Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational Uses, 17758-17760 [2015-07539]
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17758
Federal Register / Vol. 80, No. 63 / Thursday, April 2, 2015 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
Biomedical Engineering Society (BMES)
is announcing a public conference
entitled ‘‘Frontiers in Medical Devices:
Innovations in Modeling and
Simulation’’. The purpose of this
conference is to provide a forum to
discuss strategies to effectively utilize
computational modeling and simulation
in the development and evaluation of
medical devices.
Date and Time: The conference will
be held on May 18 through 20, 2015,
from 8 a.m. to 6 p.m.
Location: The public conference will
be held at the Marriott Inn and
Conference Center, University of
Maryland, 3501 University Blvd. East,
Hyattsville, MD 20783.
Contact Person: Donna R. Lochner,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 62,
Rm. 3220, Silver Spring, MD 20993,
301–796–6309, Donna.Lochner@
fda.hhs.gov.
Registration: To register for the public
conference please visit FDA’s Medical
Devices News, Events, Workshops, and
Conferences calendar at https://
www.bmes.org/meddevicesconference.
There is a registration fee to attend the
public conference to cover the expenses,
and attendees must register in advance.
The fees vary depending upon
membership status in BMES, and
include BMES members ($450), nonBMES members (includes 1 year BMES
membership) ($600), and Government
rate (BMES memberships and meals are
not included) ($250). Students will be
offered a discounted fee of $300 (BMES
member) or $350 (non-BMES member)
(includes 1 year BMES membership). A
full listing of the registration fees can be
found on the Web site listed. Although
the facilities are spacious, registration
will be on a first-come, first-served
basis.
If you need special accommodations
due to a disability, please contact Betse
Lyons at Betse@bmes.org or 301–459–
1999, 8201 Corporate Drive, Suite 1125,
Landover, MD 20785–2224, FAX: 301–
459–2444, no later than May 4, 2015.
To register for the public conference,
please visit BMES Frontiers in Medical
Devices registration page at https://
bmes.org/meddevicesregistration. Those
without Internet access should contact
Betse Lyons at 301–459–1999 to register.
SUPPLEMENTARY INFORMATION:
I. Background
The Center for Devices and
Radiological Health (CDRH) believes
that computer modeling and simulation
(M&S) has the potential to substantially
augment traditional models used to
evaluate medical devices; i.e., animal,
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bench, and human models, and to
accelerate and streamline the total
product life cycle of a medical device.
The use of computer models to simulate
multiple use conditions and to visualize
and display complex processes and data
can revolutionize the way medical
outcomes and medical devices are
understood. Non-proprietary computer
models could benchmark device
performance, yet lack of access to
biomedical data to construct the models
and rigorous methods to validate the
models limit their credibility and use.
To foster good science for M&S in the
medical device community, CDRH
needs to leverage the expertise in
industry and academia to advance M&S
for regulatory uses.
II. Topics for Discussion at the Public
Workshop
A large number of issues will be
discussed at the conference with the
overall theme being the application of
modeling and simulation for medical
devices at different stages in the total
product life cycle. Topics include, but
are not limited to the following:
• Model foundations for device
design ideation;
• concept development and design
optimization;
• modeling for robust design;
• design verification and validation;
• patient specific design;
• integration of modeling with
clinical studies;
• modeling and device
commercialization.
This public workshop may also form
the basis for future discussions related
to computer modeling and simulation
that could benefit U.S. public health.
Dated: March 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–07551 Filed 4–1–15; 8:45 am]
BILLING CODE CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
Frm 00045
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Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
Mentoring Programs for HIV/AIDS
Researchers 2.
Date: March 30, 2015.
Time: 11:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Aileen Schulte, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6140, MSC 9608,
Bethesda, MD 20892–9608, 301–443–1225,
aschulte@mail.nih.gov
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: March 27, 2015.
Carolyn A. Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–07507 Filed 4–1–15; 8:45 am]
BILLING CODE CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0481]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; New Animal Drugs
for Investigational Uses
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, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
SUMMARY:
National Institute Of Mental Health;
Notice of Closed Meeting
PO 00000
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
E:\FR\FM\02APN1.SGM
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17759
Federal Register / Vol. 80, No. 63 / Thursday, April 2, 2015 / Notices
the reporting and recordkeeping
requirements for ‘‘New Animal Drugs
for Investigational Uses’’.
DATES: Submit either electronic or
written comments on the collection of
information by June 1, 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.
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.
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
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,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
New Animal Drugs for Investigational
Uses—21 CFR Part 511 (OMB Control
Number 0910–0117)—(Extension)
SUPPLEMENTARY INFORMATION:
FDA has the authority under the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) to approve new animal
drugs. Section 512(j) of the Act (21
U.S.C. 360b(j)), authorizes FDA to issue
regulations relating to the
investigational use of new animal drugs.
The regulations setting forth the
conditions for investigational use of
new animal drugs have been codified at
21 CFR part 511. If the new animal drug
is only for tests in vitro or in laboratory
research animals, the person
distributing the new animal drug must
maintain records showing the name and
post office address of the expert or
expert organization to whom it is
shipped and the date, quantity, and
batch or code mark of each shipment
and delivery for a period of 2 years after
such shipment or delivery. Before
shipping a new animal drug for clinical
investigations in animals, a sponsor
must submit to FDA a Notice of Claimed
Investigational Exemption (NCIE). The
NCIE must contain, among other things,
the following specific information: (1)
Identity of the new animal drug, (2)
labeling, (3) statement of compliance of
any non-clinical laboratory studies with
good laboratory practices, (4) name and
address of each clinical investigator, (5)
the approximate number of animals to
be treated or amount of new animal
drug(s) to be shipped, and (6)
information regarding the use of edible
tissues from investigational animals.
Part 511 also requires that records be
established and maintained to
document the distribution and use of
the investigational new animal drug to
assure that its use is safe and that the
distribution is controlled to prevent
potential abuse. The Agency uses these
required records under its Bio-Research
Monitoring Program to monitor the
validity of the studies submitted to FDA
to support new animal drug approval
and to assure that proper use of the drug
is maintained by the investigator.
Investigational new animal drugs are
used primarily by drug industry firms,
academic institutions, and the
government. Investigators may include
individuals from these entities, as well
as research firms and members of the
medical professions. Respondents to
this collection of information are the
persons who use new animal drugs for
investigational purposes.
FDA estimates the burden of this
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section
Number of responses per
respondent
Total annual
responses
Average burden per response
Total hours
511.1(b)(4) ...........................................................................
511.1(b)(5) ...........................................................................
511.1(b)(6) ...........................................................................
511.1(b)(8)(ii) .......................................................................
511.1(b)(9) ...........................................................................
263
263
263
263
263
5.30
.26
.01
.06
.06
1,395
69
2
15
15
1
8
1
2
8
1,395
552
2
30
120
Total ..............................................................................
........................
........................
........................
........................
2,099
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
tkelley on DSK3SPTVN1PROD with NOTICES
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
511.1(a)(3) ...........................................................................
511.1(b)(3) ...........................................................................
511.1(b)(7)(ii) .......................................................................
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PO 00000
Frm 00046
Number of
records per
recordkeeper
263
263
263
Fmt 4703
Sfmt 4703
Total annual
records
2.07
5.30
5.30
E:\FR\FM\02APN1.SGM
545
1,395
1,395
02APN1
Average burden per recordkeeping
1
1
3.5
Total hours
545
1,395
4,882.5
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Federal Register / Vol. 80, No. 63 / Thursday, April 2, 2015 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
21 CFR Section
Number of
records per
recordkeeper
Total annual
records
Average burden per recordkeeping
Total hours
511.1(b)(8)(i) ........................................................................
263
5.30
1,395
3.5
4,882.5
Total ..............................................................................
........................
........................
........................
........................
11,705
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of the time required for
reporting requirements, record
preparation, and maintenance for this
collection of information is based on
informal Agency communication with
industry. Based on the number of
sponsors subject to animal drug user
fees, FDA estimates that there are 263
respondents. We use this estimate
consistently throughout the table and
calculate the ‘‘annual frequency per
respondent’’ by dividing the total
annual responses by number of
respondents. Additional information
needed to make a final calculation of the
total burden hours (i.e., the number of
respondents, the number of
recordkeepers, the number of NCIEs
received, etc.) is derived from Agency
records.
Dated: March 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2015–07545 Filed 4–1–15; 8:45 am]
Centers for Disease Control and
Prevention
tkelley on DSK3SPTVN1PROD with NOTICES
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
The meeting announced below
concerns Evaluation of a Stepped Care
Approach for Perinatal Depression
Treatment in Obstetrics and Gynecology
Clinics, DP15–005, initial review.
SUMMARY: This document corrects a
notice that was published in the Federal
Register on March 12, 2015 Volume 80,
Number 48, page 13012. The time and
date should read as follows:
Time and Date: 11:00 a.m.–6:00 p.m.,
April 1, 2015 (Closed).
FOR FURTHER INFORMATION CONTACT:
M. Chris Langub, Ph.D., Scientific
Review Officer, CDC, 4770 Buford
Highway NE., Mailstop F46, Atlanta,
Georgia 30341, Telephone: (770) 488–
3585, EEO6@cdc.gov.
The Director, Management Analysis
and Services Office, has been delegated
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[FR Doc. 2015–07544 Filed 4–1–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Centers for Disease Control and
Prevention
BILLING CODE CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
BILLING CODE CODE 4163–18–P
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
[FR Doc. 2015–07539 Filed 4–1–15; 8:45 am]
Prevention and the Agency for Toxic
Substances and Disease Registry.
The meeting announced below
concerns Using Longitudinal Data to
Characterize the Natural History of
Fragile X Syndrome to Improve Services
and Outcomes, DD15–003, initial
review.
SUMMARY: This document corrects a
notice that was published in the Federal
Register on March 25, 2015 Volume 80,
Number 57, page 15798. The time and
date should read as follows:
Time and Date: 11:00 a.m.–6:00 p.m.,
April 15, 2015 (Closed).
M.
Chris Langub, Ph.D., Scientific Review
Officer, CDC, 4770 Buford Highway NE.,
Mailstop F46, Atlanta, Georgia 30341,
Telephone: (770) 488–3585, EEO6@
cdc.gov.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received no
later than June 1, 2015.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10C–03, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
SUMMARY:
E:\FR\FM\02APN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 63 (Thursday, April 2, 2015)]
[Notices]
[Pages 17758-17760]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07539]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0481]
Agency Information Collection Activities; Proposed Collection;
Comment Request; New Animal Drugs for Investigational Uses
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,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on
[[Page 17759]]
the reporting and recordkeeping requirements for ``New Animal Drugs for
Investigational Uses''.
DATES: Submit either electronic or written comments on the collection
of information by June 1, 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 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, including
each proposed extension of an existing 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.
New Animal Drugs for Investigational Uses--21 CFR Part 511 (OMB Control
Number 0910-0117)--(Extension)
FDA has the authority under the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) to approve new animal drugs. Section 512(j) of the
Act (21 U.S.C. 360b(j)), authorizes FDA to issue regulations relating
to the investigational use of new animal drugs. The regulations setting
forth the conditions for investigational use of new animal drugs have
been codified at 21 CFR part 511. If the new animal drug is only for
tests in vitro or in laboratory research animals, the person
distributing the new animal drug must maintain records showing the name
and post office address of the expert or expert organization to whom it
is shipped and the date, quantity, and batch or code mark of each
shipment and delivery for a period of 2 years after such shipment or
delivery. Before shipping a new animal drug for clinical investigations
in animals, a sponsor must submit to FDA a Notice of Claimed
Investigational Exemption (NCIE). The NCIE must contain, among other
things, the following specific information: (1) Identity of the new
animal drug, (2) labeling, (3) statement of compliance of any non-
clinical laboratory studies with good laboratory practices, (4) name
and address of each clinical investigator, (5) the approximate number
of animals to be treated or amount of new animal drug(s) to be shipped,
and (6) information regarding the use of edible tissues from
investigational animals. Part 511 also requires that records be
established and maintained to document the distribution and use of the
investigational new animal drug to assure that its use is safe and that
the distribution is controlled to prevent potential abuse. The Agency
uses these required records under its Bio-Research Monitoring Program
to monitor the validity of the studies submitted to FDA to support new
animal drug approval and to assure that proper use of the drug is
maintained by the investigator.
Investigational new animal drugs are used primarily by drug
industry firms, academic institutions, and the government.
Investigators may include individuals from these entities, as well as
research firms and members of the medical professions. Respondents to
this collection of information are the persons who use new animal drugs
for investigational purposes.
FDA estimates the burden of this information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
511.1(b)(4)..................... 263 5.30 1,395 1 1,395
511.1(b)(5)..................... 263 .26 69 8 552
511.1(b)(6)..................... 263 .01 2 1 2
511.1(b)(8)(ii)................. 263 .06 15 2 30
511.1(b)(9)..................... 263 .06 15 8 120
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 2,099
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--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
----------------------------------------------------------------------------------------------------------------
511.1(a)(3)..................... 263 2.07 545 1 545
511.1(b)(3)..................... 263 5.30 1,395 1 1,395
511.1(b)(7)(ii)................. 263 5.30 1,395 3.5 4,882.5
[[Page 17760]]
511.1(b)(8)(i).................. 263 5.30 1,395 3.5 4,882.5
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 11,705
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The estimate of the time required for reporting requirements,
record preparation, and maintenance for this collection of information
is based on informal Agency communication with industry. Based on the
number of sponsors subject to animal drug user fees, FDA estimates that
there are 263 respondents. We use this estimate consistently throughout
the table and calculate the ``annual frequency per respondent'' by
dividing the total annual responses by number of respondents.
Additional information needed to make a final calculation of the total
burden hours (i.e., the number of respondents, the number of
recordkeepers, the number of NCIEs received, etc.) is derived from
Agency records.
Dated: March 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07539 Filed 4-1-15; 8:45 am]
BILLING CODE CODE 4164-01-P
