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Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules
HHS has examined the economic implications of this proposed rule as required by the Regulatory Flexibility Act RFA 5 U.S.C. 601612. 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. 603a, 605b. 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.
60136. 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 childrens 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 childrens 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

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.
63 Some 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.
65 See 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.
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