38648 Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 

1The 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 http://www.cdc.gov/niosh/ 

npptl/topics/respirators/disp_part/. 2FDA 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 http://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. 3For 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. 4FDA is authorizing the emergency use of certain N95 respirators as described in the scope section of this letter (Section II). 

5As 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. 

7This 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. 

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 

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Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 38649 

1The Secretary has delegated his authority to 

issue an EUA under section 564 of the act to the 

Commissioner of Food and Drugs. 

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 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. § 360bbb-3). 

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38650 Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 

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 

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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Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 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 

1FDA 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. 

3Zanamivir 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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38652 Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 

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 

• 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. 

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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38654 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 

1FDA 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. 

3The 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. 5Please 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: 

Grantee organization Location Amount of award 

Catholic Social Services ......................................................................................... Anchorage, AK ....................................... $86,931 

Colorado Department of Human Services .............................................................. Denver, CO ............................................ 798,411 

Catholic Charities of Louisville ................................................................................ Louisville, KY ......................................... 575,000 

Catholic Charities Diocese of Baton Rouge ........................................................... Baton Rouge, LA ................................... 94,368 

Massachusetts Office of Refugees and ..................................................................

Immigrants ..............................................................................................................

Boston, MA ............................................ 189,823 

FOR FURTHER INFORMATION CONTACT: Carl 

Rubenstein, Wilson-Fish Program 

Manager, Office of Refugee 

Resettlement, Aerospace Building, 8th 

Floor West, 901 D Street SW., 

Washington, DC 20447. Telephone: 

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