Agency Information Collection Activities: Proposed Collection: Comment Request, 29159-29160 [E6-7666]
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Federal Register / Vol. 71, No. 97 / Friday, May 19, 2006 / Notices
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.
Guidance on Informed Consent for In
Vitro Diagnostic Device Studies Using
Leftover Human Specimens That are
Not Individually Identifiable—(OMB
Control Number 0910–0582)—Extension
FDA’s investigational device
regulations are intended to encourage
the development of new, useful devices
in a manner that is consistent with
public health, safety, and with ethical
standards. Investigators should have
freedom to pursue the least burdensome
means of accomplishing this goal.
However, to ensure that the balance is
maintained between product
development and the protection of
public health, safety, and ethical
standards, FDA has established human
subject protection regulations
addressing requirements for informed
consent and institutional review board
(IRB) review that apply to all FDAregulated clinical investigations
involving human subjects. In particular,
informed consent requirements further
both safety and ethical considerations
by allowing potential subjects to
consider both the physical and privacy
risks they face if they agree to
participate in a trial.
Under FDA regulations, clinical
investigations using human specimens
conducted in support of premarket
submissions to FDA are considered
human subject investigations (see 21
CFR 812.3(p)). Many investigational
device studies are exempt from most
provisions of part 812 (21 CFR part 812),
Investigational Device Exemptions,
29159
under § 812.2(c)(3), but FDA’s
regulations for the protection of human
subjects (21 CFR parts 50 and 56) apply
to all clinical investigations that are
regulated by FDA (see 21 CFR 50.1; 21
CFR 56.101; 21 U.S.C. 360j(g)(3)(A), and
21 U.S.C. 360j(g)(3)(D)).
FDA regulations do not contain
exceptions from the requirements of
informed consent on the grounds that
the specimens are not identifiable or
that they are remnants of human
specimens collected for routine clinical
care or analysis that would otherwise
have been discarded. Nor do FDA
regulations allow IRBs to decide
whether or not to waive informed
consent for research involving leftover
or unidentifiable specimens.
In a level one guidance document
issued under the Good Guidances
Practices regulation, 21 CFR 10.115,
FDA outlines the circumstances in
which it intends to exercise
enforcement discretion as to the
informed consent regulations for
clinical investigators, sponsors, and
IRBs.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN
No. of Recordkeepers
Annual Frequency
per Recordkeeping
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700
1
The recommendations of this
guidance impose a minimal burden on
industry. FDA estimates that 700 studies
will be affected annually. Each study
will result in one recordkeeping per
year, estimated to take 4 hours to
complete. This results in a total
recordkeeping burden of 2,400 hours
(700 x 4 = 2,800). FDA estimates that the
cost of developing standard operating
procedures for each record keeper is
$300 (6 hours of work at $50/hour (h)).
This results in a total cost to industry of
$210,000 ($300 x 700 recordkeepers).
FDA estimates that operating costs for
collecting this information is $300 per
record keeper (6 hours of work at $50/
h). This results in a total operational
and maintenance cost to industry of
$210,000 ($300 x 700 recordkeepers).
The total cost of this recordkeeping,
capital plus operational and
maintenance cost, is estimated to be
$420,000.
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Total Annual
Records
17:37 May 18, 2006
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Hours per
Record
700
Total Hours
4
Dated: May 12, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–7617 Filed 5–18–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources And Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to OMB under the
PO 00000
Frm 00041
Fmt 4703
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2,800
Total Capital
Costs
$210,000
Total Operating and
Maintenance Costs
420,000
Paperwork Reduction Act of 1995. To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, call the HRSA Reports
Clearance Officer on (301) 443–1891.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection 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
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
E:\FR\FM\19MYN1.SGM
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29160
Federal Register / Vol. 71, No. 97 / Friday, May 19, 2006 / Notices
Proposed Project: Faculty Loan
Repayment Program (FLRP)
Application (OMB No. 0915–0150)—
Extension
Under the Health Resources and
Services Administration Faculty Loan
Repayment Program, degree-trained
health professionals from disadvantaged
backgrounds may enter into a contract
under which HRSA, with the
Department of Health and Human
Services, will make payments on
eligible health professions educational
loans in exchange for a minimum of two
years of service as a full-time or parttime faculty member of an accredited
health professions college or university.
Applicants must complete an
application and provide all other
required documentation including
information on all eligible health
professions educational loans.
The estimated response burden is as
follows:
Respondent
Number of
respondents
Responses
per
respondent
Total
responses
Hours per
response
Total burden
hours
Applicants .............................................................................
150
1
150
1
150
Send comments to Susan G. Queen,
Ph.D., HRSA Reports Clearance Officer,
Room 10–33, Parklawn Building, 5600
Fishers Lane, Rockville, MD 20857.
Written comments should be received
within 60 days of this notice.
Dated: May 15, 2006.
Tina M. Cheatham,
Director, Division of Policy Review and
Coordination.
[FR Doc. E6–7666 Filed 5–18–06; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, call the
HRSA Reports Clearance Officer on
(301) 443–1129.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the Agency,
including whether the information shall
have practical utility; (b) the accuracy of
the Agency’s estimate of the burden of
the proposed collection 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
on respondents, including the use of
automated collection techniques or
other forms of information technology.
Proposed Project: Enhanced
Performance Measurement System for
HRSA Health Professions Education
and Training Program Grants: NEW
Following the 1998 reauthorization,
HRSA’s Health Professions Education
and Training Programs have been using
a reporting system known as the
Comprehensive Performance
Management System/Uniform Progress
Report (CPMS/UPR) for preparation and
submission of applications for
continuation grants, and for reporting
program outcomes under the
Government Performance and Results
Act of 1993 (GPRA).
Part I of the CPMS/UPR measures
grantee progress toward meeting
objectives, and is used for funding
decisions. Part II collects information
used by program officers to monitor
program specific activities. Part III
collects information on program results
that can be aggregated across multiple
programs, and is used for GPRA
reporting and OMB initiated
performance assessment activities.
The instrument previously approved
for OMB for these purposes has been
revised for clarity, and modified to
better capture outcome information
related to Health Professions Education
and Training Programs that is
increasingly required for evaluating
Federal policy and program
performance. Some elements have been
added to improve measurement
capability, while others have been
streamlined to reduce burden.
Additional validation rules are also
being added to improve the quality of
the data. Portions of the instrument
have also been redesigned to improve
reporting consistency among programs.
The proposed system will be Webbased, and is planned to include a series
of preprogrammed reports to increase
access to, and analysis of, the data.
Estimates of annualized reporting
burden are as follows:
Number of
respondents
Responses
per
respondent
Total
responses
Hours per
respondent
Total hour
burden
Enhanced Performance Measurement System ...................
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Form
1,550
1
1,550
21.5
33,325
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]]>Agencies
[Federal Register Volume 71, Number 97 (Friday, May 19, 2006)]
[Notices]
[Pages 29159-29160]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-7666]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources And Services Administration
Agency Information Collection Activities: Proposed Collection:
Comment Request
In compliance with the requirement for opportunity for public
comment on proposed data collection projects (section 3506(c)(2)(A) of
Title 44, United States Code, as amended by the Paperwork Reduction Act
of 1995, Pub. L. 104-13), the Health Resources and Services
Administration (HRSA) publishes periodic summaries of proposed projects
being developed for submission to OMB under the Paperwork Reduction Act
of 1995. To request more information on the proposed project or to
obtain a copy of the data collection plans and draft instruments, call
the HRSA Reports Clearance Officer on (301) 443-1891.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection 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 on respondents,
including through the use of automated collection techniques or other
forms of information technology.
[[Page 29160]]
Proposed Project: Faculty Loan Repayment Program (FLRP) Application
(OMB No. 0915-0150)--Extension
Under the Health Resources and Services Administration Faculty Loan
Repayment Program, degree-trained health professionals from
disadvantaged backgrounds may enter into a contract under which HRSA,
with the Department of Health and Human Services, will make payments on
eligible health professions educational loans in exchange for a minimum
of two years of service as a full-time or part-time faculty member of
an accredited health professions college or university. Applicants must
complete an application and provide all other required documentation
including information on all eligible health professions educational
loans.
The estimated response burden is as follows:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Respondent respondents respondent responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Applicants......................................................... 150 1 150 1 150
--------------------------------------------------------------------------------------------------------------------------------------------------------
Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance
Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville,
MD 20857. Written comments should be received within 60 days of this
notice.
Dated: May 15, 2006.
Tina M. Cheatham,
Director, Division of Policy Review and Coordination.
[FR Doc. E6-7666 Filed 5-18-06; 8:45 am]
BILLING CODE 4165-15-P
