Termination of Declarations Justifying Emergency Use Authorizations of Certain In Vitro Diagnostic Devices, Antiviral Drugs, and Personal Respiratory Protection Devices, 36432-36435 [2010-15448]
Download as PDF
<![CDATA[
36432
Federal Register / Vol. 75, No. 122 / Friday, June 25, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Tobacco Products Scientific Advisory
Committee; Amendment of Notice
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSKH9S0YB1PROD with NOTICES
ACTION:
Notice.
The Food and Drug Administration
(FDA) is announcing an amendment to
the notice of meeting of the Tobacco
Products Scientific Advisory
Committee. This meeting was
announced in the Federal Register of
May 19, 2010 (75 FR 28027). The
amendment is being made to reflect a
change in the Agenda and Procedure
portions of the document. The Agenda
portion is changed to cancel Topic 1
regarding dissolvable tobacco products.
This portion of the meeting has been
cancelled. The Procedure portion is
changed to a 1-hour open public hearing
from 10 a.m. to 11 a.m. on July 16, 2010.
There are no other changes.
FOR FURTHER INFORMATION CONTACT:
Cristi Stark, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd,
Rockville, MD 20850, 1–877–287–1373
(choose Option 4), e-mail:
TPSAC@fda.hhs.gov or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington DC area), code 8732110002.
Please call the Information Line for upto-date information on this meeting.
SUPPLEMENTARY INFORMATION: In the
Federal Register of May 19, 2010 (75 FR
28027), FDA announced that a meeting
of the Tobacco Products Scientific
Advisory Committee would be held on
July 15 and 16, 2010. On page 28027, in
the first column, the Agenda portion of
the document is changed to read as
follows:
Agenda: On July 15, 2010, the
committee will: (1) Receive updates on
upcoming committee business related to
menthol, including Agency requests for
information from industry on menthol
cigarettes in order to prepare for the
Tobacco Products Scientific Advisory
Committee’s required report to the
Secretary of Health and Human Services
regarding the impact of use of menthol
in cigarettes on the public health and (2)
hear and discuss industry presentations
on menthol in cigarettes as they relate
to the following five topics:
Characterization of menthol, clinical
effects of menthol, biomarkers of disease
risk, marketing data, and population
effects.
VerDate Mar<15>2010
16:23 Jun 24, 2010
Jkt 220001
On page 28027, in the third column,
the Agenda portion of the document is
changed to read as follows:
Agenda: On July 16, 2010, the
committee will continue discussion on
topic 2.
On page 28028, in the first column,
the Procedure portion of the document
is changed to read as follows:
Procedure: Oral presentations from
the public (excluding the tobacco
industry) will be scheduled between
approximately 10 a.m. and 11 a.m. on
July 16, 2010.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: June 22, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–15554 Filed 6–23–10; 11:15 am]
BILLING CODE 4160–01–S
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.
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
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:
E:\FR\FM\25JNN1.SGM
25JNN1
Federal Register / Vol. 75, No. 122 / Friday, June 25, 2010 / Notices
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:
mstockstill on DSKH9S0YB1PROD with NOTICES
TABLE 1.
EUA Requestor Name and Address
Centers for Disease Control and Prevention
1600 Clifton Rd., MS D–14
Atlanta, GA 30333
VerDate Mar<15>2010
16:23 Jun 24, 2010
Jkt 220001
PO 00000
In Vitro Diagnostic Device
Swine Influenza Virus Real-time RT-PCR Detection Panel
Frm 00088
Fmt 4703
Sfmt 4703
E:\FR\FM\25JNN1.SGM
25JNN1
36434
Federal Register / Vol. 75, No. 122 / Friday, June 25, 2010 / Notices
TABLE 1.—Continued
EUA Requestor Name and Address
In Vitro Diagnostic Device
CDC 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 94089
Cepheid Xpert Flu A Panel
Diagnostic Hybrids, Inc.
1055 East State St., Suite 100
Athens, OH 45701
Diagnostic Hybrids, Inc. D3 Ultra 2009 H1N1 Influenza A Virus ID Kit
DIATHERIX Laboratories, Inc.
601 Genome Way, Suite 4208
Huntsville, AL 35806
Diatherix H1N1-09 Influenza Test
DxNA, LLC
3879 S. River Road, Bldg. A
St. George, UT 84790
GeneSTAT 2009 A/H1N1 Influenza Test
Epoch BioSciences
21720 23rd Drive S.E., Suite 150
Bothell, WA 98021
ELITech Molecular Diagnostics 2009-H1N1 Influenza A Virus Real RT-PCR test
Focus Diagnostics, Inc.
11331 Valley View Street
Cypress, CA 90630
Focus Diagnostics Influenza A H1N1 (2009) Real-Time RT-PCR IVD device
Focus Diagnostics, Inc.
11331 Valley View Street
Cypress, CA 90630
Focus Diagnostics Simplexa Influenza A H1N1 (2009)device
IntelligentMDx
19 Blackstone Street
Cambridge, MA 02139
IMDx 2009 Influenza A H1N1 Real-Time RT-PCR Assay
IQuum, Inc.
700 Nickerson Road
Marlborough, MA 01752
Liat Influenza A/2009 H1N1 Assay
Longhorn Vaccines and Diagnostics
3 Bethesda Metro Center, Suite 375
Bethesda, MD 20814
Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay
Prodesse Products
Gen-Probe
W229 N1870 Westwood Drive
Waukesha, WI 53186
Prodesse ProFlu-ST Influenza A Subtyping Assay
QIAGEN
1201 Clopper Road
Gaithersburg, MD 20878
artus® Inf. A H1N1 2009 LC RT-PCR Kit
Roche Diagnostics GmbH
Roche Applied Science
Nonnenwald 2
82377 Penzberg / Germany
Roche RealTime ready InfluenzaA/H1N1 Detection Set
TessArae, LLC
46090 Lake Center Plaza, Suite 304
Sterling, VA 20165
mstockstill on DSKH9S0YB1PROD with NOTICES
Centers for Disease Control and Prevention
1600 Clifton Rd., MS D–14
Atlanta, GA 30333
TessArray Resequencing Influenza A Microarray Detection Panel
United States Army Medical Material Development Activity
1430 Veterans Drive
Ft. Detrick, MD 21702–9232
CDC Swine Influenza Virus Real-time rRT-PCR Detection Panel on JBAIDS
ViraCor Laboratories
1001 NW Technology Drive
Lee’s Summit, MO 64086
ViraCor 2009 H1N1 Influenza A Real-time RT-PCR Test
LETTER SENT TO EUA IN VITRO DIAGNOSTIC TEST RECIPIENTS:
VerDate Mar<15>2010
16:23 Jun 24, 2010
Jkt 220001
PO 00000
Frm 00089
Fmt 4703
Sfmt 4703
E:\FR\FM\25JNN1.SGM
25JNN1
Federal Register / Vol. 75, No. 122 / Friday, June 25, 2010 / Notices
36435
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
Dated: June 22, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
publishes a Notice, on a weekly basis,
identifying unutilized, underutilized,
excess and surplus Federal buildings
and real property that HUD has
reviewed for suitability for use to assist
the homeless. Today’s Notice is for the
purpose of announcing that no
additional properties have been
determined suitable or unsuitable this
week.
[FR Doc. 2010–15448 Filed 6–22–10; 4:15 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–5375–N–24]
Federal Property Suitable as Facilities
To Assist the Homeless
Dated: June 17, 2010.
Mark R. Johnston,
Deputy Assistant Secretary for Special Needs.
[FR Doc. 2010–15090 Filed 6–24–10; 8:45 am]
Office of the Assistant
Secretary for Community Planning and
Development, HUD.
ACTION: Notice.
BILLING CODE 4210–67–P
SUMMARY: This Notice identifies
unutilized, underutilized, excess, and
surplus Federal property reviewed by
HUD for suitability for possible use to
assist the homeless.
DATES: Effective Date: June 25, 2010.
FOR FURTHER INFORMATION CONTACT:
Kathy Ezzell, Department of Housing
and Urban Development, 451 Seventh
Street, SW., Room 7262, Washington,
DC 20410; telephone (202) 708–1234;
TTY number for the hearing- and
speech-impaired (202) 708–2565 (these
telephone numbers are not toll-free), or
call the toll-free Title V information line
at 800–927–7588.
SUPPLEMENTARY INFORMATION: In
accordance with the December 12, 1988,
court order in National Coalition for the
Homeless v. Veterans Administration,
No. 88–2503–OG (D.D.C.), HUD
Bureau of Land Management
mstockstill on DSKH9S0YB1PROD with NOTICES
AGENCY:
VerDate Mar<15>2010
16:23 Jun 24, 2010
Jkt 220001
DEPARTMENT OF THE INTERIOR
[LLNVW00000 L16100000.DP0000
LXSS015F0000 241A; 10–08807;
MO#4500012011; TAS:14X1109]
Notice of Availability of the Draft
Winnemucca District Resource
Management Plan and Environmental
Impact Statement, Nevada
AGENCY: Bureau of Land Management,
Interior.
ACTION: Notice of Availability.
SUMMARY: In accordance with the
National Environmental Policy Act of
1969, as amended, and the Federal Land
Policy and Management Act of 1976, as
amended, the Bureau of Land
Management (BLM) has prepared a Draft
Resource Management Plan (RMP) and
Draft Environmental Impact Statement
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
(EIS) for the Winnemucca District and
by this notice is announcing the
opening of the comment period.
DATES: To ensure that comments will be
considered, the BLM must receive
written comments on the Draft RMP/
Draft EIS within 90 days following the
date the Environmental Protection
Agency publishes its notice of the Draft
RMP/Draft EIS in the Federal Register.
The BLM will announce future meetings
or hearings and any other public
participation activities at least 15 days
in advance through public notices,
media releases, and/or mailings.
ADDRESSES: You may submit comments
related to the Winnemucca District Draft
RMP/Draft EIS by any of the following
methods:
• Web site: https://www.blm.gov/nv/st/
en/fo/wfo/blm_information/rmp
• E-mail: wdrmp@blm.gov.
• Fax: (775) 623–1503
• Mail: Bureau of Land Management,
Winnemucca District Draft RMP/EIS,
5100 East Winnemucca Boulevard,
Winnemucca, Nevada 89445.
Copies of the Winnemucca District
Draft RMP/Draft EIS are available in the
Winnemucca District Office at the above
address or on the following website:
https://www.blm.gov/nv/st/en/fo/wfo/
blm_information/rmp
FOR FURTHER INFORMATION CONTACT: For
further information contact Bob
Edwards, RMP Team Lead, telephone
(775) 623–1597; address 5100 E.
Winnemucca Boulevard, Winnemucca,
Nevada 89445, e-mail:
Robert_Edwards@nv.blm.gov.
E:\FR\FM\25JNN1.SGM
25JNN1
]]>Agencies
[Federal Register Volume 75, Number 122 (Friday, June 25, 2010)]
[Notices]
[Pages 36432-36435]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15448]
-----------------------------------------------------------------------
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:
[[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. 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
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 36434]]
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:
[[Page 36435]]
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
