[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)]
[Notices]
[Pages 26059-26061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10477]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1419]


Withdrawal of Draft Guidance Documents Published Before December 
31, 2013

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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withdrawal of 47 draft guidance documents that published before 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.

DATES: 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.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

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 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.

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.

SUPPLEMENTARY INFORMATION:

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

[[Page 26060]]

legally 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.

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                Draft guidance                                    Docket No.                    Publication date
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1. Draft Guidance for Industry: Platelet        FDA-1998-D-0680                                        5/20/1999
 Testing and Evaluation of Platelet Substitute
 Products.
2. Draft Guidance for Industry: Precautionary   FDA-1999-D-0045                                        2/11/2002
 Measures to Reduce the Possible Risk of
 Transmission of Zoonoses by Blood and Blood
 Products from Xenotransplantation Product
 Recipients and Their Intimate Contacts.
3. Draft Guidance for Industry: Criteria for    FDA-2004-D-0420                                       10/28/2004
 Safety and Efficacy Evaluation of Oxygen
 Therapeutics as Red Blood Cell Substitutes.
4. Draft Guidance for Industry: Validation of   FDA-2008-D-0055                                        2/11/2008
 Growth-Based Rapid Microbiological Methods
 for Sterility Testing of Cellular and Gene
 Therapy Products.
5. Draft Guidance for Industry: Use of          FDA-2009-D-0137                                        3/26/2009
 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).
6. Accelerated Approval Products--Submission    FDA-1999-D-0752                                        3/26/1999
 of Promotional Materials.
7. Providing Regulatory Submissions in          FDA-2001-D-0169                                         1/1/2001
 Electronic Format--Prescription Drug
 Advertising and Promotional Labeling.
8. Comparability Protocols--Protein Drug        FDA-2003-D-0355                                         9/5/2003
 Products and Biological Products--Chemistry,
 Manufacturing, and Controls Information.
9. Providing Regulatory Submissions in          FDA-2003-D-0429                                        10/1/2003
 Electronic Format--General Considerations.
10. ``Help-Seeking'' and Other Disease          FDA-2004-D-0500                                        1/26/2004
 Awareness Communications by or on Behalf of
 Drug and Device Firms.
11. Notification to FDA of Issues that May      FDA-2012-D-0140                                        2/21/2012
 Result in a Prescription Drug or Biological
 Product Shortage.
12. Assessing the Safety and Effectiveness of   FDA-1998-N-0050                                        10/5/1988
 Home-Use In Vitro Diagnostic Devices: Draft
 Points to Consider Regarding Labeling and
 Premarket Submissions.
13. 510(k) Submission of Lymphocyte             FDA-1998-N-0050                                        9/26/1991
 Immunophenotyping IVDs Using Monoclonal        FDA-2013-N-0046
 Antibodies.
14. 510(k) Submission of Immunoglobulins A, G,  FDA-1998-N-0050                                         9/1/1992
 M, D, and E Immunoglobulin System In Vitro
 Devices.
15. Draft Guidance for Preparation of PMA       FDA-1998-N-0050                                        3/16/1993
 Applications for Testicular Prostheses.
16. Emergency Resuscitator Guidance...........  FDA-1998-N-0050                                        4/14/1993
17. 510(k) Submission Requirements for Peak     FDA-1998-N-0050                                         1/3/1994
 Flow Meters.
18. Reviewer Guidance on Face Masks and Shield  FDA-1998-N-0050                                        3/16/1994
 for CPR.
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     FDA-1997-D-0423                                         2/7/1997
 with Magnetic Resonance Imaging Systems.
22. Review Criteria Assessment of Portable      FDA-2006-P-0022-0003                                   2/28/1997
 Blood Glucose Monitoring In Vitro Diagnostic
 Devices Using Glucose Oxidase, Dehydrogenase
 or Hexokinase Methodology.
23. Distribution and Public Availability of     FDA-1998-N-0050-0002                                  10/10/1997
 Premarket Approval Application Summary of
 Safety and Effectiveness Data Packages (P97-
 1).
24. Premarket Submissions and Labeling          FDA-2003-D-0373                                        12/2/2003
 Recommendations for Drugs of Abuse Screening
 Tests.
25. Class II Special Controls Guidance          FDA-2005-D-0085                                        11/8/2005
 Document: Tinnitus Masker Devices.
26. Class II Special Controls Guidance          FDA-2006-D-0356                                       10/31/2006
 Document: Absorbable Hemostatic Device.
27. Class II Special Controls Guidance          FDA-2008-D-0603                                       12/22/2008
 Document: Tissue Expander.
28. Heart Valves: Investigational Device        FDA-2009-D-0559                                        1/20/2010
 Exemption and Premarket Approval Applications.
29. Class II Special Controls Guidance          FDA-2009-D-0495                                         4/5/2010
 Document: Electroconductive Media.
30. Class II Special Controls Guidance          FDA-2009-D-0495                                         4/5/2010
 Document: Cutaneous Electrode.
31. Class II Special Controls Guidance          FDA-2009-D-0495                                         4/5/2010
 Document: Transcutaneous Electrical Nerve
 Stimulator for Pain Relief.
32. Class II Special Controls Guidance          FDA-2009-D-0495                                         4/5/2010
 Document: Transcutaneous Electrical Nerve
 Stimulator with Limited Output for Pain
 Relief.
33. Class II Special Controls Guidance          FDA-2009-D-0495                                         4/5/2010
 Document: Transcutaneous Electrical
 Stimulator for Aesthetic Purposes.
34. Class II Special Controls Guidance          FDA-2009-D-0495                                         4/5/2010
 Document: Transcutaneous Electrical
 Stimulator with Limited Output for Aesthetic
 Purposes.
35. Class II Special Controls Guidance          FDA-2009-D-0495                                         4/5/2010
 Document: Powered Muscle Stimulator for
 Rehabilitation.
36. Class II Special Controls Guidance          FDA-2009-D-0495                                         4/5/2010
 Document: Powered Muscle Stimulator with
 Limited Output for Rehabilitation.
37. Class II Special Controls Guidance          FDA-2009-D-0495                                         4/5/2010
 Document: Powered Muscle Stimulator for
 Muscle Conditioning.
38. Class II Special Controls Guidance          FDA-2009-D-0495                                         4/5/2010
 Document: Powered Muscle Stimulator with
 Limited Output for Muscle Conditioning.
39. Class II Special Controls Guidance          FDA-2009-D-0495                                         4/5/2010
 Document: Transcutaneous Electrical Nerve
 Stimulator for Pain Relief Intended for Over
 the Counter Use.

[[Page 26061]]

 
40. Recommended Warning for Surgeon's Gloves    FDA-2011-D-0030                                         2/7/2011
 and Patient Examination Gloves.
41. Class II Special Controls Guidance          FDA-2011-D-0102                                        5/18/2011
 Document: In Vitro Diagnostic Devices for
 Bacillus spp. Detection.
42. Use of Antibiotic Resistance Marker Genes   FDA-1998-N-0050                                         9/4/1998
 in Transgenic Plants.
43. Drugs, Biologics, and Medical Devices       FDA-2002-D-0135                                        9/11/2002
 Derived from Bioengineered Plants for Use in
 Humans and Animals.
44. Preliminary Timetable for the Review of     FDA-2009-D-0563                                       11/27/2009
 Applications for Modified Risk Tobacco
 Products under the Federal Food, Drug, and
 Cosmetic Act.
45. Guidance for Industry: Regulatory           FDA-1998-N-0050                                        11/5/2002
 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.
46. Submission of Laboratory Packages By        FDA-2008-D-0510                                           1/2009
 Accredited Laboratories.
47. Guidance for the Public and FDA Staff on    FDA-2008-D-0417                                         8/1/2008
 Convening Advisory Committee Meetings.
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    Dated: April 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10477 Filed 5-5-15; 8:45 am]
BILLING CODE 4164-01-P