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Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules Inspector General, and the Comptroller General of the United States, or any of their authorized representatives, must have the right of access to any documents, papers, or other records of the non-Federal entity that is, the recipient of HHS funds which are pertinent to the Federal award, in order to make audits, examinations, excerpts, and transcriptsincluding timely and reasonable access to personnel for the purpose of interview and discussion related to such documents. 45 CFR 75.364; see also 2
CFR 200.337 OMB uniform administrative requirements. HHS
proposes to add a paragraph a1, which would specifically require that non-Federal entities that engage in human fetal tissue research pursuant to a Federal award provide the HHS
awarding agency, the Inspector General, the Comptroller General of the United States, and the pass-through entity or any of their authorized representatives, with a right of access to 1 all informed consent forms obtained by the nonFederal entity for human fetal tissue research, which may be redacted with respect to the name and signature of the woman for privacy purposes; 2 all documents, papers, or other records as are necessary to establish that the human fetal tissue was not obtained or transferred for valuable consideration;
3 all documents, papers, or other records as are necessary to establish that federal funds were not used to acquire or otherwise obtain the human fetal tissue from elective abortions; and 4
personnel familiar with the foregoing documents, for purposes of interview and discussion related to such documents.
Paragraph a1 would impose little, if any, additional burdens or costs. 45
CFR 75.364a already requires that the HHS awarding agency, inspectors general, the Comptroller General, and any of their authorized representatives have the right of access to any documents, papers, or other records of the non-Federal entity which are pertinent to the Federal award, in order to make audits, examinations, excerpts, and transcripts. Paragraph a1 would simply provide clarity to recipients involved in human fetal tissue research by specifying certain categories of the documents, papers, and records and personnel for which a right of access must be provided. Because of the unique context and serious regulatory, ethical, and moral considerations involved in human fetal tissue research, HHS believes it would be beneficial to specifically remind this subset of recipients in advance of the documents,
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papers, and records and personnel for which HHS has a right of access.
Moreover, a 2016 House of Representatives committee report found that certain institutional review boards lacked records regarding their oversight of fetal tissue research and transplantation, and the committee was unable to obtain access to records that could determine whether fetal tissue was obtained for valuable consideration.48 Because of the uncertainty over whether required documents are being maintained, HHS
proposes to reiterate that recipients must maintain required documents and provide the HHS awarding agency, among others, with access to such documents and personnel upon request.
Paragraph a1 would therefore also strengthen program integrity.
By its statutory enactments, Congress has expressed that members of the public should proceed carefully when their actions involve human fetal tissue and that valuable consideration should not be provided in order to acquire human fetal tissue. HHS proposes, below, that federal funds not be used to acquire human fetal tissue from elective abortions; HHS believes that it is particularly important to be good stewards of federal funds in this context. Given the aforementioned concerns, HHS believes that recipients should be able to document that valuable consideration was not provided to acquire human fetal tissue and that federal funds were not used to acquire human fetal tissue from elective abortions.
HHS also proposes to add a paragraph d, which would provide that, for purposes of 75.364, human fetal tissue shall have the definition ascribed to it in 49 U.S.C. 289g1.
Paragraph e would clarify for recipients what is meant by human fetal tissue, and would define that term in a way that conforms to the definition provided by Congress. As with the proposed definition of human fetal tissue for purposes of Subpart B of 45
CFR part 46, HHS believes that this proposed definition is consistent with the definition adopted in the NIH notice for purpose of implementing the enhanced review requirements.
Similarly, HHS contemplates adopting the statutory definition with the express clarifications that 1 human fetal tissue includes human fetal primary tissue, cells from such tissue, and primary cell cultures; derivative products including 48 See, e.g., Final Report of the Select Investigative Panel of the Energy & Commerce Committee Dec. 30, 2016, at xxi, xxvii, xxviii, xxix, xxxi, xxxviii, 16.

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protein or nucleic acid extracts from such tissues/cells; and any human extraembryonic cells and tissues, such as umbilical cord tissue, cord blood, placenta, amniotic fluid, and chorionic villi; and 2 human fetal tissue does not include established human fetal cell lines including immortalized cell lines, induced pluripotent stem cell lines from human fetal tissue, and differentiated cell lines; human fetal cells present in maternal blood or maternal sources; and secondary use of data from human fetal tissue. HHS seeks comment on whether it would be appropriate to incorporate some or all of the specificity of the definition and/or the exclusions from the definition contained in the NIH
notice; if so, which aspects of that definition and/or the exclusions should be incorporated into the definition for the purpose of this proposed rule; and if the contemplated express clarifications noted immediately above strike the right balance.
E. Expenses Associated With Acquiring Certain Human Fetal Tissue for Research, 75.478
In its grants regulation in 45 CFR part 75, HHS addresses certain select items of costs and identifies certain costs that are or are not allowable under HHSs funding awards.49 HHS proposes to add 75.478. Section 75.478 would provide that expenses associated with the acquisition of human fetal tissue from elective abortions for use in research are not allowable expenses under Federal awards from an HHS awarding agency.
As a result of the comprehensive review that HHS undertook and in light of the serious regulatory, moral, and ethical considerations involved, HHS has concluded that such costs should not be allowablethat is, they are not expenses that should be borne by the taxpayer through the federal research award. HHS would continue to fund research involving such human fetal tissue, consistent with the June 5, 2019
policy,50 but it proposes that funds from HHS research awards could not be used for the acquisition of human fetal tissue from elective abortions. HHS encourages the recipients of HHS awards for research involving human fetal tissue from elective abortions to obtain human fetal tissue by donation or no-cost material transfer agreement.
49 See, e.g., 45 CFR 75.42075.475 general provisions for selected items of cost, 75.47675.477
HHS selected items of cost.
50 See Statement from the Department of Health and Human Services, June 5, 2019, available at https www.hhs.gov/about/news/2019/06/05/
statement-from-the-department-of-health-andhuman-services.html.

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