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Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules
obtain the womans voluntary, informed consent. Although there is currently no express requirement for such informed consent, based on the foregoing, it is HHSs 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 understandand 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 46.204k and 46.206g 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 53 U.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.

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each research project, for a total of 1,059.2 informed consent processes per year. Assuming the informed consent process requires 1015 minutes of a registered nurses 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 46.206c 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 HHSs 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 46.206i 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 46.206h, 75.364a, and 75.478. It is HHSs understanding that requirements such as these proposed requirements are generally reflected in the grant 54 As 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 HHSs 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.

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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 tissueand 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 hoursand 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 recipients 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 75.364a1 is already subsumed within the existing 75.364a.
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 55 U.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.
56 U.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.

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