[Federal Register Volume 62, Number 56 (Monday, March 24, 1997)]
[Rules and Regulations]
[Pages 13821-13824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7278]
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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. The agency is also redesignating
certain sections of the regulations to allow for expansion in the
delegation of authority section. This action is necessary to ensure the
continued accuracy of the regulations.
EFFECTIVE DATE: March 24, 1997.
FOR FURTHER INFORMATION CONTACT: L'Tonya J. Barnes, Division of
Management Systems and Policy (HFA-340), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, 301-827-4807.
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. The regulations are also being amended by redesignating
Secs. 5.100, 5.105, 5.110, and 5.115 as Secs. 5.200, 5.205, 5.210, and
5.215, respectively, to permit the expansion of subpart B to allow for
added delegations.
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; secs. 2-12 of the Fair Packaging
[[Page 13822]]
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, 361, 362, 1701-1706,
2101 of the Public Health Service Act (42 U.S.C. 241, 242, 242a,
242l, 242n, 243, 262, 263, 264, 265, 300u-300u-5, 300aa-1); 42
U.S.C. 1395y, 3246b, 4332, 4831(a), 10007-10008; E.O. 11490, 11921,
and 12591.
Sec. 5.100 [Redesignated as Sec. 5.200]
2. Section 5.100 is redesignated as Sec. 5.200 and 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 Administrative Law Judge.
Office of Executive Secretariat.
Office of Equal Employment and Civil Rights.
Office of the Chief Counsel.
Office of Internal Affairs.
Office of External Affairs.
Industry and Small Business Liaison Staff.
Office of 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.
Office of Management and Systems.
Office of Planning and Evaluation.
Office of Human Resources and Management Services.
Office of Facilities, Acquisitions, and Central Services.
Office of Information Resources Management.
Office of Financial 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.
Scientific Coordination Staff.
Technology Advancement Staff.
Office of Planning and Resource Management
Planning Staff.
Financial Management Staff.
Evaluation 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 Administrative Services.
Division of Facilities Engineering and Maintenance.
Office of Regulatory Affairs.\3\
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\3\ Mailing address: 5600 Fishers Lane, Rockville, MD 20857.
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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
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\4\
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\4\ Mailing address: 7500 Standish Pl., rm. 250N, Rockville, MD
20855.
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Northeast Regional Office.\5\
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\5\ Mailing address: 850 Third Ave., Brooklyn, NY 11232.
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Mid-Atlantic Regional Office.\6\
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\6\ Mailing address: 900 U. S. Customhouse, Second and Chestnut
Sts., rm. 900, Philadelphia, PA 19106.
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Southeast Regional Office.\7\
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\7\ Mailing address: 60 Eighth St. NE., Atlanta, GA 30309.
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Midwest Regional Office.\8\
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\8\ Mailing address: 20 North Michigan Ave., Chicago, IL 60606.
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Southwest Regional Office.\9\
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\9\ Mailing address: 7920 Elmbrook Dr., Dallas, TX 75247.
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Pacific Area Office.\10\
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\10\ Mailing address: 13301 Clay St., Oakland, CA 94512.
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Center for Biologics Evaluation and Research.\11\
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\11\ Mailing address: 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448.
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Office of the Center Director
Equal Employment Opportunity Staff.
Scientific Advisors and Consultants Staff.
Quality Assurance Staff.
Congressional and Public Affairs Staff.
Office of Communication, Training and Manufacturers Assistance
Division of Congressional and Public Affairs.
Division of Manufacturers Assistance and Training.
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.
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.
Division of Congressional Public Affairs.
Office of Blood Research and Review
Division of Blood Applications.
Division of Transfusion Transmitted Diseases.
Division of Hematology.
Division of Blood Establishment & Products.
Center for Drug Evaluation and Research.\12\
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\12\ Mailing address: 1451 Rockville Pike, rm. 6027, Rockville,
MD 20850.
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Office of the Center Director
Advisors and Consultants Staff.
Pilot Drug Evaluation Staff.
Executive Operations Staff.
[[Page 13823]]
Equal Employment Opportunity Staff.
Regulatory Policy Staff.
Office of Management
Administrative Staff.
Division of Planning, Evaluation, and Resource Management.
Division of Management Services.
Division of Information Systems Design.
Division of Database Management.
Office of Training and Communications
Freedom of Information Staff.
Division of Training and Development.
Division of Communications Management.
Division of the 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 the Director
Product Quality Support Staff.
Operations Staff.
Office of New Drug Chemistry
Division of New Drug Chemistry I.
Division of New Drug Chemistry II.
Division of New Drug Chemistry III.
Office of Generic Drugs\13\
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\13\ Mailing address: 7500 Standish Pl., rm. 286, 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
Division of Pharmaceutical Evaluation I.
Division of Pharmaceutical Evaluation II.
Division of Pharmaceutical Evaluation III.
Office of Testing and Research
Laboratory of Clinical Pharmacology.
Regulatory Research and Analysis Staff.
Division of Product Quality Research.
Division of Applied Pharmacology Research.
Division of Testing and Applied Analytical Development.
Office of Review Management
Office of the Director
Advisors and Consultants Staff.
Office of Drug Evaluation I
Division of Neuropharmacological Drug Products.
Division of Oncology Drug Products.
Division of Cardio-Renal Drug Products.
Division of Drug Marketing, Advertising and Communication.
Office of Drug Evaluation II
Division of Metabolic and Endocrine Drug Products.
Division of Pulmonary Drug Products.
Office of Drug Evaluation III
Division of Gastrointestinal 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 Ophthalmologic Drug
Products.
Division of Dermatologic and Dental Drug Products.
Division of Over-The-Counter Drug Products.
Office of Epidemiology and Biostatistics
Quantitative Methods and 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.\14\
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14 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 Health and Industry Programs\15\
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\15\ 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.
Program Operations Staff.
Office of Compliance\16\
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\16\ Mailing address: 2098 Gaither Rd., Oak Grove Corporate
Park, Rockville, MD 20850.
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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\17\
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\17\ Mailing address: 9200 Corporate Blvd., Rockville, MD 20850.
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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.\18\
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\18\ 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\19\
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\19\ 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 Sciences.
Division of Management, Information, and Support Services.
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.
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.
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
Equal Employment Opportunity Staff.
Office of Beltsville Technical Operations
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.
[[Page 13824]]
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.
Division of HACCP Programs.
Division of Cooperative Programs.
Division of Field Program Planning and Evaluation.
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 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 and Communications
Administrative Staff.
Communications Staff.
Program Planning and Evaluation Staff.
Information Resources Management Staff.
Office of Surveillance and Compliance
Division of Compliance.
Division of Animal Feeds.
Division of Epidemiology and Surveillance.
Office of New Animal Drug Evaluation
Division of Biometrics and Production Drugs.
Division of Manufacturing Technologies.
Division of Therapeutic Drugs for Food Animals.
Division of Therapeutic Drugs for Non-Food Animals.
Division of Human Food Safety.
Office of Research
Administrative Staff.
Division of Residue Chemistry.
Division of Animal Research.
Sec. 5.105 [Redesignated as Sec. 5.205]
3. Section 5.105 is redesignated as Sec. 5.205.
4. Section 5.110 is redesignated as Sec. 5.210 and 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: 301-443-6310.
(c) Press Relations Staff (HFI-40). The Press Offices are located
in rm. 15-05, Parklawn Bldg., 5600 Fisher Lane, Rockville, MD 20857.
Telephone: 301-443-3285; and in rm. 3807, FB-8, 200 C St. SW.,
Washington, DC 20204. Telephone 202-205-4144.
5. Section 5.115 is redesignated as Sec. 5.215 and 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: 599 Delaware Ave., Buffalo, NY 14202.
MID-ATLANTIC REGION
Regional Field Office: 900 U.S. Customhouse, Second and Chestnut Sts.,
rm. 900, Philadelphia, PA 19106.
Philadelphia District Office: 900 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.
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. 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-
3179.
Minneapolis District Office: 240 Hennepin Ave., Minneapolis, MN 55401-
1912.
SOUTHWEST REGION
Regional Field Office: 7920 Elmbrook Dr., 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 Parkway, 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 98021-4421.
Dated: March 17, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-7278 Filed 3-21-97; 8:45 am]
BILLING CODE 4160-01-F