Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

NIH Blueprint for Neuroscience Research
National Institute on Aging (NIA)
National Eye Institute (NEI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Center for Complementary and Integrative Health (NCCIH formerly NCCAM)

Funding Opportunity Title

Lifespan Human Connectome Project: Aging (U01)

Activity Code

U01 Research Project – Cooperative Agreement

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AG-16-004

Companion Funding Opportunity

RFA-MH-16-150, U01 Research Project – Cooperative Agreements

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.866, 93.867, 93.273, 93.286, 93.865, 93.173, 93.121, 93.279, 93.113, 93.859, 93.242, 93.853, 93.361, 93.213 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) is issued as an initiative of the NIH Blueprint for Neuroscience Research.  The Neuroscience Blueprint is a collaborative framework through which 15 NIH Institutes, Centers and Offices jointly support neuroscience-related research, with the aim of accelerating discoveries and reducing the burden of nervous system disorders (for further information, see http://neuroscienceblueprint.nih.gov/).  The Neuroscience Blueprint is supporting a Lifespan Human Connectome Project (L-HCP) to extend the Human Connectome Project (HCP) (http://www.neuroscienceblueprint.nih.gov/connectome) to map connectivity in the developing, adult, and aging human brain.  The goal of this FOA is solicit grant applications that propose to extend the experimental protocols developed through the HCP to middle-age and elderly adults to investigate the structural and functional changes that occur in the brain during typical aging.  A companion FOA is soliciting applications that apply the HCP protocols to children and adolescents to explore changes that occur during typical development. 

Key Dates
Posted Date

February 6, 2015

Open Date (Earliest Submission Date)

May 15, 2015

Letter of Intent Due Date(s)

May 15, 2015

Application Due Date(s)

June 15, 2015, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October 2015

Advisory Council Review

January 2016

Earliest Start Date

March 2016

Expiration Date

June 16, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (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.


Table of Contents

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


Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

Purpose

This Funding Opportunity Announcement (FOA) is issued as an initiative of the NIH Blueprint for Neuroscience Research.  The Neuroscience Blueprint is a collaborative framework through which 15 NIH Institutes, Centers and Offices jointly support neuroscience-related research, with the aim of accelerating discoveries and reducing the burden of nervous system disorders (for further information, see http://neuroscienceblueprint.nih.gov/).  The Neuroscience Blueprint is supporting a Lifespan Human Connectome Project (L-HCP) to extend the Human Connectome Project (HCP) (http://www.neuroscienceblueprint.nih.gov/connectome) to map connectivity in the developing, adult, and aging human brain.   The goal of this FOA is to solicit grant applications that propose to extend the experimental protocols developed through the HCP to middle-age and elderly individuals to investigate the structural and functional connectivity changes that occur in the brain during typical aging.  A companion FOA is soliciting applications that apply the HCP protocols to children and adolescents to explore changes that occur during typical development.  The goal of these complementary FOAs is to enhance and extend the HCP dataset to capture change in early and later lifespan brain connectivity, to expand our understanding of the fundamental organization and operation of the brain and its manifestation in behavior, and to provide valuable reference data to support research examining the role of neurodevelopment and aging in brain disorders.

Background

Over the course of the last decade, there has been an explosion of interest in the organization of structural and functional brain networks, as characterized by connectivity patterns.  Mapping brain connectivity will help us understand how the brain is organized, how it develops and changes over time, and how it is altered in diseases and disorders.  Connectivity is critical in understanding, diagnosing, and treating certain neurological and psychiatric disorders.  Increasingly, disrupted or aberrant connectivity is being implicated or suspected in the etiology of disorders not previously considered from this perspective.  For example, it is very likely that quantifiable changes in connectivity accompany the variations in cortical thickness (as demonstrated with structural magnetic resonance imaging) that are seen in diseased brains (e.g., Alzheimer's), and that are seen in brains through the course of early development,  adolescence, adulthood and aging.  Similarly, it is likely that qualitative or quantitative changes in connectivity contribute to morphometric differences observed in brains of those with particular disorders, such as schizophrenia.   Less clear and ill-defined is the normative trajectory of brain connectivity across the lifespan.

The NIH Blueprint for Neuroscience Research is currently funding the Human Connectome Project (HCP), a cooperative agreement to collect and share structural and functional connectivity data from a large sample of healthy young adults, age 22-35.  One of the overarching goals of the HCP has been to develop and share knowledge about the structural and functional connectivity of the human brain to further research in this area..  This is being achieved through awards to two different multi-institutional research teams centered at Washington University (http://www.humanconnectome.org/) and Massachusetts General Hospital (http://www.humanconnectomeproject.org/).  These teams have developed and optimized non-invasive imaging technologies to acquire structural and functional in vivo data about axonal projections and neural connections from brains of hundreds of healthy young adults.  Demographic data and data regarding sensory, motor, cognitive, emotional, social function, and genotyping have also been collected for each subject.  The data and experimental protocols have been made available to the research community, and both are now being widely used.  The NIH recently issued an FOA to solicit applications that will apply the HCP data collection protocols to human disease and disorder cohorts (PAR-14-281: Connectomes Related to Human Disease (U01)).

While the HCP launched the field of human connectomics and is providing the first well-characterized, quantitative datasets of human brain connectivity, linked to genetic and behavioral data, the HCP is limited to the young adult brain – a very small portion of the overall human lifespan.  Enormous structural and functional changes occur in the brain during typical development and aging.  A complementary extension of the HCP to capture trajectories of early and late lifespan would greatly enhance the utility of the HCP dataset and provide valuable reference data to support research examining the role of neurodevelopment and aging in a variety of brain-based disorders.  An extension of the HCP to younger and older subjects will strive for data of optimum quality and comparability with the ongoing HCP.   Both HCP teams have begun pilot studies to explore the issues with extending the HCP to children and to older adults to represent the lifespan and have made strides in overcoming some of the technical and design challenges inherent to imaging younger and older subjects.  Data from these pilot studies are available at https://lifespan.humanconnectome.org/.

Research Studies and Objectives

The purpose of this FOA is to extend and build on the methods and findings from the ongoing HCP to comprehensively and systematically map structural and functional connectivity of the brain in healthy adult and aging individuals using protocols comparable to those developed by the HCP.  A parallel FOA (RFA-MH-16-150) will extend and adapt the HCP protocols to healthy children and adolescents..   The overall goal of the Lifespan Human Connectome Project (L-HCP) reflected in these two funding opportunities is to collect and share knowledge of the connectivity of the developing and aging brain.  The cumulative outcomes include:

  • Integrate 'developmental' and 'aging' connectome with HCP data via comparable neuroimaging and data acquisition and analysis protocols
  • Determine the structural and functional connectivity of the brain in typical development, adulthood, and aging
  • Assess the variability in brain connectivity across the lifespan
  • Link changes in brain connectivity to behavior and genetic variation
  • Share knowledge of the lifespan connectome by aggregating, storing and disseminating data via the Connectome Coordination Facility
  • Provide a reference dataset of the normative change in brain connectivity across the lifespan that would provide baseline data for, and insights to, understanding normal and pathological changes in brain circuits and networks. 

This L-HCP FOA aims to collect structural and functional connectome data representative of the healthy adult and aging brain.  Subjects will span the age range of 36 to 90+ years old.  It is expected that cross-sectional, multi-cohorts of different ages will be identified and that connectome data will be collected from at least 1500 subjects across the adult lifespan. Lifespan projects are strongly encouraged to include multiple timepoints, for at least a subset of participants, allowing for longitudinal (within-subject) analysis of aging trajectories in addition to cross-sectional comparisons.

L-HCP data collection must use neuroimaging and behavioral protocols compatible with the HCP centered at Washington University.  The WU-Minn HCP project is using cutting-edge magnetic resonance imaging (MRI) hardware, acquisition and analysis methods and other neuroimaging protocols to collect task-activated functional MRI (t-fMRI), resting-state fMRI (rs-fMRI), advanced diffusion MRI (dMRI), and high resolution structural MRI (s-MRI) data.  Demographic data and data regarding sensory, motor, cognitive, emotional, and social function are collected for each subject, as well as blood samples for biochemical analysis and DNA genotyping or sequencing.  Extensive description and details on the HCP protocols can be found at Project Overview | Human Connectome Project and 500 Subjects Data Release Reference | Human Connectome Project. HCP FAQs can be found at HCP FAQ: Disease-related Connectome Research | Human Connectome Project. Applicants are urged to consult these documents.  Lifespan projects must include rs-fMRI, t-fMRI, dMRI, and sMRI. Tasks chosen for t-fMRI should aim to balance compatibility with tasks employed in the HCP, age-appropriate adaptations, and relevance to scientific hypotheses about sensitive periods in aging.

HCP teams have developed and optimized cutting-edge MRI techniques which have been used to acquire structural and functional connectomics in healthy young adults. Both of the HCP scanners at Massachusetts General Hospital and at Washington University have high performing gradient systems. Multiband (also known as Simultaneous Multi-Slice) pulse sequences and reconstruction algorithms used in HCP fMRI and dMRI to substantially increase the sampling rate for a given resolution are available on multiple Siemens 3T platforms (Prisma, Skyra, and Trio) and on the Siemens 7T scanner; GE and Phillips platforms are expected to become available soon.  Diffusion MRI benefits from high maximal gradient strength, as is available on the Siemens Prisma (80 mT/m) as well as the customized Siemens MAGNETOM Connectom scanners at WashU (100 mT/m) and MGH (300 mT/m).    The L-HCP will implement and use imaging hardware, acquisition methods, and protocols to obtain neuroimaging data of optimal quality and maximal compatibility with HCP data.

HCP behavioral measures include many from the NIH Toolbox  plus additional measures from domains not covered by the NIH Toolbox.  Identical behavioral measures will be collected for the L-HCP. Addition of specific age-relevant behavioral tests or measures for a particular population is expected (e.g. walking distance or gait) and will facilitate understanding of brain connectivity-behavior relationships in middle-age and older adults.  Age-appropriate behavioral tests are likely to be useful to other researchers who are studying similar age groups and further enhance the utility of the L-HCP data.  NIH encourages the use of instruments that have already been made broadly available, such as the NIH Toolbox (http://www.nihtoolbox.org ) and the University of Pennsylvania Computerized Neurocognitive Battery (https://penncnp.med.upenn.edu/index.pl).

The HCP is currently undertaking a Lifespan Connectome Pilot Project that includes scanning protocols similar to those for the WU-Minn HCP except shorter in duration and amenable to children and older adults.  Detailed information about these modified behavioral and imaging protocols is available on the HCP website HCP Lifespan Pilot Project | Human Connectome Project.  Applicants are urged to consider results from this pilot project in the preparation of an application to this FOA

A successful, complementary extension of the HCP to adults and the elderly must overcome multiple technical challenges such as increased susceptibility of older adults to head motion and reduced tolerance for lengthy scan time.  The L-HCP will optimize data acquisition protocols to allow collection of comparable connectome data from the elderly. This effort will require quality control and quality assurance in data acquisition and various performance characteristics such as signal-to-noise ratio, contrast-to-noise ratio, and spatial or temporal resolution of different imaging methods (e.g. s-MRI, rs-fMRI, dMRI, and t-fMRI).

It is expected that L-HCP imaging data and behavioral assessments will be deposited with and made available from a new Connectome Coordination Facility (CCF) to be established at Washington University.  That centralized database will work with the L-HCP awardee to provide a single location for the community to find connectome data and will help the awardee ensure that the new imaging data can be easily compared with the existing data. Long-term maintenance of the data following deposition is the responsibility of the CCF. 

The L-HCP may include a number of diverse units and activities.  Since this initiative seeks to engage outstanding expertise for each of the units and since it is possible that such expertise will not be concentrated at a single site, it is possible that collaborators will be located across disparate locations.  All units will need to be carefully overseen and coordinated in order to achieve the specified goals within the project period.  This complex effort will require robust administrative structures and processes, objective and independent advice by appropriate experts, and strong professional project management by the grantee.  It is anticipated that a dedicated project manager will be needed for the aging component of the L-HCP.  In addition, the use of a cooperative agreement mechanism will allow significant involvement of NIH staff in the conduct of this award.

The Lifespan Human Connectome projects will consist of two progressive sets of activities.  Year 1 of award, with milestones, will entail the optimization and integration of HCP imaging and behavioral technologies, including pilot data collection, and IRB approval and initiation of subject recruitment.  Years 2-4 of award, with milestones, will entail acquisition of connectome data and deposition of data with the Connectome Coordination Facility.

Section II. Award Information
Funding Instrument

Cooperative Agreement:  A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The NIH Blueprint for Neuroscience Research intends to commit $2 million in FY 2016 to fund one award.  Future year amounts will depend on annual appropriations, but are expected to be no more than $4 million per year.

Award Budget

Application budgets need to reflect the actual needs of the proposed project, but are limited to $2 million total cost in the first year and $4 million/year total cost in subsequent years.  

Award Project Period

The scope of the proposed project should determine the project period.  The maximum project period is 4 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.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions

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.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

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 PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility
Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows.  The NIH will accept submission:

  • To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
  • Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
  • Of an application with a changed grant activity code.
Section IV. Application and Submission Information
1. Requesting an Application Package

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.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Bradley C. Wise, Ph.D.
National Institute on Aging (NIA)
7201 Wisconsin Ave., Suite 350
Bethesda, MD 20892
Telephone: 301-496-9350
Fax: 301-496-1494
Email: wiseb@nia.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

  • For this specific FOA, the Research Strategy section is limited to 30 pages.
Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed. 

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed. NIH may ask awardees to come to the Washington area every 12-18 months to describe their research activities.  Such travel expenses should be part of the requested annual budget.  Applicants should budget funds to transfer the data to the Connectome Coordination Facility which will have the responsibility to preserve the data and make it available to the research community.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.  

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy: The Research Strategy section must address the following elements:

1) Definition of the population(s) that will be included

2) Data acquisition methods and protocols

3) Data quality control and quality assurance

4) Data analysis and data release

5) Administration, operation, and project management

1) Definition of the Population(s) that will be included

The population to be studied must be clearly defined and described. Applicants must describe plans to collect connectome data representative of the healthy adult and aging brain from at least 1500 subjects spanning the age range of 36 to 90+ years old.  Cross-sectional, multi-cohorts of different age bands should be defined and inclusion of longitudinal data, strongly encouraged, for at least for a subset of the sample, should be described in order to address hypotheses about neurobiological aging trajectories. Plans should be described for collecting connectome data on typically aging adults that are representative for sex, racial and ethnic make-up of the United States, with social economic status of subjects considered. Subjects should not have a history of neurologic and psychiatric disorders or chronic medical illness, and should be well-defined in terms of demographic, physical, medical, health and lifestyle data.  Applicants should describe plans for subject recruitment: Subjects recruited from existing well-defined and -characterized (e.g., by clinical, biomarker, genetic, and/or behavioral data) aging cohorts or from proposed new cohorts or a mix of both would be appropriate as long as they are defined as typically aging individuals.

2) Data Acquisition Methods and Protocols

Both HCP teams have developed and optimized cutting-edge MRI techniques which have been used to acquire structural and functional connectomic data in healthy young adults. Applicants must describe how they will implement and use imaging hardware, acquisition methods, and protocols to obtain neuroimaging data of optimal quality and maximal compatibility with HCP data.  L-HCP imaging data acquisition should match the nominal spatial resolution reported by the HCP: anatomical, 0.8mm isotropic; dMRI, 1.25mm isotropic; fMRI, 2mm isotropic.  L-HCP dMRI data should include at least two b-values between 1000-3000. Applicants should detail the relevant data acquisition methods and protocols such as pulse sequences and reconstruction algorithms, experimental parameters including the number of head coil channels, spatial and temporal resolution, number of slices and brain coverage, number of directions for dMRI, and scan time for each imaging session. 

HCP behavioral measures include many from the NIH Toolboxplus additional measures from domains not covered by the NIH Toolbox.  Plans should be described for the L-HCP collection of identical behavioral measures, with justifications provided for adaptations of behavioral assays due to age of cohort.  Addition of specific age-relevant behavioral tests or measures for a particular population is expected (e.g. walking distance or gait) and should be described in terms of how they will facilitate understanding of brain connectivity-behavior relationships in middle-age and older adults.  Exclusion of behavioral tests that are available in the HCP data set should be justified based on the relevant population to be studied.

Applicants must describe how they will harmonize their proposed imaging and behavioral data with the data that are currently available from the HCP. 

Applicants should describe plans to collect blood, or other tissue samples, for biochemical analysis and DNA genotyping or sequencing, and plans to deposit biosamples in an NIH approved facility such as the National Cell Repository for Alzheimer's Disease (NCRAD) (http://ncrad.iu.edu/) or the NIMH Center for Collaborative Genomic Studies on Mental Disorders (http://www.nimhgenetics.org).

3) Data Quality Control and Quality Assurance

Applicants should describe how the L-HCP data acquisition protocols will be optimized to allow collection of comparable connectome data from the elderly. The development and implementation of appropriate quality control and quality assurance procedures used in the acquisition of data are important requirements and should be delineated. The use of improved hardware and/or advanced motion correction techniques is strongly encouraged and should be described as appropriate.

4) Data Analysis and Data Release

L-HCP imaging data and behavioral assessments will be deposited with and made available from a new Connectome Coordination Facility (CCF) to be established at Washington University. Applicants should describe their plans to use the CCF to aggregate and store data collected in the project supported by this FOA.  Applicants also should describe any data analysis workflows they plan to use that are beyond the ones made available by the HCP. Modified data processing and analysis pipelines should be described and made available to the research community through the CCF.

5) Administration, Operation, and Project Management

The L-HCP may include a number of diverse units and activities, with collaborators and research expertise being located across disparate locations.  Applicants should describe plans for project administration, coordination and oversight in order to achieve the specified goals within the project period.  Such plans should address the need for robust administrative structures and processes, objective and independent advice by appropriate experts, and strong project management by the grantee and/or a dedicated project manager.

Year 1 of award, with milestones, will entail the optimization and integration of HCP imaging and behavioral technologies, including pilot data collection, and IRB approval and initiation of subject recruitment.  Years 2-4 of the award, with milestones, will entail acquisition of connectome data and deposition of data with the Connectome Coordination Facility. A detailed timetable with clear milestones is expected as part of the application. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

  • All applications submitted for the January 25, 2015, due date or after are expected to comply with the NIH Genomic Data Sharing Policy as detailed in NOT-OD-14-111, as applicable.
  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
  • It is expected that data will be released to the research community as soon as it has undergone basic quality assurance procedures.  The release schedule is expected to be similar to what has been done in the Human Connectome Program.  Applicants should plan to implement the existing HCP data analysis workflows, but they can propose additional data analysis workflows.  If additional data analysis workflows are proposed, applicants should explain how those workflows will be made available to the research community.
  • Consistent with achieving the goals of the program, applicants are expected to use appropriate consent forms to allow the data to be deposited in and distributed from the Connectome Coordination Facility.  Those consent forms must make the data broadly available to qualified researchers as appropriate and consistent with achieving the goals of the program.

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.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

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 SF424(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. See Section III of this FOA for information on registration requirements.

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 System for Award Management. 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 and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIA Scientific Review Branch by email at VemuriR@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information
1. Criteria

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.

 
Overall Impact

Reviewers will provide an overall impact 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).

Scored Review Criteria

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? If the aims of the application are achieved, will scientific knowledge of human brain connectivity be advanced?  If the aims of the application are achieved, will scientific knowledge of the age group that is being studied be advanced? 

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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the project manager have appropriate qualifications and experience to operationally coordinate a project of this size and complexity? Is there evidence that the PD/PI and key personnel can work together effectively to achieve the goals of the project?  Does the overall research team have sufficient expertise in all of the critical aspects of this undertaking, e.g., knowledge about the age group being studied, neuroimaging, behavior, informatics, and recruitment?   

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?  Will the project acquire data of optimal quality and maximal comparability to the HCP neuroimaging and behavioral data acquisition protocols?  Will any changes to the HCP data collection protocol, either imaging or behavioral measures, degrade the ability of the new data to be aggregated with the existing HCP dataset? If additional age-relevant imaging and/or behavioral measures are proposed, are they scientifically justified? Will it be possible to aggregate and harmonize the L-HCP data with the existing HCP data? Will the data be deposited in a timely fashion to allow rapid access to the data by the research community? Will the proposed administration, operation and project management, including plans for leading, managing, governing, coordinating, and integrating the efforts of the various components, allow the proposed goals and objectives to be achieved? Are appropriate milestones clearly defined for the progressive research stages and are they feasible and well-developed with regards to the goals of the project?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion 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? Does the institution have an appropriate MRI scanner to conduct the proposed Lifespan HCP experiments? What are the nature and level of resource commitments from the home institution and from other participating institutions?  

Additional Review Criteria

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 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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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

Additional Review Considerations

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 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) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by National Institute on Aging, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

  • Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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 appropriate National Advisory Council or Board. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information
1. Award Notices

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 terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

  • Determining and coordinating research approaches and procedures, conducting experiments, and analyzing and interpreting research data;
  • Working closely with the NIH project scientist and NIH program officer to ensure progress towards achieving all goals within 4 years;
  • Meeting annual milestones for progress, and otherwise making satisfactory progress, toward accomplishing the goals of the funded project;
  • Overseeing the release of data, software and models according to the awardee's data sharing and software release plan and specific procedures to be developed by the awardee and consistent with NIH Resource Sharing Policy;
  • Releasing to the research community data, models, and informatics tools as soon as they have undergone basic quality control and quality assurance procedures in a timely manner;
  • Depositing the data into the Connectome Coordination Facility;
  • Providing information on progress of the Project to the NIH program officer in a standard format on an annual basis, and as needed;
  • Planning for, facilitating, and participating in pre-arranged site visits by NIH staff members;
  • Deciding whether this award will have a Project Steering or External Advisory Committee. 
  • Providing a summary of information from External Advisory Committee meetings, if one is proposed for this award, to the Program Officer;  
  • Participating and facilitating evaluations by NIH.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

The NIH Project Scientist will have the primary responsibility for:

  • Participating in project status, planning, and implementation meetings;
  • Providing a public health perspective;
  • Providing a perspective on the priorities of the participating Institutes and Centers;
  • Discussing approaches to enhance collaboration;
  • Providing technical assistance, advice, and coordination to the project, but with the dominant role and prime authority and responsibility for the activity residing with the awardee.
  • Serving as a member of the Project Steering or External Advisory Committee, if one is proposed.

The NIH Program Officer, in consultation with the HCP Blueprint Project Team, will have programmatic stewardship, which encompasses the following:

  • Serving a resource to facilitate interactions with other NIH programs and to take advantage of existing NIH resources and infrastructures;
  • Monitoring the operations of the award and providing normal programmatic stewardship on assessment of overall project directions and allocations of funds;
  • Evaluating the effectiveness of data, model, and software sharing;
  • Reviewing the progress of the awardee in achieving the goals of the HCP;
  • Conducting periodic site visits, and taking other actions as needed;
  • Determining the appropriateness of the plans for sharing data, models, and informatics tools
  • Serving as an observer at meetings of the Project Steering or External Advisory Committee, if one is proposed.

Areas of Joint Responsibility include:

A governance structure for the collaborative responsibilities across the various components of the award will be determined by the PD(s)/PI(s) of the award and will be approved by the Program Officer at the time of the award. Any project coordinating committee, such as a Steering or External Advisory Committee, will be composed of the PD(s)/PI(s), the NIH Program Officer, and the NIH Project Scientist.  Additional members may be added at the discretion of the Committee.  The role of the Committee would be to facilitate the coordination, conduct and monitoring of studies and reporting study results.  The Project Scientist will participate in decisions about the study design, implementation, procedures, and coordination of the project and will serve as a member of the Committee.  The Program Officer will be responsible for the normal scientific and programmatic stewardship of the award and will participate in Committee meetings.  It is expected that the project Committee will strive to achieve consensus in decisions regarding study procedures.  In all cases, the role of NIH staff will be to assist and facilitate, but not direct activities.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) 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.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Finding Help Online: https://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Bradley C. Wise, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: wiseb@nia.nih.gov

Peer Review Contact(s)

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9666
Email: VemuriR@nia.nih.gov

Financial/Grants Management Contact(s)

Richard Proper
National Institute on Aging (NIA)
Telephone: 301-402-7735
Email: properr@mail.nih.gov

Section VIII. Other Information

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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