Submission for OMB Review; Comment Request; Child/Parent Evaluation and Satisfaction Surveys; Brain Train4Kids: New Delivery of the Brain Power! Program, 19527-19528 [06-3596]
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Federal Register / Vol. 71, No. 72 / Friday, April 14, 2006 / Notices
June 28, 2006 to ensure their adequate
consideration in preparation of the final
document. General comments on agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Comments should be
identified with the full title of the
guidance and the docket number found
in brackets in the heading of this
document. Submit electronic comments
on the guidance via the Internet at
https://www.fda.gov/dockets/ecomments.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Michelle L. Stull, Center for Veterinary
Medicine (HFV–133), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–5058, email: michelle.stull@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
guidance document. Submit a single
copy of electronic comments or two
paper copies of any mailed comments,
except that individuals may submit one
paper copy. Comments are to be
identified with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
IV. Electronic Access
Electronic comments may be
submitted on the Internet at https://
www.fda.gov/dockets/ecomments.
Copies of the guidance document
entitled ‘‘Recommended Study Design
and Evaluation of Effectiveness Studies
for Swine Respiratory Disease Claims’’
may be obtained from the CVM Home
Page (https://www.fda.gov/cvm) and from
the Division of Dockets Management
Web site (https://www.fda.gov/ohrms/
dockets/default.htm).
Dated: April 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–5527 Filed 4–13–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
I. Background
The National Institutes of Health
The purpose of this draft guidance is
to provide the Center for Veterinary
Medicine’s current thinking regarding
the recommended design and evaluation
of effectiveness studies for SRD claims.
This guidance identifies specific
detailed recommendations for sponsors
of new animal drug applications to
consider when designing and writing
protocols for SRD effectiveness studies.
Submission for OMB Review;
Comment Request; Child/Parent
Evaluation and Satisfaction Surveys;
Brain Train4Kids: New Delivery of the
Brain Power! Program
II. Significance of Guidance
This Level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
This draft guidance represents the
agency’s current thinking on the topic.
It does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An alternate
method may be used as long as it
satisfies the requirements of applicable
statutes and regulations.
wwhite on PROD1PC65 with NOTICES
III. Comments
This draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. Interested persons may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments regarding this draft
VerDate Aug<31>2005
16:37 Apr 13, 2006
Jkt 208001
Summary: 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
National Institute on Drug Abuse
(NIDA), the National Institutes of Health
(NIH) will publish periodic summaries
of proposed projects to be submitted to
the Office of Management and Budget
(OMB) for review and approval. The
proposed information collection was
previously published in the Federal
Register on December 8, 2004, page
71060 and allowed 60 days for public
comment. No public comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment. The National Institutes of
Health may not conduct or sponsor, and
the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
PO 00000
Frm 00052
Fmt 4703
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19527
Proposed Collection
Title: BrainTrain4Kids: New Delivery
of the Brain Power Program. Type of
information Collection Request: NEW.
Need and Use of Information Collection:
This research will evaluate the effects of
BrainTrain4Kids.com, an online
program for students (Grades 2 and 3),
on: (1) Students’ knowledge of scientific
inquiry, the human nervous system, the
effects of alcohol and tobacco on the
brain, and the differences between
helpful and harmful drugs; (2) students’
attitudes toward science in general; and
(3) students’ attitudes toward substance
abuse. The secondary goals of the
summative evaluation are to determine
if changes in knowledge and attitudes
are retained over follow-up period as
well as to determine if parents and
second- and third-grade students will
report a high degree of satisfaction with
the online program. The online program
is a new delivery of a National Institute
on Drug Abuse science education
curriculum for second- and third-grade
teachers (Brain Power! The NIDA Junior
Scientist Club) adapted for the Internet
and for use by children at home under
the guidance of their parents. If the new
program is successful, the public will
have access to an evidence-based
program via the Internet that contributes
to scientific literacy and provides a
basis of knowledge upon which to build
future substance abuse prevention. In
order to evaluate the effectiveness of the
program, information will be collected
from students before (pretest) and after
(post-test) exposure to the Web site and
again 6 weeks after the program has
been completed (follow-up). Parents
will be asked to complete usage logs at
six points during their use of the
BrainTrain4Kids Web site with their
children. Prior to the evaluation study,
the knowledge and attitude assessment
instruments will be pilot-tested with a
small sample of students to determine
validity and reliability. All data
collection will occur online. Frequency
of Response: On occasion. Affected
Public: Second- and third-grade
children and their parents. Type of
Respondents: Second- and third-grade
children and their parents. The
reporting burden is as follows:
Estimated Number of Respondents: 308;
Estimated Number of Responses per
Respondents: One for two key cohorts,
three for one key cohort, and seven for
one key cohort; Average Burden Hours
per Response: 0.378; and Estimated
Total Annual Burden Hours Requested:
479.50. There are no Capital Costs to
report. There are no Operating or
Maintenance Costs to report. The
E:\FR\FM\14APN1.SGM
14APN1
19528
Federal Register / Vol. 71, No. 72 / Friday, April 14, 2006 / Notices
estimated annualized burden is
summarized below.
Type of
respondents
Number of respondents
Frequency of
responses
Children (Assessment Instrument Pilot Test) ..................................
Parents (Assessment Instrument Pilot Test) ...................................
Children (Evaluation) .......................................................................
Parents (Evaluation: 1 Satisfaction Scale/6 Usage Logs) ...............
34
34
120
120
1
1
3
1
6
Total ..........................................................................................
308
........................
Request for Comments
Written comments and/or suggestions
from the public and affected agencies
are invited on one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and the assumptions used;
(3) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Direct Comments to OMB
Written comments and/or suggestions
regarding the item(s) contained in this
notice, especially regarding the
estimated public burden and associated
response time, should be directed to the:
Office of Management and Budget,
Office of Regulatory Affairs, New
Executive Office Building, room 1–235,
Washington, DC 20503, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact Dr.
Cathrine Sasek, Coordinator, Science
Education Program. Office of Science
Policy and Communications, National
Institute on Drug Abuse, 6001 Executive
Blvd, Room 5237, Bethesda, MD 20892,
or call non-toll-free number (301) 443–
6071; fax (301) 443–6277; or by e-mail
to csasek@nida.nih.gov.
Comments Due Date
Comments regarding this information
are best assured of having their full
effect if received within 30 days of the
date of this publication.
Dated: April 10, 2006.
Laura Rosenthal,
Executive Officer, National Institute on Drug
Abuse.
[FR Doc. 06–3596 Filed 4–13–06; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Public Health Service
National Institutes of Health
Submission for OMB Review;
Comment Request; National Survey of
Primary Care Physicians’
Recommendations and Practice for
Breast, Cervical, Colorectal, and Lung
Cancer Screening
SUMMARY: Under the provisions of
section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH), National
Cancer Institute (NCI), has submitted to
the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on January 20,
2006, page 3309 and allowed 60-days
for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
Estimated
number of
respondents
Questionnaire
wwhite on PROD1PC65 with NOTICES
Average time per
response
Annual hour burden
0.75
1
0.5
0.5
0.25
25.5
34.0
180.0
240.0
................................
479.50
30 days for public comment. The
National Institutes of Health may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
Proposed Collection: Title: National
Survey of Primary Care Physicians’
Recommendations and Practice for
Breast, Cervical, Colorectal, and Lung
Cancer Screening. Type of Information
Collection Request: New. Need and Use
of Information Collection: This study
will obtain current, national data on
primary care physicians’ knowledge,
attitudes, recommendations, and
practices related to screening for breast,
cervical, colorectal, and lung cancer.
There have been substantial changes in
guidelines and/or technologies for these
types of cancer screening in recent
years. The data collected in this study
will support and further NCI work in
monitoring and evaluating providers’
cancer control knowledge, attitudes, and
practices and their impact on
population health, as well as enable
monitoring of progress toward major
cancer control goals. Two
questionnaires, one covering breast and
cervical cancer screening and the other
colorectal and lung cancer screening,
will be administered by mail or
telephone to a randomly-selected
national sample of primary care
physicians. Frequency of Response: One
Time. Affected Public: Medical
practices, clinics, or other health care
organizations. Type of Respondents:
Primary Care Physicians. Burden
estimates are as follows:
Estimated
number of
responses
per respondent
Average
burden hours
per response
Estimated total
annual burden
hours
Breast & cervical cancer screening .................................................................
Colorectal & lung cancer screening .................................................................
1250
1250
1
1
0.333
0.333
416.25
416.25
Total ..........................................................................................................
........................
........................
........................
832.5
VerDate Aug<31>2005
17:29 Apr 13, 2006
Jkt 208001
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
E:\FR\FM\14APN1.SGM
14APN1
]]>Agencies
[Federal Register Volume 71, Number 72 (Friday, April 14, 2006)]
[Notices]
[Pages 19527-19528]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-3596]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
The National Institutes of Health
Submission for OMB Review; Comment Request; Child/Parent
Evaluation and Satisfaction Surveys; Brain Train4Kids: New Delivery of
the Brain Power! Program
Summary: 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 National
Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH)
will publish periodic summaries of proposed projects to be submitted to
the Office of Management and Budget (OMB) for review and approval. The
proposed information collection was previously published in the Federal
Register on December 8, 2004, page 71060 and allowed 60 days for public
comment. No public comments were received. The purpose of this notice
is to allow an additional 30 days for public comment. The National
Institutes of Health may not conduct or sponsor, and the respondent is
not required to respond to, an information collection that has been
extended, revised, or implemented on or after October 1, 1995, unless
it displays a currently valid OMB control number.
Proposed Collection
Title: BrainTrain4Kids: New Delivery of the Brain Power Program.
Type of information Collection Request: NEW. Need and Use of
Information Collection: This research will evaluate the effects of
BrainTrain4Kids.com, an online program for students (Grades 2 and 3),
on: (1) Students' knowledge of scientific inquiry, the human nervous
system, the effects of alcohol and tobacco on the brain, and the
differences between helpful and harmful drugs; (2) students' attitudes
toward science in general; and (3) students' attitudes toward substance
abuse. The secondary goals of the summative evaluation are to determine
if changes in knowledge and attitudes are retained over follow-up
period as well as to determine if parents and second- and third-grade
students will report a high degree of satisfaction with the online
program. The online program is a new delivery of a National Institute
on Drug Abuse science education curriculum for second- and third-grade
teachers (Brain Power! The NIDA Junior Scientist Club) adapted for the
Internet and for use by children at home under the guidance of their
parents. If the new program is successful, the public will have access
to an evidence-based program via the Internet that contributes to
scientific literacy and provides a basis of knowledge upon which to
build future substance abuse prevention. In order to evaluate the
effectiveness of the program, information will be collected from
students before (pretest) and after (post-test) exposure to the Web
site and again 6 weeks after the program has been completed (follow-
up). Parents will be asked to complete usage logs at six points during
their use of the BrainTrain4Kids Web site with their children. Prior to
the evaluation study, the knowledge and attitude assessment instruments
will be pilot-tested with a small sample of students to determine
validity and reliability. All data collection will occur online.
Frequency of Response: On occasion. Affected Public: Second- and third-
grade children and their parents. Type of Respondents: Second- and
third-grade children and their parents. The reporting burden is as
follows: Estimated Number of Respondents: 308; Estimated Number of
Responses per Respondents: One for two key cohorts, three for one key
cohort, and seven for one key cohort; Average Burden Hours per
Response: 0.378; and Estimated Total Annual Burden Hours Requested:
479.50. There are no Capital Costs to report. There are no Operating or
Maintenance Costs to report. The
[[Page 19528]]
estimated annualized burden is summarized below.
----------------------------------------------------------------------------------------------------------------
Number of Frequency of Average time per
Type of respondents respondents responses response Annual hour burden
----------------------------------------------------------------------------------------------------------------
Children (Assessment Instrument Pilot 34 1 0.75 25.5
Test)..................................
Parents (Assessment Instrument Pilot 34 1 1 34.0
Test)..................................
Children (Evaluation)................... 120 3 0.5 180.0
Parents (Evaluation: 1 Satisfaction 120 1 0.5 240.0
Scale/6 Usage Logs)....................
6 0.25
-----------------------------------------------------------------------
Total............................... 308 .............. .................. 479.50
----------------------------------------------------------------------------------------------------------------
Request for Comments
Written comments and/or suggestions from the public and affected
agencies are invited on one or more of the following points: (1)
Whether the proposed collection of information is necessary for the
proper performance of the function of the agency, including whether the
information will have practical utility; (2) the accuracy of the
agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and the
assumptions used; (3) ways to enhance the quality, utility, and clarity
of the information to be collected; and (4) ways to minimize the burden
of the collection of information on those who are to respond, including
the use of appropriate automated, electronic, mechanical, or other
technological collection techniques or other forms of information
technology.
Direct Comments to OMB
Written comments and/or suggestions regarding the item(s) contained
in this notice, especially regarding the estimated public burden and
associated response time, should be directed to the: Office of
Management and Budget, Office of Regulatory Affairs, New Executive
Office Building, room 1-235, Washington, DC 20503, Attention: Desk
Officer for NIH. To request more information on the proposed project or
to obtain a copy of the data collection plans and instruments, contact
Dr. Cathrine Sasek, Coordinator, Science Education Program. Office of
Science Policy and Communications, National Institute on Drug Abuse,
6001 Executive Blvd, Room 5237, Bethesda, MD 20892, or call non-toll-
free number (301) 443-6071; fax (301) 443-6277; or by e-mail to
csasek@nida.nih.gov.
Comments Due Date
Comments regarding this information are best assured of having
their full effect if received within 30 days of the date of this
publication.
Dated: April 10, 2006.
Laura Rosenthal,
Executive Officer, National Institute on Drug Abuse.
[FR Doc. 06-3596 Filed 4-13-06; 8:45 am]
BILLING CODE 4140-01-P
