[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.
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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update of all guidance documents issued and withdrawn since the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)
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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
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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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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)
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Replacements
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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)
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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 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)
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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
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Withdrawn
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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
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[[Page 42388]]
V. Guidance Documents Issued by the Center for Food Safety and
Applied Nutrition (CFSAN)
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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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Withdrawn
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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
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New Guidances
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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
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Corrections
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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
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VI. Guidance Documents Issued by the Center for Veterinary Medicine
(CVM)
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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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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
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VII. Guidance Documents Issued by the Office of Regulatory Affairs
(ORA)
[[Page 42390]]
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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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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