[Federal Register Volume 70, Number 21 (Wednesday, February 2, 2005)]
[Notices]
[Pages 5452-5456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2028]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0040]


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; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of an Emergency Use Authorization (EUA) (the Authorization) 
for Anthrax Vaccine Adsorbed (AVA) 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. FDA is issuing this Authorization under the 
Federal Food, Drug, and Cosmetic Act (the act), as requested by DoD. 
The Authorization contains, among other things, conditions on the 
emergency use of AVA. The Authorization follows the determination by 
DoD that there is a significant potential for a military emergency 
involving a heightened risk to U.S. military forces of attack with 
anthrax. On the basis of such determination, Secretary of Health and 
Human Services Tommy G. Thompson (the Secretary) declared an emergency 
justifying the authorization of the emergency use of AVA. The 
Authorization, which includes an explanation of the reasons for its 
issuance, is reprinted in this Notice.

DATES: The Authorization is effective as of January 27, 2005.

ADDRESSES: Submit written requests for single copies of the Emergency 
Use 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: Margaret O'K. Glavin, 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 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 
declared emergency involving a heightened risk of attack on the public 
or U.S. military forces. 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 to protect the American people and the U.S. 
military.
    Section 564(b)(1) of the act provides that, before an EUA may be 
issued, the Secretary must declare an emergency based on one of the 
following grounds:
    (1) 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;
    (2) 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 
forces of attack with a specified biological, chemical, 
radiological, or nuclear agent or agents; or
    (3) a determination by the Secretary of a public health 
emergency under section 319 of the Public Health Service Act (PHS 
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, based on the information and data available to the agency, 
that the statutory criteria of section 564(c) of the act are satisfied. 
Under section 564(h)(1) of the act FDA is required to publish in the 
Federal Register notice of each authorization, and each termination or 
revocation of an authorization, and an explanation of the reasons for 
the action. The explanation may include a summary of data submitted to 
FDA in an application

[[Page 5453]]

under section 505(i) or 520(g) of the act (21 U.S.C. 355(i) or 21 
U.S.C. 360j(g)).
    Section 564 of the act permits FDA to authorize, during the 
effective period of the declaration, the introduction into interstate 
commerce of a drug, device, or biological product intended for use in 
an actual or potential 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, 
21 U.S.C. 360(k), 21 U.S.C. 360e) or section 351 of the PHS Act (42 
U.S.C. 262). FDA may issue an EUA only if, after consultation with the 
National Institutes of Health (NIH) and the Centers for Disease Control 
and Prevention (CDC) (to the extent feasible and appropriate given the 
circumstances of the emergency), FDA concludes:
    (1) That the agent specified in the declaration of emergency can 
cause a serious or life-threatening disease or condition;
    (2) That, based on the totality of scientific evidence available, 
including data from adequate and well-controlled clinical trials, if 
available, it is reasonable to believe that the product may be 
effective in diagnosing, treating, or preventing--(a) the serious or 
life-threatening disease or condition referred to in paragraph (1); or 
(b) a serious or life-threatening disease or condition caused by a 
product authorized under section 564, or approved, cleared, or licensed 
under the act or PHS Act, for diagnosing, treating, or preventing the 
disease or condition referred to in paragraph (1) and caused by the 
agent specified in the declaration of emergency;
    (3) That the known and potential benefits of the product outweigh 
the known and potential risks of the product when used to diagnose, 
prevent, or treat the serious or life-threatening disease or condition 
that is the subject of the declaration; and
    (4) That there is no adequate, approved, and available alternative 
to the product for diagnosing, preventing, or treating such serious or 
life-threatening disease or condition.

II. EUA Request for AVA

    On December 10, 2004, pursuant to section 564(b)(1)(B) of the act 
(21 U.S.C. 360bbb-3(b)(1)(B)), the Deputy Secretary of Defense 
determined that there is a significant potential for a military 
emergency involving a heightened risk to United States military forces 
of attack with anthrax. On January 14, 2005, pursuant to section 564(b) 
of the act, and on the basis of such determination, 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 is published elsewhere in 
this issue of the Federal Register.

III. Significance of Notice

    The issuance of this Authorization for the emergency use of AVA is 
the first time that the EUA authority is being used. FDA intends to 
explain clearly the reasons for each issuance, termination, or 
revocation of an EUA. The agency wishes to make its decision-making 
understandable to help ensure that members of the public, and 
particularly those individuals who may be eligible to receive a medical 
product authorized for emergency use, are informed about the basis of 
an EUA determination. The amount of information that will be provided 
regarding each authorization will depend on the circumstances of the 
emergency. We anticipate that in some circumstances, an EUA will be 
issued very quickly, and time may not permit the agency to prepare 
supplementary documents beyond the letter of authorization and the 
notice required by section 564(h)(1) of the act. Other circumstances 
may afford greater opportunity to produce materials in addition to 
those prepared and disseminated as a condition of authorization under 
section 564(e) of the act. Thus, the amount of additional information 
that we will provide will necessarily vary on a case-by-case basis. The 
agency will publish notice of each EUA and intends also to make the 
notice and certain supplementary information available on its website 
and in the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, which 
is open to the public between 9 a.m. and 4 p.m., Monday through Friday.
    Because the statute is self-executing, FDA does not require 
regulations or guidance to implement the EUA authority. However, we 
believe that it would be helpful for stakeholders and the public to 
have more information about the EUA authority, and the process that the 
agency is proposing to adopt for the consideration of EUA requests. 
Accordingly the agency is planning to issue draft guidance on this 
topic in the near future.

IV. Electronic Access

    An electronic version of this notice and the full text of the 
Authorization are available on the Internet at http://www.fda.gov/ohrms/dockets/default.htm.

V. The Authorization

    Having consulted with NIH and CDC, and having concluded that the 
criteria for issuance of this Authorization under section 564(c) of the 
act are met, FDA has 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. The Authorization follows and provides an 
explanation of the reasons for its issuance, as required by section 
564(h)(1) of the act:

William Winkenwerder, Jr., M.D.
Assistant Secretary of Defense for Health Affairs
The Pentagon
Washington, D.C. 20301-1200
    Re: Request for 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 December 22, 2004, 
requesting that the Food and Drug Administration (FDA) issue an 
Emergency Use Authorization (EUA) regarding the use of Anthrax 
Vaccine Adsorbed (AVA) for the prevention of inhalational anthrax, 
pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act 
(the Act).
    On December 10, 2004, pursuant to section 564(b)(1)(B) of the 
Act, 21 U.S.C. Sec.  360bbb-3(b)(1)(B), 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.\1\ On January 14, 2005, pursuant to 
section 564(b) of the Act, and on the basis of such determination, 
Secretary of Health and Human Services, Tommy G. Thompson declared 
an emergency justifying the authorization of the emergency use of 
AVA. Having consulted with the National Institutes of Health (NIH) 
and the Centers for Disease Control and Prevention (CDC), and having 
concluded that the criteria for issuance of this authorization under 
section 564(c) of the Act are met, I am authorizing the emergency 
use of AVA for prevention of inhalation anthrax,\2\ subject to the 
conditions established herein.\3\
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    \1\ You state in your letter that the Deputy Secretary of 
Defense has assigned authority from the Secretary of Defense to make 
the statutory determination under section 564(b)(1)(B) of the Act.
    \2\ The Secretary of Health and Human Services has delegated his 
authority to issue an EUA under section 564 to the FDA Commissioner.
    \3\ The terms ``inhalation anthrax'' and ``inhalational 
anthrax'' are used interchangeably.

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[[Page 5454]]

I. Background

    AVA was first licensed by NIH in November 1970.\4\ 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.\5\ Under this review, 
independent advisory panels evaluated the safety and effectiveness 
data of vaccines to assure 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).\6\
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    \4\ Biological products are licensed under section 351 of the 
Public Health Service Act (42 U.S.C. 262).
    \5\ See 21 C.F.R. Sec.  601.25.
    \6\ 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,\7\ FDA published a 
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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    \7\ 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.\8\ 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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    \8\ 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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II. Criteria for Issuance of Authorization

    Having considered the December 10, 2004, determination by the 
Deputy Secretary of Defense that there is a significant potential 
for a military emergency involving a heightened risk to U.S. 
military forces of attack with anthrax, and the January 14, 2005, 
declaration of emergency by the Secretary of Health and Human 
Services, and after consultation with NIH and CDC, I have concluded 
that the use of AVA to prevent inhalation anthrax meets 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.\9\
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    \9\ No other criteria of issuance have been prescribed by 
regulation under section 564(c)(4).
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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. The fatality rate for inhalation anthrax in the United 
States is estimated to be approximately 45 percent to 90 percent. 
From 1900 to October 2001, there were 18 identified cases of 
inhalation anthrax in the United States, the latest of which was 
reported in 1976, with an 89 percent (16/18) mortality rate. Most of 
these exposures occurred in industrial settings, i.e., textile 
mills. From October 4, 2001, to December 5, 2001, a total of 11 
cases of inhalation anthrax linked to intentional dissemination of 
Bacillus anthracis spores were identified in the United States. Five 
of these cases were fatal. These fatalities occurred despite 
aggressive medical care, including antibiotics.
    I have concluded that, based on the totality of scientific 
evidence available to FDA, 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 the following:
     A well-controlled efficacy field study using an earlier 
version of a protective antigen-based anthrax vaccine was conducted 
in mill workers from 1955-1959. In a comparison of anthrax cases 
between the placebo and vaccine groups, including both inhalation 
and cutaneous cases in those who were completely vaccinated, the 
calculated vaccine efficacy level against all reported cases of 
anthrax combined was 92.5 percent (lower 95 percent CI = 65 
percent). The efficacy analysis included all cases of anthrax 
disease regardless of the route of exposure or manifestation of 
disease.
     Epidemiological surveillance data on the occurrence of 
anthrax disease in at-risk industrial settings for the years 1962-
1974 provides further supportive evidence of the effectiveness of 
AVA. In that time period, individuals received either AVA, or an 
earlier version of anthrax vaccine. Of the 24 anthrax cases that 
occurred in mill employees during that period, no cases occurred in 
those who had received the full vaccination series.
     The safety of AVA was evaluated in a 5-year (1967-1971) 
open-label safety study in which 15,907 doses of AVA were 
administered to approximately 7,000 textile employees, laboratory 
workers, and other at-risk individuals. Severe local reactions were 
reported in 0.15 percent of doses administered (24 reports). There 
were 150 reports (0.94 percent of doses administered) of moderate 
local reactions and 1,373 reports (8.63 percent of doses 
administered) of mild local reactions. In the same open label study, 
four cases of systemic reactions were reported during a 5-year 
reporting period (<0.06 percent of doses administered). These 
reactions, which were reported to have been transient, included 
fever, chills, nausea, and general body aches.
     Recently (1996-1999), an assessment of safety was 
conducted as part of a randomized clinical study conducted by the 
U.S. Army Medical Research Institute of Infectious Diseases. Four of 
the 28 volunteers reported seven acute adverse events within 30 
minutes after the subcutaneous administration of AVA. These adverse 
events included erythema (3), headache (2), fever (1), and elevated 
temperature (1). Of these events, a single patient reported the 
simultaneous occurrence of headache, fever, and elevated temperature 
(100.7[deg]F). The most common local reactions reported after the 
first dose in this study were tenderness (71 percent), erythema (43 
percent), subcutaneous nodule (36 percent), induration (21 percent), 
warmth (11 percent), and local pruritus (7 percent). Local reactions 
were found to occur more often in women. No abscess or necrosis was 
observed at the injection site.
    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.

[[Page 5455]]

III. Scope of Authorization

    Pursuant to section 564(d)(1) of the Act, this authorization is 
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 scientific evidence available to FDA, 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. FDA 
has reviewed the scientific information available, including the 
studies described in Section II above, and concludes 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 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:
    (1) that FDA has authorized the emergency use of AVA for 
preventing inhalation anthrax;
    (2) of the significant known and potential benefits and risks of 
the emergency use of AVA, and the extent to which such benefits and 
risks are unknown; and
    (3) of the alternatives to AVA that are available, and of their 
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 assure 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:
    (1) that FDA has authorized the emergency use of AVA for 
preventing inhalation anthrax;
    (2) of 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) of the option to accept or refuse administration of AVA; of 
the consequences, 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.
    Other information, as outlined in your request, 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 
issue of mandatory vaccination will be reconsidered by DoD after FDA 
completes its administrative process, which DoD expects to occur 
later this year.\10\
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    \10\ 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. FDA has reviewed DoD's 
trifold brochure, submitted on January 19, 2005, and concludes that 
this brochure meets such requirements. DoD will obtain FDA's prior 
approval of any revision to the trifold brochure.
    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 6 months from the date of 
issuance. However, this EUA may be extended within the duration of 
the declaration of emergency if the criteria under section 564(c) of 
the Act for issuance of such

[[Page 5456]]

authorization are still met. Moreover, the EUA will cease to be 
effective when the declaration of emergency is terminated under 
section 564(b) of the Act or the EUA is revoked under section 564(g) 
of the Act.
    Thank you in advance for your cooperation in implementing this 
EUA.
Sincerely,
Lester M. Crawford, D.V.M., Ph.D.

    Dated: January 28, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-2028 Filed 1-31-05; 11:39 am]
BILLING CODE 4160-01-S