[Federal Register: February 2, 2005 (Volume 70, Number 21)]
[Notices]
[Page 5452-5456]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02fe05-74]
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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