Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act, 76150-76151 [2013-29796]
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76150
Federal Register / Vol. 78, No. 241 / Monday, December 16, 2013 / Notices
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2013–29767 Filed 12–13–13; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Renewal of Office of
Community Services (OCS) Community
Economic Development (CED) Standard
Reporting Format.
OMB No.: 0970–0386.
Description: The Office of Community
Services (OCS) will continue collecting
key information about projects funded
through the Community Economic
Development (CED) program. The
legislative requirement for this program
is in Title IV of the Community
Opportunities, Accountability and
Training and Educational Services Act
(COATS Human Services
Reauthorization Act) of October 27,
1998, Public Law 105–285, section
680(b) as amended. The reporting
format, Performance Progress Report
(PPR), collects information concerning
the outcomes and management of CED
projects. OCS will use the data to
critically review the overall design and
effectiveness of the program.
The PPR will continue to be
administered to all active grantees of the
CED program. Grantees will be required
to use this reporting tool for their semiannual reports to be submitted twice a
year. The current PPR replaced both the
annual questionnaire and other semiannual reporting formats, which
resulted in an overall reduction in
burden for the grantees while
significantly improving the quality of
the data collected by OCS. OCS seeks to
renew this PPR to continue to collect
quality data from grantees. To ensure
the burden on grantees is not increased,
all questions on the current PPR will
remain the same—we propose adding
only one question to the PPR regarding
the total number of jobs grantees are
creating with grant funds. Many
grantees have asked about this element
on the current PPR and currently do not
have a place to report that information.
This is information that most grantees
are already collecting. Adding this field
will allow grantees to provide this
information in a consistent format and
allow OCS to more accurately reflect the
total number of jobs created through the
CED program. Since grantees are already
familiar with the current format and
elements, and all questions on the PPR
will remain the same (with one added
question based on grantee feedback),
there will be no additional burden on
grantees.
Respondents: Current CED grantees.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses
per
respondent
Average
burden hours
per response
Total
burden hours
Questionnaire for current OCS–CED grantees ...............................................
170
2
1.50
510
Estimated Total Annual Burden
Hours: 510.
Additional Information
pmangrum on DSK3VPTVN1PROD with NOTICES
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV. Attn:
Desk Officer for the Administration for
Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2013–29798 Filed 12–13–13; 8:45 am]
BILLING CODE 4184–01–P
[Docket No. FDA–2013–D–0117]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Providing
Information About Pediatric Uses of
Medical Devices Under Section 515A of
the Federal Food, Drug, and Cosmetic
Act
Jkt 232001
PO 00000
Food and Drug Administration,
HHS.
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
13:51 Dec 13, 2013
Food and Drug Administration
AGENCY:
OMB Comment
VerDate Mar<15>2010
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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:
Frm 00051
Fmt 4703
Sfmt 4703
E:\FR\FM\16DEN1.SGM
16DEN1
Federal Register / Vol. 78, No. 241 / Monday, December 16, 2013 / Notices
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by January 15,
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-New and
title ‘‘Providing Information About
Pediatric Uses of Medical Devices
Under Section 515A of the Federal
Food, Drug, and Cosmetic Act’’. Also
include the FDA docket number found
in brackets in the heading of this
document.
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.
FOR FURTHER INFORMATION CONTACT:
Medical Devices; Pediatric Uses of
Devices; Requirement for Submission of
Information on Pediatric
Subpopulations That Suffer From a
Disease or Condition That a Device Is
Intended To Treat, Diagnose, or Cure—
(OMB Control Number 0910—New)
The draft guidance suggests that
applicants who submit certain medical
device applications include, if readily
available, pediatric use information for
diseases or conditions that the device is
being used to treat, diagnose, or cure
that are outside the device’s approved or
proposed indications for use, as well as
an estimate of the number of pediatric
patients with such diseases or
conditions. The information submitted
will allow FDA to identify pediatric
uses of devices outside their approved
or proposed indication for use in order
to determine areas where further
pediatric device development could be
useful. This recommendation applies to
applicants who submit the following
applications:
1. Any request for a humanitarian
device exemption submitted under
section 520(m) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360j(m));
2. Any premarket approval
application (PMA) or supplement to a
76151
PMA submitted under section 515 of the
FD&C Act (21 U.S.C. 360e);
3. Any product development protocol
submitted under section 515 of the
FD&C Act.
In the Federal Register of February
19, 2013, (78 FR 11654), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. However, only one
comment was interpreted as being
related to the proposed collection of
information.
One comment stated that FDA should
not require all readily available
information on pediatric uses of devices
because it is unduly burdensome, but
rather applicants should be required to
perform a reasonable search. FDA
disagrees with the comment. In order for
FDA to be provided useful,
comprehensive information and to
fulfill the statutory mandate, all readily
available information should be
submitted to FDA. Moreover, the
requirement is not unduly burdensome
because FDA is only requiring all
information that is readily available, not
all information in general.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Description
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Uses outside approved indication ........................................
148
1
148
0.5
74
pmangrum on DSK3VPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Respondents are permitted to submit
information relating to uses of the
device outside the approved or
proposed indication if such uses are
described or acknowledged in
acceptable sources of readily available
information. We estimate that 20
percent of respondents submitting
information required by section 515A of
the FD&C Act will choose to submit this
information and that it will take 30
minutes for them to do so.
This draft guidance also refers to
previously approved collections of
information found in FDA regulations.
The collections of information in part
814 (21 CFR part 814), subpart B have
been approved under OMB control
number 0910–0231, and the collections
of information in part 814, subpart H
have been approved under OMB control
number 0910–0332.
VerDate Mar<15>2010
13:51 Dec 13, 2013
Jkt 232001
Dated: December 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–29796 Filed 12–13–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
PO 00000
Frm 00052
Fmt 4703
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proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
E:\FR\FM\16DEN1.SGM
16DEN1
]]>Agencies
[Federal Register Volume 78, Number 241 (Monday, December 16, 2013)]
[Notices]
[Pages 76150-76151]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-29796]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0117]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Providing Information
About Pediatric Uses of Medical Devices Under Section 515A of the
Federal Food, Drug, and Cosmetic Act
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
[[Page 76151]]
(OMB) for review and clearance under the Paperwork Reduction Act of
1995.
DATES: Fax written comments on the collection of information by January
15, 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-New and
title ``Providing Information About Pediatric Uses of Medical Devices
Under Section 515A of the Federal Food, Drug, and Cosmetic Act''. 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.
Medical Devices; Pediatric Uses of Devices; Requirement for Submission
of Information on Pediatric Subpopulations That Suffer From a Disease
or Condition That a Device Is Intended To Treat, Diagnose, or Cure--
(OMB Control Number 0910--New)
The draft guidance suggests that applicants who submit certain
medical device applications include, if readily available, pediatric
use information for diseases or conditions that the device is being
used to treat, diagnose, or cure that are outside the device's approved
or proposed indications for use, as well as an estimate of the number
of pediatric patients with such diseases or conditions. The information
submitted will allow FDA to identify pediatric uses of devices outside
their approved or proposed indication for use in order to determine
areas where further pediatric device development could be useful. This
recommendation applies to applicants who submit the following
applications:
1. Any request for a humanitarian device exemption submitted under
section 520(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 360j(m));
2. Any premarket approval application (PMA) or supplement to a PMA
submitted under section 515 of the FD&C Act (21 U.S.C. 360e);
3. Any product development protocol submitted under section 515 of
the FD&C Act.
In the Federal Register of February 19, 2013, (78 FR 11654), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. However, only one comment was interpreted as
being related to the proposed collection of information.
One comment stated that FDA should not require all readily
available information on pediatric uses of devices because it is unduly
burdensome, but rather applicants should be required to perform a
reasonable search. FDA disagrees with the comment. In order for FDA to
be provided useful, comprehensive information and to fulfill the
statutory mandate, all readily available information should be
submitted to FDA. Moreover, the requirement is not unduly burdensome
because FDA is only requiring all information that is readily
available, not all information in general.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Description Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Uses outside approved indication................................... 148 1 148 0.5 74
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Respondents are permitted to submit information relating to uses of
the device outside the approved or proposed indication if such uses are
described or acknowledged in acceptable sources of readily available
information. We estimate that 20 percent of respondents submitting
information required by section 515A of the FD&C Act will choose to
submit this information and that it will take 30 minutes for them to do
so.
This draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
in part 814 (21 CFR part 814), subpart B have been approved under OMB
control number 0910-0231, and the collections of information in part
814, subpart H have been approved under OMB control number 0910-0332.
Dated: December 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-29796 Filed 12-13-13; 8:45 am]
BILLING CODE 4160-01-P
