Department of Health and Human Services 
OFFICE OF 
 
  
INSPECTOR GENERAL 
 
 
 
 
 
 
 
 
NIH P G
  OSTAWARD  RANT 
 
 
A  
DMINISTRATION 
 
 
O C B
AND  VERSIGHT  OULD  E 
 
 
I  
MPROVED 
 
 
 
Suzanne Murrin  
Deputy Inspector General  
for Evaluation and Inspections  
 
August 2015 
OEI-07-11-00190   
   
  
EXECUTIVE SUMMARY:  NIH POSTAWARD GRANT ADMINISTRATION AND 
OVERSIGHT COULD BE IMPROVED 
OEI-07-11-00190 
 
WHY WE DID THIS STUDY 
 
Effective oversight of grant funds is crucial to the success of programs designed to 
improve public health and well-being; however, the Inspector General consistently 
identifies grants management as one of the Department of Health and Human Services 
(HHS) top challenges, noting weaknesses in the oversight of grantees.  Within HHS, the 
National Institutes of Health (NIH) is the largest Federal funder of health research and  
development, awarding $21 billion in extramural grants during fiscal year (FY) 2014.  
This evaluation assessed NIHs postaward administration and oversight. 
 
HOW WE DID THIS STUDY  
 
We used NIHs electronic storage system for grant files to review a random sample of 
100 NIH grant files from new and continuing extramural research awards made in 
FY 2011.  We also collected and reviewed information from NIH staff regarding 
oversight of postaward administration requirements.   
 
WHAT WE FOUND 
 
NIH grant files were largely complete, but our review found weaknesses in the oversight 
of grantee progress during the life of the grants.  Specifically, we found weaknesses in 
NIHs review of progress reports. NIH approved 13 percent of awards for funding 
despite the fact that the awardee did not provide required information regarding its 
progress towards project objectives.  NIH awarded $7.2 million to four awardees that 
reported not meeting established goals or removing a goal.   Although NIH policy 
requires program staff to determine whether awardee progress towards stated goals is 
satisfactory or not satisfactory, it does not require a written statement to support those 
determinations.   
 
WHAT WE RECOMMEND 
 
We recommend that NIH (1) confirm that grants management staff ensure timely 
submission of required reports from awardees, and (2) revise the NIH Policy Manual and 
Award Worksheet Report to require a brief narrative documenting awardee progress and 
whether any change in research goals may influence continued funding.  NIH concurred 
with both recommendations. 
   
   
TABLE OF CONTENTS 
Objectives ....................................................................................................1 

Background..................................................................................................1 

Methodology................................................................................................5 

Findings........................................................................................................6 

Nearly all NIH grant files contained all required documents, but  

19 percent of files contained documents that were submitted late ..6 

We found weaknesses in NIHs review of progress reports.............7 

Conclusion and Recommendations ..............................................................9 

Agency Comments and Office of Inspector General Response .................11 
 
Appendixes ................................................................................................12 

Appendix A:  Detailed Methodology.............................................12 

Appendix B: Point Estimates and Confidence Intervals for 

Selected Statistics...........................................................................17 

Appendix C: Agency Comments ..................................................18 

Acknowledgments......................................................................................22 

 
   
   
OBJECTIVES 
1. 	  To determine the extent to which National Institutes of Health (NIH) 
grant files contain complete and timely documentation.    
2. 	  To assess how NIH program staff monitor awardee progress. 
BACKGROUND 
NIHs mission is to enhance health, lengthen life, and reduce illness and 
disability. NIH is the largest Federal funder of health research and 
development, with fiscal year (FY) 2014 awards for extramural research 
totaling $20 billion for 52,034 awards.1     
NIH is organized into Institutes and Centers (ICs), each of which is 
dedicated to a specialized area of research.  Of the 27 NIH ICs, 24 make 
awards that support basic and clinical research, research center operations, 
scientific training and fellowships, and construction projects.   
Applicable Federal Regulations, Departmental Directives, and 
Agency Policies  
Federal regulations establish uniform administrative requirements 
governing Department of Health and Human Services (HHS) awards to 
institutions of higher education, hospitals, and other nonprofit 
organizations.2 Guidance for implementing these requirements is 
contained in the HHS Grants Policy Directives, which applies to all 
agencies  within HHS, and the NIH Policy Manual, which applies to all 
ICs within NIH. 
Administrative and Oversight Roles at NIH 
Oversight of postaward administration at NIH is divided among the staff 
of the Office of Extramural Research and the staff of each IC.  Within each  
IC, oversight responsibilities are further divided between grants 
management and program management staff.  Table 1 summarizes 
administrative and oversight roles and responsibilities. 
____________________________________________________________ 
1  Using NIHs ExPorter  and RePorter Web-based tools, we included awards  with activity 
codes R, P, M, S, K, U (excluding UC6), DP1, DP2,  DP3, DP4, DP5,  D42, and G12 and  
application types 1 (new award), 2 (competing continuation award), and 5 (noncompeting 
continuation award) awarded in FY  2014.  
2  45 CFR pt. 74.  On December 19, 2014, HHS issued an  Interim Final Rule (45 CFR 
pt. 75) implementing Uniform Administrative Requirements, Cost  Principles, and Audit  
Requirements for Federal  Awards published by the Office of Management and Budget in  
December 2013.  During the study period, however, 45 CFR pt. 74 remained in effect. 
NIH Postaward Grant Administration and Oversight Could Be Improved (OEI-07-11-00190)   1   
   
Table 1: NIH Staff Responsibilities 
Applicability  Type of Staff  Responsibility  
Office of Extramural 
NIH-wide   Developing overall policy and conducting oversight 
Research staff 
Maintaining ultimate financial/administrative accountability 
Grants Management 
Officer (GMO)  Supervising grants management staff 
IC grants 
Conducting financial/administrative review 
management 
Maintaining official files 
Grants management staff 
Ensuring timely submission of required documents  
Scientific Division  
Supervising program staff  
IC program  Directors 
management  
Program staff   Conducting scientific and/or technical reviews of grants 
Source:  OIG analysis of NIH staff responsibilities, 2013. 
Office of Extramural Research.  The Office of Extramural Research issues  
the NIH Grants Policy Statement (GPS), which contains general 
information about NIH awards, terms and conditions of these awards, and 
points of contact.  The Office of Extramural Research coordinates the 
development, implementation, and oversight of NIH grant policies and 
applicable Federal policies.  The Office of Extramural Research promotes 
complianceboth from NIH staff and from awardeeswith policies and 
administers a management control program to review IC compliance with 
NIH-wide policies. 
IC grants management staff.   Grants management staff are responsible for 
maintaining official files.  GMOs responsibilities include ensuring that all 
awards meet requirements (including monitoring report due dates), that 
they do not exceed available funds, and that they include appropriate terms 
and conditions for the award. A Chief GMO is responsible for 
implementing extramural research award policies and provides guidance 
for his or her IC.  Grants management staff within each IC assist GMOs in 
ensuring that awards comply with implementation policies and 
procedures. 
IC program management staff. Program staff, under the direction of IC 
Scientific Division Directors, are responsible for evaluating awardees  
scientific/technical progress on an annual basis.  If awardees progress is 
satisfactory, program staff work with grants management staff to permit 
continued funding.  Program staff must also keep the grants management 
staff informed of concerns and changes that may impact future funding, 
require close project monitoring, or result in a need for special terms and 
conditions for the award. 
NIH Postaward Grant Administration and Oversight Could Be Improved (OEI-07-11-00190)   2   
   
Official Grant Files and Required Documents 
Grant files must allow a third party (e.g., auditor or other reviewer) to 
follow information regarding decisions made and actions taken throughout 
the entire award process from initiation through closeout.3 The contents of 
grant files must be current, easily identifiable, easily accessible, andto 
the extent possibleseparated by budget period.4  Official files must  
include electronically created or transmitted documents, including email, 
or these documents must be referenced to a separate file or repository.5  
NIHs electronic Research Administration system.  To maintain official 
grant files, NIH uses the electronic Research Administration (eRA) 
system, as well as systems developed by specific ICs and paper 
documents.  NIH staff reported that they use eRA to access official grant 
files, and that they use different eRA modules depending on their roles.  
For example, program staff use the Program module to document their 
review of awardee progress, and grants management staff use the Grants 
Management module to track adherence to terms and conditions of award.  
Chief GMOs explained that staff often use eRA to identify overdue 
reports. 
Required grant file documents. HHS permits agencies such as NIH to 
adopt their own requirements for grant file assembly and structure; 
however, certain documents are required to be maintained in NIH grant 
files by Federal and HHS rules as well as by NIH policy.   These 
documents include: 
	   Progress reportsThese describe technical scientific 
accomplishments toward meeting project objectives and also  
provide information regarding changes in scope or research 
objectives.6    Progress reports must also include reasons for not 
meeting project goals (if applicable), and plans for activities during 
the upcoming year.7  Program staff review progress reports to 
determine whether progress is satisfactory for continued funding.8  
 	  Federal Financial Reports (FFRs)These are reports of awardees 
official accounting records (e.g. spending, obligations, and the 
balance of funds). Grants management officers may review these 
____________________________________________________________ 
3 HHS, Grants Policy Directives, pt. 3.06.  
4 Ibid. 
5 Ibid. 
6 NIH,  Policy Manual, chs. 54444 and 55806.B. 
7 NIH,  Policy Manual, ch. 55808. 
8 NIH,  Policy Manual, ch. 54444. 
NIH Postaward Grant Administration and Oversight Could Be Improved (OEI-07-11-00190)   3   
   
reports to assess whether performance or financial management 
problems exist.9  Awardees may extend the expiration date of an 
award through a no-cost extension.10    
 	  Notice of AwardThe Notice of Award is the legal document 
issued to awardees that indicates that an award has been made and 
that funds may be requested from NIH.  A Notice of Award, 
showing the amount of Federal funds authorized and any 
future-year commitments, is issued for each budget period in the 
approved project period.11  
Each Operating Division must develop an approach to postaward 
monitoring that ensures that grants management staff and program staff 
make a formal coordinated determination concerning grantee performance 
and progress.12  For NIH awards, staff document their review of progress 
reports and financial reports (if applicable) in the Grants Management and 
Program Checklists, that becomes part of the Award Worksheet Report.  
The NIH Policy Manual (ch. 54444) requires program staff to determine 
whether progress is satisfactory, but does not require a written statement to 
support staffs review.   
	   Award Worksheet ReportsNIH staff document their review of 
awardee progress and approval of continued funding using separate 
grants management and program checklists in eRA.  These two 
checklists are consolidated to create an Award Worksheet Report.  
The checklists identify items that must be reviewed and prompt 
reviewers for further comments when necessary.  For example, the 
program checklist asks program staff to indicate whether the 
awardees progress is satisfactory.   The checklist includes a notes 
field that instructs program staff to document and provide direction 
to the grants specialist, if progress was not satisfactory.  In the final 
____________________________________________________________ 
9 NIH,  Grants Policy Statement, ch. 8.4.1.5.2.    
10 A no-cost extension indicates that the awardee has additional work to complete on the 
project and that necessary resources are available, or that the awardee requires additional 
time to provide an orderly closeout.  NIH,  Grants Policy Statement, ch. 8.1.1.3.  With  a 
no-cost extension, the budget  period may be extended up to  1 year beyond  the original  
funding period shown in the Notice of Award if the extension is not  prohibited by the  
terms of the award.  NIH need not issue additional funds, and the projects original scope 
does not change. Ibid.    
11 NIH,  Grants Policy Statement, pt. I, Notice of Award  and pt. II Terms  and 
Conditions  of NIH Grant Awards, Subpart A:  General.  
12 HHS, Grants Policy Directives, pt. 3.06.  
NIH Postaward Grant Administration and Oversight Could Be Improved (OEI-07-11-00190)   4   
   
year of a project, NIH staff complete separate closeout 
documentation in lieu of Award Worksheet Reports. 
Ensuring timely submission of awardee reports.   All NIH awardees must 
submit annual progress reports and routine FFRs to the awarding IC on a 
predetermined basis.13  GMOs may take progressive actions to obtain 
delinquent required reports, and IC staff should not permit continued 
funding until all required reports are submitted.14    
METHODOLOGY 
We reviewed a simple random sample of 100 FY 2011 awards from all 
award-granting ICs to determine the extent to which NIH grant files 
contained complete and timely documentation.  We also assessed how 
NIH program staff monitored awardee progress during the course of the 
grant and whether official files enabled a third-party reviewer (i.e., OIG) 
to assess whether the files were current, easily identifiable, and easily 
accessible. Appendix A provides a detailed methodology.  Appendix B 
lists point estimates and confidence intervals for the statistics reported in 
our findings. 
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. 
____________________________________________________________ 
13 45 CFR   74.51 and  74.52.  Although the CFR uses the term performance reports, 
HHS refers to the annual performance reports as progress reports.  HHS,  Grants Policy 
Statement, pt. I.    
14 NIH,  Policy Manual, ch. 55806. 
NIH Postaward Grant Administration and Oversight Could Be Improved (OEI-07-11-00190)   5   
   
FINDINGS 
Nearly all NIH grant files contained all required 
documents, but 19 percent of files contained 
documents that were submitted late  
Required documents (e.g., progress reports, FFRs, Award Worksheet 
Reports, and Notices of Award) were found in all but 1 percent of grant 
files, but documents were submitted late in 19 percent of NIH grant files.  
NIH received these reports late even though eRA sends awardees 
automatic reminders of upcoming due dates for progress reports. 
Two percent of required FFRs were missing; all expected Award 
Worksheet Reports and Notices of Award were found.  The one sampled 
grant that was missing an FFR involved new technology for accelerated 
manufacturing of cancer drugs.  
Progress reports and FFRsthe only documents that we reviewed that 
have required deadlineswere submitted late in 19 percent of grant 
files. Specifically, 14 percent of required progress reports and 16 percent 
of required FFRs were submitted late.  Late progress reports were 
submitted from 1 to 111 days past the deadline (median of 6 days past the 
deadline).  The sampled grant with the progress report that was 111 days 
late involved staff development in the field of vascular medicine.  Late 
FFRs were submitted from 2 to 247 days past the deadline (median of 
100 days past the deadline). The sampled grant with the FFR that was 
247 days late involved public health research related to the 2010 oil spill 
in the Gulf of Mexico. 
Table 2 provides information on the number of grant files with required 
documents that were not found in the grant files or were submitted late. 
Table 2: Required Documents Not Found or Submitted  
Late in Grant Files, FY2012  
Type of   Not Found  Submitted Late   
Document   (Percentage)   (Percentage)  
 
 
Progress Report   0%   14%  
 
 
FFR  2%   16%  
 
 
Award Worksheet  0%   N/A 
 
 
Notice of Award   0%   N/A 
 
 
Total Files   1%   19%    
 
 
Note:  See Appendix  A for details regarding the number of expected documents for  each  
document type. 
Source:  OIG analysis of NIH grant files, 2015.   
   
NIH Postaward Grant Administration and Oversight Could Be Improved (OEI-07-11-00190)   6   
   
We found weaknesses in NIHs review of progress 
reports 
HHS Grants Policy Directives require that each HHS operating division  
(e.g., NIH) develop an approach to postaward monitoring that ensures that 
program staff make a formal coordinated determination concerning 
grantee performance and progress.  NIH policy requires program staff to 
determine whether progress is satisfactory, but it does not require a written 
statement to support their review.   
NIH staff approved progress reports for 13 percent of grant 
files even when required information was absent 
Thirteen percent of progress reports were approved, and funding was 
continued even though the progress reports did not contain required 
information from the awardee regarding the awardees progress toward 
project objectives. The sampled awardees were funded nearly $11 million 
in FY 2012.  Six percent of progress reports lacked information as to 
whether progress was made toward each stated project goal.  Nine percent 
of progress reports lacked a description of planned activities for the 
coming year.   
NIH staff did not always document their review of progress 
reports when awardee goals were not met or were removed 
When progress reports contained all of the required information, the extent 
to which program staff reviewed that information was unclear.  In FY  
2012, NIH awarded $7.2 million to four awardees that reported not 
meeting established goals or removing a goal.  Given the nature of 
scientific research, there may be legitimate reasons for goals to be revised 
or modified for certain grants.  This underscores the importance of NIH 
having a system for reviewing awardee-proposed revisions to differentiate 
between modifications that do not negatively impact the overall 
effectiveness of the grant and modifications that may warrant 
reconsideration of grant funds. 
NIH staff are not required to document the reasons why progress is not 
satisfactory, but there are comment fields in the program checklist in 
which program staff may enter this information.  In particular, the program 
checklist contains instructions to program staff to document concerns and 
provide direction to grants specialists should progress not be satisfactory.   
This information could prove useful in evaluating whether to continue 
funding for awardees. 
NIH staff oversight of progress report reviews was limited 
Eleven of twenty-seven Scientific Division Directors stated that they did 
not conduct any reviews to determine whether program staff had 
NIH Postaward Grant Administration and Oversight Could Be Improved (OEI-07-11-00190)   7   
   
sufficiently reviewed awardees annual progress.  Several Scientific 
Division Directorssome of whom  also conducted reviews themselves, 
and some of whom did notreported that there were automatic system  
checks (i.e., the program checklist on Award Worksheet Reports) that 
ensured proper review.   
NIH Postaward Grant Administration and Oversight Could Be Improved (OEI-07-11-00190)   8   
   
CONCLUSION AND RECOMMENDATIONS 
Although NIH grant files were largely complete, our review found 
weaknesses in the oversight of grantee progress during the life of the 
grants. Specifically, we found weaknesses in NIHs review of progress 
reports. NIH approved 13 percent of awards for funding despite the fact 
that the awardee did not provide required information regarding its 
progress towards project objectives.  In addition, although NIH policy 
requires program staff to determine whether awardee progress towards 
stated goals is satisfactory or not satisfactory, it does not require a written 
statement (other than a checklist) to support those determinations.  In four 
files, awardees reported not meeting or removing goals but there was no 
documented acknowledgment from program staff that they were aware of 
the lack of progress or removal of goals.   
To ensure adequate postaward administration and oversight that supports 
NIHs mission to improve public health, we recommend that NIH:  
Confirm that grants management staff ensure timely  
submission of required awardee reports 
There are a variety of methods NIH could use to accomplish this.  For 
instance, NIH could direct Chief GMOs and Scientific Division Directors 
or other appropriate staff to establish a formal quality assurance program  
to confirm that staff across all ICs meet requirements for ensuring timely 
submission of required awardee reports and review of awardee progress.  
NIH could also ask why untimely awardees are late in filing reports and 
use the answers to develop appropriate awardee trainings and/or issue 
appropriate incentives and/or penalties as necessary.   
Revise the NIH Policy Manual and Award Worksheet Report to 
require a brief narrative documenting awardee progress and 
stating whether any change in research goals influences 
continued funding 
When NIH reviews awardee progress, NIH should ensure that it 
documents awardee accomplishments toward meeting project goals; 
reasons for not meeting project goals, if applicable; and plans for activities 
during the coming year.  To ensure complete documentation of monitoring 
of awardee progress, NIH could: 
   Dynamically link stated goals from  original applications to progress 
report forms each year.  Such linking could prompt awardees to 
provide required information annually and to flag changes in approved 
goals, and 
NIH Postaward Grant Administration and Oversight Could Be Improved (OEI-07-11-00190)   9   
   
 	  revise the program checklist to allow for more complete 
documentation of review of awardee progress and documentation of 
whether any change (e.g., modification or removal) of research goals 
should result in reconsideration of funding.   
   
NIH Postaward Grant Administration and Oversight Could Be Improved (OEI-07-11-00190)   10   
   
AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL  
RESPONSE 
NIH concurred with both of our recommendations. 
In responding to our first recommendation, NIH stated that it continues to 
devote resources to enhance oversight and monitoring and that it has 
provided grantees with tools to assist them in submitting timely reports.  
NIH requires grantees to submit electronic reports to provide consistency 
and has established a centralized point for the receipt and review of all 
progress reports. NIHs electronic grants system sends automatic emails 
and notifications of late reports to grantees to promote timely submission 
of progress reports. However, the system does not send automated 
reminders to grantees regarding the submission of their FFRs.  If such 
reminders were sent, they could help to reduce or eliminate the 
percentages of FFRs that were late (16 percent) or missing (2 percent).  
Although submission criteria for FFRs are described in notices of award, 
NIH should consider enhancing its electronic grants system to provide 
reminder functions for FFRs similar to those that are already in place for 
progress reports to help grants management staff ensure timely submission 
of required reports. 
In responding to our second recommendation, NIH stated that it currently 
requires program staff to determine if awardee progress is satisfactory 
through the use of the program checklist.  NIH stated that it is considering 
enhancing the checklist to include a provision for program officials to 
document their affirmation that progress is satisfactory.  
For the full text of NIHs comments, see Appendix C.     
NIH Postaward Grant Administration and Oversight Could Be Improved (OEI-07-11-00190)   11   
   
APPENDIX A:  DETAILED METHODOLOGY   
Scope 
We did not independently review the scientific outcomes or the attainment 
of goals described in the progress reports.  Rather, we assessed the 
decisions NIH made and the actions NIH took throughout the award 
process, including NIHs review and approval of each awardees progress.  
Limitations 
When reviewing the files, we considered only the most recent year for 
which files would be complete (FY  2012) in order to report the most 
recent information, although we did review earlier documents for 
context.15    
We excluded the 14 awards that were in the final year of the project period 
from our analysis of whether files were complete with regard to Award 
Worksheet Reports.   
Population and Sample Selection 
We randomly selected a sample of 100 awards from all 24 award-granting 
ICs and the Office of the Director.  This sample allowed us to project 
overall results to the population of 59,803 new and continuing extramural 
research awards that were administered from FY 2011 through 2012, 
which amounted to $20.2 billion.16  Table A.1 lists the number of awards 
by IC. 
   
____________________________________________________________ 
15 We focused our review on documents from FYs 2011 and 2012 because NIH officials 
reported that older documents may be in  paper files rather than the eRA system.  The 
timing of our file review  was approximately 4 months after  the latest reports for 
FY 2012 were due.  We reviewed  files between May and July of  2013 to allow adequate 
time for awardee submission  of any reports that were  due for FY 2012. 
16 We used NIHs ExPorter and RePorter Web-based tools to obtain  the list of  awards.  
We included only activity codes R, P, M, S, K, U (excluding UC6), DP1, DP2, DP3,  
DP4, DP5, D42, and G12 and application types 1 (new award), 2 (competing 
continuation award), and 5 (noncompeting continuation award) awarded in FY  2011.   We  
did not review intramural research awards. 
NIH Postaward Grant Administration and Oversight Could Be Improved (OEI-07-11-00190)   12   
   
Table A.1:  Extramural Research Awards by Institutes and Centers  
Total  
Total Value of
IC Name   Number of  
 Awards  
Awards  
Eunice Kennedy  Shriver National Institute of Child Health and Human 
2,785  $894,322,444  
Development  
Fogarty International Center   181  $45,416,109  
National Cancer Institute  8,981   $2,895,394,313  
National Center for Complementary and Integrative Health   271  $87,709,430  
National Center for Research Resources (now known as the National Center for 
6,821  $1,129,717,846  
Advancing Translational Sciences) 
National Center on Minority Health and Health Disparities  478  $164,046,284  
National Eye Institute  1,302   $546,927,074  
National Heart, Lung, and Blood Institute  5,697   $2,197,933,998  
National Human Genome Research Institute  370  $368,228,440  
National Institute of Allergy and Infectious Diseases   5,851   $2,567,746,937  
National Institute of Arthritis and Musculoskeletal and Skin Diseases  1,433   $411,898,626  
National Institute of Biomedical Imaging and Bioengineering   646  $251,528,679  
National Institute of Dental  and Craniofacial Research  780  $276,288,109  
National Institute of Diabetes and Digestive and Kidney Diseases   3,989   $1,515,894,771  
National Institute of Environmental Health Sciences   1,224   $357,562,410  
National Institute of General Medical Sciences   4,904   $1,646,626,257  
National Institute of Mental Health   3,105   $1,093,586,615  
National Institute of Neurological Disorders and Stroke  3,785   $1,244,495,380  
National Institute of Nursing Research  305  $105,309,132  
National Institute on Aging  2,544   $833,855,687  
National Institute on Alcohol Abuse and Alcoholism   984  $319,747,424  
National Institute on Deafness and  Other Communication Disorders  984  $302,240,573  
National Institute on Drug Abuse  2,148   $750,761,433  
National Library of Medicine  102  $31,409,846  
Office of the Director  133  $177,149,553  
All  59,803  $20,215,797,370  
Source:  OIG analysis of NIH grant files, 2015. 
 
   
NIH Postaward Grant Administration and Oversight Could Be Improved (OEI-07-11-00190)   13   
   
Grant File Review  
We confirmed with NIH staff the locations of relevant documents within 
NIHs eRA system, which is the official file repository.  We accessed the 
sampled grant files using eRA.  After extensive pre-testing and 
coordination with NIH staff, we developed a document review checklist to 
determine compliance with the following selected elements of postaward 
administration:   
Maintaining Official Files.   We determined whether files contained the 
following documentation required by Federal regulations and by HHS and 
NIH policies:  
 	  Signed copies of applications and signed copies of required 
performance reports (i.e., progress reports)Should be present in 
all official files because files for continuing awards should contain 
progress reports or competing continuation applications, and files 
at the end of a project period should contain final progress reports. 
 	  FFRsShould be present in all official files for all years of 
non-Streamlined Non-Competing Award Process (SNAP)17 awards, 
and for the final year of SNAP awards.  
 	  Notices of AwardShould be present in all official files except for 
the final year of a project period. 
 	  Documentation (i.e., Award Worksheet Report) that supports the 
review and approval of the applications and evidence of review 
and acceptance of performance reports by NIHShould be present 
for all official files except for the final year of a project period. 
When determining which types of documents were required during our 
review period, we considered no-cost extensions, competing continuation 
applications that featured progress reports, and other factors to which NIH 
alerted the team during pre-testing.  Of the 100 files we reviewed, 99 were 
expected to have progress Reports (1 file was in a no-cost extension period 
for FY 2012 that extended beyond the date of our review, so a progress 
report would not yet have been due), 48 were expected to have FFRs, and 
65 were expected to have Award Worksheet Reports and Notices of 
Award. 
At the conclusion of our data analysis, we followed up with NIH staff 
regarding required documents that we could not locate in the grant file.  
NIH staff clarified that final FFRs would not display in the eRA module 
____________________________________________________________ 
17 SNAP awardswhich NIH implemented in 1994undergo a streamlined award 
process that requires less documentation than the process for non-SNAP awards.    
NIH Postaward Grant Administration and Oversight Could Be Improved (OEI-07-11-00190)   14   
   
that we accessed until they were accepted by NIH staff.  NIH staff 
provided us with additional documents to complete our review.   
Ensuring Timely Submission of Required Reports.  We reviewed sampled 
files to determine whether required progress reports and FFRs were 
submitted timely according to their respective due dates.  We compared 
the budget period end date to the progress report submission date.  
Table A.2 shows the due dates for progress reports and FFRs. 
Table A.2: Due Dates for Progress Reports and FFRs  
Required Document   Type of Award1   Due Date  
Research Performance  the 15th of the month preceding the month 
Progress Report    in which the budget period ends 
Progress Report   SNAP  45 days prior to the end of the budget period 
(generally) 2 months before the beginning 
Non-SNAP  
 of the next budget period2 
Final (both SNAP and  90 days after  
  non-SNAP)   the end of the project period 
SNAP  N/A (annual FFR is not required) 
(when required on an annual basis, must be submitted 
FFR   Non-SNAP    for each budget period) no later than 90 days after the end of the 
calendar quarter in which the budget period ended3  
Final (both SNAP and 
90 days after the end of the project period3  
non-SNAP)  
1 SNAP awards undergo a streamlined process that requires less documentation.  The due dates for progress reports and 
some FFRs for SNAP awards differ from those for non-SNAP awards.  NIH began implementing Research Performance 
Progress Reports in fall 2012.   
2 DHHS, Non-Competing Continuation Progress Report (PHS 2590), 2014.  
3 45 CFR  74.52(iv).  NIH, Grants Policy Statement, chs. 8.4.1.4.2 and 8.6.  
Source: OIG analysis of HHS and NIH grants policy  documents, 2015. 
 
At the conclusion of our data analysis, we followed up with NIH staff 
regarding the timeliness of documents located in the grant file.  NIH staff  
provided us with additional documents to complete our review. 
Monitoring Awardee Progress. For continuing awards, we reviewed 
progress reports to determine whether awardees included the following 
required information in the reports: 
   awardee accomplishments toward meeting project goals; 
   reasons for not meeting project goals, if applicable; and  
   plans for activities during the coming year.  
We then reviewed Award Worksheet Reports to determine whether 
program staff documented their review of annual awardee progress for 
continued funding. We determined whether program staff indicated that 
progress was satisfactory and whether they provided any written 
statements to support their review.  If we found that awardees did not 
NIH Postaward Grant Administration and Oversight Could Be Improved (OEI-07-11-00190)   15   
   
include required information in the progress report, we noted whether staff 
commented on the absent information (in the Award Worksheet Report 
checklist or elsewhere in the file) or whether they completed the checklist 
and moved the award forward for continued funding without further 
comment. 
Interviews and Surveys of NIH Staff  
We reviewed documents, conducted interviews with Office of Extramural 
Research staff, and surveyed IC staff to confirm our understanding of 
postaward administration and oversight.   
We reviewed procedures specifying how the Office of Extramural 
Research disseminates and enforces policies across ICs, and how it detects  
and corrects noncompliance with policies.  We also conducted two 
interviews with Office of Extramural Research staff to understand how 
they administer and oversee policies related to the selected elements of  
postaward administration.   
For all 24 award-granting ICs, we collected relevant documents regarding 
policies related to the selected elements of postaward administration, such 
as procedure manuals.  We also reviewed each ICs staff training processes 
in regard to these policies.  Additionally, at least 1 Chief GMO from each 
of the 24 ICs and at least 1 Scientific Division Director from 23 of the 
24 ICs responded to our surveys.18  Questions for Chief GMOs focused on 
maintenance and obtaining timely reports, and on efforts to detect 
noncompliance with requirements.  Questions for Scientific Division 
Directors focused on guidance provided to program staff regarding review 
of awardee progress and efforts to detect noncompliance with 
requirements.  
 
 
   
____________________________________________________________ 
18 Three ICs each identified not one, but two Chief GMOs and Scientific Division  
Directors for our  surveys.   
NIH Postaward Grant Administration and Oversight Could Be Improved (OEI-07-11-00190)   16   
   
APPENDIX B 
Table B.1: Point Estimates and Confidence Intervals for 
Selected Statistics 
Sample  Point  95-Percent 
Description  
Size (n)  Estimate   Confidence Interval  
Files that did not contain at least one 
100   1.0%   0.147.0%  
required document  
Files with a required report that  was late  99  19.2%   12.528.3%  
Files that did not contain a FFR   46  2.2%   0.314.3%  
Files with progress reports that were 
93  14.0%   8.222.8%  
submitted late 
Files with FFRs that were submitted late  45  15.6%   7.529.5%  
Files that did not contain a progress report   93  0.0%   0.03.9%  
Files that did not contain an Award 
86  0.0%   0.04.2%  
Worksheet Report 
Files that did not contain a Notice of Award   100  0.0%   0.03.6%  
Files with progress reports that were 
approved even though required information  80  12.5%   6.821.9%  
was absent  
Files with progress reports that lacked a 
80  6.3%   2.614.3%  
description of progress toward stated goals  
Files with progress reports that lacked a 
description of planned activities for the  80  8.8%   4.217.4% 
coming year  
    
   Source:  OIG analysis of NIH grant files, 2015. 
NIH Postaward Grant Administration and Oversight Could Be Improved (OEI-07-11-00190)   17  APPENDIXC 
Agency Comments 
....~ 	
(.,~'f.  DEPARTMENT 01' HEALTH &. HUMAN SERVICES  Public Health Service 
National Institutes of Health 
Bethesda, Maryland 20892 
TO: 	 Suzanne Murrin 

Deputy Inspector General for Inspection and Evaluations, HHS 

FROM: 	 Director, NIH 
JUL 2 9 2015
DATE: 
SUBJECT: 	 NIH comments to the draft report NIH Postaward Grant Administralfon 

and Oversight Could Be Improved (OEI-07-11-00 190) 

Attached are the National Institutes of Health's comments on the draft Office of Inspector 
General (OIG) report NIH Postaward Grant Administration and Oversight Could Be 
Improved (OEI-07 -11-00 190). 
The NIH appreciates the review conducted by the OIG and the opportunity to provide 
clarifications on this draft report. Should you have questions or concerns, please contact 
Meredith Stein in the Office of Management Assessment at 301-402-8482. 
Francis S. Collins, M.D., Ph.D. 
Attachments: 

NIH General Comments 

NIH Technical Comments 

NIH Postaward Grant Administration and Oversight Could Be Improved (OEI-07-11-00190)  18   
   
 
NIH Postaward Grant Administration and Oversight Could Be Improved (OEI-07-11-00190)  19   
   
 
 
NIH Postaward Grant Administration and Oversight Could Be Improved (OEI-07-11-00190)  20   
   
 
 
NIH Postaward Grant Administration and Oversight Could Be Improved (OEI-07-11-00190)  21   
   
ACKNOWLEDGMENTS 
This report was prepared under the direction of Brian T.  Whitley, Regional 
Inspector General for Evaluation and Inspections in the Kansas City 
regional office.  
Jordan Clementi, Julie Dusold Culbertson, Dennis Tharp, and 
Conswelia McCourt served as analysts.  Central office staff who provided 
support include Heather Barton, Kevin Farber, Evan Godfrey, and 
Christine Moritz.  
NIH Postaward Grant Administration and Oversight Could Be Improved (OEI-07-11-00190)   22   
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: 
Office of Audit Services 
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 
administrative fraud and abuse cases involving HHS programs,  including False Claims Act, 
program exclusion, and civil monetary penalty cases.  In  connection with these cases, OCIG 
also negotiates and monitors corporate integrity agreements.  OCIG renders advisory 
opinions, issues compliance program  guidance, publishes fraud alerts, and provides other  
guidance  to  the health care industry concerning the anti-kickback statute and other  OIG  
enforcement authorities.