Statement of Organization, Functions, and Delegations of Authority, 84336-84337 [2023-26512]
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84336
Federal Register / Vol. 88, No. 232 / Tuesday, December 5, 2023 / Notices
Number of
respondents
Respondent/data collection activity
Hours per
response
Annual burden
hours
State Formula Grantees, SPR Generic ...........................................................
State Competitive Grants, PPR Generic .........................................................
Tribal Formula Grantees, PPR Generic ..........................................................
Competitive Grantees, PPR Generic ...............................................................
Veteran Organization Competitive Grantees, PPR Generic ...........................
112
56
282
1,189
275
1
2
1
2
12
70.3
1.0
60
10
0.5
7,873.60
112
16,920
23,780
1,650
Total Annual Hours ...................................................................................
........................
........................
........................
50,335.60
Dated: November 30, 2023.
Alison Barkoff,
Principal Deputy Administrator for the
Administration for Community Living,
performing the delegable duties of the
Administrator and the Assistant Secretary for
Aging.
[FR Doc. 2023–26634 Filed 12–4–23; 8:45 am]
BILLING CODE 4154–01–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.
The Food and Drug
Administration’s (FDA), Center for
Biologics Evaluation and Research
(CBER), Office of Blood Research and
Review (OBRR) and the Office of
Vaccines Research and Review (OVRR)
have modified organizational structures.
DATES: These new organizational
structures were approved by the
Secretary of Health and Human Services
on June 27, 2023.
FOR FURTHER INFORMATION CONTACT:
Yashika Rahaman, Director, Office of
Planning, Evaluation and Risk
Management, Office of Finance, Budget,
Acquisitions and Planning, FDA, 4041
Powder Mill Road, Beltsville, MD
20705–4304, 301–796–3843.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Introduction
khammond on DSKJM1Z7X2PROD with NOTICES
Responses
per
respondent
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
revised to reflect FDA’s reorganization
of CBER, OBRR and OVRR.
VerDate Sep<11>2014
16:35 Dec 04, 2023
Jkt 262001
CBER’s mission is to protect and
enhance public health through the
regulation of biological and related
products including blood, vaccines,
allergenics, tissues, and cellular and
gene therapies. With substantial growth
in innovative, novel products, as well as
a need to address an ever-changing
landscape of potential public health
threats, CBER is currently facing
scientific, medical, and regulatory
challenges that require changes to its
structure.
In OBRR, the establishment of a
Laboratory of Pathogen Reduction will
address Center-level initiatives focusing
on the optimization of new pathogen
inactivation technologies. These
technologies can dramatically help the
American public and potentially reduce
or eliminate donor deferral and/or
testing requirements. Additionally, the
proposed structural changes, keeping
OBRR’s functioning state of two
divisions instead of three, will maintain
operational consistency and enable the
divisions to build on processes and
efficiencies gained in the last 2 years.
In OVRR, the Division of Vaccines
and Related Product Applications will
split into the Division of Review
Management and Regulatory Review
and the Division of Clinical and
Toxicology Review to allow for
improved operational efficiency,
appropriate supervisory ratios, and a
better balance of workload within an
area of increased demand.
Under Part D, FDA’s CBER, Office of
Blood Research and Review, has been
restructured as follows:
DCB. ORGANIZATION. CBER is
headed by the Center Director, Center
for Biologics Evaluation and Research.
Center for Biologics Evaluation and
Research (DCB)
Office of Blood Research and Review
(DCBE)
Administrative Staff (DCBE1)
Regulatory Project Management Staff
(DCBE2)
Laboratory of Pathogen Reduction
(DCBE3)
Division of Emerging and Transfusion
Transmitted Diseases (DCBEA)
Laboratory of Molecular Virology
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
(DCBEA1)
Laboratory of Emerging Pathogens
(DCBEA2)
Product Review Branch (DCBEA4)
Laboratory of Emerging Pathogens
(DCBEA2)
Product Review Branch (DCBEA4)
Division of Blood Components and
Devices (DCBEB)
Devices Review Branch (DCBEB2)
Blood and Plasma Branch (DCBEB6)
Laboratory of Cellular Hematology
(DCBEB7)
Laboratory of Biochemistry and
Vascular Biology (DCBEB8)
Under Part D, FDA’s CBER, Office of
Vaccines Research and Review, has
been restructured as follows:
DCB. ORGANIZATION. CBER is
headed by the Center Director, Center
for Biologics Evaluation and Research.
Center for Biologics Evaluation and
Research (DCB)
Office of Vaccines Research and Review
(DCBF)
Program Operations Staff (DCBF1)
Division of Bacterial Parasitic and
Allergenic Products (DCBFA)
Laboratory of ImmunoBiochemistry
(DCBFA1)
Laboratory of Respiratory and Special
Pathogens (DCBFA2)
Laboratory of Bacterial
Polysaccharides (DCBFA3)
Laboratory of Mucosal Pathogens and
Cellular Immunology (DCBFA4)
Division of Viral Products (DCBFB)
Laboratory of Pediatric and
Respiratory Viral Diseases
(DCBFB1)
Laboratory of Hepatitis Viruses
(DCBFB2)
Laboratory of Retroviruses (DCBFB3)
Laboratory of DNA Viruses (DCBFB4)
Laboratory of Vector Borne Diseases
(DCBFB5)
Laboratory of Method Development
(DCBFB6)
Laboratory of Immunoregulation
(DCBFB7)
Division of Review Management and
Regulatory Review (DCBFD)
Regulatory Review Branch 1
(DCBFD1)
Regulatory Review Branch 2
E:\FR\FM\05DEN1.SGM
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Federal Register / Vol. 88, No. 232 / Tuesday, December 5, 2023 / Notices
(DCBFD2) Regulatory Review
Branch 3 (DCBFD3)
Review Management Support Branch
(DCBFD4)
Division of Clinical and Toxicology
Review (DCBFE)
Clinical Review Branch 1 (DCBFE1)
Clinical Review Branch 2 (DCBFE2)
Clinical Review Branch 3 (DCBFE3)
Toxicology Staff (DCBFE4)
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
After completion of the necessary
requirements for implementation, this
reorganization will be reflected in FDA’s
Staff Manual Guide (SMG) at: https://
www.fda.gov/AboutFDA/
ReportsManualsForms/
StaffManualGuides/default.htm.
Authority: 44 U.S.C. 3101.
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2023–26512 Filed 12–4–23; 8:45 am]
BILLING CODE 4164–01–P
FOR FURTHER INFORMATION CONTACT:
Cathryn Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–1394.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), FDA will
award priority review vouchers to
sponsors of approved rare pediatric
disease product applications that meet
certain criteria. FDA has determined
that XENPOZYME (olipudase alfa-rpcp),
manufactured by Genzyme Corporation,
meets the criteria for a priority review
voucher. XENPOZYME (olipudase alfarpcp) is indicated for treatment of noncentral nervous system manifestations
of acid sphingomyelinase deficiency
(ASMD) in adult and pediatric patients.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDisease
PriorityVoucherProgram/default.htm.
For further information about
XENPOZYME (olipudase alfa-rpcp), go
to the ‘‘Drugs@FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: November 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2023–26652 Filed 12–4–23; 8:45 am]
Food and Drug Administration
BILLING CODE 4164–01–P
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act)
authorizes FDA to award priority review
vouchers to sponsors of approved rare
pediatric disease product applications
that meet certain criteria. FDA is
required to publish notice of the award
of priority review voucher. FDA has
determined that XENPOZYME
(olipudase alfa-rpcp), manufactured by
Genzyme Corporation, meets the criteria
for a priority review voucher.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
16:35 Dec 04, 2023
Food and Drug Administration
[Docket No. FDA–2017–N–5569]
Notice.
VerDate Sep<11>2014
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Jkt 262001
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Device Tracking
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
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84337
Submit written comments
(including recommendations) on the
collection of information by January 4,
2024.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0442. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10 a.m.–12 p.m., 11601
Landsdown St., North Bethesda, MD
20852, 301–796–3794, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Medical Devices; Device Tracking—21
CFR Part 821
OMB Control Number 0910–0442—
Extension
Section 519(e)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
360i(e)(1)) provides that FDA may
require by order that a manufacturer
adopt a method for tracking a class II or
III medical device, if the device meets
one of the three following criteria: (1)
the failure of the device would be
reasonably likely to have serious
adverse health consequences, (2) the
device is intended to be implanted in
the human body for more than 1 year
(referred to as a ‘‘tracked implant’’), or
(3) the device is life-sustaining or lifesupporting (referred to as a ‘‘tracked l/
s-l/s device’’) and is used outside a
device user facility. Tracked device
information is collected to facilitate
identifying the current location of
medical devices and patients possessing
those devices, to the extent that patients
permit the collection of identifying
information. Manufacturers and FDA
(where necessary) use the data to: (1)
expedite the recall of distributed
medical devices that are dangerous or
defective and (2) facilitate the timely
notification of patients or licensed
practitioners of the risks associated with
the medical device.
E:\FR\FM\05DEN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 232 (Tuesday, December 5, 2023)]
[Notices]
[Pages 84336-84337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26512]
-----------------------------------------------------------------------
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's (FDA), Center for Biologics
Evaluation and Research (CBER), Office of Blood Research and Review
(OBRR) and the Office of Vaccines Research and Review (OVRR) have
modified organizational structures.
DATES: These new organizational structures were approved by the
Secretary of Health and Human Services on June 27, 2023.
FOR FURTHER INFORMATION CONTACT: Yashika Rahaman, Director, Office of
Planning, Evaluation and Risk Management, Office of Finance, Budget,
Acquisitions and Planning, FDA, 4041 Powder Mill Road, Beltsville, MD
20705-4304, 301-796-3843.
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 revised to reflect FDA's
reorganization of CBER, OBRR and OVRR.
CBER's mission is to protect and enhance public health through the
regulation of biological and related products including blood,
vaccines, allergenics, tissues, and cellular and gene therapies. With
substantial growth in innovative, novel products, as well as a need to
address an ever-changing landscape of potential public health threats,
CBER is currently facing scientific, medical, and regulatory challenges
that require changes to its structure.
In OBRR, the establishment of a Laboratory of Pathogen Reduction
will address Center-level initiatives focusing on the optimization of
new pathogen inactivation technologies. These technologies can
dramatically help the American public and potentially reduce or
eliminate donor deferral and/or testing requirements. Additionally, the
proposed structural changes, keeping OBRR's functioning state of two
divisions instead of three, will maintain operational consistency and
enable the divisions to build on processes and efficiencies gained in
the last 2 years.
In OVRR, the Division of Vaccines and Related Product Applications
will split into the Division of Review Management and Regulatory Review
and the Division of Clinical and Toxicology Review to allow for
improved operational efficiency, appropriate supervisory ratios, and a
better balance of workload within an area of increased demand.
Under Part D, FDA's CBER, Office of Blood Research and Review, has
been restructured as follows:
DCB. ORGANIZATION. CBER is headed by the Center Director, Center
for Biologics Evaluation and Research.
Center for Biologics Evaluation and Research (DCB)
Office of Blood Research and Review (DCBE)
Administrative Staff (DCBE1)
Regulatory Project Management Staff (DCBE2)
Laboratory of Pathogen Reduction (DCBE3)
Division of Emerging and Transfusion Transmitted Diseases (DCBEA)
Laboratory of Molecular Virology (DCBEA1)
Laboratory of Emerging Pathogens (DCBEA2)
Product Review Branch (DCBEA4)
Laboratory of Emerging Pathogens (DCBEA2)
Product Review Branch (DCBEA4)
Division of Blood Components and Devices (DCBEB)
Devices Review Branch (DCBEB2)
Blood and Plasma Branch (DCBEB6)
Laboratory of Cellular Hematology (DCBEB7)
Laboratory of Biochemistry and Vascular Biology (DCBEB8)
Under Part D, FDA's CBER, Office of Vaccines Research and Review,
has been restructured as follows:
DCB. ORGANIZATION. CBER is headed by the Center Director, Center
for Biologics Evaluation and Research.
Center for Biologics Evaluation and Research (DCB)
Office of Vaccines Research and Review (DCBF)
Program Operations Staff (DCBF1)
Division of Bacterial Parasitic and Allergenic Products (DCBFA)
Laboratory of ImmunoBiochemistry (DCBFA1)
Laboratory of Respiratory and Special Pathogens (DCBFA2)
Laboratory of Bacterial Polysaccharides (DCBFA3)
Laboratory of Mucosal Pathogens and Cellular Immunology (DCBFA4)
Division of Viral Products (DCBFB)
Laboratory of Pediatric and Respiratory Viral Diseases (DCBFB1)
Laboratory of Hepatitis Viruses (DCBFB2)
Laboratory of Retroviruses (DCBFB3)
Laboratory of DNA Viruses (DCBFB4)
Laboratory of Vector Borne Diseases (DCBFB5)
Laboratory of Method Development (DCBFB6)
Laboratory of Immunoregulation (DCBFB7)
Division of Review Management and Regulatory Review (DCBFD)
Regulatory Review Branch 1 (DCBFD1)
Regulatory Review Branch 2
[[Page 84337]]
(DCBFD2) Regulatory Review Branch 3 (DCBFD3)
Review Management Support Branch (DCBFD4)
Division of Clinical and Toxicology Review (DCBFE)
Clinical Review Branch 1 (DCBFE1)
Clinical Review Branch 2 (DCBFE2)
Clinical Review Branch 3 (DCBFE3)
Toxicology Staff (DCBFE4)
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
After completion of the necessary requirements for implementation,
this reorganization will be reflected in FDA's Staff Manual Guide (SMG)
at: https://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm.
Authority: 44 U.S.C. 3101.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2023-26512 Filed 12-4-23; 8:45 am]
BILLING CODE 4164-01-P
