[Federal Register Volume 65, Number 101 (Wednesday, May 24, 2000)]
[Notices]
[Pages 33553-33560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-12989]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N-0046]


Quarterly List of Guidance Documents at the Food and Drug 
Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a 
quarterly update of all guidance documents issued and withdrawn since 
we compiled the last quarterly list of guidance documents that 
published on March 14, 2000. FDA committed to publishing quarterly 
updates in our February 1997 ``Good Guidance Practices'' (GGP's) 
document, 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. We 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withdrawn during that quarter, including ``Level 2'' guidance 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 last 
quarterly list on March 14, 2000 (65 FR 13771). 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 the 
guidance was issued or, where applicable, the last date the document 
was revised. We provided document numbers where available.

II. Guidance Document Issued by the Center for Biologics Evaluation 
and Research (CBER)

 
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                                                                                                     Grouped by Intended User or         How to Obtain a Hard Copy of the Document (Name and
                      Name of Document                                Date of Issuance                   Regulatory Activity                   Address, Phone, FAX, E-mail or Internet)
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Draft guidance entitled ``International Conference on        February 11, 2000                   FDA Regulated Industry              Office of Communication, Training, and Manufacturers
 Harmonsation of Technical Requirements for Registration of                                                                           Assistance (HFM-40), Center for Biologics Evaluation and
 Pharmaceuticals for Human Use   M4: Common Technical                                                                                 Research (CBER), Food and Drug Administration, 1401
 Document''                                                                                                                           Rockville Pike, Rockville, MD 20852-1448, 1-800-835-4709
                                                                                                                                      or 301-827-1800,
                                                                                                                                     FAX Information System: 1-888-CBER-FAX (within U.S.)or 301-
                                                                                                                                      827-3844 (outside U.S. and local to Rockville, MD).
                                                                                                                                     Internet access: http://www.fda.gov/cber
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Draft Guidance for Industry: Special Protocol Assessment     December 1999                       Do                                  Do
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Draft Guidance for Reviewers: Potency Limits for             February 2000                       FDA Personnel                       Do
 Standardized Dust Mite and Grass Allergen Vaccines: A
 Revised Protocol
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[[Page 33554]]

 
Draft Guidance for Industry: IND Meetings for Human Drugs    February 2000                       FDA Regulated Industry              Do
 and Biologics: Chemistry, Manufacturing, and Controls
 Information
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Guidance for Industry: Formal Meetings With Sponsors and     February 2000                       Do                                  Do
 Applicants for PDUFA Products
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Guidance for Industry: Formal Dispute Resolution: Appeals    February 2000                       Do                                  Do
 Above the Division Level
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Guidance for Industry: Gamma Irradiation of Blood and Blood  February 2000                       Do                                  Do
 Components: A Pilot Program for Licensing
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Draft Guidance for Industry: Information Program on          March 2000                          Do                                  Do
 Clinical Trials for Serious or Life-Threatening Diseases:
 Establishment of a Data Bank
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III. Guidance Documents Issued by the Center for Devices and 
Radiological Health (CDRH)

 
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                                                                                                     Grouped by Intended User or
                      Name of Document                                Date of Issuance                   Regulatory Activity                                Date Withdrawn
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Guidance for Industry and for FDA Staff: Enforcement         February 8, 2000                    Office of Compliance (OC)           Division of Small Manufacturers Assistance; 1-800-638-2041
 Priorities for Single-Use Devices Reprocessed by Third                                                                               or 301-827-0111 or
 Parties and Hospitals, Draft Guidance-Not for                                                                                       FAX Facts-on-Demand 1-800-899-0381
 Implementation                                                                                                                      Internet access: http://www.fda.gov/cdrh
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Guidance for FDA Staff; Compliance Program Guidance Manual;  March 15, 2000                      OC/Division of Enforcement I        Do
 Field Compliance Testing of Diagnostic (Medical) X-ray                                           (DOE1)
 Equipment
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Guidance for Industry and FDA; Guidance for Indwelling       February 21, 2000                   Office of Device Evaluation (ODE )  Do
 Blood Gas Analyzer 510(k) Submissions
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Guidance on the Use of Standards in Substantial Equivalence  March 12, 2000                      Do                                  Do
 Determination
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Guidance Document for Premarket Notification Submission for  January 24, 2000                    ODE/Division of Cardiovascular,     Do
 Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and                                       Respiratory & Neurological
 Nitrogen Dioxide Analyzer                                                                        Devices (DCRND)
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Guidance for Extracorporeal Blood Circuit Defoamer 510(k)    February 16, 2000                   ODE/DCRND                           Do
 Submissions
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Guidance for Cardiopulmonary Bypass Arterial Line Blood      February 21, 2000                   Do                                  Do
 Filter 510(k) Submissions
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Guidance Document for the Preparation of IDEs for Spinal     January 13, 2000                    ODE/Division of General &           Do
 Systems (Replaces: Guidance Document for the Preparation                                         Restorative Devices (DGRD)
 of IDEs for Spinal Systems 8/26/98)
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Guidance for the Arrangement and Content of a Premarket      May 16, 1989                        ODE/Division of Dental, Infection   Do
 Approval (PMA Application for an Endosseous Implant                                              Control and General Hospital
                                                                                                  Devices (DDIGD)
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[[Page 33555]]

 
Guidance for Industry and FDA Reviewers: Reprocessing and    February 8, 2000                    Do                                  Do
 Reuse of Single-Use Devices: Review Prioritization Scheme
 (Replaces: Reprocessing and Reuse of Single-Use-Devices:
 Risk Categorization Scheme; Draft Guidance 12/9/99)
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Guidance for Industry and for FDA Reviewers/Staff; Guidance  January 16, 2000                    ODE/Division of Reproductive        Do
 for the Content of Premarket Notifications for Penile                                            Abdominal, ENT and Radiological
 Rigidity Implants (Replaced: Draft Guidance for the                                              Devices (DRAERD)
 Content of Premarket Notifications for Penile Rigidity
 Implants 5/30/95)
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Guidance for Manufacturers Seeking Marketing Clearance of    March 12, 2000                      ODE/Division of Ophthalmic and      Do
 Ear, Nose, and Throat Endoscope Sheaths Used as Protective                                       Ear, Nose, Throat Devices (DOED)
 Barriers (Replaces: Guidance for the Content of Premarket
 Notification for Disposable, Sterile, Ear, Nose and Throat
 Endoscope Sheaths with Protective Barrier Claims 10/21/96)
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Draft Guidance for Industry; Guidance on Medical Device      March 3, 2000                       Office of Health and Industry       Do
 Patient Labeling                                                                                 Programs (OHIP)/Division of
                                                                                                  Device User Programs and Systems
                                                                                                  Anaylsis (DDUPSA)
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The FDA Export Reform and Enhancement Act of 1996/Export     February 7, 2000                    OHIP/Division of Small              Do
 Certification Package including ``Instructions for                                               Manufacturers Assistance (DSMA)
 Requests for Certificate to Foreign Governments''
 (Replaces: The FDA Export Reform and Enhancement Act of
 1996/Export Certification Package including ``Instructions
 for Requests for Certificate to Foreign Governments'' 6/22/
 99)
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Compliance Guidance: The Mammography Quality Standards Act   February 25, 2000                   OHIP/Division of Mammography        Do
 Final Regulations Document #2                                                                    Quality and Radiation Programs
                                                                                                  (DMQRP)
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Guidance for Industry on the Testing of Metallic Plasma      February 2, 2000                    Office of Surveillance and          Do
 Sprayed Coatings on Orthopedic Implants to Support                                               Biometrics (OSB)/Division of
 Reconsideration of Postmarket (Replaces: Guidance for                                            Postmarket Surveillance (DPS)
 Industry on the Testing of Metallic Plasma Sprayed
 Coatings on Orthopedic Implants to Support Reconsideration
 of Postmarket Surveillance Requirements 2/22/99)
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                                                                                           WITHDRAWALS
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Name of Document                                             Date of Issuance                    Grouped by Intended User or         Date Withdrawn
                                                                                                  Regulatory Activity
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Guidance on Medical Device Tracking [FDAMA] Replaced by      February 19, 1998                   OC                                  January 24, 2000
 Guidance for Industry and FDA Staff-Guidance on Medical
 Device Tracking [FDAMA]
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Guideline for Preparing Notices of Availability of           November 1, 1985                    OC/BIMO                             February 14, 2000
 Investigational Medical Devices (Replaced by: Preparing
 Notices of Availability of Investigational Medical Devices
 and for Recruiting Study Subjects 3/19/99)
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[[Page 33556]]

 
Review Proposal for Reagents and Analyzer Systems            March 14, 1995                      ODE                                 February 17, 2000
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Implantable Pacemaker Lead Testing Guidance for the          September 1, 1989                   ODE/DCRND                           January 21, 2000
 Submission of a Section 510(k) Notification (Replaced by:
 Guidance for the Submission of Research and Marketing
 Applications for Permanent Pacemaker Leads and for
 Pacemaker Lead Adaptor 510(k) Submissions 1/14/00)
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Determining Equivalence of Intraaortic Balloon Catheters     December 12, 1989                   Do                                  April 7, 2000
 Under the 510(k) Regulations
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510(k) Guidance for Screw Type Endosseous Implants for       August 11, 1992                     ODE/DDIGD                           April 5, 2000
 Prosthetic Attachment
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Addendum to Guidance on the Content and Format of Premarket  March 9, 1994                       Do                                  February 15, 2000
 Notification [510(k)] Submissions for General Purpose
 Disinfectants
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Reprocessing and Reuse of Single-Use-Devices: Risk           December 9, 1999                    Do                                  February 9, 2000
 Categorization Scheme; Draft Guidance (Replaced by:
 Guidance for Industry and FDA Reviewers: Reprocessing and
 Reuse of Single-Use Devices: Review Prioritization Scheme
 Draft 2/8/00
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Draft Guidance on the Content and Format of Premarket        February 11, 1997                   Do                                  April 10, 2000
 Approval Application (PMA) for Sharps Needle Destruction
 Devices
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Sunglass Package; including Certification Statement for the  March 19, 1998                      ODE/DOD                             February 8, 2000
 Impact-Resistance Test of Lenses in Eyeglasses and
 Sunglasses
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Guidance for Submission of a 510(k) Premarket Notification   April 1, 1991                       ODE/DRAERD                          April 7, 2000
 for an Air Conduction Hearing Aid
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Draft Guidance for the Content of Premarket Notifications    May 30, 1995                        Do                                  March 20, 2000
 for Penile Rigidity Implants (Replaced by: Guidance for
 Industry and for FDA Reviewer/Staff; Guidance for the
 Content of Premarket Notifications for Penile Rigidity
 Implants 1/16/00)
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Guidance for the Content of Premarket Notification for       November 21, 1996                   Do                                  March 22, 2000
 Disposable, Sterile, Ear, Nose and Throat Endoscope
 Sheaths with Protective Barrier Claims (Replaced by:
 Guidance for the Content of Premarket Notification for
 Disposable, Sterile, Ear, Nose and Throat Endoscope
 Sheaths with Protective Barrier Claims 3/12/00)
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Draft Guidance to Hearing Aid Manufacturers for              August 5, 1994                      Do                                  April 14, 2000
 Substantiation of Claims
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Medical Device Reporting for Distributors                    April 1, 1996                       OHIP/DSMA                           February 16, 2000
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Compliance Guidance: The Mammography Quality Standards Act   March 5, 1999                       OHIP/DMQRP                          January 21, 2000
 Final Regulations Document #2 (Replaced by Compliance
 Guidance: The Mammography Quality Standards Act Final
 Regulations Document #2 2/25/00)
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[[Page 33557]]

 
The FDA Export Reform and Enhancement Act of 1996/Export     June 22, 1999                       Do                                  February 14, 2000
 Certification Package including ``Instructions for
 Requests for Certificate to Foreign Governments''
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Import of Medical Devices--A Workshop Manual (FDA 93-4228)   March 1, 1993                       Do                                  February 8, 2000
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Guidance for Medical Gloves--A Workshop Manual FDA 97-4257   September 1, 1997                   Do                                  Do
 (Replaced by Guidance for Industry and FDA-Medical Glove
 Guidance Manual Draft FDA 99-4257)
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Part I--FDA Structure and Functions Part II--Center for      April 14, 1999                      OHIP/DSMA                           February 15, 2000
 Devices and Radiological Health (CDRH) Structure and
 Functions/International Manual (Replaced by: U.S. FDA-
 Regulation of Medical Devices; Background Information for
 International Officials 4/14/99)
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Part III--FDA's Regulation of Medical Devices/International  April 14, 1999                      OHIP/DSMA                           Do
 Manual (Replaced by: U.S. FDA Regulation of Medical
 Devices; Background Information for International
 Officials 4/14/99)
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Part IV--Electronic Access to FDA Guidance Documents and     April 14, 1999                      OHIP/DSMA                           Do
 Information/International Manual (Replaced by: U.S. FDA-
 Regulation of Medical Devices; Background Information for
 International Officials 4/14/99)
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MDR Documents Access Information for CDRH Facts-On-Demand    February 29, 1996                   OSB                                 Do
 (FOD)
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MDR Documents Access Information for Industry Organizations  May 8, 1996                         OSB                                 Do
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Guidance for Industry on the Testing of Metallic Plasma      February 22, 1999                   OSB/DPS                             January 17, 2000
 Sprayed Coatings on Orthopedic Implants to Support
 Reconsideration of Postmarket Surveillance Requirements
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                                                                                           CORRECTIONS
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Name of Document                                             Date of Issuance                    Grouped by Intended User or         How to Obtain a Hard Copy of the Document (Name and
                                                                                                  Regulatory Group                    Address, Phone, FAX, E-mail or Internet)
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Guidance on Premarket Notification [510(k)] Submissions for  August 1, 1993                      ODE/Division of General &           Do
 Automated Endoscope Washers, Washer/Disinfectors, and                                            Restorative Devices (DGRD)
 Disinfectors Intended for Use in Health Care Facilities
 (This document was mistakenly listed as ``withdrawn'' in
 the March 14, 2000 Federal Register
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IV. Guidance Documents Issued by the Center for Drug Evaluation and 
Research (CDER)

[[Page 33558]]



 
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                                                                                                     Grouped by Intended User or         How to Obtain a Hard Copy of the Document (Name and
                      Name of Document                                Date of Issuance                   Regulatory Activity                   Address, Phone, FAX, E-mail or Internet)
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Skin Irritation and Sensitization Testing of Generic         February 3, 2000                    Generic Drug                        Office of Training and Communication, Drug Information
 Transdermal Drug Products                                                                                                            Branch, Food and Drug Administration, 5600 Fishers Lane,
                                                                                                                                      Rockville, MD 20857,
                                                                                                                                     Internet access: http://www.fda.gov.cder/ guidance/
                                                                                                                                      index.htm
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IND Meetings for Human Drugs and Biologics; Chemistry,       February 4, 2000                    Chemistry Draft                     Do
 Manufacturing, and Controls information
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Special Protocol Assessment                                  February 9, 2000                    Modernization Act Draft             Do
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Draft guidance entitled ``M4 Common Technical Document:      February 11, 2000                   ICH Draft--Joint Safety/Efficacy    Do
 Request for Comments on Initial Components''
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NDAs: Impurities in Drug Substances                          February 25, 2000                   Chemistry                           Do
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Formal Meetings With Sponsors and Applicants For PDUFA       March 7, 2000                       Modernization Act                   Do
 Products
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Formal Dispute Resolution: Appeals Above the Division Level  March 7, 2000                       Do                                  Do
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OTC Treatment of Herpes Labialis with Antiviral Agents       March 8, 2000                       Clinical/Medical Draft              Do
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Conjugated Estrogens, USP: LC-MS Method for Both             March 9, 2000                       Biopharmaceutic Draft               Do
 Qualitative chemical characterization and Documentation of
 Qualitative Pharmaceutical Equivalence
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Content and Format of New Drug Applications and Abbreviated  March 10, 2000                      Modernization Act Draft             Do
 New Drug Applications for Certain Positron Emission
 Tomography Drug Products
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Information Program on Clinical Trials for Serious or Life-  March 29, 2000                      Do                                  Do
 Threatening Diseases: Establishment of a Data Bank:
 Availability
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Court Decisions, ANDA Approvals, and 180-Day Exclusivity     March 30, 2000                      Procedural                          Do
 Under the Hatch-Waxman Amendments to the Federal Food,
 Drug, and Cosmetic Act
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Draft guidance entitled ``E11: Clinical Investigation of     April 12, 2000                      ICH Draft--Efficacy                 Do
 Medicinal Products in the Pediatric Population''
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V. Guidance Documents Issued by the Center for Veterinary Medicine 
(CVM)

 
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                                                                                                     Grouped by Intended User or         How to Obtain a Hard Copy of the Document (Name and
                      Name of Document                                Date of Issuance                   Regulatory Activity                   Address, Phone, FAX, E-mail or Internet)
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Guidance for Industry: Development of Supplemental           January 2000                        Animal Drug Industry                Communications Staff (HFV-12), FDA/CVM, 7500 Standish Pl.,
 Applications for Approved New Animal Drugs--Draft Guidance                                                                           Rockville, MD 20855, 301-594-1755,
                                                                                                                                     Internet access: http://www.fda.gov/cvm
                                                                                                                                     FAX 301-594-1831
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[[Page 33559]]

 
Guidance for Industry: Stability Testing for Medicated       March 2000                          Do                                  Do
 Premixes Guidance
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VI. Guidance Documents Issued by the Office of Regulatory Affairs 
(ORA)

 
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                                                                                                     Grouped by Intended User or         How to Obtain a Hard Copy of the Document (Name and
                      Name of Document                                Date of Issuance                   Regulatory Activity                   Address, Phone, FAX, E-mail or Internet)
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Draft Guidance for Institutional Review Baords, Clinical     March 30, 2000                      Regulated Industry                  Division of Compliance Policy (HFC-230), Office of
 Investigators, and Sponsors: Exception from Informed                                                                                 Enforcement, Food and Drug Administration, 5600 Fishers
 Consent Requirements for Emergency Research.                                                                                         Lane, Rockville, MD 20857, 301-857-0420 or
                                                                                                                                      Internet access at http://www.fda.gov/ora/compliance--ref/
                                                                                                                                      bimo__err--guide.htm
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Compliance Policy Guide, Chapter 2, Sec.252.110, NEW:        March 6, 2000                       FDA Staff                           Do
 Volume Limits for Automated collection of Source Plasma                                                                              Internet access at http://www.fda.gov/ora/compliance--ref/
                                                                                                                                      cpg/cpgbio/ cpg252.110.htm
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Compliance Policy Guide, Chapter 2, Sec. 257.100, REVISED:   March 22, 2000                      Do                                  Do--Internet at http://www.fda.gov/ora/ compliance--ref/cpg/
 Deferral of source Plasma Donors Due to Red Cell Loss                                                                                cpgbio/ cpg257.100.htm
 During collection of Source Plasma by Automated
 Plasmapheresis
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Regulatory Procedures Manual, UPDATE/ REVISION: Chapter 4,   March 21, 2000                      Do                                  Do--Internet at http://www.fda.gov/ora/compliance--ref/rpm--
 Subchapter/ Warning Letters                                                                                                          new2/ch4.html
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Investigations Operation Manual 2000                         March 2000                          Do                                  Division of Emergency and Investigational Operations (HFC-
                                                                                                                                      130) Office of Regional Operations, Food and Drug
                                                                                                                                      Administration, 5600 Fishers Lane, Rockville, MD 20857,
                                                                                                                                      301-827-5636
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Memorandum to Import Program Managers--Surveillance and      February 11, 2000                   Do                                  Division of Import Operations and Policy (HFC-170), Office
 Post Reconditioning Sampling of Bulk Spices for Pathogens                                                                            of Regional Operations, Food and Drug Administration, 5600
                                                                                                                                      Fishers Lane, Rockville, MD, 301-443-6553
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Import Alerts                                                Continuously                        Do                                  Freedom of Information staff (HFI-35), Food and Drug
                                                                                                                                      Administration, 5600 Fishers Lane, Rockville MD
                                                                                                                                     Internet at http:www.fda.gov/ora/fiars/ ora--import--
                                                                                                                                      alerts.html
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                                                                                           WITHDRAWALS
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Name of Document                                             Date of Issuance                    Grouped by Intended User or         Date Withdrawn
                                                                                                  Regulatory Activity
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Compliance Policy Guide, Chapter 2, Sec. 215.100 (CPG        July 19, 1976                       FDA Staff                           March 28, 2000
 7134.07), IND Filings; Completion of Applicable Portions
 Prior to Final Action on License Applications or License
 Amendments
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[[Page 33560]]

    Dated: May 17, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-12989 Filed 5-23-00; 8:45 am]
BILLING CODE 4160-01-F