Agency Information Collection Activities: Proposed Collection; Comment Request, 76151-76152 [2013-29759]
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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The draft guidance suggests that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.
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13:51 Dec 13, 2013
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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
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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.
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76152
Federal Register / Vol. 78, No. 241 / Monday, December 16, 2013 / Notices
pmangrum on DSK3VPTVN1PROD with NOTICES
Proposed Project: 2014–2017 National
Survey on Drug Use and Health:
Methodological Field Tests (OMB No.
0930–0110)—Extension
The National Survey on Drug Use and
Health (NSDUH) is a survey of the U.S.
civilian, non-institutionalized
population aged 12 years old or older.
The data are used to determine the
prevalence of use of tobacco products,
alcohol, illicit substances, and illicit use
of prescription drugs. The results are
used by SAMHSA, the Office of
National Drug Control Policy (ONDCP),
Federal government agencies, and other
organizations and researchers to
establish policy, direct program
activities, and better allocate resources.
Methodological tests will continue to
be designed to examine the feasibility,
quality, and efficiency of new
procedures or revisions to existing
survey protocol. Specifically, the tests
will measure the reliability and validity
of certain questionnaire sections and
items through multiple measurements
on a set of respondents; assess new
methods for gaining cooperation and
participation of respondents with the
goal of increasing response and
decreasing potential bias in the survey
estimates; and assess the impact of new
sampling techniques and technologies
on respondent behavior and reporting.
Research will involve focus groups,
cognitive laboratory testing, customer
satisfaction surveys, and field tests.
These methodological tests will
continue to examine ways to increase
data quality, lower operating costs, and
gain a better understanding of sources
and effects of nonsampling error on the
NSDUH estimates. Particular attention
will be given to minimizing the impact
of design changes so that survey data
continue to remain comparable over
time. If these tests provide successful
results, current procedures or data
collection instruments may be revised.
The number of respondents to be
included in each field test will vary,
depending on the nature of the subject
being tested and the target population.
However, the total estimated response
burden is 8,225 hours. The exact
number of subjects and burden hours for
each test are unknown at this time, but
will be clearly outlined in each
individual submission. These estimated
burden hours are distributed over three
years as follows:
VerDate Mar<15>2010
13:51 Dec 13, 2013
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DATES: Written comments should be
TABLE 1—ESTIMATED BURDEN FOR
NSDUH METHODOLOGICAL FIELD received on or before January 15, 2014
to be assured of consideration.
TESTS
Interested persons are
invited to submit written comments on
this information collection to the Office
of Information and Regulatory Affairs,
Office of Management and Budget.
Comments should be addressed to the
OMB Desk Officer for U.S. Customs and
Border Protection, Department of
Homeland Security, and sent via
electronic mail to oira_submission@
omb.eop.gov or faxed to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information
should be directed to Tracey Denning,
U.S. Customs and Border Protection,
Regulations and Rulings, Office of
International Trade, 90 K Street NE.,
10th Floor, Washington, DC 20229–
1177, at 202–325–0265.
SUPPLEMENTARY INFORMATION: CBP
invites the general public and affected
Federal agencies to submit written
comments and suggestions on proposed
and/or continuing information
collection requests pursuant to the
Paperwork Reduction Act (Pub. L. 104–
13; 44 U.S.C. 3507). Your comments
should address one of the following four
points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency/component,
including whether the information will
have practical utility;
(2) Evaluate the accuracy of the
agencies/components estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collections of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
techniques or other forms of
information.
Title: Transportation Entry and
Manifest of Goods Subject to CBP
Inspection and Permit.
OMB Number: 1651–0003.
Form Number: CBP Forms 7512 and
7512A.
Abstract: CBP Forms 7512 and 7512A
are used by carriers and brokers to serve
as the manifest and transportation entry
for cargo moving under bond within the
United States. The data on the form is
used by CBP to identify the carrier who
initiated the bonded movement and to
document merchandise moving in-bond.
These forms provide documentation
ADDRESSES:
Respondent
burden hours
Time period
May 2014 to May 2015 ........
May 2015 to May 2016 ........
May 2016 to May 2017 ........
2,742
2,742
2,741
Total ...............................
8,225
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
Room 2–1057, One Choke Cherry Road,
Rockville, MD 20857 OR email her a
copy at summer.king@samhsa.hhs.gov.
Written comments should be received
by February 14, 2014.
Summer King,
Statistician, Center for Behavioral Health
Statistics and Quality.
[FR Doc. 2013–29759 Filed 12–13–13; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Agency Information Collection
Activities: Transportation Entry and
Manifest of Goods Subject to CBP
Inspection and Permit
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: 30-Day notice and request for
comments; Extension of an existing
information collection: 1651–0003.
AGENCY:
U.S. Customs and Border
Protection (CBP) of the Department of
Homeland Security will be submitting
the following information collection
request to the Office of Management and
Budget (OMB) for review and approval
in accordance with the Paperwork
Reduction Act: Transportation Entry
and Manifest of Goods Subject to CBP
Inspection and Permit. This is a
proposed extension of an information
collection that was previously
approved. CBP is proposing that this
information collection be extended with
no change to the burden hours. This
document is published to obtain
comments from the public and affected
agencies. This information collection
was previously published in the Federal
Register (78 FR 57405) on September
18, 2013, allowing for a 60-day
comment period. This notice allows for
an additional 30 days for public
comments. This process is conducted in
accordance with 5 CFR 1320.10.
SUMMARY:
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]]>Agencies
[Federal Register Volume 78, Number 241 (Monday, December 16, 2013)]
[Notices]
[Pages 76151-76152]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-29759]
-----------------------------------------------------------------------
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
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.
[[Page 76152]]
Proposed Project: 2014-2017 National Survey on Drug Use and Health:
Methodological Field Tests (OMB No. 0930-0110)--Extension
The National Survey on Drug Use and Health (NSDUH) is a survey of
the U.S. civilian, non-institutionalized population aged 12 years old
or older. The data are used to determine the prevalence of use of
tobacco products, alcohol, illicit substances, and illicit use of
prescription drugs. The results are used by SAMHSA, the Office of
National Drug Control Policy (ONDCP), Federal government agencies, and
other organizations and researchers to establish policy, direct program
activities, and better allocate resources.
Methodological tests will continue to be designed to examine the
feasibility, quality, and efficiency of new procedures or revisions to
existing survey protocol. Specifically, the tests will measure the
reliability and validity of certain questionnaire sections and items
through multiple measurements on a set of respondents; assess new
methods for gaining cooperation and participation of respondents with
the goal of increasing response and decreasing potential bias in the
survey estimates; and assess the impact of new sampling techniques and
technologies on respondent behavior and reporting. Research will
involve focus groups, cognitive laboratory testing, customer
satisfaction surveys, and field tests.
These methodological tests will continue to examine ways to
increase data quality, lower operating costs, and gain a better
understanding of sources and effects of nonsampling error on the NSDUH
estimates. Particular attention will be given to minimizing the impact
of design changes so that survey data continue to remain comparable
over time. If these tests provide successful results, current
procedures or data collection instruments may be revised.
The number of respondents to be included in each field test will
vary, depending on the nature of the subject being tested and the
target population. However, the total estimated response burden is
8,225 hours. The exact number of subjects and burden hours for each
test are unknown at this time, but will be clearly outlined in each
individual submission. These estimated burden hours are distributed
over three years as follows:
Table 1--Estimated Burden for NSDUH Methodological Field Tests
------------------------------------------------------------------------
Respondent
Time period burden hours
------------------------------------------------------------------------
May 2014 to May 2015.................................... 2,742
May 2015 to May 2016.................................... 2,742
May 2016 to May 2017.................................... 2,741
---------------
Total............................................... 8,225
------------------------------------------------------------------------
Send comments to Summer King, SAMHSA Reports Clearance Officer, Room 2-
1057, One Choke Cherry Road, Rockville, MD 20857 OR email her a copy at
summer.king@samhsa.hhs.gov. Written comments should be received by
February 14, 2014.
Summer King,
Statistician, Center for Behavioral Health Statistics and Quality.
[FR Doc. 2013-29759 Filed 12-13-13; 8:45 am]
BILLING CODE 4162-20-P
