From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr25jn10-84]
———————————————————————–
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2009-N-0276, FDA-2009-N-0277, FDA-2009-N-0278, and
FDA-2009-N-0521]
Termination of Declarations Justifying Emergency Use
Authorizations of Certain In Vitro Diagnostic Devices, Antiviral Drugs,
and Personal Respiratory Protection Devices
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.
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.
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:
For certain personal respiratory protection devices: 74 FR
38644, August 4, 2009;
For certain antiviral drug products: 74 FR 38648, August
4, 2009; 75 FR 20430, April 19, 2010; 74 FR 56640, November 2, 2009;
and 75 FR 20437, April 19, 2010; and
For certain in vitro diagnostic devices: 74 FR 38636,
August 4, 2009; 75 FR 20441, April 19, 2010; and 75 FR 35045, June 21,
2010.
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:
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. Sec. 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. Sec. 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. Sec. 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. Sec. 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. Sec. 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 Address In Vitro Diagnostic Device
————————————————————————————————————————————————————————————————
Centers for Disease Control and Prevention Swine Influenza Virus Real-time RT-PCR Detection Panel
1600 Clifton Rd., MS D-14
Atlanta, GA 30333
————————————————————————————————————————————————————————————————
Centers for Disease Control and Prevention CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel for Respiratory Specimens (NPS,
1600 Clifton Rd., MS D-14 NS, TS, NPS/TS, NA2) and Viral Culture
Atlanta, GA 30333
————————————————————————————————————————————————————————————————
Cepheid Cepheid Xpert Flu A Panel
904 Caribbean Drive
Sunnyvale, CA 94089
————————————————————————————————————————————————————————————————
Diagnostic Hybrids, Inc. Diagnostic Hybrids, Inc. D3 Ultra 2009 H1N1 Influenza A Virus ID Kit
1055 East State St., Suite 100
Athens, OH 45701
————————————————————————————————————————————————————————————————
DIATHERIX Laboratories, Inc. Diatherix H1N1-09 Influenza Test
601 Genome Way, Suite 4208
Huntsville, AL 35806
————————————————————————————————————————————————————————————————
DxNA, LLC GeneSTAT 2009 A/H1N1 Influenza Test
3879 S. River Road, Bldg. A
St. George, UT 84790
————————————————————————————————————————————————————————————————
Epoch BioSciences ELITech Molecular Diagnostics 2009-H1N1 Influenza A Virus Real RT-PCR test
21720 23rd Drive S.E., Suite 150
Bothell, WA 98021
————————————————————————————————————————————————————————————————
Focus Diagnostics, Inc. Focus Diagnostics Influenza A H1N1 (2009) Real-Time RT-PCR IVD device
11331 Valley View Street
Cypress, CA 90630
————————————————————————————————————————————————————————————————
Focus Diagnostics, Inc. Focus Diagnostics Simplexa Influenza A H1N1 (2009)device
11331 Valley View Street
Cypress, CA 90630
————————————————————————————————————————————————————————————————
IntelligentMDx IMDx 2009 Influenza A H1N1 Real-Time RT-PCR Assay
19 Blackstone Street
Cambridge, MA 02139
————————————————————————————————————————————————————————————————
IQuum, Inc. Liat Influenza A/2009 H1N1 Assay
700 Nickerson Road
Marlborough, MA 01752
————————————————————————————————————————————————————————————————
Longhorn Vaccines and Diagnostics Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay
3 Bethesda Metro Center, Suite 375
Bethesda, MD 20814
————————————————————————————————————————————————————————————————
Prodesse Products Prodesse ProFlu-ST Influenza A Subtyping Assay
Gen-Probe
W229 N1870 Westwood Drive
Waukesha, WI 53186
————————————————————————————————————————————————————————————————
QIAGEN artus[reg] Inf. A H1N1 2009 LC RT-PCR Kit
1201 Clopper Road
Gaithersburg, MD 20878
————————————————————————————————————————————————————————————————
Roche Diagnostics GmbH Roche RealTime ready InfluenzaA/H1N1 Detection Set
Roche Applied Science
Nonnenwald 2
82377 Penzberg / Germany
————————————————————————————————————————————————————————————————
TessArae, LLC TessArray Resequencing Influenza A Microarray Detection Panel
46090 Lake Center Plaza, Suite 304
Sterling, VA 20165
————————————————————————————————————————————————————————————————
United States Army Medical Material Development Activity CDC Swine Influenza Virus Real-time rRT-PCR Detection Panel on JBAIDS
1430 Veterans Drive
Ft. Detrick, MD 21702-9232
————————————————————————————————————————————————————————————————
ViraCor Laboratories ViraCor 2009 H1N1 Influenza A Real-time RT-PCR Test
1001 NW Technology Drive
Lee’s Summit, MO 64086
————————————————————————————————————————————————————————————————
LETTER SENT TO EUA IN VITRO DIAGNOSTIC TEST RECIPIENTS:
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. Sec. 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
Dated: June 22, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-15448 Filed 6-22-10; 4:15 pm]BILLING CODE 4160-01-S
