Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products, 39952-39953 [2010-16973]
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39952
Federal Register / Vol. 75, No. 133 / Tuesday, July 13, 2010 / Notices
Attach No.
1dd .....................
Use metrics/
month—#
respond
Section/form or survey title
Estimated burden (minutes/
hours)
Frequency of
response
Total annual
usage/annual
burden hours
10
15–20
0.33
12.00
40
35
10
0.17
12.00
71
130
5–10
0.17
12.00
265
250
10–15
0.2500
1.00
63
300
10–15
0.2500
1.00
75
4 .........................
CTSU Web Site Customer Satisfaction Survey.
CTSU Helpdesk Customer Satisfaction Survey.
CTSU OPEN Survey ..................
120
10–15
0.2500
1.00
30
Annual Totals .....
....................................................
21,770
........................
..........................
........................
27,861
1ee .....................
1ff .......................
Surveys/Web Forms:
2 .........................
3 .........................
CTSU System Account Request
Form.
CTSU Request for Clinical Brochure.
CTSU Supply Request Form .....
Estimated time
for site to
complete
(minutes)
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate 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) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) 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.
jlentini on DSKJ8SOYB1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Michael Montello,
Pharm. D., CTEP, 6130 Executive Blvd.,
Rockville, MD 20852. At non-toll-free
number 301–435–9206 or e-mail your
request, including your address to:
montellom@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: July 7, 2010.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2010–17038 Filed 7–12–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0344]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Testing
Communications on Medical Devices
and Radiation-Emitting Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
communication studies involving
medical devices and radiation-emitting
products regulated by FDA. This
information will be used to explore
concepts of interest and assist in the
development and modification of
communication messages and
campaigns to fulfill the agency’s
mission to protect the public health.
DATES: Submit either electronic or
written comments on the collection of
information by September 13, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined in
44 U.S.C. 3502(3) and 5 CFR 1320.3(c)
and includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires Federal agencies
to provide a 60-day notice in the
Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
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
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
E:\FR\FM\13JYN1.SGM
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39953
Federal Register / Vol. 75, No. 133 / Tuesday, July 13, 2010 / Notices
Testing Communications on Medical
Devices and Radiation-Emitting
Products—(OMB Control Number 0910–
New)
FDA is authorized by section
1003(d)(2)(D) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
393(d)(2)(D)) to conduct educational
and public information programs
relating to the safety of regulated
medical devices and radiation-emitting
products. FDA must conduct needed
research to ensure that such programs
have the highest likelihood of being
effective. Improving communications
about medical devices and radiationemitting products will involve many
research methods, including individual
indepth interviews, mall-intercept
interviews, focus groups, selfadministered surveys, gatekeeper
reviews, and omnibus telephone
surveys.
The information collected will serve
three major purposes. First, as formative
research it will provide critical
knowledge needed about target
audiences to develop messages and
campaigns about medical device and
radiation-emitting product use.
Knowledge of consumer and health care
professional decisionmaking processes
will provide the better understanding of
target audiences that FDA needs to
design effective communication
strategies, messages, and labels. These
communications will aim to improve
public understanding of the risks and
benefits of using medical devices and
radiation-emitting products by
providing users with a better context in
which to place risk information more
completely.
Second, as initial testing, it will allow
FDA to assess the potential effectiveness
of messages and materials in reaching
and successfully communicating with
their intended audiences. Testing
messages with a sample of the target
audience will allow FDA to refine
messages while still in the
developmental stage. Respondents will
be asked to give their reaction to the
messages in either individual or group
settings.
Third, as evaluative research, it will
allow FDA to ascertain the effectiveness
of the messages and the distribution
method of these messages in achieving
the objectives of the message campaign.
Evaluation of campaigns is a vital link
in continuous improvement of
communications at FDA.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN
Section of the act
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total
Hours
Total Operating &
Maintenance
Costs1
1003(d)(2)(D)
16,448
1
16,448
0.1739
2,860
$25,239
Total
16,448
1
16,448
0.1739
2,860
$25,239
1 There
are no capital costs associated with this collection of information.
Annually, FDA projects about 30
studies using a variety of research
methods, and lasting an average of 0.17
hours each (varying from 0.08–1.5
hours). The operating and maintenance
costs include contractor expenses for
designing and conducting information
collection activities, specifically,
drawing samples, training interviewers,
collecting and analyzing information,
and reporting and disseminating
findings. FDA estimates the burden of
this collection of information based on
prior recent experience with the various
types of data collection methods
described earlier. FDA is requesting this
burden so as not to restrict the agency’s
ability to gather information on public
sentiment for its proposals in its
regulatory and communications
programs.
Dated: July 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
jlentini on DSKJ8SOYB1PROD with NOTICES
[FR Doc. 2010–16973 Filed 7–12–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Modification to the Basic Center
Program Funding Opportunity
Announcement
Program Office: Administration on
Children, Youth, & Families—Family &
Youth Services Bureau.
Funding Opportunity Title: Basic
Center Program.
Announcement Type: Modification.
Funding Opportunity Number: HHS–
2010–ACF–ACYF–CY–0002.
CFDA Number: 93.623.
Due Date for Applications:
07/19/2010.
This is a Modification to the Basic
Center Program Funding Opportunity
Announcement (FOA), HHS–2010–
ACF–ACYF–CY–0002, published to the
ACF Grant Opportunities webpage on
June 2, 2010, https://www.acf.hhs.gov/
grants/open/foa/view/HHS-2010-ACFACYF-CY-0002. A modified FOA that
incorporates the following changes was
published to the ACF Grant
Opportunities webpage on June 25,
2010. The application procedures are
hereby modified.
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
SUMMARY: The Family and Youth
Services Bureau (FYSB) is accepting
applications for the Basic Center
Program (BCP), which is authorized by
the Runaway and Homeless Youth Act
to address Runaway and Homeless
Youth (RHY) problems. BCPs provide an
alternative for runaway and homeless
youth who might otherwise end up with
law enforcement or in the child welfare,
mental health, or juvenile justice
systems. Each BCP must provide
runaway and homeless youth with a
safe and appropriate shelter; individual,
family, and group counseling, as
appropriate; and aftercare.
The purpose of the modification is to
correct information appearing in Section
IV.2 Content and Form of Application
Submission regarding application
formatting and point deduction for
noncompliance with FOA instructions.
Modification to the Published
Announcement
Please delete the following under
Section IV.2. Content and Form of
Application Submission:
‘‘Applicants that do not adhere to the
prescribed format will have points deducted
from the overall total after the grant review:
Program narrative (which includes
Objective and Need for Assistance, Results
and Benefits, Approach, Organizational
Profile, Staff and Position Data, and Budget
E:\FR\FM\13JYN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 133 (Tuesday, July 13, 2010)]
[Notices]
[Pages 39952-39953]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-16973]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0344]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Testing Communications on Medical Devices and
Radiation-Emitting Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on communication studies involving medical
devices and radiation-emitting products regulated by FDA. This
information will be used to explore concepts of interest and assist in
the development and modification of communication messages and
campaigns to fulfill the agency's mission to protect the public health.
DATES: Submit either electronic or written comments on the collection
of information by September 13, 2010.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and 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 respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
[[Page 39953]]
Testing Communications on Medical Devices and Radiation-Emitting
Products--(OMB Control Number 0910-New)
FDA is authorized by section 1003(d)(2)(D) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 393(d)(2)(D)) to conduct
educational and public information programs relating to the safety of
regulated medical devices and radiation-emitting products. FDA must
conduct needed research to ensure that such programs have the highest
likelihood of being effective. Improving communications about medical
devices and radiation-emitting products will involve many research
methods, including individual indepth interviews, mall-intercept
interviews, focus groups, self-administered surveys, gatekeeper
reviews, and omnibus telephone surveys.
The information collected will serve three major purposes. First,
as formative research it will provide critical knowledge needed about
target audiences to develop messages and campaigns about medical device
and radiation-emitting product use. Knowledge of consumer and health
care professional decisionmaking processes will provide the better
understanding of target audiences that FDA needs to design effective
communication strategies, messages, and labels. These communications
will aim to improve public understanding of the risks and benefits of
using medical devices and radiation-emitting products by providing
users with a better context in which to place risk information more
completely.
Second, as initial testing, it will allow FDA to assess the
potential effectiveness of messages and materials in reaching and
successfully communicating with their intended audiences. Testing
messages with a sample of the target audience will allow FDA to refine
messages while still in the developmental stage. Respondents will be
asked to give their reaction to the messages in either individual or
group settings.
Third, as evaluative research, it will allow FDA to ascertain the
effectiveness of the messages and the distribution method of these
messages in achieving the objectives of the message campaign.
Evaluation of campaigns is a vital link in continuous improvement of
communications at FDA.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Operating &
Section of the act No. of Annual Frequency Total Annual Hours per Total Hours Maintenance
Respondents per Response Responses Response Costs\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
1003(d)(2)(D) 16,448 1 16,448 0.1739 2,860 $25,239
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 16,448 1 16,448 0.1739 2,860 $25,239
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.
Annually, FDA projects about 30 studies using a variety of research
methods, and lasting an average of 0.17 hours each (varying from 0.08-
1.5 hours). The operating and maintenance costs include contractor
expenses for designing and conducting information collection
activities, specifically, drawing samples, training interviewers,
collecting and analyzing information, and reporting and disseminating
findings. FDA estimates the burden of this collection of information
based on prior recent experience with the various types of data
collection methods described earlier. FDA is requesting this burden so
as not to restrict the agency's ability to gather information on public
sentiment for its proposals in its regulatory and communications
programs.
Dated: July 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-16973 Filed 7-12-10; 8:45 am]
BILLING CODE 4160-01-S
