![](media/image1.png){width="5.823611111111111in"
height="2.4270833333333335in"}

**U.S. Department of Health and Human Services\
Public Health Service**

**Non-Competing Continuation Progress Report (PHS 2590)**

Instructions for PHS 2590

Revised 11/2007

> Forms Approved Through 11/30/2010

OMB No. 0925-0001

TABLE OF CONTENTS

[Notable Changes 1](#notable-changes)

[1. Continuation Progress Report 3](#continuation-progress-report)

[1.1 Continuation Progress Reports for Other PHS Agencies
3](#continuation-progress-reports-for-other-phs-agencies)

[1.2 Submission of Progress Report 3](#submission-of-progress-report)

[1.3 Electronic Submission of SNAP Progress Reports (eSNAP)
4](#electronic-submission-of-snap-progress-reports-esnap)

[1.4 GrantsInfo, DEOIR, OER, National Institutes of Health
4](#grantsinfo-deoir-oer-national-institutes-of-health)

[1.5 Paperwork Burden 5](#paperwork-burden)

[1.6 Registration Reminders 5](#registration-reminders)

[1.6.1 DUNS Registration for the Organization & Subaward/Consortium\
Organizations
5](#duns-registration-for-the-organization-subawardconsortium-organizations)

[1.6.2 CCR Registration for the Organization
5](#ccr-registration-for-the-organization)

[2. Preparing Progress Reports 6](#preparing-progress-reports)

[2.1 NIH Streamlined Noncompeting Award Process (SNAP)
6](#nih-streamlined-noncompeting-award-process-snap)

[2.1.1 SNAP Instructions for Submitting the Progress Report
6](#snap-instructions-for-submitting-the-progress-report)

[2.1.2 SNAP Questions 7](#snap-questions)

[2.2 Specific Instructions 8](#specific-instructions)

[2.2.1 Face Page 8](#face-page)

[Items 1-5. 8](#items-1-5.)

[Item 5. Administrative Official 8](#item-5.-administrative-official)

[Item 6. Human Subjects 8](#item-6.-human-subjects)

[Item 7. Vertebrate Animals. 9](#item-7.-vertebrate-animals.)

[Item 8a. Direct Costs Requested for Next Budget Period
9](#item-8a.-direct-costs-requested-for-next-budget-period)

[Item 8b. Total Costs Requested for Next Budget Period
9](#item-8b.-total-costs-requested-for-next-budget-period)

[Item 9. Inventions and Patents 9](#item-9.-inventions-and-patents)

[Item 10. Project/Performance Sites
10](#item-10.-projectperformance-sites)

[Item 11. Official Signing for Applicant Organization
10](#item-11.-official-signing-for-applicant-organization)

[Item 12: Face Page Corrections and Changes
10](#item-12-face-page-corrections-and-changes)

[Item 13. Applicant Organization Certification and Acceptance
10](#item-13.-applicant-organization-certification-and-acceptance)

[Assurances/Certifications 11](#assurancescertifications)

[2.2.2 Detailed Budget for Next Budget Period
11](#detailed-budget-for-next-budget-period)

[Consultant Costs 12](#consultant-costs)

[Equipment 13](#equipment)

[Supplies 13](#supplies)

[Travel 13](#travel)

[Patient Care Costs 13](#patient-care-costs)

[Alterations and Renovation 13](#alterations-and-renovation)

[Other Expenses 14](#other-expenses)

[Consortium/Contractual Costs 14](#consortiumcontractual-costs)

[2.2.3 Budget Justification 14](#budget-justification)

[2.2.4 Biographical Sketch 14](#biographical-sketch)

[2.2.5 Other Support 15](#other-support)

[2.2.6 Progress Report Summary 15](#progress-report-summary)

[A. Specific Aims 15](#a.-specific-aims)

[B. Studies and Results 16](#b.-studies-and-results)

[C. Significance 16](#c.-significance)

[D. Plans 16](#d.-plans)

[E. Publications 20](#e.-publications)

[F. Project-Generated Resources 21](#f.-project-generated-resources)

[2.2.7 Checklist 21](#checklist)

[Program Income 21](#program-income)

[Assurances/Certifications 21](#assurancescertifications-1)

[Facilities and Administrative Costs
21](#facilities-and-administrative-costs)

[2.2.8 Senior/Key Personnel Report 21](#seniorkey-personnel-report)

[3. Final Progress Report 22](#__RefHeading___Toc186430779)

[4. General Information 23](#general-information)

[4.1 Social Security Number 23](#social-security-number)

[4.2 Government Use of Information Under Privacy Act
23](#government-use-of-information-under-privacy-act)

[4.3 Information Available to the Program Director(s)/Principal
Investigator(s) (PD/PIs)
24](#information-available-to-the-program-directorsprincipal-investigators-pdpis)

[4.4 Information Available to the General Public
24](#information-available-to-the-general-public)

[4.5 Access to Research Data 24](#access-to-research-data)

[4.6 ClinicalTrials.gov Requirement 25](#clinicaltrials.gov-requirement)

[5. Additional Instructions for Preparing Continuation Career
Development Award\
(CDA) Progress Reports
26](#additional-instructions-for-preparing-continuation-career-development-award-cda-progress-reports)

[5.1 Specific Instructions 26](#specific-instructions-1)

[5.1.1 Detailed Budget for Next Budget Period
26](#detailed-budget-for-next-budget-period-1)

[Personnel 26](#personnel)

[5.1.2 Biographical Sketch 26](#biographical-sketch-1)

[5.1.3 Other Support 26](#other-support-1)

[5.1.4 Progress Report Summary 26](#progress-report-summary-1)

[G. Research Development. 27](#g.-research-development.)

[H. Other Activities. 27](#h.-other-activities.)

[I. Research Development and Other Activities Planned for the Next Year.
27](#i.-research-development-and-other-activities-planned-for-the-next-year.)

[J. Mentor\'s Report. 27](#j.-mentors-report.)

[5.1.5 Study Subjects 27](#study-subjects)

[5.1.6 Checklist 27](#checklist-1)

[5.1.7 Senior/Key Personnel Report 28](#seniorkey-personnel-report-1)

[6. Additional Instructions for Preparing a Progress Report for an
Institutional\
Research Training Grant, Including Ruth L. Kirschstein National
Research\
Service Awards
29](#additional-instructions-for-preparing-a-progress-report-for-an-institutional-research-training-grant-including-ruth-l.-kirschstein-national-research-service-awards)

[6.1 Specific Instructions 29](#specific-instructions-2)

[6.1.1 Face Page 29](#face-page-1)

[Items 1-5. 29](#items-1-5.-1)

[Item 6. Human Subjects 29](#item-6.-human-subjects-1)

[Item 7. Vertebrate Animals 30](#item-7.-vertebrate-animals)

[Item 9. Inventions and Patents 30](#item-9.-inventions-and-patents-1)

[Item 13. Applicant Organization Certification and Acceptance
30](#item-13.-applicant-organization-certification-and-acceptance-1)

[6.1.2 Next Budget Period 30](#next-budget-period)

[6.1.3 Budget Justification 32](#budget-justification-1)

[6.1.4 Biographical Sketch 32](#biographical-sketch-2)

[6.1.5 Other Support 32](#other-support-2)

[6.1.6 Progress Report Summary 32](#progress-report-summary-2)

[A. Training Program 32](#a.-training-program)

[B. Study Subjects 33](#b.-study-subjects)

[C. Trainees 33](#c.-trainees)

[6.1.7 Checklist 34](#checklist-2)

[Facilities and Administrative (Indirect) Costs
34](#facilities-and-administrative-indirect-costs)

[6.1.8 Senior/Key Personnel Report 34](#seniorkey-personnel-report-2)

[7. Additional Instructions for Preparing a Progress Report for an SBIR
and STTR\
Award
35](#additional-instructions-for-preparing-a-progress-report-for-an-sbir-and-sttr-award)

[Fast-Track SBIR/STTR Awards 35](#fast-track-sbirsttr-awards)

[Final Report Requirements 36](#final-report-requirements)

[Phase II Final Progress Report 36](#phase-ii-final-progress-report)

# Notable Changes

Instructions

-   Restructuring of instructions for consistency with the SF424(R&R)
    and PHS398 format. Numerous clarifications provided; redundancies
    removed; references updated. A numerical reference system is
    incorporated to more closely parallel the SF424 (R&R) and PHS398
    instructions.

-   Submission process change: Only the signed original progress report
    is required (no copies should be submitted) to be submitted to the
    centralized mailing address.

-   SNAP question #3 -- instruction rewritten to clarify the meaning of
    "Total approved budget."

Implementation of Grants.Gov Terminology

-   As part of the ongoing effort to keep the PHS 2590, the PHS398 and
    the SF424 (R&R) synchronized, new terminology is implemented
    throughout this document. For reference, the following table is
    provided:

  -----------------------------------------------------------------------
  OLD TERM                      NEW TERM
  ----------------------------- -----------------------------------------
  Non-Competing Continuation    Continuation Progress Report
  Progress Report               

  Competing/Administrative      Revision application
  Supplement                    

  Principal Investigator        Program Director/Principal Investigator

  Key Personnel                 Senior/key Personnel

  Performance site              Project/performance site

  Duly authorized               Authorized Organizational Representative
  representative                
  -----------------------------------------------------------------------

Instructions for Career Development Award Applications

-   Term *mentor* is used in place of *sponsor*. Also, there is specific
    guidance for programs that include a requirement to become a mentor.

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.

-   Replaced the use of the Human Subject Inclusion Enrollment Report
    for reporting trainee diversity with a new Trainee Diversity Report
    form page.

-   The NIH diversity recruitment and retention policy is implemented,
    defining three categories of candidates: racial and ethnic
    minorities underrepresented in science, individuals with
    disabilities, and individuals from disadvantaged backgrounds.

Registration Reminders

-   Addition of requirement for DUNS and CCR registration as part of the
    Federal Financial Assistance Transparency Act (FFATA).

Progress Report Narrative for T's and K's

-   Maximum Length of progress report narrative expanded from 2 pages to
    4 pages for Training and Career Development Awards.

**[Changes to specific form and format pages:]{.underline}**

Face Page

-   Redesigned to include FFATA data.

-   Removed boxes for "Full IRB or Expedited Review."

-   Item 11a. PI/PD name removed because of redundancy.

Project/Performance Site Format Page

-   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.

Checklist Page (Form Page 6)

-   Assurances/Certifications itemized list removed from form and refers
    grantees to the list in the instructions and to Part III of the PHS
    398 for definitions.

# 1. Continuation Progress Report

Progress reports are required to continue support of a PHS grant and for
NIH grantees, must be **submitted two months** before the beginning date
of the next budget period using the PHS 2590. All NIH progress reports
must be submitted **to the centralized mailing address:**

Division of Extramural Activities Support, OER\
National Institutes of Health\
6705 Rockledge Drive, Room 2207, MSC 7987\
Bethesda, MD  20892-7987 (for regular or US Postal Service Express
mail)\
Bethesda, MD  20817 (for other courier/express mail delivery only)\
Phone Number:  (301) 594-6584

## 1.1 Continuation Progress Reports for Other PHS Agencies

While other PHS awarding agencies use these same application forms, some
may have application requirements that are different from those for NIH
grantees. For agency specific instructions for AHRQ, CDC, FDA and IHS
refer to the terms and conditions of the Notice of Award (NoA) or their
website listed in the table below.

Further, as you will see references to the NIH Grants Policy Statement
(NIHGPS) throughout these instructions, please note that the NIHGPS is
not applicable to the other PHS awarding agencies. The agencies listed
below follow the Health and Human Services Grants Policy Statement
(HHSGPS) as their awarding guidance (<http://www.hhs.gov/grantsnet/>).

[]{#table_1_1 .anchor}

  ----------------------------------------------------- -----------------
  [**AGENCY FOR HEALTHCARE RESEARCH AND                 301-427-1447
  QUALITY**](http://www.ahrq.gov/)[]{#ahrq .anchor}     

  [**CENTERS FOR DISEASE CONTROL AND                    1-800-232-4636
  PREVENTION**](http://www.cdc.gov/)[]{#cdc .anchor}    

  [**INDIAN HEALTH                                      301-443-0578
  SERVICE**](http://www.ihs.gov/)[]{#ihs .anchor}       

  [**FOOD AND DRUG                                      301-827-7185
  ADMINISTRATION**](http://www.fda.gov/)[]{#fda         
  .anchor}                                              
  ----------------------------------------------------- -----------------

## 1.2 Submission of Progress Report

NIH grantees are required to submit the completed, signed original
progress report (with required signature). NIH grantees access a website
to determine which progress reports are due. The Office of Policy for
Extramural Research Administration, OER, National Institutes of Health
(NIH) hosts the website located at: [http://era.nih.gov/
userreports/pr_due.cfm](http://era.nih.gov/userreports/pr_due.cfm). NIH
grantees are responsible for periodically checking the list, which is
updated on/around the 30th of each month. In addition to this website,
e-mail reminders are sent to the PD/PI.

Progress report due dates are also available in the Commons Status
system. Commons registered institutions and PD/PIs also have access to
pre-populated face pages for the 2590 Progress Report via Status. For
more information on the Commons, see:
<https://commons.era.nih.gov/commons/index.jsp>.

Additional instructions for preparing continuation progress reports for
Career Development Awards are found in [Section
5](#additional-instructions-for-preparing-continuation-career-development-award-cda-progress-reports)
and additional instructions for preparing progress reports for
Institutional Research Training Awards are found in [Section
6](#additional-instructions-for-preparing-a-progress-report-for-an-institutional-research-training-grant-including-ruth-l.-kirschstein-national-research-service-awards).

You may substitute computer-generated facsimiles for any of the forms.
Substitute forms should be printed in black ink, and maintain the exact
wording and format of the government-printed forms, including all
captions and spacing. Any questions on completing this continuation
progress report should be directed to the awarding component.

The forms, in Adobe Acrobat and Microsoft Word, can be downloaded from
the NIH web site at <http://grants.nih.gov/grants/forms.htm>.
Investigators are encouraged to retain these instructions for future
submissions.

Use English only and avoid jargon. If terms are not universally known,
spell out the term the first time it is used and note the appropriate
abbreviation in parentheses. The abbreviation may be used thereafter.
Prepare the progress report single-sided and single-spaced, staying
within the margin limitations indicated on the form. NIH requires the
use of Arial, Helvetica, Palatino Linotype or Georgia typeface, a black
font color and a font size of 11-points or larger. A symbol font may be
used to insert Greek letters or special characters; the font size
requirement still applies. These fonts will conform to appropriate
formatting specifications. The progress reports must be clear and
readily legible.

Figures, charts, tables, figure legends, and footnotes may be smaller in
size but must be black ink, readily legible, and follow the font
typeface requirement.

**Do not bind or staple the original.** An incomplete or incorrectly
prepared continuation progress report may result in a delay in award of
funds.

## 1.3 Electronic Submission of SNAP Progress Reports (eSNAP)

NIH Grantee Institutions have the ability to electronically submit SNAP
progress reports for most awards. This system provides grantees the
ability to enter data into forms as well as upload files for the
progress report and other supporting documentation. For more information
on eSNAP, visit the eRA Commons at: [https://commons.era.nih.gov/
commons/index.jsp](https://commons.era.nih.gov/commons/index.jsp).

If you are using the NIH eSNAP to electronically prepare and submit your
non-competing (T-5) SNAP progress report, do not use the PHS 2590
fillable form pages for any file uploads. Text inserted into the
fillable form pages is not saved once the progress report is submitted
to NIH. Guidance on eSNAP submission is documented in the eSNAP User
Guide found at: <http://era.nih.gov/commons/index.cfm>. Questions on
eSNAP submission should be directed to:

> Email the Commons Help Desk at <commons@od.nih.gov>.
>
> Call the Commons Help Desk at 1-800-504-9552 (toll-free) or
> 301-402-7469; 301-451-5939 (TTY). Business hours are M-F 7am-8pm
> Eastern Time.

AHRQ, CDC, FDA and IHS do not participate in the eSNAP process.

## 1.4 GrantsInfo, DEOIR, OER, National Institutes of Health

The Division of Extramural Outreach and Information Resources (DEOIR)
provides general information about **NIH** extramural research and
research training programs, funding mechanisms, the peer review system,
and progress report procedures. The NIH grants Web site is at
<http://grants.nih.gov/grants/oer.htm>. The e-mail address is:
[GrantsInfo@nih.gov](mailto:grantsinfo@nih.gov). The phone number is
(301) 435-0714.

## 1.5 Paperwork Burden

PHS estimates that it will take approximately 15 hours to complete this
progress report. Items such as human subjects are cleared and accounted
for separately, and are not part of the time estimate for completing
this form. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays a
currently valid OMB control number. If you have comments regarding the
burden estimate or other aspect of the collection of information,
including suggestions for reducing the burden, send comments to: NIH,
Project Clearance Office, 6705 Rockledge Drive MSC 7974, Bethesda, MD
20892-7974, ATTN: PRA (0925-0001). Do not send progress reports to this
address.

## 1.6 Registration Reminders

### 1.6.1 DUNS Registration for the Organization & Subaward/Consortium Organizations

A Data Universal Numbering System (DUNS) number is required for all
progress reports-paper and electronic-and must be obtained prior to
submission. For organizations that already have multiple DUNS numbers,
one DUNS number should be selected by an authorized organizational
official and used consistently for all submissions. The authorized
organizational representative should be consulted to determine the
appropriate number to use.

The DUNS number is considered the Federally-recognized unique identifier
and is used for reporting purposes, particular those associated with the
*Federal Financial Assistance 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 additional
subaward/consortium organization must also be provided.

Additional information on DUNS registration is found at:
<http://fedgov.dnb.com/webform/displayHomePage.do>.

A DUNS number is required for Central Contractor Registration (see 1.6.2
below).

### 1.6.2 CCR Registration for the Organization

Prior to submission of all progress reports-paper and
electronic-organizations are required to be registered in the Central
Contractor Registration (CCR). Organizations must maintain the currency
of the information in the registry and renew the registration annually.
A DUNS number is required for CCR registration.

CCR 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 CCR 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 Financial Assistance Transparency
Act (FFATA) of 2006* (P.L. 109-282).

Organizational information entered into the CCR 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 authorized organizational representative
should be consulted to determine if the organization has properly
completed and maintained CCR registration. Additional information on CCR
registration is found at: <http://www.ccr.gov/>.

# 2. Preparing Progress Reports

[]{#snap .anchor}For submission of SNAP progress reports, follow the
instructions under Section 2.1 below.

For submission of non-SNAP progress reports, follow the instructions
under [Section 2.2.2](#detailed-budget-for-next-budget-period), Detailed
Budget for Next Budget Period. These instructions are applicable to
grantees of AHRQ, CDC, FDA and IHS which do not participate in the SNAP
process.

## 2.1 NIH Streamlined Noncompeting Award Process (SNAP)

The NIH has developed this simplified process for the submission of
information prior to the issuance of a noncompeting award. For
additional information on completing any part of PHS 2590, refer to the
Specific Instructions (Section 2.2). When additional information is
required, use the appropriate form page. For example, the biographical
sketch page is still required for new senior/key personnel and/or new
other significant contributors.

These simplified instructions apply to all R series grant mechanisms
except for Outstanding Investigator Grants (R35s), Phase 1 Small
Business Innovation Research Grants (R43) and Phase 1 Small Business
Technology Transfer Grants (R41). For Phase I SBIR/STTR awards that
exceed one year and Phase II SBIR/STTR, grantees should review the
Notice of Award to determine if their project is subject to or excluded
from the SNAP provisions. Career award mechanisms (Ks) are also
routinely covered under SNAP. Those mechanisms routinely excluded from
SNAP are generally those that do not have the authority to automatically
carry over unobligated balances (centers, cooperative agreements,
institutional training including Kirschstein-NRSA grants, non-Fast Track
Phase I SBIR and STTR awards), clinical trials (regardless of
mechanism), Program Project Grants (P01s) and Outstanding Investigator
Grants (R35s). All NIH award notices identify whether the grant is
subject to or excluded from SNAP.

### 2.1.1 SNAP Instructions for Submitting the Progress Report

Complete Face Page (Form Page 1) except for items 8a and 8b, the
Progress Report Summary (Form Page 5), and the Senior/Key Personnel
Report (Form Page 7). Complete the Checklist Page (Form Page 6) only if
there is a change in Project/Performance site(s) that will affect
facilities and administrative costs *and/or if program income is
anticipated*. If program income is anticipated, the Checklist should
reflect the amount and source(s). The Progress Report should begin on
Form Page 5. Complete all information and provide a brief, two-page
progress report following the instructions for [Progress Report
Summary](#progress-report-summary). Tables and figures that summarize
key accomplishments are not counted in the two-page limit.

For those preparing continuation CDA progress reports under SNAP, use
the SNAP instructions found in this section and the additional
abbreviated instructions found in [Section
5](#additional-instructions-for-preparing-continuation-career-development-award-cda-progress-reports),
which includes Items 5.1.4 through 5.1.7.

### 2.1.2 SNAP Questions

**Answer the following questions at the beginning of Form Page 5**.
Blank pages should be used for the Progress Report if inadequate space
remains on Form Page 5 to answer the questions and to begin the report
on the research progress. The questions to be addressed are as follows:

**Has there been a change in the other support of senior/key personnel
since the last reporting period?**

If yes, explain the change(s); if no, so state. Specific information is
to be provided only if active support has changed. If a previously
active grant has terminated and/or if a previously pending grant is now
active, **submit complete Other Support information** using the
suggested format and instructions found in the PHS 398 application
(<http://grants.nih.gov/grants/funding/phs398/phs398.html>). Annotate
this information so it is clear what has changed from the previous
submission. Submission of other support information is not necessary if
support is pending or for changes in the level of effort for active
support reported previously.

Other support information should be submitted only for the PD/PI and for
those individuals considered by the PD/PI to be key to the project.
Senior/key personnel are defined as individuals who contribute in a
substantive measurable way to the scientific development or execution of
the project, whether or not a salary is requested. Do not routinely
include Other Support information for "Other Significant Contributors";
e.g., those that may contribute to the scientific development or
execution of the project, but are not committing any specified
measurable effort to the project. However, if the level of involvement
for an individual previously listed in this category has changed such
that they are now considered "senior/key personnel," this change should
be indicated in this section and Other Support information submitted.

**Will there be, in the next budget period, a significant change in the
level of effort for the PD/PI(s) or other senior/key personnel
designated on the Notice of Award from what was approved for this
project?**

If yes, please explain (e.g., decreased level of effort from 4.8 CY
months to 3.6 CY months); if no, so state. A significant change in level
of effort is defined in Federal regulations as a **25 percent
reduction** in time devoted to the project. For example, if a
NoA-specified individual on the project is expected to reduce his/her
effort from 4.8 CY months to 3.6 CY months, which represents a 25
percent reduction in the level of effort, an explanation must be
provided at the beginning of the Progress Report Summary (Form Page 5).

**Is it anticipated that an estimated unobligated balance (including
prior year carryover) will be greater than 25 percent of the current
year\'s total approved budget?**

If yes, please provide an explanation; if no, so state. An explanation
should include why there is a significant balance and how it will be
spent if carried forward into the next budget period. The "total
approved budget" equals the current fiscal year award authorization plus
any carryover of funds from a prior year. The numerator equals the total
amount available for carryover and the denominator equals the current
year's total approved budget.

Program or grants management staff may require additional information in
order to evaluate the project for continued funding. Failure to provide
this information will result in a delayed award.

If a project or grantee organization requires closer monitoring by NIH
staff, the project or organization may not use these simplified
instructions.

**If you have any questions, contact the grants management specialist
identified on the current Notice of Award.**

## 2.2 Specific Instructions

### 2.2.1 Face Page

#### Items 1-5.

The computer-generated Face Page available in the eRA Commons has
information already preprinted through Item 5. Complete and use this as
the final copy. Add the electronic mail address information, if
applicable. Check the preprinted material carefully and, when necessary,
make corrections by entering the item number and the correct information
under Item 12. Do **not** use Item 12 to indicate change of applicant
organization. [Form PHS
398](http://grants.nih.gov/grants/funding/phs398/phs398.html) **must**
be used in such cases. **Contact the awarding component for further
instructions.**

**Note: If the preprinted copy is not provided, or extensive corrections
are necessary, use PHS 2590 Form Page 1, which is available at
<http://grants.nih.gov/grants/funding/2590/2590.htm>.**

**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 PI Leadership
Plan. Remember, all designated contact PD/PIs must be from the applicant
institution if PD/PIs are from more than one Institution.

#### Item 5. Administrative Official

If the institutional representative to be contacted for additional
information has changed, make the necessary corrections in Item 12 on
the computer-generated Face Page.

#### Item 6. Human Subjects

Policy on research involving human subjects can be found in the [*NIH
Grants Policy
Statement*](http://grants.nih.gov/grants/policy/nihgps_2003/index.htm)
or the PHS 398 application instructions
([http://grants.nih.gov/grants/funding/phs398/phs398.htm](http://grants.nih.gov/grants/funding/phs398/phs398.html)l).
Guidance pertaining to Human Subjects Research, including clinical
trials and NIH-Defined Phase III Clinical Trials, may be found in Part
II of the PHS 398 application instructions. Human subject definitions
are found in Part III of the PHS 398. 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 if the research is exempt from HHS
regulatory requirements for the protection of human subjects
(<http://grants.nih.gov/grants/funding/phs398/phs398.doc#Human_Subjects_Exemption_Cat>).

**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](http://www.hhs.gov/ohrp) (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*](http://grants.nih.gov/grants/policy/nihgps_2003/index.htm)
or the [PHS 398 application
instructions](http://grants.nih.gov/grants/funding/phs398/phs398.html)
**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.

Policy on research activities involving vertebrate animals can be found
in the [*NIH Grants Policy
Statement*](http://grants.nih.gov/grants/policy/nihgps_2003/index.htm)
or the [PHS 398 application
instructions](http://grants.nih.gov/grants/funding/phs398/phs398.html).
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 applicant 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](http://www.iedison.gov/). The
grantee is encouraged to submit reports electronically using Interagency
Edison ([http://www.iedison.gov](http://www.iedison.gov/)). Inquiries or
correspondence should be directed to:

Extramural Inventions and Technology Resources Branch

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.

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. The applicant
organization is responsible for ensuring that Project/Performance Sites
operate under approved applicable Federal Wide (human subject) or Animal
Welfare Assurances.

#### 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 duly authorized representative 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 grantee institution may be liable for the
reimbursement of funds associated with any inappropriate or fraudulent
conduct of the project activity.

#### Assurances/Certifications

Each progress report to the PHS requires that the following policies,
assurances, and/or certifications be verified by the signature of the
Official Signing For Applicant Organization on the Face Page of the
application. These assurances are explained in Part III: Policies,
Assurances, Definitions, and Other Information of the [PHS 398
application
instructions](http://grants.nih.gov/grants/funding/phs398/phs398.html).
Applicants and grantees must comply with a number of additional public
policy requirements. Refer to your institution's research grant
administrative office or the *NIH Grants Policy Statement*
(<http://grants.nih.gov/grants/policy/policy.htm>) for additional
information.

The policies, assurances and certifications listed below may or may not
be applicable to your project, program, or type of applicant
organization.

> [Human Subjects
> Research](http://grants.nih.gov/grants/funding/phs398/phs398.doc#Assur_Human)
>
> [Research on Transplantation of Human Fetal
> Tissue](http://grants.nih.gov/grants/funding/phs398/phs398.doc#Assur_HS_Fetal)
>
> [Research Using Human Embryonic Stem
> Cells](http://grants.nih.gov/grants/funding/phs398/phs398.doc#Assurances_Human_StemCell)
>
> [Women and Minority Inclusion
> Policy](http://grants.nih.gov/grants/funding/phs398/phs398.doc#Assur_Women)
>
> [Inclusion of Children
> Policy](http://grants.nih.gov/grants/funding/phs398/phs398.doc#Assur_Children)
>
> [ClinicalTrials.gov
> Requirements](http://grants.nih.gov/grants/funding/phs398/phs398.doc#Assur_ClinicalTrials)
>
> [Vertebrate
> Animals](http://grants.nih.gov/grants/funding/phs398/phs398.doc#Assur_Vertebrate)
>
> [Debarment and
> Suspension](http://grants.nih.gov/grants/funding/phs398/phs398.doc#Assur_Debar)
>
> [Drug-Free
> Workplace](http://grants.nih.gov/grants/funding/phs398/phs398.doc#Assur_Drug)
>
> [Lobbying](http://grants.nih.gov/grants/funding/phs398/phs398.doc#Assur_Lobbying)
>
> [Non-Delinquency on Federal
> Debt](http://grants.nih.gov/grants/funding/phs398/phs398.doc#Assur_Nondelinq)
>
> [Research
> Misconduct](http://grants.nih.gov/grants/funding/phs398/phs398.doc#Assur_research_Misconduct)
>
> [Civil
> Rights](http://grants.nih.gov/grants/funding/phs398/phs398.doc#Assur_Compliance)
>
> [Handicapped
> Individuals](http://grants.nih.gov/grants/funding/phs398/phs398.doc#Assur_Compliance)
>
> [Sex
> Discrimination](http://grants.nih.gov/grants/funding/phs398/phs398.doc#Assur_Compliance)
>
> [Age
> Discrimination](http://grants.nih.gov/grants/funding/phs398/phs398.doc#Assur_Compliance)
>
> [Recombinant DNA Research, including Human Gene Transfer
> Research](http://grants.nih.gov/grants/funding/phs398/phs398.doc#Assur_rDNA)
>
> [Financial Conflict of
> Interest](http://grants.nih.gov/grants/funding/phs398/phs398.doc#Assur_COI)
> (except Phase I SBIR/STTR)
>
> [Smoke-Free
> Workplace](http://grants.nih.gov/grants/funding/phs398/phs398.doc#Assur_Smokefree)
>
> [Prohibited
> Research](http://grants.nih.gov/grants/funding/phs398/phs398.doc#Assur_Prohib_Res)
>
> [Select Agent
> Research](http://grants.nih.gov/grants/funding/phs398/phs398.doc#Assur_Select_Agents)
>
> [Project Director/Principal Investigator
> Assurance](http://grants.nih.gov/grants/funding/phs398/phs398.doc#Assur_PI)
>
> [Impact of Grant Activities on the Environment and Historic
> Properties](http://grants.nih.gov/grants/funding/phs398/phs398.doc#Assur_Impact)

### 2.2.2 Detailed Budget for Next Budget Period

FORM PAGE 2

Itemize the direct costs requested for the next budget period by budget
categories. Use the recommended direct cost shown on the spreadsheet
included with the Notice of Award issued in the competitive year as the
guide for developing the line item annual budget. Use Form Page 3 and
continuation pages as necessary to provide required explanation of
budget items.

For multi-project grants where individual projects are budgeted
separately, additional copies of Form Page 2 should be prepared for each
project or core in the program. Number these pages consecutively. Do not
use suffixes such as 2a, 2b. On the individual budget pages for each
specific project, clearly identify the name of the project leader and
the title of the project.

Certain conditions may change the funding requirements for a budget
period from those originally recommended. Such proposed funding changes,
particularly increases over the recommended level, must be explained and
fully justified for PHS awarding component consideration.

**Name and Role on Project.** Starting with the PD/PI(s), list all
employees of the applicant organization who will be involved on the
project, regardless of whether or not salaries are requested.

**Months Devoted to Project.**

Enter the number of months devoted to the project. Three columns are
provided depending on the type of appointment being reflected, academic,
calendar, and/or summer months. Individuals may have consecutive
appointments within a calendar year, for example for an academic period
and a summer period. In this case, identify each appointment separately
using the corresponding column.

If effort does not change throughout the year, use only the calendar
months column. If effort varies between academic and summer months,
leave the calendar months column blank and use only the academic and
summer months columns. In cases where no contractual appointment exists
with the applicant organization and salary is requested, enter the
number of months devoted to the project period.

If a change in the level of effort for the PD/PI(s) or other Senior/Key
Personnel designated on the NoA is proposed from what was approved in
the competing year award of this project, a detailed justification must
be provided under [Section 2.2.3](#budget-justification) - Budget
Justification.

**Salary Requested.** Regardless of the number of months being devoted
to the project, enter the dollar amounts for each position for which
funds are requested. The salary requested may not proportionally exceed
**any imposed salary limitation**. Grantees are encouraged to check the
[NIH Guide for Grants and
Contracts](http://grants.nih.gov/grants/guide/index.html) for the salary
limitation each year
(<http://grants.nih.gov/grants/policy/salcap_summary.htm>).

**Fringe Benefits.** Fringe benefits may be requested in accordance with
the institutional guidelines for each position, provided the costs are
treated consistently by the applicant organization as a direct cost to
all sponsors.

**Totals.** Calculate the totals for each position and enter the
subtotals in each column where indicated.

**Special Instructions for Individuals with Joint University and
Department of Veterans Affairs (V.A.) Appointments**

Individuals with joint university and V.A. appointments may request the
university's share of their salary in proportion to the effort devoted
to the research project. The individual's salary with the university
determines the base for computing that request. Signature by the
institutional official on the application certifies that: (1) the
individual is applying as part of a joint appointment specified by a
formal Memorandum of Understanding between the university and the V.A.;
and (2) there is no possibility of dual compensation for the same work,
or of an actual or apparent conflict of interest regarding such work.
Additional information may be requested by the awarding components..

#### Consultant Costs

Whether or not costs are involved, provide the names and organizational
affiliations of all consultants, other than those involved in
consortium/contractual arrangements. Include consultant physicians in
connection with patient care and persons who serve on external
monitoring boards or advisory committees to the project. Briefly
describe on Form Page 3 any changes in services to be performed. Include
the number of days of anticipated consultation, the expected rate of
compensation, travel, per diem, and other related costs.

#### Equipment

List separately each item of equipment and justify the purchase on Form
Page 3, if not previously approved.

#### Supplies

Itemize supplies in separate categories, such as glassware, chemicals,
radioisotopes, etc. Categories in amounts less than \$1,000 do not have
to be itemized. If animals are to be purchased, state the species,
strain(s), ages, sex, and the number of animals to be used.

#### Travel

Itemize travel requests and justify on Form Page 3. Provide the purpose
and destination of each trip and the number of individuals for whom
funds are requested.

#### Patient Care Costs

Indicate the basis for estimating costs in this category in detail,
including the number of patient days, estimated cost per day, and cost
per test or treatment. If both inpatient and outpatient costs are
requested provide information for each separately, and if multiple sites
are to be used, provide the information in detail for each site.

Include information regarding projected patient accrual for the budget
period and relate this information to the budget request for patient
care costs.

Provide specific information regarding anticipated sources of other
support for patient care costs, e.g., third party recovery or
pharmaceutical companies. Include potential or expected utilization of
General Clinical Research Centers.

Patient care costs do **not** include travel, lodging, and subsistence
or donor/volunteer fees. Request these costs in the Other Expenses
category. Request the costs for consultant physician fees in the
Consultant Costs category. Patient care costs will be provided to
foreign organizations only in exceptional circumstances.

#### Alterations and Renovation

Itemize by category and justify on Form Page 3 the costs of essential
alterations and renovations, including repairs, painting, removal or
installation of partitions, shielding, or air conditioning. When
applicable, indicate the square footage involved, giving the basis for
the costs, such as an architect\'s or contractor\'s detailed estimate as
outlined in the [*NIH Grants Policy
Statement*](http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
Line drawings of the proposed alterations should be submitted with the
progress report where required by the *NIH Grants Policy Statement*.
Costs for alterations and renovations are not allowed on grants made to
foreign organizations.

#### Other Expenses

Itemize any other expenses by category and unit cost. These might
include animal maintenance (unit care costs and number of days), patient
travel, donor fees, publication costs, computer charges, rentals and
leases, equipment maintenance, service contracts, and tuition remission
when budgeted separately from salary/fringe benefits.

#### Consortium/Contractual Costs

Each participating consortium/contractual organization must submit a
separate detailed budget (Form Page 2) and budget justification (Form
Page 3) for the next budget period. If a new consortium is added, follow
the guidelines in the [PHS 398 application
instructions](http://grants.nih.gov/grants/funding/phs398/phs398.html).

List the Facilities and Administrative (F&A) costs, if any, and provide
the basis for the rate in the Consortium/Contractual Costs category.
Insert the page(s) for each consortium/contractual organization after
Form Page 3 and number them consecutively.

The sum of all consortium/contractual costs (direct and F&A) must be
entered in the Consortium/Contractual Costs category of the applicant
organization\'s budget.

### 2.2.3 Budget Justification

FORM PAGE 3

**Budget Justification.** Provide detailed justification for those line
items and amounts that represent a significant change from previously
recommended levels (e.g., Total rebudgeting greater than 25 percent of
the total award amount for this budget period).

If there has been a significant change in the level of effort devoted to
the project from what was approved in the competing year award for the
PD/PI or other Senior/Key Personnel designated on the NoA, provide a
justification of the reduction for those individuals. (A significant
change in level of effort is defined in Federal regulations as a **25
percent reduction** in time devoted to the project.)

**Current Budget Period.** In the space provided, or on additional
pages, explain any estimated unobligated balance of total costs
(including prior year funds carried over) that is greater than 25
percent of the current year\'s total approved budget. Explain why there
is a significant balance and how it will be spent if carried forward
into the next budget period. The "total approved budget" equals the
current fiscal year award authorization plus any carryover of funds from
a prior year. The numerator equals the total amount available for
carryover and the denominator equals the current year's total approved
budget.

### 2.2.4 Biographical Sketch

BIOGRAPHICAL SKETCH FORMAT PAGE

Complete a Biographical Sketch for all **new** senior/key personnel
since the previous submission.

Senior/key personnel are defined as, and should be limited to,
individuals who contribute in a substantive measurable way to the
scientific development or execution of the project, whether or not
salaries are requested.

Typically, these individuals have doctoral or other professional
degrees, although individuals at the masters or baccalaureate level
should be included if their involvement meets the definition of
senior/key personnel. Consultants should be included only when their
level of involvement meets the definition. Individuals providing
technical services are not considered senior/key personnel.

Complete a Biographical Sketch for all **new** "Other Significant
Contributors." These individuals are typically those that may contribute
to the scientific development or execution of the project, but are not
committing any specified measurable effort to the project.

### 2.2.5 Other Support

For the purposes of the continuation progress report, other support
information is **only** required on **active** support for all
senior/key personnel. Refer to the [PHS 398 application
instructions](http://grants.nih.gov/grants/funding/phs398/phs398.html)
for the instructions, definitions, policy, and format pertaining to
other support. Do not include other supporting information for
individuals designated as other significant contributors unless their
involvement has changed so that they now meet the definition of
senior/key personnel.

### 2.2.6 Progress Report Summary

FORM PAGE 5

Well-planned Progress Reports can be of great value by providing records
of accomplishments that serve as a basis for continued support of the
project. Furthermore, Progress Reports provide information to awarding
component staff that is essential in the assessment of changes in scope
or research objectives (as defined in the [*NIH Grants Policy
Statement*](http://grants.nih.gov/grants/policy/nihgps_2003/index.htm))
from those actually funded. They are also an important information
source for the awarding component staff in preparing annual reports, in
planning programs, and in communicating scientific accomplishments to
the public and to Congress.

The Progress Report should be a brief presentation of the
accomplishments on the research project during the reporting period, in
language understandable to a biomedical scientist who may not be a
specialist in the project\'s research field. The style used in
*Scientific American* articles would be appropriate. Abbreviations and
language that may not be known to the broader scientific community
should be avoided unless clearly defined.

When submitting Progress Reports for program project grants, center
grants, education grants, or other large multicomponent grants, contact
the program official of the awarding agency for specific instructions.

The entire Progress Report for regular projects, exclusive of the list
of publications and the "Inclusion Enrollment Report," **should not
exceed two pages.** The report should follow the outline and numbering
system shown below. Continuation pages may be used as necessary.

#### A. Specific Aims 

The aims, **as actually funded**, may differ in scope from those stated
in the original, competing application, because of Scientific Review
Group (SRG) and Council recommendations and/or budgetary modifications
made by the awarding component. If the aims have not been modified,
state this. If they have been modified, give the revised aims and the
reason for the modification.

#### B. Studies and Results

Describe the studies directed toward specific aims during the current
budget year and the positive and negative results obtained. If technical
problems were encountered in carrying out this project, describe how
your approach was modified.

**Revisions (formerly Supplements):** If applicable, include a separate
section(s) describing the results obtained by individuals supported on
this grant through various revisions. Examples include Research
Supplements to Promote Diversity in Health-Related Research, supplements
to enhance diversity and Re-entry and/or other similar supplements to
support addition of an individual or a discrete project.

#### C. Significance

Emphasize the significance of the findings to the scientific field and
their potential impact on health.

#### D. Plans

Summarize plans to address the Specific Aims during the next year of
support. Include any important modifications to the original plans.
Address any changes involving research using human embryonic stem cells,
human subjects, and/or vertebrate animals.

Complete Items A and B on Form Page 5 if the research involves [Human
Subjects](#Human_Subjects) or [Vertebrate Animals](#Vertebrate_Animals).
**If "Change" is checked, provide the** information **below.** Although
no specific page limitation applies to the information on Human Subjects
or Vertebrate Animals, be succinct.

[]{#Human_Subjects .anchor}**Human Subjects (Item A)**

**When submitting a non-competing progress report that includes
applicable trial/s:** NCT number/s, Brief Title/s (as defined by
ClinicalTrials.gov, see
[http://prsinfo.clinicaltrials.gov](http://prsinfo.clinicaltrials.gov/)),
and the identity of the responsible party (or parties) are to be
included in the Human Subjects section of the progress report (see
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-023.html>).

Check \"No Change\" on the Progress Report Summary page (Form Page 5) if
the protocols planned for the coming year are not different from the
previous submission.

Check \"Change\" on the Progress Report Summary page if the protocols
are different from those proposed in the previous submission. Include an
explanation of how they differ and provide a new or revised Protection
of Human Subjects section as described in the PHS 398 Research Plan
instructions. Follow the instructions for Preparing the Section on
Protection of Human Subjects in Part II.3. Include designated headings
as appropriate for Exempt Human Subjects Research, Non Exempt Human
Subjects Research, Clinical Trial, or NIH Defined Phase III Clinical
Trial. Include, as appropriate, sections on Data and Safety Monitoring
(Part II.4.1.5), Inclusion of Women and Minorities (Part II.4.2), and
Inclusion of Children (Part II.4.4). New Protocols or Protocol changes
will require IRB approval, in accord with the DHHS regulations for
protection of human subjects. Provide a protocol upon request.

If human subject studies planned for the coming year were identified in
the Research Plan of the PHS 398 application, but were not adequately
described because they were planned for a later time within the project
period, provide a Protection of the Human Subjects section as instructed
in Part II of the PHS 398 instructions.

If studies involving human subjects are planned, and they were not part
of the originally proposed research design, then you must provide a
Protection of Human Subjects section as instructed in Part II of the PHS
398 instructions, and provide the information required in Item 4 of the
Face Page of the PHS 398 grant application (see instructions in Part I
of the PHS 398 instructions).

Note that Public Law 110-85, enacted 09/27/2007, mandates registration
and results reporting of applicable clinical trials in
ClinicalTrials.gov (see Part II, 4.1.6 and Part III, 2.1.6 of the PHS
398 and Guide Notice at
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-023.html>).
In signing the application Face Page, the authorized organizational
representative of the applicant organization certifies that if the
research is an applicable clinical trial under Public Law 110-85, the
applicant organization will be in compliance with the registration and
reporting requirements of Public Law 110-85 (see Section 4.6 of 2590 and
Part III, Section 2.1.6 of the PHS 398).

**Women and Minority Inclusion in Clinical Research**

**Reporting Data on Inclusion to NIH:**

If you are conducting clinical research (see definition in the PHS 398),
you must report the cumulative enrollment of subjects and their
distribution by sex/gender and ethnicity/race, unless otherwise notified
by your program official. For awards made as a result of New and
Competing applications submitted after January 10, 2002, you should be
using the Inclusion Enrollment Report in progress reports. For awards
made as a result of New and Competing Applications received before
January 10, 2002, you may choose to report sex/gender and ethnicity/race
composition using EITHER the format in the 4/98 Version of the Inclusion
Table
(http://grants.nih.gov/grants/funding/phs398/Inclusion498version.doc) or
the Inclusion Enrollment Report. If data were collected using two
questions (one about ethnicity and one about race) and subjects were
given the option of selecting more than one race, then the Inclusion
Enrollment Report should be used. If you choose to report information
using the Inclusion Enrollment Report, you must continue to use this
format for the remaining years of the project. See detailed instructions
and frequently asked questions in
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html>.

Reporting data on inclusion is not included in the two-page limit. If
there is more than one study, provide a separate table for each study.
Information about ethnic/racial subpopulations included in the study
should be provided as an attachment to the table.

**Changes to Targeted/Planned Enrollment:** If there are changes from
the Targeted/Planned Enrollment originally approved for funding, you
should submit a revised Targeted/Planned Enrollment Table *and* an
Inclusion Enrollment Report describing data collected to-date. Explain
the changes in a footnote or attachment to the report. The NIH Policy on
Reporting Race and Ethnicity Data for Subjects in Clinical Research is
described and referenced in Part II, Section 5.8 of the PHS 398.

**NIH-defined Phase III Clinical Trial:** If you are conducting an
NIH-defined Phase III Clinical Trial (see definition in the PHS 398),
you must report on the cumulative enrollment (as described above) and
indicate if data analysis has begun for the trial. If so, you should
report on progress made in conducting valid analyses for sex/gender and
ethnic/racial differences. Refer to the definition of \"NIH-Defined
Phase III Clinical Trial\" in Part III.3, of the PHS 398 under Human
Subjects Research Definitions and Terms.

**Foreign Populations:** If you are conducting clinical research outside
of the US, you should design culturally sensitive and appropriate data
collection instruments that allow participants to self-identify their
ethnic and racial affiliation. These items, however, should be designed
in a way that allows you, the investigator, to aggregate the information
into the OMB minimally required ethnic and racial categories and
complete the Inclusion Enrollment report. When completing the Inclusion
Enrollment report, you should add an asterisk and footnote the report to
indicate that data is from foreign participants. If your study includes
both domestic and foreign participants, we suggest submitting two
separate reports -- one for domestic data and one for foreign data, with
an asterisk and footnote explaining the foreign data.

The enrollment data by race may be lower than the Targeted/Planned
enrollment by race because some individuals may designate that they
belong to more than one race and will report under \"More Than One
Race\" category. In this case, you may discuss these discrepancies in an
attachment to the Inclusion Enrollment report.

**Standards for Collecting Data from Study Participants:**

When you are planning collection of data on ethnicity and race, as well
as sex/gender, you should use the categories listed below in obtaining
the data from individuals. The collection of greater detail is
encouraged, e.g., on ethnic/racial subpopulations; however, any
collection that uses more detail shall be organized in such a way that
the additional categories can be aggregated into these minimum
categories for reporting data on ethnicity and race. Using self-report
or self-identification to collect this information, you should use two
separate questions, with ethnicity information collected first followed
by the option to select more than one racial designation. When reporting
these data in the aggregate, you should report:

\(a\) the number of subjects in each ethnic category;

\(b\) the number of subjects who selected only one category for each of
the five racial categories;

\(c\) the total number of subjects who selected multiple racial
categories reported as the "number selecting more than one race"; and,

\(d\) the number of subjects in each racial category who are Hispanic or
Latino.

NIH is required to use these definitions to allow comparisons to other
federal databases, especially the census and national health databases.
Federal agencies shall not present data on detailed categories if doing
so would compromise data quality or confidentiality standards
(<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html>).

The Inclusion Enrollment Report format is not designed for use as a data
collection instrument. You should collect the data using instruments
prepared for the study and use the information from the study database
to fill out the enrollment report. Study participants who select two or
more racial categories should be reported in the aggregate in the \"More
Than One Race\" category. An example of a format for collecting
information from a study participant can be found in the "Ethnic Origin
and Race" section of the Personal Data Form Page in the PHS 398
(<http://grants.nih.gov/grants/funding/phs398/phs398.html>).

The Office of Management and Budget (OMB) Directive No. 15 defines
minimum standards for maintaining, collecting and presenting data on
ethnicity and race for all Federal (including NIH) reporting purposes.
The categories in this classification are social-political constructs
and should not be interpreted as being anthropological in nature. The
standards were revised in 1997 and now include two ethnic categories:
"Hispanic or Latino," and "Not Hispanic or Latino." There are five
racial categories: American Indian or Alaska Native, Asian, Black or
African American, Native Hawaiian or Other Pacific Islander, and White.
Reports of data on ethnicity and race should use these categories. The
following definitions apply for the ethnic and racial categories.

**Ethnic Categories:**

**Hispanic or Latino:** A person of Cuban, Mexican, Puerto Rican, South
or Central American, or other Spanish culture or origin, regardless of
race. The term, "Spanish origin," can be used in addition to "Hispanic
or Latino".

**Not Hispanic or Latino**

**Racial Categories:**

**American Indian or Alaska Native:** A person having origins in any of
the original peoples of North, Central, or South America and maintains
tribal affiliation or community.

**Asian:** A person having origins in any if the original peoples of the
Far East, Southern Asia, or the Indian subcontinent including, for
example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the
Philippine Islands, Thailand, and Vietnam.

**Black or African American:** A person having origins in any of the
black racial groups of Africa. Terms such as "Haitian" or "Negro" can be
used in addition to "Black or African American."

**Native Hawaiian or Other Pacific Islander:** A person having origins
in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific
Islands.

**White:** A person having origins in any of the original peoples of
Europe, North Africa, or the Middle East.

**Ethnic/racial subpopulations.** In addition to the OMB ethnic and
racial categories, NIH uses the following definition for ethnic/racial
subpopulations:

**Subpopulations.** Each ethnic/racial group contains subpopulations
that are delimited by geographic origins, national origins, and/or
cultural differences. It is recognized that there are different ways of
defining and reporting racial and ethnic subpopulation data. The
subpopulation to which an individual is assigned depends on
self-reporting of specific origins and/or cultural heritage. Attention
to subpopulations also applies to individuals who self identify with
more than one ethnicity or race. These ethnic/racial combinations may
have biomedical, behavioral, and/or social-cultural implications related
to the scientific question under study.
(<http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm>).

**Human Subjects Education Requirement**

For grants involving Human Subjects, provide certification for any *new*
senior/key personnel or other significant contributors involved in the
design or conduct of research involving human subjects that they have
completed an educational program in the protection of human subjects.
This requirement may not apply to other awarding agencies. Non-NIH
grantees should contact their awarding agency for guidance (refer to
table in [Section 1.1](#table_1_1)).

[]{#Vertebrate_Animals .anchor}**Vertebrate Animals (Item B)**

If there has been no change, check \"No Change\" on the Progress Report
page.

If vertebrate animals were not involved in the last application but are
now to be included, or if significant changes regarding the use of
animals are now proposed, provide a description of the intended
involvement of animals in accord with the PHS Policy for use of
vertebrate animals in research and check \"Change\" on the Progress
Report page. Examples of changes considered to be significant include,
but are not limited to, changing animal species, changing from
noninvasive to invasive procedures, new project/performance site(s)
where animals will be used, etc. If studies involving live vertebrate
animals are planned, and they were not part of the originally proposed
research design, then you must comply with the requirements of Item 12,
"Vertebrate Animals," described in the PHS 398 instructions, and provide
the required information to NIH. Before activities with live vertebrate
animals begin, the applicant must provide all information required in
Item 12 of the Research Plan with certification of current IACUC
approval.

**Select Agent Research (Item C)**

Check \"No Change\" on the Progress Report Summary page (Form Page 5) if
the activities planned for the coming year are not different from the
previous submission.

Check \"Change\" on the Progress Report Summary page if proposed
research involving Select Agents is different from that proposed in the
previous submission. Include an explanation of how research plans differ
and provide a new or revised \"Section 5.5 Select Agent Research\" from
the PHS 398 instructions reflecting these changes.

If Select Agent Research planned for the coming year was described in
the Research Plan of the PHS 398 application, but had not been approved
by regulatory authorities, provide the Select Agent Research information
requested in the PHS 398 instructions.

If studies involving Select Agents are planned, but were not part of the
originally proposed research design, then you must provide a section on
Select Agents as instructed by the PHS 398 Research Plan Instructions in
Part I.5.5 and provide the information required in Item 13.

**Multiple PD/PI Leadership Plan (Item D)**

This section is only applicable if Multiple PD/PIs are part of the NIH
approved project. Check \"No Change\" on the Progress Report Summary
page (Form Page 5) if there is no change in the leadership plan as
originally proposed and approved.

Check \"Change\" on the Progress Report Summary page if there has been
any change in the governance and/or organizational structure of the
Multiple PD/PI Leadership Plan including communication plans and
procedures for resolving conflicts. Also discuss any changes to the
administrative, technical, and scientific responsibilities for the
PD/PIs.

If the progress report submission includes a change in the contact
PD/PI, check "Change" on the Progress Report Summary page and address
this change and the impact, if any, the change has on the
administrative, technical, and scientific responsibilities for the
PD/PIs.

#### E. Publications

Report publications resulting directly from this grant that you have not
previously reported, including manuscripts submitted or accepted for
publication. Provide the complete citation (author(s), title, journal or
book, volume, page number, year). If available electronically provide a
url or PMCID number. If not available electronically you may provide one
copy with the progress report.  State if there have been no
publications.

For each publication that falls under the Public Access Policy, provide
the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the
PubMed Central (PMC) reference number (e.g., PMCID234567), at the end of
the citation. If the PMCID is not yet available because the Journal
submits articles directly to PMC on behalf of their authors, indicate
\"PMC Journal - In Process.\" A list of these Journals is posted at:
<http://publicaccess.nih.gov/submit_process_journals.htm>.

#### F. Project-Generated Resources

If the research supported by this grant resulted in data, research
materials (such as cell lines, DNA probes, animal models), protocols,
software, or other information available to be shared with other
investigators, describe the resource and how it may be accessed.

If the initial research plan included a formal plan for sharing final
research data, describe progress in implementing that plan. A final
statement on data sharing should be included in the final progress
report or earlier, if the plan is implemented prior to closeout.

If the initial research plan included specifics for sharing model
organisms, include information on the progress of that plan as well as
information on the number of requests received and fulfilled.

If the initial research plan includes Genome Wide Association Studies
and a plan to share data with the NIH centralized data repository,
describe progress in implementing that plan. A final statement on
submitting data to the repository should be included in the final
progress report or earlier, if the plan is implemented prior to closeout
(see NOTICE OD-08-023,
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-023.html> and
NOTICE OD-07-088,
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html>).

### 2.2.7 Checklist

FORM PAGE 6

#### Program Income

See the PHS 398 application instructions and the [NIH Grants Policy
Statement](http://grants.nih.gov/grants/policy/nihgps_2003/index.htm)
for information on program income. If no program income is anticipated
during the period(s) for which grant support is requested, no other
action is necessary.

If program income is anticipated, use the format provided. If the
progress report is funded, the Notice of Award will provide specific
instructions regarding the use of such income.

#### Assurances/Certifications

Each progress report to the PHS requires that the policies, assurances
and certifications listed in [Section 2.2.1](#assurancescertifications)
be verified by the signature of the Official Signing for Applicant
Organization on the Face Page of the progress report (see Item 13). If
unable to certify compliance where applicable, provide an explanation
and place it after the Progress Report (Form Page 5).

#### Facilities and Administrative Costs

Follow the instructions on the Checklist.

### 2.2.8 Senior/Key Personnel Report

FORM PAGE 7

Using the table, list **all senior/key personnel** (salaried and
unsalaried) **for the current budget period** at the applicant
organization or elsewhere, who participated in the project during the
current budget period. Include all degrees, role on project, number of
person months devoted to the project (indicate academic, calendar,
and/or summer), and the last four digits of the Social Security number.
When requesting Social Security numbers from personnel, explain that
provision of the Social Security number is voluntary, and the
information will be used only for program management purposes.

Individuals designated as "Other Significant Contributors," (e.g., those
that may contribute to the scientific development or execution of the
project, but are not committing any specified measurable effort to the
project), should not be included in this report unless their involvement
has changed so that they now meet the definition of "senior/key
personnel."

This is the last page of the progress report. Number all pages
consecutively.

# 3. Final Progress Report

A final progress report is required for any grant that is terminated and
any award that will not be extended through award of a new competitive
segment. The final progress report should include a summary of progress
toward the achievement of the originally stated aims, a list of
significant results (positive or negative), and a list of publications.
When citing articles that fall under the Public Access Policy, provide
the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the
PubMed Central (PMC) reference number (e.g., PMCID234567) for each
article. If the PMCID is not yet available because the Journal submits
articles directly to PMC on behalf of their authors, indicate \"PMC
Journal - In Process.\" A list of these Journals is posted at:
<http://publicaccess.nih.gov/submit_process_journals.htm>.

The final progress report also should address the following:

-   Report on the inclusion of gender and minority study subjects (using
    the gender and minority inclusion table as provided in the PHS 2590)

-   Where appropriate, indicate whether children were involved in the
    study or how the study was relevant for conditions affecting
    children (see "[Public Policy Requirements and
    Objectives---Requirements for Inclusiveness in Research
    Design---Inclusion of Children as Subjects in Clinical
    Research](http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part5.htm#_Inclusion_of_Children)"
    and the [PHS
    398](http://grants.nih.gov/grants/funding/phs398/phs398.html))

-   Describe any data, research materials (such as cell lines, DNA
    probes, animal models, etc.), protocols, software, or other
    information resulting from the research that is available to be
    shared with other investigators and how it may be accessed.

If there are any other specific requirements set forth in the terms and
conditions of the award they must be addressed in the final progress
report as well. Additional information on submitting final progress
reports to [AHRQ](#ahrq), [CDC](#cdc), [FDA](#fda) and [IHS](#ihs) can
be obtained from their website.

**ELECTRONIC SUBMISSION OF FINAL PROGRESS REPORT**

Electronic submission is strongly encouraged for all NIH grantees.
Grantee institutions registered in the eRA Commons should submit the
final progress report electronically through the eRA Commons available
at <https://commons.era.nih.gov/commons/>. Additional information on
electronic submission of closeout documents is available at the NIH eRA
Commons homepage or by contacting the eRA help desk at:
<http://ithelpdesk.nih.gov/eRA/> or Toll-free (866) 504-9552, Phone
301-402-7469, TTY 301-451-5939.

If closeout documents are not submitted electronically through the eRA
Commons, the original final progress report should be submitted to the
centralized mailing address in [Section
1](#continuation-progress-report).

Additional information on submitting closeout documents to AHRQ, CDC,
FDA and IHS can be obtained from their website.

# 4. General Information

## 4.1 Social Security Number

The PHS requests the last four digits of the Social Security number for
accurate identification, referral, and review of progress reports and
for management of PHS grant programs. Provision of this section of the
Social Security number is voluntary. Please be aware that no individual
will be denied any right, benefit, or privilege provided by law because
of refusal to disclose this section of the Social Security number. The
PHS requests the last four digits of the Social Security numbers under
Sections 301 (a) and 487 of the PHS Act as amended (42 USC 241a and 42
USC 288).

## 4.2 Government Use of Information Under Privacy Act

The Privacy Act of 1974 (5 USC 552a) is a records management statute and
regulates the collection, maintenance, use, and dissemination of
personal information by Federal agencies. In accordance with the Act,
the PHS is required to provide the following notification to each
individual from whom information is requested.

The PHS maintains progress reports and grant records pursuant to its
statutory authority for awarding grants. The purpose of the information
collection is to aid in the review, award, and administration of PHS
programs. Provision of information is voluntary; however, a lack of
sufficient information may hinder the PHS\' ability to review progress
reports, monitor grantee performance, or perform overall management of
grant programs.

The Privacy Act authorizes discretionary disclosure of this information
within the Department of Health and Human Services (DHHS) and outside
the Agency to the public, as required by the Freedom of Information Act
and the associated DHHS regulations (45 CFR 5), including: Congress
acting within its legislative authority; the National Archives; the
General Accounting Office; the Bureau of Census; law enforcement
agencies; and pursuant to a court order.

Information may also be disclosed outside the Department for the
following purposes:

1\. To a Congressional office at the request of the record subject;

2\. To the Department of Justice as required for litigation;

3\. To the cognizant audit agency for auditing;

4\. To qualified experts not within the definition of Department
employees, as prescribed in Department Regulations (45 CFR 5b.2), for
opinions as part of the progress report review/award process;

5\. For an authorized research purpose under specified conditions;

6\. To contractors for the purpose of processing, maintaining, and
refining records in the system. Contractors will be required to maintain
Privacy Act safeguards with respect to such records;

7\. To a Federal agency, in response to its request, in connection with
the letting of a contract or the issuance of a license, grant, or other
benefit by the requesting agency, to the extent that the records are
relevant and necessary to the requesting agency\'s decision on the
matter; and

8\. To the applicant organization in connection with the review of a
progress report or performance or administration under the terms and
conditions of the award, or in connection with problems that might arise
in performance or administration if an award is made.

## 4.3 Information Available to the Program Director(s)/Principal Investigator(s) (PD/PIs)

Under the provisions of the Privacy Act, program directors/principal
investigators may request copies of records pertaining to their grant
progress reports from the PHS component responsible for funding
decisions. PD/PIs are given the opportunity under established procedures
to request that the records be amended if they believe the records are
inaccurate, untimely, incomplete, or irrelevant. If the PHS concurs, the
records will be amended.

## 4.4 Information Available to the General Public

The PHS makes information about awarded grants available to the public,
including the title of the project, the grantee institution, PD/PI,
abstract, and amount of the award.

The Freedom of Information Act and implementing DHHS regulations (45 CFR
Part 5) require the release of certain information about grants upon
request, regardless of the intended use of the information. Generally
available for release, upon request are: all funded grant applications
and progress reports **including** their derivative funded **revision
application (formerly noncompeting supplements)** progress reports;
pending and funded **continuation** progress reports; progress reports
of grantees; and final reports of any review or evaluation of grantee
performance conducted or caused to be conducted by the DHHS. Generally
**not** available for release to the public are: **competing** grant
progress reports (initial, competing continuation, and supplemental) for
which awards have **not** been made; evaluative portions of site visit
reports; and summary statements of findings and recommendations of
review groups. Trade secrets and commercial, financial, or otherwise
proprietary information may be withheld from disclosure. Information,
which, if disclosed, would be a clearly unwarranted invasion of personal
privacy, may also be withheld from disclosure. Although the grantee
institution and the principal investigator will be consulted about any
such release, the PHS will make the final determination. If a requested
document contains both disclosable and nondisclosable information, the
nondisclosable information will be redacted and the balance of the
document will be released.

## 4.5 Access to Research Data

By regulation (45 CFR 74.36), grantees that are institutions of higher
education, hospitals, or non-profit organizations are required to
provide, in response to a FOIA request, the research data first produced
under the award. Research data" is defined as the recorded factual
material commonly accepted in the scientific community as necessary to
validate research findings. It does not include preliminary analyses;
drafts of scientific papers; plans for future research; peer reviews;
communications with colleagues; physical objects (e.g., laboratory
samples, audio or video tapes); trade secrets; commercial information;
materials necessary to be held confidential by a researcher until
publication in a peer-reviewed journal; information that is protected
under the law (e.g. intellectual property); personnel and medical files
and similar files, the disclosure of which would constitute an
unwarranted invasion of personal privacy; or information that could be
used to identify a particular person in a research study.

These requirements do not apply to commercial organizations or to
research data produced by State or local governments. However, if a
state or local governmental grantee contracts with an educational
institution, hospital or non-profit organization, and the contract
results in covered research data, those data are subject to these
disclosure requirements.

## 4.6 ClinicalTrials.gov Requirement

Public Law 110-85 mandates registration and results reporting of
\"applicable clinical trials\" in ClinicalTrials.gov. Under the statute,
these trials generally include: (1) [Trials of Drugs and
Biologics]{.underline}: Controlled, clinical investigations, other than
Phase 1 investigations, of a product subject to FDA regulation; and (2)
[Trials of Devices]{.underline}: Controlled trials with health outcomes,
other than small feasibility studies, and pediatric postmarket
surveillance. Review the statutory definition of applicable clinical
trial to identify if registration is required to comply with the law
(See PL 110-85, Section 801(a), (adding new 42 U.S.C. 282(j)(1)(A)):
<http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf>).

NIH encourages registration of ALL trials whether required under the law
or not.

Registration is accomplished at the ClinicalTrials.gov Protocol
Registration System Information Website
(<http://prsinfo.clinicaltrials.gov/>). A unique identified, called an
NCT number will be generated during the registration process.

For new and renewal (competing) applications that include ongoing
clinical trials involving a serious and life threatening condition,
provide the NCT number/s, Brief Title/s (as defined by
ClinicalTrials.gov, see
<http://prsinfo.clinicaltrials.gov/s801-new-requirements.pdf>), and the
identity of the responsible party (or parties) in the human subjects
section of the Research Plan under a section heading entitled
ClinicalTrials.gov. The entity responsible for registering is the
"responsible party." The statute defined the responsible party as:

\(1\) the sponsor of the clinical trial (as defined in 21 C.F.R. 50.3)
(<http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/cfr_2003/aprqtr/pdf/21cfr50.3.pdf>),
or\
\
(2) the principal investigator of such clinical trial if so designated
by a sponsor, grantee, contractor, or awardee (provided that "the
principal investigator is responsible for conducting the trial, has
access to and control over the data from the clinical trial, has the
right to publish the results of the trial, and has the ability to meet
all of the requirements" for submitting information under the law)
(<http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf>).
See PL 110-85, Section 801(a), (adding new 42 U.S.C. 282(j)(1)(A)(ix)).

If a new applicable trial is proposed, under the heading
ClinicalTrials.gov include a statement that the application includes a
trial which requires registration in ClinicalTrials.gov. The signature
on the application of the Authorized Organizational Representative
assures compliance for the registration of any such trial.

For additional information and guidance see NIH Guide Notices at
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-014.html> and
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-023.html>.

# 5. Additional Instructions for Preparing Continuation Career Development Award (CDA) Progress Reports

The instructions in Sections 1-3 are to be used with these additional
instructions to request continuation of all career development awards (K
series). For those applying under the Streamlined Noncompeting Award
Process (SNAP), use the SNAP instructions in [Section 2.1, Streamlined
Noncompeting Award Process (SNAP)](#snap) and the instructions below for
Items 5.1.4 through 5.1.7. **Awardees should consult the applicable
Funding Opportunity Announcement and the awarding Federal agency for any
supplemental Instructions.**

## 5.1 Specific Instructions

### 5.1.1 Detailed Budget for Next Budget Period 

FORM PAGE 2

#### Personnel

Base the awardee\'s salary and fringe benefits request on a full-time,
12-month appointment following the guidelines in the appropriate career
award instructions. Support for other personnel and amounts in other
budget categories may be requested in accordance with applicable career
mechanism guidelines.

### 5.1.2 Biographical Sketch 

BIOGRAPHICAL SKETCH FORMAT PAGE

Complete for new senior/key personnel and other significant contributors
if allowable under guidelines for the appropriate K award.

### 5.1.3 Other Support

Provide Other Support information for the career award recipient,
sponsor/mentor(s), co-sponsors and senior/key personnel only if changed
from the previous submission. For the purposes of the noncompeting
continuation progress report, other support information is **only**
required on **active** support for these individuals. There is no form
page for Other Support. Provide the information in the format shown in
the example on the 2590 Forms Page
(<http://grants.nih.gov/grants/funding/2590/2590.htm>).

### 5.1.4 Progress Report Summary

Follow the instructions for regular research projects found in [Section
2.2.6, Progress Report Summary](#progress-report-summary), using the
outline for items A-F. Complete information on human subjects and/or
vertebrate animals only if the awardee has participated in research
involving human subjects or vertebrate animals that has not been
reported within the progress report of any other PHS-supported project.
**In addition**, complete Items G-J below. The awardee completes Items
G, H, and I; the mentor or supervisor who has the responsibility for the
awardee's research career development completes Item J. The Progress
Report Summary, including Items G-J, should not exceed four pages.

#### G. Research Development. 

Briefly describe the awardee's involvement in activities during the past
year designed to increase research skills. Include formal course work,
progress toward a research-related degree (if applicable), informal
instruction in specific research skills, scientific seminars and
meetings, training in the responsible conduct of research, visits to
other laboratories, etc. Indicate any changes in senior/key personnel
and other significant contributors (department head, sponsor, and
collaborators) during the past year.

#### H. Other Activities. 

Briefly describe the awardee\'s involvement in activities other than
research and research training during the past year. Describe activities
such as teaching, clinical care, professional consultation, service on
advisory groups, and administrative activities. Indicate percent of time
spent in each of these activities and the relationship to the awardee\'s
research career development.

For awards that include a requirement to mentor others (e.g., K05 and
K24), indicate the percent of time devoted to mentoring activities,
individuals mentored during the reporting period, the frequency and
kinds of mentoring, financial and other support provided to mentees, and
the productivity of the mentoring relationship.

#### I. Research Development and Other Activities Planned for the Next Year. 

Provide information on similar activities (to those provided in Item G
and Item H for the past year) planned for the next year. Awardees should
provide a timeline for these activities, including plans to apply for
subsequent grant support. Recipients of transition awards (e.g., K22,
K99) should report on their progress in identifying an independent
research position. Additionally, awardees charged with mentoring others
(e.g., K05, K24) should provide information describing planned mentoring
activities and proposed mentees (e.g., backgrounds, interests,
professional levels, etc.) sufficient to evaluate the quality of the
mentoring.

#### J. Mentor\'s Report. 

Prepare a statement assessing the awardee\'s progress and performance
during the past year, both in research and in terms of development into
an independent investigator in the area of the award. Include
information on the availability of support for the candidate's research
project during the next budget segment. For applicable career transition
awards (e.g., K22, K99), describe the awardee's efforts to transition
into a permanent research position and the sponsor's contributions to
that process.

### 5.1.5 Study Subjects

Provide the number of human subjects **only** if the career awardee has
participated in research involving human subjects that has not been
reported within the Progress Report of any other PHS-supported project.

### 5.1.6 Checklist

FORM PAGE 6

Facilities and Administrative (Indirect) costs on career awards will be
awarded at 8 percent of modified direct costs.

### 5.1.7 Senior/Key Personnel Report

FORM PAGE 7

Provide the information requested for the awardee and sponsor(s), if
applicable. This is the last page of the progress report. Number all
pages consecutively.

# 6. Additional Instructions for Preparing a Progress Report for an Institutional Research Training Grant, Including Ruth L. Kirschstein National Research Service Awards

Progress reports to continue support of a PHS Institutional Ruth L.
Kirschstein National Research Service Award (Kirschstein-NRSA) or
non-NRSA research training grant must be submitted on PHS 2590 forms.
The due date for these progress reports is determined by the awarding
component. Grantees access a website to determine when progress reports
are due. The Office of Policy for Extramural Research Administration,
OER, National Institutes of Health (NIH) hosts the website located at:
<http://era.nih.gov/userreports/pr_due.cfm>. Grantees are responsible
for periodically checking the list, which is updated on/around the 30th
of each month. In addition to this website, e-mail reminders are sent to
the PI.

For grantee institutions and PIs registered in the eRA Commons, the
progress report due information is available in the Commons Status
system. Commons-registered institutions and PIs also have access to
pre-populated face pages for the PHS 2590 Progress Report via Status.
For more information on the Commons, see:
<https://commons.era.nih.gov/commons/index.jsp>.

This section contains additional instructions, a substitute budget page,
Trainee Diversity Report page and Trainee Report Tables 12A and 12B to
be used to request continuation (noncompeting) support under the PHS
institutional Kirschstein-NRSA as well as non-NRSA programs. Follow both
sets of instructions in preparing your progress report.

## 6.1 Specific Instructions

### 6.1.1 Face Page

#### Items 1-5. 

Follow instructions ([Items 1-5](#items-1-5.)).

#### Item 6. Human Subjects

In many instances, trainees supported by institutional training grants
will be participating in research projects for which the Institutional
Review Board (IRB) review of human subjects is complete or an exemption
is designated. This review or exemption designation is sufficient,
providing the research would not be substantially modified by
participation of a trainee. The appropriate grants must be identified
along with their IRB review dates or exemption designation. If space is
insufficient in Item 6a, indicate \"Next Page\" and provide the
information on a plain sheet of paper after the Face Page.

If the applicant organization has an approved Federal Wide Assurance or
Multiple Project Assurance on file with the Office for Human Research
Protections (OHRP) but, at the time of progress report, plans for the
involvement of human subjects are so indefinite that IRB review and
approval are not feasible, check \"Yes\" and insert \"Indefinite\" at
Item 6a. If an award is made, human subjects may **not** be involved
until a certification of the date of IRB approval, or a designation of
exemption, has been submitted to the PHS awarding component.

#### Item 7. Vertebrate Animals

In many instances, trainees supported by institutional training grants
will be participating in research projects for which the Institutional
Animal Care and Use Committee (IACUC) review is complete. This review is
sufficient, providing the research would not be substantially modified
by participation of a trainee. The appropriate grants must be identified
along with the current IACUC review dates. IACUC approval must have
occurred within the past three years to be considered current. If space
is insufficient in Item 7, indicate \"Next Page\" and provide the
information on a plain sheet of paper after the Face Page.

Check \"Yes\" and insert \"Indefinite\" at Item 7 if the applicant
organization has an approved Animal Welfare Assurance on file with
Office of Laboratory Animal Welfare (OLAW), but at the time of progress
report, plans for the involvement of vertebrate animals are so
indefinite that IACUC review and approval are not feasible. If an award
is made, vertebrate animals may **not** be involved until a verification
of the date of IACUC approval has been submitted to the PHS awarding
component.

The institution must ensure that trainees are enrolled in the
institution's animal welfare training and occupational health and safety
programs for personnel who have contact with animals, as appropriate. It
is also the institution's responsibility to ensure that trainees are
properly supervised when working with live vertebrate animals.

#### Item 9. Inventions and Patents

Not applicable.

#### Item 13. Applicant Organization Certification and Acceptance

For Kirschstein-NRSA institutional training grants, the signature of the
official signing on behalf of the institution also assures that
postdoctoral trainees have been informed of payback requirements
associated with the Kirschstein-NRSA program.

### 6.1.2 Next Budget Period

FORM PAGE 2

A new policy concerning tuition, fees and health insurance for
Kirschstein-NRSA training grants was issued in the NIH Guide August 18,
2006; see
[NOT-OD-06-093](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-093.html)
for more details. Two sets of instructions are now provided in this
section to provide separate guidance for awards issued under the old and
new tuition policies. **For non-NRSA training grant programs, refer to
the FOA for instructions about budget reporting.**

**2a. Sunsetting Policy**

These instructions apply to non-competing continuation progress reports
where the last competing award was issued prior to fiscal year 2006
(October 1, 2005 through September 30, 2006). These grants have health
insurance awarded as part of the tuition and fees budget category and
will continue this business practice until the next competitive renewal
application.

Use the Kirschstein-NRSA substitute budget page, and follow the
instructions below, to request direct costs for the next budget period.
Any additional information should be provided on Form Page 3.

**Stipends**

Enter the number of trainees and stipend level for each trainee.
Identify, **by name, all trainees** to be continued and new trainees to
whom a commitment has been made for the next budget period.

**Tuition, Fees, and Health Insurance**

Itemize tuition, individual fees, and either self-only or family health
insurance. If tuition varies (e.g., in-state, out-of-state, student
status, or dual-degree program), identify these separately. Tuition at
the postdoctoral level is limited to that required for specified
courses. Tuition, fees, and health insurance may be requested only to
the extent that the same resident or nonresident tuition, fees, and
health insurance are charged to typical non-Federally-supported
students.

**Trainee Travel**

State the purpose of any travel; give the number of trips involved, the
destinations, and the number of individuals for whom funds are
requested. Justify foreign travel in detail, describing its importance
to the training experience.

**Training-Related Expenses**

Funds to defray other costs of training, such as staff salaries,
consultant costs, equipment, research supplies, staff travel, etc., are
requested as a lump sum based on the predetermined amount per
predoctoral and postdoctoral trainee. Enter the total dollar figure
only. No further itemization or explanation is required.

**2b. Transitioning Pilot Policy**

These instructions apply to non-competing continuation progress reports
where the last competing award was issued in fiscal year 2006 and
beyond. (Note the Federal fiscal year is from October through
September.) These grants have health insurance awarded as part of the
training related expenses budget category.

Use the Kirschstein-NRSA substitute budget page, and follow the
instructions below, to request direct costs for the next budget period.
Any additional information should be provided on Form Page 3.

**Stipends**

Enter the number of trainees and stipend amount for each trainee.
Identify, by name, all trainees to be continued and new trainees to whom
a commitment has been made for the next budget period.

**Tuition and Fees (excluding Health Insurance)**

Institutions are referred to the new policy for funding of tuition,
fees, and health insurance,
[NOT-OD-06-093](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-093.html),
dated August 18, 2006.

In this category, itemize tuition and individual fees only. If tuition
varies (e.g., in-state, out-of-state, student status, or dual-degree
program), identify these separately. Tuition at the postdoctoral level
is limited to that required for specified courses. Tuition and fees may
be requested only to the extent that the same resident or nonresident
tuition and fees are charged to regular non-Federally-supported students
and postdoctoral fellows.

**Trainee Travel**

State the purpose of any travel; give the number of trips involved, the
destinations, and the number of individuals for whom funds are
requested. Justify foreign travel in detail, describing its importance
to the training experience.

**Training Related Expenses (including Health Insurance)**

Funds to defray other costs of training, such as health insurance
(self-only or family, as applicable), staff salaries, consultant costs,
equipment, research supplies, staff travel, etc., are requested as a
lump sum based on the predetermined amount per predoctoral and
postdoctoral trainee. Enter the total dollar figure only.

While health insurance is included as part of this category and will be
awarded as a lump sum based on the [new
policy](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-093.html),
the actual costs of applicable self-only or family health insurance for
potential trainees should be separately identified in the budget.

### 6.1.3 Budget Justification

FORM PAGE 3

Indicate whether all stipends awarded for the current budget period will
be used and explain any estimated unexpended balance. Explain any
rebudgeting from trainee positions (stipends) into tuition and fees that
has occurred in the current budget period, including the number of
trainee positions (predoctoral and postdoctoral) and the estimated
dollar figure that was rebudgeted during the budget period being
reported. In addition, if rebudgeting is planned in the upcoming budget
period, include similar information on those plans as well.

### 6.1.4 Biographical Sketch

BIOGRAPHICAL SKETCH FORMAT PAGE

Provide biographical sketches **only** for newly added training faculty.

### 6.1.5 Other Support

Not applicable.

### 6.1.6 Progress Report Summary

FORM PAGE 5

Use the following instructions to prepare a progress report, which
provides a presentation of the accomplishments and changes in the
training program during the reporting period, following the outline
below: For grantees submitting the first progress report since award of
a grant renewal, the reporting period should include all months since
submission of the renewal application.

#### A. Training Program

1\. Provide a description of the training objectives and goals for the
reporting period. Highlight progress in implementation and developments
or changes that have occurred. Note any difficulties encountered by the
program. Describe changes in the program for the next budget period,
including changes in training faculty and significant changes in
available space and/or facilities. Include, as appropriate, the role of
external advisory committees, significant new training content,
procedures or experiences, and indicate how these aid in strengthening
and realizing the objectives and goals of the program.

2\. Describe the nature of the instruction in the responsible conduct of
science and the extent of trainee and faculty participation.

3\. Describe activities related to recruitment and retention of trainees
from diverse groups.

4\. If trainees took part in research involving select agents with
faculty participating in the training program, address the requirements
of Select Agent Research described in Section 2.2.6.D.

#### B. Study Subjects 

Provide data on the Inclusion Enrollment Report only if the trainees
have participated in research involving human subjects that has not been
reported within the progress report of another PHS-supported project.

#### C. Trainees 

1\. Update the data on trainees supported by the training grant in
[Table
12A](http://grants.nih.gov/grants/funding/2590/2590.htm#2590datatable12a)
and/or
[12B](http://grants.nih.gov/grants/funding/2590/2590.htm#2590datatable12b),
as applicable, to reflect new appointments and other changes that have
occurred over the reporting period. For trainees who have left the
program, and those trainees who have completed their training during
this reporting period, indicate the degree earned and the nature of
their current positions. Include the name of the institution, type,
research involvement, and any other relevant information. Do not include
data that is more than 10 years old.\
\
Grantees that have never completed Table 12A and/or Table 12B should
provide the applicable Table(s) with complete data on all trainees
supported by the grant. Instructions for completing Tables 12A and 12B
may be found in the PHS 398 Instructions for Data Tables (see:
<http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTableInstruct>).
Thereafter, updated tables will be required with each progress report
through the end of the project period.

2\. Use the Trainee Diversity Report format page to report on the
diversity of the trainees supported by this grant during the reporting
period. Enter the Grant Number including support year reported, the
Training Grant Title, and Total Number of Trainees Appointed during the
reporting period. In Part A of the report, indicate for
[all]{.underline} trainees the numbers that all into each ethnic and
racial category. The number of multi-racial trainees will be entered
into the row "more than one race." Normally, the unknown or not-reported
categories will not be needed.\
\
In Part B of the report, indicate for "Hispanic or Latino" trainees the
numbers that fall into each racial category. In Part C of the report,
indicate the number of Trainees with Disabilities or are from
Disadvantaged Backgrounds. Definitions of the indicated racial and
ethnic categories are described in the PHS 398 instructions.

3\. Include a paragraph that describes the research project and course
work of each trainee supported during the reporting period, as well as
any conference presentations, honors, fellowships, etc.

4\. List the titles and complete references (author(s), journal or book,
year, page number) of all trainee publications **not previously
reported**, including those by former trainees still in research
training. This includes manuscripts submitted or accepted for
publication. Citations that are not covered by the Public Access Policy
but are publicly available in a free, on-line format may include URLs or
the PubMed Central numbers (PMCID) along with the full reference.\
\
Peer-reviewed trainee publications that arise from support of the
training grant must be submitted to PubMed Central in accord with the
Public Access Policy, and the PubMed Central reference number (PMCID) or
NIH Manuscript Submission reference number (NIHMS ID) provided. If the
publication was already submitted because it also arose as the result of
other NIH support, simply provide the PMCID or NIHMS ID. If the PMCID is
not yet available because the Journal submits articles directly to PMC
on behalf of their authors, indicate \"PMC Journal - In Process.\" A
list of these Journals is posted at:
<http://publicaccess.nih.gov/submit_process_journals.htm>.

### 6.1.7 Checklist

FORM PAGE 6

#### Facilities and Administrative (Indirect) Costs

Facilities and Administrative (F&A) costs under institutional
Kirschstein-NRSAs, other than those issued to State or local government
agencies, will be awarded at 8 percent of total modified direct costs
(excluding the tuition/fees category and sub-grants and contracts in
excess of \$25,000). Equipment is also excluded on those training grants
where Training Related Expenses are not calculated on a lump-sum basis,
such as the MARC or COR Honors Undergraduate Research Training Grants.
The treatment of health insurance will vary according to the policies
under which a Kirschstein-NRSA award was made (for details, see Item 2).
State and local government agencies will receive awards at their full
Facilities and Administrative cost rate.

### 6.1.8 Senior/Key Personnel Report

FORM PAGE 7

Not applicable.

# 7. Additional Instructions for Preparing a Progress Report for an SBIR and STTR Award

Progress reports to continue support of a PHS Small Business Innovation
Research (SBIR) or Small Business Technology Transfer (STTR) Award must
be submitted on PHS 2590 forms. The due date for these progress reports
is determined by the awarding component. Grantees access a website to
determine which progress reports are due. The Office of Policy for
Extramural Research Administration, OER, National Institutes of Health
(NIH) hosts the website located at:
<http://era.nih.gov/userreports/pr_due.cfm>. Grantees are responsible
for periodically checking the list, which is updated on/around the 30th
of each month. In addition to this website, e-mail reminders are sent to
the PI.

For grantee institutions and PD/PIs registered in the eRA Commons, the
progress report due information is available in the Commons Status
system. Commons-registered institutions and PD/PIs also have access to
pre-populated face pages for the PHS 2590 Progress Report via Status.
For more information on the Commons, see:
<https://commons.era.nih.gov/commons/index.jsp>.

Additional information on this notification process can be found in the
NIH Guide Notice OD-03-054:
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-054.html>.

Follow the instructions in Sections I and II of this document. This
section contains additional instructions pertinent to Fast Track SBIR
and STTR awards.

## Fast-Track SBIR/STTR Awards

A Fast-Track Phase II application may be funded following submission of
an original PHS 2590 Non-competing Continuation Progress Report. Follow
the simplified instructions under the Streamlined Noncompeting Award
Process (SNAP) found in [Section 2.1](#snap) for all portions except the
research plan, which should include the following:

1\. A Phase I Final Progress Report: Follow the application instructions
in the Grants.gov SBIR/STTR Application Guide SF424 (R&R), Section 5.4,
Research Plan Component, Item 4, Preliminary Studies/Progress Report at
<http://grants.nih.gov/grants/funding/424/index.htm>.

2\. A section labeled Milestones (l) identifying either the milestones
described in the original Phase I application as approved by the peer
reviewers or the milestones modified by the peer reviewers and
negotiated with the grantee; and (2) describing the progress achieved
relative to the milestones.

3\. A one-page abstract describing the research plan for Phase II. (See
Section 6. D, \"Plans\" of the Progress Report Summary). If the aims
have not been modified from the original Phase II application, state
this. If they have been modified, give the reviewed aims and the reason
for the modifications.

4\. An updated Commercialization Plan as necessary, if changes have been
made from the original submission.

Funding for the Phase II application will be contingent upon (1)
assessment of the Phase I progress report and determination that the
Phase I goals and milestones were achieved; (2) An update (as necessary)
of the Commercialization Plan; (3) determination of the project\'s
potential for meeting the mission of the awarding component and for
commercial success; (4) review and approval of other documents necessary
for continuation; and (5) availability of funds.

**The Continuation Progress Report is due two months prior to the
anticipated start of Phase II and should be sent to the address noted on
the Notice of Award.**

The appropriate grants management and program staff of the awarding
component will review the Phase I Continuation Progress Report. If the
continuation request is not approved, then written notification will be
sent to the applicant.

## Final Report Requirements

### Phase II Final Progress Report

A Phase II Final Progress Report is required to close out your Phase II
grant.

You must submit a Final Report within 90 days of the project period end
date. Submit the **original** report to the Central mailing address
listed in Section 1 within **90 days** of the termination of the grant.

Final reports serve as an important source of material for staff of the
awarding component in preparing annual reports, for planning purposes,
and in communicating scientific accomplishments achieved through the
SBIR/STTR program.

There is no "form page" for a Final Report. It may be typed on plain
white paper (or you may use the PHS 2590 Continuation Page). *The
recommended length for the narrative portion is 10 pages*.

The format for the Phase II Final Progress Report is as follows:

1\. State the beginning and end dates for the period covered by the
SBIR/STTR **Phase II** grant.

2\. List all senior/key personnel who worked on the project during that
period (include titles, dates of service, and number of hours devoted to
the project).

3\. Summarize the specific aims of the Phase II grant.

4\. Provide a succinct account of published and unpublished results,
indicating progress toward achievement of the originally stated aims.
Include the Inclusion Enrollment Report with the final enrollment data
for clinical research.

5\. List titles and complete references to publications, and manuscripts
accepted for publication, if any, that resulted from the Phase II.

6\. List patents, copyrights, trademarks, invention reports and other
printed materials, if any, that resulted from the Phase II or describe
patent status, trade secrets or other demonstration of IP protection.

7\. Describe of the technology developed from this SBIR/STTR, its
intended use and who will use it.

8\. Describe the current status of the product (e.g., under development,
commercialized, in use, discontinued).

9\. If applicable, describe the status of FDA approval for your product,
process, or service (e.g., continuing pre-IND studies, filed an IND, in
Phase I (or II or III) clinical trials, applied for approval, review
ongoing, approved, not approved, not ready to submit for FDA approval).

10\. Describe how your company has benefited from the program and/or the
technology developed (e.g., firm\'s growth, follow-on funding, increased
technical expertise, licensing agreements, spin-off companies, public
offering \[include stock exchange and symbol\]).

11\. List of the generic and/or commercial name of product, process, or
service, if any, that resulted from SBIR/STTR funding. If applicable,
indicate the number of products sold.

12\. Provide the current number of employees (total full time
equivalents \[FTEs\]).