Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Institutional Review Boards, 12202-12203 [2014-04707]
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Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Notices
reductions in user fees assessed under
sections 735 and 736 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
379g and 21 U.S.C. 379h) (the FD&C
Act). The guidance describes the types
of waivers and reductions permitted
under the user fee provisions of the
FD&C Act, and the procedures for
submitting requests for waivers or
reductions. It also includes
recommendations for submitting
information for requests for
reconsideration of denials of waiver or
reduction requests, and for requests for
appeals. The guidance also provides
clarification on related issues such as
user fee exemptions for orphan drugs.
We estimate that the total annual
number of waiver requests submitted for
all of these categories will be 120,
submitted by 100 different sponsors. We
estimate that the average burden hours
for preparation of a submission will
total 16 hours. Because FDA may
request additional information from the
applicant during the review period, we
have also included in this estimate time
to prepare any additional information.
The reconsideration and appeal
requests are not addressed in the FD&C
Act but are discussed in the guidance.
We estimate that we will receive 3
requests for reconsideration annually,
and that the total average burden hours
for a reconsideration request will be 24
hours. We estimate that we will receive
1 request annually for an appeal of a
user fee waiver determination, and that
the time needed to prepare an appeal
would be approximately 12 hours. We
have included in this estimate both the
time needed to prepare the request for
appeal and the time needed to create
and send a copy of the request for an
appeal to the Associate Director for
Policy at the Center for Drug Evaluation
and Research.
The burden for filling out and
submitting Form FDA 3397
(Prescription Drug User Fee Coversheet)
has not been included in the burden
analysis, because that information
collection is already approved under
OMB control number 0910–0297. The
collections of information associated
with a new drug application or biologics
license application have been approved
under OMB control numbers 0910–0001
and 0910–0338, respectively.
We have included in the burden
estimate the preparation and submission
of application fee waivers for small
businesses, because small businesses
requesting a waiver must submit
documentation to FDA on the number of
their employees and must include the
information that the application is the
first human drug application, within the
meaning of the FD&C Act, to be
submitted to the Agency for approval.
Because the Small Business
Administration (SBA) makes the size
determinations for FDA, small
businesses must also submit
information to the SBA. The submission
of information to SBA is already
approved under OMB control number
3245–0101.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
User fee waivers, reductions, and refunds for drug
and biological products
Number of
respondents
Number of
responses per
respondent
Total annual responses
Average
burden
per response
Total hours
FD&C Act sections 735 and 736 ...............................
Reconsideration Requests .........................................
Appeal Requests ........................................................
100
3
1
1.2
1
1
120
3
1
16
24
12
1,920
72
12
..........................
..........................
..........................
..........................
2,004
Total ....................................................................
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 26, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by April 3,
2014.
[FR Doc. 2014–04688 Filed 3–3–14; 8:45 am]
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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 emailed 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.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1163]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Institutional
Review Boards
tkelley on DSK3SPTVN1PROD with NOTICES
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
SUMMARY:
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FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
FOR FURTHER INFORMATION CONTACT:
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collection of information to OMB for
review and clearance.
Institutional Review Boards—21 CFR
56.115—(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: (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
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Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Notices
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.
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.
In the Federal Register of October 1,
2013 (78 FR 60286), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
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
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–04707 Filed 3–3–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Assessment of DAIDS
Training Resources
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute of Allergy and
Infectious Diseases (NIAID), National
Institutes of Health (NIH), will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Written comments and/or suggestions
from the public and affected agencies
are invited on one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’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
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SUMMARY:
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collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
To Submit Comments and for Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Jacquelyn Burns, Office
for Policy in Clinical Research
Operations, DAIDS, NIAID, 6700B
Rockledge Drive, Room 4118, Bethesda,
MD 20852, or call non-toll-free number
301–402–0143, or Email your request,
including your address to: Jburns@
niaid.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Proposed Collection: Assessment of
DAIDS Training Resources, 0925-New,
National Institute of Allergy and
Infectious Diseases (NIAID), National
Institutes of Health (NIH).
Need and Use of Information
Collection: This is a new data collection
in order to assess the efficacy of training
resources and their impact on NIAIDsupported and/or sponsored research
operations. The generic OMB clearance
will allow collecting information about
the knowledge, attitudes, and behaviors
from target audiences (e.g., research
staff) to help improve and inform these
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training resources. Information collected
will be used to determine the future
direction for training resources,
including which resources should be
continued, enhanced, added, or
discontinued in order to utilize
resources efficiently.
Findings will provide data to inform
and guide the optimal development,
dissemination, and revisions to improve
NIAID trainings and resources. Various
types of data will be collected,
including post-assessment tests,
questionnaires, interviews, and focus
groups. Post-assessment tests will be
administered at the time of the trainings
to assess trainees’ immediate knowledge
gained, as well as reactions and
satisfaction to the content. Select
trainees will be queried at later time
points (e.g., three-months, six-months)
after they have participated in a training
to understand if they have been able to
apply their knowledge at the workplace,
and identify facilitators or hindrances to
implementing this new knowledge. The
assessment team will conduct repeated
data collections for these select trainees
to determine any changes throughout
time. In order to obtain information
beyond self-reported data, select
managers and supervisors will also be
queried to assess if they have observed
any changes in their staff after attending
trainings, and if the work environment
is conducive for trainees to implement
knowledge from trainings.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
847.
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]]>Agencies
[Federal Register Volume 79, Number 42 (Tuesday, March 4, 2014)]
[Notices]
[Pages 12202-12203]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04707]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1163]
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 April
3, 2014.
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 emailed 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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@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--21 CFR 56.115--(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: (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
[[Page 12203]]
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.
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.
In the Federal Register of October 1, 2013 (78 FR 60286), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
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: February 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04707 Filed 3-3-14; 8:45 am]
BILLING CODE 4160-01-P
