and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Mental Health (NIMH) |
|
Funding Opportunity Title |
Rapid Assessment Post-Impact of Disaster (R03) |
Activity Code |
R03 Small Grant Program |
Announcement Type |
Reissue of PAR-09-171 |
Related Notices
|
|
Funding Opportunity Announcement (FOA) Number |
PAR-12-180 |
Companion Funding Opportunity |
PAR-12-181, R21 Exploratory/Developmental Grant |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.242 |
Funding Opportunity Purpose |
The purpose of this Funding Opportunity Announcement (FOA) is to provide an expedited funding mechanism for research in the aftermath of disasters and mass casualty events. Potential applicants are strongly encouraged to contact NIMH Program Staff before submitting a RAPID application to determine whether or not the proposed work meets the guidelines of this program, whether requested RAPID funding is likely to be available, and whether the idea should be considered for initial submission as a fully developed, non-expedited application via a regular/parent FOA. RAPID grants described in this FOA may be used to facilitate initial research for investigators who intend to follow up with a full research application, using the preliminary time sensitive data from a RAPID grant as the basis for their subsequent application. |
Posted Date |
May 3, 2012 |
Open Date (Earliest Submission Date) |
July 3, 2012 |
Letter of Intent Due Date |
Not Applicable |
Application Due Date(s) |
Applications should be submitted within approximately six weeks of the identified disaster event. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
RAPID applications will be handled on an expedited external peer review and award basis to meet the goals of this program. |
Advisory Council Review |
RAPID applications will be handled on an expedited review basis. |
Earliest Start Date(s) |
RAPID applications will be handled on an expedited award basis. |
Expiration Date |
October 4, 2015 |
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 Traumatic Stress Disorders Research Program of the NIMH recognizes that prompt assessment may be crucial to many kinds of disaster mental health studies, including those that focus on service seeking, on efficacy of outreach or prevention efforts, and on identifying high-risk survivors on the basis of early response. Advances regarding post-traumatic psychopathology, which build on findings from basic behavioral and neuroscience research on cognitive processing, arousal, and memory, highlight the potential scientific value of rapid data collection following trauma exposure. Rapidly supported pilot-type studies can lay the foundation for larger studies on the neurobiological nature, cause, pathogenesis, treatment and prevention of post-traumatic psychopathology as well as services research studies addressing organization, access, quality, cost and outcome of services .
This kind of research most often has a serious urgency with regard to availability of, or access to, data or facilities. The RAPID grants described in this FOA are generally designed to provide limited resources for investigators who intend to follow up with a full research application, using the preliminary time-sensitive data from this initial effort as a basis for their subsequent application(s).
Objectives
Although disasters are disconcertingly prevalent in modern culture, systematic, hypothesis driven studies involving representative samples have been relatively few.
Disasters and acts of mass violence have the potential to cause great public health and economic burdens. Unlike individual traumatic events, disasters tend to strike without preference to personal characteristics that increase the risk of exposure to other kinds of traumatic events. Individual characteristics predisposing to traumatic events are also associated with vulnerability to post-traumatic psychopathology, thus confounding the effects of the event with predisposing characteristics. Disasters and acts of mass violence provide for a unique scientific aperture, the need to learn more about the biological and behavioral consequences of traumatic stress can be uniquely addressed with careful and sensitive research involving disaster exposed populations.
The Traumatic Stress Disorders Research Program is the focal point in the NIMH for support of research projects on the mental health sequelae of emergencies resulting from events in the external environment, which include natural and human-made situations. Such events range from individual to community and to larger-than-community catastrophes, and they encompass natural disasters (e.g., flood, tornado, drought), human-made emergencies (e.g., toxic waste spill, fire, bridge collapse), and violence (e.g., riot, combat, school-based shootings, suicides, workplace violence, terrorism). The Program supports research on psychological, physiological, biological, and behavioral reactions to emergencies, risk factors for developing prolonged mental health sequelae (including post-traumatic stress disorder) resulting from exposure to such emergencies, service delivery and treatment of survivors, and effectiveness of programs designed to prevent mental health problems.
Although each disaster or emergency event of potential significance for mental health is unique, the Traumatic Stress Disorders Research Program emphasizes that new RAPID research applications should clearly demonstrate that:
a) the topic to be studied/questions to be addressed represent significant scientific needs relevant to the NIMH mission (e.g., can highly predictive early indicators of distress, disorder, and functional sequelae be developed, are early interventions capable of preventing or reducing the severity of adjustment problems)
b) the disaster/event under study presents a unique scientific opportunity to acquire needed information (e.g., the research questions cannot be efficiently addressed in another context and the nature of the event and/or impacted populations are well suited for the proposed study), and
c) the insight to be gained has the potential to advance the field by producing fundamental new insights as opposed to reinforcing established findings (e.g., rather than assessing well established risk factors for adjustment problems and levels of distress, new applications might seek to identify genetic and environmental interactions that cause posttraumatic disorders, develop highly predictive early diagnostics for PTSD, establish the feasibility of cost-effective identification and treatment approaches for posttraumatic distress and psychopathology in mass causality contexts.)
Collecting information following a disaster presents special challenges; foremost among them is the need for investigators to attach the highest priority to standards of privacy, dignity, and courtesy in their interactions with participants. Any information gathering activities in this context must acknowledge and adhere to the imperatives of doing no harm, placing the care and safety of survivors above all else, and coordinating with assistance efforts. This may involve coordination with state and local response efforts as well as federally supported counseling and outreach activities such as those funded by the Federal Emergency Management Agency (FEMA) and administered by the Center for Mental Health Services (CMHS) in the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Office of Human Services Emergency Preparedness and Response (OHSEPR) in the Administration for Children & Families.
Applications for research support may include, but are not limited to, a substantive emphasis in any one or more of the following areas:
NIMH is also interested in Community-partnered approaches to research. This type of research is meant to include scientific inquiry conducted in communities and in partnership with researchers where community members, persons affected by the health condition, disability or issue under study, or other key stakeholders in the community's health have the opportunity to be full participants in each phase of the work (from conception - design - conduct - analysis - interpretation - conclusions - communication of results).
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 |
The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications. |
Award Budget |
Budgets for direct costs up to $50,000 per year and a project duration of up to two years may be requested for a maximum of $100,000 direct costs over a two year project period. |
Award Project Period |
Scope of the proposed project should determine the project period. The maximum project is 2 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
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, 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 Director(s)/Principal Investigator(s) (PD(s)/PI(s))
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 4-6 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(s)/Principal
Investigator(s) (PD(s)/PI(s)) 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 PD(s)/PI(s), visit the Multiple
Program Director(s)/Principal Investigator(s) 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 are not permitted in response to this FOA. However, an unfunded RAPID application may be resubmitted as an amended application under the regular, non-expedited submission process in response to the NIH-wide Parent R03 announcement (PA-11-262) or other appropriate standard deadline R03 announcement. Such application must 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.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
A letter of intent is not required for this funding opportunity. However, potential applicants are strongly encouraged to contact NIMH Program Staff before submitting a RAPID application to determine whether or not the proposed work meets the guidelines of this program, whether requested RAPID funding is likely to be available, and whether the idea should be considered for initial submission as a fully developed application. Inquiries not meeting the RAPID guidelines will be guided to other grant mechanisms and to program contacts to discuss alternatives
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 submission of applications for this FOA. 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:
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, with the following modifications:
Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions 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(s)/PI(s) 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. Applications that are incomplete will not be reviewed.
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.
For this particular announcement, note the following:
The R03 small grant supports discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research project usually is limited, an R03 grant application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.
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?
Investigator(s)
Are the PD(s)/PI(s), 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(s)/PI(s), 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?
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), 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 be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the appropriate National Advisory Council or Board. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD(s)/PI(s) 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’s 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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
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 Service Desk (Questions regarding ASSIST, 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]
Farris Tuma, Sc.D.
Division of Adult Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 7111, MSC 9632
Bethesda, MD 20892-9632
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-3648
FAX: (301) 443-4611
Email: [email protected]
Susan Borja, Ph.D.
Division of Adult Translational Research and Treatment
Development
National Institute of Mental Health
6001 Executive Boulevard, Room 7111A, MSC 9632
Bethesda MD 20892-9632
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-1252
FAX: (301) 443-4611
David Armstrong, Ph.D.
Division of Extramural Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9606
Bethesda, MD 20892-9606
Telephone: (301) 443-3534
FAX: (301) 443-4720
Email: [email protected]
Rebecca Claycamp
Division of Extramural Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6122 MSC 9605
Bethesda MD 20892-9605
Telephone: (301) 443-2811
FAX: (301) 443-6885
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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