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The Food and Drug Administration (FDA) is publishing a quarterly update of all guidance documents issued and withdrawn since we compiled the last quarterly list of guidance documents that published on March 14, 2000.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list of guidance documents and quarterly Federal Register notices that list all guidance documents that were issued and withdrawn during that quarter, including “Level 2” guidance documents.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/complianceref/bimoXerr—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/complianceref/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/complianceref/rpmnew2/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