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Withdrawal of Draft Guidance Documents Published Before December 31, 2013

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is announcing the withdrawal of 47 draft guidance documents that published before December 31, 2013, and have never been finalized. FDA is taking this action to improve the efficiency and transparency of the guidance development process.


Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), if you wish to submit comments on a specific withdrawal action in this notice, submit either electronic or written comments by June 5, 2015.


You may submit comments by any of the following methods:

Electronic Submissions

Submit electronic comments in the following way:

Written Submissions

Submit written submissions in the following ways:

  • Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Instructions: All submissions received must include the Docket No. FDA-2015-N-1419 for this action. All comments received may be posted without change to, including any personal information provided.

Docket: For access to the docket to read background documents or comments received, go to and insert the docket number(s), found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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Lisa M. Helmanis, Regulations Policy and Management Staff, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3326, Silver Spring, MD 20993-0002, 301-796-9135, email:

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I. Background

In September 2000, FDA codified its good guidance practices (GGPs). GGPs are FDA's policies and procedures for the development, issuance, and use of guidance documents. Level I guidance documents set forth initial interpretations of statutory or regulatory requirements, explain changes in interpretation of policies, or discuss complex scientific issues or highly controversial issues. The GGPs, generally, require that such guidances be issued in draft for public comment before they are finalized. FDA's guidance documents do not create Start Printed Page 26060legally enforceable rights or responsibilities and do not legally bind the public or FDA.

A key component of the GGPs is ensuring transparency during guidance development and issuance. In 2011, as part of the Agency's Transparency Initiative, FDA reviewed and set forth best practices for facilitating early stakeholder input, efficiency, and transparency in the Agency's processes, including GGPs.

In recent years, FDA's guidance workload has increased due to requests from the public for guidance to clarify specific issues and statutorily mandated guidances. Many of these draft guidances were not finalized most often because of higher priorities and resource issues. However, over the years, because of new information, scientific developments, and emerging technologies, a number of draft guidances have become outdated and therefore, should be withdrawn.

II. Withdrawal of Guidances

FDA is withdrawing the following 47 guidance documents.

Draft guidanceDocket No.Publication date
1. Draft Guidance for Industry: Platelet Testing and Evaluation of Platelet Substitute ProductsFDA-1998-D-06805/20/1999
2. 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 Intimate ContactsFDA-1999-D-00452/11/2002
3. Draft Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell SubstitutesFDA-2004-D-042010/28/2004
4. Draft Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy ProductsFDA-2008-D-00552/11/2008
5. Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)FDA-2009-D-01373/26/2009
6. Accelerated Approval Products—Submission of Promotional MaterialsFDA-1999-D-07523/26/1999
7. Providing Regulatory Submissions in Electronic Format—Prescription Drug Advertising and Promotional LabelingFDA-2001-D-01691/1/2001
8. Comparability Protocols—Protein Drug Products and Biological Products—Chemistry, Manufacturing, and Controls InformationFDA-2003-D-03559/5/2003
9. Providing Regulatory Submissions in Electronic Format—General ConsiderationsFDA-2003-D-042910/1/2003
10. “Help-Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device FirmsFDA-2004-D-05001/26/2004
11. Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product ShortageFDA-2012-D-01402/21/2012
12. Assessing the Safety and Effectiveness of Home-Use In Vitro Diagnostic Devices: Draft Points to Consider Regarding Labeling and Premarket SubmissionsFDA-1998-N-005010/5/1988
13. 510(k) Submission of Lymphocyte Immunophenotyping IVDs Using Monoclonal AntibodiesFDA-1998-N-0050 FDA-2013-N-00469/26/1991
14. 510(k) Submission of Immunoglobulins A, G, M, D, and E Immunoglobulin System In Vitro DevicesFDA-1998-N-00509/1/1992
15. Draft Guidance for Preparation of PMA Applications for Testicular ProsthesesFDA-1998-N-00503/16/1993
16. Emergency Resuscitator GuidanceFDA-1998-N-00504/14/1993
17. 510(k) Submission Requirements for Peak Flow MetersFDA-1998-N-00501/3/1994
18. Reviewer Guidance on Face Masks and Shield for CPRFDA-1998-N-00503/16/1994
19. Reviewer Guidance for VentilatorsFDA-1998-N-00507/1/1995
20. Testing MR Interaction with Aneurysm ClipsFDA-1998-N-00505/22/1996
21. A Primer on Medical Device Interactions with Magnetic Resonance Imaging SystemsFDA-1997-D-04232/7/1997
22. Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase MethodologyFDA-2006-P-0022-00032/28/1997
23. Distribution and Public Availability of Premarket Approval Application Summary of Safety and Effectiveness Data Packages (P97-1)FDA-1998-N-0050-000210/10/1997
24. Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening TestsFDA-2003-D-037312/2/2003
25. Class II Special Controls Guidance Document: Tinnitus Masker DevicesFDA-2005-D-008511/8/2005
26. Class II Special Controls Guidance Document: Absorbable Hemostatic DeviceFDA-2006-D-035610/31/2006
27. Class II Special Controls Guidance Document: Tissue ExpanderFDA-2008-D-060312/22/2008
28. Heart Valves: Investigational Device Exemption and Premarket Approval ApplicationsFDA-2009-D-05591/20/2010
29. Class II Special Controls Guidance Document: Electroconductive MediaFDA-2009-D-04954/5/2010
30. Class II Special Controls Guidance Document: Cutaneous ElectrodeFDA-2009-D-04954/5/2010
31. Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain ReliefFDA-2009-D-04954/5/2010
32. Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator with Limited Output for Pain ReliefFDA-2009-D-04954/5/2010
33. Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator for Aesthetic PurposesFDA-2009-D-04954/5/2010
34. Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator with Limited Output for Aesthetic PurposesFDA-2009-D-04954/5/2010
35. Class II Special Controls Guidance Document: Powered Muscle Stimulator for RehabilitationFDA-2009-D-04954/5/2010
36. Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for RehabilitationFDA-2009-D-04954/5/2010
37. Class II Special Controls Guidance Document: Powered Muscle Stimulator for Muscle ConditioningFDA-2009-D-04954/5/2010
38. Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Muscle ConditioningFDA-2009-D-04954/5/2010
39. Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter UseFDA-2009-D-04954/5/2010
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40. Recommended Warning for Surgeon's Gloves and Patient Examination GlovesFDA-2011-D-00302/7/2011
41. Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. DetectionFDA-2011-D-01025/18/2011
42. Use of Antibiotic Resistance Marker Genes in Transgenic PlantsFDA-1998-N-00509/4/1998
43. Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and AnimalsFDA-2002-D-01359/11/2002
44. Preliminary Timetable for the Review of Applications for Modified Risk Tobacco Products under the Federal Food, Drug, and Cosmetic ActFDA-2009-D-056311/27/2009
45. Guidance for Industry: Regulatory Procedures Manual—Chapter 9, Subchapter: Guidance Concerning Recommending Customs' Seizure and Destruction of Imported Human and Animal Food That has Not Been Reconditioned; Draft GuidanceFDA-1998-N-005011/5/2002
46. Submission of Laboratory Packages By Accredited LaboratoriesFDA-2008-D-05101/2009
47. Guidance for the Public and FDA Staff on Convening Advisory Committee MeetingsFDA-2008-D-04178/1/2008
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Dated: April 30, 2015.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2015-10477 Filed 5-5-15; 8:45 am]