Good guidance practices; quarterly list,
[Federal Register: July 6, 1998 (Volume 63, Number 128)]
[Notices]
[Page 36413-36424]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06jy98-50]
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.
[[Page 36414]]
SUMMARY: The Food and Drug Administration (FDA) is publishing the first quarterly update of all guidance documents issued and withdrawn since the compilation of the comprehensive list. 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 since the comprehensive list was compiled. This list also includes some guidance documents that were inadvertently not included on the comprehensive list mentioned previously.
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:
-
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list of guidance documents and quarterly Federal Register notices that list all guidance documents that were issued and withdrawn during that quarter, including ``Level 2'' guidance documents.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 by FDA since the compilation of the February 26, 1998 (63 FR 9795) list and guidance documents inadvertently not included in the comprehensive list. 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.
-
Guidance Documents Issued by the Center for Biologics Evaluation and Research (CBER)
Grouped by
Intended User or How to Obtain a Hard Copy of the Name of Document
Date of Issuance Regulatory Document (Name and Address, Phone, Activity
FAX, E-mail, or Internet)
Guidance for Industry: Industry- November 1997 FDA Regulated Office of Communication, Training, Supported Scientific and
Industry
and Manufacturers Assistance (HFM- Educational Activities
40), Center 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 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:
December 1997 Do
Do
Promoting Medical Products in a
Changing Healthcare Environment;
-
Medical Product Promotion by
Healthcare Organizations or
Pharmacy Benefits Management
Companies (PBMS)
Guidance for Industry: Year 2000 January 1998
Do
Do
Date Change for Computer Systems
and Software Applications Used in
the Manufacture of Blood Products
Draft Guidance for Industry:
January 1998
Do
Do
Efficacy Studies to Support
Marketing of Fibrin Sealant
Products Manufactured for
Commercial Use
Draft Guidance for Industry:
January 1998
Do
Do
Container and Closure Integrity
Testing in Lieu of Sterility
Testing as a Component of the
Stability Protocol for Sterile
Products
Draft Guidance for Industry:
February 1998 Do
Do
Clinical Development of Programs
for Drugs, Devices and Biological
Products Intended for Treatment of
Osteoarthritis (OA)
Draft Guidance for Industry:
November 1997 Do
Do
Environmental Assessment of Human
Drug and Biologics Applications
[[Page 36415]]
Guidance for Industry:
February 1998 Do
Do
Implementation of Section 126,
Elimination of Certain Labeling
Requirements of the Food and Drug
Administration Modernization Act
of 1997
Guidance for Industry: Clinical March 1998
Do
Do
Development Programs for Drugs,
Devices and Biological Products
for the Treatment of Rheumatoid
Arthritis (RA)
Guidance for Industry: Supplemental March 1998
Do
Do
Testing and the Notification of
Consignees of Donor Test Results
for Antibody to Hepatitis C Virus
(Anti-HCV)
Guidance for Industry: Guidance for March 1998
Do
Do
Human Somatic Cell Therapy and
Gene Therapy
Compliance Program Guidance Manual 1994
FDA Personnel National Technical Information (Drugs and Biologics) (Publication
Service (NTIS), 5285 Port Royal No. 94-920699)
Rd., Springfield, VA 22161, 703- 605-6050
-
Guidance Documents Issued by the Center for Devices and Radiological Health (CDRH)
Grouped by
Intended User or How to Obtain a Hard Copy of the Name of Document
Date of Issuance Regulatory Document (Name and Address, Phone, Activity
FAX, E-mail or Internet)
Guidance on Medical Device Tracking February 19, 1998 OC
Division of Small Manufacturers
(Docket #98D-0132)
Assistance, 1-800-638-2041 or 301- 827-0111 or (Fax) Facts-on-Demand at 1-800-899-0381 or Internet at http://www.fda.gov/cdrh
Guidance on Lead Wires and Patient March 9, 1998 OC
Do
Cables
Draft Guidance to Industry and CDRH March 20, 1998 ODE
Do
for PMA's and PMA Supplements: Use
of Published Literature, Use of
Previously Submitted Materials,
and Priority Review
PMA/510(k) Expedited Review--
March 20, 1998 ODE
Do
Guidance for Industry and CDRH
Staff
Guidance on Amended Procedures for March 20, 1998 ODE
Do
Advisory Panel Meetings
Guidance on IDE Policies and
January 20, 1998 ODE
Do
Procedures
Early Collaboration Meetings Under February 19, 1998 ODE
Do
the FDA Modernization Act (FDAMA),
Guidance for Industry and CDRH
Staff, Final Document (Docket #98D-
0078) (FOD #310)
Guidance on PMA Interactive
February 19, 1998 ODE
Do
Procedures for Day-100 Meetings
and Subsequent Deficiencies--for
Use by CDRH and Industry (Docket
Determination of Intended Use for February 19, 1998 ODE
Do
510(k) Devices: Final Document
(Docket #98D-0081) (FOD #857)
30-Day Notices and 135-day PMA February 19, 1998 ODE
Do
Supplements for Manufacturing
Method or Process Changes,
Guidance for Industry and CDRH
(Docket #98D-0080) (FOD #795)
New section 513(f)(2)--Evaluation February 19, 1998 ODE
Do
of Automatic Class III
Designation: Guidance for Industry
and CDRH Staff (Docket #98D-0082)
(FOD #199)
Procedures for Class II Device February 25, 1998 ODE
Do
Exemptions from Premarket
Notification Guidance for Industry
and CDRH Staff (Docket #98D-0083)
(FOD #159)
Electrocardiograph (ECG) Surface February 11, 1997 ODE/DCRND
Do
Electrode Tester--Version 1.0
[[Page 36416]]
Guidance for the Submission of January 1, 1997 ODE/DCRND
Do
510(k) Premarket Notifications for
Cardiovascular Intravascular
Filters
Guidance Document for Testing Bone April 20, 1996 ODE/DGRD
Do
Anchor Devices (FOD #915)
ORDB 510(k) Sterility Review
July 3, 1997
ODE/DGRD
Guidance (FOD #659)
Guidance for Testing MR Interaction May 22, 1996
ODE/DGRD
Do
With Aneurysm Clips (FOD #958)
Electroencephalograph Device Draft June 25, 1997 ODE/DGRD
Do
Guidance for 510(k) Content (FOD
Ophthalmic Device Triage List
July 25, 1997 ODE/DOD
Do
Contact Lenses: The Better the Care April 1, 1991 ODE/DOD
Do
the Safer the Wear (FDA
Publication No. 91-4220)
An FDA Survey of U.S. Contact Lens July 1, 1987
ODE/DOD
Do
Wearers (Carol L. Herman)
Reprinted from Contact Lens
Spectrum
Facts for Consumers from the
April 1, 1986 ODE/DOD
Do
Federal Trade Commission--
Eyeglasses
Important Information About Rophae August 20, 1992 ODE/DOD
Do
Intraocular Lenses
Intraocular Lens (IOL) Guidance October 10, 1997 ODE/DOD
Do
Document
FDA Guidance for Multifocal
May 1996
ODE/DOD
Do
Intraocular Lens IDE Studies and
PMA's
Premarket Notification[510(k)] May 12, 1994
ODE/DOD
Do
Guidance Document on Class II
Daily Wear Contact Lenses
Electrocardiograph (ECG) Electrode-- February 11, 1997 ODE/DRAERD
Do
Version 1.0
Electrocardiograph (ECG) Lead
February 11, 1997 ODE/DRAERD
Do
Switching Adapter--Version 1.0
Tympanostomy Tubes, Submission January 14, 1998 ODE/DRAERD
Do
Guidance for a 510(k) Premarket
Notification
Guidance for the Content of
February 5, 1998 ODE/DRAERD
Do
Premarket Notifications for Metal
Expandable Biliary Stents
FDA Modernization Act of 1997: February 6, 1998 OHIP/Regs
Do
Guidance for the Device Industry
on Implementation of Highest
Priority Provisions; Availability
Policy Notebook in a Q/A Format January 23, 1998 OHIP/DMQRP
Do
(Update to existing document)
The Small Entity Compliance Guide January 1998
OHIP/DMQRP
Do
Medical Device Appeals and
February 19, 1998 OHIP/DSMA
Do
Complaints: A Guidance on Dispute
Resolution
Medical Device Quality Systems December 1, 1996 OHIP/DSMA
Do
Manual: A Small Entity Compliance
Guide
SMDA to FDAMA: Guidance on FDA's February 19, 1998 OSB/DPS
Do
Transition Plan for Existing
Postmarket Surveillance (FOD #318)
Guidance on Procedures to Determine February 19, 1998 OSB/DPS
Do
Application of Postmarket
Surveillance Strategies (FOD #316)
Guidance on Procedures for Review February 19, 1998 OSB/DPS
Do
of Postmarket Surveillance
Submissions (FOD #317)
MDR/Policy/Guidance for Endosseus December 1992 OSB/DSS
Do
Implant Devices
MDR Guidance #4--External
September 1994 OSB/DSS
Do
Defibrillators
MDR Guidance--Blood Loss Policy December 1995 OSB/DSS
Do
Summary Reporting Approval for July 1997
OSB/DSS
Do
Adverse Events
Common Problems: Baseline Reports
OSB/DSS
Do
and MedWatch Form 3500A (letter to
manufacturers updated)
Guidance on the Recognition and Use February 19, 1998 OST
Do
of Consensus Standards
Withdrawn
[[Page 36417]]
``Draft Guidance for the Content of August 22, 1995 ODE/DCRND
Do
Preliminary Investigational Device
Exemptions (Pre-IDE)
Presentations: Teleconferences,
Meetings and Written Submissions''
Preliminary Guidance for Ambulatory September 1, 1994 ODE/DCRND
Do
Electrocardiograph for Data to be
Submitted to FDA in Support of
Premarket Notification
Applications
Preliminary Guidance for Data to be December 1, 1994 ODE/DCRND
Do
Submitted in Support of Premarket
Notifications for Analyzing ECG's/
Interpretive ECG's
Preliminary Guidance for Data to be April 25, 1994 ODE/DCRND
Do
Submitted to the FDA in Support of
Premarket Notification
Applications for External
Cardioverters and Defibrillators
Reviewer Checklist for Monitors: January 24, 1996 ODE/DCRND
Do
EMC, Battery and Software
Medical Device Tracking: Questions August 26, 1993 OC/DOEI
Do
and Answers Based on the Final
Rule
510(k) Diagnostic Ultrasound
February 1993 ODE/DRAERD
Do
Guidance 4/91 Use of Medical Index
in Place of Peak Intensity in
Determining Substantial
Equivalency for Diagnostic
Ultrasound Equip/Access/Rel. Meas.
Dev.
Review of ``YAG'' Lasers for
N/A
ODE/DGRD
Do
Neurosurgery
FDA Public Health Advisory: Retinal October 16, 1995 ODE/DOD
Do
Photic Injuries from Operating
Microscopes During Cataract
Surgery
Sterilization: Questions and
January 1985
OC/DOEII
Do
Answers from FDA, from Medical
Device Diagnostic Industry for
January, 1985, page 132
Corrections
Rechargeable Battery Preliminary January 1, 1994 ODE/DCRND
Do
Guidance for Data to be Submitted
to FDA in Support of Premarket
Notification Applications (FOD
Review Guidance for Anesthesia May 15, 1991
ODE/DCRND
Do
Conduction Catheter (FOD #783)
Guidance for Peak Flow Meters for June 1, 1993
ODE/DCRND
Do
Over-the-Counter Sale
Review Guidance for Oxygen
Undated
ODE/DCRND
Do
Generators and Oxygen Equipment
Guidance for the Preparation and December 4, 1987 ODE/DCRND
Do
Content of Applications to the
Food and Drug Administration for
Ventricular Assist Devices and
Total Artificial Hearts (draft)
Draft Premarket Notification Review June 1, 1994
ODE/DGRD
Do
Guidance for Evoked Response
Somatosensory Stimulators
Draft Version--Guidance on
September 12, 1994 ODE/DGRD
Do
Biocompatibility Requirements for
Long Term Neurological Implants:
Part 3--Implant Model
Draft Version 1--Biofeedback
August 1, 1994 ODE/DGRD
Do
Devices--Draft Guidance for 510(k)
Content
Draft Version Cranial Perforator July 13, 1994 ODE/DGRD
Do
Guidance
Draft Version Guidance for Clinical August 20, 1992 ODE/DGRD
Do
Data to be Submitted for Premarket
Approval Application for Cranial
Electrotherapy Stimulators
Draft Version Guide for Cortical August 10, 1992 ODE/DGRD
Do
Electrode 510(k) Content
Draft Version Neuro Endoscope
July 7, 1994
ODE/DGRD
Do
Guidance
Galvanic Skin Response Measurement August 23, 1994 ODE/DGRD
Do
Devices--Draft Guidance for 510(k)
Content
Guidance for Studies for Pain
May 12, 1988
ODE/DGRD
Do
Therapy Devices--General
Considerations in the Design of
Clinical Studies for Pain-
Alleviating Devices
Guide for 510(k) Review of
June 26, 1990 ODE/DGRD
Do
Processed Human Dura Mater
[[Page 36418]]
Guide for TENS 510(k) Content
August 1, 1994 ODE/DGRD
Do
(Draft)
Guidelines for Reviewing Premarket N/A
ODE/DGRD
Do
Notifications that Claim
Substantial Equivalence to Evoked
Response Stimulators
Protocol for Dermal Toxicity
N/A
ODE/DGRD
Do
Testing for Devices in Contact
With Skin (Draft)
Premarket Notification 510(k)
May 1, 1997
ODE/DOD
Do
Guidance for Contact Lens Care
Products
Amendment 1: Premarket Notification June 28, 1994 ODE/DOD
Do
[510(k)] Guidance Document for
Class II Daily Wear Contact Lenses
Premarket Approval (PMA) Manual July 1, 1997
OHIP/DSMA
Do
(FDA 97-4214)
Required Postmarket Surveillance September 30, 1997 OSB/DPS
Do
Section 522(a) Initial Device
Categories Revised
Guidance to Manufacturers on the July 16, 1996 OSB/DPS
Do
Development of Required Postmarket
Surveillance Study Protocols Under
Section 522(a)(1) of the Federal
Food, Drug, and Cosmetic Act
Variance from Manufacturer Report August 12, 1996 OSB/DSS
Do
Number Format
-
Guidance Documents Issued by the Center for Drug Evaluation and Research (CDER)
Grouped by
Intended User or How to Obtain a Hard Copy of the Name of Document
Date of Issuance Regulatory Document (Name and Address, Phone, Activity
Fax, E-mail, or Internet)
Level 1 Guidances
Environmental Assessment of Human February 12, 1998 Chemistry
Office of Training and
Drugs and Biologics Applications
Communications, Drug Information Branch, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4573 or Internet at http://www.fda.gov/ cder/guidance/index.htm
PAC-ALTS: Postapproval Changes-- April 28, 1998 Do
Do
Analytical Laboratory Testing
Sites
SUPAC IR/MR: Immediate Release and April 28, 1998 Do
Do
Modified Release Solid Oral Dosage
Forms, Manufacturing Equipment
Addendum
Clinical Development Programs for March 18, 1998 Clinical
Do
Drugs, Devices, and Biological
Products for the Treatment of
Rheumatoid Arthritis (RA)
Clinical Development Programs for February 18, 1998 Do
Do
Drugs, Devices, and Biological
Products Intended for the
Treatment of Osteoarthritis (OA)
Manufacture, Processing or Holding April 17, 1998 Compliance
Do
of Active Pharmaceutical
Ingredients
S1B Testing for Carcinogenicity in February 23, 1998 International Do
Pharmaceuticals
Conference on
Harmonization
Implementation of Section 126, February 18, 1998 FDA Modernization Do
Elimination of Certain Labeling
Act
Requirements, of the FDA
Modernization Act of 1997
National Uniformity for
May 5, 1998
Do
Do
Nonprescription Drugs Ingredient
Labeling for OTC Drugs
Repeal of Section 507 of the
February 5, 1998 Do
Do
Federal Food, Drug, and Cosmetic
Act
Level 2 Guidances
Drug Metabolism/Drug Interaction April 7, 1997 Clinical
Do
Studies in the Drug Development
Process: Studies In Vitro
[[Page 36419]]
Organization of an Abbreviated New April 7, 1997 Generic Drug
Do
Drug Application and an
Abbreviated Antibiotic Application
Aerosol Steroid Product Safety January 12, 1998 Advertising
Do
Information in Prescription Drug
Advertising and Promotional
Labeling
Withdrawn
Biopharmaceutic Considerations in November 1, 1983 Biopharmaceutic
Designing and Evaluating Novel
Drug Delivery Systems
Clinical Evaluation of Drugs to November 2, 1978 Clinical
Prevent Dental Caries
Clinical Evaluation of Drugs to November 1, 1978 Do
Prevent, Control and/or Treat
Periodontal Disease
Conjugated Estrogens (Tables) In August 21, 1991 Biopharmaceutic
Vivo Bioequivalence and In Vitro
Dissolution Testing
Current Good Manufacturing
April 22, 1997 Compliance
Practices for Positron Emission
Tomographic (PET) Drug Products
Diphenhydramine Hydrochloride
June 1, 1986
Labeling
Capsules/Elixir
Ergotamine Tartrate and Caffeine December 1, 1981 Do
Tablets and Suppositories
Glyburide Tablets
April 1, 1993 Do
Haloperidol Tablets/Oral Solution February 1, 1990 Do
(Concentrate)
Regulatory Aspects Pertinent to the February 2, 1985 Biopharmaceutic
Development of Transdermal Drug
Delivery Systems
Supplements to New Applications, December 12, 1994 Compliance
Abbreviated Antibiotic
Applications for Nonsterile Drug
Products
Terfenadine (Tablets) In Vivo
September 11, 1995 Biopharmaceutic
Bioequivalence and In Vitro
Dissolution Testing
Positron Emission Tomography
October 24, 1996 Generic Drug
Questions and Answers 1
Positron Emission Tomography
April 18, 1997 Do
Questions and Answers 2
Submission of an Environmental November 13, 1995 Chemistry
Assessment in Human Drug
Applications and Supplements
Submission of an Environmental November 13, 1995 Do
Assessment in Human Drug
Applications and Supplements
Acetohexamide (tablets) In Vivo August 1, 1988 Biopharmaceutic
Bioequivalence and In Vitro
Dissolution Testing
Allopurinol (tablets) In Vivo
July 15, 1985 Do
Bioequivalence and In Vitro
Dissolution Testing
Amiloride Hydrochloride (tablets) March 29, 1985 Do
In Vivo Bioequivalence and In
Vitro Dissolution Testing
Aminophylline (suppositories) In July 5, 1983
Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Amitriptyline Hydrochloride
July 5, 1983
Do
(tablets) In Vivo Bioequivalence
and In Vitro Dissolution Testing
Amoxicillin (capsules, tablets and June 10, 1988 Do
suspension) In Vivo Bioequivalence
and In Vitro Dissolution Testing
Baclofen (tablets) In Vivo
May 5, 1988
Do
Bioequivalence 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) March 19, 1987 Do
In Vivo Bioequivalence and In
Vitro Dissolution Testing
[[Page 36420]]
Cephradine (Capsule and Suspension) September 10, 1986 Do
In-Vivo Bioequivalence Studies
Chlordiazepoxide and
July 5, 1983
Do
Chlordiazepoxide HCl
Bioavailability and Dissolution
Studies
Chlorpropamide In-Vivo
July 5, 1983
Do
Bioavailability Studies
Chlorthalidone (Tablets)
July 5, 1983
Do
Clinical Evaluation of Drugs for
Do
the Treatment of Peripheral
Vascular Disease
Clofibrate In Vivo Bioavailability April 7, 1986 Do
Studies
Clonidine Hydrochloride Drug
December 5, 1984 Do
Products In Vivo Bioequivalence
Study and In Vitro Dissolution
Testing
Clorazepate In Vivo Bioequivalence February 17, 1987 Do
Study and In Vitro Dissolution
Testing
Cyclobenzaprine Hydrochloride
January 25, 1988 Do
(tablets) In Vivo Bioequivalence
and In Vitro Dissolution Testing
Desipramine Hydrochloride (Tablets) September 22, 1987 Do
In Vivo Bioequivalence Studies
Dicyclomine Hydrochloride Drug August 10, 1984 Do
Products In Vivo Bioequivalence
Dissolution Testing (General)
April 1, 1978 Do
Estropipate Tablets In Vivo
August 26, 1992 Do
Bioequivalence and In Vitro
Dissolution Testing (I)
Flurazepam Hydrochloride (capsules) October 15, 1985 Do
In Vivo Bioequivalence and In
Vitro Dissolution Testing
Hydrochlorothiazide (tablets) In September 28, 1987 Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Hydroxyzine Hydrochloride (tablets) March 4, 1986 Do
(dissolution only)
Indomethacin (capsules) In Vivo January 27, 1988 Do
Bioequivalence and In Vitro
Dissolution Testing
Isopropamide Iodide (tablets) In May 12, 1982
Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Loxapine Succinate (capsules) In September 10, 1987 Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Maprotiline Hydrochloride (tablets) August 27, 1987 Do
In Vivo Bioequivalence and In
Vitro Dissolution Testing
Meclofenamate Sodium (capsules) In November 12, 1986 Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Metaproterenol Sulfate (tablets) In March 18, 1986 Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Metoclopramide Hydrochloride
December 27, 1984 Do
(tablets) In Vivo Bioequivalence
and In Vitro Dissolution Testing
Nalidixic Acid In Vivo
August 19, 1987 Do
Bioequivalence and In Vitro
Dissolution Testing
Nitrofurantion Macrocrystalline January 10, 1986 Do
(capsules) In Vivo Bioequivalence
and In Vitro Dissolution Testing
Nitroglycerin Ointment In Vivo December 17, 1986 Do
Bioequivalence Studies
Perphenazine (tablets) In Vivo August 27, 1987 Do
Bioequivalence and In Vitro
Dissolution Testing
Perphenazine/Amitriptyline
August 27, 1987 Do
(tablets) In Vivo Bioequivalence
and In Vitro Dissolution Testing
Phenylbutazone Oxyphenbutazone September 28, 1987 Do
(capsules and tablets) In Vivo
Bioequivalence and In Vitro
Dissolution Testing
[[Page 36421]]
Prazepam (capsules and tablets) In July 26, 1988 Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Prednisone (tablets) (dissolution July 10, 1985 Do
only)
Probenecid Drug Products
July 26, 1983 Do
Bioavailability Study
Propoxyphene Napsylate With
March 26, 1980 Do
Acetaminphen (Tablets)
Propranolol Hydrochloride (tablets) August 1, 1984 Do
In Vivo Bioequivalence and In
Vitro Dissolution Testing
Propylthiouracil (tablets) In Vivo August 13, 1986 Do
Bioequivalence and In Vitro
Dissolution Testing
Quinidine Gluconate (tablets,
September 22, 1987 Do
controlled release) In Vivo
Bioequivalence and In Vitro
Dissolution Testing
Ritodrine Hydrochloride (tablets) August 27, 1987 Do
In Vivo Bioequivalence and In
Vitro Dissolution Testing
Sulfinpyrazone (Capsules and
September 25, 1987 Do
Tablets)
Sulfones (tablets) In Vivo
November 7, 1986 Do
Bioequivalence and In Vitro
Dissolution Testing
Temazepam In Vivo Bioequivalence August 8, 1985 Do
Studies and In Vitro Dissolution
Testing
Tolazamide (tablets) In Vivo
May 30, 1986
Do
Bioequivalence and In Vitro
Dissolution Testing
Tolbutamide (tablets) In Vivo
December 1, 1983 Do
Bioequivalence and In Vitro
Dissolution Testing
Trimipramine Maleate (capsules) In August 18, 1987 Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Verapamil Hydrochloride (tablets) July 18, 1985 Do
In Vivo Bioequivalence and In
Vitro Dissolution Testing
-
Guidance Documents Issued by the Center for Food Safety and Applied Nutrition
Grouped by
Intended User or How to Obtain a Hard Copy of the Name of Document
Date of Issuance Regulatory Document (Name and Address, Phone, Activity
FAX, E-mail, or Internet)
Level I Guidance Documents Not
Included in the February 1998
Comprehensive List
Draft Working Guide to Minimize 1998
Farmers and Food Lou Carson, Food Safety Initiative Microbial Hazards for Fresh Fruits
Packers
(HFS-3), FDA-CFSAN, 200 C St. SW., and Vegetable
Washington, DC 20204 or
jsaltsman@bangate.fda.gov
Iron-containing Supplements and 1997
Dietary Supplement Office of Special Nutritionals (HFS- Drugs: Label Warning and Unit Dose
Manufacturers; 450), FDA-CFSAN, 200 C St. SW., Packaging; Small Entity Compliance
Small Entities Washington, DC 20204
Guide
Level 2 Guidance Documents
Partial List of Enzyme Preparations 1998
FDA Regulated Office of Premarket Approval (HFS- That Are Used in Foods
Industry
200), FDA-CFSAN, 200 C St. SW., Washington, DC 20204
Partial List of Microorganisms and 1998
Do
Do
Microbial-Derived Ingredients That
Are Used in Food
Fish and Fishery Products Hazards January 1998
Do
Office of Seafood (HFS-400), FDA- and Controls Guide, 2nd Ed.
CFSAN, 200 C St. SW., Washington, DC 20204
HACCP Regulations for Fish and 1997
Do
Do
Fishery Products: Questions and
Answers
[[Page 36422]]
-
Guidance Documents Issued by the Center for Veterinary Medicine (CVM)
Grouped by
Intended User or How to Obtain a Hard Copy of the Name of Document
Date of Issuance Regulatory Document (Name and Address, Phone, Activity
FAX, E-mail, or Internet)
Validation of Analytical
December 1997 Regulated Industry Center for Veterinary Medicine (HFV- Procedures; Definition and
12), Communications Staff, Food Terminology; Draft
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1755.
Validation of Analytical
December 1997 Do
Do
Procedures; Methodology; Draft
Industry-Supported Scientific and November 1997 Do
Do
Educational Activities
Professional Flexible Labeling of January 1998
Do
Do
Antimicrobial Drugs; Draft
Small Entities Compliance Guide for February 1998 Do
Do
Renderers
Small Entities Compliance Guide for February 1998 Do
Do
Protein Blenders, Feed
Manufacturers, and Distributors
Small Entities Compliance Guide for February 1998 Do
Do
Feeders of Ruminant Animals With
On-Farm Feed Mixing Operations
Small Entities Compliance Guide for February 1998 Do
Do
Feeders of Ruminant Animals
Without On-Farm Feed Mixing
Operations
CVM Program Policy and Procedures March 19, 1998 Do
Do
Manual; Index (Guide No.
1240.0000)
CVM Guidance on Media Inquiries December 17, 1997 Do
Do
(Guide No. 1240.2325)
Requirements for Importation of March 27, 1992 Do
Do
Investigational New Animal Drugs
(Guide No. 1240.3032)
Animal Drug Applications Expedited December 3, 1997 Do
Do
Review (Guide No. 1240.3135)
CVM Research Activities (Guide No. January 6, 1998 Do
Do
1240.3700)
Initiation and Approval of Research January 6, 1998 Do
Do
Projects (Guide No. 1240.3710)
Ownership Transfer or Corporate March 19, 1998 Do
Do
Identity Change of an Application
(Guide No. 1240.4150)
CVM Makes the Analysis of Comments January 15, 1998 Do
Do
on the Fluoroquinolone and
Glycopeptide Prohibition Available
to the Public
Withdrawn
CVM Program Policy and Procedures October 29, 1997
Manual; Index (Guide No.
1240.0000)
CVM Guidance on Media Inquiries July 1, 1997
(Guide No. 1240.2325)
CVM Research Activities (Guide No. November 3, 1993
1240.3700)
Initiation and Approval of Research November 3, 1993
Projects (Guide No. 1240.3710)
Criteria for the Approval of
February 13, 1990
Euthanasia Products (Guide No.
1240.4112)
Sterility of Ophthalmic Products December 7, 1993
(Guide No. 1240.4120)
Sterility and Pyrogen Requirements November 27, 1989
for Injectable Drug Products
(Guide No. 1240.4122)
Overformulation in Animal Drug January 2, 1992
Products (Guide No. 1240.4130)
Continuous Use Production Drugs and April 16, 1990
Short-Term Therapeutic Treatments
in Feeds (Guide No. 1240.4145)
Policy on Sterilization of New September 10, 1997
Animal Drug Products and
Containers by Irradiation (Guide
No. 1240.4160)
CVM Medically Necessary Veterinary June 30, 1994
Drug Product Shortage Management
(Guide No. 1240.4170)
[[Page 36423]]
Small Entities Compliance Guide on June 1997
Animal Proteins Prohibited from
Animal Feed
-
Guidance Documents Issued by the Office of Regulatory Affairs
Grouped by
Intended User or How to Obtain a Hard Copy of the Name of Document
Date of Issuance Regulatory Document (Name and Address, Phone, Activity
FAX, E-mail, or Internet)
Investigations Operations Manual January 1998
FDA Staff
National Technical Information (PB98-913399)
Personnel
Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, or via Internet at www.fda.gov/ora/ inspect--ref/iom/iomtc.html Mammography Quality Standards Act January 1998
Do
NTIS or via Internet at www.fda.gov/ (MQSA) Auditors Guide (PB98-
ora/inspect--ref/igs/iglist.html 127178)
Guide to Inspections of
December 1997 Do
Do
Electromagnetic Compatibility
Aspects of Medical Device Quality
Systems (PB98-127152)
Guide to Inspections of Grain
March 1998
Do
Division of Emergency and
Product Manufacturers
Investigational Operations (HFC- 130), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857
Guide to Bioresearch Monitoring February 1998 Do
Do
Inspections of In Vitro Devices
Guide to Inspections of Viral
March 1998
Do
Do
Clearance Processes for Plasma
Derivatives
Guide to Inspections of
March 1998
Do
Do
Computerized Systems in the Food
Processing Industry
Regulatory Procedures Manual;
March 1998
Do
Division of Compliance Policy (HFC- Update/New Subchapter; Application
230), Office of Enforcement, Food Integrity Policy
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420 or via Internet at www.fda.gov/ora/compliance__ref/ rpm/rpmtc.html
Regulatory Procedures Manual;
March 1998
Do
Do
Update Subchapter; Warning Letters
Regulatory Procedures Manual:
April 1998
Do
Do
Update/Revised Subchapter; Import
Procedures
Regulatory Procedures Manual:
April 1998
Do
Do
Updated/Revised Subchapter;
Priority Enforcement Strategy for
Problem Importers
Regulatory Procedures Manual:
April 1998
Do
Do
Updated/Revised Subchapter; Import
Procedures
Regulatory Procedures Manual:
April 1998
Do
Do
Updated/Revised Subchapter; Notice
of Sampling
Regulatory Procedures Manual:
April 1998
Do
Do
Updated/Revised Subchapter;
Supervisory Charges
Regulatory Procedures Manual:
May 1998
Do
Do
Update/New Subchapter; Granting
and Denying Transportation and
Exportation (T&E) Entries
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__imports__alerts.html
Guidance Documents Not Included in
the February 1998 Comprehensive
List
Guideline for the Monitoring of January 1998
Regulated Industry Division of Compliance Policy (HFC- Clinical Investigations
230), 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/ rpm/rpmtc.html
Computerized Systems Used in
June 18, 1997 Do
Do
Clinical Trials
[[Page 36424]]
Compliance Program 7348.808;
August 8, 1994 FDA Staff
Do
Bioresearch Monitoring; Good
Personnel
Laboratory Practices (GLP)
(Nonclinical)
Food Laboratory Practice Program October 1, 1991 Do
Do
(Nonclinical Laboratories)
7348.808A: EPA Data Audit
Inspections
Compliance Program 7348.810:
August 18, 1994 Do
Do
Sponsors, Contract Research
Organizations and Monitors
Compliance Program 7348.809:
August 18, 1994 Do
Do
Bioresearch Monitoring;
Institutional Review Board
Compliance Program 7348.811:
August 18, 1994 Do
Do
Bioresearch Monitoring; Clinical
Investigations
-
International Conference on Harmonization Guidances (CDER)
Grouped by
Intended User or How to Obtain a Hard Copy of the Name of Document
Date of Issuance Regulatory Document (Name and Address, Phone, Activity
FAX, E-mail, or Internet)
E2B Data Elements for Transmission January 15, 1998 Regulated Industry Drug Information Branch (HFD-210), of Individual Case Safety Reports
Center for Drug Evaluation and
Research, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 or Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center 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 the United States)or 301- 827-3844 (outside of the United States and local to Rockville,
MD). Internet at http://
www.fda.gov/cder/guidance/
index.htm or http://www.fda.gov/ cber/publications.htm
E8 General Considerations for
December 17, 1997 Do
Do
Clinical Trials
M3 Timing of Nonclinical Studies November 25, 1997 Do
Do
for the Conduct of Human Clinical
Trials of Pharmaceuticals
QC3 Impurities; Residual Solvents December 24, 1997 Do
Do
S1B Testing for Carcinogenicity of February 23, 1998 Do
Do
Pharmaceuticals
S1C(R) Dose Selection for
December 4, 1997 Do
Do
Carcinogenicity Studies of
Pharmaceuticals: Addendum on a
Limit Dose and Related Notes
Dated: June 25, 1998. William B. Schultz, Deputy Commissioner for Policy.
[FR Doc. 98-17702Filed7-2-98; 8:45 am]
BILLING CODE 4160-01-F
