Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Submission Process for Voluntary Allegations to the Center for Devices and Radiological Health, 29779-29780 [2014-11922]
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Federal Register / Vol. 79, No. 100 / Friday, May 23, 2014 / Notices
29779
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Total ..............................................................................
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
........................
Activity
........................
........................
........................
Total hours
338
1 There
mstockstill on DSK4VPTVN1PROD with NOTICES
are no capital costs or operating and maintenance costs associated with this collection of information.
2 30 minutes.
The estimate of the number of firms
that will submit new written requests to
be placed on the list, biennial updates,
and occasional updates is based on the
FDA’s experience maintaining the list
over the past 8 years. The estimate of
the number of hours that it will take a
firm to gather the information needed to
be placed on the list or update its
information is based on FDA’s
experience with firms submitting
similar requests. FDA believes that the
information to be submitted will be
readily available to the firms.
Based on submissions received for the
Chile list over the past 3 years and the
China list over the past 3 months, we
estimate that, annually, an average of
100 new firms will submit written
requests to be placed on the China list
and 25 new firms will seek to be placed
on the Chile list, reported as 125 total
respondents on line 1 of table 1. We
estimate that a firm will require 1.5
hours to read the guidance, to gather the
information needed, and to prepare a
communication to FDA that contains
the information and requests that the
firm be placed on the list, for a total of
187.5 burden hours, rounded to 188, as
reported on line 1 of table 1. Under the
guidance, every 2 years each firm on the
list must provide updated information
in order to remain on the list.
There are approximately 250 firms on
the 2 lists combined. We estimate that,
each year, approximately half of the
firms on the list, 125 firms, will
resubmit the information to remain on
the list. We estimate that a firm already
on the list will require 1 hour to
biennially update and resubmit the
information to us, including time
reviewing the information and
corresponding with us, for a total of 125
hours. In addition, we expect that, each
year, approximately 50 firms will need
to submit an occasional update and each
firm will require 0.5 hour to prepare a
communication to us reporting the
change, for a total of 125 hours.
VerDate Mar<15>2010
18:44 May 22, 2014
Jkt 232001
Dated: May 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–11927 Filed 5–22–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0485]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Electronic
Submission Process for Voluntary
Allegations to the Center for Devices
and Radiological Health
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 June 23,
2014.
SUMMARY:
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
title ‘‘Electronic Submission Process for
Voluntary Allegations to the Center for
Devices and Radiological Health.’’ Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Electronic Submission Process for
Voluntary Allegations to the Center for
Devices and Radiological Health—
(OMB Control Number 0910–NEW)
This information collection request
collects information voluntarily
submitted to the Center for Devices and
Radiological Health (CDRH) on actual or
potential health risk concerns about a
medical device or radiological product
or its use. Because there has been no
established guidelines or instructions on
how to submit an allegation to CDRH,
allegations often contain minimal
information and are received via phone
calls, emails, or conversationally from
any CDRH staff. CDRH seeks to establish
a consistent format and process for the
submission of device allegations that
will enhance our timeliness in
receiving, assessing and evaluating
voluntary allegations. The information
provided in the allegations received by
CDRH may be used to clarify the
recurrence or emergence of significant
device-related risks to the general public
and the need to initiate educational
outreach or regulatory action to
minimize or mitigate identified risks.
In the Federal Register of May 6, 2013
(78 FR 26373), 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:
E:\FR\FM\23MYN1.SGM
23MYN1
29780
Federal Register / Vol. 79, No. 100 / Friday, May 23, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
700
Allegation reporting
respondent
1
700
2.25
175
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 15 minutes.
Dated: May 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
refer to the full FOA located at https://
www.grants.gov. Search by Funding
Opportunity Number: RFA–FD–14–017.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2014–N–0610]
Increasing the Quality and Efficiency
of Clinical Trials
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of grant funds for the
support of the efforts of the Center for
Drug Evaluation and Research/Office of
Medical Policy to increase the quality
and efficiency of clinical trials. The
Food and Drug Administration (FDA),
Center for Drug Evaluation and Research
(CDER), Office of Medical Policy is
announcing its intent to accept and
consider a single-source application for
the award of a grant to the Duke
University’s Duke Translational
Medicine Institute (DTMI).
DATES: The application due date is June
30, 2014, by 11:59 p.m. Eastern Time.
The expiration date is July 1, 2014.
ADDRESSES: Submit electronic
applications to: https://www.grants.gov.
For more information, see section III of
the SUPPLEMENTARY INFORMATION section
of this notice.
FOR FURTHER INFORMATION CONTACT:
Mark Lauda, Office of Medical Policy,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10990 New Hampshire
Ave., Bldg. 51, Rm. 2212, Silver Spring,
MD 20993, 301–796–0381, email:
Mark.Lauda@fda.hhs.gov; or Lisa Ko,
Office of Acquisition & Grants Services,
Food and Drug Administration, 5630
Fishers Lane, Rockville, MD, 240–402–
7592, email: Lisa.Ko@fda.hhs.gov.
For more information on this funding
opportunity announcement (FOA) and
to obtain detailed requirements, please
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:44 May 22, 2014
Jkt 232001
The goals of this program are to
develop and maintain an administrative
and scientific infrastructure to support
the creation and execution of a series of
projects under the auspices of CTTI that
will increase the quality and efficiency
of clinical trials. The following are
examples of activities that could be
supported by this grant:
• Maintaining an adequate
administrative and scientific
infrastructure to implement all related
projects under this collaborative effort.
• Identifying and/or hiring a
sufficient number of qualified personnel
to conduct activities, including project
management, such as review of project
milestones for degree of completion,
preparation/reporting of project
findings, periodic and final reports, and
for subsequent distribution in the public
domain.
• Developing plans for the conduct of
identified projects.
• Identifying, securing, and/or
building, and effectively leveraging
other resources for the conduct of
identified projects.
• Upon completion of a given project,
generating project results and
recommendations and proposing related
studies/projects, if needed, to build on
the findings of the project and
continuing to leverage established
resources and personnel.
A. Background
Food and Drug Administration
AGENCY:
B. Research Objectives
RFA–FD–14–017
93.103
[FR Doc. 2014–11922 Filed 5–22–14; 8:45 am]
investigational new drug (IND) safety
reporting, clinical trial monitoring, use
of central investigational review boards,
and antibacterial drug development.
It has long been recognized that the
clinical trial enterprise will need to
evolve in order to meet the demand to
provide data to support evidence-based
decisionmaking. A memorandum of
understanding (MOU) between FDA and
Duke University published in the
Federal Register on November 23, 2007,
served as the basis for the establishment
of the Clinical Trials Transformation
Initiative (CTTI). CTTI is a publicprivate partnership whose mission is to
identify and promote practices that will
increase the quality and efficiency of
clinical trials. This award will be made
to DTMI within Duke University to
identify and implement projects and
disseminate resulting findings that will
increase the quality and efficiency of
clinical trials, CTTI’s mission.
CTTI membership is broad and
includes stakeholders from government,
industry, patient advocacy and
consumer groups, professional societies,
clinical research organizations, and
academia. CTTI helps to effect change
through the conduct of projects that
identify existing inefficiencies,
elucidate superior practices, and/or
provide innovative approaches to
evidence generation and medical
product development. CTTI conducts
projects that are either: (1) Proposed by
its member organizations, including
FDA, developed during review by its
Steering Committee, and endorsed by its
Executive Committee or (2) responsive
to urgent needs of FDA.
The opportunity for meaningful
interaction with a broad set of
stakeholders committed to improving
the clinical trial enterprise and also the
ability to rapidly gather data to address
emerging issues offer significant value
to the clinical trial enterprise. Since its
inception, CTTI has undertaken many
projects that have direct relevance to
FDA’s mission, including
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
C. Eligibility Information
The following organization is eligible
to apply: DTMI located within Duke
University.
II. Award Information/Funds Available
A. Award Amount
This is a multiyear grant. FDA/CDER
intends to fund up to $7,500,000 in total
costs (direct and indirect) in Fiscal Year
2014. Awards are contingent upon the
availability of funds.
Subject to the availability of Federal
funds and successful performance of the
FOA’s stated goals and objectives, four
additional years of support may be
E:\FR\FM\23MYN1.SGM
23MYN1
]]>Agencies
[Federal Register Volume 79, Number 100 (Friday, May 23, 2014)]
[Notices]
[Pages 29779-29780]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-11922]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0485]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Electronic Submission
Process for Voluntary Allegations to the Center for Devices and
Radiological Health
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 June
23, 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 title ``Electronic Submission
Process for Voluntary Allegations to the Center for Devices and
Radiological Health.'' 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, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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.
Electronic Submission Process for Voluntary Allegations to the Center
for Devices and Radiological Health--(OMB Control Number 0910-NEW)
This information collection request collects information
voluntarily submitted to the Center for Devices and Radiological Health
(CDRH) on actual or potential health risk concerns about a medical
device or radiological product or its use. Because there has been no
established guidelines or instructions on how to submit an allegation
to CDRH, allegations often contain minimal information and are received
via phone calls, emails, or conversationally from any CDRH staff. CDRH
seeks to establish a consistent format and process for the submission
of device allegations that will enhance our timeliness in receiving,
assessing and evaluating voluntary allegations. The information
provided in the allegations received by CDRH may be used to clarify the
recurrence or emergence of significant device-related risks to the
general public and the need to initiate educational outreach or
regulatory action to minimize or mitigate identified risks.
In the Federal Register of May 6, 2013 (78 FR 26373), 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:
[[Page 29780]]
Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Allegation Number of
reporting Number of responses per Total annual Average burden Total hours
respondent respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
700 1 700 \2\.25 175
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ 15 minutes.
Dated: May 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11922 Filed 5-22-14; 8:45 am]
BILLING CODE 4160-01-P
