Submission for Office of Management and Budget Review; Proposed Information Collection Activity; Tribal Early Childhood Facilities Combined Application Guide (New Collection), 24010-24011 [2024-07292]
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khammond on DSKJM1Z7X2PROD with NOTICES
24010
Federal Register / Vol. 89, No. 67 / Friday, April 5, 2024 / Notices
410–786–8466 or Candace.Carter@
cms.hhs.gov).
4. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: End Stage Renal
Disease (ESRD) Annual Home Dialysis
within Nursing Home Survey Form;
Use: The End Stage Renal Disease
(ESRD) Network program is responsible
to collect, validate, and analyze data as
well as to evaluate the process by which
facilities determine the appropriateness
of patients for a treatment modality.
Additional responsibilities of the ESRD
Network program include encouraging
participation in the placement of
patients in a self-care setting, such as
home hemodialysis or peritoneal
dialysis, as described in Sec. 1881. [42
U.S.C. 1395rr] (c)(1)(A)(i)(2) of the
Social Security Act. On September 21,
2018, CMS clarified guidance that
residents in a nursing home facility can
receive dialysis either administered
and/or supervised by personnel who
meet the criteria for training, and
competency verification at 42 CFR
494.100(a) and (b) for providing
dialysis. The provision of dialysis
within a nursing home requires that the
dialysis facility have an agreement with
the nursing home. This guidance was
reinforced and updated on March 22,
2023, in a memo to the State Survey
Agency Directors titled, ‘‘Guidance and
Survey Process for Reviewing Home
Dialysis Services in a Nursing Home
REVISED’’. Since the provision of
dialysis within nursing homes is
relatively new, CMS designed the CMS–
10842 form to capture home modality
information from dialysis facilities that
provide dialysis within the nursing
home in alignment with the Centers for
Disease Control and Prevention (CDC).
The care provided to residents of a
nursing home is of particular interest
because of the fragile health state of the
patient and the susceptibility to
infection. Each facility certification/
survey record represents one provider.
CMS–10842 collects information on
dialysis facilities providing home
dialysis services within the nursing
home related to the number of patients,
setting of dialysis services provided,
who is providing dialysis services, who
is providing dressing changes to dialysis
access, staff education and use of CDC
Core Interventions used. The aggregate
patient information is collected from
each Medicare-approved home dialysis
provider to identify the specialized
needs of the ESRD community where
home dialysis is provided in Long Term
Care facilities. Form Number: CMS–
VerDate Sep<11>2014
16:44 Apr 04, 2024
Jkt 262001
10842 (OMB control number: 0938–
NEW); Frequency: Yearly; Affected
Public: Private Sector (Business or other
for-profit and Not-for-profit
institutions); Number of Respondents:
7,726; Total Annual Responses: 7,726;
Total Annual Hours: 5,795. (For policy
questions regarding this collection
contact Christina Goatee at 410–786–
6689).
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–07202 Filed 4–4–24; 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; Proposed
Information Collection Activity; Tribal
Early Childhood Facilities Combined
Application Guide (New Collection)
Office of Early Childhood
Development, Administration for
Children and Families, U.S. Department
of Health and Human Services.
ACTION: Request for public comments.
AGENCY:
The Office of Early Childhood
Development (ECD), Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS), is requesting Office of
Management and Budget (OMB)
approval of the Tribal Early Childhood
Facilities Combined Application Guide
for joint applications for construction
and major renovation projects using
both Head Start and Child Care and
Development Fund (CCDF) resources.
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
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
copies of the proposed collection of
information by emailing infocollection@
acf.hhs.gov. Identify all emailed
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: Funding for facilities
under the CCDF is authorized by
Section 658O(c)(6) of the Child Care and
Development Block Grant (CCDBG) Act,
42 U.S.C. 9858(c)(6), and is managed by
the Office of Child Care (OCC). Funding
for Head Start facilities projects is
authorized by 45 CFR part 1303
(Subpart E) Head Start Program
Performance Standards and is managed
by the Office of Head Start (OHS). The
guide streamlines the process for Tribal
CCDF Lead Agencies and American
Indian and Alaska Native (AI/AN) Head
Start programs submitting collaborative,
joint applications to use federal CCDF
and Head Start funds for facilities
projects where funds can be used for
reasonable costs and fees related to
planning for a facilities project and to
support the application development in
tribal communities. Both funds aim to
construct or improve early childhood
facilities, often serving the same
children, but application submission
and review processes are currently
unique to each respective funding
stream. The proposed information
collection will provide instructions to
Tribal CCDF Lead Agencies and AI/AN
Head Start programs on submitting joint
plans for how proposed facilities
projects will enable the programs to
better serve current AI/AN families or
increase enrollment currently limited by
inadequate facilities. The guide will
provide critical information and
resources, so recipients understand the
requirements of each program and
develop plans that reflect the needs of
their communities. Reducing and
streamlining administrative burdens for
tribal constituents follows policy
priorities laid out in the 2022 HHS
Equity Action Plan and is in alignment
with Executive Order 14095—Executive
Order on Increasing Access to HighQuality Care and Supporting Caregivers.
Respondents: AI/AN Head Start
Facilities and Tribal CCDF Lead
Agencies (information collection does
not include direct interaction with
individuals or families that receive the
services).
Annual Burden Estimates: We
estimate at most 10 applications per
year and have estimated burden based
on this maximum number.
E:\FR\FM\05APN1.SGM
05APN1
24011
Federal Register / Vol. 89, No. 67 / Friday, April 5, 2024 / Notices
Instrument
Total
number of
respondents
Annual
number of
responses per
respondent
Average
burden hours
per response
Annual
burden hours
Tribal Early Childhood Facilities Application Guide .........................................
10
1
100
1,000
Authority: 42 U.S.C. 9858(c)(6); 45
CFR part 1303 Subpart E.
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–07292 Filed 4–4–24; 8:45 am]
BILLING CODE 4184–40–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–P–0105]
Determination That GLUCOTROL
(Glipizide) Tablets, 5 Milligrams and 10
Milligrams, Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that GLUCOTROL
(glipizide) tablets, 5 milligrams (mg) and
10 mg, were not withdrawn from sale
for reasons of safety or effectiveness.
This determination means that FDA will
not begin procedures to withdraw
approval of abbreviated new drug
applications (ANDAs) that refer to these
drug products, and it will allow FDA to
continue to approve ANDAs that refer to
these products as long as they meet
relevant legal and regulatory
requirements.
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Swati Rawani, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6221,
Silver Spring, MD 20993–0002, 240–
402–9917, Swati.Rawani@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
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16:44 Apr 04, 2024
Jkt 262001
approved, and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
requires FDA to publish a list of all
approved drugs. FDA publishes this list
as part of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ Under FDA
regulations, drugs are removed from the
list if the Agency withdraws or
suspends approval of the drug’s NDA or
ANDA for reasons of safety or
effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
GLUCOTROL (glipizide) tablets, 5 mg
and 10 mg, are the subject of NDA
017783, held by Pfizer Inc., and initially
approved on May 8, 1984. GLUCOTROL
is indicated as an adjunct to diet and
exercise to improve glycemic control in
adults with type 2 diabetes mellitus.
In a letter dated June 30, 2022, Pfizer
Inc., notified FDA that GLUCOTROL
(glipizide) tablets, 5 mg and 10 mg, were
being discontinued, and FDA moved
these drug products to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Graviti Pharmaceuticals Private
Limited submitted a citizen petition
dated January 3, 2024, Docket No. FDA–
2024–P–0105, under 21 CFR 10.30,
requesting that the Agency determine
whether GLUCOTROL (glipizide)
tablets, 5 mg and 10 mg, were
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that GLUCOTROL (glipizide)
PO 00000
Frm 00051
Fmt 4703
Sfmt 9990
tablets, 5 mg and 10 mg, were not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that GLUCOTROL (glipizide)
tablets, 5 mg and 10 mg, were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
GLUCOTROL (glipizide) tablets, 5 mg
and 10 mg, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that these drug products
were not withdrawn from sale for
reasons of safety or effectiveness.1
Accordingly, the Agency will
continue to list GLUCOTROL (glipizide)
tablets, 5 mg and 10 mg, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to these
drug products. Additional ANDAs for
these drug products may also be
approved by the Agency as long as they
meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for these drug products should be
revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: April 2, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–07268 Filed 4–4–24; 8:45 am]
BILLING CODE 4164–01–P
1 FDA previously determined that GLUCOTROL
(glipizide) tablets, 2.5 mg, were not withdrawn from
sale for reasons of safety or effectiveness (87 FR
28015, May 10, 2022).
E:\FR\FM\05APN1.SGM
05APN1
]]>Agencies
[Federal Register Volume 89, Number 67 (Friday, April 5, 2024)]
[Notices]
[Pages 24010-24011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07292]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for Office of Management and Budget Review; Proposed
Information Collection Activity; Tribal Early Childhood Facilities
Combined Application Guide (New Collection)
AGENCY: Office of Early Childhood Development, Administration for
Children and Families, U.S. Department of Health and Human Services.
ACTION: Request for public comments.
-----------------------------------------------------------------------
SUMMARY: The Office of Early Childhood Development (ECD),
Administration for Children and Families (ACF), U.S. Department of
Health and Human Services (HHS), is requesting Office of Management and
Budget (OMB) approval of the Tribal Early Childhood Facilities Combined
Application Guide for joint applications for construction and major
renovation projects using both Head Start and Child Care and
Development Fund (CCDF) resources.
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: Funding for facilities under the CCDF is authorized by
Section 658O(c)(6) of the Child Care and Development Block Grant
(CCDBG) Act, 42 U.S.C. 9858(c)(6), and is managed by the Office of
Child Care (OCC). Funding for Head Start facilities projects is
authorized by 45 CFR part 1303 (Subpart E) Head Start Program
Performance Standards and is managed by the Office of Head Start (OHS).
The guide streamlines the process for Tribal CCDF Lead Agencies and
American Indian and Alaska Native (AI/AN) Head Start programs
submitting collaborative, joint applications to use federal CCDF and
Head Start funds for facilities projects where funds can be used for
reasonable costs and fees related to planning for a facilities project
and to support the application development in tribal communities. Both
funds aim to construct or improve early childhood facilities, often
serving the same children, but application submission and review
processes are currently unique to each respective funding stream. The
proposed information collection will provide instructions to Tribal
CCDF Lead Agencies and AI/AN Head Start programs on submitting joint
plans for how proposed facilities projects will enable the programs to
better serve current AI/AN families or increase enrollment currently
limited by inadequate facilities. The guide will provide critical
information and resources, so recipients understand the requirements of
each program and develop plans that reflect the needs of their
communities. Reducing and streamlining administrative burdens for
tribal constituents follows policy priorities laid out in the 2022 HHS
Equity Action Plan and is in alignment with Executive Order 14095--
Executive Order on Increasing Access to High-Quality Care and
Supporting Caregivers.
Respondents: AI/AN Head Start Facilities and Tribal CCDF Lead
Agencies (information collection does not include direct interaction
with individuals or families that receive the services).
Annual Burden Estimates: We estimate at most 10 applications per
year and have estimated burden based on this maximum number.
[[Page 24011]]
----------------------------------------------------------------------------------------------------------------
Annual number Average burden
Instrument Total number of of responses hours per Annual burden
respondents per respondent response hours
----------------------------------------------------------------------------------------------------------------
Tribal Early Childhood Facilities 10 1 100 1,000
Application Guide..........................
----------------------------------------------------------------------------------------------------------------
Authority: 42 U.S.C. 9858(c)(6); 45 CFR part 1303 Subpart E.
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024-07292 Filed 4-4-24; 8:45 am]
BILLING CODE 4184-40-P
