Determination and Declaration Regarding Emergency Use of the Antiviral Product Peramivir Accompanied by Emergency Use Information, 56640-56641 [E9-26294]
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Federal Register / Vol. 74, No. 210 / Monday, November 2, 2009 / Notices
performance of functions of the FAR,
and whether it will have practical
utility; whether our estimate of the
public burden of this collection of
information is accurate, and based on
valid assumptions and methodology;
ways to enhance the quality, utility, and
clarity of the information to be
collected; and ways in which we can
minimize the burden of the collection of
information on those who are to
respond, through the use of appropriate
technological collection techniques or
other forms of information technology.
DATES: Submit comments on or before
December 2, 2009.
ADDRESSES: Submit comments regarding
this burden estimate or any other aspect
of this collection of information,
including suggestions for reducing this
burden to: FAR Desk Officer, OMB,
Room 10102, NEOB, Washington, DC
20503, and a copy to the General
Services Administration, Regulatory
Secretariat (MVPR), 1800 F Street, NW.,
Room 4041, Washington, DC 20405.
FOR FURTHER INFORMATION CONTACT:
Edward Chambers, Procurement
Analyst, Contract Policy Branch, GSA
(202) 501–3221 or e-mail
Edward.chambers@gsa.gov.
SUPPLEMENTARY INFORMATION:
A. Purpose
Firms performing under Federal costreimbursement contracts are required to
notify the contracting officer in writing
whenever they have reason to believe—
(1) The costs the contractors expect to
incur under the contracts in the next 60
days, when added to all costs previously
incurred, will exceed 75 percent of the
estimated cost of the contracts; or
(2) The total cost for the performance
of the contracts will be greater or
substantially less than estimated. As a
part of the notification, the contractors
must provide a revised estimate of total
cost.
srobinson on DSKHWCL6B1PROD with NOTICES
B. Annual Reporting Burden
Respondents: 53,456.
Responses per Respondent: 1.
Annual Responses: 53,456.
Hours per Response: .5.
Total Burden Hours: 26,728.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat (MVPR), 1800 F
Street, NW., Room 4041, Washington,
DC 20405, telephone (202) 501–4755.
Please cite OMB Control No. 9000–0074,
Contract Funding—Limitation of Costs/
Funds, in all correspondence.
VerDate Nov<24>2008
17:03 Oct 30, 2009
Jkt 220001
Dated: October 23, 2009.
Al Matera,
Director, Acquisition Policy Division.
[FR Doc. E9–26353 Filed 10–30–09; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF DEFENSE
GENERAL SERVICES
ADMINISTRATION
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
[OMB Control No. 9000–0053]
Federal Acquisition Regulation;
Submission for OMB Review; Permits,
Authorities, or Franchises Certification
Department of Defense (DOD),
General Services Administration (GSA),
and National Aeronautics and Space
Administration (NASA).
ACTION: Notice of request for public
comments regarding a reinstatement of
a previously existing OMB clearance.
AGENCIES:
SUMMARY: Under the provisions of the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35), the Federal
Acquisition Regulation (FAR)
Secretariat will be submitting to the
Office of Management and Budget
(OMB) a request to review and approve
an extension of a currently approved
information collection requirement
concerning permits, authorities, or
franchises certification. A request for
public comments was published in the
Federal Register at 74 FR 28497 on June
16, 2009.
Public comments are particularly
invited on: Whether this collection of
information is necessary for the proper
performance of functions of the FAR,
and whether it will have practical
utility; whether our estimate of the
public burden of this collection of
information is accurate, and based on
valid assumptions and methodology;
ways to enhance the quality, utility, and
clarity of the information to be
collected; and ways in which we can
minimize the burden of the collection of
information on those who are to
respond, through the use of appropriate
technological collection techniques or
other forms of information technology.
DATES: Submit comments on or before
December 2, 2009.
ADDRESSES: Submit comments regarding
this burden estimate or any other aspect
of this collection of information,
including suggestions for reducing this
burden to the General Services
Administration, Regulatory Secretariat
(MVPR), 1800 F Street, NW., Room
4041, Washington, DC 20405.
PO 00000
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FOR FURTHER INFORMATION CONTACT:
Jeritta Parnell, Procurement Analyst,
Contract Policy Branch, GSA (202) 501–
4082 or e-mail Jeritta.Parnell@gsa.gov.
SUPPLEMENTARY INFORMATION:
A. Purpose
This certification and copies of
authorizations are needed to determine
that the offeror has obtained all
authorizations, permits, etc., required in
connection with transporting the
material involved. The contracting
officer reviews the certification and any
documents requested to ensure that the
offeror has complied with all regulatory
requirements and has obtained any
permits, licenses, etc., that are needed.
B. Annual Reporting Burden
Respondents: 1,106.
Responses per Respondent: 3.
Annual Responses: 3,318.
Hours per Response: .094.
Total Burden Hours: 312.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat (MVPR), 1800 F
Street, NW., Room 4041, Washington,
DC 20405, telephone (202) 501–4755.
Please cite OMB Control No. 9000–0053,
Permits, Authorities, or Franchises
Certification, in all correspondence.
Dated: October 23, 2009.
Al Matera,
Director, Acquisition Policy Division.
[FR Doc. E9–26348 Filed 10–30–09; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Determination and Declaration
Regarding Emergency Use of the
Antiviral Product Peramivir
Accompanied by Emergency Use
Information
AGENCY:
Office of the Secretary (OS),
HHS.
ACTION:
Notice.
SUMMARY: The Secretary of Health and
Human Services (HHS) is issuing this
notice pursuant to section 564(b) of the
Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 360bbb–3(b)(4). On
April 26, 2009, the then Acting
Secretary of HHS determined that a
public health emergency exists
nationwide involving Swine Influenza
A (now known as 2009–H1N1 Influenza
A, or 2009–H1N1 influenza) that affects
or has significant potential to affect
E:\FR\FM\02NON1.SGM
02NON1
Federal Register / Vol. 74, No. 210 / Monday, November 2, 2009 / Notices
srobinson on DSKHWCL6B1PROD with NOTICES
national security. On July 24 and
October 1, 2009 the Secretary renewed
that determination of a public health
emergency. On the basis of this
determination, on October 20, 2009 the
Secretary declared an emergency
justifying the authorization of
emergency use of the antiviral product
peramivir accompanied by emergency
use information subject to the terms of
any authorization issued by the
Commissioner of Food and Drugs
(Commissioner) under 21 U.S.C.
360bbb–3(a). The Secretary also
specified that this declaration is a
declaration of emergency as defined in
the Declaration under the Public
Readiness and Emergency Preparedness
(PREP) Act for Influenza Antiviral
peramivir.
DATES: The declaration of an emergency
justifying the authorization of
emergency use of the antiviral product
peramivir is effective October 20, 2009.
FOR FURTHER INFORMATION CONTACT:
Nicole Lurie, M.D., 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:
I. Background
Under Section 564 of the FFDCA, the
Commissioner, acting under delegated
authority from the Secretary of HHS,
may issue an Emergency Use
Authorization (EUA) authorizing the
emergency use of an unapproved drug,
an unapproved or uncleared device, or
an unlicensed biological product, or an
unapproved use of an approved drug,
approved or cleared device, or licensed
biological product. Before an EUA may
be issued, the Secretary of HHS must
declare an emergency justifying the
authorization based on one of three
determinations: A determination of a
domestic emergency, or a significant
potential for a domestic emergency, by
the Secretary of Homeland Security; a
determination of a military emergency,
or a significant potential for a military
emergency, by the Secretary of Defense;
or a determination of a public health
emergency by the Secretary of HHS. See
21 U.S.C. 360bbb–3(b)(1). In the case of
a determination by the Secretary of HHS
(as was made here), the Secretary must
determine that a public health
emergency exists under section 319 of
the Public Health Service (PHS) Act that
affects, or has a significant potential to
affect, national security, and that
involves a specified biological,
VerDate Nov<24>2008
17:03 Oct 30, 2009
Jkt 220001
chemical, radiological, or nuclear agent
or agents, or a specified disease or
condition that may be attributable to
such agent or agents. Based on such a
determination, the Secretary of HHS
may then declare an emergency that
justifies the EUA, at which point the
Commissioner may issue an EUA if the
criteria for issuance of an authorization
under section 564 of the FFDCA are
met.
The Centers for Disease Control and
Prevention (CDC), HHS, requested that
the Food and Drug Administration
(FDA) issue an EUA for the antiviral
product peramivir accompanied by
emergency use information. The
determination of a public health
emergency by the Acting Secretary of
HHS, renewal of that determination by
the Secretary of HHS, and the
declarations of an emergency by the
Secretary of HHS based on that
determination, as described below,
enable the Commissioner to issue an
EUA for certain antiviral products for
emergency use under section 564(a) of
the FFDCA, 21 U.S.C. 360bbb–3(a).
II. Determination of the Acting
Secretary of Health and Human
Services and Renewal of the
Determination by the Secretary of
Health and Human Services
On April 26, 2009, pursuant to section
564(b)(1)(C) of the FFDCA, 21 U.S.C.
360bbb–3(b)(1)(A), and section 319 of
the PHS Act, 42 U.S.C. 247d, the Acting
Secretary of HHS determined, as a
consequence of confirmed cases of
Swine Influenza A (now called ‘‘2009–
H1N1 influenza’’) in California, Texas,
Kansas, and New York, and after
consultation with public health officials
as necessary, that a public health
emergency exists nationwide involving
2009–H1N1 influenza that affects or has
significant potential to affect national
security.
On July 24 and October 1, 2009
pursuant to section 564(b)(1)(C) of the
FFDCA, 21 U.S.C. 360bbb–3(b)(1)(A),
and section 319 of the PHS Act, 42
U.S.C. 247d, because the 2009–H1N1 flu
outbreak remains a worldwide public
health threat and because the
Department should use all available
tools to ensure that we are prepared,
and after consultation with public
health officials as necessary, the
Secretary renewed the April 26, 2009
determination by then Acting Secretary
Charles E. Johnson that a public health
emergency exists nationwide involving
Swine Influenza A (now called ‘‘2009–
H1N1 influenza’’) that affects or has
significant potential to affect national
security.
PO 00000
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Fmt 4703
Sfmt 4703
56641
III. Declaration of the Secretary of
Health and Human Services
On October 20, 2009, on the basis of
my renewal on July 24 and October 1,
2009, of the April 26, 2009
determination by Acting Secretary
Charles E. Johnson that a public health
emergency exists involving Swine
Influenza A (now called ‘‘2009–H1N1
influenza’’) that affects or has significant
potential to affect national security, and
pursuant to section 564(b) of the Federal
Food, Drug and Cosmetic Act, 21 U.S.C.
360bbb–3(b), I, Kathleen Sebelius,
Secretary of the U.S. Department of
Health and Human Services, hereby
declare an emergency justifying the
authorization of the emergency use of
the antiviral peramivir, accompanied by
emergency use information, subject to
the terms of any authorization issued
under 21 U.S.C. 360bbb–3(a). This
declaration is a declaration of
emergency, as defined in the
Declaration under the Public Readiness
and Emergency Preparedness Act for
Influenza Antiviral peramivir, which
was signed September 25, 2009, and any
amendments thereto.
Notice of the authorizations issued by
the FDA Commissioner under 21 U.S.C.
360bbb–3 is provided elsewhere in this
Federal Register.
Dated: October 23, 2009.
Kathleen Sebelius,
Secretary.
[FR Doc. E9–26294 Filed 10–30–09; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: OCSE–75 Tribal Child Support
Enforcement Program Annual Data
Report.
OMB No.: 0970–0320.
Description: The data collected by
form OCSE–75 are used to prepare the
OCSE preliminary and annual data
reports. In addition, Tribes
administering CSE programs under Title
IV–D of the Social Security Act are
required to report program status and
accomplishments and submit the
OCSE–75 report annually.
Respondents: Tribal Child Support
Enforcement Organizations or the
Department/Agency/Bureau responsible
for Child Support Enforcement in each
Tribe.
E:\FR\FM\02NON1.SGM
02NON1
]]>Agencies
[Federal Register Volume 74, Number 210 (Monday, November 2, 2009)]
[Notices]
[Pages 56640-56641]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-26294]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Determination and Declaration Regarding Emergency Use of the
Antiviral Product Peramivir Accompanied by Emergency Use Information
AGENCY: Office of the Secretary (OS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Secretary of Health and Human Services (HHS) is issuing
this notice pursuant to section 564(b) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 360bbb-3(b)(4). On April 26, 2009, the
then Acting Secretary of HHS determined that a public health emergency
exists nationwide involving Swine Influenza A (now known as 2009-H1N1
Influenza A, or 2009-H1N1 influenza) that affects or has significant
potential to affect
[[Page 56641]]
national security. On July 24 and October 1, 2009 the Secretary renewed
that determination of a public health emergency. On the basis of this
determination, on October 20, 2009 the Secretary declared an emergency
justifying the authorization of emergency use of the antiviral product
peramivir accompanied by emergency use information subject to the terms
of any authorization issued by the Commissioner of Food and Drugs
(Commissioner) under 21 U.S.C. 360bbb-3(a). The Secretary also
specified that this declaration is a declaration of emergency as
defined in the Declaration under the Public Readiness and Emergency
Preparedness (PREP) Act for Influenza Antiviral peramivir.
DATES: The declaration of an emergency justifying the authorization of
emergency use of the antiviral product peramivir is effective October
20, 2009.
FOR FURTHER INFORMATION CONTACT: Nicole Lurie, M.D., 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:
I. Background
Under Section 564 of the FFDCA, the Commissioner, acting under
delegated authority from the Secretary of HHS, may issue an Emergency
Use Authorization (EUA) authorizing the emergency use of an unapproved
drug, an unapproved or uncleared device, or an unlicensed biological
product, or an unapproved use of an approved drug, approved or cleared
device, or licensed biological product. Before an EUA may be issued,
the Secretary of HHS must declare an emergency justifying the
authorization based on one of three determinations: A determination of
a domestic emergency, or a significant potential for a domestic
emergency, by the Secretary of Homeland Security; a determination of a
military emergency, or a significant potential for a military
emergency, by the Secretary of Defense; or a determination of a public
health emergency by the Secretary of HHS. See 21 U.S.C. 360bbb-3(b)(1).
In the case of a determination by the Secretary of HHS (as was made
here), the Secretary must determine that a public health emergency
exists under section 319 of the Public Health Service (PHS) Act that
affects, or has a significant potential to affect, national security,
and that involves a specified biological, chemical, radiological, or
nuclear agent or agents, or a specified disease or condition that may
be attributable to such agent or agents. Based on such a determination,
the Secretary of HHS may then declare an emergency that justifies the
EUA, at which point the Commissioner may issue an EUA if the criteria
for issuance of an authorization under section 564 of the FFDCA are
met.
The Centers for Disease Control and Prevention (CDC), HHS,
requested that the Food and Drug Administration (FDA) issue an EUA for
the antiviral product peramivir accompanied by emergency use
information. The determination of a public health emergency by the
Acting Secretary of HHS, renewal of that determination by the Secretary
of HHS, and the declarations of an emergency by the Secretary of HHS
based on that determination, as described below, enable the
Commissioner to issue an EUA for certain antiviral products for
emergency use under section 564(a) of the FFDCA, 21 U.S.C. 360bbb-3(a).
II. Determination of the Acting Secretary of Health and Human Services
and Renewal of the Determination by the Secretary of Health and Human
Services
On April 26, 2009, pursuant to section 564(b)(1)(C) of the FFDCA,
21 U.S.C. 360bbb-3(b)(1)(A), and section 319 of the PHS Act, 42 U.S.C.
247d, the Acting Secretary of HHS determined, as a consequence of
confirmed cases of Swine Influenza A (now called ``2009-H1N1
influenza'') in California, Texas, Kansas, and New York, and after
consultation with public health officials as necessary, that a public
health emergency exists nationwide involving 2009-H1N1 influenza that
affects or has significant potential to affect national security.
On July 24 and October 1, 2009 pursuant to section 564(b)(1)(C) of
the FFDCA, 21 U.S.C. 360bbb-3(b)(1)(A), and section 319 of the PHS Act,
42 U.S.C. 247d, because the 2009-H1N1 flu outbreak remains a worldwide
public health threat and because the Department should use all
available tools to ensure that we are prepared, and after consultation
with public health officials as necessary, the Secretary renewed the
April 26, 2009 determination by then Acting Secretary Charles E.
Johnson that a public health emergency exists nationwide involving
Swine Influenza A (now called ``2009-H1N1 influenza'') that affects or
has significant potential to affect national security.
III. Declaration of the Secretary of Health and Human Services
On October 20, 2009, on the basis of my renewal on July 24 and
October 1, 2009, of the April 26, 2009 determination by Acting
Secretary Charles E. Johnson that a public health emergency exists
involving Swine Influenza A (now called ``2009-H1N1 influenza'') that
affects or has significant potential to affect national security, and
pursuant to section 564(b) of the Federal Food, Drug and Cosmetic Act,
21 U.S.C. 360bbb-3(b), I, Kathleen Sebelius, Secretary of the U.S.
Department of Health and Human Services, hereby declare an emergency
justifying the authorization of the emergency use of the antiviral
peramivir, accompanied by emergency use information, subject to the
terms of any authorization issued under 21 U.S.C. 360bbb-3(a). This
declaration is a declaration of emergency, as defined in the
Declaration under the Public Readiness and Emergency Preparedness Act
for Influenza Antiviral peramivir, which was signed September 25, 2009,
and any amendments thereto.
Notice of the authorizations issued by the FDA Commissioner under
21 U.S.C. 360bbb-3 is provided elsewhere in this Federal Register.
Dated: October 23, 2009.
Kathleen Sebelius,
Secretary.
[FR Doc. E9-26294 Filed 10-30-09; 8:45 am]
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