
[Federal Register Volume 78, Number 167 (Wednesday, August 28, 2013)]
[Notices]
[Pages 53151-53152]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20916]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0918]


The Applicability of Good Laboratory Practice in Premarket Device 
Submissions: Questions and Answers; Draft Guidance for Industry and 
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``The Applicability of Good 
Laboratory Practice in Premarket Device Submissions: Questions & 
Answers.'' This draft guidance answers commonly asked questions about 
the applicability of good laboratory practice (GLP) to nonclinical 
laboratory studies conducted in support of research and marketing 
applications for medical devices. This draft guidance is not final nor 
is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 26, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``The Applicability of Good Laboratory 
Practice in Premarket Device Submissions: Questions & Answers'' to the 
Division of Small Manufacturers, International, and Consumer 
Assistance, Center for Devices and Radiological Health, Food and Drug 
Administration (CDRH), 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, 
Silver Spring, MD 20993-0002; or Office of Communication, Outreach, and 
Development (HFM-40), Center for Biologics Evaluation and Research 
(CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448. Send one self-addressed adhesive label to 
assist that office in processing your request, or fax your request to 
CDRH at 301-847-8149. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Victoria Hampshire, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 1218, Silver Spring, MD 20993-0002, 301-
796-6375; or Stephen Ripley, Center for Biologics Evaluation and 
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA issued the GLP regulations in response to public concerns that 
several important studies supporting the safety of FDA-regulated 
products were seriously flawed due to poor research practices and 
laboratory misconduct. The GLP regulations apply to nonclinical 
laboratory studies supporting the safety of FDA-regulated products (21 
CFR 58.1). The draft guidance provides clarification on GLP 
terminology, the types of medical device research or marketing 
applications that are subject to the GLP regulation, and, if 
applicable, the types of information related to GLP that should be 
provided to FDA.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on good 
laboratory practices. It does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statute and regulations.

[[Page 53152]]

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. A search capability for all CDRH guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov or from CBER 
at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive ``The 
Applicability of Good Laboratory Practice in Premarket Device 
Submissions: Questions & Answers,'' you may either send an email 
request to dsmica@fda.hhs.gov to receive an electronic copy of the 
document or send a fax request to 301-847-8149 to receive a hard copy. 
Please use the document number 1779 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    The draft guidance refers to currently approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 807, subpart E, have been 
approved under OMB control number 0910-0120; the collections of 
information in 21 CFR part 812 have been approved under OMB control 
number 0910-0078; and the collections of information in 21 CFR part 814 
have been approved under OMB control number 0910-0231.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: August 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20916 Filed 8-27-13; 8:45 am]
BILLING CODE 4160-01-P


