Commercial (For-Profit) Organization Audits FAQs

A commercial organization is defined in 45 CFR § 75.2 as an organization, institution, corporation, or other legal entity, including but not limited to partnerships, sole proprietorships, and limited liability companies, that is organized or operated for the profit or benefit of its shareholders or other owners. The term includes small and large businesses and is used interchangeably with “for-profit organization.”

Commercial organizations are also referred to as for-profit organizations in the audit community.

As stated in 45 CFR § 75.101(c), Federal agencies may apply subparts A through E to for-profit entities.

45 CFR § 75.501(i) establishes the applicability of subpart F to HHS award recipients. Accordingly, HHS recipients and subrecipients that are commercial organizations (including for-profit hospitals) have two options regarding audits:

1. A financial related audit (as defined in the Government Auditing Standards, GPO stock #020-000-00-264-4) of a particular award in accordance with Government Auditing Standards in those cases in which the recipient receives awards under one HHS program or, if awards are received under multiple HHS programs, a financial related audit of all HHS awards in accordance with Government Auditing Standards; or
2. An audit that meets the requirements contained in this subpart.

Under 45 CFR § 75.501(j), commercial organizations that receive annual awards totaling less than the audit requirement threshold in subpart F are exempt from HHS audit requirements for that year, but records must be available for review by appropriate officials of Federal agencies or the Government Accountability Office.

The threshold for audits of commercial organizations is $750,000 under 45 CFR § 75.501(j).

The audit requirements should be identified in the terms and conditions of the grant agreements or Notice of Award documents. The organization should contact the Grants Management Specialist identified in the award documents with questions specific to the HHS awards.

The NIH Office of Acquisition Management and Policy-Division of Financial Advisory Services provides FAQs for commercial organizations on its website: DFAS Frequently Asked Questions

The FAQs provide answers to questions involving audit requirements, audit threshold calculations, and related matters for audits of commercial organizations. Many technical inquiries can be answered by reviewing the FAQs posted on NIH’s website.

In addition, HHS-OIG can also be contacted through its technical assistance email at SingleAudit.TA@oig.hhs.gov for guidance on general audit questions.

Please provide sufficient details in your email to enable the technical assistance group to provide a well-researched and well-developed response. The group will review the request and promptly either provide appropriate responses or request clarifying information.

NIH provides the most recent grants policy statement on its Grants and Funding website: NIH Grants Policy Statement

HRSA provides FAQs specific to commercial organizations that received PRF funds on its website: PRB Reporting and Auditing FAQ

PRF-related questions and inquiries should be directed to HRSA via email at ProviderReliefContact@hrsa.gov. HRSA will ensure that questions and inquiries are assessed and that appropriate responses are provided.

Audit submission requirements will be identified in the terms and conditions of the grant agreements or Notice of Award documents.

Otherwise, under 45 CFR § 75.512(a)(1), the audit must be submitted within the earlier of 30 calendar days after receipt of the auditor’s report(s) or 9 months after the end of the audit period.

Audits of commercial organizations with HHS programs should be sent to the HHS Audit Resolution Division (ARD) via email at For-Profit_Audit@hhs.gov.

All commercial organization audit submission questions should be sent to ARD via email at AuditResolution@hhs.gov.

Audits of commercial organizations with HHS programs that include the HHS provider relief fund program (ALN 93.498) should be submitted electronically to HHS HRSA’s PRF Reporting Portal: Commercial Audit Reporting Portal

Commercial organizations not registered in the PRF Reporting Portal must submit audits to HRSA via email at PRFAudits@hrsa.gov.

HRSA provides copies of these audit reports to HHS ARD along with identifications of other HHS Operating Divisions or Federal agencies with findings identified in the report. ARD manages and coordinates the resolution of reported findings in commercial audit reports.

The provisions of 45 CFR Part 75 do not provide authorization for individual audit submission extensions. HHS granting officials follow the global audit submission extensions authorized by the Office of Management and Budget (OMB).

OMB authorizations of audit extensions of non-Federal audit submissions are communicated in memorandums. Copies of issued memorandums are available on OMB’s website: Memoranda | OMB | The White House

OMB will communicate through its website and memorandums any new announcements regarding submission extensions.

Note: OMB revised the Uniform Guidance and released the final updated version in April 2024.  In accordance with revised 2 CFR § 200.512 (a)(1), the Federal cognizant or oversight agency may authorize individual audit submission extensions when the nine-month timeframe would place undue burden on the auditee. Federal agency contacts are listed in Appendix III of the OMB Compliance Supplement.  

The effective date for the final guidance is October 1, 2024.  Federal agencies may elect to apply the final guidance to Federal awards issued prior to October 1, 2024, but they are not required to do so.  For agencies applying the final guidance before October 1, 2024, the effective date of the final guidance must be no earlier than June 21, 2024.

For HHS programs under the provisions of 45 CFR Part 75, only inquiries on the revised Uniform Guidance related to audit submission extension requests should be sent to the HHS Audit Resolution Division (ARD) via email at AuditResolution@hhs.gov.

Official audit submission extension requests should be sent to ARD via email at Single_Audit_Extension@hhs.gov. 

Although it is not required, the organization is encouraged to notify the Federal awarding agencies of the impending late submission of its non-Federal audit. Federal agency contacts are listed in Appendix III of the OMB Compliance Supplement.

The HHS contact is HHS ARD via email at AuditResolution@hhs.gov.

Federal agency contacts are listed in Appendix III of the OMB Compliance Supplement.

In addition, contact information for the Federal program’s Grants Management Specialist is identified in the Notice of Award documents. At HHS, audit-specific questions can be submitted to HHS-OIG via its technical assistance email at SingleAudit.TA@oig.hhs.gov.

Please provide sufficient details in your email to enable the technical assistance group to provide a well-researched and well-developed response. The group will review the request and promptly either provide appropriate responses or request clarifying information.