[Federal Register: August 3, 2005 (Volume 70, Number 148)]
[Notices]               
[Page 44657-44660]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03au05-160]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0299]

 
Authorization of Emergency Use of Anthrax Vaccine Adsorbed for 
Prevention of Inhalation Anthrax by Individuals at Heightened Risk of 
Exposure Due to Attack With Anthrax; Extension; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
extension of the Emergency Use Authorization (EUA) (the Authorization) 
for Anthrax Vaccine Adsorbed (AVA), issued on January 27, 2005, for 
prevention of inhalation anthrax for individuals between 18 and 65 
years of age who are deemed by the Department of Defense (DoD) to be at 
heightened risk of exposure due to attack with anthrax. The FDA 
Commissioner is extending the term of this Authorization on the request 
of DoD.

DATES: The extension of the Authorization was effective as of July 22, 
2005.

ADDRESSES: Submit written requests for single copies of the extension 
of the Authorization to the Office of Counterterrorism Policy and 
Planning (HF-29), Food and Drug Administration, 5600 Fishers Lane, 
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 may be sent. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the Authorization.

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

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 360bbb-3), as amended by the Project BioShield Act of 2004 
(Public Law 108-276), allows the FDA Commissioner, by delegation from 
the Secretary of Health and Human Services (the Secretary), to 
authorize the use of an unapproved medical product or an unapproved use 
of an approved medical product during a declared emergency involving a 
heightened risk of attack on the public or U.S. military forces. As a 
result of an October 27, 2004, order by the U.S. District Court for the 
District of Columbia, the use of AVA by DoD for the prevention of 
inhalation anthrax is deemed an unapproved use of an approved product 
for purposes of section 564(a)(2) of the act.
    On December 10, 2004, under section 564(b)(1)(B) of the act, the 
Deputy Secretary of Defense determined that there is a significant 
potential for a military emergency involving a heightened risk to U.S. 
military forces of attack with anthrax. On December 22, 2004, DoD 
requested an EUA for AVA for protection against inhalation anthrax. DoD 
asked for a 6-month authorization and indicated that, if necessary, it 
might ask for an extension of the duration of the EUA.
    Under section 564(b) of the act, and on the basis of the Deputy 
Secretary of Defense's determination of a significant potential for a 
military emergency, on January 14, 2005, the Secretary of Health and 
Human Services, Tommy G. Thompson, declared an emergency justifying the 
authorization of the emergency use of AVA. Notice of the determination 
of the Deputy Secretary of Defense and the declaration of the Secretary 
of Health and Human Services

[[Page 44658]]

was published in the Federal Register of February 2, 2005 (70 FR 5450).
    On January 27, 2005, after consulting with the National Institutes 
of Health (NIH) and the Centers for Disease Control and Prevention 
(CDC), and after concluding that the criteria for issuance of an 
authorization under section 564(c) of the act were met, the FDA 
Commissioner authorized the emergency use of AVA for prevention of 
inhalation anthrax for individuals between 18 and 65 years of age who 
are deemed by DoD to be at heightened risk of exposure due to attack 
with anthrax. As requested, the Authorization was effective for 6 
months from the date of issuance on January 27, 2005. Notice of the 
Authorization was published in the Federal Register of February 2, 2005 
(70 FR 5452).

II. Request for Extension

    On July 11, 2005, DoD requested an extension of the Authorization 
and stated that the information presented in its December 22, 2004, 
request for an EUA for AVA is still accurate.

III. Electronic Access

    An electronic version of this notice is available on the Internet 
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm.


IV. Extension of the Authorization

    Having confirmed that the declaration of emergency issued under 
section 564(b)(1) of the act currently remains in effect and having 
concluded that the criteria for issuance of the Authorization under 
section 564(c) of the act continue to be met, the FDA Commissioner, on 
July 22, 2005, granted DoD's request for an extension of the 
Authorization for the emergency use of AVA for prevention of inhalation 
anthrax. This EUA will be effective for the duration of the declaration 
of emergency issued on January 14, 2005.
    The letter granting the extension follows:

William Winkenwerder, Jr., M.D.
Assistant Secretary of Defense for Health Affairs
The Pentagon
Washington, D.C. 20301-1200
Re: Request for Extension of the Emergency Use Authorization for the 
Armed Forces Pending Re-determination on the Licensed Use of Anthrax 
Vaccine Adsorbed for Protection Against Inhalational Anthrax
Dear Dr. Winkenwerder:
    This is in response to your letter of July 11, 2005, requesting 
an extension of the above-referenced Emergency Use Authorization 
(EUA), which was issued on January 27, 2005,\1\ pursuant to section 
564 of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 
Sec.  360bbb-3.\2\ You requested an extension of the EUA ``for such 
time as necessary pending the upcoming FDA re-determination of the 
licensed use of AVA for protection against inhalational anthrax.''
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    \1\Notice of the issuance of the EUA for AVA was published in 
the Federal Register on February 2, 2005 (70 Fed. Reg. 5452).
    \2\The Secretary of Health and Human Services (HHS) has 
delegated the authority to issue an EUA under section 564 of the Act 
to the Commissioner of Food and Drugs.
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    The declaration of emergency\3\ justifying the EUA for AVA 
remains in effect. The Secretary of Health and Human Services, Tommy 
G. Thompson, issued this declaration of emergency on January 14, 
2005.\4\ Pursuant to section 564(b)(2)(A)(ii) of the Act, the 
declaration of emergency will terminate by expiration on January 14, 
2006, which is the end of the one year period that began on the date 
that the declaration was made.\5\
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    \3\Notice of the HHS Secretary's declaration of emergency and of 
the Deputy Secretary of Defense's determination of military 
emergency under section 564(b)(1) of the Act was published in the 
Federal Register on February 2, 2005 (70 Fed. Reg. 5450).
    \4\The declaration of emergency was not issued on January 10, 
2005, as is stated in your letter of July 11, 2005.
    \5\It is possible, under section 564(b)(2) of the Act, that the 
declaration of emergency may terminate or be renewed prior to its 
expiration.
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    Having confirmed that the declaration of emergency, issued under 
section 564(b)(1) of the Act, currently remains in effect and having 
concluded that the criteria for issuance of this authorization under 
section 564(c) of the Act continue to be met, I am granting your 
request to extend the authorization for the emergency use of AVA for 
prevention of inhalation anthrax.\6\ The extension of the EUA is for 
the duration of the existing declaration of emergency,\7\ subject to 
the conditions established herein. These conditions shall be the 
same as those that currently apply to the EUA for AVA, issued on 
January 27, 2005.
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    \6\The terms ``inhalation anthrax'' and ``inhalational anthrax'' 
are used interchangeably.
    \7\The EUA may be revoked, pursuant to section 564(g) of the 
Act, prior to the termination of the declaration of emergency if the 
criteria for issuance of the authorization are no longer met or 
other circumstances make revocation appropriate to protect the 
public health or safety.
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I. Background

    AVA was first licensed by the National Institutes of Health 
(NIH) in November 1970.\8\ Upon the delegation of vaccine regulation 
to FDA in 1972, FDA undertook a comprehensive review of the safety, 
effectiveness, and labeling of all vaccines licensed prior to July 
1, 1972.\9\ Under this review, independent advisory panels evaluated 
the safety and effectiveness data of vaccines to ensure that they 
met appropriate standards. The advisory panel that reviewed AVA 
concluded that it is safe, effective, and not misbranded, and FDA 
issued a proposal to adopt the panel's recommendation (the Bacterial 
Vaccines and Toxoids Efficacy Review).\10\
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    \8\Biological products are licensed under section 351 of the 
Public Health Service Act, 42 U.S.C. Sec.  262.
    \9\See 21 C.F.R. Sec.  601.25.
    \10\Biological Products; Bacterial Vaccines and Toxoids; 
Implementation of Efficacy Review, 50 Fed. Reg. 51002 (Dec. 13, 
1985).
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    In March 2003, six plaintiffs, known as John and Jane Doe 1 
through 6, filed suit in the United States District Court for the 
District of Columbia (the Court) seeking the Court to enjoin the 
Anthrax Vaccine Immunization Program (AVIP) of the Department of 
Defense (DoD) and to declare AVA an investigational drug when used 
for protection against inhalation anthrax. On December 22, 2003, the 
Court issued a preliminary injunction barring inoculations under the 
AVIP in the absence of informed consent or a Presidential waiver of 
the informed consent requirement.
    In the Federal Register of January 5, 2004,\11\ FDA published a 
final rule and final order (January 2004 final rule and final order) 
in response to the report and recommendations of the independent 
advisory panel that reviewed the safety and effectiveness data 
pertaining to AVA. Following FDA's issuance of the final rule and 
final order, the Court lifted the preliminary injunction on January 
7, 2004, except as it applied to the six Doe plaintiffs.
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    \11\Biological Products; Bacterial Vaccines and Toxoids; 
Implementation of Efficacy Review, 69 Fed. Reg. 255 (Jan. 5, 2004).
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    On October 27, 2004, the Court issued a memorandum opinion 
vacating and remanding the January 2004 final rule and final order 
to FDA for reconsideration, following an appropriate notice and 
comment period. The Court also enjoined operation of the AVIP for 
inoculation using AVA to prevent inhalation anthrax. On December 29, 
2004, FDA published a proposed rule and proposed order reopening the 
comment period on the Bacterial Vaccine and Toxoids Efficacy Review 
for 90 days.\12\ As a result of the Court's order of October 27, 
2004, the use of AVA by DoD for the prevention of inhalation anthrax 
under the AVIP is deemed an unapproved use of an approved product 
for purposes of section 564(a)(2) of the Act. But for the Court's 
order, FDA would not consider the use of AVA for inhalation anthrax 
to be an unapproved use.
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    \12\Biological Products; Bacterial Vaccines and Toxoids; 
Implementation of Efficacy Review; Proposed Rule and Proposed Order, 
69 Fed. Reg. 78281 (Dec. 29, 2004).
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    On December 10, 2004, pursuant to section 564(b)(1)(B) of the 
Act, the Deputy Secretary of Defense determined that there is a 
significant potential for a military emergency involving a 
heightened risk to U.S. military forces of attack with anthrax.\13\ 
On December 22, 2005, you requested an EUA to use AVA for protection 
against inhalation anthrax. You requested an authorization for a 
period of six months, pending completion of FDA's Bacterial Vaccine 
and Toxoids Efficacy Review.\14\ You also indicated that, if 
necessary, you might ask for an extension of the duration of the 
EUA.
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    \13\See supra note 3.
    \14\See supra note 12.
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    On January 14, 2005, pursuant to section 564(b) of the Act, and 
on the basis of the Deputy Secretary of Defense's determination

[[Page 44659]]

of a significant potential for a military emergency, the Secretary 
of Health and Human Services, Tommy G. Thompson, declared an 
emergency justifying the authorization of the emergency use of 
AVA.\15\ On January 27, 2005, after consulting with the NIH and the 
Centers for Disease Control and Prevention (CDC), and after 
concluding that the criteria for issuance of an authorization under 
section 564(c) of the Act were met, I authorized the emergency use 
of AVA for prevention of inhalation anthrax, subject to conditions 
of authorization set out in the authorization.\16\
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    \15\See supra note 3.
    \16\See supra note 1.
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II. Criteria for Issuance of Authorization

    The January 14, 2005, declaration of emergency by the Secretary 
of Health and Human Services remains in effect. After consultation 
with NIH and CDC, I have concluded that the use of AVA to prevent 
inhalation anthrax continues to meet the criteria for issuance of an 
authorization under section 564(c) of the Act, because I have 
concluded that:
    (1) anthrax (Bacillus anthracis) can cause a serious or life-
threatening disease or condition;
    (2) based on the totality of scientific evidence available to 
FDA, AVA is effective in preventing inhalation anthrax; therefore, 
it is reasonable to believe that AVA may be effective in preventing 
inhalation anthrax pursuant to section 564(c)(2)(A) of the Act; and 
that the known and potential benefits of AVA, when used to prevent 
inhalation anthrax, outweigh the known and potential risks of the 
product; and
    (3) there is no adequate, approved, and available alternative to 
AVA for preventing inhalation anthrax.\17\
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    \17\No other criteria of issuance have been prescribed by 
regulation under section 564(c)(4) of the Act.
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    Specifically, I have concluded, pursuant to section 564(c)(1) of 
the Act, that anthrax (Bacillus anthracis) can cause inhalation 
anthrax, which is a serious or life-threatening disease or 
condition. FDA incorporates by reference the information concerning 
inhalation anthrax contained in Section II, p. 3, of the 
authorization issued on January 27, 2005. 70 Fed. Reg. 5454 
(February 2, 2005).
    I have concluded that, based on the totality of scientific 
evidence available to FDA,\18\ including data from at least one 
well-controlled field study, AVA is effective in preventing 
inhalation anthrax; therefore, it is reasonable to believe that AVA 
may be effective in preventing inhalation anthrax pursuant to 
section 564(c)(2)(A) of the Act. In addition, pursuant to section 
564(c)(2)(B) of the Act, I have concluded that it is reasonable to 
believe that the known and potential benefits of AVA outweigh the 
known and potential risks of the product. The available scientific 
evidence that supports these conclusions includes data and 
information described in Section II of the authorization issued on 
January 27, 2005,\19\ which is hereby incorporated by reference.
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    \18\ The available scientific evidence includes FDA's review of 
adverse event reports concerning AVA submitted to the Vaccine 
Adverse Event Reporting System
    \19\70 Fed. Reg. 5454 (February 2, 2005).
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    I have concluded, pursuant to section 564(c)(3) of the Act, that 
there is no adequate, approved, and available alternative to AVA for 
preventing inhalation anthrax. No other drugs are approved for the 
prevention (pre-exposure) of anthrax infection. Antibiotics are 
effective against the germinated form of Bacillus anthracis, but are 
not effective against the spore form of the organism. Although 
antibiotics are available to treat anthrax infection, their 
effectiveness is limited, in part due to delays from the time of 
exposure to the initiation of treatment. Delays in the treatment of 
exposed persons are possible, considering the potential scenarios of 
exposure, and the difficulties that exist in identifying anthrax as 
the etiology of illness.

III. Scope of Authorization

    Pursuant to section 564(d)(1) of the Act, this authorization 
continues to be limited to the use of AVA for the prevention of 
inhalation anthrax for individuals between 18 and 65 years of age 
who are deemed by DoD to be at heightened risk of exposure due to 
attack with anthrax.
    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 
AVA, when used to prevent inhalation anthrax, outweigh the known and 
potential risks of the product for the population described above.
    I have concluded, pursuant to section 564(d)(3) of the Act, 
based on the totality of available scientific evidence reviewed by 
FDA,\20\ that AVA is effective in preventing inhalation anthrax, and 
therefore, it is reasonable to believe that AVA may be effective in 
preventing inhalation anthrax pursuant to section 564(c)(2)(A) of 
the Act.
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    \20\The scientific evidence available to the Agency includes 
studies referred to in Section II above.
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    Accordingly, I have concluded that AVA, when used for preventing 
inhalation anthrax, meets the standards set forth in section 564(c) 
of the Act.
    FDA understands that DoD recognizes that the current AVA license 
describes an immunization schedule consisting of six doses. Certain 
details of DoD's December 22, 2004, EUA request are not specifically 
addressed in the package insert, however. DoD notes that for some 
personnel, the vaccination schedule was unavoidably disrupted, and 
DoD intends for such personnel to resume vaccinations at the point 
in the dosing schedule where they left off, for individuals eligible 
under the EUA. While this practice is not addressed in the package 
insert, the practice is consistent with the general recommendations 
of the Advisory Committee on Immunization Practices. When it is 
impracticable to provide a dose on a specific date recommended by 
the schedule, DoD intends to provide the vaccine dose as soon as 
practicable thereafter. Based on the totality of the scientific 
evidence available to FDA, it is reasonable to believe that such 
administration of AVA may be effective in preventing inhalation 
anthrax. Furthermore, the known and potential benefits of AVA, when 
used to prevent inhalation anthrax in the manner described above, 
outweigh the known and potential risks of the product. DoD also 
acknowledges that during the course of the EUA, the risk status of 
individuals initially eligible for vaccination under the EUA may 
change (e.g., changes in deployment or other circumstances). In such 
cases, DoD must determine whether such individuals continue to be at 
heightened risk of exposure due to attack with anthrax, and 
therefore, whether they continue to be eligible for vaccination with 
AVA under this EUA.
    The use of AVA under this EUA must be consistent with and not 
contrary to the conditions of authorization set forth below. Subject 
to the foregoing limitations and under the circumstances set forth 
in the Deputy Secretary of Defense's determination of military 
emergency, AVA may be administered for the prevention of inhalation 
anthrax to individuals determined by DoD to be at heightened risk of 
exposure due to attack with anthrax.

IV. Conditions of Authorization

    Pursuant to section 564 of the Act, I am establishing the 
following conditions on this authorization:
    Conditions Designed to Ensure that Health Care Providers or 
Authorized Dispensers Administering the Product Are Informed. DoD 
will conduct an educational and information program under 
appropriate conditions designed to ensure that health care providers 
or authorized dispensers administering AVA under this authorization 
are informed of the following:
    (1) that FDA has authorized the emergency use of AVA for 
preventing inhalation anthrax;
    (2) that significant known and potential benefits and risks 
exist with the emergency use of AVA, and that the extent to which 
such benefits and risks exist is unknown; and
    (3) that alternatives to AVA are available, and that there are 
benefits and risks.
    With respect to condition (2), above, relating to provision of 
the significant known and potential benefits and risks of the 
emergency use of AVA, DoD will ensure that the manufacturer's 
package insert is available to all health care providers or 
authorized dispensers who administer AVA. DoD will also provide to 
all such health care providers or authorized dispensers the same 
information provided to potential vaccine recipients described 
immediately below.
    Conditions Designed to Ensure that Individuals to Whom the 
Product is Administered Are Informed. DoD will conduct an 
educational and information program under appropriate conditions 
designed to ensure that individuals to whom AVA is administered are 
informed of:
    (1) the fact that FDA has authorized the emergency use of AVA 
for preventing inhalation anthrax;
    (2) the significant known and potential benefits and risks of 
the emergency use of AVA, and of the extent to which such benefits 
and risks are unknown; and
    (3) the option to accept or refuse administration of AVA; of the 
consequences,

[[Page 44660]]

if any, of refusing administration of the product; and of the 
alternatives to AVA that are available, and of their benefits and 
risks.
    With respect to condition (3), above, relating to the option to 
accept or refuse administration of AVA, the AVIP will be revised to 
give personnel the option to refuse vaccination. Individuals who 
refuse anthrax vaccination will not be punished. Refusal may not be 
grounds for any disciplinary action under the Uniform Code of 
Military Justice. Refusal may not be grounds for any adverse 
personnel action. Nor would either military or civilian personnel be 
considered non-deployable or processed for separation based on 
refusal of anthrax vaccination. There may be no penalty or loss of 
entitlement for refusing anthrax vaccination.
    This information shall read in the trifold brochure provided to 
potential vaccine recipients as follows:
    You may refuse anthrax vaccination under the EUA, and you will 
not be punished. No disciplinary action or adverse personnel action 
will be taken. You will not be processed for separation, and you 
will still be deployable. There will be no penalty or loss of 
entitlement for refusing anthrax vaccination.
    The trifold brochure provided to potential vaccine recipients 
also shall state the following:
    On October 27, 2004, the U.S. District Court for the District of 
Columbia issued an Order declaring unlawful and prohibiting 
mandatory anthrax vaccinations to protect against inhalation 
anthrax, pending further FDA action. The Court's injunction means 
you have the right to refuse to take the vaccine without fear of 
retaliation. A copy of the Court's Order and Opinion is available at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.anthrax.mil or from the vaccination clinic.

    Other information, as outlined in your request of December 22, 
2004, is not a condition of this EUA, but may be provided, 
including: That unvaccinated people are more vulnerable to lethal 
anthrax infection; morbidity or mortality due to anthrax could 
threaten the lives of others in the unit who depend on each other; 
and anthrax infections could jeopardize the success of the mission. 
Individuals subject to the vaccination program may be informed that 
their military and civilian leaders strongly recommend anthrax 
vaccination, but such individuals may not be forced to be 
vaccinated. In addition, the January 27, 2005, authorization notes 
that the issue of mandatory vaccination will be reconsidered by DoD 
after FDA completes its administrative process.\21\
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    \21\See Section I of this authorization.
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    As a condition of this authorization, DoD will provide to each 
potential AVA recipient, prior to vaccination, information that 
meets the requirements set forth above. Based on a review of DoD's 
trifold brochure, dated April 5, 2005,\22\ I have concluded that 
this brochure continues to meet such requirements. DoD will obtain 
FDA's prior approval of any revision to the trifold brochure.
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    \22\FDA approved a revision to the trifold brochure on February 
15, 2005, and on April 6, 2005.
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    Conditions for the Monitoring and Reporting of Adverse Events 
Associated with the Emergency Use of AVA. DoD will, as a condition 
of this authorization, actively encourage health care providers or 
authorized dispensers and vaccine recipients to report adverse 
events to the Vaccine Adverse Events Reporting System (VAERS). In 
addition, we understand that DoD will conduct systematic monitoring 
of the health of recipients of AVA, e.g., cohort studies using the 
Defense Medical Surveillance System databases of active-duty 
military personnel; such monitoring is not a condition of this 
authorization.
    Conditions Concerning Recordkeeping and Reporting, Including 
Records Access by FDA. DoD will, as a condition of authorization, 
record in individual medical records, including electronic 
immunization tracking systems, the names of individual recipients of 
AVA and the dates of vaccination. DoD will provide FDA access to 
such records.
    Advertising and Promotional Descriptive Printed Matter. FDA has 
the authority, under section 564(e)(4) of the Act, to establish 
conditions on advertisements and other promotional descriptive 
printed matter that relate to the emergency use of AVA under this 
authorization. As a condition of this EUA, all advertising and 
promotional descriptive printed matter relating to the use of AVA 
shall be consistent with the trifold as well as the standards and 
requirements set forth in this authorization.

V. Duration of Authorization

    This EUA will be effective for the duration of the declaration 
of emergency issued by Secretary of Health and Human Services, Tommy 
G. Thompson, on January 14, 2005. The EUA will cease to be effective 
when 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.
    Thank you in advance for your continued cooperation in 
implementing this EUA.
Sincerely,
Lester M. Crawford, D.V.M., Ph.D.
Commissioner of Food and Drugs

    Dated: July 27, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-15233 Filed 7-28-05; 2:51 pm]

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