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The Food and Drug Administration (FDA) is announcing the withdrawal of 47 draft guidance documents that published before December 31, 2013, and have never been finalized.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:
Submit electronic comments in the following way:
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 http://www.regulations.gov, including any personal information provided.
Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov 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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FOR FURTHER INFORMATION CONTACT:
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: Lisa.Helmanis.@fda.hhs.gov.
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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 guidance||Docket No.||Publication date|
|1. Draft Guidance for Industry: Platelet Testing and Evaluation of Platelet Substitute Products||FDA-1998-D-0680||5/20/1999|
|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 Contacts||FDA-1999-D-0045||2/11/2002|
|3. Draft Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes||FDA-2004-D-0420||10/28/2004|
|4. Draft Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products||FDA-2008-D-0055||2/11/2008|
|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-0137||3/26/2009|
|6. Accelerated Approval Products—Submission of Promotional Materials||FDA-1999-D-0752||3/26/1999|
|7. Providing Regulatory Submissions in Electronic Format—Prescription Drug Advertising and Promotional Labeling||FDA-2001-D-0169||1/1/2001|
|8. Comparability Protocols—Protein Drug Products and Biological Products—Chemistry, Manufacturing, and Controls Information||FDA-2003-D-0355||9/5/2003|
|9. Providing Regulatory Submissions in Electronic Format—General Considerations||FDA-2003-D-0429||10/1/2003|
|10. “Help-Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms||FDA-2004-D-0500||1/26/2004|
|11. Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage||FDA-2012-D-0140||2/21/2012|
|12. Assessing the Safety and Effectiveness of Home-Use In Vitro Diagnostic Devices: Draft Points to Consider Regarding Labeling and Premarket Submissions||FDA-1998-N-0050||10/5/1988|
|13. 510(k) Submission of Lymphocyte Immunophenotyping IVDs Using Monoclonal Antibodies||FDA-1998-N-0050 FDA-2013-N-0046||9/26/1991|
|14. 510(k) Submission of Immunoglobulins A, G, M, D, and E Immunoglobulin System In Vitro Devices||FDA-1998-N-0050||9/1/1992|
|15. Draft Guidance for Preparation of PMA Applications for Testicular Prostheses||FDA-1998-N-0050||3/16/1993|
|16. Emergency Resuscitator Guidance||FDA-1998-N-0050||4/14/1993|
|17. 510(k) Submission Requirements for Peak Flow Meters||FDA-1998-N-0050||1/3/1994|
|18. Reviewer Guidance on Face Masks and Shield for CPR||FDA-1998-N-0050||3/16/1994|
|19. Reviewer Guidance for Ventilators||FDA-1998-N-0050||7/1/1995|
|20. Testing MR Interaction with Aneurysm Clips||FDA-1998-N-0050||5/22/1996|
|21. A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems||FDA-1997-D-0423||2/7/1997|
|22. Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology||FDA-2006-P-0022-0003||2/28/1997|
|23. Distribution and Public Availability of Premarket Approval Application Summary of Safety and Effectiveness Data Packages (P97-1)||FDA-1998-N-0050-0002||10/10/1997|
|24. Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests||FDA-2003-D-0373||12/2/2003|
|25. Class II Special Controls Guidance Document: Tinnitus Masker Devices||FDA-2005-D-0085||11/8/2005|
|26. Class II Special Controls Guidance Document: Absorbable Hemostatic Device||FDA-2006-D-0356||10/31/2006|
|27. Class II Special Controls Guidance Document: Tissue Expander||FDA-2008-D-0603||12/22/2008|
|28. Heart Valves: Investigational Device Exemption and Premarket Approval Applications||FDA-2009-D-0559||1/20/2010|
|29. Class II Special Controls Guidance Document: Electroconductive Media||FDA-2009-D-0495||4/5/2010|
|30. Class II Special Controls Guidance Document: Cutaneous Electrode||FDA-2009-D-0495||4/5/2010|
|31. Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief||FDA-2009-D-0495||4/5/2010|
|32. Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator with Limited Output for Pain Relief||FDA-2009-D-0495||4/5/2010|
|33. Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator for Aesthetic Purposes||FDA-2009-D-0495||4/5/2010|
|34. Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator with Limited Output for Aesthetic Purposes||FDA-2009-D-0495||4/5/2010|
|35. Class II Special Controls Guidance Document: Powered Muscle Stimulator for Rehabilitation||FDA-2009-D-0495||4/5/2010|
|36. Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Rehabilitation||FDA-2009-D-0495||4/5/2010|
|37. Class II Special Controls Guidance Document: Powered Muscle Stimulator for Muscle Conditioning||FDA-2009-D-0495||4/5/2010|
|38. Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Muscle Conditioning||FDA-2009-D-0495||4/5/2010|
|39. Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use||FDA-2009-D-0495||4/5/2010|
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|40. Recommended Warning for Surgeon's Gloves and Patient Examination Gloves||FDA-2011-D-0030||2/7/2011|
|41. Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection||FDA-2011-D-0102||5/18/2011|
|42. Use of Antibiotic Resistance Marker Genes in Transgenic Plants||FDA-1998-N-0050||9/4/1998|
|43. Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals||FDA-2002-D-0135||9/11/2002|
|44. Preliminary Timetable for the Review of Applications for Modified Risk Tobacco Products under the Federal Food, Drug, and Cosmetic Act||FDA-2009-D-0563||11/27/2009|
|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 Guidance||FDA-1998-N-0050||11/5/2002|
|46. Submission of Laboratory Packages By Accredited Laboratories||FDA-2008-D-0510||1/2009|
|47. Guidance for the Public and FDA Staff on Convening Advisory Committee Meetings||FDA-2008-D-0417||8/1/2008|
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Dated: April 30, 2015.
Associate Commissioner for Policy.
[FR Doc. 2015-10477 Filed 5-5-15; 8:45 am]
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