80_FR_26146 80 FR 26059 - Withdrawal of Draft Guidance Documents Published Before December 31, 2013

80 FR 26059 - Withdrawal of Draft Guidance Documents Published Before December 31, 2013

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

Page Range26059-26061
FR Document2015-10477

The Food and Drug Administration (FDA) is announcing the withdrawal of 47 draft guidance documents that published before December 31, 2013, and have never been finalized.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.

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  [www.thefederalregister.org]
[FR Doc No: 2015-10477]


-----------------------------------------------------------------------

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Withdrawal of Draft Guidance Documents Published Before December 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.

-----------------------------------------------------------------------

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withdrawal of 47 draft guidance documents that published before 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.

----------------------------------------------------------------------------------------------------------------
                Draft guidance                                    Docket No.                    Publication date
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------


    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



                                                                            Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Notices                                             26059

                                                Submit electronic comments on the                     requirements of the applicable statutes               DATES:  Although you can comment on
                                              draft guidance to http://                               and regulations.                                      any guidance at any time (see 21 CFR
                                              www.regulations.gov. Submit written                                                                           10.115(g)(5)), if you wish to submit
                                                                                                      II. Comments
                                              comments to the Division of Dockets                                                                           comments on a specific withdrawal
                                              Management (HFA–305), Food and Drug                        Interested persons may submit either               action in this notice, submit either
                                              Administration, 5630 Fishers Lane, Rm.                  electronic comments regarding this                    electronic or written comments by June
                                              1061, Rockville, MD 20852.                              document to http://www.regulations.gov                5, 2015.
                                              FOR FURTHER INFORMATION CONTACT:                        or written comments to the Division of                ADDRESSES: You may submit comments
                                              Mehul Mehta, Center for Drug                            Dockets Management (see ADDRESSES). It                by any of the following methods:
                                              Evaluation and Research, Food and                       is only necessary to send one set of
                                                                                                      comments. Identify comments with the                  Electronic Submissions
                                              Drug Administration, 10903 New
                                              Hampshire Ave., Silver Spring, MD                       docket number found in brackets in the                  Submit electronic comments in the
                                              20993, 301–796–1573.                                    heading of this document. Received                    following way:
                                              SUPPLEMENTARY INFORMATION:
                                                                                                      comments may be seen in the Division                    • Federal eRulemaking Portal: http://
                                                                                                      of Dockets Management between 9 a.m.                  www.regulations.gov. Follow the
                                              I. Background                                           and 4 p.m., Monday through Friday, and                instructions for submitting comments.
                                                 FDA is announcing the availability of                will be posted to the docket at http://
                                                                                                      www.regulations.gov.                                  Written Submissions
                                              a draft guidance for industry entitled
                                              ‘‘Waiver of In Vivo Bioavailability and                 III. Paperwork Reduction Act of 1995                     Submit written submissions in the
                                              Bioequivalence Studies for Immediate-                                                                         following ways:
                                              Release Solid Oral Dosage Forms Based                     This guidance refers to previously                     • Mail/Hand delivery/Courier (for
                                              on a Biopharmaceutics Classification                    approved collections of information that              paper submissions): Division of Dockets
                                              System.’’ This guidance provides                        are subject to review by the Office of                Management (HFA–305), Food and Drug
                                              recommendations for sponsors and                        Management and Budget (OMB) under                     Administration, 5630 Fishers Lane, Rm.
                                              applicants who wish to request a waiver                 the Paperwork Reduction Act of 1995                   1061, Rockville, MD 20852.
                                              of in vivo BA and/or BE studies for IR                  (44 U.S.C. 3501–3520). The collections                   Instructions: All submissions received
                                              solid oral dosage forms. These waivers                  of information in 21 CFR part 314,                    must include the Docket No. FDA–
                                              are intended to apply to: (1) Subsequent                including §§ 314.50 and 314.94, have                  2015–N–1419 for this action. All
                                              in vivo BA or BE studies of formulations                been approved under OMB control                       comments received may be posted
                                              after the initial establishment of the in               number 0910–0001.                                     without change to http://
                                              vivo BA of IR dosage forms during the                   IV. Electronic Access                                 www.regulations.gov, including any
                                              IND period and (2) in vivo BE studies                                                                         personal information provided.
                                                                                                        Persons with access to the Internet                    Docket: For access to the docket to
                                              of IR dosage forms in ANDAs.
                                                                                                      may obtain the document at either                     read background documents or
                                                 Regulations at 21 CFR part 320
                                                                                                      http://www.fda.gov/Drugs/Guidance                     comments received, go to http://
                                              address the requirements for BA and BE
                                                                                                      ComplianceRegulatoryInformation/                      www.regulations.gov and insert the
                                              data for approval of drug applications
                                                                                                      Guidances/default.htm or http://                      docket number(s), found in brackets in
                                              and supplemental applications.
                                                                                                      www.regulations.gov.                                  the heading of this document, into the
                                              Provision for waivers of in vivo BA/BE
                                              studies (biowaivers) under certain                        Dated: April 29, 2015.                              ‘‘Search’’ box and follow the prompts
                                              conditions is provided at § 320.22. This                Leslie Kux,                                           and/or go to the Division of Dockets
                                              guidance updates the guidance for                       Associate Commissioner for Policy.                    Management, 5630 Fishers Lane, Rm.
                                              industry on ‘‘Waiver of In Vivo                         [FR Doc. 2015–10479 Filed 5–5–15; 8:45 am]
                                                                                                                                                            1061, Rockville, MD 20852.
                                              Bioavailability and Bioequivalence                      BILLING CODE 4164–01–P                                FOR FURTHER INFORMATION CONTACT: Lisa
                                              Studies for Immediate-Release Solid                                                                           M. Helmanis, Regulations Policy and
                                              Oral Dosage Forms Based on a                                                                                  Management Staff, Office of the
                                              Biopharmaceutics Classification                         DEPARTMENT OF HEALTH AND                              Commissioner, Food and Drug
                                              System,’’ published in August 2000, and                 HUMAN SERVICES                                        Administration, 10903 New Hampshire
                                              explains when biowaivers can be                                                                               Ave., Bldg. 32, Rm. 3326, Silver Spring,
                                              requested for IR solid oral dosage forms                Food and Drug Administration                          MD 20993–0002, 301–796–9135, email:
                                              based on an approach termed the                                                                               Lisa.Helmanis.@fda.hhs.gov.
                                              Biopharmaceutics Classification System                  [Docket No. FDA–2015–N–1419]
                                                                                                                                                            SUPPLEMENTARY INFORMATION:
                                              (BCS). This guidance includes
                                                                                                      Withdrawal of Draft Guidance                          I. Background
                                              biowaiver extension to BCS class 3 drug
                                                                                                      Documents Published Before
                                              products and additional modifications,                                                                          In September 2000, FDA codified its
                                                                                                      December 31, 2013
                                              such as criteria for high permeability                                                                        good guidance practices (GGPs). GGPs
                                              and high solubility.                                    AGENCY:    Food and Drug Administration,              are FDA’s policies and procedures for
                                                 This draft guidance is being issued                  HHS.                                                  the development, issuance, and use of
                                              consistent with FDA’s good guidance                     ACTION:   Notice.                                     guidance documents. Level I guidance
                                              practices regulation (21 CFR 10.115).                                                                         documents set forth initial
                                              The draft guidance, when finalized, will                SUMMARY:   The Food and Drug                          interpretations of statutory or regulatory
                                              represent FDA’s current thinking on                     Administration (FDA) is announcing the                requirements, explain changes in
tkelley on DSK3SPTVN1PROD with NOTICES




                                              waiver of in vivo bioavailability and                   withdrawal of 47 draft guidance                       interpretation of policies, or discuss
                                              bioequivalence studies for immediate-                   documents that published before                       complex scientific issues or highly
                                              release solid oral dosage forms based on                December 31, 2013, and have never                     controversial issues. The GGPs,
                                              a BCS. It does not establish any rights                 been finalized. FDA is taking this action             generally, require that such guidances
                                              for any person and is not binding on                    to improve the efficiency and                         be issued in draft for public comment
                                              FDA or the public. You can use an                       transparency of the guidance                          before they are finalized. FDA’s
                                              alternative approach if it satisfies the                development process.                                  guidance documents do not create


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                                              26060                                Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Notices

                                              legally enforceable rights or                                     transparency in the Agency’s processes,                                of new information, scientific
                                              responsibilities and do not legally bind                          including GGPs.                                                        developments, and emerging
                                              the public or FDA.                                                   In recent years, FDA’s guidance                                     technologies, a number of draft
                                                A key component of the GGPs is                                  workload has increased due to requests                                 guidances have become outdated and
                                              ensuring transparency during guidance                             from the public for guidance to clarify                                therefore, should be withdrawn.
                                              development and issuance. In 2011, as                             specific issues and statutorily mandated
                                              part of the Agency’s Transparency                                 guidances. Many of these draft                                         II. Withdrawal of Guidances
                                              Initiative, FDA reviewed and set forth                            guidances were not finalized most often
                                              best practices for facilitating early                             because of higher priorities and resource                                FDA is withdrawing the following 47
                                              stakeholder input, efficiency, and                                issues. However, over the years, because                               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 Trans-                                              FDA–1999–D–0045               2/11/2002
                                                mission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients
                                                and Their Intimate Contacts.
                                              3. Draft Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics                                        FDA–2004–D–0420              10/28/2004
                                                as Red Blood Cell Substitutes.
                                              4. Draft Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Ste-                                         FDA–2008–D–0055               2/11/2008
                                                rility Testing of Cellular and Gene Therapy Products.
                                              5. Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of                                            FDA–2009–D–0137               3/26/2009
                                                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 of Promotional Materials .........................................                            FDA–1999–D–0752               3/26/1999
                                              7. Providing Regulatory Submissions in Electronic Format—Prescription Drug Advertising and Pro-                                           FDA–2001–D–0169                1/1/2001
                                                motional Labeling.
                                              8. Comparability Protocols—Protein Drug Products and Biological Products—Chemistry, Manufac-                                              FDA–2003–D–0355                9/5/2003
                                                turing, and Controls Information.
                                              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                                               FDA–2004–D–0500               1/26/2004
                                                Device Firms.
                                              11. Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product                                            FDA–2012–D–0140               2/21/2012
                                                Shortage.
                                              12. Assessing the Safety and Effectiveness of Home-Use In Vitro Diagnostic Devices: Draft Points                                          FDA–1998–N–0050               10/5/1988
                                                to Consider Regarding Labeling and Premarket Submissions.
                                              13. 510(k) Submission of Lymphocyte Immunophenotyping IVDs Using Monoclonal Antibodies .....                                              FDA–1998–N–0050               9/26/1991
                                                                                                                                                                                        FDA–2013–N–0046
                                              14. 510(k) Submission of Immunoglobulins A, G, M, D, and E Immunoglobulin System In Vitro De-                                             FDA–1998–N–0050                9/1/1992
                                                vices.
                                              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                                           FDA–2006–P–0022–              2/28/1997
                                                Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology.                                                                           0003
                                              23. Distribution and Public Availability of Premarket Approval Application Summary of Safety and                                          FDA–1998–N–0050–             10/10/1997
                                                Effectiveness Data Packages (P97–1).                                                                                                      0002
                                              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                                           FDA–2009–D–0495                4/5/2010
                                                Pain Relief.
                                              32. Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator                                               FDA–2009–D–0495                4/5/2010
                                                with Limited Output for Pain Relief.
                                              33. Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator for Aes-                                            FDA–2009–D–0495                4/5/2010
                                                thetic Purposes.
                                              34. Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator with Lim-                                           FDA–2009–D–0495                4/5/2010
                                                ited Output for Aesthetic Purposes.
                                              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                                            FDA–2009–D–0495                4/5/2010
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                                                for Rehabilitation.
                                              37. Class II Special Controls Guidance Document: Powered Muscle Stimulator for Muscle Condi-                                              FDA–2009–D–0495                4/5/2010
                                                tioning.
                                              38. Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output                                            FDA–2009–D–0495                4/5/2010
                                                for Muscle Conditioning.
                                              39. Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for                                           FDA–2009–D–0495                4/5/2010
                                                Pain Relief Intended for Over the Counter Use.



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                                                                             Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Notices                                                   26061

                                                                                              Draft guidance                                                              Docket No.         Publication date

                                              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.                        FDA–2011–D–0102                 5/18/2011
                                                Detection.
                                              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                         FDA–2002–D–0135                 9/11/2002
                                                and Animals.
                                              44. Preliminary Timetable for the Review of Applications for Modified Risk Tobacco Products                           FDA–2009–D–0563                11/27/2009
                                                under the Federal Food, Drug, and Cosmetic Act.
                                              45. Guidance for Industry: Regulatory Procedures Manual—Chapter 9, Subchapter: Guidance                               FDA–1998–N–0050                 11/5/2002
                                                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 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



                                                Dated: April 30, 2015.                                 guidance before it begins work on the                       treatment (i.e., from birth through the
                                              Leslie Kux,                                              final version of the guidance, submit                       21st year of life, up to but not including
                                              Associate Commissioner for Policy.                       either electronic or written comments                       the 22d birthday). Pediatric
                                              [FR Doc. 2015–10477 Filed 5–5–15; 8:45 am]               on the draft guidance by August 4, 2015.                    subpopulations are defined in section
                                              BILLING CODE 4164–01–P                                   ADDRESSES: An electronic copy of the                        520(m)(6)(E)(ii) (and adopted by
                                                                                                       guidance document is available for                          reference in section 515A(c) of the
                                                                                                       download from the Internet. See the                         FD&C Act (21 U.S.C. 360e)) to be
                                              DEPARTMENT OF HEALTH AND                                 SUPPLEMENTARY INFORMATION section for                       neonates, infants, children, and
                                              HUMAN SERVICES                                           information on electronic access to the                     adolescents.
                                                                                                       guidance. Submit written requests for a                        In an attempt to promote pediatric
                                              Food and Drug Administration                             single hard copy of the draft guidance                      medical device development, CDRH
                                              [Docket No. FDA–2015–D–1376]                             document entitled ‘‘Leveraging Existing                     published a final guidance document in
                                                                                                       Clinical Data for Extrapolation to                          2004 entitled ‘‘Premarket Assessment of
                                              Leveraging Existing Clinical Data for                    Pediatric Uses of Medical Devices’’ to                      Pediatric Medical Devices’’ (Ref. 1). This
                                              Extrapolation to Pediatric Uses of                       the Office of the Center Director,                          2004 document indicates that data can
                                              Medical Devices; Draft Guidance for                      Guidance and Policy Development,                            be extrapolated to support effectiveness
                                              Industry and Food and Drug                               Center for Devices and Radiological                         and, on a limited basis, safety for
                                              Administration Staff; Availability                       Health (CDRH), Food and Drug                                premarket approval applications (PMAs)
                                              AGENCY:    Food and Drug Administration,                 Administration, 10903 New Hampshire                         when consistent with scientific
                                              HHS.                                                     Ave., Bldg. 66, Rm. 5431, Silver Spring,                    principles. Congress was aware of this
                                                                                                       MD 20993–0002. Send one self-                               2004 document when it passed the Food
                                              ACTION:   Notice.
                                                                                                       addressed adhesive label to assist that                     and Drug Administration Amendments
                                              SUMMARY:    The Food and Drug                            office in processing your request.                          Act of 2007 (FDAAA). Title III of
                                              Administration (FDA) is announcing the                      Submit electronic comments on the                        FDAAA is the Pediatric Medical Device
                                              availability of the draft guidance                       draft guidance to http://                                   Safety and Improvement Act (PMDSIA).
                                              entitled ‘‘Leveraging Existing Clinical                  www.regulations.gov. Submit written                         The FDAAA specifically authorized the
                                              Data for Extrapolation to Pediatric Uses                 comments to the Division of Dockets                         use of adult data to demonstrate
                                              of Medical Devices.’’ This draft                         Management (HFA–305), Food and Drug                         pediatric effectiveness. While safety
                                              guidance is being issued to explain the                  Administration, 5630 Fishers Lane, Rm.                      exploration is not discussed in PMDSIA,
                                              circumstances in which it may be                         1061, Rockville, MD 20852. Identify                         FDA believes that there are specific
                                              appropriate to leverage existing clinical                comments with the docket number                             cases where it will be appropriate to
                                              data to support pediatric device                         found in brackets in the heading of this                    consider extrapolation of existing
                                              indications in premarket approval                        document.                                                   clinical safety data to support or
                                              applications (PMAs) and humanitarian                     FOR FURTHER INFORMATION CONTACT:                            enhance evidence for pediatric
                                              device exemptions (HDEs). The draft                      Jacqueline Francis, Center for Devices                      indications. FDA seeks comment on the
                                              guidance also describes the approach                     and Radiological Health, Food and Drug                      appropriateness of extrapolating from
                                              that FDA would use to determine                          Administration, 10903 New Hampshire                         adult clinical data to support medical
                                              whether extrapolation is appropriate in                  Ave., Bldg. 66, Silver Spring, MD                           device safety in pediatric patients.
                                              medical devices, and the factors that                    20993–0002, 301–796–6405; or Stephen                           FDA aims to increase the availability
                                              would be considered within a statistical                 Ripley, Center for Biologics Evaluation                     of safe and effective pediatric devices
                                              model for extrapolation. Extrapolation                   and Research (CBER), Food and Drug                          while ensuring that the approval of
                                              may be appropriate when the course of                    Administration, 10903 New Hampshire                         these devices is based on valid scientific
                                              the disease or condition and the effects                 Ave., Bldg. 71, Rm. 7301, Silver Spring,                    evidence. Extrapolation of adult data for
                                              of the device are sufficiently similar in                MD 20993–0002, 240–402–7911.                                pediatric use may benefit pediatric
                                              adults and pediatric patients and the                    SUPPLEMENTARY INFORMATION:                                  patients by making it possible for
tkelley on DSK3SPTVN1PROD with NOTICES




                                              adult data are of high quality for                                                                                   devices to be approved for pediatric-
                                              borrowing. This draft guidance is not                    I. Background                                               specific indications and labeling, even
                                              final nor is it in effect at this time.                     Section 520(m)(6)(E)(i) of the Federal                   when there is little or no existing
                                              DATES: Although you can comment on                       Food, Drug, and Cosmetic Act (FD&C                          pediatric data. Extrapolation facilitates
                                              any guidance at any time (see 21 CFR                     Act) (21 U.S.C. 360j) defines pediatric                     the use of available relevant data by
                                              10.115(g)(5)), to ensure that the Agency                 device patients as persons aged 21 or                       making optimal use of what is already
                                              considers your comment of this draft                     younger at the time of their diagnosis or                   known about device effects in other


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Document Created: 2015-12-16 07:40:46
Document Modified: 2015-12-16 07:40:46
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAlthough 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.
ContactLisa 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]
FR Citation80 FR 26059 

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