D  epartment of Health and Human Services 
 
Office of Inspector General 
 
 
 
NIH Did Not Consistently 
Meet Federal Single Audit 
Requirements for Extramural 
Grants 
 
Ann Maxwell  
Deputy Inspector General 
   for Evaluation and Inspections 
December 2023, OEI-04-21-00160  Department of Health and Human Services 
 
Office of Inspector General 
Report in Brief 
December 2023, OEI-04-21-00160 
Why OIG Did This Review  NIH Did Not Consistently Meet Federal 
Single audits promote the efficient and 
Single Audit Requirements for Extramural 
effective use of Federal, extramural 
grant funding.  Single audits are costly  Grants  
for the Federal government and time-
consuming for grant recipients (e.g.,     What OIG Found 
universities, States and localities, for-
Key Takeaway 
NIH did not consistently ensure that 
profit Small Business Innovation 
NIH did not routinely meet  recipients took appropriate and timely 
Research (SBIR) award recipients).  
Federal single audit  corrective action on single audit 
Therefore, it is important that they be 
requirements that help ensure  findings, as required by Federal 
effectively used to protect Federal 
that extramural recipients have  regulation.  Specifically, for over half of 
funds.  Compliance with single audit 
sound financial practices and  the single audits in our review, NIH did 
requirements is especially important 
internal controls.  NIHs lack of  not issue management decision letters 
for the Department of Health and 
oversight and routine use of  (MDLs) that met the required 6-month 
Human Services (HHS), as HHS is the 
single audits, as required, could  deadline to document that it had 
largest grant-making agency in the 
put grants that fund important  assessed whether recipients were 
Federal government.  Within HHS, the 
research at risk for  taking corrective actions to address 
National Institutes of Health (NIH) 
mismanagement.    single audit findings.  On average, late 
awards a significant number of these 
MDLs were about 10 months beyond 
grants.  Other Federal offices also rely 
the 6-month deadline.  Further, NIH did not use a risk-based approach to 
on NIH to comply with single audit 
prioritize single audit findings, as encouraged by HHS policy, despite multiple 
requirements.  Previous HHS Office of 
audits having factors identified by HHS policy as high-risk.  Also, because NIH 
Inspector General (OIG) work found 
did not issue some MDLs within 2 years, NIH may no longer have the legal 
that NIH did not follow up on single 
authority to ensure that recipients address the corresponding audit findings, 
audit findings within the required 6 
according to Federal regulation.   
months.  This review revisits whether 
NIH is following up in a timely manner  Additionally, NIHs use of single audit findings in making decisions about new 
and evaluates NIHs compliance with  and ongoing awards during our review period was limited.  NIH does have 
other single audit requirements.  This is  policies to convey that awarding officials must review audit findings when 
OIGs first assessment of NIHs  making award decisions.  However, NIH used a list of high-risk recipients that 
oversight and use of single audits since  has not been updated since 2018 to inform these decisions.  NIHs process for 
some responsibilities transferred from  issuing alerts about vulnerabilities identified in single audit findings did not 
OIG to HHSs Assistant Secretary for  result in any alerts for recipients in our review period, despite multiple audits 
Financial Resources (ASFR) in 2018.  in our review having unresolved high-risk findings.   
How OIG Did This Review  Finally, ASFR provides some data to NIH, but NIH does not track the 
We collected and reviewed HHS and  effectiveness of single audit processes and single audits use.  However, NIH 
NIH policies on single audits.  We also  does not have processes to use ASFRs metrics or other data to track the 
analyzed data and relevant  effectiveness of its single audit processes and single audits use.  Using such 
documentation (e.g., single audit  data could help NIH oversee and ensure the integrity of awards it funds. 
reports) for all management decision 
letters (MDLs) between September 1,  What OIG Recommends and How the Agency Responded 
2020, and August 31, 2021.  MDLs  We recommend that NIH (1) ensure that the 6-month requirement for issuing 
document NIHs review of single audits  MDLs for all single audits is met; (2) use risk to prioritize the issuance of MDLs; 
and corresponding corrective action  (3) ensure that relevant single audit data are available and used by NIH staff 
plans.  We also interviewed staff within  to inform decisions about new and ongoing awards; and (4) track the 
NIH and ASFR due to ASFRs role in  effectiveness of single audit processes and single audits use.  NIH concurred 
coordinating HHSs, and as such NIHs,  with all four of our recommendations.
single audit processes. 
   
TABLE OF CONTENTS 
 
 
BACKGROUND ................................................................................................................................................ 1 
FINDINGS ......................................................................................................................................................... 8 
NIH did not consistently ensure that recipients took appropriate and timely corrective action on 
single audit findings, as required ........................................................................................................................................ 8 
NIHs use of single audits in making decisions about new and ongoing awards during our review 
period was limited .................................................................................................................................................................. 11 
ASFR provides some data to NIH, but NIH does not track the effectiveness of single audit processes 
and single audits use ............................................................................................................................................................ 13 
CONCLUSION AND RECOMMENDATIONS ........................................................................................... 14 
Ensure that the 6-month requirement for issuing MDLs for all single audits is met .................................... 14 
Use risk to prioritize the issuance of MDLs ................................................................................................................... 14 
Ensure that relevant single audit data are available and used by NIH staff to inform decisions about 
new and ongoing awards .................................................................................................................................................... 15 
Track the effectiveness of single audit processes and single audits use .......................................................... 15 
AGENCY COMMENTS AND OIG RESPONSE ......................................................................................... 17 
APPENDIX ...................................................................................................................................................... 18 
Appendix: Agency Comments ............................................................................................................................................ 18 
ACKNOWLEDGMENTS AND CONTACT ................................................................................................ 24 
ABOUT THE OFFICE OF INSPECTOR GENERAL .................................................................................... 25 
ENDNOTES ................................................................................................................................................... 26 
 
 
 
 
   
BACKGROUND 
OBJECTIVES 
To determine how and the extent to which the National Institutes of Health (NIH) met 
Federal single audit requirements by: 
1.  Ensuring that extramural grant recipients take appropriate and timely 
corrective action to resolve single audit findings; 
2.  Using single audit findings when making decisions about new and ongoing 
awards; and 
3.  Tracking the effectiveness of its single-audit processes and single audits use 
in improving recipient accountability. 
 
Single audits promote sound financial management and internal controls, and they 
decrease the risk of non-Federal recipients (e.g., universities, States and localities, 
Small Business Innovation Research (SBIR) award recipients) mismanaging taxpayer 
dollars.  Recipients expending $750,000 or more in Federal funds per year are 
required to have an independent audit (hereafter referred to as a single audit) for the 
year.1      
The independent auditor reviews the recipients financial management system, 
including the effectiveness of internal controls.2  When an auditor identifies a 
vulnerability, he or she will develop a finding, including a recommendation for an 
appropriate corrective action.  Not all single audits have findings.  Federal agencies 
must review and assess any corrective actions recipients take or plan to take to 
address any findings.3 
Generally, NIH has three main responsibilities regarding single audits. 
1.  NIH must ensure that recipients take appropriate and timely corrective action on 
single audit findings.4  To do this, NIH receives and reviews single audit reports, as 
well as any corrective action plans submitted to address findings.5  NIH is required 
to issue a management decision letters (MDL) to the recipient within 6 months. 6  
MDLs document NIHs review and assessment of the recipient single audit 
findings and proposed corrective actions.  In the MDLs, NIH should convey 
whether the proposed corrective actions are sufficient.  In cases in which the 
proposed corrective actions are insufficient, NIH can work with the recipient to 
revise the proposed corrective actions before and/or after issuing the MDL.7  
However, NIH must still issue the MDL within 6 months.  HHS policy encourages
but does not requireNIH to use a risk-based approach throughout this process 
to focus and tailor these activities.8   
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2.  NIH must review recipients current and previous single audit findings (1) prior to 
awarding a new or ongoing award;9 (2) at least annually as a regular part of 
monitoring; and (3) at the award closeout.10    
3.  NIH must track, over time, the effectiveness of its single-audit processes and 
single audits use in improving recipient accountability.11   
NIHs responsibilities regarding single audits 
 
Previous HHS OIG work found that, in 2016, NIH delayed issuing MDLs beyond the 
required 6 months.12  These delays put NIH at risk of noncompliance with Federal 
requirements and mismanagement of Federal funds.  As a result, in July 2020, NIH 
updated its policies to issue MDLs within the required 6 months.   
OIG is also issuing a related audit on NIHs oversight of foreign grant recipients 
compliance with Federal audit requirements.13   
Issuing Management Decision Letters and Ensuring That 
Recipients Implement Corrective Actions 
Within NIH, the Division of Financial Advisory Services (DFAS) is 
responsible for receiving and reviewing single audit findings and 
ensuring that recipients take appropriate and timely corrective action.14, 
15, 16  As such, DFAS is responsible for issuing MDLs within 6 months.17  
According to Federal regulations, if 2 years pass from the date the 
recipient submits a single audit and DFAS has neither followed up with 
the recipient nor issued an MDL, the recipient has a valid reason to 
claim that the findings do not warrant further action.18  As such, DFAS 
may no longer have the legal authority to ensure that the recipients 
address these audit findings. 
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DFAS is also responsible for assessing risk associated with single audits.19  See Exhibit 
1 for the risk factors that HHS policies indicate DFAS should consider when 
conducting risk reviews of single audit findings and reports to tailor the resolution 
process.  Further, risk can also refer to the type of funding that the recipient receives:  
The Small Business Innovation Research (SBIR) program is considered high-risk 
funding to for-profit startups and small businesses.20     
Exhibit 1: HHS-identified risk factors DFAS should consider when conducting risk reviews to 
tailor audit resolution activities 
Risk Factor  Description  Example  
Going  A statement the auditor includes in the single  Financial difficulties experienced by the 
Concern    audit report which indicates aggregate  larger organization have significant 
conditions or events that raise substantial doubt  adverse impacts on the recipient, given 
about a recipients ability to continue its  the recipients reliance on the larger 
operations.  organization and the lack of available 
funding alternatives at reasonable interest 
rates. 
Modified  An opinion in which the auditor concludes (1)  The recipient failed to ensure that 
Opinion  that on the basis of the audit evidence obtained,  subrecipients complied with requirements, 
the financial information includes material  including requirements for single audits 
misstatements or (2) that the auditor cannot  and for processes to ensure that expenses 
obtain sufficient, appropriate evidence that the  were allowable.  The recipient also failed 
financial information is free from  to obtain multiple bids from potential 
misstatements.21    contractors. 
Material  A deficiency, or a combination of deficiencies, in  An audit found a lack of segregation of 
Weakness  internal controls over financial reporting that  duties, which represented a systemic 
indicate a reasonable possibility that financial  problem.  The recipient prepared, 
misstatements will not be prevented, detected, or  reviewed, and approved items which did 
corrected in a timely way.  not align with the segregation of duties. 
Questioned  Costs that are questioned by the auditor because  The recipient did not have effective 
Costs  they (1) violate or possibly violate a statute,  internal controls in place to ensure that 
regulation, or term or condition of the award; (2)  salaries paid to employees did not exceed 
are not supported by adequate documentation at  the salary cap limitations published by 
the time of the audit; or (3) appear unreasonable  NIH.  The auditors sample identified 
and do not reflect the actions a prudent person  questioned costs of approximately 
would take in the circumstances.  $55,000. 
Repeat  A finding from the preceding years single audit  The recipient did not maintain records 
Findings  that repeats in the current single audit because  sufficient to document procurement 
corrective action was not implemented or was  decisions.  Records must explain the 
not effective.  The finding may also be new but  method of procurement, type of contract, 
substantially similar to one in the previous single  selection of contractor, and basis for the 
audit.  price, but they did not. 
Source: OIG analysis of 2020 Assistant Secretary for Financial Resources (ASFR) and American Institute of Certified Public 
Accountants (AICPA) information and single audits from fiscal years ending in 2020. 
 
Prior to October 1, 2018, HHS OIGs National External Audit Review Center received 
the Departments single audits and assigned them to HHS Operating Divisions. 22   
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Part of OIGs role was to identify recipients with negative or potentially negative audit 
findings on the basis of its review of recipients single audits.  OIG then transmitted 
the results of these reviews to the appropriate Operating Division via NEAR alerts.  
Within NIH, staff compiled the recipients included in these alerts into a list, referred to 
as the NEAR alert list.  When the responsibilities to receive and assign HHSs single 
audits shifted from OIG to the Assistant Secretary for Financial Resources (ASFR) in 
2018, OIG stopped transmitting NEAR alerts, and NIH stopped updating the NEAR 
alert list.  
Using Single Audit Findings When Making Award Decisions 
In addition to using single audit findings to retroactively protect the 
integrity of funds that recipients have expended, NIH may also use the 
findings for proactive decision making and monitoring for new and 
ongoing grants for those same recipients.  NIH is required to review 
recipients current and previous single audit reports at least annually and 
before awarding new or ongoing awards.23  Recipients current and 
previous single audit findings may inform NIH, for example, of the 
recipients inability to safeguard Federal funds.  By reviewing recipients 
single audit reports prior to funding a new grant, NIH may be able to 
identify and mitigate potential risks these recipients may pose to 
pending Federal awards.24  NIH may modify the terms and conditions of 
recipients awards to help safeguard against vulnerabilities identified in single audits.    
NIHs Office of Extramural Research provides guidance to Institutes and Centers (ICs) 
Grants Management Officers to help them determine recipients financial capability.25  
The guidance directs ICs to look for specific concerns raised by auditors (e.g., financial 
concerns) when considering new awards.   
Additionally, NIHs Office of Policy for Extramural Research Administration (OPERA), 
within the Office of Extramural Research, sends out alerts to ICs for various oversight 
reasons to help inform award decisions and oversight.  These alerts can be based on 
vulnerabilities identified in single audit findings.   
 
 
 
 
 
 
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Tracking the Effectiveness of Single Audit Processes and Single 
Audits Use 
Federal regulations require NIH to develop a baseline, metrics, and 
targets to track, over time, the effectiveness of its processes to follow up 
on single audit findings and on the use of single audits in improving 
recipient accountability and their use in making award decisions.26  
According to HHS, one way NIH could do this is by identifying trends in 
single audit findings across recipients and/or grant programs and 
addressing those trends.27  Doing so could not only identify problems 
with recipients operations, but also could identify deficiencies in NIHs 
own operations and policies.  For example, if NIH identifies a trend in 
single audit findings related to a certain grant program, it could indicate 
that NIH is not clearly communicating the requirements to or 
appropriately overseeing recipients of that grant.  As a result, NIH could develop 
guidance to help the recipients of that program comply.    
To improve the effectiveness of single audits, HHS and other awarding agencies are 
responsible for providing the Office of Management and Budget (OMB) with updates 
to the Federal guidelines for single audits (these updates are hereinafter referred to as 
the Compliance Supplement).28  Specifically, NIH has subject matter expertise 
regarding the Research and Development (R&D) cluster of program requirements in 
the Compliance Supplement.  NIHs feedback to OMB helps focus future single audits 
on issues most likely to threaten the integrity of R&D awards.  OMB updates the 
Compliance Supplement each year on the basis of feedback from Federal agencies, 
including HHS.29, 30   
Methodology 
We analyzed multiple data sources to describe NIHs oversight and use of single 
audits during our review period (i.e., September 1, 2020, to August 31, 2021). 
To determine the extent to which NIH ensures that recipients take appropriate and 
timely corrective action to resolve single audit findings, we reviewed HHS, NIH, and 
recipient documents (e.g., policies, single audit report packages), and we conducted 
interviews with DFAS staff.  We reviewed documentation and policies to help guide 
our data analysis, and we performed interviews to contextualize the results of our 
analysis.   
We also reviewed the data associated with single audits during our review period.  We 
analyzed data for non-profit, domestic versus for-profit or foreign recipients separately 
because the requirements differ for them: 
  Federal governmentwide regulations for single audits apply only to non-
Federal, domestic recipients, such as State and local governments; institutions 
of higher education; or non-profit organizations (hereafter referred to as non-
profit recipients).  The threshold for conducting these audits applies to each 
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non-profit, domestic recipients Federal expenditures for the year, combined 
across all Federal agencies.31   
  HHS has developed additional requirements for for-profit or foreign 
recipients.  HHS requires for-profit or foreign recipients to conduct single 
audits if the recipients expend $750,000 or more in HHS funds in a year.32   
NIH data are compiled separately for non-profit, domestic versus for-profit or foreign 
single audits because NIH receives single audit packages differently for each.   
  Non-profit, domestic recipients submit single audit reports into the Federal 
Audit Clearinghouse and fill out a standardized data collection form.  The data 
collection form prompts recipients to enter certain data variables, which can 
be tracked across audits and analyzed by funding agencies.  Audit data from 
the Federal Audit Clearinghouse are then automatically routed and uploaded 
into HHSs Audit Tracking and Analysis System, which NIH uses to track the 
resolution of findings for which it is responsible.   
  In contrast, for-profit or foreign recipients send their single audit reports 
directly to ASFR.33  ASFR manually reviews the audits and assigns relevant 
findings to NIH via email.  NIH then manually compiles the data associated 
with for-profit or foreign audits in a spreadsheet for tracking purposes.   
Of the recipients in our population, only onea Canadian universitywas foreign.    
All other recipients in our population were either non-profit (and domestic) or for-
profit.  Hereafter, we refer to these two groups as either non-profit or for-profit.  We 
indicate in our findings when the single foreign entity is included in our results.   
We also conducted quality assurance on a sample of data for both non-profit and for-
profit recipients separately by comparing the data we received from NIH to the single 
audit reports and other documentation (e.g., MDLs) we also received.  We identified 
some initial errors in the for-profit data, so we reviewed the audits of all for-profit 
recipients to ensure that we captured all risk factors associated with each audit in our 
analysis.  After conducting this additional quality assurance, we determined that the 
data were sufficient to use in our analyses.  In our findings, we describe the risk 
factors that were originally missing from the NIH data. 
To determine the extent to which NIH uses audit findings when making award 
decisions and the extent to which NIH tracks effectiveness, we reviewed HHS, NIH, 
and recipient documents (e.g., policies, single audit report packages) and conducted 
interviews with DFAS, OPERA, and ASFR staff.  We reviewed documentation and 
policies to help inform our interview questions.  
Limitations 
We did not independently verify that the population of MDLs provided by ASFR and 
NIH was complete.   
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Standards 
We conducted this study in accordance with the Quality Standards for Inspection and 
Evaluation issued by the Council of the Inspectors General on Integrity and Efficiency. 
 
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FINDINGS 
NIH did not consistently ensure that recipients took appropriate 
and timely corrective action on single audit findings, as required   
NIH did not issue MDLs within the required 6 months for over half of the MDLs in our 
review.  These delays put NIH in noncompliance with Federal requirements and put 
recipients at risk of mismanaging Federal funds.  Due to delays in issuing some MDLs, 
NIH may no longer have the legal authority to ensure that some recipients address 
audit findings.   
NIH also did not prioritize its activities on the basis of risk, in contrast to HHS policy 
recommendations.  NIH reported that it issues MDLs in the order in which it receives 
the single audits rather than by risk.   
For over half of the audits in our review, NIH did not issue 
management decision letters within the required 6 months    
Across all recipients (non-profit and for-profit) in our review, NIH did not issue MDLs 
within the required 6 months for over half of the audits.  On average, the late MDLs 
were 313 days (about 10 months) beyond the 6-month deadline at the time of our 
analysis.  MDLs were more often late for for-profit recipients:   
  Seventy-four percent (40 out of 54) of MDLs for single audits of for-profit 
recipients were late.  At the time of our analysis, DFAS had not issued MDLs 
for 23 of the 40 single audits.  The 40 late MDLs ranged from 21 to 678 days 
late and were, on average, over a year (368 days) late.34   
  In contrast, 33 percent (11 out of 33) of MDLs for single audits of non-profit 
recipients were late.  At the time of our analysis, DFAS had issued all 11 of the 
late MDLs (i.e., none were pending).  These 11 late MDLs ranged from 4 days 
to 247 days late, with an average of less than 4 months (112 days) late.   
 
 
 
 
 
 
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Exhibit 2: NIH did not meet Federal timelines for issuing MDLs for more single 
audits of for-profit recipients than for non-profit recipients.  
 
Source: OIG analysis of audits with MDLs due from NIH between September 1, 2020, and August 31, 2021. 
These data indicate that NIH does not consistently follow its updated policy to issue 
MDLs timely.  This policy was put into place to implement OIGs previous 
recommendation to issue MDLs within the required 6 months.35   
NIHs system for tracking MDLs of for-profit recipients may contribute to MDL delays 
due to the manual nature of the process.  NIH manually updates a spreadsheet to 
track audits of for-profit recipients to whom it needs to issue an MDL.  As a result of 
our data request in July 2022, DFAS identified two single audits of for-profit recipients 
that it was responsible for resolving but had not previously included in its 
spreadsheet.  DFAS stated that the spreadsheet was missing these two audits due to 
human error and the challenges posed by manually tracking single audits of for-profit 
recipients.  DFAS began tracking these two single audits as a result of our July 2022 
data request.  These MDLs were eventually issued 815 days and 563 days beyond the 
6-month deadline.  
DFAS does not use risk to prioritize its review, in contrast to HHS 
recommendations  
DFAS reported that it issues MDLs in the order in which it receives the single audits 
rather than by risk.  Of the single audits with at least one risk factor, over half had late 
MDLs (27 of 48).36  Exhibit 3 provides examples of some of the high-risk findings 
associated with late MDLs in our review.  Further, nearly all (37 of 40) of the late MDLs 
of for-profit recipients were for recipients of SBIR funding, which is also considered 
high-risk.37 
 
 
 
 
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Exhibit 3: Examples of high-risk single audit findings of recipients with late MDLs 
 
Source: OIG analysis of audits with MDLs due from NIH between September 1, 2020, and August 31, 2021. 
Further, DFAS is not accurately capturing all of the risk factors that could assist with 
prioritization by risk.  The manually updated NIH spreadsheet that tracks audits of for-
profit recipients did not capture all of the risk factors associated with each single audit 
in our review.38   Specifically, we identified, through our review of single audit 
findings, the following risk factors that were not documented in the tracking 
spreadsheet: 
  5 material weaknesses, 
  10 questioned costs, and 
  10 repeat findings. 
 
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NIHs delays in issuing management decision letters may 
jeopardize its ability to ensure that some recipients address audit 
findings 
During our review, we identified nine single audits for which the 2-year review period 
had already expired or that were approaching the end of the 2-year review period.  
For these nine single audits, NIH had neither issued an MDL nor conducted other 
followup with the recipient.  As a result, some of these recipients have a valid reason 
to claim that the single audit findings no longer warrant further action.  In these cases, 
NIH may have missed the opportunity to ensure that these recipients financial 
practices have appropriate internal controls to protect taxpayer dollars from 
mismanagement. 
Specifically, we identified five single audits of for-profit recipients for which the 2-year 
period had already expired.  Of these five single audits, three had HHS-identified risk 
factors, including material weaknesses and a questioned cost.   
For the remaining four single audits, NIH was approaching the 2-year deadline and 
had neither issued an MDL nor conducted other followup.  Three of these four audits 
were 5 to 7 days prior to the 2-year deadline, and the fourth audit was 4 months prior 
to the 2-year deadline.  Three of these audits had HHS-identified risk factors, 
including a qualified opinion, material weaknesses, and repeat findings.  We notified 
NIH about these single audits, and NIH confirmed that it had not previously followed 
up with these recipients.  After receiving the notification from us, NIH followed up 
with these recipients before the 2-year deadline passed. 
NIHs use of single audits in making decisions about new and 
ongoing awards during our review period was limited 
NIHs use of single audit findings to proactively inform decision making and 
monitoring of new and ongoing awards during our review period was limited.  NIH 
policies convey to ICs that audit findings must be used in making award decisions, 
and NIH reported that ICs follow these policies.  However, information about audit 
findings was not readily available and ICs did not modify any award terms and 
conditions for new or ongoing awards as a result of single audit findings during our 
review period. 
NIH stated that ICs still used the outdated NEAR alert list to inform award decisions; 
this list has not been updated since 2018.  NIH reported that it is in the process of 
finalizing a tool that will replace the NEAR alert list.  The new tool will be updated at 
least monthly.   
NIH also reported that OPERA issues alerts, which can be based on vulnerabilities 
related to single audit findings, help inform ICs award decisions.  However, NIH did 
not issue any OPERA alerts for awardees in our review.39  This is despite multiple 
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single audits in our review identifying HHS-identified risk factors that pose continued 
financial or management vulnerabilities.40     
The processes that grant officials must follow to obtain single audit information 
pertinent to new or ongoing awards is also limited and inefficient.  NIH instructs grant 
officials to check the publicly available Federal Audit Clearinghouse or obtain the 
most recent single audit directly from the recipient.41  However, neither the Federal 
Audit Clearinghouse nor the single audits themselves reflect the current status of any 
findings (i.e., resolved or unresolved).  Therefore, neither of these steps would allow a 
grant official to determine whether an MDL has been issued or whether a recipient 
has taken sufficient corrective action to address the findings.   
NIH grant officials do not have direct access to HHSs Audit Tracking and Analysis 
System.  Therefore, to obtain this information, grant officials must coordinate with 
DFAS to determine the current status of any findings related to HHS awards via HHSs 
Audit Tracking and Analysis System.   
HHSs Audit Tracking and Analysis System, as is indicated in its name, only contains 
information about HHS awards.  There is no governmentwide system for tracking the 
resolution status of single audit findings.  Instead, ASFR reported that it has the 
responsibility for determining the status of single audit findings assigned to other 
Federal agencies (e.g., to determine if MDLs were issued).  However, ASFR 
acknowledged that it does not conduct this outreach to other Federal agencies. 
The limited use of single audit findings in making new and ongoing award decisions 
could put awards that fund important research at risk of mismanagement.  Three 
recipients received new or ongoing funding from NIH that totaled over $14 million 
while the recipients MDLs were late and pending, meaning that NIH had not 
documented that the recipients were taking appropriate and timely action to address 
single-audit findings.  These three recipients were for-profit recipients who received 
high-risk SBIR awards, and the single audits in our review for two of these recipients 
contained HHS-identified risk factors.  Further, the three recipients were among those 
for which the 2-year period was approaching without an MDL or other followup from 
NIH.   
NIH reported that it was in the process of moving its guidance for staff to review and 
mitigate risks for single audits to a standalone document specific to the review of 
annual audits.  NIH believes that moving this guidance will ensure that grant officials 
access and use information about the status of single audit findings when making 
award decisions and providing ongoing oversight.  However, NIH did not describe 
how it would verify that staff are following the guidance when making award 
decisions.  
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ASFR provides some data to NIH, but NIH does not track the 
effectiveness of single audit processes and single audits use   
As a part of its coordinating role for HHS, ASFR reported in June 2023 that it recently 
finalized and implemented nine single-audit metrics.  These metrics would, among 
other things, allow NIH to assess the timeliness of issuing MDLs, particularly for high-
priority findings.  ASFR analyzes the data across various timeframes and by HHS 
Operating and Staffing Division.  ASFR reported that it shares the analysis with each 
HHS Operating and Staffing Division, including NIH, at several points throughout the 
year.  ASFR also reported that it will consider adding additional metrics in Fiscal Year 
2024.   
Some of ASFRs data establish targets, but the targets do not conform with Federal 
regulation.  Specifically, ASFR identifies a 50-percent target for MDLs issued within 6 
months.  In contrast, Federal regulation requires that all MDLs be issued within 6 
months.  
Additionally, ASFRs data do not include certain information that could be valuable to 
NIH in tracking the effectiveness of single audit processes and single audits use.  
ASFR does not include data that would help NIH identify trends in single audit 
findings across recipients.  According to HHS, identifying and addressing these trends 
is one way NIH could identify deficiencies in NIHs own operations and policies.  ASFR 
also does not analyze the data separately for non-profit versus for-profit (including 
foreign) recipients.  Finally, ASFR does not track how long MDLs are overdue to 
determine whether they are nearing the end of the 2-year review period.   
Considering the limitations in ASFRs data, NIH also does not have its own procedures 
for collecting, reviewing, and taking action on relevant information.    This information 
could include whether grant officials are using single audit findings to inform 
decisions about new or ongoing awards.  NIH could, for example, track how often 
safeguards (e.g., modified terms and conditions) are implemented as a result of single 
audit findings, and whether these safeguards are associated with a subsequent 
reduction in single audit findings across those awardees.  Doing so would help NIH 
ensure the integrity of awards it funds to recipients with HHS-identified risk factors.  If 
NIH collected and analyzed this information, it could also improve the information it 
shares with HHS and, in turn, with OMB for the Compliance Supplement, which helps 
focus future single audits on the issues most likely to threaten the integrity of R&D 
awards, such as those that NIH funds.   
 
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OEI-04-21-00160  Findings | 13    
CONCLUSION AND RECOMMENDATIONS 
Single audits are an important tool to help protect Federal funds from 
mismanagement.  However, NIH did not consistently meet Federal requirements to (1) 
ensure that extramural recipients take appropriate and timely corrective action on 
single audit findings; (2) use single audit findings in making decisions about new and 
ongoing awards; and (3) track the effectiveness of its single audit processes and single 
audits use.   
These findings, paired with OIGs other work in this area, demonstrate concerning 
vulnerabilities in NIHs oversight and use of single audits to help protect important 
research, both foreign and domestic, from mismanagement.  Single audits can 
address recipients financial mismanagement practices (e.g., unallowable costs) that 
take funding away from the research itself.  Such research helps advance the 
treatment, management, and cure of serious diseases, such as cancer.  
Mismanagement of this type of research could impair or delay important medical 
advances.   
We offer the following recommendations to NIH to help ensure its compliance with 
Federal single-audit requirements intended to prevent mismanagement of Federal 
funds: 
Ensure that the 6-month requirement for issuing MDLs for all 
single audits is met 
NIH should ensure that it is complying with the 6-month Federal requirement for 
issuing MDLs.  Compliance with this requirement helps NIH ensure that recipients are 
taking appropriate and timely corrective actions on single audit findings.  To avoid 
delays in MDLs of for-profit (including foreign) recipients, in particular, NIH should 
take additional quality assurance steps to ensure that its manual updates to its 
tracking spreadsheet include all audits for these recipients.   
Use risk to prioritize the issuance of MDLs   
As encouraged by HHS policy, NIH should implement a process for prioritizing MDLs 
for findings that pose a greater risk to Federal programs and funds.  This includes 
single audits with HHS-identified risk factors and single audits of recipients receiving 
funding from high-risk programs (e.g., SBIR).  To ensure that NIH is appropriately 
prioritizing risk, it needs to ensure that it is identifying and capturing all of the HHS-
identified risk factors associated with an audit.  This includes ensuring that its tracking 
spreadsheet for audits of for-profit (including foreign) recipients contains all risk 
factors.  Then, NIH should use the risk factors in prioritizing its work so the most high-
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OEI-04-21-00160   Conclusion and Recommendations | 14    
risk recipients and findings are addressed as soon as possible within the required 6-
month period.   
Ensure that relevant single audit data are available and used by 
NIH staff to inform decisions about new and ongoing awards    
NIH should ensure that it is using available information on single audits to inform 
decisions for new and ongoing awards as efficiently as possible.  NIH should finalize 
the tool to replace the NEAR alert list and monitor if and how staff use the tool.  Until 
NIH implements a tool to replace the NEAR alert list, NIH should ensure that its 
system for issuing OPERA alerts consistently incorporates and communicates 
information about single audits containing HHS-identified risk factors.   
NIH should also move its guidance for staff to review and mitigate risks identified in 
single audits to the standalone document specific to the review of annual audits, as 
planned.  Then, NIH should verify that staff are following the guidance, such as by 
tracking whether safeguards (e.g., modified terms and conditions) are implemented to 
address high-risk single audit findings.   
In addition, NIH should ensure that its grant officials efficiently access and use 
information about the status of single audit findings assigned to HHS and other 
Federal agencies when making award decisions.  Until a governmentwide database 
containing this information exists, NIH could work with ASFR to ensure that HHSs 
systems are current and complete regarding the status of all Federal agencies 
findings and, to the extent appropriate, shared with HHS grants officials and with 
other Federal agencies for use in making decisions about new and ongoing awards.   
Track the effectiveness of single audit processes and single 
audits use    
NIH should ensure that it is complying with Federal requirements to track the 
effectiveness of its single audit processes and single audits use.  As such, NIH should 
work with ASFR to:  
  Ensure that current metrics and targets conform with Federal regulations; 
  Establish metrics to track how long MDLs are overdue and whether any are 
nearing the end of the 2-year review period; 
  Collect and analyze data separately for non-profit, domestic versus for-profit 
or foreign recipients; and 
  Identify trends in single audit findings across recipients. 
If ASFR chooses not to collect and analyze this data, NIH should collect and analyze it.   
NIH Did Not Consistently Meet Federal Single Audit Requirements for Extramural Grants   
OEI-04-21-00160   Conclusion and Recommendations | 15    
Finally, NIH should use these data to monitor its processes and use of single audits 
and make improvements, as necessary, to ensure that they are as effective as possible.  
For example, NIH could track how often safeguards, such as modifying terms and 
conditions, are used as a result of single audit findings, and whether these safeguards 
are associated with a subsequent reduction in single audit findings across those 
awardees.  If terms and conditions are not updated for unresolved high-risk single 
audit findings before new or ongoing awards are funded to the recipients, NIH could 
further improve its guidance and consider offering training to IC grant officials to 
ensure that they understand expectations on how they should use single audit 
findings when making award decisions. 
 
 
NIH Did Not Consistently Meet Federal Single Audit Requirements for Extramural Grants   
OEI-04-21-00160   Conclusion and Recommendations | 16    
AGENCY COMMENTS AND OIG RESPONSE  
NIH concurred with all four of OIGs recommendations. 
In response to our first recommendation, NIH stated that it will ensure that the 6-
month requirement for issuing MDLs for all single audits is met.  NIH will also ensure 
that its tracking spreadsheet includes all single audits for recipients with findings 
assigned to NIH. 
In response to our second recommendation, NIH noted that it will add fields in its 
tracking spreadsheet to capture all risk factors associated with single audits.  NIH will 
use those risk factors to prioritize its resolution of the highest-risk findings as soon as 
possible within the required 6-month period. 
In response to our third recommendation, NIH stated that it recently released a new 
tool in eRA that replaces the NEAR alert list.  NIH added that OPERA will manually 
provide monthly updates and that NIH will consider automating this information at a 
later time.  Additionally, NIH plans to transition to a standalone compliance document 
for staff to review and mitigate risks identified in single audits.  
In response to our fourth recommendation, NIH provided an update on the new 
reports ASFR provides to NIH.  ASFR will now provide seven new reports, including 
information on metrics for foreign and for-profit single audits; the timeliness of 
unresolved audit findings; and risk factors, among other things.   
OIG believes NIHs planned actions will implement these recommendations and 
improve NIHs oversight and use of single audits. 
For the full text of NIHs comments, see the Appendix. 
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OEI-04-21-00160  Agency Comments and OIG Response | 17    
APPENDIX 
Appendix: Agency Comments   
Following this page are the official comments from NIH.  
 
   
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NIH Did Not Consistently Meet Federal Single Audit Requirements for Extramural Grants   
OEI-04-21-00160   Appendix | 19    
 
NIH Did Not Consistently Meet Federal Single Audit Requirements for Extramural Grants   
OEI-04-21-00160   Appendix | 20    
 
NIH Did Not Consistently Meet Federal Single Audit Requirements for Extramural Grants   
OEI-04-21-00160   Appendix | 21    
   
NIH Did Not Consistently Meet Federal Single Audit Requirements for Extramural Grants   
OEI-04-21-00160   Appendix | 22    
 
NIH Did Not Consistently Meet Federal Single Audit Requirements for Extramural Grants   
OEI-04-21-00160   Appendix | 23    
ACKNOWLEDGMENTS AND CONTACT 
Acknowledgments 
Margaret Dore served as the team leader for this study.  Others in the Office of 
Evaluation and Inspections who conducted the study include Lucio Verani, Rebekah 
Schwartz, Victoria Coxon, and Brianna Weldon.  Office of Evaluation and Inspections 
headquarters staff who provided support include Joe Chiarenzelli, Robert Gibbons, 
and Sara Swisher.  
This report was prepared under the direction of Dwayne Grant, Regional Inspector 
General for Evaluation and Inspections in the Atlanta regional office, and Jaime 
Stewart, Assistant Regional Inspector General. 
Contact 
To obtain additional information concerning this report, contact the Office of Public 
Affairs at Public.Affairs@oig.hhs.gov.  OIG reports and other information can be found 
on the OIG website at oig.hhs.gov. 
Office of Inspector General 
U.S. Department of Health and Human Services 
330 Independence Avenue, SW 
Washington, DC 20201 
 
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OEI-04-21-00160   Acknowledgments and Contact | 24    
ABOUT THE OFFICE OF INSPECTOR GENERAL 
Office of Inspector General 
https://oig.hhs.gov 
The mission of the Office of Inspector General (OIG) is to provide objective oversight 
to promote the economy, efficiency, effectiveness, and integrity of the Department of 
Health and Human Services (HHS) programs, as well as the health and welfare of the 
people they serve.  Established by Public Law No. 95-452, as amended, OIG carries out 
its mission through audits, investigations, and evaluations conducted by the following 
operating components: 
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.  The audits examine the performance of HHS programs, funding recipients, 
and contractors in carrying out their respective responsibilities and provide 
independent assessments of HHS programs and operations to reduce waste, abuse, 
and mismanagement. 
The Office of Evaluation and Inspections.  OEIs national evaluations 
provide HHS, Congress, and the public with timely, useful, and reliable information on 
significant issues.  To promote impact, OEI reports also provide practical 
recommendations for improving program operations. 
The Office of Investigations.  OIs criminal, civil, and administrative 
investigations of fraud and misconduct related to HHS programs and operations 
often lead to criminal convictions, administrative sanctions, and civil monetary 
penalties.  OIs nationwide network of investigators collaborates with the Department 
of Justice and other Federal, State, and local law enforcement authorities.  OI works 
with public health entities to minimize adverse patient impacts following enforcement 
operations.  OI also provides security and protection for the Secretary and other 
senior HHS officials. 
The Office of Counsel to the Inspector General.  OCIG provides legal 
advice to OIG on HHS programs and OIGs internal operations.  The law office also 
imposes exclusions and civil monetary penalties, monitors Corporate Integrity 
Agreements, and represents HHSs interests in False Claims Act cases.  In addition, 
OCIG publishes advisory opinions, compliance program guidance documents, fraud 
alerts, and other resources regarding compliance considerations, the anti-kickback 
statute, and other OIG enforcement authorities.
NIH Did Not Consistently Meet Federal Single Audit Requirements for Extramural Grants   
OEI-04-21-00160   About OIG | 25    
ENDNOTES 
 
1 Recipients may conduct several types of audits.  Many recipients choose to conduct single audits to meet the annual audit 
requirement.  Alternatively, a recipient may perform a program-specific audit if it receives permission and only receives Federal 
funding in one program area.  We use the term single audits to encompass both single and program-specific audits. 
2 45 CFR  75.507 and 45 CFR  75.514. 
3 Corrective action plans outline how the recipient will address each single audit finding included in the current year audit 
reports.  The corrective action plan must provide the name(s) of the contact person(s) responsible for the corrective action, the 
corrective action planned, and the anticipated completion date.  If the recipient does not agree with the single audit findings or 
believes corrective action is not required, then the corrective action plan must include an explanation and specific reasons.  
HHS Single Audit Resolution Standard Operating Procedure (v1.2), September 2019.  45 CFR  75.511(c). 
4 45 CFR  75.513(c)(3). 
5 45 CFR  75.513(c)(3). 
6 45 CFR  75.521(d).   
7 HHS Single Audit Resolution Standard Operating Procedure (v1.2), Review of the Recipients Response, pages 7-8, September 
2019. 
8 HHS Single Audit Resolution Standard Operating Procedure (v1.2), Initial Step in Audit Resolution Review, page 6, September 
2019. 
9 Our use of the term new includes both continuing awards and supplemental awards.  A continuing award is the granting of 
a request for funding to renew, by one or more budget periods, a project that would otherwise expire.  A supplemental award 
is the granting of a request for additional funds beyond those currently awarded, including those for a low-cost extension.  
HHS, HHS Grants Policy Administration Manual, Part I. Audits b.(17), December 2015.  The Grants Policy Administration Manual 
establishes HHS policies for the administration of grants and cooperative agreements and reflects the departmental policies 
that result from the implementing regulations at 45 CFR part 75. 
10 HHS Grants Policy Administration Manual, Part I. Audits b.(17), December 2015. 
11 45 CFR  75.513(c)(3)(iv). 
12 The National Institutes of Health Submitted OIG Clearance Documents for Just Over One-Half of Its Audit Recommendations, 
and the Remaining 225 Recommendations Were Unresolved as of September 30, 2016 (A-07-19-03236) January 21, 2020.   
13 HHS OIG, W-00-21-59457, ongoing.  Accessed at https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-
summary-0000580.asp on May 9, 2023.  
14 45 CFR  75.513(c)(3). 
15 NIH is responsible for overseeing the resolution process when the single audit findings relate to awards funded by NIH, even 
if HHS is not the cognizant agency for audit.  The cognizant agency for audit is the Federal agency designated to carry out the 
responsibilities described in OMBs Uniform Guidance in the event that the recipient expends more than $50 million of Federal 
awards in a fiscal year.  The cognizant agency for audit must be the Federal awarding agency that provides the most direct 
funding to a non-Federal recipient unless OMB designates a specific cognizant agency for audit.  The oversight agency for 
audit is the Federal awarding agency that provides the most direct funding to a recipient that is not assigned a cognizant 
agency for audit.  When there is no direct funding, the Federal agency with the most indirect funding is to assume the 
oversight responsibilities.  2 CFR  200.513(a)(1) and 45 CFR  75.513(a)(1).   
16 DFAS is within NIHs Office of Acquisition Management Policy.   
17 45 CFR  75.521(d). 
 
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OEI-04-21-00160   Endnotes | 26    
 
18 45 CFR  75.511(b)(3).   
19 HHS policy states that staff should conduct risk reviews of the single audit findings and reports to focus and tailor their audit 
resolution activities.  HHS Single Audit Resolution Standard Operating Procedure (v1.2), page 6, September 2019. 
20 Program Basics  What Is the Purpose of the SBIR and STTR Programs?  Accessed at https://www.sbir.gov/tutorials/program-
basics/tutorial-1 on March 23, 2023. 
21 A modified opinion can be a qualified opinion (when financial information may contain misstatements that are limited in 
scope), an adverse opinion (when audit evidence indicates that financial records may contain pervasive material 
misstatements), or a disclaimer of opinion (when the auditor is unable to form an opinion due to the absence of financial 
records or insufficient cooperation from the recipients management).  AICPA, AU-C Section 705 Modifications to the Opinion 
in the Independent Auditors Report.  Accessed at https://www.aicpa.org/Research/Standards/AuditAttest/ 
DownloadableDocuments/AU-C-00705.pdf on September 9, 2021.      
22 The National External Audit Review Center is now called the Single Audit Division.  
23  HHS Grants Policy Administration Manual, Part I. Audits b.(17), December 2015.  
24 NIHs Office of Extramural Research, Pre-award Financial Capability Review Compliance Guidance, August 25, 2020. 
25 NIH is composed of 27 Institutes and Centers, each with a specific research concentration, often focusing on certain body 
systems or types of disease.  NIH, Institutes at NIH.  Accessed at https://www.nih.gov/institutes-nih on March 20, 2023. 
26 45 CFR  75.513(c)(3)(iv).  The HHS awarding agency must develop a baseline, metrics, and targets to track, over time, the 
effectiveness of the Federal agencys process to follow-up on audit findings and on the effectiveness of Single Audits in 
improving non-Federal entity accountability and their use by HHS awarding agencies in making award decisions. 
27 HHS Single Audit Resolution Standard Operating Procedure (v1.2), Audit Metrics, pages 16-17, September 2019. 
28 45 CFR  75.513(c)(4).  The Compliance Supplement reflects the areas of compliance that OMB identifies as the areas for 
auditors to focus on during the review period.  The Compliance Supplement focuses the auditor to test the compliance 
requirements most likely to cause improper payments, fraud, waste, or abuse, or generate audit findings for which the Federal 
awarding agency will take sanctions.  In establishing the Compliance Supplement each year, OMB uses input from HHS and 
other agencies.   
29 Starting in 2019 and continuing in 2021, the Compliance Supplement reduced the areas for compliance reviews from a 
maximum of 12 to a maximum of 6.  This reduction focused the agencies and the auditors on the areas that are most 
important for federal awarding agencies to manage programs more efficiently, moving from a focus on compliance to one on 
performance. 
30 Office of Management and Budget, 2021 Compliance Supplement, July 2021.  Accessed at https://www.whitehouse.gov/wp-
content/uploads/2021/08/OM.B-2021-Compliance-Supplement_Final_V2.pdf on March 23, 2023. 
31 45 CFR  75.501(a). 
32 45 CFR  75.501(i-j)- Audit Requirements.  45 CFR  74.26.  For-profit recipients that expend $750,000 or more in HHS awards 
per year are subject to audit requirements [45 CFR  75.501(j)].  
33 ASFRs Office of Program Audit Coordination serves as the central point of contact for coordinating audit resolution and 
followup activities across HHS.  81 FR 88249, p. 88251.  ASFRs Audit Resolution Division (ARD) is a subcomponent within the 
Office of Program Audit Coordination.  ARD reviews all audit-related documentation, determines if there are findings in the 
current report, and assigns them to the responsible HHS agency.  ARD then sends the material to the responsible HHS agency 
to complete the audit resolution process.   
34 The MDL for the foreign recipient in our review was 77 days late.   
35 The National Institutes of Health Submitted OIG Clearance Documents for Just Over One-Half of Its Audit Recommendations, 
and the Remaining 225 Recommendations Were Unresolved as of September 30, 2016 (A-07-19-03236) January 21, 2020. 
 
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OEI-04-21-00160   Endnotes | 27    
 
36 One of these 27 single audits was for the foreign recipient in our review, which had a late MDL.  The single audit contained a 
questioned cost.   
37 One of the three remaining MDLs was for the foreign recipient that did not receive SBIR funding.   
38 To conduct this analysis, we used the HHS-identified risk factors outlined in Exhibit 1. 
39 NIH did provide examples of two recipients with OPERA alerts, but neither of these recipients was in our review.  These alerts 
required ICs to request DFAS to conduct a financial capability review prior to funding any awards to these recipients in a fiscal 
year. 
40 Twenty-nine audits of for-profit recipients had at least one HHS-identified risk factor.  Nineteen audits of non-profit 
recipients had at least one HHS-identified risk factor. 
41  The Federal Audit Clearinghouse, the main NIH source for information about single audit findings assigned to other Federal 
agencies, is transitioning to the General Services Administration (GSA) in October 2023, and ASFR reported that this transition 
will also shut down HHSs Audit Tracking and Analysis System.  ASFR reported that HHSs Audit Tracking and Analysis System 
will be replaced with a new case management system but did not provide details on the new system.  
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OEI-04-21-00160   Endnotes | 28