[Federal Register Volume 74, Number 214 (Friday, November 6, 2009)]
[Notices]
[Pages 57503-57504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-26737]
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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 [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 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]
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