Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Institutional Review Boards, 78252 [2010-31389]
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78252
Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices
Dated: December 8, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–31381 Filed 12–14–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0418]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Institutional
Review Boards
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 January 14,
2011.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
SUMMARY:
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0130. Also
include the FDA 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.,
PI50–400B, Rockville, MD 20850,. 301–
796–3792.
Elizabeth.Berbakos@fda.hhs.gov.
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.
Institutional Review Boards—OMB
Control Number 0910–0130—Extension
When reviewing clinical research
studies regulated by FDA, institutional
review boards (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, the
basis for requiring changes in or
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.
In the Federal Register of August 17,
2010 (75 FR 50766), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received regarding the information
collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
Annual
frequency per
recordkeeping
Total annual
records
Hours per
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.
hsrobinson on DSK69SOYB1PROD with NOTICES
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: December 8, 2010.
Leslie Kux,
Acting Assistant, Commissioner for Policy.
Food and Drug Administration
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
[Docket No. FDA–2010–N–0184]
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Experimental
Study of Patient Information
Prototypes
AGENCY:
Food and Drug Administration,
HHS.
Notice.
[FR Doc. 2010–31389 Filed 12–14–10; 8:45 am]
ACTION:
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SUMMARY:
VerDate Mar<15>2010
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
19:10 Dec 14, 2010
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Fax written comments on the
collection of information by January 14,
2011.
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:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–new and
title ‘‘Experimental Study of Patient
Information Prototypes.’’ Also include
ADDRESSES:
E:\FR\FM\15DEN1.SGM
15DEN1
]]>Agencies
[Federal Register Volume 75, Number 240 (Wednesday, December 15, 2010)]
[Notices]
[Page 78252]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31389]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0418]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Institutional Review
Boards
AGENCY: Food and Drug Administration, HHS.
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 January
14, 2011.
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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0130.
Also include the FDA 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.,
PI50-400B, Rockville, MD 20850,. 301-796-3792.
Elizabeth.Berbakos@fda.hhs.gov.
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.
Institutional Review Boards--OMB Control Number 0910-0130--Extension
When reviewing clinical research studies regulated by FDA,
institutional review boards (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, the
basis for requiring changes in or 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.
In the Federal Register of August 17, 2010 (75 FR 50766), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received regarding the
information collection.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
21 CFR section Number of frequency per Total annual Hours per Total hours
recordkeepers recordkeeping records recordkeeper
--------------------------------------------------------------------------------------------------------------------------------------------------------
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: December 8, 2010.
Leslie Kux,
Acting Assistant, Commissioner for Policy.
[FR Doc. 2010-31389 Filed 12-14-10; 8:45 am]
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