Renewal of Declaration Regarding Emergency Use of All Oral Formulations of Doxycycline Accompanied by Emergency Use Information, 39708-39709 [2012-16531]
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39708
Federal Register / Vol. 77, No. 129 / Thursday, July 5, 2012 / Notices
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Deadline: Comments on the ICR must
be received within 60 days of the
issuance of this notice.
ADDRESSES: Submit your comments,
including the document identifier HHS–
EGOV–16815–60D, to
ed.calimag@hhs.gov or by calling (202)
690–7569.
Copies of the supporting statement
and any related forms for the ICR may
also be requested through the above
email or telephone number.
Information Collection Request Title:
SF–424 Individual.
Abstract: The SF–424 Individual form
is the common Federal (standard) form
for grant applications for individuals. It
replaced numerous agency-specific
forms.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions, to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information, to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information, and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR,
summarized in the table below, are
based on information gathered from the
National Endowment for the Arts (NEA)
and the National Endowment for the
Humanities (NEH).
TOTAL ESTIMATED ANNUALIZED BURDEN FOR SF–424 INDIVIDUAL—HOURS
Number of
respondents
Organization
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
NEA ..................................................................................................................
NEH .................................................................................................................
1,591
3,394
1
1
1
1
1,591
3,394
Total ..........................................................................................................
4,985
........................
........................
4,985
Keith A. Tucker,
Information Collection Clearance Officer,
Department of Health and Human Services.
[FR Doc. 2012–16284 Filed 7–3–12; 8:45 am]
BILLING CODE 4151– AE–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Renewal of Declaration Regarding
Emergency Use of All Oral
Formulations of Doxycycline
Accompanied by Emergency Use
Information
AGENCY:
Office of the Secretary (OS),
HHS.
ACTION:
Notice.
The Secretary of Homeland
Security determined on September 23,
2008 that there is a significant potential
for a domestic emergency involving a
heightened risk of attack with a
specified biological, chemical,
radiological, or nuclear agent or
agents—in this case, Bacillus anthracis.
On the basis of that determination, and
pursuant to section 564(b) of the Federal
Food, Drug, and Cosmetic Act (‘‘FD&C
Act’’), the Secretary of Health and
Human Services is renewing her July 20,
2011 declaration of an emergency
justifying the authorization of
emergency use of all oral formulations
of doxycycline accompanied by
emergency use information subject to
the terms of any authorization issued by
the Commissioner of Food and Drugs
TKELLEY on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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16:48 Jul 03, 2012
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under 21 U.S.C. 360bbb–3(a). This
notice is being issued in accordance
with section 564(b)(4) of the FD&C Act,
21 U.S.C. 360bbb–3(b)(4).
DATES: This Notice and referenced HHS
declaration are effective as of June 28,
2012.
FOR FURTHER INFORMATION CONTACT:
Nicole Lurie, MD, MSPH, Assistant
Secretary for Preparedness and
Response, Office of the Secretary,
Department of Health and Human
Services, 200 Independence Avenue
SW., Washington, DC 20201, Telephone
(202) 205–2882 (this is not a toll free
number).
SUPPLEMENTARY INFORMATION: On
September 23, 2008, former Secretary of
Homeland Security, Michael Chertoff,
determined that there is a significant
potential for a domestic emergency,
involving a heightened risk of attack
with a specified biological, chemical,
radiological, or nuclear agent or
agents—in this case, Bacillus
anthracis—although there is no current
domestic emergency involving anthrax,
no current heightened risk of an anthrax
attack, and no credible information
indicating an imminent threat of an
attack involving Bacillus anthracis.
On October 1, 2008, on the basis of
that determination, and pursuant to
section 564(b) of the FD&C Act, 21
U.S.C. 360bbb–3(b), former Secretary of
Health and Human Services, Michael O.
Leavitt, declared an emergency
justifying the emergency use of
doxycycline hyclate tablets
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Fmt 4703
Sfmt 4703
accompanied by emergency use
information subject to the terms of any
authorization issued under 21 U.S.C.
360bbb–3(a).1 On October 1, 2009 and
October 1, 2010, I renewed the former
Secretary’s declaration,2 and on July 20,
2011, I renewed and amended the
declaration to declare that the
emergency justifies emergency use of all
oral formulations of doxycycline
accompanied by emergency use
information subject to the terms of any
authorization issued under 21 U.S.C.
360bbb–3(a).3
On the basis of the September 23,
2008 determination by the Secretary of
Homeland Security and pursuant to
section 564(b) of the FD&C Act, I hereby
renew my July 20, 2011 declaration that
the emergency justifies emergency use
of all oral formulations of doxycycline
accompanied by emergency use
information subject to the terms of any
authorization issued under 21 U.S.C.
360bbb–3(a). I am issuing this notice in
accordance with section 564(b)(4) of the
1 Pursuant to section 564(b)(4) of the FD&C Act,
notice of the determination by the Secretary of
Homeland Security and the declaration by the
Secretary of Health and Human Services was
provided at 73 FR 58242 (October 6, 2008).
2 Pursuant to section 564(b)(4) of the FD&C Act,
notices of the renewal of the declaration of the
Secretary of Health and Human Services were
provided at 74 FR 51,279 (Oct. 6, 2009) and 75 FR
61,489 (Oct. 5, 2010).
3 Pursuant to section 564(b)(4) of the FD&C Act,
notice of the renewal and amendment of the
declaration of the Secretary of Health and Human
Services was provided at 76 FR 44,926 (July 27,
2011).
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Federal Register / Vol. 77, No. 129 / Thursday, July 5, 2012 / Notices
Federal Food, Drug, and Cosmetic Act,
21 U.S.C. 360bbb–3(b)(4).
Dated: June 28, 2012.
Kathleen Sebelius,
Secretary.
[FR Doc. 2012–16531 Filed 7–3–12; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
TKELLEY on DSK3SPTVN1PROD with NOTICES
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: U.S. Repatriation Program
Forms.
OMB No.: 0970–NEW.
Description: Description: The United
States (U.S.) Repatriation Program was
established by Title XI, Section 1113 of
the Social Security Act (Assistance for
U.S. Citizens Returned from Foreign
Countries) to provide temporary
assistance to U.S. citizens and their
dependents who have been identified by
the Department of State (DOS) as having
returned, or been brought from a foreign
country to the U.S. because of
destitution, illness, war, threat of war,
or a similar crisis, and are without
available resources immediately
accessible to meet their needs. The
Secretary of the Department of Health
and Human Services was provided with
the authority to administer this
Program. On or about 1994, this
authority was delegated by the HHS
Secretary to the Administration for
Children and Families and later redelegated to the Office of Refugee
Resettlement. The Repatriation Program
works with States, Federal agencies, and
non-governmental organizations to
provide eligible individuals with
temporary assistance for up to 90-days.
This assistance is in the form of a loan
and must be repaid to the Federal
Government.
The Program was later expanded in
response to legislation enacted by
Congress to address the particular needs
of persons with mental illness (24
U.S.C. 321 through 329). Further
refinements occurred in response to
Executive Order (EO) 11490 (as
amended) where HHS was given the
responsibility to ‘‘develop plans and
procedures for assistance at ports of
entry to U.S. personnel evacuated from
overseas areas, their onward movement
to final destination, and follow-up
assistance after arrival at final
destination.’’ In addition, under EO
12656 (53 CFR 47491), ‘‘Assignment of
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emergency preparedness
responsibilities’’, HHS was given the
lead responsibility to develop plans and
procedures in order to provide
assistance to U.S. citizens or others
evacuated from overseas areas.
Overall, the Program manages two
major activities, Emergency and Nonemergency Repatriation Activities. The
ongoing routine arrivals of individual
repatriates and the repatriation of
individuals with mental illness
constitute the Program Non-emergency
activities. Emergency activities are
comprised of group repatriations
(evacuations of 50–500 individuals) and
emergency repatriations (evacuations of
500 or more individuals). Operationally,
these activities involve different kinds
of preparation, resources, and
implementation. However, the core
Program policies and administrative
procedures are essentially the same.
1. The U.S. Repatriation Program
Emergency and Group Processing Form:
Under 45 CFR parts 211 and 212, ORR
is to make findings setting forth the
pertinent facts and conclusions
according to established standards to
determine whether an individual is an
eligible person. This form allows
authorized staff to gather necessary
information to determine eligibility and
to identify the services that need to be
provided. This form is to be utilized
during emergencies and group
repatriations. Individuals interested in
receiving Repatriation assistance will
complete appropriate portions of this
form. State personnel will utilize this
form as a guide to perform an initial
assessment and to identify the type of
services an eligibility person might be
able to receive. Furthermore, an
authorized federal staff from the
Administration for Children and
Families (ACF) will make final
eligibility determination by completing
the appropriate section of this form.
2. The U.S. Repatriation Program
Privacy and Repayment Agreement
Form: Under 45 CFR parts 211 and 212,
individuals who receive Program
assistance are required to repay the
federal government for the cost
associated to the services received. This
form authorizes ORR to release personal
identifiable information to partners for
the purpose of providing services to
eligible repatriates. In addition, through
this form eligible repatriates agree to
accept services under the terms and
conditions of the Program. Specifically,
eligible repatriates commit to repay the
federal government for all services
received while in the Program. This
form is to be completed by eligible
repatriates or authorized legal
custodian. Exception applies to minors
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39709
and individuals eligible under 45 CFR
part 211 when no legal custodian is
identified.
3. Relinquish Repatriation Services
Form: For individuals who are eligible
to receive repatriation assistance but opt
to relinquish services, this form is
utilized to confirm and record
repatriate’s decision to refuse Program
assistance. This form is to be completed
by eligible repatriates or authorized
legal custodian. Exception applies to
minors and individuals eligible under
45 CFR part 211 when no legal
custodian is identified.
4. The U.S. Repatriation Program
Emergency Reimbursement Form: Under
Section 1113 of the Social Security Act,
ORR is authorized to provide temporary
assistance directly or through utilization
of the services and facilities of
appropriate public or private agencies
and organizations, in accordance with
agreements providing for payment, in
advance or by way of reimbursement, as
may be determined by ORR. This form
is to be utilized and completed by ORR
partners to request reimbursement of
reasonable and allowable costs, both
administrative and actual temporary
services, associated to services provided
under the Program Emergency activities.
For the purpose of this document, the
word partner has the same meaning of
‘‘agency.’’ Definition is found under 45
CFR 212.1 (i).
5. The U.S. Repatriation Program
Non-emergency Reimbursement Form:
Under Section 1113 of the Social
Security Act, ORR is authorized to
provide temporary assistance directly or
through utilization of the services and
facilities of appropriate public or private
agencies and organizations, in
accordance with agreements providing
for payment, in advance or by way of
reimbursement, as may be determined
by ORR. This form is to be utilized and
completed by ORR partners to request
reimbursement of reasonable and
allowable costs, both administrative and
actual temporary services, associated to
services provided under the Program
non-emergency activities.
6. The U.S. Repatriation Program
Financial Waiver Request Form: Under
45 CFR parts 211 & 212 individuals who
have received Repatriation assistance
may be eligible to receive waivers and/
or deferral if they fall within the
repayment exceptions found with theses
regulations. This form is to be
completed by eligible repatriates or
authorized legal custodian or state
repatriation coordinator whenever
appropriate. Exception applies to
minors and individuals eligible under
45 CFR part 211 when no legal
custodian is identified.
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]]>Agencies
[Federal Register Volume 77, Number 129 (Thursday, July 5, 2012)]
[Notices]
[Pages 39708-39709]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-16531]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Renewal of Declaration Regarding Emergency Use of All Oral
Formulations of Doxycycline Accompanied by Emergency Use Information
AGENCY: Office of the Secretary (OS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Secretary of Homeland Security determined on September 23,
2008 that there is a significant potential for a domestic emergency
involving a heightened risk of attack with a specified biological,
chemical, radiological, or nuclear agent or agents--in this case,
Bacillus anthracis. On the basis of that determination, and pursuant to
section 564(b) of the Federal Food, Drug, and Cosmetic Act (``FD&C
Act''), the Secretary of Health and Human Services is renewing her July
20, 2011 declaration of an emergency justifying the authorization of
emergency use of all oral formulations of doxycycline accompanied by
emergency use information subject to the terms of any authorization
issued by the Commissioner of Food and Drugs under 21 U.S.C. 360bbb-
3(a). This notice is being issued in accordance with section 564(b)(4)
of the FD&C Act, 21 U.S.C. 360bbb-3(b)(4).
DATES: This Notice and referenced HHS declaration are effective as of
June 28, 2012.
FOR FURTHER INFORMATION CONTACT: Nicole Lurie, MD, MSPH, Assistant
Secretary for Preparedness and Response, Office of the Secretary,
Department of Health and Human Services, 200 Independence Avenue SW.,
Washington, DC 20201, Telephone (202) 205-2882 (this is not a toll free
number).
SUPPLEMENTARY INFORMATION: On September 23, 2008, former Secretary of
Homeland Security, Michael Chertoff, determined that there is a
significant potential for a domestic emergency, involving a heightened
risk of attack with a specified biological, chemical, radiological, or
nuclear agent or agents--in this case, Bacillus anthracis--although
there is no current domestic emergency involving anthrax, no current
heightened risk of an anthrax attack, and no credible information
indicating an imminent threat of an attack involving Bacillus
anthracis.
On October 1, 2008, on the basis of that determination, and
pursuant to section 564(b) of the FD&C Act, 21 U.S.C. 360bbb-3(b),
former Secretary of Health and Human Services, Michael O. Leavitt,
declared an emergency justifying the emergency use of doxycycline
hyclate tablets accompanied by emergency use information subject to the
terms of any authorization issued under 21 U.S.C. 360bbb-3(a).\1\ On
October 1, 2009 and October 1, 2010, I renewed the former Secretary's
declaration,\2\ and on July 20, 2011, I renewed and amended the
declaration to declare that the emergency justifies emergency use of
all oral formulations of doxycycline accompanied by emergency use
information subject to the terms of any authorization issued under 21
U.S.C. 360bbb-3(a).\3\
---------------------------------------------------------------------------
\1\ Pursuant to section 564(b)(4) of the FD&C Act, notice of the
determination by the Secretary of Homeland Security and the
declaration by the Secretary of Health and Human Services was
provided at 73 FR 58242 (October 6, 2008).
\2\ Pursuant to section 564(b)(4) of the FD&C Act, notices of
the renewal of the declaration of the Secretary of Health and Human
Services were provided at 74 FR 51,279 (Oct. 6, 2009) and 75 FR
61,489 (Oct. 5, 2010).
\3\ Pursuant to section 564(b)(4) of the FD&C Act, notice of the
renewal and amendment of the declaration of the Secretary of Health
and Human Services was provided at 76 FR 44,926 (July 27, 2011).
---------------------------------------------------------------------------
On the basis of the September 23, 2008 determination by the
Secretary of Homeland Security and pursuant to section 564(b) of the
FD&C Act, I hereby renew my July 20, 2011 declaration that the
emergency justifies emergency use of all oral formulations of
doxycycline accompanied by emergency use information subject to the
terms of any authorization issued under 21 U.S.C. 360bbb-3(a). I am
issuing this notice in accordance with section 564(b)(4) of the
[[Page 39709]]
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Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb-3(b)(4).
Dated: June 28, 2012.
Kathleen Sebelius,
Secretary.
[FR Doc. 2012-16531 Filed 7-3-12; 8:45 am]
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