022
(Section 6101 of the Consolidated
Appropriations Act, 2023) extended
funding for the Maternal, Infant, and
Early Childhood Home Visiting
(MIECHV) Program for an additional 5
years and adopted new program
requirements. This included a new
requirement for the Secretary of Health
and Human Services to assess and
reduce burden on MIECHV funding
recipients in administering the program
by: (1) eliminating duplication and
streamlining reporting requirements; (2)
analyzing ways, in consultation with
administering agencies (i.e., MIECHV
funding recipients) to reduce the
number of hours spent on complying
with paperwork requirements by at least
15 percent; (3) reviewing paperwork and
data collection requirements for tribal
MIECHV funding recipients and
exploring, in consultation with tribes
and tribal organizations, ways to reduce
administrative burden, respect
sovereignty, and acknowledge the
different focus points for tribal funding
recipients; (4) collecting input from
relevant state fiscal officials to align
fiscal requirements and oversight for
states and eligible entities to ensure
consistency with standards and
guidelines for other federal formula
grant programs; and (5) consulting with
administering agencies and service
delivery model representatives on
needed and unneeded data elements
regarding the dashboards provided for
in newly added Social Security Act
subsection 511(d)(1)(B), consistent with
the data requirements of such
subsection.
Through this ICR, HRSA aims to
survey state, jurisdiction, and tribal
MIECHV funding recipients to obtain
feedback regarding potential ways to
reduce administrative burden, as
described above.
A 60-day notice was published in the
Federal Register on December 20, 2023,
vol. 88, No. 243; pp. 88084–88085.
HRSA received four comments and the
information collection tools have been
revised in response. These changes
addressed concerns with the burden
estimate and to modify items for clarity
and increase the burden estimates for
respondents to more accurately reflect
the time it will reasonably take
respondents to respond to this
information collection. HRSA also
considered additional feedback from
certain home visiting model developers
and is removing from this ICR the
proposed plan to survey home visiting
model developers.
Need and Proposed Use of the
Information: Section 511(h)(6)(A) of the
Social Security Act requires the
Secretary of Health and Human Services
to assess and reduce administrative
burden on MIECHV funding recipients
in specified ways. Information gained
from this information collection will
inform recommendations to reduce
administrative burden.
Likely Respondents: State and
jurisdiction MIECHV Program funding
recipients that are states, territories,
and, where applicable, nonprofit
organizations receiving MIECHV
funding to provide home visiting
services within states; and tribal
MIECHV Program funding recipients
that are tribes and tribal organizations.
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
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
responses
State and Jurisdiction MIECHV Funding Recipient Survey
Tribal MIECHV Funding Recipient Survey ..........................
56
29
1
1
56
29
27
4
1,512
116
Total ..............................................................................
85
........................
85
........................
1,628
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024–11563 Filed 5–24–24; 8:45 am]
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Total burden
hours
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]]>Agencies
[Federal Register Volume 89, Number 103 (Tuesday, May 28, 2024)]
[Notices]
[Pages 46141-46142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11563]
-----------------------------------------------------------------------
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; Implement Maternal,
Infant, and Early Childhood Home Visiting Program 2022 Legislative
Changes: Assessment of Administrative Burden
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with 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 June 27,
2024.
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 Joella Roland, the HRSA
Information Collection Clearance Officer, at [email protected] or call
(301) 443-3983.
SUPPLEMENTARY INFORMATION:
[[Page 46142]]
Information Collection Request Title: Implement Maternal, Infant,
and Early Childhood Home Visiting Program 2022 Legislative Changes:
Assessment of Administrative Burden
OMB No. 0915-xxxx--[NEW]
Abstract: The Consolidated Appropriations Act, 2023, Public Law
117-328, section 6101, the Jackie Walorski Maternal and Child Home
Visiting Reauthorization Act of 2022 (Section 6101 of the Consolidated
Appropriations Act, 2023) extended funding for the Maternal, Infant,
and Early Childhood Home Visiting (MIECHV) Program for an additional 5
years and adopted new program requirements. This included a new
requirement for the Secretary of Health and Human Services to assess
and reduce burden on MIECHV funding recipients in administering the
program by: (1) eliminating duplication and streamlining reporting
requirements; (2) analyzing ways, in consultation with administering
agencies (i.e., MIECHV funding recipients) to reduce the number of
hours spent on complying with paperwork requirements by at least 15
percent; (3) reviewing paperwork and data collection requirements for
tribal MIECHV funding recipients and exploring, in consultation with
tribes and tribal organizations, ways to reduce administrative burden,
respect sovereignty, and acknowledge the different focus points for
tribal funding recipients; (4) collecting input from relevant state
fiscal officials to align fiscal requirements and oversight for states
and eligible entities to ensure consistency with standards and
guidelines for other federal formula grant programs; and (5) consulting
with administering agencies and service delivery model representatives
on needed and unneeded data elements regarding the dashboards provided
for in newly added Social Security Act subsection 511(d)(1)(B),
consistent with the data requirements of such subsection.
Through this ICR, HRSA aims to survey state, jurisdiction, and
tribal MIECHV funding recipients to obtain feedback regarding potential
ways to reduce administrative burden, as described above.
A 60-day notice was published in the Federal Register on December
20, 2023, vol. 88, No. 243; pp. 88084-88085. HRSA received four
comments and the information collection tools have been revised in
response. These changes addressed concerns with the burden estimate and
to modify items for clarity and increase the burden estimates for
respondents to more accurately reflect the time it will reasonably take
respondents to respond to this information collection. HRSA also
considered additional feedback from certain home visiting model
developers and is removing from this ICR the proposed plan to survey
home visiting model developers.
Need and Proposed Use of the Information: Section 511(h)(6)(A) of
the Social Security Act requires the Secretary of Health and Human
Services to assess and reduce administrative burden on MIECHV funding
recipients in specified ways. Information gained from this information
collection will inform recommendations to reduce administrative burden.
Likely Respondents: State and jurisdiction MIECHV Program funding
recipients that are states, territories, and, where applicable,
nonprofit organizations receiving MIECHV funding to provide home
visiting services within states; and tribal MIECHV Program funding
recipients that are tribes and tribal organizations.
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 Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
State and Jurisdiction MIECHV 56 1 56 27 1,512
Funding Recipient Survey.......
Tribal MIECHV Funding Recipient 29 1 29 4 116
Survey.........................
-------------------------------------------------------------------------------
Total....................... 85 .............. 85 .............. 1,628
----------------------------------------------------------------------------------------------------------------
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024-11563 Filed 5-24-24; 8:45 am]
BILLING CODE 4165-15-P
