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Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules preclude the inclusion of any expenses associated with the acquisition of human fetal tissue from elective abortion in allowable costs that could be charged against HHS award funds. The proposed limitation on the sources of human fetal tissue from abortion should not have any impact on the costs associated with the acquisition of such tissue because the statutory bar on the provision of valuable consideration in connection with the transfer of human fetal tissue provides a statutory limit on the ability of tissue procurement organizations and other organizations to seek to take advantage of such a regulatory limitation to exact higher consideration. To the extent that recipients currently incur permissible costs associated with the acquisition of human fetal tissue from elective abortions, HHS acknowledges that the proposal to exclude human fetal tissue from elective abortion from allowable costs under HHS research grants, cooperative agreements, and R&D
contracts would effect a transfer of costs from HHS through its awards to the recipients of such research awards. Prior to NIHs July 2019 notice, recipients had not been required to separately identify or account for such expenditures of award funds, so HHS and NIH do not have complete data on the expenses incurred by awardees with respect to the acquisition of human fetal tissue from elective abortions. Accordingly, HHS uses the costs incurred by intramural NIH researchers to acquire human fetal tissue from elective abortions as a proxy. During the HHS
review and audit, it reviewed NIH
documentation with respect to intramural research involving human fetal tissue and the expenditures made to acquire such tissue in fiscal year FY
2018; NIH also provided information concerning intramural projects involving human fetal tissue, and the expenditures made with respect to them, in FY 2015. In FY 2015, intramural researchers incurred a total of $26,915 in the acquisition of such tissue across 14 research projects, for an average expenditure of $1,922.50 per project. And in FY 2018, intramural researchers incurred a total of approximately $55,195 to acquire human fetal tissue across approximately 12 research projects, for an average expenditure of $4,599.58 per project.
Across the two fiscal years, the average annual expenditure for fetal tissue per project was, thus, $3,261.04. Assuming that award recipients needed to acquire human fetal tissue for each project each yearan assumption that would tend to
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overestimate costs 57this would suggest transfer costs of $3,261.04 per project per year, for a total annual cost of $431,761.70 and an average annual cost per unique recipient of $5,397.02
132.4 projects $3,261.04 cost per project per year/80 unique recipients.58
Except for the potential costs of the separate informed consent process and the acquisition of human fetal tissue from elective abortions, these costs would be one-time costs that would be experienced in the first year of implementation. Accordingly, if all recipients that receive HHS funds for research involved human fetal tissue were to implement the proposed requirements,59 HHS estimates that these proposed requirements if finalized as proposed would impose first year costs including both one-time costs and annual cost of the informed consent process and the acquisition of fetal tissue totaling between $484,074.07
and $490,621.60, with cost per unique recipient of between $6,050.92 and $6,132.77. Thereafter, there would be total annual costs undiscounted of $444,936.47 to $451,484 and $5,561.70
to $5,643.55 per unique recipient again, undiscounted.60
57 It is likely that researchers do not need to obtain human fetal tissue for their HHS-funded research projects annually. In addition, it is likely that some researchers and projects obtained such tissue through no-cost material transfer agreements.
However, since HHS lacks knowledge as to how often funded research projects would need to obtain such tissue or how much would need to be expended to acquire such tissueand the frequency and expense could vary from project to projectfor purposes of the analysis of the regulatory impact of this proposed rule, HHS will assume that each project has to acquire human fetal tissue from abortion on an annual basis.
58 If only new research projects need to acquire fetal tissue from elective abortions, this would suggest total transfer costs of $92,613.54 per year, and an average annual cost per unique recipient of $1,157.67 28.4 projects $3,261.04 cost per project per year/80 unique recipients.
HHS notes that in FYs 2015 and 2018, the largest expenditure by an intramural research project for fetal tissue was $21,400 and $25,785, respectively, for an average of $23,592.50. Even if this number is used as the proxy for the annual expense that the recipient of an award for research involving human fetal tissue might incur to acquire such tissueand it is assumed that every research project would incur such expenditures each yearthis only results in a total annual expenditure of $3,123,647
$23,592.50 132.4 projects, and an average annual cost per unique recipient of $39,045.59 132.4
projects $23,592.50/80 unique recipients.
59 If recipients have already acquired all of the human fetal tissue needed for the funded research which could be the case especially for those organizations that have received grant renewals, revisions, extensions, or continuationsthey may conclude that they do not need to undertake any action associated with some of the proposed requirements. This would reduce the costs that such recipients would incur to implement any final rule resulting from this proposed rule.
60 If the average of the highest annual intramural expenditures for fetal tissue is used to calculate the
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Executive Order 13771
The White House issued Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs on January 30, 2017. Section 2a of Executive Order 13771 requires an agency, unless prohibited by law, to identify at least two existing regulations to be repealed when the agency publicly proposes for notice and comment or otherwise promulgates a new regulation.
In furtherance of this requirement, section 2c of Executive Order 13771
requires that the new incremental costs associated with new regulations shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations. This rule, while significant under Executive Order 12866, will impose de minimis costs and, therefore, is not anticipated to be a regulatory or deregulatory action under Executive Order 13771. HHSs human subjects protection regulations permit HHSfunded or conducted research involving human fetal tissue to be conducted only in accord with any applicable Federal, State, or local laws and regulations regarding such activities. Current federal law and regulations require informed consent for human fetal tissue transplantation research and research with human fetal tissue with associated information that can identify a human being. In addition, most states require informed consent for the use of fetal tissue in researchand NIH has indicated that it expects informed consent to have been obtained from the donor for any NIH-funded research using human fetal tissue. As a result, HHS expects that HHS recipients conducting such research would incur only de minimis costs to become familiar with the regulation, to update their informed consent forms to include the specific statements proposed in this proposed rule, to obtain the necessary informed consents, to properly dispose of human fetal tissue, and to update their grants policies and procedures or compliance manuals. Federal law already prohibits the transfer of human fetal tissue for valuable consideration, and federal regulation gives HHS the right of access to any documents, papers, or other records of Department recipients which are pertinent to the annual expenditure to acquire fetal tissue, the total first year costs including both one-time and annual costs of fetal tissue acquisition would range from $3,175,959.37 to $3,182,506.90, with total first year costs per unique recipient ranging between $39,699.49 and $39,781.65 Thereafter, total annual costs undiscounted would total $3,136,821.77 to $3,143,369.30, with annual costs undiscounted of $39,210.27 to $39,292.12 per unique recipient.

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