Document ID: FDA-2010-D-0395-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability
Posted Date: 2010-08-06T04:00Z

[Federal Register: August 6, 2010 (Volume 75, Number 151)]
[Notices]               
[Page 47603-47604]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06au10-84]                         

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

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Draft Guidance for Industry and Food and Drug Administration 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.

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

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availability of the draft guidance entitled ``Draft Guidance for 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 This draft guidance document 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 This draft guidance is not final nor 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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 4, 2010.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance document entitled ``Recommendations for Premarket 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    Submit electronic comments on the draft guidance to http://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 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 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]
BILLING CODE 4160-01-S