[Federal Register Volume 60, Number 62 (Friday, March 31, 1995)]
[Rules and Regulations]
[Pages 16567-16570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-7934]



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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 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 accuracy of the 
regulations.

EFFECTIVE DATE: March 31, 1995.

FOR FURTHER INFORMATION CONTACT: Edna Morgan, 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 revisions is not necessary under the 
Administrative Procedure Act because this is a rule of agency 
organization (5 U.S.C. 553(b)). [[Page 16568]] 

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 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 U.S.C. 138a, 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, 361, 362, 1701-
1706; 2101, 2125, 2127, 2128 of the Public Health Service Act (42 
U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263, 263b, 264, 265, 
300u-300u-5, 300aa-1-300aa-25, 300aa-27, 300aa-28); 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 Injury 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\

    \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 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 Biotechnology

Office of Orphan Products Development

National Center for Toxicological Research\2\

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

Environmental Health and Program Assurance Staff.
Scientific Coordination 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

Contaminants Policy Coordination Staff.
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 Field Investigations.
Division of Emergency and Epidemiological Operations.
Division of Import Operations and Policy.

Office of Criminal Investigations\3\

    \3\Mailing address: 7500 Standish Pl., rm. 250N, Rockville, MD 
20855.
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Northeast Area Office.\4\

    \4\Mailing address: 10 Exchange Pl., 18th floor, Jersey City, NJ 
07302.
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Mid-Atlantic Area Office.3
Southeast Area Office.\5\

    \5\Mailing address: 8525 NW 53d Terrace, suite 204, Miami, FL 
33166.
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Midwest Area Office.\6\

    \6\Mailing address: 3 Arboretum 801 Warrenville Rd., suite 550, 
Lisle, IL 60532.
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Southwest Area Office.\7\

    \7\Mailing address: 10901 West 84th Terrace, suite 201, Lenexa, 
KS 66214-3338.
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Pacific Area Office.\8\

    \8\Mailing address: 4365 Executive Dr., suite 230, San Diego, CA 
92122.
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Center for Biologics Evaluation and Research\9\

    \9\Mailing address: 1401 Rockville Pike, suite 200S, Rockville, 
MD 20852-1448.
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Office of the Center Director

Equal Employment and Minority Recruitment Staff.
Congressional and Public Affairs Staff.
Scientific Advisors and Consultants Staff.

Office of Management

Division of Management and Budget.
Division of Scientific and Management Information Systems.
Division of Administrative Management.

Office of Compliance

Division of Case Management.
Division of Bioresearch Monitoring and Regulations.
Division of Inspection 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 16569]] 

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 Research1

Office of the Center Director

Pilot Drug Evaluation Staff.
Advisors and Consultants Staff.
Professional Development Staff.
CDER Executive Secretariat Staff.
Equal Employment Opportunity Staff.

Office of Management

Division of Drug Information Resources.
Division of Information Systems Design.
Medical Library.
Division of Management and Budget.

Office of Compliance

Division of Drug Quality Evaluation.
Division of Drug Labeling Compliance.
Division of Manufacturing and Product Quality.
Division of Scientific Investigations.
Division of Regulatory Affairs.

Office of Drug Evaluation I

Division of Cardio-Renal Drug Products.
Division of Oncology and Pulmonary Drug Products.
Division of Neuropharmacological Drug Products.
Division of Medical Imaging, Surgical, and Dental Drug Products.
Division of Gastrointestinal and Coagulation Drug Products.

Office of Drug Evaluation II

Division of Anti-Infective Drug Products.
Division of Metabolism and Endocrine Drug Products.
Division of Anti-Viral Drug Products.
Division of Topical Drug Products.

Office of Drug Standards

Division of Drug Marketing, Advertising, and Communications.

Office of Epidemiology and Biostatistics

Division of Epidemiology and Surveillance.
Division of Biometrics.

Office of Generic Drugs\10\

    \10\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 Over-the-Counter Drug Evaluation

Monograph Review Staff.
OTC Drug Policy Staff.
Medical Review Staff.

Office of Research Resources

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

Center for Devices and Radiological Health\11\

    \11\Mailing address: 2094 Gaither Rd., Rockville, MD 20850.
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Office of the Center Director

Office of Management Services

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

Office of Health Physics11

Office of Health and Industry Programs\12\

    \12\Mailing address: 1350 Piccard Dr., Rockville, MD 20850.
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Office of Standards and Regulations11

Office of Information Systems\13\

    \13\Mailing address: 2098 Gaither Rd., Rockville, MD 20850.
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Division of Computer Services.
Division of Information Resources.

Office of Compliance11

Division of Program Operations.
Division of Bioresearch Monitoring.
Division of Enforcement 1.
Division of Enforcement 2.
Division of Enforcement 3.

Office of Device Evaluation12

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.
Division of Ophthalmic Devices.

Office of Science and Technology1

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

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 Biometrics12

Division of Biostatistics.\14\

    \14\Mailing address: 9200 Corporate Blvd., Rockville, MD 20850.
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Division of Postmarket Surveillance.
Division of Surveillance Systems.

Center for Food Safety and Applied Nutrition\15\

    \15\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.

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 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. [[Page 16570]] 
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 Management Services and Policy.
Division of Planning and Financial Management.
Division of Information Resources Management.
Division of Administrative Services.

Office of Scientific Analysis and Support

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

Center for Veterinary Medicine\16\

    \16\Mailing address: 7500 Standish Pl., 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: 830 Third Ave., Brooklyn, NY 11232.
Northeast Regional Laboratory: 850 Third Ave., Brooklyn , NY 11232.
New York District Office: 850 Third Ave., Brooklyn, NY 11232.
Boston 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.
Newark 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: 4296 Elysian Fields Ave., New Orleans, LA 
70122.
Orlando 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. 510, Chicago, IL 
60602.
Chicago District Office: 300 South Riverside Plaza, suite 550, 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: 3032 Bryan St., Dallas, TX 75204.
Dallas District Office: 3032 Bryan St., Dallas, TX 75204.
Denver District Office: Bldg. 20, Denver Federal Center, Sixth and 
Kipling Sts., P.O. Box 25087, Denver, CO 80225-0087.
Kansas City District Office: 11630 West 80th St., Lenexa, KS 66214-
3340.
St. Louis Branch: 808 North Collins Alley, St. Louis, MO 63102.

PACIFIC REGION

Regional Field Office: Federal Office Bldg., rm. 568, 50 U.N. Plaza, 
San Francisco, CA 94102.
San Francisco District Office: Federal Office Bldg., rm. 526, 50 U.N. 
Plaza, San Francisco, CA 94102.
Los Angeles District Office: 1521 West Pico Blvd., Los Angeles, CA 
90015-2486.
Seattle District Office: 22201 23d Dr. SE., Bothell, WA 98021-4421.

    Dated: March 27, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-7934 Filed 3-30-95; 8:45 am]
BILLING CODE 4160-01-F