[Federal Register: May 24, 2000 (Volume 65, Number 101)] [Notices] [Page 33553-33560] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr24my00-58] ----------------------------------------------------------------------- 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SUMMARY: The Food and Drug Administration (FDA) is publishing a quarterly update of all guidance documents issued and withdrawn since we compiled the last quarterly list of guidance documents that published on March 14, 2000.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list of guidance documents and quarterly Federal Register notices that list all guidance documents that were issued and withdrawn during that quarter, including ``Level 2'' guidance documents.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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Draft Guidance for Industry: Special Protocol Assessment December 1999 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Draft Guidance for Reviewers: Potency Limits for February 2000 FDA Personnel Do Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 33554]] Draft Guidance for Industry: IND Meetings for Human Drugs February 2000 FDA Regulated Industry Do and Biologics: Chemistry, Manufacturing, and Controls Information ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry: Formal Meetings With Sponsors and February 2000 Do Do Applicants for PDUFA Products ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry: Formal Dispute Resolution: Appeals February 2000 Do Do Above the Division Level ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry: Gamma Irradiation of Blood and Blood February 2000 Do Do Components: A Pilot Program for Licensing ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Draft Guidance for Industry: Information Program on March 2000 Do Do Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ III. Guidance Documents Issued by the Center for Devices and Radiological Health (CDRH) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Grouped by Intended User or Name of Document Date of Issuance Regulatory Activity Date Withdrawn ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry and FDA; Guidance for Indwelling February 21, 2000 Office of Device Evaluation (ODE ) Do Blood Gas Analyzer 510(k) Submissions ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on the Use of Standards in Substantial Equivalence March 12, 2000 Do Do Determination ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Extracorporeal Blood Circuit Defoamer 510(k) February 16, 2000 ODE/DCRND Do Submissions ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Cardiopulmonary Bypass Arterial Line Blood February 21, 2000 Do Do Filter 510(k) Submissions ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Compliance Guidance: The Mammography Quality Standards Act February 25, 2000 OHIP/Division of Mammography Do Final Regulations Document #2 Quality and Radiation Programs (DMQRP) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ WITHDRAWALS ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Name of Document Date of Issuance Grouped by Intended User or Date Withdrawn Regulatory Activity ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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] ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 33556]] Review Proposal for Reagents and Analyzer Systems March 14, 1995 ODE February 17, 2000 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Determining Equivalence of Intraaortic Balloon Catheters December 12, 1989 Do April 7, 2000 Under the 510(k) Regulations ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 510(k) Guidance for Screw Type Endosseous Implants for August 11, 1992 ODE/DDIGD April 5, 2000 Prosthetic Attachment ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Draft Guidance on the Content and Format of Premarket February 11, 1997 Do April 10, 2000 Approval Application (PMA) for Sharps Needle Destruction Devices ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Sunglass Package; including Certification Statement for the March 19, 1998 ODE/DOD February 8, 2000 Impact-Resistance Test of Lenses in Eyeglasses and Sunglasses ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Submission of a 510(k) Premarket Notification April 1, 1991 ODE/DRAERD April 7, 2000 for an Air Conduction Hearing Aid ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Draft Guidance to Hearing Aid Manufacturers for August 5, 1994 Do April 14, 2000 Substantiation of Claims ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Medical Device Reporting for Distributors April 1, 1996 OHIP/DSMA February 16, 2000 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[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'' ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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 September 1, 1997 Do Do (Replaced by Guidance for Industry and FDA-Medical Glove Guidance Manual Draft FDA 99-4257) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ MDR Documents Access Information for CDRH Facts-On-Demand February 29, 1996 OSB Do (FOD) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ MDR Documents Access Information for Industry Organizations May 8, 1996 OSB Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ CORRECTIONS ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ IV. Guidance Documents Issued by the Center for Drug Evaluation and Research (CDER) [[Page 33558]] ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ IND Meetings for Human Drugs and Biologics; Chemistry, February 4, 2000 Chemistry Draft Do Manufacturing, and Controls information ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Special Protocol Assessment February 9, 2000 Modernization Act Draft Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Draft guidance entitled ``M4 Common Technical Document: February 11, 2000 ICH Draft--Joint Safety/Efficacy Do Request for Comments on Initial Components'' ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ NDAs: Impurities in Drug Substances February 25, 2000 Chemistry Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Formal Meetings With Sponsors and Applicants For PDUFA March 7, 2000 Modernization Act Do Products ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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 March 9, 2000 Biopharmaceutic Draft Do Qualitative chemical characterization and Documentation of Qualitative Pharmaceutical Equivalence ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Information Program on Clinical Trials for Serious or Life- March 29, 2000 Do Do Threatening Diseases: Establishment of a Data Bank: Availability ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Draft guidance entitled ``E11: Clinical Investigation of April 12, 2000 ICH Draft--Efficacy Do Medicinal Products in the Pediatric Population'' ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ V. Guidance Documents Issued by the Center for Veterinary Medicine (CVM) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 33559]] Guidance for Industry: Stability Testing for Medicated March 2000 Do Do Premixes Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ VI. Guidance Documents Issued by the Office of Regulatory Affairs (ORA) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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 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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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 Date Withdrawn Regulatory Activity ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[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