Agency Information Collection Request. 30-Day Public Comment Request, 2362-2363 [2023-00558]
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Federal Register / Vol. 88, No. 9 / Friday, January 13, 2023 / Notices
existing information in the labeling for
a currently approved drug in a
supplement to such applications.
This draft guidance provides
examples of required and recommended
information in the DOSAGE AND
ADMINISTRATION section. This
guidance provides recommendations on
including certain dosage- and
administration-related information in
the DOSAGE AND ADMINISTRATION
section that is particularly critical to the
safe and effective use of the drug (e.g.,
lack of knowledge of the information or
nonadherence to a recommendation
could have serious consequences for
patients).
This draft guidance addresses the
dosage and route of administration for
each indication in the DOSAGE AND
ADMINISTRATION section and
information about the dosage range, the
starting or loading dose and dosage,
titration schedule, the maximum
recommended dosage, the maximum
recommended duration, monitoring for
effectiveness, and concomitant therapy
information in the DOSAGE AND
ADMINISTRATION section, as
appropriate.
This draft guidance also addresses the
following information in the DOSAGE
AND ADMINISTRATION section:
• Other drugs used before, during, or
after drug treatment or administration;
• Dosage modifications for adverse
reactions or for drug interactions;
• Dosage in specific populations (e.g.,
pediatric patients, geriatric patients,
patients with renal impairment, patients
with hepatic impairment);
• Information about switching to the
subject drug from other products or
substitution involving the subject drug;
• Recommendations regarding missed
dose(s);
• Recommendations in event of
vomiting after oral drug administration;
• Recommendations for drug
discontinuation or dosage reduction
when there are risks of withdrawal; and
• The recommended dosage for fixedcombination drug products and copackaged products.
Furthermore, this draft guidance
addresses when and how to include
information in the DOSAGE AND
ADMINISTRATION section on the
preparation and/or administration of the
drug (e.g., parenteral products, a
product stored in the refrigerator or
freezer, pharmacy bulk packages,
imaging bulk packages, solid oral dosage
forms with qualified liquids or soft
foods, oral dosage forms via enteral
feeding tubes, liposome drug products);
instructions to avoid harm related to
drug handling and administration,
radiation dosimetry; and information on
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drug incompatibilities if the drug is
mixed with other drugs. This guidance
also provides information on storage
instructions for the reconstituted or
diluted product.
Finally, this draft guidance describes
information that should ordinarily not
be included in the DOSAGE AND
ADMINISTRATION section.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on the ‘‘Dosage and Administration
Section of Labeling for Human
Prescription Drug and Biological
Products—Content and Format.’’ 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 refers to previously
approved collections of information
found in FDA regulations. These
collections of information 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). The collections of information in
21 CFR 314 and 21 CFR 601 have been
approved under OMB control number
0910–0001 and 0910–0338. The
collections of information in 21 CFR
201.57 have been approved under OMB
control number 0910–0572.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics, or https://
www.regulations.gov.
Dated: January 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–00619 Filed 1–12–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier OS–0945–0008]
Agency Information Collection
Request. 30-Day Public Comment
Request
AGENCY:
PO 00000
Office of the Secretary, HHS.
Frm 00051
Fmt 4703
Sfmt 4703
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before February 13, 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 information
collection by selecting ‘‘Currently under
30-day Review—Open for Public
Comments’’ or by using the search
function.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 264–0041. When submitting
comments or requesting information,
please include the document identifier
0990-New-30D and project title for
reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Type of Collection: Reinstatement
with changes.
OMB No.: 0945–0008.
Abstract: This Information Collection
Request is for a reinstatement with
changes to previously approved
collection 0945–0008 that is expired in
December 2022, titled: Assurance of
Compliance, Form HHS–690, subject to
minor modifications. Such an assurance
is required by the federal civil rights
laws enforced by the Office for Civil
Rights, as described herein. One method
that the federal government uses to
ensure civil rights compliance is to
require covered entities to submit
written assurances of compliance when
applying for federal financial assistance.
The assurances alert covered entities of
their civil rights obligations and provide
the Department with a valuable
enforcement tool, as a recipient’s
written assurance and certification
documents can provide an independent
SUMMARY:
E:\FR\FM\13JAN1.SGM
13JAN1
2363
Federal Register / Vol. 88, No. 9 / Friday, January 13, 2023 / Notices
contractual basis for enforcement of
nondiscrimination requirements. This is
for a 3year request.
Type of Respondent; Affected Public:
States, certain health care providers,
other persons, or entities receiving/
requesting Funding.
Frequency: The Applicant provides
this Assurance of Compliance when it
applies for or receives new HHS funds.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent
Form name
States, certain health care providers, other persons, and
entities.
Total ...............................................................................
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2023–00558 Filed 1–12–23; 8:45 am]
BILLING CODE 4150–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
lotter on DSK11XQN23PROD with NOTICES1
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Special Emphasis
Panel; HHS–NIH–CDC–SBIR PHS 2021–1
Phase II: Rapid, Point of Care Molecular
Diagnostics for HCV (Topic 99).
Date: February 6, 2023.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F30,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Scott Jakes, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3F30, Rockville, MD
20852, (240) 669–5931, jakesse@mail.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; HHS–NIH–CDC–SBIR PHS
VerDate Sep<11>2014
19:26 Jan 12, 2023
Jkt 259001
Form HHS–
690.
......................
Number
responses per
respondent
Number of
respondents
1
4
38,380
........................
........................
........................
38,380
Dated: January 9, 2023.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–00595 Filed 1–12–23; 8:45 am]
BILLING CODE 4140–01–P
Frm 00052
Fmt 4703
Total burden
hours
9595
2021–1 Phase II: Development of Priority
Diagnostics for Chagas Disease (Topic 96).
Date: February 7, 2023.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F30,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Scott Jakes, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3F30, Rockville, MD
20852, (240) 669–5931, jakesse@mail.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; HHS–NIH–CDC–SBIR PHS
2023–1 Phase I: Adaptation of CRISPR-based
in vitro Diagnostics for Rapid Detection of
Select Eukaryotic Pathogens (Topic 119).
Date: February 9, 2023.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F30,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Scott Jakes, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3F30, Rockville, MD
20852, (240) 669–5931, jakesse@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
PO 00000
Avg. burden/
response
(in hours)
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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.
Name of Committee: National Institute of
Neurological Disorders and Stroke Initial
Review Group; Neurological Sciences and
Disorders C Study Section Translational
Neural, Brain, and Pain Relief Devices.
Date: February 6–7, 2023.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Ana Olariu, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Activities,
NINDS/NIH, NSC, 6001 Executive Boulevard,
Bethesda, MD 20892, 301–496–9223,
Ana.Olariu@nih.gov.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; SEP—Translational Neural,
Brain and Pain Relief Devices.
Date: February 7, 2023.
Time: 1:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
E:\FR\FM\13JAN1.SGM
13JAN1
]]>Agencies
[Federal Register Volume 88, Number 9 (Friday, January 13, 2023)]
[Notices]
[Pages 2362-2363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00558]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier OS-0945-0008]
Agency Information Collection Request. 30-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the Office of the Secretary (OS), Department of Health and
Human Services, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before February 13,
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 information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected]
or (202) 264-0041. When submitting comments or requesting information,
please include the document identifier 0990-New-30D and project title
for reference.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
Type of Collection: Reinstatement with changes.
OMB No.: 0945-0008.
Abstract: This Information Collection Request is for a
reinstatement with changes to previously approved collection 0945-0008
that is expired in December 2022, titled: Assurance of Compliance, Form
HHS-690, subject to minor modifications. Such an assurance is required
by the federal civil rights laws enforced by the Office for Civil
Rights, as described herein. One method that the federal government
uses to ensure civil rights compliance is to require covered entities
to submit written assurances of compliance when applying for federal
financial assistance. The assurances alert covered entities of their
civil rights obligations and provide the Department with a valuable
enforcement tool, as a recipient's written assurance and certification
documents can provide an independent
[[Page 2363]]
contractual basis for enforcement of nondiscrimination requirements.
This is for a 3year request.
Type of Respondent; Affected Public: States, certain health care
providers, other persons, or entities receiving/requesting Funding.
Frequency: The Applicant provides this Assurance of Compliance when
it applies for or receives new HHS funds.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number Avg. burden/
Type of respondent Form name Number of responses per response (in Total burden
respondents respondent hours) hours
----------------------------------------------------------------------------------------------------------------
States, certain health care Form HHS-690..... 9595 1 4 38,380
providers, other persons,
and entities.
---------------------------------------------------------------
Total.................... ................. .............. .............. .............. 38,380
----------------------------------------------------------------------------------------------------------------
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2023-00558 Filed 1-12-23; 8:45 am]
BILLING CODE 4150-01-P
