[Federal Register Volume 78, Number 167 (Wednesday, August 28, 2013)]
[Notices]
[Pages 53151-53152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20916]
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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Submissions: Questions and Answers; Draft Guidance for Industry and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.
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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availability of the draft guidance entitled ``The Applicability of Good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 This draft guidance answers commonly asked questions about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 This draft guidance is not final nor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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 26, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``The Applicability of Good Laboratory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Submit electronic comments on the draft guidance to http://www.regulations.gov.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 [email protected] 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]
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