Amended Authorization of Emergency Use of Doxycycline Hyclate Tablet Emergency Kits for Eligible United States Postal Service Participants and Their Household Members; Availability, 72935-72950 [2011-30450]
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Federal Register / Vol. 76, No. 228 / Monday, November 28, 2011 / Notices
grants, governed by two separate
Program Instructions (PIs). The training
and data grants are governed by the
‘‘new grant’’ PI and the basic grant is
governed by the ‘‘basic grant’’ PI.
Current PIs require separate
applications and program assessment
reports for each grant. Every State
applies for at least two of the grants
annually and most States apply for all
three. As many of the application
requirements are the same for all three
grants, this results in duplicative work
and high degrees of repetition for State
courts applying for more than one CIP
grant.
The purpose of this Program
Instruction is to streamline and simplify
the application and reporting processes
by consolidating the PIs into one single
PI and requiring one single,
consolidated application (App) package
and program assessment report (PAR)
per State court annually. These
revisions will satisfy statutory
programmatic requirements and reduce
both the number of required responses
and associated total burden hours for
State courts.
This new PI also describes
programmatic and fiscal provisions and
reporting requirements for the grants,
specifies the application submittal and
approval procedures for the grants for
fiscal years 2012 through 2015, and
identifies technical resources for use by
State courts during the course of the
grants. The agency uses the information
received to ensure compliance with the
statute and provide training and
technical assistance to the grantees.
Respondents: Highest State Courts of
Appeal
ANNUAL BURDEN ESTIMATES
App ...................................................................................................
PAR ..................................................................................................
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Estimated Total Annual Burden
Hours: 9,256.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 370 L’Enfant Promenade SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: (202) 395–7285,
Email: OIRA_SUBMISSION@OMB.EOP.
GOV, Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–30553 Filed 11–25–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0264]
Amended Authorization of Emergency
Use of Doxycycline Hyclate Tablet
Emergency Kits for Eligible United
States Postal Service Participants and
Their Household Members; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
amendment to the Emergency Use
Authorization (EUA) (the Authorization)
for doxycycline hyclate tablet
emergency kits for eligible United States
Postal Service (USPS) participants in
the Cities Readiness Initiative (CRI) and
their household members issued on
October 3, 2008, as amended on
February 25, 2009, and on August 23,
2010, under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as
requested by the Biomedical Advanced
Research and Development Authority
(BARDA), Office of the Assistant
Secretary for Preparedness and
Response (ASPR), Department of Health
and Human Services (HHS). Following
issuance of FDA’s August 23, 2010,
amended Authorization letter, on April
8, 2011, BARDA submitted a request on
behalf of ASPR to further amend the
Authorization to reflect certain
programmatic changes, including by
replacing references to the CRI with the
National Postal Model (NPM). In
SUMMARY:
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Average
burden
hours per
response
Number of
responses per
respondent
Number of
respondents
Instrument
1
1
Total
burden
hours
92
86
4784
4472
response to BARDA’s request, FDA
amended the Authorization letter and
reissued the Authorization in its
entirety on October 14, 2011. The
Authorization, as amended and
reissued, includes explanations for its
reissuance and is reprinted in this
document.
DATES: The amended Authorization is
effective as of October 14, 2011.
ADDRESSES: Submit written requests for
single copies of the EUA to the Office
of Counterterrorism and Emerging
Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32,
Rm. 4121, Silver Spring, MD 20993.
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:
Luciana Borio, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, Rm.
4280, Silver Spring, MD 20993–0002,
(301) 796–4637.
SUPPLEMENTARY INFORMATION:
I. Amendment to the October 3, 2008,
Authorization for Doxycyline Hyclate
Tablet Emergency Kits, as Amended
In 2004, the Secretary of the
Department of Homeland Security
(DHS) issued a material threat
determination indicating that Bacillus
anthracis (B. anthracis), the biological
agent that causes anthrax disease,
presents a material threat against the
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population of the United States
sufficient to affect national security. On
September 23, 2008, under section
564(b)(1)(A) of the FD&C Act (21 U.S.C.
360bbb–3(b)(1)(A)), as amended by the
Project BioShield Act of 2004 (Pub. L.
108–276), the Secretary of DHS
determined that there is a significant
potential for a domestic emergency
involving a heightened risk of attack
with a specific biological, chemical,
radiological, or nuclear agent or
agents—in this case, B. anthracis. On
October 1, 2008, under section 564(b) of
the FD&C Act, and on the basis of such
determination, the Secretary of HHS
then declared an emergency justifying
the authorization of the emergency use
of doxycycline hyclate tablets
accompanied by emergency use
information subject to the terms of any
authorization issued under section
564(a) of the FD&C Act, and on October
1, 2009, and on October 1, 2010,
renewed the declaration. On July 20,
2011, the Secretary of HHS renewed and
amended the declaration to apply to all
oral formulations of doxycycline,
including doxycycline hyclate tablets
covered by the Authorization,
accompanied by emergency use
information subject to the terms of any
authorization issued under section
564(a) of the FD&C Act. Notice of the
declaration of the Secretary was
published in the Federal Register of
July 27, 2011 (76 FR 44926).
On October 1, 2008, BARDA
requested and on October 3, 2008, FDA
issued an EUA for doxycycline hyclate
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tablet emergency kits for eligible USPS
participants in the CRI and their
household members, subject to the
terms and conditions of the
Authorization. As required under
section 564(h)(1) of the FD&C Act, in the
Federal Register of October 21, 2008 (73
FR 62507), FDA published the
Authorization for doxycycline tablet
emergency kits for eligible USPS
participants in the CRI and their
household members, including an
explanation of the reasons for its
issuance. On February 19, 2009, BARDA
submitted a request on behalf of ASPR
to amend the Authorization to make
certain changes to the written
information authorized to accompany
the doxycycline hyclate tablet
emergency kits and to clarify the roles
and responsibilities provided for in the
Authorization. On February 25, 2009, in
response to BARDA’s request, FDA
amended the Authorization letter and
reissued the Authorization letter in its
entirety. In the Federal Register of June
26, 2009 (74 FR 30577), FDA published
the amended Authorization, including
an explanation of the reasons for the
amendment. On August 4, 2010,
BARDA requested that the EUA be
further amended to permit the use of a
certain manufacturer and a certain
repackager under the EUA. On August
23, 2010, in response to BARDA’s
request, FDA amended the
Authorization letter and reissued the
Authorization letter in its entirety. On
April 8, 2011, BARDA requested that
the EUA be further amended to reflect
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programmatic and operational changes,
including by replacing references to the
CRI with the NPM, clarifying roles and
responsibilities, and revising or
removing certain written materials
provided for in the Authorization. On
October 14, 2011, in response to
BARDA’s request, FDA amended the
Authorization letter and reissued the
Authorization letter in its entirety.
II. Electronic Access
An electronic version of this
document and the full text of the
Authorization are available on the
Internet at https://www.regulations.gov.
III. The Authorization
Having concluded that the criteria for
issuance of the Authorization under
section 564(c) of the FD&C Act were
met, on October 3, 2008, FDA
authorized the emergency use of
doxycycline hyclate tablet emergency
kits for eligible USPS participants in the
CRI and their household members
subject to the terms and conditions of
the Authorization. The letter of
Authorization in its entirety (not
including the amended authorized
versions of the fact sheets and other
written materials), as amended on
February 25, 2009, on August 23, 2010,
and on October 14, 2011, follows and
provides an explanation of the reasons
for its amendment.
Dated: November 21, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
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[FR Doc. 2011–30450 Filed 11–25–11; 8:45 am]
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–P–0488]
Determination That TAXOTERE
(Docetaxel) Injection, 40 Milligrams/
Milliliter Was Not Withdrawn From Sale
for Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that TAXOTERE (docetaxel) Injection,
40 milligrams/milliliter (mg/mL), was
not withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for docetaxel
injection, 40 mg/mL, if all other legal
and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Nam
Kim, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6320, Silver Spring,
MD 20993–0002, (301) 796–3472.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA). The only clinical data required
in an ANDA are data to show that the
drug that is the subject of the ANDA is
bioequivalent to the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
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Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
TAXOTERE (docetaxel) Injection, 40
mg/mL is the subject of NDA 20–449,
held by Sanofi-aventis U.S., and
initially approved on May 14, 1996.
TAXOTERE is indicated for breast
cancer, non-small cell lung cancer,
hormone refractory prostate cancer,
gastric adenocarcinoma, and squamous
cell carcinoma of the head and neck
cancer as described in detail on the drug
product’s labeling.
TAXOTERE (docetaxel) Injection, 40
mg/mL, is currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Sandoz, Inc. (Sandoz), submitted a
citizen petition dated June 21, 2011
(Docket No. FDA–2011–P–0488), under
21 CFR 10.30, requesting that the
Agency determine whether TAXOTERE
(docetaxel) Injection, 40 mg/mL, was
withdrawn from sale for reasons of
safety or effectiveness. After considering
the citizen petition and reviewing
Agency records and based on the
information we have at this time, FDA
has determined under § 314.161 that
TAXOTERE (docetaxel) Injection, 40
mg/mL was not withdrawn for reasons
of safety or effectiveness. The petitioner
Sandoz has identified no data or other
information suggesting that TAXOTERE
(docetaxel) Injection, 40 mg/mL, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
TAXOTERE (docetaxel) Injection, 40
mg/mL, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that this product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list TAXOTERE (docetaxel)
Injection, 40 mg/mL, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
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‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to TAXOTERE (docetaxel) Injection, 40
mg/mL, may be approved by the Agency
as long as they meet all other legal and
regulatory requirements for the approval
of ANDAs. If FDA determines that
labeling for this drug product should be
revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: November 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–30472 Filed 11–25–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0799]
Draft Guidance for Industry: Use of
Nucleic Acid Tests on Pooled and
Individual Samples From Donors of
Whole Blood and Blood Components,
Including Source Plasma, to Reduce
the Risk of Transmission of Hepatitis
B Virus
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft document entitled
‘‘Guidance for Industry: Use of Nucleic
Acid Tests (NAT) on Pooled and
Individual Samples from Donors of
Whole Blood and Blood Components
(including Recovered Plasma, Source
Plasma and Source Leukocytes) to
Adequately and Appropriately Reduce
the Risk of Transmission of Hepatitis B
Virus (HBV), and Requalification of
Donors Who Test HBV NAT Positive,’’
dated November 2011. The draft
guidance document provides
recommendations on the use of FDAlicensed nucleic acid tests (NAT) to
screen blood donors for hepatitis B virus
(HBV) deoxyribonucleic acid (DNA) and
recommendations for product testing
and disposition, donor management,
methods for donor requalification, and
product labeling. In addition, the draft
guidance provides notification that FDA
considers the use of an FDA-licensed
HBV NAT to be necessary to reduce
adequately and appropriately the risk of
transmission of HBV. The guidance is
intended for blood establishments that
SUMMARY:
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]]>Agencies
[Federal Register Volume 76, Number 228 (Monday, November 28, 2011)]
[Notices]
[Pages 72935-72950]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30450]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0264]
Amended Authorization of Emergency Use of Doxycycline Hyclate
Tablet Emergency Kits for Eligible United States Postal Service
Participants and Their Household Members; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the Emergency Use Authorization (EUA) (the Authorization)
for doxycycline hyclate tablet emergency kits for eligible United
States Postal Service (USPS) participants in the Cities Readiness
Initiative (CRI) and their household members issued on October 3, 2008,
as amended on February 25, 2009, and on August 23, 2010, under the
Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by
the Biomedical Advanced Research and Development Authority (BARDA),
Office of the Assistant Secretary for Preparedness and Response (ASPR),
Department of Health and Human Services (HHS). Following issuance of
FDA's August 23, 2010, amended Authorization letter, on April 8, 2011,
BARDA submitted a request on behalf of ASPR to further amend the
Authorization to reflect certain programmatic changes, including by
replacing references to the CRI with the National Postal Model (NPM).
In response to BARDA's request, FDA amended the Authorization letter
and reissued the Authorization in its entirety on October 14, 2011. The
Authorization, as amended and reissued, includes explanations for its
reissuance and is reprinted in this document.
DATES: The amended Authorization is effective as of October 14, 2011.
ADDRESSES: Submit written requests for single copies of the EUA to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4121, Silver
Spring, MD 20993. 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: Luciana Borio, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, Rm. 4280, Silver Spring, MD 20993-
0002, (301) 796-4637.
SUPPLEMENTARY INFORMATION:
I. Amendment to the October 3, 2008, Authorization for Doxycyline
Hyclate Tablet Emergency Kits, as Amended
In 2004, the Secretary of the Department of Homeland Security (DHS)
issued a material threat determination indicating that Bacillus
anthracis (B. anthracis), the biological agent that causes anthrax
disease, presents a material threat against the
[[Page 72936]]
population of the United States sufficient to affect national security.
On September 23, 2008, under section 564(b)(1)(A) of the FD&C Act (21
U.S.C. 360bbb-3(b)(1)(A)), as amended by the Project BioShield Act of
2004 (Pub. L. 108-276), the Secretary of DHS determined that there is a
significant potential for a domestic emergency involving a heightened
risk of attack with a specific biological, chemical, radiological, or
nuclear agent or agents--in this case, B. anthracis. On October 1,
2008, under section 564(b) of the FD&C Act, and on the basis of such
determination, the Secretary of HHS then declared an emergency
justifying the authorization of the emergency use of doxycycline
hyclate tablets accompanied by emergency use information subject to the
terms of any authorization issued under section 564(a) of the FD&C Act,
and on October 1, 2009, and on October 1, 2010, renewed the
declaration. On July 20, 2011, the Secretary of HHS renewed and amended
the declaration to apply to all oral formulations of doxycycline,
including doxycycline hyclate tablets covered by the Authorization,
accompanied by emergency use information subject to the terms of any
authorization issued under section 564(a) of the FD&C Act. Notice of
the declaration of the Secretary was published in the Federal Register
of July 27, 2011 (76 FR 44926).
On October 1, 2008, BARDA requested and on October 3, 2008, FDA
issued an EUA for doxycycline hyclate tablet emergency kits for
eligible USPS participants in the CRI and their household members,
subject to the terms and conditions of the Authorization. As required
under section 564(h)(1) of the FD&C Act, in the Federal Register of
October 21, 2008 (73 FR 62507), FDA published the Authorization for
doxycycline tablet emergency kits for eligible USPS participants in the
CRI and their household members, including an explanation of the
reasons for its issuance. On February 19, 2009, BARDA submitted a
request on behalf of ASPR to amend the Authorization to make certain
changes to the written information authorized to accompany the
doxycycline hyclate tablet emergency kits and to clarify the roles and
responsibilities provided for in the Authorization. On February 25,
2009, in response to BARDA's request, FDA amended the Authorization
letter and reissued the Authorization letter in its entirety. In the
Federal Register of June 26, 2009 (74 FR 30577), FDA published the
amended Authorization, including an explanation of the reasons for the
amendment. On August 4, 2010, BARDA requested that the EUA be further
amended to permit the use of a certain manufacturer and a certain
repackager under the EUA. On August 23, 2010, in response to BARDA's
request, FDA amended the Authorization letter and reissued the
Authorization letter in its entirety. On April 8, 2011, BARDA requested
that the EUA be further amended to reflect programmatic and operational
changes, including by replacing references to the CRI with the NPM,
clarifying roles and responsibilities, and revising or removing certain
written materials provided for in the Authorization. On October 14,
2011, in response to BARDA's request, FDA amended the Authorization
letter and reissued the Authorization letter in its entirety.
II. Electronic Access
An electronic version of this document and the full text of the
Authorization are available on the Internet at https://www.regulations.gov.
III. The Authorization
Having concluded that the criteria for issuance of the
Authorization under section 564(c) of the FD&C Act were met, on October
3, 2008, FDA authorized the emergency use of doxycycline hyclate tablet
emergency kits for eligible USPS participants in the CRI and their
household members subject to the terms and conditions of the
Authorization. The letter of Authorization in its entirety (not
including the amended authorized versions of the fact sheets and other
written materials), as amended on February 25, 2009, on August 23,
2010, and on October 14, 2011, follows and provides an explanation of
the reasons for its amendment.
Dated: November 21, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
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[FR Doc. 2011-30450 Filed 11-25-11; 8:45 am]
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