Food and Drug Administration, HHS.
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 . 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).
Submit written or electronic comments on this guidance at any time. General comments on agency guidelines are welcome at any time.
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.Start Further Info
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.End Further Info End Preamble Start Supplemental Information
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 Start Printed Page 57504public. 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@example.com 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.
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.Start Signature
Dated: November 2, 2009.
Assistant Commissioner for Policy.
1. Swine Influenza A is now known as 2009 H1N1 Influenza (2009 H1N1).Back to Citation
[FR Doc. E9-26737 Filed 11-5-09; 8:45 am]
BILLING CODE 4160-01-S