REVISED PHS 398 AND PHS 2590 NOW AVAILABLE Release Date: July 10, 2001 (See Addenda NOT-OD-01-054, NOT-OD-02-002,
and NOT-OD-02-027 and NOT-OD-02-059) NOTICE: NOT-OD-01-049 National Institutes of Health EFFECTIVE DATE: Applications using the newly revised Application for a DHHS Public Health Service Grant (PHS 398, rev. 5/01) and U.S. Department of Health and Human Services Public Health Service Non- Competing Grant Progress Report (PHS 2590, rev. 5/01) instructions and forms will be accepted immediately. All applications received on or after January 10, 2002 must use the new forms. Applications using the previous version (rev. 4/98) of the PHS 398 and PHS 2590 will be accepted through January 9, 2002. After this date, applications using the previous version (rev. 4/98) will be returned to the applicant. The newly revised instructions and forms are available at http://grants.nih.gov/grants/forms.htm. The forms available on the website have been modified to enable the fields to be filled in directly using Adobe Acrobat Reader Software. Free Adobe Software may be accessed at http://www.adobe.com/products/acrobat/readstep.html. Applicants are encouraged to access the instructions and forms via the Internet because they provide valuable links to current policy documents and allow easy navigation of the instructions. For further information, contact GrantsInfo@nih.gov. As in the past, applicants should read the instructions carefully. The following is a list of notable changes. Notable Changes to the PHS 398 (rev. 5/01): o The PHS 398 (rev. 5/01) is available primarily in electronic format. o Forms have been modified to enable the fields to be filled in directly using Adobe Acrobat Reader Software. o Forms and Instructions incorporate the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grant Programs. o Links have been added to instructions on required Policy Information, Guide Notices and Procedures. o Form Page 1: Items for Social Security Number and Organizational Code have been eliminated. Human Subjects Research Box (Item 4) has been modified as follows: o 4a: No/Yes check boxes for Research Exempt and Exemption Number , but no IRB approval date. o 4b: Human Subjects Assurance Number using the instructions from the Office for Human Research Protections (OHRP). o 4c: No/Yes checkboxes for NIH Defined Phase III Clinical Trial o Modular Budget Format Page: Budget Justification Page for Modular Research Grant Applications. A format page and specific instructions are provided for preparing grant applications submitted in a modular format. o Biographical Sketch Format Page: A standardized format for the Biographical Sketch (Maximum of four pages for each key person will be used for all (modular and other) research grant applications. A format page, including a sample biographical sketch, has been developed. o Resources Format Page: This is now a format page rather than a form page. As long as the format is followed, the space allotted for each item is flexible. o Checklist Form Page: Assurances and Certifications. This section has been updated to include Research on Transplantation of Human Fetal Tissue, Women and Minority Inclusion in Clinical Research Policy, Inclusion of Children Policy, Recombinant DNA, and for STTR only, Certification of Research Institution Participation. o Facilities and Administrative (F&A) Costs: This section includes spaces to calculate F & A costs for the initial year through the entire budget period. (F& A) costs were formerly referred to as Indirect Costs for some types of applications.) o Research Plan: This section was revised to place all human subjects issues under the Human Subjects heading. o Race/Ethnicity Tables: Updated and changed to follow the Office of Management and Budget (OMB) criteria. o Other Support Format Page: A standardized format for the other support information will be used for all (modular and other) research grant applications. Do NOT submit Other Support information with the application. NIH staff will request this information at an appropriate time after peer review. o Appendix Material: Applicants may ONLY include manuscripts that have been accepted for publication. Manuscripts submitted for publication may no longer be included. Notable Changes to the PHS 2590 (rev. 5/01): o PHS 2590 is now named Grant Progress Report o The PHS 2590 (rev. 5/01) is available primarily in electronic format at http://grants.nih.gov/grants/forms.htm. o Forms have been modified to enable the fields to be filled in directly using Adobe Acrobat Reader Software. o Links have been added to instructions on required Policy Information, Guide Notices and Procedures. o Form Page 1: Items for Social Security Number and Organizational Code have been eliminated. Human Subjects Research Box (Item 6) has been modified as follows: o 6a: No/Yes check boxes for Research Exempt and Exemption Number , and IRB approval date. o 6b: Human Subjects Assurance Number using the instructions from the Office for Human Research Protections (OHRP). o 6c: No/Yes checkboxes for NIH Defined Phase III Clinical Trial. o Race/Ethnicity Tables: Updated and changed to follow the Office of Management and Budget (OMB) criteria. For Institutional National Research Service Award Progress Reports: o NRSA Summary of Trainees form has a revised race/ethnicity table for reporting number of trainees. Special Note: NIH will continue to provide the pre-printed PHS 2590 Face Page for awards with start dates through September 2002. After September 2002, as part of our transition to electronic forms and submission, the NIH will discontinue mailing the pre-printed PHS 2590 Face Page. Notification of a progress report due date will become electronic. If you have any questions about this using the new forms and the Adobe Acrobat Reader Software process, please do not hesitate to contact us on (301) 435-0940. Direct inquiries to: Ms. Jan Heffernan Office of Policy for Extramural Research Administration National Institutes of Health 6705 Rockledge Drive, Room 1196 Bethesda, MD 20892 Telephone: (301) 435-0940 FAX: (301) 435-3059 Email: HeffernJ@od.nih.gov


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