[Federal Register Volume 65, Number 50 (Tuesday, March 14, 2000)]
[Notices]
[Pages 13771-13785]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-6117]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0046]
Quarterly List of Guidance Documents at the Food and Drug
Administration
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is publishing an update
of all guidance documents issued and withdrawn since we compiled the
annual comprehensive list of guidance documents that published on June
10, 1999. FDA committed to publishing quarterly updates in its February
1997 ``Good Guidance Practices'' (GGP's) final rule, which set forth
the agency's policies and procedures for developing, issuing, and using
guidance documents. This list is intended to inform the public of the
existence and availability of guidance documents issued since the
annual comprehensive list was compiled.
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. For information on where to obtain single copies
of guidance documents listed here, see the specific center's list of
guidance documents.
FOR FURTHER INFORMATION CONTACT: LaJuana D. Caldwell, Office of Policy
(HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-7010.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of February 27, 1997 (62 FR 8961), FDA
published a notice announcing its ``Good Guidance Practices'' (GGP's),
which set forth our policies and procedures for developing, issuing,
and using 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 our guidance documents.
As part of FDA's effort to ensure meaningful interaction with the
public regarding guidance documents, we committed to publishing 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withdrawn during that quarter, including ``Level 2'' guidance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 that we issued or withdrew since we published the annual
comprehensive list on June 10,1999 (64 FR 31228). The guidance
documents are organized by the issuing center or office within FDA, and
are further grouped by the intended users or relevant regulatory
activities. Dates provided in the following list refer to the date of
the guidance was issued or, where applicable, the last date the
document was revised. We provided document numbers where available.
[[Page 13772]]
II. Guidance Documents Issued by the Center for Biologics
Evaluation and Research (CBER)
------------------------------------------------------------------------
How to Obtain a Hard
Grouped by Copy of the Document
Name of Document Date of Intended User (Name and Address,
Issuance or Regulatory Phone, FAX, E-mail
Activity or Internet)
------------------------------------------------------------------------
Draft Guidance for May 1999 FDA Regulated Office of
Industry: Industry Communication,
Monoclonal Training, and
Antibodies Used as Manufacturers
Reagents in Drug Assistance (HFM-
Manufacturing 40), Center for
Biologics
Evaluation and
Research (CBER),
Food and Drug
Administration,
1401 Rockville
Pike, Rockville, MD
20852-1448, 800-835-
4709 or 301-827-
1800,
FAX Information
System: 1-888-CBER-
FAX (within U.S.)
or 301-827-3844
(outside U.S. and
local to Rockville,
MD).
Internet access:
http://www.fda.gov/
cber
____________________________________
Guidance for May 1999 Do Do
Industry: Container
Closure Systems for
Packaging Human
Drugs and
Biologics;
Chemistry,
Manufacturing, and
Controls
Documentation
------------------------------------------------------------------------
Draft Guidance for June 1999 Do Do
Industry:
Establishing
Pregnancy
Registries
------------------------------------------------------------------------
Draft Reviewer June 1999 Do Do
Guidance:
Evaluation of Human
Pregnancy Outcome
Data
------------------------------------------------------------------------
Draft Guidance for June 1999 Do Do
Industry: Current
Good Manufacturing
Practice for Blood
and Blood
Components: (1)
Quarantine and
Disposition of
Prior Collections
from donors with
Repeatedly Reactive
Screening Tests for
Hepatitis C Virus
(HCV); (2)
Supplemental
Testing, and the
Notification of
Consignees and
Transfusion
Recipients of donor
Test Results for
Antibody to HCV
(Anti-HCV)
------------------------------------------------------------------------
ICH Guidance on the June 25, Do Do
Duration of Chronic 1999
Toxicity Testing in
Animals (Rodent and
Nonrodent Toxicity
Testing)
------------------------------------------------------------------------
Draft Guidance for July 1999 Do Do
Industry: Clinical
Development
Programs for Drugs,
Devices, and
Biological Products
Intended for the
Treatment of
Osteoarthritis (OA)
------------------------------------------------------------------------
Draft Guidance for July 1999 Do Do
Industry:
Interpreting
Sameness of
Monoclonal Antibody
Products Under the
Orphan Drug
Regulations
------------------------------------------------------------------------
Draft Guidance for August 1999 Do Do
Industry:
Cooperative
Manufacturing
Arrangements for
Licensed Biologics
------------------------------------------------------------------------
Guidance for August 1999 Do Do
Industry: Consumer-
Directed Broadcast
Advertisements
------------------------------------------------------------------------
Draft Guidance for August 1999 Do Do
Industry:
Information Request
and Discipline
Review Letters
Under the
Prescription Drug
User Fee Act
------------------------------------------------------------------------
ICH Guidance on August 18, Do Do
Specifications: 1999
Test Procedures and
Acceptance Criteria
for
Biotechnological/
Biological Products
------------------------------------------------------------------------
Guidance for August 1999 Do Do
Industry: Possible
Dioxin/PCB
Contamination of
Drug and Biological
Products
------------------------------------------------------------------------
[[Page 13773]]
Guidance for August 1999 Do Do
Industry:
Submission of
Abbreviated Reports
and Synopses in
Support of
Marketing
Applications
------------------------------------------------------------------------
Draft Guidance for September Do Do
Industry: Revised 1999
Recommendations for
the Invalidation of
Test Results When
Using Licensed and
510(k) Cleared
Bloodborne Pathogen
Assays to Test
Donors
------------------------------------------------------------------------
International September Do Do
Conference on 24, 1999
Harmonisation Draft
Guidance; Choice of
Control Group in
Clinical Trials
------------------------------------------------------------------------
Guidance for September Do Do
Industry: 1999
Qualifying for
Pediatric
Exclusivity Under
Section 505A of the
Federal Food, Drug,
and Cosmetic Act
------------------------------------------------------------------------
Draft Guidance for November Do Do
Industry: 1999
Supplemental
Guidance on Testing
for Replication
Competent
Retrovirus in
Retroviral Vector
Based Gene Therapy
Products and During
Follow-up of
Patients in
Clinical Trials
Using Retroviral
Vectors
------------------------------------------------------------------------
Guidance for November Do Do
Industry: Providing 1999
Regulatory
Submissions to the
Center for
Biologics
Evaluation and
Research (CBER) in
Electronic Format--
Biologics Marketing
Applications
[Biologics License
Application (BLA),
Product License
Application (PLA) /
Establishment
License Application
(ELA) and New Drug
Application (NDA)]--
Revised
------------------------------------------------------------------------
Guidance for November Do Do
Industry: Revised 1999
Precautionary
Measures to Reduce
the Possible Risk
of Transmission of
Creutzfeldt-Jakob
Disease (CJD) and
New Variant
Creutzfeldt-Jakob
Disease (nvCJD) by
Blood and Blood
Products
------------------------------------------------------------------------
Guidance for November Do Do
Industry: In Vivo 1999
Drug Metabolism /
Drug Interaction
Studies--Study
Design, Data
Analysis and
Recommendations for
Dosing and Labeling
------------------------------------------------------------------------
Draft Guidance for November Do Do
Industry: 1999
Application of
Current Statutory
Authority to
Nucleic Acid
Testing of Pooled
Plasma
------------------------------------------------------------------------
Draft Guidance for November Do Do
Industry: 1999
Pharmacokinetics in
Patients With
Impaired Hepatic
Function: Study
Design, Data
Analysis and Impact
on Dosing and
Labeling
------------------------------------------------------------------------
Guidance for December Do Do
Industry: In the 1999
Manufacture and
Clinical Evaluation
ofIn VitroTests to
Detect Nucleic Acid
Sequences of Human
Immunodeficiency
Viruses Types 1 and
2
------------------------------------------------------------------------
Draft Guidance for December Do Do
Industry: 1999
Precautionary
Measures to Reduce
the Possible Risk
of Transmission of
Zoonoses by Blood
and Blood Products
from
Xenotransplantation
Product Recipients
and Their Contacts
------------------------------------------------------------------------
[[Page 13774]]
Draft Guidance for January 2000 Do Do
Industry: Changes
to an Approved
Application:
Biological
Products: Human
Blood and Blood
Components Intended
for Transfusion or
for Further
Manufacture
------------------------------------------------------------------------
III. Guidance Documents Issued by the Center for Device and
Radiological Health (CDRH)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
How to Obtain a Hard Copy of the
Name of Document Date of Issuance Group by Intended User or Regulatory Activity Document (Name and Address, Phone, FAX,
E-mail or Internet)
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Guidance for Industry and FDA Staff--Guidance on Medical January 24, 2000 Office of Compliance (OC) Division of Small Manufacturers
Device Tracking (FDAMA) (Replaces: Guidance for Industry Assistance, 1-800-638-2041 or 301-827-
and FDA Staff--Guidance on Medical Device Tracking 0111 or
(FDAMA) 2/12/99) (FAX) Facts-on-Demand at 1-800-899-0381
or
Internet: http://www.fda.gov/cdrh
________________________________________________________________________________________________
Guidance for FDA Staff--Civil Money Penalty Policy June 8, 1999 Do Do
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Alternative to Certain Prescription Device Labeling January 21, 2000 Do Do
Requirements
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Guidance for Industry--Guidance on Information Disclosure October 18, 1999 OC/Division of Enforcement I (DOEI) Do
by Manufacturers to Assemblers for Diagnostic X-ray
Systems
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Guidance on Electrosurgical Devices and the Application November 15, 1999 Do Do
of the Performance Standard for Electrode Lead Wires and
Patient Cables
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Guidance for Industry--Draft Guidance on Quality System August 3, 1999 OC/Division of Enforcement II (DOE II) Do
Regulation Information for Various Premarket Submissions
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Guidance for FDA Staff--Regulating In Vitro Diagnostic December 17, 1999 OC/Division of Bioresearch Monitoring (DBM) Do
Device (IVD) Studies
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Guidance for Industry on the Likelihood of Facilities August 5, 1999 OC/Division of Program Operations (DPO) Do
Inspections When Modifying Devices Subject to Premarket
Approval
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The FDA Export Reform and Enhancement Act of 1996/Export June 22, 1999 Do Do
Certification Package including ``Instructions for
Requests for Certificate to Foreign Governments''
(Replaces: The FDA Export Reform and Enhancement Act of
1996/Export Certification 10/1/96)
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Draft Compliance Program Guidance Manual: Inspection of August 12, 1999 Do Do
Medical Devices
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Guidance for Off-the-Shelf Software Use in Medical September 9, 1999 Office of Device Evaluation (ODE) Do
Devices--Draft Guidance (Replaces: Guidance for Off-the-
Shelf Software Use in Medical Devices--Draft Guidance
August 17, 1998)
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[[Page 13775]]
Guidance for Industry and FDA Reviewers on Evidence September 1, 1999 DO Do
Models for the Least Burdensome Means to Market
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Guidance on the Labeling for Over-the-Counter Sample December 21, 1999 ODE/Division of Clinical Laboratory Devices (DCLD) Do
Collection Systems for Drugs of Abuse Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Labeling for Laboratory Tests June 24, 1999 DO Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance on Premarket Approval Applications for October 8, 1999 Do Do
Assays Pertaining to Hepatitis C Viruses (HCV) that Are
Indicated for Diagnosis or Monitoring of HCV Infection
or Associated Disease
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance and Format of Premarket Notification (510(k)) January 3, 2000 ODE/Division of Dental, Infection Control and General Do
Submissions for Liquid Chemical Sterilants/High Level Hospital Devices (DDIGD)
Disinfectants (Replaces: Draft Guidance on the Content
and Format of Premarket Notification (510(k)) Submission
for Liquid Chemical Sterilants and High Level
Disinfectants (12/18/97)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Reprocessing and Reuse of Single-Use Devices--Risk December 9, 1999 Do Do
Categorization Scheme
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Conducting Stability Testing To Support An November 16, 1999 Do Do
Expiration Date Labeling Claim for Medical Gloves
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Cardiovascular Intravascular Filter 510(k) November 26, 1999 ODE/Division of Cardiovascular, Respiratory & Do
Submission Neurological Devices (DCRND)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and for FDA Reviewers: Recommended May 7, 1999 Do Do
Clinical Study Design for Ventricular Tachycardia
Ablation
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Vascular Prostheses 510(k) November 26, 1999 Do Do
Submissions
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Annuloplasty Rings 510(k) Submissions November 26, 1999 Do Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Cardiovascular Intravascular Filter 510(k) November 26, 1999 Do Do
Submissions
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Cardiopulmonary Bypass Oxygenators 510(k) January 17, 2000 Do Do
Submissions
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Research and Marketing January 14, 2000 Do Do
Applications for Permanent Pacemaker Leads and for
Pacemaker Lead Adaptor 510(k) Submissions (Replaces:
Implantable Pacemaker Lead Testing Guidance for the
Submission of a Section 510(k) Notification September 1,
1989)
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Guidance for Industry and/or for FDA Reviewers/Staff and/ May 7, 1999 ODE/Division of General & Restorative Devices (DGRD) Do
or Compliance--Guidance for Spinal System 510(k)s
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[[Page 13776]]
Guidance for Industry--Guidance for the Preparation of a August 30, 1999 Do Do
Premarket Notification Application for Processed Human
Dura Mater (Replaces: Guidance for Industry--Guidance
for the Preparation of a Premarket Notification
Application for Processed Human Dura Mater July 31,
1999)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance Document for Neurological August 13, 1999 Do Do
Embolization Devices
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance Document for Dura August 13, 1999 DO Do
Substitute Devices
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance on Preclinical and October 5, 1999 Do Do
Clinical Data and Labeling for Breast Prostheses
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry, FDA Reviewers/Staff and June 9, 1999 Do Do
Compliance--Guidance Document for Powered Muscle
Stimulator 510(k)s
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Resorbable Adhesion Barrier Devices for Use December 16, 1999 Do Do
in Abdominal and/or Pelvic Surgery
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Intraocular Lens (IOL) Guidance Document; Draft (Replaces October 14, 1999 ODE/Division of Ophthalmic Devices (DOD) Do
Intraocular Lens (IOL) Guidance Document Draft,
September 10, 1997)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and for FDA Reviewers-- August 4, 1999 Do Do
Accountability for Clinical Studies for Ophthalmic
Devices
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and for FDA Reviewers/Staff-- -- ODE/DOD Do
Guidance on 510(k) Submissions for Keratoprostheses
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Home Uterine Activity Monitors: Guidance for the July 30, 1999 ODE/Division of Reproductive, Abdominal, ENT & Do
Submission of 510(k) Premarket Notifications (Replaces: Radiological Devices (DRAERD)
Premarket Testing Guidelines for Home Uterine Activity
Monitors March 31, 1993)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of 510(k)s for Solid State X- August 6, 1999 Do Do
ray Imaging Devices
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Electro-optical Sensors for the In August 25, 1999 Do Do
Vivo Detection of Cervical Cancer and its Precursors:
Submission Guidance for an IDE/PMA; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Announcement for FOD: Guidance for Industry and FDA-- August 12, 1999 Office of Health and Industry Programs (OHIP)/Division of Do
Medical Glove Guidance Manual; Draft FDA 99-4257 Small Manufacturers Assistance (DSMA)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Device Use Safety: Incorporating August 3, 1999 OHIP/Division of Device User Programs and Systems Do
Human Factors in Risk Management Analysis (DUPSA)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guidance: The Mammography Quality Standards January 14, 2000 OHIP/Division of Mammography Quality and Radiation
Act Final Regulations Document #2 Programs (DMQRP)
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[[Page 13777]]
Compliance Guidance: The Mammography Quality Standards December 8, 1999 Do Do
Act Final Regulations Document #3
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guidance--Mammography Facility Survey and May 5, 1999 Do Do
Medical Physicist Qualification Requirements Under MQSA
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guidance--The Mammography Quality Standards May 5, 1999 Do Do
Act Final Regulations--Preparing for MQSA Inspections
(Replaces: Compliance Guidance--Preparing for MQSA
Inspections 6/30/95)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Request and Issuance of Interim Notice May 4, 1999 Do Do
Letters for Mammography Facilities Under the mammography
Quality Standards Act, 42 U.S.C. Section 263(b)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Addendum to the Instructions for Completing FDA Form June 9, 1999 Office of Surveillance and Biometrics (OSB) Do
3500A with Coding Manual (MEDWATCH) (MDR)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA Reviewers: Guidance on May 6, 1999 Office of Science and Technology (OST)/Division of Life Do
Immunotoxicity Testing Science (DLS)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--CDRH Standard Operating Procedures August 6, 1999 OST/ODE Do
for the Identification and Evaluation of Candidate
Consensus Standard for Recognition
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry on the Testing of Metallic Plasma February 22, 1999 OSB/Division of Postmarket Surveillance (DPS) Do
Sprayed Coatings on Orthopedic Implants to Support
Reconsideration of Postmarket (Replaces: Guidance for
Industry on the Testing of Metallic Plasma Sprayed
Coatings on Orthopedic Implants to Support
Reconsideration of Postmarket--No Date Available)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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Withdrawals
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Name of Document Date of Issuance Group by Intended User or Regulatory Activity Date Withdrawn
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notification 510(k) for Sterilizers March 3, 1993 OC June 29, 1999
Intended for Use in Health Care Facilities March 3, 1993
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Global Harmonization Task Force Study Group 3--Draft 1998 Do June 22, 1999
Process Validation Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA Staff--Guidance on Medical February 12, 1999 Do January 24, 2000
Device Tracking (FDAMA) (Replaced by: Guidance for
Industry and FDA Staff--Guidance on Medical Device
Tracking (FDAMA) January 24, 2000)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Requirements for Medical Gloves--A Workshop September 1, 1996 OC/DOEII July 7, 1999
Manual FDA Publication No 96.4257
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[[Page 13778]]
The FDA Export Reform and Enhancement Act of 1996/Export October 1, 1996 OC/DPO September 29, 1999
Certification
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Abbreviated 510(k) Submissions for 1998 ODE June 29, 1999
In Vitro Diagnostic Calibrators
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Freedom of Information/510(K) Process Changes May 15, 1997 Do May 26, 1999
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Off-the-Shelf Software Use in Medical August 17, 1998 Do October 5, 1999
Devices--Draft Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Reexamination of the Evaluation Process for Liquid May 19, 1997 Do January 11, 2000
Chemical Sterilants and High Level Disinfectants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
PMA Summaries of Safety and Effectiveness--Review by the July 25, 1986 ODE/BlueBook May 26, 1999
Office of General Counsel (blue book memo #P85-1)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of 510(k) Premarket February 11, 1997 ODE/DCRND December 13, 1999
Notifications for Cardiovascular Intravascular Filters--
Version 1.0
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance For The Submission of June 1, 1998 Do October 18, 1999
Research and Marketing Applications for Permanent
Pacemaker Leads
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Outline of Recommended Procedures for a Clinical 1998 ODE/Division of Dental, Infection Control and General May 5, 1999
Investigation of Endosseous Implants Under a 510(k) Hospital Devices (DDIGD)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Outline of Recommended Procedures for Animal Laboratory 1998 Do May 5, 1999
Studies of Endosseous Implants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Information Needed for Hydroxyapatite Coated July 6, 1993 Do Do
Titanium Endosseous Implants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Information Needed for Ti-Powder Coated Titanium July 13, 1993 Do Do
Endosseous Implants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Information Needed for Metallurgical Endosseous August 12, 1993 Do Do
Implants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket January 23, 1995 Do Do
Notifications [510(k)s] for Temporomandibular Joint
Implants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance on the Content and Format of Premarket December 18, 1997 Do January 11, 2000
Notification (510(k)) Submission for Liquid Chemical
Sterilants and High Level Disinfectants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guideline for Reviewing Spinal Fixation Device January 9, 1997 ODE/DGRD June 1, 1999
Systems
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for 510(k) Review of Processed Human Dura Mater June 26, 1990 Do August 9, 1999
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Preparation of PMA Applications for January 18, 1995 Do August 16, 1999
Silicone Inflatable (Saline) Breast Prostheses
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Testing of Alternative Breast September 1, 1994 Do September 1, 1994
Prostheses (nonsilicone gel-filled)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 13779]]
Draft Guidance for Preparation of FDA Submissions of May 11, 1992 Do August 16, 1999
Silicone Gel-Filled Breast Prostheses
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Guidance for Industry--Guidance for the Preparation of a July 31, 1999 Do September 7, 1999
Premarket Notification Application for Processed Human
Dura Mater
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Technological Reporting For Powered Muscle Stimulator January 1, 1993 DO June 29, 1999
510(k) (EMS)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket July 26, 1995 Do June 29, 1999
Notification [510(k)] Applications for Powered Muscle
Stimulators, and Ultrasound Diathermy and Muscle
Stimulators
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Electrical Muscle Stimulator (EMS) Labeling Indications; July 11, 1985 Do June 29, 1999
Contraindications; Warnings; etc.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Intraocular Lens (IOL) Guidance Document October 10, 1997 ODE/DOD July 21, 1999
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for February 5, 1998 ODE/DRAERD June 29, 1999
Metal Expandable Biliary Stents
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
In-vivo Devices for the Detection of Cervical Cancer and June 14, 1997 Do May 26, 1999
its Precursors: Submission Guidance for an IDE Draft
Document
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Testing Guidelines for Home Uterine Activity March 31, 1993 Do June 2, 1999
Monitors
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Information for Manufacturers Seeking Marketing Clearance June 19, 1996 Do June 29, 1999
of Digital Mammography Systems
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Obtaining CDRH Guidance Documents March 29, 1999 OHIP/DSMA May 11, 1999
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
List of Current CDRH Addresses for Report Submission and July 30, 1996 OHIP/DUPSA October 20, 1999
Ordering of CDRH Forms
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Addendum to What a Mammography Facility Should do to July 31, 1996 OHIP/DMQRP May 12, 1999
Prepare for an MQSA Inspection
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guidance--Preparing for MQSA Inspections June 30, 1995 Do May 13, 1999
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Instructions for completing Semi-Annual Report, Form 3419 September 24, 1996 OSB May 21, 1999
(MDR)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry on the Testing of Metallic Plasma No date available OSB/Division of Postmarket Surveillance (DPS) January 7, 2000
Sprayed Coatings on Orthopedic Implants to Support
Reconsideration of Postmarket
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 13780]]
IV. Guidance Documents Issued by the Center for Drug Evaluation and
Research (CDER)
----------------------------------------------------------------------------------------------------------------
How to Obtain a Hard
Grouped by Intended Copy of the Document
Name of Document Date of Issuance User or Regulatory (Name and Address,
Activity Phone, FAX, E-mail or
Internet)
----------------------------------------------------------------------------------------------------------------
ANDAs: Blend Uniformity Analysis August 26, 1999 Generic Drug Draft Office of Training and
Communication, Drug
Information Branch,
Food and Drug
Administration, 5600
Fishers Lane,
Rockville, Md 20857,
Internet: http://
www.fda.gov/cder/
guidance/index.htm
________________________________________________________
ANDAs: Impurities in Drug Substances December 3, 1999 Generic Drug Do
----------------------------------------------------------------------------------------------------------------
Applications Covered by Section December 8, 1999 Procedural Draft Do
505(b)(2)
----------------------------------------------------------------------------------------------------------------
Average, Population, and Individual August 27, 1999 Biopharmaceutic Draft Do
Approaches to Establishing
Bioequivalence
----------------------------------------------------------------------------------------------------------------
BA and BE Studies for Orally August 27, 1999 Do Do
Administered Drug Products
----------------------------------------------------------------------------------------------------------------
Bioavailability and Bioequivalence June 2, 1999 Do Do
Studies for Nasal Aerosols and Nasal
Sprays for Local Action
----------------------------------------------------------------------------------------------------------------
Catheter-Related Bloodstream Infections - October 18, 99 Clinical Antimicrobial Do
Developing Antimicrobial Drugs for Draft
Treatment
----------------------------------------------------------------------------------------------------------------
Changes to an Approved NDA or ANDA November 23, 1999 Chemistry Do
----------------------------------------------------------------------------------------------------------------
Clinical Considerations for Accelerated September 1, 1999 Clinical Medical Draft Do
and Traditional Approval of
Antiretroviral Drugs Using Plasma HIV
RNA Measurements
----------------------------------------------------------------------------------------------------------------
Clinical Development Programs for Drugs, July 15, 1999 Do Do
Devices, and Biological Products
Intended for the Treatment of
Osteoarthritis (OA)
----------------------------------------------------------------------------------------------------------------
Computerized Systems Used in Clinical May 10, 1999 Compliance Do
Trials
----------------------------------------------------------------------------------------------------------------
Consumer-Directed Broadcast August 9, 1999 Advertising Do
Advertisements
----------------------------------------------------------------------------------------------------------------
Disclosure of Materials Provided to November 30, 1999 Procedural Do
Advisory Committees in Connection with
Open Advisory Committee Meetings
Convened by the Center for Drug
Evaluation and Research
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry on December 22, 1999 Procedural Draft Do
Disclosing Information Provided to
Advisory Committees in Connection with
Open Advisory Committee Meetings
Related to the Testing or Approval of
New Drugs and Convened by CDER,
Beginning January 1, 2000; Availability
----------------------------------------------------------------------------------------------------------------
Drug Master Files for Bulk Antibiotic November 29, 1999 Chemistry Do
Drug Substances: Availability
----------------------------------------------------------------------------------------------------------------
E10 - Choice of Control Group in September 24, 1999 ICH Draft - Efficacy Do
Clinical Trials
----------------------------------------------------------------------------------------------------------------
Establishing Pregnancy Registries June 4, 1999 Clinical Medical Draft Do
----------------------------------------------------------------------------------------------------------------
Evaluation of Human Pregnancy Outcome June 4, 1999 Do Do
Data
----------------------------------------------------------------------------------------------------------------
In Vivo Metabolism/Drug Interaction November 24, 1999 Clinical Pharmacology Do
Studies - Study Design, Data Analysis,
and Recommendations for Dosing and
Labeling
----------------------------------------------------------------------------------------------------------------
[[Page 13781]]
In Vivo Pharmacokinetics and June 10, 1999 Clinical Medical Draft Do
Bioavailability Studies and In Vitro
Dissolution Testing for Levothyroxine
Sodium Tablets
----------------------------------------------------------------------------------------------------------------
Information Request and Discipline August 17, 1999 Procedural Draft Do
Review Letters Under the Prescription
Drug User Fee Act
----------------------------------------------------------------------------------------------------------------
Labeling OTC Human Drug Products Using a December 1, 1999 OTC Draft Do
Column Format
----------------------------------------------------------------------------------------------------------------
Levothyroxine Sodium August 18, 1999 Clinical Medical Draft Do
----------------------------------------------------------------------------------------------------------------
Major, Minor, Facsimile, and Telephone August 11,1999 Generic Drug Do
Amendments to Original Abbreviated New
Drug Applications
----------------------------------------------------------------------------------------------------------------
Monoclonal Antibodies Used as Reagents June 24, 1999 Chemistry Draft Do
in Drug Manufacturing
----------------------------------------------------------------------------------------------------------------
Nasal Spray and Inhalation Solution, June 2, 1999 Do Do
Suspension, and Spray Drug Products
----------------------------------------------------------------------------------------------------------------
Noncontraceptive Estrogen Class Labeling September 27, 1999 Labeling Draft Do
----------------------------------------------------------------------------------------------------------------
Pharmacokinetics in Patients With December 7, 1999 Clinical Pharmacology Do
Impaired Hepatic Function: Study
Design, Data Analysis, and Impact on
Dosing and Labeling
----------------------------------------------------------------------------------------------------------------
Photosafety Testing January 10, 2000 Pharmacology/ Do
Toxicology
----------------------------------------------------------------------------------------------------------------
Possible Dioxin/PCB Contamination of August 23, 1999 Compliance Do
Drug and Biological Products
----------------------------------------------------------------------------------------------------------------
Preparing Data for Electronic Submission September 21, 1999 Generic Drug Do
in ANDAs
----------------------------------------------------------------------------------------------------------------
Q6B-Test Procedures and Acceptance August 18, 1999 ICH-Quality Do
Criteria for Biotechnological/
Biological Products
----------------------------------------------------------------------------------------------------------------
Qualifying for Pediatric Exclusivity October 1, 1999 Procedural Do
Under Section 505A of the Federal Food,
Drug, and Cosmetic Act-Revised
----------------------------------------------------------------------------------------------------------------
S4A Duration of Chronic Toxicity Testing June 25, 1999 ICH-Safety Do
in Animals (Rodent and Nonrodent
Toxicity Testing)
----------------------------------------------------------------------------------------------------------------
Submission of Abbreviated Reports and September 13, 1999 Clinical Medical Do
Synopses in Support of Marketing
Applications
----------------------------------------------------------------------------------------------------------------
Submission of Documentation in Drug July 7, 1999 Chemistry Do
Applications for Container Closure
Systems Used for the Packaging of Human
Drugs and Biologics
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Withdrawals
-----------------------------------------------------------------------------------------------------------------
Grouped by Intended
Name of Document Date of Issuance User or Regulatory Date Withdrawn
Activity
----------------------------------------------------------------------------------------------------------------
Alprazolam Tablets In Vivo November 27, 1992 Biopharmaceutic July 8, 1999
Bioequivalence and In Vitro Dissolution
Testing
----------------------------------------------------------------------------------------------------------------
Bumetanide Tablets In Vivo April 23, 1993 Do Do
Bioequivalence and In Vitro Dissolution
Testing
----------------------------------------------------------------------------------------------------------------
Carbidopa and Levodopa Tablets In Vivo June 19, 1992 Do Do
Bioequivalence and In Vitro Dissolution
Testing
----------------------------------------------------------------------------------------------------------------
Cefaclor Capsules and Suspension In Vivo April 23, 1993 Do Do
Bioequivalence and In Vitro Dissolution
Testing
----------------------------------------------------------------------------------------------------------------
[[Page 13782]]
Diflunisal Tablets In Vivo May 16, 1992 Do Do
Bioequivalence and In Vitro Dissolution
Testing
----------------------------------------------------------------------------------------------------------------
Diltiazem Hydrochloride Tablets In Vivo May 16, 1992 Do Do
Bioequivalence and In Vitro Dissolution
Testing
----------------------------------------------------------------------------------------------------------------
Flurbiprofen (tablets) In Vivo June 8, 1995 Do Do
Bioequivalence and In Vitro Dissolution
Testing
----------------------------------------------------------------------------------------------------------------
Gemfibrozil Capsules or Tablets In Vivo June 16, 1992 Do Do
Bioequivalence and In Vitro Dissolution
Testing
----------------------------------------------------------------------------------------------------------------
Guanabenz Acetate Tablets In Vivo April 23, 1993 Do Do
Bioequivalence and In Vitro Dissolution
Testing
----------------------------------------------------------------------------------------------------------------
Hydroxychloroquine Sulfate (tablets) In December 28, 1995 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
----------------------------------------------------------------------------------------------------------------
Indapamide (tablets) In Vivo April 23, 1993 Do Do
Bioequivalence and In Vitro Dissolution
Testing
----------------------------------------------------------------------------------------------------------------
Ketoprofen (capsules) In Vivo April 23, 1993 Do July 8, 1999
Bioequivalence and In Vitro Dissolution
Testing
----------------------------------------------------------------------------------------------------------------
Leucovorin Calcium (tablets) In Vivo August 4, 1988 Do Do
Bioequivalence and In Vitro Dissolution
Testing
----------------------------------------------------------------------------------------------------------------
Medroxyprogesterone Acetate (tablets) In September 17, 1987 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
----------------------------------------------------------------------------------------------------------------
Metoprolol Tartrate (tablets) In Vivo June 12, 1992 Do Do
Bioequivalence and In Vitro Dissolution
Testing
----------------------------------------------------------------------------------------------------------------
Nadolol (tablets) In Vivo Bioequivalence May 16, 1992 Do Do
and In Vitro Dissolution Testing
----------------------------------------------------------------------------------------------------------------
Naproxen (tablets) In Vivo June 8, 1995 Do Do
Bioequivalence and In Vitro Dissolution
Testing
----------------------------------------------------------------------------------------------------------------
Nortriptyline Hydrochloride (capsules) June 12, 1992 Do Do
In Vivo Bioequivalence and In Vitro
Dissolution Testing
----------------------------------------------------------------------------------------------------------------
Pentoxifylline (extended-release December 22, 1995 Do Do
tablets) In Vivo Bioequivalence and In
Vitro Dissolution Testing
----------------------------------------------------------------------------------------------------------------
Pindolol (tablets) In Vivo April 23, 1993 Do Do
Bioequivalence and In Vitro Dissolution
Testing
----------------------------------------------------------------------------------------------------------------
Piroxicam (capsules) In Vivo June 15, 1999 Do Do
Bioequivalence and In Vitro Dissolution
Testing
----------------------------------------------------------------------------------------------------------------
Ranitidine Hydrochloride (tablets) In April 23, 1993 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
----------------------------------------------------------------------------------------------------------------
Trazodone Hydrochloride (tablets) In April 30, 1988 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
----------------------------------------------------------------------------------------------------------------
Waiver Policy March 29, 1993 Biopharmaceutic Draft Do
----------------------------------------------------------------------------------------------------------------
Bioavailability Policies and Guidelines N/A Biopharmaceutic Draft Do
----------------------------------------------------------------------------------------------------------------
SUPAC-IR: Immediate Release and Solid October 21, 1997 Chemistry Draft February 26, 1999
Oral Dosage Forms; Manufacturing
Equipment Addendum
----------------------------------------------------------------------------------------------------------------
Selegiline Hydrochloride (tablets) In December 22, 1995 Biopharmaceutic December 27, 1999
Vivo Bioequivalence and In Vitro
Dissolution Testing
----------------------------------------------------------------------------------------------------------------
[[Page 13783]]
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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Antimicrobial Food Additives--Guidance July 1999 Industry and Center for Food Safety Mark Hepp, Ph.D., (HFS-215)
and Applied Nutrition Staff OPA/CFSAN/FDA
200 C Street. S.W.
Washington, DC 20204
202-418-3098
Internet: http://vm.cfsan.fda.gov/
dms/opa-antg.html
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Preparation of Sept. 1999 Regulated Industry Mitch Cheeseman, Ph.D., (HFS-215)
Premarket Notifications for Food Contact OPA/CFSAN/FDA
Substances--Chemistry Recommendations 200 C Street. S.W.
Washington, DC 20204
202-418-3083
Internet: http://vm.cfsan.fda.gov/
dms/opa-pmnc.html
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Preparation of Sept. 1999 Regulated Industry Mitch Cheeseman, Ph.D., (HFS-215)
Premarket Notifications for Food Contact OPA/CFSAN/FDA
Substances--Toxicology Recommendations 200 C Street. S.W.
Washington, DC 20204
202-418-3083
Internet: http://vm.cfsan.fda.gov/
dms/
opa-pmnt.html
--------------------------------------------------------------------------------------------------------------------------------------------------------
VI. Guidance Documents Issued by the Center for Veterinary Medicine
(CVM)
------------------------------------------------------------------------
How to Obtain a
Hard Copy of the
Grouped by Document (Name
Name of Document Date of Issuance Intended User or and Address,
Regulatory Phone, FAX, E-
Activity mail or
Internet)
------------------------------------------------------------------------
Guidance for June 1999 Animal Drug Communications
Industry: Industry Staff (HFV-12),
Chemistry, FDA/CVM, 7500
Manufacturing Standish Pl.,
and Controls Rockville, MD
Changes to an 20855, 301-594-
Approved NADA or 1755,
ANADA: Draft FAX 301-594-1831
Guidance Internet: http://
www.fda.gov/cvm
____________________________________
Draft Guidance July 1999 Do Do
for Industry:
Good Clinical
Practices
------------------------------------------------------------------------
Guidance for July 1999 Do Do
Industry:
Efficacy of
Anthelmintics:
General Recom-
mendations:
Draft Guidance
------------------------------------------------------------------------
Guidance for July 1999 Do Do
Industry:
Stability
Testing for
Medicated
Premixes Draft
Guidance
------------------------------------------------------------------------
Guidance for July 1999 Do Do
Industry:
Impurities in
New Veterinary
Drug Substances
Draft Guidance
------------------------------------------------------------------------
Guidance for July 1999 Do Do
Industry:
Impurities in
New Veterinary
Medical Products
Draft Guidance
------------------------------------------------------------------------
Guidance for July 1999 Do Do
Industry:
Efficacy of
Anthelmintics:
Specific
Recommendations
for Bovines:
Draft Guidance
------------------------------------------------------------------------
Guidance for July 1999 Do Do
Industry:
Efficacy of
Anthelmintics:
Specific
Recommendations
for Ovines:
Draft Guidance
------------------------------------------------------------------------
[[Page 13784]]
Guidance for July 1999 Do Do
Industry--Valida
tion of
Analytical
Procedures:
Definition and
Terminology
------------------------------------------------------------------------
Guidance for July 1999 Do Do
Industry--Valida
tion of
Analytical
Procedures:
Methodology:
Final Guidance
------------------------------------------------------------------------
Guidance for July 1999 Do Do
Industry:
Efficacy of
Anthelmintics:
Specific
Recommendations
for Caprines:
Draft Guidance
------------------------------------------------------------------------
Guidance for August 1999 Do Do
Industry:
Manufacture and
Distribution of
Unapproved
Piperazine
Products
------------------------------------------------------------------------
Guidance for August 1999 Do Do
Industry:
Possible Dioxin/
PCB
Contamination of
Drug and
Biological
Products
------------------------------------------------------------------------
Guidance for August 1999 Do Do
Industry--Consum
er-Directed
Broadcast
Advertisements:
Final Guidance
------------------------------------------------------------------------
Guidance for September 1999 Do Do
Industry:
Stability
Testing of New
Veterinary
Dosage Forms
VICH GL4: Final
Guidance
------------------------------------------------------------------------
Guidance for September 1999 Do Do
Industry:
Stability
Testing of New
Veterinary Drug
Substances and
Medicinal
Products VICH
GL3: Final
Guidance
------------------------------------------------------------------------
Guidance for September 1999 Do Do
Industry:
Environmental
Impact
Assessments
(EIA's) for
Veterinary
Medicinal
Products
(VMP's)--Phase
I: Draft
Guidance
------------------------------------------------------------------------
Guidance for September 1999 Do Do
Industry:
Quality of
Biotechnological
Products in the
Veterinary
Field: Stability
Testing of
Biotechnological/
Biological
Products VICH GL
17: Draft
Guidance
------------------------------------------------------------------------
Guidance for September 1999 Do Do
Industry:
Impurities:
Residual
Solvents VICH GL
18: Draft
Guidance
------------------------------------------------------------------------
Guidance for September 1999 Do Do
Industry--Conten
t and Format of
Effectiveness
and Target
Animal Safety
Technical
Sections and
Final Study
Reports for
Submission to
the Division of
Therapeutic
Drugs for Non-
Food Animals
------------------------------------------------------------------------
Guidance for September 1999 Do Do
Industry:
Stability
Testing:
Photostability
Testing of New
Veterinary Drug
Substances and
Medicinal
Products: Final
Guidance
------------------------------------------------------------------------
Computerized October 1999 Do Do
Systems Used in
Clinical Trials
------------------------------------------------------------------------
[[Page 13785]]
Dioxin in Anti- October 1999 Do Do
Caking Agents
Used in Animal
Feed and Feed
Ingredients
------------------------------------------------------------------------
Guidance for December 1999 Do Do
Industry--Evalua
tion of the
Human Health
Impact of the
Microbial
Effects of
Antimicrobial
New Animal Drugs
Intended for Use
in Food-
Producing
Animals
------------------------------------------------------------------------
VII. Guidance Documents Issued by Office of Regulatory Affairs
----------------------------------------------------------------------------------------------------------------
How to obtain a Hard Copy
Grouped by Intended User of the Document (Name and
Name of Document Date of Issuance of Regulatory Activity Address, Phone, FAX, E-
mail or Internet)
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of August 1999 FDA Personnel Division of Emergency and
Quality Systems Investigational
Operations (HFC-130),
Office of Regional
Operations, Food and Drug
Administration, 5600
Fishers Lane, Rockville,
MD 20857, 301-827-5636
Internet: http://
www.fda.gov/ora/inspect_
ref/igs/qsit/
QSITGUIDE.PDF
________________________________________________________
Import Alerts Continuously FDA Personnel Freedom of Information
Staff (HFI-35), Food and
Drug Administration, 5600
Fishers Lane, Rockville,
MD
Internet: http://
www.fda.gov/ora/fiars/
ora_import_alerts.html
----------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------
Grouped by
Intended User or
Withdrawals Date of Issuance Regulatory Date Withdrawn
Activity
------------------------------------------------------------------------
Compliance Policy FDA Personnel December 23,
Guide (CPG), 1999
Chapter 3, Sec.
305.100,
Accupuncture
Devices and
Accessories (CPG
7124.11)
Revoked:
December 23,
1999.
------------------------------------------------------------------------
Dated: March 7, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-6117 Filed 3-13-00; 8:45 am]
BILLING CODE 4160-01-F