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DEPARTMENT OF EDUCATION ‘‘January 20, 2021’’ to read ‘‘January 21, not sufficiently assured that the contract 2021.’’ included the appropriate protections 34 CFR Part 300 [FR Doc. C1–2020–28117 Filed 1–12–21; 8:45 am] applicable to fetal tissue research or met all other procurement requirements. [Docket ID ED–2020–OSERS–0191] BILLING CODE 1301–00–D HHS subsequently initiated a Proposed Guidance; Questions and comprehensive review of all HHS Answers on Serving Children With DEPARTMENT OF HEALTH AND research involving human fetal tissue Disabilities Placed by Their Parents in HUMAN SERVICES from elective abortions to ensure Private Schools consistency with the statutes and Office of the Secretary regulations governing such research and Correction to ensure the adequacy of procedures In proposed rule document 2020– 45 CFR Parts 46 and 75 and oversight in light of the serious regulatory, moral, and ethical 27872 appearing on pages 82994–82995 RIN 0991–AC15 in the issue of Monday, December 21, considerations involved. 2020, make the following correction: Establishment of Safeguards and Promoting the dignity of human life (1) On page 82994, in the third Program Integrity Requirements for from conception to natural death is one column, in the DATES section, change Health and Human Services-Funded of the top priorities of President ‘‘January 20, 2021’’ to read ‘‘January 21, Extramural Research Involving Human Trump’s administration. The audit and 2021.’’ Fetal Tissue review informed the policy process that led to the administration’s decision, [FR Doc. C1–2020–27872 Filed 1–12–21; 8:45 am] AGENCY: Office of the Secretary, announced June 5, 2019,1 to discontinue BILLING CODE 1301–00–D Department of Health and Human National Institutes of Health (NIH) Services. intramural research—research ACTION: Notice of proposed rulemaking. conducted within NIH by NIH ENVIRONMENTAL PROTECTION researchers—involving the use of AGENCY SUMMARY: This is a notice of proposed human fetal tissue from elective rulemaking to amend certain regulatory abortion. With respect to extramural 40 CFR Part 52 provisions in order to adopt or research (research conducted outside of, [EPA–R07–OAR–2020–0620; FRL–10017– strengthen safeguards and program but funded by, NIH, e.g., at universities), 81–Region 7] integrity requirements applicable to the administration announced that, for extramural research involving human new extramural research grant Air Plan Approval; Missouri; Removal fetal tissue from elective abortions. applications or current research projects of Control of Emissions From Solvent DATES: Comments must be submitted on in the competitive renewal process Cleanup Operations or before February 12, 2021. (generally every five years) that propose to use fetal tissue from elective Correction ADDRESSES: Comments must be identified by RIN 0991–AC15. Because abortions and that are recommended for In proposed rule document 2020– of staff and resource limitations, potential funding through NIH’s two- 28121 appearing on pages 82995 comments must be submitted level external scientific review process, through 82998 in the issue of Monday, electronically to www.regulations.gov. an ethics advisory board will be December 21, 2020, make the following Follow the ‘‘Submit a comment’’ convened to review the research correction: instructions. proposal and recommend whether, in (1) On page 82995, in the second Inspection of Public Comments: All light of the ethical considerations, NIH column, in the DATES section, change comments received before the close of should fund the research project— ‘‘January 20, 2021’’ to read ‘‘January 21, the comment period are available for pursuant to a law passed by Congress 2021.’’ viewing by the public, including (42 U.S.C 289a–1). [FR Doc. C1–2020–28121 Filed 1–12–21; 8:45 am] personally identifiable or confidential In the same policy statement, HHS BILLING CODE 1301–00–D business information that is included in announced that it would also undertake a comment. Before or after the close of changes to its regulations and to NIH the comment period, the Department of grants policy to adopt or strengthen ENVIRONMENTAL PROTECTION Health and Human Services will post all safeguards and program integrity AGENCY comments that were received before the requirements applicable to extramural end of the comment period on research involving human fetal tissue 40 CFR Part 180 www.regulations.gov. Follow the search from elective abortions.2 In this notice [EPA–HQ–OPP–2020–0053; FRL–10016–93] instructions on that website to view the of proposed rulemaking, HHS proposes public comments. revisions to its Human Research Receipt of Several Pesticide Petitions FOR FURTHER INFORMATION CONTACT: Subjects Protection Regulations (45 CFR Filed for Residues of Pesticide Daniel Barry at [email protected]. part 46, subpart B, Additional Chemicals in or on Various SUPPLEMENTARY INFORMATION: Protections for Pregnant Women, Commodities (October 2020) Human Fetuses, and Neonates) and its I. Introduction Correction In September 2018, the Department of 1 See Statement from the Department of Health and Human Services, June 5, 2019, available at In proposed rule document 2020– Health and Human Services (HHS) https://www.hhs.gov/about/news/2019/06/05/ 28117 appearing on pages 82998 terminated a contract that provided statement-from-the-department-of-health-and- through 83000 in the issue of Monday, human fetal tissue from elective human-services.html. December 21, 2020, make the following abortions to the Food and Drug 2 See Statement from the Department of Health and Human Services, June 5, 2019, available at correction: Administration (FDA) for the https://www.hhs.gov/about/news/2019/06/05/ (1) On page 82998, in the second development of testing protocols. HHS statement-from-the-department-of-health-and- column, in the DATES section, change terminated the contract because it was human-services.html.

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grants regulations (45 CFR part 75) to research is conducted in accordance Since the Common Rule was first provide additional safeguards with those principles. In 1979, the developed, the landscape of research concerning the use of such tissue in National Commission published activities has changed dramatically, HHS-funded research. This proposed ‘‘Ethical Principles and Guidelines for accompanied by a marked increase in rule would strengthen the Protection of Human Subjects of the volume of research. It is estimated requirements in Subpart B and help Research,’’ also known as the Belmont that total spending on health-related ensure compliance with the statutory Report (http://www.hhs.gov/ohrp/ research and development by the drug ban on the provision of valuable policy/belmont.html). The Belmont industry and the Federal government consideration for human fetal tissue Report identified three fundamental has more than tripled since 1990.5 through clarifying recordkeeping and ethical principles for all human subjects While traditional biomedical research maintenance requirements for the research: , conducted in academic medical centers acquisition of human fetal tissue for , and . Like the continues to flourish, many studies are research. and Helsinki now also conducted at community hospitals, outpatient clinics, or II. Background Declaration, the stressed the importance of obtaining physician-based practices. Clinical U.S. Federal regulations governing the informed consent before engaging in research is regularly conducted at protection of human subjects in research human subjects research. multiple institutions across the U.S. and have been in existence for more than Based on the Belmont Report and other countries. Recruitment firms, three decades. Nearly thirty years have other work of the National Commission, bioinformatics specialists, clinical trial passed since the ‘‘Common Rule’’ was HHS revised and expanded its coordinating centers, protocol adopted by 15 U.S. Federal departments regulations for the protection of human developers, data analysts, contract and agencies in an effort to promote subjects in the late 1970s and early research organizations (CROs), data and uniformity, understanding, and 1980s. The HHS regulations are codified safety monitoring boards, community- compliance with human subject at 45 CFR part 46, subparts A through based organizations, and other entities protections. (HHS adopted the Common E: have joined investigators and sponsors Rule in Subpart A of 45 CFR part 46.) • Subpart A: Basic HHS Policy for as part of the The history of contemporary human Protection of Human Research enterprise. subjects protections began in 1947 with Subjects The rapid growth and expansion of the Nuremberg Code, developed for the • Subpart B: Additional Protections for human subjects research generated Nuremberg Military Tribunal as Pregnant Women, Human Fetuses, many questions about whether the standards by which to judge the human and Neonates Involved in Research regulatory framework is adequate and experimentation conducted by the • Subpart C: Additional Protections appropriate for the protection of human 3 Nazis. The Nuremberg Code set forth Pertaining to Biomedical and subjects in the 21st century. many of the basic principles governing Behavioral Research Involving Furthermore, decades of experience the ethical conduct of human subjects Prisoners as Subjects have revealed a great deal about the research. Similar recommendations • Subpart D: Additional Protections for functioning—and limitations—of were made by the World Medical Children Involved in Research existing regulations, and prompted Association in its Declaration of • Subpart E: Registration of Institutional critical evaluations by the Institute of 67 Helsinki: Recommendations Guiding Review Boards Medicine (IOM), the U.S. Government Accountability Office,8910 and many Medical Doctors in Biomedical Research The statutory authority for the HHS Involving Human Subjects (Helsinki scholars.11 12 13 Federal consideration of regulations derives from 5 U.S.C. 301; such revisions to the regulatory schema, Declaration), first adopted in 1964 and 42 U.S.C. 300v–1(b); and 42 U.S.C. 289. subsequently revised many times.4 Basic regulations governing the In 1991, 14 other Federal departments 5 Congressional Budget Office. Research and protection of human subjects in research and agencies joined HHS in adopting a Development in the Pharmaceutical Industry. October 2006. supported or conducted by HHS (then uniform set of rules for the protection of human subjects, known as the 6 Federman DD, Hanna KE, Rodriguez LL, eds. the Department of Health, Education Responsible Research: A Systems Approach to and Welfare) were first published in ‘‘Common Rule,’’ identical to subpart A Protecting Research Participants. Washington, DC: 1974, after a series of highly publicized of 45 CFR part 46 of the HHS National Academies Press; 2002. research abuses. The enactment of the regulations. 7 Nass SJ, Levit LA, Gostin LO, eds. Beyond the The Common Rule requires that HIPAA Privacy Rule: Enhancing Privacy, Improving 1974 National Research Act (Pub. L. 93– Health Through Research. Washington, DC: 348) created the National Commission Federally funded investigators in most National Academies Press; 2009. for the Protection of Human Subjects of instances obtain and document the 8 Human Subjects Research: HHS Takes Steps to Biomedical and Behavioral Research informed consent of research subjects; Strengthen Protections, But Concerns Remain. (National Commission). One of the requires Federally funded research be GAO–01–775T, May 23, 2001. reviewed by an institutional review 9 Scientific Research: Continued Vigilance charges of the National Commission was Critical to Protecting Human Subjects. T–HEHS– to identify the basic ethical principles board (IRB); and describes the 96–102, Mar 12, 1996. that should underlie the conduct of requirements for IRB membership, 10 Scientific Research: Continued Vigilance biomedical and behavioral research function, operations, research review, Critical to Protecting Human Subjects. HEHS–96– involving human subjects and to and recordkeeping. The regulations also 72, Mar 8, 1996. delineate criteria for, and levels of, IRB 11 Kim S, Ubel P, De Vries R. Pruning the develop guidelines to assure that such regulatory tree: For human-subjects research, review. Currently, except for human maximum regulation does not mean maximum 3 See Nuremberg Code, available at https:// subjects research that is determined to protection. Nature 2009;457: 534–535. history.nih.gov/display/history/Nuremberg+Code. be exempt from the regulations, 12 Emanuel EJ, Wood A, Fleischman A, et al. 4 See World Medical Association, Declaration of Federally funded research involving Oversight of human participants research: Helsinki—Ethical Principles for Medical Research human subjects is reviewed by an IRB Identifying problems to evaluate reform proposals. Involving Human Subjects, available at Ann Int Med 2004; 141(4): 282–291. www.wma.net/policies-post/wma-declaration-of- in one of two ways: (1) By a convened 13 Lynn J, Baily MA, Bottrell M, et al. The ethics helsinki-ethical-principles-for-medical-research- IRB, or (2) through an expedited review of using quality improvement methods in health involving-human-subjects/. process. care. Ann Int Med 2007;146(9):666– 673.

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in addition to the issues that suggest a tissue taken from an individual is used in research.23 Those states that have not need for revision, is not without in research. In the seminal case of banned human fetal tissue research precedent. In its 2001 concluding Canterbury v. Spence, the D.C. Circuit often require the consent of the pregnant report, the National Advisory Court of Appeals observed that ‘‘ ‘[e]very woman for the fetal tissue donation.24 Commission (NBAC) made 30 human being of adult years and sound The research and medical recommendations that addressed areas mind has a right to determine what shall communities have also recognized the including the scope and structure of the be done with his own body. . . .’ True importance of obtaining informed oversight system and the level of review consent to what happens to one’s self is consent before engaging in human fetal applied to research; it emphasized the the informed exercise of a choice, and tissue research. In June 2016, the importance of the informed consent that entails an opportunity to evaluate American Medical Association (AMA) process, documentation and waiver of knowledgeably the options available issued a Code of informed consent, protecting privacy and the risks attendant upon each.’’ 18 Opinion (Code of Ethics Opinion) that and confidentiality, adverse event Moreover, it is ‘‘normally impossible to listed several steps that physicians reporting, and review of cooperative or obtain a consent worthy of the name involved in human fetal tissue research multi-site research studies.14 unless the physician first elucidates the should take, including obtaining the In January 2017, as part of an options and the perils for the patient’s informed consent of the pregnant Executive Branch-wide update to the edification. Thus the physician has long woman.25 The AMA recognized that the Common Rule, HHS promulgated borne a duty, on pain of liability for use of fetal tissue for research purposes revisions to Subpart A in order to unauthorized treatment, to make ‘‘raises a number of ethical modernize, strengthen, and make the adequate disclosure to the patient.’’ 19 considerations, including the degree to Common Rule more effective. Among Subsequent courts have expounded which a woman’s decision to have an other things, the revisions established that informed consent is necessary if a abortion might be influenced by the new requirements regarding the patient’s tissue is to be used in research, opportunity to donate fetal tissue.’’ 26 It information that must be given as part especially where the physician further recognized that ‘‘[c]oncerns have of the informed consent process to extracting the tissue or his or her also been raised about potential prospective research subjects.15 The institution has a research or commercial conflicts of interest when there is executive summary of the 2017 final interest. For example, in Moore v. possible financial benefit to those who rule noted that, ‘‘to the extent Regents of University of California, the are involved in the retrieval, storage, appropriate, the intent is to eventually California Supreme Court held that, testing, preparation, and delivery of amend the other subparts of the HHS prior to providing medical treatment, a fetal tissues.’’ Consequently, ‘‘[t]o human subjects protection regulations physician must obtain the patient’s protect the interests of pregnant women in 45 CFR part 46 (subparts B, C, D, and informed consent, which requires as well as the integrity of science,’’ the E).’’ 16 disclosing all of the physician’s research Code of Ethics Opinion stated that The notice of proposed rulemaking and economic interests.20 As Moore physicians who are involved in research which led to the January 2017 revisions recognized, informed consent is that uses human fetal tissue should: to the Common Rule proposed requiring particularly important where the • Not ‘‘offer[ ] money in exchange for consent for the use of de-identified physician extracts human cells for use fetal tissue.’’ biospecimens (but not for the use of in subsequent research, since ‘‘a • ‘‘In all instances, obtain the biospecimens from deceased physician who treats a patient in whom woman’s voluntary, informed consent,’’ individuals, which was outside the he also has a research interest has including for fetal tissue from a scope of the Common Rule). As a result potentially conflicting loyalties. This is miscarriage (spontaneous abortion) for of comments, the Common Rule because medical treatment decisions are research. Under the Code of Ethics agencies declined to finalized such made on the basis of proportionality— Opinion, informed consent includes a requirements in the 2017 Common Rule. weighing the benefits to the patient ‘‘disclosure of the nature of the research See Federal Policy for the Protection of against the risks to the patient. ... A including the purpose of using fetal Human Subjects, 82 FR 7149, 7150, physician who adds his own research tissue, as well as informing the woman 7153 (Jan. 17, 2017).17 interests to this balance may be tempted of a right to refuse to participate.’’ However, federal and state courts to order a scientifically useful procedure • When fetal tissue from an induced have recognized the importance of or test that offers marginal, or no, abortion is used for research purposes, obtaining informed consent prior to benefits to the patient.’’ 21 Courts in ensure that: conducting medical procedures or other states have since recognized that Æ ‘‘The woman’s decision to research on human subjects, or before informed consent is required prior to terminate the pregnancy is made prior conducting research or performing to and independent of any discussion of 14 National Bioethics Advisory Commission, various medical procedures.22 Ethical and Policy Issues in Research Involving Many states have banned or placed 23 E.g., Ariz. Rev. Stat. Ann. § 36–2302 (2016); Human Participants. Bethesda, MD; 2001. strict limits on using human fetal tissue Ark. Code Ann. § 20–17–802 (2019); Fla. Stat. Ann. 15 82 FR 7150. Examples of provisions of the § 390.0111 (2018); Ky. Rev. Stat. Ann. § 436.026; La. Common Rule governing informed consent can Rev. Stat. Ann. § 40:1061.24 (2015); Me. Rev. Stat. currently be found at 75 CFR 46.116, 46.117, 18 Canterbury v. Spence, 464 F.2d 772, 780 (D.C. Ann. tit. 22, § 1593; Mass. Gen. Laws Ann. ch. 112, 46.204, and 46.205. Cir. 1972). § 12J (2008); Mich. Comp. Laws § 333.2685; Minn. 16 82 FR 7151. 19 Id. at 783. Stat. Ann. § 145.422; Mo. Ann. Stat. § 188.036; N.D. 17 For purposes of the 2017 Common Rule, a 20 See Moore v. Regents of Univ. of Cal., 793 P.2d Cent. Code § 14–02.2–01; N.D. Cent. Code §§ 14– human subject includes a living person from whom 479, 483 (Cal. 1990). 02.2–02; N.M. Stat. Ann. § 24–9A–3; Ohio Rev. a researcher obtains a biospecimen and, thus, 21 Id. at 484 (emphasis in original). Code Ann. § 2919.14; Okla. Stat. Ann. tit. 63, § 1– requires informed consent with respect to the use 22 See, e.g., T.D. v. N.Y. State Office of Mental 735; R.I. Gen. Laws § 11–54–1; S.D. Codified Laws of identifiable biospecimens in research. See, e.g., Health, 228 A.D.2d 95, 116 (N.Y. App. Div. 1996) § 34–23A–17; Utah Code Ann. § 76–7–310; Wyo. 45 CFR 46.101(a), 46.102(e) (definition of human (describing New York law regarding informed Stat. Ann. § 35–6–115 (2017). subject), 46.104(d)(7), (d)(8). Similarly, under consent for being a human research subject); 24 E.g., 17 CA ADC § 100085 (2019). Subpart B, if information associated with fetal DeGennaro v. Tandon, 873 A.2d 191, 189–197 25 AMA Code of Medical Ethics Opinion 7.3.5, material is recorded for research purposes in a (Conn. App. 2005) (collecting cases requiring available at https://www.ama-assn.org/delivering- manner that living individuals can be identified, informed consent prior to undergoing medical care/ethics/research-using-human-fetal-tissue. they are research subjects. 45 CFR 46.206(b). procedures). 26 Id.

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using the fetal tissue for research additional requirements of section 498A collection.’’ 36 In October 2018, these purposes.’’ with respect to research on human fetal expectations and requirements became Æ ‘‘Decisions regarding the technique tissue transplantation.31 Given its pre- part of NIH’s Grants Policy Statement.37 used to induce abortion and the timing eminent role in conducting and funding As noted above, in September 2018, of the abortion in relation to the biomedical research, NIH has also HHS initiated a comprehensive review gestational age of the fetus are based on issued guidance on human fetal tissue of all HHS research involving human concern for the safety of the pregnant in research. For example, on August 14, fetal tissue from elective abortions to woman.’’ 2015, it released ‘‘Reminder of Legal ensure consistency with statutory and • ‘‘Ensure that health care personnel Requirements Regarding the Acquisition regulatory requirements and to ensure involved in the termination of a and Use of Human Fetal Tissue for the adequacy of procedures and pregnancy do not benefit from their Research Purposes,’’ NOT–OD–15–143. oversight of such research in light of the participation in the termination.’’ 27 In that notice, NIH reminded its serious regulatory, moral, and ethical HHS research and human research grantees and contractors that ‘‘research considerations involved. As part of this protection components have also involving human fetal tissue must be audit and review, HHS personnel adopted policies and provided guidance conducted in accordance with reviewed the contracts (or purchase on research involving human fetal applicable Federal, State and local laws, orders, as applicable) executed by tissue. Subpart B requires that such regulations, and policies, including the personnel at NIH for the acquisition of research ‘‘be conducted only in accord NIH Grants Policy Statement,’’ making human fetal tissue from elective with any applicable Federal, State, or specific reference to the Public Health abortions, and sought to obtain, from the Service Act provisions and to 45 CFR organizations that supplied such tissue local laws and regulations regarding 32 such activities’’; the regulations further 46.204(h)–(j) and 46.206. Early the to the NIH researchers, copies of the direct that ‘‘[n]o inducements, monetary following year, in 2016, NIH released its required informed consents for the or otherwise, will be offered to policy, applicable to both NIH donation of the fetal tissue for research terminate a pregnancy’’ and that intramural research investigators and purposes, as well as documentation that ‘‘[i]ndividuals engaged in the research extramural researchers, NIH ‘‘Policy on valuable consideration was not sought will have no part in any decisions as to Informed Consent for Human Fetal or given in connection with the transfers Tissue Research.’’ 33 In that notice, NIH, the timing, method, or procedures used of fetal tissue. One tissue procurement which is ‘‘committed to ensuring that to terminate a pregnancy.’’ 45 CFR organization, which procured human research involving human fetal tissue is 46.206(a), 46.204(h)–(i). Following fetal tissue for a number of NIH conducted responsibly and meets the enactment of the NIH Revitalization Act intramural research projects, provided highest ethical standards,’’ stated that of 1993—which amended the Public its template informed consent ‘‘NIH-funded research involving human Health Service Act to add (among other document. It, however, refused to fetal tissue must be conducted in provisions) section 498A (42 U.S.C. produce any executed informed compliance with all applicable federal, 289g–1), establishing certain consents or documentation of its state, and local laws and compliance with laws and NIH policies requirements for research on fetal tissue 34 regulations....’’ NIH further noted on the informed consent of the mother transplantation, and section 498B (42 that ‘‘[c]urrent federal laws and U.S.C. 289g–2), barring valuable to donate the fetal tissue for research, regulations require informed consent for and would not make any consideration in connection with the research involving the transplantation of acquisition, receipt, or transfer of representations to HHS that such human fetal tissue and for research with informed consents had been obtained. human fetal tissue—the Office for human fetal material associated with Human Research Protections issued The organization also declined to information that can identify a living provide HHS with financial guidance on fetal tissue transplantation individual’’ and that ‘‘[m]ost states 28 documentation for HHS to assess research. In the January 2007 HHS require informed consent for the use of 29 compliance with federal prohibitions on Grants Policy Statement, HHS fetal tissue in research. Accordingly, included specific provisions on research valuable consideration. Informed NIH expects informed consent to have consents were obtained from two other on human fetal tissue and been obtained from the donor for any organizations, an academic institution transplantation of human fetal tissue. In NIH-funded research using human fetal that maintains a tissue bank and another the Grants Policy Statement, HHS noted tissue.35 NIH further noted that ‘‘[w]hen private tissue procurement organization, that ‘‘[t]he scientific and ethical obtaining primary human fetal tissue for which provided fetal tissue for two challenges associated with research research purposes, NIH expects grantees intramural research projects. While utilizing human fetal tissue make it and contractors to maintain appropriate HHS’s inability to obtain information imperative that researchers and their documentation, such as an attestation from one tissue procurement organizations be fully aware of and in from the health care provider or a third organization to confirm compliance compliance with the Federal party supplier, that informed consent with informed consent requirements requirements,’’ noting particularly was obtained at the time of tissue section 498B of the Public Health and the bar on valuable consideration 30 Service Act. It also noted the default/files/grants/grants/policies-regulations/ occurred in the context of HHS’s audit hhsgps107.pdf. of intramural research involving human 27 Id. The Code of Ethics Opinion also addresses 31 Id. at II–17—II–18. fetal tissue from elective abortions, and the use of fetal tissue in transplantation research or 32 See Reminder of Legal Requirements Regarding clinical care. the Acquisition and Use of Huma Fetal Tissue for 36 Id. FDA’s Staff Manual Guides also contains 28 See, e.g., Fetal Tissue Transplantation Research Research Purposes, NOT=OD–15.143 (Aug. 14, guidance for FDA- funded or conducted research Guidance (2003), available at https://www.hhs.gov/ 2015), available at https://grants.nih.gov/grants/ involving human fetal tissue. See FDA Staff Manual ohrp/regulations-and-policy/guidance/fetal-tissue- guide/notice-files/NOT-OD-15-143.html. Guides, Volume IV—Agency Program Directive, transplanation/index.html. 33 See NIH Policy on Informed Consent for General or Multidiscipline, Research Involving 29 HHS Grants Policy Statement (Jan. 1, 2007), Human Fetal Tissue Research, NOT–OD–16–033 Human Fetal Tissue, SMG 9001.3 (Feb. 11, 2016). available at https://www.hhs.gov/sites/default/files/ (Feb. 11, 2016), available at https://grants.nih.gov/ 37 October 2018 NIH Grants Policy Statement, grants/grants/policies-regulations/hhsgps107.pdf. grants/guide/notice-files/not-od-16-033.html. Section 4.1.14, available at https://grants.nih.gov/ 30 See HHS Grants Policy Statement (Jan. 1, 2007) 34 Id. grants/policy/nihgps/html5/section_4/4.1.14_ at II–16, available at https://www.hhs.gov/sites/ 35 Id. (emphasis added). human_fetal_tissue_research.htm.

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there are other sources from which the acquisition of such tissue. The of the medical community, State laws, researchers can and do obtain human notice outlined NIH’s expectations for and a comprehensive review of the use fetal tissue, the organization at issue the contents of the informed consents of human fetal tissue in research by also provides human fetal tissue to a (and related assurances): Language that HHS. HHS recognizes that, with respect number of NIH-funded extramural the informed consent for donation of to informed consent, this proposal goes researchers. As a result, HHS also human fetal tissue was obtained by beyond the approach taken by the became concerned that grantees, or someone other than the person who Common Rule (in subpart A) with those from whom fetal tissue had been obtained the informed consent for respect to biospecimens. However, HHS obtained by grantees, may not always abortion, occurred after the informed has long recognized the need for have readily available documentation of consent for abortion, and would not additional research protections for informed consents for fetal tissue affect the method of abortion; no certain vulnerable populations or research, or documentation that enticements, benefits, or financial certain types of research—hence, the valuable consideration was not incentives were used at any level of the existence of Subparts B, C, and D—and provided in exchange for human fetal process to incentivize abortion or the believes that the additional protections tissue in connection with HHS-funded donation of human fetal tissue; and the proposed here are warranted to protect research, notwithstanding NIH’s policy informed consent was signed by both the interests of pregnant women and the requirements and section 498B of the the woman and the person who integrity of science, as well as the Public Health Service Act (42 U.S.C. obtained the informed consent. NIH also serious moral and ethical considerations 289g–2(a)), which prohibits acquiring, indicated that the NIH award recipient noted above. With respect to research receiving, or otherwise transferring should have documentation from the involving human fetal tissue, this human fetal tissue for valuable human fetal tissue donating proposed rule would also align Subpart consideration if the transfer affects organization assuring adherence to the B more expressly with NIH policy and interstate commerce. requirements of the informed consent the AMA’s Code of Ethics Opinion on Building on these developments, in process and documentation that human the need for informed consent. HHS June 2019, HHS announced the fetal tissue was not obtained or acquired considered making no changes to 45 Administration’s new policy with for valuable consideration; the awardee CFR part 46 subpart B and part 75, or respect to human fetal tissue research. would be expected to provide such making more limited changes. However, That announcement included a assurance for each year of the award HHS has determined that a rulemaking commitment to undertake changes to such research is conducted for the life is necessary to, among other things, HHS regulations and to NIH’s grants of the award and to maintain this adopt, clarify, or strengthen safeguards policy to adopt or strengthen safeguards documentation in accordance with the and program integrity requirements and, and program integrity requirements NIH Record Retention and Access thus, to ensure compliance with the applicable to extramural research policy.40 federal statutes and policies addressing involving human fetal tissue. As the next step in this process, HHS the use of human fetal tissue in HHS- NIH began implementing the now proposes to make modifications to funded research. Administration’s policy with the 45 CFR part 46 Subpart B, which issuance of Changes to NIH provides additional protections for III. Summary of the Notice of Proposed Requirements Regarding Proposed pregnant women, human fetuses and Rulemaking Human Fetal Tissue Research, NOT– neonates involved in research, and 45 HHS proposes to amend 45 CFR part OD–19–128.38 In that notice, NIH CFR part 75, which implements 46, subpart B, Protection of Human outlined for its extramural research standard requirements for Subjects, Additional Protections for community the new requirements and administrative and financial Pregnant Women, Human Fetuses and review considerations with respect to management of Federal awards. The Neonates Involved in Research, and 45 research supported by NIH that involves decision to amend HHS’s regulations CFR part 75, Uniform Administrative the proposed use of human fetal tissue was the result of HHS’s comprehensive Requirements, Cost Principles, and obtained from abortions in extramural review of HHS research involving Audit Requirements for HHS Awards, in applications for grants, cooperative human fetal tissue from elective the following ways: agreements, and research and abortions. Given the serious regulatory, A. Definitions, § 46.202 development (R&D) contracts. It moral, and ethical considerations ‘‘remind[ed] the community of involved, HHS concluded that it is HHS is proposing to add a paragraph expectations to obtain informed consent appropriate to (1) clearly identify, in (i) to § 46.202. Paragraph (i) would from the donor for any NIH-funded regulation, the minimum requirements provide that, for purposes of Subpart B research using [human fetal tissue].’’ 39 for informed consent for the donation of 45 CFR part 46, human fetal tissue The notice included requirements for a and use of human fetal tissue in shall have the definition ascribed to it justification for the use of human fetal research, especially when the fetal in 42 U.S.C. 289g–1(g), namely ‘‘tissue tissue for the proposed research; for tissue is obtained from elective or cells obtained from a dead human planned written, voluntary, informed abortions; (2) impose certain embryo or fetus after a spontaneous or consent process for cell/tissue donation; requirements to help ensure compliance induced abortion, or after a stillbirth.’’ and for budget information and with the statutory bar on the provision While HHS proposes to define the term justification for the quantity, type, and of valuable consideration for human consistent with the statutory definition source of human fetal tissue, as well as fetal tissue. These conclusions also applicable to fetal tissue transplantation a certification that valuable follow from consideration of the research and the prohibition on valuable consideration has not been provided for authorities described above, the views consideration, many of the provisions proposed below would only apply to 38 See Changes to NIH Requirements Regarding 40 Id. The notice also required that the application human fetal tissue derived from elective Proposed Human Fetal Tissue Research, NOT–OD– describe plans for the treatment of human fetal abortions and to HHS-funded research 19–128 (July 26, 2019), available at https:// tissue and its disposal when the research was grants.nih.gov/grants/guide/notice-files/NOT-OD- complete, as well as assurances that such treatment involving such tissue. 19-128.html. and disposal would be consistent with such plans. For the purpose of implementing the 39 Id. (citing NOT–OD–16–033). Id. June 2019 policy through NOT–OD–19–

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128, NIH provided a more technical proposes to adopt the statutory human fetal tissue obtained from the definition of research involving human definition for these regulations, HHS is woman is used in HHS-funded research. fetal tissue from elective abortions as of the belief that this proposed Subpart A of the Common Rule ‘‘research involving the study, analysis, definition is consistent with the generally requires that, before research or use of primary [human fetal tissue], definition adopted in the NIH notice, for is conducted on a human research cells, and derivatives, and human fetal purpose of implementing the enhanced subject, the human subject must provide primary cell cultures obtained from review requirements, including review informed consent, but not for elective abortions’’ and stated that it of such research proposals that fall unidentifiable biospecimens.41 As includes (1) human fetal primary or within a fundable scoring range by discussed previously, state law secondary cell cultures, whether ethics advisory boards, pursuant to 42 generally requires informed consent for derived by the investigator or obtained U.S.C. 289a–1. Taking into participation in research, as well as from a vendor; (2) animal models consideration the different purposes and informed consent for the donation of incorporating human fetal tissue from scope of the proposed regulation (which tissue for research. In light of the serious elective abortions, including obtaining would apply to research involving all ethical and moral considerations such models from a vendor; (3) human fetal tissue, regardless of presented by the use of fetal tissue for derivative products from elective whether it was obtained from elective research purposes, as well as to protect abortion tissues or cells such as protein abortion) and the NIH notice the interests of pregnant women (and or nucleic acid extracts; and (4) any (addressing research involving only the integrity of science), HHS proposes human extra-embryonic cells and tissue, human fetal tissue from elective that the requirement for informed such as umbilical cord tissue, cord abortion), HHS contemplates adopting consent for tissue donation should blood, placenta, amniotic fluid, and the statutory definition with the express apply to research involving human fetal chorionic villi, if obtained from the clarifications that (1) human fetal tissue tissue. Because the fetus cannot provide process of elective abortion.’’ NIH noted includes human fetal primary tissue, informed consent, it is appropriate to that this definition is consistent with cells from such tissue, and primary cell obtain the informed consent of the the statutory definition that HHS cultures; derivative products (including woman from whom the fetal tissue proposes to adopt here for purposes of protein or nucleic acid extracts) from would be obtained. Such a requirement these regulations. To provide further such tissues/cells; and any human extra- was included in the 2016 AMA Code of specificity about the issue, NIH embryonic cells and tissues, such as Ethics Opinion.42 For these reasons, excluded certain types of research from umbilical cord tissue, cord blood, HHS proposes to add these the definition of research involving placenta, amniotic fluid, and chorionic requirements in paragraph (k). HHS, human fetal tissue from elective villi; and (2) human fetal tissue does not however, does not propose to include in abortion, namely (1) human fetal include established human fetal cell proposed paragraph (k) all statements primary or secondary cell cultures, if lines (including immortalized cell lines, that should be included in such an cells were not derived from an elective induced pluripotent stem cell lines from informed consent. HHS further proposes abortion; (2) already-established (as of human fetal tissue, and differentiated that the requirement for such informed June 5, 2019) human fetal cell lines (e.g., cell lines; human fetal cells present in consent would apply with respect to induced pluripotent stem cell lines from maternal blood or maternal sources; and donations of fetal tissue by women human fetal tissue, immortalized cell secondary use of data from human fetal occurring after the effective date of the lines, differentiated cell lines); (3) tissue. HHS seeks comment on whether final rule. HHS proposes that paragraph (k) derivative products from human fetal it would be appropriate to incorporate would also establish specific tissue or cells (e.g., DNA, RNA, protein) some or all of the specificity of the requirements in order to meet informed if not derived from elective abortion; (4) definition (and/or the exclusions from consent requirements in this unique human extra-embryonic cells and tissue, the definition) contained in the NIH notice; if so, which aspects of that context: including, but not limited to, umbilical • The pregnant woman’s consent cord tissue, cord blood, placenta, definition (and/or the exclusions) should be incorporated into the must be documented on a written amniotic fluid, and chorionic villi if not definition for the purpose of this informed consent form that is signed by derived from elective abortion; (5) proposed rule; and if the contemplated the pregnant woman and written in human fetal cells present in maternal express clarifications noted immediately plain language that is clear and easily blood or other maternal sources; (6) above strike the right balance. understandable. As explained in embryonic stem cells or embryonic cell Canterbury v. Spence, true consent is lines; and (7) research on B. Research Involving Pregnant Women the informed exercise of a choice, and transplantation of human fetal tissue or Fetuses, § 46.204 that entails an opportunity to evaluate from elective abortion for therapeutic HHS proposes to add paragraph (k) to knowledgeably the options available purposes (because of the statutory § 46.204, which governs research and the risks attendant upon each.43 provision(s) addressing such research, involving pregnant women or fetuses. This cannot occur if the pregnant i.e., National Institutes of Health Section 46.204 currently has two woman’s options are presented using Revitalization Act of 1993, Pub. L. 103– provisions which address abortion. complex medical jargon. For this reason, 43, sec. 113, 107 Stat. 126 (June 10, Section 46.204(h) states that ‘‘[n]o in promulgating its 2017 revisions to the 1993), which generally prohibits the inducements, monetary or otherwise, Common Rule, HHS ‘‘considered a imposition of a policy that precludes will be offered to terminate a growing body of literature that suggests HHS from conducting or supporting any pregnancy.’’ Similarly, § 46.204(i) informed consent forms have grown too research on the transplantation of currently requires that ‘‘[i]ndividuals lengthy and complex, adversely human fetal tissue for therapeutic engaged in research will have no part in purposes). any decisions as to the timing, method, 41 45 CFR 46.116, 46.117. NIH noted that its definition of or procedures used to terminate a 42 AMA Code of Medical Ethics Opinion 7.3.5, available at https://www.ama-assn.org/delivering- research involving human fetal tissue pregnancy.’’ Proposed paragraph (k) care/ethics/research-using-human-fetal-tissue. from elective abortions is consistent would require that the pregnant woman 43 Canterbury v. Spence, 464 F.2d 772, 780 (D.C. with the statutory definition. As HHS provide informed consent before the Cir. 1972).

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affecting their ability to effectively • The form documenting the Likewise, the 2016 AMA Code of Ethics convey the information needed for informed consent must permit the Opinion states that physicians involved prospective participants to make an pregnant woman to choose to donate in research that uses human fetal tissue informed decision about participating in fetal tissue for research or to decline to should ensure that the woman’s research.’’ 44 For the pregnant woman’s donate fetal tissue for research. In order decision to terminate the pregnancy is consent to be informed, the for informed consent for the donation of made prior to, and independent of, any consequences of her decision must be human fetal tissue to be truly voluntary, discussion of using the fetal tissue for written in plain language that is clear the donor has to understand that the research purposes. Congress and the and easily understandable. Moreover, donation decision is truly voluntary and AMA recognize that a woman may not the pregnant woman’s consent should that she can choose to donate the fetal be truly providing informed consent to be documented in writing. Requiring tissue or can choose to decline to donate a human fetal tissue donation if the such documentation would also the fetal tissue. HHS proposes to require decision to donate is intermingled with minimize costs by reducing uncertainty including both options on the form; it the decision about whether to have an and the risk of subsequent disputes or believes that this would help to ensure abortion. • litigation. that the informed consent is truly The pregnant woman’s informed • voluntary. consent must be obtained by an The form documenting the • individual other than the individual informed consent must include a The form documenting the informed consent must be signed by who obtained the informed consent for statement that there have been and will the pregnant woman’s abortion. This be no enticements, benefits, or financial both the pregnant woman and the individual obtaining the informed proposed requirement would help incentives to incentivize the donation or ensure that the decision whether to acquisition of human fetal tissue, or the consent for the donation, with both individuals attesting to the truth of the donate human fetal tissue is abortion (if any) from which such tissue independent of the decision whether to is obtained. This would require statements in the form. Given the serious moral and ethical considerations have an abortion. participants to document that they are • The pregnant woman must be at or following federal and state law. The involved in human fetal tissue donation, it is appropriate to propose to require over the age of majority in the Public Health Service Act already makes jurisdiction in which the pregnant it unlawful for any person to knowingly written documentation that the donor has provided informed consent and that woman’s donation is made. American acquire, receive, or otherwise transfer law has long recognized that important any human fetal tissue for valuable the individual obtaining the informed consent has acted properly. Requiring decisions about medical procedures consideration if the transfer affects should generally be made by adults.46 interstate commerce. See 42 U.S.C. both individuals’ signatures would reduce costs by reducing the risks of That is all the more so in this unique 289g–2. Many states also forbid persons context that raises serious moral and from providing enticements, benefits, or litigation or other disputes—and assist HHS and the research grant recipient ethical concerns. Accordingly, HHS financial incentives to donate human proposes to impose this requirement fetal tissue.45 HHS proposes that the ensure compliance with the statutory and regulatory requirements. with respect to the donation of human statement also indicate that no fetal tissue. enticement, benefit or financial These provisions would be applicable to • The form documenting the incentive was provided to incentivize all donations of human fetal tissue, informed consent must include a the abortion—as a mechanism to ensure regardless of whether the tissue was statement that the decision to have an that persons do not evade the statutory obtained from an elective abortion. This abortion and the method of abortion prohibition on providing valuable requirement is based on principals of have not been affected by the decision consideration for human fetal tissue by informed consent or on a statute with whether to donate human fetal tissue. providing incentives for the abortion. respect to human fetal tissue, both of This would require documentation that Furthermore, after conducting its which are independent of the methods the requirement concerning the order in review, HHS has determined that it is by which the fetal tissue is obtained. which the informed consents are unlikely that persons involved in Where the human fetal tissue is to be obtained, above, has been met. It would human fetal tissue research would obtained from an elective abortion, HHS also ensure that the pregnant woman’s provide enticements, benefits, or further proposes that the informed consent to the human fetal tissue financial incentives to incentivize an consent include several additional donation is informed and independent, abortion, without also seeking to provisions: • since the method of abortion would not incentivize the human fetal tissue The pregnant woman’s informed be affected by the decision whether to donation. consent must be obtained after the donate human fetal tissue. decision to have an abortion has been HHS proposes to provide, in an 44 82 FR 7211. conclusively made and informed appendix to the preamble, sample 45 See, e.g., CA HLTH & S § 125320 (‘‘A person consent for the abortion has been informed consent form provisions, as may not knowingly, for valuable consideration, obtained. This proposed requirement guidance to regulated entities on the purchase or sell embryonic or cadaveric fetal tissue would be consistent with Congressional for research purposes pursuant to this chapter.’’); type of informed consent form CO ST § 25–2–111.5 (‘‘No physician or institution intent and the views of the medical that performs procedures for the induced community. Congress required that 46 See Moore, 793 P.2d at 483 (‘‘[A] person of termination of pregnancy shall transfer such tissue research on the transplantation of adult years and in sound mind has the right, in the for valuable consideration to any organization or human fetal tissue that is funded or exercise of control over his own body, to determine person that conducts research using fetal tissue.’’); whether or not to submit to lawful medical IN ST 35–46–5–1.5 (making it a Level 5 felony to conducted by HHS can only occur if the treatment.’’) (quoting Cobbs v. Grant, 8 Cal. 3d 229, intentionally acquire, receive, sell, or transfer fetal attending physician who obtains the 242 (1972)); Canterbury, 464 F.2d at 780 (‘‘The root tissue); MO ST 188.036 (‘‘No person shall offer any tissue declares that the consent of the premise is the concept, fundamental in American inducement, monetary or otherwise, to the mother woman for the abortion was obtained jurisprudence, that ‘[e]very human being of adult or father of an unborn child for the purpose of years and sound mind has a right to determine what procuring an abortion for the medical, scientific, prior to requesting or obtaining consent shall be done with his own body.’ ’’) (quoting experimental or therapeutic use of the fetal organs for the donation of the tissue for use in Schloendorff v. Soc’y of N.Y. Hosp., 105 NE 92, 93 or tissue.’’). research. 42 U.S.C. 289g–(b)(2)(A)(i). (N.Y. 1914)).

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provisions that would comply with the consideration for the abortion, other academic medical centers. In this proposed informed consent enforcement actions arising out of context that implicates serious moral requirements. This proposal would payments for human fetal tissue would and ethical considerations, HHS is provide certainty to the regulated frequently face evidentiary questions committed to ensuring that research entities that they have sufficiently about whether the payment was for the conducted using human fetal tissue has obtained informed consent and met the costs associated with the abortion, been obtained through appropriate requirements of this proposed rule. rather than the human fetal tissue. procedures, including that the informed However, the use of the sample Paragraph (e) would require that no consent associated with the donation of provisions would not be required, and person who solicits or knowingly fetal tissue is truly voluntary and not relevant parties would be free to use acquires, receives, or accepts a donation performed on an ad hoc basis or by their own language in a form for of human fetal tissue for use in research those who are not sufficiently qualified. informed consent for the donation of shall provide valuable consideration for Thus, this proposed requirement would human fetal tissue as long as the form the costs associated with the donation establish additional safeguards to ensure meets the proposed requirements. HHS or acquisition of human fetal tissue. that the procurement of human fetal seeks comment on the contents of HHS proposes to add paragraph (e) for tissue is conducted by organizations or sample informed consent form some of the same reasons that it institutions that are familiar with, and provisions. proposes to add paragraph (k)(1)(B) to accustomed to complying with, § 46.204. Furthermore, paragraph (e) informed consent requirements and that C. Research Involving Pregnant Women would (1) eliminate any uncertainty are regularly subject to oversight by or Fetuses, § 46.206 about whether 42 U.S.C. 289g–2’s HHS—and is not obtained by HHS proposes to add paragraphs (c), prohibition on providing valuable organizations or individuals that are not (d), (e), (f), (g), (h), and (i) to § 46.206. consideration for the acquisition, qualified to implement such Paragraph (c) would require that, at receipt, or transfer of human fetal tissue requirements, that are not otherwise all stages in the process to acquire or applies to human fetal tissue research, subject to regulation and oversight by otherwise obtain human fetal tissue for and (2) specify what is required to HHS, and that accordingly may not use in research, there would be no comply with that provision in the respond to requests for access to enticements, benefits, or financial human fetal tissue research context. records. HHS also believes that incentives provided to the pregnant Paragraph (f) would define ‘‘valuable paragraph (h) strengthens program woman or attending physician to consideration’’ for purposes of integrity by making sure that the entities incentivize the occurrence of an paragraphs (d) and (e) as all payments obtaining human fetal tissue for abortion or the donation or acquisition other than payments associated with the research are substantially more likely to of human fetal tissue. HHS proposes to transportation, implantation, comply with these requirements, add this paragraph for the same reasons processing, preservation, quality especially in a manner that complies that it proposes to add paragraph control, or storage of human fetal tissue. with the concerns expressed by (k)(1)(B) to § 46.204. Paragraph (c) Paragraph (f) is in accord with 42 U.S.C. Congress when it placed limits on the would help implement 42 U.S.C. 289g– 289g–2(e)(3), which provides that use of human fetal tissue in the Public 2 and specify what is required by that ‘‘valuable consideration’’ does not Health Service Act. provision in the context of research include reasonable payments associated Paragraph (i) requires that, once involving pregnant women, fetuses, or with the transportation, implantation, human fetal tissue is no longer to be human fetal tissue. processing, preservation, quality used in research, it shall be treated Paragraph (d) would require that no control, or storage of human fetal tissue. respectfully and disposed of reasonably person who solicits or knowingly Paragraph (f) would also provide and in compliance with any additional acquires, receives, or accepts a donation certainty to those involved in human laws or regulations imposed by of human fetal tissue for use in research fetal tissue research, by making clear applicable state law. By its statutory shall provide valuable consideration for that the enumerated costs are the only enactments, Congress has expressed that the costs associated with the acquisition ones that do not constitute ‘‘valuable members of the public should proceed of the fetal tissue or with any abortion consideration’’ for purposes of § 46.206. carefully when their actions involve that may be the source of the human Paragraph (g) would emphasize that human fetal tissue. HHS believes that fetal tissue used or to be used in the human fetal tissue may be used in paragraph (i) would further implement research. HHS proposes to add research only if an informed consent this concern at minimal burden. Many paragraph (d) for some of the same that meets the applicable requirements states and accredited academic reasons that it proposes to add of § 46.204(k) has been obtained with institutions have already adopted paragraph (k)(1)(B) to § 46.204. respect to the tissue donation. HHS statutes or policies with similar Permitting a person to provide valuable proposes that the requirement would requirements.47 HHS asks for comment consideration for costs associated with apply with respect to donations of fetal on this proposed regulatory requirement the abortion that is the source of the tissue by women where the initial and the contours of such proposed human fetal tissue could impact the donation occurs after the effective date requirement. decision whether to donate human fetal of the final rule. tissue which should be independent of Paragraph (h) would provide that D. Access to Records, § 75.364 the decision whether to have an human fetal tissue from elective HHS’s grants regulations, at abortion. Moreover, permitting a person abortions can only be used in research § 75.364(a), provide that, among others, to provide valuable consideration for conducted or funded by HHS if the the HHS awarding agency, HHS such costs could enable the person, by human fetal tissue is acquired or claiming they are merely paying for the otherwise obtained from Federal or 47 See, e.g., AR Code § 20–17–801; GA ST § 16– costs of the abortion and not the human State Governments, Federal or State 12–141.1 (2017); IN ST § 16–34–3–4 (2016); SD ST fetal tissue, to circumvent the Government-owned entities, § 34–25–32.4; University of Minnesota Policy Statement Regarding Acquisition, Use, and prohibition on providing valuable universities, colleges, accredited degree- Disposition of Donated Human Fetal Tissue for consideration for human fetal tissue. If granting institutions of higher Transplantation Research, available at https:// a person could provide valuable education, or university hospitals or policy.umn.edu/research/fetalresearch.

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Inspector General, and the Comptroller papers, and records (and personnel) for protein or nucleic acid extracts) from General of the , or any of which HHS has a right of access. such tissues/cells; and any human extra- their authorized representatives, ‘‘must Moreover, a 2016 House of embryonic cells and tissues, such as have the right of access to any Representatives committee report found umbilical cord tissue, cord blood, documents, papers, or other records’’ of that certain institutional review boards placenta, amniotic fluid, and chorionic the non-Federal entity (that is, the lacked records regarding their oversight villi; and (2) human fetal tissue does not recipient of HHS funds) which are of fetal tissue research and include established human fetal cell ‘‘pertinent to the Federal award, in transplantation, and the committee was lines (including immortalized cell lines, order to make audits, examinations, unable to obtain access to records that induced pluripotent stem cell lines from excerpts, and transcripts’’—including could determine whether fetal tissue human fetal tissue, and differentiated ‘‘timely and reasonable access to was obtained for valuable cell lines; human fetal cells present in personnel for the purpose of interview consideration.48 Because of the maternal blood or maternal sources; and and discussion related to such uncertainty over whether required secondary use of data from human fetal documents.’’ 45 CFR 75.364; see also 2 documents are being maintained, HHS tissue. HHS seeks comment on whether CFR 200.337 (OMB uniform proposes to reiterate that recipients it would be appropriate to incorporate administrative requirements). HHS must maintain required documents and some or all of the specificity of the proposes to add a paragraph (a)(1), provide the HHS awarding agency, definition (and/or the exclusions from which would specifically require that among others, with access to such the definition) contained in the NIH non-Federal entities that engage in documents and personnel upon request. notice; if so, which aspects of that human fetal tissue research pursuant to Paragraph (a)(1) would therefore also definition (and/or the exclusions) a Federal award provide the HHS strengthen program integrity. should be incorporated into the awarding agency, the Inspector General, By its statutory enactments, Congress definition for the purpose of this the Comptroller General of the United has expressed that members of the proposed rule; and if the contemplated States, and the pass-through entity or public should proceed carefully when express clarifications noted immediately any of their authorized representatives, their actions involve human fetal tissue above strike the right balance. with a right of access to (1) all informed and that valuable consideration should consent forms obtained by the non- not be provided in order to acquire E. Expenses Associated With Acquiring Federal entity for human fetal tissue human fetal tissue. HHS proposes, Certain Human Fetal Tissue for research, which may be redacted with below, that federal funds not be used to Research, § 75.478 acquire human fetal tissue from elective respect to the name and signature of the In its grants regulation in 45 CFR part abortions; HHS believes that it is woman (for privacy purposes); (2) all 75, HHS addresses certain select items particularly important to be good documents, papers, or other records as of costs and identifies certain costs that stewards of federal funds in this are necessary to establish that the are or are not allowable under HHS’s context. Given the aforementioned human fetal tissue was not obtained or funding awards.49 HHS proposes to add concerns, HHS believes that recipients transferred for valuable consideration; § 75.478. Section 75.478 would provide should be able to document that (3) all documents, papers, or other that expenses associated with the valuable consideration was not records as are necessary to establish that acquisition of human fetal tissue from provided to acquire human fetal tissue federal funds were not used to acquire elective abortions for use in research are and that federal funds were not used to or otherwise obtain the human fetal not allowable expenses under Federal acquire human fetal tissue from elective tissue from elective abortions; and (4) awards from an HHS awarding agency. personnel familiar with the foregoing abortions. HHS also proposes to add a paragraph As a result of the comprehensive review documents, for purposes of interview that HHS undertook and in light of the and discussion related to such (d), which would provide that, for purposes of § 75.364, ‘‘human fetal serious regulatory, moral, and ethical documents. considerations involved, HHS has Paragraph (a)(1) would impose little, tissue’’ shall have the definition ascribed to it in 49 U.S.C. 289g–1. concluded that such costs should not be if any, additional burdens or costs. 45 allowable—that is, they are not CFR 75.364(a) already requires that the Paragraph (e) would clarify for recipients what is meant by ‘‘human expenses that should be borne by the HHS awarding agency, inspectors taxpayer through the federal research general, the Comptroller General, and fetal tissue,’’ and would define that term in a way that conforms to the definition award. HHS would continue to fund any of their authorized representatives research involving such human fetal have the right of access to any provided by Congress. As with the proposed definition of ‘‘human fetal tissue, consistent with the June 5, 2019 documents, papers, or other records of policy,50 but it proposes that funds from the non-Federal entity which are tissue’’ for purposes of Subpart B of 45 CFR part 46, HHS believes that this HHS research awards could not be used pertinent to the Federal award, in order for the acquisition of human fetal tissue to make audits, examinations, excerpts, proposed definition is consistent with the definition adopted in the NIH notice from elective abortions. HHS encourages and transcripts. Paragraph (a)(1) would the recipients of HHS awards for simply provide clarity to recipients for purpose of implementing the enhanced review requirements. research involving human fetal tissue involved in human fetal tissue research from elective abortions to obtain human by specifying certain categories of the Similarly, HHS contemplates adopting the statutory definition with the express fetal tissue by donation or no-cost documents, papers, and records (and material transfer agreement. personnel) for which a right of access clarifications that (1) human fetal tissue must be provided. Because of the includes human fetal primary tissue, cells from such tissue, and primary cell 49 See, e.g., 45 CFR 75.420–75.475 (general unique context and serious regulatory, provisions for selected items of cost), 75.476–75.477 ethical, and moral considerations cultures; derivative products (including (HHS selected items of cost). involved in human fetal tissue research, 50 See Statement from the Department of Health 48 See, e.g., Final Report of the Select and Human Services, June 5, 2019, available at HHS believes it would be beneficial to Investigative Panel of the Energy & Commerce https://www.hhs.gov/about/news/2019/06/05/ specifically remind this subset of Committee (Dec. 30, 2016), at xxi, xxvii, xxviii, statement-from-the-department-of-health-and- recipients in advance of the documents, xxix, xxxi, xxxviii, 16. human-services.html.

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IV. Request for Comment under Executive Order 12866, § 3(f)(4), requirements relate to the informed HHS seeks comment on all aspects of in as much as it raises novel legal or consent process and the statutory bar on this proposed rule and the model policy issues that arise out of legal the provision of valuable consideration informed consent form provisions, mandates, the President’s priorities, or in connection with the transfer of including the likely impacts of the the principles set forth in an Executive human fetal tissue. HHS believes that Order, but that it is not economically additional informed consent statements proposed rule, as compared to the status significant in that it will not have an and procedures are needed to ensure quo. HHS also seeks comment on its annual effect on the economy of greater that (1) the informed consent to the regulatory impact analysis. than $100 million in one year. Thus, the donation of human fetal tissue from V. Regulatory Impact Analysis Office of Management and Budget has abortion is in fact voluntary and HHS has examined the impacts of this reviewed it. Under Executive Order informed, and not motivated by any proposed rule as required under 13563, in proposing this rule, HHS has enticements, benefits, or financial Executive Order 12866 on Regulatory attempted to promote coordination, considerations, and (2) there is Planning and Review, 58 FR 51,735 simplification, and harmonization; has separation between the decision and (Oct. 4, 1993); Executive Order 13563 on sought to identify means to achieve consent for abortion and the decision on regulatory goals that are designed to the donation of fetal tissue, such that Improving Regulation and Regulatory promote innovation; and has ensured the abortion decision is not influenced Review, 76 FR 3821 (Jan. 21, 2011); the objectivity of any scientific and by considerations relating to the Executive Order 13771 on Reducing technological information and processes research, including the potential Regulation and Controlling Regulatory used to support this proposed rule. contribution to biomedical research that Costs, 82 FR 9339 (Feb. 3, 2017); the could cure disease, advance Regulatory Flexibility Act (Pub. L. 96– Summary of and Need for Proposed understanding of diseases, and the like. 354 (Sept. 19, 1980) (codified as Rule Similarly, HHS desires to strengthen amended at 5 U.S.C. 601–612)) and HHS recognizes that conducting and recipients’ understanding of, and Executive Order 13272 on Proper funding research involving human fetal compliance with, the informed consent Consideration of Small Entities in tissue from abortions presents serious requirements and the statutory bar on Agency Rulemaking, 67 FR 53461 (Aug. regulatory, moral, and ethical the provision and receipt of valuable 16, 2002); section 202 of the Unfunded considerations. The principle of consideration for human fetal tissue by Mandates Reform Act of 1995 (Pub. L. informed consent is central to the ensuring access to records relating to 104–04, 109 Stat. 48 (Mar. 22, 1995)); practice of medicine, as well as to such issues for oversight purposes. Executive Order 13132 on Federalism, human subjects research. Federal and Accordingly, the proposed rule 64 FR 43255 (Aug. 4, 1999), Subtitle E state laws and policies recognize the would: of the Small Business Regulatory importance of informed consent, not • Require, prior to conducting Enforcement Fairness Act of 1996 (Pub. only for research involving human research on human fetal tissue, that L. 104–121, 110 Stat. 847 (Mar. 29, subjects, but also for the donation of informed consent, including certain 1996) (codified as amended at 5 U.S.C. human tissue and cells for research statements, be obtained from the 801–808)) (commonly known as the purposes. This informed consent is pregnant woman; Congressional Review Act); section 654 especially important when the tissue • Prohibit providing enticements, of the Treasury and General being donated is human fetal tissue and benefits, or financial incentives to the Government Appropriations Act of 1999 the source of such tissue is elective pregnant woman or attending physician (the Assessment of Federal Regulation abortions. Congress has similarly to incentivize the occurrence of an and Policies on Families); and the recognized the moral and ethical issues abortion or human fetal tissue donation; Paperwork Reduction Act of 1995, 44 implicated by the acquisition of human • Prohibit providing valuable U.S.C. 3501 et seq. fetal tissue and the use of human fetal consideration for costs associated with Executive Orders 12866 and 13563 tissue in research: It amended the Public obtaining human fetal tissue or the Determination Health Service Act to, among other abortion (if any) that is the source of the things, make it unlawful ‘‘for any person human fetal tissue; Executive Order 12866 directs to knowingly acquire, receive, or • Mandate that research involving agencies to assess all costs and benefits otherwise transfer any human fetal human fetal tissue from elective of available regulatory alternatives and, tissue for valuable consideration’’— abortions can only use human fetal if regulation is necessary, to select which ‘‘does not include reasonable tissue that is acquired or otherwise regulatory approaches that maximize payments associated with the obtained from a Government, net benefits (including potential transportation, implantation, Government-owned entities, university, economic, environmental, public health processing, preservation, quality college, accredited degree-granting and safety effects; distributive impacts; control, or storage of human fetal institution of higher education, and equity). Executive Order 13563 is tissue’’—if the transfer affects interstate university hospital, or academic supplemental to Executive Order 12866 commerce. medical center; and reaffirms the principles, structures, As a result of a comprehensive review • Require that human fetal tissue be and definitions governing regulatory of HHS research involving human fetal treated respectfully and disposed of review established there. For significant tissue from elective abortion and in light reasonably when no longer to be used in regulatory actions, Executive Order of the serious regulatory, moral and research; 12866 requires ‘‘an assessment, ethical considerations involved, HHS • Require HHS recipients that engage including the underlying analysis,’’ of determined that it would be appropriate in human fetal tissue research to benefits and costs ‘‘anticipated from the to undertake changes to its regulations provide HHS, inspectors general, and regulatory action.’’ Executive Order to adopt or strengthen safeguards and the Comptroller General with a right of 12866, §§ 6(a)(3)(C), 3(f)(1). program integrity requirements access to all informed consent forms The Office of Management and Budget applicable to extramural research obtained for human fetal tissue research, (OMB) has determined this proposed involving human fetal tissue. These and documents, papers, or other records rule is a ‘‘significant regulatory action’’ safeguards and program integrity as are necessary to establish that the

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human fetal tissue was not obtained or Expected Benefits and Costs of the institutions and several corporations. transferred for valuable consideration Proposed Rule Many of these entities hold multiple and that federal funds were not used to HHS expects several benefits from NIH grants, cooperative agreements, or acquire or otherwise obtain the human this proposed rule. The proposed rule R&D contracts for research involving the fetal tissue; and would provide better assurance of use of human fetal tissue. In FY 2019, • Provide that expenses associated compliance with federal statutory there were a total of 71 unique with the acquisition of human fetal requirements with respect to the institutions with active NIH awards for tissue for use in research are not acquisition and use of human fetal research involving human fetal tissue. allowable expenses under Federal tissue in research. It would better align Thus, to ensure that costs are not awards from an HHS awarding agency. federal and state law with respect to underestimated, for purposes of estimating the costs associated with this Alternatives Considered informed consent for the use of fetal tissue in research, and ensure the rulemaking, HHS will use 80 as the HHS carefully considered several uniformity across HHS/NIH grants with number of organizations that would be alternatives, but rejected the potential respect to the elements of informed affected by this proposed rule. Given the alternatives for a number of reasons: consent for the donation of human fetal size and sophistication of these entities, • Alternative 1: Not taking any action. tissue for research. It would strengthen the task of familiarization would likely HHS concluded that this alternative was the informed consent process. It would fall to the equivalent of a lawyer in the unacceptable because of the serious also strengthen HHS’s ability to conduct entities’ law departments. According to 51 regulatory, moral and ethical oversight of, and monitor compliance the U.S. Bureau of Labor Statistics, considerations involved with respect to on, these issues (informed consent, bar lawyers have a mean hourly rate of research involving human fetal tissue on valuable consideration). While $69.86. HHS assumes that the total from elective abortions. maintaining, consistent with the Public dollar value of labor, which includes • Alternative 2: Making no changes to Health Service Act, the ability of NIH to wages, benefits, and overhead, is equal 45 CFR part 46, subpart B or to part Part fund research involving human fetal to 200% of the wage rate, or $139.72. 75, but issuing guidance on (1) best tissue from abortion, this proposed rule The changes proposed in the proposed practices for (and the elements that would also ensure that—in light of the rule are straightforward and easy to should be included in) informed serious moral and ethical issues understand. Accordingly, HHS consent for the donation of human fetal involved—the costs associated with estimates that it would take a recipient tissue for research, (2) the such human fetal tissue would not be approximately an hour to become documentation that should be borne by the federal taxpayer. familiar with the requirements if the maintained with respect to compliance HHS believes that the costs associated proposed rule is finalized as proposed. with the statutory bar on valuable with the proposed rule will be de HHS, thus, concludes that the total cost consideration for the transfer of human minimis. In the main, the costs would for recipient familiarization with such a fetal tissue, and (3) encouraging the consist of the administrative costs to the final rule would total $11,177.60 × practice of obtaining human fetal tissue relevant recipients to (1) become ($139.72 80). by donation or non-cost material familiar with the requirements of the Informed Consent and Informed transfer agreement. HHS concluded that final rule; (2) update their informed Consent Forms. As noted above, since this alternative would be inadequate consent documents; and (3) update their not later than 2016, NIH has conveyed because the guidance mechanism (1) did grant policies and procedures (or to researchers working with human fetal not seem commensurate with the nature compliance manuals) on grant record tissue that receive NIH grants for such and seriousness of the issue and (2) may retention to reflect certain information research that (1) NIH-funded research not be sufficient to permit HHS to retention requirements, practices involving human fetal tissue must be conduct appropriate oversight and concerning treatment and disposal of conducted in compliance with all ensure compliance with/enforce the human fetal tissue, the bar on valuable applicable federal, state, and local laws identified informed consent standards consideration, and the unallowability of and regulations; 52 (2) most states and the bar on valuable consideration. costs associated with the acquisition of require informed consent for the use of • Alternative 3: Make more limited human fetal tissue from abortion. fetal tissue in research; and (3) NIH changes to 45 CFR part 46, subpart B Familiarization Costs. NIH is the only expects informed consent to have been and Part 75, such as by (1) requiring HHS component that funds grants, obtained from the donor for any NIH- that, with respect to research involving cooperative agreements, or R&D funded research using human fetal human fetal tissue from elective contracts for research involving human tissue. See NOT–OD–16–033; NIH abortions, HHS-funded projects obtain fetal tissue. Between FY 2015 and FY Grants Policy Statement, Sec. 4.1.14. informed consent for the donation of 2019, NIH funded between Recently, NIH informed grantees, human fetal tissue from elective approximately 120 and 178 research contractors, and applicants that it abortion, without specifying any projects involving the use of human expects such informed consent forms to required content of the informed fetal tissue from abortions each year, contain certain statements that are consent document; or (2) clarifying including between 15 and 55 new consistent with the statements proposed recordkeeping and access requirements. research projects per year; with NIH- in this proposed rule. See NOT–OD–19– HHS concluded that this alternative funded projects usually having a five 128. In addition, the AMA has would be inadequate because, among year project period, most such annually indicated, through its 2016 Code of other reasons, it would not ensure that funded research projects represented Ethics Opinion, that physicians who are the informed consent process included renewals, revisions, extensions, or involved in research that uses human measures and statements to ensure that continuations. The entities that hold the fetal tissue should, in all instances, the informed consent was truly NIH awards for such research projects voluntary and truly informed and that include major colleges and universities, 51 U.S. Bureau of Labor Statistics, May 2019 National Occupational Employment and Wage no consideration or inducements had medical schools, academic medical Estimates United States, available at https:// been provided for the human fetal centers, major hospitals and children’s www.bls.gov/oes/current/oes_nat.htm. tissue. hospitals, biomedical research 52 See 45 CFR 46.206(a).

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obtain the woman’s voluntary, informed each research project, for a total of administration or compliance policies consent. Although there is currently no 1,059.2 informed consent processes per and procedures (or manuals) that are express requirement for such informed year. Assuming the informed consent maintained by recipients of the size and consent, based on the foregoing, it is process requires 10–15 minutes of a sophistication of those that tend to HHS’s understanding that informed registered nurse’s time, this results in a receive NIH grants for research consent is generally obtained from the total of between 176.89 and 264.8 involving human fetal tissue—and that donor for NIH-funded research burden hours per year for the separate recipient personnel tend to consult such involving human fetal tissue. HHS and independent informed consent documents in connection with their assumes that recipients have an process, or between $13,174.77 and activities. Accordingly, HHS believes informed consent form that they use or $19,722.30 in total annual costs. This that the only costs that recipients would require their contractors to use in suggests a total annual burden of incur as a result of these proposed obtaining the informed consent to the between 2.21 and 3.31 hours per unique requirements would likely be associated donation of human fetal tissue. recipient, and cost on an annual basis with the updating of such policies and Accordingly, the only costs HHS (undiscounted) for each unique procedures (or manuals). Given the size expects that recipients would incur recipient of between $164.68 and and sophistication of these entities, the associated with the proposed informed $246.53 for a separate and independent task of familiarization would likely fall consent requirements would be the informed consent process for the to the equivalent of a lawyer in the costs to update such forms. Such a task donation of human fetal tissue for entities’ law departments or a would again likely fall to the equivalent research.54 compliance officer in their compliance of a lawyer in the entities’ law Prohibitions on Valuable offices. According to the U.S. Bureau of departments. According to the U.S. Consideration. The proposed Labor Statistics, lawyers have a mean Bureau of Labor Statistics,53 lawyers substantive prohibitions on valuable hourly rate of $69.86,55 and compliance have a mean hourly rate of $69.86. HHS consideration in proposed § 46.206(c)– officers have a mean hourly rate of assumes that the total dollar value of (f) merely reiterate current statutory $35.03.56 HHS assumes that the total labor, which includes wages, benefits, requirements with respect to the dollar value of labor, which includes and overhead, is equal to 200% of the provision or receipt of valuable wages, benefits, and overhead, is equal wage rate, or $139.72. The informed consideration associated with the to 200% of the wage rate, or $139.72 for consent requirements in the proposed transfer of human fetal tissue. lawyers, and $70.06 for compliance rule are straightforward and easy to Accordingly, HHS does not believe that officers. HHS believes that the updating understand—and HHS has provided recipients would incur any additional or of such documents would likely take a sample informed consent form incremental costs as a result of these total of two hours—and assumes that provisions. Accordingly, HHS estimates proposed requirements. half of the work would be completed by that it would take a recipient Disposal of Human Fetal Tissue. It is compliance officers and half would be approximately an hour to update its HHS’s understanding that the proposed completed by lawyers. Accordingly, informed consent for the donation of requirement for the respectful treatment HHS estimates that the total cost human fetal tissue from elective and disposal of human fetal tissue when incurred by recipients as a result of the abortion for research. HHS, thus, such tissue is no longer needed for proposed requirements would be concludes that the costs likely to be research (proposed § 46.206(i)) is $16,782.40 (($139.72 + $70.06) × 80). incurred to update informed consent consistent with good clinical practice on Records and Access to Records and forms as a result of the proposed the part of researchers. Accordingly, Personnel. HHS proposes to amend its informed consent requirements HHS believes that recipients would current provision requiring awardees to (proposed §§ 46.204(k) and 46.206(g)) incur de minimis costs, if any, as a provide access to records relating to a would total $11,177.60 ($139.72 × 80). result of this proposed requirement. recipient’s award to specify that Although HHS believes that most, if Updating of Policies and Procedures recipients of awards for research not all, recipients of NIH awards for (or Manuals). HHS would classify, as involving human fetal tissue would research involving human fetal tissue grant administration requirements, the need to provide access on the part of have processes in place to obtain proposed requirements on the sourcing HHS, the Inspector General, GAO, and informed consent for the donation of of human fetal tissue for research; on others, to specific grant-related human fetal tissue for research, HHS access to grant-related information information. All of the information that recognizes that some may not conduct a pertaining to informed consent, valuable is specifically referenced in proposed process to obtain informed consent for consideration, and use of grant funds; § 75.364(a)(1) is already subsumed the donation that is separate and and on the unallowability of costs within the existing § 75.364(a). independent from the process to obtain associated with the acquisition of Accordingly, HHS does not believe that informed consent for the abortion. As human fetal tissue (proposed the proposed records access set forth in greater detail in the §§ 46.206(h), 75.364(a), and 75.478). It is requirements would add any Paperwork Reduction Act section of this HHS’s understanding that requirements incremental burden. regulatory impact analysis, and using such as these proposed requirements are Acquisition of Human Fetal Tissue. NIH intramural data as a proxy, HHS generally reflected in the grant HHS proposes to limit the sources from estimates that, on an annual basis, each which HHS recipients for research 54 research project would need to conduct As noted below, in that section, HHS believes involving human fetal tissue can obtain that most, if not all, recipients obtain informed human fetal tissue from abortion and to the informed consent process for the consents for the donation of human fetal tissue for donation of human fetal tissue an research and that many recipients utilize or require average of 8 times, in order to obtain the the utilization of a separate and independent 55 U.S. Bureau of Labor Statistics, May 2019 informed consent process. Accordingly, these National Occupational Employment and Wage amount of human fetal tissue needed for estimates represent HHS’s estimate of the total cost Estimates United States, available at https:// of a separate and independent informed consent www.bls.gov/oes/current/oes_nat.htm. 53 U.S. Bureau of Labor Statistics, May 2019 process on an annual basis, not the likely 56 U.S. Bureau of Labor Statistics, May 2019 National Occupational Employment and Wage incremental costs resulting from this proposed rule. National Occupational Employment and Wage Estimates United States, available at https:// However, HHS will use these costs for simplicity Estimates United States, available at https:// www.bls.gov/oes/current/oes_nat.htm. of analysis in this proposed rule. www.bls.gov/oes/current/oes131041.htm.

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

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award. Public comments will inform the • Prohibit providing enticements, year project period, most such annually ultimate designation of this rule. benefits, or financial incentives to the funded research projects represented pregnant woman or attending physician renewals, revisions, extensions, or Regulatory Flexibility Act to incentivize the occurrence of an continuations. The entities that hold the HHS has examined the economic abortion or human fetal tissue donation; NIH awards for such research projects implications of this proposed rule as • Prohibit providing valuable include major colleges and universities, required by the Regulatory Flexibility consideration for costs associated with medical schools, academic medical Act (RFA) (5 U.S.C. 601–612). The RFA obtaining human fetal tissue or the centers, major hospitals and children’s requires an agency to describe the abortion (if any) that is the source of the hospitals, biomedical research impact of a proposed rulemaking on human fetal tissue; institutions and several corporations. • small entities by providing an initial Mandate that research involving Many of these entities hold multiple regulatory flexibility analysis unless the human fetal tissue from elective NIH grants, cooperative agreements, or agency expects that the proposed rule abortions can only use such human fetal R&D contracts for research involving the will not have a significant impact on a tissue that is acquired or otherwise use of human fetal tissue; in FY 2019, substantial number of small entities, obtained from a Government, a there were a total of 71 unique provides a factual basis for this Government-owned entity, university, institutions with active NIH awards for determination, and proposes to certify college, accredited degree-granting research involving human fetal tissue.62 the statement. 5 U.S.C. 603(a), 605(b). If institution of higher education, university hospital, or academic Even if all of the entities that receive an agency must provide an initial such NIH awards were considered small regulatory flexibility analysis, this medical center; • Require that human fetal tissue be entities by virtue of their size or analysis must address the consideration nonprofit status,63 the proposed rule of regulatory options that would lessen treated respectfully and disposed of reasonably when no longer to be used in would not have a serious impact on a the economic effect of the rule on small significant number of small entities. The entities. For purposes of the RFA, small research; • Require HHS recipients that engage proposed rule would not impose entities include proprietary firms in human fetal tissue research to significant burdens not already imposed meeting the size standards of the Small provide HHS, inspectors general, and by federal or state law. As discussed Business Administration (SBA); 61 the Comptroller General with a right of above, if the proposed rule is finalized nonprofit organizations that are not access to all informed consent forms as proposed, each unique NIH awardee dominant in their fields; and small obtained for human fetal tissue research, would likely experience, at most, first governmental jurisdictions with and documents, papers, or other records year costs (including both one-time populations of less than 50,000. 5 U.S.C. as are necessary to establish that the costs, the cost of the separate informed 601(3)–(6). HHS considers a rule to have human fetal tissue was not obtained or consent process for the donation of a significant impact on a substantial transferred for valuable consideration human fetal tissue, and the cost of number of small entities if it has at least and that federal funds were not used to acquiring fetal tissue) totaling between a three percent impact on revenue on at acquire or otherwise obtain the human $6,050.92 and $6,132.77, associated least five percent of small entities. fetal tissue; and with the incremental burden of the Executive Order 13272 on Proper • Provide that expenses associated requirements proposed in this proposed Consideration of Small Entities in with the acquisition of human fetal rule and, thereafter, $5,561.70 to Agency Rulemaking reinforces the tissue from elective abortion for use in $5,643.55 per year in expenses for the requirements of the RFA and requires research are not allowable expenses separate informed consent process and HHS to notify the Chief Counsel for under Federal awards from an HHS for unreimbursed expenses to acquire Advocacy of the Small Business awarding agency. fetal tissue for the research.64 As noted Administration if the final rule may NIH is the only HHS component the above, the entities that hold the NIH have a significant economic impact on funds grants, cooperative agreements, or awards for such research projects a substantial number of small entities R&D contracts for research involving include major colleges and universities, under the RFA. Executive Order 13272, human fetal tissue. Between FY 2015 medical schools, academic medical 67 FR 53461 (Aug. 16, 2002). and FY 2019, NIH funded between centers, major hospitals and children’s As discussed, the proposed rule approximately 120 and 178 research hospitals, biomedical research would projects involving the use of human institutions and several corporations. • Require, prior to conducting fetal tissue from abortions each year, These entities generally correspond to research on human fetal tissue, that including between 15 and 55 new the following North American Industry informed consent be obtained from the research projects per year; with NIH- Classification (NAIC) codes and small pregnant woman; funded projects usually having a five entity size guidelines: 65

61 In the health care sector, from which the Department may draw recipients is the educational fields and, thus, also not small entities for purposes Department draws many of its biomedical research services sector, where the relevant small business of RFA. recipients, SBA considers businesses to be small by sizes range from $12.0 million to $30.0 million in 64 If the average of the highest annual intramural virtue of having less than between $8.0 million and annual revenues. Id. (sector 61). expenditures for fetal tissue is used to calculate the $41.5 million in average annual revenues, 62 In the regulatory impact analyses, HHS is using annual expenditure to acquire fetal tissue, the first depending on the particular type of business. See 80 as the number of unique organizations that year costs (including both one-time and annual U.S. Small Business Administration, Table of Small would be affected by the proposed rule, to ensure costs of fetal tissue acquisition) per unique Business Size Standards Matched to North that costs are not underestimated. recipient would range between $39,699.49 and American Industry Classification System Codes, 63 $39,781.65. Thereafter, annual costs (undiscounted) effective August 19, 2019 (sector 62), available at Some of the entities receiving NIH awards for https://www.sba.gov/sites/default/files/2019-08/ research involving the use of human fetal tissue are would total $39,210.27 and $39,292.12 per unique SBA%20Table%20of%20Size%20Standards_ public colleges or universities that may be awardee, associated with the costs of the separate Effective%20Aug%2019%2C%202019_Rev.pdf. considered components of state governments and, informed consent process and of acquiring human Inasmuch as colleges, universities and professional thus, not small entities for purposes of RFA. fetal tissue. schools (e.g., medical schools) and other Similarly, some of the entities are major private 65 See https://www.sba.gov/sites/default/files/ educational institutions may also receive colleges or universities, medical schools, academic 2019-08/SBA%20Table%20of%20Size%20 Department funding to conduct biomedical medical centers, or hospitals that may be nonprofit Standards_Effective%20Aug%2019%2C%202019_ research, the other sector from which the organizations that are considered dominant in their Rev.pdf.

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3% impact on Industry NAIC code Small entity size guideline revenue

Colleges, Universities and Professional Schools ...... 611310 $30 million in annual revenue ...... $900,000 HMO Medical Centers ...... 621491 $35 million in annual revenue ...... 1,050,000 General Medical and Surgical Hospitals ...... 622110 $41.5 million in annual revenue ...... 1,245,000 Specialty (except Psychiatric and Substance Abuse) Hospitals 622310 $41.5 million in annual revenue ...... 1,245,000 Research and Development in the Physical, Engineering and 541715 1,000 employees...... Life Sciences (except Nanotechnology and Biotechnology).

As noted above, HHS considers a rule in any one year. Accordingly, HHS has minimal impacts on such state colleges to have a significant impact on a not prepared a budgetary impact and universities. Therefore, HHS has substantial number of small entities if it statement or specifically addressed the determined that this proposed rule has at least a three percent impact on regulatory alternatives considered. would not have sufficient Federalism revenue on at least five percent of small implications to warrant the preparation Executive Order 13132—Federalism entities. The estimated potential impact of a Federalism summary impact on recipients of HHS/NIH awards for Executive Order 13132 establishes statement under Executive Order 13132, research involving human fetal tissue is certain requirements that an agency and that the rule would not implicate significantly lower than three percent of must meet when it promulgates a rule the requirements of Executive Orders the annual revenues of small entities in that imposes substantial direct 12866 and 13175 with respect to tribes. the relevant industries. Thus, HHS requirement costs on State and local Congressional Review Act anticipates that this rulemaking, if governments or has federalism finalized, would have minimal implications. Executive Order 13132, 64 Title E of the Small Business economic impact—and would not have FR 43255 (Aug. 10, 1999). HHS does not Regulatory Fairness Enforcement Act of a significant impact on a substantial believe that this proposed rule would 1996, also known as the Congressional number of small entities. HHS (1) impose substantial direct Review Act, defines a ‘‘major rule’’ as anticipates that the information requirements costs on State or local ‘‘any rule that the Administrator of the disclosures that would be required by governments; (2) preempt State law; or Office of Information and Regulatory the rule would, to the extent they would (3) otherwise have Federalism Affairs (OIRA) of the Office of result in a change from current practice, implications. Thus, the Department has Management and Budget finds has allow affected individuals to make determined that this proposed rule does resulted in or is likely to result in—(A) better informed decisions and allow not impose such costs or have any an annual effect on the economy of affected entities to better deploy Federalism implications. $100,000,000 or more; (B) a major resources in line with established Executive Order 12866 directs that increase in costs or prices for requirements for HHS recipients. As a significant regulatory actions avoid consumers, individual industries, result, HHS has determined, and the undue interference with State, local, or federal, State, or local government Secretary certifies, that this proposed tribal governments, in the exercise of agencies, or geographic regions; or (C) rule would not have a significant impact their governmental functions. Executive significant adverse effects on on a substantial number of small Order 12866 at 6(a)(3)(B). Executive competition, employment, investment, entities. Order 13175 further directs that productivity, innovation, or on the HHS seeks comment on this analysis agencies respect Indian tribal self- ability of United States-based of the impact of the proposed rule on government and sovereignty, honor enterprises to compete with foreign- small entities, and the assumptions that tribal treaty and other rights, and strive based enterprises in domestic and underlie this analysis. to meet the responsibilities that arise export markets.’’ 5 U.S.C. 804(2). Based from the unique legal relationship Unfunded Mandates Reform Act on the analysis of this proposed rule between the Federal Government and under Executive Order 12866, OMB has Section 202 of the Unfunded Indian tribal governments. Executive determined that this proposed rule Mandates Reform Act of 1995 (2 U.S.C. Order 13175 at 2(a). HHS does not would not likely to result in an annual 1532) requires that covered agencies believe that the proposed rule would effect of $100,000,000 or more, and prepare a budgetary impact statement implicate the requirements of Executive would not otherwise be a major rule for before promulgating a rule that includes Orders 12866 and 13175 with respect to purposes of the Congressional Review any Federal mandate that may result in tribal sovereignty. Act. the expenditure by State, local, and The proposed rule would add tribal governments, in the aggregate, or specificity to federal and state law Assessment of Federal Regulation and by the private sector, of $100 million in requirements with respect to informed Policies on Families 1995 dollars, updated annually for consent for the donation of human fetal Section 654 of the Treasury and inflation. Currently, that threshold is tissue for HHS-funded or conducted General Government Appropriations approximately $154 million. If a research and to federal law Act of 1999 requires Federal budgetary impact statement is required, requirements on the maintenance of departments and agencies to determine section 205 of the Unfunded Mandates documentation with respect to whether a proposed policy or regulation Act also requires covered agencies to compliance with federal law on could affect family well-being.66 If the identify and consider a reasonable informed consent and the bar on the number of regulatory alternatives before receipt of valuable consideration for 66 Public Law 105–277, Div. A, § 654, 112 Stat. promulgating a rule. HHS has human fetal tissue. Some HHS grants for 2681–480, 2681–528 (Oct. 21, 1998), codified at 5 determined that this proposed rule will research involving human fetal tissue U.S.C. 601 note. may be held by state colleges or Before implementing regulations that may affect not result in expenditures by State, family well-being, an agency is required to assess local, and tribal governments, or by the universities. However, HHS anticipates the actions as to whether the action private sector, of $154 million or more that the proposed rule would have only Continued

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determination is affirmative, then the research (45 CFR 46.204(k), 46.206(g)) elective abortion.70 Thus, HHS department or agency must prepare an and the proposal to expressly require estimated 80 burden hours at 200% of impact assessment to address criteria access to certain records (45 CFR the wage rate for an attorney, or a total specified in the law.67 HHS has 75.364(a)(1). of $11,177.60. determined that these proposed Informed Consent for the Donation of HHS estimates that an informed regulations would not have an impact Human Fetal Tissue. HHS proposes to consent process for the donation of on family well-being, as defined in the require, among other things, that (1) human fetal tissue that is independent Act. informed consent for the donation of of, and separate from, the process of human fetal tissue for research purposes Paperwork Reduction Act of 1995 obtaining informed consent for the be obtained from the woman; (2) the abortion procedure might take between Under the Paperwork Reduction Act informed consents contain certain 10 and 15 minutes per informed of 1995 (PRA), as amended (44 U.S.C. specific statements and be signed by consent. HHS expects that a nurse 3501–3520), agencies are required to both the woman and the person would be assigned to obtain the provide a 60-day notice in the Federal obtaining the informed consent; and (3) informed consents. Mean hourly wages Register and solicit public comment the informed consent for donation be for nurses range from $23.32 for before a collection of information obtained after the abortion decision has licensed practical nurses to $53.77 for requirement is submitted to the Office of been made and informed consent has nurse practitioners. HHS believes that it Management and Budget (OMB) for been provided for the abortion and is likely that such tasks would be review and approval. In order to fairly person obtaining the informed consent assigned to registered nurses. According evaluation whether an information be someone other than the person who to the Bureau of Labor Statistics,71 collection should be approved by OMB, obtains the informed consent for the registered nurses have a mean hourly section 3506(c)(2)(A) of the PRA abortion procedure. Current federal rate of $37.24. HHS assumes that the requires that agencies solicit comment human subjects protection regulations at total dollar value of labor, which on (1) whether the information 45 CFR 46.206 requires that HHS- includes wages, benefits, and overhead, collection is necessary and useful to funded research involving human fetal is equal to 200% of the wage rate, or carry out the proper functions of the tissue be conducted only in accord with $74.48. HHS does not have information agency; (2) the accuracy of the agency’s any applicable federal, state, or local on the number of times informed estimate of burden of the proposed laws and regulations. As noted above in consent would need to be sought, in collection of information; (3) the more detail, (1) most states require order to obtain the donation of human quality, utility, and clarity of the informed consent for the use of fetal fetal tissue necessary on an annual basis information to be collected (and ways to tissue in research; (2) since early 2016, for extramural research projects. enhance the same); and (4) NIH has expressed the expectation that Accordingly, HHS uses the likely recommendations to minimize the ‘‘informed consent to have been number of informed consents that burden of the collection of information obtained from the donor for any NIH- would have been necessary with respect on respondents, including through the funded research using human fetal to the human fetal tissue acquired by use of automated collection techniques, 68 tissue;’’ and (3) an AMA Ethics intramural NIH researchers for when appropriate, and other forms of Opinion, issued in June 2016, indicates intramural research projects, using the information and technology. that ‘‘physicians who are involved in number of human fetuses from which In accordance with these research that uses human fetal tissues tissue was obtained as a further proxy requirements, HHS is soliciting public should . . . [i]n all instances, obtain the for the number of informed consents. comments on the following proposed woman’s voluntary, informed consent in During the HHS review and audit, it requirements that may implicate the keeping with ethics guidance....’’69 reviewed NIH documentation with PRA. These proposed collection of Accordingly, HHS believes that all respect to the acquisition of human fetal information requirements relate to the entities receiving NIH funding for tissue for intramural research projects in proposal to require informed consent for research involving the use of human FY 2018; NIH also provided information the donation of human fetal tissue for fetal tissue have an informed consent concerning on-going intramural research form for the donation of human fetal projects invoIving human fetal tissue. In (1) strengthens or erodes the stability or safety of tissue and that such informed consent is FY 2018, intramural researchers the family and, particularly, the marital being obtained in most, if not all, commitment; instances. engaged in approximately 12 intramural (2) strengthens or erodes the authority and rights HHS recognizes that it proposes to research projects involving human fetal of parents in the education, nurture, and tissue, and acquired human fetal tissue supervision of their children; require certain specific statements in the (3) helps the family perform its functions, or informed consents that may not from approximately 45 fetuses, for an substitutes governmental activity for the function; currently be contained in such informed average of 3.75 per project. Accordingly, (4) increases or decreases disposable income or consent forms. Above, HHS estimated HHS proposes to estimate that, on an poverty of families and children; that it would take each recipient annual basis, each research project (5) action’s proposed benefits justify the financial approximately one hour of attorney time involving human fetal tissue would impact on the family; need to obtain an average of 4 informed (6) may be carried out by State or local to update its informed consent form for government or by the family; and the donation of human fetal tissue from consents for donation of human fetal (7) establishes an implicit or explicit policy tissue, for a total of 529.6 informed concerning the relationship between the behavior 68 See NIH Policy on Informed Consent for and personal responsibility of youth, and the norms Human Fetal Tissue Research, NOT–OD–16–033 70 In that regard, HHS proposes to provide sample of society. (Feb. 11, 2016), available at https://grants.nih/gov/ informed consent form provisions for voluntary use 5 U.S.C. 601 (note). grants/guide/notice-files/not-od-16-033.html; by recipients in an appendix to this preamble. To 67 If a regulation may affect family well-being, the October 2018 NIH Grants Policy Statement, Section the extent that recipients used the sample informed head of the agency is required to submit a written 4.1.14, available at https://grants.nih/gov/grants/ consent form provisions, it would tend to reduce certification to the director of OMB and to Congress policy/nihgps/html5/section_4/4.1.14_human_ burden on recipients. that the regulation has been assessed and to provide fetal_tissue_research.htm. 71 U.S. Bureau of Labor Statistics, May 2019 an adequate rationale for implementation of a 69 AMA Code of Medical Ethics Opinion 7.3.5, National Occupational Employment and Wage regulation that may negatively affect family well- available at https://www.ama.assn.org/delivering- Estimates United States, available at https:// being. Id. care/ethics/research-using-human-fetal-tissue. www.bls.gov/oes/current/oes291141.htm.

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consents (4 × 132.4, the average number informed consent process for the at the time of tissue collection’’; such of extramural research projects donation of human fetal tissue, utilizing ‘‘policy will be included in the terms involving human fetal tissue). HHS different personnel from, and occurring and conditions of grant and cooperative recognizes that not every woman who is after, the informed consent to the agreement awards as well as contracts asked to donate human fetal tissue abortion. These estimates would suggest issued for research involving human would agree; accordingly, HHS will that (1) 40 recipients would not fetal tissue.’’ Further, in NIH–OD–19– estimate that the informed consent experience any additional burden from 128,73 NIH indicated that all grants and process would need to be conducted an the proposed informed consent cooperative agreements awarded with, average of 8 times per project in order provisions because they are already or adding, human fetal tissue on or after to obtain the necessary human fetal using a separate informed consent September 25, 2019 would include tissue. On an annual basis, this results process for donation of human fetal certain terms and conditions, including in a total of between 176.89 and 264.8 tissue; (2) up to 20% (or 16 recipients) that the recipient has documentation burden hours for a separate and might experience the full per-recipient from the donating organization of independent informed consent process burden identified above as a result of compliance with the requirements of the for the donation of human fetal tissue, the proposed requirements because they informed consent process and for a total of between $13,174.77 and are not conducting any informed documentation that the human fetal $19,722.30. This suggests a total annual consent process; and (3) at least 30% (or tissue was not obtained or acquired for burden of between 2.21 and 3.31 hours 24 recipients) would experience some valuable consideration. Accordingly, the per unique recipient, and cost on an burden because they would need to proposed records access provision annual basis (undiscounted) for each divide their current informed consent merely provides specificity to the unique recipient of between $164.68 process into two processes. For general requirement in 45 CFR and $246.53 for a separate and example, the informed consent for 75.364(a), which parallels 2 CFR independent informed consent process donation of human fetal tissue, when 200.337(a), but does not impose any for the donation of human fetal tissue combined with the informed consent for new information collection for research. abortion, may take a shorter period of requirements. time as compared to two separate and HHS solicits public comment on the This would represent the collection of independent processes because of the potential burden associated with the information burden associated with the need to repeat certain information in the proposed requirements that would proposed informed consent second process. However, there could impose collection of information requirements if no recipients of NIH be some cost savings if the health care requirements, as outlined in this funding for research involving human provider conducting the informed section, including HHS’s assumptions fetal tissue were otherwise obtaining consent for the donation of human fetal and analysis, as well as on each of the such informed consents. However, as tissue was paid at a low hourly rate than required issues under section discussed in greater detail above, the health care provider conducting the 3506(c)(2)(A) of the PRA with respect to because of the state law requirements, informed consent for the abortion. each of these proposed requirements. the previous NIH policy statements, and Access to certain records. HHS HHS asks for public comment on the the AMA Ethics Opinion, as well as the proposes expressly to require that proposed information collection, size and sophistication of such NIH recipients provide access to informed including what additional benefits may recipients, HHS believes that most, if consent forms for research involving be cited as a result of this proposed rule. not all, recipients obtain informed human fetal tissue and such records as Comments regarding the collection of consents. Furthermore, the AMA Ethics are necessary to establish that such information proposed in this proposed Opinion emphasized that physicians tissue was not obtained or transferred rule must refer to the proposed rule by engaged in research that uses human for valuable consideration and that name and docket number as indicated fetal tissue should ensure that ‘‘[t]he federal funds were not used to acquire under ADDRESSES by the date specified woman’s decisions to terminate the or otherwise obtain human fetal tissue. under DATES. pregnancy is made prior to and HHS believes that this merely makes These information collection independent of any discussion of using express recipients’ current requirements will be submitted to OMB the fetal tissue for research purposes,’’ recordkeeping and access obligations. for review and approval. which suggests that the process to HHS’s grants regulations currently discuss, and obtain informed consent Appendix to the Preamble—Model require that recipients provide access to Informed Consent Form Provisions for, donation of human fetal tissue for the recipient’s records pertinent to the HHS provides these model informed research purposes should be separate federal award. 45 CFR 75.364; see also consent form provisions for comment. from and independent of the informed 2 CFR 200.337 (OMB uniform This is only model language to illustrate consent for the abortion, and NIH’s administrative requirements). NIH has the proposed informed consent Changes to NIH Requirements Regarding made its expectations on maintenance provisions in this proposed rule. HHS Proposed Human Fetal Tissue Research. and access to records regarding NIH- contemplates providing updated NOT–OD–19–128, indicated that NIH funded research involving human fetal guidance upon publication of the final expected that the informed consent for tissue clear: For example, in NIH Policy rule. These model provisions would donation of human fetal tissue would be on Informed Consent for Human Fetal obtained by someone other than the help regulated entities more easily Tissue Research,72 NIH stated that, person who obtained the informed comply with the informed consent ‘[w]hen obtaining primary human fetal consent for the abortion and would provisions of this proposed rule, tissue for research purposes, NIH occur after the informed consent for assuming the rule is finalized as expects grantees and contractors to abortion. Based on the foregoing, HHS proposed. However, use of such model maintain appropriate documentation estimates that 80% to 100% of NIH’s . . . that informed consent was obtained recipients obtain informed consent for 73 Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research, NOT–OD– the donation of human fetal tissue and 72 NIH–OD–16–033 (Feb. 11, 2016), available at 9–128 (July 26, 2019), available at https:// that 50% of such recipients already https://grants.nih.gov/grants/guide/notice-files/not- grants.nih/gov/grants/guide/notice-files/NOT-OD- require a separate and independent od-16-033.html. 19-128.html.

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provisions would not be required for I have had an opportunity to discuss Human Services proposes to amend 45 compliance with this proposed rule. In this with my provider and my questions CFR parts 46 and 75 as follows: addition, the language could be have been answered. amended to more accurately reflect the Please mark the statement that best PART 46—PROTECTION OF HUMAN understandings of the fetal tissue donor matches your preference: SUBJECTS and the particular situations. These or __I consent to donating fetal tissue for ■ 1. The authority citation for part 46 is similar provisions may be incorporated research. revised to read as follows: into a regulated entity’s informed __I do not want to donate fetal tissue consent form for donation of fetal tissue. to be used for research. Authority: 5 U.S.C. 301; 31 U.S.C. 503(b)(2)(2); 41 U.S.C. Ch. 13; 42; U.S.C. These concepts only address concepts Date and Time: lllllllllll and requirements set forth in this 216(b); 42 U.S.C. 289(a); 42 U.S.C. 289g–1; 42 Patient Name: lllllllllll U.S.C. 289g–2. proposed rule, and alone are not llllllllll sufficient to result in legally sufficient Patient Signature: ■ 2. Amend § 46.202 by adding informed consent for the donation of * * * * * paragraph (i) to read as follows: fetal tissue under State law and do not Attestation of Provider § 46.202 Definitions. include some formalities and substantive provisions that are required I attest that * * * * * (i) Human fetal tissue shall have the or typically included in legally • All options were presented to the definition ascribed to the term in 42 sufficient informed consents. Reliance patient. • U.S.C. 289g–1(g). on these model provisions is not I have documented the patient’s ■ preferences. 3. Amend § 46.204 by adding sufficient for compliance with state law paragraph (k) to read as follows: and does not replace consultation with • All relevant laws and regulations a lawyer. Furthermore, a regulated will be followed in completing the § 46.204 Research involving pregnant entity may want to include other abortion. women or fetuses. • provisions that are related to this The patient’s decision to donate * * * * * proposed rule, but that HHS has not fetal tissue will not affect the manner, (k) Notwithstanding any provisions to proposed through this proposed rule. methods and/or procedures used to the contrary in this Part, HHS-funded perform the abortion, nor will it affect research involving human fetal tissue Model Informed Consent for Human the timing of the abortion. The abortion obtained by donation from a pregnant Fetal Tissue Donation Provisions 74 will be performed in the same way, woman occurring after [the effective It is important to us that your regardless of the patient’s decision on date of the final rule] may not occur preferences and beliefs are respected. fetal tissue donation. without the written informed consent of If you are willing to donate fetal • I am not the individual who the pregnant woman from whom the tissue, the following statements apply: obtained the informed consent for the human fetal tissue was obtained. • I already have completed my patient’s abortion. (1) For purposes of this paragraph (k), consent form for the abortion. • No payments, in cash or in kind, informed consent requires that: • My decision about whether to were offered or provided to the patient (i) The pregnant woman’s consent be donate fetal tissue will not affect how or for the donation of human fetal tissue. documented on a written informed when my abortion is done. Regardless of Neither [insert name of facility] nor I consent form that is signed by the what I decide, the doctor will complete have provided, or obtained, any pregnant woman and written in plain my abortion in the usual way. valuable consideration for the human language that is clear and easily • The fetal tissue that I donate may be fetal tissue. understandable (‘‘Informed Consent kept for many years and may be used for Date and Time: lllllllllll Form’’); various research purposes. (ii) The Informed Consent Form • Provider Name, Title, and ID No.: lll The doctor performing the abortion include a statement that there have been will not benefit in any way from my Provider Signature: lllllllll and will be no enticements, benefits, or decision. * * * * * • financial incentives exchanged for the I will not receive any payment, Witness: donation or acquisition of human fetal benefit, or other incentives for donating Date and Time: lllllllllll tissue or the abortion (if any) from tissue. Name of Witness: llllllllll which such tissue was obtained; • I will not receive any medical Signature of Witness: llllllll (iii) The Informed Consent Form benefit from any research conducted permit the pregnant woman to choose to with the donated fetal tissue. List of Subjects donate fetal tissue for research or to • The research using the donated fetal 45 CFR Part 46 decline to donate fetal tissue for tissue may have commercial potential, research; and but I will not receive any financial or Human research subjects, Reporting (iv) The Informed Consent Form be other benefit from any commercial and record-keeping requirements, signed by both the pregnant woman and development from the research. Research. the individual obtaining the informed • I am [insert the age of majority in 45 CFR Part 75 consent for the donation, with the latter the jurisdiction where the informed attesting to the truth of the statements consent is being signed] or older. Accounting, Administrative practice • in the form. My preferences about donating fetal and procedure, Cost principles, Grant (2) With respect to human fetal tissue tissue for research will not affect my programs, Grant programs—health, obtained from elective abortions, care today or in the future at [insert Grants administration, Hospitals, informed consent also requires that: name of facility]. Nonprofit organizations reporting and (i) The pregnant woman’s informed recordkeeping requirements, and State consent be obtained after the decision to 74 Words or phrases contained in brackets are and local governments. intended as instructions to users of these model have an abortion has been conclusively provisions and are not intended to be included in For the reasons set forth in the made and informed consent for the the informed consent form provisions. preamble, the Department of Health and abortion has been obtained;

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(ii) The pregnant woman’s informed granting institution of higher education, elective abortions for use in research are consent be obtained by an individual university hospital, or academic not allowable expenses under Federal other than the individual who obtained medical center. awards from an HHS awarding agency. the informed consent for the pregnant (i) Once human fetal tissue is no Dated: December 29, 2020. woman’s abortion; longer to be used in research, it shall be Alex M. Azar II, (iii) The pregnant woman be at or over treated respectfully and disposed of Secretary, Department of Health and Human the age of majority in the jurisdiction in reasonably and in compliance with any Services. which the pregnant woman’s donation additional laws or regulations imposed [FR Doc. 2020–29107 Filed 1–11–21; 4:15 pm] is made; and by applicable state law. (iv) The Informed Consent Form BILLING CODE 4151–26–P include a statement that the decision to PART 75—UNIFORM ADMINISTRATIVE have an abortion and the method of REQUIREMENTS, COST PRINCIPLES, AND AUDIT REQUIREMENTS FOR HHS DEPARTMENT OF HEALTH AND abortion have not been affected by the HUMAN SERVICES decision whether to donate human fetal AWARDS tissue. ■ 45 CFR Part 5b ■ 5. The authority citation for 45 CFR 4. Amend § 46.206 by adding part 75 continues to read as follows: paragraphs (c) through (i) to read as [Docket Number NIH–2016–0002] follows: Authority: 5 U.S.C. 301. RIN 0925–AA62 ■ 6. Amend § 75.364 by adding § 46.206 Research involving, after delivery, Privacy Act; Implementation the placenta, the dead fetus or fetal paragraph (a)(1), adding and reserving material. paragraph (a)(2) and adding paragraph AGENCY: Department of Health and (d) to read as follows: * * * * * Human Services. (c) At all stages in the process to § 75.364 Access to records. ACTION: Notice of Proposed Rulemaking. acquire or otherwise obtain human fetal (a) * * * SUMMARY: tissue for use in research, there shall be The Department of Health and (1) For non-Federal entities that Human Services (HHS or Department) no enticements, benefits, or financial engage in human fetal tissue research incentives provided to the pregnant proposes to exempt confidential source pursuant to a Federal award, the HHS identifying information in a system of woman or attending physician to awarding entity, Inspectors General, the incentivize the occurrence of an records maintained by the National Comptroller General of the United Institutes of Health (NIH) from certain abortion or the donation or acquisition States, and the pass-through entity, or requirements of the Privacy Act. The of human fetal tissue. any of their authorized representatives, affected system of records is 09–25– (d) No person who solicits or must have the right of access to: knowingly acquires, receives, or accepts 0165, ‘‘National Institutes of Health (i) Copies of the informed consent (NIH) Office of Loan Repayment and a donation of human fetal tissue for use forms signed by each pregnant woman Scholarship (OLRS) Record System, in research shall provide valuable who is the source of human fetal tissue HHS/NIH/OD’’ (to be renamed ‘‘NIH consideration for the costs associated used by the non-Federal entity in Loan Repayment Records’’). Elsewhere with the abortion that is the source of research, which may be redacted with in today’s Federal Register, HHS/NIH the human fetal tissue used or to be respect to the name and signature of the has published an updated system of used in the research. woman; records notice (SORN) for system 09– (e) No person who solicits or (ii) all documents, papers, or other 25–0165 for public notice and comment. knowingly acquires, receives, or accepts records as are necessary to establish that DATES: Submit either electronic or a donation of human fetal tissue for use the human fetal tissue was not obtained in research shall provide valuable written comments regarding this or transferred for valuable document by March 15, 2021. consideration for the costs associated consideration, as that term is defined in ADDRESSES: You may submit comments, with the donation or acquisition of 45 CFR 46.206(f); identified by Docket Number NIH– human fetal tissue. (iii) all documents, papers, or other 2015–0002, via any of the following (f) For purposes of paragraphs (d) and records as are necessary to establish that methods: (e) of this section, the term ‘‘valuable federal funds were not used to acquire consideration’’ includes all payments or otherwise obtain the human fetal Electronic Submission other than reasonable payments tissue from elective abortions; and Submit electronic comments in the associated with the transportation, (iv) personnel familiar with such following way: implantation, processing, preservation, documents, for purposes of interview • Federal eRulemaking Portal: quality control, or storage of human and discussion concerning such https://www.regulations.gov. Follow the fetal tissue. documents, at reasonable times and instructions provided for submitting (g) Human fetal tissue obtained by locations. comments. donation from a woman occurring after (2) [Reserved] [the effective date of the final rule] may * * * * * Written Submission be used in research only if an informed (d) For purposes of this section, Submit written submissions in the consent that meets the applicable ‘‘human fetal tissue’’ shall have the following ways: requirements of § 46.204(k) has been definition ascribed to the term in 42 • Fax: 301–402–0169. • obtained with respect to the tissue. U.S.C. 289g–1(g). Mail: Daniel Hernandez, Acting (h) Research involving human fetal ■ 7. Add § 75.478 to subpart E to read NIH Regulations Officer, Office of tissue can use human fetal tissue from as follows: Management Assessment, National elective abortions only if such tissue is Institutes of Health, 6011 Executive acquired or otherwise obtained from a § 75.478 Expenses associated with Boulevard, Suite 601, MSC 7669, Federal or State Government, a Federal acquiring human fetal tissue for research. Rockville, MD 20852. or State Government-owned entity, Expenses associated with the In order to ensure more timely university, college, accredited degree- acquisition of human fetal tissue from processing of comments, HHS/NIH is no

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