Published 60d FRN

41079

Federal Register / Vol. 72, No. 143 / Thursday, July 26, 2007 / Notices
ESTIMATE OF ANNUALIZED BURDEN HOURS—Continued
Average
burden per
response
(in hours)

Total burden
hours

High Risk Inpatient Influenza Vaccine—Summary Form Method A ...............
High Risk Inpatient Influenza Vaccine-Numerator Data Form Method B .......
High Risk Inpatient Influenza Vaccine—Summary Form Method B ...............
High Risk Inpatient Influenza Vaccine—Denominator Data Form Method B
Laboratory Identified MDRO Event—Summary Form .....................................
Long-term Acute Care Hospital Survey ...........................................................

1,500
500
500
500
1,500
75

5
250
5
250
3
1

16
10/60
4
5/60
1
30/60

120,000
20,833
10,000
10,417
4,500
38

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

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

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

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

1,276,153

Dated: July 19, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–14432 Filed 7–25–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–07–0106]

Proposed Data Collections Submitted
for Public Comment and
Recommendations

rwilkins on PROD1PC63 with NOTICES

Average
number of
responses per
respondent

Number of
respondents

Form

In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Maryam I. Daneshvar,
CDC Acting Reports Clearance Officer,
1600 Clifton Road, MS–D74, Atlanta,
GA 30333 or send an e-mail to
[email protected].
Comments are invited 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)
ways to enhance 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. Written comments should

VerDate Aug<31>2005

17:41 Jul 25, 2007

Jkt 211001

be received within 60 days of this
notice.
Proposed Project
Preventive Health and Health Services
Block Grant, Annual Application and
Reports—Revision—National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
In 1994, OMB approved the collection
of information provided in the grant
applications and annual reports for the
Preventive Health and Health Services
Block Grant (OMB #0920–0106). This
approval expires on October 31, 2008.
* * * CDC is requesting OMB clearance
for this legislatively mandated
information collection until January 31,
2011. The request is to approve the
development and adherence to Healthy
People 2010, the Nation’s Health
Objectives which was released the
Spring of 2000. The PHHS block grant
is mandated according to section 1904
to adhere to the Healthy People
framework, therefore, the current
application and report format was
restructured to coincide with 2010.
This information collected through
the applications from the official State
health agencies is required from section
1905 of the Public Health Service Act.
The information collected from the
annual reports is required by section
1906. * * * The data collection tool is
being moved from software that is
installed to each user’s desktop to a
web-based system. The following
changes will be incorporated into the
web-based system: (1) Applications are
referred to as Work Plans, (2) Grantees
are asked to submit Work Plans within
recommended page ranges based on the
amount of funding with the objective of
reducing the number of pages submitted
per grantee, (3) Review functions have
been added to the Work Plan, Success
Stories, and Annual Report sections, (4)
The rationale that was used by the
Preventive Health and Health Services

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Block Grant (PHHSBG) Advisory
Committee to prioritize use of PHHSBG
funds is identified via check boxes
versus a free form text field, (5)
Information is captured relative to the
percent of time dedicated to the
PHHSBG by the Block Grant
Coordinator and other Full Time
Equivalents (FTEs) that are paid for in
whole or in part with Block Grant
dollars, (6) Grantees select the Evidence
Based Guideline or Best Practice that is
used as the basis for interventions from
a pre-defined list, (7) Grantees select the
CDC Goals that are being addressed with
Block Grant Funds from a pre-defined
list and identify the location wherein
the funds are being applied, (8)
Information items are broken down into
discrete fields, for example, specific
begin and end dates are entered for
objectives and activities, and the
components for a SMART (Specific
Measurable Achievable, Realistic and
Time based) objective are entered
individually versus via free form text
fields, (9) Grantees select a percent from
a pre-defined list in the Annual Report
section to identify the extent to which
objectives and activities have been
accomplished. Written detail is
provided only for those items that are
‘exceptions’ to projected outcomes, (10)
A Compliance Review section has been
added to provide grantees with general
information regarding the Compliance
Review process and specific information
that pertains to past reviews of their
state/territory/tribe.
The total burden hours is estimated at
3355 hours, a reduction of 915 hours
below the previous data collection
estimate (4270). The number of hours is
equal to 61 grantees × 25 hours (1525
hrs) for completion of the application
and 61 grantees × 30 hours (1830 hrs)
for completion of the annual report.
Respondent burden is based upon
experience with the Grant Application
and Reporting system that is used to
complete applications and annual
reports.

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41080

Federal Register / Vol. 72, No. 143 / Thursday, July 26, 2007 / Notices

There are no costs to respondents
except their time to participate in the
survey.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hrs.)

Total burden
(in hours)

Form name

Grantees ...........................................

Annual Application ...........................
Annual Report ..................................

61
61

1
1

25
30

1525
1830

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

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

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

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

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

3355

Dated: July 20, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–14439 Filed 7–25–07; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Committee for Injury
Prevention and Control (ACIPC),
Science and Program Review
Subcommittee
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces, the following meeting for
the aforementioned committee and
subcommittee:

rwilkins on PROD1PC63 with NOTICES

Number of
responses per
respondent

Number of
respondents

Respondents

Name: Science and Program Review
Subcommittee (SPRS).
Times and Date: 11:30 a.m.–11:35 a.m.,
August 20, 2007 (Open). 11:35 a.m.–12:30
p.m., August 20, 2007 (Closed).
Place: CDC, Koger Center, Vanderbilt
Building, Room 1006, 2939 Flowers Road,
Atlanta, Georgia 30341–3724.
Purpose: The subcommittee provides
advice on the needs, structure, progress, and
performance of programs in the National
Center for Injury Prevention and Control
(NCIPC).
Matters To Be Discussed: The
subcommittee will have a secondary review,
discussion, and evaluation on the individual
research grant and cooperative agreement
applications submitted in response to the two
Fiscal Year 2007 Requests for Applications
(RFAs) related to the following individual
research announcements: RFA–CE–05–020,
Youth Violence Prevention through
Community-Level Change; and RFA–CE–07–
011, Multi-Level Parent Training
Effectiveness Trial—Phase II (U49).
Following this meeting, the voting
members of ACIPC will meet via
teleconference to vote on the
recommendations of the SPRS regarding the
RFAs.

VerDate Aug<31>2005

16:36 Jul 25, 2007

Jkt 211001

Name: Advisory Committee for Injury
Prevention and Control.
Times and Date: 12:30 p.m.–12:55 p.m.,
August 20, 2007 (Open). 12:55 p.m.–1:30
p.m., August 20, 2007 (Closed).
Place: CDC, Koger Center, Vanderbilt
Building, Room 1006, 2939 Flowers Road,
Atlanta, Georgia 30341–3724.
Purpose: The committee advises and makes
recommendations to the Secretary,
Department of Health and Human Services,
the Director, CDC, and the Director, NCIPC
regarding feasible goals for the prevention
and control of injury. The committee makes
recommendations regarding policies,
strategies, objectives, and priorities, and
reviews progress toward injury prevention
and control.
Matters To Be Discussed: Agenda items for
the open portion include the call to order and
introductions and request for public
comments. The committee will vote on the
results of the secondary review. This portion
of the meeting will be closed to the public
in accordance with the provisions set forth in
section 552b(c)(4) and (b), title 5 U.S.C., and
the Determination of the Acting Director,
Management Analysis and Services Office,
CDC pursuant to Public Law 92–463.
Agenda items are subject to change as
priorities dictate.
For Further Information Contact: Ms. Amy
Harris, Executive Secretary, ACIPC, NCIPC,
CDC, 4770 Buford Highway, NE., M/S K61,
Atlanta, Georgia 30341–3724, Telephone
(770) 488–4936.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: July 17, 2007.
Elaine L. Baker,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E7–14430 Filed 7–25–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0290]

Draft Guidance for Industry: Cell
Selection Devices for Point of Care
Production of Minimally Manipulated
Autologous Peripheral Blood Stem
Cells; Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft document entitled
‘‘Guidance for Industry: Cell Selection
Devices for Point of Care Production of
Minimally Manipulated Autologous
Peripheral Blood Stem Cells (PBSCs)’’
dated July 2007. The draft guidance
document discusses certain cell
selection devices that minimally
manipulate autologous PBSCs at the
point of care for specific clinical
indications, and the applicability of the
requirements to such PBSCs. The
guidance also discusses the submission
of data intended to support approval of
cell selection devices.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance submit
written or electronic comments on the
draft guidance by October 24, 2007.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448.
Send one self-addressed adhesive label
to assist the office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–

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