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, 44657-44660 [05-15233]
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Federal Register / Vol. 70, No. 148 / Wednesday, August 3, 2005 / Notices
44657
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Section of the Act
801
3,406
1There
Total Annual
Responses
1,089
Hours per
Response
3,709,134
Total Hours
.14
519,279
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 27, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–15371 Filed 8–2–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N–0564]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Temporary Marketing Permit
Applications; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Annual Frequency
per Response
Notice; correction.
15:22 Aug 02, 2005
Dated: July 27, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–15369 Filed 8–2–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0299]
SUMMARY: The Food and Drug
Administration is correcting a notice
that appeared in the Federal Register of
July 26, 2005 (70 FR 43159). The
document announced Office of
Management Budget approval for State
petitions for exemption from
preemption. The document was
published with an incorrect title and an
incorrect docket number. This
document corrects those errors.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
SUPPLEMENTARY INFORMATION: In FR Doc.
05–14697, appearing on page 43159 in
the Federal Register of Tuesday, July
26, 2005, the following corrections are
made:
1. On page 43159, in the third
column, in the heading of the
document, ‘‘[Docket No. 2004N–0565]’’
is corrected to read ‘‘[Docket No.
2004N–0564]’’.
2. On page 43159, in the third
column, in the heading of the
document, ‘‘Agency Information
Collection Activities; Announcement of
Office of Management and Budget
Approval; State Petitions for Exemption
From Preemption’’ is corrected to read
‘‘Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
VerDate jul<14>2003
Temporary Marketing Permit
Applications’’.
3. On page 43159, in the third
column, in the SUMMARY section of the
document, beginning in the fourth line,
‘‘State Petitions for Exemption From
Preemption’’ is corrected to read
‘‘Temporary Marketing Permit
Applications’’.
Jkt 205001
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.
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 selfaddressed adhesive label to assist that
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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
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Federal Register / Vol. 70, No. 148 / Wednesday, August 3, 2005 / Notices
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 https://
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 abovereferenced Emergency Use Authorization
(EUA), which was issued on January 27,
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15:22 Aug 02, 2005
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2005,1 pursuant to section 564 of the Federal
Food, Drug, and Cosmetic Act (the Act), 21
U.S.C. § 360bbb–3.2 You requested an
extension of the EUA ‘‘for such time as
necessary pending the upcoming FDA redetermination of the licensed use of AVA for
protection against inhalational anthrax.’’
The declaration of emergency3 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
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.
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
1Notice of the issuance of the EUA for AVA was
published in the Federal Register on February 2,
2005 (70 Fed. Reg. 5452).
2The 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.
3Notice 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).
4The declaration of emergency was not issued on
January 10, 2005, as is stated in your letter of July
11, 2005.
5It is possible, under section 564(b)(2) of the Act,
that the declaration of emergency may terminate or
be renewed prior to its expiration.
6The terms ‘‘inhalation anthrax’’ and
‘‘inhalational anthrax’’ are used interchangeably.
7The 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.
8Biological products are licensed under section
351 of the Public Health Service Act, 42 U.S.C.
§ 262.
9See 21 C.F.R. § 601.25.
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Bacterial Vaccines and Toxoids Efficacy
Review).10
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.
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.
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.
On January 14, 2005, pursuant to section
564(b) of the Act, and on the basis of the
Deputy Secretary of Defense’s determination
10Biological Products; Bacterial Vaccines and
Toxoids; Implementation of Efficacy Review, 50
Fed. Reg. 51002 (Dec. 13, 1985).
11Biological Products; Bacterial Vaccines and
Toxoids; Implementation of Efficacy Review, 69
Fed. Reg. 255 (Jan. 5, 2004).
12Biological Products; Bacterial Vaccines and
Toxoids; Implementation of Efficacy Review;
Proposed Rule and Proposed Order, 69 Fed. Reg.
78281 (Dec. 29, 2004).
13See supra note 3.
14See supra note 12.
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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
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
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 wellcontrolled 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
15See
supra note 3.
supra note 1.
17No other criteria of issuance have been
prescribed by regulation under section 564(c)(4) of
the Act.
18 The available scientific evidence includes
FDA’s review of adverse event reports concerning
AVA submitted to the Vaccine Adverse Event
Reporting System
16See
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15:22 Aug 02, 2005
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issued on January 27, 2005,19 which is
hereby incorporated by reference.
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 (preexposure) 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.
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,
Fed. Reg. 5454 (February 2, 2005).
scientific evidence available to the Agency
includes studies referred to in Section II above.
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20The
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44659
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,
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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
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
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.
Conditions for the Monitoring and
Reporting of Adverse Events Associated with
21See
Section I of this authorization.
22FDA approved a revision to the trifold brochure
on February 15, 2005, and on April 6, 2005.
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15:22 Aug 02, 2005
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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]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N–0355]
Critical Path Initiative; Developing
Prevention Therapies; Planning of
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Request for Comments.
SUMMARY: The Food and Drug
Administration (FDA) is planning a 2day workshop to explore approaches
and potential obstacles to developing
PO 00000
Frm 00108
Fmt 4703
Sfmt 4703
drugs, disease biomarkers, medical
devices, and vaccines to prevent or
reduce the risk of illness. The agency
plans to hold the workshop as part of its
Critical Path Initiative. Speakers at the
workshop will be asked to discuss the
challenges in developing
chemoprevention therapies (i.e.,
prevention therapies other than lifestyle
changes, dietary supplements, or dietary
choices that could reduce the risk of
certain illnesses such as cancer,
diabetes, and obesity). Because
prevention of illness is widely
recognized to be an important goal and
the possible scope of this workshop is
very broad, FDA welcomes comments
related to the scope of this workshop.
DATES: Submit written or electronic
comments by November 1, 2005.
General comments are welcome at any
time.
ADDRESSES: The FDA invites you to
submit written comments on the
proposed scope of the workshop. Please
submit comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Nancy Stanisic, Center for Drug
Evaluation and Research (HFD–05),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20852,
301–827–1660, FAX: 301–443–9718, email: Stanisicn@cder.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The development of methods to
prevent disease has been the single,
most effective advance in healthcare in
the past century, particularly in
developed countries. The widespread
ravages of smallpox, infantile diarrhea,
plague, cholera, typhoid, and polio are
gone from the United States.
The challenge that lies ahead is to
prevent the diseases that still ravage our
population, including: Heart disease,
cancer, diabetes, Alzheimer’s disease,
and others. In recent decades,
substantial effort has been made in the
chemoprevention or early intervention
for some of the top killers in the United
States, notably cardiovascular disease
and some cancers. Examples of effective
preventive interventions include the
aggressive treatment of hypertension to
reduce the risk of stroke, statins to lower
cholesterol and decrease the risk of a
myocardial infarction, the use of lowdose aspirin and beta blockers to
prevent death in patients after a
myocardial infarction, tamoxifen to
reduce the risk of recurrent breast
E:\FR\FM\03AUN1.SGM
03AUN1
]]>Agencies
[Federal Register Volume 70, Number 148 (Wednesday, August 3, 2005)]
[Notices]
[Pages 44657-44660]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-15233]
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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 https://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.''
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\12\Biological Products; Bacterial Vaccines and Toxoids;
Implementation of Efficacy Review; Proposed Rule and Proposed Order,
69 Fed. Reg. 78281 (Dec. 29, 2004).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\13\See supra note 3.
\14\See supra note 12.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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\
---------------------------------------------------------------------------
\17\No other criteria of issuance have been prescribed by
regulation under section 564(c)(4) of the Act.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\20\The scientific evidence available to the Agency includes
studies referred to in Section II above.
---------------------------------------------------------------------------
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
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\
---------------------------------------------------------------------------
\21\See Section I of this authorization.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\22\FDA approved a revision to the trifold brochure on February
15, 2005, and on April 6, 2005.
---------------------------------------------------------------------------
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]
BILLING CODE 4160-01-S
