Department of Health and Human Services 
OFFICE OF 
   
INSPECTOR GENERAL 
 
 
 
 
 
 
 
NIH A
  DMINISTRATION OF THE 
 
 
C T
LINICAL AND  RANSLATIONAL 
 
S   A P  
CIENCE  WARDS  ROGRAM
 
 
 
 
 
 
 
 
Daniel R. Levinson  
Inspector General 
 
December 2011 
OEI-07-09-00300   
 
   
 
 E X E C U T I V E   S U M M A R Y  
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, NIHs 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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E  X E C U T I V E   S U M M A R Y  
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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E X E C U T I V E   S U M M A R Y  
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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 T A B L E   O F   C O N T E N T S  
 
EX ECUT I VE  SUM M ARY  ..................................... i 
 
 
 
 
  I NT RO DU CT I O N  ............................................ 1 
   
   
  F I NDI NG S  .................................................  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 
 
 
 
 
RECO M M END AT I O N S  ..................................... 17 
 
  Agency Comments and Office of Inspector General Response ... 18 
 
 
 
 
 
APP EN DI X ES  ............................................. 19 
 
  A:  Responsibilities of Clinical and Translational Science Award 
Program Staff .......................................... 19 
 
 
  B:  Example of Awardee Goals and Milestones ...............  20 
 
    C:  Agency Comments ...................................  21 
 
   
   
  ACKNO WL E DG M E N T S .....................................  30 
 
 
 
   
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 II NN TT RR OO DD UU CC TT II OO NN   
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 Institutes 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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I N T R O D U C T I O N  
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  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. 
The role of NIH grants management staff, including CTSA program 
staff,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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I N T R O D U C T I O N  
  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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I N T R O D U C T I O N  
  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 
awardees 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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I N T R O D U C T I O N  
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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I N T R O D U C T I O N  
  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 NIHs 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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I N T R O D U C T I O N  
all awardees requested 5 years of support, a total of 74 budget periods 
were reviewed for the 38 cooperative agreements during our review 
period12 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   
Budget  Total 
Number of 
Fiscal Year  Periods  Budget 
Awardees 
Reviewed  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 NIHs 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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I N T R O D U C T I O N  
  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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I N T R O D U C T I O N  
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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 F I N D I N G S  
Despite completing basic checklists, CTSA  We reviewed Award Worksheet 
program staff did not document awardees  Reports to determine whether 
CTSA program staff documented 
progress in compliance with NIH policy 
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 awardees production in line 
with that of the other awardees.  
Similarly, CTSA program staff noted only one awardees 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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F I N D I N G S  
Awardees were frequently late in submitting  Awardees commonly 
required reports; CTSA program staff did not  submitted progress reports 
and FSRs late.  Despite 
take action to address timeliness 
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   
Total  Progress  Number   Percentage  
Year  CTSA  Reports  Received  Received 
Awards  Received  Late  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   
 
Total  Number   Percentage  
FSRs 
Year  CTSA  Received  Received 
Received 
Awards  Late  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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F I N D I N G S  
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  Similarly, files contained 11 FSRs that were more than 
4 months late and 9 of those FSRs were more than 5 months late. 
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.   
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 awardees FSRs were 67 days late in 2007, 351 days late 
in 2008, and 184 days late in 2009.  This awardees 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 awardees 
violation of the terms and conditions of award.  
 
36 None of the progress reports were more than 90 days late. 
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F I N D I N G S  
Official CTSA files were not maintained in  Official files must be complete, 
accordance with HHS policy   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 
   Number Missing  
Number of 
Award Year  Document  From Official File 
Awards 
Source 
Entire application  7 
Prior to Award  38 
Implementation and Milestones 
21 
eaSection of application 
FSR  6 
Progress Report  17 
Year 1  38 
Award Worksheet Report  16 
Notice of Award  12 
FSR  8 
Progress Report  15 
Year 2  24 
Award Worksheet Report  8 
Notice of Award  12 
FSR  5 
Progress Report  4 
Year 3  12 
Award Worksheet Report  1 
Notice of Award  6 
 Source:  OIG analysis of official CTSA files, 2009. 
 
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F I N D I N G S  
 
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  Files Are  Files Are  Files Are  Files Are  Files Are 
Data Source  Easy to  Easy to  Separated by 
Date  Complete  Current 
Identify  Access  Budget Period 
October 
Official files  No  No  No  Yes  Sometimes 
2009 
March 
2010  IMPAC II  No  Yes  Yes  No  Yes 
 
April   Electronic Award 
No  Yes  Yes  No  Yes 
2010  Worksheet Reports 
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.   
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F I N D I N G S  
According to Federal statute, 
No files contained evidence that CTSA program 
cooperative agreements 
staff provided substantial involvement to 
necessitate substantial 
awardees in accordance with Federal 
involvement37 by the awarding 
regulations and NIH policy   
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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F I N D I N G S  
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 awardees 
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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 R E C O M M E N D A T I O N S  
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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R E C O M M E N D A T I O N S  
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 NIHs comments.  For the full text of NIHs comments, see 
Appendix C. 
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 AAA PPP PPP EEE NNN DDD III XXX     AAA    
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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 A P P E N D I X   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 15 indicate the quarter(s) in which the awardee intends to complete the listed activity.   
 
   
  OEI-07-09-00300  NIH ADMINISTRATION OF THE CLINICAL AND TRANSLATIONAL SCIENCE AWARDS PROGRAM  20    .. APPENDIX  C 
Agency Comments 
DDAllTMENT Of BIALTH .. HUMAN SlRVlCES  PUbliC He llth 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 301-4028482. 
Francis S. Collins, M.D., Ph.D. 
Attachment 
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 A C K N O W L E D G M E N T S  
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.  
 
  OEI-07-09-00300  NIH ADMINISTRATION OF THE CLINICAL AND TRANSLATIONAL SCIENCE AWARDS PROGRAM  30     
Office of Inspector General 
http://oig.hhs.gov 
 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as 
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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The Office of Audit Services (OAS) provides auditing services for HHS, either by conducting 
audits with its own audit resources or by overseeing audit work done by others.  Audits 
examine the performance of HHS programs and/or its grantees and contractors in carrying 
out their respective responsibilities and are intended to provide independent assessments of 
HHS programs and operations.  These assessments help reduce waste, abuse, and 
mismanagement and promote economy and efficiency throughout HHS. 
Office of Evaluation and Inspections 
The Office of Evaluation and Inspections (OEI) conducts national evaluations to provide 
HHS, Congress, and the public with timely, useful, and reliable information on significant 
issues.  These evaluations focus on preventing fraud, waste, or abuse and promoting 
economy, efficiency, and effectiveness of departmental programs.  To promote impact, OEI 
reports also present practical recommendations for improving program operations.  
Office of Investigations 
The Office of Investigations (OI) conducts criminal, civil, and administrative investigations 
of fraud and misconduct related to HHS programs, operations, and beneficiaries.  With 
investigators working in all 50 States and the District of Columbia, OI utilizes its resources 
by actively coordinating with the Department of Justice and other Federal, State, and local 
law enforcement authorities.  The investigative efforts of OI often lead to criminal 
convictions, administrative sanctions, and/or civil monetary penalties. 
Office of Counsel to the Inspector General 
The Office of Counsel to the Inspector General (OCIG) provides general legal services to 
OIG, rendering advice and opinions on HHS programs and operations and providing all 
legal support for OIGs internal operations.  OCIG represents OIG in all civil and 
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enforcement authorities.