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Federal Register / Vol. 86, No. 54 / Tuesday, March 23, 2021 / Rules and Regulations effective date of this final rule is consistent with the intent of the Regulatory Freeze Pending Review memorandum.
2. Delay Implementation Based on Health Centers Role in National COVID19 Vaccination Campaign Approximately 169 commenters suggested that the impact of implementing the Implementation of Executive Order on Access to Affordable Life-Saving Medications rule on health centers efforts to vaccinate hard-toreach populations against COVID19
should be considered as a new issue of fact, law, and policy, necessitating a further delay. These commenters noted that since the rule was initially delayed in January, health centers have been requested to perform a critical role in the national efforts to vaccinate hard-toreach populations. Commenters stated that, in taking on this responsibility, health centers staff and resources are being stretched to unprecedented levels, making the administrative and financial burden of implementing the rule even more challenging.
Response: HHS agrees that health centers need to focus efforts on expeditiously vaccinating their patient populations against COVID19, including as part of the Health Center COVID19 Vaccine Program, is a factor that supports a further delay in the effective date of the Implementation of Executive Order on Access to Affordable Life-saving Medications rule. Health centers across the nation are engaging in mitigating and otherwise responding to the effects of COVID19, and many health centers are participating in the Health Center COVID19 Vaccine Program, to ensure the nations underserved communities and those disproportionately affected by COVID
19 are equitably vaccinated against COVID19. In addition, under the American Rescue Plan Act of 2021 Pub.
L. 1172, HHS will soon be issuing additional funds for health centers to increase efforts to plan, prepare for, promote, distribute, administer, and track COVID19 vaccines and to carry out a range of activities to further support detecting, diagnosing, tracing, and monitoring of COVID19 infections necessary to mitigate the spread of COVID19.
3. Delay Implementation Due to Administrative Procedure Act Concerns One commenter urged HHS to rescind the rule implementing Executive Order 13937 or delay implementation until the rule could be adequately considered and substantive shortcomings under the Administrative Procedure Act APA

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addressed. This commenter further noted that neither a rational basis nor legal authority was offered to target health centers for differential treatment nor to establish different policies for insulin and injectable epinephrine. In addition, the commenter expressed concern that the Implementation of Executive Order on Access to Affordable Life-saving Medications rule neither provided a rational basis for implementation of the new policy, nor addressed comments concerning the complexity and administrative challenges of implementation.
Response: HHS appreciates the commenters support for delaying the effective date of the rule. During the period of additional delay, HHS will consider whether potential APA issues were raised by the promulgation of the Implementation of Executive Order on Access to Affordable Life-saving Medications rule. HHS plans to use the delay period to review and consider all questions of fact, law, and policy.
4. Delay Implementation for Duration of COVID19 Public Health Emergency One commenter requested HHS
consider delaying the effective date of the Implementation of Executive Order on Access to Affordable Life-saving Medications rule for the duration of the COVID19 public health emergency.
Response: HHS appreciates the commenters support for delaying the effective date of the rule. This final rule will delay the effective date of the Implementation of Executive Order on Access to Affordable Life-saving Medications rule for 120 days, until July 20, 2021. HHS plans to use the delay period to review and consider all questions of fact, law, and policy that would be presented by implementation of the Implementation of Executive Order on Access to Affordable Lifesaving Medications rule, including the ongoing COVID19 public health emergency. As the NPRM for this delay specified the new effective date of July 20, 2021, and as the duration of the COVID19 public health emergency is currently unknown, HHS declines at this time to change the period of delay to extend through the duration of the COVID19 public health emergency.
5. Delay To Allow Health Centers Time To Come Into Compliance With the Regulation One commenter, a patient with Type 1 diabetes who supported the underlying rule, requested HHS delay the effective date of the rule to allow health centers time and resources to come into compliance with the Implementation of Executive Order on
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Access to Affordable Life-saving Medications rule. The commenter also stated that implementing the new rule will take substantial time and resources for health centers who are currently playing a critical role leading the national COVID19 vaccination campaign.
Response: HHS appreciates the commenters support for delaying the effective date of the rule. HHS agrees that health centers need to continue to focus efforts on the critical work of responding to the COVID19 public health emergency while continuing to provide essential comprehensive primary care to medically underserved communities. HHS will continue during the delay period to further consider and review questions of fact, law, and policy that impact the implementation of the final rule.
6. Opposition to Proposed Delay Three commenters opposed further delaying the effective date of the rule.
Two of the three commenters opposed to delaying the effective date of the rule, including the family member of a patient with diabetes, cited the importance of insulin to patients with Type 1 diabetes. One of the three commenters opposed to delaying the effective date, supported implementation of the Implementation of Executive Order on Access to Affordable Life-saving Medications rule because access to affordable insulin is a top priority that can help those with Type 1 diabetes avoid emergency room visits, inpatient admissions, other complications, and save lives. The commenter cited the cost of insulin as a substantial economic burden for those living with Type 1 diabetes, and stated that the Implementation of Executive Order on Access to Affordable Lifesaving Medications rule will benefit certain health center patients between 200% and 350% of the Federal Poverty Guidelines by helping them afford the insulin they need to survive. The commenter also encouraged HHS to limit any administrative burden to health centers subject to the Implementation of Executive Order on Access to Affordable Life-saving Medications rule. Another of the three commenters, a patient of a health center, expressed concern that further delaying of the effective date would keep muchneeded pharmaceuticals out of the hands of certain patients, especially those with disabilities.
Response: HHS appreciates the commenters opposition to delaying the effective date of the rule, as well as the concern about limiting administrative burden to health centers associated with
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