[Federal Register Volume 63, Number 72 (Wednesday, April 15, 1998)]
[Rules and Regulations]
[Pages 18314-18317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9865]


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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 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: April 15, 1998.

FOR FURTHER INFORMATION CONTACT: Rudy Guillen, Division of Management 
Systems and Policy (HFA-340), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4810.

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.
    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).
    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; 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 Executive Secretariat.
Office of Equal Employment and Civil Rights.
Office of the Administrative Law Judge.
Office of Internal Affairs.
Office of Operations.
Center for Biologics Evaluation and Research. \2\
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    \2\ 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 Staff.
Quality Assurance Staff.
Congressional and Public Affairs Staff.
Regulations and Policy Staff.
Office of Management
Division of Planning, Evaluation, and Budget.
Division of Management Services.
Division of Information Technology Operations.
Division of Infrastructure and Systems Development.
Office of Compliance and Biologics Quality
Team Biologics Liaison Staff.
Division of Case Management.
Division of Inspections and Surveillance.
Division of Manufacturing and Product Quality.
Office of Blood Research and Review
Division of Transfusion Transmitted Diseases.

[[Page 18315]]

Division of Hematology.
Division of Blood Applications.
Division of Blood Establishment and Products.
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.
Regulatory Information Management Staff.
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.
Office of Communication, Training, and Manufacturers Assistance
Division of Congressional and Public Affairs.
Division of Manufacturers Assistance and Training.
Center for Food Safety and Applied Nutrition. \3\
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    \3\ Mailing address: 200 C St. SW., Washington, DC 20204.
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Office of the Center Director
Equal Employment Opportunity Staff.
Office of Policy, Planning, and Strategic Initiatives
Executive Operations Staff.
Office of Programs
Beltsville Technical Operations Staff.
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 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 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
Clinical Research and Review Staff.
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 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 and Programs.
Division of HACCP Programs.
Division of Cooperative Programs.
Office of Management Systems
Safety Management Staff.
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 Drug Evaluation and Research. \4\
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    \4\ Mailing address: 1451 Rockville Pike, Rockville MD 20857
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Office of the Center Director
Advisors and Consultants Staff.
Equal Employment Opportunity Staff.
Pilot Drug Evaluation Staff.
Executive Operations Staff.
Regulatory Policy Staff.
Office of Management
Special Projects Staff.
Division of Planning, Evaluation, and Resource Management.
Division of Management Services.
Office of Training and Communications1
Freedom of Information Staff.
Division of Communications Management.
Division of the Medical Library.
Division of Training and Development.
Office of Compliance \5\
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    \5\ Mailing address: 7520 Standish Pl., Rockville, MD 20857
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Division of Manufacturing and Product Quality.
Division of Scientific Investigations.
Division of Prescription Drug Compliance and Surveillance.
Division of Labeling and Nonprescription Drug Compliance.
Office of Information Technology1
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 Review Management4
Advisors and Consultants Staff.
Office of Drug Evaluation I
Division of Cardio-Renal Drug Products.
Division of Drug Marketing, Advertising and Communication.1
Division of Neuropharmacological Drug Products.
Division of Oncology Drug Products.
Office of Drug Evaluation II
Division of Metabolic and Endocrine Drug Products.
Division of Pulmonary Drug Products.
Division of Reproductive and Urologic Drug Products.
Office of Drug Evaluation III
Division of Anesthetic, Critical Care, and Addiction Drug Products.
Division of Gastro-Intestinal and Coagulation Drug Products.
Division of Medical Imaging and Radiopharmaceutical Drug Products.
Office of Drug Evaluation IV \6\
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    \6\ Mailing address: 9200 Corporate Blvd., Rockville, MD 20850
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Division of Anti-Infective Drug Products.
Division of Anti-Viral Drug Products.
Division of Special Pathogen and Immunologic Drug Products.
Office of Drug Evaluation V
Division of Anti-Inflammatory, Analgesic, and Ophthalmologic Drug 
Products.
Division of Dermatologic and Dental Drug Products.
Division of Over-The-Counter Drug Evaluation.
Office of Epidemiology and Biostatistics1
Quantitative Methods and Research Staff.
Division of Biometrics I.4
Division of Pharmacovigilance and Epidemiology.1
Division of Biometrics II.
Division of Biometrics III.
Division of Biometrics IV.6
Office of Pharmaceutical Science4
Quality Implementation Staff.1
Operations Staff.4
Office of Clinical Pharmacology and Biopharmaceutics
Pharmacometrics Staff.
Division of Pharmaceutical Evaluation I.4
Division of Pharmaceutical Evaluation II.1

[[Page 18316]]

Division of Pharmaceutical Evaluation III.6
Office of Generic Drugs \7\
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    \7\ Mailing address: 7500 Standish Pl., Rockville, MD 20855
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Division of Bioequivalence.
Division of Chemistry I.
Division of Chemistry II.
Division of Labeling and Program Support.
Office of New Drug Chemistry1
Division of New Drug Chemistry I.4
Division of New Drug Chemistry II.1
Division of New Drug Chemistry III. \8\
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    \8\ Mailing address: 9201 Corporate Blvd., Rockville, MD 20850
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Office of Testing and Research1
Regulatory Research and Analysis Staff.
Laboratory of Clinical Pharmacology. \9\
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    \9\ Mailing address: Four Research Ct., Rockville, MD 20850
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Division of Applied Pharmacology Research. \10\
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    \10\ Mailing address: 8301 Muirkird Rd., Rockville, MD 20708
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Division of Testing and Applied Analytical Development. \11\
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    \11\ Mailing address: 1114 Market St., St. Louis, MO 63101
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Division of Product Quality Research.1
Office of Regulatory Affairs \12\
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    \12\ Mailing address: 5600 Fishers Lane, Rockville, MD 20857
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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
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 \13\
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    \13\ Mailing address: 7500 Standish Pl., rm. 250N, Rockville, MD 
20855.
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Northeast Regional Office. \14\
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    \14\ Mailing address: 850 Third Ave., Brooklyn, NY 11232.
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Pacific Area Office. \15\
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    \15\ Mailing address: 13301 Clay St., Oakland, CA 94512.
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Southeast Regional Office. \16\
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    \16\ Mailing address: 60 Eighth St. NE., Atlanta, GA 30309.
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Southwest Regional Office. \17\
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    \17\ Mailing address: 7920 Elmbrook Rd., Dallas, TX 75247.
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Central Regional Office. \18\
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    \18\ Mailing address: 900 U.S. Customhouse, Second Chestnut St., 
Philadelphia, PA 19106.
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National Center for Toxicological Research. \19\
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    \19\ 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.
Scientific Coordination Staff.
Technology Advancement Staff.
Office of Planning and Resource Management
Planning Staff.
Evaluation Staff.
Financial Management Staff.
Office of Research
Research Coordination Staff.
Biomarkers Laboratory Staff.
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 Facilities Engineering and Maintenance.
Division of Administrative Services.
Center for Veterinary Medicine. \20\
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    \20\ 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.
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 Epidemiology and Surveillance.
Division of Animal Feeds.
Division of Compliance.
Office of Research
Administrative Staff.
Division of Residue Chemistry.
Division of Animal Research.
Center for Devices and Radiological Health. \21\
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    \21\ 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.
Financial Resources Staff.
Division of Information Dissemination.
Division of Information Technology Management.
Division of Planning, Analysis and Finance.
Office of Compliance21
Promotion and Advertising Policy Staff.
Division of Program Operations.
Division of Bioresearch Monitoring.
Division of Enforcement I.
Division of Enforcement II.
Division of Enforcement III.
Office of Device Evaluation
Program Operations Staff.
Program Management Staff.
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.
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.
Division of Device User Program and Systems Analysis.
Division of Small Manufacturers Assistance.
Division of Mammography Quality and Radiation Programs.
Division of Communication Media.
Office of Surveillance and Biometrics
Division of Biostatistics.
Division of Postmarket Surveillance.
Division of Surveillance Systems.
Office of Orphan Products Development.1
Office of Science.
Office of External Affairs.1
Industry and Small Business Liaison Staff.
Medwatch Staff.
Office of Public Affairs
Press Relations Staff.
Communications Staff.
Freedom of Information Staff.
Speechwriting Staff.
Management Staff.
Broadcast Media Staff.

[[Page 18317]]

Office of Health Affairs
Medicine Staff.
Health Assessment Policy Staff.
Office of Legislative Affairs
Congressional Affairs Staff I.
Congressional Affairs Staff II.
Special Projects Staff.
Office of Consumer Affairs
Office of AIDS and Special Health Issues
Office of Women's Health
Office of International Affairs
Office of Management and Systems
Operations Coordination Staff.
Executive Management Staff.
Office of Planning and Evaluation
Planning and Management Communications Staff.
Evaluation and Analysis Staff.
Economics Staff.
Office of Information Resources Management
Planning Resources and Information Systems Management Staff.
Administrative Management Staff.
Division of Information Services and Policy.
Division of Operations and Technology Services.
Division of Software Engineering Services.
Division of Facilities Telecommunications and Planning Support.
Office of Financial Management
Division of Financial Systems.
Division of Accounting.
Division of Budget Formulation.
Office of Human Resources and Management Services
Division of Personnel Operations I.
Division of Personnel Operations II.
Division of Employee and Labor Management Relations.
Division of Recruitment and Staffing.
Division of Compensation Benefits and Training.
Division of Management Systems and Policy.
Division of Personnel Operations III.
Office of Facilities, Acquisitions and Central Services \22\
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    \22\ Mailing address: 12420 Parklawn Dr., Rockville, MD 20857
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Policy Evaluation and Support Staff.
Division of Contracts and Procurement Management.
Division of Construction and Facilities Support Contracting.
Division of Central Services.
Division of Real Property Management.
Project Analysis and Evaluation Staff.
Division of Facilities Planning, Engineering and Safety.
Facilities Planning Staff.
FDA Safety Staff.
Office of Policy
Regulations Policy and Management Staff.
Policy Development and Coordination Staff.
Policy Research Staff.
International Policy Staff.
    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. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857. Telephone: 301-443-1753.
    (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: 301-827-6500
    (c) Press Relations Staff (HFI-40). The Press Offices are located 
in rm. 15A-07, Parklawn Bldg., 5600 Fishers Lane, Rockville, MD 20857. 
Telephone: 301-827-6242; and in rm. 3807, FB-8, 200 C St. SW., 
Washington, DC 20204. Telephone 202-245-1141.
    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.
Buffalo District Office: Olympic Towers, 300 Pearl St., Buffalo, NY 
14202.

CENTRAL REGION

Regional Field 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: 1141 Central Pkwy., Cincinnati, OH 45202-
1097.
New Jersey District Office: Waterview Corporate Center, 10 Waterview 
Blvd., 3d Floor, Parsippany, NJ 07054.
Philadelphia District Office: U.S. Customhouse, Second and Chestnut 
Sts., rm. 900, Philadelphia, PA 19106.
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 Pl., suite 200., Maitland, FL 
32751.
San Juan District Office: 466 Fernandez Juncos Ave., San Juan, PR 
00901-3223.

SOUTHWEST REGION

Regional Field Office: 7920 Elmbrook Rd., 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.
St. Louis Branch: 12 Sunnen Dr., St. Louis, MO 63143.

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 92612-2445.
Seattle District Office: 22201 23d Dr. SE., Bothell, WA 98021-4421.

    Dated: April 8, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-9865 Filed 4-14-98; 8:45 am]
BILLING CODE 4160-01-F