14720 Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 

Examining the AD Docket 

You may examine the AD docket on 

the Internet at http:// 

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. 

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. 

Authority for This Rulemaking 

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. 

Regulatory Findings 

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. 

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: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

■ 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. 

Effective Date 

(a) This airworthiness directive (AD) 

becomes effective May 6, 2009. 

Affected ADs 

(b) None. 

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. 

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. 

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 

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. 

Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 14721 

1Mailing address: 10903 New Hampshire Ave., 

Bldg. 1, Silver Spring, MD 20993–0002. 

2The 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. 

3Mailing address: 5600 Fishers Lane, Rockville, 

MD 20852. 

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). 

■ 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. 

14722 Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 

4Mailing address: 3900 NCTR Rd., Jefferson, AR 

72079. 

5Mailing address: 15800 Crabbs Branch Way, 

Rockville, MD 20855. 

6Mailing address: Mailing address: 5630 Fishers 

Lane, Rockville, MD 20852. 

7Mailing address: 5515 Security Ln., Rockville, 

MD 20852. 

8Mailing address: 5100 Paint Branch Pkwy., 

College Park, MD 20740–3835. 

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

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. 

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. 

Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 14723 

9Mailing address: 7519 Standish Pl., Rockville, 

MD 20855. 

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. 

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. 

14724 Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 

10Mailing address: 7500 Standish Pl., Rockville, 

MD 20855. 

11Mailing address: 11750 Beltsville Dr., 

Beltsville, MD 20705. 

12Mailing address: 901 Warrenville Rd., Lisle, IL 

60532. 

13Mailing address: 10 Exchange Pl., Jersey City, 

NJ 07302. 

14Mailing address: 201 Avenida Fabricante, San 

Clemente, CA 92672. 

15Mailing address: 865 SW., 78th Ave., 

Plantation, FL 33324. 

16Mailing address: 5799 Broadmoor St., Mission, 

KS 66202. 

17Mailing address: 7500 Standish Pl. (MPN–2), 

Rockville, MD 20855. 

18Mailing address: 9200 Corporate Blvd., 

Rockville, MD 20850. 

1The Office of the Chief Counsel (also known as 

the Food and Drug Division, Office of the General 

Counsel, Department of Health and Human 

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

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

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. 

CENTER FOR DEVICES AND 

RADIOLOGICAL HEALTH.18

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. 

§ 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

Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 14725 

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. 

§ 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 

AGENCY: Office of the Secretary, HUD. 

ACTION: Final rule, technical 

amendment. 

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 

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. 

SUPPLEMENTARY INFORMATION: 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. 

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 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations. 

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