Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 50917-50919 [2014-20318]
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Federal Register / Vol. 79, No. 165 / Tuesday, August 26, 2014 / Notices
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: On October 8, the committee
will discuss, make recommendations
and vote on information related to the
premarket approval application
regarding the Boston Scientific
Corporation’s WATCHMAN Left Atrial
Appendage (LAA) Closure Technology.
FDA is seeking committee review and
recommendations regarding new
clinical data and associated additional
adverse events including stroke that
have become available since the
previous advisory committee meeting
on the WATCHMAN device, which was
held December 11, 2013. The
WATCHMAN LAA Closure Technology
is a percutaneously delivered
permanent cardiac implant placed in
the left atrial appendage. This device is
indicated to prevent thromboembolism
(TE) from the left atrial appendage. It
may be considered for use in patients
with non-valvular atrial fibrillation who
are eligible for warfarin therapy to
reduce the risk of stroke and systemic
embolism based on CHADS2 (congestive
heart failure, hypertension, age >75
years, diabetes, and prior stroke or
transient ischemic attack (TIA)) or
CHA2DS2-VASc (congestive heart
failure, hypertension, age >75 years,
diabetes mellitus, stroke/TIA/TE,
vascular disease, age 65–74, and sex
category) scores.
On October 9, the committee will
discuss and make recommendations
regarding the classification of morethan-minimally manipulated allograft
heart valves (MMM Allograft HVs). A
MMM Allograft HV is a human valve or
valved conduit that has been aseptically
recovered from qualified donors,
dissected free from the human heart,
and then subjected to a manufacturing
process(es) that alters the original
relevant characteristics of the tissue (21
CFR 1271.3(f), 21 CFR 1271.10(a)(1),
and 21 CFR 1271.20). The valve is then
stored until needed by a recipient. An
example of such a manufacturing
process is one that intentionally
removes the cells and cellular debris
with the goal of reducing in vivo
antigenicity.
MMM Allograft HVs are considered
preamendment devices because they
were found substantially equivalent to
devices in commercial distribution prior
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to May 28, 1976, when the Medical
Device Amendments became effective.
MMM Allograft HVs are currently
regulated under Product Code OHA,
‘‘Heart Valve, More than Minimally
Manipulated Allograft,’’ as unclassified
devices and reviewed under the
premarket notification, 510(k), authority
(21 CFR part 807). FDA is seeking
committee input on the safety and
effectiveness of MMM Allograft HVs
and the regulatory classification for
MMM Allograft HVs.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before September 30, 2014.
On October 8, oral presentations from
the public will be scheduled between
approximately 1 p.m. and 2 p.m. On
October 9, oral presentations from the
public will be scheduled between
approximately 9:45 a.m. and 10:15 a.m.
Those individuals interested in making
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before September 22, 2014. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
September 24, 2014.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
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50917
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact AnnMarie
Williams, Conference Management
Staff, 301–796–5966,
Annmarie.Williams@fda.hhs.gov at least
7 days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 20, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
[FR Doc. 2014–20165 Filed 8–25–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than September 25,
2014.
SUMMARY:
Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
ADDRESSES:
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50918
Federal Register / Vol. 79, No. 165 / Tuesday, August 26, 2014 / Notices
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
AIDS Drug Assistance Program Data
Report OMB No. 0915–0345—Revision.
Abstract: HRSA’s AIDS Drug
Assistance Program (ADAP) is funded
through The Ryan White HIV/AIDS
Program, Part B, Title XXVI of the
Public Health Service Act, which
provides grants to states and territories.
ADAP provides medications for the
treatment of HIV/AIDS. Program funds
may also be used to purchase health
insurance for eligible clients and for
services that enhance access, adherence,
and monitoring of drug treatments.
Each of the 50 states, the District of
Columbia, Puerto Rico, and several
territories receive ADAP grants. As part
of the funding requirements, ADAPs
submit reports concerning information
on patients served; eligibility
requirements; pharmaceuticals
prescribed; and pricing and other
sources of support to provide AIDS
medication treatment, cost data, and
coordination with Medicaid. Since
2005, ADAPs have supplied aggregate
data to HRSA using the ADAP Quarterly
Report (AQR). However, aggregate data
cannot be analyzed with the detail that
is required to assess quality of care or
to sufficiently account for the use of
Ryan White HIV/AIDS Program Funds.
To address this limitation, HRSA’s HIV/
AIDS Bureau (HAB) developed a clientlevel data system for ADAPs called the
ADAP Data Report (ADR), and in 2013,
ADAPs began submitting the ADR. As of
April 30, 2104, HAB retired the AQR
and now only requires the submission
of the ADR. The ADR will be submitted
annually and consists of a Grantee
Report and a client-level data file.
Need and Proposed Use of the
Information: The Ryan White HIV/AIDS
Program requires the submission of
annual reports by the Secretary of the
Department of Health and Human
Services (HHS) to the appropriate
committees of Congress. The collection
of grantee-level and client level data
enables HRSA to more effectively
respond to requests from the Secretary
of HHS. In addition, client-level
information is needed by HRSA in order
to respond to the request for reviews of
program performance and information
for strategic planning. Client-level data
is also needed to support the
implementation and monitoring of the
National HIV/AIDS Strategy (NHAS).
On April 11, 2012, a memo from the
Secretary of HHS directed the Health
Resources and Services Administration
(HRSA) along with other Health and
Human Services Operating Divisions
(OpDivs) to work together to: (1)
Identify seven common core HIV/AIDS
indicators; (2) develop implementation
plans to deploy these indicators; and (3)
streamline data collection; and reduce
reporting by at least 20 to 25 percent. In
November 2012, the HIV/AIDS
Indicators Implementation Group
(HAIIG), comprised of representatives
from HHS OpDivs, the Department of
Housing and Urban Development, the
Veterans’ Health Administration, and
community partners successfully
identified the required common core
HIV/AIDS indicators.
Revisions to the ADR are required to
support implementation of the core
indicators, streamlining data collection
and reducing reporting burden. Eleven
data elements will be deleted from the
ADR and several variables were
modified to reduce reporting burden.
Sex at Birth, defined as the biological
sex assigned to the client at birth, will
be added to align with variables
collected by other HHS OpDivs. Type of
ADAP-funded insurance assistance
received will also be added to track
ADAP’s payment of full or partial
premium and co-pays and deductibles.
In addition to the new data elements
noted above, other new variables will be
added to the ADR address provisions set
forth in Section 4302 of the Affordable
Care Act (ACA). The ACA includes
several provisions aimed at eliminating
health disparities in America. Section
4302 (Understanding health disparities:
Data collection and analysis) of the ACA
focuses on the standardization,
collection, analysis, and reporting of
health disparities data. Section 4302
requires the Secretary of HHS to
establish data collection standards for
race, ethnicity, and sex. The race/
ethnicity data elements include
reporting of Hispanic, Asian, and Native
Hawaiian/Pacific Islander subgroups.
The categories for HHS data standards
for race and ethnicity are based on the
disaggregation of the OMB standard
used in the American Community
Survey and the 2000 and 2010
Decennial Census. The subgroup
categories can be rolled-up to the OMB
standard. These new data elements will
be used in data analysis intended to
identify and understand health
disparities.
Likely Respondents: State ADAPs of
Ryan White Part B grantees.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
54
54
1
1
54
54
6
81
324
4,374
Total ..............................................................................
tkelley on DSK3SPTVN1PROD with NOTICES
Grantee Report ....................................................................
Client-level Report ...............................................................
........................
........................
........................
87
4,698
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Federal Register / Vol. 79, No. 165 / Tuesday, August 26, 2014 / Notices
Dated: August 19, 2014.
Jackie Painter,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2014–20318 Filed 8–25–14; 8:45 am]
[FR Doc. 2014–20312 Filed 8–25–14; 8:45 am]
BILLING CODE 4165–15–P
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Health Resources and Services
Administration
National Advisory Council on Migrant
Health; Notice of Meeting
tkelley on DSK3SPTVN1PROD with NOTICES
Dated: August 19, 2014.
Jackie Painter,
Acting Director, Division of Policy and
Information Coordination.
Centers for Disease Control and
Prevention (CDC)/Health Resources
and Services Administration (HRSA)
Advisory Committee on HIV, Viral
Hepatitis, and Sexually Transmitted
Disease (STD) Prevention and
Treatment
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Public Law 92–463), notice is hereby
given of the following meeting:
Name: National Advisory Council on
Migrant Health
Dates and Times: October 22, 2014,
8:00 a.m. to 5:00 p.m. October 23, 2014,
8:00 a.m. to 5:00 p.m.
Place: Sheraton Pittsburgh Hotel at
Station Square, 300 W Station Square
Drive, Pittsburgh, Pennsylvania 15219,
Telephone: 412–261–2000, Fax: 412–
261–2932.
Status: The meeting will be open to
the public.
Purpose: The purpose of the meeting
is to discuss services and issues related
to the health of migratory and seasonal
agricultural workers and their families
and to formulate recommendations for
the Secretary of Health and Human
Services.
Agenda: The agenda includes an
overview of the Council’s general
business activities. The Council will
also hear presentations from experts on
agricultural worker issues, including the
status of agricultural worker health at
the local and national levels.
In addition, the Council will be
holding a public hearing at which
migratory and seasonal agricultural
workers will have the opportunity to
testify before the Council regarding
matters that affect the health of
migratory and seasonal agricultural
workers. The hearing is scheduled for
Wednesday, October 22, 2014 from 1:30
p.m. to 4:30 p.m., at the Sheraton
Pittsburgh Hotel at Station Square.
Agenda items are subject to change as
priorities indicate.
FOR FURTHER INFORMATION CONTACT:
Gladys Cate, Office of National
Assistance and Special Populations,
Bureau of Primary Health Care, Health
Resources and Services Administration,
5600 Fishers Lane, Room 15–74,
Maryland 20857; telephone (301) 594–
0367.
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21:48 Aug 25, 2014
Jkt 232001
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Notice; correction.
AGENCY:
HRSA is requesting
nominations to fill three vacancies on
the CDC/HRSA Advisory Committee on
HIV, Viral Hepatitis and STD Prevention
and Treatment (CHACHSPT). The action
is to provide correction listed under
addresses to provide more time for
public input.
FOR FURTHER INFORMATION CONTACT:
Shelley B. Gordon, Public Health,
Analyst, HIV/AIDS Bureau, HRSA, 5600
Fishers Lane, Room 7C–26, Rockville,
Maryland 20857, email at
sgordon@hrsa.gov, or telephone at (301)
443–9684.
SUMMARY:
Correction
In the Federal Register, FR 2014–
19199 (August 14, 2014), please make
the following corrections:
In the ADDRESSES Section please
change the date all nominations should
be submitted by to no later than
September 15, 2014.
Dated: August 19, 2014.
Jackie Painter,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2014–20313 Filed 8–25–14; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources AND Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration, HHS.
AGENCY:
PO 00000
Frm 00036
Fmt 4703
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ACTION:
50919
Notice.
The Health Resources and
Services Administration (HRSA) is
publishing this notice of petitions
received under the National Vaccine
Injury Compensation Program (the
Program), as required by Section
2112(b)(2) of the Public Health Service
(PHS) Act, as amended. While the
Secretary of Health and Human Services
is named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the Program in
general, contact the Clerk, United States
Court of Federal Claims, 717 Madison
Place, NW., Washington, DC 20005,
(202) 357–6400. For information on
HRSA’s role in the Program, contact the
Director, National Vaccine Injury
Compensation Program, 5600 Fishers
Lane, Room 11C–26, Rockville, MD
20857; (301) 443–6593.
SUPPLEMENTARY INFORMATION: The
Program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
the U.S. Court of Federal Claims and to
serve a copy of the petition on the
Secretary of Health and Human
Services, who is named as the
respondent in each proceeding. The
Secretary has delegated this
responsibility under the Program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the Table) set forth at Section
2114 of the PHS Act or as set forth at
42 CFR 100.3, as applicable. This Table
lists for each covered childhood vaccine
the conditions which may lead to
compensation and, for each condition,
the time period for occurrence of the
first symptom or manifestation of onset
or of significant aggravation after
vaccine administration. Compensation
may also be awarded for conditions not
listed in the Table and for conditions
that are manifested outside the time
periods specified in the Table, but only
SUMMARY:
E:\FR\FM\26AUN1.SGM
26AUN1
]]>Agencies
[Federal Register Volume 79, Number 165 (Tuesday, August 26, 2014)]
[Notices]
[Pages 50917-50919]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20318]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health Resources and Services Administration
(HRSA) has submitted an Information Collection Request (ICR) to the
Office of Management and Budget (OMB) for review and approval. Comments
submitted during the first public review of this ICR will be provided
to OMB. OMB will accept further comments from the public during the
review and approval period.
DATES: Comments on this ICR should be received no later than September
25, 2014.
ADDRESSES: Submit your comments, including the Information Collection
Request Title, to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202-395-5806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email the
[[Page 50918]]
HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or
call (301) 443-1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: AIDS Drug Assistance Program
Data Report OMB No. 0915-0345--Revision.
Abstract: HRSA's AIDS Drug Assistance Program (ADAP) is funded
through The Ryan White HIV/AIDS Program, Part B, Title XXVI of the
Public Health Service Act, which provides grants to states and
territories. ADAP provides medications for the treatment of HIV/AIDS.
Program funds may also be used to purchase health insurance for
eligible clients and for services that enhance access, adherence, and
monitoring of drug treatments.
Each of the 50 states, the District of Columbia, Puerto Rico, and
several territories receive ADAP grants. As part of the funding
requirements, ADAPs submit reports concerning information on patients
served; eligibility requirements; pharmaceuticals prescribed; and
pricing and other sources of support to provide AIDS medication
treatment, cost data, and coordination with Medicaid. Since 2005, ADAPs
have supplied aggregate data to HRSA using the ADAP Quarterly Report
(AQR). However, aggregate data cannot be analyzed with the detail that
is required to assess quality of care or to sufficiently account for
the use of Ryan White HIV/AIDS Program Funds. To address this
limitation, HRSA's HIV/AIDS Bureau (HAB) developed a client-level data
system for ADAPs called the ADAP Data Report (ADR), and in 2013, ADAPs
began submitting the ADR. As of April 30, 2104, HAB retired the AQR and
now only requires the submission of the ADR. The ADR will be submitted
annually and consists of a Grantee Report and a client-level data file.
Need and Proposed Use of the Information: The Ryan White HIV/AIDS
Program requires the submission of annual reports by the Secretary of
the Department of Health and Human Services (HHS) to the appropriate
committees of Congress. The collection of grantee-level and client
level data enables HRSA to more effectively respond to requests from
the Secretary of HHS. In addition, client-level information is needed
by HRSA in order to respond to the request for reviews of program
performance and information for strategic planning. Client-level data
is also needed to support the implementation and monitoring of the
National HIV/AIDS Strategy (NHAS).
On April 11, 2012, a memo from the Secretary of HHS directed the
Health Resources and Services Administration (HRSA) along with other
Health and Human Services Operating Divisions (OpDivs) to work together
to: (1) Identify seven common core HIV/AIDS indicators; (2) develop
implementation plans to deploy these indicators; and (3) streamline
data collection; and reduce reporting by at least 20 to 25 percent. In
November 2012, the HIV/AIDS Indicators Implementation Group (HAIIG),
comprised of representatives from HHS OpDivs, the Department of Housing
and Urban Development, the Veterans' Health Administration, and
community partners successfully identified the required common core
HIV/AIDS indicators.
Revisions to the ADR are required to support implementation of the
core indicators, streamlining data collection and reducing reporting
burden. Eleven data elements will be deleted from the ADR and several
variables were modified to reduce reporting burden. Sex at Birth,
defined as the biological sex assigned to the client at birth, will be
added to align with variables collected by other HHS OpDivs. Type of
ADAP-funded insurance assistance received will also be added to track
ADAP's payment of full or partial premium and co-pays and deductibles.
In addition to the new data elements noted above, other new
variables will be added to the ADR address provisions set forth in
Section 4302 of the Affordable Care Act (ACA). The ACA includes several
provisions aimed at eliminating health disparities in America. Section
4302 (Understanding health disparities: Data collection and analysis)
of the ACA focuses on the standardization, collection, analysis, and
reporting of health disparities data. Section 4302 requires the
Secretary of HHS to establish data collection standards for race,
ethnicity, and sex. The race/ethnicity data elements include reporting
of Hispanic, Asian, and Native Hawaiian/Pacific Islander subgroups. The
categories for HHS data standards for race and ethnicity are based on
the disaggregation of the OMB standard used in the American Community
Survey and the 2000 and 2010 Decennial Census. The subgroup categories
can be rolled-up to the OMB standard. These new data elements will be
used in data analysis intended to identify and understand health
disparities.
Likely Respondents: State ADAPs of Ryan White Part B grantees.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Grantee Report.................. 54 1 54 6 324
Client-level Report............. 54 1 54 81 4,374
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. 87 4,698
----------------------------------------------------------------------------------------------------------------
[[Page 50919]]
Dated: August 19, 2014.
Jackie Painter,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2014-20318 Filed 8-25-14; 8:45 am]
BILLING CODE 4165-15-P
