Agency Information Collection Activities: Proposed Collection; Comment Request; Institutional Review Boards, 60286-60287 [2013-23864]
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60286
Federal Register / Vol. 78, No. 190 / Tuesday, October 1, 2013 / Notices
emcdonald on DSK67QTVN1PROD with NOTICES
system will be given credentials to use
OLDC. Upon request, ACF will provide
credentials and access to use the OLDC
system to all applicants and grantees.
Individuals already authorized to use
OLDC may need their authorization
updated to include additional programs
or documents, if applicable. Affected
ACF Program Offices will send detailed
instructions to grantees and applicants.
7. The same commenter also asked
whether submitted State Plans could be
viewed by the public through ACF’s
OLDC system.
ACF responds that the OLDC system
does not have the capability to allow
viewing of submitted plans or reports by
the public. ACF Program Offices that
provide public viewing of submitted
plans on their Web sites will continue
that practice. States and Tribes should
follow their internal procedures in
making the determination to provide
plans and reports for public viewing.
8. A commenter objected to the
requirement by some ACF Program
Offices that a paper copy of a submitted
plan be distributed to the relevant ACF
Regional Office. The same commenter
also recommended that, once a plan is
electronically signed and submitted to
OLDC, ACF should not allow
subsequent changes to the data unless
the grantee is submitting a revised
report, according to the reporting
instructions.
ACF responds that, with the
implementation of this requirement,
once a grantee submits its plan or
reporting forms into OLDC, the
submission of a second paper copy is no
longer required. ACF’s Regional Office
staff will access plans and reports using
OLDC, eliminating the requirement for
distribution of additional copies. And,
we note that once a submission is
signed and submitted in OLDC, any
revisions, changes, or updates must be
made by entering a revised report in
OLDC. We note that there is no limit to
the number of revised reports a grantee
may submit; however, some date
restrictions by the cognizant Program
Office may apply to submission of
revisions.
Statutory Authority: Financial Assistance
Management Improvement Act of 1999, Pub.
L. 106–107.
Robert Noonan,
Deputy Assistant Secretary for
Administration, Administration for Children
and Families.
[FR Doc. 2013–23773 Filed 9–30–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1163]
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).
DATES: Submit either electronic or
written comments on the collection of
information by December 2, 2013.
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@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) 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,
SUMMARY:
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
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
Part 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:
(1) Written procedures describing the
structure and membership of the IRB
and the methods that the IRB will use
in performing its functions; (2) the
research protocols, informed consent
documents, progress reports, and
reports of injuries to subjects submitted
by investigators to the IRB; (3) 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; (4) records of continuing
review activities; copies of all
correspondence between investigators
and the IRB; (5) statement of significant
new findings provided to subjects of the
research; and (6) 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.
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Federal Register / Vol. 78, No. 190 / Tuesday, October 1, 2013 / 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 person-
60287
time per meeting are required to meet
the requirements of the regulation.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR Section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden
per recordkeeping
Total hours
56.115 ..................................................................................
2,500
14.6
36,500
100
3,650,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–23864 Filed 9–30–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1164]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Testing
Communications on Biological
Products
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
communication studies involving
biological products that are regulated by
FDA.
DATES: Submit either electronic or
written comments on the collection of
information by December 2, 2013.
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
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
14:45 Sep 30, 2013
Jkt 232001
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@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) 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.
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
Testing Communications on Biological
Products—(OMB Control Number 0910–
0687)—Extension
FDA is authorized by section
1003(d)(2)(D) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C.
§ 393(d)(2)(D)) to conduct educational
and public information programs
relating to the safety of regulated
biological products. FDA conducts
needed research to help ensure that
such programs have the highest
likelihood of being effective. FDA
expects that improving communications
about biological products will involve
many research methods, including
individual in-depth interviews, mallintercept interviews, focus groups, selfadministered surveys, gatekeeper
reviews, and omnibus telephone
surveys. The information will be used to
explore concepts of interest and assist in
the development and modification of
communication messages and
campaigns to fulfill the Agency’s
mission to protect the public health.
The information collected will serve
three major purposes. First, as formative
research it will provide critical
knowledge needed about target
audiences to develop messages and
campaigns about biological product use.
Knowledge of consumer and healthcare
professional decision-making processes
will provide the better understanding of
target audiences that FDA needs to
design effective communication
strategies, messages, and labels. These
communications will aim to improve
public understanding of the risks and
benefits of using biological products by
providing users with a better context in
which to place risk information more
completely.
Second, as initial testing, it will allow
FDA to assess the potential effectiveness
of messages and materials in reaching
and successfully communicating with
their intended audiences. Testing
messages with a sample of the target
audience will allow FDA to refine
messages while still in the
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]]>Agencies
[Federal Register Volume 78, Number 190 (Tuesday, October 1, 2013)]
[Notices]
[Pages 60286-60287]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-23864]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1163]
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 December 2, 2013.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@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) 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 Part 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: (1) Written procedures describing the structure and
membership of the IRB and the methods that the IRB will use in
performing its functions; (2) the research protocols, informed consent
documents, progress reports, and reports of injuries to subjects
submitted by investigators to the IRB; (3) 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; (4) records of continuing review
activities; copies of all correspondence between investigators and the
IRB; (5) statement of significant new findings provided to subjects of
the research; and (6) 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.
[[Page 60287]]
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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR Section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
56.115............................................................. 2,500 14.6 36,500 100 3,650,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-23864 Filed 9-30-13; 8:45 am]
BILLING CODE 4160-01-P
