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NIH released a new notice that the PHS 398 instructions and forms have been
updated. Please make sure you read the document attached below or from the NIH
website at:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-028.htm
Notice Number: NOT-OD-08-028
Key Dates
Release Date: January 4, 2008
Issued by
National Institutes of Health (NIH)
EFFECTIVE DATE: The newly revised "Application for a DHHS Public Health
Service Grant" (PHS 398, rev. 11/07) instructions and forms are now available
and will be accepted for due dates on or after January 25, 2008. All
applications received for May 25, 2008 and subsequent due dates must use the
new instructions and forms. During the transition period the previous version
(interim revision 04/2006) will continue to be available, and applications
using the previous version will be accepted. However, applications submitted
using instructions and forms other than the PHS 398 (rev 11/07) for May 25,
2008 and subsequent due dates will be returned to the applicant.
NIH continues to transition grant mechanisms from the PHS 398 to the SF424
(R&R) and electronic submission through Grants.gov. The paper PHS 398 is
required for all grant mechanisms that have not transitioned to the SF424
(R&R), including New, Resubmission, Renewal, and Revision applications.
Mechanisms that have not yet transitioned to electronic submission include
research training grants, research career development awards, changes of
grantee institution, and complex mechanisms such as cooperative agreements,
program project and centers. Once a mechanism has transitioned to electronic
submission the applicant must apply through Grants.gov using the SF424
(R&R) and electronic PHS 398 components that are provided as part of the
electronic application forms. For more information on NIH's transition plans,
including a timeline for the transition of various mechanisms, see the website
for Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/.
The newly revised instructions and forms are available at http://grants.nih.gov/grants/forms.htm.
The forms available on the website continue to be provided in two formats--MS
Word and PDF-fillable using Adobe Acrobat Reader Software. Free Adobe Software
may be accessed at http://www.adobe.com/products/acrobat/readstep.html.
Applicants are strongly 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.
Notable Changes to the PHS 398 Instructions (rev.
11/07):
This edition of the PHS 398 implements a number of important policy changes,
including NIH Policy for Sharing of Data Obtained in NIH-Supported or Conducted
Genome-Wide Association Studies, and registration of clinical trials in
ClinicalTrials.gov as required by Public Law 110-85. The Foreword of the
instructions includes a Summary of Changes (see Page I-1). Additional changes
are highlighted as follows:
Implementation of Grants.Gov Terminology
As part of the ongoing effort to keep the PHS 398 and the SF424 (R&R)
synchronized, new terminology is implemented in the PHS 398:
- OLD TERM NEW TERM
- Competing continuation application Renewal application
- Revision or amendment [to application] Resubmission application
- Competing supplement Revision application
- Principal Investigator Program Director/Principal Investigator (PD/PI)
- Key Personnel Senior/key Personnel
- Performance site Project/performance site
- Duly authorized representative Authorized Organizational
Representative
- Definition of New Investigator (revised to provide clarity)
Structure of Document
- Instructions are reorganized for greater consistency with the SF424
(R&R) and PHS 398 Component Instructions used for electronic submission. A
numerical reference system is incorporated in order to more closely parallel
the SF424 (R&R) instructions.
- In Part I, the Research Plan is reorganized for consistency with the SF424
(R&R) instructions, with one exception: The section titled ""Bibliography
and References Cited" in the PHS 398 is requested in Section 5.5 Content of
Research Plan, item 7.a; while in the SF424 (R&R), this information is
located in 4.4 Other Project Information Component, as item 8.
- Part II is revised for purposes of clarity and ease of reference, and the
definitions related to human subjects research are moved to Part III.
Suggested Cover Letter Format
- A suggested cover letter format is provided for greater consistency and to
facilitate the use of requests for specific Institutes or Centers (ICs) or
Scientific Review Groups.
Budget Justification
- The instructions for justification of a foreign applicant or foreign
component are reworded for consistency with NIH criteria for funding a foreign
project (i.e., the project must present special opportunities for furthering
research programs through the use of unusual talents, resources, populations,
or environmental characteristics that augment existing U.S. resources).
Indefinite Plans for Involvement of Human Subjects or Use of
Vertebrate Animals
- Instructions for the Research Plan sections addressing human subjects and
vertebrate animals are modified to provide guidance to applicants when plans
are indefinite at the time of application.
Instructions for Career Development Award Applications
- The term mentor is used in place of sponsor.
- Numerous instructional clarifications are provided.
Institutional Research Training Application Including Ruth L.
Kirschstein-NRSA Applications
- Instructions and forms are renamed to acknowledge that there are
institutional training programs that are not Ruth L. Kirschstein National
Research Service Awards.
- Implementation of the NIH diversity recruitment and retention policy
described in institutional Kirschstein-NRSA training grant, institutional
career development, and research education Funding Opportunity Announcements
(e.g., PA-06-048).
- Narrative instructions for training data tables are replaced with fillable
format tables and examples of completed tables.
- Provision for multiple PD/PIs is included for institutional training
grants.
Appendix Format
Appendix material is to be submitted on CDs in PDF format, and will no
longer be accepted on paper (see NIH Guide Notice OD-08-031).
Part II, Instructions for Preparing the Protection of Human Subjects Section of
the Research Plan
- All exemptions appear in one scenario (Scenario C).
- A scenario for "Delayed Onset of Human Subjects Research" is
incorporated.
Changes of Note to Specific PHS 398 Form and Format
Pages:
- 398 Face Page - IACUC approval date (formerly item 5a) deleted since
information is collected only as Just-in-Time; Item 5b renumbered 5a.
- 398 Form Page 2 and Project/Performance Site Format Page -Form page 2 is
revised, and the Project/Performance Site Format Page created to collect
information for each project/performance site as required by the Federal
Financial Accountability and Transparency Act.
Modular Budget Form Page
- Form page is no longer included since mechanisms using modular budgets have
transitioned to SF424 (R&R) and do not use the PHS 398 paper application.
Modular budget form pages still exist as part of electronic submission.
Checklist Form Page
- A Disclosure Permission Statement checkbox is added to allow disclosure of
certain information to organizations that may be interested in possible
collaboration, investment, etc.
Institutional Training Grant Data Tables
- Fillable format pages and samples of completed tables provided to afford
structure for and promote consistency in data.
Inquiries on any changes to the forms and instructions may be directed
to:
Grants Info
Office of Extramural Research
National Institutes of Health
Telephone: 301-435-0714
TTY: 301-435-0088
Email: Grantsinfo@nih.gov
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