Department of Health and Human Services 

 

OFFICE OF 

INSPECTOR GENERAL 

NIH POSTAWARD GRANT 

ADMINISTRATION 

AND OVERSIGHT COULD BE 

IMPROVED 

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 NIH’s postaward administration and oversight. 

HOW WE DID THIS STUDY 

We used NIH’s 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 

NIH’s 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 NIH’s 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 

NIH’s 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 NIH’s 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 

NIH-wide Office of Extramural 

Research staff Developing overall policy and conducting oversight 

IC grants 

management 

Grants Management 

Officer (GMO) 

Maintaining ultimate financial/administrative accountability 

Supervising grants management staff 

Grants management staff 

Conducting financial/administrative review 

Maintaining official files 

Ensuring timely submission of required documents 

IC program 

Scientific Division 

Directors Supervising program staff 

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 

compliance—both from NIH staff and from awardees—with 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, and—to 

the extent possible—separated 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 

NIH’s 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 reports—These 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 Award—The 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 staff’s review. 

	 Award Worksheet Reports—NIH 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 

awardee’s 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 project’s 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 FFRs—the only documents that we reviewed that 

have required deadlines—were 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 

Document 

Not Found 

(Percentage) 

Submitted Late 

(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 NIH’s 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 awardee’s 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 Directors—some of whom also conducted reviews themselves, 

and some of whom did not—reported 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 NIH’s 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 

NIH’s 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. NIH’s 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 NIH’s 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 NIH’s review and approval of each awardee’s 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 NIH’s 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 

IC Name 

Total 

Number of 

Awards 

Total Value of

 Awards 

Eunice Kennedy Shriver National Institute of Child Health and Human 

Development 2,785 $894,322,444 

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 

Advancing Translational Sciences) 6,821 $1,129,717,846 

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 

NIH’s 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. 

	 FFRs—Should 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 Award—Should 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 NIH—Should 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 awards—which NIH implemented in 1994—undergo 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 

Progress Report 

the 15th of the month preceding the month

 in which the budget period ends 

Progress Report SNAP 45 days prior to the end of the budget period 

Non-SNAP (generally) 2 months before the beginning 

 of the next budget period2 

Final (both SNAP and 

non-SNAP) 

90 days after 

the end of the project period 

SNAP N/A (annual FFR is not required) 

FFR Non-SNAP 

(when required on an annual basis, must be submitted 

 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 

non-SNAP) 90 days after the end of the project period3 

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 IC’s 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 

Description Sample 

Size (n) 

Point 

Estimate 

95-Percent 

Confidence Interval 

Files that did not contain at least one 

required document 100 1.0% 0.14–7.0% 

Files with a required report that was late 99 19.2% 12.5–28.3% 

Files that did not contain a FFR 46 2.2% 0.3–14.3% 

Files with progress reports that were 

submitted late 93 14.0% 8.2–22.8% 

Files with FFRs that were submitted late 45 15.6% 7.5–29.5% 

Files that did not contain a progress report 93 0.0% 0.0–3.9% 

Files that did not contain an Award 

Worksheet Report 86 0.0% 0.0–4.2% 

Files that did not contain a Notice of Award 100 0.0% 0.0–3.6% 

Files with progress reports that were 

approved even though required information 

was absent 

80 12.5% 6.8–21.9% 

Files with progress reports that lacked a 

description of progress toward stated goals 80 6.3% 2.6–14.3% 

Files with progress reports that lacked a 

description of planned activities for the 

coming year 

80 8.8% 4.2–17.4%

 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 Public Health Service 01' HEALTH &. HUMAN SERVICES 

National Institutes of Health 

Bethesda, Maryland 20892 

TO: 	 Suzanne Murrin 


Deputy Inspector General for Inspection and Evaluations, HHS 


FROM: 	 Director, NIH 

DATE: JUL 2 9 2015

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 OIG’s 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.