Submission for OMB Review; Comment Request; Pretesting of NIAID's Biomedical HIV Prevention Research Communication Messages, 70270-70271 [2010-28980]
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70270
Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Notices
TABLE 1—ESTIMATES OF ANNUAL BURDEN HOURS—Continued
Type of
respondents
Survey instrument
Board Members .........
Pediatric CIRB Reviewer Findings—Initial
Review of Cooperative Group Protocol
(Attachment 6B).
Adult CIRB Reviewer Findings Cooperative
Group Response to CIRB Review (Attachment 6C).
Pediatric CIRB Reviewer Findings Cooperative Group Response to CIRB Review
(Attachment 6D).
Adult CIRB Reviewer Findings Amendment
Cooperative Group Protocol (Attachment
6E).
Pediatric CIRB Reviewer Findings Amendment to Cooperative Group Protocol (Attachment 6F).
Adult CIRB Reviewer Findings Continuing
Review of Cooperative Group Protocol
(Attachment 6G).
Pediatric CIRB Reviewer Findings Continuing Review of Cooperative Group Protocol (Attachment 6H).
CIRB Reviewer Form (Attachment 6I) .........
CIRB Statistical Reviewer Form (Attachment 6J).
CIRB SAE Reviewer Worksheet (Attachment 6K).
Board Members .........
Board Members .........
Board Members .........
Board Members .........
Board Members .........
Board Members .........
Board Members .........
Board Members .........
Board Members .........
mstockstill on DSKH9S0YB1PROD with NOTICES
Total ...................
.......................................................................
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.
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
Attention: NIH Desk Officer, Office of
Management and Budget, at
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974. To request more
information on the proposed project or
to obtain a copy of the data collection
VerDate Mar<15>2010
Number of
respondents
17:30 Nov 16, 2010
Jkt 223001
Frequency of
response
1
4 hours ......................
48
25
1
1 hour ........................
25
70
1
1 hour ........................
70
130
1
1.5 hours ...................
195
50
1
1.5 hours ...................
75
150
1
.5 hour .......................
75
110
1
.5 hour .......................
55
20
20
1
1
2 hours ......................
2 hours ......................
40
40
10
15
30/60 (.5 hour) ..........
75
4,904
........................
...................................
2,209
Dated: November 10, 2010.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2010–28883 Filed 11–16–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Pretesting of
NIAID’s Biomedical HIV Prevention
Research Communication Messages
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 of Allergy and
Infectious Diseases (NIAID), the
SUMMARY:
Frm 00072
Fmt 4703
Annual burden
hours
12
plans and instruments, contact Jeanne
Adler, Division of Cancer Treatment and
Diagnosis or call non-toll-free number
301–594–0083 or e-mail your request,
including your address to:
adlerj@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
PO 00000
Average time per
response
(min/hr)
Sfmt 4703
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.
Proposed Collection: Title: Pretesting
of NIAID’s Biomedical HIV Prevention
Research Communication Messages.
Type of Information Collection Request:
Revision of a previously approved
collection. Need and Use of Information
Collection: This is a request for
clearance to pretest messages, materials
and program activities about biomedical
HIV prevention research. The primary
objectives of the pretests are to (1)
Assess audience knowledge, attitudes,
behaviors and other characteristics for
the planning/development of health
messages, education products,
communication strategies, and public
information programs; and (2) pretest
these health messages, products,
strategies, and program components
while they are in developmental form to
assess audience comprehension,
reactions, and perceptions. The
information obtained from audience
research and pretesting results in more
effective messages, materials, and
programmatic strategies. By maximizing
the effectiveness of these messages and
strategies for reaching targeted
audiences, the frequency with which
publications, products, and programs
E:\FR\FM\17NON1.SGM
17NON1
Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Notices
need to be modified is reduced.
Frequency of Response: On occasion.
Affected Public: Individuals. Type of
Respondents: Adults at risk for HIV/
AIDS; representatives of organizations
disseminating HIV-related messages or
materials. The annual reporting burden
is shown in the table below. There are
Estimated number
of respondents
Type of respondents
70271
no Capital Costs to report. There are no
Operating or Maintenance Costs to
report.
Estimated number
of responses per
respondent
Average burden
hours per response
Estimated total
annual burden hours
requested
General public ................................................................
Community-Based Organization Managers ...................
Healthcare Providers .....................................................
2,988
749
107
1
1–3
1
.40
.31
.32
1,195.2
232.19
34.24
Total ........................................................................
3,844
................................
................................
1,461.63
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.
To request
more information on the proposed
project or to obtain a copy of the data
collection plans and instruments,
contact Katharine Kripke, Assistant
Director, Vaccine Research Program,
Division of AIDS, NIAID, NIH, 6700B
Rockledge Dr., Bethesda, MD 20892–
7628, or call non-toll-free number 301–
402–0846, or E-mail your request,
including your address to
kripkek@niaid.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.
mstockstill on DSKH9S0YB1PROD with NOTICES
FOR FURTHER INFORMATION:
Dated: November 10, 2010.
John J. McGowan,
Deputy Director for Science Management
NIAID.
[FR Doc. 2010–28980 Filed 11–16–10; 8:45 am]
BILLING CODE 4140–01–P
VerDate Mar<15>2010
16:21 Nov 16, 2010
Jkt 223001
Manufacturers, International, and
Consumer Assistance, Center for
Devices and Radiological Health, Food
Food and Drug Administration
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4617,
[Docket No. FDA–2010–D–0515]
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
Guidance for Industry and Food and
assist that office in processing your
Drug Administration Staff; Class II
Special Controls Guidance Document: request, or fax your request to 301–847–
8149. See the SUPPLEMENTARY
Non-Powered Suction Apparatus
Device Intended for Negative Pressure INFORMATION section for information on
electronic access to the guidance.
Wound Therapy; Availability
Submit electronic comments on the
AGENCY: Food and Drug Administration, guidance to https://www.regulations.gov.
HHS.
Submit written comments to the
ACTION: Notice.
Division of Dockets Management (HFA–
305), Food and Drug Administration,
SUMMARY: The Food and Drug
5630 Fishers Lane, Rm. 1061, Rockville,
Administration (FDA) is announcing the MD 20852. Identify comments with the
availability of the guidance entitled
docket number found in brackets in the
‘‘Class II Special Controls Guidance
heading of this document.
Document: Non-powered Suction
FOR FURTHER INFORMATION CONTACT:
Apparatus Device Intended for Negative Jiyoung M. Dang, Center for Devices and
Pressure Wound Therapy (NPWT).’’ This Radiological Health, Food and Drug
guidance document describes a means
Administration, 10903 New Hampshire
by which non-powered suction
Ave., Bldg. 66, Rm. 3615, Silver Spring,
apparatus devices intended for NPWT
MD 20993, 301–796–5650.
may comply with the requirement of
SUPPLEMENTARY INFORMATION:
special controls for class II devices.
Elsewhere in this issue of the Federal
I. Background
Register, FDA is publishing a final rule
Elsewhere in this issue of the Federal
to classify non-powered suction
Register, FDA is publishing a final rule
apparatus devices intended for NPWT
classifying non-powered suction
into class II (special controls). This
apparatus devices intended for negative
guidance document is immediately in
pressure wound therapy into class II
effect as the special control for non(special controls) under section 513(f)(2)
powered suction apparatus devices
of the Federal Food, Drug, and Cosmetic
intended for NPWT, but it remains
Act (the FD&C Act) (21 U.S.C.
subject to comment in accordance with
360c(f)(2)). This guidance document
the Agency’s good guidance practices
will serve as the special control for non(GGPs).
powered suction apparatus devices
DATES: Submit either electronic or
intended for negative pressure wound
written comments on the guidance at
therapy device. Section 513(f)(2) of the
any time. General comments on Agency FD&C Act provides that any person who
guidance documents are welcome at any submits a premarket notification under
time.
section 510(k) of the FD&C Act (21
U.S.C. 360(k)) for a device that has not
ADDRESSES: Submit written requests for
previously been classified may, within
single copies of the guidance document
30 days after receiving an order
entitled ‘‘Class II Special Controls
classifying the device in class III under
Guidance Document: Non-powered
section 513(f)(1) of the FD&C Act,
Suction Apparatus Device Intended for
request that FDA classify the device
Negative Pressure Wound Therapy
under the criteria set forth in section
(NPWT)’’ to the Division of Small
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
E:\FR\FM\17NON1.SGM
17NON1
]]>Agencies
[Federal Register Volume 75, Number 221 (Wednesday, November 17, 2010)]
[Notices]
[Pages 70270-70271]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28980]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Pretesting of NIAID's
Biomedical HIV Prevention Research Communication Messages
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 of Allergy
and Infectious Diseases (NIAID), 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.
Proposed Collection: Title: Pretesting of NIAID's Biomedical HIV
Prevention Research Communication Messages. Type of Information
Collection Request: Revision of a previously approved collection. Need
and Use of Information Collection: This is a request for clearance to
pretest messages, materials and program activities about biomedical HIV
prevention research. The primary objectives of the pretests are to (1)
Assess audience knowledge, attitudes, behaviors and other
characteristics for the planning/development of health messages,
education products, communication strategies, and public information
programs; and (2) pretest these health messages, products, strategies,
and program components while they are in developmental form to assess
audience comprehension, reactions, and perceptions. The information
obtained from audience research and pretesting results in more
effective messages, materials, and programmatic strategies. By
maximizing the effectiveness of these messages and strategies for
reaching targeted audiences, the frequency with which publications,
products, and programs
[[Page 70271]]
need to be modified is reduced. Frequency of Response: On occasion.
Affected Public: Individuals. Type of Respondents: Adults at risk for
HIV/AIDS; representatives of organizations disseminating HIV-related
messages or materials. The annual reporting burden is shown in the
table below. There are no Capital Costs to report. There are no
Operating or Maintenance Costs to report.
----------------------------------------------------------------------------------------------------------------
Estimated number Estimated total
Type of respondents Estimated number of responses per Average burden annual burden hours
of respondents respondent hours per response requested
----------------------------------------------------------------------------------------------------------------
General public................. 2,988 1 .40 1,195.2
Community-Based Organization 749 1-3 .31 232.19
Managers......................
Healthcare Providers........... 107 1 .32 34.24
--------------------------------------------------------------------------------
Total...................... 3,844 .................. .................. 1,461.63
----------------------------------------------------------------------------------------------------------------
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.
FOR FURTHER INFORMATION: To request more information on the proposed
project or to obtain a copy of the data collection plans and
instruments, contact Katharine Kripke, Assistant Director, Vaccine
Research Program, Division of AIDS, NIAID, NIH, 6700B Rockledge Dr.,
Bethesda, MD 20892-7628, or call non-toll-free number 301-402-0846, or
E-mail your request, including your address to kripkek@niaid.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: November 10, 2010.
John J. McGowan,
Deputy Director for Science Management NIAID.
[FR Doc. 2010-28980 Filed 11-16-10; 8:45 am]
BILLING CODE 4140-01-P
