Draft Guidances Published in 2000

Dockets Management

DRAFT GUIDANCES - FEDERAL REGISTER NOTICES - 2000

Draft guidances published in the Federal Register in: Current Year | 2005 | 2004| 2003| 2002| 2001| 2000| 1999

Final guidance published in the Federal Register in: Current Year | 2005| 2004| 2003| 2002| 2001} 2000| 1999

Draft Guidances

December

Vol. 65 (December 20, 2000): Docket No. 00D-1618. Draft ``Guidance for Industry: Variances for Blood Collection from Individuals with Hereditary Hemochromatosis;'' Availability. Pages 79866-79867 [FR Doc. 00-32377] [ TXT ] [ PDF ] Written comments by March 20, 2001

Vol. 65 (December 19, 2000): Docket No. 00D-1630. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance on Safety Studies for Veterinary Drug Residues in Human Food: Reproduction Studies (VICH GL22); Availability; Request for Comments. Pages 79373-79374 [FR Doc. 00-32197] [ TXT ] [ PDF ] Written comments by February 20, 2001

Vol. 65 (December 19, 2000): Docket No. 00D-1584. Draft Guidance for Industry on Labeling OTC Human Drug Products-Sumitting Requests for Exemptions and Deferrals; Availability. Page 79371 [FR Doc. 00-32195] [ TXT ] [ PDF ] Written comments by February 20, 2001

Vol. 65 (December 18, 2000): Docket No. 00D-1629. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidances for Industry on Effectiveness of Anthelmintics: Specific Recommendations for Feline (VICH GL20) and Effectiveness of Anthelmintics: Specific Recommendations for Poultry (VICH GL21); Availability; Request for Comments. Pages 79113-79114 [FR Doc. 00-32057] [ TXT ] [ PDF ] Written comments by January 17, 2001

Vol. 65 (December 18, 2000): Docket No. 00D-1632. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance on Pharmacovifilance of Veterinary Medicinal Products: Management of Adverse Event Reports (AER's) (VICH GL24); Availability; Request of Comments. Pages 79111-79113 [FR Doc. 00-32056] [ TXT ] [ PDF ]Written comments by January 17, 2001

Vol. 65 (December 18, 2000): Docket No. 00D-1631. International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Safety Studies for Veterinary Drug Residues in Human Food: Genotoxicity Studies (VICH GL23); Availability; Request for Comments. Pages 79106-79107 [FR Doc. 00-32113] [ TXT ] [ PDF ] Written comments by January 17, 2001

Vol. 65 (December 15, 2000): Docket No. 00D-1392. Draft Guidance for Industry on Botanical Drug Products; Availability; Reopening of Comment Period. Pages 78496-78497 [FR Doc. 00-31948] [ TXT ] [ PDF ] Written comments by March 15, 2001

November

Vol. 65 (November 14, 2000): Docket No. 00D-1587. Medical Devices Draft Guidance on Guidance for Prescription Use Drugs of Abuse Assays Premarket Notifications; Availability. Pages 68152-68153 [FR Doc. 00-29110] [ TXT ] [ PDF ]Written comments by February 12, 2001

Vol. 65 (November 14, 2000): Docket No. 99D-1020. Medical Devices Draft Guidance on Over the Counter (OTC) Screening Tests for Drugs of Abuse: Guidance for Premarket Notifications; Availability. Pages 68151-68152 [FR Doc. 00-29109] [ TXT ] [ PDF ] Written comments by February 12, 2001

Vol. 65 (November 14, 2000): Docket No. 00D-1555. Draft Guidance for Industry on Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery Products; Availability. Pages 68150-68151 [FR Doc. 00-29011] [ TXT ] [ PDF ] Written comments by December 14, 2000

Vol. 65 (November 9, 2000): Docket No. 00D-1562. Draft Guidance for Industry on Cancer Drug and Biological Products--Clinical Data in Marketing Applications; Availability. Pages 67389-67390 [FR Doc. 00-28776] [ TXT ] [ PDF ] Written comments by January 8, 2001

Vol. 65 (November 7, 2000): Docket No. 00D-1563. Draft Guidance for Industry on Carcinogenicity Study Protocol Submissions; Availability. Page 66757 [FR Doc. 00-28521] [ TXT ] [ PDF ] Comments by February 5, 2001

October

Vol. 65 (October 26, 2000): Docket No. 00D-1537. Draft Guidance for Industry on Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications; Availability. Pages 64225-64226 [FR Doc. 00-27452] [ TXT ] [ PDF ] Written comments by January 24, 2001

Vol. 65 (October 19, 2000): Docket No. 00D-1532. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidances for Industry on ``Effectiveness of Anthelmintics: Specific Recommendations for Equine'' (VICH GL15), ``Effectiveness of Anthelmintics: Specific Recommendations for Porcine'' (VICH GL16), and ``Effectiveness of Anthelmintics: Specific Recommendations for Canine'' (VICH GL19); Availability; Request for Comments. Pages 62723-62724 [FR Doc. 00-26897] [ TXT ] [ PDF ] Written comments by December 18, 2000

Vol. 65 (October 3, 2000): Docket No. 00D-1492. Mutual Recognition Agreement, Medical Device Annex; Confidence Building Activities: Availability of Draft Guidances. Pages 59006-59007 [FR Doc. 00-25351] [ TXT ] [ PDF ] Written comments by November 2, 2000

September

Vol. 65 (September 22, 2000): Docket No. 00D-1458. Draft Guidance for Infant/Child Apnea Monitor 510(k) Submissions; Availability. Pages 57355-57356 [FR Doc. 00-24336] [ TXT ] [ PDF ] Written comments by December 21, 2000

Vol. 65 (September 13, 2000): Docket No. 00D-1497. Draft Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document 1B4; Availability. Pages 55265-55266 [FR Doc. 00-23478] [ TXT ] [ PDF ] Written comments by December 12, 2000

Vol. 65 (September 8, 2000): Docket No. 00D-1400. Draft ``Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease Indications;'' Availability. Pages 54534-54535 [FR Doc. 00-23052] [ TXT ] [ PDF ] Written comments by December 7, 2000

Vol. 65 (September 6, 2000): Docket No. 00D-1455. Draft Guidance for Industry; Special Control Guidance for Premarket Notifications for Totally Implanted Spinal Cord Stimulators for Pain Relief; Availability. Pages 54058-54059 [FR Doc. 00-22619] [ TXT ] [ PDF ] Written comments by October 6, 2000

August

Vol. 65 (August 30, 2000): Docket No. 00D-1424. Draft Guidance for Industry on Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls Documentation; Availability. Pages 52776-52777 [FR Doc. 00-22143] [ TXT ] [ PDF ] Written comments by November 28, 2000

Vol. 65 (August 24, 2000): Docket No. 00D-0186. International Conference on Harmonisation; Draft Guidance on M4 Common Technical Document; Availability. Pages 51621-51624 [FR Doc. 00-21563] [ TXT ] [ PDF ] Comments due September 30, 2000

Vol. 65 (August 14, 2000): Docket No. 00D-1383. Draft Guidance for Industry on Surveillance and Detention Without Physical Examination of Condoms; Availability. Pages 49585-49586 [FR Doc. 00-20463] [ TXT ] [ PDF ] Written comments by November 13, 2000

Vol. 65 (August 14, 2000): Docket No. 00D-1401. Draft Guidance for Industry on Administrative Procedures for CLIA Categorization; Availability. Pages 49582-49583 [FR Doc. 00-20464] [ TXT ] [ PDF ] Written comments by November 13, 2000

Vol. 65 (August 11, 2000): Docket No. 00D-1392. Draft Guidance for Industry on Botanical Drug Products; Availability. Pages 49247-49248 [FR Doc. 00-20343] [ TXT ] [ PDF ] Written comments by October 10, 2000

Vol. 65 (August 9, 2000): Docket No. 00D-1408. International Conference on Harmonisation; Draft Guidance on Principles for Clinical Evaluation of New Antihypertensive Drugs; Availability. Pages 48720-48721 [FR Doc. 00-20172] [ TXT ] [ PDF ] Written comments by November 7, 2000

Vol. 65 (August 7, 2000): Docket No. 00D-1407. International Conference on Harmonisation; Draft Guidance on Safety Pharmacology Studies for Human Pharmaceuticals; Availability. Pages 48246-48247 [FR Doc. 00-19941 ] [ TXT ] [ PDF ] Written comments on draft guidance by September 6, 2000

Vol. 65 (August 1, 2000): Docket No. 00D-1385. Draft Guidance for Industry on Refractive Implants: Investigational Device Exemptions (IDE's) and Premarket Approval Applications (PMA's); Availability. Page 46938 [FR Doc. 00-19337] [ TXT ] [ PDF ] Written comments due October 30, 2000

Vol. 65 (August 1, 2000): Docket No. 00D-1418. International Conference on Harmonisation; Draft Guidance on Good Manufacturing Practice for Active Pharmaceutical Ingredients; Availability. NOTE: [PRE-PUB] document contains internal links on the top of the second page. Pages 46936-46937 [FR Doc. 00-19332] [ TXT ] [ PDF ] Written comments due October 2, 2000

July

Vol. 65 (July 31, 2000): Docket No. 98D-0785. Revised Draft Guidance for Industry on Developing Medical Imaging Drugs and Biologics; Availability. Pages 46674-46677 [FR Doc. 00-19176] [ TXT ] [ PDF ] Written comments by September 29, 2000

Vol. 65 (July 26, 2000): Docket No. 00D-1384. Medical Devices; Draft Guidance for Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves; Availability. Pages 45991-45992 [FR Doc. 00-18830] [ TXT ] [ PDF ] Written comments on draft guidance by October 4, 2000

Vol. 65 (July 20, 2000): Docket No. 94D-0325. International Conference on Harmonisation; Draft Revised Guidance on Impurities in New Drug Substances. Pages 45085-45090 [FR Doc. 00-18151] [ TXT ] [ PDF ] Written comments by September 18, 2000 NOTE: Draft guidance is part of the FR Notice

Vol. 65 (July 18, 2000): Docket No. 98N-0331. Medical Devices; Draft Guidance for Staff, Industry, and Third Parties Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Availability. Pages 44540-44542 [FR Doc. 00-18083] [ TXT ] [ PDF ]

Vol. 65 (July 18, 2000): Docket No. 00D-1341. Blood Standards; Pilot Program for Licensing and Draft Guidance for Industry: CBER Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained From an Outside Supplier;'' Availability. Pages 44537-44538 [FR Doc. 00-18059] [ TXT ] [ PDF ]

Vol. 65 (July 13, 2000): Docket No. 00D-1360. Draft Guidance for Industry: Food-Contact Substance Notification System; Availability. Page 43377 [FR Doc. 00-17654] [ TXT ] Comments on draft guidance by September 26, 2000

June

Vol. 65 (June 29, 2000): Docket No. 00D-1315. Draft Guidance for Industry on How to Use E-Mail to Submit Information to the Center for Veterinary Medicine; Availability. Pages 40109-40111 [FR Doc. 00-16395] [ TXT ] [ PDF ] Written comments by August 28, 2000

Vol. 65 (June 29, 2000): Docket No. 00D-1316. Draft Guidance for Industry on How to Use E-Mail to Submit a Request for a Meeting or Teleconference to the Office of New Animal Drug Evaluation; Availability. Pages 40108-40109 [FR Doc. 00-16394] [ TXT ] [ PDF ] Written comments by August 28, 2000

Vol. 65 (June 29, 2000): Docket No. 00D-1314. Draft Guidance for Industry on How to Use E-Mail to Submit a Notice of Intent to Slaughter for Human Food Purposes; Availability. Pages 40106-40107 [FR Doc. 00-16393] [ TXT ] [ PDF ] Written comments by August 28, 2000

Vol. 65 (June 29, 2000): Docket No. 00D-1313. Draft Guidance for Industry on How to Use E-Mail to Submit a Notice of Final Disposition of Animals Not Intended for Immediate Slaughter; Availability. Pages 40104-40106 [FR Doc. 00-16392] [ TXT ] [ PDF ] Written comments by August 28, 2000

Vol. 65 (June 28, 2000): Docket No. 00D-1318. Draft Guidance for Industry on Chronic Cutaneous Ulcer and Burn Wounds-Developing Products for Treatment; Availability. Page 39912 [FR Doc. 00-16394] [ TXT ] [ PDF ] Written comments on draft guidance on August 28, 2000

Vol. 65 (June 21, 2000): Docket No. 00D-1336. Draft Guidance for Industry: Pediatric Oncology Studies in Response to a Written Request; Availability. Pages 38564-38565 [FR Doc. 00-15629] [ TXT ] [ PDF ]Written comments on draft guidance by September 18, 2000

Vol. 65 (June 21, 2000): Docket No. 00D-1306. Draft Guidance for Industry on the Content and Format of the Adverse Reactions Section of Labeling for Human Prescription Drugs and Biologics; Availability. Pages 38563-38564 [FR Doc. 00-15633] [ TXT ] [ PDF ] Written comments on draft guidance by September 19, 2000

Vol. 65 (June 21, 2000): Docket No. 00D-1335. Draft Guidance for Industry on Allergic Rhinitis: Clinical Development Programs for Drug Products; Availability. Page 38563 [FR Doc. 00-15632] [ TXT ] [ PDF ] Written comments by September 19, 2000

Vol. 65 (June 16, 2000): Docket No. 00D-1305. Foods: ``Apple Juice, Apple Juice Concentrates, and Apple Juice Products_Adulteration with Patulin;'' Draft Compliance Policy Guide; Availability and ``Patulin in Apple Juice, Apple Juice Concentrates, and Apple Juice Products;'' Draft Supporting Document; Availability. Pages 37791-37792 [FR Doc. 00-15122] [ TXT ] [ PDF ]Written comments by August 15, 2000

Vol. 65 (June 14, 2000): Docket No. 00D-1307. Draft Guidance for Industry on Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis; Availability. Page 37396 [FR Doc. 00-14986] [ TXT ] [ PDF ] Written comments on draft guidance by August 14, 2000

Vol. 65 (June 8, 2000): Docket No. 00D-1267. Draft Guidance for Industry: Recommendations for Donor Questioning Regarding Possible Exposure to Malaria; Availability. Pages 36452-36453 [FR Doc. 00-14371] [ TXT ] [ PDF ] Written comments on draft guidance by September 6, 2000

Vol. 65 (June 2, 2000): Docket No. 00D-1309. METHYL PARATHION; DRAFT GUIDANCE. Pages 35376-35379 [FR Doc. 00-13813] [ TXT ] [ PDF ] Written comments due by August 1, 2000

May

Vol. 65 (May 19, 2000): Docket No. 00D-1278. Draft Guidance for Industry on Female Sexual Dysfunction: Clinical Development of Drug Products for Treatment; Availability. Pages 31916-31917 [FR Doc. 00-12594] [ TXT ] [ PDF ] written comments by July 18, 2000

April

March

Vol. 65 (March 30, 2000): Docket No. 00D-0805. Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception From Informed Consent Requirements for Emergency Research; Availability. (NOTE: The URL referred to in the TXT and PDF versions are incorrect. The correct url is http://www.fda.gov/ora/compliance_ref/bimo/default.htm ). Pages 16923 -16924 [FR Doc. 00-07778 ] [ TXT ] [ PDF ]

Vol. 65 (March 29, 2000): Docket No. 00D-1033. Draft Guidance for Industry on Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank; Availability. Pages 16620-16623 [FR Doc. 00-07654 ] [ TXT ] [ PDF ]

Vol. 65 (March 10, 2000): Docket No. 00D-0892. Draft Guidance for Industry on the Content and Format of New Drug Applications and Abbreviated New Drug Applications for Certain Positron Emission Tomography Drug Products; Availability (GUIDANCE DOCUMENT ALSO HAS INTERNAL HYPERLINKS TO THE FOUR (4) ATTACHMENTS LISTED BELOW). Pages 13010-13012 [FR Doc. 00-05866] [ TXT ] [ PDF ] Written comments by June 8, 2000

Vol. 65 (March 9, 2000): Docket No. 00D-0835. "Draft Guidance for Industry on Conjugated Estrogens, USP: LC09MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence; Availability. Page 12556 [FR Doc. 00-05751 ] [ TXT ] [ PDF ] Written comments by June 8, 2000

Vol. 65 (March 8, 2000): Docket No. 99D-0357. Draft Guidance for Industry on OTC Treatment of Herpes Labialis With Antiviral Agents; Availability. Pages 12272-12273 [FR Doc. 00-05525] [ TXT ] [ PDF ] Written comments by May 8, 2000

Vol. 65 (March 8, 2000): Docket No. 00D-0109. Draft Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices; Availability. Pages 12271-12272 [FR Doc. 00-05524] [ TXT ] [ PDF ] Written comments by June 7, 2000

Vol. 65 (March 3, 2000): Docket No. 00D-0785. Draft Guidance for Industry; Guidance on Medical Device Patient Labeling; Availability. Pages 11586-11587 [FR Doc. 00-5086] [ TXT ] [ PDF ] Written comments by June 2, 2000

February

Vol. 65 (February 15, 2000): Docket No. 00D-0218. Draft ``Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol;'' Availability. Pages 7557-7558 [FR Doc. 00-03407] [ TXT ] [ PDF ] Written comments by May 15, 2000

Vol. 65 (February 11, 2000): Docket No. 00D-0053. Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme; and Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals - Availability. Pages 7027-7029 [FR Doc. 00-3345 ] [ TXT ] [ PDF ] Written comments by April 11, 2000

Vol. 65 (February 11, 2000): Docket No. 00D-0186. International Conference on Harmonisation; M4 Common Technical Document; Request for Comments on Initial Components;Availability. Pages 7024-7027 [FR Doc. 00-3343 ] [ TXT ] [ PDF ] Written comments by March 13, 2000

Vol. 65 (February 9, 2000): Docket No. 00D-0084. Draft Guidance for Industry on Special Protocol Assessment; Availability. Pages 6377-6380 [FR Doc. 00-02982 ] [ TXT ] [ PDF ] Written comments by April 10, 2000

Vol. 65 (February 8, 2000): Docket No. 99N-2912. Review of Supplemental Applications for Approved New Animal Drugs; Center Responsibility and Standards for Prompt Review; Availability of Draft Guidance. Pages 6214-6216 [FR Doc. 00-2767] [ TXT ] [ PDF ] Written comments by May 8, 2000

Vol. 65 (February 4, 2000): Docket No. 00D-0087. Draft Guidance for Industry on IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Information; Availabilitiiy. Pages 5645-5646 [FR Doc. 00-02436] [ TXT ] [ PDF ]Written comments by May 4, 2000

Vol. 65 (February 2, 2000): Docket No. 00D-0053. Draft Guidance on Reprocessing and Reuse of Single-Use Devices: Risk Categorization Scheme; Availability. Pages 4985-4986 [FR Doc. 00-02244 ] [ TXT ] [ PDF ] Written comments by March 3, 2000

January

Vol. 65 (January 10, 2000): Docket No. 99D-5435. Draft Guidance for Industry on Photosafety Testing; Availability. Pages 1399-1400 [FR Doc. 00-00429] [ TXT ] [ PDF ] Written comments by April 10, 2000

Vol. 65 (January 3, 2000): Docket No. 99D-5046. Draft Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture; Availability. Pages 134-135 [FR Doc. 99-34039] [ TXT ] [ PDF ]

Page created September 24, 2003 jb
Page updated June 16, 2006 jb

FDA/Dockets Management