Document ID: FDA-2009-D-0319-0001
Agency: fda
Document Type: Notice
Title: Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency; Availability
Posted Date: 2009-11-06T05:00Z

[Federal Register: November 6, 2009 (Volume 74, Number 214)]
[Notices]               
[Page 57503-57504]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06no09-64]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0319]

 
Guidance for Industry and Food and Drug Administration Staff; In 
Vitro Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency; 
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 guidance entitled ``In Vitro Diagnostic 2009 H1N1 
Tests for Use in the 2009 H1N1 Emergency.'' FDA is issuing this 
guidance to inform industry and agency staff of its recommendations for 
the type of information and data FDA believes needs to be included in 
an Emergency Use Authorization Request (EUA) for in vitro diagnostic 
(IVD) devices intended for use in diagnosing 2009 H1N1 Influenza virus 
infections during the emergency involving Swine Influenza A\1\. The 
Secretary of the Department of Health and Human Services (HHS) declared 
the emergency on April 26, 2009, in accordance with the Federal Food, 
Drug, and Cosmetics Act (the Act).
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    \1\ Swine Influenza A is now known as 2009 H1N1 Influenza (2009 
H1N1).

DATES: Submit written or electronic comments on this guidance at any 
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time. General comments on agency guidelines are welcome at any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``In Vitro Diagnostic 2009 H1N1 Tests for Use in the 
2009 H1N1 Emergency'' 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. 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 written comments concerning this guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.regulations.gov. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Sally Hojvat, Center for Devices and 
Radiological Health WO/66, rm. 5552, Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-5455.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance document provides recommendations on the types of 
information and data that FDA believes needs to be included in an 
Emergency Use Authorization Request (EUA) for in vitro diagnostic (IVD) 
devices intended for use in diagnosing 2009 H1N1 Influenza virus 
infections during the emergency involving Swine Influenza A. While FDA 
encourages the submission of premarket notifications (510(k)s) for all 
2009 H1N1 tests, the agency is aware that during a declared emergency, 
it may not be possible for manufacturers of 2009 H1N1 tests to submit a 
510(k) prior to distributing or offering a test. For example, during 
the initial phase of the emergency, positive clinical specimens may not 
be readily available for use in device evaluations. The identification 
of acute test capacity need may limit the ability to test the usual 
number of specimens needed for a 510(k). Additionally, appropriate 
validation specimens may not be available in certain areas at the time 
the test is needed. If manufacturers of 2009 H1N1 tests are unable to 
submit a premarket notification and there is a continued public health 
need for 2009 H1N1 tests during this declared emergency, manufacturers 
should submit an EUA request to FDA. Public participation is not 
feasible or appropriate since the agency must act immediately to 
protect the public health during the declared emergency concerning 2009 
H1N1 Influenza. This guidance applies to 2009 H1N1 tests during the 
time that the declaration of emergency concerning 2009 H1N1 Influenza 
is in effect.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on in vitro diagnostic 2009 H1N1 tests for 
use in the 2009 H1N1 emergency. It does not create or confer any rights 
for or on any person and does not operate to bind FDA or the

[[Page 57504]]

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 guidance may do so by 
using the Internet. To receive ``In Vitro Diagnostic 2009 H1N1 Tests 
for Use in the 2009 H1N1 Emergency,'' 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 1706 to identify the guidance you are 
requesting.
    CDRH maintains an entry on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with Internet access. Updated on a regular 
basis, the CDRH home page includes device safety alerts, Federal 
Register reprints, information on premarket submissions (including 
lists of approved applications and manufacturers' addresses), small 
manufacturer's assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH web site may be accessed at http://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations and guidance documents. 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 
814 have been approved under OMB Control No. 0910-0231; the collections 
of information in 21 CFR part 807 Subpart E have been approved under 
OMB Control No. 0910-0120; the collections of information in 21 U.S.C. 
360bbb-3(b) have been approved under OMB Control No. 0910-0584; the 
collections of information in 21 CFR part 812 have been approved under 
OMB Control No. 0910-0078; the collections in 21 CFR 493.17 have been 
approved under OMB Control No. 0910-0607; the collections of 
information in 21 CFR part 56 have been approved under OMB Control No. 
0910-0130; the collections of information in Section 564(b)(1) of the 
FD&C Act have been approved under OMB Control No. 0910-0595; the 
collections of information in 21 CFR part 820 have been approved under 
OMB Control No. 0910-0073; and the collections of information in 21 CFR 
809.10 have been approved under OMB Control No. 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified 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: November 2, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26737 Filed 11-5-09; 8:45 am]

BILLING CODE 4160-01-S