
[Federal Register: August 4, 2009 (Volume 74, Number 148)]
[Notices]               
[Page 38648-38654]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04au09-57]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0276]

 
Authorizations of Emergency Use of Certain Antiviral Drugs--
Zanamivir and Oseltamivir Phosphate; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of two Emergency Use Authorizations (EUAs) (the 
Authorizations) for certain products from the neuraminidase class of 
antivirals--Zanamivir and oseltamivir phosphate. FDA is issuing the 
Authorizations under the Federal Food, Drug, and Cosmetic Act (the 
act), as requested by the Centers for Disease Control and Prevention 
(CDC). The Authorizations contain, among other things, conditions on 
the emergency use of the authorized zanamivir and oseltamivir phosphate 
products. The Authorizations follow the determination by the Acting 
Secretary of the Department of Health and Human Services, Charles E. 
Johnson (the Acting Secretary), that a public health emergency exists 
involving Swine Influenza A (now known as 2009 H1N1 Influenza A or 2009 
H1N1 flu) that affects, or has the significant potential to affect, 
national security. On the basis of such determination, the Acting 
Secretary declared an emergency justifying the authorization of the 
emergency use of certain products from the neuraminidase class of 
antivirals--Zanamivir and oseltamivir phosphate, accompanied by 
emergency use information subject to the terms of any authorization 
issued under the act. The Authorizations, which include an explanation 
of the reasons for issuance, are reprinted in this document. Elsewhere 
in this issue of the Federal Register, FDA is announcing the issuance 
of EUAs for certain in vitro diagnostic devices and the issuance of an 
EUA for certain personal respiratory protection devices.

DATES: The Authorizations are effective as of April 27, 2009.

ADDRESSES: Submit written requests for single copies of the EUAs to the 
Office of Counterterrorism and Emerging Threats (HF-29), Food and Drug 
Administration, 5600 Fishers Lane, rm. 14C-26, Rockville, MD 20857. 
Send one self-addressed adhesive label to assist that office in 
processing your request or include a fax number to which the 
Authorization(s) may be sent. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the Authorizations.

FOR FURTHER INFORMATION CONTACT: Boris Lushniak, Office of 
Counterterrorism and Emerging Threats (HF-29), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4067.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the act (21 U.S.C. 360bbb-3), as amended by the 
Project BioShield Act of 2004 (Public Law 108-276), allows FDA to 
strengthen the public health protections against biological, chemical, 
nuclear, and radiological agents. Among other things, section 564 of 
the act allows FDA to authorize the use of an unapproved medical 
product or an unapproved use of an approved medical product during a 
public health emergency that affects, or has a significant potential to 
affect, national security, and that involves biological, chemical, 
radiological, or nuclear agent or agents, or a specified disease or 
condition that may be attributable to such agent or agents. With this 
EUA authority, FDA can help assure that medical countermeasures may be 
used in an emergency to diagnose, treat, or prevent serious or life-
threatening diseases or conditions caused by such agents, when there 
are no adequate, approved, and available alternatives.
    Section 564(b)(1) of the act provides that, before an EUA may be 
issued, the Secretary must declare an emergency justifying the 
authorization based on one of the following grounds: ``(A) a 
determination by the Secretary of Homeland Security that there is a 
domestic emergency, or a significant potential for a domestic 
emergency, involving a heightened risk of attack with a specified 
biological, chemical, radiological, or nuclear agent or agents; (B) a 
determination by the Secretary of Defense that there is a military 
emergency, or a significant potential for a military emergency, 
involving a heightened risk to United States military

[[Page 38649]]

forces of attack with a specified biological, chemical, radiological, 
or nuclear agent or agents; or (C) a determination by the Secretary of 
a public health emergency under section 319 of the Public Health 
Service Act that affects, or has a significant potential to affect, 
national security, and that involves a specified biological, chemical, 
radiological, or nuclear agent or agents, or a specified disease or 
condition that may be attributable to such agent or agents.''
    Once the Secretary has declared an emergency justifying an 
authorization under section 564 of the act, FDA may authorize the 
emergency use of a drug, device, or biological product if the agency 
concludes that the statutory criteria are satisfied. Under section 
564(h)(1) of the act, FDA is required to publish, in the Federal 
Register, a notice of each authorization, and each termination or 
revocation of an authorization, and an explanation of the reasons for 
the action. Section 564 of the act permits FDA to authorize the 
introduction into interstate commerce of a drug, device, or biological 
product intended for use in a declared emergency. Products appropriate 
for emergency use may include products and uses that are not approved, 
cleared, or licensed under sections 505, 510(k), and 515 of the act (21 
U.S.C. 355, 360(k), and 360e) or section 351 of the Public Health 
Service Act (PHS Act) (42 U.S.C. 262). FDA may issue an EUA only if, 
after consultation with the National Institutes of Health and CDC (to 
the extent feasible and appropriate given the circumstances of the 
emergency), FDA\1\ concludes: (1) That an agent specified in a 
declaration of emergency can cause a serious or life-threatening 
disease or condition; (2) that, based on the totality of scientific 
evidence available to FDA, including data from adequate and well-
controlled clinical trials, if available, it is reasonable to believe 
that: (A) the product may be effective in diagnosing, treating, or 
preventing--(1) such disease or condition; or (2) a serious or life-
threatening disease or condition caused by a product authorized under 
Section 564, approved or cleared under this Act, or licensed under 
Section 351 of the PHS Act, for diagnosing, treating, or preventing 
such a disease or condition caused by such an agent; and (B) the known 
and potential benefits of the product, when used to diagnose, prevent, 
or treat such disease or condition, outweigh the known and potential 
risks of the product; (3) that there is no adequate, approved, and 
available alternative to the product for diagnosing, preventing, or 
treating such disease or condition; and (4) that such other criteria as 
the Secretary may by regulation prescribe are satisfied.
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    \1\ The Secretary has delegated his authority to issue an EUA 
under section 564 of the act to the Commissioner of Food and Drugs.
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    No other criteria of issuance have been prescribed by regulation 
under section 564(c)(4) of the act. Because the statute is self-
executing, FDA does not require regulations or guidance to implement 
the EUA authority. However, in the Federal Register of July 26, 2007 
(72 FR 41083), FDA announced the availability of a guidance entitled 
``Emergency Use Authorization of Medical Products.'' The guidance 
provides more information for stakeholders and the public about the EUA 
authority and the agency's process for the consideration of EUA 
requests.

II. EUA Request for Certain Products From the Neuraminidase Class of 
Antivirals, Zanamivir and Oseltamivir Phosphate

    On April 26, 2009, under section 564(b)(1)(C) of the act, the 
Acting Secretary determined that a public health emergency exists, 
involving Swine Influenza A (now known as 2009 H1N1 Influenza A or 2009 
H1N1 flu) that affects, or has the significant potential to affect, 
national security. On April 26, 2009, under section 564(b) of the act, 
and on the basis of such determination, the Acting Secretary declared 
an emergency justifying the authorization of the emergency use of 
certain products from the neuraminidase class of antivirals--Zanamivir 
and oseltamivir phosphate, accompanied by emergency use information 
subject to the terms of any authorization issued under 21 U.S.C. 
360bbb-3(a). Notice of the determination and the declaration of the 
Acting Secretary is published elsewhere in this issue of the Federal 
Register. On April 26, 2009, CDC requested and, on April 27, 2009, FDA 
issued EUAs for zanamivir inhalation powder and certain oseltamivir 
phosphate capsules and oral suspension for the treatment and 
prophylaxis of influenza, accompanied by emergency use instructions, 
which are authorized under the EUAs. On April 27, 2009, FDA also 
amended the EUAs for zanamivir and oseltamivir phosphate, including the 
emergency use instructions authorized under the EUAs.

III. Electronic Access

    An electronic version of this document and the full text of the 
Authorizations are available on the Internet at http://
www.regulations.gov.

IV. The Authorizations

    Having concluded that the criteria for issuance of the 
Authorizations under section 564(c) of the act are met, FDA has 
authorized the emergency use of certain zanamivir inhalation powder and 
certain oseltamivir phosphate capsules and oral suspension for the 
treatment and prophylaxis of influenza, accompanied by emergency use 
information, subject to the terms and conditions of the authorizations.
    The Authorization (as amended) for certain zanamivir inhalation 
powder follows and provides an explanation of the reasons for its 
issuance, as required by section 564(h)(1) of the act:

 Richard E. Besser, MD
 Acting Director
 Centers for Disease Control and Prevention
 1600 Clifton Rd, MS D-14
 Atlanta, GA 30333

 Dear Dr. Besser:

 This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for the emergency use of zanamivir inhalation powder for
 treatment and prophylaxis of influenza, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. Sec.   360bbb-3).


[[Page 38650]]


 On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. Sec.   360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (DHHS) determined that a
 public health emergency exists involving Swine Influenza A that affects or has significant potential to affect national security. Pursuant to section 564(b) of the Act (21 U.S.C. Sec.
 360bbb-3(b)), and on the basis of such determination, the Secretary of DHHS then declared an emergency justifying the authorization of the emergency use of certain zanamivir products subject
 to the terms of any authorization issued under section 564(a) of the Act (21 U.S.C. Sec.   360bbb-3(a)).

 Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. Sec.   360bbb-3(b)) are met, I am authorizing the emergency use of certain
 zanamivir products\1\ for the treatment and prophylaxis of influenza, subject to the terms of this authorization.

 I. Criteria for Issuance of Authorization

 I have concluded that the emergency use of certain zanamivir products for the treatment and prophylaxis of influenza meets the criteria for issuance of an authorization under section 564(c)
 of the Act, because I have concluded that:

    (1) Swine Influenza A can cause influenza, a serious or life-threatening disease or condition;

    (2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that certain zanamivir products may be effective for the treatment and prophylaxis of
     influenza, and that the known and potential benefits of certain zanamivir products, when used for the treatment and prophylaxis of influenza, outweigh the known and potential risks of
     such products; and

    (3) there is no adequate, approved, and available alternative to the emergency use of certain zanamivir products for the treatment and prophylaxis of influenza.\2\

 Therefore, I have concluded that the emergency use of certain zanamivir products for the treatment and prophylaxis of influenza meets the above statutory criteria for issuance of an
 authorization.

 II. Scope of Authorization

 I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of authorized zanamivir products for the treatment and prophylaxis of
 influenza for individuals exposed to Swine Influenza A. The emergency use of authorized zanamivir products under this EUA must be consistent with, and may not exceed, the terms of this
 letter, including the scope and the conditions of authorization set forth below.

 The authorized zanamivir products are as follows:

     Relenza (zanamivir) Inhalation Powder

 Zanamivir products are approved and indicated for the treatment of uncomplicated acute illness due to influenza A and B virus in adults and pediatric patients 7 years of age and older who
 have been symptomatic for no more than 2 days. Zanamivir products are also approved and indicated for prophylaxis of influenza in adults and pediatric patients 5 years of age and older.\3\

 1. The above zanamivir products are authorized for use at later time points (i.e., patients who are symptomatic for more than 2 days) and/or in patients sick enough to require hospitalization
 (i.e., patients who do not have ``uncomplicated acute illness'' per se).

 2. The above zanamivir products labeled consistent with the manufacturer's label are authorized to be distributed under this EUA. Such products are authorized to be distributed or dispensed
 without the requisite prescription label information under section 503(b)(2) of the Act (e.g., name and address of dispenser, serial number, date of prescription or of its filling, name of
 prescriber, name of patient, if stated on prescription, directions for use and cautionary statements, if contained in the prescription).

 3. The above zanamivir products are authorized to be accompanied by the following written information pertaining to the emergency use, which are authorized to be made available to health care
 providers\4\ and recipients:

         Fact Sheet for Health Care Provider
         Fact Sheet for Recipients

 CDC and the appropriate state and/or local public health authority(ies) are also authorized to make available additional information relating to the emergency use of authorized zanamivir
 products that is consistent with, and does not exceed, the terms of this letter of authorization. (See section IV).

 I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of authorized zanamivir products, when used for the
 treatment and prophylaxis of influenza, outweigh the known and potential risks of such products.

 I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized zanamivir
 products may be effective for the treatment and prophylaxis of influenza pursuant to section 564(c)(2)(A) of the Act. FDA has reviewed the scientific information available, including the
 information supporting the conclusions described in Section I above, and concludes that the authorized zanamivir products, when used for the treatment and prophylaxis of influenza in the
 specified population, meet the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.


[[Page 38651]]


 Subject to the terms of this EUA and under the circumstances set forth in the Secretary of DHHS's determination under section 564(b)(1)(C) described above and the Secretary of DHHS's
 corresponding declaration under section 564(b)(1), the zanamivir products described above are authorized for the treatment and prophylaxis of influenza for individuals exposed to Swine
 Influenza A.

 This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.

 III. Current Good Manufacturing Practice

 I am waiving current good manufacturing practice requirements with respect to the holding of authorized zanamivir products by CDC and other public health authority(ies) for a period of ninety
 days.

 IV. Conditions of Authorization

 Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:

 CDC

  A. CDC will verify that authorized zanamivir products distributed to the Receive, Stage, Storage (RSS) sites are within their labeled expiration dates.

  B. CDC will ensure that the appropriate state and/or local public health authority(ies) are informed of this EUA, including the terms and conditions herein.

  C. CDC will make available to the appropriate state and/or local public health authority(ies) through appropriate means the authorized Fact Sheet for Health Care Providers, authorized Fact
   Sheet for Recipients, and at least one representative FDA-approved package insert that covers the dosage forms and strengths of authorized zanamivir products.

  D. Only CDC may request changes to the authorized Fact Sheet for Health Care Providers and authorized Fact Sheet for Recipients. Such requests will be made by contacting FDA concerning FDA
   review and approval.

 State and/or Local Public Health Authority(ies)

  E. The appropriate state and/or local public health authority(ies) will ensure that authorized zanamivir products are distributed to recipients in accordance with applicable state and local
   laws and/or in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the covered
   countermeasures, and their officials, agents, employees, contractors, or volunteers following a declaration of an emergency.

  F. The appropriate state and/or local public health authority(ies) will make available through appropriate means authorized Fact Sheets for Health Care Providers, authorized Fact Sheets for
   Recipients, and at least one representative FDA-approved package insert that covers the dosage forms and strengths of authorized zanamivir products.

 CDC and State and/or Local Public Health Authority(ies)

  G. CDC and the appropriate state and/or local public health authority(ies) are also authorized to make available additional information relating to the emergency use of authorized zanamivir
   products that is consistent with, and does not exceed, the terms of this letter of authorization.

 The emergency use of authorized zanamivir products as described in this letter of authorization must comply with the conditions above and all other terms of this authorization.

 V. Duration of Authorization

 This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act.

                   Joshua M. Sharfstein, M.D.
                   Principal Deputy Commissioner
                   Acting Commissioner of Food and Drugs


 \1\ FDA is authorizing the emergency use of Relenza (zanamivir) inhalation powder for treatment and prophylaxis of influenza as described in the scope section of this letter (Section II). For
  ease of reference, this letter of authorization will use the terms ``certain zanamivir product(s)'' and ``authorized zanamivir product(s).''
\2\ No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
\3\ Zanamivir products are not recommended for treatment or prophylaxis of influenza in individuals with underlying airways disease (such as asthma or chronic obstructive pulmonary disease)
  due to risk of serious bronchospasm. Zanamivir products have not been proven effective for treatment of influenza in individuals with underlying airways disease. Zanamivir products have not
  been proven effective for prophylaxis of influenza in the nursing home setting. Zanamivir products are not a substitute for early vaccination on an annual basis as recommended by the Centers
  for Disease Control and Prevention Advisory Committee on Immunization Practices. Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness.
  Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug
  susceptibility patterns and treatment effects when deciding whether to use zanamivir products. There is no evidence for efficacy of zanamivir in any illness caused by agents other than
  Influenza A and B. Patients should be advised that the use of zanamivir products for treatment of influenza has not been shown to reduce the risk of transmission of influenza to others.

[[Page 38652]]


\4\ It is possible that public health officials or other volunteers might distribute authorized zanamivir products to recipients, if permitted, in accordance with applicable state and local
  law and/or in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the covered
  countermeasures, and their officials, agents, employees, contractors, or volunteers following a declaration of an emergency. For ease of reference, this letter will use the term ``health
  care provider(s)'' to refer collectively to these individuals.

    (Please note that certain written emergency use information was 
also amended).
    The Authorization (as amended) for certain oseltamivir phosphate 
capsules and oral suspension follows and provides an explanation of the 
reasons for its issuance, as required by section 564(h)(1) of the act:

 Richard E. Besser, MD
 Acting Director
 Centers for Disease Control and Prevention
 1600 Clifton Rd, MS D-14
 Atlanta, GA 30333

 Dear Dr. Besser:

 This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for the emergency use of certain oseltamivir phosphate
 capsules and oral suspension for treatment and prophylaxis of influenza, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. Sec.   360bbb-3).

 On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. Sec.   360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (DHHS) determined that a
 public health emergency exists involving Swine Influenza A that affects or has significant potential to affect national security. Pursuant to section 564(b) of the Act (21 U.S.C. Sec.
 360bbb-3(b)), and on the basis of such determination, the Secretary of DHHS then declared an emergency justifying the authorization of the emergency use of certain oseltamivir phosphate
 products subject to the terms of any authorization issued under section 564(a) of the Act (21 U.S.C. Sec.   360bbb-3(a))

 Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. Sec.   360bbb-3(b)) are met, I am authorizing the emergency use of certain
 oseltamivir phosphate products\1\ for the treatment and prophylaxis of influenza, subject to the terms of this authorization.

 I. Criteria for Issuance of Authorization

 I have concluded that the emergency use of certain oseltamivir phosphate products for the treatment and prophylaxis of influenza meets the criteria for issuance of an authorization under
 section 564(c) of the Act, because I have concluded that:

    (1) Swine Influenza A can cause influenza, a serious or life-threatening disease or condition;

    (2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that certain oseltamivir phosphate products may be effective for the treatment and
     prophylaxis of influenza, and that the known and potential benefits of certain oseltamivir phosphate products, when used for the treatment and prophylaxis of influenza, outweigh the known
     and potential risks of such products; and

    (3) there is no adequate, approved, and available alternative to the emergency use of certain oseltamivir phosphate products for the treatment and prophylaxis of influenza.\2\

 Therefore, I have concluded that the emergency use of certain oseltamivir phosphate products for the treatment and prophylaxis of influenza meets the above statutory criteria for issuance of
 an authorization.

 II. Scope of Authorization

 I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of authorized oseltamivir phosphate products for the treatment and
 prophylaxis of influenza for individuals exposed to Swine Influenza A. The emergency use of authorized oseltamivir phosphate products under this EUA must be consistent with, and may not
 exceed, the terms of this letter, including the scope and the conditions of authorization set forth below.

 The authorized oseltamivir phosphate products are as follows:

     Tamiflu (oseltamivir phosphate) (30 mg, 45 mg, and 75 mg) capsules

     Tamiflu (oseltamivir phosphate) oral suspension

 Oseltamivir phosphate products are approved and indicated for the treatment of uncomplicated acute illness due to influenza infections in patients 1 year and older who have been symptomatic
 for no more than 2 days. Oseltamivir phosphate products are also approved and indicated for the prophylaxis of influenza in patients 1 year and older.\3\

 1. The above oseltamivir phosphate products are authorized for use in patients less than 1 year old. Such products are also authorized for use at later time points (i.e., patients who are
 symptomatic for more than 2 days) and/or in patients sick enough to require hospitalization (i.e., patients who do not have ``uncomplicated acute illness'' per se).


[[Page 38653]]


 2. The above oseltamivir phosphate products labeled consistent with the manufacturer's label are authorized to be distributed under this EUA. Such products are authorized to be distributed or
 dispensed without the requisite prescription label information under section 503(b)(2) of the Act (e.g., name and address of dispenser, serial number, date of prescription or of its filling,
 name of prescriber, name of patient, if stated on prescription, directions for use and cautionary statements, if contained in the prescription).

 3. The above oseltamivir phosphate products may include products that are deployed from the Strategic National Stockpile (SNS) and that are authorized to have their expiration date extended
 under the federal government's Shelf Life Extension Program (SLEP).

 4. The above oseltamivir phosphate products are authorized to be accompanied by the following written information pertaining to the emergency use, which are authorized to be made available to
 health care providers\4\ and recipients:

         Fact Sheet for Health Care Provider
         Fact Sheet for Patients and Parents

 CDC and the appropriate state and/or local public health authority(ies) are also authorized to make available additional information relating to the emergency use of authorized oseltamivir
 phosphate products that is consistent with, and does not exceed, the terms of this letter of authorization. (See section IV).

 I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of authorized oseltamivir phosphate products, when used for
 the treatment and prophylaxis of influenza, outweigh the known and potential risks of such products.

 I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized oseltamivir
 phosphate products may be effective for the treatment and prophylaxis of influenza pursuant to section 564(c)(2)(A) of the Act. FDA has reviewed the scientific information available,
 including the information supporting the conclusions described in Section I above, and concludes that the authorized oseltamivir phosphate products, when used for the treatment and
 prophylaxis of influenza in the specified population, meet the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.\5\

 Subject to the terms of this EUA and under the circumstances set forth in the Secretary of DHHS's determination under section 564(b)(1)(C) described above and the Secretary of DHHS's
 corresponding declaration under section 564(b)(1), the oseltamivir phosphate products described above are authorized for the treatment and prophylaxis of influenza for individuals exposed to
 Swine Influenza A.

 This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.

 III. Current Good Manufacturing Practice

 I am waiving current good manufacturing practice requirements with respect to the holding of authorized oseltamivir phosphate products by CDC and other public health authority(ies) for a
 period of ninety days.

 IV. Conditions of Authorization

 Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:

 CDC

  A. CDC will verify that authorized oseltamivir phosphate products distributed to the Receive, Stage, Storage (RSS) sites are within their labeled (or SLEP-relabeled) expiration dates.

  B. CDC will ensure that the appropriate state and/or local public health authority(ies) are informed of this EUA, including the terms and conditions herein.

  C. CDC will make available to the appropriate state and/or local public health authority(ies) through appropriate means the authorized Fact Sheet for Health Care Providers, Fact Sheet for
   Patients and Parents, and at least one representative FDA-approved package insert that covers the dosage forms and strengths of authorized oseltamivir phosphate products.

  D. Only CDC may request changes to the authorized Fact Sheet for Health Care Providers and authorized Fact Sheet for Patients and Parents. Such requests will be made by contacting FDA
   concerning FDA review and approval.

 State and/or Local Public Health Authority(ies)

  E. The appropriate state and/or local public health authority(ies) will ensure that authorized oseltamivir phosphate products are distributed to recipients in accordance with applicable
   state and local laws and/or in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or
   dispense the covered countermeasures, and their officials, agents, employees, contractors, or volunteers following a declaration of an emergency.

  F. The appropriate state and/or local public health authority(ies) will make available through appropriate means authorized Fact Sheet for Health Care Providers, Fact Sheet for Patients and
   Parents, and at least one representative FDA-approved package insert that covers the dosage forms and strengths of authorized oseltamivir phosphate products.

 CDC and State and/or Local Public Health Authority(ies)

[[Page 38654]]



  G. CDC and the appropriate state and/or local public health authority(ies) are also authorized to make available additional information relating to the emergency use of authorized
   oseltamivir phosphate products that is consistent with, and does not exceed, the terms of this letter of authorization.

 The emergency use of authorized oseltamivir phosphate products as described in this letter of authorization must comply with the conditions above and all other terms of this authorization.

 V. Duration of Authorization

 This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act.

                   Joshua M. Sharfstein, M.D.
                   Principal Deputy Commissioner
                   Acting Commissioner of Food and Drugs


 \1\ FDA is authorizing the emergency use of Tamiflu (oseltamivir phosphate) (30 mg, 45 mg, and 75 mg) capsules and oral suspension for treatment and prophylaxis of influenza as described in
  the scope section of this letter (Section II). For ease of reference, this letter of authorization will use the terms ``certain oseltamivir phosphate product(s)'' and ``authorized
  oseltamivir phosphate product(s).''
\2\ No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
\3\ The following points should be considered before initiating treatment or prophylaxis with oseltamivir phosphate products. Oseltamivir phosphate products are not a substitute for early
  vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices. Influenza viruses change over time. Emergence of
  resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should
  consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use oseltamivir phosphate products.
\4\ It is possible that public health officials or other volunteers might distribute authorized oseltamivir phosphate products to recipients, if permitted, in accordance with applicable state
  and local law and/or in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the
  covered countermeasures, and their officials, agents, employees, contractors, or volunteers following a declaration of an emergency. For ease of reference, this letter will use the term
  ``health care provider(s)'' to refer collectively to these individuals.
\5\ Please note that with respect to authorized oseltamivir phosphate products for use in patients less than 1 year old, the conclusions above are based on limited data available for review
  under the limited timeframe given the circumstances of the emergency. The conclusions above may evolve as the emergency circumstances evolve and as more information becomes available.

    (Please note that certain written emergency use information was 
also amended).

    Dated: June 30, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-18568 Filed 8-3-09; 8:45 am]

BILLING CODE 4160-01-S
