Agency Information Collection Activities; Proposed Collection; Comment Request; Institutional Review Boards, 50766-50767 [2010-20273]
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50766
Federal Register / Vol. 75, No. 158 / Tuesday, August 17, 2010 / Notices
Dated: August 10, 2010.
Elaine Parry,
Director, Office of Program Services.
Proposed Project: Multiplier Surveys—
NEW
[FR Doc. 2010–20262 Filed 8–16–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
While all SAMHSA programming is
intended to support the SAMHSA
vision of a life in the community for
everyone, and its strategic goals of
accountability, capacity, and
effectiveness, there has been little
systematic investigation of the longrange impact of different categories of
discretionary programs. The Multiplier
Surveys will inform SAMHSA policy
and budget development by determining
which types of investments are most
appropriate for achieving different
policy objectives, including
sustainability of the program or its
intended outcomes after Federal
funding ends. It also seeks to determine
which program types or factors are best
at achieving certain objectives after the
conclusion of Federal funding, such as
capacity improvement, system change,
sustainability and influence on other
programs. Findings will be used to make
recommendations to SAMHSA
Responses
per
respondent
Number of
respondents
Information source
management to better inform policy and
budget development and to determine
which types of investments are most
appropriate for achieving different
policy objectives.
To achieve the goals of the Multiplier
Surveys four programs have been
chosen from each of SAMHSA’s three
Centers. Four Project Directors from
each of the 12 programs (48 respondents
in all), whose Federal funding ended no
later than September 30, 2008 will be
interviewed by telephone to determine
how the project was sustained after
Federal funding ended and what factors
contributed to its sustainability.
In addition, all grantees from each of
the 12 selected programs meeting
inclusion criteria will be invited via email to complete a short on-line survey
about their project and how/if it was
sustained after Federal funding ended.
A 20 percent response rate or about 100
respondents to the on-line survey is
expected.
The estimated response burden is as
follows:
Total
responses
Hours per
response
Total
hours
Project Director ..................................................................
Web-based Survey ............................................................
48
100
1
1
48
100
1.25
.75
60
75
Total ............................................................................
148
........................
148
..........................
135
Written comments and
recommendations concerning the
proposed information collection should
be sent by September 16, 2010 to:
SAMHSA Desk Officer, Human
Resources and Housing Branch, Office
of Management and Budget, New
Executive Office Building, Room 10235,
Washington, DC 20503; due to potential
delays in OMB’s receipt and processing
of mail sent through the U.S. Postal
Service, respondents are encouraged to
submit comments by fax to: 202–395–
5806.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: August 10, 2010.
Elaine Parry,
Director, Office of Program Services.
SUMMARY:
[FR Doc. 2010–20261 Filed 8–16–10; 8:45 am]
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Food and Drug Administration
[Docket No. FDA–2010–N–0418]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Institutional
Review Boards
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the recordkeeping requirements for
institutional review boards (IRBs).
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Submit either electronic or
written comments on the collection of
information by October 18, 2010.
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:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
Pl50–400B, Rockville, MD 20850, 301–
796–3792, e-mail:
Elizabeth.Berbakos@fda.hhs.gov.
DATES:
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)
SUPPLEMENTARY INFORMATION:
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50767
Federal Register / Vol. 75, No. 158 / Tuesday, August 17, 2010 / Notices
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,
including each proposed extension of an
existing collection of information,
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.
Institutional Review Boards—21 CFR
56.115 (OMB Control Number 0910–
0130)—Extension
When reviewing clinical research
studies regulated by FDA, IRBs are
required to create and maintain records
describing their operations, and make
the records available for FDA inspection
when requested. These records include:
Written procedures describing the
structure and membership of the IRB
and the methods that the IRB will use
in performing its functions; the research
protocols, informed consent documents,
progress reports, and reports of injuries
to subjects submitted by investigators to
the IRB; minutes of meetings showing
attendance, votes, and decisions made
by the IRB, the number of votes on each
decision for, against, and abstaining,
and the basis for requiring changes in
research or for disapproving research;
records of continuing review activities;
copies of all correspondence between
investigators and the IRB; statement of
significant new findings provided to
subjects of the research; and a list of IRB
members by name, showing each
member’s earned degrees, representative
capacity, and experience in sufficient
detail to describe each member’s
contributions to the IRB’s deliberations,
and any employment relationship
between each member and the IRB’s
institution. This information is used by
FDA in conducting audit inspections of
IRBs to determine whether IRBs and
clinical investigators are providing
adequate protections to human subjects
participating in clinical research.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
CFR Section
56.115
Annual Frequency
of Recordkeeping
2,500
Total Annual
Records
14.6
Hours per
Recordkeeper
36,500
100
Total
are no capital costs or operating and maintenance costs associated with this collection of information.
The recordkeeping requirement
burden is based on the following: The
burden for each of the paragraphs under
21 CFR 56.115 has been considered as
one estimated burden. FDA estimates
that there are approximately 2,500 IRBs.
The IRBs meet on an average of 14.6
times annually. The agency estimates
that approximately 100 hours of persontime per meeting are required to meet
the requirements of the regulation.
Dated: August 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–20273 Filed 8–16–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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3,650,000
3,650,000
1 There
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
AGENCY:
ACTION:
Total Hours
Notice.
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The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
SUMMARY:
Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
ADDRESSES:
Glioblastoma Diagnostics and
Therapeutics
Description of Invention: Investigators
at the NIH have discovered an Anti-TNF
Induced Apoptosis (ATIA) protein,
PO 00000
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which protects cells against apoptosis.
ATIA is highly expressed in
glioblastoma and astrocytomas and its
inhibition results in increased cell
sensitivity to TNF-related apoptosisinducing ligand induced cell death.
Hence, ATIA assays may enable
clinicians to effectively stratify patients
for appropriate treatment. ATIA exists
in a soluble form that can be detected
in culture medium of ATIA expressing
cells indicating it could be used to
develop a non-invasive, blood based
diagnostic test such as an ELISA.
Glioblastomas and astrocytomas can be
diagnosed via MRI and CT scans;
however, these scans cannot detect
tumor type, i.e. glioblastoma vs.
medulloblastoma. The investigators
found that ATIA is induced in cells
under hypoxia conditions. More
importantly, knockdown of ATIA in
human glioblastoma cells renders cells
to apoptosis under hypoxia conditions.
Therefore, ATIA is a potential novel
therapeutic target for treating human
glioblastoma.
Glioblastoma arise from astrocytes,
cells that provide neurons structural
and metabolic support. Glioblastomas
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]]>Agencies
[Federal Register Volume 75, Number 158 (Tuesday, August 17, 2010)]
[Notices]
[Pages 50766-50767]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-20273]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0418]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Institutional Review Boards
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the recordkeeping requirements
for institutional review boards (IRBs).
DATES: Submit either electronic or written comments on the collection
of information by October 18, 2010.
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: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
Pl50-400B, Rockville, MD 20850, 301-796-3792, e-mail:
Elizabeth.Berbakos@fda.hhs.gov.
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)
[[Page 50767]]
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, including each
proposed extension of an existing collection of information, 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.
Institutional Review Boards--21 CFR 56.115 (OMB Control Number 0910-
0130)--Extension
When reviewing clinical research studies regulated by FDA, IRBs are
required to create and maintain records describing their operations,
and make the records available for FDA inspection when requested. These
records include: Written procedures describing the structure and
membership of the IRB and the methods that the IRB will use in
performing its functions; the research protocols, informed consent
documents, progress reports, and reports of injuries to subjects
submitted by investigators to the IRB; minutes of meetings showing
attendance, votes, and decisions made by the IRB, the number of votes
on each decision for, against, and abstaining, and the basis for
requiring changes in research or for disapproving research; records of
continuing review activities; copies of all correspondence between
investigators and the IRB; statement of significant new findings
provided to subjects of the research; and a list of IRB members by
name, showing each member's earned degrees, representative capacity,
and experience in sufficient detail to describe each member's
contributions to the IRB's deliberations, and any employment
relationship between each member and the IRB's institution. This
information is used by FDA in conducting audit inspections of IRBs to
determine whether IRBs and clinical investigators are providing
adequate protections to human subjects participating in clinical
research.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency of Total Annual Hours per
CFR Section Recordkeepers Recordkeeping Records Recordkeeper Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
56.115 2,500 14.6 36,500 100 3,650,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 3,650,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The recordkeeping requirement burden is based on the following: The
burden for each of the paragraphs under 21 CFR 56.115 has been
considered as one estimated burden. FDA estimates that there are
approximately 2,500 IRBs. The IRBs meet on an average of 14.6 times
annually. The agency estimates that approximately 100 hours of person-
time per meeting are required to meet the requirements of the
regulation.
Dated: August 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-20273 Filed 8-16-10; 8:45 am]
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