Announcement of the Intent To Award Single-Source Cooperative Agreements to Approved but Unfunded Diaper Distribution Pilot Applications From FY2022, 25657-25658 [2023-08830]
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Federal Register / Vol. 88, No. 81 / Thursday, April 27, 2023 / Notices
develop SOPs specific to its use of
hazardous drugs.
6. USP <800>
Public comment: Several commenters
offered suggestions on the document’s
use of USP <800>. Most were concerned
that USP should be cited more often.
NIOSH response: In response to
commenters, USP <800> has been cited
in the document where it could be
determined that it could provide new
information that did not originate with
NIOSH (thus avoiding circular
references).
Public comment: NIOSH should be
differentiating between controls for
antineoplastics and other hazardous
drugs.
NIOSH response: NIOSH reaffirms
that this document is intended to apply
to all drugs on the 2023 List and not just
antineoplastics. No change to Managing
Exposures has been made in response to
this comment.
Public comment: One commenter
suggested that guidance on performing
an individual drug risk assessment that
meets the USP <800> standard would be
helpful as alternative containment
strategies and/or work practices for
specific dosage forms weren’t included.
NIOSH response: NIOSH disagrees
with providing guidance for ‘‘specific
dosage forms’’ as that is beyond the
scope of this general guidance
document. However, the text ‘‘[t]he risk
assessment should include evaluating
the dosage form and identifying the
probability of exposure’’ has been added
to Sec. 5.0 Risk Assessment, for clarity.
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7. Other Topics
Public comment: One commenter
noted that the term ‘‘pills’’ is referred
throughout the document, for example,
on pages 38 and 66. According to the
commenter, ‘‘pill’’ is a nonspecific,
outdated term and should be replaced
with the word ‘‘tablet’’ instead.
NIOSH response: NIOSH agrees and
has made this change throughout the
final Managing Exposures.
Public comment: Several commenters
noted spelling mistakes, errors in tables,
and other editorial improvements.
NIOSH response: NIOSH thanks the
commenters for pointing out these
errors. NIOSH has accepted all
appropriate editorial, spelling, and
correction comments in its revision of
Managing Exposures.
V. Summary of Changes to Documents
A. Procedures for Developing the NIOSH
List of Hazardous Drugs in Healthcare
Settings
As described in the responses to
comments above, only limited
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clarifications were made in the
Procedures document. Notable changes
include a revision to footnote 12 to
clarify that only CDER-approved drugs
are included on the List and the
addition of a new footnote 29 to clarify
NIOSH’s intent regarding drugs with
insufficient information in the package
insert to determine whether the drug
meets the NIOSH definition of a
hazardous drug. Other changes
comprised only minor editorial
improvements.
B. Managing Hazardous Drug
Exposures: Information for Healthcare
Settings
Changes were made to the document,
Managing Exposures, in response to
comments received. There were some
reorganizations, added references and
information, and clarification of
recommendations, as follows:
• In response to commenters, USP
<800> was cited in document where it
could be determined that it had new
information that did not originate with
NIOSH (thus avoiding circular
references). ONS 2018 was cited and
listed as an additional resource.
• The language in the document was
clarified to specify that each facility
should conduct their own risk
assessment and develop SOPs specific
to their use of hazardous drugs.
• Under Administrative Control
recommendations, the language was
clarified that automated counting
machines should be prohibited unless
the automated counting machine has
been evaluated and found to not release
powders.
• In the recommendations on PPE,
several changes were made in response
to comments:
D Gloving recommendations for
receiving and unpacking were changed
to a single glove.
D Recommendation to ‘‘spray’’ sterile
alcohol on gloves was removed.
D Recommendation for the use of
sleeves was changed to ‘‘Consider using
sleeve covers if there is a gap between
the gown and the glove.’’
• In the Table of Control Approaches:
D Ophthalmologic administration
guidance was added.
D Recommendation for double
flushing of toilets in homes was
removed and replaced with new
guidance that states ‘‘Close toilet lid or
use a plastic-backed absorbent pad
placed over the toilet without a lid
during flushing.’’
D ‘‘Crushing or manipulating tablets or
capsules’’ was moved from the
compounding activity formulation
column to the administering activity
formulation column.
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25657
• The document was edited to
highlight the potential risk from
exposure to human waste products
(urine, feces, vomit). The topic of
Medical Surveillance was moved
forward in the document under Risk
Management for clarity. Three new
sections were added to increase the
clarity and utility of the
recommendations:
D Section 6.5 Surface Contamination
D Section 7.1 Hazardous Waste
D Section 7.2 Spill Control
• Chapter 9 was created to reorganize
information in the previous draft for
clarity:
D Chapter 9.0 Additional
Considerations for Handling Hazardous
Drugs
D Section 9.1 Home Healthcare
D Section 9.2 Veterinary Clinics
(formerly Section 8.3 Steps to reduce
potential exposure to hazardous drugs)
Additional references were added as
suggested by commenters and peer
reviewers to provide additional
resources for readers.
John J. Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention, Department of Health and
Human Services.
[FR Doc. 2023–08900 Filed 4–26–23; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[CFDA Number: 93.647]
Announcement of the Intent To Award
Single-Source Cooperative
Agreements to Approved but
Unfunded Diaper Distribution Pilot
Applications From FY2022
Office of Community Services
(OCS), Administration for Children and
Families (ACF), Department of Health
and Human Services (HHS).
ACTION: Notice of issuance of singlesource awards.
AGENCY:
The ACF, OCS, Division of
Community Discretionary and
Demonstration Programs (DCDDP)
announces the intent to award seven
single-source cooperative agreements in
the aggregate amount of up to
$8,181,779 to approved but unfunded
applications submitted to the Diaper
Distribution Demonstration and
Research Pilot (DDDRP) Notice of
Funding Opportunity HHS–2022–ACF–
OCS–EDA–0161.
SUMMARY:
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Federal Register / Vol. 88, No. 81 / Thursday, April 27, 2023 / Notices
The purpose of these awards is to
evaluate the ability of community action
agencies, social services agencies, and
other non-profit community
organizations to provide diapers and
diapering supplies on a consistent basis
through diaper distribution programs,
while also offering support services for
families with low incomes. Recipients
will operate and expand diaper
distribution programs for families with
low incomes.
The proposed period of
performance is May 1, 2023, to April 30,
2025.
FOR FURTHER INFORMATION CONTACT:
Thom Campbell, Office of Community
Services, 330 C Street SW, Washington,
DC 20201. Telephone: 202–401–5455;
Email: thom.campbell@acf.hhs.gov.
SUPPLEMENTARY INFORMATION: The
above-mentioned awards will be made
pursuant to Congressional intent as
reflected in the Explanatory Statement
(p. S8891) accompanying the
Consolidated Appropriations Act, 2023:
DATES:
Social Services Research and
Demonstration.—The agreement
continues funding for the Diaper
Distribution Demonstration and
Research Pilot and expects that
$10,000,000 of the funds made available
for awards for direct services be made
to approved but unfunded applicants of
funding opportunity HHS–2022–ACF–
OCS–EDA–0161, as well as technical
assistance and evaluation activities for
such grants.
OCS announces the intent to award
the following single-source awards:
Recipient
Award amount
Massachusetts Association of Community Action Programs, Boston, MA ...................................................................................
California Community Action Partnership Association, Sacramento, CA .....................................................................................
Ohio Community Action Training Organization, Columbus, OH ...................................................................................................
Maryland Community Action Partnership, Annapolis, MD ............................................................................................................
Utah Community Action Partnership Association Inc, Layton, UT ................................................................................................
Community Action Association of Alabama, Birmingham, AL ......................................................................................................
Sisseton-Wahpeton Oyate of the Lake Traverse Reservation, Agency Village, SD ....................................................................
Statutory Authority
The DDDRP is authorized under
section 1110 of the Social Security Act;
42 U.S.C. 1310. This program was first
funded by Div. H, Title II of the
Consolidated Appropriations Act, 2022
(Pub. L. 117–103) as a non-statutory
earmark for the Social Services Research
and Demonstration.
Karen D. Shields,
Senior Grants Policy Specialist, Office of
Grants Policy, Office of Administration.
[FR Doc. 2023–08830 Filed 4–26–23; 8:45 am]
BILLING CODE 4184–XX–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0145]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Reporting
Associated With Animal Drug and
Animal Generic Drug User Fees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
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SUMMARY:
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including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions of FDA’s animal
drug and animal generic drug user fee
programs.
DATES: Either electronic or written
comments on the collection of
information must be submitted by June
26, 2023.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
June 26, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
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$1,200,000.00
1,200,000.00
1,200,000.00
1,200,000.00
1,101,779.00
1,200,000.00
1,080,000.00
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2020–N–0145 for ‘‘Reporting Associated
With Animal Drug and Animal Generic
Drug User Fees.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
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]]>Agencies
[Federal Register Volume 88, Number 81 (Thursday, April 27, 2023)]
[Notices]
[Pages 25657-25658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08830]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
[CFDA Number: 93.647]
Announcement of the Intent To Award Single-Source Cooperative
Agreements to Approved but Unfunded Diaper Distribution Pilot
Applications From FY2022
AGENCY: Office of Community Services (OCS), Administration for Children
and Families (ACF), Department of Health and Human Services (HHS).
ACTION: Notice of issuance of single-source awards.
-----------------------------------------------------------------------
SUMMARY: The ACF, OCS, Division of Community Discretionary and
Demonstration Programs (DCDDP) announces the intent to award seven
single-source cooperative agreements in the aggregate amount of up to
$8,181,779 to approved but unfunded applications submitted to the
Diaper Distribution Demonstration and Research Pilot (DDDRP) Notice of
Funding Opportunity HHS-2022-ACF-OCS-EDA-0161.
[[Page 25658]]
The purpose of these awards is to evaluate the ability of community
action agencies, social services agencies, and other non-profit
community organizations to provide diapers and diapering supplies on a
consistent basis through diaper distribution programs, while also
offering support services for families with low incomes. Recipients
will operate and expand diaper distribution programs for families with
low incomes.
DATES: The proposed period of performance is May 1, 2023, to April 30,
2025.
FOR FURTHER INFORMATION CONTACT: Thom Campbell, Office of Community
Services, 330 C Street SW, Washington, DC 20201. Telephone: 202-401-
5455; Email: [email protected].
SUPPLEMENTARY INFORMATION: The above-mentioned awards will be made
pursuant to Congressional intent as reflected in the Explanatory
Statement (p. S8891) accompanying the Consolidated Appropriations Act,
2023:
Social Services Research and Demonstration.--The agreement
continues funding for the Diaper Distribution Demonstration and
Research Pilot and expects that $10,000,000 of the funds made available
for awards for direct services be made to approved but unfunded
applicants of funding opportunity HHS-2022-ACF-OCS-EDA-0161, as well as
technical assistance and evaluation activities for such grants.
OCS announces the intent to award the following single-source
awards:
------------------------------------------------------------------------
Recipient Award amount
------------------------------------------------------------------------
Massachusetts Association of Community Action $1,200,000.00
Programs, Boston, MA................................
California Community Action Partnership Association, 1,200,000.00
Sacramento, CA......................................
Ohio Community Action Training Organization, 1,200,000.00
Columbus, OH........................................
Maryland Community Action Partnership, Annapolis, MD. 1,200,000.00
Utah Community Action Partnership Association Inc, 1,101,779.00
Layton, UT..........................................
Community Action Association of Alabama, Birmingham, 1,200,000.00
AL..................................................
Sisseton-Wahpeton Oyate of the Lake Traverse 1,080,000.00
Reservation, Agency Village, SD.....................
------------------------------------------------------------------------
Statutory Authority
The DDDRP is authorized under section 1110 of the Social Security
Act; 42 U.S.C. 1310. This program was first funded by Div. H, Title II
of the Consolidated Appropriations Act, 2022 (Pub. L. 117-103) as a
non-statutory earmark for the Social Services Research and
Demonstration.
Karen D. Shields,
Senior Grants Policy Specialist, Office of Grants Policy, Office of
Administration.
[FR Doc. 2023-08830 Filed 4-26-23; 8:45 am]
BILLING CODE 4184-XX-P
