[Federal Register Volume 75, Number 151 (Friday, August 6, 2010)]
[Notices]
[Pages 47603-47604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19419]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0395]
Draft Guidance for Industry and Food and Drug Administration
Staff; Recommendations for Premarket Notifications for Lamotrigine and
Zonisamide Assays; 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availability of the draft guidance entitled ``Draft Guidance for
Industry and FDA Staff; Recommendations for Premarket Notifications for
Lamotrigine and Zonisamide Assays.'' This draft guidance document
discusses information to be included in premarket notifications for
lamotrigine or zonisamide assays. This draft guidance is not final nor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this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 4, 2010.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Recommendations for Premarket
Notifications for Lamotrigine and Zonisamide Assays'' to the Division
of Small Manufacturers, International, and Consumer Assistance, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to 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Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Avis Danishefsky, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 5620, Silver Spring, MD 20993-0002, 301-
796-6142.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is issuing this draft guidance document to describe its current
thinking concerning issues that should be addressed in premarket
notifications for assays intended to quantitate the anti-seizure drugs
lamotrigine and zonisamide in serum. The Therapeutic Drug Monitoring
(TDM) Roundtable of the American Association of Clinical Chemists
(AACC) submitted to FDA recommendations for lamotrigine assays. Many of
the recommendations in this draft guidance document are consistent with
the AACC TDM Roundtable recommendations. Some of the general concepts
in this guidance may also be helpful in preparing 510(k) submissions
for other therapeutic drug assays previously cleared by FDA and
classified within 21 CFR part 862, subpart D.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance
[[Page 47604]]
practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on therapeutic
drug assays that measure lamotrigine or zonisamide. 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.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. To receive ``Recommendations for Premarket
Notifications for Lamotrigine and Zonisamide Assays,'' you may either
send an e-mail 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 1654 to identify the guidance
you are requesting. 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.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to previously 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 809.10 have been approved under OMB control
number 0910-0485.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.
Dated: August 2, 2010.
Nancy Stade,
Acting Associate Director for Regulations and Policy, Center for
Devices and Radiological Health.
[FR Doc. 2010-19419 Filed 8-5-10; 8:45 am]
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