CDC Chief Regulatory Officer Noah Aleshire explains the value of a collaborative and informed regulatory process.
In a conversation with The Regulatory Review, Noah Aleshire, Chief Regulatory Officer at the U.S. Centers for Disease Control and Prevention (CDC), shares his perspective on CDC’s regulatory work, focusing on collaboration between agency branches, the agency itself, and the public.
The CDC, a division of the Department of Health and Human Services, has developed guidelines over the past few years in response to the COVID-19 pandemic and has recently attracted public attention for its rules regarding the importation of dogs and cats into the United States.
Alesher said CDC regulations should be shaped by efforts to improve available public health data, exemplified recently by the agency's data modernization initiative. Alesher also spoke about the importance of interagency collaboration and the value of a regulatory process in which agencies “lay their cards on the table.”
As the national public health agency's chief regulatory officer, Aleshire works to shape CDC's rulemaking initiatives. Aleshire has worked at CDC for 14 years and previously worked as a policy analyst at the agency.
A graduate of the University of San Diego School of Law and a recipient of the James D'Angelo Outstanding Children's Advocate Award, Ms. Aleshire began her legal career as a Presidential Management Fellow at the CDC.
Regulatory Review is pleased to share the following interview with Noah Aleshire.
Regulatory Review: What is your role at CDC?
I am CDC's Chief Regulatory Officer and lead the Regulatory Affairs unit in the CDC Office of the Director. My team and I work with regulatory programs across the agency to support rulemaking, helping develop effective rules, navigate the approval and review process, and build CDC's regulatory strategy. Our office is also responsible for CDC's interagency regulatory review, helping our sister agencies incorporate a public health perspective into the rules they issue. This unit is relatively new and is one of many organizational reforms CDC has made in the wake of the COVID-19 public health emergency.
TRR: The CDC has been very active in the public health response to COVID-19 and also recently issued rules regulating the entry of dogs and cats into the U.S. What are your thoughts on the scope of CDC’s rulemaking authority and agenda?
CDC has several different regulatory agencies. We work with the USDA Animal and Plant Health Inspection Service to administer the Federal Specific Pathogens Program, which regulates the possession, use, and transfer of biological weapons, such as Ebola and anthrax, and toxins that may pose a threat to the public. Our National Institute for Occupational Safety and Health has occupational safety regulations, including approval of respirators such as the N-95.
We also have rules in place to prevent the introduction or spread of communicable diseases into the United States, such as the quarantine rules, the set of rules issued during the COVID-19 emergency, and the dog importation rules that you mentioned, which are intended to reduce the risk of rabies being brought into the U.S. CDC has also partnered with the Centers for Medicare and Medicaid Services to jointly issue rules on laboratory requirements under the Clinical Laboratory Improvement Amendments of 1988.
These are diverse areas of rulemaking, but they are united by a common theme: protecting people from health and disease threats and mitigating their impacts.
TRR: How is your work on developing regulations informed by public health data?
Everyone at the CDC is eventually told the story of John Snow, the 19th century physician who mapped the distribution of cholera cases in London and traced it back to a single water pump. He persuaded the local council to shut down the pump, and the outbreak ended. This is a classic example of data driving regulation. But the question is not just that data drives regulation: how can regulation get better data?
CDC is undertaking a major data modernization initiative to strengthen the nation's data infrastructure, and regulations play a key role. CDC is working closely with HHS's Office of the National Coordinator for Health Information Technology to help build seamless connections between health information technology and public health data systems. This collaboration is an example of how inter-agency relationships can drive better data for public health agencies and drive policies that reduce burdens on health care providers.
TRR: How does the work that you and your colleagues do relate to and collaborate with other parts of the Department of Health and Human Services (HHS) and other federal agencies in the regulatory process?
While CDC is the nation's public health agency, the health of the American people is a whole-of-government effort, with countless agencies making health part of their responsibilities. An early focus of CDC's Regulatory Affairs unit is to strengthen these interagency relationships and provide them with effective, useful feedback and partnerships. A core premise of good rulemaking is to free agencies from silos and echo chambers and incorporate diverse voices to make rules thoughtful and more effective. We hope that strong, long-lasting interagency relationships will make our rules, and those of other agencies, more effective in addressing the range of health threats facing the public.
TRR: What changes have there been in CDC’s approach to regulatory decision-making in recent years?
An important change is not just in regulations, but in how CDC thinks about policy overall. Public health guidance has rapidly become more complex, and the COVID-19 emergency has led to a concerted effort at CDC to strengthen our processes for effectively translating science into actionable, easy-to-understand policy. This mission has impacted every part of our policy work, most directly leading to the establishment of a Regulatory Affairs Unit in the Office of the Director. The unit will serve as a hub for regulatory affairs and strategy, bringing a big-picture perspective to regulatory goals and providing partnership and support to regulatory functions across CDC.
TRR: How does public trust impact CDC’s work, particularly the agency’s regulatory work? What is the importance of public engagement in the regulatory process?
From day one, CDC Director Mandy Cohen has emphasized the need to prioritize building and rebuilding public trust in CDC and public health agencies. Since taking on this role, I've noticed that when we talk about how to build trust, it's very similar to what regulators do every day: engaging with the public and outside groups, detailing policy arguments, laying out the costs and shortcomings of the agency's approach, presenting data, considering alternatives, and acknowledging uncertainty. While most of CDC's work is not regulatory, I think we can learn a lot about building strong, clear, evidence-based policy by examining the regulatory process and how it forces agencies to speak up and engage directly with the public.
