EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Center for Complementary and Alternative Medicine
(NCCAM) |
|
Funding Opportunity Title |
Translational Tools for Clinical Studies of Mind/Body and Manual Therapy CAM Interventions (R01) |
Activity Code |
R01 Research Project Grant |
Announcement Type |
Reissue of RFA-AT-10-001 |
Related Notices |
None |
Funding Opportunity Announcement (FOA) Number |
RFA-AT-11-003 |
Companion FOA |
None |
Catalog of Federal Domestics Assistance (CFDA) Number(s) |
93.213 |
FOA Purpose |
This Funding Opportunity Announcement (FOA) issued by the National Center for Complementary and Alternative Medicine (NCCAM) of the National Institutes of Health (NIH) encourages investigator(s)-initiated applications that propose to develop, enhance, and validate translational tools to facilitate rigorous study of complementary/alternative medicine (CAM) approaches that are in wide use by the public. Data from the most recent National Health Interview Survey [http://www.cdc.gov/nchs/nhis.htm] establish that Americans are utilizing CAM approaches to promote health and well-being, to treat or prevent disease, and for symptom relief. CAM approaches being widely used include manual therapies, meditation, and yoga with chronic pain, back pain and musculoskeletal pain being the most commonly cited reasons for their use. This FOA focuses on encouraging the development of improved research methodology to study safety, efficacy, and clinical effectiveness of mind-body interventions (such as meditation), manual therapies (such as spinal manipulation or massage), and/or yoga therapy. Investigations of other CAM interventions (including natural products, dietary supplements, acupuncture or traditional Chinese medicine) are not allowed for this FOA. |
Posted Date |
November 16, 2010 |
Open Date (Earliest Submission Date) |
March 29, 2011 |
Letter of Intent Due Date |
March 29, 2011 |
Application Due Date(s) |
April 29, 2011, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
July 2011 |
Advisory Council Review |
August 2011 |
Earliest Start Date(s) |
September 2011 |
Expiration Date |
April 30, 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
This Funding Opportunity Announcement (FOA) issued by the National Center for Complementary and Alternative Medicine (NCCAM) of the National Institutes of Health (NIH) encourages investigator(s)-initiated applications that propose to develop, enhance, and/or validate Translational Tools to facilitate rigorous study of complementary/alternative medicine (CAM) interventions that are in wide use by the public. Data from the most recent National Health Interview Survey (NHIS) [http://www.cdc.gov/nchs/data/nhsr/nhsr012.pdf] continue to show that large numbers of Americans are utilizing CAM to promote health and well-being, and to treat chronic health problems. Specifically, adults used CAM most often to treat pain including back and/or neck pain, joint pain or stiffness, arthritis pain, and other painful musculoskeletal conditions. CAM approaches being widely used include manipulative therapies, massage therapy, meditation and yoga. Compared to results from the 2002 NHIS, there has been a significant increase in the use of controlled breathing, meditation, massage therapy, and yoga.
Rigorous study of all clinical interventions requires well-established methodology that has undergone careful preliminary assessment and feasibility testing. Large, multi-site clinical studies are considered an essential component of the evidence base for clinical efficacy or effectiveness, but in order to implement such studies, detailed treatment algorithms need to be developed that can be subjected to rigorous efficacy testing. Methods need to be in place to ensure consistent protocol implementation and minimize practitioner variability. In addition, well-characterized outcome measures are needed that will accurately assess the impact of interventions on patient well-being and wellness.
This FOA focuses on the development of improved research methodology (i.e., translational tools) utilized to study safety, efficacy, and effectiveness of the following CAM modalities, which have been identified as currently high priority for NCCAM: mind-body interventions (e.g., meditation), manual therapies (e.g., spinal manipulation), and/or yoga therapy. Mind-body interventions focus on the interactions among the brain, mind, body, and behavior, with the intent to use the mind to affect physical functioning and promote health. Examples of CAM mind-body interventions include: meditation, deep-breathing exercises, guided imagery, hypnotherapy, progressive relaxation, internal qi gong, and tai chi. CAM manual therapies include spinal manipulation, joint manipulation, and massage. There are many systems/styles of Yoga Therapy but all include both postures (asanas) and meditation/breathing/relaxation. Prior versions of this FOA have resulted in a number of awards in other specific CAM therapies. Hence, applications proposing research on other CAM therapies (including natural products, dietary supplements, acupuncture and Traditional Chinese Medicine) will be considered non-responsive to the FOA and administratively withdrawn and not reviewed or considered for funding. Investigators are strongly encouraged to contact the Program Officer in the early stage of developing their application to determine whether their proposal would be considered appropriate for this FOA.
Study of many CAM interventions pose a number of special challenges, as highlighted in the July 2008 Meditation for Health Purposes Workshop (http://nccam.nih.gov/news/pastmeetings/meditation08/summary.htm). Practitioners frequently use highly variable approaches, and indeed the personalization of treatment may be a fundamental aspect of the intervention. For some interventions, the subjective experience of the patient may be an important component of the treatment effect; hence masking (aka "blinding") of subjects may not always be feasible or appropriate, but the identification of appropriate controls or comparison groups is nonetheless critical. Standardized treatment algorithms and manualization approaches (see Wilson GT, Behav Res Ther, 1996) have recently begun to be utilized in developing more rigorous methods for conducting CAM clinical trials (see Schnyer & Allen, J Alt Comp Med, 2002 and Schnyer et al., J Alt Comp Med, 2008). Such algorithms enable the study of individualized approaches within reasonable constraints that facilitate the conduct of a well-designed and interpretable clinical trial.
The extent of patient adherence can be an important variable for some interventions, and methods to assess adherence, which pragmatically affects the dose of the intervention, could be of great utility. There is also a critical need for a more systematic approach to measurement of subjective outcomes, for example perceived psychological stress, that are of particular relevance to these CAM interventions. In addition, there is need for the identification and validation of biological measures (i.e., biomarkers) that would provide objective correlates of improvement or suggest mechanisms for health benefits.
Improvement in such translational tools for CAM clinical research will potentially increase the quality and consistency of clinical trials in CAM and ultimately elucidate new understanding of the clinical utility and applicability of CAM interventions. It is anticipated that many types of studies may be appropriate for the development and validation of translational tools, including ancillary collections of new data in on-going clinical studies, psychometric investigations, and primary development and/or validation studies. The NIH definition of translational research is as follows: Translational research includes two areas of translation. One is the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans. The second area of translation concerns research aimed at enhancing the adoption of best practices in the community. This FOA focuses on the first area of translational research, which is sometimes called T1 , rather than the second area of translational research, which is sometimes called T2 .
Multidisciplinary studies and collaboration among investigators with expertise in appropriate disciplines are encouraged. When investigators are at different institutions, individual R01 applications may include consortium arrangements.
Collaborative arrangements with ongoing studies that provide patient populations, specimens, and data may be particularly relevant for the purposes of this FOA. Such arrangements should be clearly delineated in the application.
Examples of Translational Tools research topics in the areas of mind-body, manual therapies, and/or yoga include, but are not limited to, the following:
This FOA is not to be used for randomized controlled trials of efficacy or effectiveness for these CAM interventions, and applications that do propose such trials will be considered non-responsive. Applications proposing research on other CAM therapies (including natural products, dietary supplements, acupuncture and Traditional Chinese Medicine) will be considered non-responsive to the FOA and administratively withdrawn and not reviewed or considered for funding.
Funding Instrument |
Grant |
Application Types Allowed |
New Only Revisions and Resubmissions to previous versions of this FOA are acceptable. The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
NCCAM intends to commit an estimated total of $3 million per year to support up to 5 new grants. |
Award Budget |
Up to $300,000 (direct costs) per year. |
Award Project Period |
Scope of the proposed project should determine the project period. The maximum period is 5 years. |
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 Project 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.
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 may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
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.
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.
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
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide
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 and responsiveness by NCCAM, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
Nonresponsive applications include those that meet any of the following:
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115
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 will the described research improve the design and conduct of future randomized controlled trials or other large scale clinical research of CAM interventions?
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? Do they have appropriate expertise in complementary and alternative medicine (CAM)?
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?
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? How will the proposed translational tools improve the measurement of important and relevant outcomes
of CAM interventions, document clinical effects of such interventions, enhance
the comparability and generalizability of CAM interventions, and/or facilitate
rigorous study of CAM practices?
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? Do(es) the institution(s) have a history of successful investigations in CAM research?
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
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
Not applicable
Revisions
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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 NCCAM (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.
As part of the scientific peer review, all applications will:
Applications will be assigned to the appropriate NIH Institute or Center. 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 NCCAM National Advisory Council . 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]
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process, finding NIH grant resources)
Telephone 301-710-0267
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registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]
Partap S. Khalsa, DC, PhD, DABCO
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-594-3462
Email: [email protected]
Dale Birkle Dreer, PhD
National Center for Complementary and Alternative Medicine
(NCCAM)
Telephone: 301-594-2014
Email: [email protected]
George Tucker, MBA
National Center for Complementary and Alternative Medicine(NCCAM)
Telephone: 301-594-9102
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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