Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Appeals of Science-Based Decisions Above the Division Level at the Center for Veterinary Medicine, 36331-36332 [E8-14515]
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36331
Federal Register / Vol. 73, No. 124 / Thursday, June 26, 2008 / Notices
Estimated Total Annual Burden
Hours: 125
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. E-mail 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: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: June 18, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–14161 Filed 6–25–08; 8:45 am]
BILLING CODE 4184–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Office of Refugee Resettlement;
Unaccompanied Alien Children Shelter
Care Facilities
Office of Refugee Resettlement,
ACF, DHHS.
AGENCY:
Notice to award ten noncompetitive supplements to existing
Unaccompanied Alien Children (UAC)
Shelter Care Facilities.
ACTION:
CFDA #: 93.676.
Legslative Authority: The Office of
Refugee Resettlement (ORR) is
mandated by Section 462 of the
Homeland Security Act to ensure
appropriate placement of all
unaccompanied alien children referred
to ORR for care and custody by the
Department of Homeland Security
(DHS).
Amount of Award: $2,521,320.
SUMMARY: This notice announces that
the Administration for Children and
Families (ACF), Office of Refugee
Resettlement intends to award ten
unaccompanied alien shelter care
providers in the amount of $2,521,320.
This funding will support services
through September 30, 2008.
Location
Southwest Key—El Paso ..............................
The Children’s Village ...................................
Florence Crittenton .......................................
Lutheran Social Services of the South .........
Heartland/ICC ...............................................
Southwest Indiana Youth Village ..................
International Educational Services—Foster
Care.
International Educational Services—Foster
Care.
Pioneer Services ...........................................
Southwest Key—Pleasant Hill ......................
rfrederick on PROD1PC67 with NOTICES
Grantee
El Paso, TX ..................................................
New York, NY ...............................................
Los Angeles, CA ..........................................
Austin, TX .....................................................
Chicago, IL ...................................................
Vincennes, IN ...............................................
Brownsville, TX .............................................
06/10/08–09/30/08
06/10/08–09/30/08
06/10/08–09/30/08
06/10/08–09/30/08
06/10/08–09/30/08
06/10/08–09/30/08
06/10/08–09/30/08
$390,320
445,000
336,000
600,000
325,000
120,000
90,000
Harlingen, TX ...............................................
06/10/08–09/30/08
70,000
Fife, WA ........................................................
Pleasant Hill, CA ..........................................
06/10/08–09/30/08
06/10/08–09/30/08
85,000
60,000
This funding will support the
expansion of shelter/foster/staff secure/
secured/therapeutic care program bed
capacity to meet the number of
unaccompanied alien children referrals
from the Department of Homeland
Security (DHS). This expansion is
necessary to replace bed capacity
discontinued at several sites as well as
to accommodate the increase of length
of stay of UAC in ORR’s care. This
supplemental funding will support the
additional bed capacity through the
summer high season, terminating at the
end of the 2008 fiscal year.
To ensure the program would have
complete flexibility to expand and
contract to meet the ever-changing
demands of the program, ORR
specifically included language in its
program announcement to stipulate that
funding and capacity may increase
based on the needs of the program. The
program has very specific requirements
for the provision of services. Existing
grantees are the only entities with the
infrastructure, licensing, experience and
appropriate level of trained staff to meet
VerDate Aug<31>2005
15:05 Jun 25, 2008
Jkt 214001
Project period
the service requirements and the urgent
need for expansion. The program’s
ability to avoid a backlog of children
waiting in border patrol stations for
placement can only be accommodated
through the expansion of existing
programs through this supplemental
award process.
FOR FURTHER INFORMATION CONTACT:
Kenneth Tota, Office of Refugee
Resettlement, Administration for
Children and Families, 370 L’Enfant
Promenade, SW., Washington, DC
20447, telephone (202) 401–4858.
Dated: June 17, 2008.
David H. Siegel,
Acting Director, Office of Refugee
Resettlement.
[FR Doc. E8–14429 Filed 6–25–08; 8:45 am]
BILLING CODE 4184–01–P
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Amount
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0173]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Appeals of
Science-Based Decisions Above the
Division Level at the Center for
Veterinary Medicine
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 July 28,
2008.
E:\FR\FM\26JNN1.SGM
26JNN1
36332
Federal Register / Vol. 73, No. 124 / Thursday, June 26, 2008 / Notices
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
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0566. 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 the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
collection of information to OMB for
review and clearance.
Appeals of Science-Based Decisions
Above the Division Level at the Center
for Veterinary Medicine (OMB Control
Number 0910–0566)—Extension
CVM’s (Center for Veterinary
Medicine) ‘‘Guidance for Industry #79—
Dispute Resolution Procedures for
Science-Based Decisions on Products
Regulated by the Center for Veterinary
Medicine’’ describes the process by
which CVM formally resolves disputes
relating to scientific controversies. A
scientific controversy involves issues
concerning a specific product regulated
by CVM related to matters of technical
expertise and requires specialized
education, training or experience to be
understood and resolved. Further, the
guidance details information on how the
agency intends to interpret and apply
provisions of the existing regulations
regarding internal agency review of
decisions. In addition, the guidance
outlines the established recommended
procedures for persons who are
applicants, including sponsor
applicants or manufacturers, for animal
drugs or other products regulated by
CVM, that wish to submit a request for
review of a scientific dispute. When an
applicant has a scientific disagreement
and a written decision by CVM, the
applicant may submit a request for
review of that decision by following the
established agency channels of
supervision for review.
Respondents to this collection of
information are applicants that wish to
submit a request for review of a
scientific dispute.
In the Federal Register of March 26,
2008 (73 FR 16021), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
respondents
21 CFR section
10.75
2
1There
Dated: June 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–14515 Filed 6–25–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Hematology and Pathology Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting
rfrederick on PROD1PC67 with NOTICES
Total annual
responses
4
Hours per
response
8
Total hours
10
80
are no capital costs or operating and maintenance costs associated with this collection of information.
This estimated annual reporting
burden is based on CVM’s experience
over the past 3 years in handling formal
appeals for scientific disputes. The
number of respondents multiplied by
the annual frequency of response equals
the total annual responses. The number
of hours per response is based on
discussions with industry and may vary
depending on the complexity of the
issue(s) involved and the duration of the
appeal process.
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Annual frequency
per response
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
VerDate Aug<31>2005
15:05 Jun 25, 2008
Jkt 214001
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Hematology and
Pathology Devices Panel of the Medical
Devices Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on July 18, 2008, from 8 a.m. to 5
p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B, and C,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Louise E. Magruder,
Center for Devices and Radiological
Health (HFZ–440), Food and Drug
Administration, 2098 Gaither Rd.,
Rockville, MD 20850, 240–276–1248, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014512515. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
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about possible modifications before
coming to the meeting.
Agenda: The committee will discuss
and make recommendations on issues
relevant to the potential for automated
differential cell counters being waived
under the Clinical Laboratory
Improvement Amendments of 1988. The
discussion will include pre-analytical,
analytical, and post-analytical issues
associated with performing automated
hematology complete blood counts and
differentials in a waived setting. (See
www.fda.gov/cdrh/oivd/guidance/
1171.html).
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the
year 2008 and scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
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]]>Agencies
[Federal Register Volume 73, Number 124 (Thursday, June 26, 2008)]
[Notices]
[Pages 36331-36332]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-14515]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0173]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Appeals of Science-
Based Decisions Above the Division Level at the Center for Veterinary
Medicine
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 July
28, 2008.
[[Page 36332]]
ADDRESSES: 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 baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0566. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Appeals of Science-Based Decisions Above the Division Level at the
Center for Veterinary Medicine (OMB Control Number 0910-0566)--
Extension
CVM's (Center for Veterinary Medicine) ``Guidance for Industry
79--Dispute Resolution Procedures for Science-Based Decisions
on Products Regulated by the Center for Veterinary Medicine'' describes
the process by which CVM formally resolves disputes relating to
scientific controversies. A scientific controversy involves issues
concerning a specific product regulated by CVM related to matters of
technical expertise and requires specialized education, training or
experience to be understood and resolved. Further, the guidance details
information on how the agency intends to interpret and apply provisions
of the existing regulations regarding internal agency review of
decisions. In addition, the guidance outlines the established
recommended procedures for persons who are applicants, including
sponsor applicants or manufacturers, for animal drugs or other products
regulated by CVM, that wish to submit a request for review of a
scientific dispute. When an applicant has a scientific disagreement and
a written decision by CVM, the applicant may submit a request for
review of that decision by following the established agency channels of
supervision for review.
Respondents to this collection of information are applicants that
wish to submit a request for review of a scientific dispute.
In the Federal Register of March 26, 2008 (73 FR 16021), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual frequency Total annual Hours per
21 CFR section respondents per response responses response Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
10.75 2 4 8 10 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
This estimated annual reporting burden is based on CVM's experience
over the past 3 years in handling formal appeals for scientific
disputes. The number of respondents multiplied by the annual frequency
of response equals the total annual responses. The number of hours per
response is based on discussions with industry and may vary depending
on the complexity of the issue(s) involved and the duration of the
appeal process.
Dated: June 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14515 Filed 6-25-08; 8:45 am]
BILLING CODE 4160-01-S
