60 Day FR Notice

59544

Federal Register / Vol. 74, No. 221 / Wednesday, November 18, 2009 / Notices
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For Further Information Contact:
Sandra M. Peay, Contact Representative,
or Renee Hallman, Contact
Representative, Federal Trade
Commission, Premerger Notification
Office, Bureau of Competition, Room H–
303, Washington, DC 20580, (202) 326–
3100.
By Direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. E9–27413 Filed 11–17–09; 8:45 am]

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Party name
Intuit Inc.
Mint Software Inc.
Mint Software Inc.
Clayton, Dubilier & Rice Fund VIII, L.P.
Appointive Distributing Trust B u/a Samuel Johnson, 1988 T#1.
JohnsonDiversey Holdings, Inc.
Emerson Electric Co.
Avocent Corporation.
Avocent Corporation.
Oak Hill Capital Partners Ill, L.P.
ODN Holding Corporation.
ODN Holding Corporation.
Macquarie Group Limited.
Fox-Pitt Kelton Cochran Caronia, Waller LLC
Fox-Pitt Kelton Cochran Caronia Waller LLC.
GrainCorp Limited.
United Malt Holdings LP.
Malt U.K. Holdco Limited.
Malt Luxco S.a.r.l.
Malt U.S. Holdco, Inc.
Iconix Brand Group, Inc.
Seth Gerszberg.
Yakira, L.L.C.
Iconix Brand Group, Inc.
Marc Ecko.
Yakira, L.L.C.
Macquarie Group Limited.
Lincoln National Corporation.
Delaware Management Holdings, Inc.
AOl Bedding Super Holdings, LLC.
Thomas H. Lee Equity Fund V, L.P.
THL–SC Bedding Company.
Bayer AG.
Athenix Corp.
Athenix Corp.
Abbott Laboratories.
Evalve, Inc.
Evalve, Inc.
ViaSat, Inc.
WildBIue Holding, Inc.
WildBlue Holding, Inc.
Schering-Plough Corporation.
Merck & Co., Inc.
Merck & Co., Inc.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Request for Public Comment: 60-Day
Proposed Information Collection:
Office of Urban Indian Health
Programs Uniform Data System
Indian Health Service.
Notice.

AGENCY:
ACTION:

SUMMARY: In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 which requires
60 day advance opportunity for public
comment on proposed information
collection projects, the Indian Health
Service (IHS) is publishing for comment
a summary of a proposed information
collection to be submitted to the Office
of Management and Budget (OMB) for
review.

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Proposed Collection: Title: Office of
Urban Indian Health Programs (OUIHP)
Uniform Data System (UDS). Type of
Information Collection Request: Initial
request and four year extension, for data
collection to ensure compliance with
legislative mandates and report to
Congress and policymakers on program
accomplishments. Form Number(s):
New data collection. There are currently
no form numbers. Reporting formats are
contained in the UDS Instruction
Manual. Need and Use of Information
Collection: The Uniform Data System
(UDS) contains the annual reporting
requirements for the cluster of primary
health care and case management/
outreach and referral grantees funded by
the IHS. The UDS includes reporting
requirements for grantees of the OUIHP.
The authorizing statute is Title V of
Public Law 94–437, of the Indian Health
Care Improvement Act, as amended. IHS

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Federal Register / Vol. 74, No. 221 / Wednesday, November 18, 2009 / Notices
will collect data in the UDS which will
be used to ensure compliance with the
legislative mandates and report to
Congress and policymakers on program
accomplishments. To meet these
objectives, the OUIHP requires a core set
of data collected annually that is

appropriate for monitoring and
evaluating performance and reporting
on annual trends. Affected Public: Title
V funded Urban Indian health programs.
Type of Respondents: Title V Urban
Indian health programs.
Responses
per respondent

Number of
respondents

Data collection instrument(s)

Total annual
responses

59545

The table below provides: Types of
data collection instruments, Number of
respondents, Response per respondent,
Total annual responses, Average burden
hour per response, and Total annual
burden hours.

Average burden hour per response *

Total annual
burden hours

Universal Report ...............................
American Indian/Alaska Native Report.

34
34

1
1

34
34

8.00 (480 min) ..................................
8.00 (480 min) ..................................

272
272

Total ...........................................

68

........................

........................

...........................................................

544

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* For ease of understanding, burden hours are also provided in actual minutes.

There are no Capital Costs, Operating
Costs, and/or Maintenance Costs to
report.
Request for Comments: Your written
comments and/or suggestions are
invited on one or more of the following
points: (a) Whether the information
collection activity is necessary to carry
out an agency function; (b) whether the
agency processes the information
collected in a useful and timely fashion;
(c) the accuracy of public burden
estimate (the estimated amount of time
needed for individual respondents to
provide the requested information); (d)
whether the methodology and
assumptions used to determine the
estimate are logical; (e) ways to enhance
the quality, utility, and clarity of the
information being collected; and (f)
ways to minimize the public burden
through the use of automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Send Comments and Requests for
Further Information: Send your written
comments and requests for more
information on the proposed collection
or requests to obtain a copy of the data
collection instrument(s) and
instructions to: Ms. Betty Gould,
Reports Clearance Officer, 801
Thompson Avenue, TMP, Suite 450,
Rockville, MD 20852; call non-toll free
(301) 443–7899; send via facsimile to
(301) 443–9879; or send your e-mail
requests, comments, and return address
to: [email protected].
Comment Due Date: Your comments
regarding this information collection are
best assured of having full effect if
received within 60 days of the date of
this publication.
Dated: November 10, 2009.
Yvette Roubideaux,
Director, Indian Health Service.
[FR Doc. E9–27540 Filed 11–17–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES

collection of information to OMB for
review and clearance.

Food and Drug Administration

Infectious Disease Issues in
Xenotransplantation—(OMB Control
Number 0910–0456)—Extension

[Docket No. FDA–2009–N–0291]

Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Infectious Disease
Issues in Xenotransplantation
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
18, 2009.
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
[email protected]. All
comments should be identified with the
OMB control number 0910–0456. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Liz
Berbakos, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3792,
[email protected].

In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed

SUPPLEMENTARY INFORMATION:

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The statutory authority to collect this
information is provided under sections
351 and 361 of the Public Health
Service (PHS) Act (42 U.S.C. 262 and
264) and the provisions of the Federal
Food, Drug, and Cosmetic Act that
apply to drugs (21 U.S.C. 301 et seq.).
The PHS guideline recommends
procedures to diminish the risk of
transmission of infectious agents to the
xenotransplantation product recipient
and to the general public. The PHS
guideline is intended to address public
health issues raised by
xenotransplantation, through
identification of general principles of
prevention and control of infectious
diseases associated with
xenotransplantation that may pose a
hazard to the public health. The
collection of information described in
this guideline is intended to provide to
sponsors general guidance on the
following topics: (1) The development
of xenotransplantation clinical
protocols, (2) the preparation of
submissions to FDA, and (3) the
conduct of xenotransplantation clinical
trials. Also, the collection of
information will help ensure that the
sponsor maintains important
information in a cross-referenced system
that links the relevant records of the
xenotransplantation product recipient,
xenotransplantation product, source
animal(s), animal procurement center,
and significant nosocomial exposures.
The PHS guideline describes an
occupational health service program for
the protection of health care workers
involved in xenotransplantation
procedures, caring for
xenotransplantation product recipients,

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