and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Library of Medicine (NLM) |
|
Funding Opportunity Title |
NLM Advanced Informatics for Health (R01) |
Activity Code |
R01 Research Project Grant |
Announcement Type |
New |
Related Notices |
None |
Funding Opportunity Announcement (FOA) Number |
RFA-LM-11-002 |
Companion FOA |
None |
Catalog of Federal Domestic
Assistance (CFDA) Number(s) |
93.879 |
FOA Purpose |
This FOA solicits Research Project Grant (R01) applications from institutions/organizations proposing exceptionally innovative informatics research on novel hypotheses or difficult problems relating to complex health decisions. The NLM Advanced Informatics for Health grant program supports extremely novel, high impact research that is germane to the mission of the National Library of Medicine. This FOA is for support of new projects, not continuation of projects that have already been initiated. It does not support pilot projects, i.e., projects of limited scope that are designed primarily to generate data that will enable the PD/PI to seek other funding. Rather, it is anticipated that projects will begin and be completed during the funding period. |
Posted Date |
May 17, 2011 |
Open Date (Earliest Submission Date) |
June 25, 2011 |
Letter of Intent Due Date |
June 25, 2011 |
Application Due Date(s) |
July 25, 2011, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not applicable. |
Scientific Merit Review |
November 2011 |
Advisory Council Review |
January 2012 |
Earliest Start Date(s) |
April 1, 2012 |
Expiration Date |
July 26, 2011 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The purpose of the NLM Advanced Informatics for Health grant is to foster exceptionally innovative informatics research that, if successful, will have an unusually high impact on a problem in health or biomedical research.
The research topic for this funding opportunity announcement (FOA) relates to computational support for complex health decisions: NLM seeks innovative applications to strengthen and support patients' decisions in complex health areas by taking advantage of advances in computational search and analysis techniques. More specifically, it seeks applications to construct an intelligent computer program that offers health advice to a person about a complex health problem, based upon knowledge from (1) the person's computer-based health records and (2) knowledge sources in the public domain. The personal information may be drawn from a personal electronic health record maintained by the patient or from electronic medical records managed by a caregiver or hospital, or both. The intelligent computer program should be able to explain its reasoning and defend its conclusions to the patient, and state the certainty and reliability of its recommendations.
To encourage exceptionally innovative research, this FOA solicits applications from investigators who want to test novel, unconventional hypotheses or pursue major methodological or technical challenges. The potential impact of the proposed research must be substantial, in terms of both the size of the community affected and the magnitude of its impact on that community. The investigator should anticipate starting and completing the project during the term of the award, since this FOA is not for support of ongoing research or for pilot projects, and awards are not renewable. Only new grant applications will be accepted. If it is the hypothesis that is novel, the investigator should be able to prove or disprove that hypothesis by the end of the funding period. If it is the methodology or technology approach that is exceptionally innovative, the investigator should be able to develop and evaluate it by the end of the funding period or demonstrate conclusively that the approach is not feasible.
The rationale for this grant program is that for informatics advances to have significant impact in health and science, investigators must have opportunities to test unconventional, potentially paradigm-shifting hypotheses, and to use novel, innovative approaches to solve difficult technical and conceptual problems that severely impede progress in a field. Applications proposing such research require a different evaluation approach in comparison to more typical investigator-initiated R01 research grant applications, in which the emphasis tends to be more on the feasibility of the proposed research than on the strength of its innovation or potential broad impact
Several key features of the FOA have been designed to emphasize to applicants and peer reviewers that these applications are very different from conventional, investigator-initiated R01s. The application format, through its page limitations and requirements for explicitly addressing specific issues, focuses attention on the importance of the problem, the novelty of the hypothesis and/or the proposed approach and the magnitude of the potential impact rather than on experimental details. Reviewers will be instructed to emphasize significance and innovation in their evaluations. It is axiomatic that risk is inherent in highly innovative research. Accordingly, although reviewers will be asked to assess the logic of the experimental plan to determine whether the project has some (non-zero) likelihood of success, they will be reminded that risk is a hallmark of exceptionally innovative research and, in most cases, should not detract from the merit of an application. A PD/PI’s record of overcoming difficult scientific hurdles, appropriate to his/her career stage, may also be useful in assessing the likelihood of success, although the focus of this initiative is on the project rather than the investigator. These features are intended to steer applicants and reviewers, at each step of the process, toward the goals of the NLM Advanced Informatics for Health initiative, which are to solicit and fund unusually bold and potentially transformative research.
It is anticipated that the NLM Advanced Informatics for Health grant projects will begin and be completed during the funding period. Contingent on the availability of grant funds, NLM is planning to issue one NLM Advanced Informatics for Health FOA each fiscal year (FY), with a single receipt date. Each FOA will pose a problem in health or biology for which there is no current widely-adopted informatics solution. The specific problem posed in the NLM Advanced Informatics for Health FOA for each FY may be different from the problem posed for other FYs.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Funding Instrument |
Grant |
Application Types Allowed |
New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. NLM intends to commit $1,000,000 in FY 2012 to fund 3 awards. Future year amounts will depend on annual appropriations. |
Award Budget |
Support may be requested for up to $1,000,000 in direct costs (excluding consortium Facilities and Administrative [F&A] costs) over a four-year period, prorated for shorter terms ($750,000 for three years, $500,000 for two years). Regardless of the term of support, direct costs (excluding consortium F&A costs) may not exceed $250,000 in any one year. |
Award Project Period |
Applicants may request up to 4 years for the project period |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions:
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For profit Organizations
Governments
Other
Foreign (non-U.S.) components of U.S. Organizations are allowed.
Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.
All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.
All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least four (4) weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple
Program Director/Principal Investigator Policy and submission details in the Senior/Key
Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
NLM encourages participation in informatics research by engineers, computer scientists, information scientists, social & behavioral scientists and others not traditionally involved in biomedical research.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications are not permitted in response to this FOA.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity
The letter of intent should be sent by electronic mail to:
Arthur Petrosian, Ph.D.
Extramural Programs
National Library of Medicine
6705 Rockledge Drive, Suite 301
Bethesda, MD 20892
Telephone: (301) 496-4253
Email: [email protected]
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
In the Research Strategy section, within the page limit, the applicant should address the following six points, using headings that correspond to each of the six points, as listed below (e.g., the heading for the response to point 1 should be The Challenge ). Applications will be evaluated by review panels that represent a diversity of scientific interests. Therefore, jargon must be avoided. Explain the challenge, the potential impact, and the approach in language that scientists in other fields can understand.
1. The Challenge: What is the hypothesis or problem that will be addressed? If you are testing an unconventional, exceptionally novel hypothesis, how does it challenge the standard paradigm? If you are addressing a technological or methodological problem, what makes the problem especially challenging?
2. The Potential Impact: Why is testing the hypothesis or solving the problem important? How broad is the potential impact? Which community will be affected? What is the size of that community? Will the potential impact on that community be major or incremental?
3. The Approach: How will you attempt to verify the novel hypothesis, or solve the problem? Provide enough information so that reviewers can determine what, in general, you are proposing to do, but do not include a detailed experimental plan. If it is your methodology that is novel, what is unconventional and exceptionally innovative about your approach? How does your approach differ from what other investigators have attempted to do?
4. The Appropriateness of FOA: Why is the proposed research uniquely suited to the stated goals of the NLM Advanced Informatics for Health initiative, rather than a conventional research grant application? How does the proposed research differ from what you are already funded to do?
5. The Likelihood of Success: Briefly describe the past achievements that best illustrate your exceptional innovativeness, your ability to make paradigm-shifting discoveries or solve very difficult problems, and the impact of your past discoveries or solutions. The achievements that you highlight need not be conceptually related to the hypothesis or problem that you are addressing in this application. If your previous research was not unusually innovative, and you have not yet made a paradigm-shifting discovery or solved a very difficult problem, which aspect of the logic of the experimental approach suggests that there is some probability that the proposed research will be successful?
6. Timeline: Provide a timeline for the proposed research. To facilitate evaluation of progress reports, indicate when you anticipate that essential components of the project (e.g., optimization of protocols, critical experiments to verify the hypothesis, validation of novel tools or techniques) will be completed.
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide
Appendix
Appendix is not allowed for this FOA.
Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important
reminders:
All PD/PIs must include their eRA Commons ID in the Credential
field of the Senior/Key Person Profile Component of the SF 424(R&R) Application
Package. Failure to register in the Commons and to include a valid PD/PI
Commons ID in the credential field will prevent the successful submission of an
electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH and responsiveness by NLM, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115, but note for this FOA that no updates will be accepted.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? How important is it for the community to address the problem or test the hypothesis? If the effort is successful, how broad a community will be affected?
Investigator(s)
Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? How innovative or novel is the hypothesis or methodology? Is it significantly different from conventional hypotheses or methodologies?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable
Renewals
Not Applicable
Revisions
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s)convened by NLM , in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NLM Board of Regents. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS,
CCR Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
Not Applicable.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
eRA Commons Help Desk(Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]
Dr. Jane Ye
NLM Extramural Programs
6705 Rockledge Drive
Rockledge 1, Suite 301
Bethesda, MD 20892-
Telephone: (301) 594-4882
Fax: (301) 402-2952
Email: [email protected]
Dr. Arthur Petrosian
NLM Extramural Programs
6705 Rockledge Drive
Rockledge 1, Suite 301
Bethesda, MD 20892-
Telephone: (301) 594-4933
Fax: (301) 402-2952
Email: [email protected]
Mr. Dwight Mowery
NLM Extramural Programs
6705 Rockledge Drive
Rockledge 1, Suite 301
Bethesda, MD 20892-
Telephone: (301) 496-4221
Fax: (301) 402-0421
Email:[email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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