Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Rules and Regulations 15961 

Dated: March 14, 2012. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2012–6544 Filed 3–16–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

[Docket No. FDA–2011–N–0003] 

Oral Dosage Form New Animal Drugs; 

Phenylpropanolamine 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of an original new animal drug 

application (NADA) filed by Pegasus 

Laboratories, Inc. The NADA provides 

for the veterinary prescription use of 

phenylpropanolamine hydrochloride 

chewable tablets for the control of 

urinary incontinence due to urethral 

sphincter hypotonus in dogs. 

DATES: This rule is effective March 19, 

2012. 

FOR FURTHER INFORMATION CONTACT: Lisa 

M. Troutman, Center for Veterinary 

Medicine (HFV–116), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8322, 

email: lisa.troutman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pegasus 

Laboratories, Inc., 8809 Ely Rd., 

Pensacola, FL 32514, filed NADA 141– 

324 that provides for the veterinary 

prescription use of PROIN 

(phenylpropanolamine hydrochloride) 

Chewable Tablets for the control of 

urinary incontinence due to urethral 

sphincter hypotonus in dogs. The 

NADA is approved as of August 4, 2011, 

and the regulations are amended in 

21 CFR part 520 to reflect the approval. 

A summary of safety and effectiveness 

data and information submitted to 

support approval of this application 

may be seen in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, between 

9 a.m. and 4 p.m., Monday through 

Friday. 

The agency has determined under 

21 CFR 25.33 that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

Under section 512(c)(2)(F)(i) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360b(c)(2)(F)(i)), this 

approval qualifies for 5 years of 

marketing exclusivity beginning on the 

date of approval. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’ 

Therefore, it is not subject to the 

congressional review requirements in 

5 U.S.C. 801–808. 

List of Subjects in 21 CFR Part 520 

Animal drugs. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 

21 CFR part 520 is amended as follows: 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 2. Add § 520.1760 to read as follows: 

§ 520.1760 Phenylpropanolamine. 

(a) Specifications. Each chewable 

tablet contains 25, 50, or 75 milligram 

(mg) phenylpropanolamine 

hydrochloride. 

(b) Sponsors. See No. 055246 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use in dogs—(1) 

Amount. Administer 2 mg/kg of body 

weight twice daily. 

(2) Indications for use. For the control 

of urinary incontinence due to urethral 

sphincter hypotonus in dogs. 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

Dated: March 14, 2012. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2012–6553 Filed 3–16–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Chapter I 

[Docket No. FDA–2012–N–0222] 

Revision of Organization and 

Conforming Changes to Regulations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing this 

final rule to amend the regulations to 

reflect organizational change 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, 

2012. 

FOR FURTHER INFORMATION CONTACT: 

Vanessa Starks, Human Capital 

Management, Food and Drug 

Administration, 19903 New Hampshire 

Ave., Silver Spring, MD 20903, 301– 

796–8846. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is issuing this final rule to 

amend its regulations by updating the 

organizational information in part 5 

(21 CFR part 5). 

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. 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, 

Executive Order 13563, the Regulatory 

Flexibility Act (5 U.S.C. 601–612), and 

the Unfunded Mandates Reform Act of 

1995 (Pub. L. 104–4). Executive Orders 

12866 and 13563 direct 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 


emcdonald on DSK29S0YB1PROD with RULES
15962 Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Rules and Regulations 

not a significant regulatory action under 

Executive Order 12866. 

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. 

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 $136 

million, using the most current (2010) 

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 collection 

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 a 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 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 5 is 

revised 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 Food and Drug Administration 

consists of the following: 

Office of the Commissioner. 

Office of Executive Secretariat. 

Office of the Chief Counsel. 

Office of the Counselor to the 

Commissioner. 

Office of Crisis Management. 

Office of Emergency Operations. 

Office of Policy and Planning. 

Office of Policy. 

Policy Development and Coordination 

Staff. 

Regulations Policy and Management 

Staff. 

Regulations Editorial Section. 

Office of Planning. 

Planning Staff. 

Program Evaluation and Process 

Improvement Staff. 

Economics Staff. 

Risk Communications Staff. 

Office of Legislation. 

Office of External Affairs. 

Web Communications Staff. 

Office of External Relations. 

Communications Staff. 

Office of Public Affairs. 

Office of Special Health Issues. 

Office of Minority Health. 

Office of Women’s Health. 

Office of the Chief Scientist. 

Office of Counter-Terrorism and 

Emerging Threats. 

Office of Scientific Integrity. 

Office of Regulatory Science and 

Innovation. 

Division of Science Innovation and 

Critical Path. 

Division of Scientific Computing and 

Medical Information. 

Office of Scientific Professional 

Development. 

National Center for Toxicological 

Research. 

Office of the Center Director. 

Office of Management. 

Office of Scientific Coordination. 

Office of Research. 

Division of Biochemical Toxicology. 

Division of Genetic and Molecular 

Toxicology. 

Division of Personalized Nutrition 

and Medicine. 

Biometry Branch. 

Pharmacogenomics Branch. 

Division of Microbiology. 

Division of Neurotoxicology. 

Division of Systems Biology. 

Office of Operations. 

Office of Equal Employment 

Opportunity. 

Conflict Prevention and Resolution 

Staff. 

Compliance Staff. 

Diversity Staff. 

Office of Finance, Budget, and 

Acquisitions. 

Office of Budget. 

Office of Acquisitions and Grants 

Services. 

Division of Acquisition Operations. 

Division of Acquisition Support and 

Grants. 

Division of Acquisition Programs. 

Division of Information Technology. 

Office of Financial Operations. 

Office of Financial Management. 

User Fees Staff. 

Division of Accounting. 

Division of Budget Execution and 

Control. 

Office of Financial Services. 

Payroll Staff. 

Division of Payment Services. 

Division of Travel Services. 

Office of Information Management. 

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. 

Ethics and Integrity Staff. 

Office of Management Programs. 

Office of Security Operations. 

Office of Facilities, Engineering and 

Mission Support Services. 

Jefferson Lab Complex Staff. 

Business Operations and Initiatives 

Staff. 

Division of Operations Management 

and Community Relations. 

Auxiliary Program Management 

Branch. 

Logistics and Transportation 

Management Branch. 

Facilities Maintenance and 


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Operations Branch. 

Division of Planning, Engineering, 

and Space Management. 

Planning and Space Management 

Branch. 

Employee Safety and Environmental 

Management Branch. 

Engineering Management Branch. 

Office of Library and Employee 

Services. 

Employee Resource and Information 

Center. 

FDA Biosciences Library. 

Public Services Branch. 

Technical Services Branch. 

FDA History Office. 

Division of Freedom of Information. 

Division of Dockets Management. 

Office of Foods. 

Center for Food Safety and Applied 

Nutrition. 

Office of the Center Director. 

Executive Operations Staff. 

International Staff. 

Office of Management. 

Safety Staff. 

Division of Planning and Budget and 

Planning. 

Division of Program 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 Program 

Support Staff. 

Division of Seafood Science and 

Technology. 

Chemical Hazard Branch. 

Microbiological Hazard Branch. 

Division of Food Processing Science 

and Technology. 

Process Engineering Branch. 

Food Technology Branch. 

Division of Plant and Dairy Food 

Safety. 

Plant Products Branch. 

Dairy and Egg Branch. 

Division of Seafood Safety. 

Shellfish and Aquaculture Policy 

Branch. 

Seafood Processing and Technology 

Policy Branch. 

Office of Cosmetics and Colors. 

Cosmetic Staff. 

Division of Color Certification and 

Technology. 

Office of Regulatory Science. 

Division of Analytical Chemistry. 

Methods Branch. 

Spectroscopy and Mass Spectrometry 

Branch. 

Division of Microbiology. 

Microbial Methods and Development 

Branch. 

Molecular Methods and Subtyping 

Branch. 

Division of Bioanalytical Chemistry. 

Bioanalytical Methods Branch. 

Chemical Contaminants Branch. 

Office of Food Additive Safety. 

Division of Food Contact 

Notifications. 

Division of Biotechnology and GRAS 

Notice Review. 

Division of Petition Review. 

Office of Compliance. 

Division of Enforcement. 

Division of Field Programs and 

Guidance. 

Office of Applied Research and Safety 

Assessment. 

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. 

Division of Social Sciences. 

Office of Nutrition, Labeling, and 

Dietary Supplements. 

Nutrition Programs Staff. 

Division of Dietary Supplement 

Programs. 

Center for Veterinary Medicine. 

Office of the Center Director. 

Office of Management. 

Management Logistics Staff. 

Human Capital Management Staff. 

Program and Resource Management 

Staff. 

Talent Development Staff. 

Budget Planning and Evaluation 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 Food Safety. 

Division of Manufacturing 

Technologies. 

Division of Scientific Support. 

Division of Generic Animal Drugs. 

Office of Surveillance and Compliance. 

Division of Surveillance. 

Division of Animal Feeds. 

Division of Compliance. 

Division of Veterinary Product Safety. 

Office of Research. 

Division of Residue Chemistry. 

Division of Animal Research. 

Division of Animal and Food 

Microbiology. 

Office of Minor Use and Minor Species 

Animal Drug Development. 

Office of Medical Products and 

Tobacco. 

Office of Special Medical Programs. 

Advisory Committee Oversight and 

Management Staff. 

Good Clinical Practice Staff. 

Office of Combination Products. 

Office of Orphan Products 

Development. 

Office of Pediatric Therapeutics. 

Center for Biologics Evaluation and 

Research. 

Office of the Center Director. 

Regulations Policy Staff. 

Quality Assurance Staff. 

Office of Management. 

Regulatory Information Management 

Staff. 

Division of Planning, Evaluation, and 

Budget. 

Division of Veterinary Services. 

Division of Program Services. 

Division of Scientific Advisors and 

Consultants. 

Building Operations Staff. 

Office of Compliance and Biologics 

Quality. 

Division of Case Management. 

Division of Inspections 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 Information Operations. 

Division of Information Development. 

Office of Blood Research and Review. 

Policy and Publications Staff. 

Division of Emerging and Transfusion 

Transmitted Diseases. 

Division of Hematology. 

Division of Blood Applications. 

Office of Vaccines Research and Review. 

Program Operation Staff. 

Division of Product Quality. 

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 Cellular and Gene 

Therapies. 

Division of Clinical Evaluation and 

Pharmacology/Toxicology. 

Division of Human Tissues. 

Office of Communication, Outreach and 

Development. 

Division of Disclosure and Oversight 

Management. 

Division of Manufacturers Assistance 

and Training. 

Division of Communication and 

Consumer Affairs. 

Center for Devices and Radiological 

Health. 

Office of the Center Director. 

Regulations Staff. 

Office of Management Operations. 

Division of Ethics and Management 

Operations. 

Human Resource and Administrative 


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15964 Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Rules and Regulations 

Management Branch. 

Integrity, Conference and Committee 

Management Branch. 

Division of Planning, Analysis and 

Finance. 

Planning Branch. 

Financial Management Branch. 

Office of Compliance. 

Promotion and Advertising Policy 

Staff. 

Program Management Staff. 

Quality Management Program Staff. 

Division of Bioresearch Monitoring. 

Program Enforcement Branch A. 

Program Enforcement Branch B. 

Special Investigations Branch. 

Division of Risk Management 

Operations. 

Field Programs Branch. 

Recall Branch. 

Regulatory Policy Branch. 

Division of Enforcement. 

General Surgery Devices Branch. 

Dental Ear, Nose, Throat and 

Ophthalmic Devices Branch. 

Gastroenterology and Urology Branch. 

General Hospital Devices Branch. 

Division of Enforcement B. 

Radiology, Anesthesiology, and 

Neurology Devices Branch. 

Cardiac Rhythm and 

Electrophysiology Devices Branch. 

Vascular and Circulatory Support 

Devices Branch. 

Orthopedic and Physical Medicine 

Devices Branch. 

Office of Device Evaluation. 

Program Management Staff. 

Program Operations Staff. 

Pre-Market Approval Staff. 

Investigational Device Exemption 

Staff. 

Pre-Market Notification Section. 

Division of Cardiovascular Devices. 

Circulatory Support and Prosthetic 

Branch. 

Interventional Cardiology Devices 

Branch. 

Pacing, Defibrillators, and Leads 

Branch. 

Cardiac Electrophysiology and 

Monitoring Devices Branch. 

Peripheral Scads Vascular Devices 

Branch. 

Division of Reproductive, GastroRenal, and Urological Devices. 

Gynecology Devices Branch. 

Urology and Lithotripsy Devices 

Branch. 

Gastroenterology and Renal Devices 

Branch. 

Division of Surgical, Orthopedic, and 

Restorative Devices. 

General Surgery Devices Branch. 

Restorative Devices Branch. 

Plastic and Reconstructive Surgery 

Devices Branch. 

Orthopedic Joint Devices Branch. 

Orthopedic Spine Devices Branch. 

Division of Ophthalmic, Neurological, 

and Ear, Nose, and Throat Devices. 

Intraocular, Corneal, and 

Neuromaterial Devices Branch. 

Ophthalmic Laser, Neuromuscular 

Stimulators, and Diagnostic Devices 

Branch. 

Neurodiagnostic and 

Neurotherapeutic Devices Branch. 

Ear, Nose, and Throat Devices Branch. 

Division of Anesthesiology, General 

Hospital, Infection Control, and 

Dental Devices. 

General Hospital Devices Branch. 

Infection Control Devices Branch. 

Dental Devices Branch. 

Anesthesiology and Respiratory 

Devices Branch. 

Office of Science and Engineering 

Laboratories. 

Management Support Staff. 

Division of Biology. 

Division of Chemistry and Materials 

Science. 

Division of Solid and Fluid 

Mechanics. 

Division of Physics. 

Division of Imaging and Applied 

Mathematics. 

Division of Solid and Fluid 

Mechanics. 

Division of Electrical and Software 

Engineering. 

Office of Communication, Education 

and Radiation Programs. 

Program Operations Staff. 

Staff College. 

Division of Health Communication. 

Web Communication Branch. 

Risk Communication Branch. 

Division of Small Manufacturers 

International and Consumer 

Assistance. 

Technical Assistance Branch. 

International Relations and External 

Affairs Staff. 

Regulatory Assistance Branch. 

Division of Mammography Quality 

and Radiation Programs. 

Inspection and Compliance Branch. 

Information Management Branch. 

Diagnostic Devices Branch. 

Electronic Devices Branch. 

Division of Communication Media. 

Television Design and Development 

Branch. 

Division of Freedom of Information. 

Freedom of Information Branch A. 

Freedom of Information Branch B. 

Office of Surveillance and Biometrics. 

Program Management Staff. 

Division of Biostatistics. 

Cardiovascular and Ophthalmic 

Devices Branch. 

Diagnostic Devices Branch. 

General and Surgical Devices Branch. 

Division of Postmarket Surveillance. 

Product Evaluation Branch 1. 

Product Evaluation Branch 2. 

Information Analysis Branch. 

MDR Policy Branch. 

Division of Patient Safety Partnership. 

Patient Safety Branch 1. 

Patient Safety Branch 2. 

Division of Epidemiology. 

Epidemiology Evaluation and 

Research Branch 1. 

Epidemiology Evaluation and 

Research Branch 2. 

Office of In Vitro Diagnostic Device 

Evaluation and Safety. 

Division of Chemistry and Toxicology 

Devices. 

Division of Immunology and 

Hematology Devices. 

Division of Microbiology Devices. 

Division of Radiological Devices. 

Center for Drug Evaluation and 

Research. 

Office of the Center Director. 

Controlled Substances Staff. 

Safe Use Staff. 

Office of Regulatory Policy. 

Division of Regulatory Policy I. 

Division of Regulatory Policy II. 

Division of Regulatory Policy III. 

Division of Information Disclosure 

Policy. 

Office of Management. 

Division of Management and Budget. 

Planning and Resource Management 

Branch. 

Management Analysis Branch. 

Division of Management Services. 

Program Management Services 

Branch. 

Interface Management Branch. 

Office of Communications. 

Division of Online Communications. 

Division of Health Communications. 

Division of Drug Information. 

Office of Surveillance and 

Epidemiology. 

Regulatory Science Staff. 

Regulatory Affairs Staff. 

Executive Operations and Strategic 

Planning Staff. 

Technical Information Staff. 

Program Management and Analysis 

Staff. 

Project Management Staff. 

Office of Medication Error Prevention. 

Division of Medication Error 

Prevention and Analysis. 

Division of Risk Management. 

Office of Pharmacovigilance and 

Epidemiology. 

Division of Epidemiology I. 

Division of Epidemiology II. 

Division of Pharmacovigilance I. 

Division of Pharmacovigilance II. 

Office of Compliance. 

Office of Drug Security, Integrity, and 

Recalls. 

Division of Import Operations and 

Recalls. 

Recall Coordination Branch. 

Import Operations Branch. 


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Division of Supply Chain Integrity. 

Office of Unapproved Drugs and 

Labeling Compliance. 

Division of Prescription Drugs. 

Prescription Drugs Branch. 

Compounding and Pharmacy Practice 

Branch. 

Division of Non-Prescription Drugs 

and Health Fraud. 

Over-the-Counter Drugs Branch. 

Health Fraud and Consumer Outreach 

Branch. 

Office of Manufacturing and Product 

Quality. 

Division of International Drug 

Quality. 

International Compliance Branch I. 

International Compliance Branch II. 

Division of Domestic Drug Quality. 

Domestic Compliance Branch 1. 

Domestic Compliance Branch 2. 

Division of Policy, Collaboration, and 

Data Operations. 

Regulatory Policy and 

Communications Branch. 

Drug Surveillance and Data Reporting 

Branch. 

Division of GMP Assessment. 

Biotech Manufacturing Assessment 

Branch. 

New Drug Manufacturing Assessment 

Branch. 

Generic Drug Manufacturing 

Assessment Branch. 

Office of Scientific Investigations. 

Division of Bioequivalence and Good 

Laboratory Practice Compliance. 

Good Laboratory Practice Branch. 

Bioequivalence Branch. 

Division of Good Clinical Practice 

Compliance. 

Good Clinical Practice Enforcement 

Branch 

Good Clinical Practice Assessment 

Branch 

Division of Safety Compliance. 

Post Market Safety Branch. 

Human Subject Protection Branch. 

Office of New Drugs. 

Pediatric and Maternal Health Staff. 

Program Management Analysis Staff. 

Office of Drug Evaluation I. 

Division of Cardiovascular and Renal 

Products. 

Division of Neurology Products. 

Division of Psychiatry Products. 

Office of Drug Evaluation II. 

Division of Metabolism and 

Endocrinology Products. 

Division of Pulmonary, Allergy, and 

Rheumatology Products. 

Division of Anesthesia, Analgesia, 

and Addiction Products. 

Office of Drug Evaluation III. 

Division of Gastroenterology and 

Inborn Effects Products. 

Division of Reproductive and 

Urologic Products. 

Division of Dermatology and Dental 

Products. 

Office of Antimicrobial Products. 

Division of Anti-Infective Products. 

Division of Anti-Viral Products. 

Division of Transplant and 

Ophthalmology Products. 

Office of Drug Evaluation IV. 

Division of Nonprescription Clinical 

Evaluation. 

Division of Nonprescription 

Regulation Development. 

Division of Medical Imaging Products. 

Office of Hematology and Oncology 

Drug Products. 

Division of Oncology Products 1. 

Division of Oncology Products 2. 

Division of Hematology Products. 

Division of Hematology Oncology 

Toxicology. 

Office of Pharmaceutical Science. 

Program Activities Review Staff. 

Operations Staff. 

Science and Research Staff. 

New Drug Microbiology Staff. 

Office of Generic Drugs. 

Division of Bioequivalence 1. 

Division of Bioequivalence 2. 

Division of Labeling and Program 

Support. 

Labeling Review Branch. 

Regulatory Branch. 

Review Support Branch. 

Division of Chemistry I. 

Division of Chemistry II. 

Division of Chemistry III. 

Division of Chemistry IV. 

Division of Clinical Review. 

Division of Microbiology. 

Office of New Drug Quality 

Assessment. 

Division of New Drug Quality 

Assessment I. 

Branch I. 

Branch II. 

Branch III. 

Division of New Drug Quality 

Assessment II. 

Branch IV. 

Branch V. 

Branch VI. 

Division of New Drug Quality 

Assessment III. 

Branch VII. 

Branch VIII. 

Branch IX. 

Office of Testing and Research. 

Division of Drug Safety Research. 

Division of Pharmaceutical Analysis. 

Division of Product Quality Research. 

Office of Biotechnology Products. 

Division of Monoclonal Antibodies. 

Division of Therapeutic Protein. 

Office of Medical Policy. 

Office of Prescription Drug 

Promotion. 

Division of Consumer Drug 

Promotion. 

Division of Professional Drug 

Promotion. 

Office of Medical Policy Initiatives. 

Division of Medical Policy 

Development. 

Division of Medical Policy Programs. 

Office of Executive Programs. 

Division of Training and 

Development. 

Training and Development Branch I. 

Training and Development Branch II. 

Division of Executive Operations. 

Division of Advisory Committee and 

Consultant Management. 

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. 

Division of Biometrics VII. 

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. 

Division of Pharmacometrics. 

Office of Counter-Terrorism and 

Emergency Coordination. 

Office of Planning and Informatics. 

Office of Planning and Analysis. 

Office of Business Informatics. 

Division of Records Management. 

Division of Regulatory Review 

Support. 

Division of Business Analysis and 

Reporting. 

Division of Project Development. 

Center for Tobacco Products. 

Office of the Center Director. 

Office of Management. 

Office of Policy. 

Office of Regulations. 

Office of Science. 

Office of Health Communication and 

Education. 

Office of Compliance and 

Enforcement. 

Office of Global Regulatory 

Operations and Policy. 

Office of International Programs. 

Office of Regulatory Affairs. 

Office of Resource Management. 

Division of Planning, Evaluation, and 

Management. 

Program Planning and Workforce 

Management Branch. 

Program Evaluation Branch. 

Division of Human Resource 

Development. 

Division of Management Operations. 

Office of Enforcement. 

Division of Compliance Management 

and Operations. 

Division of Compliance Policy. 

Division of Compliance Information 

and Quality Assurance. 

Office of Regional Operations. 


emcdonald on DSK29S0YB1PROD with RULES
15966 Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Rules and Regulations 

Division of Federal-State Relations. 

State Contracts Staff. 

State Information Staff. 

Public Affairs and Health Fraud Staff. 

Division of Field Science. 

FERN National Program Branch. 

Scientific Compliance and Regulatory 

Review Branch. 

Laboratory Operations Branch. 

Division of Import Operations and 

Policy. 

Systems Branch. 

Operations and Policy Branch. 

Division of Foreign Field 

Investigations. 

International Operations Branch. 

Foreign Food Branch. 

Foreign Drug Branch. 

Foreign Devices Branch. 

Division of Domestic Field 

Investigations. 

Team Biologics Staff. 

National Expert Staff. 

Domestic Operations Branch. 

Division of Food Defense Targeting. 

Office of Criminal Investigations. 

Mid-Atlantic Area Office. 

Midwest Area Office. 

Northeast Area Office. 

Pacific Area Office. 

Southeast Area Office. 

Southwest Area Office. 

Regional Food and Drug Directors. 

Regional Field Office, Central Region, 

Chicago, IL. 

State Cooperative Programs Staff I. 

State Cooperative Programs Staff II. 

Regional Operations Staff. 

District Office, Baltimore, MD. 

Compliance Branch. 

Investigations Branch. 

District Office, Cincinnati, OH. 

Compliance Branch. 

Investigations Branch. 

Forensic Chemistry Center. 

Inorganic Chemistry Branch. 

Organic Chemistry Branch. 

District Office, Parsippany, NJ 

Compliance Branch. 

Investigations Branch. 

District Office, Philadelphia, PA. 

Compliance Branch. 

Investigations Branch. 

Laboratory Branch. 

District Office, Chicago, IL. 

Compliance Branch. 

Investigations Branch. 

District Office, Minneapolis, MN. 

Compliance Branch. 

Investigations Branch. 

District Office, Detroit, MI. 

Compliance Branch. 

Investigations Branch. 

Laboratory Branch. 

Regional Field Office, Northeast 

Region, Jamaica, NY. 

Operations Staff. 

Intergovernmental Affairs Staff. 

District Office, New York. 

Domestic Compliance Branch. 

Domestic Investigations Branch. 

Import Operations Branch 

(Downstate). 

Import Operations Branch (Upstate). 

Northeast Regional Laboratory. 

Microbiological Science Branch. 

Food Chemistry Branch. 

Drug Chemistry Branch. 

District Office New England. 

Compliance Branch. 

Investigations Branch. 

Winchester Engineering and 

Analytical Center. 

Analytical Branch. 

Engineering Branch. 

Regional Field Office, Pacific Region, 

Oakland, CA. 

District Office, San Francisco, CA 

Compliance Branch. 

Investigations Branch. 

Laboratory Branch. 

District Office, Los Angeles, CA. 

Compliance Branch. 

Domestic Investigations Branch. 

Import Operations Branch. 

District Office, Seattle, WA. 

Compliance Branch. 

Investigations Branch. 

Pacific Regional Laboratory 

Southwest Los Angeles, CA. 

Food Chemistry Branch. 

Drug Chemistry Branch. 

Microbiology Branch. 

Pacific Regional Laboratory Northwest 

Bothell, WA. 

Chemistry Branch. 

Microbiology Branch. 

Seafood Products Research Center. 

Regional Field Office, Southeast 

Region, Atlanta, GA. 

District Office, Atlanta, GA. 

Compliance Branch. 

Investigations Branch. 

District Office, FL. 

Compliance Branch. 

Investigations Branch. 

District Office, New Orleans, LA. 

Compliance Branch. 

Investigations Branch. 

Nashville Branch. 

District Office, San Juan, PR. 

Compliance Branch. 

Investigations Branch. 

Laboratory Branch. 

Southeast Regional Laboratory, 

Atlanta, GA. 

Chemistry Branch I. 

Microbiology Branch. 

Atlanta Center for Nutrient Analysis. 

Chemistry Branch II. 

Regional Field Office, Southwest 

Region. 

District Office, Dallas, TX. 

Compliance Branch. 

Investigations Branch. 

District Office, Kansas City, MO. 

Compliance Branch. 

Investigations Branch. 

Science Operations Branch. 

Total Diet and Pesticide Research 

Center. 

District Office, Denver, CO. 

Compliance Branch. 

Investigations Branch. 

Laboratory Branch. 

Arkansas Regional Laboratory. 

General Chemistry Branch. 

Pesticide Chemistry Branch. 

Microbiology Branch. 

Southwest Import District Office, 

Dallas, TX. 

Compliance Branch. 

Investigations Branch. 

§ 5.1105 Chief Counsel, Food and Drug 

Administration. 

The Office of the Chief Counsel’s 

mailing address is White Oak Bldg. 1, 

10903 New Hampshire Ave., Silver 

Spring, MD 20993. 

§ 5.1110 FDA public information offices. 

(a) Division of Dockets Management. 

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. The Division of Freedom of 

Information public room is located in 

rm. 1050, Element Bldg., 12420 

Parklawn Dr., Rockville, MD 20857, 

Telephone: 301–796–3900. 

(c) Press Relations Staff. Press offices 

are located in White Oak Bldg. 1, 10903 

New Hampshire Ave., Silver Spring, MD 

20993, Telephone: 301–827–6242; and 

at 5100 Paint Branch Pkwy., College 

Park, MD 20740, Telephone: 301–436– 

2335. 

Dated: March 14, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6517 Filed 3–16–12; 8:45 am] 

BILLING CODE 4160–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 271 

[FRL–9646–5] 

Ohio: Final Authorization of State 

Hazardous Waste Management 

Program Revision 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is granting Ohio final 

authorization of the changes to its 

hazardous waste program under the 

Resource Conservation and Recovery 

Act (RCRA). The agency published a 

proposed rule on September 14, 2011 at 


emcdonald on DSK29S0YB1PROD with RULES