Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning Experiences With Approved New Animal Drugs: Adverse Event Reports, 58355-58357 [2014-23059]
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Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Notices
under the accommodation described
previously, through an adjustment in
the Federally-facilitated Exchange (FFE)
user fee payable by an issuer
participating in an FFE.
In order to facilitate the FFE user fee
adjustment, and ensure that these user
fee adjustments reflect payments for
contraceptive services provided under
this accommodation and that the
adjustment is applied to the appropriate
participating issuer in an FFE, the final
rule requires an information collection
from applicable participating issuers
and third party administrators. In
particular, the final regulations at 45
CFR 156.50(d)(2)(i) provide that a
participating issuer who seeks an FFE
user fee adjustment must submit to HHS
in the year following the benefit year in
which payments for contraceptive
services were made under the
previously mentioned accommodation,
identifying information for the
participating issuer, each third party
administrator, and each self-insured
group health plan, as well as the total
dollar amount of the payments for
contraceptive services that were
provided during the applicable calendar
year under the accommodation. The
final regulation at 45 CFR
156.50(d)(2)(iii) also requires the third
party administrator to submit to HHS
identifying information for the third
party administrator, the participating
issuer, and each self-insured group
health plan, as well as the total number
of participants and beneficiaries in each
self-insured group health plan during
the applicable calendar year, the total
dollar amount of payments made for
contraceptive services, and an
attestation that the payments for
contraceptive services were made in
compliance with 26 CFR 54.9815–
2713A(b)(2) or 29 CFR 2590.715–
2713A(b)(2).
Furthermore, to determine the
potential number of submissions
provided by third party administrators
and allow HHS to prepare to receive
submissions in calendar year 2015, the
final regulation at 45 CFR
156.50(d)(2)(ii) requires third party
administrators to submit to HHS a
notification that the third party
administrator intends for a participating
issuer to seek an FFE user fee
adjustment, by the later of January 1,
2014, or the 60th calendar day following
the date on which the third party
administrator receives a copy of a selfcertification from an eligible
organization. Additionally, a health
insurance issuer providing payments for
contraceptive services for participants
and beneficiaries in insured plans (or
student enrollees and covered
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dependents in student health insurance
coverage) of eligible organizations to
provide a written notice to such plan
participants and beneficiaries (or such
student enrollees and covered
dependents) informing them of the
availability of such payments.
The burden associated with these
processes includes the time for
applicable participating issuers and
third party administrators to submit
identifying information and total
payments made for contraceptive
services in the prior calendar year, and
for third party administrators to notify
HHS of their intent to seek the user fee
adjustment. HHS estimates 488 third
party administrators, 48 QHP issuers,
and 325 fully insured issuers of eligible
organizations will submit this
information. HHS anticipates that
participating issuers in an FFE seeking
a user fee adjustment and third party
administrators with respect to which the
FFE user fee adjustment is received will
submit this information electronically.
Form Number: CMS–10492 (OMB
Control Number: 0938–NEW);
Frequency: Once, Yearly. Affected
Public: Private Sector—Business or
other for-profits and Not-for-profit
institutions; Number of Respondents:
861; Total Annual Responses: 861 Total
Annual Hours: 12,930. (For policy
questions regarding this collection
contact Jaya Ghildiyal at (301) 492–
5149.)
Dated: September 24, 2014.
Martique Jones,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2014–23132 Filed 9–26–14; 8:45 am]
BILLING CODE 4120–01–U–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1409]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Records and
Reports Concerning Experiences With
Approved New Animal Drugs: Adverse
Event Reports
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
SUMMARY:
PO 00000
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58355
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
adverse event reporting by FDA on new
animal drugs and product/
manufacturing defects collected on
paper forms.
DATES: Submit either electronic or
written comments on the collection of
information by November 28, 2014.
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
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58356
Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Notices
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.
Records and Reports Concerning
Experiences With Approved New
Animal Drugs: Adverse Event Reports
on Paper Forms FDA 1932, 1932a, and
2301—21 CFR 514.80; OMB Control
Number 0910–0284—Extension
Section 512(l) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360b(l) and 514.80 (21 CFR
514.80) of FDA regulations require
applicants of approved new animal drug
applications (NADAs) and abbreviated
new animal drug applications
(ANADAs) to report adverse drug
experiences and product/manufacturing
defects (see § 514.80)(b)). Additionally,
Section 571(e)(3) of the FD&C Act (21
U.S.C. 360ccc(e)(3)) requires that
applicants for conditional approval of
new animal drugs (CNADAs) maintain
adequate reports and records of adverse
drug experiences and product/
manufacturing defects as applicable
under section 512(l) of the FD&C Act.
The continuous monitoring of
approved NADAs, ANADAs, and
CNADAs affords the primary means by
which FDA obtains information
regarding potential problems with the
safety and efficacy of marketed
approved new animal drugs as well as
potential product/manufacturing
problems. Post-approval marketing
surveillance is important because data
previously submitted to FDA may not be
adequate as animal drug effects can
change over time and less apparent
effects may take years to manifest.
Under § 514.80(d), an applicant must
report adverse drug experiences and
product/manufacturing defects on Form
FDA 1932, ‘‘Veterinary Adverse Drug
Reaction, Lack of Effectiveness, Product
Defect Report.’’ Periodic drug
experience reports and special drug
experience reports must be
accompanied by a completed Form FDA
2301, ‘‘Transmittal of Periodic Reports
and Promotional Material for New
Animal Drugs,’’ (see § 514.80). Form
FDA 1932a, ‘‘Veterinary Adverse Drug
Reaction, Lack of Effectiveness or
Product Defect Report,’’ allows for
voluntary reporting of adverse drug
experiences or product/manufacturing
defects.
In 2010, electronic versions of Forms
FDA 1932 and 1932a were incorporated
into the FDA Safety Reporting Portal.
This electronic system is used for
collecting, submitting, and processing
adverse event reports and other safety
information for all FDA-regulated
products. Burden for the electronic
version of these forms is accounted for
under OMB control number 0910–0645.
This approval request accounts for the
collection of information using existing
paper Forms FDA 1932, 1932a, and
2301 and is currently approved under
OMB control number 0910–0284. FDA
estimates that, at this time,
approximately 50 percent of the
respondents utilize paper forms for
submitting this information. We expect
this number to decrease as more
respondents make use of the FDA Safety
Reporting Portal.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section or section of the FD&C Act
FDA
form
No.
514.80(b)(1), 514.80(b)(2)(i) and (ii), 514.80(b)(3) ..........
Voluntary reporting FDA Form 1932a for the public .......
514.80(b)(4) .....................................................................
514.80(b)(5)(i) ..................................................................
514.80(b)(5)(ii) .................................................................
514.80(b)(5)(iii) .................................................................
1932
1932a
2301
2301
2301
2301
22
197
200
200
200
190
81.05
1
8.11
0.57
20.12
0.1
1,783
197
1,622
114
4,024
20
1
1
16
2
2
2
1,783
197
25,952
228
8,048
40
Total Hours ...............................................................
............
........................
........................
........................
........................
36,248
1 There
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total
hours
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR Section
Number of
record keepers
Number of
records per
record keeper
Total annual
records
Average
burden per
record
keeping
Total hours
514.80(e) ..............................................................................
646
7.20
4651
14
65117
tkelley on DSK3SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Notices
Dated: September 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FR Doc. 2014–23059 Filed 9–26–14; 8:45 am]
[Docket No. FDA–2014–D–0397]
BILLING CODE 4164–01–P
Internet/Social Media Platforms With
Character Space Limitations:
Presenting Risk and Benefit
Information for Prescription Drugs and
Medical Devices; Draft Guidance for
Industry; Reopening of the Comment
Period
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0623]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Voluntary Cosmetic Registration
Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Voluntary Cosmetic Registration
Program’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
SUMMARY:
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:
On July 8,
2014, the Agency submitted a proposed
collection of information entitled
‘‘Voluntary Cosmetic Registration
Program’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0027. The
approval expires on August 31, 2017. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
tkelley on DSK3SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: September 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–23066 Filed 9–26–14; 8:45 am]
BILLING CODE 4164–01–P
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AGENCY:
Food and Drug Administration,
HHS.
Notice; reopening of the
comment period.
ACTION:
The Food and Drug
Administration (FDA) is reopening the
comment period for the notice of
availability of the draft guidance
entitled ‘‘Internet/Social Media
Platforms with Character Space
Limitations: Presenting Risk and Benefit
Information for Prescription Drugs and
Medical Devices,’’ published in the
Federal Register of June 18, 2014. FDA
is reopening the comment period in
response to a request for additional time
and to allow interested persons more
time to submit comments.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comments on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
by October 29, 2014.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Regarding human prescription drugs:
Jean-Ah Kang, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Silver Spring,
MD 20993, 301–796–1200.
Regarding prescription human
biological products: Stephen Ripley,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993–0002, 240–402–7911.
Regarding animal prescription drugs:
Dorothy McAdams, Center for
Veterinary Medicine (HFV–216), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855, 240–276–
9300.
SUMMARY:
PO 00000
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58357
Regarding medical devices for human
use: Deborah Wolf, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3414, Silver Spring,
MD 20993, 301–796–5732.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 18,
2014 (79 FR 34759), FDA announced the
availability of a draft guidance for
industry entitled ‘‘Internet/Social Media
Platforms with Character Space
Limitations: Presenting Risk and Benefit
Information for Prescription Drugs and
Medical Devices.’’ In that document,
FDA requested comments on the draft
guidance, which responds to (among
other things) stakeholder requests for
specific guidance. The draft guidance
describes FDA’s current thinking on
how manufacturers, packers, and
distributors of prescription human and
animal drugs and medical devices for
human use, including biological
products, that choose to present benefit
information should present both benefit
and risk information within advertising
and promotional labeling of their FDAregulated medical products on
electronic/digital platforms that are
associated with character space
limitations, specifically on the Internet
and through social media or other
technological venues. The draft
guidance represents FDA’s current
thinking on specific aspects of FDA’s
evolving consideration of social media
platforms and other Internet-related
matters. FDA actively continues to
review, analyze, and develop
approaches to a variety of topics related
to the labeling and advertising of
medical products, including the
development of this and other guidance
addressing the use of social media
platforms and the Internet.
Interested persons were originally
given until September 16, 2014, to
submit comments on the draft guidance.
II. Request for Comments
Following publication of the June 18,
2014, notice, FDA received a request for
additional time to develop meaningful
and thoughtful comments, especially in
light of the concurrent comment period
with another draft guidance entitled
‘‘Internet/Social Media Platforms:
Correcting Independent Third-Party
Misinformation About Prescription
Drugs and Medical Devices’’ published
elsewhere in this volume of the Federal
Register.
FDA has considered the request and
will reopen the comment period for an
additional 30 days. The Agency believes
that an additional 30 days allows
E:\FR\FM\29SEN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 188 (Monday, September 29, 2014)]
[Notices]
[Pages 58355-58357]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23059]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1409]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Records and Reports Concerning Experiences With
Approved New Animal Drugs: Adverse Event Reports
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 adverse event reporting by FDA
on new animal drugs and product/manufacturing defects collected on
paper forms.
DATES: Submit either electronic or written comments on the collection
of information by November 28, 2014.
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
[[Page 58356]]
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.
Records and Reports Concerning Experiences With Approved New Animal
Drugs: Adverse Event Reports on Paper Forms FDA 1932, 1932a, and 2301--
21 CFR 514.80; OMB Control Number 0910-0284--Extension
Section 512(l) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360b(l) and 514.80 (21 CFR 514.80) of FDA
regulations require applicants of approved new animal drug applications
(NADAs) and abbreviated new animal drug applications (ANADAs) to report
adverse drug experiences and product/manufacturing defects (see Sec.
514.80)(b)). Additionally, Section 571(e)(3) of the FD&C Act (21 U.S.C.
360ccc(e)(3)) requires that applicants for conditional approval of new
animal drugs (CNADAs) maintain adequate reports and records of adverse
drug experiences and product/manufacturing defects as applicable under
section 512(l) of the FD&C Act.
The continuous monitoring of approved NADAs, ANADAs, and CNADAs
affords the primary means by which FDA obtains information regarding
potential problems with the safety and efficacy of marketed approved
new animal drugs as well as potential product/manufacturing problems.
Post-approval marketing surveillance is important because data
previously submitted to FDA may not be adequate as animal drug effects
can change over time and less apparent effects may take years to
manifest.
Under Sec. 514.80(d), an applicant must report adverse drug
experiences and product/manufacturing defects on Form FDA 1932,
``Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product
Defect Report.'' Periodic drug experience reports and special drug
experience reports must be accompanied by a completed Form FDA 2301,
``Transmittal of Periodic Reports and Promotional Material for New
Animal Drugs,'' (see Sec. 514.80). Form FDA 1932a, ``Veterinary
Adverse Drug Reaction, Lack of Effectiveness or Product Defect
Report,'' allows for voluntary reporting of adverse drug experiences or
product/manufacturing defects.
In 2010, electronic versions of Forms FDA 1932 and 1932a were
incorporated into the FDA Safety Reporting Portal. This electronic
system is used for collecting, submitting, and processing adverse event
reports and other safety information for all FDA-regulated products.
Burden for the electronic version of these forms is accounted for under
OMB control number 0910-0645. This approval request accounts for the
collection of information using existing paper Forms FDA 1932, 1932a,
and 2301 and is currently approved under OMB control number 0910-0284.
FDA estimates that, at this time, approximately 50 percent of the
respondents utilize paper forms for submitting this information. We
expect this number to decrease as more respondents make use of the FDA
Safety Reporting Portal.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
FDA Number of
21 CFR Section or section of form Number of responses per Total annual Average burden Total
the FD&C Act No. respondents respondent responses per response hours
----------------------------------------------------------------------------------------------------------------
514.80(b)(1), 514.80(b)(2)(i) 1932 22 81.05 1,783 1 1,783
and (ii), 514.80(b)(3)........
Voluntary reporting FDA Form 1932a 197 1 197 1 197
1932a for the public..........
514.80(b)(4)................... 2301 200 8.11 1,622 16 25,952
514.80(b)(5)(i)................ 2301 200 0.57 114 2 228
514.80(b)(5)(ii)............... 2301 200 20.12 4,024 2 8,048
514.80(b)(5)(iii).............. 2301 190 0.1 20 2 40
--------------------------------------------------------------------------------
Total Hours................ ....... .............. ............. .............. .............. 36,248
----------------------------------------------------------------------------------------------------------------
\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 record Total hours
record keepers record keeper records keeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(e).......................................................... 646 7.20 4651 14 65117
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 58357]]
Dated: September 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-23059 Filed 9-26-14; 8:45 am]
BILLING CODE 4164-01-P
