Supporting Healthy Start Performance Project, 60218-60219 [2023-18798]
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60218
Federal Register / Vol. 88, No. 168 / Thursday, August 31, 2023 / Notices
the identification and tracing of certain
prescription drugs as they are
distributed within the United States.
Section 202 of the DSCSA added section
582 to the FD&C Act (21 U.S.C. 360eee1), which established product tracing,
product identifier, authorized trading
partner, and verification requirements
for manufacturers, repackagers,
wholesale distributors, and dispensers
to facilitate the tracing of products
through the pharmaceutical distribution
supply chain. Section 582 of the FD&C
Act also imposed requirements for
enhanced drug distribution security that
go into effect on November 27, 2023.
Trading partners, along with Federal
and State authorities, have an important
role in ensuring the quality of
prescription drugs and protecting the
integrity of the pharmaceutical
distribution supply chain. The DSCSA
requirements, which have been phased
in since 2013, improve supply chain
security activities by trading partners
involved in prescription drug
manufacturing, repackaging, wholesale
distribution, warehousing or related
logistical activities, and dispensing. The
gradual implementation of the DSCSA
requirements for product tracing,
product identification, authorized
trading partners, and verification
facilitates the development of electronic
interoperability to enhance the security
of the pharmaceutical distribution
supply chain.
Section 582(g)(1) of the FD&C Act sets
forth the requirements for enhanced
drug distribution security as of
November 27, 2023, including (as
described in that provision and
generally summarized here):
• The exchange of transaction
information and transaction statements
in a secure, interoperable, electronic
manner.
• Transaction information that
includes the product identifier at the
package level for each package included
in the transaction.
• Systems and processes for
verification of product at the package
level.
• Systems and processes needed to
promptly respond to requests from FDA
(or other appropriate Federal or State
officials) for product transaction
information in the event of a recall or
to investigate suspect and illegitimate
products.
This guidance clarifies the enhanced
drug distribution security requirements
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and pursuant to section 582(h)(3) of the
FD&C Act describes recommendations
for system attributes necessary for
enhanced product tracing and enhanced
verification, including when the use of
aggregation and inference may be
appropriate.
This guidance finalizes the draft
guidance entitled ‘‘Enhanced Drug
Distribution Security at the Package
Level Under the Drug Supply Chain
Security Act’’ issued on June 4, 2021 (86
FR 30053). FDA considered comments
received on the draft guidance as the
guidance was finalized. Changes from
the draft to the final guidance include
removal of the term ‘‘enhanced system’’
when referring to the requirements in
section 582(g) of the FD&C Act to avoid
confusion and clarification of
recommendations addressing (1)
reconciliation of transaction
information, (2) aggregation and
inference, and (3) verification of
saleable returns, including a brief
discussion of the sunset provisions of
section 582(k) of the FD&C Act. Changes
also include clarification of
requirements for provision of certain
information in response to requests
stemming from investigation of suspect
or illegitimate product. In addition,
editorial changes were made to improve
clarity.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Enhanced Drug
Distribution Security at the Package
Level Under the Drug Supply Chain
Security Act.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This guidance includes information
collection provisions that are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). FDA intends to solicit public
comment and obtain OMB approval for
any information collections
recommended in this guidance that are
new or that would represent substantive
or material modifications to those
previously approved collections of
information found in FDA regulations or
guidance.
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III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: August 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–18831 Filed 8–30–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Supporting Healthy Start Performance
Project
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
Announcing period of
performance supplement for the
Supporting Healthy Start Performance
Project (SHSPP) recipient.
ACTION:
HRSA will provide
supplemental award funds to the
current SHSPP recipient, in fiscal year
2023 to provide new and continued
support to Healthy Start grant
recipients.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Rochelle Logan, Healthy Start Team
lead, Division of Healthy Start and
Perinatal Services, Maternal and Child
Health Bureau, Health Resources and
Services Administration, at rlogan@
hrsa.gov or (301) 443–0543.
SUPPLEMENTARY INFORMATION:
Amount of Non-Competitive
Award(s): One award for $1,900,000.
Project Period: June 1, 2023, to May
31, 2024.
Assistance Listing (CFDA) Number:
93.926.
Award Instrument: Supplement.
Authority: 42 U.S.C. 254c–8 (title III,
section 330H of the Public Health
Service Act).
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Federal Register / Vol. 88, No. 168 / Thursday, August 31, 2023 / Notices
60219
TABLE 1—RECIPIENTS AND AWARD AMOUNTS
Grant No.
Award recipient name
City, state
Award
amount
UF5MC32750 ..........................
National Institute for Children’s Health Quality ........................
Boston, MA .............................
$1,900,000
Justification: HRSA will provide
supplemental award funds to the
current SHSPP recipient in fiscal year
2023 to provide new and continued
support to Healthy Start grant
recipients. The current recipient of the
SHSPP is best positioned to address the
objectives that to be supported by the
supplemental funds, including
supporting data collection and
evaluation and implementing applicable
Executive Orders.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Carole Johnson,
Administrator.
ACTION:
[FR Doc. 2023–18798 Filed 8–30–23; 8:45 am]
SUMMARY:
Health Resources and Services
Administration
HRSA-Initiated Supplemental Funding
to the Supporting Maternal Health
Innovation Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
Notice of supplemental award.
HRSA is providing
supplemental funds not to exceed
$1,500,000 to the Supporting Maternal
Health Innovation Program, also
referred to as the Maternal Health
Learning and Innovation Center
(MHLIC), in fiscal year (FY) 2023 to
provide support and capacity building
to HRSA’s new maternal health award
recipients under the State Maternal
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Health Innovation (MHI) Program
(HRSA–23–108).
FOR FURTHER INFORMATION CONTACT:
Kimberly Sherman, Chief, Maternal and
Women’s Health Branch, Division of
Healthy Start and Perinatal Services,
Maternal and Child Health Bureau,
HRSA, at ksherman@hrsa.gov or (301)
443–1702.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award: One
award to the University of North
Carolina at Chapel Hill, the current
recipient under the Supporting Maternal
Health Innovation Program, now known
as MHLIC, as listed in Table 1.
Amount of Non-Competitive Award:
Up to $1,500,000.
Project Period: September 30, 2019, to
September 29, 2024.
CFDA Number: 93.110.
Award Instrument: Supplement.
Authority: 42 U.S.C. 701(a)(2) (title V,
section 501(a)(2) of the Social Security
Act).
ddrumheller on DSK120RN23PROD with NOTICES1
TABLE 1—SUPPORTING MHI PROGRAM AWARD RECIPIENT (2019–2024)
Grant No.
Grantee organization
City, state
Award
amount
U7CMC33636
University of North Carolina at Chapel Hill .....................................................................................
Raleigh, NC ...
$1,500,000
Justification: The Consolidated
Appropriations Act, 2023 (Pub. L. 117–
328) included additional Special
Projects of Regional and National
Significance funding. The Explanatory
Statement accompanying the
Consolidated Appropriations Act
specified a $26 million increase for the
State MHI Program to establish new
cooperative agreements in FY 2023 with
up to 23 new states. MHLIC provides
support and capacity building to
HRSA’s maternal health award
recipients. Supplemental funds to
MHLIC will be used to provide support
and capacity building to the new cohort
of FY 2023 State MHI award recipients.
The requested activities are within
scope of the Supporting Maternal Health
Innovation Program.
Carole Johnson,
Administrator.
[FR Doc. 2023–18799 Filed 8–30–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
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Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; NIDDK SEP High
Risk Multi-Center Clinical Study Cooperative
Agreement U01.
Date: September 28, 2023.
Time: 12:00 p.m. to 1:00 p.m.
Agenda: To review and evaluate
cooperative agreement applications.
Place: National Institutes of Health,
NIDDK, Democracy II, Suite 7000A, 6707
Democracy Boulevard, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Cheryl Nordstrom, Ph.D.,
MPH, Scientific Review Officer, NIDDK/
Scientific Review Branch, National Institutes
of Health, 6707 Democracy Blvd., Room
7013, Bethesda, MD 20892, 301–402–6711,
cheryl.nordstrom@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
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]]>Agencies
[Federal Register Volume 88, Number 168 (Thursday, August 31, 2023)]
[Notices]
[Pages 60218-60219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18798]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Supporting Healthy Start Performance Project
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Announcing period of performance supplement for the Supporting
Healthy Start Performance Project (SHSPP) recipient.
-----------------------------------------------------------------------
SUMMARY: HRSA will provide supplemental award funds to the current
SHSPP recipient, in fiscal year 2023 to provide new and continued
support to Healthy Start grant recipients.
FOR FURTHER INFORMATION CONTACT: Rochelle Logan, Healthy Start Team
lead, Division of Healthy Start and Perinatal Services, Maternal and
Child Health Bureau, Health Resources and Services Administration, at
[email protected] or (301) 443-0543.
SUPPLEMENTARY INFORMATION:
Amount of Non-Competitive Award(s): One award for $1,900,000.
Project Period: June 1, 2023, to May 31, 2024.
Assistance Listing (CFDA) Number: 93.926.
Award Instrument: Supplement.
Authority: 42 U.S.C. 254c-8 (title III, section 330H of the Public
Health Service Act).
[[Page 60219]]
Table 1--Recipients and Award Amounts
----------------------------------------------------------------------------------------------------------------
Grant No. Award recipient name City, state Award amount
----------------------------------------------------------------------------------------------------------------
UF5MC32750............................ National Institute for Boston, MA.............. $1,900,000
Children's Health Quality.
----------------------------------------------------------------------------------------------------------------
Justification: HRSA will provide supplemental award funds to the
current SHSPP recipient in fiscal year 2023 to provide new and
continued support to Healthy Start grant recipients. The current
recipient of the SHSPP is best positioned to address the objectives
that to be supported by the supplemental funds, including supporting
data collection and evaluation and implementing applicable Executive
Orders.
Carole Johnson,
Administrator.
[FR Doc. 2023-18798 Filed 8-30-23; 8:45 am]
BILLING CODE 4165-15-P
