Quarterly List of Guidance Documents at the Food and Drug Administration
Federal RegisterMay 24, 2000
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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.
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The Food and Drug Administration (FDA) is publishing a quarterly update of all guidance documents issued and withdrawn since we compiled the last quarterly list of guidance documents that published on March 14, 2000.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notices that list all guidance documents that were issued and withdrawn during that quarter, including “Level 2” guidance documents.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)
Name of Document
Date of Issuance
Grouped by Intended User or Regulatory Activity
How to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, E-mail or Internet)
Draft guidance entitled “International Conference on Harmonsation of Technical Requirements for Registration of Pharmaceuticals for Human Use M4: Common Technical Document”
February 11, 2000
FDA Regulated Industry
Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 1-800-835-4709 or 301-827-1800,
FAX Information System: 1-888-CBER-FAX (within U.S.)or 301-827-3844 (outside U.S. and local to Rockville, MD).
Internet access: http://www.fda.gov/cber
Draft Guidance for Industry: Special Protocol Assessment
December 1999
Do
Do
Draft Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol
February 2000
FDA Personnel
Do
Draft Guidance for Industry: IND Meetings for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information
February 2000
FDA Regulated Industry
Do
Guidance for Industry: Formal Meetings With Sponsors and Applicants for PDUFA Products
February 2000
Do
Do
Guidance for Industry: Formal Dispute Resolution: Appeals Above the Division Level
February 2000
Do
Do
Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A Pilot Program for Licensing
February 2000
Do
Do
Draft Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank
March 2000
Do
Do
III. Guidance Documents Issued by the Center for Devices and Radiological Health (CDRH)
Name of Document
Date of Issuance
Grouped by Intended User or Regulatory Activity
Date Withdrawn
Guidance for Industry and for FDA Staff: Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals, Draft Guidance-Not for Implementation
February 8, 2000
Office of Compliance (OC)
Division of Small Manufacturers Assistance; 1-800-638-2041 or 301-827-0111 or
FAX Facts-on-Demand 1-800-899-0381
Internet access: http://www.fda.gov/cdrh
Guidance for FDA Staff; Compliance Program Guidance Manual; Field Compliance Testing of Diagnostic (Medical) X-ray Equipment
March 15, 2000
OC/Division of Enforcement I (DOE1)
Do
Guidance for Industry and FDA; Guidance for Indwelling Blood Gas Analyzer 510(k) Submissions
February 21, 2000
Office of Device Evaluation (ODE )
Do
Guidance on the Use of Standards in Substantial Equivalence Determination
March 12, 2000
Do
Do
Guidance Document for Premarket Notification Submission for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer
January 24, 2000
ODE/Division of Cardiovascular, Respiratory & Neurological Devices (DCRND)
Do
Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions
February 16, 2000
ODE/DCRND
Do
Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions
February 21, 2000
Do
Do
Guidance Document for the Preparation of IDEs for Spinal Systems (Replaces: Guidance Document for the Preparation of IDEs for Spinal Systems 8/26/98)
January 13, 2000
ODE/Division of General & Restorative Devices (DGRD)
Do
Guidance for the Arrangement and Content of a Premarket Approval (PMA Application for an Endosseous Implant
May 16, 1989
ODE/Division of Dental, Infection Control and General Hospital Devices (DDIGD)
Do
Guidance for Industry and FDA Reviewers: Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme (Replaces: Reprocessing and Reuse of Single-Use-Devices: Risk Categorization Scheme; Draft Guidance 12/9/99)
February 8, 2000
Do
Do
Guidance for Industry and for FDA Reviewers/Staff; Guidance for the Content of Premarket Notifications for Penile Rigidity Implants (Replaced: Draft Guidance for the Content of Premarket Notifications for Penile Rigidity Implants 5/30/95)
January 16, 2000
ODE/Division of Reproductive Abdominal, ENT and Radiological Devices (DRAERD)
Do
Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective 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)
March 12, 2000
ODE/Division of Ophthalmic and Ear, Nose, Throat Devices (DOED)
Do
Draft Guidance for Industry; Guidance on Medical Device Patient Labeling
March 3, 2000
Office of Health and Industry Programs (OHIP)/Division of Device User Programs and Systems Anaylsis (DDUPSA)
Do
The FDA Export Reform and Enhancement Act of 1996/Export Certification Package including “Instructions for 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)
February 7, 2000
OHIP/Division of Small Manufacturers Assistance (DSMA)
Do
Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document #2
February 25, 2000
OHIP/Division of Mammography Quality and Radiation Programs (DMQRP)
Do
Guidance for Industry on the Testing of Metallic Plasma 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 Surveillance Requirements 2/22/99)
February 2, 2000
Office of Surveillance and Biometrics (OSB)/Division of Postmarket Surveillance (DPS)
Do
WITHDRAWALS
Name of Document
Date of Issuance
Grouped by Intended User or Regulatory Activity
Date Withdrawn
Guidance on Medical Device Tracking [FDAMA] Replaced by Guidance for Industry and FDA Staff-Guidance on Medical Device Tracking [FDAMA]
February 19, 1998
OC
January 24, 2000
Guideline for Preparing Notices of Availability of Investigational Medical Devices (Replaced by: Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects 3/19/99)
November 1, 1985
OC/BIMO
February 14, 2000
Review Proposal for Reagents and Analyzer Systems
March 14, 1995
ODE
February 17, 2000
Implantable Pacemaker Lead Testing Guidance for the 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)
September 1, 1989
ODE/DCRND
January 21, 2000
Determining Equivalence of Intraaortic Balloon Catheters Under the 510(k) Regulations
December 12, 1989
Do
April 7, 2000
510(k) Guidance for Screw Type Endosseous Implants for Prosthetic Attachment
August 11, 1992
ODE/DDIGD
April 5, 2000
Addendum to Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for General Purpose Disinfectants
March 9, 1994
Do
February 15, 2000
Reprocessing and Reuse of Single-Use-Devices: Risk 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
December 9, 1999
Do
February 9, 2000
Draft Guidance on the Content and Format of Premarket Approval Application (PMA) for Sharps Needle Destruction Devices
February 11, 1997
Do
April 10, 2000
Sunglass Package; including Certification Statement for the Impact-Resistance Test of Lenses in Eyeglasses and Sunglasses
March 19, 1998
ODE/DOD
February 8, 2000
Guidance for Submission of a 510(k) Premarket Notification for an Air Conduction Hearing Aid
April 1, 1991
ODE/DRAERD
April 7, 2000
Draft Guidance for the Content of Premarket Notifications 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)
May 30, 1995
Do
March 20, 2000
Guidance for the Content of Premarket Notification for 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)
November 21, 1996
Do
March 22, 2000
Draft Guidance to Hearing Aid Manufacturers for Substantiation of Claims
August 5, 1994
Do
April 14, 2000
Medical Device Reporting for Distributors
April 1, 1996
OHIP/DSMA
February 16, 2000
Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document #2 (Replaced by Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document #2 2/25/00)
March 5, 1999
OHIP/DMQRP
January 21, 2000
The FDA Export Reform and Enhancement Act of 1996/Export Certification Package including “Instructions for Requests for Certificate to Foreign Governments”
June 22, 1999
Do
February 14, 2000
Import of Medical Devices—A Workshop Manual (FDA 93-4228)
March 1, 1993
Do
February 8, 2000
Guidance for Medical Gloves—A Workshop Manual FDA 97-4257 (Replaced by Guidance for Industry and FDA-Medical Glove Guidance Manual Draft FDA 99-4257)
September 1, 1997
Do
Do
Part I—FDA Structure and Functions Part II—Center for 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)
April 14, 1999
OHIP/DSMA
February 15, 2000
Part III—FDA's Regulation of Medical Devices/International Manual (Replaced by: U.S. FDA Regulation of Medical Devices; Background Information for International Officials 4/14/99)
April 14, 1999
OHIP/DSMA
Do
Part IV—Electronic Access to FDA Guidance Documents and Information/International Manual (Replaced by: U.S. FDA-Regulation of Medical Devices; Background Information for International Officials 4/14/99)
April 14, 1999
OHIP/DSMA
Do
MDR Documents Access Information for CDRH Facts-On-Demand (FOD)
February 29, 1996
OSB
Do
MDR Documents Access Information for Industry Organizations
May 8, 1996
OSB
Do
Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements
February 22, 1999
OSB/DPS
January 17, 2000
CORRECTIONS
Name of Document
Date of Issuance
Grouped by Intended User or Regulatory Group
How to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, E-mail or Internet)
Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities (This document was mistakenly listed as “withdrawn” in the March 14, 2000
Federal Register
August 1, 1993
ODE/Division of General & Restorative Devices (DGRD)
Do
IV. Guidance Documents Issued by the Center for Drug Evaluation and Research (CDER)
Name of Document
Date of Issuance
Grouped by Intended User or Regulatory Activity
How to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, E-mail or Internet)
Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products
February 3, 2000
Generic Drug
Office of Training and Communication, Drug Information Branch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
Internet access: http://www.fda.gov.cder/ guidance/index.htm
IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls information
February 4, 2000
Chemistry Draft
Do
Special Protocol Assessment
February 9, 2000
Modernization Act Draft
Do
Draft guidance entitled “M4 Common Technical Document: Request for Comments on Initial Components”
February 11, 2000
ICH Draft—Joint Safety/Efficacy
Do
NDAs: Impurities in Drug Substances
February 25, 2000
Chemistry
Do
Formal Meetings With Sponsors and Applicants For PDUFA Products
March 7, 2000
Modernization Act
Do
Formal Dispute Resolution: Appeals Above the Division Level
March 7, 2000
Do
Do
OTC Treatment of Herpes Labialis with Antiviral Agents
March 8, 2000
Clinical/Medical Draft
Do
Conjugated Estrogens, USP: LC-MS Method for Both Qualitative chemical characterization and Documentation of Qualitative Pharmaceutical Equivalence
March 9, 2000
Biopharmaceutic Draft
Do
Content and Format of New Drug Applications and Abbreviated New Drug Applications for Certain Positron Emission Tomography Drug Products
March 10, 2000
Modernization Act Draft
Do
Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank: Availability
March 29, 2000
Do
Do
Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act
March 30, 2000
Procedural
Do
Draft guidance entitled “E11: Clinical Investigation of Medicinal Products in the Pediatric Population”
April 12, 2000
ICH Draft—Efficacy
Do
V. Guidance Documents Issued by the Center for Veterinary Medicine (CVM)
Name of Document
Date of Issuance
Grouped by Intended User or Regulatory Activity
How to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, E-mail or Internet)
Guidance for Industry: Development of Supplemental Applications for Approved New Animal Drugs—Draft Guidance
January 2000
Animal Drug Industry
Communications Staff (HFV-12), FDA/CVM, 7500 Standish Pl., Rockville, MD 20855, 301-594-1755,
Internet access: http://www.fda.gov/cvm
FAX 301-594-1831
Guidance for Industry: Stability Testing for Medicated Premixes Guidance
March 2000
Do
Do
VI. Guidance Documents Issued by the Office of Regulatory Affairs (ORA)
Name of Document
Date of Issuance
Grouped by Intended User or Regulatory Activity
How to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, E-mail or Internet)
Draft Guidance for Institutional Review Baords, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research.
March 30, 2000
Regulated Industry
Division of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-857-0420 or
Internet access at http://www.fda.gov/ora/compliance—ref/bimo
X
err—guide.htm
Compliance Policy Guide, Chapter 2, Sec.252.110, NEW: Volume Limits for Automated collection of Source Plasma
March 6, 2000
FDA Staff
Do
Internet access at http://www.fda.gov/ora/compliance—ref/cpg/cpgbio/ cpg252.110.htm
Compliance Policy Guide, Chapter 2, Sec. 257.100, REVISED: Deferral of source Plasma Donors Due to Red Cell Loss During collection of Source Plasma by Automated Plasmapheresis
March 22, 2000
Do
Do—Internet at http://www.fda.gov/ora/ compliance—ref/cpg/cpgbio/ cpg257.100.htm
Regulatory Procedures Manual, UPDATE/ REVISION: Chapter 4, Subchapter/ Warning Letters
March 21, 2000
Do
Do—Internet at http://www.fda.gov/ora/compliance—ref/rpm—new2/ch4.html
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
Memorandum to Import Program Managers—Surveillance and Post Reconditioning Sampling of Bulk Spices for Pathogens
February 11, 2000
Do
Division of Import Operations and Policy (HFC-170), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 301-443-6553
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
WITHDRAWALS
Name of Document
Date of Issuance
Grouped by Intended User or Regulatory Activity
Date Withdrawn
Compliance Policy Guide, Chapter 2, Sec. 215.100 (CPG 7134.07), IND Filings; Completion of Applicable Portions Prior to Final Action on License Applications or License Amendments
July 19, 1976
FDA Staff
March 28, 2000
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
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