Agency Information Collection Activities; Proposed Collection; Comment Request; Institutional Review Boards, 35492-35493 [E7-12496]
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Federal Register / Vol. 72, No. 124 / Thursday, June 28, 2007 / Notices
and international officials and scientists
to establish and maintain dietary
surveillance systems related to maternal
and child health, chronic disease
nutrition, and risk factors; (3) analyzes,
interprets, and disseminates data from
surveys, surveillance activities, and
epidemiologic studies related to
maternal and child nutrition and
nutrition factors affecting chronic
disease; (4) designs, implements, and
evaluates epidemiologic studies and
intervention projects for domestic and
international application to address
micronutrient nutrition; (5) develops
and disseminates nutrition guidelines
and recommendations for maternal and
child health, child growth and
development, and prevention/reduction
of chronic disease; (6) coordinates and
collaborates with appropriate Federal
agencies, national and international
organizations, and other partners to
strengthen and extend nutrition
surveillance and epidemiology; and (7)
conducts cross-functional nutritionrelated activities throughout NCCDPHP.
Physical Activity and Health Branch
(CUCHD). (1) Plans, coordinates, and
conducts surveillance activities in
domestic and international settings
related to physical activity levels as well
as factors associated with physical
activity practices; (2) conducts
epidemiologic research related to
physical activity and its impact on
health, obesity, and chronic disease; (3)
provides leadership in the development
of evidence-based guidelines and
recommendations for physical activity;
(4) provides technical expertise,
consultation and training to state, local,
and international officials related to
physical activity; (5) disseminates
findings from surveillance and
epidemiologic research through
publications in scientific literature; (6)
coordinates and collaborates with
appropriate Federal agencies, national
and international organizations, and
other partners to strengthen and extend
surveillance and epidemiology related
to physical activity and health and to
enhance development of science-based
guidelines and recommendations for
physical activity; and (7) conducts
cross-functional physical activityrelated activities throughout NCCDHP.
Obesity Prevention and Control
Branch (CUCHG). (1) Plans, coordinates,
and conducts surveillance to assess
levels of healthy weight, overweight,
and obesity and associated factors and
behaviors; (2) provides expertise,
consultation and training to state, local,
and international officials and scientists
to establish and maintain surveillance
systems related to healthy weight,
overweight, and obesity; (3) analyzes,
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interprets, and disseminates data from
surveys, surveillance activities, and
epidemiologic studies related to obesity
and overweight; (4) designs,
implements, and evaluates
epidemiologic studies and intervention
projects; (5) develops and disseminates
guidelines and recommendations; (6)
coordinates and collaborates with
appropriate Federal agencies, national
and international organizations, and
other partners to strengthen and extend
surveillance and epidemiology; and (7)
conducts cross-functional obesityrelated activities throughout NCCDPHP.
Program Development and Evaluation
Branch (CUCHH). (1) Provides
programmatic leadership, technical
expertise, and guidance for state-based
nutrition, physical activity, and obesity
prevention programs; (2) delivers
technical assistance and consultation to
states, communities, and the public in
health promotion and chronic disease
prevention; (3) identifies and promotes
effective program management
approaches and ensures performancebased distribution of public funds; (4)
uses research findings, guidelines, and
recommendations to develop strategies
and interventions that support physical
activity, good nutrition, and health
weight; (5) conducts behavioral and
communications research to understand
knowledge, attitudes, and beliefs, and
institute health-conscious behavior
changes in populations; (6) conducts
research to identify effective outreach
strategies, particularly for underserved
populations and those at highest risk of
chronic disease; (7) obtains, analyzes,
disseminates, and publishes data from
state-based programs to develop
operational strategies for translation of
results into improved and promising
practices; (8) monitors, tracks, and
evaluates program interventions and
activities for health impact; and (9)
establishes and maintains collaborative
relationships with external partners and
groups, including research institutions,
schools of public health, medical
schools, state health departments,
national and voluntary organizations,
and others to ensure that the Division’s
efforts reflect state-of-the-art practices
and methods.
Dated: June 20, 2007.
William H. Gimson,
Chief Operating Officer, Centers for Disease
Control and Prevention (CDC).
[FR Doc. 07–3162 Filed 6–27–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0241]
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 written or electronic
comments on the collection of
information by August 27, 2007.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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 the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1482.
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
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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]
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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.
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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]
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]]>Agencies
[Federal Register Volume 72, Number 124 (Thursday, June 28, 2007)]
[Notices]
[Pages 35492-35493]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-12496]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0241]
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 written or electronic comments on the collection of
information by August 27, 2007.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. 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 the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1482.
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
[[Page 35493]]
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 Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency of Total Annual Hours per
21 CFR Section Recordkeepers Recordkeeping Records Recordkeeper Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
56.115 5,000 14.6 73,000 100 7,300,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 7,300,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 5,000 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: June 21, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-12496 Filed 6-27-07; 8:45 am]
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