On February 28, the Department of Health and Human Services (HHS) announced that it was rescinding the Richardson Waiver, a policy in place since 1971 which said HHS would provide notice of proposed rulemaking in certain cases where it was not otherwise required to do so by law. This announcement signals a policy shift for the agency and suggests that where permitted by law, HHS will generally now issue rules relating to “agency management or personnel or to public property, loans, grants, benefits, or contracts” without providing notice and comment to stakeholders, and may otherwise find good cause to forego notice and comment procedures.

Background

Under the Administrative Procedure Act (APA), federal agencies are required to provide notice and opportunity for comment on proposed rules, subject to certain exemptions, including for matters “relating to agency management or personnel, or to public property, loans, grants, benefits, or contracts,” and when the agency finds “good cause” that notice and public procedures are “impracticable, unnecessary, or contrary to public interest.”

In 1971, Elliot Richardson, then the Secretary of Health, Education, and Welfare waived some applicability of these exemptions, issuing a statement of policy stating that the Department and its agencies would follow APA notice and comment procedures on matters relating to public property, loans, grants, benefits, or contracts. Further, the statement of policy said that the good cause exemption in the APA “should be used sparingly.” The policy has remained in place since it was first issued.

Under the announcement of February 28, Secretary of HHS Robert F. Kennedy, Jr. said the Richardson Waiver is rescinded “effective immediately”, and matters relating to public property, loans, grants, benefits, or contracts are exempt from notice and comment procedures. Further, claiming that the direction to use the good cause exemption sparingly was “contrary to the clear text of the APA,” and “impose[s] costs on the Department and the public,” Secretary Kennedy said that the good cause exemption “should be used in appropriate circumstances.” The announcement does not elaborate on what the Department determines would be an “appropriate circumstance.” The statement also notes individual agencies and offices within HHS would have discretion to provide notice and comment procedures, but would not be required to do so except where required by law and the Department would follow the APA when required by the statutory text of the law.

Context and Analysis

Secretary Kennedy’s policy announcement makes clear that the agency will provide notice and opportunity for comment less frequently than stakeholders may have become accustomed to under the policy in place for the past 54 years. This will inevitably allow the agency to issue new rules and policies concerning grants and contracts more quickly, with little to no stakeholder input and transparency.

The policy announcement comes after the Trump Administration previously announced a freeze of all federal grants. Despite court orders to resume grantmaking, public reports indicate that grants at the National Institutes of Health (NIH) were delayed after HHS has prohibited the agency from providing public notice of grant review meetings in the Federal Register, a necessary step for awarding grants.

Although this new announcement indicates that the agency will follow the strictures of the APA, in practical terms, the ramifications of this announcement could be significant. Regarding the delay of NIH grants noted above, for example, a move toward issuance of rulemaking that would further restrict or reduce new NIH grantmaking without an opportunity for notice and a comment period will likely hinder the ability of affected stakeholders to become aware of the measures in a timely manner and may limit opportunity for input in the policymaking process. 

Crowell attorneys are monitoring ongoing policy developments at the Department of Health and Human Services, including changes to federal grantmaking. They are available to assist clients in developing appropriate legal and government affairs strategies to address concerns and take advantage of opportunities.

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Photo of Linda Malek Linda Malek

Linda Malek is a partner in Crowell’s Health Care and Privacy & Cybersecurity Groups, where she advises a broad array of health care and life sciences clients on compliance with federal, state, and international law governing clinical research, data privacy, cybersecurity, and fraud

Linda Malek is a partner in Crowell’s Health Care and Privacy & Cybersecurity Groups, where she advises a broad array of health care and life sciences clients on compliance with federal, state, and international law governing clinical research, data privacy, cybersecurity, and fraud and abuse. Her clients include national hospitals systems and academic medical centers, genetic and biotechnology companies, pharmaceutical companies, medical device companies, financial institutions involved in healthcare services, research foundations and international scientific organizations.

In the healthcare context, Linda is particularly focused on regulatory compliance issues related to clinical research and clinical trials. She creates and implements comprehensive policies governing the conduct of research involving human subjects, and advises clients on human subject research compliance issues. Linda also counsels on legal issues related to conducting secondary research on existing data repositories and tissue banks, including on data privacy and informed consent issues related to the ability to conduct future research. She has experience advising clients on a wide variety of research areas, including biologics, pharmacogenomics, translational research, secondary research, tissue banking, and data repositories. Linda also advises clients in general health care matters related to fraud and abuse, including issues under the Stark laws and federal and state anti-kickback statutes. Her work includes structuring complex transactions in compliance with such laws, assisting in the creation of internal compliance programs, and advising on issues related to the False Claims Act.

Photo of Jason Johnson Jason Johnson

Jason Johnson is a partner in Crowell’s Health Care and Privacy & Cybersecurity Groups, where he draws on his experience as a former research scientist to advise clients on complex compliance, legal, regulatory, and transactional matters. He helps clients in the health care

Jason Johnson is a partner in Crowell’s Health Care and Privacy & Cybersecurity Groups, where he draws on his experience as a former research scientist to advise clients on complex compliance, legal, regulatory, and transactional matters. He helps clients in the health care and life sciences industries navigate data privacy and cybersecurity issues under U.S. and European law. He also offers strategic insights to assist clients with product development, marketing, clinical research, and other core business initiatives.

Jason is well-versed on even the most complicated regulatory challenges that his clients face. As a former research scientist in academic and pharmaceutical settings, as well as a clinical research monitor who trained physicians, Jason knows the rules firsthand. He employs this knowledge to assist clients with the full range of issues that arise in the research and development process, including drafting and negotiating research, clinical trial, licensing, and manufacturing agreements; intellectual property and technology transfer issues; collection, transfer and sharing of data, including patient registries and bio-repositories; and advising clients on mergers and acquisitions and related transactions. Jason’s clients in this area include academic medical centers, healthcare technology companies, emerging to late stage biotechnology companies, pharmaceutical and medical device companies, and other health care and research organizations.

Photo of Stephen Holland Stephen Holland

Stephen Holland is a senior counsel in Crowell & Moring’s Government Affairs Group, where he leverages his extensive experience advising members of Congress and their staff as a policy advisor and attorney active in health care legislation. Stephen has been responsible for crafting

Stephen Holland is a senior counsel in Crowell & Moring’s Government Affairs Group, where he leverages his extensive experience advising members of Congress and their staff as a policy advisor and attorney active in health care legislation. Stephen has been responsible for crafting dozens of provisions in law to improve food, drug, and medical device innovation and regulation at the Food and Drug Administration (FDA), health coverage and access, public health communication and coordination, prescription drug affordability, and emergency preparedness and response.

Prior to joining Crowell, Stephen served in senior policy roles in the U.S. House of Representatives for over 10 years. Most recently, Stephen spent five years on the Energy and Commerce Committee staff under the leadership of Ranking Member and former Chairman Frank Pallone of New Jersey.  On the Committee staff, he was responsible for legislative action related to numerous agencies and programs, including the FDA, the Biomedical Advanced Research and Development Authority (BARDA), and the 340B drug program. Notably, his work on the Committee included leading negotiations and drafting of the Food and Drug Omnibus Reform Act of 2022 (FDORA), a package of more than 50 policies to expand research, development, and innovation for drugs, medical devices, and personal care products. During the COVID-19 response, Stephen worked to secure billions of dollars for research, development, distribution, and promotion of vaccines, treatment, and diagnostic tests in the CARES Act, the Fiscal Year 2021 Omnibus, and the American Rescue Plan Act.