HIPAA Audit Survey 60-day Notice

Federal Register / Vol. 89, No. 29 / Monday, February 12, 2024 / Notices
Performance Goals and Program
Enhancements Fiscal Years 2023–2027
(GDUFA III commitment letter),1 FDA
agreed to conduct annual public
workshops ‘‘to solicit input from
industry and stakeholders for inclusion
in an annual list of GDUFA III
regulatory science initiatives.’’ This
public workshop scheduled for May 20
and 21, 2024, seeks to fulfill this
agreement.
II. Topics for Discussion at the Public
Workshop
The purpose of this public workshop
is to obtain input from industry and
other interested stakeholders on
identifying generic drug science and
research initiatives for FY 2025. FDA is
interested in receiving input about
regulatory science initiatives for the
ongoing years of the GDUFA III science
and research program, and particularly
for FY 2025.
Topics discussed during the
workshop will focus on research that is
needed to address scientific knowledge
gaps and associated challenges
impacting the development and
regulatory assessment of generic
products, including complex generics.
As examples, topics discussed will
likely relate to nitrosamine drug
substance-related impurities, drugdevice combination products, predictive
tools to improve the efficiency of
generic product development, and other
topics that can enhance public access to
high quality, safe and effective generic
products. Specific presentations and
discussions at this workshop will be
announced at a later date and may differ
from the topics above. Input about the
topics above will help the Agency
identify and expand its scientific focus
for the next fiscal year.
FDA will consider all comments made
at this workshop or received through the
docket (see ADDRESSES) as it develops its
FY 2025 science and research
initiatives. Information concerning the
science and research initiatives for
generic drugs can be found on the
Science & Research website at https://
www.fda.gov/drugs/generic-drugs/
science-research.

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III. Participating in the Public
Workshop
Registration: Registration is free.
Persons interested in attending this
public workshop must register online at
https://fda.zoomgov.com/webinar/
register/WN_qwJcEJcWQeeglLe
ZMD2MCg. Registration may be
1 The GDUFA III commitment letter is available
at https://www.fda.gov/media/153631/download.

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performed at any time before or during
the workshop.
If you need special accommodations
due to a disability, please contact FDA
via email at GDUFARegulatoryScience@
fda.hhs.gov no later than 11:59 p.m.
eastern time on May 10, 2024.
Requests for Oral Presentations:
During online registration you may
indicate if you wish to present your
public comments. Requests to provide
public comments via a pre-recorded
presentation or a live presentation,
including in-person or virtual
presentations, should be submitted via
email to GDUFARegulatoryScience@
fda.hhs.gov by 11:59 p.m. Eastern Time
on March 8, 2024. We will do our best
to accommodate requests to make public
comments. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
presentations, and request time for a
joint presentation, or submit requests for
designated representatives to participate
in the workshop. Based upon the public
comment presentation requests received
by March 8, 2024, at 11:59 p.m. eastern
time, we will determine the amount of
time allotted to each presenter and the
approximate time each oral presentation
is to begin; we will select and notify
participants by April 1, 2024. If selected
for presentation, any presentation
materials must be emailed to GDUFA
[email protected] no later
than May 10, 2024, 11:59 p.m. eastern
time. No commercial or promotional
material will be permitted to be
presented or distributed at the public
workshop.
Streaming Webcast of the Public
Workshop: This public workshop will
be webcast. Please register online (as
described above) to attend the workshop
remotely (virtually). Registrants will
receive a hyperlink that provides access
to the webcast on both days. Although
FDA verified the website addresses in
this document, please note that websites
are subject to change over time.
Transcripts: Please be advised that as
soon as a video recording and audio
transcript of the public workshop are
available, they will be accessible at
https://www.regulations.gov or via the
Science & Research FDA website
accessible at https://www.fda.gov/drugs/
generic-drugs/science-research. They
may also be available for viewing at the
Dockets Management Staff (see
ADDRESSES).
Dated: February 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–02841 Filed 2–9–24; 8:45 am]
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9857

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0945–0005]

Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.

AGENCY:
ACTION:

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 April 12, 2024.
ADDRESSES: Submit your comments to
[email protected], [email protected],
or by calling (202) 264–0041.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0945–0005 and
project title for reference, to Sherrette A.
Funn, email: [email protected],
[email protected], or call (202) 264–0041
the Reports Clearance Officer.
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.
Title of the Collection: HIPAA Audit
Review Survey.
Type of Collection: Reinstatement,
with Change, of a Previously Approved
Collection OMB No. 0945–0005: Office
for Civil Rights (OCR)—Health
Information Privacy Division.
Abstract: This information collection
consists of 39 online survey questions
that will be sent to 207 covered entities
and business associates that participated
in the 2016–2017 OCR HIPAA Audits.
The survey will gather information
relating to the effect of the audits on the
audited entities and the entities’
opinions about the audit process.
OCR is conducting a review of the
2016–2017 HIPAA Audits to determine
its efficacy in assessing the HIPAA
compliance efforts of covered entities.
SUMMARY:

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Federal Register / Vol. 89, No. 29 / Monday, February 12, 2024 / Notices

As part of that review, the online survey
will be used to:
Measure the effect of the 2016–2017
HIPAA Audits on covered entities’ and
business associates’ subsequent actions
to comply with the HIPAA Rules.
Provide entities with an opportunity
to give feedback on the Audit and its
features, such as the helpfulness of

audit-related documents and to respond
to audit-related requests; and
Seek feedback on the effect of the
HIPAA Audit program on the entities’
day-to-day business operations.
The information, opinions, and
comments collected using the online
survey will be used to improve future
OCR HIPAA Audits.

HHS’ guidance materials and
communications, the utility of the
online submission portal, whether the
Audit helped improve entity
compliance, and the entities’ responses
to the Audit-report findings and
recommendations.
Provide OCR with information on the
burden imposed on entities to collect

ANNUALIZED BURDEN HOUR TABLE
Form name
OCR HIPAA Audit Participant Survey.
OCR HIPAA Audit Participant Survey.
Total ...........................................

1

45/60

124.5

41

1

45/60

30.75

...........................................................

207

........................

........................

155.25

[FR Doc. 2024–02737 Filed 2–9–24; 8:45 am]

National Institutes of Health

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National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Maximizing
Investigators’ Research Award—E Study
Section, March 05, 2024, 8 a.m. to
March 6, 2024, 6 p.m., Center for
Scientific Review, RKL2, 6701
Rockledge Dr, Bethesda, MD, 20817
which was published in the Federal
Register on February 06, 2024, 89 FR
8218, Doc 2024–02265.
This meeting is being amended to
change the meeting start time from 8
a.m. to 9 a.m. The meeting is closed to
the public.
Dated: February 6, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–02775 Filed 2–9–24; 8:45 am]
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Total
burden
hours

166

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

21:06 Feb 09, 2024

Average
burden per
response

Covered Entity Privacy and Security
Officer(s) or Administrators.
Business Associate Privacy and Security Officer(s) or Administrators.

Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.

VerDate Sep<11>2014

Number of
responses per
respondent

Number of
respondents

Respondents

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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.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Investigator Initiated
Extended Clinical Trial (R01 Clinical Trial
Required).
Date: March 8, 2024.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Rockville, MD
20892 (Video Assisted Meeting).
Contact Person: Lindsey M. Pujanandez,
Ph.D., Scientific Review Officer, Immunology
Review Branch, Scientific Review Program,
Division of Extramural Activities, National
Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers
Lane, MSC 9834, Rockville, MD 20852, (240)
627–3206, [email protected].

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(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)
Dated: February 6, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–02773 Filed 2–9–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; 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.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; URGenT: Translational
Efforts to Advance Gene-based Therapies for
Ultra-Rare Neurological and Neuromuscular
Disorders.
Date: February 27, 2024.
Time: 10:00 a.m. to 1:00 p.m.

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