[Federal Register Volume 64, Number 149 (Wednesday, August 4, 1999)]
[Notices]
[Pages 42382-42391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19978]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0046]


Update of Guidance Documents at the Food and Drug Administration

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is publishing an 
update of all guidance documents issued and withdrawn since the 
compilation of the previous quarterly list that published on January 6, 
1999, and the annual comprehensive list that published on June 10, 
1999. FDA committed to publishing quarterly updates in its February 
1997 ``Good Guidance Practices'' (GGP's), which set forth the agency's 
policies and

[[Page 42383]]

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 for the first part of 
this year. 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: 
     For general information regarding GGP's: Lisa M. Helmanis, 
Regulations Policy and Management Staff (HF-26), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3480.

SUPPLEMENTARY INFORMATION:

I. Background

     In the Federal Register of February 27, 1997 (62 FR 8961), FDA 
published a notice announcing its 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. Because the agency has fallen behind in issuing its 
quarterly updates, this document covers guidance documents issued and 
withdrawn since the publication of the last quarterly list on January 
6, 1999 (64 FR 888), and the annual comprehensive list on June 10, 1999 
(64 FR 31228).
    On June 1, 1998, the President instructed all Federal agencies to 
ensure the use of ``plain language'' in all new documents. As part of 
this initative, FDA is taking steps to ensure that the principles of 
``plain language'' set forth by the President are being incorporated 
into its guidance documents. The agency invites public comment on the 
clarity of its guidances.
    The following list of guidance documents represents all guidances 
issued or withdrawn by FDA since the compilation of the January 6, 
1999, quarterly list and the June 10, 1999, annual comprehensive 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)


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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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: FDA Approval of New   December 1998               FDA--Regulated Industry              Office of Communication, Training, and
 Cancer Treatment Uses for Marketed Drug                                                                       Manufacturers Assistance (HFM-40), Center
 and Biological Products                                                                                       for Biologics Evaluation and Research,
                                                                                                               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 the United States) or 301-827-
                                                                                                               3844 (outside of the United States and
                                                                                                               local to Rockville, MD). Internet access:
                                                                                                               http://www.fda.gov/cber
Draft Guidance for Industry: Product Name    January 1999                Do                                   Do
 Placement, Size, and Prominence in
 Advertising and Promotional Labeling
Guidance for Industry: Population            February 1999               Do                                   Do
 Pharmacokinetics
Guidance for Industry: Clinical Development  Do                          Do                                   Do
 Programs for Drugs, Devices, and
 Biological Products for the Treatment of
 Rheumatoid Arthritis (RA) February 1999
Guidance for Industry: For the Submission    February 1999               Do                                   Do
 of Chemistry, Manufacturing and Controls
 and Establishment Description Information
 for Human Plasma-Derived Biological
 Products, Animal Plasma or Serum-Derived
 Products
Draft Guidance for Industry: Formal          February 1999               Do                                   Do
 Meetings With Sponsors and Applicants for
 PDUFA Products

[[Page 42384]]


Draft Guidance for Industry: Formal Dispute  February 1999               Do                                   Do
 Resolution: Appeals Above the Division
 Level
Draft Guidance for Industry: IND's for       February 1999               Do                                   Do
 Phase 2 and 3 Studies of Drugs, Including
 Specified Therapeutic Biotechnology-
 Derived Products, Chemistry Manufacturing
 and Controls Content and Format
Draft Guidance for Industry: Accelerated     March 1999                  Do                                   Do
 Approval Products--Submission of
 Promotional Materials
Guidance for Industry: Content and Format    March 1999                  Do                                   Do
 of Chemistry, Manufacturing and Controls
 Information and Establishment Description
 Information for a Biological In Vitro
 Diagnostic Product
Update on Abbokinase (Urokinase)             March 16, 1999              Healthcare Providers                 Do
Update on Abbokinase (Urokinase)             March 22, 1999              Do                                   Do
Guidance for Industry: Public Health Issues  April 1999                  FDA--Regulated Industry              Do
 Posed by the Use of Nonhuman Primate
 Xenografts in Humans
Guidance for Industry on the Content and     April 1999                  Do                                   Do
 Format of Chemistry, Manufacturing and
 Controls Information and Establishment
 Description Information for an Allergenic
 Extract or Allergen Patch Test
Guidance for Industry for the Submission of  May 1999                    Do                                   Do
 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 Form FDA
 356h ``Application to Market a New Drug,
 Biologic or an Antibiotic Drug for Human
 Use''
Guidance for Industry for Platelet Testing   May 1999                    Do                                   Do
 and Evaluation of Platelet Substitute
 Products
Guidance for Industry: Efficacy Studies to   May 1999                    Do                                   Do
 Support Marketing of Fibrin Sealant
 Products Manufactured for Commercial Use
Dear Colleague Letter--Hypotension and       May 5, 1999                 Healthcare Providers                 Do
 Bedside Leukocyte Reduction Filters
--------------------------------------------------------------------------------------------------------------------------------------------------------

III. Guidance Documents Issued by the Center for Devices and 
Radiological (CDRH)


--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                               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 on Preparing Notices   March 25, 1999              Office of Compliance (OC)            Division of Small Manufacturers
 of Availability of Investigational Medical                                                                    Assistance, 1-800-638-2041 or 301-827-
 Devices and for Recruiting Study Subjects                                                                     0111 or (FAX) Facts-on-Demand at 1-800-
                                                                                                               899-0381 or Internet at http://
www.fda.gov/cdrh
Document for Special Controls for            April 28, 1999              Office of Device Evaluation (ODE)/   Do
 Erythropoietin Assay Premarket                                           Division of Clinical Laboratories
 Notifications (510(k))                                                   Devices (DCLD)
In Vitro Diagnostic Fibrin Monomer           April 27, 1999              Do                                   Do
 Paracoagulation Test

[[Page 42385]]


Recommended Clinical Study Design for        May 7, 1999                 ODE/Division of Cardiovascular,      Do
 Ventricular Tachycardia Ablation                                         Respiratory, and Neurological
                                                                          Devices (DCRND)
Guidance for the Preparation of a Premarket  March 2, 1999               ODE/Division of General and          Do
 Notification Application for a Surgical                                  Restorative Devices (DGRD)
 Mesh
Guidance for the Submission of a Premarket   March 2, 1999               Do                                   Do
 Notification for a Dermabrasion Device
Accountability Analysis for Clinical         March 15, 1999              ODE/Division of Ophthalmic Device    Do
 Studies for Ophthalmic Devices                                           (DOD)
Guidance on 510(k) Submissions for           March 31, 1999              Do                                   Do
 Keratoprostheses
The Mammography Quality Standards Act Final  March 5, 1999               Office of Health of Industry         Do
 Regulations Compliance Guidance--Document                                Program (OHIP)/Division of
 2 (Draft)                                                                Mammography Quality and Radiation
                                                                          Programs (DMQRP)
Compliance Guidance: The Mammography         March 23, 1999              Do                                   Do
 Quality Standards Act Final Regulations
 Motion of Tube-Image Receptor Assembly
The Mammography Quality Standards Act Final  May 5, 1999                 Do                                   Do
 Regulations Facility Survey and Medical
 Physicist Qualification Requirements
 Guidance to Industry on the Testing of      February 23, 1999           Office of Surveillance and           Do
 Metallic Plasma Sprayed Coatings on                                      Biometrics (OSB)/Division of
 Orthopedic Implants to Support                                           Postmarket Surveillance (DPS)
 Reconsideration of Postmarket Surveillance
 Requirements (Draft)
MDR Reporting Guidance for Date-Related      April 16, 1999              OSB/Division of Surveillance         Do
 Problems Including Y2K                                                   Systems (DSS)
Variance From Manufacturer Report Number     August 12, 1996             Do                                   Do
 Format (Variance No. 5)
Immunotoxicity Testing Guidance              May 6, 1999                 Office of Science and Technologies   Do
                                                                          (OST)/Division of Life Sciences
                                                                          (DLS)
--------------------------------------------------------------------------------------------------------------------------------------------------------

Replacements

--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Abbreviated 510(k)    February 22, 1999           ODE/DCLD                             Do
 Submissions for In Vitro Diagnostic
 Calibrators (Replaces: In Vitro Diagnostic
 Calibrators)
Guidance for Spinal System 510(k)'s          May 7, 1999                 ODE/DGRD                             Do
 (Replaces: Draft Guideline for Reviewing
 Spinal Fixation Device Systems)
Electro-Optical Sensors for the In Vivo      May 12, 1999                ODE/Division of Reproductive,        Do
 Detection of Cervical Cancer and its                                     Abdominal, Ear, Nose, and Throat
 Precursors: Submission Guidance for an IDE/                              Devices Branch (DRAERD)
 PMA (Replaces: In Vivo Devices for the
 Detection of Cervical Cancer and its
 Precursors: Submission Guidance for an IDE
 Draft Document)
Home Uterine Activity Monitors: Guidance     May 12, 1999                Do                                   Do
 for the Submission of 510(k) Premarket
 Notifications (Replaces: Premarket Testing
 Guidelines for Home Uterine Activity
 Monitors)
Compliance Guidance: The Mammography         March 4, 1999               OHIP/DMQRP                           Do
 Quality Standards Act Final Regulation--
 Document 1 (Replaces: Compliance Guidance:
 The Mammography Quality Standards Act
 Final Regulation)

[[Page 42386]]


Guidance for Request and Issuance of         May 4, 1999                 Do                                   Do
 Interim Notice Letters for Mammography
 Facilities Under the Mammography Quality
 Standards Act (42 U.S.C. 263(b))
 (Replaces: Guidance for Request and
 Issuance of Interim Notice Letters for
 Mammography Facilities Under the
 Mammography Quality Standards Act (42
 U.S.C. 263(b))
Compliance Guidance: The Mammography         May 5, 1999                 Do                                   Do
 Quality Standards Act Final Regulations--
 Preparing for MQSA Inspections (Replaces:
 ``What a Mammography Facility Should Do to
 Prepare for an MQSA Inspection'' and
 ``Addendum to What a Mammography Facility
 Should Do To Prepare for an MQSA
 Inspection''
Regulations of Medical Devices Background    April 14, 1999              OHIP/Division of Small               Do
 Information for International Officials                                  Manufacturers Assistance (DSMA)
 (Replaces: Regulations of Medical Devices
 Background Information for Foreign
 Officials)
--------------------------------------------------------------------------------------------------------------------------------------------------------

IV. Guidance Documents Issued by the Center for Drug Evaluation and 
Research (CDER)


--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                              How to Obtain a Copy of the Document (Name
              Name of Document                    Date of Issuance           Grouped by Intended User or          and Address, Phone, FAX, E-mail, or
                                                                                 Regulatory Activity                           Internet)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Accelerated Approval Products--Submission    March 26, 1999              Advertising Draft                    Drug Information Branch (HFD-210), Center
 of Promotional Materials                                                                                      for Drug Evaluation and Research, Food
                                                                                                               and Drug Administration, 5600 Fishers
                                                                                                               Lane, Rockville, MD 20857, 301-827-4573,
                                                                                                               or via the Internet at http://www.fda.gov/
cder/guidance/index.htm
ANDA's: Impurities in Drug Products          January 5, 1999             Generic Drug Draft                   Do
BACPAC 1: Intermediates In Drug Substance    November 30, 1998           Chemistry Draft                      Do
 Synthesis (Bulk Actives Postapproval
 Changes: Chemistry, Manufacturing, and
 Controls Documentation)
Bioanalytical Methods Validations for Human  January 5, 1999             Biopharmaceutic Draft                Do
 Studies
Bioavailability and Bioequivalence Studies   June 1999                   Do                                   Do
 for Nasal Aerosols and Nasal Sprays for
 Local Action
Clinical Development Programs for Drugs,     February 17, 1999           Clinical Medical                     Do
 Devices, and Biological Products for the
 Treatment of Rheumatoid Arthritis (RA)
Content and Format of Geriatric Labeling     January 21, 1999            Labeling Draft                       Do
Enforcement Policy During Implementation of  November 23, 1998           Procedural                           Do
 Section 503A of the Federal Food, Drug,
 and Cosmetic Act
Establishing Pregnancy Registries            June 4, 1999                Clinical Medical Draft               Do
Evaluation of Human Pregnancy Outcome Data;  June 4, 1999                Do                                   Do
 Draft Guidance for Reviewers
Fast Track Drug Development Programs:        November 18, 1998           Procedural                           Do
 Designation, Development, and Application
 Review
FDA Approval of New Cancer Treatment Uses    December 1998               Clinical Medical                     Do
 for Marketed Drug and Biological Products

[[Page 42387]]


Formal Meetings With Sponsors and            March 19, 1999              Procedural Draft                     Do
 Applicants for PDUFA Products
Formal Dispute Resolution: Appeals Above     March 19, 1999              Do                                   Do
 the Division Level
General Considerations for Pediatric         November 30, 1998           Clinical Pharmacological Draft       Do
 Pharmacokinetic Studies for Drugs and
 Biological Products
In Vivo Metabolism/Drug Interaction          November 19, 1998           Do                                   Do
 Studies--Study Design, Data Analysis, and
 Recommendations for Dosing and Labeling
IND's for Phase 2 and 3 Studies of Drugs,    April 20, 1999              Chemistry Draft                      Do
 Including Specified Therapeutic
 Biotechnology-Derived Products; Chemistry,
 Manufacturing, and Controls Content and
 Format
Metered Dose Inhalers (MDI's) and Dry        November 19, 1998           Do                                   Do
 Powder Inhalers (DPI's) Drug Products;
 Chemistry, Manufacturing, and Controls
 Documentation
Nasal Spray and Inhalation Solution,         May 1999                    Do                                   Do
 Suspension, and Spray Drug Products
NDA's: Impurities in Drug Substances         January 21, 1999            Do                                   Do
Noncontraceptive Estrogen Drug Products--    January 8, 1999             Labeling Draft                       Do
 Physician and Patient Labeling
Organization of an ANDA                      March 2, 1999               Generic Drug                         Do
Population Pharmacokinetics                  February 10, 1999           Clinical Pharmacology                Do
Product Name, Placement, Size, and           March 12, 1999              Advertising Draft                    Do
 Prominence in Advertising and Promotional
 Labeling
Regulatory Submissions in Electronic         January 28, 1999            Electronic Submissions               Do
 Format; General Considerations
Regulatory Submissions in Electronic         January 28, 1999            Do                                   Do
 Format; New Drug Applications
Skin Irritation and Sensitization Testing    February 26, 1999           Generic Drug Draft                   Do
 of Generic Transdermal Drug Products
SUPAC IR/MR: Immediate-Release and Modified- February 26, 1999           Chemistry                            Do
 Release Solid Oral Dosage Forms;
 Manufacturing Equipment Addendum
SUPAC--SS: Nonsterile Semisolid Dosage       January 5, 1999             Chemistry Draft                      Do
 Forms
Therapeutic Equivalence Code Placement on    January 28, 1999            Labeling Draft                       Do
 Prescription Drug Labels and Labeling
Variations in Drug Products that May Be      January 27, 1999            Generic Drug                         Do
 Included in a Single ANDA
Waiver of In Vivo Bioavailability and        February 17, 1999           Biopharmaceutic Draft                Do
 Bioequivalence Studies for Immediate-
 Release Solid Oral Dosage Forms Containing
 Certain Active Moieties/Active Ingredients
 Based on a Biopharmaceutics Classification
 System
--------------------------------------------------------------------------------------------------------------------------------------------------------

Withdrawn

--------------------------------------------------------------------------------------------------------------------------------------------------------
Archiving Submissions in Electronic Format-- September 23, 1997
 NDA's
Clinical Evaluation of Drugs to Prevent,     November 1, 1978
 Control and/or Treat Periodontal Disease
Content and Format of Investigational New    December 10, 1997
 Drug Applications (IND's) for Phases 2 and
 3 Studies of Drugs, Including Specific
 Therapeutic Biotechnology-Derived
 Products; Preliminary Draft
Providing Regulatory Submissions in          April 6, 1998
 Electronic Format--NDA's
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 42388]]

V. Guidance Documents Issued by the Center for Food Safety and 
Applied Nutrition (CFSAN)


--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                               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)
--------------------------------------------------------------------------------------------------------------------------------------------------------

--------------------------------------------------------------------------------------------------------------------------------------------------------
Withdrawn

--------------------------------------------------------------------------------------------------------------------------------------------------------
Preparing Environmental Assessments:         August 1990
 General Suggestions
Step-by-Step Guidance for Preparing          March 1987
 Environmental Assessments
Partial List of Enzyme Preparations That      1998
 are Used in Foods
Partial List of Microorganisms and            1998
 Microbial-Derived Ingredients That Are
 Used in Food
FDA Nutrition Labeling Guide for Using Data  1993
 Bases NOTE: ONLY DELETE THE 1993 VERSION
--------------------------------------------------------------------------------------------------------------------------------------------------------

New Guidances

--------------------------------------------------------------------------------------------------------------------------------------------------------
Sanitizing Solutions: Chemistry Guidelines   1993                        Petitioners for Food Contact         Office of Premarket Approval (HFS-200),
 for Food Additive Petitions NOTE: REISSUED                               Applications                         Center for Food Safety and Applied
 DUE TO QUALITY FOOD PROTECTION ACT                                                                            Nutrition, Food and Drug Administration,
 JURISDICTION OVER FOOD CONTACT SUBSTANCES                                                                     200 C St. SW., Washington, DC 20204, 202-
 FOR A MORE LIMITED PURPOSE                                                                                    418-3100, or via the Internet at http://
vm.cfsan.fda.gov/dms/opa-
                                                                                                               cg3a.html
Statement of Identity Nutrition Labeling     January 4, 1999             Dietary Supplement Manufacturers     Industry Activities Staff (HFS-565),
 and Ingredient Labeling of Dietary                                                                            Center for Food Safety and Applied
 Supplements; Small Entity Compliance Guide                                                                    Nutrition, Food and Drug Administration,
                                                                                                               200 C St. SW., Washington, DC 20204, 202-
                                                                                                               205-5251
--------------------------------------------------------------------------------------------------------------------------------------------------------

Corrections

--------------------------------------------------------------------------------------------------------------------------------------------------------
Statement of Policy: Foods Derived From New  May 29, 1992                Developers of New Plant Food         Office of Premarket Approval (HFS-200),
 Plant Varieties: Notice                                                  Varieties                            Center for Food Safety and Applied
                                                                                                               Nutrition, Food and Drug Administration,
                                                                                                               200 C St. SW. , Washington, DC 20204, 202-
                                                                                                               418-3100
Guidance for Submitting Requests under 21    1996                        Food Packaging Industry              Do--Internet at http://vm.cfsan.fda.gov/
 CFR 170.39, Threshold of Regulation for                                                                       dms/opa-gg2.html
 Substances Used in Food Articles
Guidelines for the Preparation of Petition   1996                        Food Ingredient or Packaging         Do--Internet at http://vm.cfsan.fda.gov/
 Submissions                                                              Industry                             dms/opa-prep.html
Guidelines for Approval of Color Additives   1996                        Color or Contact Lens Industry       Do
 in Contact Lenses Intended as Colors
FDA Recommendations for Submission of        February 1993               Color Additives Industry             Do--Internet at http://vm.cfsan.fda.gov/
 Chemical and Technological Data on Color                                                                      dms/opa-col1.html
 Additives for Food, Drugs, or Cosmetics
 Use
Points to Consider for the Use of Recycled   December 1992               Food Packaging Industry              Do--Internet at http://vm.cfsan.fda.gov/
 Plastics in Food Packaging: Chemistry                                                                         dms/opa-cg3.html
 Considerations
Recommendations for Submission of Chemical   May 1993                    Do                                   Do--Internet at http://vm.cfsan.fda.gov/
 and Technological Data for Direct Food                                                                        dms/opa-cg4.html
 Additive and GRAS Food Ingredient
 Petitions
Recommendations for Chemistry Data for       June 1995                   Do                                   Do--Internet at http://vm.cfsan.fda.gov/
 Indirect Food Additive Petitions                                                                              dms/opa-cg5.html
Enzyme Preparations: Chemistry               January 1993                Food Enzyme Industry                 Do--Internet at http://vm.cfsan.fda.gov/
 Recommendations for Food Additive and GRAS                                                                    dms/opa-cg7.html
 Affirmation Petitions
Estimating Exposure to Direct Food Additive  September 1995              Food and Food Ingredient Industry    Do--Internet at http://vm.cfsan.fda.gov/
 and Chemical Contaminants in the Diet                                                                         dms/opa-cg8.html

[[Page 42389]]


Toxicological Principles for the Safety      1982                        Petitioners for Food or Color        National Technical Information Service,
 Assessment of Direct Food Additives and                                  Additives                            5285 Port Royal Rd., Springfield, VA
 Color Additives Used in Food (also known                                                                      22161, Publication No. PR-83-170696
 as Redbook I)
Environmental Assessment Technical Handbook  March 1987                  Do                                   Do--Publication No. PB87175345-AS, A-01
Environmental Assessment of Food-Packaging   February 1994               Do                                   Office of Premarket Approval (HFS-200),
 Materials With Enhanced Degradation                                                                           Center for Food Safety and Applied
 Characteristics                                                                                               Nutrition, Food and Drug Administration,
                                                                                                               200 C St. SW., Washington, DC 20204, 202-
                                                                                                               418-3100
Color Additive Petitions Information and     1996                        Do                                   Do
 Guidance
Toxological Testing of Food Additives        1983                        Do                                   Do--Internet at http://vm.cfsan.fda.gov/
 (Updated 1997)                                                                                                dms/opa-tg1.html
FDA's Policy for Foods Developed by          1995                        Food Industry                        Internet at http://vm.cfsan.fda.gov
 Biotechnology
Food Additive Petition Expedited Review      January 1999                Guidance for Industry and CFSAN      Robert L. Martin, Office of Premarket
                                                                                                               Approval (HFS-215), 200 C St. SW.,
                                                                                                               Washington, DC 20204, 202-418-3074, or e-
                                                                                                               mail [email protected], or via the
                                                                                                               Internet at http://vm.cfsan.fda.gov/
                                                                                                               dms/opa-expe.html
Use of Antibiotic Resistance Marker Genes    September 1998              Do                                   Nega Beru, Office of Premarket Approval
 in Transgenic Plants                                                                                          (HFS-206), 200 C St. SW., Washington, DC
                                                                                                               20204, 202-418-3097, or e-mail
                                                                                                               [email protected] or via the
                                                                                                               Internet at http://vm.cfsan.fda.gov/
                                                                                                               dms/opa-armg.html
--------------------------------------------------------------------------------------------------------------------------------------------------------

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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Evaluation of the Human Health Impact of     January 1999                Animal Drug Industry                 Communications Staff (HFV-12), Center for
 the Microbial Effects of Antimicrobial New                                                                    Veterinary Medicine, Food and Drug
 Animal Drugs Intended for Use in Food-                                                                        Administration, 7500 Standish Pl.,
 Producing Animals                                                                                             Rockville, MD 20855, 301-594-1755, FAX
                                                                                                               301-594-1831 or via the Internet at http:/
                                                                                                               /www.fda.gov/cvm
Guidance for Industry: Submitting a Notice   January 1999 (Revised)      Do                                   Do
 of Claimed Investigational Exemption in
 Electronic Format to CVM via E-mail
Draft Guidance for Industry: Product Name    March 1999                  Do                                   Do
 Placement, Size, and Prominence in
 Advertising and Promotional Labeling
Guidance for Industry: FDA Approval of New   April 1999 (Revised)        Do                                   Do
 Animal Drugs for Minor Uses and for Minor
 Species
--------------------------------------------------------------------------------------------------------------------------------------------------------

VII. Guidance Documents Issued by the Office of Regulatory Affairs 
(ORA)

[[Page 42390]]




--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                               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, Chapter 1, Sec.     May 13, 1999                FDA Personnel                        Division of Compliance Policy (HFC-230),
 160.850: NEW, Enforcement Policy: 21 CFR                                                                      Office of Enforcement, Food and Drug
 Part 11; Electronic Records; Electronic                                                                       Administration, 5600 Fishers Lane,
 Signatures (CPG 7153.17)                                                                                      Rockville, MD 20857, 301-827-0420 or via
                                                                                                               the Internet at http://www.fda.gov/ora/
compliance__ ref/cpg/cpggenl/cpg160-
                                                                                                               180.htm
Compliance Policy Guide, Chapter 1, Sec.     April 26, 1999              Do                                   Do--Internet at http://www.fda.gov/ora/
160.800, NEW: Year 2000 (Y2K) Computer                                                                        compliance__ref/cpg/cpggenl/cpg160-800/
 Compliance                                                                                                    html
Compliance Policy Guide, Chapter 5, Sec.     March 23, 1999              Do                                   Do--Internet at http://www.fda.gov/ora/
555.425, NEW: Foods--Adulteration                                                                             compliance__ref/cpg/cpgfod/cpg555-425.htm
 Involving Hard or Sharp Foreign Objects
Compliance Policy Guide, Chapter 1,          April 26, 1999              Do                                   Do--Internet at http://www.fda.gov/ora/
Sec.140.100, REVISION/DRAFT: Regulatory                                                                       compliance__ref/cpg/cpgfod/draftrev-
 Policy on the Disposition of Publications                                                                     cpg715313.htm
 that Constitute Labeling (CPG 7153.13)
Compliance Policy Guide, Chapter 2, Sec.     July 9, 1999                Do                                   Do--Internet at http://www.fda.gov/ora/
230.140, NEW, Evaluation and Processing of                                                                    compliance__ref/default.htm
 Post Donation Information Reports
Computerized Systems Used in Clinical        April 1999                  FDA--Regulated Industry              Do--Internet at http://www.fda.gov/ora/
 Trials                                                                                                        compliance__ref/bimo/ffinalcct.htm
Draft Guidance Policy Statement: Draft       May 18, 1999                FDA Personnel and Regulated          Do--Internet at http://www.fda.gov/ohrms/
 Civil Money Penalty Reduction Policy for                                 Industry                             Dockets/98fr/051899f.txt
 Small Entities
Medical Device Warning Letter Pilot          March 8, 1999               Do                                   Do--Internet at http://www.fda.gov/ohrms/
Dockets/98fr/030899e.pdf
Guidelines for Entry Review of Radiation-    March 12, 1999              FDA Personnel                        Division of Import Operations and Policy
 Emitting Electronic Devices                                                                                   (HFC-170), Office of Regional Operations,
                                                                                                               Food and Drug Administration, 5600
                                                                                                               Fishers Lane, Rockville, MD 20857, 301-
                                                                                                               594-1218
Import Alerts                                Continuously                Do                                   Freedom of Information Staff (HFI-35),
                                                                                                               Food and Drug Administration, 5600
                                                                                                               Fishers Lane, Rockville, MD 20857, or via
                                                                                                               the Internet at http://www.fda.gov/ora/
fiars/ora__import_alerts.html
Inspectional Policy Regarding Y2K Issues     February 11, 1999 (Revised  Do                                   Division of Emergency and Investigational
                                              March 29, 1999)                                                  Operations (HFC-130), Food and Drug
                                                                                                               Administration, 5600 Fishers Lane,
                                                                                                               Rockville, MD 20857, 301-827-5645
Laboratory Procedures Manual, NEW Chapter    May 1999                    Do                                   Division of Field Science (HFC-140),
 X, Method Validation Samples                                                                                  Office of Regional Operations, Food and
                                                                                                               Drug Administration, 5600 Fishers Lane,
                                                                                                               Rockville, MD 20857, 301-827-7605
Investigations Operations Manual, Chapter    June 1999                   Do                                   Division of Emergency Operations (HFC-
 5, Subchapter 520, Section 523.2,                                                                             130), Office of Regional Operations, Food
 REVISION, Photo/Video Identification and                                                                      and Drug Administration, 5600 Fishers
 Submission                                                                                                    Lane, Rockville, MD 20857, 301-827-5636
                                                                                                               or via the Internet at http://fda.gov/ora/
inspect__ref/iom/IOMCoverPg.html
Guide to International Inspections and       July 1999                   Do                                   Do--Updated version not yet available on
 Travel, REVISION (Formerly: FDA/ORA                                                                           Internet
 International Inspection Manual and Travel
 Guide)
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Withdrawn

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Compliance Policy Guide, Chapter 2, Sec.     December 21, 1998
 205.100, Standards and Minimum
 Requirements for Biologic Products (CPG
 7134.03)
Compliance Policy Guide, Chapter 3, Sec.     January 4, 1999
 300.200, Reconditioners/Rebuilders of
 Medical Devices (CPG 7124.28),

[[Page 42391]]


Compliance Policy Guide, Chapter 2, Sec.     April 26, 1999
 210.100, Licensing--Changes To Be Reported
 to the Office of Biologics (CPG 7134.05)
Compliance Policy Guide, Chapter 4, Sec.     January 8, 1999
 460.200, Manufacture, Distribution, and
 Promotion of Adulterated, Misbranded, or
 Unapproved New Drugs for Human Use by
 State-Licensed Pharmacies (CPG 7132.16)
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    Dated: July 27, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-19978 Filed 8-3-99; 8:45 am]
BILLING CODE 4160-01-F