80 FR 57187 - Announcement of Requirements and Registration for Healthcare Associated Venous Thromboembolism Prevention Challenge
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 80, Issue 183 (September 22, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 183 (September 22, 2015)
| Page Range | 57187-57189 | |
| FR Document | 2015-23990 |
[Federal Register Volume 80, Number 183 (Tuesday, September 22, 2015)] [Notices] [Pages 57187-57189] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-23990] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Announcement of Requirements and Registration for Healthcare Associated Venous Thromboembolism Prevention Challenge Authority: 15 U.S.C. 3719 AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). Award Approving Official: Thomas R. Frieden, MD, MPH, Director, Centers for Disease Control and Prevention, and Administrator, Agency for Toxic Substances and Disease Registry. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces the launch of the Healthcare Associated Venous Thromboembolism (HA-VTE) Prevention Challenge on November 2, 2015. The challenge will be open until January 10, 2016. Venous thromboembolism (VTE), blood clots occurring as deep vein thrombosis (DVT), pulmonary embolism (PE), or both, is an important and growing public health issue. Prevention of healthcare associated VTE (HA-VTE) is a national hospital safety priority. Many HA-VTEs can be prevented, but VTE prevention strategies and are still not being applied regularly or effectively across the United States. To support and promote HA-VTE prevention, HHS/CDC is announcing the 2015 HA-VTE Prevention Challenge. The challenge will bring prestige to organizations that invest in VTE prevention, improve understanding of successful implementation strategies at the health system level, and motivate health systems to strengthen their VTE prevention efforts. The top-judged organizations found to have implemented innovative and effective VTE prevention strategies will be recognized as HA-VTE Prevention Champions. HHS/CDC will document these successful strategies and highlight the systems, processes, and staffing that contributed to exceptional VTE prevention outcomes achieved by Champions. Champions will receive a cash prize (if eligible) and other forms of recognition. DATES: Contest begins on November 2, 2015 and ends on January 10, 2016. FOR FURTHER INFORMATION CONTACT: Michele Beckman, Division of Blood Disorders, National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, 1600 Clifton Road NE., Mailstop E-64, Atlanta, GA 30329, Telephone: 404-498-6474, Fax: 404-498-6799, Attention: HA-VTE Prevention Challenge, Email: havtechallenge@cdc.gov. SUPPLEMENTARY INFORMATION: The challenge is authorized by Public Law 111-358, the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education and Science Reauthorization Act of 2010 (COMPETES Act). Subject of Challenge Competition Entrants of the HA-VTE Prevention Challenge will be asked to describe the VTE prevention strategy and reasons that support the strategy choice developed by their organization. In addition, entrants will be asked to describe the specific intervention(s) (e.g. implementation of VTE protocols and order sets, risk assessment, electronic alerts, clinical decision support tools, performance monitoring systems and dashboards, patient and/or provider education and awareness, post-discharge follow-up, etc.), methods, and systems used to implement, support and evaluate the strategy. Entrants will be asked to submit at least one quantitative measure showing an increase of VTE prevention (e.g. number of patients assessed for VTE risk, number of at risk patients receiving appropriate VTE prevention, number of patients and/or providers receiving education on VTE prevention, etc.) and/or decrease in HA-VTE rates for the organization's population of interest. Each measure submitted must include two data points: One for the control or pre-intervention period and a second for the post- intervention period. Control/pre-intervention and post-intervention measures must cover a period of at least six months. This information collection is approved by the Office of Management and Budget under OMB Control Number 0990-0390, expiration April 30, 2018. Eligibility Rules for Participating in the Competition To be eligible to win a monetary prize under this challenge, an individual or entity-- (1) Shall have completed and submitted the nomination form in its entirety to participate in the competition under the rules promulgated by HHS/CDC; (2) Must be a hospital, multi-hospital system, hospital network or managed care organization, incorporated in and maintaining a primary place of business in the United States that provides inpatient medical care for patients. (3) May not be a Federal entity or Federal employee acting within the scope of their employment (Federal entities or employees are eligible to participate in the challenge; however, they are not eligible to receive a monetary prize. Federal entities are eligible for non-monetary recognition only.); (4) Shall not be an HHS employee working on their applications or submissions during assigned duty hours; (5) Shall not be an employee or contractor at HHS/CDC; (6) Federal grantees may not use Federal funds to develop COMPETES Act challenge applications unless consistent with the purpose of their grant award. (7) Federal contractors may not use Federal funds from a contract to develop COMPETES Act challenge applications or to fund efforts in support of a COMPETES Act challenge submission; (8) Must agree to participate in a data validation process to be conducted by an HHS/CDC-selected contractor. To the extent applicable law allows, data will be kept confidential by the contractor and will be shared with the CDC in aggregate form only; i.e., the VTE prevention coverage rate for the practice not individual data; (9) Must have a data management system (electronic or paper) that allows HHS/CDC or their contractor to check data submitted; (10) Individual nominees and individuals in a group practice must be free from convictions or pending investigations of criminal and health care fraud offenses such as felony health care fraud, patient abuse or neglect; felony convictions for other healthcare-related fraud, theft, or other financial misconduct; and felony convictions relating to unlawful manufacture, distribution, prescription, or dispensing of controlled substances as verified through the Office of the Inspector General List of Excluded Individuals [[Page 57188]] and Entities. http://oig.hhs.gov/exclusions/background.asp Individual nominees must be free from serious sanctions, such as those for misuse or mis-prescribing of prescription medications. Such serious sanctions will be determined at the discretion of the agency consistent with CDC's public health mission. HHS/CDC's contractor may perform background checks on individual clinicians or medical practices. (11) Health systems must have a written policy in place that conducts periodic background checks as described in (10) on all providers and takes appropriate action accordingly. In addition, a health system background check may be conducted, as deemed necessary, by HHS/CDC or an HHS/CDC contractor that includes a search for The Joint Commission sanctions and current investigations for serious institutional misconduct (e.g., attorney general investigation). HHS/ CDC's contractor may also request the policy and any supporting information deemed necessary. (12) Must agree to accept the monetary prize and be recognized if selected, and agree to participate in an interview to develop a success story that describes the systems and processes that support VTE prevention. Champions will be recognized on HHS/CDC Web sites. Strategies used by Champions that support VTE prevention may be written into a success story, placed on HHS/CDC Web sites, and attributed to Champions. An individual or entity shall not be deemed ineligible because the individual or entity used Federal facilities or consulted with Federal employees during a competition if the facilities and employees are made available to all individuals and entities participating in the competition on an equal basis. By participating in this challenge, an individual or organization agrees to assume any and all risks related to participating in the challenge. Individuals or organizations also agree to waive claims against the Federal Government and its related entities, except in the case of willful misconduct, when participating in the challenge, including claims for injury; death; damage; or loss of property, money, or profits, and including those risks caused by negligence or other causes. By participating in this challenge, individuals or organizations agree to protect the Federal Government against third party claims for damages arising from or related to challenge activities. Entrants who are a U.S. federal hospital, multi-hospital system, hospital network or managed care organization that provides inpatient medical care for patients may apply for non-monetary recognition. No monetary prize will be awarded. Entrants who are an international hospital, multi-hospital system, hospital network or managed care organization that provides inpatient medical care for patients may apply for non-monetary recognition. No monetary prize will be awarded. Registration Process for Participants To participate, interested parties will navigate to www.challenge.gov. On this site, nominees will have access to the nomination form. Information required of the nominees on the nomination form includes:The organization name, address, and contact information of the nominee. The size, scope, and general demographic characteristics of the nominees' patient population. Details regarding the nominee's VTE prevention strategy and implementation including the population(s) observed, intervention, and methods of implementation. Examples of strategies include implementation of sustainable systems or processes that support VTE prevention. These may include but are not limited to implementation of VTE protocols and order sets, risk assessment, electronic alerts, clinical decision support tools, performance monitoring systems and dashboards, patient and/or provider education and post-discharge follow-up. A description of the observed results of the VTE prevention strategy including the pre-implementation and post- implementation measures for the observed VTE prevention activity. Examples of outcome measures include but are not limited to the number of patients assessed for VTE risk, the number of at risk patients receiving appropriate VTE prevention, and the number of patients and/or providers receiving education on VTE prevention. A brief summary of the barriers and successes to implementation. The VTE prevention rates achieved should be for the organizations entire patient population observed as outlined in their strategy and intervention methods, not limited to a sample. Data on subpopulations is allowed, but must be inclusive of all patients seen during the stated time period of study. Examples of ineligible data submissions include VTE prevention interventions limited to treatment cohorts from clinical trials of novel anticoagulant drugs. The estimated burden for completing the nomination form is 30 minutes to 1 hour. Amount of the Monetary Prize An estimated 7 of highest scoring U.S. hospitals, multi-hospital systems, hospital networks and managed care organizations will be recognized as HA-VTE Prevention Champions and will receive a cash award of $10,000. A maximum of $70,000 will be awarded in this challenge. Additional honorable mention awards, pending availability of funds, may be made if the judges identify more than 7 deserving entries. Federal and international winners will receive non-monetary recognition but no prize. Payment of the Monetary Prize Monetary prizes awarded under this challenge will be paid by electronic funds transfer and may be subject to Federal income taxes. HHS will comply with the Internal Revenue Service withholding and reporting requirements, where applicable. Basis Upon Which Winner Will Be Selected Challenge submissions will be evaluated by a panel of three to five judges (CDC, HHS agencies such as the Agency for Healthcare Research and Quality and the Centers for Medicare and Medicaid Services, and external industry experts) using the information provided on, and in accordance with, the nomination form. The judges will score the nomination form using a rubric based on the following evaluation criteria: methods (30% of score); results (50% of score); and feasibility/utility (20% of score) of the strategy and interventions associated with the intended outcome of interest. Nominees with the highest score will be required to participate in a process to verify their data. Final selection will take into account all the information form the nomination form, the background check, and data verification. Geographic location and population treated may be used to break any ties in the event of tie scores at any point in the selection process. An estimated 7 organizations will be recognized as prize winners. Some Champions will participate in a post-challenge telephone interview. The interview will include questions about the strategies employed by the organization to achieve high rates of VTE prevention, including barriers and facilitators for those strategies. The interview will focus on systems and processes and should not require preparation time by the Champion. The estimated time for the interview is one [[Page 57189]] hour, which includes time to review the interview protocol with the interviewer, respond to the interview questions, and review a summary report about the Champion's practices. The summary will be written as a success story and will be posted on the CDC Web site. Additional Information Information received from nominees will be stored in a password protected file on a secure server. The challenge Web site may post the number of nominations received but will not include information about individual nominees. The database of information submitted by nominees will not be posted on the Web site. Personal information collected and stored from nominees will only include general details, such as the organization name, address, and contact information of the nominee. This type of information is generally publically available. The nomination form and submission will collect and store only aggregate clinical data through the nomination process; no individual identifiable patient data will be collected or stored. Confidential or propriety data, clearly marked as such, will be secured to the full extent allowable by law. Information for selected Champions, such as the hospital or health system's name, location, VTE prevention outcomes, and practices that support HA-VTE prevention will be shared through press releases, the challenge Web site, social media, and other HHS/CDC resources. Summary data on the types of systems and processes used to increase VTE prevention will be shared in documents or other communication products that describe generally used practices for successful VTE prevention. HHS/CDC will use the summary data only as described. Compliance With Rules and Contacting Contest Winners Finalists must comply with all terms and conditions of these official rules, and winning is contingent upon fulfilling all requirements herein. The finalists will be notified by email, telephone, or mail after the date of judging. Privacy Personal information provided by entrants on the nomination form through the challenge Web site will be used to contact selected finalists. Information is not collected for commercial marketing. Winners are permitted to cite that they won this challenge. The names, cities, and states of selected Champions will be made available in HHS/CDC's educational materials on VTE prevention and at recognition events. General Conditions HHS/CDC reserves the right to cancel suspend, and/or modify the challenge, or any part of it, for any reason, as HHS/CDC's sole discretion. Dated: September 15, 2015. Sandra Cashman, Acting Director, Division of the Executive Secretariat, Office of the Chief of Staff, Centers for Disease Control and Prevention. [FR Doc. 2015-23990 Filed 9-21-15; 8:45 am] BILLING CODE 4163-18-P
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Leroy A. Richardson, contributed to exceptional VTE Eligibility Rules for Participating in the
Chief, Information Collection Review Office, prevention outcomes achieved by Competition
Office of Scientific Integrity, Office of the Champions. Champions will receive a
Associate Director for Science, Office of the
To be eligible to win a monetary prize
cash prize (if eligible) and other forms under this challenge, an individual or
Director, Centers for Disease Control and
Prevention.
of recognition. entity—
[FR Doc. 2015–24030 Filed 9–21–15; 8:45 am] DATES: Contest begins on November 2, (1) Shall have completed and
BILLING CODE 4163–18–P 2015 and ends on January 10, 2016. submitted the nomination form in its
entirety to participate in the
FOR FURTHER INFORMATION CONTACT: competition under the rules
DEPARTMENT OF HEALTH AND Michele Beckman, Division of Blood promulgated by HHS/CDC;
HUMAN SERVICES Disorders, National Center on Birth (2) Must be a hospital, multi-hospital
Defects and Developmental Disabilities, system, hospital network or managed
Centers for Disease Control and Centers for Disease Control and care organization, incorporated in and
Prevention Prevention, 1600 Clifton Road NE., maintaining a primary place of business
Mailstop E–64, Atlanta, GA 30329, in the United States that provides
Announcement of Requirements and Telephone: 404–498–6474, Fax: 404– inpatient medical care for patients.
Registration for Healthcare Associated 498–6799, Attention: HA–VTE (3) May not be a Federal entity or
Venous Thromboembolism Prevention Prevention Challenge, Email: Federal employee acting within the
Challenge havtechallenge@cdc.gov. scope of their employment (Federal
entities or employees are eligible to
Authority: 15 U.S.C. 3719 SUPPLEMENTARY INFORMATION: The participate in the challenge; however,
AGENCY: Centers for Disease Control and challenge is authorized by Public Law they are not eligible to receive a
Prevention (CDC), Department of Health 111–358, the America Creating monetary prize. Federal entities are
and Human Services (HHS). Opportunities to Meaningfully Promote eligible for non-monetary recognition
Award Approving Official: Thomas R. Excellence in Technology, Education only.);
Frieden, MD, MPH, Director, Centers for and Science Reauthorization Act of (4) Shall not be an HHS employee
Disease Control and Prevention, and 2010 (COMPETES Act). working on their applications or
Administrator, Agency for Toxic submissions during assigned duty
Subject of Challenge Competition hours;
Substances and Disease Registry.
ACTION: Notice. Entrants of the HA–VTE Prevention (5) Shall not be an employee or
Challenge will be asked to describe the contractor at HHS/CDC;
SUMMARY: The Centers for Disease (6) Federal grantees may not use
VTE prevention strategy and reasons
Control and Prevention (CDC) located Federal funds to develop COMPETES
that support the strategy choice
within the Department of Health and Act challenge applications unless
developed by their organization. In consistent with the purpose of their
Human Services (HHS) announces the
launch of the Healthcare Associated addition, entrants will be asked to grant award.
Venous Thromboembolism (HA–VTE) describe the specific intervention(s) (e.g. (7) Federal contractors may not use
Prevention Challenge on November 2, implementation of VTE protocols and Federal funds from a contract to develop
2015. The challenge will be open until order sets, risk assessment, electronic COMPETES Act challenge applications
January 10, 2016. alerts, clinical decision support tools, or to fund efforts in support of a
Venous thromboembolism (VTE), performance monitoring systems and COMPETES Act challenge submission;
blood clots occurring as deep vein dashboards, patient and/or provider (8) Must agree to participate in a data
thrombosis (DVT), pulmonary embolism education and awareness, post- validation process to be conducted by
(PE), or both, is an important and discharge follow-up, etc.), methods, and an HHS/CDC-selected contractor. To the
growing public health issue. Prevention systems used to implement, support and extent applicable law allows, data will
of healthcare associated VTE (HA–VTE) evaluate the strategy. Entrants will be be kept confidential by the contractor
is a national hospital safety priority. asked to submit at least one quantitative and will be shared with the CDC in
Many HA–VTEs can be prevented, but measure showing an increase of VTE aggregate form only; i.e., the VTE
VTE prevention strategies and are still prevention (e.g. number of patients prevention coverage rate for the practice
not being applied regularly or assessed for VTE risk, number of at risk not individual data;
effectively across the United States. patients receiving appropriate VTE (9) Must have a data management
To support and promote HA–VTE prevention, number of patients and/or system (electronic or paper) that allows
prevention, HHS/CDC is announcing the providers receiving education on VTE HHS/CDC or their contractor to check
2015 HA–VTE Prevention Challenge. prevention, etc.) and/or decrease in HA– data submitted;
The challenge will bring prestige to (10) Individual nominees and
VTE rates for the organization’s
organizations that invest in VTE individuals in a group practice must be
population of interest. Each measure
prevention, improve understanding of free from convictions or pending
successful implementation strategies at submitted must include two data points:
investigations of criminal and health
the health system level, and motivate One for the control or pre-intervention care fraud offenses such as felony health
health systems to strengthen their VTE period and a second for the post- care fraud, patient abuse or neglect;
prevention efforts. The top-judged intervention period. Control/pre- felony convictions for other healthcare-
intervention and post-intervention
tkelley on DSK3SPTVN1PROD with NOTICES
organizations found to have related fraud, theft, or other financial
implemented innovative and effective measures must cover a period of at least misconduct; and felony convictions
VTE prevention strategies will be six months. This information collection relating to unlawful manufacture,
recognized as HA–VTE Prevention is approved by the Office of distribution, prescription, or dispensing
Champions. HHS/CDC will document Management and Budget under OMB of controlled substances as verified
these successful strategies and highlight Control Number 0990–0390, expiration through the Office of the Inspector
the systems, processes, and staffing that April 30, 2018. General List of Excluded Individuals
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![Federal Register / Vol. 80, No. 183 / Tuesday, September 22, 2015 / Notices 57189
hour, which includes time to review the available in HHS/CDC’s educational occupational respiratory disease and
interview protocol with the interviewer, materials on VTE prevention and at optimizing workers’ respiratory health;
respond to the interview questions, and recognition events. (3) upon request, conducts hazard
review a summary report about the evaluations and provides technical
General Conditions
Champion’s practices. The summary assistance to address challenges,
will be written as a success story and HHS/CDC reserves the right to cancel including emerging issues, in
will be posted on the CDC Web site. suspend, and/or modify the challenge, occupational respiratory disease; (4)
or any part of it, for any reason, as HHS/ plans, designs, and conducts a national
Additional Information CDC’s sole discretion. surveillance program for occupational
Information received from nominees Dated: September 15, 2015. and work-related respiratory disease; (5)
will be stored in a password protected communicates study findings to prevent
Sandra Cashman,
file on a secure server. The challenge occupational respiratory disease and
Acting Director, Division of the Executive
Web site may post the number of optimize workers’ respiratory health,
Secretariat, Office of the Chief of Staff,
nominations received but will not Centers for Disease Control and Prevention. and evaluates the effectiveness of these
include information about individual communications; (6) administers a
[FR Doc. 2015–23990 Filed 9–21–15; 8:45 am]
nominees. The database of information program of legislatively mandated
BILLING CODE 4163–18–P
submitted by nominees will not be medical monitoring services for coal
posted on the Web site. Personal miners under the Federal Mine Safety
information collected and stored from DEPARTMENT OF HEALTH AND and Health Act of 1977; and (7) provides
nominees will only include general HUMAN SERVICES rewarding educational and training
details, such as the organization name, opportunities in occupational and work-
address, and contact information of the Centers for Disease Control and related respiratory disease prevention to
nominee. This type of information is Prevention visiting scientists, Epidemiologic
generally publically available. The Investigations Service Officers, fellows,
nomination form and submission will Statement of Organization, Functions, residents, interns, students and others
collect and store only aggregate clinical and Delegations of Authority through a variety of temporary
data through the nomination process; no assignments in various Division
individual identifiable patient data will Part C (Centers for Disease Control
and Prevention) of the Statement of activities.
be collected or stored. Confidential or Office of the Director (CCH1). Directs
propriety data, clearly marked as such, Organization, Functions, and
Delegations of Authority of the and manages the operations of the
will be secured to the full extent Respiratory Health Division.
allowable by law. Department of Health and Human
Services (45 FR 67772–76, dated Field Studies Branch (CCHB). (1)
Information for selected Champions,
October 14, 1980, and corrected at 45 FR Plans, designs, and conducts short- and
such as the hospital or health system’s
69296, October 20, 1980, as amended long-term field investigations relevant to
name, location, VTE prevention
most recently at 80 FR 34643–34644, preventing occupational respiratory
outcomes, and practices that support
dated June 6, 2015) is amended to diseases and optimizing workers’
HA–VTE prevention will be shared
reflect the reorganization of the National respiratory health; (2) responds to
through press releases, the challenge
Institute for Occupational Safety and requests for health hazard evaluations
Web site, social media, and other HHS/
Health, Centers for Disease Control and and technical assistance relevant to
CDC resources. Summary data on the
Prevention. occupational respiratory disease; (3)
types of systems and processes used to
Section C–B, Organization and conducts morbidity and mortality
increase VTE prevention will be shared
Functions, is hereby amended as studies relating to occupational
in documents or other communication
follows: respiratory diseases in selected worker
products that describe generally used
Delete in its entirety the title and populations and the general population
practices for successful VTE prevention.
function statements for the Division of in order to identify causal agents and
HHS/CDC will use the summary data
Respiratory Disease Studies (CCH) and other risk factors, quantify exposure
only as described.
insert the following: effect relationships, and evaluate
Compliance With Rules and Contacting Respiratory Health Division (CCH). prevalence and severity of specific
Contest Winners The Respiratory Health Division (RHD) respiratory diseases; (4) conducts
Finalists must comply with all terms seeks to advance protection against environmental studies, medical test
and conditions of these official rules, work-related hazards and exposures that evaluations, industrial hygiene research,
and winning is contingent upon cause or contribute to respiratory laboratory research, demonstrations of
fulfilling all requirements herein. The illness, injury, and death and to workplace exposures and controls, and
finalists will be notified by email, promote workplace-based interventions studies the challenges created by new
telephone, or mail after the date of that improve respiratory health. To technologies; (5) provides statistical
judging. accomplish its mission, the Division design and implements data analysis
gathers and synthesizes information, and verification for Division research
Privacy makes recommendations, and delivers projects; and (6) develops and evaluates
Personal information provided by products and services to a range of research methods of data collection,
entrants on the nomination form stakeholders, including partners able to processing, and statistical analysis that
through the challenge Web site will be effect prevention. Specifically, RHD: (1) are relevant to the Division mission,
tkelley on DSK3SPTVN1PROD with NOTICES
used to contact selected finalists. Prevents work-related respiratory including medical tests, sampling
Information is not collected for disease and improves workers’ approaches and equipment, sample
commercial marketing. Winners are respiratory health by generating new analyses, exposure and dose assessment
permitted to cite that they won this knowledge and transferring that and modeling (including dermal
challenge. knowledge into practice; (2) plans, exposure), bioavailability of exposures,
The names, cities, and states of designs, and conducts a national biomarkers of exposure and health
selected Champions will be made research program relevant to preventing effects, and protective measures.
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Document Created: 2015-12-15 09:35:29
Document Modified: 2015-12-15 09:35:29
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Contest begins on November 2, 2015 and ends on January 10, 2016. | |
| Contact | Michele Beckman, Division of Blood Disorders, National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, 1600 Clifton Road NE., Mailstop E-64, Atlanta, GA 30329, Telephone: 404-498-6474, Fax: 404-498-6799, Attention: HA-VTE Prevention Challenge, Email: [email protected] | |
| FR Citation | 80 FR 57187 |
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