Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic User Fee Payment Request Forms, 36822-36824 [2015-15711]
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36822
Federal Register / Vol. 80, No. 123 / Friday, June 26, 2015 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
generally encompasses three steps—
point-of-use processing, thorough
cleaning, and disinfection or
sterilization. The Reprocessing
Guidance makes clear, however, that
certain devices may be suitably
reprocessed after cleaning alone and
may not require further disinfection or
sterilization. It is important to note that
the Reprocessing Guidance is intended,
among other things, to provide guidance
in crafting and validating reprocessing
instructions to be included in the
labeling of reusable devices generally,
and it may not be applicable for
determining whether a UDI direct
marking should be required on a
specific device intended to be reused.
For purposes of UDI direct marking
requirements, FDA considers a device
that is intended to be cleaned and either
sterilized or disinfected to be intended
to be reprocessed. FDA has some
concern about whether cleaning alone,
without subsequent sterilization and/or
disinfection, should fit within the
definition of ‘‘reprocessing’’ for
purposes of UDI direct marking
requirements. Therefore, FDA is seeking
additional information on this issue.
FDA is particularly interested in
receiving information relating to the
following questions:
• FDA is concerned that devices
intended to be used more than once
tend to be separated from its original
label during reprocessing, making
accurate identification of devices
difficult or impossible. Should the
definition of ‘‘reprocessing’’ for
purposes of UDI direct marking
requirements include cleaning alone
without subsequent disinfection and/or
sterilization of the device?
• What public health benefits would
be served by requiring a UDI direct
marking to be affixed to devices
intended to be reused for which
reprocessing instructions include
cleaning only and not disinfection and/
or sterilization?
This draft guidance, when finalized,
is intended to assist industry,
particularly labelers, as defined under
21 CFR 801.3, and FDA staff understand
FDA’s requirements for UDI direct
marking of devices, and the criteria for
exceptions.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance represents the
Agency’s current thinking on ‘‘Unique
Device Identification: Direct Marking of
Devices.’’ It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
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An alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
Dated: June 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
III. Electronic Access
BILLING CODE 4164–01–P
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Unique Device Identification: Direct
Marking of Devices’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number 1400031 to identify the
guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information described in FDA
regulations. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in 21 CFR
part 801 have been approved under
OMB control number 0910–0485; the
collections of information in 21 CFR
part 807, subpart E, have been approved
under OMB control number 0910–0120;
the collections of information in 21 CFR
part 814, subparts A through E, have
been approved under OMB control
number 0910–0231; and the collections
of information in 21 CFR part 830
pertaining to GUDID labeler accounts
and data submissions addressed in this
draft guidance document have been
approved under OMB control number
0910–0720.
V. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
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[FR Doc. 2015–15719 Filed 6–25–15; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–1837]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Electronic User
Fee Payment Request Forms
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 and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
Electronic User Fee Payment Request
Forms.
DATES: Submit either electronic or
written comments on the collection of
information by August 25, 2015.
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, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, 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
SUMMARY:
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Federal Register / Vol. 80, No. 123 / Friday, June 26, 2015 / Notices
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
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.
Electronic User Fee Payment Request
Forms—Form FDA 3913 and Form FDA
3914 (OMB Control Number (0910–
NEW)
The Government Paperwork
Elimination Act (GPEA), Public Law
105–277, title XVII, was signed into law
on October 21, 1998. GPEA requires
Federal Agencies to allow individuals or
entities that deal with the Agencies the
option to submit information or transact
business with the Agency electronically,
when practicable, and to maintain
records electronically, when practicable.
Its goal is to encourage agencies to
incorporate technologically improved
respondent reporting as this process
typically lowers the burden on the
respondent. GPEA allows FDA to collect
information relating to a user fee
payment refund request and transfer
request.
Form FDA 3913, User Fee Payment
Refund Request, is designed to provide
the minimum necessary information for
FDA to review and process a user fee
payment refund. The information
collected includes the organization,
contact, and payment information. The
information is used to determine the
reason for the refund, the refund
amount, and who to contact if there are
any questions regarding the refund
request. A submission of the User Fee
Payment Refund Request form does not
guarantee that a refund will be issued.
FDA estimates an average of 0.40 hours
per response, including the time to
review instructions, search existing data
sources, gather and maintain the data
needed, and complete and review the
collection of information. The estimated
hours are based on past FDA experience
with the user fee payment refund
request.
In fiscal year 2014, approximately
1,741 user fee refunds were processed
for cover sheets and invoices including
27 for Animal Drug User Fee Act, 5 for
Animal Generic Drug User Fee Act, 3 for
Biosimilar Drug User Fee Act, 1 for a
Center for Tobacco Products Civil
Money Penalties, 216 for Export
Certificate Program, 79 for Freedom of
Information Act requests, 523 for
Generic Drug User Fee Amendments,
539 for Medical Device User Fee
Amendments, 266 for Mammography
inspection fee, 81 for Prescription Drug
User Fee Act, and 1 for a Tobacco
product fee.
Form FDA 3914, User Fee Payment
Transfer Request, is designed to provide
the minimum necessary information for
FDA to review and process a user fee
payment transfer request. The
information collected includes payment
and organization information. The
information is used to determine the
reason for the transfer, how the transfer
should be performed, and who to
contact if there are any questions
regarding the transfer request. A
submission of the User Fee Payment
Transfer Request form does not
guarantee that a transfer will be
36823
performed. FDA estimates an average of
0.25 hours per response, including the
time to review instructions, search
existing data sources, gather and
maintain the data needed, and complete
and review the collection of
information. FDA estimated hours are
based on past FDA experience with the
user fee payment transfer request.
In fiscal year 2014, approximately
1,291 user fee payment transfers were
processed for cover sheets and invoices
including 21 for Animal Drug User Fee
Act, 2 for Animal Generic Drug User Fee
Act, 544 for Generic Drug User Fee
Amendments, 627 for Medical Device
User Fee Amendments, and 97 for
Prescription Drug User Fee Act.
Respondents for the electronic request
forms include domestic and foreign
firms (including pharmaceutical,
medical device, etc.). Specifically,
refund request forms target respondents
who submitted a duplicate payment or
overpayment for a user fee cover sheet
or invoice. Respondents may also
include firms that withdrew an
application or submission. Transfer
request forms target respondents who
submitted payment for a user fee cover
sheet or invoice and need that payment
to be re-applied to another cover sheet
or invoice (transfer of funds).
The electronic user fee payment
request forms will streamline the refund
and transfer processes, facilitate
processing, and improve the tracking of
requests. The burden for this collection
of information is the same for all
customers (small and large
organizations). The information being
requested or required has been held to
the absolute minimum required for the
intended use of the data. Customers will
be able to request a user fee payment
refund and transfer online at https://
www.fda.gov/forindustry/userfees/
default.htm. This electronic submission
is intended to reduce the burden for
customers to submit a user fee payment
refund and transfer request.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
tkelley on DSK3SPTVN1PROD with NOTICES
21 CFR Section
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
User Fee Payment Refund Request—Form FDA
3913 ........................................................................
User Fee Payment Transfer Request—Form FDA
3914 ........................................................................
1,700
1
1,700
0.40 (24 minutes)
680
1,700
1
1,700
0.25 (15 minutes)
425
Total ....................................................................
........................
........................
........................
..................................
1,105
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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36824
Federal Register / Vol. 80, No. 123 / Friday, June 26, 2015 / Notices
Dated: June 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–15711 Filed 6–25–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0197]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Emergency
Shortages Data Collection System
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 July 27,
2015.
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
OMB control number 0910–0491. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
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:
Emergency Shortages Data Collection
System—(OMB Control Number 0910–
0491)—Extension
Under section 903(d)(2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
393(d)(2)), the Commissioner of Food
and Drugs is authorized to implement
general powers (including conducting
research) to carry out effectively the
mission of FDA. Subsequent to the
events of September 11, 2001, and as
part of broader counterterrorism and
emergency preparedness activities,
FDA’s Center for Devices and
Radiological Health (CDRH) began
developing operational plans and
interventions that would enable CDRH
to anticipate and respond to medical
device shortages that might arise in the
context of Federally declared disasters/
emergencies or regulatory actions. In
particular, CDRH identified the need to
acquire and maintain detailed data on
domestic inventory, manufacturing
capabilities, distribution plans, and raw
material constraints for medical devices
that would be in high demand, and/or
would be vulnerable to shortages in
specific disaster/emergency situations
or following specific regulatory actions.
Such data could support prospective
risk assessment, help inform risk
mitigation strategies, and support realtime decision-making by the
Department of Health and Human
Services during actual emergencies or
emergency preparedness exercises.
FDA developed ‘‘The Emergency
Medical Device Shortages Program
Survey’’ in 2002 to support the
acquisition of such data from medical
device manufacturers. In 2004, CDRH
changed the process for the data
collection, and the electronic database
in which the data were stored was
formally renamed the ‘‘Emergency
Shortages Data Collection System’’
(ESDCS). Recognizing that some of the
data collected may be commercially
confidential, access to the ESDCS is
restricted to members of the CDRH
Emergency Shortage Team (EST) and
senior management with a need-toknow. At this time, the need-to-know
senior management personnel are
limited to two senior managers. Further,
the data are used by this defined group
only for decision making and planning
in the context of a Federally declared
disaster/emergency, an official
emergency preparedness exercise, or a
potential public health risk posed by
non-disaster-related device shortage.
The data procurement process
consists of an initial scripted telephone
call to a regulatory officer at a registered
manufacturer of one or more key
medical devices tracked in the ESDCS.
In this initial call, the EST member
describes the intent and goals of the
data collection effort and makes the
specific data request. After the initial
call, one or more additional follow-up
calls and/or electronic mail
correspondence may be required to
verify/validate data sent from the
manufacturer, confirm receipt, and/or
request additional detail. Although the
regulatory officer is the agent who the
EST member initially contacts,
regulatory officers may designate an
alternate representative within their
organization to correspond subsequently
with the CDRH EST member who is
collecting or verifying/validating the
data.
Because of the dynamic nature of the
medical device industry, particularly
with respect to specific product lines,
manufacturing capabilities, and raw
material/subcomponent sourcing, it is
necessary to update the data in the
ESDCS at regular intervals. The EST
makes such updates on a regular basis,
but makes efforts to limit the frequency
of outreach to a specific manufacturer to
no more than every 4 months.
The ESDCS will only include those
medical devices for which there will
likely be high demand during a specific
emergency/disaster, or for which there
are sufficiently small numbers of
manufacturers such that disruption of
manufacture or loss of one or more of
these manufacturers would create a
shortage.
In the Federal Register of March 18,
2015 (80 FR 14138), 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:
tkelley on DSK3SPTVN1PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity/FD&C act section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Emergency Shortages Data Collection System (903(d)(2)) ........
125
3
375
0.5 (30 minutes)
188
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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]]>Agencies
[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)]
[Notices]
[Pages 36822-36824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15711]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-1837]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Electronic User Fee Payment Request Forms
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 and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on Electronic User Fee Payment Request Forms.
DATES: Submit either electronic or written comments on the collection
of information by August 25, 2015.
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, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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
[[Page 36823]]
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 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.
Electronic User Fee Payment Request Forms--Form FDA 3913 and Form FDA
3914 (OMB Control Number (0910-NEW)
The Government Paperwork Elimination Act (GPEA), Public Law 105-
277, title XVII, was signed into law on October 21, 1998. GPEA requires
Federal Agencies to allow individuals or entities that deal with the
Agencies the option to submit information or transact business with the
Agency electronically, when practicable, and to maintain records
electronically, when practicable. Its goal is to encourage agencies to
incorporate technologically improved respondent reporting as this
process typically lowers the burden on the respondent. GPEA allows FDA
to collect information relating to a user fee payment refund request
and transfer request.
Form FDA 3913, User Fee Payment Refund Request, is designed to
provide the minimum necessary information for FDA to review and process
a user fee payment refund. The information collected includes the
organization, contact, and payment information. The information is used
to determine the reason for the refund, the refund amount, and who to
contact if there are any questions regarding the refund request. A
submission of the User Fee Payment Refund Request form does not
guarantee that a refund will be issued. FDA estimates an average of
0.40 hours per response, including the time to review instructions,
search existing data sources, gather and maintain the data needed, and
complete and review the collection of information. The estimated hours
are based on past FDA experience with the user fee payment refund
request.
In fiscal year 2014, approximately 1,741 user fee refunds were
processed for cover sheets and invoices including 27 for Animal Drug
User Fee Act, 5 for Animal Generic Drug User Fee Act, 3 for Biosimilar
Drug User Fee Act, 1 for a Center for Tobacco Products Civil Money
Penalties, 216 for Export Certificate Program, 79 for Freedom of
Information Act requests, 523 for Generic Drug User Fee Amendments, 539
for Medical Device User Fee Amendments, 266 for Mammography inspection
fee, 81 for Prescription Drug User Fee Act, and 1 for a Tobacco product
fee.
Form FDA 3914, User Fee Payment Transfer Request, is designed to
provide the minimum necessary information for FDA to review and process
a user fee payment transfer request. The information collected includes
payment and organization information. The information is used to
determine the reason for the transfer, how the transfer should be
performed, and who to contact if there are any questions regarding the
transfer request. A submission of the User Fee Payment Transfer Request
form does not guarantee that a transfer will be performed. FDA
estimates an average of 0.25 hours per response, including the time to
review instructions, search existing data sources, gather and maintain
the data needed, and complete and review the collection of information.
FDA estimated hours are based on past FDA experience with the user fee
payment transfer request.
In fiscal year 2014, approximately 1,291 user fee payment transfers
were processed for cover sheets and invoices including 21 for Animal
Drug User Fee Act, 2 for Animal Generic Drug User Fee Act, 544 for
Generic Drug User Fee Amendments, 627 for Medical Device User Fee
Amendments, and 97 for Prescription Drug User Fee Act.
Respondents for the electronic request forms include domestic and
foreign firms (including pharmaceutical, medical device, etc.).
Specifically, refund request forms target respondents who submitted a
duplicate payment or overpayment for a user fee cover sheet or invoice.
Respondents may also include firms that withdrew an application or
submission. Transfer request forms target respondents who submitted
payment for a user fee cover sheet or invoice and need that payment to
be re-applied to another cover sheet or invoice (transfer of funds).
The electronic user fee payment request forms will streamline the
refund and transfer processes, facilitate processing, and improve the
tracking of requests. The burden for this collection of information is
the same for all customers (small and large organizations). The
information being requested or required has been held to the absolute
minimum required for the intended use of the data. Customers will be
able to request a user fee payment refund and transfer online at https://www.fda.gov/forindustry/userfees/default.htm. This electronic
submission is intended to reduce the burden for customers to submit a
user fee payment refund and transfer request.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of responses per Total annual Average burden per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
User Fee Payment Refund Request--Form FDA 3913..................... 1,700 1 1,700 0.40 (24 minutes) 680
User Fee Payment Transfer Request--Form FDA 3914................... 1,700 1 1,700 0.25 (15 minutes) 425
------------------------------------------------------------------------------------
Total.......................................................... .............. .............. .............. ................... 1,105
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 36824]]
Dated: June 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15711 Filed 6-25-15; 8:45 am]
BILLING CODE 4164-01-P
