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DRAFT GUIDANCES - FEDERAL REGISTER NOTICES - 1999 |
Draft guidances published in the Federal Register in: Current Year | 2005 | 2004| 2003| 2002| 2001| 2000| 1999Final guidance published in the Federal Register in: Current Year | 2005| 2004| 2003| 2002| 2001} 2000| 1999 Draft Guidances |
| January | February | March | April | May | June | July | August | September | October | November |
DecemberVol. 64 (December 30, 1999): Docket No. 99D-5347. “Draft ``Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products From Xenotransplantation Product Recipients and Their Contacts;'' Availability”. Pages 73562-73563 [FR Doc. 99-33940] [ TXT ] [ PDF ] Vol. 64 (December 22, 1999): Docket No. 99D-4959. Draft Guidance for Industry on Disclosing Information Provided to Advisory Committees in Connection With Open Advisory Committee Meetings Related to the Testing or Approval of New Drugs and Convened by the Center for Drug Evaluation and Research, Beginning on January 1, 2000; Availability. Pages 71794-71797 [FR Doc. 99-33092] [ TXT ] [ PDF ] Written comments by February 22, 2000 Vol. 64 (December 21, 1999): Docket No. 99D-5125. Draft Guidance on the Labeling for Over-the-Counter Sample Collection Systems for Drugs of Abuse Testing; Availability. Pages 71461-71462 [FR Doc. 99-33002] [ TXT ] [ PDF ] Written comments by March 22, 2000 Vol. 64 (December 16, 1999): Docket No. 99D-5199. Medical Devices; Draft Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Availability. Pages 70264-70265 [FR Doc. 99-32589] [ TXT ] [ PDF ] Written comments by March 16, 2000 Vol. 64 (December 8, 1999): Docket No. 99D-4809. Draft Guidance for Industry on Applications Covered by Section 505(b)(2); Availability. Pages 68697-68698 [FR Doc. 99-31698 ] [ TXT ] [ PDF ] Written comments by February 7, 2000 Vol. 64 (December 8, 1999): Docket No. 99D-4910. Draft Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document #3; Availability. Pages 68696-68697 [FR Doc. 99-31777 ] [ TXT ] [ PDF ] Written comments by March 8, 2000 Vol. 64 (December 7, 1999): Docket No. 99D-5047. Draft Guidance for Industry on Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling; Availability”. Page 68357 [FR Doc. 99-31608] [ TXT ] [ PDF ] Vol. 64 (December 1, 1999): Docket No. 99D-5013. Draft Guidance for Industry on Labeling of Over-the-Counter Human Drug Products Using a Column Format; Availability,. Page 67291 [FR Doc. 99-31124 ] [ TXT ] [ PDF ] Written comments by January 31, 2000 NovemberVol. 64 (November 26, 1999): Docket No. 99D-4577. Draft ``Guidance for Industry: Application of Current Statutory Authority to Nucleic Acid Testing of Pooled Plasma;'' Availability. Pages 66481-66482 [FR Doc. 99-30702] [ TXT ] [ PDF ] Vol. 64 (November 16, 1999): Docket No. 99D-4487. Medical Devices; Draft Guidance for Conducting Stability Testing to Support an Expiration Date Labeling Claim for Medical Gloves; Availability. Pages 62208-62209 [FR Doc. 99-29791] [ TXT ] [ PDF ] Written comments by February 14, 2000 Vol. 64 (November 12, 1999): Docket Nos. 99d-4575, 99d-4576. Draft Guidances for Industry on Food-Contact Substance Notification System; Availability. Pages 61648-61649 [FR Doc. 99-29493] [ TXT ] [ PDF ] Written comments on information collection by January 11, 2000 Written comments on guidance by February 14, 2000 Vol. 64 (November 3, 1999): Docket No. 99D-4114. Draft ``Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors;'' Availability. Pages 59783-59784 [FR Doc. 99-28560 ] [ TXT ] [ PDF ] OctoberVol. 64 (October 28, 1999): Docket No. 99D-2335. Medical Gloves; Draft Guidance Manual; Availability; Extension of Comment Period. Pages 58070-58071 [FR Doc. 99-28110 ] [ TXT ] [ PDF ] Comment period extended to January 27, 2000 Vol. 64 (October 26, 1999): Docket No. 99D-4396. Draft Guidance for Industry on Financial Disclosure by Clinical Investigators; Availability. Pages 57640-57641 [FR Doc. 99-27840 ] [ TXT ] [ PDF ] Vol. 64 (October 21, 1999): Docket No. 99D-4328. Draft Guidance for Industry on Developing Antimicrobial Drugs to Treat Catheter-Related Bloodstream Infections; Availability. Page 56799 [FR Doc. 99-27580] [ TXT ] [ PDF ] Written comments by December 20, 1999 Vol. 64 (October 14, 1999): Docket No. 99D-4052. Medical Devices; Draft Guidance for the Preparation of a Premarket Notification Application for Processed Human Dura Mater; Availability. Pages 55736-55737 [FR Doc. 99-26720] [ TXT ] [ PDF ] Written comments by January 12, 2000 Vol. 64 (October 14, 1999): Docket No. 99D-4054. Draft Guidance for Industry on Intraocular Lens; Availability. Pages 55735-55736 [FR Doc. 99-26719] [ TXT ] [ PDF ] Written comments by January 12, 2000 Vol. 64 (October 12, 1999): Docket No. 99D-4071. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); VICH GL18 Draft Guidance on ``Impurities: Residual Solvents;'' Availability; Request for Comments. Pages 55296-55297 [FR Doc. 99-26503] [ TXT ] [ PDF ] Written comments by November 12, 1999 Vol. 64 (October 12, 1999): Docket No. 98D-0566. International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH); Final Guidances entitled ``Stability Testing of New Veterinary Drug Substances and Medicinal Products'' (VICH GL3); ``Stability Testing of New Veterinary Dosage Forms'' (VICH GL4); ``Stability Testing: Photostability Testing of New Veterinary Drug Substances and Medicinal Products'' (VICH GL5); Availability. Pages 55293-55294 [FR Doc. 99-26501] [ TXT ] [ PDF ]
Vol. 64 (October 8, 1999): Docket No. 99D-4130. Medical Devices; Draft Guidance on Information Disclosure by Manufacturers to Assemblers for Diagnostic X-Ray Systems; Availability. Pages 54901-54902 [FR Doc. 99-26220] [ TXT ] [ PDF ] Written comments by January 6, 2000 SeptemberVol. 64 (September 27, 1999): Docket No. 98D-0834. Draft Guidance for Industry on Noncontraceptive Estrogen Class Labeling; Availability. Pages 52100-52101 [FR Doc. 99-24981] [ TXT ] [ PDF ]Written comments by November 26, 1999 Vol. 64 (September 17, 1999): Docket No. 99D-2975. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); VICH GL6 Draft Guidance on `Environmental Impact Assessments (EIA's) for Veterinary Medicinal Products (VMP's)-Phase I;'' Availability; Request for Comments. Pages 50519-50520 [FR Doc. 99-24208] [ TXT ] [ PDF ] Written comments by October 18, 1999 Vol. 64 (September 8, 1999): Docket No. 97D-0433. Draft Guidance for Industry on Average, Population, and Individual Approaches to Establishing Bioequivalence; Availability. Pages 48842-48843 [FR Doc. 99-23228] [ TXT ] [ PDF ] written comments by November 8, 1999 Vol. 64 (September 8, 1999): Docket No. 99D-2726. Medical Devices; Draft Guidance on Labeling For Laboratory Tests; Availability. Pages 48843-48844 [FR Doc. 99-23229] [ TXT ] [ PDF ] written comments by December 7, 1999 Vol. 64 (September 3, 1999): Docket No. 99D-27291. Draft Guidance for Industry on BA and BE Studies for Orally Administered Drug Products -- General considerations;. Pages 48409-48410 [FR Doc. 99-23009 ] [ TXT ] [ PDF ] Written comments by November 2, 1999 Vol. 64 (September 1, 1999): Docket No. 99D-2213. Draft``Guidance for Industry: Revised Recommendations for the Invalidation of Test Results When Using Licensed and 510(k) Cleared Bloodborne Pathogen Assays to Test Donors;'' Availability. Page 47847 [FR Doc. 99-22801] [ TXT ] [ PDF ] Written comments by November 30, 1999 Vol. 64 (September 1, 1999): Docket No. 99D-2873. Medical Devices; Draft Guidance on Evidence Models for the Least Burdensome Means to Market; Availability. Pages 47846-47847 [FR Doc. 99-22677] [ TXT ] [ PDF ] Written comments by November 30, 1999 Vol. 64 (September 1, 1999): Docket No. 99D-2445. Draft Guidance for Industry on Clinical Considerations for Accelerated and Traditional Approval of Antiretroviral Drugs Using Plasma HIV RNA Measurements; Availability. Pages 47844-47845 [FR Doc. 99-22720] [ TXT ] [ PDF ] Written comments by November 30, 1999 Vol. 64 (August 27, 1999): Docket No. 99D-2635. Draft Guidance for Industry on ANDA's: Blend Uniformity Analysis; Availability. Page 46917 [FR Doc. 99-22317 ] [ TXT ] [ PDF ] Written comments by October 26, 1999 AugustVol. 64 (August 25, 1999): Docket No. 99D-2638. Use of Medicated Feeds for Minor Species; Draft Compliance Policy Guide; Availability. Page 46400 [FR Doc. 99-21961] [ TXT ] [ PDF ] Written comments by November 23, 1999 Vol. 64 (August 25, 1999): Docket No. 99D-2211. Medical Devices; Draft Guidance for Industry on the Electro-Optical Sensors for the In Vivo Detection of Cervical Cancer and its Precursors: Submission Guidance for an IDE/PMA; Availability. Pages 46399-46400 [FR Doc. 99-21962] [ TXT ] [ PDF ] Written comments by November 23, 1999 Vol. 64 (August 18, 1999): Docket No. 99D-2636. Draft Guidance for Industry on Levothyroxine Sodium; Availability. Page 44935 [FR Doc. 99-21353] [ TXT ] [ PDF ] Written comments by October 18, 1999 Vol. 64 (August 17, 1999): Docket No. 99D-2405. Draft ``Guidance for Industry: Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act;'' Availability. Pages 44741-44742 [FR Doc. 99-21254] [ TXT ] [ PDF ] Written comments by November 15, 1999 Vol. 64 (August 12, 1999): Docket No. 98D-0449. Draft Compliance Program Guidance Manual: Inspection of Medical Devices; Availability. Page 44024 [FR Doc. 99-20885] [ TXT ] [ PDF ] Written comments by November 10, 1999 Vol. 64 (August 9, 1999): Docket No. 97D-0302. Guidance For Industry on Consumer-Directed Broadcast Advertisements; Availability. Pages 43197-43198 [FR Doc. 99-20364] [ TXT ] [ PDF ] Vol. 64 (August 5, 1999): Docket No. 99D-2167. Medical Devices; Draft Guidance on the Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket Approval; Availability. Pages 42700-42701 [FR Doc. 99-20089] [ TXT ] [ PDF ] Written Comments by November 3, 1999 Vol. 64 (August 4, 1999): Docket No. 99D-2171. Medical Devices; Draft Guidance for the Accountability Analysis for Clinical Studies for Ophthalmic Devices; Availability. Pages 42391-42392 [FR Doc. 99-19976] [ TXT ] [ PDF ] Written comments by November 2, 1999 Vol. 64 (August 3, 1999): Docket No. 99D-2152. Medical Devices; Device Use Safety: Incorporating Human Factors in Risk Management; Availability. Pages 42138-42139 [FR Doc. 99-19870] [ TXT ] [ PDF ] Vol. 64 (August 3, 1999): Docket No. 99D-2212. Medical Devices; Draft Guidance on Quality Systems Regulation Information for Various Premarket Submissions; Availability. Pages 42137-42138 [FR Doc. 99-19869] [ TXT ] [ PDF ] Vol. 64 (August 3, 1999): Docket No. 99D-2013. Draft ``Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics''; Availability. Pages 42136-42137 [FR Doc. 99-19796] [ TXT ] [ PDF ] Vol. 64 (August 3, 1999): Docket No. 99D-2406. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance on VICH GL9 Good Clinical Practices; Request for Comments. Pages 42135-42136 [FR Doc. 99-19871] [ TXT ] [ PDF ] JulyVol. 64 (July 30, 1999): Docket No. 99D-2335. Medical Gloves; Draft Guidance Manual; Availability. Pages 41744-41745 [FR Doc. 99-19192] [ TXT ] [ PDF ] Written comments by October 28, 1999 Vol. 64 (July 26, 1999): Docket No. 99D-2096. Draft Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations; Availability. Pages 40381-40382 [FR Doc. 99-18928] [ TXT ] [ PDF ] Vol. 64 (July 22, 1999): Docket No. 99D-2215. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); VICH GL10 Draft Guidance on ``Impurities in New Veterinary Drug Substances;'' Availability; Request for Comments. Pages 39516-39517 [FR Doc. 99-18697] [ TXT ] [ PDF ] Written comments by August 23, 1999 Vol. 64 (July 22, 1999): Docket No. 99D-2249. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance on Stability Testing for Medicated Premixes; Availability; Request for Comments. Pages 39515-39516 [FR Doc. 99-18692] [ TXT ] [ PDF ] Written comments by August 23, 1999 Vol. 64 (July 22, 1999): Docket No. 99D-2145. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); VICH GL11 Draft Guidance on Impurities in New Veterinary Medicinal Products; Availability; Request for Comments. Pages 39514-39515 [FR Doc. 99-18688] [ TXT ] [ PDF ] Written comments by August 23, 1999 Vol. 64 (July 16, 1999): Docket No. 99D-2248. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidances on Efficacy of Anthelmintics: General Recommendations (1B90), Efficacy of Anthelmintics: Specific Recommendations for Bovines (1B95), Efficacy of Anthelmintics: Specific Recommendations for Ovines (1B96), and Efficacy of Anthelmintics: Specific Recommendations for Caprines (1B97); Availability; Request for Comments. Pages 38445-38446 [FR Doc. 99-18166] [ TXT ] [ PDF ] Vol. 64 (July 15, 1999): Docket No. 98D-0077. Draft Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA); Availability. Pages 38201-38202 [FR Doc. 99-18031] [ TXT ] [ PDF ] JuneVol. 64 (June 28, 1999): Docket No. 99D-0529 Draft Guidance for Industry on Changes to an Approved NDA or ANADA; Availability. Pages 34660-34661 [FR Doc. 99-16190] [ TXT ] [ PDF ] Written comments by August 27, 1999 Vol. 64 (June 24, 1999): Docket No. 99D-1738. Draft Guidance for Industry on Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action; Availability. Page 33869 [FR Doc. 99-16140] [ TXT ] [ PDF ]
Vol. 64 (June 24, 1999): Docket No. 99D-1718. Draft Guidance for Industry on Monoclonal Antibodies Used as Reagents in Drug Manufacturing; Availability. Pages 33868-33869 [FR Doc. 99-16139] [ TXT ] [ PDF ] Vol. 64 (June 22, 1999): Docket No. 99D-1878. `Draft Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis C Virus (HCV); (2) Supplemental Testin. Pages 33309-33313 [FR Doc. 99-15754] [ TXT ] [ PDF ] Written comments by August 23, 1999 Vol. 64 (June 10, 1999): Docket No. 99D-1149. Draft Guidance for Industry on in Vivo Pharmacokinetics and Bioavailability Studies and in Vitro Dissolution Testing for Levothyroxine Sodium Tablets; Availability. Page 31280 [FR Doc. 99-14751] [ TXT ] [ PDF ] Written comments by August 9, 1999 Vol. 64 (June 8, 1999): Docket No. 99D-1273. Medical Devices; Draft Guidance for FDA Staff on Civil Money Penalty Policy; Availability. Pages 30527-30528 [FR Doc. 99-14405] [ TXT ] [ PDF ] Written comments by September 7, 1999 Vol. 64 (June 4, 1999): Docket No. 99D-1541. Draft Guidance for Industry on Establishing Pregnancy Registries; Availability. Page 30041 [FR Doc. 99-14151] [ TXT ] [ PDF ] Written comments by September 2, 1999 Vol. 64 (June 4, 1999): Docket No. 99D-1540. Draft Guidance for Reviewers on Evaluation of Human Pregnancy Outcome Data; Availability. Pages 30040-30041 [FR Doc. 99-14149] [ TXT ] [ PDF ] Written comments by September 2, 1999 Vol. 64 (June 2, 1999): Docket No. 99D-1454. Draft Guidance for Industry on Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products; Chemistry, Manufacturing, and Controls Documentation; Availability. Page 29657 [FR Doc. 99-13921] [ TXT ] [ PDF ] MayAprilMarchVol. 64 (February 8, 1999): Docket No. 98D-1165. Draft Guidance for the Content of Premarket Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi; Availability. Pages 6100-6101 [FR Doc. 99-2690] [ TXT ] [ PDF ] Written comments by May 10, 1999 Vol. 64 (February 3, 1999): Docket No. 98D-1232. Points To Consider Guidance Document on Assayed and Unassayed Quality Control Material; Draft; Availability. Pages 5300-5301 [FR Doc. 99-2508] [ TXT ] [ PDF ] Written comments by May 4, 1999 January |
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