Paperwork Reduction Act Exemptions

When Congress enacted the 21st Century Cures Act of 2016, it included a targeted administrative change affecting the National Institutes of Health (NIH): Section 2036 carved out a limited exemption from the Paperwork Reduction Act (PRA) for certain research-related information collections. It provides that certain information collections conducted during the course of biomedical research are not subject to the PRA’s clearance requirements or process. The exemption was designed to reduce delays that researchers sometimes faced when initiating surveys or other data collection instruments tied to scientific studies (Riley & Blizinsky, 2017).

As a result, the NIH does not need to seek OMB clearance for qualifying research collections. Because qualifying NIH research collections are exempt from PRA clearance, they are not subject to that structured OMB review and lack OMB’s assessment of whether such collections align with government-wide data standards—such as Statistical Policy Directive Number 15 (SPD-15) regarding race and ethnicity data—or whether they duplicate existing federally-funded data efforts. There is also no notice-and-comment period required for these collections, reducing public oversight and input into how NIH conducts research surveys.

The exemption does not eliminate other safeguards. NIH research remains subject to Institutional Review Board oversight, human subjects protections under the Common Rule, privacy protections, and other statutory constraints. But the PRA’s centralized, government-wide coordination function—particularly OMB’s role in reviewing redundancy and standards compliance—does not apply to exempt collections.

Conclusion

In short, the NIH exemption in the 21st Century Cures Act was intended to accelerate biomedical research by reducing administrative friction. The tradeoff is a narrower layer of cross-agency oversight into whether qualifying research data collections are harmonized with federal data standards or unnecessarily duplicative. The exemption, despite the benefits it provides to accelerate biomedical research, poses an administrative risk to federal data integrity by removing a mechanism for federal-wide standards conformity and public input in to survey collections.

References

1. Riley, W. T., & Blizinsky, K. D. (2017). Implications of the 21st century cures act for the behavioral and social sciences at the national institutes of health. Health Education & Behavior, 44(3), 356–359. https://doi.org/10.1177/1090198117707964