Submission for OMB Review; Comment Request, 63152-63153 [E8-25285]
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63152
Federal Register / Vol. 73, No. 206 / Thursday, October 23, 2008 / Notices
Institutions Not Engaged in Human
Subjects Research
dwashington3 on PRODPC61 with NOTICES
Release of Identifiable Private
Information or Biological Specimens
In the Federal Register of December 8,
2006 (71 FR 71169), OHRP noted that
the office was particularly interested in
the public’s comments on the proposal
that institutions whose employees or
agents release to investigators at another
institution identifiable private
information or identifiable biological
specimens pertaining to the subjects of
the research, not be considered engaged
in human subjects research.
The public comments supported this
proposed scenario. OHRP retained this
scenario in the final guidance
document, with only minor clarifying
changes (see scenario B.(6) in the final
guidance).
Administration of Clinical Trial-Related
Medical Services
In the Federal Register of December 8,
2006 (71 FR 71169), OHRP also noted
that the office was particularly
interested in the public’s comments on
the proposal that institutions (including
private practices) not selected as
research sites whose employees or
agents administer clinical trial-related
medical services, not be considered
engaged in human subjects research
provided that specified conditions were
met. One of the proposed conditions
was that the institution’s employees or
agents do not administer the primary
study interventions being tested under
the protocol.
The public comments on this
proposed scenario were generally
supportive, but several commenters
sought clarifications on some of the
proposed conditions. In addition, a few
of the commenters recommended that
OHRP expand the scenario to permit the
employees or agents of an institution
not selected as a research site to
administer the study intervention being
tested or evaluated under the protocol,
and still not consider such an
institution to be engaged in human
subjects research.
In the final guidance, OHRP retained
the proposed scenario, with minor
changes in response to the public
comments (see scenario B.(2) in the final
guidance). However, OHRP also has
included another scenario in the final
guidance that would allow employees or
agents of an institution not initially
selected as a research site to administer
the study interventions being tested or
evaluated under the protocol, provided
that this occurs on a one-time or short-
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14:58 Oct 22, 2008
Jkt 217001
term basis, and specified conditions are
met (see scenario B.(3) in the final
guidance). OHRP believes this is
responsive to the concern raised in a
public comment that research subjects
are sometimes unexpectedly
hospitalized or otherwise unexpectedly
unable to receive a study intervention
being tested or evaluated in a protocol
from an institution that had previously
been designated as a research site.
III. Comments
Interested persons may submit
comments regarding this guidance
document to OHRP at any time. Please
see the ADDRESSES section for
information on where to submit written
comments.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance document on
OHRP’s Web site at https://www.hhs.gov/
ohrp/humansubjects/guidance/
engage08.htm.
Dated: October 16, 2008.
Ivor A. Pritchard,
Acting Director, Office for Human Research
Protections.
[FR Doc. E8–25177 Filed 10–22–08; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Community-Based Abstinence
Education Performance Progress Report.
OMB No.: 0970–0272.
Description: The discretionary
funding Community-Based Abstinence
Education Program (CBAE) is
authorized by Title XI, Section 1110, of
the Social Security Act (using the
definitions contained in Title V, Section
510(b)(2) of the Social Security Act).
Performance Progress Report/Program
Narrative
The CBAE Performance Progress
Report/Program Narrative is a
semiannual report form through which
grantees report performance information
used by the Administration for Children
and Families (ACF) to evaluate each
grantee’s compliance with Federal law
and progress toward achieving its goals.
Performance information includes:
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
Description of major activities and
accomplishments during the reporting
period;
Description of deviations or
departures from the original project;
Description of significant findings and
events;
Description of dissemination
activities;
Description of other activities; and
Description of activities planned for
the next reporting period, including
goals and objectives.
Program-Specific Performance Measure
The CBAE program is developing a
program-specific performance measure
in response to the PART review (a
process by which the Office of
Management and Budget analyzes and
rates a Federal program’s procedures
and strategies for evaluating its
effectiveness), for which the program
received a rating of Adequate. In an
effort to gather program-specific data on
rates of abstinence pre- and postprogram participation, ACF and the
Office of Management and Budget
determined that a program-specific
performance measure should be
developed to assess key outcomes
among program participants. The CBAE
office convened a panel of abstinence
education experts to gather input on the
measure, and, based on the input
provided, the CBAE office is developing
the measure. CBAE grantees will be
required to ask ten to fifteen questions
of the youth served in a pre- and postsurvey, as well as a representative
sample of the youth served in a postpost-survey.
The questions are being carefully
constructed by an experienced evaluator
to measure initiation and
discontinuation of sexual intercourse as
well as two key predictors of initiation:
Sexual values and behavioral intentions.
The program office will collect and
compile data to establish baselines and
ambitious targets for the programspecific performance measure. The data
will be aggregated and results will be
shared with the public as they become
available.
Respondents: Performance Progress
Report/Program Narrative—Non-profit
community-based organizations, faithbased organizations, schools/school
districts, universities/colleges,
hospitals, public health agencies, local
governments, Tribal councils, small
businesses/for-profit entities, housing
authorities, etc. Program-Specific
Performance Measure—Youth
Participants.
E:\FR\FM\23OCN1.SGM
23OCN1
63153
Federal Register / Vol. 73, No. 206 / Thursday, October 23, 2008 / Notices
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Community-Based Abstinence Education Program Announcement Performance Progress Report/Program Narrative ....................................................
Community-Based Abstinence Education Program—Program-Specific Performance Measure .......................................................................................
Estimated Total Annual Burden
Hours: 516,000
Additional Information
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: October 20, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–25285 Filed 10–22–08; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
dwashington3 on PRODPC61 with NOTICES
[Docket No. FDA–2008–N–0546]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Electronic Data
Collection Using MedWatchPlus Portal
and Rational Questionnaire
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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14:58 Oct 22, 2008
Jkt 217001
Frm 00022
Fmt 4703
Sfmt 4703
Average
burden hours
per response
Total burden
hours
60
2
50
6,000
1,000,000
3
0.17
510,000
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
the use of MedWatchPlus Portal and
Rational Questionnaire to collect
electronically all adverse event,
consumer complaint/product problem
and medication use error data submitted
to FDA.
DATES: Submit written or electronic
comments on the collection of
information by December 22, 2008.
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:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
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
PO 00000
Number of
responses per
respondent
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.
Electronic Data Collection Using
MedWatchPlus Portal and Rational
Questionnaire—21 CFR 310.305,
314.80, 314.98, 514.80, 600.80, 1271.350
and Part 803
FDA is implementing electronic data
collection to improve adverse event
reporting across the agency. FDA’s
current processes and systems for
adverse event reporting vary across its
centers and are not optimal for the
efficient collection of voluntary and
mandatory adverse event reports,
product problems/consumer
complaints, or errors associated with the
use of FDA-regulated products. Current
FDA reporting forms (Forms FDA 3500,
3500A, 1932, and 1932a) are an
outgrowth of a paper process era and
frequently result in the submission of
inconsistent and poor quality
information. In addition, the agency is
limited in its ability to modify its paper
forms to keep pace with changes in the
types of regulated products and the
information necessary to meet evolving
standards to ensure post market safety.
Further, the existing supporting
business processes are not able to
efficiently manage the information being
provided on the paper forms. For
example, the upfront data integrity
E:\FR\FM\23OCN1.SGM
23OCN1
]]>Agencies
[Federal Register Volume 73, Number 206 (Thursday, October 23, 2008)]
[Notices]
[Pages 63152-63153]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-25285]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Community-Based Abstinence Education Performance Progress
Report.
OMB No.: 0970-0272.
Description: The discretionary funding Community-Based Abstinence
Education Program (CBAE) is authorized by Title XI, Section 1110, of
the Social Security Act (using the definitions contained in Title V,
Section 510(b)(2) of the Social Security Act).
Performance Progress Report/Program Narrative
The CBAE Performance Progress Report/Program Narrative is a
semiannual report form through which grantees report performance
information used by the Administration for Children and Families (ACF)
to evaluate each grantee's compliance with Federal law and progress
toward achieving its goals. Performance information includes:
Description of major activities and accomplishments during the
reporting period;
Description of deviations or departures from the original project;
Description of significant findings and events;
Description of dissemination activities;
Description of other activities; and
Description of activities planned for the next reporting period,
including goals and objectives.
Program-Specific Performance Measure
The CBAE program is developing a program-specific performance
measure in response to the PART review (a process by which the Office
of Management and Budget analyzes and rates a Federal program's
procedures and strategies for evaluating its effectiveness), for which
the program received a rating of Adequate. In an effort to gather
program-specific data on rates of abstinence pre- and post-program
participation, ACF and the Office of Management and Budget determined
that a program-specific performance measure should be developed to
assess key outcomes among program participants. The CBAE office
convened a panel of abstinence education experts to gather input on the
measure, and, based on the input provided, the CBAE office is
developing the measure. CBAE grantees will be required to ask ten to
fifteen questions of the youth served in a pre- and post-survey, as
well as a representative sample of the youth served in a post-post-
survey.
The questions are being carefully constructed by an experienced
evaluator to measure initiation and discontinuation of sexual
intercourse as well as two key predictors of initiation: Sexual values
and behavioral intentions.
The program office will collect and compile data to establish
baselines and ambitious targets for the program-specific performance
measure. The data will be aggregated and results will be shared with
the public as they become available.
Respondents: Performance Progress Report/Program Narrative--Non-
profit community-based organizations, faith-based organizations,
schools/school districts, universities/colleges, hospitals, public
health agencies, local governments, Tribal councils, small businesses/
for-profit entities, housing authorities, etc. Program-Specific
Performance Measure--Youth Participants.
[[Page 63153]]
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average
Instrument Number of responses per burden hours Total burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
Community-Based Abstinence Education Program 60 2 50 6,000
Announcement Performance Progress Report/
Program Narrative..............................
Community-Based Abstinence Education Program-- 1,000,000 3 0.17 510,000
Program-Specific Performance Measure...........
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 516,000
Additional Information
Copies of the proposed collection may be obtained by writing to the
Administration for Children and Families, Office of Administration,
Office of Information Services, 370 L'Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests
should be identified by the title of the information collection. E-mail
address: infocollection@acf.hhs.gov.
OMB Comment
OMB is required to make a decision concerning the collection of
information between 30 and 60 days after publication of this document
in the Federal Register. Therefore, a comment is best assured of having
its full effect if OMB receives it within 30 days of publication.
Written comments and recommendations for the proposed information
collection should be sent directly to the following: Office of
Management and Budget, Paperwork Reduction Project, Fax: 202-395-6974,
Attn: Desk Officer for the Administration for Children and Families.
Dated: October 20, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8-25285 Filed 10-22-08; 8:45 am]
BILLING CODE 4184-01-P
