Statement of Organization, Functions, and Delegations of Authority
| Court | Food And Drug Administration |
| Citation | 88 FR 55053 |
| Published date | 14 August 2023 |
| Record Number | 2023-17379 |
| Section | Notices |
55053
Federal Register / Vol. 88, No. 155 / Monday, August 14, 2023 / Notices
resembles an in-person advisory
committee meeting.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the Committee. All electronic and
written submissions to the Docket (see
ADDRESSES
) on or before August 18,
2023, will be provided to the
Committee. Oral presentations from the
public will be scheduled on September
7, 2023, between approximately 10:05
a.m. and 10:35 a.m., 1:15 p.m. and 1:45
p.m., and 3:30 p.m. and 4 p.m. Eastern
Time; and on September 8, 2023,
between approximately 10:30 a.m. and
11:30 a.m. Eastern Time. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before August 10, 2023. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by August 11, 2023.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Artair Mallett,
at Artair.Mallett@fda.hhs.gov or 301–
796–9638 at least 7 days in advance of
the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. 1001 et seq.). This meeting notice
also serves as notice that, pursuant to 21
CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the
location of advisory committee meetings
are hereby waived to allow for this
meeting to take place using an online
meeting platform. This waiver is in the
interest of allowing greater transparency
and opportunities for public
participation, in addition to
convenience for advisory committee
members, speakers, and guest speakers.
No participant will be prejudiced by
this waiver, and that the ends of justice
will be served by allowing for this
modification to FDA’s advisory
committee meeting procedures.
Dated: August 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–17287 Filed 8–11–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Statement of Organization, Functions,
and Delegations of Authority
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice.
SUMMARY
: The Food and Drug
Administration (FDA), Center for
Devices and Radiological Health
(CDRH), Office of Strategic Partnerships
and Technology Innovation (OST) has
modified its organizational structure.
DATES
: These new organizations’
structures were approved by the
Secretary of Health and Human Services
on June 27, 2023, and effective on
August 8, 2023.
FOR FURTHER INFORMATION CONTACT
:
Denise Huttenlocker, Associate Director
for Management, Office of Management,
Center for Devices and Radiological
Health, Food and Drug Administration,
Bldg. 66, 10903 New Hampshire Ave.,
Silver Spring, MD 20993, 240–743–
1760.
SUPPLEMENTARY INFORMATION
:
I. Introduction
Part D, Chapter D–B, (Food and Drug
Administration), the Statement of
Organization, Functions and
Delegations of Authority for the
Department of Health and Human
Services (35 FR 3685, February 25,
1970, 60 FR 56606, November 9, 1995,
64 FR 36361, July 6, 1999, 72 FR 50112,
August 30, 2007, 74 FR 41713, August
18, 2009, 76 FR 45270, July 28, 2011,
and 84 FR 22854, May 20, 2019) is
amended to reflect Food and Drug
Administration’s reorganization of
CDRH, OST.
This reorganization changed the OST
organizational structure from an office
with three divisions to an office with
five suboffices each with their own
divisions. The previous divisions were:
the Division of All Hazards Response,
Science and Strategic Partnerships, the
Division of Digital Health, and the
Division of Technology and Data
Services. The OST will elevate the
programs performed by these former
divisions to a super office structure
whereby these divisions are abolished,
and their functions and resources are
realigned across five new OST
suboffices. DCCC. ORGANIZATION.
The Office of Office of Strategic
Partnerships and Technology
Innovation is headed by the Director of
Strategic Partnerships and Technology
Innovation and includes the following
organizational units:
Office of Readiness and Response
Division of All Hazards Preparedness
and Response
Division of Standards and Conformity
Assessment
Division of Medical Device
Cybersecurity
Office of Equity and Innovative
Development
Division of Patient-Centered
Development
Division of Heath Equity
Division of Partnerships and Innovation
Digital Health Center of Excellence
Division of Digital Health Policy
Division of Digital Health Technology
Assessment
Division of Digital Health Outreach
Office of Technology and Data Services
Division of Business Transformation
Delivery
Division of Technology Services
Division of Data Services
Office of Supply Chain Resilience
Division of Prevention, Innovation, and
Resilience
Division of Shortage Assessment and
Product Authentication
II. Delegations of Authority
Pending further delegation, directives,
or orders by the Commissioner of Food
and Drugs, all delegations and
redelegations of authority made to
officials and employees of affected
organizational components will
continue in them or their successors
pending further redelegations, provided
they are consistent with this
reorganization.
III. Electronic Access
This reorganization is reflected in
FDA’s Staff Manual Guide (SMG).
Persons interested in seeing the
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55054
Federal Register / Vol. 88, No. 155 / Monday, August 14, 2023 / Notices
complete SMG can find it on FDA’s
website at: http://www.fda.gov/
AboutFDA/ReportsManualsForms/
StaffManualGuides/default.htm.
(Authority: 44 U.S.C. 3101.)
Dated: August 9, 2023.
Xavier Becerra,
Secretary of Health and Human Services.
[FR Doc. 2023–17379 Filed 8–11–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–4040–0010]
Agency Information Collection
Request; 60-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 October 13, 2023.
ADDRESSES
: Submit your comments to
sagal.musa@hhs.gov or by calling (202)
205–2634.
FOR FURTHER INFORMATION CONTACT
:
When submitting comments or
requesting information, please include
the document identifier 4040–0010–60D
and project title for reference, to Sagal
Musa, email: sagal.musa@hhs.gov, or
call (202) 205–2634 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: Project/
Performance Site Location(s), Project
Abstract, and Key Contacts forms.
Type of Collection: Revision.
OMB No.: 4040–0010.
Abstract: The Project/Performance
Site Location(s), Project Abstract, and
Key Contacts forms provide the Federal
grant-making agencies an alternative to
the Standard Form 424 data set and
form. Agencies may use Project/
Performance Site Location(s), Project
Abstract, and Key Contacts forms for
grant programs not required to collect
all the data that is required on the SF–
424 core data set and form. Project/
Performance Site Location(s), Project
Abstract, and Key Contacts forms are
used by organizations to apply for
Federal financial assistance in the form
of grants. This form is submitted to the
Federal grant-making agencies for
evaluation and review. Previously, 26
Federal grant-making entities were
using this information collection. This
information collection will now be
utilized by 51 Federal grant-making
agencies and additional grant-making
entities. To improve the transparency of
reading and enhance user-friendliness
of the supporting statement A, language
modifications were implemented within
sections 3 through 16. For section 14,
Cost to the Federal Government was
adjusted to the 2023 base general
schedule.Grants.gov is requesting a
revision of this collection to allow for
data reporting and publication by
agencies requesting to use the common
form. The information collection (IC)
expires on November 30, 2025.
Grants.gov seeks a three-year clearance
of these collections.
A
NNUALIZED
B
URDEN
H
OUR
T
ABLE
Forms (if necessary) Respondents (if necessary) Number of
respondents
Number of
responses per
respondents
Average
burden per
response
Total burden
hours
Project/Performance Site
Location(s). Grant Applicants ............................. 127,281 1 1 127,281
Project Abstract .............................. Grant Applicants ............................. 230 1 1 230
Key Contacts .................................. Grant Applicants ............................. 4,566 1 1 4,566
Total ......................................... ......................................................... 132,077 1 1 132,077
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2023–17395 Filed 8–11–23; 8:45 am]
BILLING CODE 4150–AE–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of
Meetings
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of
meetings of the National Advisory
Allergy and Infectious Diseases Council.
This will be a hybrid meeting held in-
person and virtually and will be open to
the public as indicated below.
Individuals who plan to attend in-
person or view the virtual meeting and
need special assistance or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting. The meeting
can be accessed from the NIH Videocast
at the following link: https://
videocast.nih.gov/.
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 Advisory
Allergy and Infectious Diseases Council.
Date: September 11, 2023.
Open: 10:30 a.m. to 11:30 a.m.
Agenda: Report of Institute Acting
Director.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, Conference Room: Grand Hall, 5601
Fishers Lane, MD 20852 (Hybrid Meeting).
Closed: 11:45 a.m. to 12:00 p.m.
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