Attachment 10 - Federal Register Notice - 60 day

76342

Federal Register / Vol. 71, No. 244 / Wednesday, December 20, 2006 / Notices

Respondents & percent of form name use

ATSDR
ATSDR
ATSDR
ATSDR
ATSDR
ATSDR

Web
Web
Web
Web
Web
Web

site
site
site
site
site
site

Visitors
Visitors
Visitors
Visitors
Visitors
Visitors

Number of responses per
respondent

Number of
respondents

Average
burden per
response
(in hours)

Total burden
(in hours)

(50%) ............................................
(15%) ............................................
(15%) ............................................
(5%) ..............................................
(8%) ..............................................
(7%) ..............................................

WSUS .........
TPUS ...........
TFUS ...........
PHSUS ........
TCCUS ........
TP–CDUS ...

1,000
300
300
100
160
140

1
1
1
1
1
1

5/60
5/60
5/60
5/60
5/60
5/60

83
25
25
8
13
12

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

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

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

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

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

166

Dated: December 14, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E6–21718 Filed 12–19–06; 8:45 am]
BILLING CODE 4163–18–P

Centers for Disease Control and
Prevention
[60Day–07–06BU]

Proposed Data Collections Submitted
for Public Comment and
Recommendations
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 Seleda Perryman,
CDC Assistant 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

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20:03 Dec 19, 2006

Jkt 211001

on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
The Effectiveness of Teen Safe
Driving Messages and Creative Elements
on Parents and Teens—New—National
Center for Injury Prevention and Control
(NCIPC), Centers for Disease Control
and Prevention (CDC).

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

sroberts on PROD1PC70 with NOTICES

Form name

Background and Brief Description
Car crashes are the number one killer
of teens, accounting for approximately
one-third of all deaths within this age
group. The National Center for Health
Statistics reports that in 2004, a total of
3,620 young drivers were killed and an
additional 303,000 were injured in
motor vehicle crashes.
In order to reduce these preventable
deaths and injuries, parental awareness
and education about Graduated Driver’s
Licensing (GDL) laws and the ways that
parents can influence their children’s
safe driving are necessary. In
preparation for a national campaign to
educate parents about their role in their
teens’ driver education, it is necessary
to determine the most effective
messages and channels through which
to communicate with parents.
Ogilvy Public Relations Worldwide,
on behalf of CDC, will conduct two
studies to assess the appropriateness
and impact of messages and creative
materials intended to (a) increase
parental involvement in their teen’s
driving education and experience, and
(b) encourage teens to adopt safer
driving practices.
The first information collection will
be accomplished through focus group
testing of campaign messages and

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materials with representatives from our
target audiences, parents and teens, in
two cities in the U.S. The findings will
provide valuable information regarding
parents’ and teens’ levels of awareness
and concern about safe driving;
motivators for behavior change,
especially GDL compliance; and
message/channel preferences. The
information collected will be used to
develop final creative materials to
implement the teen safe driving
campaign in pilot cities.
The second information collection
will be accomplished through pilot city
testing, which will evaluate knowledge,
attitude and behaviors of intended
audiences both pre- and postcommunications campaign. The
campaign will target parents of newlylicensed drivers. It will encourage
parents to understand state regulations
regarding new drivers, talk with their
teens about safe driving practices, and
both manage and monitor their teens’
driving behavior. Testing will be
conducted through brief telephone
surveys intended to assess knowledge,
attitudes and behaviors of parents and
teens related to safe driving practices,
GDL laws, and parental management of
new drivers before and after the
campaign; with the goal of observing a
marked increase in parental
management at the time of the postcampaign survey. CDC anticipates
screening 1,777 individuals and that
45% of these will qualify for the survey
testing. Pending CDC’s decision whether
or not to include teens in survey testing,
the breakdown of the groups shown in
the tables below may change. However,
the total number of respondents and
screeners will remain the same.
There is no cost to the respondents
other than their time.
Estimated Annualized Burden Hours:

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76343

Federal Register / Vol. 71, No. 244 / Wednesday, December 20, 2006 / Notices
PHASE 1.—FOCUS GROUP TESTING
Estimated
number of responses per
respondent

Estimated
number of
respondents

Type of respondents

Average
burden per response
(in hours)

Annual total
burden
requested
(in hours)

Rejected Screeners .........................................................................................
Accepted Screeners ........................................................................................
Parents .............................................................................................................
Teens ...............................................................................................................

152
48
32
16

1.0
1.0
1.0
1.0

1/60
5/60
2.0
2.0

2
4
64
32

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

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

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

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

102

PHASE 2.—PRE- AND POST-INTERVENTION PILOT CITY SURVEY TESTING
[based on two cities]
Average
burden per
response
(in hours)

Estimated annual total burden hours
requested

Screeners .........................................................................................................
Parents .............................................................................................................
Teens ...............................................................................................................

1,777
600
200

2.0
2.0
2.0

1/60
15/60
15/60

59
300
100

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

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

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

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

459

Dated: December 13, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E6–21719 Filed 12–19–06; 8:45 am]

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857,301–827–
4659.

Food and Drug Administration

SUPPLEMENTARY INFORMATION:

BILLING CODE 4163–18–P

In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.

[Docket No. 2006N–0237]

Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Product
Jurisdiction: Assignment of Agency
Component for Review of Premarket
Applications
AGENCY:

Product Jurisdiction: Assignment of
Agency Component for Review of
Premarket Applications—(OMB Control
Number 0910–0523)—Extension

Food and Drug Administration,

HHS.
ACTION:

sroberts on PROD1PC70 with NOTICES

Estimated
number of responses per
respondent

Estimated
number of
respondents

Type of respondents

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 January 19,
2007.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written

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This regulation relates to agency
management and organization and has
two purposes. The first is to implement
section 503(g) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 353(g)), as
added by the Safe Medical Devices Act
of 1990 (Public Law 101–629), and
amended by the Medical Device User
Fee and Modernization Act of 2002
(Public Law 107–250), by specifying
how FDA will determine the
organizational component within FDA
assigned to have primary jurisdiction for
the premarket review and regulation of
products that are comprised of any of
the following combinations: (1) A drug
and a device; (2) a device and a
biological; (3) a biological and a drug; or

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(4) a drug, a device, and a biological.
The second purpose of this regulation is
to enhance the efficiency of agency
management and operations by
providing procedures for classifying and
determining which agency component
is designated to have primary
jurisdiction for any drug, device, or
biological product where such
jurisdiction is unclear or in dispute. The
regulation establishes a procedure by
which an applicant may obtain an
assignment or designation
determination. The regulation requires
that the request include the identity of
the applicant, a comprehensive
description of the product and its
proposed use, and the applicant’s
recommendation as to which agency
component should have primary
jurisdiction, with an accompanying
statement of reasons. The information
submitted would be used by FDA as the
basis for making the assignment or
designation decision. Most information
required by the regulation is already
required for premarket applications
affecting drugs, devices, biologicals, and
combination products. The respondents
will be businesses or other for-profit
organizations.
In the Federal Register of June 22,
2006 (71 FR 35916), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:

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