Advertisement
News
Advertisement

Federal Register: Termination of Declarations Justifying Emergency Use Authorizations of Certain In Vitro Diagnostic Devices, Antiviral Drugs, and Personal Respiratory Protect...

Fri, 06/25/2010 - 7:34am
U.S. Food & Drug Administration

[Federal Register: June 25, 2010 (Volume 75, Number 122)]

[Notices]

[Page 36432-36435]

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:

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

SOURCE

Advertisement

Share this Story

X
You may login with either your assigned username or your e-mail address.
The password field is case sensitive.
Loading