Part 1. Overview Information

Participating Organization(s) National Institutes of Health (NIH) Components of Participating Organizations National Institute on Drug Abuse (NIDA) Funding Opportunity Title Research on Marijuana Legalization in the US (Admin Supp) Activity Code Administrative Supplement Additional funds may be awarded as supplements to parent awards using the following Activity Code(s): https://grants.nih.gov/grants/ElectronicReceipt/files/Timeline_NIH_Complex_Transition.pdf R01 Research Project Grant

R03 Small Grant Program

R15 Academic Research Enhancement Award (AREA)

R21 Exploratory/Developmental Research Grant Award Announcement Type New Related Notices None Funding Opportunity Announcement (FOA) Number PA-13-138 Companion Funding Opportunity None Number of Applications See Section III. 3. Additional Information on Eligibility. Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.279 Funding Opportunity Purpose The NIDA announces the availability of administrative supplements to inform social, behavioral, and public health impacts of recent US marijuana legalization laws/policies.

Key Dates

Posted Date March 7, 2013 Open Date (Earliest Submission Date) April 30, 2013 Letter of Intent Due Date(s) Not Applicable Application Due Date(s) May 31, 2013 by 5:00 PM local time of applicant organization AIDS Application Due Date(s) Not Applicable Scientific Merit Review Not Applicable Advisory Council Review Not Applicable Earliest Start Date August 2013 Expiration Date June 1, 2013 Due Dates for E.O. 12372 Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide or PHS 398 Application Guide, as appropriate) 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 & Objectives

In November 2012, voters passed ballot initiatives in the states of Washington and Colorado to legalize marijuana for adult recreational use. We know little about the impact this shifting marijuana policy environment has had or will have on epidemiology, prevention and treatment of substance use, misuse, and related health outcomes such as HIV and other risk behavior (i.e. drugged driving). The National Institute on Drug Abuse (NIDA) encourages administrative supplements to research that will inform social, behavioral, and public health impacts of marijuana legalization laws/policies. This Funding Opportunity Announcement will support projects with the ability to harness these “quasi-natural experiments” currently underway in the United States to ascertain the effects of these recent changes. Research topics may include but are not limited to: Health outcomes (i.e. respiratory illness, learning and memory, psychiatric symptoms, etc.); Risk behaviors (i.e. drugged driving, sexual/HIV risk behavior); Educational attainment; Crime and delinquency; Moderation of prevention intervention outcomes; Changes in state prevention policies. Secondary data applications which utilize national or state level longitudinal or panel data are highly encouraged.

Scope of Support

The research proposed under the administrative supplement program must be within the original scope of the parent grant and will contribute to a greater understanding of the implications of marijuana legalization laws/policies on attitudes, substance use, misuse, dependence, disorder, related health outcomes such as HIV risk behaviors, and other risk behaviors such as drugged driving. The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives related to effects of the shifting marijuana policy environment as long as they remain within the original scope of the project. Any cost increases need to result from making modifications to the project in order to take advantage of opportunities that would increase the value of the project consistent with its originally approved objectives and purposes.

IC Specific Considerations

Applicants are strongly encouraged to discuss their proposed supplement project with the IC Program Official of the parent grant prior to submission of a supplement application in order to ensure that the supplement content area fits with the scientific priorities of the IC, is within the scope of the parent grant, the budget is appropriate, and to ensure the IC will support a supplement to the parent grant. If the parent grant is supported by an IC other than NIDA, applicants are encouraged to discuss with both parent IC and NIDA scientific contact.

Section II. Award Information

Funding Instrument The funding instrument will be the same as the parent award. Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed Non-competing Administrative Supplements 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. NIDA intends to commit $2 million for one year of funding in FY 2013. Award Budget Application budgets are limited $250,000 in Direct Costs for one year, must reflect the actual needs of the proposed project, and can be no more than the amount of the current parent award. The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives, as long as the research objectives are within the original scope of the project, or the cost increases are for unanticipated expenses within the original scope of the project. Any cost increases need to result from making modifications to the project that would increase or preserve the overall impact of the project consistent with its originally approved objectives and purposes. Award Project Period The project and budget periods must be within the currently approved project period for the existing parent award.

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

All organizations administering an eligible parent award may apply for a supplement under this announcement.

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

This announcement is for supplements to existing projects. To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.

IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the 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.

System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.

Grants.gov (required for all electronic application submissions)

eRA Commons

All Program Directors/Principal Investigators (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 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Individual(s) must hold an active grant or cooperative agreement, and the research proposed in the supplement must be accomplished within the competitive segment of the active award. Individuals are invited to work with their organizations to develop applications for support.



For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award. Do not use this administrative supplement application to add, delete, or change the PDs/PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator Policy in the SF424 (R&R) Application Guide for more information.

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 is sufficiently distinct from any other administrative supplement currently under consideration by the awarding NIH Institute or Center.





Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants are required to prepare applications according to the current application forms in accordance with the Application Guide.

For electronic submissions, applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this announcement, or use the eRA Commons streamlined submission process.

2. Content and Form of Application Submission

All forms should be completed for the supplemental activities only and should not reflect funding or activities for the previously awarded parent award.



It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide or PHS 398 Application Guide, as appropriate) 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.

Page Limitations

All page limitations described in the Application Guide and the Table of Page Limits must be followed.

Application Submission

The process for submitting an application varies depending on whether the activity code of the parent award requires electronic submission (as of the submission date of the supplement application). Visit the list of Activity Codes Processed Electronically by eRA to determine if the activity code of the parent award has transitioned to electronic submission.

If the parent award’s activity code has not transitioned to electronic submission, then you must use the PHS 398 Application Forms and follow the PHS 398 Application Guide.

If the parent award’s activity code has transitioned to electronic submission, then you may either (A) electronically submit using the SF424 (R&R) Application Forms and Grants.gov/Apply, (B) electronically submit using the streamlined submission process of eRA Commons, or (C) submit using the paper-based PHS 398 Application forms and the PHS 398 Application Guide.

Instructions for Submissions using Grants.gov/Apply for electronic-based submissions

For grants with activity codes that have transitioned to electronic submission using the SF424 (R&R) application forms, administrative supplement requests may be submitted electronically as a Revision application type on the R&R Cover Component. Prepare applications using the SF424 (R&R) application forms associated with this announcement. Please note that some components marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional components.

Special Instructions for Streamlined Submissions using the eRA Commons for electronic-based submissions

NIH now offers a streamlined system through the eRA Commons for submitting administrative supplements. Login to the eRA Commons, identify the parent award, and prepare an administrative supplement request. A User’s Guide for submitting through this system is available.

Include the Research Strategy and any other required documentation (described below) as a PDF file using the “Add Other Attachments” function. Budget information should be entered for the grantee institution in the fields provided. There is no template or form available for subaward information; instead, all subaward information should be included as a separate attachment showing the funds requested (by budget period) using the same categories provided for the grantee institution. Also include a budget justification for the subawardee institution in the same file.

Instructions for Submissions using the PHS 398 Application Forms (for paper-based submissions)

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. The grantee institution, on behalf of the PD/PI of the parent award, must submit the request for supplemental funds directly to the awarding component that supports the parent award. Submit a signed, typewritten original of the application, including the checklist, and two signed photocopies in one package to:

Director – Administrative Supplements

Office of Extramural Affairs, NIDA

6001 Executive Blvd, Room 4243, MSC 9550

Bethesda, Maryland 20892-9550

Telephone: (301) 435-1389

FAX: (301) 443-0538

On the face page of the application form, note that your application is in response to a specific program announcement, and enter the title and number of this announcement.

PHS 398 Research Plan (Research Plan)

All instructions in the Application Guide must be followed for all Research Plan sections applicable to the proposed supplement activities. At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities.

Project/Performance Site Locations (Project/Performance Sites)

All instructions in the Application Guide must be followed, with the following additional instructions:

Include the primary site where the proposed supplement activities will be performed.

If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.

Senior/Key Personnel Form

All instructions in the Application Guide must be followed, with the following additional instructions:

List the PD/PI as the first person (regardless of their role on the supplement activities).

List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each.

R&R Detailed Budget Form (for use with electronic submissions)

All budgets should be submitted using the R&R Detailed Budget form, regardless of the form used for the parent award, and should only include funds requested for the additional supplement activities.

Budget for the Entire Proposed Period of Support (for use with paper-based submissions)

A proposed budget should be submitted using the PHS 398 budget forms, in accordance with the PHS 398 Application Guide, and should only include funds requested for the additional supplement activities.

Other Project Information (for applications submitted electronically); Appendix (for applications submitted on paper)

All instructions in the Application Guide must be followed, with the following additional instructions:

IACUC Documentation and IRB Documentation (Uploaded via the Other Attachments Section for electronic submissions)

If applicable, include documentation that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects’ involvement is planned for the supplement component.

The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

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 as described above. 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 before the due date in the eRA Commons to ensure accurate and successful submission.

For electronic application submission, information on the submission process and a definition of on-time submission are provided in the SF424(R&R) Application Guide.



For paper-based application submission, iinformation on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS 398 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 using the instructions specified above

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:

For applications submitted electronically on the SF424 (R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.



The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the Application Guide.



See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and/or responsiveness by the awarding Institute or Center. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

Not Applicable





Section V. Application Review Information

1. Criteria

Administrative Supplements do not receive peer review. Instead, the administrative criteria described below will be considered in the administrative evaluation process.

The staff of the NIH awarding component will evaluate requests for a supplement to determine its overall merit. The following general criteria will be used:

Budget and Period of Support

NIH Staff will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Overall Impact

NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of award:

Will the administrative supplement increase or preserve the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved?

Will the administrative supplement increase or preserve the likelihood that the fellowship will enhance the candidate's potential for, and commitment to, a productive independent scientific research career in a health-related field?

Will the administrative supplement increase or preserve the likelihood for the candidate to maintain a strong research program?

Will the administrative supplement increase or preserve the likelihood for the program to exert a sustained, powerful influence on the research field(s) involved?

Will the administrative supplement increase or preserve the potential benefit of the instrument requested for the overall research community and its potential impact on NIH-funded research?

In addition, each of the following criteria will be evaluated as applicable for the proposed supplement.

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, NIH staff 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, NIH staff 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, NIH staff 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

NIH Staff 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

NIH Staff 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.

2. Review and Selection Process

Administrative supplement requests will undergo an administrative evaluation by NIH staff, but not a full peer review. Applications submitted for this funding opportunity will be assigned to the awarding component for the parent award and will be administratively evaluated using the criteria shown above.

3. Anticipated Announcement and Award Dates

Not Applicable





Section VI. Award Administration Information

1. Award Notices

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. This may be as an NoA for the supplemental activities only; alternatively, it may be as either a revision to the current year NoA or included as part of a future year NoA. 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, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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. This includes the following legislative mandates contained in the Consolidated Appropriation Act, 2012 (Public Law 112-74).

Limitation on Use of Funds for Promotion of Legalization of Controlled Substances

No funds may be used for any activity that promotes the legalization of any drug or other substance included in schedule I of the schedules of controlled substances established under section 202 of the Controlled Substances Act except for normal and recognized executive-congressional communications. This limitation shall not apply when there is significant medical evidence of a therapeutic advantage to the use of such drug or other substance or that federally sponsored clinical trials are being conducted to determine therapeutic advantage.

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

Any supplements to Cooperative Agreements will be subject to the same Cooperative Agreement terms and conditions as the parent award.

3. Reporting

Reporting requirements will be specified in the terms and conditions of award as applicable to the supplemental activities. In most non-competing continuation applications, the progress report and budget for the supplement must be included with, but clearly delineated from, the progress report and budget for the parent award. The progress report must include information about the activities supported by the supplement even if support for future years is not requested. Continuation of support for the supplement activities in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the NIH awarding component of progress for both the parent award and the supplement project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. This information is submitted with the Non-Competing Grant Progress Report, PHS 2590 or RPPR, and financial statements as required 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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)

Contact Center Phone: 800-518-4726

Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)

Telephone 301-710-0267

TTY 301-451-5936

Email: GrantsInfo@nih.gov

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: commons@od.nih.gov

Scientific/Research Contact(s)

Marsha F. Lopez, Ph.D., M.H.S

Division of Epidemiology, Services, and Prevention Research

National Institute on Drug Abuse (NIDA)/NIH

Telephone: 301-402-1846

Email: lopezmar@nida.nih.gov

Peer Review Contact(s)

Not Applicable

Financial/Grants Management Contact(s)

Pam Fleming

Chief, Grants Management Branch

National Institute on Drug Abuse (NIDA)/NIH

Telephone: 301-332-4859

Email: pfleming@nida.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.

Authority and Regulations

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.