Agency Information Collection Request. 60-Day Public Comment Request, 72803-72804 [E8-28389]
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Federal Register / Vol. 73, No. 231 / Monday, December 1, 2008 / Notices
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By Direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. E8–28164 Filed 11–28–08; 8:45 am]
BILLING CODE 6750–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–New]
Agency Information Collection
Request. 60-Day Public Comment
Request
Office of the Secretary, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
AGENCY:
identifier, to
Sherette.funncoleman@hhs.gov, or call
the Reports Clearance Office on (202)
690–6162. Written comments and
recommendations for the proposed
information collections must be directed
to the OS Paperwork Clearance Officer
at the above e-mail address within 60days.
Proposed Project: Evaluation of the
National Bone Health Campaign Pilot
Site Project—OMB No. 0990–NEW—
Office on Women’s Health (OWH)
Abstract: The Office on Women’s
Health (OWH) is requesting clearance
for forms to evaluate the
implementation and effectiveness of the
revised BodyWorks program; an obesity
prevention program targeting parents
and girls that highlights behaviors
known to improve bone health. Using a
technical assistance model, the revised
BodyWorks program will be
implemented by local coalitions in three
pilot sites. Clearance is also requested
for forms to assess the success of this
technical assistance model.
Paperwork Reduction Act of 1995, the
Office of the Secretary (OS), Department
of Health and Human Services, is
publishing the following summary of a
proposed information collection request
for public comment. Interested persons
are invited to send comments regarding
this burden estimate or any other aspect
of this collection of information,
including any of the following subjects:
(1) The necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, e-mail your request,
including your address, phone number,
OMB number, and OS document
ESTIMATED ANNUALIZED BURDEN TABLE
Type of respondent
Parent/Caregiver participant in the
Revised BodyWorks program.
Adolescent participant in the Revised BodyWorks program.
Adolescent Revised BodyWorks
program comparison group participant.
Trainers of the Revised BodyWorks
program.
Coalition leaders, members, and
site coordinators.
Total Hours ...............................
VerDate Aug<31>2005
16:47 Nov 28, 2008
Parent/Caregiver
naire.
Parent/Caregiver
tionnaire.
Parent/Caregiver
tion Forms (10
Parent/Caregiver
naire.
Number of
responses
per
respondent
Average
burden
per response
(in hours)
Total burden
(in hours)
Pre test Question-
171
1
30/60
85.5
Post test Ques-
153
1
30/60
76.5
Session Evaluaforms).
Pre test Question-
153
10
3/60
76.5
63
1
30/60
31.5
Parent/Caregiver Post test Questionnaire.
Adolescent Pretest Questionnaire ...
50
1
30/60
25
228
1
30/60
114
Adolescent Post test Questionnaire
Adolescent
Session
Evaluation
Forms (10 forms).
Adolescent Pre test Questionnaire
204
204
1
10
30/60
3/60
102
102
63
1
30/60
31.5
Adolescent Post test Questionnaire
Facilitator Feedback Forms (10
forms).
Coalition Pre test Survey ................
50
22
1
10
30/60
5/60
25
18.3
86
1
20/60
28.7
Coalition Post test Survey ...............
Parent/Caregiver
Revised
BodyWorks program comparison
group participant.
rwilkins on PROD1PC63 with NOTICES
Number of
respondents
Form name
72
1
30/60
36
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........................
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72804
Federal Register / Vol. 73, No. 231 / Monday, December 1, 2008 / Notices
John Teeter,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. E8–28389 Filed 11–28–08; 8:45 am]
Department of Health and
Human Services, Office of the Secretary,
Office of Public Health and Science,
Office for Human Research Protections.
ACTION: Notice.
of Subject Participation’’ in the subject
line.
• Fax: 301–402–2071.
• Mail/Hand delivery/Courier [For
paper, disk, or CD–ROM submissions]:
Michael A. Carome, M.D., Captain, U.S.
Public Health Service, OHRP, 1101
Wootton Parkway, Suite 200, Rockville,
MD 20852.
Comments received within the public
comment period, including any
personal information, will be made
available to the public upon request.
FOR FURTHER INFORMATION CONTACT:
Michael A. Carome, M.D., Captain, U.S.
Public Health Service, OHRP, 1101
Wootton Parkway, Suite 200, Rockville,
MD 20852, 240–453–6900; e-mail
Michael.Carome@hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY: The Office for Human
Research Protections (OHRP), Office of
Public Health and Science, is
announcing the availability of a draft
guidance document entitled, ‘‘Guidance
on Important Considerations for When
Participation of Human Subjects in
Research is Discontinued,’’ and is
seeking comment on the draft guidance.
The draft guidance document, when
finalized, would provide OHRP’s first
formal guidance on this topic. The draft
document, which is available on the
OHRP Web site at https://www.hhs.gov/
ohrp/requests/, is intended primarily for
institutional review boards (IRBs),
investigators, and funding agencies that
may be responsible for the review or
oversight of human subject research
conducted or supported by the
Department of Health and Human
Services (HHS). OHRP will consider
comments received before issuing the
final guidance document.
DATES: Submit written comments by
January 30, 2009.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled, ‘‘Guidance on
Important Considerations for When
Participation of Human Subjects in
Research is Discontinued,’’ to the
Division of Policy and Assurances,
Office for Human Research Protections,
1101 Wootton Parkway, Suite 200,
Rockville, MD 20852. Send one selfaddressed adhesive label to assist that
office in processing your request, or fax
your request to 301–402–2071. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
draft guidance document.
You may submit comments by any of
the following methods:
• E-mail:
discontinueparticipation@hhs.gov.
Include ‘‘Guidance on Discontinuation
I. Background
The OHRP, Office of Public Health
and Science, is announcing the
availability of a draft guidance
document entitled, ‘‘Guidance on
Important Considerations for When
Participation of Human Subjects in
Research is Discontinued.’’ The draft
guidance document, when finalized,
would provide OHRP’s first formal
guidance on this topic. The draft
document is intended primarily for
IRBs, investigators, and funding
agencies that may be responsible for the
review or oversight of human subject
research conducted or supported by
HHS.
The proposed guidance document
would apply to non-exempt human
subjects research conducted or
supported by HHS. It would provide
guidance on important considerations
for when participation of human
subjects in research is discontinued,
either because a subject voluntarily
chooses to discontinue participation
during the course of the research, or
because an investigator terminates a
subject’s participation in the research
without regard to the subject’s consent.
In particular, the proposed guidance
addresses the following topics:
(1) What does the word participation,
as used in HHS regulations at 45 CFR
part 46, subpart A, mean?
(2) What does discontinuation of a
subject’s participation in research
mean?
(3) The distinction between a
complete versus a partial
discontinuation of a subject’s
participation in research.
(4) Clarification that investigators may
continue to analyze already collected
individually identifiable private
information about a subject even when
the subject’s participation has been
completely discontinued.
BILLING CODE 4150–33–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Draft Guidance on Important
Considerations for When Participation
of Human Subjects in Research Is
Discontinued
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(5) Considerations regarding the
discontinuation of a subject’s
participation in emergency research for
which the requirements for obtaining
informed consent were waived by the
IRB.
(6) Clarification that research can
continue to involve human subjects
even when the participation of all
subjects has been completed or
discontinued.
(7) Recommendations for
documenting the discontinuation of
subjects’ participation in research.
OHRP notes that the Food and Drug
Administration (FDA) is publishing
elsewhere in this issue a notice
announcing the availability of a final
guidance document entitled ‘‘Guidance
for Sponsors, Clinical Investigators, and
IRBs: Data Retention When Subjects
Withdraw from FDA-Regulated Clinical
Trials.’’ OHRP believes the
interpretations provided in the
proposed draft guidance are harmonious
with those provided in FDA’s final
guidance document. In particular,
FDA’s guidance document explains that
under applicable FDA law and
regulations, data collected on study
subjects enrolled in an FDA-regulated
clinical trial up to the time of subject
withdrawal must remain in the trial
database in order for the study to be
scientifically valid. Likewise, OHRP’s
proposed draft guidance clarifies that
when a subject informs an investigator
of his/her decision to discontinue
participation in research, or an
investigator decides to terminate a
subject’s participation regardless of the
subject’s consent, the investigator may
continue to analyze already collected
individually identifiable private
information about that subject. In
addition, OHRP believes that its
proposed draft guidance document is
consistent with the HIPAA Privacy Rule
(45 CFR part 160 and Subparts A and E
of 56 CFR part 164), where applicable.
The Privacy Rule gives an individual
the right to revoke Authorization in
writing, except to the extent a covered
entity has taken action in reliance on
the Authorization. In the context of
research, this reliance exception permits
the continued use and disclosure of
protected health information already
obtained pursuant to the Authorization
prior to its revocation, to the extent
necessary to protect the integrity of the
research study.
II. Electronic Access
Persons with access to the Internet
may obtain the draft guidance document
on OHRP’s Web site at https://
www.hhs.gov/ohrp/requests/.
E:\FR\FM\01DEN1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 231 (Monday, December 1, 2008)]
[Notices]
[Pages 72803-72804]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-28389]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-New]
Agency Information Collection Request. 60-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Office of the Secretary (OS),
Department of Health and Human Services, is publishing the following
summary of a proposed information collection request for public
comment. Interested persons are invited to send comments regarding this
burden estimate or any other aspect of this collection of information,
including any of the following subjects: (1) The necessity and utility
of the proposed information collection for the proper performance of
the agency's functions; (2) the accuracy of the estimated burden; (3)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (4) the use of automated collection techniques or
other forms of information technology to minimize the information
collection burden.
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, e-mail your
request, including your address, phone number, OMB number, and OS
document identifier, to Sherette.funncoleman@hhs.gov, or call the
Reports Clearance Office on (202) 690-6162. Written comments and
recommendations for the proposed information collections must be
directed to the OS Paperwork Clearance Officer at the above e-mail
address within 60-days.
Proposed Project: Evaluation of the National Bone Health Campaign
Pilot Site Project--OMB No. 0990-NEW--Office on Women's Health (OWH)
Abstract: The Office on Women's Health (OWH) is requesting
clearance for forms to evaluate the implementation and effectiveness of
the revised BodyWorks program; an obesity prevention program targeting
parents and girls that highlights behaviors known to improve bone
health. Using a technical assistance model, the revised BodyWorks
program will be implemented by local coalitions in three pilot sites.
Clearance is also requested for forms to assess the success of this
technical assistance model.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondent Form name respondents responses per response (in (in hours)
respondent hours)
----------------------------------------------------------------------------------------------------------------
Parent/Caregiver participant Parent/Caregiver 171 1 30/60 85.5
in the Revised BodyWorks Pre test
program. Questionnaire.
Parent/Caregiver 153 1 30/60 76.5
Post test
Questionnaire.
Parent/Caregiver 153 10 3/60 76.5
Session
Evaluation
Forms (10
forms).
Parent/Caregiver Revised Parent/Caregiver 63 1 30/60 31.5
BodyWorks program comparison Pre test
group participant. Questionnaire.
Parent/Caregiver 50 1 30/60 25
Post test
Questionnaire.
Adolescent participant in the Adolescent 228 1 30/60 114
Revised BodyWorks program. Pretest
Questionnaire.
Adolescent Post 204 1 30/60 102
test
Questionnaire.
Adolescent 204 10 3/60 102
Session
Evaluation
Forms (10
forms).
Adolescent Revised BodyWorks Adolescent Pre 63 1 30/60 31.5
program comparison group test
participant. Questionnaire.
Adolescent Post 50 1 30/60 25
test
Questionnaire.
Trainers of the Revised Facilitator 22 10 5/60 18.3
BodyWorks program. Feedback Forms
(10 forms).
Coalition leaders, members, Coalition Pre 86 1 20/60 28.7
and site coordinators. test Survey.
Coalition Post 72 1 30/60 36
test Survey.
----------------------------------------------------------------------------------
Total Hours.............. ................ .............. .............. .............. 752.5
----------------------------------------------------------------------------------------------------------------
[[Page 72804]]
John Teeter,
Office of the Secretary, Paperwork Reduction Act Reports Clearance
Officer.
[FR Doc. E8-28389 Filed 11-28-08; 8:45 am]
BILLING CODE 4150-33-P
