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Notice

Termination of Declarations Justifying Emergency Use Authorizations of Certain In Vitro Diagnostic Devices, Antiviral Drugs, and Personal Respiratory Protection Devices

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is issuing this notice, under the Federal Food, Drug, and Cosmetic Act (the act), of the termination of the declarations of emergency justifying Emergency Use Authorizations (EUAs) of certain in vitro diagnostic devices, personal respiratory protection devices, and antiviral products that were issued in response to the public health emergency involving 2009 H1N1 Influenza. Advance notice of the termination of the declarations was provided under the act.

DATES:

The Authorizations are terminated as of June 23, 2010.

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FOR FURTHER INFORMATION CONTACT:

RADM Boris Lushniak, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4140, Silver Spring, MD 20993, 301-796-8510.

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SUPPLEMENTARY INFORMATION:

I. Background

On April 26, 2009, the then Acting Secretary of the Department of Health and Human Services (DHHS) determined, under section 564(b)(1)(C) of the act (21 U.S.C. 360bbb-3(b)(1)(C)) that a public health emergency exists involving Swine Influenza A (now known as 2009 H1N1 Influenza) that affects, or has significant potential to affect, national security. The determination was renewed four times: March 26, 2010, December 28, 2009, October 1, 2009, and July 24, 2009. On March 26, 2010, the Secretary of DHHS renewed the declarations justifying the authorization for the emergency use of certain in vitro diagnostic devices, antiviral drugs, and personal respiratory protection devices. For additional background information on the declarations, see the April 2, 2010, renewal notice (75 FR 16810).

For additional background information on the products authorized for emergency use in response to the public health emergency involving 2009 H1N1 Influenza, see the following Federal Register notices:

II. Advance Notice of Termination

FDA is issuing this notice, under section 564(b)(4) of the act, of the termination of the declarations of emergency justifying EUAs of certain in vitro diagnostic devices, personal respiratory protection devices, and antiviral products that were issued in response to the public health emergency involving 2009 H1N1 Influenza. Under section 564(b)(3) of the act, the Commissioner of Food and Drugs provided advance notice of the termination of the declaration of emergency to the EUA requestor for each product authorized for emergency use in response to the public health emergency involving 2009 H1N1 Influenza. The June 21, 2010, letters notifying the EUA requestors of the termination of the declaration of emergency follow:Start Printed Page 36433

 Thomas R. Frieden, MD, MPH
 Director
 Centers for Disease Control and Prevention
 1600 Clifton Rd., MS D-14
 Atlanta, GA 30333
 Re: Termination of Declarations of Emergency Justifying Emergency  Use Authorization (EUA) of Certain Antiviral Drugs—Zanamivir, Oseltamivir Phosphate, and Peramivir
 Dear Dr. Frieden:
 This letter is to provide advance notice of the termination of:
(1) the declaration of emergency that was issued by the then Acting Secretary of the Department of Health and Human Services (HHS) Charles E. Johnson on April 26, 2009, pursuant to section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 360bbb-3, justifying the authorization of the emergency use of certain products from the neuraminidase class of antivirals Oseltamivir Phosphate and Zanamivir; and
(2) the declaration of emergency that was issued by the Secretary of HHS on October 20, 2009, pursuant to section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3, justifying the authorization of the emergency use of the antiviral peramivir.
 Both of the declarations described above will terminate when the Public Health Emergency determination for 2009 H1N1 influenza expires on June 23, 2010. Therefore, after June 23, 2010, the EUA authorizing the unapproved uses of zanamivir and oseltamivir phosphate and the use of the unapproved drug peramivir will no longer be in effect. For any patient who began a treatment course of peramivir prior to June 23, 2010, the authorization shall continue to be effective after June 23, 2010, to allow completion of that treatment course, to the extent the patient's attending physician finds continued treatment necessary. 21 U.S.C. § 360bbb-3(f)(2).
 The advance notice of termination will be published in the Federal Register, pursuant to section 564(b)(4) of the Act, 21 U.S.C. § 360bbb-3(b)(4).
                    Sincerely,
                    Margaret A. Hamburg, M.D.                     Commissioner of Food and Drugs
 Thomas R. Frieden, MD, MPH
 Director
 Centers for Disease Control and Prevention
 1600 Clifton Rd., MS D-14
 Atlanta, GA 30333
 Re: Termination of Declaration of Emergency Justifying the Authorization of Emergency  Use of Certain Personal Respiratory Protection Devices
 Dear Dr. Frieden:
 This letter is to provide advance notice of the termination of the declaration of emergency that was issued by the then Acting Secretary of the Department of Health and Human Services Charles E. Johnson on April 27, 2009, pursuant to section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 360bbb-3, justifying the authorization of emergency use of certain Personal Respiratory Protection Devices. This declaration of emergency will terminate when the Public Health Emergency determination for 2009 H1N1 influenza expires on June 23, 2010.
 Advance notice of termination will be published in the Federal Register, pursuant to section 564(b)(4) of the Act.
                    Sincerely,
                    Margaret A. Hamburg, M.D.                     Commissioner of Food and Drugs

With regard to in vitro diagnostic devices, the following letter was sent to each of the listed EUA requestors with respect to the identified devices:

Table 1.

EUA Requestor Name and AddressIn Vitro Diagnostic Device
Centers for Disease Control and Prevention 1600 Clifton Rd., MS D-14 Atlanta, GA 30333Swine Influenza Virus Real-time RT-PCR Detection Panel
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Centers for Disease Control and Prevention 1600 Clifton Rd., MS D-14 Atlanta, GA 30333CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel for Respiratory Specimens (NPS, NS, TS, NPS/TS, NA2) and Viral Culture
Cepheid 904 Caribbean Drive Sunnyvale, CA 94089Cepheid Xpert Flu A Panel
Diagnostic Hybrids, Inc. 1055 East State St., Suite 100 Athens, OH 45701Diagnostic Hybrids, Inc. D3 Ultra 2009 H1N1 Influenza A Virus ID Kit
DIATHERIX Laboratories, Inc. 601 Genome Way, Suite 4208 Huntsville, AL 35806Diatherix H1N1-09 Influenza Test
DxNA, LLC 3879 S. River Road, Bldg. A St. George, UT 84790GeneSTAT 2009 A/H1N1 Influenza Test
Epoch BioSciences 21720 23rd Drive S.E., Suite 150 Bothell, WA 98021ELITech Molecular Diagnostics 2009-H1N1 Influenza A Virus Real RT-PCR test
Focus Diagnostics, Inc. 11331 Valley View Street Cypress, CA 90630Focus Diagnostics Influenza A H1N1 (2009) Real-Time RT-PCR IVD device
Focus Diagnostics, Inc. 11331 Valley View Street Cypress, CA 90630Focus Diagnostics Simplexa Influenza A H1N1 (2009)device
IntelligentMDx 19 Blackstone Street Cambridge, MA 02139IMDx 2009 Influenza A H1N1 Real-Time RT-PCR Assay
IQuum, Inc. 700 Nickerson Road Marlborough, MA 01752Liat Influenza A/2009 H1N1 Assay
Longhorn Vaccines and Diagnostics 3 Bethesda Metro Center, Suite 375 Bethesda, MD 20814Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay
Prodesse Products Gen-Probe W229 N1870 Westwood Drive Waukesha, WI 53186Prodesse ProFlu-ST Influenza A Subtyping Assay
QIAGEN 1201 Clopper Road Gaithersburg, MD 20878artus® Inf. A H1N1 2009 LC RT-PCR Kit
Roche Diagnostics GmbH Roche Applied Science Nonnenwald 2 82377 Penzberg / GermanyRoche RealTime ready InfluenzaA/H1N1 Detection Set
TessArae, LLC 46090 Lake Center Plaza, Suite 304 Sterling, VA 20165TessArray Resequencing Influenza A Microarray Detection Panel
United States Army Medical Material Development Activity 1430 Veterans Drive Ft. Detrick, MD 21702-9232CDC Swine Influenza Virus Real-time rRT-PCR Detection Panel on JBAIDS
ViraCor Laboratories 1001 NW Technology Drive Lee's Summit, MO 64086ViraCor 2009 H1N1 Influenza A Real-time RT-PCR Test
 LETTER SENT TO EUA IN VITRO DIAGNOSTIC TEST RECIPIENTS:
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 Re: Termination of Declaration of Emergency Justifying Emergency  Use Authorization (EUA) of Certain In Vitro Diagnostic Tests
 Dear [Recipient]:
 This letter is to provide advance notice of the termination of the above-referenced declaration of emergency that was issued by the then Acting Secretary of the Department of Health and Human Services Charles E. Johnson on April 26, 2009, pursuant to section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 360bbb-3, justifying the EUAs for in vitro diagnostics for detection of 2009 H1N1 influenza virus. The declaration will terminate when the Public Health Emergency determination for 2009 H1N1 influenza expires on June 23, 2010. Therefore, after June 23, 2010, the in vitro diagnostic tests that were authorized by FDA for use by clinical laboratories to detect the 2009 H1N1 virus will no longer be authorized by FDA.
 FDA recognizes that there remain a significant number of clinical laboratories that have purchased and are using authorized tests for detection of 2009 H1N1 virus and that these devices will remain in laboratory inventories, within their expiration dates, after the June 23, 2010 EUA termination date. After June 23, 2010, FDA intends to exercise enforcement discretion regarding such devices if they are already within clinical laboratory inventories on or before that date. FDA encourages manufacturers of the authorized 2009 H1N1 virus detection devices to work with FDA to submit the additional information that may be necessary to obtain FDA clearance or approval for their device. FDA is fully prepared and welcomes the opportunity to work with the manufacturer of each of the authorized in vitro diagnostic devices for detection of 2009 H1N1 virus to help facilitate the rapid efficient review of such tests.
 Advance notice of termination will be published in the Federal Register, pursuant to section 564(b)(4) of the Act.
                    Sincerely,
                    Margaret A. Hamburg, M.D.                     Commissioner of Food and Drugs
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Dated: June 22, 2010.

David Dorsey,

Acting Deputy Commissioner for Policy, Planning and Budget.

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[FR Doc. 2010-15448 Filed 6-22-10; 4:15 pm]

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