Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules 2615 

1See Statement from the Department of Health 

and Human Services, June 5, 2019, available at 

https://www.hhs.gov/about/news/2019/06/05/ 

statement-from-the-department-of-health-andhuman-services.html. 

2See Statement from the Department of Health 

and Human Services, June 5, 2019, available at 

https://www.hhs.gov/about/news/2019/06/05/ 

statement-from-the-department-of-health-andhuman-services.html. 

DEPARTMENT OF EDUCATION 

34 CFR Part 300 

[Docket ID ED–2020–OSERS–0191] 

Proposed Guidance; Questions and 

Answers on Serving Children With 

Disabilities Placed by Their Parents in 

Private Schools 

Correction 

In proposed rule document 2020– 

27872 appearing on pages 82994–82995 

in the issue of Monday, December 21, 

2020, make the following correction: 

(1) On page 82994, in the third 

column, in the DATES section, change 

‘‘January 20, 2021’’ to read ‘‘January 21, 

2021.’’ 

[FR Doc. C1–2020–27872 Filed 1–12–21; 8:45 am] 

BILLING CODE 1301–00–D 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R07–OAR–2020–0620; FRL–10017– 

81–Region 7] 

Air Plan Approval; Missouri; Removal 

of Control of Emissions From Solvent 

Cleanup Operations 

Correction 

In proposed rule document 2020– 

28121 appearing on pages 82995 

through 82998 in the issue of Monday, 

December 21, 2020, make the following 

correction: 

(1) On page 82995, in the second 

column, in the DATES section, change 

‘‘January 20, 2021’’ to read ‘‘January 21, 

2021.’’ 

[FR Doc. C1–2020–28121 Filed 1–12–21; 8:45 am] 

BILLING CODE 1301–00–D 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2020–0053; FRL–10016–93] 

Receipt of Several Pesticide Petitions 

Filed for Residues of Pesticide 

Chemicals in or on Various 

Commodities (October 2020) 

Correction 

In proposed rule document 2020– 

28117 appearing on pages 82998 

through 83000 in the issue of Monday, 

December 21, 2020, make the following 

correction: 

(1) On page 82998, in the second 

column, in the DATES section, change 

‘‘January 20, 2021’’ to read ‘‘January 21, 

2021.’’ 

[FR Doc. C1–2020–28117 Filed 1–12–21; 8:45 am] 

BILLING CODE 1301–00–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

45 CFR Parts 46 and 75 

RIN 0991–AC15 

Establishment of Safeguards and 

Program Integrity Requirements for 

Health and Human Services-Funded 

Extramural Research Involving Human 

Fetal Tissue 

AGENCY: Office of the Secretary, 

Department of Health and Human 

Services. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: This is a notice of proposed 

rulemaking to amend certain regulatory 

provisions in order to adopt or 

strengthen safeguards and program 

integrity requirements applicable to 

extramural research involving human 

fetal tissue from elective abortions. 

DATES: Comments must be submitted on 

or before February 12, 2021. 

ADDRESSES: Comments must be 

identified by RIN 0991–AC15. Because 

of staff and resource limitations, 

comments must be submitted 

electronically to www.regulations.gov. 

Follow the ‘‘Submit a comment’’ 

instructions. 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including 

personally identifiable or confidential 

business information that is included in 

a comment. Before or after the close of 

the comment period, the Department of 

Health and Human Services will post all 

comments that were received before the 

end of the comment period on 

www.regulations.gov. Follow the search 

instructions on that website to view the 

public comments. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Barry at daniel.barry@hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

In September 2018, the Department of 

Health and Human Services (HHS) 

terminated a contract that provided 

human fetal tissue from elective 

abortions to the Food and Drug 

Administration (FDA) for the 

development of testing protocols. HHS 

terminated the contract because it was 

not sufficiently assured that the contract 

included the appropriate protections 

applicable to fetal tissue research or met 

all other procurement requirements. 

HHS subsequently initiated a 

comprehensive review of all HHS 

research involving human fetal tissue 

from elective abortions to ensure 

consistency with the statutes and 

regulations governing such research and 

to ensure the adequacy of procedures 

and oversight in light of the serious 

regulatory, moral, and ethical 

considerations involved. 

Promoting the dignity of human life 

from conception to natural death is one 

of the top priorities of President 

Trump’s administration. The audit and 

review informed the policy process that 

led to the administration’s decision, 

announced June 5, 2019,1 to discontinue 

National Institutes of Health (NIH) 

intramural research—research 

conducted within NIH by NIH 

researchers—involving the use of 

human fetal tissue from elective 

abortion. With respect to extramural 

research (research conducted outside of, 

but funded by, NIH, e.g., at universities), 

the administration announced that, for 

new extramural research grant 

applications or current research projects 

in the competitive renewal process 

(generally every five years) that propose 

to use fetal tissue from elective 

abortions and that are recommended for 

potential funding through NIH’s twolevel external scientific review process, 

an ethics advisory board will be 

convened to review the research 

proposal and recommend whether, in 

light of the ethical considerations, NIH 

should fund the research project— 

pursuant to a law passed by Congress 

(42 U.S.C 289a–1). 

In the same policy statement, HHS 

announced that it would also undertake 

changes to its regulations and to NIH 

grants policy to adopt or strengthen 

safeguards and program integrity 

requirements applicable to extramural 

research involving human fetal tissue 

from elective abortions.2 In this notice 

of proposed rulemaking, HHS proposes 

revisions to its Human Research 

Subjects Protection Regulations (45 CFR 

part 46, subpart B, Additional 

Protections for Pregnant Women, 

Human Fetuses, and Neonates) and its 

2616 Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules 

3See Nuremberg Code, available at https://

history.nih.gov/display/history/Nuremberg+Code. 

4See World Medical Association, Declaration of 

Helsinki—Ethical Principles for Medical Research 

Involving Human Subjects, available at 

www.wma.net/policies-post/wma-declaration-ofhelsinki-ethical-principles-for-medical-researchinvolving-human-subjects/. 

5Congressional Budget Office. Research and 

Development in the Pharmaceutical Industry. 

October 2006. 

6Federman DD, Hanna KE, Rodriguez LL, eds. 

Responsible Research: A Systems Approach to 

Protecting Research Participants. Washington, DC: 

National Academies Press; 2002. 

7Nass SJ, Levit LA, Gostin LO, eds. Beyond the 

HIPAA Privacy Rule: Enhancing Privacy, Improving 

Health Through Research. Washington, DC: 

National Academies Press; 2009. 

8Human Subjects Research: HHS Takes Steps to 

Strengthen Protections, But Concerns Remain. 

GAO–01–775T, May 23, 2001. 

9Scientific Research: Continued Vigilance 

Critical to Protecting Human Subjects. T–HEHS– 

96–102, Mar 12, 1996. 

10Scientific Research: Continued Vigilance 

Critical to Protecting Human Subjects. HEHS–96– 

72, Mar 8, 1996. 

11 Kim S, Ubel P, De Vries R. Pruning the 

regulatory tree: For human-subjects research, 

maximum regulation does not mean maximum 

protection. Nature 2009;457: 534–535. 

12Emanuel EJ, Wood A, Fleischman A, et al. 

Oversight of human participants research: 

Identifying problems to evaluate reform proposals. 

Ann Int Med 2004; 141(4): 282–291. 

13Lynn J, Baily MA, Bottrell M, et al. The ethics 

of using quality improvement methods in health 

care. Ann Int Med 2007;146(9):666– 673. 

grants regulations (45 CFR part 75) to 

provide additional safeguards 

concerning the use of such tissue in 

HHS-funded research. This proposed 

rule would strengthen informed consent 

requirements in Subpart B and help 

ensure compliance with the statutory 

ban on the provision of valuable 

consideration for human fetal tissue 

through clarifying recordkeeping and 

maintenance requirements for the 

acquisition of human fetal tissue for 

research. 

II. Background 

U.S. Federal regulations governing the 

protection of human subjects in research 

have been in existence for more than 

three decades. Nearly thirty years have 

passed since the ‘‘Common Rule’’ was 

adopted by 15 U.S. Federal departments 

and agencies in an effort to promote 

uniformity, understanding, and 

compliance with human subject 

protections. (HHS adopted the Common 

Rule in Subpart A of 45 CFR part 46.) 

The history of contemporary human 

subjects protections began in 1947 with 

the Nuremberg Code, developed for the 

Nuremberg Military Tribunal as 

standards by which to judge the human 

experimentation conducted by the 

Nazis.3 The Nuremberg Code set forth 

many of the basic principles governing 

the ethical conduct of human subjects 

research. Similar recommendations 

were made by the World Medical 

Association in its Declaration of 

Helsinki: Recommendations Guiding 

Medical Doctors in Biomedical Research 

Involving Human Subjects (Helsinki 

Declaration), first adopted in 1964 and 

subsequently revised many times.4

Basic regulations governing the 

protection of human subjects in research 

supported or conducted by HHS (then 

the Department of Health, Education 

and Welfare) were first published in 

1974, after a series of highly publicized 

research abuses. The enactment of the 

1974 National Research Act (Pub. L. 93– 

348) created the National Commission 

for the Protection of Human Subjects of 

Biomedical and Behavioral Research 

(National Commission). One of the 

charges of the National Commission was 

to identify the basic ethical principles 

that should underlie the conduct of 

biomedical and behavioral research 

involving human subjects and to 

develop guidelines to assure that such 

research is conducted in accordance 

with those principles. In 1979, the 

National Commission published 

‘‘Ethical Principles and Guidelines for 

the Protection of Human Subjects of 

Research,’’ also known as the Belmont 

Report (http://www.hhs.gov/ohrp/ 

policy/belmont.html). The Belmont 

Report identified three fundamental 

ethical principles for all human subjects 

research: Respect for persons, 

beneficence, and justice. Like the 

Nuremberg Code and Helsinki 

Declaration, the Belmont Report 

stressed the importance of obtaining 

informed consent before engaging in 

human subjects research. 

Based on the Belmont Report and 

other work of the National Commission, 

HHS revised and expanded its 

regulations for the protection of human 

subjects in the late 1970s and early 

1980s. The HHS regulations are codified 

at 45 CFR part 46, subparts A through 

E: 

• Subpart A: Basic HHS Policy for 

Protection of Human Research 

Subjects 

• Subpart B: Additional Protections for 

Pregnant Women, Human Fetuses, 

and Neonates Involved in Research 

• Subpart C: Additional Protections 

Pertaining to Biomedical and 

Behavioral Research Involving 

Prisoners as Subjects 

• Subpart D: Additional Protections for 

Children Involved in Research 

• Subpart E: Registration of Institutional 

Review Boards 

The statutory authority for the HHS 

regulations derives from 5 U.S.C. 301; 

42 U.S.C. 300v–1(b); and 42 U.S.C. 289. 

In 1991, 14 other Federal departments 

and agencies joined HHS in adopting a 

uniform set of rules for the protection of 

human subjects, known as the 

‘‘Common Rule,’’ identical to subpart A 

of 45 CFR part 46 of the HHS 

regulations. 

The Common Rule requires that 

Federally funded investigators in most 

instances obtain and document the 

informed consent of research subjects; 

requires Federally funded research be 

reviewed by an institutional review 

board (IRB); and describes the 

requirements for IRB membership, 

function, operations, research review, 

and recordkeeping. The regulations also 

delineate criteria for, and levels of, IRB 

review. Currently, except for human 

subjects research that is determined to 

be exempt from the regulations, 

Federally funded research involving 

human subjects is reviewed by an IRB 

in one of two ways: (1) By a convened 

IRB, or (2) through an expedited review 

process. 

Since the Common Rule was first 

developed, the landscape of research 

activities has changed dramatically, 

accompanied by a marked increase in 

the volume of research. It is estimated 

that total spending on health-related 

research and development by the drug 

industry and the Federal government 

has more than tripled since 1990.5

While traditional biomedical research 

conducted in academic medical centers 

continues to flourish, many studies are 

now also conducted at community 

hospitals, outpatient clinics, or 

physician-based practices. Clinical 

research is regularly conducted at 

multiple institutions across the U.S. and 

other countries. Recruitment firms, 

bioinformatics specialists, clinical trial 

coordinating centers, protocol 

developers, data analysts, contract 

research organizations (CROs), data and 

safety monitoring boards, communitybased organizations, and other entities 

have joined investigators and sponsors 

as part of the clinical research 

enterprise. 

The rapid growth and expansion of 

human subjects research generated 

many questions about whether the 

regulatory framework is adequate and 

appropriate for the protection of human 

subjects in the 21st century. 

Furthermore, decades of experience 

have revealed a great deal about the 

functioning—and limitations—of 

existing regulations, and prompted 

critical evaluations by the Institute of 

Medicine (IOM),6 7 the U.S. Government 

Accountability Office,8 9 10 and many 

scholars.11 12 13 Federal consideration of 

such revisions to the regulatory schema, 

Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules 2617 

14National Bioethics Advisory Commission, 

Ethical and Policy Issues in Research Involving 

Human Participants. Bethesda, MD; 2001. 

15 82 FR 7150. Examples of provisions of the 

Common Rule governing informed consent can 

currently be found at 75 CFR 46.116, 46.117, 

46.204, and 46.205. 

16 82 FR 7151. 

17For purposes of the 2017 Common Rule, a 

human subject includes a living person from whom 

a researcher obtains a biospecimen and, thus, 

requires informed consent with respect to the use 

of identifiable biospecimens in research. See, e.g., 

45 CFR 46.101(a), 46.102(e) (definition of human 

subject), 46.104(d)(7), (d)(8). Similarly, under 

Subpart B, if information associated with fetal 

material is recorded for research purposes in a 

manner that living individuals can be identified, 

they are research subjects. 45 CFR 46.206(b). 

18Canterbury v. Spence, 464 F.2d 772, 780 (D.C. 

Cir. 1972). 

19 Id. at 783. 

20See Moore v. Regents of Univ. of Cal., 793 P.2d 

479, 483 (Cal. 1990). 

21 Id. at 484 (emphasis in original). 

22See, e.g., T.D. v. N.Y. State Office of Mental 

Health, 228 A.D.2d 95, 116 (N.Y. App. Div. 1996) 

(describing New York law regarding informed 

consent for being a human research subject); 

DeGennaro v. Tandon, 873 A.2d 191, 189–197 

(Conn. App. 2005) (collecting cases requiring 

informed consent prior to undergoing medical 

procedures). 

23E.g., Ariz. Rev. Stat. Ann. § 36–2302 (2016); 

Ark. Code Ann. § 20–17–802 (2019); Fla. Stat. Ann. 

§ 390.0111 (2018); Ky. Rev. Stat. Ann. § 436.026; La. 

Rev. Stat. Ann. § 40:1061.24 (2015); Me. Rev. Stat. 

Ann. tit. 22, § 1593; Mass. Gen. Laws Ann. ch. 112, 

§ 12J (2008); Mich. Comp. Laws § 333.2685; Minn. 

Stat. Ann. § 145.422; Mo. Ann. Stat. § 188.036; N.D. 

Cent. Code § 14–02.2–01; N.D. Cent. Code §§ 14– 

02.2–02; N.M. Stat. Ann. § 24–9A–3; Ohio Rev. 

Code Ann. § 2919.14; Okla. Stat. Ann. tit. 63, § 1– 

735; R.I. Gen. Laws § 11–54–1; S.D. Codified Laws 

§ 34–23A–17; Utah Code Ann. § 76–7–310; Wyo. 

Stat. Ann. § 35–6–115 (2017). 

24E.g., 17 CA ADC § 100085 (2019). 

25AMA Code of Medical Ethics Opinion 7.3.5, 

available at https://www.ama-assn.org/deliveringcare/ethics/research-using-human-fetal-tissue. 

26 Id. 

in addition to the issues that suggest a 

need for revision, is not without 

precedent. In its 2001 concluding 

report, the National Bioethics Advisory 

Commission (NBAC) made 30 

recommendations that addressed areas 

including the scope and structure of the 

oversight system and the level of review 

applied to research; it emphasized the 

importance of the informed consent 

process, documentation and waiver of 

informed consent, protecting privacy 

and confidentiality, adverse event 

reporting, and review of cooperative or 

multi-site research studies.14

In January 2017, as part of an 

Executive Branch-wide update to the 

Common Rule, HHS promulgated 

revisions to Subpart A in order to 

modernize, strengthen, and make the 

Common Rule more effective. Among 

other things, the revisions established 

new requirements regarding the 

information that must be given as part 

of the informed consent process to 

prospective research subjects.15 The 

executive summary of the 2017 final 

rule noted that, ‘‘to the extent 

appropriate, the intent is to eventually 

amend the other subparts of the HHS 

human subjects protection regulations 

in 45 CFR part 46 (subparts B, C, D, and 

E).’’ 16

The notice of proposed rulemaking 

which led to the January 2017 revisions 

to the Common Rule proposed requiring 

consent for the use of de-identified 

biospecimens (but not for the use of 

biospecimens from deceased 

individuals, which was outside the 

scope of the Common Rule). As a result 

of comments, the Common Rule 

agencies declined to finalized such 

requirements in the 2017 Common Rule. 

See Federal Policy for the Protection of 

Human Subjects, 82 FR 7149, 7150, 

7153 (Jan. 17, 2017).17

However, federal and state courts 

have recognized the importance of 

obtaining informed consent prior to 

conducting medical procedures or 

research on human subjects, or before 

tissue taken from an individual is used 

in research. In the seminal case of 

Canterbury v. Spence, the D.C. Circuit 

Court of Appeals observed that ‘‘ ‘[e]very 

human being of adult years and sound 

mind has a right to determine what shall 

be done with his own body. . . .’ True 

consent to what happens to one’s self is 

the informed exercise of a choice, and 

that entails an opportunity to evaluate 

knowledgeably the options available 

and the risks attendant upon each.’’ 18

Moreover, it is ‘‘normally impossible to 

obtain a consent worthy of the name 

unless the physician first elucidates the 

options and the perils for the patient’s 

edification. Thus the physician has long 

borne a duty, on pain of liability for 

unauthorized treatment, to make 

adequate disclosure to the patient.’’ 19

Subsequent courts have expounded 

that informed consent is necessary if a 

patient’s tissue is to be used in research, 

especially where the physician 

extracting the tissue or his or her 

institution has a research or commercial 

interest. For example, in Moore v. 

Regents of University of California, the 

California Supreme Court held that, 

prior to providing medical treatment, a 

physician must obtain the patient’s 

informed consent, which requires 

disclosing all of the physician’s research 

and economic interests.20 As Moore 

recognized, informed consent is 

particularly important where the 

physician extracts human cells for use 

in subsequent research, since ‘‘a 

physician who treats a patient in whom 

he also has a research interest has 

potentially conflicting loyalties. This is 

because medical treatment decisions are 

made on the basis of proportionality— 

weighing the benefits to the patient 

against the risks to the patient. . . . A 

physician who adds his own research 

interests to this balance may be tempted 

to order a scientifically useful procedure 

or test that offers marginal, or no, 

benefits to the patient.’’ 21 Courts in 

other states have since recognized that 

informed consent is required prior to 

conducting research or performing 

various medical procedures.22

Many states have banned or placed 

strict limits on using human fetal tissue 

in research.23 Those states that have not 

banned human fetal tissue research 

often require the consent of the pregnant 

woman for the fetal tissue donation.24

The research and medical 

communities have also recognized the 

importance of obtaining informed 

consent before engaging in human fetal 

tissue research. In June 2016, the 

American Medical Association (AMA) 

issued a Code of Medical Ethics 

Opinion (Code of Ethics Opinion) that 

listed several steps that physicians 

involved in human fetal tissue research 

should take, including obtaining the 

informed consent of the pregnant 

woman.25 The AMA recognized that the 

use of fetal tissue for research purposes 

‘‘raises a number of ethical 

considerations, including the degree to 

which a woman’s decision to have an 

abortion might be influenced by the 

opportunity to donate fetal tissue.’’ 26 It 

further recognized that ‘‘[c]oncerns have 

also been raised about potential 

conflicts of interest when there is 

possible financial benefit to those who 

are involved in the retrieval, storage, 

testing, preparation, and delivery of 

fetal tissues.’’ Consequently, ‘‘[t]o 

protect the interests of pregnant women 

as well as the integrity of science,’’ the 

Code of Ethics Opinion stated that 

physicians who are involved in research 

that uses human fetal tissue should: 

• Not ‘‘offer[ ] money in exchange for 

fetal tissue.’’ 

• ‘‘In all instances, obtain the 

woman’s voluntary, informed consent,’’ 

including for fetal tissue from a 

miscarriage (spontaneous abortion) for 

research. Under the Code of Ethics 

Opinion, informed consent includes a 

‘‘disclosure of the nature of the research 

including the purpose of using fetal 

tissue, as well as informing the woman 

of a right to refuse to participate.’’ 

• When fetal tissue from an induced 

abortion is used for research purposes, 

ensure that: 

Æ ‘‘The woman’s decision to 

terminate the pregnancy is made prior 

to and independent of any discussion of 

2618 Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules 

27 Id. The Code of Ethics Opinion also addresses 

the use of fetal tissue in transplantation research or 

clinical care. 

28See, e.g., Fetal Tissue Transplantation Research 

Guidance (2003), available at https://www.hhs.gov/ 

ohrp/regulations-and-policy/guidance/fetal-tissuetransplanation/index.html. 

29HHS Grants Policy Statement (Jan. 1, 2007), 

available at https://www.hhs.gov/sites/default/files/ 

grants/grants/policies-regulations/hhsgps107.pdf. 

30See HHS Grants Policy Statement (Jan. 1, 2007) 

at II–16, available at https://www.hhs.gov/sites/ 

default/files/grants/grants/policies-regulations/ 

hhsgps107.pdf. 

31 Id. at II–17—II–18. 

32See Reminder of Legal Requirements Regarding 

the Acquisition and Use of Huma Fetal Tissue for 

Research Purposes, NOT=OD–15.143 (Aug. 14, 

2015), available at https://grants.nih.gov/grants/ 

guide/notice-files/NOT-OD-15-143.html. 

33See NIH Policy on Informed Consent for 

Human Fetal Tissue Research, NOT–OD–16–033 

(Feb. 11, 2016), available at https://grants.nih.gov/ 

grants/guide/notice-files/not-od-16-033.html. 

34 Id. 

35 Id. (emphasis added). 

36 Id. FDA’s Staff Manual Guides also contains 

guidance for FDA- funded or conducted research 

involving human fetal tissue. See FDA Staff Manual 

Guides, Volume IV—Agency Program Directive, 

General or Multidiscipline, Research Involving 

Human Fetal Tissue, SMG 9001.3 (Feb. 11, 2016). 

37October 2018 NIH Grants Policy Statement, 

Section 4.1.14, available at https://grants.nih.gov/ 

grants/policy/nihgps/html5/section_4/4.1.14_

human_fetal_tissue_research.htm. 

using the fetal tissue for research 

purposes.’’ 

Æ ‘‘Decisions regarding the technique 

used to induce abortion and the timing 

of the abortion in relation to the 

gestational age of the fetus are based on 

concern for the safety of the pregnant 

woman.’’ 

• ‘‘Ensure that health care personnel 

involved in the termination of a 

pregnancy do not benefit from their 

participation in the termination.’’ 27

HHS research and human research 

protection components have also 

adopted policies and provided guidance 

on research involving human fetal 

tissue. Subpart B requires that such 

research ‘‘be conducted only in accord 

with any applicable Federal, State, or 

local laws and regulations regarding 

such activities’’; the regulations further 

direct that ‘‘[n]o inducements, monetary 

or otherwise, will be offered to 

terminate a pregnancy’’ and that 

‘‘[i]ndividuals engaged in the research 

will have no part in any decisions as to 

the timing, method, or procedures used 

to terminate a pregnancy.’’ 45 CFR 

46.206(a), 46.204(h)–(i). Following 

enactment of the NIH Revitalization Act 

of 1993—which amended the Public 

Health Service Act to add (among other 

provisions) section 498A (42 U.S.C. 

289g–1), establishing certain 

requirements for research on fetal tissue 

transplantation, and section 498B (42 

U.S.C. 289g–2), barring valuable 

consideration in connection with the 

acquisition, receipt, or transfer of 

human fetal tissue—the Office for 

Human Research Protections issued 

guidance on fetal tissue transplantation 

research.28 In the January 2007 HHS 

Grants Policy Statement,29 HHS 

included specific provisions on research 

on human fetal tissue and 

transplantation of human fetal tissue. In 

the Grants Policy Statement, HHS noted 

that ‘‘[t]he scientific and ethical 

challenges associated with research 

utilizing human fetal tissue make it 

imperative that researchers and their 

organizations be fully aware of and in 

compliance with the Federal 

requirements,’’ noting particularly 

section 498B of the Public Health 

Service Act.30 It also noted the 

additional requirements of section 498A 

with respect to research on human fetal 

tissue transplantation.31 Given its preeminent role in conducting and funding 

biomedical research, NIH has also 

issued guidance on human fetal tissue 

in research. For example, on August 14, 

2015, it released ‘‘Reminder of Legal 

Requirements Regarding the Acquisition 

and Use of Human Fetal Tissue for 

Research Purposes,’’ NOT–OD–15–143. 

In that notice, NIH reminded its 

grantees and contractors that ‘‘research 

involving human fetal tissue must be 

conducted in accordance with 

applicable Federal, State and local laws, 

regulations, and policies, including the 

NIH Grants Policy Statement,’’ making 

specific reference to the Public Health 

Service Act provisions and to 45 CFR 

46.204(h)–(j) and 46.206.32 Early the 

following year, in 2016, NIH released its 

policy, applicable to both NIH 

intramural research investigators and 

extramural researchers, NIH ‘‘Policy on 

Informed Consent for Human Fetal 

Tissue Research.’’ 33 In that notice, NIH, 

which is ‘‘committed to ensuring that 

research involving human fetal tissue is 

conducted responsibly and meets the 

highest ethical standards,’’ stated that 

‘‘NIH-funded research involving human 

fetal tissue must be conducted in 

compliance with all applicable federal, 

state, and local laws and 

regulations. . . .’’ 34 NIH further noted 

that ‘‘[c]urrent federal laws and 

regulations require informed consent for 

research involving the transplantation of 

human fetal tissue and for research with 

human fetal material associated with 

information that can identify a living 

individual’’ and that ‘‘[m]ost states 

require informed consent for the use of 

fetal tissue in research. Accordingly, 

NIH expects informed consent to have 

been obtained from the donor for any 

NIH-funded research using human fetal 

tissue.35 NIH further noted that ‘‘[w]hen 

obtaining primary human fetal tissue for 

research purposes, NIH expects grantees 

and contractors to maintain appropriate 

documentation, such as an attestation 

from the health care provider or a third 

party supplier, that informed consent 

was obtained at the time of tissue 

collection.’’ 36 In October 2018, these 

expectations and requirements became 

part of NIH’s Grants Policy Statement.37

As noted above, in September 2018, 

HHS initiated a comprehensive review 

of all HHS research involving human 

fetal tissue from elective abortions to 

ensure consistency with statutory and 

regulatory requirements and to ensure 

the adequacy of procedures and 

oversight of such research in light of the 

serious regulatory, moral, and ethical 

considerations involved. As part of this 

audit and review, HHS personnel 

reviewed the contracts (or purchase 

orders, as applicable) executed by 

personnel at NIH for the acquisition of 

human fetal tissue from elective 

abortions, and sought to obtain, from the 

organizations that supplied such tissue 

to the NIH researchers, copies of the 

required informed consents for the 

donation of the fetal tissue for research 

purposes, as well as documentation that 

valuable consideration was not sought 

or given in connection with the transfers 

of fetal tissue. One tissue procurement 

organization, which procured human 

fetal tissue for a number of NIH 

intramural research projects, provided 

its template informed consent 

document. It, however, refused to 

produce any executed informed 

consents or documentation of its 

compliance with laws and NIH policies 

on the informed consent of the mother 

to donate the fetal tissue for research, 

and would not make any 

representations to HHS that such 

informed consents had been obtained. 

The organization also declined to 

provide HHS with financial 

documentation for HHS to assess 

compliance with federal prohibitions on 

valuable consideration. Informed 

consents were obtained from two other 

organizations, an academic institution 

that maintains a tissue bank and another 

private tissue procurement organization, 

which provided fetal tissue for two 

intramural research projects. While 

HHS’s inability to obtain information 

from one tissue procurement 

organization to confirm compliance 

with informed consent requirements 

and the bar on valuable consideration 

occurred in the context of HHS’s audit 

of intramural research involving human 

fetal tissue from elective abortions, and 

Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules 2619 

38See Changes to NIH Requirements Regarding 

Proposed Human Fetal Tissue Research, NOT–OD– 

19–128 (July 26, 2019), available at https://

grants.nih.gov/grants/guide/notice-files/NOT-OD19-128.html. 

39 Id. (citing NOT–OD–16–033). 

40 Id. The notice also required that the application 

describe plans for the treatment of human fetal 

tissue and its disposal when the research was 

complete, as well as assurances that such treatment 

and disposal would be consistent with such plans. 

Id. 

there are other sources from which 

researchers can and do obtain human 

fetal tissue, the organization at issue 

also provides human fetal tissue to a 

number of NIH-funded extramural 

researchers. As a result, HHS also 

became concerned that grantees, or 

those from whom fetal tissue had been 

obtained by grantees, may not always 

have readily available documentation of 

informed consents for fetal tissue 

research, or documentation that 

valuable consideration was not 

provided in exchange for human fetal 

tissue in connection with HHS-funded 

research, notwithstanding NIH’s policy 

requirements and section 498B of the 

Public Health Service Act (42 U.S.C. 

289g–2(a)), which prohibits acquiring, 

receiving, or otherwise transferring 

human fetal tissue for valuable 

consideration if the transfer affects 

interstate commerce. 

Building on these developments, in 

June 2019, HHS announced the 

Administration’s new policy with 

respect to human fetal tissue research. 

That announcement included a 

commitment to undertake changes to 

HHS regulations and to NIH’s grants 

policy to adopt or strengthen safeguards 

and program integrity requirements 

applicable to extramural research 

involving human fetal tissue. 

NIH began implementing the 

Administration’s policy with the 

issuance of Changes to NIH 

Requirements Regarding Proposed 

Human Fetal Tissue Research, NOT– 

OD–19–128.38 In that notice, NIH 

outlined for its extramural research 

community the new requirements and 

review considerations with respect to 

research supported by NIH that involves 

the proposed use of human fetal tissue 

obtained from abortions in extramural 

applications for grants, cooperative 

agreements, and research and 

development (R&D) contracts. It 

‘‘remind[ed] the community of 

expectations to obtain informed consent 

from the donor for any NIH-funded 

research using [human fetal tissue].’’ 39

The notice included requirements for a 

justification for the use of human fetal 

tissue for the proposed research; for 

planned written, voluntary, informed 

consent process for cell/tissue donation; 

and for budget information and 

justification for the quantity, type, and 

source of human fetal tissue, as well as 

a certification that valuable 

consideration has not been provided for 

the acquisition of such tissue. The 

notice outlined NIH’s expectations for 

the contents of the informed consents 

(and related assurances): Language that 

the informed consent for donation of 

human fetal tissue was obtained by 

someone other than the person who 

obtained the informed consent for 

abortion, occurred after the informed 

consent for abortion, and would not 

affect the method of abortion; no 

enticements, benefits, or financial 

incentives were used at any level of the 

process to incentivize abortion or the 

donation of human fetal tissue; and the 

informed consent was signed by both 

the woman and the person who 

obtained the informed consent. NIH also 

indicated that the NIH award recipient 

should have documentation from the 

human fetal tissue donating 

organization assuring adherence to the 

requirements of the informed consent 

process and documentation that human 

fetal tissue was not obtained or acquired 

for valuable consideration; the awardee 

would be expected to provide such 

assurance for each year of the award 

such research is conducted for the life 

of the award and to maintain this 

documentation in accordance with the 

NIH Record Retention and Access 

policy.40

As the next step in this process, HHS 

now proposes to make modifications to 

45 CFR part 46 Subpart B, which 

provides additional protections for 

pregnant women, human fetuses and 

neonates involved in research, and 45 

CFR part 75, which implements 

standard requirements for 

administrative and financial 

management of Federal awards. The 

decision to amend HHS’s regulations 

was the result of HHS’s comprehensive 

review of HHS research involving 

human fetal tissue from elective 

abortions. Given the serious regulatory, 

moral, and ethical considerations 

involved, HHS concluded that it is 

appropriate to (1) clearly identify, in 

regulation, the minimum requirements 

for informed consent for the donation 

and use of human fetal tissue in 

research, especially when the fetal 

tissue is obtained from elective 

abortions; (2) impose certain 

requirements to help ensure compliance 

with the statutory bar on the provision 

of valuable consideration for human 

fetal tissue. These conclusions also 

follow from consideration of the 

authorities described above, the views 

of the medical community, State laws, 

and a comprehensive review of the use 

of human fetal tissue in research by 

HHS. HHS recognizes that, with respect 

to informed consent, this proposal goes 

beyond the approach taken by the 

Common Rule (in subpart A) with 

respect to biospecimens. However, HHS 

has long recognized the need for 

additional research protections for 

certain vulnerable populations or 

certain types of research—hence, the 

existence of Subparts B, C, and D—and 

believes that the additional protections 

proposed here are warranted to protect 

the interests of pregnant women and the 

integrity of science, as well as the 

serious moral and ethical considerations 

noted above. With respect to research 

involving human fetal tissue, this 

proposed rule would also align Subpart 

B more expressly with NIH policy and 

the AMA’s Code of Ethics Opinion on 

the need for informed consent. HHS 

considered making no changes to 45 

CFR part 46 subpart B and part 75, or 

making more limited changes. However, 

HHS has determined that a rulemaking 

is necessary to, among other things, 

adopt, clarify, or strengthen safeguards 

and program integrity requirements and, 

thus, to ensure compliance with the 

federal statutes and policies addressing 

the use of human fetal tissue in HHSfunded research. 

III. Summary of the Notice of Proposed 

Rulemaking 

HHS proposes to amend 45 CFR part 

46, subpart B, Protection of Human 

Subjects, Additional Protections for 

Pregnant Women, Human Fetuses and 

Neonates Involved in Research, and 45 

CFR part 75, Uniform Administrative 

Requirements, Cost Principles, and 

Audit Requirements for HHS Awards, in 

the following ways: 

A. Definitions, § 46.202 

HHS is proposing to add a paragraph 

(i) to § 46.202. Paragraph (i) would 

provide that, for purposes of Subpart B 

of 45 CFR part 46, human fetal tissue 

shall have the definition ascribed to it 

in 42 U.S.C. 289g–1(g), namely ‘‘tissue 

or cells obtained from a dead human 

embryo or fetus after a spontaneous or 

induced abortion, or after a stillbirth.’’ 

While HHS proposes to define the term 

consistent with the statutory definition 

applicable to fetal tissue transplantation 

research and the prohibition on valuable 

consideration, many of the provisions 

proposed below would only apply to 

human fetal tissue derived from elective 

abortions and to HHS-funded research 

involving such tissue. 

For the purpose of implementing the 

June 2019 policy through NOT–OD–19– 

2620 Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules 

41 45 CFR 46.116, 46.117. 42AMA Code of Medical Ethics Opinion 7.3.5, 

available at https://www.ama-assn.org/deliveringcare/ethics/research-using-human-fetal-tissue. 43Canterbury v. Spence, 464 F.2d 772, 780 (D.C. 

Cir. 1972). 

128, NIH provided a more technical 

definition of research involving human 

fetal tissue from elective abortions as 

‘‘research involving the study, analysis, 

or use of primary [human fetal tissue], 

cells, and derivatives, and human fetal 

primary cell cultures obtained from 

elective abortions’’ and stated that it 

includes (1) human fetal primary or 

secondary cell cultures, whether 

derived by the investigator or obtained 

from a vendor; (2) animal models 

incorporating human fetal tissue from 

elective abortions, including obtaining 

such models from a vendor; (3) 

derivative products from elective 

abortion tissues or cells such as protein 

or nucleic acid extracts; and (4) any 

human extra-embryonic cells and tissue, 

such as umbilical cord tissue, cord 

blood, placenta, amniotic fluid, and 

chorionic villi, if obtained from the 

process of elective abortion.’’ NIH noted 

that this definition is consistent with 

the statutory definition that HHS 

proposes to adopt here for purposes of 

these regulations. To provide further 

specificity about the issue, NIH 

excluded certain types of research from 

the definition of research involving 

human fetal tissue from elective 

abortion, namely (1) human fetal 

primary or secondary cell cultures, if 

cells were not derived from an elective 

abortion; (2) already-established (as of 

June 5, 2019) human fetal cell lines (e.g., 

induced pluripotent stem cell lines from 

human fetal tissue, immortalized cell 

lines, differentiated cell lines); (3) 

derivative products from human fetal 

tissue or cells (e.g., DNA, RNA, protein) 

if not derived from elective abortion; (4) 

human extra-embryonic cells and tissue, 

including, but not limited to, umbilical 

cord tissue, cord blood, placenta, 

amniotic fluid, and chorionic villi if not 

derived from elective abortion; (5) 

human fetal cells present in maternal 

blood or other maternal sources; (6) 

embryonic stem cells or embryonic cell 

lines; and (7) research on 

transplantation of human fetal tissue 

from elective abortion for therapeutic 

purposes (because of the statutory 

provision(s) addressing such research, 

i.e., National Institutes of Health 

Revitalization Act of 1993, Pub. L. 103– 

43, sec. 113, 107 Stat. 126 (June 10, 

1993), which generally prohibits the 

imposition of a policy that precludes 

HHS from conducting or supporting any 

research on the transplantation of 

human fetal tissue for therapeutic 

purposes). 

NIH noted that its definition of 

research involving human fetal tissue 

from elective abortions is consistent 

with the statutory definition. As HHS 

proposes to adopt the statutory 

definition for these regulations, HHS is 

of the belief that this proposed 

definition is consistent with the 

definition adopted in the NIH notice, for 

purpose of implementing the enhanced 

review requirements, including review 

of such research proposals that fall 

within a fundable scoring range by 

ethics advisory boards, pursuant to 42 

U.S.C. 289a–1. Taking into 

consideration the different purposes and 

scope of the proposed regulation (which 

would apply to research involving all 

human fetal tissue, regardless of 

whether it was obtained from elective 

abortion) and the NIH notice 

(addressing research involving only 

human fetal tissue from elective 

abortion), HHS contemplates adopting 

the statutory definition with the express 

clarifications that (1) human fetal tissue 

includes human fetal primary tissue, 

cells from such tissue, and primary cell 

cultures; derivative products (including 

protein or nucleic acid extracts) from 

such tissues/cells; and any human extraembryonic cells and tissues, such as 

umbilical cord tissue, cord blood, 

placenta, amniotic fluid, and chorionic 

villi; and (2) human fetal tissue does not 

include established human fetal cell 

lines (including immortalized cell lines, 

induced pluripotent stem cell lines from 

human fetal tissue, and differentiated 

cell lines; human fetal cells present in 

maternal blood or maternal sources; and 

secondary use of data from human fetal 

tissue. HHS seeks comment on whether 

it would be appropriate to incorporate 

some or all of the specificity of the 

definition (and/or the exclusions from 

the definition) contained in the NIH 

notice; if so, which aspects of that 

definition (and/or the exclusions) 

should be incorporated into the 

definition for the purpose of this 

proposed rule; and if the contemplated 

express clarifications noted immediately 

above strike the right balance. 

B. Research Involving Pregnant Women 

or Fetuses, § 46.204 

HHS proposes to add paragraph (k) to 

§ 46.204, which governs research 

involving pregnant women or fetuses. 

Section 46.204 currently has two 

provisions which address abortion. 

Section 46.204(h) states that ‘‘[n]o 

inducements, monetary or otherwise, 

will be offered to terminate a 

pregnancy.’’ Similarly, § 46.204(i) 

currently requires that ‘‘[i]ndividuals 

engaged in research will have no part in 

any decisions as to the timing, method, 

or procedures used to terminate a 

pregnancy.’’ Proposed paragraph (k) 

would require that the pregnant woman 

provide informed consent before the 

human fetal tissue obtained from the 

woman is used in HHS-funded research. 

Subpart A of the Common Rule 

generally requires that, before research 

is conducted on a human research 

subject, the human subject must provide 

informed consent, but not for 

unidentifiable biospecimens.41 As 

discussed previously, state law 

generally requires informed consent for 

participation in research, as well as 

informed consent for the donation of 

tissue for research. In light of the serious 

ethical and moral considerations 

presented by the use of fetal tissue for 

research purposes, as well as to protect 

the interests of pregnant women (and 

the integrity of science), HHS proposes 

that the requirement for informed 

consent for tissue donation should 

apply to research involving human fetal 

tissue. Because the fetus cannot provide 

informed consent, it is appropriate to 

obtain the informed consent of the 

woman from whom the fetal tissue 

would be obtained. Such a requirement 

was included in the 2016 AMA Code of 

Ethics Opinion.42 For these reasons, 

HHS proposes to add these 

requirements in paragraph (k). HHS, 

however, does not propose to include in 

proposed paragraph (k) all statements 

that should be included in such an 

informed consent. HHS further proposes 

that the requirement for such informed 

consent would apply with respect to 

donations of fetal tissue by women 

occurring after the effective date of the 

final rule. 

HHS proposes that paragraph (k) 

would also establish specific 

requirements in order to meet informed 

consent requirements in this unique 

context: 

• The pregnant woman’s consent 

must be documented on a written 

informed consent form that is signed by 

the pregnant woman and written in 

plain language that is clear and easily 

understandable. As explained in 

Canterbury v. Spence, true consent is 

the informed exercise of a choice, and 

that entails an opportunity to evaluate 

knowledgeably the options available 

and the risks attendant upon each.43

This cannot occur if the pregnant 

woman’s options are presented using 

complex medical jargon. For this reason, 

in promulgating its 2017 revisions to the 

Common Rule, HHS ‘‘considered a 

growing body of literature that suggests 

informed consent forms have grown too 

lengthy and complex, adversely 

Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules 2621 

44 82 FR 7211. 

45See, e.g., CA HLTH & S § 125320 (‘‘A person 

may not knowingly, for valuable consideration, 

purchase or sell embryonic or cadaveric fetal tissue 

for research purposes pursuant to this chapter.’’); 

CO ST § 25–2–111.5 (‘‘No physician or institution 

that performs procedures for the induced 

termination of pregnancy shall transfer such tissue 

for valuable consideration to any organization or 

person that conducts research using fetal tissue.’’); 

IN ST 35–46–5–1.5 (making it a Level 5 felony to 

intentionally acquire, receive, sell, or transfer fetal 

tissue); MO ST 188.036 (‘‘No person shall offer any 

inducement, monetary or otherwise, to the mother 

or father of an unborn child for the purpose of 

procuring an abortion for the medical, scientific, 

experimental or therapeutic use of the fetal organs 

or tissue.’’). 

46See Moore, 793 P.2d at 483 (‘‘[A] person of 

adult years and in sound mind has the right, in the 

exercise of control over his own body, to determine 

whether or not to submit to lawful medical 

treatment.’’) (quoting Cobbs v. Grant, 8 Cal. 3d 229, 

242 (1972)); Canterbury, 464 F.2d at 780 (‘‘The root 

premise is the concept, fundamental in American 

jurisprudence, that ‘[e]very human being of adult 

years and sound mind has a right to determine what 

shall be done with his own body.’ ’’) (quoting 

Schloendorff v. Soc’y of N.Y. Hosp., 105 NE 92, 93 

(N.Y. 1914)). 

affecting their ability to effectively 

convey the information needed for 

prospective participants to make an 

informed decision about participating in 

research.’’ 44 For the pregnant woman’s 

consent to be informed, the 

consequences of her decision must be 

written in plain language that is clear 

and easily understandable. Moreover, 

the pregnant woman’s consent should 

be documented in writing. Requiring 

such documentation would also 

minimize costs by reducing uncertainty 

and the risk of subsequent disputes or 

litigation. 

• The form documenting the 

informed consent must include a 

statement that there have been and will 

be no enticements, benefits, or financial 

incentives to incentivize the donation or 

acquisition of human fetal tissue, or the 

abortion (if any) from which such tissue 

is obtained. This would require 

participants to document that they are 

following federal and state law. The 

Public Health Service Act already makes 

it unlawful for any person to knowingly 

acquire, receive, or otherwise transfer 

any human fetal tissue for valuable 

consideration if the transfer affects 

interstate commerce. See 42 U.S.C. 

289g–2. Many states also forbid persons 

from providing enticements, benefits, or 

financial incentives to donate human 

fetal tissue.45 HHS proposes that the 

statement also indicate that no 

enticement, benefit or financial 

incentive was provided to incentivize 

the abortion—as a mechanism to ensure 

that persons do not evade the statutory 

prohibition on providing valuable 

consideration for human fetal tissue by 

providing incentives for the abortion. 

Furthermore, after conducting its 

review, HHS has determined that it is 

unlikely that persons involved in 

human fetal tissue research would 

provide enticements, benefits, or 

financial incentives to incentivize an 

abortion, without also seeking to 

incentivize the human fetal tissue 

donation. 

• The form documenting the 

informed consent must permit the 

pregnant woman to choose to donate 

fetal tissue for research or to decline to 

donate fetal tissue for research. In order 

for informed consent for the donation of 

human fetal tissue to be truly voluntary, 

the donor has to understand that the 

donation decision is truly voluntary and 

that she can choose to donate the fetal 

tissue or can choose to decline to donate 

the fetal tissue. HHS proposes to require 

including both options on the form; it 

believes that this would help to ensure 

that the informed consent is truly 

voluntary. 

• The form documenting the 

informed consent must be signed by 

both the pregnant woman and the 

individual obtaining the informed 

consent for the donation, with both 

individuals attesting to the truth of the 

statements in the form. Given the 

serious moral and ethical considerations 

involved in human fetal tissue donation, 

it is appropriate to propose to require 

written documentation that the donor 

has provided informed consent and that 

the individual obtaining the informed 

consent has acted properly. Requiring 

both individuals’ signatures would 

reduce costs by reducing the risks of 

litigation or other disputes—and assist 

HHS and the research grant recipient 

ensure compliance with the statutory 

and regulatory requirements. 

These provisions would be applicable to 

all donations of human fetal tissue, 

regardless of whether the tissue was 

obtained from an elective abortion. This 

requirement is based on principals of 

informed consent or on a statute with 

respect to human fetal tissue, both of 

which are independent of the methods 

by which the fetal tissue is obtained. 

Where the human fetal tissue is to be 

obtained from an elective abortion, HHS 

further proposes that the informed 

consent include several additional 

provisions: 

• The pregnant woman’s informed 

consent must be obtained after the 

decision to have an abortion has been 

conclusively made and informed 

consent for the abortion has been 

obtained. This proposed requirement 

would be consistent with Congressional 

intent and the views of the medical 

community. Congress required that 

research on the transplantation of 

human fetal tissue that is funded or 

conducted by HHS can only occur if the 

attending physician who obtains the 

tissue declares that the consent of the 

woman for the abortion was obtained 

prior to requesting or obtaining consent 

for the donation of the tissue for use in 

research. 42 U.S.C. 289g–(b)(2)(A)(i). 

Likewise, the 2016 AMA Code of Ethics 

Opinion states that physicians involved 

in research that uses human fetal tissue 

should ensure that the woman’s 

decision to terminate the pregnancy is 

made prior to, and independent of, any 

discussion of using the fetal tissue for 

research purposes. Congress and the 

AMA recognize that a woman may not 

be truly providing informed consent to 

a human fetal tissue donation if the 

decision to donate is intermingled with 

the decision about whether to have an 

abortion. 

• The pregnant woman’s informed 

consent must be obtained by an 

individual other than the individual 

who obtained the informed consent for 

the pregnant woman’s abortion. This 

proposed requirement would help 

ensure that the decision whether to 

donate human fetal tissue is 

independent of the decision whether to 

have an abortion. 

• The pregnant woman must be at or 

over the age of majority in the 

jurisdiction in which the pregnant 

woman’s donation is made. American 

law has long recognized that important 

decisions about medical procedures 

should generally be made by adults.46

That is all the more so in this unique 

context that raises serious moral and 

ethical concerns. Accordingly, HHS 

proposes to impose this requirement 

with respect to the donation of human 

fetal tissue. 

• The form documenting the 

informed consent must include a 

statement that the decision to have an 

abortion and the method of abortion 

have not been affected by the decision 

whether to donate human fetal tissue. 

This would require documentation that 

the requirement concerning the order in 

which the informed consents are 

obtained, above, has been met. It would 

also ensure that the pregnant woman’s 

consent to the human fetal tissue 

donation is informed and independent, 

since the method of abortion would not 

be affected by the decision whether to 

donate human fetal tissue. 

HHS proposes to provide, in an 

appendix to the preamble, sample 

informed consent form provisions, as 

guidance to regulated entities on the 

type of informed consent form 

2622 Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules 

47See, e.g., AR Code § 20–17–801; GA ST § 16– 

12–141.1 (2017); IN ST § 16–34–3–4 (2016); SD ST 

§ 34–25–32.4; University of Minnesota Policy 

Statement Regarding Acquisition, Use, and 

Disposition of Donated Human Fetal Tissue for 

Transplantation Research, available at https://

policy.umn.edu/research/fetalresearch. 

provisions that would comply with the 

proposed informed consent 

requirements. This proposal would 

provide certainty to the regulated 

entities that they have sufficiently 

obtained informed consent and met the 

requirements of this proposed rule. 

However, the use of the sample 

provisions would not be required, and 

relevant parties would be free to use 

their own language in a form for 

informed consent for the donation of 

human fetal tissue as long as the form 

meets the proposed requirements. HHS 

seeks comment on the contents of 

sample informed consent form 

provisions. 

C. Research Involving Pregnant Women 

or Fetuses, § 46.206 

HHS proposes to add paragraphs (c), 

(d), (e), (f), (g), (h), and (i) to § 46.206. 

Paragraph (c) would require that, at 

all stages in the process to acquire or 

otherwise obtain human fetal tissue for 

use in research, there would be no 

enticements, benefits, or financial 

incentives provided to the pregnant 

woman or attending physician to 

incentivize the occurrence of an 

abortion or the donation or acquisition 

of human fetal tissue. HHS proposes to 

add this paragraph for the same reasons 

that it proposes to add paragraph 

(k)(1)(B) to § 46.204. Paragraph (c) 

would help implement 42 U.S.C. 289g– 

2 and specify what is required by that 

provision in the context of research 

involving pregnant women, fetuses, or 

human fetal tissue. 

Paragraph (d) would require that no 

person who solicits or knowingly 

acquires, receives, or accepts a donation 

of human fetal tissue for use in research 

shall provide valuable consideration for 

the costs associated with the acquisition 

of the fetal tissue or with any abortion 

that may be the source of the human 

fetal tissue used or to be used in the 

research. HHS proposes to add 

paragraph (d) for some of the same 

reasons that it proposes to add 

paragraph (k)(1)(B) to § 46.204. 

Permitting a person to provide valuable 

consideration for costs associated with 

the abortion that is the source of the 

human fetal tissue could impact the 

decision whether to donate human fetal 

tissue which should be independent of 

the decision whether to have an 

abortion. Moreover, permitting a person 

to provide valuable consideration for 

such costs could enable the person, by 

claiming they are merely paying for the 

costs of the abortion and not the human 

fetal tissue, to circumvent the 

prohibition on providing valuable 

consideration for human fetal tissue. If 

a person could provide valuable 

consideration for the abortion, 

enforcement actions arising out of 

payments for human fetal tissue would 

frequently face evidentiary questions 

about whether the payment was for the 

costs associated with the abortion, 

rather than the human fetal tissue. 

Paragraph (e) would require that no 

person who solicits or knowingly 

acquires, receives, or accepts a donation 

of human fetal tissue for use in research 

shall provide valuable consideration for 

the costs associated with the donation 

or acquisition of human fetal tissue. 

HHS proposes to add paragraph (e) for 

some of the same reasons that it 

proposes to add paragraph (k)(1)(B) to 

§ 46.204. Furthermore, paragraph (e) 

would (1) eliminate any uncertainty 

about whether 42 U.S.C. 289g–2’s 

prohibition on providing valuable 

consideration for the acquisition, 

receipt, or transfer of human fetal tissue 

applies to human fetal tissue research, 

and (2) specify what is required to 

comply with that provision in the 

human fetal tissue research context. 

Paragraph (f) would define ‘‘valuable 

consideration’’ for purposes of 

paragraphs (d) and (e) as all payments 

other than payments associated with the 

transportation, implantation, 

processing, preservation, quality 

control, or storage of human fetal tissue. 

Paragraph (f) is in accord with 42 U.S.C. 

289g–2(e)(3), which provides that 

‘‘valuable consideration’’ does not 

include reasonable payments associated 

with the transportation, implantation, 

processing, preservation, quality 

control, or storage of human fetal tissue. 

Paragraph (f) would also provide 

certainty to those involved in human 

fetal tissue research, by making clear 

that the enumerated costs are the only 

ones that do not constitute ‘‘valuable 

consideration’’ for purposes of § 46.206. 

Paragraph (g) would emphasize that 

human fetal tissue may be used in 

research only if an informed consent 

that meets the applicable requirements 

of § 46.204(k) has been obtained with 

respect to the tissue donation. HHS 

proposes that the requirement would 

apply with respect to donations of fetal 

tissue by women where the initial 

donation occurs after the effective date 

of the final rule. 

Paragraph (h) would provide that 

human fetal tissue from elective 

abortions can only be used in research 

conducted or funded by HHS if the 

human fetal tissue is acquired or 

otherwise obtained from Federal or 

State Governments, Federal or State 

Government-owned entities, 

universities, colleges, accredited degreegranting institutions of higher 

education, or university hospitals or 

other academic medical centers. In this 

context that implicates serious moral 

and ethical considerations, HHS is 

committed to ensuring that research 

conducted using human fetal tissue has 

been obtained through appropriate 

procedures, including that the informed 

consent associated with the donation of 

fetal tissue is truly voluntary and not 

performed on an ad hoc basis or by 

those who are not sufficiently qualified. 

Thus, this proposed requirement would 

establish additional safeguards to ensure 

that the procurement of human fetal 

tissue is conducted by organizations or 

institutions that are familiar with, and 

accustomed to complying with, 

informed consent requirements and that 

are regularly subject to oversight by 

HHS—and is not obtained by 

organizations or individuals that are not 

qualified to implement such 

requirements, that are not otherwise 

subject to regulation and oversight by 

HHS, and that accordingly may not 

respond to requests for access to 

records. HHS also believes that 

paragraph (h) strengthens program 

integrity by making sure that the entities 

obtaining human fetal tissue for 

research are substantially more likely to 

comply with these requirements, 

especially in a manner that complies 

with the concerns expressed by 

Congress when it placed limits on the 

use of human fetal tissue in the Public 

Health Service Act. 

Paragraph (i) requires that, once 

human fetal tissue is no longer to be 

used in research, it shall be treated 

respectfully and disposed of reasonably 

and in compliance with any additional 

laws or regulations imposed by 

applicable state law. By its statutory 

enactments, Congress has expressed that 

members of the public should proceed 

carefully when their actions involve 

human fetal tissue. HHS believes that 

paragraph (i) would further implement 

this concern at minimal burden. Many 

states and accredited academic 

institutions have already adopted 

statutes or policies with similar 

requirements.47 HHS asks for comment 

on this proposed regulatory requirement 

and the contours of such proposed 

requirement. 

D. Access to Records, § 75.364 

HHS’s grants regulations, at 

§ 75.364(a), provide that, among others, 

the HHS awarding agency, HHS 

Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules 2623 

48See, e.g., Final Report of the Select 

Investigative Panel of the Energy & Commerce 

Committee (Dec. 30, 2016), at xxi, xxvii, xxviii, 

xxix, xxxi, xxxviii, 16. 

49See, e.g., 45 CFR 75.420–75.475 (general 

provisions for selected items of cost), 75.476–75.477 

(HHS selected items of cost). 

50See Statement from the Department of Health 

and Human Services, June 5, 2019, available at 

https://www.hhs.gov/about/news/2019/06/05/ 

statement-from-the-department-of-health-andhuman-services.html. 

Inspector General, and the Comptroller 

General of the United States, or any of 

their authorized representatives, ‘‘must 

have the right of access to any 

documents, papers, or other records’’ of 

the non-Federal entity (that is, the 

recipient of HHS funds) which are 

‘‘pertinent to the Federal award, in 

order to make audits, examinations, 

excerpts, and transcripts’’—including 

‘‘timely and reasonable access to 

personnel for the purpose of interview 

and discussion related to such 

documents.’’ 45 CFR 75.364; see also 2 

CFR 200.337 (OMB uniform 

administrative requirements). HHS 

proposes to add a paragraph (a)(1), 

which would specifically require that 

non-Federal entities that engage in 

human fetal tissue research pursuant to 

a Federal award provide the HHS 

awarding agency, the Inspector General, 

the Comptroller General of the United 

States, and the pass-through entity or 

any of their authorized representatives, 

with a right of access to (1) all informed 

consent forms obtained by the nonFederal entity for human fetal tissue 

research, which may be redacted with 

respect to the name and signature of the 

woman (for privacy purposes); (2) all 

documents, papers, or other records as 

are necessary to establish that the 

human fetal tissue was not obtained or 

transferred for valuable consideration; 

(3) all documents, papers, or other 

records as are necessary to establish that 

federal funds were not used to acquire 

or otherwise obtain the human fetal 

tissue from elective abortions; and (4) 

personnel familiar with the foregoing 

documents, for purposes of interview 

and discussion related to such 

documents. 

Paragraph (a)(1) would impose little, 

if any, additional burdens or costs. 45 

CFR 75.364(a) already requires that the 

HHS awarding agency, inspectors 

general, the Comptroller General, and 

any of their authorized representatives 

have the right of access to any 

documents, papers, or other records of 

the non-Federal entity which are 

pertinent to the Federal award, in order 

to make audits, examinations, excerpts, 

and transcripts. Paragraph (a)(1) would 

simply provide clarity to recipients 

involved in human fetal tissue research 

by specifying certain categories of the 

documents, papers, and records (and 

personnel) for which a right of access 

must be provided. Because of the 

unique context and serious regulatory, 

ethical, and moral considerations 

involved in human fetal tissue research, 

HHS believes it would be beneficial to 

specifically remind this subset of 

recipients in advance of the documents, 

papers, and records (and personnel) for 

which HHS has a right of access. 

Moreover, a 2016 House of 

Representatives committee report found 

that certain institutional review boards 

lacked records regarding their oversight 

of fetal tissue research and 

transplantation, and the committee was 

unable to obtain access to records that 

could determine whether fetal tissue 

was obtained for valuable 

consideration.48 Because of the 

uncertainty over whether required 

documents are being maintained, HHS 

proposes to reiterate that recipients 

must maintain required documents and 

provide the HHS awarding agency, 

among others, with access to such 

documents and personnel upon request. 

Paragraph (a)(1) would therefore also 

strengthen program integrity. 

By its statutory enactments, Congress 

has expressed that members of the 

public should proceed carefully when 

their actions involve human fetal tissue 

and that valuable consideration should 

not be provided in order to acquire 

human fetal tissue. HHS proposes, 

below, that federal funds not be used to 

acquire human fetal tissue from elective 

abortions; HHS believes that it is 

particularly important to be good 

stewards of federal funds in this 

context. Given the aforementioned 

concerns, HHS believes that recipients 

should be able to document that 

valuable consideration was not 

provided to acquire human fetal tissue 

and that federal funds were not used to 

acquire human fetal tissue from elective 

abortions. 

HHS also proposes to add a paragraph 

(d), which would provide that, for 

purposes of § 75.364, ‘‘human fetal 

tissue’’ shall have the definition 

ascribed to it in 49 U.S.C. 289g–1. 

Paragraph (e) would clarify for 

recipients what is meant by ‘‘human 

fetal tissue,’’ and would define that term 

in a way that conforms to the definition 

provided by Congress. As with the 

proposed definition of ‘‘human fetal 

tissue’’ for purposes of Subpart B of 45 

CFR part 46, HHS believes that this 

proposed definition is consistent with 

the definition adopted in the NIH notice 

for purpose of implementing the 

enhanced review requirements. 

Similarly, HHS contemplates adopting 

the statutory definition with the express 

clarifications that (1) human fetal tissue 

includes human fetal primary tissue, 

cells from such tissue, and primary cell 

cultures; derivative products (including 

protein or nucleic acid extracts) from 

such tissues/cells; and any human extraembryonic cells and tissues, such as 

umbilical cord tissue, cord blood, 

placenta, amniotic fluid, and chorionic 

villi; and (2) human fetal tissue does not 

include established human fetal cell 

lines (including immortalized cell lines, 

induced pluripotent stem cell lines from 

human fetal tissue, and differentiated 

cell lines; human fetal cells present in 

maternal blood or maternal sources; and 

secondary use of data from human fetal 

tissue. HHS seeks comment on whether 

it would be appropriate to incorporate 

some or all of the specificity of the 

definition (and/or the exclusions from 

the definition) contained in the NIH 

notice; if so, which aspects of that 

definition (and/or the exclusions) 

should be incorporated into the 

definition for the purpose of this 

proposed rule; and if the contemplated 

express clarifications noted immediately 

above strike the right balance. 

E. Expenses Associated With Acquiring 

Certain Human Fetal Tissue for 

Research, § 75.478 

In its grants regulation in 45 CFR part 

75, HHS addresses certain select items 

of costs and identifies certain costs that 

are or are not allowable under HHS’s 

funding awards.49 HHS proposes to add 

§ 75.478. Section 75.478 would provide 

that expenses associated with the 

acquisition of human fetal tissue from 

elective abortions for use in research are 

not allowable expenses under Federal 

awards from an HHS awarding agency. 

As a result of the comprehensive review 

that HHS undertook and in light of the 

serious regulatory, moral, and ethical 

considerations involved, HHS has 

concluded that such costs should not be 

allowable—that is, they are not 

expenses that should be borne by the 

taxpayer through the federal research 

award. HHS would continue to fund 

research involving such human fetal 

tissue, consistent with the June 5, 2019 

policy,50 but it proposes that funds from 

HHS research awards could not be used 

for the acquisition of human fetal tissue 

from elective abortions. HHS encourages 

the recipients of HHS awards for 

research involving human fetal tissue 

from elective abortions to obtain human 

fetal tissue by donation or no-cost 

material transfer agreement. 

2624 Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules 

IV. Request for Comment 

HHS seeks comment on all aspects of 

this proposed rule and the model 

informed consent form provisions, 

including the likely impacts of the 

proposed rule, as compared to the status 

quo. HHS also seeks comment on its 

regulatory impact analysis. 

V. Regulatory Impact Analysis 

HHS has examined the impacts of this 

proposed rule as required under 

Executive Order 12866 on Regulatory 

Planning and Review, 58 FR 51,735 

(Oct. 4, 1993); Executive Order 13563 on 

Improving Regulation and Regulatory 

Review, 76 FR 3821 (Jan. 21, 2011); 

Executive Order 13771 on Reducing 

Regulation and Controlling Regulatory 

Costs, 82 FR 9339 (Feb. 3, 2017); the 

Regulatory Flexibility Act (Pub. L. 96– 

354 (Sept. 19, 1980) (codified as 

amended at 5 U.S.C. 601–612)) and 

Executive Order 13272 on Proper 

Consideration of Small Entities in 

Agency Rulemaking, 67 FR 53461 (Aug. 

16, 2002); section 202 of the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–04, 109 Stat. 48 (Mar. 22, 1995)); 

Executive Order 13132 on Federalism, 

64 FR 43255 (Aug. 4, 1999), Subtitle E 

of the Small Business Regulatory 

Enforcement Fairness Act of 1996 (Pub. 

L. 104–121, 110 Stat. 847 (Mar. 29, 

1996) (codified as amended at 5 U.S.C. 

801–808)) (commonly known as the 

Congressional Review Act); section 654 

of the Treasury and General 

Government Appropriations Act of 1999 

(the Assessment of Federal Regulation 

and Policies on Families); and the 

Paperwork Reduction Act of 1995, 44 

U.S.C. 3501 et seq. 

Executive Orders 12866 and 13563 

Determination 

Executive Order 12866 directs 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

if regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety effects; distributive impacts; 

and equity). Executive Order 13563 is 

supplemental to Executive Order 12866 

and reaffirms the principles, structures, 

and definitions governing regulatory 

review established there. For significant 

regulatory actions, Executive Order 

12866 requires ‘‘an assessment, 

including the underlying analysis,’’ of 

benefits and costs ‘‘anticipated from the 

regulatory action.’’ Executive Order 

12866, §§ 6(a)(3)(C), 3(f)(1). 

The Office of Management and Budget 

(OMB) has determined this proposed 

rule is a ‘‘significant regulatory action’’ 

under Executive Order 12866, § 3(f)(4), 

in as much as it raises novel legal or 

policy issues that arise out of legal 

mandates, the President’s priorities, or 

the principles set forth in an Executive 

Order, but that it is not economically 

significant in that it will not have an 

annual effect on the economy of greater 

than $100 million in one year. Thus, the 

Office of Management and Budget has 

reviewed it. Under Executive Order 

13563, in proposing this rule, HHS has 

attempted to promote coordination, 

simplification, and harmonization; has 

sought to identify means to achieve 

regulatory goals that are designed to 

promote innovation; and has ensured 

the objectivity of any scientific and 

technological information and processes 

used to support this proposed rule. 

Summary of and Need for Proposed 

Rule 

HHS recognizes that conducting and 

funding research involving human fetal 

tissue from abortions presents serious 

regulatory, moral, and ethical 

considerations. The principle of 

informed consent is central to the 

practice of medicine, as well as to 

human subjects research. Federal and 

state laws and policies recognize the 

importance of informed consent, not 

only for research involving human 

subjects, but also for the donation of 

human tissue and cells for research 

purposes. This informed consent is 

especially important when the tissue 

being donated is human fetal tissue and 

the source of such tissue is elective 

abortions. Congress has similarly 

recognized the moral and ethical issues 

implicated by the acquisition of human 

fetal tissue and the use of human fetal 

tissue in research: It amended the Public 

Health Service Act to, among other 

things, make it unlawful ‘‘for any person 

to knowingly acquire, receive, or 

otherwise transfer any human fetal 

tissue for valuable consideration’’— 

which ‘‘does not include reasonable 

payments associated with the 

transportation, implantation, 

processing, preservation, quality 

control, or storage of human fetal 

tissue’’—if the transfer affects interstate 

commerce. 

As a result of a comprehensive review 

of HHS research involving human fetal 

tissue from elective abortion and in light 

of the serious regulatory, moral and 

ethical considerations involved, HHS 

determined that it would be appropriate 

to undertake changes to its regulations 

to adopt or strengthen safeguards and 

program integrity requirements 

applicable to extramural research 

involving human fetal tissue. These 

safeguards and program integrity 

requirements relate to the informed 

consent process and the statutory bar on 

the provision of valuable consideration 

in connection with the transfer of 

human fetal tissue. HHS believes that 

additional informed consent statements 

and procedures are needed to ensure 

that (1) the informed consent to the 

donation of human fetal tissue from 

abortion is in fact voluntary and 

informed, and not motivated by any 

enticements, benefits, or financial 

considerations, and (2) there is 

separation between the decision and 

consent for abortion and the decision on 

the donation of fetal tissue, such that 

the abortion decision is not influenced 

by considerations relating to the 

research, including the potential 

contribution to biomedical research that 

could cure disease, advance 

understanding of diseases, and the like. 

Similarly, HHS desires to strengthen 

recipients’ understanding of, and 

compliance with, the informed consent 

requirements and the statutory bar on 

the provision and receipt of valuable 

consideration for human fetal tissue by 

ensuring access to records relating to 

such issues for oversight purposes. 

Accordingly, the proposed rule 

would: 

• Require, prior to conducting 

research on human fetal tissue, that 

informed consent, including certain 

statements, be obtained from the 

pregnant woman; 

• Prohibit providing enticements, 

benefits, or financial incentives to the 

pregnant woman or attending physician 

to incentivize the occurrence of an 

abortion or human fetal tissue donation; 

• Prohibit providing valuable 

consideration for costs associated with 

obtaining human fetal tissue or the 

abortion (if any) that is the source of the 

human fetal tissue; 

• Mandate that research involving 

human fetal tissue from elective 

abortions can only use human fetal 

tissue that is acquired or otherwise 

obtained from a Government, 

Government-owned entities, university, 

college, accredited degree-granting 

institution of higher education, 

university hospital, or academic 

medical center; 

• Require that human fetal tissue be 

treated respectfully and disposed of 

reasonably when no longer to be used in 

research; 

• Require HHS recipients that engage 

in human fetal tissue research to 

provide HHS, inspectors general, and 

the Comptroller General with a right of 

access to all informed consent forms 

obtained for human fetal tissue research, 

and documents, papers, or other records 

as are necessary to establish that the 

Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules 2625 

51U.S. Bureau of Labor Statistics, May 2019 

National Occupational Employment and Wage 

Estimates United States, available at https://

www.bls.gov/oes/current/oes_nat.htm. 

52See 45 CFR 46.206(a). 

human fetal tissue was not obtained or 

transferred for valuable consideration 

and that federal funds were not used to 

acquire or otherwise obtain the human 

fetal tissue; and 

• Provide that expenses associated 

with the acquisition of human fetal 

tissue for use in research are not 

allowable expenses under Federal 

awards from an HHS awarding agency. 

Alternatives Considered 

HHS carefully considered several 

alternatives, but rejected the potential 

alternatives for a number of reasons: 

• Alternative 1: Not taking any action. 

HHS concluded that this alternative was 

unacceptable because of the serious 

regulatory, moral and ethical 

considerations involved with respect to 

research involving human fetal tissue 

from elective abortions. 

• Alternative 2: Making no changes to 

45 CFR part 46, subpart B or to part Part 

75, but issuing guidance on (1) best 

practices for (and the elements that 

should be included in) informed 

consent for the donation of human fetal 

tissue for research, (2) the 

documentation that should be 

maintained with respect to compliance 

with the statutory bar on valuable 

consideration for the transfer of human 

fetal tissue, and (3) encouraging the 

practice of obtaining human fetal tissue 

by donation or non-cost material 

transfer agreement. HHS concluded that 

this alternative would be inadequate 

because the guidance mechanism (1) did 

not seem commensurate with the nature 

and seriousness of the issue and (2) may 

not be sufficient to permit HHS to 

conduct appropriate oversight and 

ensure compliance with/enforce the 

identified informed consent standards 

and the bar on valuable consideration. 

• Alternative 3: Make more limited 

changes to 45 CFR part 46, subpart B 

and Part 75, such as by (1) requiring 

that, with respect to research involving 

human fetal tissue from elective 

abortions, HHS-funded projects obtain 

informed consent for the donation of 

human fetal tissue from elective 

abortion, without specifying any 

required content of the informed 

consent document; or (2) clarifying 

recordkeeping and access requirements. 

HHS concluded that this alternative 

would be inadequate because, among 

other reasons, it would not ensure that 

the informed consent process included 

measures and statements to ensure that 

the informed consent was truly 

voluntary and truly informed and that 

no consideration or inducements had 

been provided for the human fetal 

tissue. 

Expected Benefits and Costs of the 

Proposed Rule 

HHS expects several benefits from 

this proposed rule. The proposed rule 

would provide better assurance of 

compliance with federal statutory 

requirements with respect to the 

acquisition and use of human fetal 

tissue in research. It would better align 

federal and state law with respect to 

informed consent for the use of fetal 

tissue in research, and ensure the 

uniformity across HHS/NIH grants with 

respect to the elements of informed 

consent for the donation of human fetal 

tissue for research. It would strengthen 

the informed consent process. It would 

also strengthen HHS’s ability to conduct 

oversight of, and monitor compliance 

on, these issues (informed consent, bar 

on valuable consideration). While 

maintaining, consistent with the Public 

Health Service Act, the ability of NIH to 

fund research involving human fetal 

tissue from abortion, this proposed rule 

would also ensure that—in light of the 

serious moral and ethical issues 

involved—the costs associated with 

such human fetal tissue would not be 

borne by the federal taxpayer. 

HHS believes that the costs associated 

with the proposed rule will be de 

minimis. In the main, the costs would 

consist of the administrative costs to the 

relevant recipients to (1) become 

familiar with the requirements of the 

final rule; (2) update their informed 

consent documents; and (3) update their 

grant policies and procedures (or 

compliance manuals) on grant record 

retention to reflect certain information 

retention requirements, practices 

concerning treatment and disposal of 

human fetal tissue, the bar on valuable 

consideration, and the unallowability of 

costs associated with the acquisition of 

human fetal tissue from abortion. 

Familiarization Costs. NIH is the only 

HHS component that funds grants, 

cooperative agreements, or R&D 

contracts for research involving human 

fetal tissue. Between FY 2015 and FY 

2019, NIH funded between 

approximately 120 and 178 research 

projects involving the use of human 

fetal tissue from abortions each year, 

including between 15 and 55 new 

research projects per year; with NIHfunded projects usually having a five 

year project period, most such annually 

funded research projects represented 

renewals, revisions, extensions, or 

continuations. The entities that hold the 

NIH awards for such research projects 

include major colleges and universities, 

medical schools, academic medical 

centers, major hospitals and children’s 

hospitals, biomedical research 

institutions and several corporations. 

Many of these entities hold multiple 

NIH grants, cooperative agreements, or 

R&D contracts for research involving the 

use of human fetal tissue. In FY 2019, 

there were a total of 71 unique 

institutions with active NIH awards for 

research involving human fetal tissue. 

Thus, to ensure that costs are not 

underestimated, for purposes of 

estimating the costs associated with this 

rulemaking, HHS will use 80 as the 

number of organizations that would be 

affected by this proposed rule. Given the 

size and sophistication of these entities, 

the task of familiarization would likely 

fall to the equivalent of a lawyer in the 

entities’ law departments. According to 

the U.S. Bureau of Labor Statistics,51

lawyers have a mean hourly rate of 

$69.86. HHS assumes that the total 

dollar value of labor, which includes 

wages, benefits, and overhead, is equal 

to 200% of the wage rate, or $139.72. 

The changes proposed in the proposed 

rule are straightforward and easy to 

understand. Accordingly, HHS 

estimates that it would take a recipient 

approximately an hour to become 

familiar with the requirements if the 

proposed rule is finalized as proposed. 

HHS, thus, concludes that the total cost 

for recipient familiarization with such a 

final rule would total $11,177.60 

($139.72 × 80). 

Informed Consent and Informed 

Consent Forms. As noted above, since 

not later than 2016, NIH has conveyed 

to researchers working with human fetal 

tissue that receive NIH grants for such 

research that (1) NIH-funded research 

involving human fetal tissue must be 

conducted in compliance with all 

applicable federal, state, and local laws 

and regulations; 52 (2) most states 

require informed consent for the use of 

fetal tissue in research; and (3) NIH 

expects informed consent to have been 

obtained from the donor for any NIHfunded research using human fetal 

tissue. See NOT–OD–16–033; NIH 

Grants Policy Statement, Sec. 4.1.14. 

Recently, NIH informed grantees, 

contractors, and applicants that it 

expects such informed consent forms to 

contain certain statements that are 

consistent with the statements proposed 

in this proposed rule. See NOT–OD–19– 

128. In addition, the AMA has 

indicated, through its 2016 Code of 

Ethics Opinion, that physicians who are 

involved in research that uses human 

fetal tissue should, in all instances, 

2626 Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules 

53U.S. Bureau of Labor Statistics, May 2019 

National Occupational Employment and Wage 

Estimates United States, available at https://

www.bls.gov/oes/current/oes_nat.htm. 

54As noted below, in that section, HHS believes 

that most, if not all, recipients obtain informed 

consents for the donation of human fetal tissue for 

research and that many recipients utilize or require 

the utilization of a separate and independent 

informed consent process. Accordingly, these 

estimates represent HHS’s estimate of the total cost 

of a separate and independent informed consent 

process on an annual basis, not the likely 

incremental costs resulting from this proposed rule. 

However, HHS will use these costs for simplicity 

of analysis in this proposed rule. 

55U.S. Bureau of Labor Statistics, May 2019 

National Occupational Employment and Wage 

Estimates United States, available at https://

www.bls.gov/oes/current/oes_nat.htm. 

56U.S. Bureau of Labor Statistics, May 2019 

National Occupational Employment and Wage 

Estimates United States, available at https://

www.bls.gov/oes/current/oes131041.htm. 

obtain the woman’s voluntary, informed 

consent. Although there is currently no 

express requirement for such informed 

consent, based on the foregoing, it is 

HHS’s understanding that informed 

consent is generally obtained from the 

donor for NIH-funded research 

involving human fetal tissue. HHS 

assumes that recipients have an 

informed consent form that they use or 

require their contractors to use in 

obtaining the informed consent to the 

donation of human fetal tissue. 

Accordingly, the only costs HHS 

expects that recipients would incur 

associated with the proposed informed 

consent requirements would be the 

costs to update such forms. Such a task 

would again likely fall to the equivalent 

of a lawyer in the entities’ law 

departments. According to the U.S. 

Bureau of Labor Statistics,53 lawyers 

have a mean hourly rate of $69.86. HHS 

assumes that the total dollar value of 

labor, which includes wages, benefits, 

and overhead, is equal to 200% of the 

wage rate, or $139.72. The informed 

consent requirements in the proposed 

rule are straightforward and easy to 

understand—and HHS has provided 

sample informed consent form 

provisions. Accordingly, HHS estimates 

that it would take a recipient 

approximately an hour to update its 

informed consent for the donation of 

human fetal tissue from elective 

abortion for research. HHS, thus, 

concludes that the costs likely to be 

incurred to update informed consent 

forms as a result of the proposed 

informed consent requirements 

(proposed §§ 46.204(k) and 46.206(g)) 

would total $11,177.60 ($139.72 × 80). 

Although HHS believes that most, if 

not all, recipients of NIH awards for 

research involving human fetal tissue 

have processes in place to obtain 

informed consent for the donation of 

human fetal tissue for research, HHS 

recognizes that some may not conduct a 

process to obtain informed consent for 

the donation that is separate and 

independent from the process to obtain 

informed consent for the abortion. As 

set forth in greater detail in the 

Paperwork Reduction Act section of this 

regulatory impact analysis, and using 

NIH intramural data as a proxy, HHS 

estimates that, on an annual basis, each 

research project would need to conduct 

the informed consent process for the 

donation of human fetal tissue an 

average of 8 times, in order to obtain the 

amount of human fetal tissue needed for 

each research project, for a total of 

1,059.2 informed consent processes per 

year. Assuming the informed consent 

process requires 10–15 minutes of a 

registered nurse’s time, this results in a 

total of between 176.89 and 264.8 

burden hours per year for the separate 

and independent informed consent 

process, or between $13,174.77 and 

$19,722.30 in total annual costs. This 

suggests a total annual burden of 

between 2.21 and 3.31 hours per unique 

recipient, and cost on an annual basis 

(undiscounted) for each unique 

recipient of between $164.68 and 

$246.53 for a separate and independent 

informed consent process for the 

donation of human fetal tissue for 

research.54

Prohibitions on Valuable 

Consideration. The proposed 

substantive prohibitions on valuable 

consideration in proposed § 46.206(c)– 

(f) merely reiterate current statutory 

requirements with respect to the 

provision or receipt of valuable 

consideration associated with the 

transfer of human fetal tissue. 

Accordingly, HHS does not believe that 

recipients would incur any additional or 

incremental costs as a result of these 

proposed requirements. 

Disposal of Human Fetal Tissue. It is 

HHS’s understanding that the proposed 

requirement for the respectful treatment 

and disposal of human fetal tissue when 

such tissue is no longer needed for 

research (proposed § 46.206(i)) is 

consistent with good clinical practice on 

the part of researchers. Accordingly, 

HHS believes that recipients would 

incur de minimis costs, if any, as a 

result of this proposed requirement. 

Updating of Policies and Procedures 

(or Manuals). HHS would classify, as 

grant administration requirements, the 

proposed requirements on the sourcing 

of human fetal tissue for research; on 

access to grant-related information 

pertaining to informed consent, valuable 

consideration, and use of grant funds; 

and on the unallowability of costs 

associated with the acquisition of 

human fetal tissue (proposed 

§§ 46.206(h), 75.364(a), and 75.478). It is 

HHS’s understanding that requirements 

such as these proposed requirements are 

generally reflected in the grant 

administration or compliance policies 

and procedures (or manuals) that are 

maintained by recipients of the size and 

sophistication of those that tend to 

receive NIH grants for research 

involving human fetal tissue—and that 

recipient personnel tend to consult such 

documents in connection with their 

activities. Accordingly, HHS believes 

that the only costs that recipients would 

incur as a result of these proposed 

requirements would likely be associated 

with the updating of such policies and 

procedures (or manuals). Given the size 

and sophistication of these entities, the 

task of familiarization would likely fall 

to the equivalent of a lawyer in the 

entities’ law departments or a 

compliance officer in their compliance 

offices. According to the U.S. Bureau of 

Labor Statistics, lawyers have a mean 

hourly rate of $69.86,55 and compliance 

officers have a mean hourly rate of 

$35.03.56 HHS assumes that the total 

dollar value of labor, which includes 

wages, benefits, and overhead, is equal 

to 200% of the wage rate, or $139.72 for 

lawyers, and $70.06 for compliance 

officers. HHS believes that the updating 

of such documents would likely take a 

total of two hours—and assumes that 

half of the work would be completed by 

compliance officers and half would be 

completed by lawyers. Accordingly, 

HHS estimates that the total cost 

incurred by recipients as a result of the 

proposed requirements would be 

$16,782.40 (($139.72 + $70.06) × 80). 

Records and Access to Records and 

Personnel. HHS proposes to amend its 

current provision requiring awardees to 

provide access to records relating to a 

recipient’s award to specify that 

recipients of awards for research 

involving human fetal tissue would 

need to provide access on the part of 

HHS, the Inspector General, GAO, and 

others, to specific grant-related 

information. All of the information that 

is specifically referenced in proposed 

§ 75.364(a)(1) is already subsumed 

within the existing § 75.364(a). 

Accordingly, HHS does not believe that 

the proposed records access 

requirements would add any 

incremental burden. 

Acquisition of Human Fetal Tissue. 

HHS proposes to limit the sources from 

which HHS recipients for research 

involving human fetal tissue can obtain 

human fetal tissue from abortion and to 

Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules 2627 

57 It is likely that researchers do not need to 

obtain human fetal tissue for their HHS-funded 

research projects annually. In addition, it is likely 

that some researchers and projects obtained such 

tissue through no-cost material transfer agreements. 

However, since HHS lacks knowledge as to how 

often funded research projects would need to obtain 

such tissue or how much would need to be 

expended to acquire such tissue—and the frequency 

and expense could vary from project to project—for 

purposes of the analysis of the regulatory impact of 

this proposed rule, HHS will assume that each 

project has to acquire human fetal tissue from 

abortion on an annual basis. 

58 If only new research projects need to acquire 

fetal tissue from elective abortions, this would 

suggest total transfer costs of $92,613.54 per year, 

and an average annual cost per unique recipient of 

$1,157.67 (28.4 projects × $3,261.04 cost per project 

per year/80 unique recipients). 

HHS notes that in FYs 2015 and 2018, the largest 

expenditure by an intramural research project for 

fetal tissue was $21,400 and $25,785, respectively, 

for an average of $23,592.50. Even if this number 

is used as the proxy for the annual expense that the 

recipient of an award for research involving human 

fetal tissue might incur to acquire such tissue—and 

it is assumed that every research project would 

incur such expenditures each year—this only 

results in a total annual expenditure of $3,123,647 

($23,592.50 × 132.4 projects), and an average annual 

cost per unique recipient of $39,045.59 (132.4 

projects × $23,592.50/80 unique recipients). 

59 If recipients have already acquired all of the 

human fetal tissue needed for the funded research— 

which could be the case especially for those 

organizations that have received grant renewals, 

revisions, extensions, or continuations—they may 

conclude that they do not need to undertake any 

action associated with some of the proposed 

requirements. This would reduce the costs that 

such recipients would incur to implement any final 

rule resulting from this proposed rule. 

60 If the average of the highest annual intramural 

expenditures for fetal tissue is used to calculate the 

annual expenditure to acquire fetal tissue, the total 

first year costs (including both one-time and annual 

costs of fetal tissue acquisition) would range from 

$3,175,959.37 to $3,182,506.90, with total first year 

costs per unique recipient ranging between 

$39,699.49 and $39,781.65 Thereafter, total annual 

costs (undiscounted) would total $3,136,821.77 to 

$3,143,369.30, with annual costs (undiscounted) of 

$39,210.27 to $39,292.12 per unique recipient. 

preclude the inclusion of any expenses 

associated with the acquisition of 

human fetal tissue from elective 

abortion in allowable costs that could be 

charged against HHS award funds. The 

proposed limitation on the sources of 

human fetal tissue from abortion should 

not have any impact on the costs 

associated with the acquisition of such 

tissue because the statutory bar on the 

provision of valuable consideration in 

connection with the transfer of human 

fetal tissue provides a statutory limit on 

the ability of tissue procurement 

organizations and other organizations to 

seek to take advantage of such a 

regulatory limitation to exact higher 

consideration. To the extent that 

recipients currently incur permissible 

costs associated with the acquisition of 

human fetal tissue from elective 

abortions, HHS acknowledges that the 

proposal to exclude human fetal tissue 

from elective abortion from allowable 

costs under HHS research grants, 

cooperative agreements, and R&D 

contracts would effect a transfer of costs 

from HHS (through its awards) to the 

recipients of such research awards. Prior 

to NIH’s July 2019 notice, recipients had 

not been required to separately identify 

or account for such expenditures of 

award funds, so HHS and NIH do not 

have complete data on the expenses 

incurred by awardees with respect to 

the acquisition of human fetal tissue 

from elective abortions. Accordingly, 

HHS uses the costs incurred by 

intramural NIH researchers to acquire 

human fetal tissue from elective 

abortions as a proxy. During the HHS 

review and audit, it reviewed NIH 

documentation with respect to 

intramural research involving human 

fetal tissue and the expenditures made 

to acquire such tissue in fiscal year (FY) 

2018; NIH also provided information 

concerning intramural projects 

involving human fetal tissue, and the 

expenditures made with respect to 

them, in FY 2015. In FY 2015, 

intramural researchers incurred a total 

of $26,915 in the acquisition of such 

tissue across 14 research projects, for an 

average expenditure of $1,922.50 per 

project. And in FY 2018, intramural 

researchers incurred a total of 

approximately $55,195 to acquire 

human fetal tissue across approximately 

12 research projects, for an average 

expenditure of $4,599.58 per project. 

Across the two fiscal years, the average 

annual expenditure for fetal tissue per 

project was, thus, $3,261.04. Assuming 

that award recipients needed to acquire 

human fetal tissue for each project each 

year—an assumption that would tend to 

overestimate costs 57—this would 

suggest transfer costs of $3,261.04 per 

project per year, for a total annual cost 

of $431,761.70 and an average annual 

cost per unique recipient of $5,397.02 

(132.4 projects × $3,261.04 cost per 

project per year/80 unique recipients).58

Except for the potential costs of the 

separate informed consent process and 

the acquisition of human fetal tissue 

from elective abortions, these costs 

would be one-time costs that would be 

experienced in the first year of 

implementation. Accordingly, if all 

recipients that receive HHS funds for 

research involved human fetal tissue 

were to implement the proposed 

requirements,59 HHS estimates that 

these proposed requirements if finalized 

as proposed would impose first year 

costs (including both one-time costs and 

annual cost of the informed consent 

process and the acquisition of fetal 

tissue) totaling between $484,074.07 

and $490,621.60, with cost per unique 

recipient of between $6,050.92 and 

$6,132.77. Thereafter, there would be 

total annual costs (undiscounted) of 

$444,936.47 to $451,484 and $5,561.70 

to $5,643.55 per unique recipient (again, 

undiscounted).60

Executive Order 13771 

The White House issued Executive 

Order 13771 on Reducing Regulation 

and Controlling Regulatory Costs on 

January 30, 2017. Section 2(a) of 

Executive Order 13771 requires an 

agency, unless prohibited by law, to 

identify at least two existing regulations 

to be repealed when the agency publicly 

proposes for notice and comment or 

otherwise promulgates a new regulation. 

In furtherance of this requirement, 

section 2(c) of Executive Order 13771 

requires that the new incremental costs 

associated with new regulations shall, to 

the extent permitted by law, be offset by 

the elimination of existing costs 

associated with at least two prior 

regulations. This rule, while significant 

under Executive Order 12866, will 

impose de minimis costs and, therefore, 

is not anticipated to be a regulatory or 

deregulatory action under Executive 

Order 13771. HHS’s human subjects 

protection regulations permit HHSfunded or conducted research involving 

human fetal tissue to be conducted only 

in accord with any applicable Federal, 

State, or local laws and regulations 

regarding such activities. Current 

federal law and regulations require 

informed consent for human fetal tissue 

transplantation research and research 

with human fetal tissue with associated 

information that can identify a human 

being. In addition, most states require 

informed consent for the use of fetal 

tissue in research—and NIH has 

indicated that it expects informed 

consent to have been obtained from the 

donor for any NIH-funded research 

using human fetal tissue. As a result, 

HHS expects that HHS recipients 

conducting such research would incur 

only de minimis costs to become 

familiar with the regulation, to update 

their informed consent forms to include 

the specific statements proposed in this 

proposed rule, to obtain the necessary 

informed consents, to properly dispose 

of human fetal tissue, and to update 

their grants policies and procedures (or 

compliance manuals). Federal law 

already prohibits the transfer of human 

fetal tissue for valuable consideration, 

and federal regulation gives HHS the 

right of access to any documents, 

papers, or other records of Department 

recipients which are pertinent to the 

2628 Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules 

61 In the health care sector, from which the 

Department draws many of its biomedical research 

recipients, SBA considers businesses to be small by 

virtue of having less than between $8.0 million and 

$41.5 million in average annual revenues, 

depending on the particular type of business. See 

U.S. Small Business Administration, Table of Small 

Business Size Standards Matched to North 

American Industry Classification System Codes, 

effective August 19, 2019 (sector 62), available at 

https://www.sba.gov/sites/default/files/2019-08/ 

SBA%20Table%20of%20Size%20Standards_

Effective%20Aug%2019%2C%202019_Rev.pdf. 

Inasmuch as colleges, universities and professional 

schools (e.g., medical schools) and other 

educational institutions may also receive 

Department funding to conduct biomedical 

research, the other sector from which the 

Department may draw recipients is the educational 

services sector, where the relevant small business 

sizes range from $12.0 million to $30.0 million in 

annual revenues. Id. (sector 61). 

62 In the regulatory impact analyses, HHS is using 

80 as the number of unique organizations that 

would be affected by the proposed rule, to ensure 

that costs are not underestimated. 

63Some of the entities receiving NIH awards for 

research involving the use of human fetal tissue are 

public colleges or universities that may be 

considered components of state governments and, 

thus, not small entities for purposes of RFA. 

Similarly, some of the entities are major private 

colleges or universities, medical schools, academic 

medical centers, or hospitals that may be nonprofit 

organizations that are considered dominant in their 

fields and, thus, also not small entities for purposes 

of RFA. 

64 If the average of the highest annual intramural 

expenditures for fetal tissue is used to calculate the 

annual expenditure to acquire fetal tissue, the first 

year costs (including both one-time and annual 

costs of fetal tissue acquisition) per unique 

recipient would range between $39,699.49 and 

$39,781.65. Thereafter, annual costs (undiscounted) 

would total $39,210.27 and $39,292.12 per unique 

awardee, associated with the costs of the separate 

informed consent process and of acquiring human 

fetal tissue. 

65See https://www.sba.gov/sites/default/files/ 

2019-08/SBA%20Table%20of%20Size%20

Standards_Effective%20Aug%2019%2C%202019_

Rev.pdf. 

award. Public comments will inform the 

ultimate designation of this rule. 

Regulatory Flexibility Act 

HHS has examined the economic 

implications of this proposed rule as 

required by the Regulatory Flexibility 

Act (RFA) (5 U.S.C. 601–612). The RFA 

requires an agency to describe the 

impact of a proposed rulemaking on 

small entities by providing an initial 

regulatory flexibility analysis unless the 

agency expects that the proposed rule 

will not have a significant impact on a 

substantial number of small entities, 

provides a factual basis for this 

determination, and proposes to certify 

the statement. 5 U.S.C. 603(a), 605(b). If 

an agency must provide an initial 

regulatory flexibility analysis, this 

analysis must address the consideration 

of regulatory options that would lessen 

the economic effect of the rule on small 

entities. For purposes of the RFA, small 

entities include proprietary firms 

meeting the size standards of the Small 

Business Administration (SBA); 61

nonprofit organizations that are not 

dominant in their fields; and small 

governmental jurisdictions with 

populations of less than 50,000. 5 U.S.C. 

601(3)–(6). HHS considers a rule to have 

a significant impact on a substantial 

number of small entities if it has at least 

a three percent impact on revenue on at 

least five percent of small entities. 

Executive Order 13272 on Proper 

Consideration of Small Entities in 

Agency Rulemaking reinforces the 

requirements of the RFA and requires 

HHS to notify the Chief Counsel for 

Advocacy of the Small Business 

Administration if the final rule may 

have a significant economic impact on 

a substantial number of small entities 

under the RFA. Executive Order 13272, 

67 FR 53461 (Aug. 16, 2002). 

As discussed, the proposed rule 

would 

• Require, prior to conducting 

research on human fetal tissue, that 

informed consent be obtained from the 

pregnant woman; 

• Prohibit providing enticements, 

benefits, or financial incentives to the 

pregnant woman or attending physician 

to incentivize the occurrence of an 

abortion or human fetal tissue donation; 

• Prohibit providing valuable 

consideration for costs associated with 

obtaining human fetal tissue or the 

abortion (if any) that is the source of the 

human fetal tissue; 

• Mandate that research involving 

human fetal tissue from elective 

abortions can only use such human fetal 

tissue that is acquired or otherwise 

obtained from a Government, a 

Government-owned entity, university, 

college, accredited degree-granting 

institution of higher education, 

university hospital, or academic 

medical center; 

• Require that human fetal tissue be 

treated respectfully and disposed of 

reasonably when no longer to be used in 

research; 

• Require HHS recipients that engage 

in human fetal tissue research to 

provide HHS, inspectors general, and 

the Comptroller General with a right of 

access to all informed consent forms 

obtained for human fetal tissue research, 

and documents, papers, or other records 

as are necessary to establish that the 

human fetal tissue was not obtained or 

transferred for valuable consideration 

and that federal funds were not used to 

acquire or otherwise obtain the human 

fetal tissue; and 

• Provide that expenses associated 

with the acquisition of human fetal 

tissue from elective abortion for use in 

research are not allowable expenses 

under Federal awards from an HHS 

awarding agency. 

NIH is the only HHS component the 

funds grants, cooperative agreements, or 

R&D contracts for research involving 

human fetal tissue. Between FY 2015 

and FY 2019, NIH funded between 

approximately 120 and 178 research 

projects involving the use of human 

fetal tissue from abortions each year, 

including between 15 and 55 new 

research projects per year; with NIHfunded projects usually having a five 

year project period, most such annually 

funded research projects represented 

renewals, revisions, extensions, or 

continuations. The entities that hold the 

NIH awards for such research projects 

include major colleges and universities, 

medical schools, academic medical 

centers, major hospitals and children’s 

hospitals, biomedical research 

institutions and several corporations. 

Many of these entities hold multiple 

NIH grants, cooperative agreements, or 

R&D contracts for research involving the 

use of human fetal tissue; in FY 2019, 

there were a total of 71 unique 

institutions with active NIH awards for 

research involving human fetal tissue.62

Even if all of the entities that receive 

such NIH awards were considered small 

entities by virtue of their size or 

nonprofit status,63 the proposed rule 

would not have a serious impact on a 

significant number of small entities. The 

proposed rule would not impose 

significant burdens not already imposed 

by federal or state law. As discussed 

above, if the proposed rule is finalized 

as proposed, each unique NIH awardee 

would likely experience, at most, first 

year costs (including both one-time 

costs, the cost of the separate informed 

consent process for the donation of 

human fetal tissue, and the cost of 

acquiring fetal tissue) totaling between 

$6,050.92 and $6,132.77, associated 

with the incremental burden of the 

requirements proposed in this proposed 

rule and, thereafter, $5,561.70 to 

$5,643.55 per year in expenses for the 

separate informed consent process and 

for unreimbursed expenses to acquire 

fetal tissue for the research.64 As noted 

above, the entities that hold the NIH 

awards for such research projects 

include major colleges and universities, 

medical schools, academic medical 

centers, major hospitals and children’s 

hospitals, biomedical research 

institutions and several corporations. 

These entities generally correspond to 

the following North American Industry 

Classification (NAIC) codes and small 

entity size guidelines: 65

Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules 2629 

66Public Law 105–277, Div. A, § 654, 112 Stat. 

2681–480, 2681–528 (Oct. 21, 1998), codified at 5 

U.S.C. 601 note. 

Before implementing regulations that may affect 

family well-being, an agency is required to assess 

the actions as to whether the action 

Continued 

Industry NAIC code Small entity size guideline 3% impact on 

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 

Life Sciences (except Nanotechnology and Biotechnology).

541715 1,000 employees ............................................. ........................

As noted above, HHS considers a rule 

to have a significant impact on a 

substantial number of small entities if it 

has at least a three percent impact on 

revenue on at least five percent of small 

entities. The estimated potential impact 

on recipients of HHS/NIH awards for 

research involving human fetal tissue is 

significantly lower than three percent of 

the annual revenues of small entities in 

the relevant industries. Thus, HHS 

anticipates that this rulemaking, if 

finalized, would have minimal 

economic impact—and would not have 

a significant impact on a substantial 

number of small entities. HHS 

anticipates that the information 

disclosures that would be required by 

the rule would, to the extent they would 

result in a change from current practice, 

allow affected individuals to make 

better informed decisions and allow 

affected entities to better deploy 

resources in line with established 

requirements for HHS recipients. As a 

result, HHS has determined, and the 

Secretary certifies, that this proposed 

rule would not have a significant impact 

on a substantial number of small 

entities. 

HHS seeks comment on this analysis 

of the impact of the proposed rule on 

small entities, and the assumptions that 

underlie this analysis. 

Unfunded Mandates Reform Act 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 (2 U.S.C. 

1532) requires that covered agencies 

prepare a budgetary impact statement 

before promulgating a rule that includes 

any Federal mandate that may result in 

the expenditure by State, local, and 

tribal governments, in the aggregate, or 

by the private sector, of $100 million in 

1995 dollars, updated annually for 

inflation. Currently, that threshold is 

approximately $154 million. If a 

budgetary impact statement is required, 

section 205 of the Unfunded Mandates 

Act also requires covered agencies to 

identify and consider a reasonable 

number of regulatory alternatives before 

promulgating a rule. HHS has 

determined that this proposed rule will 

not result in expenditures by State, 

local, and tribal governments, or by the 

private sector, of $154 million or more 

in any one year. Accordingly, HHS has 

not prepared a budgetary impact 

statement or specifically addressed the 

regulatory alternatives considered. 

Executive Order 13132—Federalism 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a rule 

that imposes substantial direct 

requirement costs on State and local 

governments or has federalism 

implications. Executive Order 13132, 64 

FR 43255 (Aug. 10, 1999). HHS does not 

believe that this proposed rule would 

(1) impose substantial direct 

requirements costs on State or local 

governments; (2) preempt State law; or 

(3) otherwise have Federalism 

implications. Thus, the Department has 

determined that this proposed rule does 

not impose such costs or have any 

Federalism implications. 

Executive Order 12866 directs that 

significant regulatory actions avoid 

undue interference with State, local, or 

tribal governments, in the exercise of 

their governmental functions. Executive 

Order 12866 at 6(a)(3)(B). Executive 

Order 13175 further directs that 

agencies respect Indian tribal selfgovernment and sovereignty, honor 

tribal treaty and other rights, and strive 

to meet the responsibilities that arise 

from the unique legal relationship 

between the Federal Government and 

Indian tribal governments. Executive 

Order 13175 at 2(a). HHS does not 

believe that the proposed rule would 

implicate the requirements of Executive 

Orders 12866 and 13175 with respect to 

tribal sovereignty. 

The proposed rule would add 

specificity to federal and state law 

requirements with respect to informed 

consent for the donation of human fetal 

tissue for HHS-funded or conducted 

research and to federal law 

requirements on the maintenance of 

documentation with respect to 

compliance with federal law on 

informed consent and the bar on the 

receipt of valuable consideration for 

human fetal tissue. Some HHS grants for 

research involving human fetal tissue 

may be held by state colleges or 

universities. However, HHS anticipates 

that the proposed rule would have only 

minimal impacts on such state colleges 

and universities. Therefore, HHS has 

determined that this proposed rule 

would not have sufficient Federalism 

implications to warrant the preparation 

of a Federalism summary impact 

statement under Executive Order 13132, 

and that the rule would not implicate 

the requirements of Executive Orders 

12866 and 13175 with respect to tribes. 

Congressional Review Act 

Title E of the Small Business 

Regulatory Fairness Enforcement Act of 

1996, also known as the Congressional 

Review Act, defines a ‘‘major rule’’ as 

‘‘any rule that the Administrator of the 

Office of Information and Regulatory 

Affairs (OIRA) of the Office of 

Management and Budget finds has 

resulted in or is likely to result in—(A) 

an annual effect on the economy of 

$100,000,000 or more; (B) a major 

increase in costs or prices for 

consumers, individual industries, 

federal, State, or local government 

agencies, or geographic regions; or (C) 

significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or on the 

ability of United States-based 

enterprises to compete with foreignbased enterprises in domestic and 

export markets.’’ 5 U.S.C. 804(2). Based 

on the analysis of this proposed rule 

under Executive Order 12866, OMB has 

determined that this proposed rule 

would not likely to result in an annual 

effect of $100,000,000 or more, and 

would not otherwise be a major rule for 

purposes of the Congressional Review 

Act. 

Assessment of Federal Regulation and 

Policies on Families 

Section 654 of the Treasury and 

General Government Appropriations 

Act of 1999 requires Federal 

departments and agencies to determine 

whether a proposed policy or regulation 

could affect family well-being.66 If the 

2630 Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules 

(1) strengthens or erodes the stability or safety of 

the family and, particularly, the marital 

commitment; 

(2) strengthens or erodes the authority and rights 

of parents in the education, nurture, and 

supervision of their children; 

(3) helps the family perform its functions, or 

substitutes governmental activity for the function; 

(4) increases or decreases disposable income or 

poverty of families and children; 

(5) action’s proposed benefits justify the financial 

impact on the family; 

(6) may be carried out by State or local 

government or by the family; and 

(7) establishes an implicit or explicit policy 

concerning the relationship between the behavior 

and personal responsibility of youth, and the norms 

of society. 

5 U.S.C. 601 (note). 

67 If a regulation may affect family well-being, the 

head of the agency is required to submit a written 

certification to the director of OMB and to Congress 

that the regulation has been assessed and to provide 

an adequate rationale for implementation of a 

regulation that may negatively affect family wellbeing. Id. 

68See NIH Policy on Informed Consent for 

Human Fetal Tissue Research, NOT–OD–16–033 

(Feb. 11, 2016), available at https://grants.nih/gov/ 

grants/guide/notice-files/not-od-16-033.html; 

October 2018 NIH Grants Policy Statement, Section 

4.1.14, available at https://grants.nih/gov/grants/ 

policy/nihgps/html5/section_4/4.1.14_human_

fetal_tissue_research.htm. 

69AMA Code of Medical Ethics Opinion 7.3.5, 

available at https://www.ama.assn.org/deliveringcare/ethics/research-using-human-fetal-tissue. 

70 In that regard, HHS proposes to provide sample 

informed consent form provisions for voluntary use 

by recipients in an appendix to this preamble. To 

the extent that recipients used the sample informed 

consent form provisions, it would tend to reduce 

burden on recipients. 

71U.S. Bureau of Labor Statistics, May 2019 

National Occupational Employment and Wage 

Estimates United States, available at https://

www.bls.gov/oes/current/oes291141.htm. 

determination is affirmative, then the 

department or agency must prepare an 

impact assessment to address criteria 

specified in the law.67 HHS has 

determined that these proposed 

regulations would not have an impact 

on family well-being, as defined in the 

Act. 

Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (PRA), as amended (44 U.S.C. 

3501–3520), agencies are required to 

provide a 60-day notice in the Federal 

Register and solicit public comment 

before a collection of information 

requirement is submitted to the Office of 

Management and Budget (OMB) for 

review and approval. In order to fairly 

evaluation whether an information 

collection should be approved by OMB, 

section 3506(c)(2)(A) of the PRA 

requires that agencies solicit comment 

on (1) whether the information 

collection is necessary and useful to 

carry out the proper functions of the 

agency; (2) the accuracy of the agency’s 

estimate of burden of the proposed 

collection of information; (3) the 

quality, utility, and clarity of the 

information to be collected (and ways to 

enhance the same); and (4) 

recommendations to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information and technology. 

In accordance with these 

requirements, HHS is soliciting public 

comments on the following proposed 

requirements that may implicate the 

PRA. These proposed collection of 

information requirements relate to the 

proposal to require informed consent for 

the donation of human fetal tissue for 

research (45 CFR 46.204(k), 46.206(g)) 

and the proposal to expressly require 

access to certain records (45 CFR 

75.364(a)(1). 

Informed Consent for the Donation of 

Human Fetal Tissue. HHS proposes to 

require, among other things, that (1) 

informed consent for the donation of 

human fetal tissue for research purposes 

be obtained from the woman; (2) the 

informed consents contain certain 

specific statements and be signed by 

both the woman and the person 

obtaining the informed consent; and (3) 

the informed consent for donation be 

obtained after the abortion decision has 

been made and informed consent has 

been provided for the abortion and 

person obtaining the informed consent 

be someone other than the person who 

obtains the informed consent for the 

abortion procedure. Current federal 

human subjects protection regulations at 

45 CFR 46.206 requires that HHSfunded research involving human fetal 

tissue be conducted only in accord with 

any applicable federal, state, or local 

laws and regulations. As noted above in 

more detail, (1) most states require 

informed consent for the use of fetal 

tissue in research; (2) since early 2016, 

NIH has expressed the expectation that 

‘‘informed consent to have been 

obtained from the donor for any NIHfunded research using human fetal 

tissue;’’ 68 and (3) an AMA Ethics 

Opinion, issued in June 2016, indicates 

that ‘‘physicians who are involved in 

research that uses human fetal tissues 

should . . . [i]n all instances, obtain the 

woman’s voluntary, informed consent in 

keeping with ethics guidance. . . .’’ 69

Accordingly, HHS believes that all 

entities receiving NIH funding for 

research involving the use of human 

fetal tissue have an informed consent 

form for the donation of human fetal 

tissue and that such informed consent is 

being obtained in most, if not all, 

instances. 

HHS recognizes that it proposes to 

require certain specific statements in the 

informed consents that may not 

currently be contained in such informed 

consent forms. Above, HHS estimated 

that it would take each recipient 

approximately one hour of attorney time 

to update its informed consent form for 

the donation of human fetal tissue from 

elective abortion.70 Thus, HHS 

estimated 80 burden hours at 200% of 

the wage rate for an attorney, or a total 

of $11,177.60. 

HHS estimates that an informed 

consent process for the donation of 

human fetal tissue that is independent 

of, and separate from, the process of 

obtaining informed consent for the 

abortion procedure might take between 

10 and 15 minutes per informed 

consent. HHS expects that a nurse 

would be assigned to obtain the 

informed consents. Mean hourly wages 

for nurses range from $23.32 for 

licensed practical nurses to $53.77 for 

nurse practitioners. HHS believes that it 

is likely that such tasks would be 

assigned to registered nurses. According 

to the Bureau of Labor Statistics,71

registered nurses have a mean hourly 

rate of $37.24. HHS assumes that the 

total dollar value of labor, which 

includes wages, benefits, and overhead, 

is equal to 200% of the wage rate, or 

$74.48. HHS does not have information 

on the number of times informed 

consent would need to be sought, in 

order to obtain the donation of human 

fetal tissue necessary on an annual basis 

for extramural research projects. 

Accordingly, HHS uses the likely 

number of informed consents that 

would have been necessary with respect 

to the human fetal tissue acquired by 

intramural NIH researchers for 

intramural research projects, using the 

number of human fetuses from which 

tissue was obtained as a further proxy 

for the number of informed consents. 

During the HHS review and audit, it 

reviewed NIH documentation with 

respect to the acquisition of human fetal 

tissue for intramural research projects in 

FY 2018; NIH also provided information 

concerning on-going intramural research 

projects invoIving human fetal tissue. In 

FY 2018, intramural researchers 

engaged in approximately 12 intramural 

research projects involving human fetal 

tissue, and acquired human fetal tissue 

from approximately 45 fetuses, for an 

average of 3.75 per project. Accordingly, 

HHS proposes to estimate that, on an 

annual basis, each research project 

involving human fetal tissue would 

need to obtain an average of 4 informed 

consents for donation of human fetal 

tissue, for a total of 529.6 informed 

Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules 2631 

72NIH–OD–16–033 (Feb. 11, 2016), available at 

https://grants.nih.gov/grants/guide/notice-files/notod-16-033.html. 

73Changes to NIH Requirements Regarding 

Proposed Human Fetal Tissue Research, NOT–OD– 

9–128 (July 26, 2019), available at https://

grants.nih/gov/grants/guide/notice-files/NOT-OD19-128.html. 

consents (4 × 132.4, the average number 

of extramural research projects 

involving human fetal tissue). HHS 

recognizes that not every woman who is 

asked to donate human fetal tissue 

would agree; accordingly, HHS will 

estimate that the informed consent 

process would need to be conducted an 

average of 8 times per project in order 

to obtain the necessary human fetal 

tissue. On an annual basis, this results 

in a total of between 176.89 and 264.8 

burden hours for a separate and 

independent informed consent process 

for the donation of human fetal tissue, 

for a total of between $13,174.77 and 

$19,722.30. This suggests a total annual 

burden of between 2.21 and 3.31 hours 

per unique recipient, and cost on an 

annual basis (undiscounted) for each 

unique recipient of between $164.68 

and $246.53 for a separate and 

independent informed consent process 

for the donation of human fetal tissue 

for research. 

This would represent the collection of 

information burden associated with the 

proposed informed consent 

requirements if no recipients of NIH 

funding for research involving human 

fetal tissue were otherwise obtaining 

such informed consents. However, as 

discussed in greater detail above, 

because of the state law requirements, 

the previous NIH policy statements, and 

the AMA Ethics Opinion, as well as the 

size and sophistication of such NIH 

recipients, HHS believes that most, if 

not all, recipients obtain informed 

consents. Furthermore, the AMA Ethics 

Opinion emphasized that physicians 

engaged in research that uses human 

fetal tissue should ensure that ‘‘[t]he 

woman’s decisions to terminate the 

pregnancy is made prior to and 

independent of any discussion of using 

the fetal tissue for research purposes,’’ 

which suggests that the process to 

discuss, and obtain informed consent 

for, donation of human fetal tissue for 

research purposes should be separate 

from and independent of the informed 

consent for the abortion, and NIH’s 

Changes to NIH Requirements Regarding 

Proposed Human Fetal Tissue Research. 

NOT–OD–19–128, indicated that NIH 

expected that the informed consent for 

donation of human fetal tissue would be 

obtained by someone other than the 

person who obtained the informed 

consent for the abortion and would 

occur after the informed consent for 

abortion. Based on the foregoing, HHS 

estimates that 80% to 100% of NIH’s 

recipients obtain informed consent for 

the donation of human fetal tissue and 

that 50% of such recipients already 

require a separate and independent 

informed consent process for the 

donation of human fetal tissue, utilizing 

different personnel from, and occurring 

after, the informed consent to the 

abortion. These estimates would suggest 

that (1) 40 recipients would not 

experience any additional burden from 

the proposed informed consent 

provisions because they are already 

using a separate informed consent 

process for donation of human fetal 

tissue; (2) up to 20% (or 16 recipients) 

might experience the full per-recipient 

burden identified above as a result of 

the proposed requirements because they 

are not conducting any informed 

consent process; and (3) at least 30% (or 

24 recipients) would experience some 

burden because they would need to 

divide their current informed consent 

process into two processes. For 

example, the informed consent for 

donation of human fetal tissue, when 

combined with the informed consent for 

abortion, may take a shorter period of 

time as compared to two separate and 

independent processes because of the 

need to repeat certain information in the 

second process. However, there could 

be some cost savings if the health care 

provider conducting the informed 

consent for the donation of human fetal 

tissue was paid at a low hourly rate than 

the health care provider conducting the 

informed consent for the abortion. 

Access to certain records. HHS 

proposes expressly to require that 

recipients provide access to informed 

consent forms for research involving 

human fetal tissue and such records as 

are necessary to establish that such 

tissue was not obtained or transferred 

for valuable consideration and that 

federal funds were not used to acquire 

or otherwise obtain human fetal tissue. 

HHS believes that this merely makes 

express recipients’ current 

recordkeeping and access obligations. 

HHS’s grants regulations currently 

require that recipients provide access to 

the recipient’s records pertinent to the 

federal award. 45 CFR 75.364; see also 

2 CFR 200.337 (OMB uniform 

administrative requirements). NIH has 

made its expectations on maintenance 

and access to records regarding NIHfunded research involving human fetal 

tissue clear: For example, in NIH Policy 

on Informed Consent for Human Fetal 

Tissue Research,72 NIH stated that, 

‘[w]hen obtaining primary human fetal 

tissue for research purposes, NIH 

expects grantees and contractors to 

maintain appropriate documentation 

. . . that informed consent was obtained 

at the time of tissue collection’’; such 

‘‘policy will be included in the terms 

and conditions of grant and cooperative 

agreement awards as well as contracts 

issued for research involving human 

fetal tissue.’’ Further, in NIH–OD–19– 

128,73 NIH indicated that all grants and 

cooperative agreements awarded with, 

or adding, human fetal tissue on or after 

September 25, 2019 would include 

certain terms and conditions, including 

that the recipient has documentation 

from the donating organization of 

compliance with the requirements of the 

informed consent process and 

documentation that the human fetal 

tissue was not obtained or acquired for 

valuable consideration. Accordingly, the 

proposed records access provision 

merely provides specificity to the 

general requirement in 45 CFR 

75.364(a), which parallels 2 CFR 

200.337(a), but does not impose any 

new information collection 

requirements. 

HHS solicits public comment on the 

potential burden associated with the 

proposed requirements that would 

impose collection of information 

requirements, as outlined in this 

section, including HHS’s assumptions 

and analysis, as well as on each of the 

required issues under section 

3506(c)(2)(A) of the PRA with respect to 

each of these proposed requirements. 

HHS asks for public comment on the 

proposed information collection, 

including what additional benefits may 

be cited as a result of this proposed rule. 

Comments regarding the collection of 

information proposed in this proposed 

rule must refer to the proposed rule by 

name and docket number as indicated 

under ADDRESSES by the date specified 

under DATES. 

These information collection 

requirements will be submitted to OMB 

for review and approval. 

Appendix to the Preamble—Model 

Informed Consent Form Provisions 

HHS provides these model informed 

consent form provisions for comment. 

This is only model language to illustrate 

the proposed informed consent 

provisions in this proposed rule. HHS 

contemplates providing updated 

guidance upon publication of the final 

rule. These model provisions would 

help regulated entities more easily 

comply with the informed consent 

provisions of this proposed rule, 

assuming the rule is finalized as 

proposed. However, use of such model 

2632 Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules 

74Words or phrases contained in brackets are 

intended as instructions to users of these model 

provisions and are not intended to be included in 

the informed consent form provisions. 

provisions would not be required for 

compliance with this proposed rule. In 

addition, the language could be 

amended to more accurately reflect the 

understandings of the fetal tissue donor 

and the particular situations. These or 

similar provisions may be incorporated 

into a regulated entity’s informed 

consent form for donation of fetal tissue. 

These concepts only address concepts 

and requirements set forth in this 

proposed rule, and alone are not 

sufficient to result in legally sufficient 

informed consent for the donation of 

fetal tissue under State law and do not 

include some formalities and 

substantive provisions that are required 

or typically included in legally 

sufficient informed consents. Reliance 

on these model provisions is not 

sufficient for compliance with state law 

and does not replace consultation with 

a lawyer. Furthermore, a regulated 

entity may want to include other 

provisions that are related to this 

proposed rule, but that HHS has not 

proposed through this proposed rule. 

Model Informed Consent for Human 

Fetal Tissue Donation Provisions 74

It is important to us that your 

preferences and beliefs are respected. 

If you are willing to donate fetal 

tissue, the following statements apply: 

• I already have completed my 

consent form for the abortion. 

• My decision about whether to 

donate fetal tissue will not affect how or 

when my abortion is done. Regardless of 

what I decide, the doctor will complete 

my abortion in the usual way. 

• The fetal tissue that I donate may be 

kept for many years and may be used for 

various research purposes. 

• The doctor performing the abortion 

will not benefit in any way from my 

decision. 

• I will not receive any payment, 

benefit, or other incentives for donating 

tissue. 

• I will not receive any medical 

benefit from any research conducted 

with the donated fetal tissue. 

• The research using the donated fetal 

tissue may have commercial potential, 

but I will not receive any financial or 

other benefit from any commercial 

development from the research. 

• I am [insert the age of majority in 

the jurisdiction where the informed 

consent is being signed] or older. 

• My preferences about donating fetal 

tissue for research will not affect my 

care today or in the future at [insert 

name of facility]. 

I have had an opportunity to discuss 

this with my provider and my questions 

have been answered. 

Please mark the statement that best 

matches your preference: 

__I consent to donating fetal tissue for 

research. 

__I do not want to donate fetal tissue 

to be used for research. 

Date and Time: lllllllllll

Patient Name: lllllllllll

Patient Signature: llllllllll

* * * * * 

Attestation of Provider 

I attest that 

• All options were presented to the 

patient. 

• I have documented the patient’s 

preferences. 

• All relevant laws and regulations 

will be followed in completing the 

abortion. 

• The patient’s decision to donate 

fetal tissue will not affect the manner, 

methods and/or procedures used to 

perform the abortion, nor will it affect 

the timing of the abortion. The abortion 

will be performed in the same way, 

regardless of the patient’s decision on 

fetal tissue donation. 

• I am not the individual who 

obtained the informed consent for the 

patient’s abortion. 

• No payments, in cash or in kind, 

were offered or provided to the patient 

for the donation of human fetal tissue. 

Neither [insert name of facility] nor I 

have provided, or obtained, any 

valuable consideration for the human 

fetal tissue. 

Date and Time: lllllllllll

Provider Name, Title, and ID No.: lll

Provider Signature: lllllllll

* * * * * 

Witness: 

Date and Time: lllllllllll

Name of Witness: llllllllll

Signature of Witness: llllllll

List of Subjects 

45 CFR Part 46 

Human research subjects, Reporting 

and record-keeping requirements, 

Research. 

45 CFR Part 75 

Accounting, Administrative practice 

and procedure, Cost principles, Grant 

programs, Grant programs—health, 

Grants administration, Hospitals, 

Nonprofit organizations reporting and 

recordkeeping requirements, and State 

and local governments. 

For the reasons set forth in the 

preamble, the Department of Health and 

Human Services proposes to amend 45 

CFR parts 46 and 75 as follows: 

PART 46—PROTECTION OF HUMAN 

SUBJECTS 

■ 1. The authority citation for part 46 is 

revised to read as follows: 

Authority: 5 U.S.C. 301; 31 U.S.C. 

503(b)(2)(2); 41 U.S.C. Ch. 13; 42; U.S.C. 

216(b); 42 U.S.C. 289(a); 42 U.S.C. 289g–1; 42 

U.S.C. 289g–2. 

■ 2. Amend § 46.202 by adding 

paragraph (i) to read as follows: 

§ 46.202 Definitions. 

* * * * * 

(i) Human fetal tissue shall have the 

definition ascribed to the term in 42 

U.S.C. 289g–1(g). 

■ 3. Amend § 46.204 by adding 

paragraph (k) to read as follows: 

§ 46.204 Research involving pregnant 

women or fetuses. 

* * * * * 

(k) Notwithstanding any provisions to 

the contrary in this Part, HHS-funded 

research involving human fetal tissue 

obtained by donation from a pregnant 

woman occurring after [the effective 

date of the final rule] may not occur 

without the written informed consent of 

the pregnant woman from whom the 

human fetal tissue was obtained. 

(1) For purposes of this paragraph (k), 

informed consent requires that: 

(i) The pregnant woman’s consent be 

documented on a written informed 

consent form that is signed by the 

pregnant woman and written in plain 

language that is clear and easily 

understandable (‘‘Informed Consent 

Form’’); 

(ii) The Informed Consent Form 

include a statement that there have been 

and will be no enticements, benefits, or 

financial incentives exchanged for the 

donation or acquisition of human fetal 

tissue or the abortion (if any) from 

which such tissue was obtained; 

(iii) The Informed Consent Form 

permit the pregnant woman to choose to 

donate fetal tissue for research or to 

decline to donate fetal tissue for 

research; and 

(iv) The Informed Consent Form be 

signed by both the pregnant woman and 

the individual obtaining the informed 

consent for the donation, with the latter 

attesting to the truth of the statements 

in the form. 

(2) With respect to human fetal tissue 

obtained from elective abortions, 

informed consent also requires that: 

(i) The pregnant woman’s informed 

consent be obtained after the decision to 

have an abortion has been conclusively 

made and informed consent for the 

abortion has been obtained; 

Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules 2633 

(ii) The pregnant woman’s informed 

consent be obtained by an individual 

other than the individual who obtained 

the informed consent for the pregnant 

woman’s abortion; 

(iii) The pregnant woman be at or over 

the age of majority in the jurisdiction in 

which the pregnant woman’s donation 

is made; and 

(iv) The Informed Consent Form 

include a statement that the decision to 

have an abortion and the method of 

abortion have not been affected by the 

decision whether to donate human fetal 

tissue. 

■ 4. Amend § 46.206 by adding 

paragraphs (c) through (i) to read as 

follows: 

§ 46.206 Research involving, after delivery, 

the placenta, the dead fetus or fetal 

material. 

* * * * * 

(c) At all stages in the process to 

acquire or otherwise obtain human fetal 

tissue for use in research, there shall be 

no enticements, benefits, or financial 

incentives provided to the pregnant 

woman or attending physician to 

incentivize the occurrence of an 

abortion or the donation or acquisition 

of human fetal tissue. 

(d) No person who solicits or 

knowingly acquires, receives, or accepts 

a donation of human fetal tissue for use 

in research shall provide valuable 

consideration for the costs associated 

with the abortion that is the source of 

the human fetal tissue used or to be 

used in the research. 

(e) No person who solicits or 

knowingly acquires, receives, or accepts 

a donation of human fetal tissue for use 

in research shall provide valuable 

consideration for the costs associated 

with the donation or acquisition of 

human fetal tissue. 

(f) For purposes of paragraphs (d) and 

(e) of this section, the term ‘‘valuable 

consideration’’ includes all payments 

other than reasonable payments 

associated with the transportation, 

implantation, processing, preservation, 

quality control, or storage of human 

fetal tissue. 

(g) Human fetal tissue obtained by 

donation from a woman occurring after 

[the effective date of the final rule] may 

be used in research only if an informed 

consent that meets the applicable 

requirements of § 46.204(k) has been 

obtained with respect to the tissue. 

(h) Research involving human fetal 

tissue can use human fetal tissue from 

elective abortions only if such tissue is 

acquired or otherwise obtained from a 

Federal or State Government, a Federal 

or State Government-owned entity, 

university, college, accredited degreegranting institution of higher education, 

university hospital, or academic 

medical center. 

(i) Once human fetal tissue is no 

longer to be used in research, it shall be 

treated respectfully and disposed of 

reasonably and in compliance with any 

additional laws or regulations imposed 

by applicable state law. 

PART 75—UNIFORM ADMINISTRATIVE 

REQUIREMENTS, COST PRINCIPLES, 

AND AUDIT REQUIREMENTS FOR HHS 

AWARDS 

■ 5. The authority citation for 45 CFR 

part 75 continues to read as follows: 

Authority: 5 U.S.C. 301. 

■ 6. Amend § 75.364 by adding 

paragraph (a)(1), adding and reserving 

paragraph (a)(2) and adding paragraph 

(d) to read as follows: 

§ 75.364 Access to records. 

(a) * * * 

(1) For non-Federal entities that 

engage in human fetal tissue research 

pursuant to a Federal award, the HHS 

awarding entity, Inspectors General, the 

Comptroller General of the United 

States, and the pass-through entity, or 

any of their authorized representatives, 

must have the right of access to: 

(i) Copies of the informed consent 

forms signed by each pregnant woman 

who is the source of human fetal tissue 

used by the non-Federal entity in 

research, which may be redacted with 

respect to the name and signature of the 

woman; 

(ii) all documents, papers, or other 

records as are necessary to establish that 

the human fetal tissue was not obtained 

or transferred for valuable 

consideration, as that term is defined in 

45 CFR 46.206(f); 

(iii) all documents, papers, or other 

records as are necessary to establish that 

federal funds were not used to acquire 

or otherwise obtain the human fetal 

tissue from elective abortions; and 

(iv) personnel familiar with such 

documents, for purposes of interview 

and discussion concerning such 

documents, at reasonable times and 

locations. 

(2) [Reserved] 

* * * * * 

(d) For purposes of this section, 

‘‘human fetal tissue’’ shall have the 

definition ascribed to the term in 42 

U.S.C. 289g–1(g). 

■ 7. Add § 75.478 to subpart E to read 

as follows: 

§ 75.478 Expenses associated with 

acquiring human fetal tissue for research. 

Expenses associated with the 

acquisition of human fetal tissue from 

elective abortions for use in research are 

not allowable expenses under Federal 

awards from an HHS awarding agency. 

Dated: December 29, 2020. 

Alex M. Azar II, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2020–29107 Filed 1–11–21; 4:15 pm] 

BILLING CODE 4151–26–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Part 5b 

[Docket Number NIH–2016–0002] 

RIN 0925–AA62 

Privacy Act; Implementation 

AGENCY: Department of Health and 

Human Services. 

ACTION: Notice of Proposed Rulemaking. 

SUMMARY: The Department of Health and 

Human Services (HHS or Department) 

proposes to exempt confidential source 

identifying information in a system of 

records maintained by the National 

Institutes of Health (NIH) from certain 

requirements of the Privacy Act. The 

affected system of records is 09–25– 

0165, ‘‘National Institutes of Health 

(NIH) Office of Loan Repayment and 

Scholarship (OLRS) Record System, 

HHS/NIH/OD’’ (to be renamed ‘‘NIH 

Loan Repayment Records’’). Elsewhere 

in today’s Federal Register, HHS/NIH 

has published an updated system of 

records notice (SORN) for system 09– 

25–0165 for public notice and comment. 

DATES: Submit either electronic or 

written comments regarding this 

document by March 15, 2021. 

ADDRESSES: You may submit comments, 

identified by Docket Number NIH– 

2015–0002, via any of the following 

methods: 

Electronic Submission 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions provided for submitting 

comments. 

Written Submission 

Submit written submissions in the 

following ways: 

• Fax: 301–402–0169. 

• Mail: Daniel Hernandez, Acting 

NIH Regulations Officer, Office of 

Management Assessment, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 601, MSC 7669, 

Rockville, MD 20852. 

In order to ensure more timely 

processing of comments, HHS/NIH is no