Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567, 35493 [E7-12497]
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35493
Federal Register / Vol. 72, No. 124 / Thursday, June 28, 2007 / Notices
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, 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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
56.115
Annual Frequency
of Recordkeeping
5,000
Total Annual
Records
14.6
Hours per
Recordkeeper
73,000
Total Hours
100
Total
1There
7,300,000
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 5,000 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: June 21, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–12496 Filed 6–27–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0430]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
General Licensing Provisions:
Biologics License Application,
Changes to an Approved Application,
Labeling, Revocation and Suspension,
Postmarketing Studies Status Reports,
and Forms FDA 356h and 2567
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
mstockstill on PROD1PC66 with NOTICES
7,300,000
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘General Licensing Provisions:
Biologics License Application, Changes
to an Approved Application, Labeling,
Revocation and Suspension,
Postmarketing Studies Status Reports,
and Forms FDA 356h and 2567’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
VerDate Aug<31>2005
18:23 Jun 27, 2007
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FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
In the
Federal Register of February 2, 2007 (72
FR 5057), the agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0338. The
approval expires on June 30, 2010. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
SUPPLEMENTARY INFORMATION:
Dated: June 21, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–12497 Filed 6–27–07; 8:45 am]
BILLING CODE 4160–01–S
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[Federal Register Volume 72, Number 124 (Thursday, June 28, 2007)]
[Notices]
[Page 35493]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-12497]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0430]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; General Licensing Provisions:
Biologics License Application, Changes to an Approved Application,
Labeling, Revocation and Suspension, Postmarketing Studies Status
Reports, and Forms FDA 356h and 2567
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``General Licensing Provisions:
Biologics License Application, Changes to an Approved Application,
Labeling, Revocation and Suspension, Postmarketing Studies Status
Reports, and Forms FDA 356h and 2567'' has been approved by the Office
of Management and Budget (OMB) under the Paperwork Reduction Act of
1995.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: In the Federal Register of February 2, 2007
(72 FR 5057), the agency announced that the proposed information
collection had been submitted to OMB for review and clearance under 44
U.S.C. 3507. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0338.
The approval expires on June 30, 2010. A copy of the supporting
statement for this information collection is available on the Internet
at https://www.fda.gov/ohrms/dockets.
Dated: June 21, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-12497 Filed 6-27-07; 8:45 am]
BILLING CODE 4160-01-S
