Change to the Definition of “Human Organ” Under Section 301 of the National Organ Transplant Act of 1984, 60810-60813 [2013-24094]

Download as PDF 60810 ACTION: Federal Register / Vol. 78, No. 191 / Wednesday, October 2, 2013 / Proposed Rules Proposed rule; notice of intent. The Environmental Protection Agency (EPA) Region 2 is issuing a Notice of Intent to Delete the Ludlow Sand & Gravel Superfund Site (Site), located in Paris, New York, from the National Priorities List (NPL) and requests public comments on this proposed action. The NPL, promulgated pursuant to Section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). EPA and the State of New York, through the New York State Department of Environmental Conservation, have determined that all appropriate response actions under CERCLA, other than monitoring and maintenance and five-year reviews, have been completed. However, the deletion does not preclude future action under Superfund. DATES: Comments must be received by November 1, 2013. ADDRESSES: Submit your comments, identified by Docket ID no. EPA–HQ– SFUND–1983–0002, by one of the following methods: • http://www.regulations.gov. Follow the on-line instructions for submitting comments. • Email: rodrigues.isabel@epa.gov. • Fax: To the attention of Isabel Rodrigues at 212–637–4284. • Mail: To the attention of Isabel Rodrigues, Remedial Project Manager, Emergency and Remedial Response Division, U.S. Environmental Protection Agency, Region 2, 290 Broadway, 20th Floor, New York, NY 10007–1866. • Hand Delivery: Superfund Records Center, 290 Broadway, 18th Floor, New York, NY 10007–1866 (telephone: 212– 637–4308). Such deliveries are only accepted during the Record Center’s normal hours of operation (Monday to Friday from 9:00 a.m. to 5:00 p.m.). Special arrangements should be made for deliveries of boxed information. Instructions: Direct your comments to Docket ID no. EPA–HQ–SFUND–1983– 0002: EPA’s policy is that all comments received will be included in the Docket without change and may be made available online at http:// www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through http:// www.regulations.gov or via email. The mstockstill on DSK4VPTVN1PROD with PROPOSALS SUMMARY: VerDate Mar<15>2010 17:27 Oct 01, 2013 Jkt 232001 http://www.regulations.gov Web site is an ‘‘anonymous access’’ system, which means EPA will not know your identity or contact information unless you provide it in the body of your comments. If you send comments to EPA via email, your email address will be included as part of the comment that is placed in the Docket and made available on the Web site. If you submit electronic comments, EPA recommends that you include your name and other contact information in the body of your comments and with any disks or CD– ROMs that you submit. If EPA cannot read your comments due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comments. Electronic files should avoid the use of special characters and any form of encryption and should be free of any defects or viruses. Docket: All documents in the Docket are listed in the http:// www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available Docket materials can be viewed electronically at http://www.regulations.gov or obtained in hard copy at: U.S. Environmental Protection Agency, Region 2, Superfund Records Center, 290 Broadway, 18th Floor, New York, NY 10007–1866, Phone: 212–637– 4308, Hours: Monday to Friday from 9:00 a.m. to 5:00 p.m., and Town of Paris, Town Hall, 2580 Sulphur Springs Road, Sauquoit, NY 13456– 0451, Phone: 315–839–5400, Hours: Monday-Thursday from 9:00 a.m. to 4:00 p.m., Friday from 9:00 a.m. to 12:00 p.m., and NYSDEC Central Office, 625 Broadway, Albany, NY 12233–7016, Phone: 518– 402–9775, Hours: Monday-Friday from 9:00 a.m. to 5:00 p.m., Please call for an appointment, and NYSDEC Region 6 Sub-Office, State Office Building, 207 Genesee Street, Utica, NY 13501, Phone: 315–793– 2555, Hours: Monday-Friday from 8:30 a.m. to 4:45 p.m., Please call for an appointment. FOR FURTHER INFORMATION CONTACT: Isabel Rodrigues, Remedial Project Manager, by mail at Emergency and Remedial Response Division, U.S. Environmental Protection Agency, Region 2, 290 Broadway, 20th floor, New York, NY 10007–1866; telephone at 212–637–4248; fax at 212–637–4284; or email at rodrigues.isabel@epa.gov. PO 00000 Frm 00027 Fmt 4702 Sfmt 4702 In the ‘‘Rules and Regulations’’ Section of today’s Federal Register, EPA is publishing a direct final Notice of Deletion of the Site without prior Notice of Intent to Delete because EPA views this as a noncontroversial revision and anticipate no adverse comment. EPA has explained its reasons for this deletion in the preamble to the direct final Notice of Deletion. If EPA receives no adverse comment(s) on this Notice of Intent to Delete or the direct final Notice of Deletion, EPA will proceed with the deletion without further notice on this Notice of Intent to Delete. If EPA receives adverse comment(s), EPA will withdraw the direct final Notice of Deletion and it will not take effect. EPA will, as appropriate, address all public comments in a subsequent final Notice of Deletion based on this Notice of Intent to Delete. EPA will not institute a second comment period on this Notice of Intent to Delete. Any parties interested in commenting must do so at this time. For additional information, see the direct final Notice of Deletion, which is located in the ‘‘Rules’’ section of this Federal Register. SUPPLEMENTARY INFORMATION: List of Subjects in 40 CFR Part 300 Environmental protection, Air pollution control, Chemicals, Hazardous waste, Hazardous substances, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Superfund, Water pollution control, Water supply. Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. 9601–9657; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR, 1987 Comp., p. 193. Dated: September 20, 2013. Judith A. Enck, Regional Administrator, EPA, Region 2. [FR Doc. 2013–24115 Filed 10–1–13; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 121 RIN 0906–AB02 Change to the Definition of ‘‘Human Organ’’ Under Section 301 of the National Organ Transplant Act of 1984 Health Resources and Services Administration, HHS. ACTION: Notice of proposed rulemaking. AGENCY: This notice seeks public comment on the proposed change in the definition of ‘‘human organ’’ in section SUMMARY: E:\FR\FM\02OCP1.SGM 02OCP1 mstockstill on DSK4VPTVN1PROD with PROPOSALS Federal Register / Vol. 78, No. 191 / Wednesday, October 2, 2013 / Proposed Rules 301 of the National Organ and Transplant Act of 1984, as amended, (NOTA) to explicitly incorporate hematopoietic stem cells (HSCs) within peripheral blood in the definition of ‘‘bone marrow.’’ This would clarify that the prohibition on transfers of human organs for valuable consideration applies to HSCs regardless of whether they were recovered directly from bone marrow (by aspiration) or from peripheral blood (by apheresis). This amendment will also conform section 301 to the provisions of the Stem Cell Research and Therapeutic Act of 2005, as amended. DATES: To be considered, comments should be submitted by December 2, 2013. Subject to consideration of the comments submitted, the Department intends to publish final regulations. ADDRESSES: You may submit comments, identified by Regulatory Information Number RIN 0906–AB02, by any of the following methods, but the first option is preferred: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. • Agency Web site: http:// www.hrsa.gov/. Follow the instructions for submitting comments on the Agency Web site. • Email: SGrant@hrsa.gov. Include RIN 0906–AB02 in the subject line of the message. • Fax: (301) 594–6095. • Mail: Shelley Grant, MHSA, Branch Chief, Blood Stem Cell Transplantation Program, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Room 12C–06, Rockville, Maryland 20857. Instructions: All submissions must include the agency name and RIN for this rulemaking. All comments received will be posted without change to http://www.hrsa.gov/, including any personal information provided. Additional information concerning the submission of comments and/or the rulemaking process can be obtained from the Regulations Officer, Division of Policy Information and Coordination, Health Resources and Services Administration, 5600 Fishers Lane, Room 14–101, Rockville, Maryland 20857. Docket: For access to the docket to read background documents or comments received, go to the Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Room 12C–06, Rockville, Maryland 20857, weekdays (Federal holidays excepted) between the hours of 8:30 VerDate Mar<15>2010 17:27 Oct 01, 2013 Jkt 232001 a.m. and 5 p.m. To schedule an appointment to view public comments, phone (301) 443–7757. FOR FURTHER INFORMATION CONTACT: Shelley Grant, MHSA, at the above address; telephone number (301) 443– 8036. SUPPLEMENTARY INFORMATION: I. Background A. Statutory Background Congress enacted the National Organ Transplant Act of 1984 (NOTA), Public Law 98–507, to develop a national comprehensive policy regarding organ transplantation. Within NOTA, section 301 criminalizes the transfer of organs for use in human transplantation for ‘‘valuable consideration.’’ ‘‘Human organ’’ is defined to include ‘‘bone marrow * * * or any subpart thereof’’ or any organ specified by the Secretary in regulation. NOTA section 301(c)(1) [codified at 42 U.S.C. 274e(c)(1)]. The law criminalizes the transfer of any human organ for valuable consideration with a fine of up to $50,000 and imprisonment up to five years. Though the general prohibition has been in place since 1984, Congress has made numerous amendments to NOTA and otherwise has focused recurring attention on organ and bone marrow donation and transplantation. In 1988, Congress specifically amended section 301 to broaden the definition of ‘‘human organ’’ to include ‘‘any subpart thereof.’’ Organ Transplant Amendments of 1988, Pub. L. 100–607, section 407, 102 Stat. 3048, 3116 (Nov 4, 1988). Congress again amended section 301 in 2007 to exclude paired donation from the definition of ‘‘valuable consideration.’’ Charlie Norwood Living Organ Donation Act. Sec. 102, Public Law 110–144, section 102, 121 Stat. 1813 (2007). When enacted, NOTA provided for a demonstration study on the feasibility of a ‘‘national registry of voluntary bone marrow donors.’’ Sec. 401, Public Law 98–507, 98 Stat. 2347 (1984). In 1988, in the same law which broadened the definition of organ to ‘‘any subpart thereof,’’ Congress directed the Secretary to establish a national bone marrow registry. Sec. 404, Public Law 100–607, 102 Stat. 3116 (1988). Subsequently, Congress established the National Bone Marrow Donor Registry. Transplant Amendments Act of 1990. Sec.101, Public Law 101–616, 104 Stat. 3279 (1990). The National Bone Marrow Donor Registry is now called the C.W. Bill Young Cell Transplantation Program, Public Law 109–129, 119 Stat. 2250 (2005) [42 U.S.C. 274k, et seq.]. Enacted in 2005, and reauthorized in 2010, the statute defines ‘‘bone marrow’’ PO 00000 Frm 00028 Fmt 4702 Sfmt 4702 60811 as ‘‘the cells found in adult bone marrow and peripheral blood.’’ 42 U.S.C. 274l–1 (emphasis added). B. Scientific Development Hematopoietic stem cells (HSCs) originate in the spongy tissue within bones commonly referred to as ‘‘bone marrow’’ and give rise to mature blood cells, namely red blood cells, white blood cells, and platelets. HSCs are found in the highest concentration in bone marrow and in lower concentrations in circulating (peripheral) blood. What are commonly referred to as ‘‘bone marrow’’ transplants are actually transplants of hematopoietic stem cells, regardless of source. ‘‘Bone marrow’’ transplantation (i.e., HSC transplantation) is commonly used to treat certain blood cancers like leukemia, other blood diseases like aplastic anemia, and immune-deficiency diseases. Until recently, available techniques required that HSCs be obtained from the marrow by inserting a needle into the marrow to extract liquid containing the HSCs. The extracted material is then put through a filtration process to separate HSCs from other marrow components and concentrate them, before the HSCs are then transplanted into the transplant recipient. This type of HSC collection is known as the ‘‘aspiration method.’’ Under a newer process, known as peripheral blood stem cell apheresis, donors receive five daily injections of an HSC stimulating drug that causes increased production and mobilization of HSCs from the bone marrow into the circulating blood stream (peripheral blood). Once these drug doses have been administered, a sufficient quantity and concentration of HSCs become available for retrieval in a donor’s peripheral blood. At this point, a needle is inserted into one of the donor’s peripheral or central veins, and his or her blood then passes through an apheresis machine that isolates and collects the hematopoietic stem cells. The remaining blood components are then returned to the donor through the intravenous catheter. The apheresis collection procedure can take up to eight hours. Most apheresis donations occur in one daylong session, although some are completed over the course of two days. A donor’s total blood volume is run through the process three to five times to collect a sufficient number of hematopoietic stem cells necessary for successful transplantation. The C.W. Bill Young Cell Transplantation Program and its predecessor program, the National Bone Marrow Donor Registry, have coordinated apheresis donations since 1999. U.S. General E:\FR\FM\02OCP1.SGM 02OCP1 mstockstill on DSK4VPTVN1PROD with PROPOSALS 60812 Federal Register / Vol. 78, No. 191 / Wednesday, October 2, 2013 / Proposed Rules Accounting Office, Bone Marrow Transplants: Despite Recruitment Success, National Program may be Underutilized 6 (2002). Hematopoietic stem cells themselves have always been recognized as the critical component of bone marrow donation. Thomas’ Hematopoietic Cell Transplantation 36– 37, 72–7, 618 (Frederick Appelbaum, et al., eds. 4th ed. 2009). Though safer and less invasive than aspiration, apheresis still carries risks to the donor. Side-effects of the HSC stimulating drug may include rupture of the spleen or a low platelet count (thrombocytopenia). There may also be serious risks related to the placement of a central venous line in larger veins (jugular, subclavian, or femoral) in donors without adequate peripheral vein access. More importantly, aspiration is the medically indicated method of donation for a substantial number of transplants. American Society of Hematology, ‘‘Increased Incidence of Chronic Graft-Versus-Host Disease (GVHD) and No Survival Advantage with Filgrastim-Mobilized Peripheral Blood Stem Cells (PBSC) Compared to Bone Marrow (BM) Transplants From Unrelated Donors: Results of Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Protocol 0201, a Phase III, Prospective, Randomized Trial,’’ Anasetti, Claudio, Confer, Dennis, et al., 2011; Biology of Blood and Marrow Transplantation, ‘‘Peripheral Blood Grafts from Unrelated Donors Are Associated with Increased Acute and Chronic Graft-Versus-Host Disease without Improved Survival,’’ Eapen, Mary, Anasetti, Claudio, et al., 2007. It is important to note that, even assuming the relative safety of apheresis, a substantial number of potential transplant recipients will continue to require HSCs obtained by aspiration. Congress has consistently updated the law as advances in organ donation technology have been made. As noted above, Congress expanded the scope of NOTA’s definition of organ in 1988 to include ‘‘any subpart thereof.’’ In the 2005 Act, Congress defined ‘‘bone marrow’’ to include HSCs in the ‘‘peripheral blood.’’ And, as previously stated, Congress expressly granted the Secretary authority to define organs through regulation as the field of transplantation evolves. C. Litigation On March 27, 2012, a panel of the United States Ninth Circuit Court of Appeals issued an opinion holding that bone marrow donors may be compensated if the apheresis method of donation is used. Flynn v. Holder, 684 VerDate Mar<15>2010 17:27 Oct 01, 2013 Jkt 232001 F.3d 852 (9 Cir. 2012). The plaintiffs in the case alleged that the ban on sale of ‘‘bone marrow’’ under NOTA lacked a ‘‘rational basis’’ under the equal protection clause of the Fifth Amendment. Plaintiffs sought to operate a program offering $3,000 awards, in the form of scholarships, housing allowances, or gifts to charity, to bone marrow donors. The district court found multiple rational bases for the prohibition. However, the Ninth Circuit panel held there was no constitutional question since the apheresis method of marrow harvesting was not covered by the statutory prohibition on the transfer of organs for ‘‘valuable consideration.’’ In rejecting the government’s arguments that bone marrow included HSCs in the peripheral blood, the Ninth Circuit panel instead focused on the recent development of apheresis technology as foreclosing the possibility that Congress intended the NOTA, when enacted, to cover HSCs in the blood stream. Since apheresis was not used to procure HSCs in 1984, the Court held that Congress could not have intended HSCs obtained through this method to fall under the ban in section 301. Therefore, the Ninth Circuit panel believed that the non-commodification principle and other negative consequences Congress sought to avoid were not relevant to HSCs in the peripheral blood. Importantly, however, the Ninth Circuit panel did recognize in its written opinion that the Secretary had regulatory authority to define peripheral blood stem cells as organs. The effect of exercising this authority through this proposed amendment is to clarify that HSCs are covered by the prohibition on transfers of human organs for valuable consideration found in NOTA section 301(c)(1) [codified at 42 U.S.C. 274e(c)(1)]. While focused on the proposal of the plaintiffs before it, the Court’s holding does not limit the compensation donors can demand to scholarships, housing allowances, or charitable gifts. Particularly in light of the much more stringent matching required between donor and recipient for HSC transplants to be successful, the opportunities for exploitation of those in medical need of HSC transplantation are much greater than for solid organ transplantation. blood as part of the definition of ‘‘bone marrow’’ for the purposes for section 301. Notwithstanding the Ninth Circuit’s decision in the Flynn case, the statute expresses a Congressional intent to ban the commodification of HSCs that are used in human transplants, curb opportunities for coercion and exploitation, encourage altruistic donations, and decrease the likelihood of disease transmission resulting from paid donations. Furthermore, the Department has clear regulatory authority to clarify the regulatory definition of ‘‘human organ’’ to make explicit that the prohibition applies to both types of collection methods (apheresis and aspiration)—authority that the Ninth Circuit expressly recognized. For these reasons, the Department is proposing to amend 42 CFR 121.13 to read: ‘‘Human organ’’ as covered by section 301 of the National Organ Transplant Act, as amended, means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow and other hematopoietic stem/progenitor cells without regard to the method of their collection, cornea, eye, bone, skin, and intestine, including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract.’’ The Department has amended, and proposed to amend, the definition of ‘‘human organ’’ on several occasions, as medical knowledge has progressed. See 72 FR 10616 (March 9, 2007) (defining prohibition in section 301 to include intestines), and 76 FR 78216 (December 16, 2011) (proposing to include vascularized composite allografts in the definition of ‘‘human organ’’). The proposed change will clarify that the meaning of ‘‘bonemarrow,’’ for purpose of the prohibition, does not hinge on the collection method used to obtain the cells. The proposed change to the definition of ‘‘human organ’’ in section 301 does not affect the Food and Drug Administration’s regulation of whole blood and blood components, and of human cells, tissues, and cellular-and tissue-based products (HCT/Ps). II. Proposed Rule In light of the Congressional, Departmental, and scientific community’s long understanding of bone marrow as encompassing HSCs in peripheral blood, the Department is proposing to amend the definition of ‘‘human organ’’ in section 301 to explicitly include HSCs in peripheral Economic and Regulatory Impact Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when rulemaking is necessary, to select regulatory approaches that provide the greatest net benefits (including potential economic, environmental, public health, safety, distributive, and equity effects). PO 00000 Frm 00029 Fmt 4702 Sfmt 4702 III. Impact Analysis Executive Order 12866 and Paperwork Reduction Act E:\FR\FM\02OCP1.SGM 02OCP1 mstockstill on DSK4VPTVN1PROD with PROPOSALS Federal Register / Vol. 78, No. 191 / Wednesday, October 2, 2013 / Proposed Rules In addition, under the Regulatory Flexibility Act, if a rule has a significant economic effect on a substantial number of small entities the Secretary must specifically consider the economic effect of a rule on small entities and analyze regulatory options that could lessen the impact of the rule. The Secretary has determined that minimal resources are required to implement the requirements in this rule because the organizations involved (e.g., marrow registries and transplant hospitals) currently implement their programs in accordance with the procedures announced in this proposed rule. Therefore, in accordance with the Regulatory Flexibility Act of 1980 (RFA), and the Small Business Regulatory Enforcement Act of 1996, which amended the RFA, the Secretary certifies that this rule will not have a significant impact on a substantial number of small entities. The Secretary also has determined that this proposed rule does not meet the criteria for a major rule as defined by Executive Order 12866 and would not have a major effect on the economy or Federal expenditures. We have determined that the proposed rule is not a major rule within the meaning of the statute providing for Congressional Review of Agency Rulemaking, 5 U.S.C. 801. Similarly, it will not have effects on state, local, and tribal governments or on the private sector such as to require consultation under the Unfunded Mandates Reform Act of 1995. The provisions of this rule will not affect the following elements of family well-being: Family safety, family stability, marital commitment; parental rights in the education, nurture, and supervision of their children; family functioning, disposable income, or poverty; or the behavior and personal responsibility of youth, as determined under section 654(c) of the Treasury and General Government Appropriations Act of 1999. Section 202 (a) of the Unfunded Mandates Reform Act of 1995 requires that agencies assess anticipated costs and benefits before issuing any rule that includes a federal mandate that could result in expenditure in any one year by state, local, or tribal governments, in the aggregate, or by the private sector, of $100 million in 1995 dollars, updated annually for inflation. The current threshold after adjustment for inflation using the Implicit Price Deflator for Gross Domestic Product is about $141 million. This rule would not meet or exceed that threshold. This rule is not economically significant under section 3(f) of VerDate Mar<15>2010 17:27 Oct 01, 2013 Jkt 232001 Executive Order 12866 and is not being treated as a ‘‘significant regulatory action’’ under section 3(f). Accordingly, the rule has not been reviewed by the Office of Management and Budget. As stated above, this proposed rule would modify the regulations governing the nation’s Organ Procurement and Transplantation Network (OPTN) and section 301 of NOTA based on legal authority. Paperwork Reduction Act of 1995 The amendments proposed in this Rule will not impose any additional data collection requirements beyond those already imposed under the current information collection requirements, which have been approved by the Office of Management and Budget (OMB No. 0915–0310). The currently approved data collection includes worksheets and burden for all marrow transplants. List of Subjects in 42 CFR Part 121 Healthcare, Hospitals, Organ transplantation. Dated: September 19, 2013. Mary K. Wakefield, Administrator, Health Resources and Services Administration Approved: September 25, 2013. Kathleen Sebelius, Secretary. Therefore, under the authority of section 301 of NOTA, as amended, and for the reasons stated in the preamble, the Department proposes to amend 42 CFR part 121 as follows: PART 121—ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK 1. The authority citation continues to read as follows: ■ Authority: Sections 215, 371–376 of the Public Health Service Act (42 U.S.C. 216, 273–274d); sections 1102, 1106, 1138 and 1871 of the Social Security Act (42 U.S.C. 1302, 1306, 1320b-8 and 1395hh); and section 301 of the National Organ Transplant Act, as amended (42 U.S.C. 274e). 2. Section 121.13 is revised to read as follows: ■ § 121.13 Definition of human organ under section 301 of the National Organ Transplant Act of 1984, as amended. ‘‘Human organ,’’ as covered by section 301 of the National Organ Transplant Act, as amended, means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow and other hematopoietic stem/progenitor cells without regard to the method of their collection, cornea, eye, bone skin, and intestine, including the esophagus, stomach, small and/or large intestine, or PO 00000 Frm 00030 Fmt 4702 Sfmt 4702 60813 any portion of the gastrointestinal tract.’’ [FR Doc. 2013–24094 Filed 10–1–13; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 [Docket No. FWS–HQ–ES–2013–0073; FXES11130900000C2–134–FF09E32000] RIN 1018–AY00 Endangered and Threatened Wildlife and Plants; Removing the Gray Wolf (Canis lupus) From the List of Endangered and Threatened Wildlife and Maintaining Protections for the Mexican Wolf (Canis lupus baileyi) by Listing It as Endangered Fish and Wildlife Service, Interior. ACTION: Proposed rule; announcement of public hearing. AGENCY: We, the U.S. Fish and Wildlife Service (Service), recently published a proposal to remove the gray wolf from the List of Endangered and Threatened Wildlife (List) but to maintain endangered status for the Mexican wolf by listing it as a subspecies (Canis lupus baileyi). On September 5, 2013, we announced three public hearings on the proposed rule and extended the public comment period to October 28, 2013. We now announce an additional public hearing to be held on October 17, 2013, in Denver, Colorado. DATES: Written Comments: The public comment period on the proposal to remove the gray wolf from the List of Endangered and Threatened Wildlife but to maintain endangered status for the Mexican wolf by listing it as a subspecies is open through October 28, 2013. Please note that comments submitted electronically using the Federal eRulemaking Portal (see ADDRESSES, below) must be received by 11:59 p.m. Eastern Time on the closing date. If you are submitting your comments by hard copy, please mail them by October 28, 2013, to ensure that we receive them in time to give them full consideration. Public Hearings: We will hold a public hearing on October 17, 2013, from 6 p.m. to 8:30 p.m. in Denver, Colorado. SUMMARY: Written Comments: You may submit comments by one of the following methods: ADDRESSES: E:\FR\FM\02OCP1.SGM 02OCP1

Agencies

[Federal Register Volume 78, Number 191 (Wednesday, October 2, 2013)]
[Proposed Rules]
[Pages 60810-60813]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-24094]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 121

RIN 0906-AB02


Change to the Definition of ``Human Organ'' Under Section 301 of 
the National Organ Transplant Act of 1984

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: This notice seeks public comment on the proposed change in the 
definition of ``human organ'' in section

[[Page 60811]]

301 of the National Organ and Transplant Act of 1984, as amended, 
(NOTA) to explicitly incorporate hematopoietic stem cells (HSCs) within 
peripheral blood in the definition of ``bone marrow.'' This would 
clarify that the prohibition on transfers of human organs for valuable 
consideration applies to HSCs regardless of whether they were recovered 
directly from bone marrow (by aspiration) or from peripheral blood (by 
apheresis). This amendment will also conform section 301 to the 
provisions of the Stem Cell Research and Therapeutic Act of 2005, as 
amended.

DATES: To be considered, comments should be submitted by December 2, 
2013. Subject to consideration of the comments submitted, the 
Department intends to publish final regulations.

ADDRESSES: You may submit comments, identified by Regulatory 
Information Number RIN 0906-AB02, by any of the following methods, but 
the first option is preferred:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.hrsa.gov/. Follow the 
instructions for submitting comments on the Agency Web site.
     Email: SGrant@hrsa.gov. Include RIN 0906-AB02 in the 
subject line of the message.
     Fax: (301) 594-6095.
     Mail: Shelley Grant, MHSA, Branch Chief, Blood Stem Cell 
Transplantation Program, Division of Transplantation, Healthcare 
Systems Bureau, Health Resources and Services Administration, 5600 
Fishers Lane, Room 12C-06, Rockville, Maryland 20857.
    Instructions: All submissions must include the agency name and RIN 
for this rulemaking. All comments received will be posted without 
change to http://www.hrsa.gov/, including any personal information 
provided. Additional information concerning the submission of comments 
and/or the rulemaking process can be obtained from the Regulations 
Officer, Division of Policy Information and Coordination, Health 
Resources and Services Administration, 5600 Fishers Lane, Room 14-101, 
Rockville, Maryland 20857.
    Docket: For access to the docket to read background documents or 
comments received, go to the Division of Transplantation, Healthcare 
Systems Bureau, Health Resources and Services Administration, 5600 
Fishers Lane, Room 12C-06, Rockville, Maryland 20857, weekdays (Federal 
holidays excepted) between the hours of 8:30 a.m. and 5 p.m. To 
schedule an appointment to view public comments, phone (301) 443-7757.

FOR FURTHER INFORMATION CONTACT: Shelley Grant, MHSA, at the above 
address; telephone number (301) 443-8036.

SUPPLEMENTARY INFORMATION: 

I. Background

A. Statutory Background

    Congress enacted the National Organ Transplant Act of 1984 (NOTA), 
Public Law 98-507, to develop a national comprehensive policy regarding 
organ transplantation. Within NOTA, section 301 criminalizes the 
transfer of organs for use in human transplantation for ``valuable 
consideration.'' ``Human organ'' is defined to include ``bone marrow * 
* * or any subpart thereof'' or any organ specified by the Secretary in 
regulation. NOTA section 301(c)(1) [codified at 42 U.S.C. 274e(c)(1)]. 
The law criminalizes the transfer of any human organ for valuable 
consideration with a fine of up to $50,000 and imprisonment up to five 
years. Though the general prohibition has been in place since 1984, 
Congress has made numerous amendments to NOTA and otherwise has focused 
recurring attention on organ and bone marrow donation and 
transplantation. In 1988, Congress specifically amended section 301 to 
broaden the definition of ``human organ'' to include ``any subpart 
thereof.'' Organ Transplant Amendments of 1988, Pub. L. 100-607, 
section 407, 102 Stat. 3048, 3116 (Nov 4, 1988). Congress again amended 
section 301 in 2007 to exclude paired donation from the definition of 
``valuable consideration.'' Charlie Norwood Living Organ Donation Act. 
Sec. 102, Public Law 110-144, section 102, 121 Stat. 1813 (2007).
    When enacted, NOTA provided for a demonstration study on the 
feasibility of a ``national registry of voluntary bone marrow donors.'' 
Sec. 401, Public Law 98-507, 98 Stat. 2347 (1984). In 1988, in the same 
law which broadened the definition of organ to ``any subpart thereof,'' 
Congress directed the Secretary to establish a national bone marrow 
registry. Sec. 404, Public Law 100-607, 102 Stat. 3116 (1988). 
Subsequently, Congress established the National Bone Marrow Donor 
Registry. Transplant Amendments Act of 1990. Sec.101, Public Law 101-
616, 104 Stat. 3279 (1990). The National Bone Marrow Donor Registry is 
now called the C.W. Bill Young Cell Transplantation Program, Public Law 
109-129, 119 Stat. 2250 (2005) [42 U.S.C. 274k, et seq.]. Enacted in 
2005, and reauthorized in 2010, the statute defines ``bone marrow'' as 
``the cells found in adult bone marrow and peripheral blood.'' 42 
U.S.C. 274l-1 (emphasis added).

B. Scientific Development

    Hematopoietic stem cells (HSCs) originate in the spongy tissue 
within bones commonly referred to as ``bone marrow'' and give rise to 
mature blood cells, namely red blood cells, white blood cells, and 
platelets. HSCs are found in the highest concentration in bone marrow 
and in lower concentrations in circulating (peripheral) blood. What are 
commonly referred to as ``bone marrow'' transplants are actually 
transplants of hematopoietic stem cells, regardless of source. ``Bone 
marrow'' transplantation (i.e., HSC transplantation) is commonly used 
to treat certain blood cancers like leukemia, other blood diseases like 
aplastic anemia, and immune-deficiency diseases.
    Until recently, available techniques required that HSCs be obtained 
from the marrow by inserting a needle into the marrow to extract liquid 
containing the HSCs. The extracted material is then put through a 
filtration process to separate HSCs from other marrow components and 
concentrate them, before the HSCs are then transplanted into the 
transplant recipient. This type of HSC collection is known as the 
``aspiration method.''
    Under a newer process, known as peripheral blood stem cell 
apheresis, donors receive five daily injections of an HSC stimulating 
drug that causes increased production and mobilization of HSCs from the 
bone marrow into the circulating blood stream (peripheral blood). Once 
these drug doses have been administered, a sufficient quantity and 
concentration of HSCs become available for retrieval in a donor's 
peripheral blood. At this point, a needle is inserted into one of the 
donor's peripheral or central veins, and his or her blood then passes 
through an apheresis machine that isolates and collects the 
hematopoietic stem cells. The remaining blood components are then 
returned to the donor through the intravenous catheter. The apheresis 
collection procedure can take up to eight hours. Most apheresis 
donations occur in one daylong session, although some are completed 
over the course of two days. A donor's total blood volume is run 
through the process three to five times to collect a sufficient number 
of hematopoietic stem cells necessary for successful transplantation. 
The C.W. Bill Young Cell Transplantation Program and its predecessor 
program, the National Bone Marrow Donor Registry, have coordinated 
apheresis donations since 1999. U.S. General

[[Page 60812]]

Accounting Office, Bone Marrow Transplants: Despite Recruitment 
Success, National Program may be Underutilized 6 (2002). Hematopoietic 
stem cells themselves have always been recognized as the critical 
component of bone marrow donation. Thomas' Hematopoietic Cell 
Transplantation 36-37, 72-7, 618 (Frederick Appelbaum, et al., eds. 4th 
ed. 2009).
    Though safer and less invasive than aspiration, apheresis still 
carries risks to the donor. Side-effects of the HSC stimulating drug 
may include rupture of the spleen or a low platelet count 
(thrombocytopenia). There may also be serious risks related to the 
placement of a central venous line in larger veins (jugular, 
subclavian, or femoral) in donors without adequate peripheral vein 
access. More importantly, aspiration is the medically indicated method 
of donation for a substantial number of transplants. American Society 
of Hematology, ``Increased Incidence of Chronic Graft-Versus-Host 
Disease (GVHD) and No Survival Advantage with Filgrastim-Mobilized 
Peripheral Blood Stem Cells (PBSC) Compared to Bone Marrow (BM) 
Transplants From Unrelated Donors: Results of Blood and Marrow 
Transplant Clinical Trials Network (BMT CTN) Protocol 0201, a Phase 
III, Prospective, Randomized Trial,'' Anasetti, Claudio, Confer, 
Dennis, et al., 2011; Biology of Blood and Marrow Transplantation, 
``Peripheral Blood Grafts from Unrelated Donors Are Associated with 
Increased Acute and Chronic Graft-Versus-Host Disease without Improved 
Survival,'' Eapen, Mary, Anasetti, Claudio, et al., 2007. It is 
important to note that, even assuming the relative safety of apheresis, 
a substantial number of potential transplant recipients will continue 
to require HSCs obtained by aspiration.
    Congress has consistently updated the law as advances in organ 
donation technology have been made. As noted above, Congress expanded 
the scope of NOTA's definition of organ in 1988 to include ``any 
subpart thereof.'' In the 2005 Act, Congress defined ``bone marrow'' to 
include HSCs in the ``peripheral blood.'' And, as previously stated, 
Congress expressly granted the Secretary authority to define organs 
through regulation as the field of transplantation evolves.

C. Litigation

    On March 27, 2012, a panel of the United States Ninth Circuit Court 
of Appeals issued an opinion holding that bone marrow donors may be 
compensated if the apheresis method of donation is used. Flynn v. 
Holder, 684 F.3d 852 (9 Cir. 2012). The plaintiffs in the case alleged 
that the ban on sale of ``bone marrow'' under NOTA lacked a ``rational 
basis'' under the equal protection clause of the Fifth Amendment. 
Plaintiffs sought to operate a program offering $3,000 awards, in the 
form of scholarships, housing allowances, or gifts to charity, to bone 
marrow donors. The district court found multiple rational bases for the 
prohibition. However, the Ninth Circuit panel held there was no 
constitutional question since the apheresis method of marrow harvesting 
was not covered by the statutory prohibition on the transfer of organs 
for ``valuable consideration.''
    In rejecting the government's arguments that bone marrow included 
HSCs in the peripheral blood, the Ninth Circuit panel instead focused 
on the recent development of apheresis technology as foreclosing the 
possibility that Congress intended the NOTA, when enacted, to cover 
HSCs in the blood stream. Since apheresis was not used to procure HSCs 
in 1984, the Court held that Congress could not have intended HSCs 
obtained through this method to fall under the ban in section 301. 
Therefore, the Ninth Circuit panel believed that the non-
commodification principle and other negative consequences Congress 
sought to avoid were not relevant to HSCs in the peripheral blood. 
Importantly, however, the Ninth Circuit panel did recognize in its 
written opinion that the Secretary had regulatory authority to define 
peripheral blood stem cells as organs. The effect of exercising this 
authority through this proposed amendment is to clarify that HSCs are 
covered by the prohibition on transfers of human organs for valuable 
consideration found in NOTA section 301(c)(1) [codified at 42 U.S.C. 
274e(c)(1)].
    While focused on the proposal of the plaintiffs before it, the 
Court's holding does not limit the compensation donors can demand to 
scholarships, housing allowances, or charitable gifts. Particularly in 
light of the much more stringent matching required between donor and 
recipient for HSC transplants to be successful, the opportunities for 
exploitation of those in medical need of HSC transplantation are much 
greater than for solid organ transplantation.

II. Proposed Rule

    In light of the Congressional, Departmental, and scientific 
community's long understanding of bone marrow as encompassing HSCs in 
peripheral blood, the Department is proposing to amend the definition 
of ``human organ'' in section 301 to explicitly include HSCs in 
peripheral blood as part of the definition of ``bone marrow'' for the 
purposes for section 301. Notwithstanding the Ninth Circuit's decision 
in the Flynn case, the statute expresses a Congressional intent to ban 
the commodification of HSCs that are used in human transplants, curb 
opportunities for coercion and exploitation, encourage altruistic 
donations, and decrease the likelihood of disease transmission 
resulting from paid donations. Furthermore, the Department has clear 
regulatory authority to clarify the regulatory definition of ``human 
organ'' to make explicit that the prohibition applies to both types of 
collection methods (apheresis and aspiration)--authority that the Ninth 
Circuit expressly recognized.
    For these reasons, the Department is proposing to amend 42 CFR 
121.13 to read: ``Human organ'' as covered by section 301 of the 
National Organ Transplant Act, as amended, means the human (including 
fetal) kidney, liver, heart, lung, pancreas, bone marrow and other 
hematopoietic stem/progenitor cells without regard to the method of 
their collection, cornea, eye, bone, skin, and intestine, including the 
esophagus, stomach, small and/or large intestine, or any portion of the 
gastrointestinal tract.'' The Department has amended, and proposed to 
amend, the definition of ``human organ'' on several occasions, as 
medical knowledge has progressed. See 72 FR 10616 (March 9, 2007) 
(defining prohibition in section 301 to include intestines), and 76 FR 
78216 (December 16, 2011) (proposing to include vascularized composite 
allografts in the definition of ``human organ''). The proposed change 
will clarify that the meaning of ``bone-marrow,'' for purpose of the 
prohibition, does not hinge on the collection method used to obtain the 
cells. The proposed change to the definition of ``human organ'' in 
section 301 does not affect the Food and Drug Administration's 
regulation of whole blood and blood components, and of human cells, 
tissues, and cellular-and tissue-based products (HCT/Ps).

III. Impact Analysis

Executive Order 12866 and Paperwork Reduction Act

Economic and Regulatory Impact
    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, when rulemaking is 
necessary, to select regulatory approaches that provide the greatest 
net benefits (including potential economic, environmental, public 
health, safety, distributive, and equity effects).

[[Page 60813]]

In addition, under the Regulatory Flexibility Act, if a rule has a 
significant economic effect on a substantial number of small entities 
the Secretary must specifically consider the economic effect of a rule 
on small entities and analyze regulatory options that could lessen the 
impact of the rule.
    The Secretary has determined that minimal resources are required to 
implement the requirements in this rule because the organizations 
involved (e.g., marrow registries and transplant hospitals) currently 
implement their programs in accordance with the procedures announced in 
this proposed rule. Therefore, in accordance with the Regulatory 
Flexibility Act of 1980 (RFA), and the Small Business Regulatory 
Enforcement Act of 1996, which amended the RFA, the Secretary certifies 
that this rule will not have a significant impact on a substantial 
number of small entities.
    The Secretary also has determined that this proposed rule does not 
meet the criteria for a major rule as defined by Executive Order 12866 
and would not have a major effect on the economy or Federal 
expenditures. We have determined that the proposed rule is not a major 
rule within the meaning of the statute providing for Congressional 
Review of Agency Rulemaking, 5 U.S.C. 801. Similarly, it will not have 
effects on state, local, and tribal governments or on the private 
sector such as to require consultation under the Unfunded Mandates 
Reform Act of 1995.
    The provisions of this rule will not affect the following elements 
of family well-being: Family safety, family stability, marital 
commitment; parental rights in the education, nurture, and supervision 
of their children; family functioning, disposable income, or poverty; 
or the behavior and personal responsibility of youth, as determined 
under section 654(c) of the Treasury and General Government 
Appropriations Act of 1999.
    Section 202 (a) of the Unfunded Mandates Reform Act of 1995 
requires that agencies assess anticipated costs and benefits before 
issuing any rule that includes a federal mandate that could result in 
expenditure in any one year by state, local, or tribal governments, in 
the aggregate, or by the private sector, of $100 million in 1995 
dollars, updated annually for inflation. The current threshold after 
adjustment for inflation using the Implicit Price Deflator for Gross 
Domestic Product is about $141 million. This rule would not meet or 
exceed that threshold.
    This rule is not economically significant under section 3(f) of 
Executive Order 12866 and is not being treated as a ``significant 
regulatory action'' under section 3(f). Accordingly, the rule has not 
been reviewed by the Office of Management and Budget.
    As stated above, this proposed rule would modify the regulations 
governing the nation's Organ Procurement and Transplantation Network 
(OPTN) and section 301 of NOTA based on legal authority.

 Paperwork Reduction Act of 1995

    The amendments proposed in this Rule will not impose any additional 
data collection requirements beyond those already imposed under the 
current information collection requirements, which have been approved 
by the Office of Management and Budget (OMB No. 0915-0310). The 
currently approved data collection includes worksheets and burden for 
all marrow transplants.

List of Subjects in 42 CFR Part 121

    Healthcare, Hospitals, Organ transplantation.


    Dated: September 19, 2013.
Mary K. Wakefield,
Administrator, Health Resources and Services Administration
    Approved: September 25, 2013.
Kathleen Sebelius,
Secretary.

    Therefore, under the authority of section 301 of NOTA, as amended, 
and for the reasons stated in the preamble, the Department proposes to 
amend 42 CFR part 121 as follows:

PART 121--ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK

0
1. The authority citation continues to read as follows:

    Authority: Sections 215, 371-376 of the Public Health Service 
Act (42 U.S.C. 216, 273-274d); sections 1102, 1106, 1138 and 1871 of 
the Social Security Act (42 U.S.C. 1302, 1306, 1320b-8 and 1395hh); 
and section 301 of the National Organ Transplant Act, as amended (42 
U.S.C. 274e).

0
2. Section 121.13 is revised to read as follows:


Sec.  121.13  Definition of human organ under section 301 of the 
National Organ Transplant Act of 1984, as amended.

    ``Human organ,'' as covered by section 301 of the National Organ 
Transplant Act, as amended, means the human (including fetal) kidney, 
liver, heart, lung, pancreas, bone marrow and other hematopoietic stem/
progenitor cells without regard to the method of their collection, 
cornea, eye, bone skin, and intestine, including the esophagus, 
stomach, small and/or large intestine, or any portion of the 
gastrointestinal tract.''

[FR Doc. 2013-24094 Filed 10-1-13; 8:45 am]
BILLING CODE 4165-15-P