Statement of Organization, Functions, and Delegations of Authority, 45270-45271 [2011-19111]
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45270
Federal Register / Vol. 76, No. 145 / Thursday, July 28, 2011 / Notices
includes the following organizational
units that report to the Commissioner:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0013]
Statement of Organization, Functions,
and Delegations of Authority
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has conducted a
reorganization to modify its structure, to
align similar functions under common
executive leadership, and to reduce and
change the reporting relationships to the
Agency head. The reorganization creates
four ‘‘directorates’’ within which most
of FDA’s activities will reside—
Administrative operations, food and
veterinary medicine, medical products
and tobacco, and foreign and domestic
regulatory operations. However, this
restructuring will not change the basic
form of FDA’s programs, which will
continue to reside in the Agency’s seven
operating Centers and the Office of
Regulatory Affairs. It is intended to
provide a more efficient span of control
for executive leadership and to organize
like activities together, not to change the
essential programmatic activities under
which FDA implements the Federal
Food, Drug, and Cosmetic Act.
FOR FURTHER INFORMATION CONTACT:
Kimberly A. Holden, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4239, Silver Spring,
MD 20993–0002, 301–796–4750.
SUMMARY:
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I. Summary
Part D, Chapter D–B (Food and Drug
Administration), Statement of
Organization, Functions and
Delegations of Authority for the
Department of Health and Human
Services (35 FR 3685, February 25,
1970, and 60 FR 56605, November 9,
1995, 64 FR 36361, July 6, 1999, 72 FR
50112, August 30, 2007, 74 FR 41713,
August 18, 2009) is amended to reflect
the restructuring of the Office of the
Commissioner and other components,
FDA that was approved by the Secretary
of Health and Human Services on July
8, 2011 as follows. This reorganization
is explained in Staff Manual Guide
1111.1, 1118.1, 1140.1, 1114.1, 1117.1,
1160.1, 1180.1, and 1115.1.
Under Part D, FDA, the Office of the
Commissioner has been restructured as
follows:
DA. ORGANIZATION—FDA is
headed by the Commissioner of Food
and Drugs (the Commissioner) and
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Office of the Commissioner
Office of the Counselor to the Commissioner
Office of Legislation
Office of Policy and Planning
Office of External Affairs
Office of the Chief Scientist
Office of Operations
Office of Foods
Office of Medical Products and Tobacco
Office of Global Regulatory Operations and
Policy
Office of Women’s Health
Office of Minority Health
The following organizations remain
substantively unchanged: Center for
Veterinary Medicine, Center for Food
Safety and Applied Nutrition, Center for
Devices and Radiological Health, Center
for Drug Evaluation and Research,
Center for Biologics Evaluation and
Research, Center for Tobacco Products,
National Center for Toxicological
Research, Office of Regulatory Affairs,
Office of International Programs, and
Office of Special Medical Programs.
However, some organizations will
have different reporting relationships
under the new organizational structure,
as follows:
Office of the Commissioner
Headed by the Commissioner, the
Office of the Commissioner will be
comprised of the Office of the Counselor
to the Commissioner, the Office of
Legislation, the Office of Policy and
Planning, the Office of External Affairs,
the Office of the Chief Scientist, the
Office of Women’s Health, and the
Office of Minority Health. Those offices
will remain unchanged, with the
exception of the realignment of
functions of the Office of Budget from
the Office of Policy, Planning and
Budget (OPPB) to the Office of
Operations, and the renaming of OPPB
to the Office of Policy and Planning.
The administrative functions that were
formerly within the Office of the
Commissioner will be relocated to the
new Office of Operations. Although the
National Center for Toxicological
Research will remain unchanged as an
operating Center, the Chief Scientist
will assume direct line authority over
the Center.
Office of Operations
Directed by a Chief Operating Officer
(COO), the Office of Operations will
assume the functions previously
overseen by the Deputy Commissioner
for Administration. The COO will, on
behalf of the Commissioner, have
Agency-wide authority for strengthening
the management of business programs
and operations of the Agency. The COO
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oversees day-to-day management issues,
effective implementation of
Congressional and Commissioner
priorities and initiatives, and the
delivery of quality services by the
Agency and its Centers. Under this new
structure, the COO will have direct line
authority over the Office of Information
Management, the Office of Management,
the Office of Equal Employment
Opportunity, and a new Office of
Finance, Budget and Acquisition (which
will receive the Office of Budget from
the former Office of Policy, Planning
and Budget). The Offices overseen by
the COO were previously located within
the Office of the Commissioner.
Office of Foods
This office, headed by a Deputy
Commissioner for Foods is unchanged.
The Center for Veterinary Medicine and
Center for Food Safety and Applied
Nutrition remain within this Office and
are unchanged. This Deputy
Commissioner will continue the goal
established in the 2009 creation of this
Office to integrate all of FDA’s foodrelated functions into one seamless
enterprise, as well as provide executive
direction to the two Centers under the
Deputy Commissioner’s direction.
Office of Medical Products and Tobacco
This new Office will be comprised of
four Centers that previously reported
directly to the Commissioner—the
Center for Devices and Radiological
Health, the Center for Biologics
Evaluation and Research, the Center for
Drug Evaluation and Research, and the
Center for Tobacco Products. Directed
by the Deputy Commissioner for
Medical Products and Tobacco, it will
also oversee the Office of Special
Medical Programs, which contains four
Offices that were previously in the
Office of the Commissioner (the Office
of Orphan Product Development, the
Office of Pediatric Therapeutics, the
Office of Combination Products, and the
Office of Good Clinical Practice). The
newly created position of Deputy
Commissioner for Medical Products and
Tobacco will have direct line authority
over the four medical product Centers
and the special medical programs and,
as such, will provide advice and
counsel to the Commissioner on all FDA
medical product and tobacco-related
programs and issues. The Centers and
special medical programs remain
unchanged in this reorganization.
Office of Global Regulatory Operations
and Policy
This new office, directed by a Deputy
Commissioner for Global Regulatory
Operations and Policy, will be
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Federal Register / Vol. 76, No. 145 / Thursday, July 28, 2011 / Notices
comprised of two existing organizations
that will otherwise remain unchanged—
the Office of Regulatory Affairs and the
Office of International Programs. In
addition to exercising direct line
authority over those two existing
Offices, this new Deputy Commissioner
will provide executive oversight,
strategic leadership, and policy
direction to FDA’s domestic and
international product quality and safety
efforts, including global collaboration,
global data-sharing, development and
harmonization of standards, field
operations, compliance, and
enforcement activities.
II. Delegations of Authority
Pending further delegation, directives,
or orders by the Commissioner, 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
Persons interested in seeing the
complete Staff Manual Guide can find it
on FDA’s Web site at: https://
www.fda.gov/AboutFDA/
ReportsManualsForms/
StaffManualGuides/default.htm
Dated: July 25, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2011–19111 Filed 7–27–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Review and Qualification of Clinical
Outcome Assessments; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) is announcing a
public workshop to discuss
measurement principles for clinical
outcome assessments (COAs) for use in
clinical trials for new drugs. COAs
include patient-reported outcome (PRO)
measures, clinician-reported outcome
(ClinRO) measures, and observerreported outcome (ObsRO) measures.
This public workshop is intended to
provide information for and gain
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SUMMARY:
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perspectives from patient advocates,
health care providers, researchers,
regulators, individuals from academia,
industry, and other interested persons
on various aspects of the development
and implementation of COAs in the
evaluation of treatment benefit.
Regulatory review issues regarding
context of use and documentation of the
measurement properties of a COA will
be covered during panel discussions.
The input from this public workshop
will be published in the form of a white
paper or a series of manuscripts.
DATES: Date and Time: The public
workshop will be held on October 19,
2011, from 8:30 a.m. to 5 p.m.
Participants are encouraged to arrive
early to ensure time for parking and
routine security check before the
workshop.
Location: The public workshop will
be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(rm. 1503), Silver Spring, MD 20993–
0002. Entrance for the public meeting
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm. Attendees are
responsible for their own
accommodations.
The public workshop will also be
available to be viewed online via Web
cast at https://collaboration.fda.gov/
coaworkshop/. Persons interested in
participating by Web cast must register
online by October 17, 2011.
Contact Person: Shauna Shupe,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, rm. 6417, Silver Spring,
MD 20993–0002, 301–796–0900, e-mail:
Shauna.Shupe@fda.hhs.gov.
Registration: Registration is free for
the public workshop. Interested parties
are encouraged to register early because
space is limited to 150 attendees.
Workshop space will be filled in order
of receipt of registration. Those accepted
into the workshop will receive
confirmation. Registration will close
after the workshop is filled. Registration
at the site is not guaranteed but may be
possible on a space available basis on
the day of the public workshop
beginning at 7:30 a.m.
To register electronically, e-mail
registration information (including
name, title, firm name, address,
telephone, and FAX number) to
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45271
COAworkshop@fda.hhs.gov. For those
without Internet access, please call
Shauna Shupe (see Contact Person) to
register.
If you need special accommodations
due to a disability, please contact
Shauna Shupe at least 7 days in
advance.
The
Center for Drug Evaluation and Research
(CDER) reviews COAs including PRO
measures, (ClinRO) measures, and
ObsRO measures when submitted with
an investigational new drug application,
a new drug application, or a biologics
licensing application. The FDA
guidance for industry entitled ‘‘PatientReported Outcome Measures: Use in
Medical Product Development to
Support Labeling Claims,’’ available at
https://www.fda.gov/downloads/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
UCM193282.pdf, explains how FDA
reviews PRO measures.
CDER also reviews a COA when
submitted for qualification as a drug
development tool (DDT). Qualification
of a COA is a regulatory determination
that the COA is well-suited for a specific
context of use in drug development.
Following a public announcement of the
qualification decision by FDA, the COA
will be publicly available for use in any
appropriate drug development program.
Because the qualification process is
separate from the drug marketing
application process, qualification is
conducive to public-private
partnerships engaging in this COA
development effort. Such collaborative
approaches may increase the efficiency
of COA development when more than
one entity is interested in the use of a
COA for a specific context of use. The
FDA draft guidance for industry entitled
‘‘Qualification Process for Drug
Development Tools,’’ available at
https://www.fda.gov/downloads/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
UCM230597.pdf, provides the draft
process for CDER participation in the
consultation, advice, and qualification
review for COAs and other DDTs.
This workshop will focus on FDA
review principles specific to all type of
COAs, i.e., PRO, ClinRO, and ObsRO
measures. More specifically, the
workshop will provide researchers
involved in the drug development
process with information on the
following topics concerning FDA review
of COAs for treatment benefit
evaluation:
• COA measurement principles;
• COA nomenclature;
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 76, Number 145 (Thursday, July 28, 2011)]
[Notices]
[Pages 45270-45271]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19111]
[[Page 45270]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0013]
Statement of Organization, Functions, and Delegations of
Authority
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has conducted a
reorganization to modify its structure, to align similar functions
under common executive leadership, and to reduce and change the
reporting relationships to the Agency head. The reorganization creates
four ``directorates'' within which most of FDA's activities will
reside--Administrative operations, food and veterinary medicine,
medical products and tobacco, and foreign and domestic regulatory
operations. However, this restructuring will not change the basic form
of FDA's programs, which will continue to reside in the Agency's seven
operating Centers and the Office of Regulatory Affairs. It is intended
to provide a more efficient span of control for executive leadership
and to organize like activities together, not to change the essential
programmatic activities under which FDA implements the Federal Food,
Drug, and Cosmetic Act.
FOR FURTHER INFORMATION CONTACT: Kimberly A. Holden, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4239, Silver
Spring, MD 20993-0002, 301-796-4750.
I. Summary
Part D, Chapter D-B (Food and Drug Administration), Statement of
Organization, Functions and Delegations of Authority for the Department
of Health and Human Services (35 FR 3685, February 25, 1970, and 60 FR
56605, November 9, 1995, 64 FR 36361, July 6, 1999, 72 FR 50112, August
30, 2007, 74 FR 41713, August 18, 2009) is amended to reflect the
restructuring of the Office of the Commissioner and other components,
FDA that was approved by the Secretary of Health and Human Services on
July 8, 2011 as follows. This reorganization is explained in Staff
Manual Guide 1111.1, 1118.1, 1140.1, 1114.1, 1117.1, 1160.1, 1180.1,
and 1115.1.
Under Part D, FDA, the Office of the Commissioner has been
restructured as follows:
DA. ORGANIZATION--FDA is headed by the Commissioner of Food and
Drugs (the Commissioner) and includes the following organizational
units that report to the Commissioner:
Office of the Commissioner
Office of the Counselor to the Commissioner
Office of Legislation
Office of Policy and Planning
Office of External Affairs
Office of the Chief Scientist
Office of Operations
Office of Foods
Office of Medical Products and Tobacco
Office of Global Regulatory Operations and Policy
Office of Women's Health
Office of Minority Health
The following organizations remain substantively unchanged: Center
for Veterinary Medicine, Center for Food Safety and Applied Nutrition,
Center for Devices and Radiological Health, Center for Drug Evaluation
and Research, Center for Biologics Evaluation and Research, Center for
Tobacco Products, National Center for Toxicological Research, Office of
Regulatory Affairs, Office of International Programs, and Office of
Special Medical Programs.
However, some organizations will have different reporting
relationships under the new organizational structure, as follows:
Office of the Commissioner
Headed by the Commissioner, the Office of the Commissioner will be
comprised of the Office of the Counselor to the Commissioner, the
Office of Legislation, the Office of Policy and Planning, the Office of
External Affairs, the Office of the Chief Scientist, the Office of
Women's Health, and the Office of Minority Health. Those offices will
remain unchanged, with the exception of the realignment of functions of
the Office of Budget from the Office of Policy, Planning and Budget
(OPPB) to the Office of Operations, and the renaming of OPPB to the
Office of Policy and Planning. The administrative functions that were
formerly within the Office of the Commissioner will be relocated to the
new Office of Operations. Although the National Center for
Toxicological Research will remain unchanged as an operating Center,
the Chief Scientist will assume direct line authority over the Center.
Office of Operations
Directed by a Chief Operating Officer (COO), the Office of
Operations will assume the functions previously overseen by the Deputy
Commissioner for Administration. The COO will, on behalf of the
Commissioner, have Agency-wide authority for strengthening the
management of business programs and operations of the Agency. The COO
oversees day-to-day management issues, effective implementation of
Congressional and Commissioner priorities and initiatives, and the
delivery of quality services by the Agency and its Centers. Under this
new structure, the COO will have direct line authority over the Office
of Information Management, the Office of Management, the Office of
Equal Employment Opportunity, and a new Office of Finance, Budget and
Acquisition (which will receive the Office of Budget from the former
Office of Policy, Planning and Budget). The Offices overseen by the COO
were previously located within the Office of the Commissioner.
Office of Foods
This office, headed by a Deputy Commissioner for Foods is
unchanged. The Center for Veterinary Medicine and Center for Food
Safety and Applied Nutrition remain within this Office and are
unchanged. This Deputy Commissioner will continue the goal established
in the 2009 creation of this Office to integrate all of FDA's food-
related functions into one seamless enterprise, as well as provide
executive direction to the two Centers under the Deputy Commissioner's
direction.
Office of Medical Products and Tobacco
This new Office will be comprised of four Centers that previously
reported directly to the Commissioner--the Center for Devices and
Radiological Health, the Center for Biologics Evaluation and Research,
the Center for Drug Evaluation and Research, and the Center for Tobacco
Products. Directed by the Deputy Commissioner for Medical Products and
Tobacco, it will also oversee the Office of Special Medical Programs,
which contains four Offices that were previously in the Office of the
Commissioner (the Office of Orphan Product Development, the Office of
Pediatric Therapeutics, the Office of Combination Products, and the
Office of Good Clinical Practice). The newly created position of Deputy
Commissioner for Medical Products and Tobacco will have direct line
authority over the four medical product Centers and the special medical
programs and, as such, will provide advice and counsel to the
Commissioner on all FDA medical product and tobacco-related programs
and issues. The Centers and special medical programs remain unchanged
in this reorganization.
Office of Global Regulatory Operations and Policy
This new office, directed by a Deputy Commissioner for Global
Regulatory Operations and Policy, will be
[[Page 45271]]
comprised of two existing organizations that will otherwise remain
unchanged--the Office of Regulatory Affairs and the Office of
International Programs. In addition to exercising direct line authority
over those two existing Offices, this new Deputy Commissioner will
provide executive oversight, strategic leadership, and policy direction
to FDA's domestic and international product quality and safety efforts,
including global collaboration, global data-sharing, development and
harmonization of standards, field operations, compliance, and
enforcement activities.
II. Delegations of Authority
Pending further delegation, directives, or orders by the
Commissioner, 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
Persons interested in seeing the complete Staff Manual Guide can
find it on FDA's Web site at: https://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm
Dated: July 25, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-19111 Filed 7-27-11; 8:45 am]
BILLING CODE 4160-01-P
