Agency Forms Undergoing Paperwork Reduction Act Review, 52881-52882 [E7-18231]
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52881
Federal Register / Vol. 72, No. 179 / Monday, September 17, 2007 / Notices
ESTIMATED ANNUAL RESPONDENT BURDEN—Continued
Number of respondents *
Estimated time
per respondent in minutes
Estimated total
burden hours
2nd Quarter ..................................................................................................................................
3rd Quarter ..................................................................................................................................
500
500
10
10
83.33
83.33
Annual Total .........................................................................................................................
1500
........................
250
Survey
* The estimate for number of respondents for the initial implementation is 100 per quarter. The estimate included in the table assumes wider
implementation by the Agency.
Estimated Annual Costs to the Federal
Government
The annual cost to the government is
$100,000 for licensing, support and
maintenance.
Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ health care research and health
care information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) 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 upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Carolyn M. Clancy,
Director.
[FR Doc. 07–4577 Filed 9–14–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
jlentini on PROD1PC65 with NOTICES
Notice of Meetings
In accordance with section 10(d) of
the Federal Advisory Committee Act as
amended (5 U.S.C., Appendix 2), the
Agency for Healthcare Research and
Quality (AHRQ) announces meetings of
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scientific peer review groups. The
subcommittees listed below are part of
the Agency’s Health Services Research
Initial Review Group Committee.
The subcommittee meetings will be
closed to the public in accordance with
the Federal Advisory Committee Act,
section 10(d) of 5 U.S.C., Appendix 2
and 5 U.S.C. 552b (c)(6). Grant
applications are to be reviewed and
discussed at these meetings. These
discussions are likely to involve
information concerning individuals
associated with the applications,
including assessments of their personal
qualifications to conduct their proposed
projects. This information is exempt
from mandatory disclosure under the
above-cited statutes.
1. Name of Subcommittee: Health
Systems Research.
Date: October 18, 2007 (Open from 8
a.m. to 8:15 a.m. on October 18 and
closed for remainder of the meeting).
Place: Agency for Healthcare Research
and Quality (AHRQ), John Eisenberg
Conference Center, 540 Gaither Road,
Rockville, Maryland 20850.
2. Name of Subcommittee: Health
Care Research Training.
Date: October 18–19, 2007 (Open from
9 a.m. to 9:15 a.m. on October 18 and
closed for remainder of the meeting).
Place: Agency for Healthcare Research
and Quality (AHRQ), John Eisenberg
Conference Center, 540 Gaither Road,
Rockville, Maryland 20850.
3. Name of Subcommittee: Health
Care Quality and Effectiveness
Research.
Date: October 24, 2007 (Open from 8
a.m. to 8:15 a.m. on October 24 and
closed for remainder of the meeting).
Place: Agency for Healthcare Research
and Quality (AHRQ), John Eisenberg
Conference Center, 540 Gaither Road,
Rockville, Maryland 20850.
4. Name of Subcommittee: Health
Care Technology and Decision Sciences.
Date: October 25–26, 2007 (Open from
8 a.m. to 8:15 a.m. on October 25 and
closed for remainder of the meeting).
Place: Agency for Healthcare Research
and Quality (AHRQ), John Eisenberg
Conference Center, 540 Gaither Road,
Rockville, Maryland 20850.
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Contact Person: Anyone wishing to
obtain a roster of members, agenda or
minutes of the nonconfidential portions
of the meetings should contact Mrs.
Bonnie Campbell, Committee
Management Officer, Office of
Extramural Research, Education and
Priority Populations, AHRQ, 540
Gaither Road, Suite 2000, Rockville,
Maryland 20850, Telephone (301) 427–
1554.
Agenda items for these meetings are
subject to change as priorities dictate.
Carolyn M. Clancy,
Director.
[FR Doc. 07–4576 Filed 9–14–07; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–07–07AD]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–6974. Written
comments should be received within 30
days of this notice.
Proposed Project
Formative Research to Inform an HIV
Testing Social Marketing Campaign for
African American Heterosexual Men—
New collection—National Center for
HIV/AIDS, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Coordinating
Center for Infectious Diseases (CCID),
Centers for Disease Control and
Prevention (CDC).
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52882
Federal Register / Vol. 72, No. 179 / Monday, September 17, 2007 / Notices
Background and Brief Description
This project involves formative
research to inform the development of
the HIV Testing Social Marketing
Campaign for African American
Heterosexual Men, a CDC-sponsored
social marketing campaign aimed at
increasing HIV testing rates among
young, single, African American men.
The study entails conducting focus
groups and interviews with a sample of
single African American heterosexual
men, ages 18 to 44, with less than 4
years of college education to: (1) Explore
participants’ knowledge, attitudes and
beliefs about HIV and HIV testing to
inform the development of campaign
messages; (2) identify the most
motivating approach, supporting data,
and key messages for materials
development; (3) test creative concepts,
potential campaign themes, logos and
names; and (4) test creative materials
developed based on the findings from
the previous phases of the research.
Findings from this study will be used by
CDC and its partners to inform current
and future program activities.
We expect 153 participants to be
screened for eligibility annually. Of the
153 participants who are screened, we
anticipate that 72 will participate. The
72 participants will be divided; 36
participating in focus groups and 36
participating in interviews.
Additionally, all focus group and
interview participants will complete a
short ‘‘Paper and Pencil’’ questionnaire.
This is a burden hour reduction from
the 60 Day Federal Register Notice
which estimated the annual number of
respondents at 306, with 153
participating; 81 in focus groups and 72
in interviews. There are no costs to the
respondents other than their time. The
total estimated annual burden hours are
146.
ESTIMATED ANNUALIZED BURDEN HOURS AND BURDEN TABLE
Number of respondents
Respondents
Number of responses per
respondent
153
36
36
72
1
1
1
1
Screener ......................................................................................................................................
Focus Group ................................................................................................................................
Interview .......................................................................................................................................
Paper and Pencil Survey .............................................................................................................
Dated: September 7, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–18231 Filed 9–14–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0231]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Premarket
Approval of Medical Devices
AGENCY:
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with NOTICES
ACTION:
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 October 17,
2007.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
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17:00 Sep 14, 2007
Jkt 211001
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0073. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance:
Premarket Approval of Medical
Devices—21 CFR Part 814 and Food
and Drug Administration
Modernization Act Sections 201, 202,
205, 208, and 209 (OMB Control
Number 0910–0231)—Extension
Section 515 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
360e) sets forth the requirements for
premarket approval of certain class III
medical devices. Class III devices are
either preamendments devices that have
been classified into class III, or
postamendments devices which are not
substantially equivalent to a
preamendments device, or transitional
devices. Class III devices are devices
such as implants, life sustaining or life
supporting devices, devices that are of
substantial importance in preventing
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Average
burden per
response
(in hours)
10/60
2
1
10/60
impairment of human health, and
devices that otherwise present a
potentially unreasonable risk of illness
or injury. Most premarket approval
application (PMAs) are for
postamendments class III devices.
Under section 515 of the act, an
application must contain certain
specific information, including full
reports of all information concerning
investigations showing whether the
device is reasonably safe and effective.
The application should also include a
statement of components, ingredients,
and properties of the principles of
operation for such a device. In addition,
the application should also include a
full description of the methods used in,
and the facilities and controls used for,
the manufacture and processing of the
device and labeling specimens. The
implementing regulations, contained in
part 814 (21 CFR part 814), further
specify the contents of a PMA for a class
III medical device and the criteria FDA
sets forth in approving, denying, or
withdrawing approval of a PMA as well
as supplements to PMAs. The purpose
of these regulations is to establish an
efficient and thorough procedure for
FDA’s review of PMAs and supplements
to PMAs for certain class III (premarket
approval), medical devices. The
regulations under part 814 facilitate the
approval of PMAs and supplements to
PMAs for devices that have been shown
to be reasonably safe and effective and
otherwise meet the statutory criteria for
approval. The regulations also ensure
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17SEN1
Agencies
[Federal Register Volume 72, Number 179 (Monday, September 17, 2007)]
[Notices]
[Pages 52881-52882]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-18231]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-07-07AD]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail
to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC or by fax to (202) 395-6974.
Written comments should be received within 30 days of this notice.
Proposed Project
Formative Research to Inform an HIV Testing Social Marketing
Campaign for African American Heterosexual Men--New collection--
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
(NCHHSTP), Coordinating Center for Infectious Diseases (CCID), Centers
for Disease Control and Prevention (CDC).
[[Page 52882]]
Background and Brief Description
This project involves formative research to inform the development
of the HIV Testing Social Marketing Campaign for African American
Heterosexual Men, a CDC-sponsored social marketing campaign aimed at
increasing HIV testing rates among young, single, African American men.
The study entails conducting focus groups and interviews with a sample
of single African American heterosexual men, ages 18 to 44, with less
than 4 years of college education to: (1) Explore participants'
knowledge, attitudes and beliefs about HIV and HIV testing to inform
the development of campaign messages; (2) identify the most motivating
approach, supporting data, and key messages for materials development;
(3) test creative concepts, potential campaign themes, logos and names;
and (4) test creative materials developed based on the findings from
the previous phases of the research. Findings from this study will be
used by CDC and its partners to inform current and future program
activities.
We expect 153 participants to be screened for eligibility annually.
Of the 153 participants who are screened, we anticipate that 72 will
participate. The 72 participants will be divided; 36 participating in
focus groups and 36 participating in interviews. Additionally, all
focus group and interview participants will complete a short ``Paper
and Pencil'' questionnaire. This is a burden hour reduction from the 60
Day Federal Register Notice which estimated the annual number of
respondents at 306, with 153 participating; 81 in focus groups and 72
in interviews. There are no costs to the respondents other than their
time. The total estimated annual burden hours are 146.
Estimated Annualized Burden Hours and Burden Table
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Respondents respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Screener........................................................ 153 1 10/60
Focus Group..................................................... 36 1 2
Interview....................................................... 36 1 1
Paper and Pencil Survey......................................... 72 1 10/60
----------------------------------------------------------------------------------------------------------------
Dated: September 7, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E7-18231 Filed 9-14-07; 8:45 am]
BILLING CODE 4163-18-P