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«Forms Approved Through 08/31/2018 Instructions for PHS 2590 Revised 03/2016 OMB No. 0925-0002 TABLE OF CONTENTS Notable and Upcoming Changes 1. ...»

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The DUNS number is considered the Federally-recognized unique identifier and is used for reporting purposes, particular those associated with the Federal Funding Accountability and Transparency Act (FFATA) of 2006 (P.L. 109-282).

FFATA also includes a requirement for reporting on subaward information. Therefore an accurate DUNS number for each first-tier subaward/consortium organization must also be provided as part of the Project/Performance Site Information.

Additional information on DUNS registration is found at:

http://fedgov.dnb.com/webform/displayHomePage.do.

A DUNS number is required for System for Award Management Registration (see 1.5.2 below).

1.5.2 System for Award Management (SAM) Registration for the Recipient Organization Prior to submission of all progress reports-paper and electronic-organizations are required to be registered in the System for Award Management (SAM) (formerly CCR). Organizations must maintain the currency of the information in the registry and renew the registration annually or more frequently if required by changes in information or another award term. For additional information regarding maintaining an active SAM registration, see NIH Guide Notice NOT-OD-11-004.

SAM is a government-wide registry for organizations doing business with the U.S. Government. The registry collects, validates, stores, and disseminates data in support of agency acquisition missions, including Federal agency contract and assistance awards. The SAM registry will be used by Federal agencies to validate the DUNS number provided. Validation of the DUNS number will be critical for agencies to comply with the requirements of the Federal Funding Accountability and Transparency Act (FFATA) of 2006 (P.L. 109-282).

Organizational information entered into the SAM must match that in the eRA Commons. Since CCR Registration can take several days to complete, the process should be started well in advance of a submission date to avoid potential delays. An AOR should be consulted to determine if the organization has properly completed and maintained SAM registration. Use the SAM.gov “Manage Entity” function to manage entity registrations. See the Grants Registrations User Guide at http:///www.sam.gov for additional information.

–  –  –

2.1 Face Page Items 1-5.

Provide the requested information, noting all changes in Section 12 of the Face Page.

Multiple PD/PIs: If multiple PD/PIs are part of the NIH approved project, use the Face Page-Continued page to provide items 2a – 2e for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI.” This individual should be listed in block 2a of the Face Page with all additional PD/PIs listed on the Face Page - Continued.

If this progress report submission includes a change in the contact PD/PI, include the name and contact information for the new contact PD/PI in Section 2a of the Face Page (Form Page 1). Note this change in Section 12 of the Face Page. All other PD/PIs should be listed using the Face Page-continued page.

Also address this change in the Progress Report Summary by indicating a Change in the Multiple PD/PI Leadership Plan. Remember, the designated contact PD/PI must be from the recipient institution if PD/PIs are from more than one Institution.

Item 6. Human Subjects Policy on research involving human subjects can be found in the NIH Grants Policy Statement or the competing application instructions.

Guidance pertaining to Human Subjects Research, including clinical trials and NIH-Defined Phase III Clinical Trials, may be found in Part II of the Supplemental Grant Instructions for All Competing Application and Progress Reports. Human subject definitions are found in Part III of the Supplemental Grant Instructions for All Competing Application and Progress Reports.

Check "No" if activities involving human subjects are not planned at any time during the proposed budget period. The remaining parts of Item 6 are then not applicable.Check "Yes" if activities involving human subjects are planned at any time during the budget period, either at the applicant organization or at any other project/performance site or collaborating institution. “Yes” should be checked even if the research is exempt from HHS regulatory requirements for the protection of human subjects.

Appropriately designating whether human subjects are involved may facilitate processing of an award. Information about how the regulations apply to the proposed research may be obtained from the Office for Human Research Protections (OHRP), Department of Health and Human Services, http://www.hhs.gov/ohrp, or the program administrator in the awarding component.

The PHS will make a final determination as to whether the proposed activities are covered by the regulations (i.e., non-exempt) or are in an exempt category.

Exempt Research. If all the activities are designated to be exempt from the regulations, insert the exemption number(s) corresponding to one or more of the six exemption categories listed in the NIH Grants Policy Statement or the competing application instructions or the Protection of Human Subject regulations (45 CFR 46.101(b)). The remaining parts of Item 6 are then not applicable.

Non-Exempt Research. If any of the planned activities involving human subjects are not exempt, complete the remaining parts of Item 6. If the applicant organization has a current approved Federal Wide Assurance on file with the OHRP, insert the Assurance number and the most recent date of approval by the Institutional Review Board (IRB) for the proposed activities. This date must not be earlier than one year before the start date for which the Progress Report is submitted. No Progress Report for continuation support should be submitted until the necessary certification of annual IRB review has been obtained.





Item 7. Vertebrate Animals.

PHS 2590 5 Policy on research activities involving vertebrate animals can be found in the NIH Grants Policy Statement or the competing application instructions. If activities involving vertebrate animals are not planned at any time during the proposed budget period, check "No." The remaining parts of Item 7 are then not applicable.

Check "Yes” if activities involving vertebrate animals are planned at any time during the budget period, either at the applicant organization or at any other project/performance site or collaborating institution. If the applicant organization has a current approved Animal Welfare Assurance on file with the Office of Laboratory Animal Welfare (OLAW), enter the Assurance number of the applicant organization in Item 7b. In addition, provide certification of current Institutional Animal Care and Use Committee (IACUC) approval of the animal activities. PHS Policy requires that IACUC approval occur within the past three years to be considered current. Progress reports for continuation support should NOT be submitted until the necessary verification of IACUC review has been obtained.

Item 8a. Direct Costs Requested for Next Budget Period Enter the direct costs from Form Page 2.

Item 8b. Total Costs Requested for Next Budget Period Enter the sum of the total direct costs from Item 8a and F&A costs.

Item 9. Inventions and Patents Check "No," if no inventions were conceived or reduced to practice during the course of work under this project during the previous budget period.

Check "Yes," if any inventions were conceived or reduced to practice during the course of work under this project during the previous budget period. Check the appropriate box to indicate whether this information has or has not been previously reported to the PHS or to the official responsible for patent matters at the recipient organization.

According to NIH Grants Policy and Federal law, NIH recipient organizations must promptly report all inventions that are either conceived or first actually reduced to practice using NIH grant funds. Invention reporting compliance as specified at 37 CFR 401.14 is described at http://www.iedison.gov. The recipient is encouraged to submit reports electronically using Interagency Edison (http://www.iedison.gov).

Inquiries or correspondence should be directed to:

Division of Extramural Inventions and Technology Resources Office of Policy for Extramural Research Administration, OER, NIH 6705 Rockledge Dr., MSC 7980 Bethesda, MD 20892-7980 (301) 435-1986 Information from these reports is retained by the NIH as confidential and submission does not constitute any public disclosure. Failure to report as described at 37CFR Section 401.14 is a violation of 35 USC 202 and may result in loss of the rights of the recipient organization.

Item 10. Project/Performance Sites Indicate where work described will be conducted.

If work will be conducted at the applicant institution, state “applicant” under Name of Organization; it is not necessary to re-enter the address, DUNS, and Congressional District if it is the same as that provided in block 3 of the Face Page. If more than one site, use the Project/Performance Site Format Page to list all the sites, including Department of Veterans Affairs (VA) facilities and foreign sites. One of the sites indicated must be the applicant organization or be identified as off site in accordance with the applicant organization’s negotiated Facilities and Administrative (F&A) agreement.

PHS 2590 6 If including a NEW Project/Performance Site where either human subjects or vertebrate animals will be involved, indicate a change on the Progress Report Summary, Form Page 5, and address the change in the Summary under D. Plans, item A or B, as appropriate.

If a Project/Performance Site is engaged in research involving human subjects, the applicant organization is responsible for ensuring that the Project/Performance Site operates under an appropriate Federal Wide Assurance for the protection of human subjects and complies with 45 CFR Part 46 and other NIH human subject related policies described in Part II of the Supplemental Grant Instructions for All Competing Application and Progress Reports and the NIH Grants Policy Statement.

For research involving live vertebrate animals, the applicant organization must ensure that all Project/Performance Sites hold OLAW-approved Assurances. If the applicant organization does not have an animal program or facilities and the animal work will be conducted at an institution with an Assurance, the applicant must obtain an Assurance from OLAW prior to an award.

Item 11. Official Signing for Applicant Organization Name of individual authorized to act for the applicant organization and to assume the obligations imposed by the Federal laws, requirements, and conditions for a grant or grant application, including the applicable Federal regulations.

Provide name, title and contact information for the signing official.

Item 12: Face Page Corrections and Changes Use this space for corrections and changes.

Item 13. Applicant Organization Certification and Acceptance An original signature, in ink, is required.

Only an institutional official with formal designated or delegated authority to sign on behalf of the organization may sign the form. The signature must be dated. In signing the Face Page, the AOR of the applicant organization certifies that the applicant organization will comply with all applicable assurances and certifications listed below. The applicant organization is responsible for verifying the accuracy, validity, and conformity with the most current institutional guidelines of all the administrative, fiscal, and scientific information in the progress report, including the Facilities and Administrative cost rate. Deliberate withholding, falsification, or misrepresentation of information could result in administrative actions, such as withdrawal of a progress report, suspension and/or termination of an award, debarment of individuals, as well as possible criminal penalties. The signer further certifies that the applicant organization will be accountable both for the appropriate use of any funds awarded and for the performance of the grant-supported project or activities resulting from this progress report. The recipient institution may be liable for the reimbursement of funds associated with any inappropriate or fraudulent conduct of the project activity.



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