Revision of Organization and Conforming Changes to Regulations, 14720-14725 [E9-7349]
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14720
Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations
Examining the AD Docket
Regulatory Findings
You may examine the AD docket on
the Internet at https://
www.regulations.gov; or in person at the
Docket Operations office between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket
contains this AD, the regulatory
evaluation, any comments received, and
other information. The street address for
the Docket Operations office (telephone
(800) 647–5527) is provided in the
ADDRESSES section. Comments will be
available in the AD docket shortly after
receipt.
We have determined that this AD will
not have federalism implications under
Executive Order 13132. This AD will
not have a substantial direct effect on
the States, on the relationship between
the national government and the States,
or on the distribution of power and
responsibilities among the various
levels of government.
For the reasons discussed above, I
certify that this AD:
(1) Is not a ‘‘significant regulatory
action’’ under Executive Order 12866;
(2) Is not a ‘‘significant rule’’ under
DOT Regulatory Policies and Procedures
(44 FR 11034, February 26, 1979); and
(3) Will not have a significant
economic impact, positive or negative,
on a substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
We prepared a summary of the costs
to comply with this AD and placed it in
the AD Docket. You may get a copy of
this summary at the address listed
under ADDRESSES.
Comments
We provided the public the
opportunity to participate in the
development of this AD. We have
considered the comment received. The
commenter supports the proposal.
Conclusion
We have carefully reviewed the
available data, including the comment
received, and determined that air safety
and the public interest require adopting
the AD as proposed.
Costs of Compliance
We estimate that this AD will affect
10 engines installed on airplanes of U.S.
registry. We also estimate that it will
take about 110 work-hours per engine to
perform the actions, and that the
average labor rate is $80 per work-hour.
Required parts will cost about $437,000
per engine. Based on these figures, we
estimate the total cost of the AD to U.S.
operators to be $4,458,000.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Safety.
Adoption of the Amendment
Accordingly, under the authority
delegated to me by the Administrator,
the Federal Aviation Administration
amends 14 CFR part 39 as follows:
■
PART 39—AIRWORTHINESS
DIRECTIVES
1. The authority citation for part 39
continues to read as follows:
■
Authority for This Rulemaking
Authority: 49 U.S.C. 106(g), 40113, 44701.
Title 49 of the United States Code
specifies the FAA’s authority to issue
rules on aviation safety. Subtitle I,
Section 106, describes the authority of
the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more
detail the scope of the Agency’s
authority.
We are issuing this rulemaking under
the authority described in Subtitle VII,
Part A, Subpart III, Section 44701,
‘‘General requirements.’’ Under that
section, Congress charges the FAA with
promoting safe flight of civil aircraft in
air commerce by prescribing regulations
for practices, methods, and procedures
the Administrator finds necessary for
safety in air commerce. This regulation
is within the scope of that authority
because it addresses an unsafe condition
that is likely to exist or develop on
products identified in this rulemaking
action.
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Unsafe Condition
(d) This AD results from an error by GE
that incorrectly cited a cyclic life of 12,600
CSN in the Airworthiness Limitations
Section (ALS) of the Instructions for
Continued Airworthiness (ICA) for the HPTR
stage 1 disk, P/N 9367M45G06. We are
issuing this AD to prevent the HPTR stage 1
disk from exceeding its part life, which could
cause fatigue cracks to start and grow. These
cracks could result in a possible uncontained
disk failure and damage to the airplane.
Compliance
(e) You are responsible for having the
actions required by this AD performed within
the compliance times specified unless the
actions have already been done.
New Reduced Life Limit for HPTR Stage 1
Disks, P/N 9367M45G06
(f) After the effective date of this AD,
remove HPTR stage 1 disks, P/N
9367M45G06, from service before exceeding
the new, reduced life limit of 2,075 cyclessince-new.
Alternative Methods of Compliance
(g) The Manager, Engine Certification
Office, has the authority to approve
alternative methods of compliance for this
AD if requested using the procedures found
in 14 CFR 39.19.
Special Flight Permits
(h) Under 14 CFR part 39.23, we are
prohibiting any special flight permits.
Related Information
(i) Contact Robert Green, Aerospace
Engineer, Engine Certification Office, FAA,
Engine & Propeller Directorate, 12 New
England Executive Park, Burlington, MA
01803; e-mail: robert.green@faa.gov;
telephone (781) 238–7754; fax (781) 238–
7199, for more information about this AD.
Material Incorporated by Reference
(j) None.
2. The FAA amends § 39.13 by adding
the following new airworthiness
directive:
2009–07–10 General Electric Company:
Amendment 39–15869. Docket No.
FAA–2008–1206; Directorate Identifier
2008–NE–19–AD.
Issued in Burlington, Massachusetts, on
March 25, 2009.
Peter A. White,
Assistant Manager, Engine and Propeller
Directorate, Aircraft Certification Service.
[FR Doc. E9–7280 Filed 3–31–09; 8:45 am]
BILLING CODE 4910–13–P
§ 39.13
[Amended]
■
Effective Date
(a) This airworthiness directive (AD)
becomes effective May 6, 2009.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Affected ADs
(b) None.
Food and Drug Administration
21 CFR Part 5
Applicability
(c) This AD applies to General Electric Co.
(GE) CF6–80A, CF6–80A1, CF6–80A2, and
CF6–80A3 turbofan engines with a highpressure turbine rotor (HPTR) stage 1 disk,
part number (P/N) 9367M45G06, installed.
These engines are installed on, but not
limited to, Airbus A310 series and Boeing
767 series airplanes.
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[Docket No. FDA–2009–N–0144]
Revision of Organization and
Conforming Changes to Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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Final rule.
01APR1
Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations
SUMMARY: The Food and Drug
Administration (FDA) is issuing this
final rule to amend the regulations to
reflect organizational changes in the
agency and to make other conforming
changes. This action is editorial in
nature and is intended to improve the
accuracy of the agency’s regulations.
DATES: This rule is effective April 1,
2009.
FOR FURTHER INFORMATION CONTACT:
Vanessa Starks, Office of Management
Programs (HFA–410), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4654; or
Sharon Burgess, Office of Management
Programs (HFA–410), 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
2065.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is issuing this final rule to
amend the agency’s regulations by
updating the organizational information
in part 5 (21 CFR part 5). The agency
has updated the references to part 5,
subpart M.
The portion of this final rule updating
the organizational information in part 5,
subpart M is a rule of agency
organization, procedure, or practice.
FDA is issuing these provisions as a
final rule without publishing a general
notice of proposed rulemaking because
such notice is not required for rules of
agency organization, procedure, or
practice under 5 U.S.C. 553(b)(3)(A). For
the conforming changes to the other
regulations, the agency finds good cause
under 5 U.S.C. 553(b)(3)(B) to dispense
with prior notice and comment, and
good cause under 5 U.S.C. 553(d)(3) to
make these conforming changes
effective less than 30 days after
publication because such notice and
comment and delayed effective date are
unnecessary and contrary to the public
interest. As discussed previously, these
conforming changes merely update the
footnotes in part 5, subpart M. These
changes do not result in any substantive
change in the regulations.
II. Analysis of Impacts
FDA has examined the impacts of the
final rule under Executive Order 12866
and the Regulatory Flexibility Act (5
U.S.C. 601–612), and the Unfunded
Mandates Reform Act of 1995 (Public
Law 104–4). Executive Order 12866
directs agencies to assess all costs and
benefits of available regulatory
alternatives and, when regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety,
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and other advantages; distributive
impacts; and equity). The agency
believes that this final rule is consistent
with the principles identified in the
Executive order. In addition, the final
rule is not a significant regulatory action
as defined by the Executive order and so
is not subject to review under the
Executive order.
The Regulatory Flexibility Act
requires agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. Because this rule simply
updates the organizational information,
it does not impose any additional costs
on industry. Consequently, the agency
certifies that the final rule will not have
a significant economic impact on a
substantial number of small entities.
Therefore, under the Regulatory
Flexibility Act, no further analysis is
required.
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘any rule that
includes any Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation)
in any one year.’’ The current threshold
after adjustment for inflation is $130
million, using the most current (2007)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this final rule to result in any 1-year
expenditure that would meet or exceed
this amount.
III. Paperwork Reduction Act of 1995
This final rule contains no collections
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 is not required.
IV. Environmental Impact
FDA has determined under 21 CFR
25.30(h) that this action is of a type that
does not individually or cumulatively
have significant effect on the human
environment. Therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
V. Federalism
FDA has analyzed this final rule in
accordance with the principles set forth
in Executive Order 13132. FDA has
determined that the rule does not
contain policies that have substantial
direct effects on the States, on the
relationship between the National
Government and the States, or on the
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14721
distribution of power and
responsibilities among the various
levels of government. Accordingly the
agency has concluded that the rule does
not contain policies that have
federalism implications as defined in
the Executive order and, consequently,
a federalism summary impact statement
is not required.
List of Subjects in 21 CFR Part 5
Authority delegations (Government
agencies), Imports, Organization and
functions (Government agencies).
■ Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
authority of the Commissioner of Food
and Drugs, 21 CFR part 5 is amended as
follows:
■ 1. Revise part 5 to read as follows:
PART 5—ORGANIZATION
Subparts A–L—[Reserved]
Subpart M—Organization
Sec.
5.1100 Headquarters.
5.1105 Chief Counsel, Food and Drug
Administration.
5.1110 FDA Public Information Offices.
Authority: 5 U.S.C. 552; 21 U.S.C. 301–
397.
Subparts A–L—[Reserved]
Subpart M—Organization
§ 5.1100
Headquarters.
The central organization of the Food
and Drug Administration consists of the
following:
OFFICE OF THE COMMISSIONER.1
Office of the Chief Counsel.2
Office of the Administrative Law Judge.
Office of Chief of Staff.
Office of Executive Secretariat.
Office of Public Affairs.
Office of Legislation.3
Office of External Relations.
Office of the Ombudsman.
Office of Scientific and Medical
Programs.
Office of Critical Path.
Office of Science and Health
Coordination.
1 Mailing address: 10903 New Hampshire Ave.,
Bldg. 1, Silver Spring, MD 20993–0002.
2 The Office of the Chief Counsel (also known as
the Food and Drug Division, Office of the General
Counsel, Department of Health and Human
Services), while administratively within the Office
of the Commissioner, is part of the Office of the
General Counsel of the Department of Health and
Human Services.
3 Mailing address: 5600 Fishers Lane, Rockville,
MD 20852.
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Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations
Office of Orphan Products
Development.
Office of Women’s Health.
National Center for Toxicology
Research.4
Office of Management, NCTR.
Office of Executive Programs and
Services, NCTR.
Office of Scientific Coordination, NCTR.
Office of Research, NCTR.
Division of Biochemical Toxicology,
NCTR.
Division of Genetic and Reproductive
Toxicology, NCTR.
Division of Personalized Nutrition and
Medicine, NCTR.
Division of Microbiology, NCTR.
Division of Neurotoxicology, NCTR.
Division of Veterinary Services, NCTR.
Office of Regulatory Compliance and
Risk Management, NCTR.
Office of Management, NCTR.
Office of Executive Programs and
Services, NCTR.
Office of Scientific Coordination, NCTR.
Office of Research, NCTR.
Division of Biochemical Toxicology,
NCTR.
Division of Genetic and Reproductive
Toxicology, NCTR.
Division of Personalized Nutrition and
Medicine, NCTR.
Division of Microbiology, NCTR.
Division of Neurotoxicology, NCTR.
Division of Veterinary Services, NCTR.
Office of Regulatory Compliance and
Risk Management, NCTR.
Office of International Activities and
Strategic Initiatives.3
Office of International Programs.3
Office of Pediatric Therapeutics.3
Office of Combination Products.5
Office of Operations.1
Office of Information Management.3
Division of Business Partnership and
Support.
Division of Chief Information Officer
Support.
Division of Systems Management.
Division of Infrastructure Operations.
Division of Technology.
Office of Management.1
Office of Management Programs.3
Division of Human Capital
Management.
Division of Freedom of Information.
Division of Dockets Management.6
Office of Shared Services.6
Office of Acquisitions and Grants
Services.
Division of Contracts and Grants
Management.
Office of Financial Services.
Division of Travel Services.
Division of Payment Services.
Office of Equal Employment
Opportunity and Diversity
Management.3
Office of Real Property.6
Division of Portfolio Development.
Division of Engineering Services.
Division of Facilities Operations.
Division of Logistic Services.
Office of Field Financial and
Acquisition Services.6
FDA Bioscience Library.6
Office of Financial Management.3
Division of Financial Support Services.
Division of Accounting.
Division of Budget Execution and
Control.
Office of Executive Operations.3
Office of Crisis Management.1
Office of Emergency Operations.3
Office of Security Operations.6
Office of Policy, Planning, and
Preparedness.1
Office of Counter-Terrorism and
Emerging Threats.1
Office of Integrity and Accountability.1
Office of Policy and Planning.3
Office of Policy.3
Office of Planning.3
4 Mailing address: 3900 NCTR Rd., Jefferson, AR
72079.
5 Mailing address: 15800 Crabbs Branch Way,
Rockville, MD 20855.
6 Mailing address: Mailing address: 5630 Fishers
Lane, Rockville, MD 20852.
7 Mailing address: 5515 Security Ln., Rockville,
MD 20852.
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CENTER FOR BIOLOGICS
EVALUATION AND RESEARCH.7
Office of the Center Director.
Office of Management.
Regulatory Information Management
Staff.
Division of Planning, Evaluation, and
Budget.
Division of Management Services.
Office of Compliance and Biologics
Quality.
Division of Case Management.
Division of Inspection and Surveillance.
Division of Manufacturing and Product
Quality.
Office of Biostatistics and Epidemiology.
Division of Biostatistics.
Division of Epidemiology.
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Office of Information Management.
Division of Vaccines and Related
Products Applications.
Office of Communication, Training, and
Manufacturers Assistance.
Division of Disclosure and Oversight
Management.
Division of Manufacturers Assistance
and Training.
Division of Communication and
Consumer Affairs.
Office of Biostatistics and Epidemiology.
Division of Biostatistics.
Division of Epidemiology.
Office of Information Management.
Division of Information Operations.
Division of Information Development.
Office of Cellular, Tissue, and Gene
Therapies.
Division of Cell and Gene Therapies.
Division of Clinical Evaluation and
Pharmacology/Toxicology Review.
Division of Human Tissues.
Information Technology Staff.
Division of Information Operations.
Division of Information Development.
Office of Blood Research and Review.
Division of Emerging and Transfusion
Transmitted Diseases.
Division of Hematology.
Division of Blood Applications.
Office of Vaccines Research and Review.
Analytical Chemistry Staff.
Standards and Testing Staff.
Program Operation Staff.
Division of Bacterial, Parasitic, and
Allergenic Products.
Division of Viral Products.
Division of Vaccines and Related
Product Applications.
Office of Cellular, Tissue, and Gene
Therapies.
Regulatory Management Staff.
Division of Cell and Gene Therapies.
Division of Clinical Evaluation and
Pharmacology/Toxicology Review.
Division of Human Tissues.
Office of Communication, Training, and
Manufacturers Assistance.
Division of Disclosure and Oversight
Management.
Division of Manufacturers Assistance
and Training.
Division of Communication and
Consumer Affairs.
CENTER FOR FOOD SAFETY AND
APPLIED NUTRITION.8
Office of the Center Director.
8 Mailing address: 5100 Paint Branch Pkwy.,
College Park, MD 20740–3835.
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Senior Science Advisor Staff.
Executive Operations Staff.
International Staff.
Office of Management Systems.
Division of Planning and Financial
Resources Management.
Division of Program Support Services.
Office of Food Defense, Communication
and Emergency Response.
Division of Education and
Communication.
Division of Public Health and
Biostatistics.
Office of Food Safety.
Retail Food and Cooperative Programs
Support Staff
Division of Seafood Science and
Technology.
Division of Food Processing Science and
Technology.
Division of Plant and Dairy Food Safety.
Division of Seafood Safety.
Office of Cosmetics and Colors.
Cosmetic Staff.
Division of Color Certification and
Technology.
Office of Regulatory Science.
Division of Analytical Chemistry.
Division of Microbiology.
Division of Bioanalytical Chemistry.
Office of Food Additive Safety.
Senior Science and Policy Staff.
Division of Food Contact Notifications.
Division of Biotechnology and GRAS
Notice Review.
Office of Compliance.
Division of Enforcement.
Division of Field Programs and
Guidance.
Office of Applied Research and Safety
Assessment.
Muirkirk Technical Operations Staff.
Division of Molecular Biology.
Division of Virulence Assessment.
Division of Toxicology.
Office of Regulations, Policy and Social
Sciences.
Regulations and Special Government
Employees Management Staff.
Office of Nutrition, Labeling and Dietary
Supplements.
Food Labeling and Standards Staff.
Nutrition Programs Staff.
Infant Formula and Medical Foods Staff.
Division of Dietary Supplement
Programs.
CENTER FOR DRUG EVALUATION
AND RESEARCH.1
Office of the Center Director.
Equal Employment Opportunity Staff.
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Controlled Substance Staff.
Office of Regulatory Policy.
Division of Regulatory Policy I.
Division of Regulatory Policy II.
Division of Information Disclosure
Policy.
Office of Management.
Division of Management and Budget.
Division of Management Services.
Office of Training and Communication.
Medwatch Staff.
Division of Library and Information
Services.
Division of Training and Development.
Division of Public Affairs.
Division of Drug Information.
Office of Surveillance Research and
Communication Support.
Division of Medical Errors and
Technical Support.
Division of Drug Risk Evaluation.
Office of Compliance.
Division of Compliance Risk
Management and Surveillance.
Division of New Drugs and Labeling
Compliance.
Division of Manufacturing and Product
Quality.
Division of Scientific Investigations.
Office of New Drugs.
Office of Drug Evaluation I.
Division of Cardiorenal Drug Products.
Division of Neuropharmacological Drug
Products.
Division of Metabolic and Endocrine
Drug Products.
Division of Pulmonary and Allergy Drug
Products.
Division of Anesthetic, Critical Care and
Addiction Drug Products.
Division of Oncology Drug Products.
Office of Drug Evaluation II.
Division of Metabolic and Endocrine
Drug Products.
Division of Pulmonary and Allergy Drug
Products.
Division of Anesthetic, Critical Care and
Addiction Drug Products.
Office of Drug Evaluation III.
Division of Gastrointestinal and
Coagulation Drug Products.
Division of Medical Imaging and
Radiopharmaceutical Drug Products.
Division of Reproductive and Urologic
Drug Products.
Office of Drug Evaluation IV.
Division of Anti-Infective Drug
Products.
Division of Anti-Viral Drug Products.
Division of Special Pathogen and
Immunologic Drug Products.
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14723
Office of Drug Evaluation V.
Division of Anti-Inflammatory,
Analgesic and Ophthalmologic Drug
Products.
Division of Dermatologic and Dental
Drug Products.
Division of Over-The-Counter Drug
Products.
Office of Drug Evaluation VI.
Division of Therapeutic Biological
Oncology Products.
Division of Therapeutic Biological
Internal Medicine Products.
Division of Review Management and
Policy.
Office of Post-Marketing Drug Risk
Assessment.
Division of Therapeutic Biological
Oncology Products.
Division of Therapeutic Biological
Internal Medicine Products.
Division of Review Management and
Policy.
Office of Post-Marketing Drug Risk
Assessment.
Extramural Programs Staff.
Information Technology Staff.
Division of Drug Risk Evaluation I.
Division of Drug Risk Evaluation II.
Office of Pediatric Drug Development
and Program Initiatives.
Pediatric Therapeutics Staff.
Program Initiatives Staff.
Office of Pharmaceutical Science.
Quality Implementation Staff.
Operations Staff.
Informatics and Computational Safety
Analysis Staff.
Office of Clinical Pharmacology and
Biopharmaceutics.
Division of Pharmaceutical Evaluation I.
Division of Pharmaceutical Evaluation
II.
Division of Pharmaceutical Evaluation
III.1
Office of Generic Drugs.9
Division of Bioequivalence.
Division of Chemistry I.
Division of Chemistry II.
Division of Labeling and Program
Support.
Division of Chemistry III.
Office of New Drug Chemistry.
Division of New Drug Chemistry I.
Division of New Drug Chemistry II.
Division of New Drug Chemistry III.
Office of Testing and Research.
Laboratory of Clinical Pharmacology.
9 Mailing address: 7519 Standish Pl., Rockville,
MD 20855.
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Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations
Division of Applied Pharmacology
Research.
Division of Pharmaceutical Analysis.
Division of Product Quality Research.
Office of Biotechnology Products.
Division of Monoclonal Antibodies.
Division of Therapeutic Protein.
Office of Information Technology.3
Division of Applications Development
and Services.3
Division of Infrastructure Management
and Service.
Office of Medical Policy.
Division of Drug Marketing, Advertising
and Communication.
Office of Executive Programs.
Executive Operations Staff.
Quality Assurance Staff.
Advisors and Consultants Staff.3
Office of Translational Science.
Office of Biostatistics.
Division of Biometrics I.
Division of Biometrics II.
Division of Biometrics III.
Division of Biometrics IV.
Division of Biometrics V.
Division of Biometrics VI.
Office of Clinical Pharmacology.
Division of Clinical Pharmacology I.
Division of Clinical Pharmacology II.
Division of Clinical Pharmacology III.
Division of Clinical Pharmacology IV.
Division of Clinical Pharmacology V.
Office of Counter-Terrorism and
Pediatric Drug Development.
Mid-Atlantic Area Office.11
Midwest Area Office.12
Northeast Area Office.13
Pacific Area Office.14
Southeast Area Office.15
Southwest Area Office.16
OFFICE OF REGULATORY AFFAIRS.3
Equal Employment Opportunity Staff.
Office of Resource Management.3
Division of Planning, Evaluation, and
Management.
Division of Human Resource
Development.
Division of Management Operations.
Division of Personnel Operations.
Office of Information Technology.
Office of Enforcement.5
Division of Compliance Management
and Operations.
Division of Compliance Policy.
Division of Compliance Information and
Quality Assurance.
Office of Regional Operations.3
Division of Federal-State Relations.
Division of Field Science.
Division of Import Operations and
Policy.
Division of Field Investigations.
Office of Criminal Investigations.10
CENTER FOR DEVICES AND
RADIOLOGICAL HEALTH.18
10 Mailing
address: 7500 Standish Pl., Rockville,
MD 20855.
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CENTER FOR VETERINARY
MEDICINE.17
Office of the Center Director.
Office of Management.
Management Services Staff.
Information Resources Management
Staff.
Office of New Animal Drug Evaluation.
Division of Therapeutic Drugs for NonFood Animals.
Division of Biometrics and Production
Drugs.
Division of Therapeutic Drugs for Food
Animals.
Division of Human Safety.
Division of Manufacturing
Technologies.
Division of Scientific Support.
Office of Surveillance and Compliance.
Division of Surveillance.
Division of Animal Feeds.
Division of Compliance.
Division of Epidemiology.
Office of Research.
Division of Residue Chemistry.
Division of Animal Research.
Division of Animal and Food
Microbiology.
Office of the Center Director.
Office of Systems and Management.
Division of Ethics and Management
Operations.
Division of Planning, Analysis and
Finance.
Division of Information Dissemination.
Division of Information Technology.
Office of Compliance.
Promotion and Advertising Policy Staff.
11 Mailing address: 11750 Beltsville Dr.,
Beltsville, MD 20705.
12 Mailing address: 901 Warrenville Rd., Lisle, IL
60532.
13 Mailing address: 10 Exchange Pl., Jersey City,
NJ 07302.
14 Mailing address: 201 Avenida Fabricante, San
Clemente, CA 92672.
15 Mailing address: 865 SW., 78th Ave.,
Plantation, FL 33324.
16 Mailing address: 5799 Broadmoor St., Mission,
KS 66202.
17 Mailing address: 7500 Standish Pl. (MPN–2),
Rockville, MD 20855.
18 Mailing address: 9200 Corporate Blvd.,
Rockville, MD 20850.
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Division of Bioresearch Monitoring.
Division of Program Operations.
Division of Enforcement A.
Division of Enforcement B.
Office of Device Evaluation.
Program Management Staff.
Program Operations Staff.
Division of Cardiovascular Devices.
Division of Reproductive, Abdominal,
and Radiological Devices.
Division of General, Restorative, and
Neurological Devices.
Division of Ophthalmic, and Ear, Nose
and Throat Devices.
Division of Anesthesiology, General
Hospital, Infection Control, and Dental
Devices.
Office of Science and Engineering
Laboratories.1
Division of Biology.
Management Support Staff.
Standards Management Staff.
Division of Chemistry and Materials
Science.
Division of Solid and Fluid Mechanics.
Division of Physic.
Division of Imaging and Applied
Mathematics.
Office of Communication, Education
and Radiation Programs.
Program Operations Staff.
Regulations Staff.
Staff College.
Division of Device User Programs and
Systems Analysis.
Division of Small Manufacturers
Assistance.
Division of Mammography Quality and
Radiation Programs.
Division of Communication Media.
Office of Surveillance and Biometrics.
Issues Management Staff.
Division of Biostatistics.
Division of Postmarket Surveillance.
Division of Surveillance Systems.
Office of In Vitro Diagnostic Device
Evaluation and Safety.
Division of Chemistry and Toxicology
Devices.
Division of Immunology and
Hematology Devices.
Division of Microbiology.
§ 5.1105 Chief Counsel, Food and Drug
Administration.
The Office of the Chief Counsel’s
mailing address is 5600 Fishers Lane,
rm. 6–05, Rockville, MD 20857.1
1 The Office of the Chief Counsel (also known as
the Food and Drug Division, Office of the General
Counsel, Department of Health and Human
E:\FR\FM\01APR1.SGM
01APR1
Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations
§ 5.1110
FDA public information offices.
(a) Division of Dockets Management
(HFA–305). The Division of Dockets
Management public room is located in
rm. 1061, 5630 Fishers Lane, Rockville,
MD 20852, Telephone: 301–827–6860.
(b) Division of Freedom of
Information (HFI–35). The Freedom of
Information public room is located in
rm. 6–30, Parklawn Bldg., 5600 Fishers
Lane, Rockville, MD 20857, Telephone:
301–827–6567.
(c) Press Relations Staff (HFI–40).
Press offices are located at 10903 New
Hampshire Ave., Bldg. 1, Silver Spring,
MD 20993–0002, Telephone: 301–827–
6242; and at 5100 Paint Branch Pkwy.,
College Park, MD 20740, Telephone:
301–436–2335.
Dated: March 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–7349 Filed 3–31–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
24 CFR Part 30
[Docket No. FR–5081–C–04]
RIN 2501–AD23
Civil Money Penalties: Certain
Prohibited Conduct; Technical
Amendment
Office of the Secretary, HUD.
ACTION: Final rule, technical
amendment.
AGENCY:
SUMMARY: On January 15, 2009, HUD
published a final rule to revise HUD’s
regulations that govern the imposition
of civil money penalties. The effect of
the rulemaking was to remove one item
from the list of actions for which the
Mortgagee Review Board may initiate a
civil money penalty action against a
mortgagee or lender, reducing the list
from 15 numbered items to 14, and
redesignating the 15th item as item
number 14. However, a related cross
reference was not updated to reflect this
change. In addition, a section revised in
2006 involving delinquent mortgages,
also requires a cross-reference change.
This document corrects these crossreferences.
DATES: Effective Date: April 1, 2009.
FOR FURTHER INFORMATION CONTACT:
Dane Narode, Associate General
Services), while administratively within the Office
of the Commissioner, is part of the Office of the
General Counsel of the Department of Health and
Human Services.
VerDate Nov<24>2008
17:40 Mar 31, 2009
Jkt 217001
Counsel for Program Enforcement,
Department of Housing and Urban
Development, 1250 Maryland Avenue,
SW., Suite 200, Washington, DC 20024–
0500; telephone number 202–708–2350
(this is not a toll-free number), or e-mail
address Dane.M.Narode@hud.gov.
Individuals with hearing or speech
impairments may access this number
through TTY by calling the toll-free
Federal Information Relay Service at
800–877–8339.
On
January 15, 2009 (74 FR 2750), HUD
published a final rule that revised
HUD’s regulations that govern the
imposition of civil money penalties,
located at part 30 of Title 24 of the Code
of Federal Regulations. The final rule
followed a proposed rule published on
October 17, 2008 (73 FR 61754), that
provided a 60 day public comment
period. HUD received no comments in
response to the proposed rule, the
proposed rule was adopted as final
without change., The rule was adopted
as final effective February 17, 2009, see
74 FR 2750, Jan. 15, 2009.
The civil money penalty regulations
at 24 CFR 30.35 contain a list of actions,
the commission of which allows the
mortgagee review board to initiate a
civil money penalty action. There were
originally 14 such actions (see 61 FR
50216–50217). On April 26, 2005, HUD
amended the rule to add a 15th action,
failure to engage in loss mitigation. This
action was codified at 24 CFR
30.35(a)(15). Along with this addition,
24 CFR 30.35(c)(2) was added pursuant
to statutory requirement to provide for
a triple civil money penalty for
violations of this section.
On January 15, 2009, HUD adopted as
final regulations that revised 24 CFR
30.35(a) to remove item 24 CFR
30.35(a)(14) from the list, and to
redesignate the failure to engage in loss
mitigation item from 24 CFR
30.35(a)(15) to 24 CFR 30.35(a)(14) (74
FR 2751, Jan. 15, 2009). However, the
2009 rule failed to incorporate the
related cross reference. Therefore, this
technical amendment revises 24 CFR
30.35(c)(2) to refer to § 30.35(a)(14).
The civil money penalty regulations
at § 30.35(a)(9)(vi) contain a provision
stating that the mortgagee review board
may initiate a civil money penalty
action for failure to report all delinquent
mortgages to HUD. Section
30.35(a)(9)(vi) cross-references § 203.332
on delinquent mortgages. In 2006,
§ 203.332 was moved to § 203.330 and
revised (71 FR 16234, Mar.31, 2006).
Therefore, this technical amendment
revises the cross-reference.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00023
Fmt 4700
Sfmt 4700
14725
List of Subjects in 24 CFR Part 30
Administrative practice and
procedure, Grant programs-housing and
community development, Loan
programs-housing and community
development, Mortgages, Penalties.
■ Accordingly, 24 CFR part 30 is
amended as follows:
PART 30—[AMENDED]
1. The authority citation for 24 CFR
part 30 continues to read as follows:
■
Authority: 12 U.S.C. 1701q–1, 1703, 1723i,
1735f–14, 1735f–15; 15 U.S.C. 1717a; 28
U.S.C. 2461 note; 42 U.S.C. 1437z–1 and
3535(d).
2. Amend § 30.35 by revising
paragraphs (a)(9)(vi) and (c)(2) to read as
follows.
■
§ 30.35
Mortgagees and lenders.
(a) * * *
(9) * * *
(vi) Report all delinquent mortgages to
HUD, as required by § 203.330 of this
title;
*
*
*
*
*
(c) * * *
(2) Maximum penalty for failing to
engage in loss mitigation. The penalty
for a violation of paragraph (a)(14) of
this section shall be three times the
amount of the total mortgage insurance
benefits claimed by the mortgagee with
respect to any mortgage for which the
mortgagee failed to engage in such loss
mitigation actions.
Dated: March 25, 2009.
Aaron Santa Anna,
Assistant General Counsel for Regulations.
[FR Doc. E9–7078 Filed 3–31–09; 8:45 am]
BILLING CODE
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[USCG–2009–0150]
Drawbridge Operation Regulations;
Chelsea River, Chelsea and East
Boston, MA
Coast Guard, DHS.
Notice of temporary deviation
from regulations.
AGENCY:
ACTION:
SUMMARY: The Commander, First Coast
Guard District, has issued a temporary
deviation from the regulation governing
the operation of the P.J. McArdle Bridge
across the Chelsea River, mile 0.3,
between Chelsea and East Boston,
Massachusetts. This deviation is
E:\FR\FM\01APR1.SGM
01APR1
]]>Agencies
[Federal Register Volume 74, Number 61 (Wednesday, April 1, 2009)]
[Rules and Regulations]
[Pages 14720-14725]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-7349]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 5
[Docket No. FDA-2009-N-0144]
Revision of Organization and Conforming Changes to Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
[[Page 14721]]
SUMMARY: The Food and Drug Administration (FDA) is issuing this final
rule to amend the regulations to reflect organizational changes in the
agency and to make other conforming changes. This action is editorial
in nature and is intended to improve the accuracy of the agency's
regulations.
DATES: This rule is effective April 1, 2009.
FOR FURTHER INFORMATION CONTACT: Vanessa Starks, Office of Management
Programs (HFA-410), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4654; or Sharon Burgess, Office of
Management Programs (HFA-410), 5600 Fishers Lane, Rockville, MD 20857,
301-827-2065.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is issuing this final rule to amend the agency's regulations by
updating the organizational information in part 5 (21 CFR part 5). The
agency has updated the references to part 5, subpart M.
The portion of this final rule updating the organizational
information in part 5, subpart M is a rule of agency organization,
procedure, or practice. FDA is issuing these provisions as a final rule
without publishing a general notice of proposed rulemaking because such
notice is not required for rules of agency organization, procedure, or
practice under 5 U.S.C. 553(b)(3)(A). For the conforming changes to the
other regulations, the agency finds good cause under 5 U.S.C.
553(b)(3)(B) to dispense with prior notice and comment, and good cause
under 5 U.S.C. 553(d)(3) to make these conforming changes effective
less than 30 days after publication because such notice and comment and
delayed effective date are unnecessary and contrary to the public
interest. As discussed previously, these conforming changes merely
update the footnotes in part 5, subpart M. These changes do not result
in any substantive change in the regulations.
II. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is consistent with the principles identified in the
Executive order. In addition, the final rule is not a significant
regulatory action as defined by the Executive order and so is not
subject to review under the Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this rule simply updates the organizational
information, it does not impose any additional costs on industry.
Consequently, the agency certifies that the final rule will not have a
significant economic impact on a substantial number of small entities.
Therefore, under the Regulatory Flexibility Act, no further analysis is
required.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $130 million, using the most current (2007) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
III. Paperwork Reduction Act of 1995
This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
IV. Environmental Impact
FDA has determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have significant effect
on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
V. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly the agency has concluded that
the rule does not contain policies that have federalism implications as
defined in the Executive order and, consequently, a federalism summary
impact statement is not required.
List of Subjects in 21 CFR Part 5
Authority delegations (Government agencies), Imports, Organization
and functions (Government agencies).
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
authority of the Commissioner of Food and Drugs, 21 CFR part 5 is
amended as follows:
0
1. Revise part 5 to read as follows:
PART 5--ORGANIZATION
Subparts A-L--[Reserved]
Subpart M--Organization
Sec.
5.1100 Headquarters.
5.1105 Chief Counsel, Food and Drug Administration.
5.1110 FDA Public Information Offices.
Authority: 5 U.S.C. 552; 21 U.S.C. 301-397.
Subparts A-L--[Reserved]
Subpart M--Organization
Sec. 5.1100 Headquarters.
The central organization of the Food and Drug Administration
consists of the following:
OFFICE OF THE COMMISSIONER.\1\
\1\ Mailing address: 10903 New Hampshire Ave., Bldg. 1, Silver
Spring, MD 20993-0002.
Office of the Chief Counsel.\2\
---------------------------------------------------------------------------
\2\ The Office of the Chief Counsel (also known as the Food and
Drug Division, Office of the General Counsel, Department of Health
and Human Services), while administratively within the Office of the
Commissioner, is part of the Office of the General Counsel of the
Department of Health and Human Services.
---------------------------------------------------------------------------
Office of the Administrative Law Judge.
Office of Chief of Staff.
Office of Executive Secretariat.
Office of Public Affairs.
Office of Legislation.\3\
---------------------------------------------------------------------------
\3\ Mailing address: 5600 Fishers Lane, Rockville, MD 20852.
---------------------------------------------------------------------------
Office of External Relations.
Office of the Ombudsman.
Office of Scientific and Medical Programs.
Office of Critical Path.
Office of Science and Health Coordination.
[[Page 14722]]
Office of Orphan Products Development.
Office of Women's Health.
National Center for Toxicology Research.\4\
---------------------------------------------------------------------------
\4\ Mailing address: 3900 NCTR Rd., Jefferson, AR 72079.
---------------------------------------------------------------------------
Office of Management, NCTR.
Office of Executive Programs and Services, NCTR.
Office of Scientific Coordination, NCTR.
Office of Research, NCTR.
Division of Biochemical Toxicology, NCTR.
Division of Genetic and Reproductive Toxicology, NCTR.
Division of Personalized Nutrition and Medicine, NCTR.
Division of Microbiology, NCTR.
Division of Neurotoxicology, NCTR.
Division of Veterinary Services, NCTR.
Office of Regulatory Compliance and Risk Management, NCTR.
Office of Management, NCTR.
Office of Executive Programs and Services, NCTR.
Office of Scientific Coordination, NCTR.
Office of Research, NCTR.
Division of Biochemical Toxicology, NCTR.
Division of Genetic and Reproductive Toxicology, NCTR.
Division of Personalized Nutrition and Medicine, NCTR.
Division of Microbiology, NCTR.
Division of Neurotoxicology, NCTR.
Division of Veterinary Services, NCTR.
Office of Regulatory Compliance and Risk Management, NCTR.
Office of International Activities and Strategic Initiatives.\3\
Office of International Programs.\3\
Office of Pediatric Therapeutics.\3\
Office of Combination Products.\5\
---------------------------------------------------------------------------
\5\ Mailing address: 15800 Crabbs Branch Way, Rockville, MD
20855.
---------------------------------------------------------------------------
Office of Operations.\1\
Office of Information Management.\3\
Division of Business Partnership and Support.
Division of Chief Information Officer Support.
Division of Systems Management.
Division of Infrastructure Operations.
Division of Technology.
Office of Management.\1\
Office of Management Programs.\3\
Division of Human Capital Management.
Division of Freedom of Information.
Division of Dockets Management.\6\
Office of Shared Services.\6\
Office of Acquisitions and Grants Services.
Division of Contracts and Grants Management.
Office of Financial Services.
Division of Travel Services.
Division of Payment Services.
Office of Equal Employment Opportunity and Diversity Management.\3\
Office of Real Property.\6\
---------------------------------------------------------------------------
\6\ Mailing address: Mailing address: 5630 Fishers Lane,
Rockville, MD 20852.
---------------------------------------------------------------------------
Division of Portfolio Development.
Division of Engineering Services.
Division of Facilities Operations.
Division of Logistic Services.
Office of Field Financial and Acquisition Services.\6\
FDA Bioscience Library.\6\
Office of Financial Management.\3\
Division of Financial Support Services.
Division of Accounting.
Division of Budget Execution and Control.
Office of Executive Operations.\3\
Office of Crisis Management.\1\
Office of Emergency Operations.\3\
Office of Security Operations.\6\
Office of Policy, Planning, and Preparedness.\1\
Office of Counter-Terrorism and Emerging Threats.\1\
Office of Integrity and Accountability.\1\
Office of Policy and Planning.\3\
Office of Policy.\3\
Office of Planning.\3\
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH.\7\
---------------------------------------------------------------------------
\7\ Mailing address: 5515 Security Ln., Rockville, MD 20852.
---------------------------------------------------------------------------
Office of the Center Director.
Office of Management.
Regulatory Information Management Staff.
Division of Planning, Evaluation, and Budget.
Division of Management Services.
Office of Compliance and Biologics Quality.
Division of Case Management.
Division of Inspection and Surveillance.
Division of Manufacturing and Product Quality.
Office of Biostatistics and Epidemiology.
Division of Biostatistics.
Division of Epidemiology.
Office of Information Management.
Division of Vaccines and Related Products Applications.
Office of Communication, Training, and Manufacturers Assistance.
Division of Disclosure and Oversight Management.
Division of Manufacturers Assistance and Training.
Division of Communication and Consumer Affairs.
Office of Biostatistics and Epidemiology.
Division of Biostatistics.
Division of Epidemiology.
Office of Information Management.
Division of Information Operations.
Division of Information Development.
Office of Cellular, Tissue, and Gene Therapies.
Division of Cell and Gene Therapies.
Division of Clinical Evaluation and Pharmacology/Toxicology Review.
Division of Human Tissues.
Information Technology Staff.
Division of Information Operations.
Division of Information Development.
Office of Blood Research and Review.
Division of Emerging and Transfusion Transmitted Diseases.
Division of Hematology.
Division of Blood Applications.
Office of Vaccines Research and Review.
Analytical Chemistry Staff.
Standards and Testing Staff.
Program Operation Staff.
Division of Bacterial, Parasitic, and Allergenic Products.
Division of Viral Products.
Division of Vaccines and Related Product Applications.
Office of Cellular, Tissue, and Gene Therapies.
Regulatory Management Staff.
Division of Cell and Gene Therapies.
Division of Clinical Evaluation and Pharmacology/Toxicology Review.
Division of Human Tissues.
Office of Communication, Training, and Manufacturers Assistance.
Division of Disclosure and Oversight Management.
Division of Manufacturers Assistance and Training.
Division of Communication and Consumer Affairs.
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION.\8\
---------------------------------------------------------------------------
\8\ Mailing address: 5100 Paint Branch Pkwy., College Park, MD
20740-3835.
Office of the Center Director.
[[Page 14723]]
Senior Science Advisor Staff.
Executive Operations Staff.
International Staff.
Office of Management Systems.
Division of Planning and Financial Resources Management.
Division of Program Support Services.
Office of Food Defense, Communication and Emergency Response.
Division of Education and Communication.
Division of Public Health and Biostatistics.
Office of Food Safety.
Retail Food and Cooperative Programs Support Staff
Division of Seafood Science and Technology.
Division of Food Processing Science and Technology.
Division of Plant and Dairy Food Safety.
Division of Seafood Safety.
Office of Cosmetics and Colors.
Cosmetic Staff.
Division of Color Certification and Technology.
Office of Regulatory Science.
Division of Analytical Chemistry.
Division of Microbiology.
Division of Bioanalytical Chemistry.
Office of Food Additive Safety.
Senior Science and Policy Staff.
Division of Food Contact Notifications.
Division of Biotechnology and GRAS Notice Review.
Office of Compliance.
Division of Enforcement.
Division of Field Programs and Guidance.
Office of Applied Research and Safety Assessment.
Muirkirk Technical Operations Staff.
Division of Molecular Biology.
Division of Virulence Assessment.
Division of Toxicology.
Office of Regulations, Policy and Social Sciences.
Regulations and Special Government Employees Management Staff.
Office of Nutrition, Labeling and Dietary Supplements.
Food Labeling and Standards Staff.
Nutrition Programs Staff.
Infant Formula and Medical Foods Staff.
Division of Dietary Supplement Programs.
CENTER FOR DRUG EVALUATION AND RESEARCH.\1\
Office of the Center Director.
Equal Employment Opportunity Staff.
Controlled Substance Staff.
Office of Regulatory Policy.
Division of Regulatory Policy I.
Division of Regulatory Policy II.
Division of Information Disclosure Policy.
Office of Management.
Division of Management and Budget.
Division of Management Services.
Office of Training and Communication.
Medwatch Staff.
Division of Library and Information Services.
Division of Training and Development.
Division of Public Affairs.
Division of Drug Information.
Office of Surveillance Research and Communication Support.
Division of Medical Errors and Technical Support.
Division of Drug Risk Evaluation.
Office of Compliance.
Division of Compliance Risk Management and Surveillance.
Division of New Drugs and Labeling Compliance.
Division of Manufacturing and Product Quality.
Division of Scientific Investigations.
Office of New Drugs.
Office of Drug Evaluation I.
Division of Cardiorenal Drug Products.
Division of Neuropharmacological Drug Products.
Division of Metabolic and Endocrine Drug Products.
Division of Pulmonary and Allergy Drug Products.
Division of Anesthetic, Critical Care and Addiction Drug Products.
Division of Oncology Drug Products.
Office of Drug Evaluation II.
Division of Metabolic and Endocrine Drug Products.
Division of Pulmonary and Allergy Drug Products.
Division of Anesthetic, Critical Care and Addiction Drug Products.
Office of Drug Evaluation III.
Division of Gastrointestinal and Coagulation Drug Products.
Division of Medical Imaging and Radiopharmaceutical Drug Products.
Division of Reproductive and Urologic Drug Products.
Office of Drug Evaluation IV.
Division of Anti-Infective Drug Products.
Division of Anti-Viral Drug Products.
Division of Special Pathogen and Immunologic Drug Products.
Office of Drug Evaluation V.
Division of Anti-Inflammatory, Analgesic and Ophthalmologic Drug
Products.
Division of Dermatologic and Dental Drug Products.
Division of Over-The-Counter Drug Products.
Office of Drug Evaluation VI.
Division of Therapeutic Biological Oncology Products.
Division of Therapeutic Biological Internal Medicine Products.
Division of Review Management and Policy.
Office of Post-Marketing Drug Risk Assessment.
Division of Therapeutic Biological Oncology Products.
Division of Therapeutic Biological Internal Medicine Products.
Division of Review Management and Policy.
Office of Post-Marketing Drug Risk Assessment.
Extramural Programs Staff.
Information Technology Staff.
Division of Drug Risk Evaluation I.
Division of Drug Risk Evaluation II.
Office of Pediatric Drug Development and Program Initiatives.
Pediatric Therapeutics Staff.
Program Initiatives Staff.
Office of Pharmaceutical Science.
Quality Implementation Staff.
Operations Staff.
Informatics and Computational Safety Analysis Staff.
Office of Clinical Pharmacology and Biopharmaceutics.
Division of Pharmaceutical Evaluation I.
Division of Pharmaceutical Evaluation II.
Division of Pharmaceutical Evaluation III.\1\
Office of Generic Drugs.\9\
Division of Bioequivalence.
Division of Chemistry I.
Division of Chemistry II.
Division of Labeling and Program Support.
Division of Chemistry III.
---------------------------------------------------------------------------
\9\ Mailing address: 7519 Standish Pl., Rockville, MD 20855.
---------------------------------------------------------------------------
Office of New Drug Chemistry.
Division of New Drug Chemistry I.
Division of New Drug Chemistry II.
Division of New Drug Chemistry III.
Office of Testing and Research.
Laboratory of Clinical Pharmacology.
[[Page 14724]]
Division of Applied Pharmacology Research.
Division of Pharmaceutical Analysis.
Division of Product Quality Research.
Office of Biotechnology Products.
Division of Monoclonal Antibodies.
Division of Therapeutic Protein.
Office of Information Technology.\3\
Division of Applications Development and Services.\3\
Division of Infrastructure Management and Service.
Office of Medical Policy.
Division of Drug Marketing, Advertising and Communication.
Office of Executive Programs.
Executive Operations Staff.
Quality Assurance Staff.
Advisors and Consultants Staff.\3\
Office of Translational Science.
Office of Biostatistics.
Division of Biometrics I.
Division of Biometrics II.
Division of Biometrics III.
Division of Biometrics IV.
Division of Biometrics V.
Division of Biometrics VI.
Office of Clinical Pharmacology.
Division of Clinical Pharmacology I.
Division of Clinical Pharmacology II.
Division of Clinical Pharmacology III.
Division of Clinical Pharmacology IV.
Division of Clinical Pharmacology V.
Office of Counter-Terrorism and Pediatric Drug Development.
OFFICE OF REGULATORY AFFAIRS.\3\
Equal Employment Opportunity Staff.
Office of Resource Management.\3\
Division of Planning, Evaluation, and Management.
Division of Human Resource Development.
Division of Management Operations.
Division of Personnel Operations.
Office of Information Technology.
Office of Enforcement.\5\
Division of Compliance Management and Operations.
Division of Compliance Policy.
Division of Compliance Information and Quality Assurance.
Office of Regional Operations.\3\
Division of Federal-State Relations.
Division of Field Science.
Division of Import Operations and Policy.
Division of Field Investigations.
Office of Criminal Investigations.\10\
---------------------------------------------------------------------------
\10\ Mailing address: 7500 Standish Pl., Rockville, MD 20855.
Mid-Atlantic Area Office.\11\
---------------------------------------------------------------------------
\11\ Mailing address: 11750 Beltsville Dr., Beltsville, MD
20705.
Midwest Area Office.\12\
---------------------------------------------------------------------------
\12\ Mailing address: 901 Warrenville Rd., Lisle, IL 60532.
Northeast Area Office.\13\
---------------------------------------------------------------------------
\13\ Mailing address: 10 Exchange Pl., Jersey City, NJ 07302.
Pacific Area Office.\14\
---------------------------------------------------------------------------
\14\ Mailing address: 201 Avenida Fabricante, San Clemente, CA
92672.
Southeast Area Office.\15\
---------------------------------------------------------------------------
\15\ Mailing address: 865 SW., 78th Ave., Plantation, FL 33324.
Southwest Area Office.\16\
---------------------------------------------------------------------------
\16\ Mailing address: 5799 Broadmoor St., Mission, KS 66202.
CENTER FOR VETERINARY MEDICINE.\17\
---------------------------------------------------------------------------
\17\ Mailing address: 7500 Standish Pl. (MPN-2), Rockville, MD
20855.
---------------------------------------------------------------------------
Office of the Center Director.
Office of Management.
Management Services Staff.
Information Resources Management Staff.
Office of New Animal Drug Evaluation.
Division of Therapeutic Drugs for Non-Food Animals.
Division of Biometrics and Production Drugs.
Division of Therapeutic Drugs for Food Animals.
Division of Human Safety.
Division of Manufacturing Technologies.
Division of Scientific Support.
Office of Surveillance and Compliance.
Division of Surveillance.
Division of Animal Feeds.
Division of Compliance.
Division of Epidemiology.
Office of Research.
Division of Residue Chemistry.
Division of Animal Research.
Division of Animal and Food Microbiology.
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH.\18\
---------------------------------------------------------------------------
\18\ Mailing address: 9200 Corporate Blvd., Rockville, MD 20850.
---------------------------------------------------------------------------
Office of the Center Director.
Office of Systems and Management.
Division of Ethics and Management Operations.
Division of Planning, Analysis and Finance.
Division of Information Dissemination.
Division of Information Technology.
Office of Compliance.
Promotion and Advertising Policy Staff.
Division of Bioresearch Monitoring.
Division of Program Operations.
Division of Enforcement A.
Division of Enforcement B.
Office of Device Evaluation.
Program Management Staff.
Program Operations Staff.
Division of Cardiovascular Devices.
Division of Reproductive, Abdominal, and Radiological Devices.
Division of General, Restorative, and Neurological Devices.
Division of Ophthalmic, and Ear, Nose and Throat Devices.
Division of Anesthesiology, General Hospital, Infection Control, and
Dental Devices.
Office of Science and Engineering Laboratories.\1\
Division of Biology.
Management Support Staff.
Standards Management Staff.
Division of Chemistry and Materials Science.
Division of Solid and Fluid Mechanics.
Division of Physic.
Division of Imaging and Applied Mathematics.
Office of Communication, Education and Radiation Programs.
Program Operations Staff.
Regulations Staff.
Staff College.
Division of Device User Programs and Systems Analysis.
Division of Small Manufacturers Assistance.
Division of Mammography Quality and Radiation Programs.
Division of Communication Media.
Office of Surveillance and Biometrics.
Issues Management Staff.
Division of Biostatistics.
Division of Postmarket Surveillance.
Division of Surveillance Systems.
Office of In Vitro Diagnostic Device Evaluation and Safety.
Division of Chemistry and Toxicology Devices.
Division of Immunology and Hematology Devices.
Division of Microbiology.
Sec. 5.1105 Chief Counsel, Food and Drug Administration.
The Office of the Chief Counsel's mailing address is 5600 Fishers
Lane, rm. 6-05, Rockville, MD 20857.\1\
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\1\ The Office of the Chief Counsel (also known as the Food and
Drug Division, Office of the General Counsel, Department of Health
and Human Services), while administratively within the Office of the
Commissioner, is part of the Office of the General Counsel of the
Department of Health and Human Services.
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Sec. 5.1110 FDA public information offices.
(a) Division of Dockets Management (HFA-305). The Division of
Dockets Management public room is located in rm. 1061, 5630 Fishers
Lane, Rockville, MD 20852, Telephone: 301-827-6860.
(b) Division of Freedom of Information (HFI-35). The Freedom of
Information public room is located in rm. 6-30, Parklawn Bldg., 5600
Fishers Lane, Rockville, MD 20857, Telephone: 301-827-6567.
(c) Press Relations Staff (HFI-40). Press offices are located at
10903 New Hampshire Ave., Bldg. 1, Silver Spring, MD 20993-0002,
Telephone: 301-827-6242; and at 5100 Paint Branch Pkwy., College Park,
MD 20740, Telephone: 301-436-2335.
Dated: March 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-7349 Filed 3-31-09; 8:45 am]
BILLING CODE 4160-01-S
