Federal Register, Volume 80 Issue 87 (Wednesday, May 6, 2015)

[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Withdrawal of Draft Guidance Documents Published Before December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withdrawal of 47 draft guidance documents that published before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: [email protected].

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]
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