[Federal Register Volume 65, Number 72 (Thursday, April 13, 2000)]
[Rules and Regulations]
[Pages 19829-19833]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9126]


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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 and organization by updating 
the addresses for headquarters and the field offices. This action is 
necessary to ensure the accuracy of the regulations.

DATES: This rule is effective April 13, 2000.

FOR FURTHER INFORMATION CONTACT: Rodolfo Guillen, Jr., Division of 
Management Programs (HFA-340), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4815.

SUPPLEMENTARY INFORMATION: The regulations are being amended in subpart 
C of part 5 (21 CFR part 5) to reflect the central organization of the 
agency and to provide current addresses for headquarters and field 
offices.

[[Page 19830]]

    Notice and comment about the 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).
    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: 15 U.S.C. 504, 552, App. 2; 7 U.S.C. 138a, 2271; 15 
U.S.C. 638, 1261-1282, 3701-3711a; 15 U.S.C. 1451-1461; 21 U.S.C. 
41-50, 61-63, 141-149, 321-394, 467f, 679(b), 801-886, 1031-1309; 35 
U.S.C. 156; 42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263, 
264, 265, 300u-300u-5, 300aa-1; 1395y, 3246b, 4332, 4831(a), 10007-
10008; E.O. 11921, 41 FR 24294, 3 CFR, 1977 Comp., p. 124-131; E.O. 
12591, 52 FR 13414, 3 CFR, 1988 Comp., p. 220-223.

    2. Section 5.200 is revised to read as follows:


Sec. 5.200  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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    Office of the Chief Counsel.
    Office of Equal Opportunity.
    Office of the Administrative Law Judge.
    Office of the Senior Associate Commissioner.
    Office of Executive Secretariat.
    Office of Public Affairs.
    Office of the Ombudsman.
    Office of Orphan Products Development.
    Office of Internal Affairs.
    Office of Executive Operations.
    Office of International and Constituent Relations.
    Office of International Programs.
    Office of Consumer Affairs.
    Office of Women's Health.
    Office of Special Health Issues.
    Office of Policy, Planning, and Legislation.
    Office of Policy.
    Office of Planning.
    Office of Legislation.
    Office of Management and Systems.
    Office of Human Resources and Management Services.
    Office of Information Resources Management.
    Office of Financial Management.
    Office of Facilities, Acquisitions, and Central Services.\2\
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    \2\ Mailing address: 5630 Fishers Lane, Rockville, MD 20852.
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    Center for Biologics Evaluation and Research.\3\
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    \3\ Mailing address: 1401 Rockville Pike, Rockville, MD 20852-
1448.
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    Office of the Center Director.
    Scientific Advisors and Consultants Staff.
    Equal Employment Opportunity and Workforce Diversity Staff.
    Quality Assurance Staff.
    Regulations and Policy Staff.
    Veterinary Services Staff.
    Office of Management.
    Regulatory Information Management Staff.
    Division of Planning, Evaluation, and Budget.
    Division of Management Services.
    Office of Information Technology Management.
    Division of Information Technology Operations.
    Division of Information Technology Development.
    Division of Information Technology Infrastructure.
    Office of Compliance and Biologics Quality.
    Team Biologics Liaison Staff.
    Advertising and Promotional Labeling Staff.
    Division of Case Management.
    Division of Manufacturing and Product Quality.
    Division of Inspections and Surveillance.
    Office of Blood Research and Review.
    Human Tissue Staff.
    Policy and Publications Staff.
    Division of Emerging and Transfusion Transmitted Diseases.
    Division of Hematology.
    Division of Blood Applications.
    Office of Therapeutics Research and Review.
    Division of Cellular and Gene Therapies.
    Division of Therapeutic Proteins.
    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 Bacterial, Parasitic, and Allergenic Products.
    Division of Viral Products.
    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.
    Center for Food Safety and Applied Nutrition.\4\
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    \4\ Mailing address: 200 C St. SW., Washington DC 20204.
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    Office of the Center Director.
    Food Safety Initiatives Staff.
    Senior Science Advisor's Staff.
    Office of Regulations and Policy.
    Regulations Coordination Staff.
    Office of Constituent Operations.
    Consumer Education Staff.
    International Activities Staff.
    Industry Activities Staff.
    Office of Management Systems.
    Safety Management Staff.
    Division of Information Resources Management.
    Division of Planning and Financial Resources Management.
    Division of Management Operations.
    Division of Administrative Services Management.
    Office of Operations.
    Equal Employment Opportunity Staff.
    Executive Operations Staff.
    Office of Cosmetics and Colors.
    Division of Programs and Enforcement Policy.
    Division of Science and Applied Technology.
    Office of Nutritional Products, Labeling, and Dietary Supplements.
    Clinical Research and Review Staff.
    Division of Compliance and Enforcement.
    Division of Standards and Labeling Regulations.
    Division of Nutrition Science Policy.
    Division of Research and Applied Technology.
    Office of Premarket 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 Virulence Assessment.
    Division of Pesticides and Industrial Chemicals.
    Division of Natural Products.
    Division of Food Processing and Packaging.
    Division of Plant Product Safety.
    Division of Dairy and Egg Safety.

[[Page 19831]]

    Division of Risk Assessment.
    Office of Seafood.
    Division of Special Programs.
    Division of Programs and Enforcement Policy.
    Division of Science and Applied Technology.
    Office of Special Research Skills.
    Division of Toxicology Research.
    Division of Microbiological Studies.
    Office of Field Programs.
    Division of Enforcement and Programs.
    Division of HACCP Programs.
    Division of Cooperative Programs.
    Office of Scientific Analysis and Support.
    Division of General Scientific Support.
    Division of Mathematics.
    Division of Market Studies.
    Center for Drug Evaluation and Research.1
    Office of the Center Director.
    Equal Employment Opportunity Staff.
    Executive Operations Staff.
    Regulatory Policy Staff.
    Office of Management.1
    Strategic Planning Staff.\5\
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    \5\ Mailing address: 7500 Standish Pl., Rockville, MD 20855.
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    Division of Management and Budget.5
    Division of Management Services.5
    Office of Training and Communication.1
    Division of Communications Management.
    Division of the Medical Library.
    Division of Training and Development.
    Division of Freedom of Information.
    Office of Compliance.\6\
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    \6\ Mailing address 7520 Standish Pl., Rockville, MD 20855.
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    Division of Manufacturing and Product Quality.
    Division of Prescription Drug Compliance and Surveillance.
    Division of Labeling and Non-Prescription Drug Compliance.
    Office of Information Technology.1
    Quality Assurance Staff.
    Technology Support Services Staff.
    Division of Data Management and Services.
    Division of Applications Development and Services.
    Division of Infrastructure Management and Services.
    Office of Medical Policy.1
    Division of Drug Marketing, Advertising, and 
Communication1
    Division of Scientific Investigations.6
    Office of Review Management.1
    Advisors and Consultants Staff.2
    Office of Drug Evaluation I.1
    Division of Cardio-Renal Drug Products.
    Division of Neuropharmacological Drug Products.
    Division of Oncology Drug Products.
    Office of Drug Evaluation II.1
    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.1
    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 Opthalmologic Drug 
Products.
    Division of Dermatologic and Dental Drug Products.
    Division of Over-the-Counter Drug Products.
    Office of Biostatistics.1
    Quantitative Methods Research Staff.
    Division of Biometrics I.
    Division of Biometrics II.
    Division of Biometrics III.
    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 Pharmaceutical Science.1
    Quality Implementation Staff.1
    Operations Staff.1
    Office of Clinical Pharmacology and Biopharmaceutics.
    Pharmacometrics Staff.
    Division of Pharmaceutical Evaluation I.1
    Division of Pharmaceutical Evaluation II.1
    Division of Pharmaceutical Evaluation III.1
    Office of Generic Drugs.5
    Division of Bioequivalence.
    Division of Chemistry I.
    Division of Chemistry II.
    Division of Labeling and Program Support.
    Office of New Drug Chemistry.1
    Division of New Drug Chemistry I.1
    Division of New Drug Chemistry II.1
    Division of New Drug Chemistry III.1
    Office of Testing and Research.1
    Regulatory Research and Analysis Staff.
    Laboratory of Clinical Pharmacology.\7\
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    \7\ Mailing address: Four Research Ct., Rockville, MD 20850.
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    Division of Applied Pharmacology Research.\8\
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    \8\ Mailing address: 8308 Muirkirk Rd., Laurel, MD 20708.
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    Division of Testing and Applied Analytical Development.\9\
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    \9\ Mailing address: 1114 Market St., St. Louis, MO 63101.
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    Division of Product Quality Research.1
    Office of Regulatory Affairs.1
    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.
    Division of Personnel Operations.
    Office of Enforcement.
    Medical Products Quality Assurance Staff.
    Division of Compliance Management and Operations.
    Division of Compliance Policy.
    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.
    Mid-Atlantic Area Office.\10\
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    \10\ Mailing address: 900 U.S. Courthouse, Second Chestnut St., 
Philadelphia, PA 19106.
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    Midwest Area Office.\11\
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    \11\Mailing address: 901 Warrenville Rd., suite 360, Lisle, IL 
60532.
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    Northeast Area Office.\12\
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    \12\ Mailing address: 850 Third Ave., Brooklyn, NY 11232.
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    Pacific Area Office.\13\
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    \13\ Mailing address: 13301 Clay St., Oakland, CA 94512.
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    Southeast Area Office.\14\
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    \14\ Mailing address: 60 Eighth St. NE., Atlanta, GA 30309.
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    Southwest Area Office.\15\
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    \15\ Mailing address: 7920 Elmbrook Rd., Dallas, TX, 75247.
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    Center for Veterinary Medicine.\16\
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    \16\ Mailing address: 7500 Standish Pl., MPN-2, Rockville, MD 
20855.
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    Office of the Center Director.
    Office of Management and Communications.
    Administrative Staff.
    Communications Staff.
    Program Planning and Evaluation Staff.
    Information Resources Management Staff.
    Office of New Animal Drug Evaluation.
    Division of Therapeutic Drugs for Food Animals.

[[Page 19832]]

    Division of Biometrics and Production Drugs.
    Division of Therapeutic Drugs for Non-Food Animals.
    Division of Human Food Safety.
    Division of Manufacturing Technologies.
    Office of Surveillance and Compliance.
    Division of Surveillance.
    Division of Animal Feeds.
    Division of Compliance.
    Division of Epidemiology.
    Office of Research.
    Administrative Staff.
    Division of Residue Chemistry.
    Division of Animal Research.
    Division of Animal and Food Microbiology.
    Center for Devices and Radiological Health.\17\
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    \17\ Mailing address: 9200 Corporate Blvd., Rockville, MD 20850.
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    Office of the Center Director.
    Equal Employment Opportunity Staff.
    Office of Systems and Management.
    Integrity Committee and Conference Management Staff.
    Division of Management Operations.
    Division of Information Dissemination.
    Division of Information Technology Management.
    Division of Planning, Analysis, and Finance.
    Office of Compliance.
    Promotion and Advertising Policy Staff.
    Division of Bioresearch Monitoring.
    Division of Program Operations.
    Division of Enforcement I.
    Division of Enforcement II.
    Division of Enforcement III.
    Office of Device Evaluation.
    Program Management Staff.
    Program Operations Staff.
    Division of Cardiovascular, Respiratory, and Neurological Devices.
    Division of Reproductive, Abdominal, Ear, Nose, Throat, and 
Radiological Devices.
    Division of General and Restorative Devices.
    Division of Clinical Laboratory Devices.
    Division of Ophthalmic Devices.
    Division of Dental, Infection Control, and General Hospital 
Devices.
    Office of Science and Technology.
    Division of Mechanics and Materials Science.
    Division of Life Sciences.
    Division of Physical Sciences.
    Division of Electronics and Computer Sciences.
    Division of Management Information and Support Services.
    Office of Health and Industry 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.
    National Center for Toxicological Research.\18\
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    \18\ Mailing address: 3900 NCTR Dr., Jefferson, AR 72079.
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    Office of the Center Director.
    Environmental Health and Program Assurance Staff.
    Office of Research.
    Technology Advancement Staff.
    Division of Biochemical Toxicology.
    Division of Genetic and Reproductive Toxicology.
    Division of Biometry and Risk Assessment.
    Division of Microbiology.
    Division of Chemistry.
    Division of Neurotoxicology.
    Division of Veterinary Services.
    Division of Molecular Epidemiology.
    Office of Management.
    Office of Management Services.
    Contracts and Procurement Staff.
    Division of Facilities, Engineering, and Maintenance.
    Division of Administrative Services.
    Office of Planning, Finance and Information Technology.
    Division of Planning.
    Division of Financial Management.
    Division of Information Technology.
    3. Section 5.210 is revised to read as follows:


Sec. 5.210  FDA Public Information Offices.

    (a) Dockets Management Branch (HFA-305). The Dockets Management 
Branch Public Room is located in rm. 1061, 5630 Fishers Lane, 
Rockville, MD 20852. Telephone: 301-827-6860.
    (b) Freedom of Information Staff (HFI-35). The Freedom of 
Information Public Room is located in rm. 12A-30, Parklawn Bldg., 5600 
Fishers Lane, Rockville, MD 20857. Telephone: 301-827-6567.
    (c) Press Relations Staff (HFI-40). The Press Offices are located 
in rm. 15-05, Parklawn Bldg., 5600 Fisher Lane, Rockville, MD 20857. 
Telephone: 301-827-6242; and in rm. 3807, FB-8, 200 C St. SW., 
Washington, DC 20204. Telephone 202-205-4144.
    4. Section 5.215 is revised to read as follows:


Sec. 5.215  Field structure.

NORTHEAST REGION

    Regional Field Office: 850 Third Ave., Brooklyn, NY 11232.
    Northeast Regional Laboratory: 850 Third Ave., Brooklyn, NY 11232-
1593.
    New York District Office: 850 Third Ave., Brooklyn, NY 11232-1593.
    New England District Office: One Montvale Ave., Stoneham, MA 02180.
    Winchester Engineering and Analytical Center: 109 Holton St., 
Winchester, MA 01890.

CENTRAL REGION

    Regional Field Office: U.S. Customhouse, Second and Chestnut Sts., 
rm. 900, Philadelphia, PA 19106.
    Philadelphia District Office: U.S. Customhouse, Second and Chestnut 
Sts., rm. 900, Philadelphia, PA 19106.
    Baltimore District Office: 900 Madison Ave., Baltimore, MD 21201-
2199.
    Cincinnati District Office: 6751 Steger Dr., Cincinnati, OH 45237-
3097.
    Forensic Chemistry Center: 1141 Central Pkwy., Cincinnati, OH 
45202-1097.
    New Jersey District Office: Waterview Corporate Center, 10 
Waterview Blvd., 3d Floor, Parsippany, NJ 07054.
    Chicago District Office: 300 South Riverside Plaza, suite 550, 
South Chicago, IL 60606.
    Detroit District Office: 1560 East Jefferson Ave., Detroit, MI 
48207-3179.
    Minneapolis District Office: 240 Hennepin Ave., Minneapolis, MN 
55401-1912.

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: 555 Winderley, suite 200, Maitland, FL 
32751.
    San Juan District Office: 466 Fernandez Juncos Ave., San Juan, PR 
00901-3223.

SOUTHWEST REGION

    Regional Field Office: 7920 Elmwood Rd., suite 102, Dallas, TX 
75247-4982.
    Dallas District Office: 3310 Live Oak 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-
3338.

[[Page 19833]]

    St. Louis Branch:12 Sunnen Dr., suite 122, St. Louis, MO 63143-
3800.
    Arkansas Regional Laboratory: 3900 NCTR Rd., Bldg. 14-T, rm. 104, 
Jefferson, AR 72079-9502.

PACIFIC REGION

    Regional Field Office: 1301 Clay St., suite 1180-N, Oakland, CA 
94612-5217.
    San Francisco District Office: 1431 Harbor Bay Pkwy., Alameda, CA 
94502-7070.
    Los Angeles District Office: 19900 MacArthur Blvd., suite 300, 
Irvine, CA 92715.
    Seattle District Office: P.O. Box 3012, Bothell, WA 98021-3012.
    Pacific Regional Laboratory, SW.: 1521 West Pico Blvd., Los 
Angeles, CA 90015-2488.
    Pacific Regional Laboratory, NW.: 22201 23d Dr. SE., Bothell, WA 
98021-4421.

    Dated: April 5, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-9126 Filed 4-12-00; 8:45 am]
BILLING CODE 4160-01-F