Authorizations of Emergency Use of Certain Antiviral Drugs-Zanamivir and Oseltamivir Phosphate; Availability, 38648-38654 [E9-18568]
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1 The specific products covered are listed below, in Section II (scope of authorization). For purposes of this document, we will refer
to the devices covered by this authorization as ‘‘certain N95 respirators.’’ Only respirators that have passed specific testing by NIOSH
may be labeled as NIOSH-certified. Each NIOSH-certified respirator (also called a filtering facepiece) bears a rating which refers to
its certified level of filtration efficiency: for example, N95 signifies that the respirator filters at least 95% of airborne particles (and is
not resistant to oil). 42 CFR 84.170. For more information on disposable NIOSH-certified respirators, see https://www.cdc.gov/niosh/
npptl/topics/respirators/disp_part/.
2 FDA has cleared four models of disposable N95 respirators for use by the general public in public health medical emergencies,
such as influenza pandemic: 3M Respirators 8612F and 8670F, and Pasture Pharma Respirators F550G and A520G. See 21 CFR
880.6260 (product code NZJ) and https://www.fda.gov/cdrh/ode/guidance/1626.pdf. These four models of N95 respirators are already
FDA-cleared for a use contemplated by this letter of authorization.
3 For purposes of this letter of authorization, the term ‘‘general public’’ is broad and includes people performing work-related duties.
This authorization affects only requirements applicable under the Federal Food, Drug, and Cosmetic Act. If respirators are used for
people performing work-related duties, employers must comply with the Occupational Safety and Health Administration (OSHA) Respiratory Protection Standard, 29 CFR 1910.134, found at www.OSHA.gov.
4 FDA is authorizing the emergency use of certain N95 respirators as described in the scope section of this letter (Section II).
5 As described in footnote 2, FDA has cleared four models of N95 respirators for use by the general public in public health medical
emergencies, such as influenza pandemic. A shortage of FDA-cleared respirators is nonetheless expected for the following reasons:
not all of the four cleared models have been marketed extensively to date, and in fact two such models were only recently cleared by
FDA; the respirators are disposable, and so one user is expected to use multiple respirators over a span of time; and, to ensure
proper fit, each user may need to try on various sizes and models of respirators before selecting one for use. There are also some
models of N95 respirators that are cleared by FDA for use in certain workplace settings. However, under the circumstances of this
emergency, shortage of supplies of these models is expected.
6 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
7 This Summary Fact Sheet contains, among other information, known and potential risks of use, including risks to children as a result of breathing difficulties and improper fit.
8 In a work setting, OSHA requirements also apply (see note 3 of this letter).
Dated: June 30, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–18570 Filed 8–3–09; 8:45 am]
BILLING CODE 4160–01–S
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.
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ACTION:
Notice.
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
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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.
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.
ADDRESSES:
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:
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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
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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), FDA1 concludes: (1) That
an agent specified in a declaration of
emergency can cause a serious or lifethreatening 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 lifethreatening 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.
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 https://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
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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. § 360bbb-3).
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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On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. § 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. § 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.
§ 360bbb-3(a)).
Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. § 360bbb-3(b)) are
met, I am authorizing the emergency use of certain zanamivir products1 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 providers4 and recipients:
• Fact Sheet for Health Care Provider
• Fact Sheet for Recipients
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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.
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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.
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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.
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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. § 360bbb-3).
On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. § 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. § 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. § 360bbb-3(a))
Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. § 360bbb-3(b)) are
met, I am authorizing the emergency use of certain oseltamivir phosphate products1 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
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• 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).
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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 providers4 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.
mstockstill on DSKH9S0YB1PROD with NOTICES
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)
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Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices
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.
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families; Office of Refugee
Resettlement
AGENCY: Office of Refugee Resettlement,
ACF, HHS.
ACTION: Notice to Award Five Program
Expansion Supplements to Wilson-Fish
Projects.
CFDA Number: 93.583.
Legislative Authority: The Refugee Act
of 1980 as amended, Wilson-Fish
Amendment, 8 U.S.C. 1522(e)(7);
section 412(e)(7)(A) of the Immigration
and Nationality Act.
Amount of Award: $1,744,533.
Period Of Support: 09/30/2009–09/
29/2010.
SUMMARY: The Office of Refugee
Resettlement (ORR) announces the
award of program expansion
supplements to five Wilson-Fish
Program grantees. The Wilson-Fish
Program is an alternative to traditional
State-administered refugee assistance
programs and provides integrated
assistance and services to refugees,
asylees, Amerasian Immigrants, Cuban
and Haitian Entrants, Trafficking
Victims and Iraqi/Afghani Special
Immigrant Visas (SIVs). The five
supplemental awards will allow the
grantees to provide cash and medical
assistance to arriving refugees and to
others who are also eligible for refugee
benefits through the remainder of Fiscal
Year (FY) 2009. The expansion
supplement awards will enable the
grantees to provide services needed to a
higher number of arrivals than
originally planned. The Refugee Act of
1980 mandates that the ORR reimburse
State agencies and Wilson-Fish projects
for the costs of cash and medical
assistance for newly arriving refugees.
Since 1991, ORR has reimbursed State
agencies and Wilson-Fish agencies for
providing cash and medical assistance
to eligible individuals during their first
eight months in the United States. The
following Wilson-Fish Program grantees
are awarded program expansion
supplemental funding:
mstockstill on DSKH9S0YB1PROD with NOTICES
Grantee organization
Location
Catholic Social Services .........................................................................................
Colorado Department of Human Services ..............................................................
Catholic Charities of Louisville ................................................................................
Catholic Charities Diocese of Baton Rouge ...........................................................
Massachusetts Office of Refugees and ..................................................................
Immigrants ..............................................................................................................
Anchorage, AK .......................................
Denver, CO ............................................
Louisville, KY .........................................
Baton Rouge, LA ...................................
Boston, MA ............................................
FOR FURTHER INFORMATION CONTACT:
Carl
Rubenstein, Wilson-Fish Program
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Resettlement, Aerospace Building, 8th
PO 00000
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Amount of award
$86,931
798,411
575,000
94,368
189,823
Floor West, 901 D Street SW.,
Washington, DC 20447. Telephone:
E:\FR\FM\04AUN1.SGM
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Agencies
[Federal Register Volume 74, Number 148 (Tuesday, August 4, 2009)]
[Notices]
[Pages 38648-38654]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18568]
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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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\1\ The Secretary has delegated his authority to issue an EUA
under section 564 of the act to the Commissioner of Food and Drugs.
---------------------------------------------------------------------------
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 https://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)
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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