and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Heart, Lung, and Blood Institute (NHLBI) |
|
Funding Opportunity Title |
Getting from Genes to Function in Lung Disease (R01) |
Activity Code |
R01 Research Project Grant |
Announcement Type |
Reissue of PA-11-011 |
Related Notices |
None |
Funding Opportunity Announcement (FOA) Number |
PA-12-110 |
Companion FOA |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.838 |
FOA Purpose |
This FOA encourages applications that propose to characterize the function of gene(s) and their associated variants identified by genome-wide association studies (GWAS) or other genetic approaches to be involved in lung diseases. Studies should use integrated approaches across scientific disciplines to determine the pathobiological function of these genes. |
Posted Date |
February 22, 2012 |
Open Date (Earliest Submission Date) |
May 5, 2012 |
Letter of Intent Due Date |
Not Applicable |
Application Due Date(s) |
June 5, 2012, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
September 7, 2012, by 5:00 PM local time of applicant organization. |
Scientific Merit Review |
|
Advisory Council Review |
|
Earliest Start Date(s) |
April 2013 |
Expiration Date |
September 8, 2012 |
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 FOA issued by the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health, encourages Research Project Grant (R01) applications from institutions/organizations that propose to characterize the function of genes(s) and their associated variants identified by genome-wide association studies (GWAS) or other genetic approaches to be involved in lung diseases. Studies should use integrated approaches across scientific disciplines to determine the pathobiological function of these genes.
Background
Recent genetics studies of asthma, chronic obstructive pulmonary disease (COPD), sarcoidosis, idiopathic pulmonary fibrosis (IPF), and other lung-relevant phenotypes have clearly shown the usefulness of genome-wide association studies (GWAS) for gene discovery. Many genes or chromosomal regions have already been associated with lung dysfunction, and the number of related genes is expected to increase markedly over the next year as the results of ongoing meta-analyses and resequencing studies are published. In addition to genes already considered as candidates (e.g., RAD50, which is in the same linkage block as IL13, FcERA, TSLP), GWAS results have suggested involvement of many novel genes about which little is known. The identification of novel genes is especially significant because these may point to pathways and mechanisms not previously recognized in lung diseases. There now exists an exciting possibility that follow-up studies of pathways and mechanisms related to these genetic variants may quickly generate knowledge that leads to novel and more effective ways to prevent and treat a variety of pulmonary conditions. However, in many cases, the functions of the identified genes and their variants, and the mechanisms by which they may contribute to lung diseases are completely unknown.
A critical next step is to elucidate the biological functions of these genes and their variants in the lung. Fortunately, the experimental approaches and tools required for this are readily available, including genetic manipulations of in vitro and animal models; -omics measures; systems biological analyses; eQTL analyses; and human studies of gene-gene and gene-envoronment interactions, epigenetic variations, and evoked biomarker phenotypes. Nevertheless, progress in getting from genes to function in pulmonary diseases has been remarkably slow. A major impediment to progress appears to be the requirement for diverse, multidisciplinary investigative teams. Very few existing groups can bridge from genetics to molecular biology to cell physiology to disease as is required to learn how a particular genetic variant affects molecular and cellular function in a way that promotes disease. Furthermore, studies of different genetic variants often require very different experimental approaches, model systems, and investigative teams, based on what is already known about the genetic region and the pulmonary condition. Each genetic variant may require a unique team and research plan for follow-up, and this is properly considered high-risk research by grant reviewers. A FOA is needed to bring this pivotal research effort to the forefront, to bring biology into what has to date been a purely genetic exercise, and to build the necessary research teams critical to ensuring successful attainment of the research goals.
Research Scope
The purpose of this initiative is to accelerate research in functional genetics of lung diseases by supporting follow-up functional studies of particular genetic variants that have been linked to pulmonary conditions. Each study will use a multidisciplinary team to investigate the function of a single genetic variant or a small number of related genes. Applicants will be encouraged to employ genomic and system genetic approaches and integrate studies of individual genes with pathways and regulatory networks, using a variety of model systems. However, the initiative will not be limited to particular experimental methods but will allow investigators to employ a wide variety of investigative approaches, ranging from exploration in model systems to proof of concept studies with human biospecimens. Investigators may focus on one lung disease or may investigate a single genetic variant across lung diseases. Because a major bottleneck to this research has been the need to build diverse, multidisciplinary investigative teams that cross scientific disciplines, this program strongly encourages the forging of new collaborations among top-tier pulmonary and non-pulmonary investigators in different scientific disciplines (system genetics, informatics, various model systems) and building diverse, multidisciplinary teams that integrate genetics, molecular biology, cell physiology, and bioinformatics. Investigator meetings will be held yearly to enable investigators to share their successes and challenges with the varied approaches being used to explore how the genetic variation results in functional changes and how the genes are involved in lung disease pathogenesis.
Through this program, we expect to gain mechanistic understanding of: (1) the biological function of genes identified through GWAS or other genetic approaches to be associated with various lung diseases, (2) how the genetic variation influences gene expression or function, and (3) how particular genes and specific variants are involved in lung disease pathogenesis. Research related to each of these categories should be addressed using integrated approaches across disciplines (genetics, bioinformatics, systems biology, and phenotype/clinical) and should utilize appropriate technologies such as -omics, systems genetics/biology and pathway/network analysis, animal models of lung disease, human studies in ethnically/racially diverse populations, and mining of data from existing resources. The latter could include, but is not limited to, data from clinical trial cohorts and population-based cohorts, studies of transcriptional and proteomic profiling in relevant tissues, animal models of lung disease, and repositories of banked tissues. The proposed studies must include the study of human subjects or utilize human tissue or cells from well-characterized subjects with lung disease. Animal studies, if included, must be complementary to the proposed human research and address mechanistic or therapeutic questions that cannot be addressed directly in humans. Development of new technologies, tools, and model systems will be allowed if required to address the specific questions being asked in the research proposal.
Research topics to be addressed as part of this initiative include, but are not limited to:
1. Functional characterization of genes (and variation) identified by GWAS to be involved in the pathogenesis of lung disease using integrated omic (genetics, genomics, transcriptomics, proteomics, metabolomics, phenomics, etc) approaches across scientific disciplines (genetics, bioinformatics, systems biology, and phenotype/clinical) aimed at determining the mechanism by which genetic variation affects lung disease (potentially through gene x gene, gene x environment, epigenetics, integrated/comparative approaches).
2. Exploration of the role of the environment and mechanisms of transcriptional regulation (eQTLs and epigenetic modifications) of identified genes including examining changes over time/development in different cell types and in response to environmental stimuli in humans and mice and other appropriate model systems, and by incorporating systems genetics and network building.
3. Development of model systems (including mice, flies, zebrafish, worms, and yeast) and high throughput functional screening methods to assess how lung disease-related genes function in complex biological systems. This can include comparative genomics and phenomics to understand gene function in other targets.
4. Exploration of the contribution of the lung disease-related variants to abnormalities in gene expression or function in biospecimens from human or animal disease models as proof of concept.
5. Application of integrative systems biology, genomic, and bioinformatic approaches for comprehensive mining of existing data sets to identify novel genes (and associated variants) and pathways involved in lung disease including in silico studies of function or putative function for prioritizing variants or genes after GWAS to inform the types of functional studies to pursue.
Applications focused on lung cancer are not within the mission of the NHLBI and will not be considered to be within the scope of this FOA.
Funding Instrument |
Grant |
Application Types Allowed |
New |
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 |
Application budgets are not limited, but need to reflect actual needs of the proposed project. |
Award Project Period |
The scope of the proposed project should determine the project period up to a maximum of five 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, renewal, or revision applications should be submitted using another FOA for R01 applications that permits resubmission, renewal, or revision applications (e.g. the Parent R01 FOA, currently PA-11-260).
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.
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.
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(s)/PI(s) 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 requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF 424 (R&R) Application Guide.
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?
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 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 NHLBI Advisory Council. The following will be considered in making funding decisions:
Meritorious applications within the scope of this FOA will have high program relevance for NHLBI funding consideration and will be considered for funding 5% (percentile) above regular pay line for R01. Any pay line advantage will not be applied to resubmissions and renewals.
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 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]
Susan Banks-Schlegel, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10152, MSC 7952
Bethesda, MD 20892-7952
Telephone: 301 435-0202
FAX: 301 480-5577
Email: schleges@nhlbi.nih.gov
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
John Diggs
Office of Grants Management
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7158
Bethesda, MD 20892-7926
Telephone: 301-435-0166
FAX: 301-451-5462
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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