[Federal Register Volume 64, Number 3 (Wednesday, January 6, 1999)]
[Notices]
[Pages 888-903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-155]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0046]
Quarterly List of Guidance Documents at the Food and Drug
Administration
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is publishing a
quarterly update of all guidance documents issued and withdrawn since
the compilation of the quarterly list that published on July 6, 1998.
FDA committed to publishing quarterly updates in its February 1997
``Good Guidance Practices'' (GGP's), which set forth the agency's
policies and procedures for the development, issuance, and use of
guidance documents. This list is intended to inform the public of the
existence and availability of guidance documents issued during this
quarter. This list also includes some guidance documents that were
inadvertently not included on previously published lists.
DATES: General comments on this list and on agency guidance documents
are welcome at any time.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Information on where to obtain single copies of
listed guidance documents is provided for each agency center
individually in the specific center's list of guidance documents.
FOR FURTHER INFORMATION CONTACT: Lisa L. Barclay, Office of Policy (HF-
22), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-3360.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of February 27, 1997 (62 FR 8961), FDA
published a notice announcing its ``Good Guidance Practices'' (GGP's),
which set forth the agency's policies and procedures for the
development, issuance, and use of guidance documents. The agency
adopted the GGP's to ensure public involvement in the development of
guidance documents and to enhance public understanding of the
availability, nature, and legal effect of such guidance.
As part of FDA's effort to ensure meaningful interaction with the
public regarding guidance documents, the agency committed to publish an
annual comprehensive list of guidance documents and quarterly Federal
Register notices that list all guidance documents that were issued and
withdrawn during that quarter, including ``Level 2'' guidance
documents. The following list of guidance documents represents all
guidances issued or withdrawn by FDA since the compilation of the July
6, 1998 (63 FR 36413) quarterly list and any guidance documents
inadvertently not included on previously published lists. The guidance
documents are organized by the issuing Center or Office within FDA, and
are further grouped by the intended users or regulatory activities to
which they pertain. Dates provided in the following list refer to the
date of issuance or, where applicable, the date of last revision of the
document. Document numbers are provided where available.
II. Guidance Documents Issued by the Center for Biologics
Evaluation and Research (CBER)
[[Page 889]]
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How to Obtain a Hard Copy of the Document
Name of Document Date of Issuance Grouped by Intended User or (Name and Address, Phone, FAX, E-mail or
Regulatory Activity Internet)
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Draft Guidance for Industry: Manufacturing, March 1998 FDA Regulated Industry Office of Communication, Training, and
Processing or Holding Active Manufacturers Assistance (HFM-40), Center
Pharmaceutical Ingredients for Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, Rockville, MD 20852-
1448, 1-800-835-4709 or 301-827-1800, FAX
Information System: 1-888-CBER-FAX
(within U.S.)or 301-827-3844 (outside
U.S. and local to Rockville, MD).
Internet access: http://www.fda.gov/cber
Draft Guidance for Industry: Instructions May 1998 Do Do
for Submitting Electronic Lot Release
Protocols to the Center for Biologics
Evaluation and Research
Draft Guidance for Industry: Pilot Program May 1998 Do Do
for Electronic Investigational New Drug
(eIND) Applications for Biological
Products
Draft Guidance for Industry: Electronic May 1998 Do Do
Submissions of Case Report Forms (CRF's),
Case Report Tabulations (CRT's) and Data
to the Center for Biologics Evaluation and
Research
Draft Guidance for Industry: Electronic May 1998 Do Do
Submissions of a Biologics License
Application (BLA) or Product License
Application (PLA)/Establishment License
Application (ELA) to the Center for
Biologics Evaluation and Research
Guidance for Industry: Submitting and May 1998 Do Do
Reviewing Complete Responses to Clinical
Holds
Guidance for Industry: Classifying May 1998 Do Do
Resubmissions in Response to Action
Letters
Guidance for Industry: Pharmacokinetics in May 1998 Do Do
Patients with Impaired Renal Function--
Study Design, Data Analysis and Impact on
Dosing and Labeling
Guidance for Industry: Standards for the May 1998 Do Do
Prompt Review of Efficacy Supplements,
Including Priority Efficacy Supplements
Guidance for Industry: Providing Clinical May 1998 Do Do
Evidence of Effectiveness for Human Drugs
and Biological Products
Draft Guidance for Industry: Stability June 1998 Do Do
Testing of Drug Substances and Drug
Products
ICH Draft Guidance on Specifications: Test June 9, 1998 Do Do
Procedures and Acceptance Criteria for
Biotechnological/Biological Products
ICH Guidance on Ethnic Factors in the June 10, 1998 Do Do
Acceptability of Foreign Clinical Data
Draft Guidance for Industry: Exports and June 12, 1998 Do Do
Imports Under the FDA Export Reform and
Enhancement Act of 1996
Draft Guidance for Industry: Content and June 1998 Do Do
Format of Chemistry, Manufacturing and
Controls Information and Establishment
Description Information for a Vaccine or
Related Product
Guidance for Industry: Qualifying for June 1998 Do Do
Pediatric Exclusivity Under Section 505A
of the Federal Food, Drug and Cosmetic Act
[[Page 890]]
Draft Guidance for Industry: In the July 1998 Do Do
Manufacture and Clinical Evaluation of In
Vitro Tests to Detect Nucleic Acid
Sequences of Human Immunodeficiency Virus
Type 1
Draft Guidance for Industry: For the July 1998 Do Do
Submission of Chemistry, Manufacturing and
Controls and Establishment Description
Information for Human Blood and Blood
Components Intended for Transfusion or for
Further Manufacture and For the Completion
of the FDA Form 356h ``Application to
Market a New Drug, Biologic or an
Antibiotic Drug for Human Use''
Guidance for Industry: Implementation of July 1998 Do Do
Section 126 of the Food and Drug
Administration Modernization Act of 1997--
Elimination of Certain Labeling
Requirements
Guidance for Industry: Environmental July 1998 Do Do
Assessment of Human Drug and Biologics
Applications
Draft Guidance for Industry: July 1998 Do Do
Recommendations for Collecting Red Blood
Cells by Automated Apheresis Methods
Draft Guidance for Industry: Content and August 1998 Do Do
Format of Chemistry, Manufacturing and
Controls Information and Establishment
Description Information for an Allergenic
Extract or Allergen Patch Test
ICH Guidance on Statistical Principles for September 16, 1998 Do Do
Clinical Trials
ICH Guidance on Quality of Biotechnological/ September 21, 1998 Do Do
Biological Products: Derivation and
Characterization of Cell Substrates Used
for Production of Biotechnological/
Biological Products
Guidance for Industry: Current Good September 1998 Do Do
Manufacturing Practice for Blood and Blood
Components: (1) Quarantine and Disposition
of Units from Prior Collections from
Donors with Repeatedly Reactive Screening
Tests for Antibody to Hepatitis C Virus
(Anti-HCV); (2) Supplemental Testing, and
the Notification of Consignees and Blood
Recipients of Donor Test Results for Anti-
HCV
ICH Guidance on Viral Safety Evaluation of September 24, 1998 Do Do
Biotechnology Products Derived From Cell
Lines of Human or Animal Origin
Guidance for Industry: Errors and Accidents June 1998 Do Do
Regarding Saline Dilution of Samples Used
for Viral Marker Testing (Level 2)
Guidance for Industry: How to Complete the September 1998 Do Do
Vaccine Adverse Reporting System Form
(VAERS-1) (Level 2)
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Withdrawn
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Guidance for Industry: Supplemental Testing September 1998 Do Do
and the Notification of Consignees of
Donor Test Results for Antibody to
Hepatitis C Virus (Anti-HCV)--March 1998
[[Page 891]]
Memorandum: Revised Precautionary Measures September 1998 Do Do
to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease
(CJD) by Blood and Blood Products--
December 11, 1996 (Partial Withdrawal)
(Withdrawal of recommendations pertaining
to retrieval, quarantine, destruction, and
notification for plasma derivatives)
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III. Guidance Documents Issued by the Center for Devices and
Radiological (CDRH)
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How to Obtain a Hard Copy of the Document
Name of Document Date of Issuance Grouped by Intended User or (Name and Address, Phone, FAX, E-mail or
Regulatory Activity Internet)
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Medical Devices: Draft Global Harmonization July 16, 1998 Office of Compliance (OC) Division of Small Manufacturers
Task Force Study Group 3 Process Assistance, 1-800-638-2041 or 301-827-
Validation Guidance (Draft) 0111 or (FAX) Facts-on-Demand at 1-800-
899-0381 or Internet at http://
www.fda.gov/cdrh
Global Harmonization Task Force: Draft October 28, 1998 Do Do
Document on the Essential Principles of
Safety and Performance of Medical Devices
on a Global Basis
Global Harmonization Task Force: August 31, 1998 OC/Office of Surveillance and Do
Availability of Draft Documents on Adverse Biometrics (OSB)
Event and Vigilance Reporting of Medical
Device Events
Guidance for Industry--Contents of a PDP April 25, 1998 Office of Device Evaluation (ODE)
Medical Device Labeling--Suggested Format May 9, 1997 Do Do
and Content
Guidance for the Content of Premarket May 28, 1998 Do Do
Submissions for Software Contained in
Medical Devices (replaces Reviewer
Guidance for Computer-Controlled Medical
Devices Undergoing 510(k) Review 8/29/91)
New Model Medical Device Development June 3, 1998 Do Do
Process
Modifications to Devices Subject to August 6, 1998 Do Do
Premarket Approval the PMA Supplement
Decision Making Process
Guidance for Off-the Shelf Software Use in August 17, 1998 Do Do
Medical Devices
Convenience Kits Interim Regulatory May 20, 1997 Do Do
Guidance
Kit Certification for 510(k)s July 1997 Do Do
Guidance to Industry Supplements to May 20, 1998 Do Do
Approved Applications for Class III
Medical Devices: Use of Published
Literature, Use of Previously Submitted
Materials, and Priority Review
30-Day Notices and 135-Day PMA Supplements February 19, 1998 Do Do
for Manufacturing Method or Process
Changes, Guidance for Industry and CDRH
Procedures for Class II Device Exemptions February 19, 1998 Do Do
from Premarket Notification, Guidance for
Industry and CDRH Staff
Guidance for Submission of June 6, 1998 ODE/Division of Clinical Laboratory Do
Immunohistochemistry Applications to the Devices (DCLD)
FDA
[[Page 892]]
In Vitro Diagnostic Creatinine Test System July 2, 1998 Do Do
In Vitro Diagnostic Bicarbonate/Carbon July 6, 1998 Do Do
Dioxide Test System
In Vitro Diagnostic Chloride Test System July 6, 1998 Do Do
In Vitro Diagnostic Glucose Test System July 6, 1998 Do Do
In Vitro Diagnostic Potassium Test System July 6, 1998 Do Do
In Vitro Diagnostic Sodium Test System July 6, 1998 Do Do
In Vitro Diagnostic Urea Nitrogen Test July 6, 1998 Do Do
System
In Vitro Diagnostic C-Reactive July 20, 1998 Do Do
Immunological Test System
In Vitro Diagnostic Calibrators July 20, 1998 Do Do
Points To Consider For Hematology Quality September 30, 1997 Do Do
Control Materials
Points to Consider for Approval of Home September 16, 1997 Do Do
Drugs of Abuse Test Kits Draft
Review Criteria for Assessment of November 6, 1996 Do Do
Professional Use Human Chorionic
Gonadotropin (hCG) in Vitro Diagnostic
Devices (IVD's)
Letter to IVD Manufacturers on Streamlined December 22, 1997 Do Do
PMA
Reviewer Guidance for Premarket July 19, 1995 ODE/Division of Cardiovascular, Do
Notification (510(k)) Submissions-- Respiratory, and Neurological
Labeling, Performance and Environmental Devices (DCRND)
Testing for Electronic Devices
Draft Guidance for Format and Content for July 19, 1995 Do Do
Premarket Notification 510(k)
Guidance on the Content and Format of December 18, 1997 ODE/Division of Dental, Infection Do
Premarket Notifications [510(k)] Control, and General Hospital
Submissions for Liquid Chemical Sterilants Devices (DDIGD)
and High Level Disinfectants
Guidance on the Content and Format of January 16, 1998 Do Do
Premarket Notification [510(k)]
Submissions for Surgical Masks
Guidance on the Content and Format of February 13, 1998 Do Do
Premarket Notification [510(k)]
Submissions for Testing for Skin
Sensitization to Chemicals in Latex
Products
CDRH Regulatory Guidance Document for April 27, 1998 Do Do
Preamendments Unclassified Washers and
Washer-Disinfectors Intended for
Processing Reusable Medical Devices
Guidance on the Content and Format of August 4, 1998 Do Do
Premarket Notification [510(k)]
Submissions of Washers and Washer-
Disinfectors
Devices for the Treatment and/or Diagnosis June 10, 1998 Do Do
of Temporomandibular Joint Dysfunction and/
or Orofacial Pain
Dental Impression Materials Premarket August 17, 1998 Do Do
Notification
OTC Denture Cushions, Pads, Reliners, August 18, 1998 Do Do
Repair Kits, and Partially Fabricated
Denture Kits
Dental Cements Premarket Notification August 18, 1998 Do Do
Further Information on the Regulation of August 18, 1997 Do Do
Liquid Chemical Sterilants and High Level
Disinfectants
Letter to Orthopedic Surgical Manufacturers November 26, 1997 ODE/Division of General and Do
Association Restorative Devices (DGRD)
Letter to the Health Industry Manufacturers November 26, 1997 Do Do
Association
[[Page 893]]
Guidance Document for Industry and CDRH March 18, 1998 Do Do
Staff for the Preparation of
Investigational Device Exemptions and
Premarket Approval Applications for Bone
Growth Stimulator Devices (Replaces:
Guidance Document for the Preparation of
Investigational Device Exemptions and
Premarket Approval Applications for Bone
Growth Stimulator Devices 8/12/88)
Guidance for Content of Premarket April 28, 1998 Do Do
Notifications for Esophageal and Tracheal
Prostheses
Guidance Document for Surgical Lamp 510ks July 13, 1998 Do Do
Retinoscope Guidance July 8, 1998 ODE/Division of Opthalmic Devices Do
(DOD)
Opthalmoscope Guidance July 8, 1998 Do Do
Slit Lamp Guidance July 8, 1998 Do Do
Revised Procedures for Adding Lens August 11, 1998 Do Do
Finishing Laboratories to Approved
Premarket Approval Applications for Class
III Rigid Gas Permeable Contact Lens for
Extended Wear
Third Party Review Guidance for Vitreous January 31, 1997 Do Do
Aspiration and Cutting Device Premarket
Notification (510K)
Third Party Review Guidance for January 31, 1997 Do Do
Phacofragmentation System Device Premarket
Notification (510K)
Dear Sponsor Letter Concerning the May 20, 1997 Do Do
Revocation of 21 CFR part 813 IOL IDE
Regulations
Guidance for the Content of Premarket August 7, 1998 ODE/Division of Reproductive Do
Notification for Conventional and High Abdominal, ENT, and Radiological
Permeability Hemodialyzers (replaces: Devices (DRAERD)
Guidelines for Premarket Testing of New
Conventional Hemodialyers, High
Premeability Hemodialyzers and
Hemofilters)
Uniform Contraceptive Labeling July 23, 1998 Do Do
Guidance for the Content of Premarket August 7, 1998 Do Do
Notifications for Conventional and High
Permeability Hemodialyzers
Guidance for Industry and CDRH Reviewers on August 7, 1998 Do Do
the Content of Premarket Notifications for
Hemodialysis Delivery Systems
Devices Used for In Vitro Fertilization and September 10, 1998 Do Do
Related Assisted Reproduction Procedures
Letter to Manufacturers of Falloposcopes September 5, 1996 Do Do
Letter to Manufacturers of Prescription September 6, 1996 Do Do
Home Monitors for Non-Stress Tests
Continuing Education Credits for Reading/ April 17, 1998 Office of Health and Industry Do
Writing Articles/Papers and Presenting Programs (OHIP)/Division of
Courses/Lectures Mammography Quality and Radiation
Programs (DMQRP)
Accidental Radioactive Contamination of August 13, 1998 Do Do
Human Food and Animal Feeds:
Recommendations for State and Local
Agencies
Additional Mammography Review Policy March 26, 1998 Do Do
Guidance For Review of Cases of Possible March 26, 1998 Do Do
Suspension or Revocation of Mammography
Facility Certificates Under the
Mammography Quality Standards Act, 42.
U.S.C. section 263b
[[Page 894]]
Guidance for Review of Requests for March 26, 1998 Do Do
Reconsideration of Adverse Decisions on
Accreditation of Mammography Facilities
Under the Mammography Quality Standards
Act, 42. U.S.C. section 263b
Guidance for Submission of Requests for March 26, 1998 Do Do
Reconsideration of Adverse Decisions on
Accreditation of Mammography Facilities
Under the Mammography Quality Standards
Act, 42. U.S.C. section 263b
Supplement to ``The Physician's Continuing April 9, 1998 Do Do
Experience Requirement''
Requalification for Interpreting May 28, 1998 Do Do
Physician's Continuing Experience
MQSA Policy Statements in a Question and June 2, 1998 Do Do
Answer
Compliance Guidance: The Mammography July 8, 1998 Do Do
Quality Standards Act Final Regulations
MQSA Policy Statements for the Interim August 6, 1998 Do Do
Regulations
Policy for Facilities Changing April 15, 1998 Do Do
Accreditation Bodies
Guidance on FDA's Expectations of Medical May 15, 1998 Office of Science and Technology Do
Device Manufacturers Concerning the Year (OST)/ Division of Electronics and
2000 Date Computer Science (DESC)
Immunotoxicity Testing 1996 OST/Division of Life Sciences (DLS) Do
Guidance on the Recognition and Use of February 19, 1998 OST/Office of the Director (OD) Do
Consensus Standards
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Deletions
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Biotechnology and FDA Regulation of January 1, 1986 ODE Do
Hybridoma In-Vitro Diagnostic Products:
List of Current Devices and Guidelines for
Manufacturers
DCRND--Draft Guidance for Format and July 19, 1995 ODE/DCRND Do
Content for Premarket Notification 510(k)
[replaces 908] [cardiovascular,
respiratory, neurological]
Guidance for Safety and Effectiveness Data March 1, 1983 Do Do
Required in Premarket Notification
(510(k)) Applications for Blood
Oxygenators
Automated Defibrillators: Operator's Shift August 8, 1991 Do Do
Checklist and Manual Defibrillators:
Operator's Shift Checklist
Guidance for the Preparation and Content of December 4, 1987 Do Do
Applications to the Food and Drug
Administration for Ventricular Assist
Devices and Total Artificial Hearts
(draft)
Guidance Document for the Preparation of August 12, 1988 ODE/DGRD/ORDB Do
IDE and PMA Applications for Bone Growth
Stimulator Devices
Reviewer Guidance for Computer Controlled August 29, 1991 ODE Do
Medical Devices Undergoing 510(k) Review
Guidelines for Premarket Testing of New March 1, 1982 ODE/DRAERD/GRDB Do
Conventional Hemodialyzers, High
Permeability Hemodialyzers, and
Hemofilters
Frequently Asked Questions on Recognition February 19, 1998 OST Do
of Consensus Standards
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Corrections
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[[Page 895]]
Determining Equivalence of Intraaortic December 8, 1993 ODE/DCRND Do
Balloon Catheters Under the 510(k)
Regulations
Guidance for the Preparation of the Annual September 1, 1990 Do Do
Report to the PMA Approved Heart Valve
Prostheses
Electrocardiograph (ECG) Electrode February 11, 1997 Do Do
Electrocardiograph (ECG) Lead Switching February 11, 1997 Do Do
Adapter
Electrocardiograph (ECG) Surface Electrode February 11, 1997 Do Do
Tester
Reviewer Guidance for Nebulizers, Metered October 1, 1993 Do Do
Dose Inhalers, Spacers and Actuators
Reexamination of the Evaluation Process for May 19, 1997 ODE/DDIGD Do
Liquid Chemical Sterilant and Height Level
Disinfectants
FDA Guidelines for Multifocal Intraocular May 29, 1997 ODE/DOD Do
Lens IDE Studies and PMAs
Information for Manufacturers Seeking September 30, 1997 ODE/DRAERD/RDB Do
Marketing Clearance of Diagnostic
Ultrasound Systems and Transducers
Tympanostomy Tubes, Submission Guidance for January 14, 1998 ODE/DRAERD Do
a 510(k) Premarket Notification
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IV. Guidance Documents Issued by the Center for Drug Evaluation and
Research (CDER)
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How to Obtain a Hard Copy of the Document
Name of Document Date of Issuance Grouped by Intended User or (Name and Address, Phone, FAX, E-mail or
Regulatory Activity Internet)
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Topical Dermatological Drug Product NDA's June 18, 1998 Biopharmaceutic Office of Training and Communication, Drug
and ANDA's--In Vivo Bioavailability, Information Branch, Food and Drug
Bioequivalence, In Vitro Release and Administration, 5600 Fishers Lane,
Associated Studies, Draft Rockville, MD 20857. Internet access:
http://www.fda.gov/cder/guidance/
index.htm
Buspirone Hydrochloride Tablets In Vivo May 15, 1998 Do Do
Bioequivalence and In Vitro Dissolution
Testing
SUPAC IR/MR: Immediate Release and Modified April 28, 1998 Chemistry Do
Release Solid Oral Dosage Forms
Manufacturing Equipment Addendum, Draft
Stability Testing of Drug Substances and June 8, 1998 Do Do
Drug Products, Draft
PAC-ATLS: Postapproval Changes- Analytical April 28, 1998 Do Do
Testing Laboratory Sites
Environmental Assessment of Human Drugs and July 27, 1998 Do Do
Biologics Applications
Uncomplicated and Complicated Skin and Skin July 22, 1998 Clinical Antimicrobial Guidances Do
Structure Infections; Developing
Antimicrobial Drugs for Treatment, Draft
Acute Bacterial Meningitis; Developing July 22, 1998 Do Do
Antimicrobial Drugs for Treatment, Draft
Uncomplicated Gonorrhea--Cervical, July 22, 1998 Do Do
Urethral, Rectal, and/or Pharyngeal;
Developing Antimicrobial Drugs for
Treatment, Draft
Complicated Urinary Tract Infections and July 22, 1998 Do Do
Pylonephritis; Developing Antimicrobial
Drugs for Treatment, Draft
[[Page 896]]
Streptococcal Pharyngitis and Tonsillitis; July 22, 1998 Do Do
Developing Antimicrobial Drugs for
Treatment, Draft
Secondary Bacterial Infections of Acute July 22, 1998 Do Do
Bronchitis; Developing Antimicrobial Drugs
for Treatment, Draft
Uncomplicated Urinary Tract Infections; July 22, 1998 Do Do
Developing Antimicrobial Drugs for
Treatment, Draft
Nosocomial Pneumonia; Developing July 22, 1998 Do Do
Antimicrobial Drugs for Treatment, Draft
Vulvovaginal Candidiasis; Developing July 22, 1998 Do Do
Antimicrobial Drugs for Treatment, Draft
Lyme Disease; Developing Antimicrobial July 22, 1998 Do Do
Drugs for Treatment, Draft
Empiric Therapy of Febrile Neutropenia; July 22, 1998 Do Do
Developing Antimicrobial Drugs for
Treatment, Draft
Community Acquired Pneumonia; Developing July 22, 1998 Do Do
Antimicrobial Drugs for Treatment, Draft
Bacterial Vaginosis; Developing July 22, 1998 Do Do
Antimicrobial Drugs for Treatment, Draft
Acute Otitis Media; Developing July 22, 1998 Do Do
Antimicrobial Drugs for Treatment, Draft
Acute Bacterial Sinusitis; Developing July 22, 1998 Do Do
Antimicrobial Drugs for Treatment, Draft
Acute Bacterial Exacerbation of Chronic July 22, 1998 Do Do
Bronchitis; Developing Antimicrobial Drugs
for Treatment, Draft
General Considerations for Clinical Trials; July 22, 1998 Do Do
Developing Antimicrobial Drugs for
Treatment, Draft
Acute or Chronic Bacterial Prostatitis; July 22, 1998 Do Do
Developing Antimicrobial Drugs for
Treatment, Draft
Submission of Abbreviated Reports and September 21, 1998 Clinical Medical Do
Synopses in Support of Marketing
Applications; Draft
Developing Medical Imaging Drugs and October 13, 1998 Do Do
Biologics
Providing Clinical Evidence of May 15, 1998 Do Do
Effectiveness for Human Drug and
Biological Products
Pharmacokinetics and Pharmacodynamics in May 15, 1998 Clinical Pharmacology Do
Patients with Impaired Renal Function:
Study Design, Data Analysis, and Impact on
Dosing and Labeling
Manufacture, Processing or Holding of April 17, 1998 Compliance Do
Active Pharmaceutical Ingredients, Draft
Investigating Out of Specification (OOS) September 30, 1998 Do Do
Test Results for Pharmaceutical Production
ANDA's: Impurities in Drug Substances, July 24, 1998 Generic Drug Do
Draft
E5 Ethnic Factors in the Acceptability of June 10, 1998 ICH Efficacy Do
Foreign Clinical Data, Draft
E9 Statistical Principles for Clinical September 16, 1998 Do Do
Trials
Q6B Specifications: Test Procedures and June 9, 1998 ICH Quality Do
Acceptance Criteria for Biotechnological/
Biological Products, Draft
Q5D Quality of Biotechnological/Biological September 21, 1998 Do Do
Products: Derivation and Characterization
of Cell Substrates Used for Production of
Biotechnological/Biological Products
Q5A Biotechnological/Biological September 24, 1998 Do Do
Pharmaceutical Products; Viral Safety
Evaluation
[[Page 897]]
OTC Topical Drug Products for the Treatment July 16, 1998 Labeling Do
of Vaginal Yeast Infections (Vulvovaginal
Candidiasis), Draft
Dipirefrin Hydrochloride Opthalmic Solution October 1, 1998 Do Do
USP
Non-Contraceptive Estrogen Class Labeling October 15, 1998 Do Do
Submitting Debarment Certification October 2, 1998 Procedural Guidances Do
Statements, Draft
National Uniformity for Nonprescription April 9, 1998 Do Do
Drugs Ingredient Labeling for OTC Drugs
Standards for the Prompt Review of Efficacy May 15, 1998 Do Do
Supplements, Including Priority Efficacy
Supplements
Repeal of Section 507 of the Federal Food, June 15, 1998 Do Do
Drug, and Cosmetic Act
Qualifying for Pediatric Exclusivity Under June 29, 1998 Do Do
Section 505A of the Federal Food, Drug,
and Cosmetic Act
180-Day Generic Drug Exclusivity Under the July 14, 1998 Do Do
Hatch-Waxman Amendments to the Federal
Food, Drug, and Cosmetic Act
Implementation of Section 126, Elimination July 21, 1998 Do Do
of Certain Labeling Requirements of the
FDA Modernization Act of 1997
Advisory Committees: Implementing Section November 2, 1998 Do Do
120 of the FDA Modernization Act of 1997
Submitting and Reviewing Complete Responses May 14, 1998 User Fee Do
to Clinical Holds
Classifying Resubmissions in Response to May 14, 1998 Do Do
Action Letters
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Withdrawn
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Pharmacokinetic Considerations in Drug Biopharmaceutic
Studies
Carbamazepine (tablets) In Vivo January 20, 1988 Do
Bioequivalence and In Vitro Dissolution
Testing
Evaluation of Controlled Release Drug April 18, 1984 Do
Products; Division Guidelines
Approaches to Statistical Data Analysis of November 11, 1985 Do
Bioavailability/Bioequivalence Studies
Controlled Release Dosage Forms: Issues and September 10, 1985 Do
Controversies (Conference Report)
Submission of Data for Bioequivalence Do
Studies in Computer Format
Albuterol Inhalation Aerosols (Metered Dose January 27, 1994 Do
Inhalers) In Vivo Bioequivalence and In
Vitro Dissolution Testing
Albuterol Sulfate (tablets) In Vivo May 29, 1987 Do
Bioequivalence and In Vitro Dissolution
Testing
Amoxapine (tablets) In Vivo Bioequivalence August 5, 1988 Do
and In Vitro Dissolution Testing
Atenolol (tablets) In Vivo Bioequivalence October 6, 1988 Do
and In Vitro Dissolution Testing
Clindamycin Hydrochloride (capsules) In May 31, 1988 Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Diazepam In Vivo Bioequivalence Study July 8, 1985 Do
Dipyridamole Drug Products Bioavailability September 25, 1987 Do
Disopyramide Phosphate (Capsules) July 9, 1985 Do
Doxepin Hydrochloride Drug Products In Vivo October 9, 1986 Do
Bioequivalence Study
Doxycycline Hyclate In Vivo Studies and In April 11, 1988 Do
Vitro Dissolution Testing
[[Page 898]]
Erythromycin Capsules (Enteric Coated September 21, 1988 Do
Pellets) In Vivo Bioequivalence Study and
In Vitro Dissolution Testing
Fenoprofen (capsules and tablets) In Vivo February 3, 1988 Do
Bioequivalence Study and In Vitro
Dissolution Testing
Haloperidol (tablets) In Vivo April 30, 1987 Do
Bioequivalence Study and In Vitro
Dissolution Testing
Hydroxyzine Pamoate (capsules) In Vivo September 28, 1987 Do
Bioequivalence Study and In Vitro
Dissolution Testing
Isosorbide Dinitrate (chewable tablets, September 22, 1987 Do
oral tablets, and sublingual tablets) In
Vivo Bioequivalence Study and In Vitro
Dissolution Testing
Isosorbide Dinitrate (Controlled Release) November 6, 1985 Do
In Vivo Bioavailability Studies
Lorazepam (tablets) In Vivo Bioequivalence September 16, 1987 Do
Study and In Vitro Dissolution Testing
Megestrol Acetate (tablets) In Vivo August 17, 1987 Do
Bioequivalence Study and In Vitro
Dissolution Testing
Methylprednisolone (tablets) In Vivo June 12, 1986 Do
Bioequivalence Study and In Vitro
Dissolution Testing
Minoxidil (tablets) June 12, 1986 Do
Nafcillin Sodium (Capsules and Tablets) In September 10, 1987 Do
Vivo Bioequivalence Study and In Vitro
Dissolution Testing
Norethindrone and Ethinyl Estradiol March 18, 1988 Do
(tablets) In Vivo Bioequivalence Study and
In Vitro Dissolution Testing
Norethindrone and Mestranol (tablets) In May 13, 1988 Do
Vivo Bioequivalence Study and In Vitro
Dissolution Testing
Orphenadrine Citrate (tablets) In Vivo July 22, 1983 Do
Bioequivalence Study and In Vitro
Dissolution Testing
Procainamide In Vivo Bioavailability September 28, 1987 Do
Studies
Rifampin (capsules) In Vivo Bioequivalence September 8, 1988 Do
Study and In Vitro Dissolution Testing
Silver Sulfadiazine (cream) May 7, 1987 Do
Spironolactone In Vivo Single Dose Studies January 1, 1986 Do
and In Vitro Dissolution Testing
Sulfasalazine (tablets) In Vivo October 8, 1987 Do
Bioequivalence and In Vitro Dissolution
Testing
Sulindac (tablets) In Vivo Bioequivalence July 18, 1988 Do
and In Vitro Dissolution Testing
Theophylline (conventional dosage form) In September 1, 1984 Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Timolol Maleate (tablets) In Vivo August 9, 1988 Do
Bioequivalence and In Vitro Dissolution
Testing
Tolmetin Sodium (tablets and capsules) In October 6, 1994 Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Triazolam (tablets) In Vivo Bioequivalence December 24, 1992 Do
and In Vitro Dissolution Testing
Acetohexamide (tablets) In Vivo August 1, 1988 Do
Bioequivalence and In Vitro Dissolution
Testing
Allopurinol (tablets) In Vivo July 15, 1985 Do
Bioequivalence and In Vitro Dissolution
Testing
[[Page 899]]
Amiloride Hydrochloride (tablets) In Vivo March 29, 1985 Do
Bioequivalence and In Vitro Dissolution
Testing
Aminophylline (suppositories) In Vivo July 5, 1983 Do
Bioequivalence and In Vitro Dissolution
Testing
Amitriptyline Hydrochloride (tablets) In July 5, 1983 Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Amoxicillin (capsules, tablets, and July 10, 1988 Do
suspensions) In Vivo Bioequivalence and In
Vitro Dissolution Testing
Baclofen (tablets) In Vivo Bioequivalence May 5, 1988 Do
and In Vitro Dissolution Testing
Cefadroxil (capsules, tablets, and October 7, 1988 Do
suspension) In Vivo Bioequivalence and In
Vitro Dissolution Testing
Cephalexin (tablets and capsules) In Vivo March 19, 1987 Do
Bioequivalence and In Vitro Dissolution
Testing
Cephradine (capsule and suspension) In Vivo September 10, 1986 Do
Bioequivalence Studies
Chlordiazepoxide and Chlordiazepoxide HCI July 5, 1983 Do
Bioavailability and Dissolution Studies
Chlorpropamide In Vivo Bioavailability July 5, 1983 Do
Studies
Chlorthalidone (tablets) July 5, 1983 Do
Clofibrate In Vivo Bioavailability Studies April 7, 1986 Do
Clonidine Hydrochloride Drug Products In December 5, 1984 Do
Vivo Bioequivalence Study and In Vitro
Dissolution Testing
Clorazepate In Vivo Bioequivalence Study February 17, 1987 Do
and In Vitro Dissolution Testing
Cyclobenzaprine Hydrochloride (tablets) In January 25, 1988 Do
Vivo Bioequivalence Study and In Vitro
Dissolution Testing
Desipramine Hydrochloride (tablets) In Vivo September 22, 1987 Do
Bioequivalence Studies
Dicyclomine Hydrochloride Drug Products In August 10, 1984 Do
Vivo Bioequivalence
Dissolution Testing (General) April 1, 1978 Do
Estopipate Tablets In Vivo Bioequivalence August 26, 1992 Do
Study and In Vitro Dissolution Testing
Flurazepam Hydrochloride (capsules) In Vivo October 15, 1985 Do
Bioequivalence Study and In Vitro
Dissolution Testing
Hydrochlorothiazide (tablets) In Vivo September 28, 1987 Do
Bioequivalence Study and In Vitro
Dissolution Testing
Hydroxyzine Hydrochloride (tablets) March 4, 1986 Do
(dissolution only)
Indomethacin (capsules) In Vivo January 27, 1988 Do
Bioequivalence Study and In Vitro
Dissolution Testing
Isopropamide Iodide (tablets) In Vivo May 12, 1982 Do
Bioequivalence Study and In Vitro
Dissolution Testing
Loxapine Succinate (capsules) In Vivo September 10, 1987 Do
Bioequivalence Study and In Vitro
Dissolution Testing
Maprotiline Hydrochloride (tablets) In Vivo August 27, 1987 Do
Bioequivalence Study and In Vitro
Dissolution Testing
Meclofenamate Sodium (capsules) In Vivo November 12, 1986 Do
Bioequivalence Study and In Vitro
Dissolution Testing
Metaproterenol Sulfate (tablets) In Vivo March 18, 1986 Do
Bioequivalence Study and In Vitro
Dissolution Testing
[[Page 900]]
Metoclopramide Hydrochloride (tablets) In December 27, 1984 Do
Vivo Bioequivalence Study and In Vitro
Dissolution Testing
Nalidixic Acid In Vivo Bioequivalence Study August 19, 1987 Do
and In Vitro Dissolution Testing
Nitrofurantion Macrocrystalline (capsules) January 10, 1986 Do
In Vivo Bioequivalence Study and In Vitro
Dissolution Testing
Nitroglycerin Ointment In Vivo December 17, 1986 Do
Bioequivalence Studies
Perphenazine (tablets) In Vivo August 27, 1987 Do
Bioequivalence Study and In Vitro
Dissolution Testing
Perphenazine/Amitriptyline (tablets) In August 27, 1987 Do
Vivo Bioequivalence Study and In Vitro
Dissolution Testing
Phenylbutazone Oxyphenbutazone (capsules September 28, 1987 Do
and tablets) In Vivo Bioequivalence Study
and In Vitro Dissolution Testing
Prazepam (capsules and tablets) In Vivo July 26, 1988 Do
Bioequivalence Study and In Vitro
Dissolution Testing
Prednisone (tablets) (dissolution only) July 10, 1985 Do
Probenecid Drug Products Bioavailability July 26, 1983 Do
Study
Propoxyphene Napsylate with Acetaminphen March 26, 1980 Do
(tablets)
Propranolol Hydrochloride (tablets) In Vivo August 1, 1984 Do
Bioequivalence Study and In Vitro
Dissolution Testing
Propylthiouracil (tablets) In Vivo August 13, 1986 Do
Bioequivalence Study and In Vitro
Dissolution Testing
Quinidine Gluconate (tablets, controlled September 22, 1987 Do
release) In Vivo Bioequivalence Study and
In Vitro Dissolution Testing
Ritodrine Hydrochloride (tablets) In Vivo August 27, 1987 Do
Bioequivalence Study and In Vitro
Dissolution Testing
Sulfinpyrazone (Capsules and Tablets) September 25, 1987 Do
Sulfones (tablets) In Vivo Bioequivalence November 7, 1986 Do
Study and In Vitro Dissolution Testing
Temazepam In Vivo Bioequivalence Study and August 8, 1985 Do
In Vitro Dissolution Testing
Tolazamide (tablets) In Vivo Bioequivalence May 30, 1986 Do
Study and In Vitro Dissolution Testing
Tolbutamide (tablets) In Vivo December 1, 1983 Do
Bioequivalence Study and In Vitro
Dissolution Testing
Trimipramine Maleate (capsules) In Vivo August 18, 1987 Do
Bioequivalence Study and In Vitro
Dissolution Testing
Verapamil Hydrochloride (tablets) In Vivo July 18, 1985 Do
Bioequivalence Study and In Vitro
Dissolution Testing
Clinical Evaluation of Drugs for the Clinical
Treatment of Peripheral Vascular Disease
Clinical Evaluation of Bronchodilator Drugs November 1, 1978 Clinical/Medical
Topical Corticosteriod Class Labeling Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
V. Guidance Documents Issued by the Center for Food Safety and
Applied Nutrition (CFSAN)
[[Page 901]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
How to Obtain a Hard Copy of the Document
Name of Document Date of Issuance Grouped by Intended User or (Name and Address, Phone, FAX, E-mail or
Regulatory Activity Internet)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Level I Guidances
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Working Guide to Minimize Microbial 1998 Farmers and Food Packers Lou Carson (HFS-3), Food and Drug
Hazards for Fresh Fruits and Vegetables Administration, 200 C. St. SW.,
Washington, DC 20204 or
jsaltsman@bangate.fda.gov
Notification of a Health Claim or Nutrient 1998 Regulated Industry Office of Food Labeling (HFS-150), Food
Content Claim Based on an Authoritative and Drug Administration, 200 C. St. NW.,
Statement of a Scientific Body Washington, DC 20204
--------------------------------------------------------------------------------------------------------------------------------------------------------
VI. Guidance Documents Issued by the Center for Veterinary Medicine
(CVM)
--------------------------------------------------------------------------------------------------------------------------------------------------------
How to Obtain a Hard Copy of the Document
Name of Document Date of Issuance Grouped by Intended User or (Name and Address, Phone, FAX, E-mail or
Regulatory Activity Internet)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Use of Human April 1998 FDA Regulated Industry CVM Internet Home Page at http://
Chorionic Gonadotropin (HCG) as a Spawning www.fda.gov/cvm, or from CVM's
Aid for Fish Communications Staff (HFV-12), Food and
Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1755, fax
301-594-1831
Guidance for Industry: GMP's For Medicated May 1998 Do Do
Feed Manufacturers Not Required to
Register and Be Licensed With FDA
VICH Draft Guidance for Industry: Stability July 1998 Do Do
Testing of New Animal Drug Substances and
Products
VICH Draft Guidance for Industry: Stability July 1998 Do Do
Testing for New Dosage Forms of New Animal
Drugs: Draft Guidance
VICH Draft Guidance for Industry: Stability July 1998 Do Do
Testing: Photostability Testing of New
Animal Drug Substances and Products
Guidance for Industry: Questions and July 1998 Do Do
Answers; BSE Feed Regulations
Guidance for Industry: Interpretation of On- August 1998 Do Do
Farm Feed Manufacturing and Mixing
Operations; Draft
Tolerances Established for Tetracyclines in August 11, 1998 (Updated) Do Do
Milk
--------------------------------------------------------------------------------------------------------------------------------------------------------
Withdrawn
--------------------------------------------------------------------------------------------------------------------------------------------------------
Points to Consider Guideline: Development 1993 Do
of a Pharmacokinetic Guideline Enabling
Flexible Labeling of Therapeutic
Antimicrobials
--------------------------------------------------------------------------------------------------------------------------------------------------------
VII. Guidance Documents Issued by the Office of Regulatory Affairs
[[Page 902]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
How to Obtain a Hard Copy of the Document
Name of Document Date of Issuance Grouped by Intended User or (Name and Address, Phone, FAX, E-mail or
Regulatory Activity Internet)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide Medical Device August 27, 1998 FDA Staff Personnel Division of Compliance Policy (HFC-230),
Warning Letter Draft Pilot Office of Enforcement, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-0420 or via
Internet at www.fda.gov/ora/compliance--
ref/dev--pl.pdf
Compliance Policy Guide 675.400 (CPG November 13, 1998 Do Do--Internet at www.fda.gov/ora/
7126.24): REVISION Rendered Animal Feed compliance--ref/cpg/cpgvet/
Ingredients cpg675.400.html
Regulatory Procedures Manual: UPDATE/ June 1998 Do Do--Internet at www.fda.gov/ora/
REVISION Subchapter/Seizure compliance--ref/rpm--new2/ch6.html
Regulatory Procedures Manual: UPDATE/ June 1998 Do Do--Internet at www.fda.gov/ora/
REVISION Subchapter/Supervisory Charges compliance--ref/rpm--new2/ch9chgs.html
Regulatory Procedures Manual: NEW July 1998 Do Do--Internet at www.fda.gov/ora/
Subchapter/Civil Penalties--Electronic compliance--ref/ch6civpen.html
Product Radiation Control
Guide to Traceback of Fresh Fruits and August 1998 Do Division of Emergency and Investigational
Vegetables Implicated in Epidemiological Operations (HFC-130), Office of Regional
Investigations Operations, Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857
301-443-3276
Guide to Inspections of Computerized August 1998 Do Do--Internet at www.fda.gov/ora/inspect--
Systems in the Food Processing Industry ref/igf/iglist.html
Import Alerts Continuously Do Freedom of Information Staff (HFI-35),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, or via
Internet at www.fda.gov/ora/fiars/ora--
import--alerts.html
Investigations Operations Manual-REVISION; July 1998 Do Division of Emergency and Investigational
Chapter 4--Sampling Operations (HFC-130), Office of Regional
Operations, Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857
301-443-3276 or via internet at
www.fda.gov/ora/inspect--ref/iom/
iomtc.html
Investigations Operations Manual-REVISION; July 1998 Do Do
Chapter 5--Establishment Inspection
--------------------------------------------------------------------------------------------------------------------------------------------------------
Documents Not Included on Previously Published Lists
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide--DRAFT January 5, 1998 Do Division of Compliance Policy (HFC-230),
Commercialization of In Vitro Diagnostic Office of Enforcement, Food and Drug
Devices (IVD's) Labeled for Research Use Administration, 5600 Fishers Lane,
Only or Investigational Use Only Rockville, MD 301-827-0420 or via
internet at www.fda.gov/cdrh/comp/
ivddrfg.html
Compliance Policy Guide--DRAFT Distributor August 28, 1998 Do Do or via internet at www.fda/gov/ora/
Medical Device Reporting compliance--ref/cpg--mdr3.txt
--------------------------------------------------------------------------------------------------------------------------------------------------------
Withdrawn
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide 530.400 (CPG September 23, 1997 Do
7121.02) Vitamin Products for Human Use--
Low Potency
Compliance Policy Guide 210.150 ( CPG
7134.09)Importation of Licensed Biological
Products for Human Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
Corrections to July 6, 1998 Quarterly List
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline for the Monitoring of Clinical Revised November 1998 FDA Regulated Industry Division of Compliance Policy (HFC-230),
Investigators Office of Enforcement, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-0420
Computerized Systems Used in Clinical June 18, 1997 Do Do
Trials Should be identified as a DRAFT
[[Page 903]]
ComplianceProgram 7348.808, Bioresearch Revised August 17, 1998 FDA Staff Personnel Do--Internet http://www.fda.gov/ora/
Monitoring; Good Laboratory Practices compliance--ref/bimo/default.html
(Nonclinical)
Compliance Program 7348.810; Sponsors, Revised October 30, 1998 Do Do--Internet http://www.fda.gov/ora/
Contract Research Organizations and compliance--ref/bimo/default.html
Monitors
Compliance Program 7348.811; Bioresearch Revised September 2, 1998 Do Do--Internet http://www.fda.gov/ora/
Monitoring; Clinical Investigations compliance--ref/bimo/default.html
The following documents are not available October 1, 1991 Do Do
via the internet: Food Laboratory Practice
Program (Nonclinical Laboratories)
7348.808A; EPA Data Audit Inspections
Compliance Program 7348.809; Bioresearch August 18, 1994
Monitoring; Institutional Review Board
--------------------------------------------------------------------------------------------------------------------------------------------------------
VIII. Guidance Documents Issued by the Office of the Commissioner
and the Office of Policy
----------------------------------------------------------------------------------------------------------------
How to Obtain a Hard Copy of the
Name of Document Date of Grouped by Intended User or Document (Name and Address, Phone,
Issuance Regulatory Activity FAX, E-mail or Internet)
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry; June 1998 FDA Regulated Industry Via Internet at http://www.fda.gov/
Exports and Imports under the FDA opacom/fedregister/frexport.html
Export Review and Enhancement Act
of 1996
Policy & Guidance Handbook for FDA 1994 FDA Staff Personnel National Technical Information
Advisory Committees Service (NTIS), 5285 Port Royal
Rd., Springfield, VA 22161, 703-
487-4650 (Order No. PB94-158854)
----------------------------------------------------------------------------------------------------------------
Dated: December 28, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-155 Filed 1-5-99; 8:45 am]
BILLING CODE 4160-01-F
