Proposed Information Collection Activity; Comment Request, 56641-56642 [E9-26315]
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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,
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17:03 Oct 30, 2009
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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.
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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]
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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.
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56642
Federal Register / Vol. 74, No. 210 / Monday, November 2, 2009 / Notices
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
OCSE–75 .........................................................................................................
Estimated Total Annual Burden
Hours: 2,160.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded 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. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: October 28, 2009.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. E9–26315 Filed 10–30–09; 8:45 am]
srobinson on DSKHWCL6B1PROD with NOTICES
BILLING CODE 4184–01–P
36
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0360]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food and Drug
Administration Public Health
Notification Readership Survey
(Formerly Known as ‘‘Safety Alert/
Public Health Advisory Readership
Survey’’)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by December
2, 2009.
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0341. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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Number of
responses per
respondent
1
Average
burden hours
per response
60
Total burden
hours
2,160
FDA Public Health Notification
Readership Survey (formerly known as
Safety Alert/Public Health Advisory
Readership Survey) (PHS Act, Section
1701(a)(4)); (OMB Control Number
0910–0341—Extension)
Section 705(b) of the Federal Food
Drug and Cosmetic Act (the act) (21
U.S.C. 375(b)) authorizes FDA to
disseminate information concerning
imminent danger to public health by
any regulated product. The Center for
Devices and Radiological Health
(CDRH), communicates these risks to
user communities through two
publications: (1) The Public Health
Notification (PHN) and (2) the
Preliminary Public Health Notification
(PPHN). The PHN is published when
CDRH has information or a message to
convey to health care practitioners that
they would want to know in order to
make informed clinical decisions about
the use of a device or device type, and
that information may not be readily
available to the affected target audience
in the health care community. CDRH
can make recommendations that will
help the health care practitioner
mitigate or avoid the risk.
The PPHN is also published when
CDRH has information to convey to
health care practitioners that they
would want to know in order to make
informed clinical decisions about the
use of a device or device type. However,
two additional conditions exist that
make the use of this type of notification
preferable: (1) CDRH’s understanding of
the problem, its cause(s), and the scope
of the risk that is still evolving, so that
in order to minimize the risk, the center
believes that health care practitioners
needs the information they can provide,
however incomplete, as soon as possible
and (2) the problem is actively being
investigated by the center, private
industry, another agency or some other
reliable entity, so that the center expects
to be able to update the PPHN when
definitive new information becomes
available. Notifications are sent to
organizations affected by risks discussed
in the notification, such as hospitals,
nursing homes, hospices, home health
care agencies, retail pharmacies, and
other health care providers. Through a
process for identifying and addressing
postmarket safety issues related to
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[Federal Register Volume 74, Number 210 (Monday, November 2, 2009)]
[Notices]
[Pages 56641-56642]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-26315]
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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.
[[Page 56642]]
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
OCSE-75......................................... 36 1 60 2,160
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 2,160.
In compliance with the requirements of Section 506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
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. E-mail
address: infocollection@acf.hhs.gov. All requests should be identified
by the title of the information collection.
The Department specifically requests comments on: (a) Whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden of the collection
of information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Dated: October 28, 2009.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. E9-26315 Filed 10-30-09; 8:45 am]
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