Statement of Organization, Functions, and Delegations of Authority, 5549-5550 [2024-01613]
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Federal Register / Vol. 89, No. 19 / Monday, January 29, 2024 / Notices
manufacturer price exceeds the
inflation-adjusted payment amount.
Section 1860D–14B(g)(1)(A) of the Act
defines a ‘‘Part D rebatable drug,’’ in
part, as a drug or biological described at
section 1860D–14B(g)(1)(C) that is a
‘‘covered Part D drug’’ as that term is
defined in section 1860D–2(e) of the
Act. The definition of a Part D rebatable
drug includes generic drugs that meet
certain statutory criteria (effectively sole
source generics). The definition of a Part
D rebatable drug does not include a drug
or biological if, as determined by the
Secretary, the ‘‘average annual total
cost’’ for such drug or biological under
Part D for a year per individual that uses
such a drug or biological is less than the
applicable threshold.
Sections 1847A(i)(3)(G)(ii) and
1860D–14B(b)(1)(C)(ii) of the Act
require that CMS reduce or waive the
inflation rebate amount owed (if any) for
a Part B rebatable biosimilar biological
product and generic Part D rebatable
drug or biosimilar when CMS
determines there is a severe supply
chain disruption during a calendar
quarter or applicable period,
respectively, such as that caused by a
natural disaster or other unique or
unexpected event. CMS must also
reduce or waive the inflation rebate
amount owed (if any) for a generic Part
D rebatable drug if CMS determines that
without such reduction or waiver, the
drug is likely to be in shortage in a
subsequent applicable period, as
required by section 1860D–
14B(b)(1)(C)(iii) of the Act.
CMS does not have information
necessary to determine whether
manufacturers of Part B and Part D
rebatable drugs should have their rebate
amount reduced due to either a severe
supply chain disruption or a likely
shortage as required by sections
1847A(i)(3)(G)(ii), 1860D–
14B(b)(1)(C)(ii), and 1860D–
14B(b)(1)(C)(iii) of the Act. Some of the
information and supporting
documentation needed for CMS to make
a determination regarding a severe
supply chain disruption and the
likelihood of a future shortage are held
by manufacturers and are not available
to CMS. As such, for CMS to determine
whether there is a severe supply chain
disruption or likelihood of future
shortage, in accordance with sections
1847A(i)(3)(G)(ii), 1860D–
14B(b)(1)(C)(ii), and 1860D–
14B(b)(1)(C)(iii) of the Act, a
manufacturer must submit to CMS a
request for a rebate reduction along with
supporting documentation. Form
Number: CMS–10858 (OMB control
number: 0938–New); Frequency: Once;
Affected Public: Private sector and
VerDate Sep<11>2014
18:33 Jan 26, 2024
Jkt 262001
business or other for-profits; Number of
Respondents: 10; Total Annual
Responses: 20; Total Annual Hours:
620. (For policy questions regarding this
collection contact Elisabeth Daniel at
667–290–8793.)
2. Type of Information Collection
Request: Extension of currently
approved collection; Title of
Information Collection: Identifying
Medicaid Payment for Physician
Administered Drugs; Use: States are
required to provide for the collection
and submission of utilization data for
certain physician-administered drugs in
order to receive Federal financial
participation for these drugs.
Physicians, serving as respondents to
States, submit National Drug Code
numbers and utilization information for
‘‘J’’ code physician-administered drugs
so that the States will have sufficient
information to collect drug rebate
dollars. Form Number: CMS–10215
(OMB control number: 0938–1026);
Frequency: Weekly; Affected Public:
Business or other for-profits and not-forprofit institutions); Number of
Respondents: 26,000; Total Annual
Responses: 39,053,932; Total Annual
Hours: 162,074. (For policy questions
regarding this collection contact
Michael Forman at 410–786–2666.)
2. Type of Information Collection
Request: Revision with change of a
currently approved collection; Title of
Information Collection: Application to
be a Qualified Entity to Receive
Medicare Data for Performance
Measurement/Reapplication/Annual
Report Worksheet; Use: The Patient
Protection and Affordable Care Act
(ACA) was enacted on March 23, 2010
(Pub. L. 111–148). ACA amends section
1874 of the Social Security Act by
adding a new subsection (e) to make
standardized extracts of Medicare
claims data under Parts A, B, and D
available to QEs to evaluate the
performance of providers of services
and suppliers. This is the Application,
Reapplication, and ARW which
provides CMS with the information it
needs to determine whether an
organization earns approval and
continues as a QE.
CMS established the Qualified Entity
Certification Program (QECP) to
evaluate an organization’s eligibility
across three areas: (1) organizational and
governance capabilities, (2) addition of
claims data from other sources (as
required in the statute), and (3) data
privacy and security. QE certification
lasts for 3 years. Organizations that are
interested in remaining in the QE
program must submit a Reapplication
that is reviewed and approved by QECP.
In addition, each year QEs must submit
PO 00000
Frm 00070
Fmt 4703
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5549
an annual report to QECP that provides
information required by statute. Form
Number: CMS–10394 (OMB control
number: 0938–1144); Frequency: Yearly;
Affected Public: Business or other forprofits; Number of Respondents: 40;
Total Annual Responses: 210; Total
Annual Hours: 17,400. (For policy
questions regarding this collection
contact Kari Gaare at kari.gaare@
cms.hhs.gov).
Dated: January 24, 2024.
William N. Parham, III
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–01723 Filed 1–26–24; 8:45 am]
BILLING CODE 4120–01–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 (FDA), Center for Drug
Evaluation and Research (CDER), Office
of Pharmaceutical Quality (OPQ) has
modified its organizational structure.
This new structure was approved by the
Secretary of Health and Human Services
on August 10, 2023.
FOR FURTHER INFORMATION CONTACT:
Michael Kopcha, Director, Office of
Pharmaceutical Quality, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 240–402–2461.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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 reorganization of
CDER, OPQ.
This reorganization changed the OPQ
organizational structure from an office
with nine suboffices to 10 suboffices.
The former offices with divisions and
branches had their branches abolished
and the branch functions and resources
E:\FR\FM\29JAN1.SGM
29JAN1
ddrumheller on DSK120RN23PROD with NOTICES1
5550
Federal Register / Vol. 89, No. 19 / Monday, January 29, 2024 / Notices
were realigned to their respective
divisions.
The OPQ retitled four of its suboffices
and retitled the majority of its divisions.
The OPQ will establish the Office of
Quality Assurance and within it
established the Quality Assurance Staff,
Learning and Professional Staff, and the
Project Management Staff.
FDA, CDER, OPQ has been
restructured as follows:
DCDL. ORGANIZATION. The Office
of Pharmaceutical Quality is headed by
the Director of Pharmaceutical Quality
and includes the following
organizational units:
Office of Pharmaceutical Quality
(DCDL)
Office of Product Quality Assessment I
(DCDLH)
Division of Product Quality
Assessment I (DCDLHA)
Division of Product Quality
Assessment II (DCDLHB)
Division of Product Quality
Assessment III (DCDLHC)
Division of Product Quality
Assessment IV (DCDLHD)
Division of Product Quality
Assessment V (DCDLHE)
Division of Product Quality
Assessment VI (DCDLHF)
Office of Product Quality Assessment II
(DCDLB)
Division of Product Quality
Assessment VII (DCDLBA)
Division of Product Quality
Assessment VIII (DCDLBB)
Division of Product Quality
Assessment IX (DCDLBC)
Division of Product Quality
Assessment X (DCDLBD)
Division of Product Quality
Assessment XI (DCDLBE)
Division of Product Quality
Assessment XII (DCDLBF)
Office of Product Quality Assessment III
(DCDLA)
Division of Product Quality
Assessment XIII (DCDLAA)
Division of Product Quality
Assessment XIV (DCDLAB)
Division of Product Quality
Assessment XV (DCDLAC)
Division of Product Quality
Assessment XVI (DCDLAD)
Division of Product Quality
Assessment XVII (DCDLAE)
Division of Product Quality
Assessment XVIII (DCDLAF)
Division of Product Quality
Assessment XIX (DCDLAG)
Office of Pharmaceutical Manufacturing
Assessment (DCDLD)
Division of Pharmaceutical
Manufacturing Assessment I
(DCDLDA)
Division of Pharmaceutical
VerDate Sep<11>2014
18:33 Jan 26, 2024
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Manufacturing Assessment II
(DCDLDB)
Division of Pharmaceutical
Manufacturing Assessment III
(DCDLDC)
Division of Pharmaceutical
Manufacturing Assessment IV
(DCDLDD)
Division of Pharmaceutical
Manufacturing Assessment V
(DCDLDE)
Division of Pharmaceutical
Manufacturing Assessment VI
(DCDLDF)
Office of Program and Regulatory
Operations (DCDLG)
Division of Regulatory & Business
Process Management I (DCDLGA)
Division of Regulatory & Business
Process Management II (DCDLGB)
Division of Regulatory & Business
Process Management III (DCDLGC)
Division of Regulatory & Business
Process Management IV (DCDLGD)
Office of Pharmaceutical Quality
Research (DCDLF)
Division of Pharmaceutical Quality
Research I (DCDLFA)
Division of Pharmaceutical Quality
Research II (DCDLFB)
Division of Pharmaceutical Quality
Research III (DCDLFC)
Division of Pharmaceutical Quality
Research IV (DCDLFD)
Division of Pharmaceutical Quality
Research V (DCDLFE)
Division of Pharmaceutical Quality
Research VI (DCDLFF)
Office of Policy for Pharmaceutical
Quality (DCDLC)
Compendial Operations and
Standards Staff (DCDLCA)
Division of Regulations and Guidance
(DCDLCB)
Division of Internal Policy and
Communication (DCDLCC)
Division of Editorial and Project
Management (DCDLCD)
Office of Quality Assurance (DCDLJ)
Quality Assurance Staff (DCDLJ1)
Learning and Professional
Development Staff (DCDLJ2)
Enterprise Project Management Staff
(DCDLJ3)
Office of Quality Surveillance (DCDLE)
Division of Quality Intelligence I
(DCDLEB)
Division of Quality Intelligence II
(DCDLEC)
Division of Quality Intelligence III
(DCDLED)
Office of Administrative Operations
(DCDLI)
Administrative Analysis Staff
(DCDLI1)
Administrative Operations Staff 1
(DCDLI2)
Administrative Operations Staff 2
(DCDLI3)
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Frm 00071
Fmt 4703
Sfmt 4703
Administrative Operations Staff 3
(DCDLI4)
Administrative Operations Staff 4
(DCDLI5)
Financial Services Staff (DCDLI6)
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
complete SMG can find it on FDA’s
website at: https://www.fda.gov/
AboutFDA/ReportsManualsForms/
StaffManualGuides/default.htm.
(Authority: 44 U.S.C. 3101).
Xavier Becerra,
Secretary of Health and Human Services.
[FR Doc. 2024–01613 Filed 1–26–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request
Collection of Grants and Contracts
Data the Historically Black Colleges and
Universities (HBCUs) and Small
Businesses May Be Interested in
Pursuing (Office of the Director)
AGENCY: National Institutes of Health,
HHS.
ACTION: Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH),
Office of the Director, Office of
Acquisitions and Logistics Management
(OALM), Small Business Program Office
(SBPO), has submitted to the Office of
Management and Budget (OMB) a
request for review and approval of the
information collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
SUMMARY:
Written comments and
recommendations for the proposed
information collection should be sent
ADDRESSES:
E:\FR\FM\29JAN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 19 (Monday, January 29, 2024)]
[Notices]
[Pages 5549-5550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01613]
-----------------------------------------------------------------------
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 Drug
Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ)
has modified its organizational structure. This new structure was
approved by the Secretary of Health and Human Services on August 10,
2023.
FOR FURTHER INFORMATION CONTACT: Michael Kopcha, Director, Office of
Pharmaceutical Quality, Center for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD
20993, 240-402-2461.
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
reorganization of CDER, OPQ.
This reorganization changed the OPQ organizational structure from
an office with nine suboffices to 10 suboffices. The former offices
with divisions and branches had their branches abolished and the branch
functions and resources
[[Page 5550]]
were realigned to their respective divisions.
The OPQ retitled four of its suboffices and retitled the majority
of its divisions. The OPQ will establish the Office of Quality
Assurance and within it established the Quality Assurance Staff,
Learning and Professional Staff, and the Project Management Staff.
FDA, CDER, OPQ has been restructured as follows:
DCDL. ORGANIZATION. The Office of Pharmaceutical Quality is headed
by the Director of Pharmaceutical Quality and includes the following
organizational units:
Office of Pharmaceutical Quality (DCDL)
Office of Product Quality Assessment I (DCDLH)
Division of Product Quality Assessment I (DCDLHA)
Division of Product Quality Assessment II (DCDLHB)
Division of Product Quality Assessment III (DCDLHC)
Division of Product Quality Assessment IV (DCDLHD)
Division of Product Quality Assessment V (DCDLHE)
Division of Product Quality Assessment VI (DCDLHF)
Office of Product Quality Assessment II (DCDLB)
Division of Product Quality Assessment VII (DCDLBA)
Division of Product Quality Assessment VIII (DCDLBB)
Division of Product Quality Assessment IX (DCDLBC)
Division of Product Quality Assessment X (DCDLBD)
Division of Product Quality Assessment XI (DCDLBE)
Division of Product Quality Assessment XII (DCDLBF)
Office of Product Quality Assessment III (DCDLA)
Division of Product Quality Assessment XIII (DCDLAA)
Division of Product Quality Assessment XIV (DCDLAB)
Division of Product Quality Assessment XV (DCDLAC)
Division of Product Quality Assessment XVI (DCDLAD)
Division of Product Quality Assessment XVII (DCDLAE)
Division of Product Quality Assessment XVIII (DCDLAF)
Division of Product Quality Assessment XIX (DCDLAG)
Office of Pharmaceutical Manufacturing Assessment (DCDLD)
Division of Pharmaceutical Manufacturing Assessment I (DCDLDA)
Division of Pharmaceutical Manufacturing Assessment II (DCDLDB)
Division of Pharmaceutical Manufacturing Assessment III (DCDLDC)
Division of Pharmaceutical Manufacturing Assessment IV (DCDLDD)
Division of Pharmaceutical Manufacturing Assessment V (DCDLDE)
Division of Pharmaceutical Manufacturing Assessment VI (DCDLDF)
Office of Program and Regulatory Operations (DCDLG)
Division of Regulatory & Business Process Management I (DCDLGA)
Division of Regulatory & Business Process Management II (DCDLGB)
Division of Regulatory & Business Process Management III (DCDLGC)
Division of Regulatory & Business Process Management IV (DCDLGD)
Office of Pharmaceutical Quality Research (DCDLF)
Division of Pharmaceutical Quality Research I (DCDLFA)
Division of Pharmaceutical Quality Research II (DCDLFB)
Division of Pharmaceutical Quality Research III (DCDLFC)
Division of Pharmaceutical Quality Research IV (DCDLFD)
Division of Pharmaceutical Quality Research V (DCDLFE)
Division of Pharmaceutical Quality Research VI (DCDLFF)
Office of Policy for Pharmaceutical Quality (DCDLC)
Compendial Operations and Standards Staff (DCDLCA)
Division of Regulations and Guidance (DCDLCB)
Division of Internal Policy and Communication (DCDLCC)
Division of Editorial and Project Management (DCDLCD)
Office of Quality Assurance (DCDLJ)
Quality Assurance Staff (DCDLJ1)
Learning and Professional Development Staff (DCDLJ2)
Enterprise Project Management Staff (DCDLJ3)
Office of Quality Surveillance (DCDLE)
Division of Quality Intelligence I (DCDLEB)
Division of Quality Intelligence II (DCDLEC)
Division of Quality Intelligence III (DCDLED)
Office of Administrative Operations (DCDLI)
Administrative Analysis Staff (DCDLI1)
Administrative Operations Staff 1 (DCDLI2)
Administrative Operations Staff 2 (DCDLI3)
Administrative Operations Staff 3 (DCDLI4)
Administrative Operations Staff 4 (DCDLI5)
Financial Services Staff (DCDLI6)
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 complete SMG can find it on FDA's
website at: https://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm.
(Authority: 44 U.S.C. 3101).
Xavier Becerra,
Secretary of Health and Human Services.
[FR Doc. 2024-01613 Filed 1-26-24; 8:45 am]
BILLING CODE 4164-01-P
