Department of Health and Human Services 

OFFICE OF

INSPECTOR GENERAL

 

NIH ADMINISTRATION OF THE 

CLINICAL AND TRANSLATIONAL 

SCIENCE AWARDS PROGRAM 

 

 

Daniel R. Levinson 

Inspector General 

December 2011 

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 EXECUTIVE SUMMARY

OBJECTIVES

1. To determine the extent to which the National Institutes of 

Health (NIH) administered the Clinical and Translational 

Science Award (CTSA) program in accordance with Federal 

regulations and Department of Health and Human Services 

(HHS) and NIH policies for: 

• monitoring awardee progress in achieving the goals and 

milestones of the program (awardee progress), 

• ensuring timely submission of reports, and

• maintaining official files.

2. To determine whether CTSA program staff provided substantial 

involvement to awardees in accordance with Federal regulations

and HHS and NIH policies. 

BACKGROUND

In 2006, NIH’s National Center for Research Resources (NCRR) 

established the CTSA program to provide external research awards for

expediting scientific research for new medical treatments. As of 

March 2011, NCRR had awarded CTSA research awards to 55 domestic 

graduate schools, with planned 5-year funding of more than $2.2 billion. 

The role of NIH grants management staff, including CTSA program 

staff, is to oversee awardees to ensure that they follow all applicable 

Federal regulations, departmental and agency policies, and terms and 

conditions of awards. CTSA program staff must ensure that awardees 

submit annual progress reports and financial status reports and must 

determine whether awardee progress remains satisfactory before 

awardees receive continued funding. 

NIH uses three funding mechanisms for research awards: grants, 

cooperative agreements, and contracts. The CTSA program uses 

cooperative agreements. Under cooperative agreements, NIH staff 

provide assistance to awardees above and beyond the levels usually 

required for program stewardship of grants. This level of stewardship is 

known as substantial involvement. CTSA program staff assign NIH 

Project Scientists to awardees to provide substantial involvement 

through technical assistance, advice, and coordination. Names of 

substantially involved staff and an annual summary of staff 

involvement should be documented in the official files.
 

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EXECUTIVE SUMMARY

We reviewed files for the 38 CTSA cooperative agreements awarded in 

fiscal years (FY) 2006 through 2008 to determine whether CTSA 

program staff administered the program in compliance with Federal 

requirements and HHS and NIH policies and whether they provided 

substantial involvement to awardees. 

FINDINGS

Despite completing basic checklists, CTSA program staff did not 

document awardees’ progress in compliance with NIH policy. For 

only 1 of 38 awardees, CTSA program staff documented a comparison of 

accomplishments to research objectives. Although reviews for six

awardees’ files mentioned an inability to fulfill goals, only one file 

included a note from CTSA program staff regarding resolution. 

Similarly, plans for the upcoming year were noted in only one file. 

Awardees were frequently late in submitting required reports; CTSA 

program staff did not take action to address timeliness. Most 

progress reports and one-half of financial status reports were late, yet 

the CTSA files contained no evidence that staff tried to obtain 

delinquent reports. Also, despite widespread report delinquency, no 

enforcement actions were documented in official files. 

Official CTSA files were not maintained in accordance with HHS

policy. Official CTSA files were incomplete, were not current, were 

often not separated by budget period, and did not enable third-party 

review. 

No files contained evidence that CTSA program staff provided 

substantial involvement to awardees in accordance with Federal 

regulations and NIH policy. The CTSA files contained no evidence of 

expected substantial involvement by Project Scientists. Additionally, 

the files contained no other evidence of substantial involvement by any 

CTSA program staff beyond usual program stewardship activities.

RECOMMENDATIONS

For better oversight of the CTSA program, we recommend that NIH 

ensure that CTSA program staff: 

Document their monitoring of awardee progress. NIH must ensure that 

staff document awardee accomplishments toward meeting project goals;

reasons for not meeting project goals, if applicable; and plans for activities 

during the coming year. 
 

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EXECUTIVE SUMMARY

Ensure timely submission of required reports. NIH should ensure that 

staff document correspondence with awardees as they act to obtain 

delinquent progress reports and financial status reports.

Maintain official files in accordance with HHS policy. NIH must

establish a single comprehensive filing system in which files are 

complete, current, easy to identify, easy to access, and separated by 

budget period. This would promote a coordinated approach to oversight 

for NIH staff and third-party reviewers.

Provide substantial involvement to CTSA awardees. At a minimum, 

staff must clearly list the Project Scientists involved and include the 

annual summary of involvement within the award files.

AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 

RESPONSE 

NIH concurred with our recommendations. NIH stated that it (1) will 

issue specific guidance on documentation requirements for monitoring 

awardee progress and obtaining delinquent reports, (2) has already 

implemented the recommendation to maintain official files in 

accordance with HHS policy, and (3) will work with NCRR to revise 

its cooperative agreement terms of award.
 

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 TABLE OF CONTENTS

EXECUTIVE SUMMARY ................................ ..... i

INTRODUCTION ............................................ 1 

FINDINGS ................................................. 10

Despite completing basic checklists, CTSA program staff 

did not document awardees’ progress in compliance 

with NIH policy ........................................ 10

Awardees were frequently late in submitting required 

reports; CTSA program staff did not take action to 

address timeliness ...................................... 11

Official CTSA files were not maintained in accordance with HHS 

policy ................................................ 13

No files contained evidence that CTSA program staff provided 

substantial involvement to awardees in accordance with Federal 

regulations and NIH policy ............................... 15 

RECOMMENDATIONS ..................................... 17 

Agency Comments and Office of Inspector General Response ... 18 

APPENDIXES ............................................. 19 

A: Responsibilities of Clinical and Translational Science Award 

Program Staff.......................................... 19 

B: Example of Awardee Goals and Milestones ............... 20

C: Agency Comments ................................... 21

ACKNOWLEDGMENTS ..................................... 30
 

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 INTRODUCTION

OBJECTIVES 

1. To determine the extent to which the National Institutes of 

Health (NIH) administered the Clinical and Translational 

Science Award (CTSA) program in accordance with Federal 

regulations and Department of Health and Human Services 

(HHS) and NIH policies for: 

• monitoring awardee progress in achieving the goals and 

milestones of the program (awardee progress), 

• ensuring timely submission of reports, and

• maintaining official files.

2. To determine whether CTSA program staff provided substantial 

involvement to awardees in accordance with Federal regulations 

and HHS and NIH policies.

BACKGROUND

The National Center for Research Resources (NCRR) is one of the 

funding institutes or centers within NIH.1 NCRR established the CTSA 

program to provide external research awards for scientists to transform 

basic research and patient observations into clinical practice and new 

treatments.2 As of March 2011, NCRR had awarded CTSA research 

awards to 55 domestic graduate schools, with planned 5-year funding of 

more than $2.2 billion.3

Previous Office of Inspector General (OIG) reviews of award programs 

administered by NIH and other agencies highlighted opportunities for 

improvements in the oversight of grantee funds and compliance.

 

4

1 NIH, Institutes, Centers, and Offices. Accessed at http://www.nih.gov on April 25, 

2011. See also NIH, Scientific Management Review Board Report on Translational 

Medicine and Therapeutics. Accessed at http://smrb.od.nih.gov on April 12, 2011. 

2 NCRR, Clinical and Translational Science Awards Fact Sheet. Accessed at 

http://www.ncrr.nih.gov on August 26, 2010. NIH, “Request for Applications RM-06-002: 

Institutional Clinical and Translational Science Award.”

3 NCRR, Clinical and Translational Science Awards and Five-Year Funding Amounts 

by Institution. Accessed at http://www.ncrr.nih.gov on March 30, 2011. 

4 OIG, National Cancer Institute’s Monitoring of Research Project Grants 

(OEI-07-07-00120) and Agency for Healthcare Research and Quality: Monitoring Patient 

Safety Grants (OEI-07-04-00460).
 

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INTRODUCTION

Award oversight is a top management challenge for the Department of 

Health and Human Services (HHS), as award programs are at risk of 

fraud, waste, abuse, and ineffectiveness without proper controls to 

ensure the appropriate use of Federal funds.5 Moreover, expansion in 

the number and size of awards, such as that occurring in the CTSA 

program, will magnify oversight vulnerabilities.6

Federal Requirements and Departmental Guidance for Award Administration 

 

Federal regulations establish uniform administrative requirements 

governing HHS awards to institutions of higher education, hospitals, 

and other nonprofit organizations.7

The role of NIH grants management staff, including CTSA program

staff,

 Guidance in implementing these 

regulatory requirements is contained in the HHS Grants Policy 

Directives (GPD), which apply to all organizational levels within HHS; 

the NIH Policy Manual, which applies to internal operations of NIH; 

and the CTSA Consortium Governance Manual, which is specific to the 

CTSA program.

8 is to oversee awards to ensure that awardees use funding 

properly and prudently and follow all applicable laws, regulations, and 

policies.9 Grants management staff are responsible for usual program 

stewardship, including the business administration of award programs 

and resolving questions regarding the applicability of departmental and 

agency policies.10

If awardees materially fail to comply with the terms and conditions of 

an award, the Grants Management Officer may take one or more of the 

following enforcement actions:

 

• temporarily withhold payments pending the correction of 

deficiencies,

• disallow funds on the cost of the activity not in compliance,

5 OIG, FY 2010 Top Management and Performance Challenges Identified by the Office 

of the Inspector General. Accessed at http://oig.hhs.gov on March 30, 2011.

6 Ibid.

7 45 CFR pt.74.

8 For the purposes of this report, CTSA program staff are the staff responsible for both 

the business and programmatic aspects of the CTSA awards, including Grants 

Management Officers, Grants Management Specialists, Program Officials, and Project 

Scientists. 

9 See Appendix A for a listing of specific responsibilities of grants management staff, 

including Grants Management Officer business responsibilities and Program Official 

programmatic responsibilities. 

10 HHS, GPD, pt. 1.02; NIH, Policy Manual, ch. 54444. 
 

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INTRODUCTION

• suspend or terminate the current award, and/or

• withhold further awards.11

Ensuring Submission of Required Reports

All NIH awardees12 must submit annual performance reports and 

financial status reports (FSR).13 The Grants Management Officer

should not release continued funding until required reports are 

submitted.14

For many NIH research awards, including CTSA awards, annual 

progress reports are due 2 months before the beginning of the next 

budget period.15 Awardees must provide a comparison of the

accomplishments during the progress period to the goals and milestones

and, if applicable, reasons that the goals and milestones were not met. 

If an awardee is delinquent in submitting a progress report, the Grants 

Management Officer must:

• send an initial request letter to the awardee 30 days beyond the 

due date, 

• send a second request letter to an official at the awardee 

institution 60 days beyond the due date, 

• send a third request letter to the head of the awardee institution

90 days beyond the due date, and

• refer the matter to the designated NIH official if there is not an 

acceptable response 120 days beyond the due date.16 

All NIH awardees, including CTSA awardees, must submit an FSR no 

later than 90 days after the close of the budget period.17 The FSR 

shows the status of awarded funds for that budget period. When FSRs 

are 4 months overdue (i.e., when 7 months have elapsed since the end of 

the budget period), the Grants Management Officer must:

11 45 CFR § 74.62.

12 For the purposes of this report, the term “all awardees” refers to those subject to the 

Streamlined Noncompeting Award Process, including CTSA awardees. 

13 45 CFR §§ 74.51 and 74.52. NIH refers to the annual performance reports as 

“progress reports.” NIH, Grants Policy Statement, pt. 1. 

14 NIH, Policy Manual, ch. 55806. CTSA awards may include continued funding for 

4 years after the initial award year, for a total of 5 years. NIH, “Request for Applications 

RM-06-002: Institutional Clinical and Translational Science Award.”

15 Office of Management and Budget, U.S. Department of Health and Human Services 

Public Health Service Non-Competing Grant Progress Report (PHS [Public Health 

Service] 2590). Accessed at http://grants.nih.gov on December 6, 2010.

16 NIH, Policy Manual, ch. 55806.

17 45 CFR § 74.52; NIHGPS, pt. 2, pt. II-87.
 

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INTRODUCTION

• send a request letter to the awardee requesting submission of the 

report within 30 days, 

• send a letter to the head of the awardee institution if there is no 

reply to the initial request within 30 days (i.e., 5 months beyond 

the due date), 

• not make continuation awards until required reports have been 

received, and

• refer the matter to the designated NIH official if an awardee 

institution is consistently delinquent in submitting FSRs. 18

Monitoring Awardee Progress

Grants management staff must identify programmatic and financial 

deficiencies, if any, throughout the award period.19 This includes 

reviewing the annual progress reports to ensure that awardees achieve 

the goals and milestones of the program. Staff must also review FSRs 

to monitor awardees’ expenditures and compliance with financial 

reporting requirements. When reviewing awardee progress, grants 

management staff must include, at a minimum, the following:

• evidence of accomplishments toward meeting project goals, 

• reasons for not meeting project goals (if applicable), and 

• plans for activities during the next year.20 

Grants management staff use award checklists to document their 

review of annual progress as reflected in the Award Worksheet 

Reports.21 

Official File Maintenance

As part of a coordinated approach to postaward administration, 

awarding offices, such as NCRR, must create and maintain files that 

enable a third party (e.g., auditor or other reviewer) to follow the life of 

the award, from initiation through closeout.22 A third-party reviewer 

should be able to view information regarding decisions made and 

actions taken throughout the entire award. An individual official file 

18 NIH, Policy Manual, ch. 55806. The Manual does not define the term “consistently 

delinquent.”

19 HHS, GPD, pt. 3.06; NIH, Policy Manual, ch. 54815 and 54444.

20 NIH, Policy Manual, ch. 55808.

21 NCRR staff use the same Award Worksheet Reports to document review of each 

awardee’s annual progress report and FSR. NIH, Grants Management User Guide, 

System Version 2.16.0.0. Accessed at http://era.nih.gov on August 11, 2010. 

22 HHS, GPD, pt. 3.06.
 

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INTRODUCTION

must be created for each award and must contain the following 

documentation:

• signed copies of applications and all documentation that supports 

the review and approval of the applications;

• Notices of Award;

• performance and financial reports and evidence of review and 

acceptance by the awarding agency;

• site visit reports, records of telephone calls, and documents to 

support postaward technical assistance provided; and

• documentation related to enforcement actions, including any 

award appeals.23

Official file contents must be current, easy to identify, easy to access, 

and separated by budget period to the extent possible.24 Official files 

must also include hardcopies of electronically created or transmitted 

documents, including email, or be referenced to a separate file or 

repository.25 

Cooperative Agreement Award Mechanism

NIH uses three funding mechanisms for research awards: grants, 

cooperative agreements, and contracts. The CTSA program uses the 

cooperative agreement award mechanism. Federal requirements for 

award administration are generally the same for grants and cooperative 

agreements. Under cooperative agreements, however, NIH facilitates 

the awardees’ performance of the funded activity in a “partnership” 

role.26 

In such a partnership, NIH staff provide assistance to awardees above 

and beyond the levels usually required for program stewardship of 

grants, but without dominating the relationship.27 This increased NIH 

staff involvement with awardees is known as substantial involvement.28 

The NIH Policy Manual states that substantial involvement could 

include: 

23 HHS, GPD, pt. 3.06; NIH, Policy Manual, ch. 55806.

24 HHS, GPD, pt. 3.06.

25 Ibid.

26 NIH, Policy Manual, chs.1820 and 54815. 

27 Ibid.

28 The Federal Grant and Cooperative Agreement Act of 1977, 31 U.S.C. § 6305; HHS, 

GPD, pts. 1.02 and 2.02.
 

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INTRODUCTION

• cooperation, coordination, or participation in assisting awardees 

in performing project activities (e.g., development of research 

protocols; data collection, analyses, and interpretations; or

reestablishment of objectives during the course of a project);

• an option to halt a project activity if technical performance 

requirements are not met;

• review or approval of one stage of a project before work may begin 

on a subsequent stage during a current approved project period;

• assistance with, or approval of, the selection of contractors or 

subawardees and of key project personnel other than principal 

investigators of projects or subprojects; 

• technical monitoring to permit specified directions of the work, 

including approval of changes in experimental approaches; and

• participation on committees or in other functions responsible for 

helping to guide the course of long-term projects or activities.29

The NIH Policy Manual states that the names of substantially involved 

staff and an annual summary of staff involvement in the award must be 

documented in the award files.30 

For the CTSA program, the Governance Manual indicates that at least

one Project Scientist is assigned to each CTSA awardee to provide 

substantial involvement through technical assistance, advice, and 

coordination.31 Project Scientists are not responsible for usual program 

stewardship. Instead, Project Scientists are responsible for reviewing 

and commenting on critical stages in implementation of the awards and 

for promoting collaboration among awardees.32 See Appendix A for a 

listing of all responsibilities for Project Scientists (as well as the 

responsibilities of grants management staff). 

METHODOLOGY

Scope

This evaluation reviewed NIH’s administration of the 38 CTSA research 

awards funded in fiscal years (FY) 2006 through 2008.33 NIH awarded 

$606 million to these awardees during our 3-year review period. Since 

29 NIH, Policy Manual, ch. 1820.

30 NIH, Policy Manual, ch. 54815.

31 CTSA Consortium, Governance Manual, Working Document, Version 2008.8.14. 

Accessed at http://www.ctsaweb.org on June 22, 2009.

32 Ibid.

33 The required reports for these awards were due during FYs 2007 to 2009.
 

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INTRODUCTION

all awardees requested 5 years of support, a total of 74 budget periods 

were reviewed for the 38 cooperative agreements during our review 

period—12 awardees were in the third year of operation (36 budget 

periods), 12 were in the second year (24 budget periods), and 14 were in 

the first year (14 budget periods). See Table 1 for a description of the 

number of awards and budget periods by award year. 

Table 1: CTSA Award Summary 

Fiscal Year

Budget 

Periods 

Reviewed

Number of 

Awardees

Total 

Budget 

Periods

2006 3 12 36

2007 2 12 24

2008 1 14 14

Total 38 74

Source: OIG analysis of CTSA files, 2009.

We did not review the research or scientific outcomes described in the 

progress reports or the appropriateness of the information reported in 

FSRs. However, we did determine the extent to which CTSA program 

staff documented their own review of research or scientific outcomes 

when evaluating awardee progress. 

Data Sources 

NCRR staff scanned their official files for the 38 CTSA awards into an 

electronic format for our review. NCRR staff stated that the electronic 

files contained both the scanned versions of the paper files and 

supplemental information from NIH’s electronic grants management 

system, Information for Management, Planning, Analysis, and 

Coordination (IMPAC II). For the purposes of our review, we refer to 

these scanned files as the official files. 

If documents were missing from the official files, we consulted two 

additional sources to complete our review: IMPAC II via direct access

and electronic copies of the Award Worksheet Reports not present in 

IMPAC II.

Data Collection and Analysis

We reviewed the following documents when present in the CTSA files, 

regardless of data source: 

• CTSA applications; 
 

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INTRODUCTION

• Award Worksheet Reports;

• Notices of Award;

• progress reports;

• FSRs; and

• any documentation of postaward assistance in emails, telephone 

records, reports, or other documents.

We developed a checklist to conduct our review of these files to 

determine compliance with Federal regulations and HHS and NIH 

policies. We determined whether any CTSA program staff performed 

the following activities, regardless of which staff were charged with 

responsibility for each activity: 

Ensuring Submission of Required Reports. We reviewed the CTSA files to 

determine whether required progress reports:

• were submitted 2 months before the beginning of the next budget 

period;

• contained a self-reported comparison of accomplishments with 

awardee goals and milestones34 established for the budget period; 

and

• explained the reasons that goals and milestones were not met, if 

applicable.

We determined whether required FSRs were received within 90 days 

after the close of the budget period and whether they reflected the 

status of funds. We determined whether CTSA program staff ensured 

the submission of required progress reports and FSRs through 

correspondence with awardees to obtain delinquent reports and 

enforcement actions in the event of continued delinquency.

Monitoring Awardee Progress. We reviewed Award Worksheet Reports to 

determine whether CTSA program staff reviewed annual awardee 

progress for continued funding. Specifically, we determined whether 

the following were documented: 

• awardee accomplishments toward meeting project goals;

• reasons for not meeting project goals, if applicable; and

• plans for activities during the coming year.

Award Worksheet Reports contain a yes/no option that enables grants 

management staff to indicate whether awardee progress was 

34 See Appendix B for an example of the goals and milestones section of an application. 
 

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INTRODUCTION

satisfactory. The Award Worksheet Reports also contain a narrative 

field for staff comments.

Maintaining Official Files. We determined whether official files enabled a 

third party to follow the life of CTSA awards. Specifically, we 

determined whether file contents were current, easy to identify, easy to 

access, and separated by budget period. We also determined whether

files were complete, containing the following documentation specified in 

HHS and NIH policy: 

• signed copies of applications and documentation that supports the 

review and approval of the applications (e.g., Award Worksheet 

Reports); 

• Notices of Award;

• progress and financial reports and evidence of review and 

acceptance by the awarding agency;

• site visit reports, records of telephone calls, and documents to 

support postaward technical assistance provided; and

• documentation related to enforcement actions, including any 

award appeals.

Providing Substantial Involvement. We reviewed the CTSA files for 

evidence of substantial involvement by CTSA program staff, including 

technical or scientific assistance from Project Scientists regarding 

program implementation35 and any other assistance beyond usual 

program stewardship. We determined whether files contained the 

names of substantially involved staff and the annual summaries of staff 

involvement specified in agency policy. 

Standards

This study was conducted in accordance with the Quality Standards for 

Inspection and Evaluation issued by the Council of the Inspectors 

General on Integrity and Efficiency.

35 See Appendix A for information from the CTSA Governance Manual regarding

Project Scientists’ responsibilities with regard to programmatic involvement. 
 

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Despite completing basic checklists, CTSA

program staff did not document awardees’ 

progress in compliance with NIH policy

 FINDINGS

We reviewed Award Worksheet 

Reports to determine whether 

CTSA program staff documented 

the following when reviewing 

awardees’ progress: awardee accomplishments toward meeting project 

goals; reasons for not meeting goals, if applicable; and plans for 

activities during the coming year. For all but one file, a simple “yes/no” 

checklist item on these reports indicated that progress was satisfactory 

each year. However, CTSA program staff largely failed to document the 

support for their answers as specified in NIH policy. 

CTSA program staff documented their comparison of awardee 

accomplishments from the prior year to project goals for only 1 of the 

38 files. For two other files, the section of the application outlining the 

goals and milestones was missing altogether, which prevented annual 

comparisons of progress to milestones. For the remaining 35 files, the 

goals and milestones sections of the application were present; however, 

comparisons to annual accomplishments were not documented. 

In the 38 files, 8 Award Worksheet Reports noted awardees’ inability to 

fulfill project goals. CTSA program staff attributed most of these 

deficiencies to budget cuts, although one file indicated that the goal was 

too ambitious, and another did not provide a reason. Moreover, only one 

of these six files contained a plan for resolution. In this case, the 

awardee was producing less than other awardees and developed an 

advisory committee to address this concern. CTSA program staff noted 

that this strategy was likely to bring this awardee’s production in line 

with that of the other awardees. 

Similarly, CTSA program staff noted only one awardee’s plans for the 

upcoming year. In this case, the Award Worksheet Report narrative 

included a copy of an email from the awardee that described activities 

that occurred after the submission of the annual progress report and 

plans for the upcoming project period.
 

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FINDINGS

Awardees were frequently late in submitting 

required reports; CTSA program staff did not 

take action to address timeliness

Awardees commonly 

submitted progress reports 

and FSRs late. Despite 

frequent delinquencies in the 

submission of required reports, CTSA program staff did not take action 

to address the noncompliance. 

Most progress reports and half of FSRs were late 

During our study period, 66 of the 74 (89 percent) progress reports were

late. Progress reports were late an average of 12 days. Table 2 

summarizes the number of progress reports received late during each 

year of our review period. 

Table 2: Timeliness of Progress Reports Submitted From 2007 to 2009 

Year

Total 

CTSA 

Awards

Progress 

Reports 

Received

Number 

Received 

Late

Percentage 

Received 

Late

2007 12 12 11 92% 

2008 24 24 20 83% 

2009 38 38 35 92% 

 Total 74 74 66 89% 

Source: OIG analysis of CTSA files, 2010.

During our study period, 36 of 74 FSRs (49 percent) were late. FSRs 

were late an average of 113 days. One report was not submitted within 

the period of our review. Table 3 summarizes the number of FSRs 

received late during each year of our review period.

Table 3: Timeliness of FSRs Submitted From 2007 to 2009 

Year

Total 

CTSA 

Awards

FSRs 

Received

Number 

Received 

Late

Percentage 

Received 

Late

2007 12 12 6 50%

2008 24 24 13 54%

2009 38 37 17 45% 

 Total 74 73 36 49% 

Source: OIG analysis of CTSA files, 2010.
 

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FINDINGS

Staff did not ensure timely submission of required reports

The NIH Policy Manual instructs CTSA program staff to document 

correspondence with awardees to obtain delinquent reports; however, no 

such documentation was present in the files. 

NIH policy requires CTSA program staff to send notices to awardees 

regarding delinquent reports when progress reports are 30, 60, 90, and 

120 days late and when FSRs are 4 and 5 months late. None of the files 

contained these reminder notices. However, files contained 8 progress 

reports that were more than 30 days late; 4 of those were more than 

60 days late.36

For all of the research awards, only one file contained documentation of 

an instance when CTSA program staff contacted an awardee about a 

late report, but this request was late and therefore was not in 

compliance with the NIH Policy Manual. To illustrate, the CTSA 

program staff member emailed the awardee to request an FSR that was 

due 9 months earlier. The awardee finally submitted the FSR to CTSA 

program staff 3 months after the request, nearly a year after the 

original due date. 

 Similarly, files contained 11 FSRs that were more than 

4 months late and 9 of those FSRs were more than 5 months late. 

NIH policy also instructs CTSA program staff to document enforcement 

actions taken to address continued delinquency. Despite widespread

report delinquency, no enforcement actions were documented. For 

example, one awardee’s FSRs were 67 days late in 2007, 351 days late 

in 2008, and 184 days late in 2009. This awardee’s progress reports 

were also late each year. Even though these reports were repeatedly 

late, no evidence in the files documented any of the enforcement actions 

that CTSA program staff could have taken to address this awardee’s 

violation of the terms and conditions of award. 

36 None of the progress reports were more than 90 days late.
 

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FINDINGS

Official CTSA files were not maintained in

accordance with HHS policy 

Official files must be complete, 

current, easy to identify, easy to 

access, and separated by budget 

period. Official award files must also enable third-party review in order 

to provide a coordinated approach to award oversight. Official CTSA 

files maintained by NCRR did not meet these criteria. 

NCRR staff stated that the official files for the CTSA awards contained 

scanned versions of their paper files and supplemental information from 

IMPAC II. However, at least 1 required document was missing from the 

official file for each of the 38 awards. Table 4 provides a summary of 

the missing documents.

Table 4: Summary of Documents Missing From Official CTSA Files

Award Year Number of 

Awards Document

Number Missing 

From Official File 

Source

Prior to Award 38

Entire application 7 

Implementation and Milestones 

eaSection of application 21

Year 1 38

FSR 6 

Progress Report 17

Award Worksheet Report 16

Notice of Award 12 

Year 2 24

FSR 8 

Progress Report 15

Award Worksheet Report 8

Notice of Award 12

Year 3 12

FSR 5 

Progress Report 4

Award Worksheet Report 1

Notice of Award 6

Source: OIG analysis of official CTSA files, 2009. 
 

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Official CTSA files were also not current. All CTSA awards were into 

the second quarter of a new budget period at the time of our request, 

and for this reason, the Notice of Award for the new budget period 

should have been filed by that time. However, none of the files 

contained information from that budget period (e.g., Notices of Award, 

site visit reports, records of telephone calls, or emails). 

Official CTSA files were often not separated by budget period. Files 

were not consistently separated by budget period for 16 of the 38 CTSA 

awards. Files for 13 awards combined 2 or more years into 1 section, 

while files for the other 3 awards divided single award years into 

multiple small sections. 

Additionally, official CTSA files do not enable third-party review. 

Because the official files maintained by NCRR are incomplete, a 

third-party review would be inaccurate if it relied solely on these files. 

To complete a comprehensive review of CTSA files, we consulted two 

additional file sources. Table 5 summarizes the file sources used and 

the extent to which they complied with Federal policy from a third-party 

perspective. 

Table 5: Extent to Which File Sources Met Requirements of Federal Policies for File Maintenance

Access 

Date Data Source Files Are Complete

Files Are 

Current

Files Are 

Easy to 

Identify

Files Are 

Easy to 

Access

Files Are 

Separated by 

Budget Period

October 

2009 Official files No No No Yes Sometimes

March 

2010 IMPAC II No Yes Yes No Yes

April 

2010

Electronic Award 

Worksheet Reports No Yes Yes No Yes

Source: OIG analysis of CTSA files, 2010. 

No single file source met all the requirements of the Federal policies for 

maintaining files. IMPAC II contained all documents missing from the 

official file except the Award Worksheet Reports. NCRR could not 

locate four Award Worksheet Reports electronically; however, these 

reports were present in the official files for the respective awards. 

FINDINGS
 

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FINDINGS

No files contained evidence that CTSA program 

staff provided substantial involvement to 

awardees in accordance with Federal 

regulations and NIH policy 

According to Federal statute, 

cooperative agreements 

necessitate substantial 

involvement37

 

by the awarding 

agency in partnership with the 

awardee throughout the life of the 

award. NIH policy states that the names of substantially involved staff 

and annual summaries of substantial staff involvement in the 

cooperative agreements must be documented in the files. According to 

the CTSA Consortium Governance Manual, Project Scientists are 

responsible for providing substantial involvement for CTSA cooperative 

agreements. However, file documentation contained no evidence of this 

type of involvement by Project Scientists or any other CTSA staff.

The CTSA files contained no evidence of substantial Project Scientist 

involvement 

The award files contained no documentation of technical assistance

from Project Scientists regarding program implementation for any of 

the cooperative agreements. Additionally, files had no evidence that

Project Scientists did any of the following: 

• assisted awardees in performing project activities,

• halted a project activity if technical performance requirements 

were not met,

• reviewed or approved stages of a project,

• approved the selection of contractors or subawardees or key 

project personnel,

• conducted technical monitoring to permit specified directions of 

the work, or 

• participated on committees.

None of the files listed names of Project Scientists, and only two files 

contained any mention of a Project Scientist. In one instance, the 

Project Scientist emailed his intent to attend a teleconference with 

CTSA program staff and the awardee regarding restructuring of the 

CTSA program. However, the file contained no documentation 

explaining what, if any, technical advice the Project Scientist 

contributed during that meeting or documentation of any other 

37 Substantial involvement includes activities beyond those usually required for 

program stewardship.
 

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FINDINGS

involvement. In the other instance, a Program Official with the title 

“Scientific Project Officer” in her email signature emailed the Grants 

Management Specialist to inquire about the status of an awardee’s 

request to purchase equipment. 

The CTSA files contained no other evidence of substantial involvement

We searched for documentation of any involvement beyond usual 

program stewardship by CTSA program staff. A checklist item on 

Award Worksheet Reports indicates whether the annual summaries of 

substantial staff involvement in the awards were present in the file. 

Despite the fact that checklists for all but one of the files indicated that 

these summaries were present for at least 1 year of the project, they 

were not in the files. 

In 11 of the files, the annual summary consisted of a brief note from 

CTSA program staff stating that only usual program stewardship was 

provided or describing usual program stewardship activities, such as 

correspondence with awardees. In two other files, the brief note from 

the CTSA program staff instead described the awardees’ level of 

involvement rather than NIH staff involvement. For the rest of the 

files, such notes were not provided. 

Throughout our review of the files, we were able to identify only

documentation from CTSA program staff related to usual program 

stewardship, such as correction of financial information. Some of the 

documentation of usual program stewardship that had the potential to 

include evidence of substantial involvement was not present. For 

example, a few of the files indicated that site visits occurred, which is

considered usual program stewardship. However, these same files 

contained no site visit reports. Consequently, we could not determine 

whether CTSA program staff provided involvement beyond usual 

program stewardship during these site visits. 
 

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 RECOMMENDATIONS

Our review of files for FYs 2006 to 2008 demonstrated that 

administration of the CTSA program was noncompliant with the 

following: monitoring awardee progress, ensuring timely submission of 

required reports, and maintaining official files. Also, no files contained 

evidence that CTSA program staff provided substantial involvement to

awardees in accordance with the cooperative agreement funding 

mechanism. 

For better oversight of the CTSA program, we recommend that NIH 

ensure that CTSA program staff:

Document Their Monitoring of Awardee Progress

When staff review awardee progress, NIH must ensure that they 

document awardee accomplishments toward meeting project goals;

reasons for not meeting project goals, if applicable; and plans for 

activities during the coming year. To assist staff in documenting these 

elements of annual progress, NIH may consider revising the Award 

Worksheet Report to require a narrative related to awardee 

accomplishments. NIH also may consider formally tracking awardee 

goals and milestones from the time that they are submitted in the 

application through the life of the award, which would facilitate a 

streamlined comparison of accomplishments to goals and milestones 

when evaluating annual awardee progress. This could be accomplished 

through IMPAC II or another mechanism. 

Ensure Timely Submission of Required Reports

NIH should ensure that staff document correspondence with awardees 

as they act to obtain delinquent reports.

Maintain Official Files in Accordance With HHS Policy

NIH must establish a single comprehensive filing system for the CTSA 

program in which files are complete, current, easy to identify, easy to 

access , and separated by budget period. This would promote a 

coordinated approach to award oversight by better enabling third-party 

review. 

Provide Substantial Involvement to CTSA Awardees

NIH involvement may include collaboration, participation, and/or 

intervention in cooperative agreement activities. At a minimum, staff 

must clearly list within the award files the Project Scientists involved 

and include the annual summary of involvement.
 

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RECOMMENDATIONS

AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 

RESPONSE 

NIH concurred with our recommendations. In response to our first and 

second recommendations, NIH stated that it will issue specific guidance 

on documentation requirements for monitoring awardee progress and 

obtaining delinquent reports. NIH stated that it has already 

implemented our third recommendation by using electronic grant files. 

In response to our fourth recommendation, NIH stated that NCRR will 

revise its cooperative agreement terms of award to identify the names 

and titles of program staff who will provide substantial involvement as 

CTSA Project Collaborators. We did not make any changes to the report 

based on NIH’s comments. For the full text of NIH’s comments, see 

Appendix C.
 

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 APPENDIX A

Responsibilities of Clinical and Translational Science Awards Program Staff 

Source: National Institutes of Health, CTSA Consortium Governance Manual, version 2008.08.14; Department of Health and Human Services,

Grants Policy Directives, pt. 1.01.

Note on acronyms used in the table: CTSA is Clinical and Translational Science Award. NCRR is the National Center for Research Resources 

(NCRR). NIH is the National Institutes of Health. 
 

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 APPENDIX B

 Example of Awardee Goals and Milestones*

Source: Excerpts from one Clinical and Translational Science Award application on file, accessed by the Office of Inspector General in 

October 2009.

Note: Potentially identifying information (e.g., names of centers, studies, and committees) has been redacted.

Note on acronym used in the table: IRB is Institutional Review Board.

* Shaded areas under Years 1–5 indicate the quarter(s) in which the awardee intends to complete the listed activity. 
.. APPENDIX C 

Agency Comments 

DDAllTMENT Of BIALTH .. HUMAN SlRVlCES PUbliC H ellth Service 

NedonellnSlItute$ 01 HealU1 

8ethesda, Maryl.llnd 204!192 

TO: Stuart Wright 

Deputy Inspector Genem! for Inspection and Evaluations, OIG. HHS 

FROM: Direetor, NIH 

SUBJECT: NIH Comments to the Draft Office of Inspector General Report. NlR 

Administration ofthe Clinical and Trans/aliella} Science Awards Program 

(OEI-07..Q9..00300) 

Attached are the National Institutes of Health's comments on the draft 010 report entitltd, 

NIH Administration ofthe Clinical and TransJalianol Science Awards Program (OEl'()7· 

09-0(300). 

We appreciate the opportunity to review and comment on this important topic. Should you 

have questions or concerns regarding our comments, please contact Meredith Stein in the 

Office of Management Assessment at 301-402·8482. 

Francis S. Collins, M.D., Ph.D. 

Attachment 

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APPENDIX~C
 

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APPENDIX~C
 

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APPENDIX~C
 

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APPENDIX~C

APPENDIX~C
 

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APPENDIX~C
 

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APPENDIX~C
 

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APPENDIX~C
 

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APPENDIX~C
 

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 ACKNOWLEDGMENTS

This report was prepared under the direction of Brian T. Pattison, 

Regional Inspector General for Evaluation and Inspections in the 

Kansas City regional office, and Deborah K. Walden, Deputy Regional 

Inspector General. 

Julie Dusold Culbertson served as the project leader for this study. 

Other principal Office of Evaluation and Inspections staff from the 

Kansas City regional office who contributed to the report include 

Perry Seaton and Dennis Tharp; central office staff who contributed

include Pamela J. Langer and Talisha Searcy. 
Office of Inspector General http://oig.hhs.gov 

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amended, is to protect the integrity of the Department of Health and Human Services 

(HHS) programs, as well as the health and welfare of beneficiaries served by those 

programs. This statutory mission is carried out through a nationwide network of audits, 

investigations, and inspections conducted by the following operating components:

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audits with its own audit resources or by overseeing audit work done by others. Audits 

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convictions, administrative sanctions, and/or civil monetary penalties.

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The Office of Counsel to the Inspector General (OCIG) provides general legal services to 

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