Agency Information Collection Activities: Proposed Collection; Comment Request, 12254-12256 [2019-06192]
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12254
Federal Register / Vol. 84, No. 62 / Monday, April 1, 2019 / Notices
EXHIBIT A.2—ESTIMATED ANNUALIZED COST BURDEN—Continued
Number of
respondents
Form name
Average hourly wage rate *
167
337
67
7,583
a 98.83
83
4,167
4,167
4,167
83
4,167
4,167
4,167
b 27.87
30
60
334
167
60
120
4,008
2,505
14,022
27,064
b. Structural Assessments—Cohort 4 (baseline and endline) .................
2. Team Antibiotic Review Form (Cohorts 1, 2, and 3) ..................................
3. AHRQ Patient Safety Culture Surveys:
a. HSOPS, NHSOPS, MOSOPS (Cohort 1) ............................................
b. HSOPS (Cohort 2) ................................................................................
c. NHSOPS (Cohort 3) .............................................................................
d. MOSOPS (Cohort 4) ............................................................................
4. Semi-structured qualitative interviews (Cohort 1):
a. Physicians ............................................................................................
b. Other Health Practitioners ....................................................................
5. EHR data (Cohorts 1, 2, and 3) ..................................................................
6. EHR data (Cohort 4) ...................................................................................
Total ...................................................................................................
Total burden
hours
a 98.83
b 27.87
b 27.87
b 27.87
a 98.83
Total cost
burden
6,622
749,428
2,313
116,134
116,134
116,134
b 27.87
5,930
3,344
111,703
69,814
........................
1,311,096
b 27.87
b 27.87
* National Compensation Survey: Occupational wages in the United States May 2016 ‘‘U.S. Department of Labor, Bureau of Labor Statistics:’’
https://www.bls.gov/oes/current/oes_stru.htm.
a Based on the mean wages for 29–1069 Physicians and Surgeons, All Other.
b Based on the mean wages for 29–9099 Miscellaneous Health Practitioners and Technical Workers: Healthcare Practitioners and Technical
Workers, All Other.
Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ’s health care
research and health care information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) of information; (c) ways to
enhance the quality, utility and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Gopal Khanna,
Director.
[FR Doc. 2019–06193 Filed 3–29–19; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
AGENCY:
ACTION:
Notice.
This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project ‘‘Online
Submission Form for Supplemental
Evidence and Data for Systematic
Reviews for the Evidence-based Practice
Center Program.’’
SUMMARY:
Comments on this notice must be
received by May 31, 2019.
DATES:
Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by
email at doris.lefkowitz@AHRQ.hhs.gov.
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
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Proposed Project
Online Submission Form for
Supplemental Evidence and Data for
Systematic Reviews for the EvidenceBased Practice Center Program
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3521,
AHRQ invites the public to comment on
this proposed information collection.
The AHRQ Evidence-based Practice
Center (EPC) Program develops
evidence reports and technology
assessments that summarize evidence
for federal and other partners on topics
relevant to clinical and other health care
organization and delivery issues—
specifically those that are common,
expensive, and/or significant for the
Medicare and Medicaid populations.
Better understanding and use of
evidence in practice, policy, and
delivery of care improves the quality of
health care.
These reports, reviews, and
technology assessments are based on
rigorous, comprehensive syntheses and
analyses of the scientific literature on
topics. EPC reports and assessments
emphasize explicit and detailed
documentation of methods, rationale,
and assumptions. EPC reports are
conducted in accordance with an
established policy on financial and
nonfinancial interests.
This research has the following goals:
Æ Use research methods to gather
knowledge on the effectiveness or
comparative effectiveness of treatments,
screening, diagnostic, management or
health care delivery strategies for
specific medical conditions, both
published and unpublished, to evaluate
the quality of research studies and the
evidence from these studies.
E:\FR\FM\01APN1.SGM
01APN1
12255
Federal Register / Vol. 84, No. 62 / Monday, April 1, 2019 / Notices
Æ Promote the use of evidence in
health care decision making to improve
health care and health
Æ Identify research gaps to inform
future research investments
The 2011 Institute of Medicine report
‘‘Finding What Works in Health Care:
Standards for Systematic Review’’
includes an assessment of publication
bias through the identification of
unpublished studies. This is an
important source for bias which could
affect the nature and direction of
research findings. Identifying and
including the results of these additional
unpublished studies may provide a
more complete and accurate assessment
of an intervention’s effect on outcomes.
An important way to identify
unpublished studies is through requests
to medical device manufacturers,
pharmaceutical companies, and other
intervention developers.
The proposed project involves
sending a notification via an email
listserv and via Federal Register notice
as needed of the opportunity to submit
information on unpublished studies or
other scientific information to the EPC
Program website, with one request per
systematic review topic. Because
research on each topic must be
completed in a timely manner in order
for it to be useful, the collections are
never ongoing—there is one request and
collection per topic. Investigators in the
EPC Program will review the
information and assess potential risk of
bias from both published and
unpublished studies and its impact on
the EPC Program’s findings.
This study is being conducted by
AHRQ, pursuant to AHRQ’s statutory
authority to conduct and support
research on health care and on systems
for the delivery of such care, including
activities with respect to the quality,
effectiveness, efficiency,
appropriateness and value of health care
services. 42 U.S.C 299a(a)(1).
Method of Collection
To achieve the goals of this project the
following data collections will be
implemented:
• Online Submission Form
Instrument. This information is
collected for the purposes of providing
supplemental evidence and data for
systematic reviews (SEADS). The
purpose of SEADS requests is not to
collect generalizable data, but to
supplement the published and grey
literature searches EPC investigators are
conducting. The online submission form
(OSF) collects data from respondents on
their name and the information packet.
This happens following notification of
opportunity to submit via email listserv
and/or Federal Register notice as
needed, with one request per topic. For
the purposes of meta-analyses, trial
summary data from missing and
unidentified studies are sought. For the
purposes of constructing evidence tables
and quality ratings (e.g., on public
reporting of cost measures or health
information exchange), data can vary
(e.g., URLs, study designs, and
consumer-mediated exchange forms).
Submitters are informed of the types of
information that would be most helpful
to include in the information packet,
which includes a list of all sponsored
but unpublished studies (both
completed and ongoing), as well as
comment on the completeness of
information provided.
The EPC Program currently uses a
broad-based email announcement via
email listserv and a Federal Register
notice, as needed, to publicize the
opportunity to submit scientific
information about each topic. The
proposed project does not duplicate
other available sources of this
information. Available study registries
and databases may not sufficiently
inform the Program’s research. The EPC
Program does not anticipate more than
15 topics per year with SEADS requests.
Estimated Annual Respondent Burden
Exhibit 1 presents estimates of the
reporting burden hours for the data
collection efforts. Time estimates are
based on pilot testing of materials and
what can reasonably be requested of
respondents. The number of
respondents listed in ‘‘Number of
respondents per SEADS request’’ of
Exhibit 1 reflects a projected 33%
response rate with approximately 1–2
responses per request and assumes
about 15 SEADS requests per year.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Number
of SEADS
requests
Number
of SEADS
request that
receive
response
Number of
responses per
SEADS
request
Annual
number
of SEADS
responses
Hours per
response
Total burden
hours per
annum
Online Submission Form (OSF) ..............
15
5
1.5
7.5
15/60
1.87
Average
hourly wage
rate *
Total cost
burden
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
SEADS
requests
Form name
OSF ..................................................................................................................
Total burden
hours per
SEADS
15
1.87
$61.39 a
$115.10
* Occupational Employment Statistics, May 2017 National Occupational Employment and Wage Estimates United States, U.S. Department of
Labor, Bureau of Labor Statistics. https://www.bls.gov/oes/current/oes_nat.htm#11-0000.
a Based on the mean wages for Public Relations and Fundraising Managers, 11–2031, the occupational group most likely tasked with completing the OSF.
Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
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17:22 Mar 29, 2019
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performance of AHRQ’s health care
research and health care information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
PO 00000
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collection(s) of information; (c) ways to
enhance the quality, utility and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
E:\FR\FM\01APN1.SGM
01APN1
12256
Federal Register / Vol. 84, No. 62 / Monday, April 1, 2019 / Notices
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Gopal Khanna,
Director.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1725–N]
Medicare Program; Meeting
Announcement for the Medicare
Advisory Panel on Clinical Diagnostic
Laboratory Tests
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
[FR Doc. 2019–06192 Filed 3–29–19; 8:45 am]
BILLING CODE 4160–90–P
This notice announces the
next public meeting dates for the
Medicare Advisory Panel on Clinical
Diagnostic Laboratory Tests (the Panel)
on Monday, July 22, 2019 and Tuesday,
July 23, 2019. The purpose of the Panel
is to advise the Secretary of the
Department of Health and Human
Services and the Administrator of the
Centers for Medicare & Medicaid
Services on issues related to clinical
diagnostic laboratory tests.
DATES: Meeting Dates: The meeting of
the Panel is scheduled for Monday, July
22, 2019 from 8:00 a.m. to 4:30 p.m.,
Eastern Daylight Time (E.D.T.) and
Tuesday, July 23, 2019, from 8:00 a.m.
to 4:30 p.m., E.D.T. The Panel is also
expected to participate in the Clinical
Laboratory Fee Schedule (CLFS) Annual
Public Meeting for Calendar Year (CY)
2020 on June 24, 2019 in order to gather
information and ask questions to
presenters. Notice of the CLFS Annual
Public Meeting for CY 2020 is published
elsewhere in this issue of the Federal
Register.
Deadline for Registration: The public
may attend the Panel meeting in person,
view via webcast or listen via
teleconference. Beginning Monday,
April 8, 2019 and ending Monday, July
1, 2019 at 5:00 p.m. E.D.T., registration
to attend the Panel meeting in person
may be completed online at https://
cms.gov/Regulations-and-Guidance/
Guidance/FACA/AdvisoryPanelon
ClinicalDiagnosticLaboratoryTests.html.
On this web page, under ‘‘Panel
Meetings,’’ click the ‘‘Register for July
22 through 23, 2019 Panel Meeting’’ link
and enter the required information. We
refer readers to Section IV. of this notice
for additional details related to meeting
registration.
Webinar, Webcast, and
Teleconference Information:
Teleconference dial-in instructions, and
related webcast and webinar details will
be posted on the meeting agenda, which
will be available on the CMS website
approximately 2 weeks prior to the
meeting at https://www.cms.gov/
SUMMARY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP)—CE19–004,
Etiologic and Effectiveness Research
To Address Polysubstance Impaired
Driving; Amended Notice of Meeting
Notice is hereby given of a change in
the meeting of the Disease, Disability,
and Injury Prevention and Control
Special Emphasis Panel (SEP)–CE19–
004, Etiologic and Effectiveness
Research to Address Polysubstance
Impaired Driving; May 7–8, 2019; 8:30
a.m.–5:30 p.m., (EDT) which was
published in the Federal Register on
February 15, 2019, Volume 84, Number
32, page/s/4446–4447.
The meeting is being amended to
change the meeting location to The W
Buckhead, 3377 Peachtree Road, NE,
Atlanta, GA 30326]. The meeting is
closed to the public.
FOR FURTHER INFORMATION CONTACT:
Mikel L. Walters, M.A., Ph.D., Scientific
Review Official, NCIPC, CDC, 4770
Buford Highway NE, Mailstop F–63,
Atlanta, Georgia 30341,(404) 639–0913;
mwalters@cdc.gov.
The Chief Operating Officer, Centers
for Disease Control and Prevention, 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
Prevention and the Agency for Toxic
Substances and Disease Registry.
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2019–06146 Filed 3–29–19; 8:45 am]
BILLING CODE 4163–18–P
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Regulations-and-Guidance/Guidance/
FACA/AdvisoryPanelonClinical
DiagnosticLaboratoryTests.html. A
preliminary agenda is described in
Section II. of this notice.
ADDRESSES: The Panel meeting will be
held in the auditorium of the Centers for
Medicare & Medicaid Services (CMS),
Central Building, 7500 Security
Boulevard, Baltimore, Maryland 21244–
1850.
FOR FURTHER INFORMATION CONTACT:
Rasheeda Arthur, Ph.D., (410) 786–3434,
email CDLTPanel@cms.hhs.gov. Press
inquiries are handled through the CMS
Press Office at (202) 690–6145. For
additional information on the Panel,
refer to the CMS website at https://
www.cms.gov/Regulations-andGuidance/Guidance/FACA/Advisory
PanelonClinicalDiagnosticLaboratory
Tests.html.
SUPPLEMENTARY INFORMATION:
I. Background
The Medicare Advisory Panel on
Clinical Diagnostic Laboratory Tests (the
Panel) is authorized by section
1834A(f)(1) of the Social Security Act
(the Act) (42 U.S.C. 1395m–1), as
established by section 216(a) of the
Protecting Access to Medicare Act of
2014 (PAMA) (Pub. L. 113–93), enacted
on April 1, 2014. The Panel is subject
to the Federal Advisory Committee Act
(FACA), as amended (5 U.S.C.
Appendix 2), which sets forth standards
for the formation and use of advisory
panels.
Section 1834A(f)(1) of the Act directs
the Secretary of the Department of
Health and Human Services (the
Secretary) to consult with an expert
outside advisory panel established by
the Secretary, composed of an
appropriate selection of individuals
with expertise in issues related to
clinical diagnostic laboratory tests,
which may include the development,
validation, performance, and
application of such tests. Such
individuals may include molecular
pathologists, researchers, and
individuals with expertise in laboratory
science or health economics.
The Panel will provide input and
recommendations to the Secretary and
the Administrator of the Centers for
Medicare & Medicaid Services (CMS) on
the following:
• The establishment of payment rates
under section 1834A of the Act for new
clinical diagnostic laboratory tests,
including whether to use
‘‘crosswalking’’ or ‘‘gapfilling’’
processes to determine payment for a
specific new test.
E:\FR\FM\01APN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 62 (Monday, April 1, 2019)]
[Notices]
[Pages 12254-12256]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06192]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Agency for Healthcare Research and Quality, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) approve the proposed information collection
project ``Online Submission Form for Supplemental Evidence and Data for
Systematic Reviews for the Evidence-based Practice Center Program.''
DATES: Comments on this notice must be received by May 31, 2019.
ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email at
[email protected].
Copies of the proposed collection plans, data collection
instruments, and specific details on the estimated burden can be
obtained from the AHRQ Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by email at
[email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
Online Submission Form for Supplemental Evidence and Data for
Systematic Reviews for the Evidence-Based Practice Center Program
In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3521, AHRQ invites the public to comment on this proposed information
collection. The AHRQ Evidence-based Practice Center (EPC) Program
develops evidence reports and technology assessments that summarize
evidence for federal and other partners on topics relevant to clinical
and other health care organization and delivery issues--specifically
those that are common, expensive, and/or significant for the Medicare
and Medicaid populations. Better understanding and use of evidence in
practice, policy, and delivery of care improves the quality of health
care.
These reports, reviews, and technology assessments are based on
rigorous, comprehensive syntheses and analyses of the scientific
literature on topics. EPC reports and assessments emphasize explicit
and detailed documentation of methods, rationale, and assumptions. EPC
reports are conducted in accordance with an established policy on
financial and nonfinancial interests.
This research has the following goals:
[cir] Use research methods to gather knowledge on the effectiveness
or comparative effectiveness of treatments, screening, diagnostic,
management or health care delivery strategies for specific medical
conditions, both published and unpublished, to evaluate the quality of
research studies and the evidence from these studies.
[[Page 12255]]
[cir] Promote the use of evidence in health care decision making to
improve health care and health
[cir] Identify research gaps to inform future research investments
The 2011 Institute of Medicine report ``Finding What Works in
Health Care: Standards for Systematic Review'' includes an assessment
of publication bias through the identification of unpublished studies.
This is an important source for bias which could affect the nature and
direction of research findings. Identifying and including the results
of these additional unpublished studies may provide a more complete and
accurate assessment of an intervention's effect on outcomes. An
important way to identify unpublished studies is through requests to
medical device manufacturers, pharmaceutical companies, and other
intervention developers.
The proposed project involves sending a notification via an email
listserv and via Federal Register notice as needed of the opportunity
to submit information on unpublished studies or other scientific
information to the EPC Program website, with one request per systematic
review topic. Because research on each topic must be completed in a
timely manner in order for it to be useful, the collections are never
ongoing--there is one request and collection per topic. Investigators
in the EPC Program will review the information and assess potential
risk of bias from both published and unpublished studies and its impact
on the EPC Program's findings.
This study is being conducted by AHRQ, pursuant to AHRQ's statutory
authority to conduct and support research on health care and on systems
for the delivery of such care, including activities with respect to the
quality, effectiveness, efficiency, appropriateness and value of health
care services. 42 U.S.C 299a(a)(1).
Method of Collection
To achieve the goals of this project the following data collections
will be implemented:
Online Submission Form Instrument. This information is
collected for the purposes of providing supplemental evidence and data
for systematic reviews (SEADS). The purpose of SEADS requests is not to
collect generalizable data, but to supplement the published and grey
literature searches EPC investigators are conducting. The online
submission form (OSF) collects data from respondents on their name and
the information packet. This happens following notification of
opportunity to submit via email listserv and/or Federal Register notice
as needed, with one request per topic. For the purposes of meta-
analyses, trial summary data from missing and unidentified studies are
sought. For the purposes of constructing evidence tables and quality
ratings (e.g., on public reporting of cost measures or health
information exchange), data can vary (e.g., URLs, study designs, and
consumer-mediated exchange forms). Submitters are informed of the types
of information that would be most helpful to include in the information
packet, which includes a list of all sponsored but unpublished studies
(both completed and ongoing), as well as comment on the completeness of
information provided.
The EPC Program currently uses a broad-based email announcement via
email listserv and a Federal Register notice, as needed, to publicize
the opportunity to submit scientific information about each topic. The
proposed project does not duplicate other available sources of this
information. Available study registries and databases may not
sufficiently inform the Program's research. The EPC Program does not
anticipate more than 15 topics per year with SEADS requests.
Estimated Annual Respondent Burden
Exhibit 1 presents estimates of the reporting burden hours for the
data collection efforts. Time estimates are based on pilot testing of
materials and what can reasonably be requested of respondents. The
number of respondents listed in ``Number of respondents per SEADS
request'' of Exhibit 1 reflects a projected 33% response rate with
approximately 1-2 responses per request and assumes about 15 SEADS
requests per year.
Exhibit 1--Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of SEADS
Number of SEADS request that Number of Annual number Hours per Total burden
Form name requests receive responses per of SEADS response hours per annum
response SEADS request responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Online Submission Form (OSF)...................... 15 5 1.5 7.5 15/60 1.87
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Total burden
Form name Number of hours per Average hourly Total cost
SEADS requests SEADS wage rate * burden
----------------------------------------------------------------------------------------------------------------
OSF............................................. 15 1.87 $61.39 \a\ $115.10
----------------------------------------------------------------------------------------------------------------
* Occupational Employment Statistics, May 2017 National Occupational Employment and Wage Estimates United
States, U.S. Department of Labor, Bureau of Labor Statistics. https://www.bls.gov/oes/current/oes_nat.htm#11-0000 0000.
\a\ Based on the mean wages for Public Relations and Fundraising Managers, 11-2031, the occupational group most
likely tasked with completing the OSF.
Request for Comments
In accordance with the Paperwork Reduction Act, comments on AHRQ's
information collection are requested with regard to any of the
following: (a) Whether the proposed collection of information is
necessary for the proper performance of AHRQ's health care research and
health care information dissemination functions, including whether the
information will have practical utility; (b) the accuracy of AHRQ's
estimate of burden (including hours and costs) of the proposed
collection(s) of information; (c) ways to enhance the quality, utility
and clarity of the information to be collected; and (d) ways to
minimize the burden of the collection of information upon the
respondents, including the use of
[[Page 12256]]
automated collection techniques or other forms of information
technology.
Comments submitted in response to this notice will be summarized
and included in the Agency's subsequent request for OMB approval of the
proposed information collection. All comments will become a matter of
public record.
Gopal Khanna,
Director.
[FR Doc. 2019-06192 Filed 3-29-19; 8:45 am]
BILLING CODE 4160-90-P
