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Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Rules and Regulations
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President delegated FEMA 4 the authority to exercise section 101 of the DPA with respect to health and medical resources needed to respond to the spread of COVID19 within the United States. The EMPAS regulation defines health and medical resources as drugs, biological products, medical devices, materials, facilities, health supplies, services, and equipment required to diagnose, mitigate, prevent the impairment of, improve, treat, cure, or restore the physical or mental health conditions of the population. This definition mirrors the definition of health resources established by the Department of Health and Human Services HHS in their Health Resources Priority and Allocations System HRPAS regulation 5 to ensure consistency across agencies delegated authority by the President to utilize these resources to respond to the COVID19 pandemic. Vaccines, which are defined as biological products under section 351i of the Public Health Service Act 42 U.S.C. 262i, are considered a health and medical resource and thus would fall within the scope of the HRPAS and EMPAS
regulations, including any materials associated with vaccines, including glass vials and other packaging.6
Similarly, distribution systems and medical facilities for vaccine distribution also constitute health and medical resources under EMPAS.7
Given the need for consistency across agencies to ensure a unified response in combating this pandemic and avoid any confusion in implementation, FEMA is retaining the definition of health and medical resources from the interim final rule and believes the definition provides sufficient clarity regarding the resources covered by the rule.
The same commenter pointed out that, while FEMA already possesses subdelegated authority to use both the Department of Commerces Defense Priority and Allocations System DPAS
and the Department of Agricultures 4 See Executive Order 13911, 85 FR 18403 Apr.
1, 2020, DHS Delegation 09052 Rev. 00 Delegation of Defense Production Act Authority to the Administrator of the Federal Emergency Management Agency Jan. 3, 2017, and DHS
Delegation 09052 Rev. 00.1, Delegation of Defense Production Act Authority to the Administrator of the Federal Emergency Management Agency Apr.
1, 2020.
5 See 45 CFR 101.20.
6 HHS has long held resource authority for health resources. See Executive Order 13603, 77 FR 16651
Mar. 22, 2012 and more recently Executive Order 13909, 85 FR 16227 Mar. 23, 2020. While Executive Order 13911 delegated the same authorities to DHS, HHSs extensive expertise in this area would be required for any vaccine development-related efforts.
7 See 44 CFR 333.8. See also 45 CFR 101.20.

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Agriculture Priority and Allocations System APAS regulations, having the EMPAS regulations should enhance predictability. The commenter noted the EMPAS regulations were generally patterned after other Federal Priority and Allocations System FPAS
regulations, with some exceptions. For example, the EMPAS regulations discuss rated orders placed by FEMA or a Delegate Agency to facilitate sales to third parties. The commenter noted this distinction could refer to contracts placed in support of hospitals or other health entities or serve as a more general reference to the overarching distributorstyle role FEMA and other Federal entities have played during the COVID
19 pandemic response to date. The distinction could also set up a type of hybrid rated order/allocation action.
FEMA may leverage the EMPAS
regulation to facilitate sales to third parties with respect to contracts placed in support of entities seeking scarce and critical health and medical resources and to assist in the distribution of these resources as appropriate. The agency does not intend to create a hybrid rated order/allocation action.
This commenter urged FEMA to be prepared to exercise EMPAS authority and delegate authority to assure the ability to produce, manufacture, fill, and finish coronavirus vaccines, specifically requesting the regulation make clear that emergency authority includes the ability to pre-manufacture vials and syringes as necessary to provide a large number of vaccine doses. As explained above, although vaccines and associated materials are within the authority delegated by Executive Order 13911, HHS is the agency with expertise in vaccine development and FEMA does not anticipate having a role in that process. FEMA believes the regulation provides sufficient clarity regarding the resource authority delegated by Executive Order 13911 and no changes are required in this final rule.
Another commenter offered suggested improvements to 333.13 regarding timelines for responses to rated order requests. Specifically, the commenter recommended changes to 333.13d2
to allow for responses within 6 or 12
hours after confirmation of receipt by vendor/contractor personnel during normal business hours. FEMA
appreciates that the proposed change would allow vendors and contractors more time to handle rated order requests consistent with their normal business practices, but rated orders are designated as such specifically because of the need to handle them differently than ordinary orders. The language in 333.13d2 mirrors the existing
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Department of Commerce DPAS
regulations at 15 CFR 700.13d2. As explained in the preamble to the interim final rule, FEMA adopted language consistent with the DPAS regulation because rated orders placed for the purpose of emergency preparedness would require a shorter timeframe to ensure delivery in time to provide disaster assistance, emergency response, or similar activities. Further, the timeframes given in 333.13d2 are the minimum allowed and only apply when expedited action is necessary or appropriate. As such, FEMA does not expect 6- or 12-hour response deadlines to be used frequently, and therefore does not expect the regulatory provision to impose a substantial burden on vendors and contractors. To ensure consistency across FPAS regulations, and because of the nature of FEMAs mission, FEMA is retaining the language from the interim final rule in the final rule. Additionally, the commenter suggested the use of the term immediately in 333.13d3 and elsewhere could not be realistically defined. The commenter recommended alternative language, such as, as soon as reasonably practicable or promptly with commercially reasonable efforts.
Again, the language in EMPAS is consistent with the Department of Commerces DPAS regulations, where this provision has been in use since 2014. Given the exigent circumstances under which FEMA must provide emergency preparedness, mitigation, response, and recovery services, the requirement for immediate notification is necessary to ensure the ultimate timely delivery of these services. In addition, FEMA does not believe that the alternative terms provide a significantly more definite meaning.
Therefore, FEMA is retaining the language from the interim final rule to ensure consistency across FPAS
regulations.
Two commenters focused their comments exclusively on vaccines, a topic not directly addressed by EMPAS.
One commenter requested an ethically produced vaccine that is not developed from aborted fetal cells. The EMPAS
regulation does not discuss vaccine development. As explained above, FEMAs EMPAS regulation is limited to establishing standards and procedures for priority and allocation orders for health and medical resources as defined in the interim final rule at 333.8. Although vaccines fall within the scope of health and medical resources authority delegated to HHS
and to FEMA, FEMA has not played a substantial role in the development of
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