[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Pages 24223-24226]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12091]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5


Delegations of Authority and Organization

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
regulations for delegations of authority to set forth the current 
organizational structure of the agency as well as the current addresses 
for headquarters and field offices. This action is necessary to ensure 
the continued accuracy of the regulations.

EFFECTIVE DATE: May 14, 1996.
FOR FURTHER INFORMATION CONTACT: Ellen Rawlings, Division of Management 
Systems and Policy (HFA-340), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-4976.

SUPPLEMENTARY INFORMATION: The regulations are being amended in 21 CFR 
5.100 and 5.115 to reflect the current organizational structure of the 
agency and to provide current addresses for headquarters and for field 
and district offices.
    Notice and comment on these amendments are not necessary under the 
Administrative Procedure Act because this is a rule of agency 
organization (5 U.S.C. 553(b)).
List of Subjects in 21 CFR Part 5

    Authority delegations (Government agencies), Imports, Organization 
and functions (Government agencies).

[[Page 24224]]

    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 amended as follows:

PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION

    1. The authority citation for 21 CFR Part 5 continues to read as 
follows:

    Authority: 5 U.S.C. 504, 552, App. 2; 7 138a U.S.C. 2271; 15 
U.S.C. 638, 1261-1282, 3701-3711a; secs. 2-12 of the Fair Packaging 
and Labeling Act (15 U.S.C. 1451-1461); 21 U.S.C. 41-50, 61-63, 141-
149, 467f, 679(b), 801-886, 1031-1309; secs. 201-903 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321-394); 35 U.S.C. 156; 
secs. 301, 302, 303, 307, 310, 311, 351, 352, 354-360F, 361, 362, 
1701-1706; 2101-2672 of the Public Health Service Act (42 U.S.C. 
241, 242, 242a, 242l, 242n, 243, 262, 263, 263b-263n, 264, 265, 
300u-300u-5, 300aa-1-300ff); 42 U.S.C. 1395y, 3246b, 4332, 4831(a), 
10007-10008; E.O. 11490, 11921, and 12591 secs. 312, 313, 314 of the 
National Childhood Vaccine Act of 1986, Pub. L. 99-660 (42 U.S.C. 
300aa-1 note).
    2. Section 5.100 is revised to read as follows:


Sec. 5.100  Headquarters.-

    The central organization of the Food and Drug Administration 
consists of the following:

Office of the Commissioner\1\
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    \1\Mailing address: 5600 Fishers Lane, Rockville, MD 20857.
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Immediate Office

Office of the Administrative Law Judge.
Office of Executive Operations.
Office of Equal Employment Opportunity and Civil Rights.
Office of Chief Counsel.
Office of Internal Affairs.

Office of External Affairs.

Office of AIDS and Special Health Issues.
Office of Consumer Affairs.
Office of Health Affairs.
Office of Legislative Affairs.
Office of Public Affairs.
Office of Women's Health.
Office of International Affairs.
Industry and Small Business Liaison Staff.

Office of Management and Systems

Office of Planning and Evaluation.
Office of Management.
Office of Information Resources Management.

Office of Policy

Regulations Policy and Management Staff.
Policy Development and Coordination Staff.
Policy Research Staff.
International Policy Staff.

Office of Operations-

Office of Science

Office of Orphan Products Development

National Center for Toxicological Research\2\
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    \2\Mailing address: Jefferson, AR 72079-9502.
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Office of the Center Director

Environmental Health and Program Assurance Staff.
Equal Employment Opportunity Staff.
Technology Advancement Staff.

Office of Planning and Resource Management

Planning Staff.
Financial Management Staff.
Evaluation Staff.

Office of Research

Division of Reproductive and Developmental Toxicology.
Division of Genetic Toxicology.
Division of Biochemical Toxicology.
Division of Nutritional Toxicology.
Division of Biometry and Risk Assessment.
Division of Chemistry.
Division of Microbiology.
Division of Neurotoxicology.

Office of Research Support

Veterinary Services Staff.
Information Technology Staff.
Division of Administrative Services.
Division of Facilities Engineering and Maintenance.

Office of Regulatory Affairs

Office of the Associate Commissioner

Equal Employment Opportunity Staff.
Strategic Initiatives Staff.

Office of Resource Management

Division of Planning, Evaluation, and Management.
Division of Information Systems.
Division of Human Resource Development.
Division of Management Operations.

Office of Enforcement

Division of Compliance Management and Operations.
Division of Compliance Policy.
Division of Medical Products Quality Assurance.

Office of Regional Operations

Division of Federal-State Relations.
Division of Field Science.
Division of Emergency and Investigational Operations.
Division of Import Operations and Policy.

Office of Criminal Investigations\3\
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    \3\Mailing address: 7500 Standish Pl., rm. 250N, Rockville, MD 
20855.
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Northeast Area Office.\4\
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    \4\Mailing address: 10 Exchange Pl., 18th Floor, Jersey City, NJ 
07302.
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Mid-Atlantic Area Office.\5\
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    \5\Mailing address: 7500 Standish Pl., rm. 250N, Rockville, MD 
20855.
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Southeast Area Office.\6\
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    \6\Mailing address: 8525 North West 53d Terrace, suite 204, 
Miami, FL 33166.
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Midwest Area Office.\7\
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    \7\Mailing address: 801 Warrenville Rd., suite 500, Lisle, IL 
60532.
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Southwest Area Office.\8\
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    \8\Mailing address: 10901 West 84th Terrace, suite 201, Lenexa, 
KS 66214-3338.
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Pacific Area Office.\9\
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    \9\Mailing address: 4365 Executive Dr., suite 230, San Diego, CA 
92121.
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Center for Biologics Evaluation and Research\10\
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    \10\Mailing address: 1401 Rockville Pike, suite 200N, Rockville, 
MD 20852-1448.
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Office of the Center Director

Equal Employment Opportunity Staff.
Congressional and Public Affairs Staff.
Scientific Advisors and Consultants Staff.

Office of Communication, Training, and Manufacturers Assistance

Division of Congressional and Public Affairs.

Office of Management

Division of Management Services.
Division of Applied Information Technology.
Division of Planning, Evaluation, and Budget.

Office of Compliance

Division of Case Management.
Division of Regulations and Policy.
Division of Inspections and Surveillance.

Office of Therapeutics Research and Review

Division of Cytokine Biology.
Division of Cellular and Gene Therapies.
Division of Hematologic Products.
Division of Monoclonal Antibodies.
Division of Clinical Trial Design and Analysis.
Division of Application Review and Policy.

Office of Vaccines Research and Review

Division of Allergenic Products and Parasitology.
Division of Bacterial Products.
Division of Viral Products.
Division of Vaccines and Related Products Applications.

[[Page 24225]]

Office of Establishment Licensing and Product Surveillance

Division of Product Quality Control.
Division of Veterinary Services.
Division of Biostatistics and Epidemiology.
Division of Establishment Licensing.

Office of Blood Research and Review

Division of Blood Applications.
Division of Transfusion Transmitted Diseases.
Division of Hematology.

Center for Drug Evaluation and Research\11\
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    \11\Mailing address: 5600 Fishers Lane, WOC II, rm. 6027, 
Rockville, MD 20857.
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Office of the Center Director

Associate Director for Policy.
Regulatory Policy Staff.
Associate Director for Medical Policy.
Division of Drug Marketing, Advertising and Communications.
Executive Operations Staff.
Equal Employment Opportunity Staff.

Office of Management

Division of Management and Budget.
Division of Management Services.
Division of Drug Information Resources.
Division of Information Systems Resources.

Office of Training and Communications

Freedom of Information Staff.
Division of Training and Development.
Division of Communications Management.
Medical Library.

Office of Compliance

Division of Labeling and Nonprescription Drug Compliance.
Division of Prescription Drug Compliance and Surveillance.
Division of Manufacturing and Product Quality.
Division of Scientific Investigations.

Office of Pharmaceutical Science

Office of New Drug Chemistry

Microbiology Team.
Division of New Drug Chemistry I.
Division of New Drug Chemistry II.
Division of New Drug Chemistry III.

Office of Generic Drugs\12\
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    \12\Mailing address: 7500 Standish Pl., rm. 150, Rockville, MD 
20855.
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Division of Chemistry I.
Division of Chemistry II.
Division of Bioequivalence.
Division of Labeling and Program Support.

Office of Clinical Pharmacology and Biopharmaceutics

Pharmacometrics Staff.
Division of Pharmaceutical Evaluation I.
Division of Pharmaceutical Evaluation II.
Division of Pharmaceutical Evaluation III.

Office of Testing and Research

Division of Research and Testing.
Division of Clinical Pharmacology Research.
Division of Drug Analysis.

Office of Review Management

Office of Drug Evaluation I

Division of Neuropharmacological Drug Products.
Division of Oncologic Drug Products.
Division of Cardio-Renal Drug Products.

Office of Drug Evaluation II

Division of Metabolic and Endocrine Drug Products.
Division of Pulmonary Drug Products.

Office of Drug Evaluation III

Division of Gastro-Intestinal and Coagulation Drug Products.
Division of Anesthetic, Critical Care, and Addiction Drug Products.
Division of Medical Imaging and Radiopharmaceutical Drug Products.

Office of Drug Evaluation IV

Division of Anti-Infective Drug Products.
Division of Anti-Viral Drug Products.

Office of Drug Evaluation V

Division of Anti-Inflammatory, Analgesic, and Dental Drug Products.
Division of Dermatologic and Ophthalmologic Drug Products.
Division of Over-The-Counter Drug Evaluation.

Office of Epidemiology and Biostatistics

Quantitative Methods Research Staff.
Division of Pharmacovigilance and Epidemiology.
Division of Biometrics I.
Division of Biometrics II.
Division of Biometrics III.
Division of Biometrics IV.

Center for Devices and Radiological Health\13\
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    \13\Mailing address: 9200 Corporate Blvd., Rockville, MD 20850.
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Office of the Center Director

Office of Systems and Management

Division of Planning, Evaluation, and Information Services.
Division of Resource Management.
Division of Computer Services.
Division of Information Resources.

Office of Health and Industry Programs\14\
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    \14\Mailing address: 1350 Piccard Dr., Rockville, MD 20850.
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Office of Compliance\15\
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    \15\Mailing address: 2094 Gaither Rd., Oak Grove Center, 
Rockville, MD 20850.
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Division of Program Operations.
Division of Bioresearch Monitoring.
Division of Enforcement 1.
Division of Enforcement 2.
Division of Enforcement 3.

Office of Device Evaluation\16\
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    \16\Mailing address: 9200 Corporate Blvd., Rockville, MD 20850.
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Division of Cardiovascular, Respiratory and Neurological Devices.
Division of Reproductive, Abdominal, Ear, Nose, and Throat, and 
Radiological Devices.
Division of General and Restorative Devices.
Division of Clinical Laboratory Devices.\17\
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    \17\Mailing address: 2098 Gaither Rd., Rockville, MD 20850.
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Division of Ophthalmic Devices.
Division of Dental, Infection Control, and General Hospital Devices.

Office of Science and Technology\18\
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    \18\Mailing address: 12720 Twinbrook Pkwy., Bldg. 1, Rockville, 
MD 20857.
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Division of Mechanics and Materials Science.
Division of Life Sciences.
Division of Physical Sciences.
Division of Electronics and Computer Science.
Division of Management, Information, and Support Services.

Office of Health and Industry Programs\19\
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    \19\Mailing address: 1350 Piccard Dr., Rockville, MD 20850.
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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\20\
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    \20\Mailing address: 1350 Piccard Dr., Rockville, MD 20850.
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Division of Biostatistics.
Division of Postmarket Surveillance.
Division of Surveillance Systems.

Center for Food Safety and Applied Nutrition\21\
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    \21\Mailing address: 200 C St. SW., Washington, DC 20204.
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Office of the Center Director

Office of Policy, Planning, and Strategic Initiatives.

[[Page 24226]]

Office of Programs

Office of Cosmetics and Colors

Division of Programs and Enforcement Policy.
Division of Science and Applied Technology.

Office of Food Labeling

Division of Programs and Enforcement Policy.
Division of Technical Evaluation.
Division of Science and Applied Technology.

Office of Pre-Market Approval

Division of Product Policy.
Division of Petition Control.
Division of Health Effects Evaluation.
Division of Molecular Biological Research and Evaluation.
Division of Product Manufacture and Use.

Office of Plant and Dairy Foods and Beverages

Division of Programs and Enforcement Policy.
Division of Microanalytical Evaluations.-
Division of Programs and Enforcement Policy.
Division of Virulence Assessment.
Division of Pesticides and Industrial Chemicals.
Division of Natural Products.
Division of Food Processing and Packaging.

Office of Seafood

Division of Special Programs.
Division of Programs and Enforcement Policy.
Division of Science and Applied Technology.

Office of Special Nutritionals

Division of Programs and Enforcement Policy.
Division of Science and Applied Technology.

Office of Special Research Skills

Division of Toxicological Research.
Division of Microbiological Studies.

Office of Systems and Support

Quality Assurance Staff.

Office of Constituent Operations

Consumer Education Staff.
Legislative Activities Staff.
Industry Activities Staff.
International Activities Staff.

Office of Field Programs

Division of Enforcement.
Division of HACCP Programs.
Division of Cooperative Programs.
Division of Field Program Planning and Evaluation.

Office of Management Systems

Division of Information Resources Management.
Division of Planning and Resources Management.

Office of Scientific Analysis and Support

Division of Mathematics.
Division of General Scientific Support.
Division of Market Studies.

Center for Veterinary Medicine\22\
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    \22\Mailing Address: 7500 Standish Pl., MPN-2, Rockville, MD 
20855.
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Office of the Center Director

Office of Management

Division of Program and Information Systems.
Division of Program Communications and Administrative Management.

Office of Surveillance and Compliance

Division of Compliance.
Division of Animal Feeds.
Division of Surveillance.
Division of Voluntary Compliance and Hearings Development.

Office of New Animal Drug Evaluation

Division of Biometrics and Production Drugs.
Division of Chemistry.
Division of Therapeutic Drugs for Food Animals.
Division of Therapeutic Drugs for Non-Food Animals.
Division of Toxicology and Environmental Sciences.

Office of Science

Division of Residue Chemistry.
Division of Animal Research.
    3. Section 5.115 is revised to read as follows:


Sec. 5.115  Field Structure.

NORTHEAST REGION

Regional Field Office: 850 Third Ave., Brooklyn, NY 11232.
Northeast Regional Laboratory:  850 Third Ave., Brooklyn, NY 11232.
New York District Office:  850 Third Ave., Brooklyn, NY 11232.
New England District Office:  One Montvale Ave., Stoneham, MA 02180.
Buffalo District Office:  599 Delaware Ave., Buffalo, NY 14202.

MID-ATLANTIC REGION

Regional Field Office: 900 U.S. Customhouse, Second and Chestnut Sts., 
Philadelphia, PA 19106.
Philadelphia District Office: 900 U.S. Customhouse, Second and Chestnut 
Sts., -Philadelphia, PA 19106.
Baltimore District Office: 900 Madison Ave., Baltimore, MD 21201.
Cincinnati District Office: 1141 Central Pkwy., Cincinnati, OH 45202-
1097.
New Jersey District Office: Waterview Corporate Center, 10 Waterview 
Blvd., 3d Floor, Parsippany, NJ 07054.

SOUTHEAST REGION

Regional Field Office: 60 Eighth St. NE., Atlanta, GA 30309.
Southeast Regional Laboratory: 60 Eighth St. NE., Atlanta, GA 30309.
Atlanta District Office:  60 Eighth St. NE., Atlanta, GA 30309.
Nashville District Office:  297 Plus Park Blvd., Nashville, TN 37217.
New Orleans District Office:  4298 Elysian Fields Ave., New Orleans, LA 
70122.
Florida District Office: 7200 Lake Ellenor Dr., suite 120, Orlando, FL 
32809.
San Juan District Office: 466 Fernandez Juncos Ave., San Juan, PR 
00901-3223.

MIDWEST REGION

Regional Field Office: 20 North Michigan Ave., rm. 550, Chicago, IL 
60602.
Chicago District Office: 300 South Riverside Plaza, suite 500, South 
Chicago, IL 60606.
Detroit District Office: 1560 East Jefferson Ave., Detroit, MI 48207.
Minneapolis District Office: 240 Hennepin Ave., Minneapolis, MN 55401.

SOUTHWEST REGION

Regional Field Office: 7920 Elmbrook Dr., suite 102, Dallas, TX 75247-
4982.
Dallas District Office: 3032 Bryan St., Dallas, TX 75204.
Denver District Office: Bldg. 20, Denver Federal Center, Sixth and 
Kipling Sts., -P.O. Box 20587, Denver, CO 80255-0087.
Kansas City District Office: 11510 West 80th St., Lenexa, KS 66214-
3340.
St. Louis Branch: 808 North Collins Alley, St. Louis, MO 63102.

PACIFIC REGION

Regional Field Office:  Oakland Federal Office Bldg., suite 1180-N, 
1301 Clay St., Oakland, CA 94512-5217.
San Francisco District Office: 1431 Harbor Bay Pkwy., Alameda, CA 
94502-7070.
Los Angeles District Office: 19900 MacArthur Blvd., suite 300, Irvine, 
CA 92715-2445.
Seattle District Office: 22201 23d Dr. SE., Bothell, WA 98201-4421.

    Dated: May 1, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-12091 Filed 5-13-96; 8:45 am]
BILLING CODE 4160-01-F