Organ Procurement and Transplantation Network, 70765-70768 [05-23149]

Download as PDF Federal Register / Vol. 70, No. 225 / Wednesday, November 23, 2005 / Proposed Rules 8. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use DEPARTMENT OF HEALTH AND HUMAN SERVICES This rule is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not a significant regulatory action as defined in Executive Order 12866. 42 CFR Part 121 Health Resources and Services Administration RIN 0906AA62 9. National Technology Transfer Advancement Act Organ Procurement and Transplantation Network EPA approves state programs as long as they met criteria required by RCRA, so it would be inconsistent with applicable law for EPA, in its review of a state program, to require the use of any particular voluntary consensus standard in place of another standard that meets requirements of RCRA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply to this rule. AGENCY: 10. Executive Order 12988 As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. 11. Executive Order 12630: Evaluation of Risk and Avoidance of Unanticipated Takings EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the Attorney General’s Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings issued under the Executive Order. List of Subjects in 40 CFR Part 271 Environmental protection, Administrative practice and procedure, Confidential business information, Hazardous waste, Hazardous waste transportation, Indian lands, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements. Authority: This action is issued under the authority of sections 2002(a), 3006, and 7004(b) of the Solid Waste Disposal Act as amended, 42 U.S.C. 6912(a), 6926, 6974(b). Dated: November 9, 2005. Margaret M. Guerriero, Acting Regional Administrator, Region 5. [FR Doc. 05–23213 Filed 11–22–05; 8:45 am] BILLING CODE 6560–50–P VerDate Aug<31>2005 15:39 Nov 22, 2005 Jkt 208001 Health Resources and Services Administration, HHS. ACTION: Notice of proposed rulemaking. SUMMARY: This notice sets forth the Secretary’s proposal to include intestines within the definition of organs covered by the rules governing the operation of the Organ Procurement and Transplantation Network. The Secretary further proposes a corresponding change to the definition of human organs covered by section 301 of the National Organ Transplant Act, as amended. DATES: To be considered, comments on this proposed rule must be submitted by January 23, 2006. Subject to consideration of the comments submitted, the Department intends to publish final regulations. ADDRESSES: You may submit comments, identified by RIN 0906AA62, by any of the following methods: • 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. • E-mail: jburdick@hrsa.gov. Include RIN 0906AA62 in the subject line of the message. • Fax: 301–594–6095. • Mail: Jim Burdick, M.D., Director, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration (HRSA), 5600 Fishers Lane, Room 12C–06, Rockville, Maryland 20857. • Hand Delivery/Courier: Jim Burdick, M.D., Director, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration (HRSA), 5600 Fishers Lane, Room 12C–06, Rockville, Maryland 20857. Instructions: All submissions received must include the agency name and Regulatory Information Number (RIN) for this rulemaking. All comments received will be posted without change to http://www.hrsa.gov/, including any personal information provided. For detailed instructions on submitting PO 00000 Frm 00020 Fmt 4702 Sfmt 4702 70765 comments and additional information on the rulemaking process, see the ‘‘Public Participation’’ heading of the SUPPLEMENTARY INFORMATION section of this document. 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 (HRSA), 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: Jim Burdick, M.D. at the above address; telephone number (301) 443–7577. SUPPLEMENTARY INFORMATION: Adding Intestines to the Definition of Organs Covered by the Rules Governing the Operation of the Organ Procurement and Transplantation Network (OPTN) Based upon a review of intestinal transplants, the Secretary believes that intestines should now be included within the definition of organs covered by the rules governing the operation of the OPTN (42 CFR part 121) (hereinafter the final rule). This notice sets forth the history of intestinal transplants, the factors that have persuaded the Department of the advisability of including intestines within the ambit of the regulations governing the operation of the OPTN, and the anticipated consequences of this proposal. The first successful intestinal transplant was performed in 1989. Intestinal transplantation may be considered for patients with irreversible intestinal failure due to surgery, trauma, or acquired or congenital disease who cannot be managed through the intravenous delivery of nutrients, also referred to as total parenteral nutrition (TPN). Although intestinal transplants have been performed for years, considerable morbidity and mortality have limited widespread clinical use. Complications are frequent and include acute and chronic rejection, lymphoproliferative disease, and serious infections such as cytomegalovirus disease. For patients who received intestinal transplants in the United States from January 2000 through June 2002, one-year graft and patient survival rates were 67 percent and 81 percent respectively for adults, and 58 percent and 65 percent respectively for pediatric recipients. Despite the shortcomings, the number of candidates for intestinal transplants and the number of intestinal E:\FR\FM\23NOP1.SGM 23NOP1 70766 Federal Register / Vol. 70, No. 225 / Wednesday, November 23, 2005 / Proposed Rules transplants performed annually is increasing. The OPTN first adopted voluntary intestinal organ allocation policies and began to maintain a list of patients waiting for intestinal transplants in 1993. On December 31, 1993, only 43 candidates were listed on the intestinal transplant waiting list, compared to 169 candidates on this list on October 24, 2003. The number of intestinal transplants performed annually has more than tripled from 34 transplants in 1993 to 109 transplants in 2002. However, the volume of transplants per transplant center is relatively small. Ten transplant centers performed one or more intestinal transplants in 2002; only five of these centers performed ten or more transplants. Overall median waiting time was 319 days for patients added to the intestinal transplant waiting list in 2001. According to the OPTN, intestinal organ allocation may include the stomach, small and/or large intestine, or any portion of the gastrointestinal tract as determined by the medical needs of individual patients (OPTN Policy 3.11). OPTN voluntary policies are available at http://www.optn.org/policiesandbylaws/ policies.asp. In addition to allocation for isolated intestinal transplants, the OPTN addresses allocation of the liverintestine combination and multiple organs. The nature of the regulatory framework governing the operation of the OPTN underlies the importance of including intestines within the definition of organs covered by the final rule. Under the final rule, the OPTN must submit proposed policies for review and approval by the Secretary. 42 CFR 121.4. Upon consideration of public comments on proposed policies that are considered significant, the Secretary will determine whether to make such proposed policies enforceable in accordance with § 121.10 of the final rule. Any transplant hospital that fails to comply with any allocation policy approved as enforceable by the Secretary under this process will be subject to the enforcement sanctions delineated in § 121.10 of the rule, including termination from the Medicare and Medicaid programs. The Secretary is legally obliged, as part of his responsibilities in administering the Medicare and Medicaid programs, to require hospitals that transplant organs to comply with the rules and requirements of the OPTN as a condition of their participation in Medicare and Medicaid. 42 U.S.C. 1320b–8(a)(1)(B). Because intestines are not included within the final rule’s definition of organs, the Secretary VerDate Aug<31>2005 15:39 Nov 22, 2005 Jkt 208001 cannot currently make any intestinal allocation policy enforceable. If intestines are added as covered organs under the final rule as proposed here, the Secretary could take appropriate enforcement actions against a transplant hospital for failing to comply with the OPTN’s intestinal allocation policy if such a policy has been approved as enforceable by the Secretary under the process outlined above. This enforcement authority is particularly significant given that many recipients of transplanted intestines receive such organs together with other organs covered under the final rule. It is necessary to ensure that intestinal organ allocation, whether pertaining to isolated intestinal transplants or combined/multi-organ transplants, is consistent with the goal of an equitable national system for organ allocation, as described in the final rule. Enforcing allocation for organs currently covered under the final rule, such as livers, would be difficult in instances in which intestines are transplanted together with such organs if intestinal allocation is not subject to the Secretary’s enforcement authority. As the field of intestinal transplantation evolves, it will become more critical that intestinal organ allocation keeps pace with advances in the field; that policy development include performance indicators to assess whether the goals of an equitable transplant system are being achieved; that the Secretary has the authority to make those policies enforceable; and that patients and physicians have timely access to accurate data that will assist them in making decisions regarding intestinal transplantation. Upon consideration of the foregoing factors, and in order to achieve the most equitable and medically effective use of donated organs, the Secretary announces his conclusion that intestines should explicitly be added to the definition of organs covered by the final rule. Public Participation Additional information on the submission of comments and/or the rulemaking process can be obtained from the Director, Division of Policy Review and Coordination, Health Resources and Services Administration (HRSA), 5600 Fishers Lane, Room 14A– 11, Rockville, Maryland 20857. Soliciting Public Comment as to Whether Any Other Organs Should Be Covered by the Rules Governing the Operation of the OPTN The Secretary also invites public comment as to the advisability of PO 00000 Frm 00021 Fmt 4702 Sfmt 4702 including any other organ within the ambit of the final rule. In addition to intestines, there may be other organs not currently covered under the final rule that, as a result of factors such as medical advances, a growing demand for transplantation, and concerns about equitable allocation, should be considered for inclusion under the final rule. Including Intestines Within the Definition of Human Organs Covered by Section 301 of NOTA The Secretary further proposes including intestines within the definition of human organs covered by section 301, as amended, of the National Organ Transplant Act (NOTA) (hereinafter section 301), which prohibits the purchase or sale of human organs for human transplantation. Specifically, section 301, as amended, provides as follows: Prohibition of Organ Purchases (a) Prohibition It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce. (b) Penalties Any person who violates subsection (a) of this section shall be fined not more than $50,000 or imprisoned not more than five years, or both. (c) Definitions For purposes of subsection (a) of this section: (1) The term ‘‘human organ’’ means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof and any other human organ (or any subpart thereof, including that derived from a fetus) specified by the Secretary of Health and Human Services by regulation. (2) The term ‘‘valuable consideration’’ does not include the reasonable payments associated with the removal, transportation, implantation, processing, preservation, quality control, and storage of a human organ or the expenses of travel, housing, and lost wages incurred by the donor of a human organ in connection with the donation of the organ. (3) The term ‘‘interstate commerce’’ has the meaning prescribed for it by section 321(b) of Title 21. 42 U.S.C. 274e. When it originally enacted NOTA, Congress defined the term ‘‘human organ,’’ within the E:\FR\FM\23NOP1.SGM 23NOP1 Federal Register / Vol. 70, No. 225 / Wednesday, November 23, 2005 / Proposed Rules meaning of this section as ‘‘the human kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin and any other human organ specified by the Secretary of Health and Human Services by regulation.’’ NOTA, Pub. L. 98–507, Title III, section 301, 98 Stat. 2346–2347 (1984). This section was subsequently amended by Congress to include fetal organs, as well as subparts of the specified organs. Pub. L. 100–607, Title IV, section 407, 102 Stat. 3116 (1988). As set forth by statute, Congress authorized the Secretary to add additional organs to the definition of ‘‘human organ’’ covered by section 301 through rulemaking in order to include the transplantation of additional human organs within section 301’s prohibition. Through this notice, the Secretary proposes to add intestines to the list of human organs covered by section 301. The Secretary proposes adding a new section to part 121 to effectuate this addition, which section 301 authorizes the Secretary to make by rulemaking. 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). 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. Executive Order 12866 requires that all regulations reflect consideration of alternatives, of costs, of benefits, of incentives, of equity, and of available information. Regulations must meet certain standards, such as avoiding an unnecessary burden. Regulations which are ‘‘significant’’ because of cost, adverse effects on the economy, inconsistency with other agency actions, effects on the budget, or novel legal or policy issues, require special analysis. The Secretary has determined that no resources are required to implement the requirements in this 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. Since independent and hospital-based organ procurement organizations VerDate Aug<31>2005 15:39 Nov 22, 2005 Jkt 208001 (OPOs) are not considered small rural hospitals, because OPOs generally service large geographical areas, a regulatory flexibility analysis under the RFA and a rural impact analysis under section 1102(b) of the Act are not required. The Secretary has also determined that this proposed rule does not meet the criteria for a major rule as defined by Executive Order 12866 and would have no 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 and on the private sector such as to require consultation under the Unfunded Mandates Reform Act of 1995. Nor on the basis of family well-being will the provisions of this rule affect the following family elements: 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. As stated above, this proposed rule would modify the regulations governing the OPTN and section 301 of NOTA based on legal authority. Impact of the New Rule This proposed rule would have the effect of including transplanted human intestines within the ambit of the regulations governing the operation of the OPTN, and would include transplanted human intestines within the prohibition set forth at section 301 of NOTA. If implemented, the proposals set forth in this rule would authorize the Secretary to take enforcement actions against entities violating OPTN policies pertaining to the transplantation of intestines once such policies are approved as enforceable by the Secretary. In addition, if this proposal is implemented, individuals violating section 301 of NOTA with respect to intestinal transplants would be subject to criminal penalties. Paperwork Reduction Act of 1995 The amendments proposed in this notice of proposed rulemaking will not impose any additional data collection requirements beyond those already imposed under the current final rule, which have been approved by the Office PO 00000 Frm 00022 Fmt 4702 Sfmt 4702 70767 of Management and Budget (OMB No. 0915–0157). The currently approved data collection includes worksheets and burden for intestinal transplants. List of Subjects in 42 CFR Part 121 Health care, Hospitals, Organ transplantation, Reporting and recordkeeping requirements. Dated: March 1, 2005. Elizabeth M. Duke, Administrator, Health Resources and Services Administration. Approved: May 20, 2005. Michael O. Leavitt, Secretary. Editorial Note: This document was received at the Office of the Federal Register November 18, 2005. Accordingly, 42 CFR part 121 is proposed to be amended as set forth below: PART 121—ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK 1. The authority citation for part 121 is revised 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. Amend § 121.1 as follows: a. Revise paragraph (a) by replacing the phrase ‘‘this part apply’’ with the phrase ‘‘this part, with the exception of § 121.13, apply.’’ b. Redesignate paragraph (b) as paragraph (c). c. Add a new paragraph (b). The revision reads as follows: § 121.1 Applicability. * * * * * (b) The provisions of § 121.13 apply to the prohibition set forth in section 301 of the National Organ Transplant Act, as amended. * * * * * 3. Revise the definition of ‘‘organ’’ in § 121.2 to read as follows: § 121.2 Definitions. * * * * * Organ means a human kidney, liver, heart, lung, pancreas, or intestine. * * * * * 4. Add a new § 121.13 to read as follows: § 121.13 Definition of Human Organ Under section 301 of the National Organ Transplant Act, as amended. ‘‘Human organ,’’ as covered by section 301 of the National Organ Transplant E:\FR\FM\23NOP1.SGM 23NOP1 70768 Federal Register / Vol. 70, No. 225 / Wednesday, November 23, 2005 / Proposed Rules Act, as amended, means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, skin, and intestine (or any subpart thereof). [FR Doc. 05–23149 Filed 11–22–05; 8:45 am] BILLING CODE 4160–15–P NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES 45 CFR Part 1182 RIN 3137–AA17 Institute of Museum and Library Services; Implementation of the Privacy Act of 1974 Institute of Museum and Library Services (IMLS), NFAH. ACTION: Proposed rule. AGENCY: SUMMARY: The Institute of Museum and Library Services (Institute) in publishing a proposed rule setting forth regulations under the Privacy Act of 1974 and conforming to the President’s memorandum of June 1, 1998—Plain Language in Government Writing. These regulations establish procedures by which an individual may determine whether a system of records maintained by the Institute contains a record pertaining to him or her; gain access to such records; and request correction or amendment of such records. These regulations also establish exemptions from certain Privacy Act requirements for all or part of certain systems or records maintained by the Institute. DATES: Comments are invited and must be received by no later than December 23, 2005. ADDRESSES: Address all comments concerning this proposed rule to Nancy E. Weiss, General Counsel, Institute of Museum and Library Services, 1800 M Street, NW., 9th Floor, Washington, DC 20036. Submit electronic comments to nweiss@imls.gov. Telephone: (202) 653– 4784. Facsimile: (202) 653–4625. FOR FURTHER INFORMATION CONTACT: Nancy E. Weiss, General Counsel, Institute of Museum and Library Services, 1800 M Street, NW., Ninth Floor, Washington, DC 20036. E-mail: nweiss@imls.gov. Telephone: (202) 653– 4787. Facsimile: (202) 653–4625. SUPPLEMENTARY INFORMATION: The Institute operates as part of the National Foundation on the Arts and the Humanities under the National Foundation on the Arts and the Humanities Act of 1965, as amended (20 U.S.C. 951 et seq.). The corresponding regulations published at 45 CFR Chapter VerDate Aug<31>2005 15:39 Nov 22, 2005 Jkt 208001 XI, Subchapter A apply to the entire Foundation, while the regulations published at 45 CFR Chapter XI, Subchapter E apply only to the Institute. This proposed rules adds Privacy Act regulations to Subchapter E (45 CFR part 1182), replacing the existing regulations in Subchapter A (45 CFR part 1115) with regard to the Institute. The new regulations provide additional detail concerning several provisions of the Privacy Act, and are intended to increase understanding of the Institute’s Privacy Act policies. The Institute is authorized to propose the new regulations under 5 U.S.C. 552a(f) of the Privacy Act. SUPPLEMENTARY INFORMATION: I. Public Comment Procedures The regulatory repeal proposed in this rulemaking eliminates outdated regulations and makes technical amendments to reflect Congress’ reauthorization of the Institute of Museum and Library Services under The Museum and Library Services Act of 2003, Public Law 108–81 (September 25, 2003). These changes are proposed to ensure that all regulations governing provision of grants made by the Institute are consistent with current statutory guidance and agency practice. The public is invited to make substantive comment on any of these proposed changes. Comments should be submitted in writing to the address indicated in the ADDRESSES section of this document. All comments received will be available upon request for public inspection at Institute of Museum and Library Services, 1800 M Street, NW., Ninth Floor, Washington, DC 20036. All written comments received by the date indicated in the DATES section of this document and all other relevant information in the record will be carefully assessed and fully considered prior to publication of the final rule. Any information considered to be confidential must be so identified and submitted in writing. We will not consider comments submitted anonymously. However, if you wish us to withhold your name and/or address, you must state this prominently at the beginning of your comment. II. Matters of Regulatory Procedure Regulatory Planning and Review (E.O. 12866) Under Executive Order 12866, the Institute must determine whether the regulatory action is ‘‘significant’’ and therefore subject to OMB review and the requirements of the Executive Order. The Order defines a ‘‘significant PO 00000 Frm 00023 Fmt 4702 Sfmt 4702 regulatory action’’ as one that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles set forth in the Executive Order. The Proposed rules would add Privacy Act regulations to subchapter E (45 CFR part 1182), replacing the existing regulations in Subchapter A (45 CFR part 1115) with regard to the Institute. The new regulations provide additional detail concerning several provisions of the Privacy Act, and are intended to increase understanding of the Institute’s Privacy Act policies. As such, it does not impose a compliance burden on the economy generally or on any person or entity. Accordingly, this rule is not a ‘‘significant regulatory action’’ from an economic standpoint, and it does not otherwise create any inconsistencies or budgetary impacts to any other agency or Federal Program. Regulatory Flexibility Act Because this proposed rule would add Privacy Act regulations to Subchapter E (45 CFR part 1182), replacing the existing regulations in Subchapter A (45 CFR part 1115) with regard to the Institute, the Institute has determined in Regulatory Flexibility Act (5 U.S.C. 601 et seq.) review that this proposed rule will not have a significant economic impact on a substantial number of small entities. Paperwork Reduction Act This rule is exempt from the requirements of the Paperwork Reduction Act, since it adds Privacy Act regulations to Subchapter E (45 CFR part 1182), replacing the existing regulations in Subchapter A (45 CFR part 1115) with regard to the Institute. An OMB form 83–1 is not required. Unfunded Mandates Reform Act For purposes of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. chapter 25, subchapter II), this rule will not significantly or uniquely affect small governments and will not result in increased expenditures by State, local, E:\FR\FM\23NOP1.SGM 23NOP1

Agencies

[Federal Register Volume 70, Number 225 (Wednesday, November 23, 2005)]
[Proposed Rules]
[Pages 70765-70768]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-23149]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

42 CFR Part 121

RIN 0906AA62


Organ Procurement and Transplantation Network

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: This notice sets forth the Secretary's proposal to include 
intestines within the definition of organs covered by the rules 
governing the operation of the Organ Procurement and Transplantation 
Network. The Secretary further proposes a corresponding change to the 
definition of human organs covered by section 301 of the National Organ 
Transplant Act, as amended.

DATES: To be considered, comments on this proposed rule must be 
submitted by January 23, 2006. Subject to consideration of the comments 
submitted, the Department intends to publish final regulations.

ADDRESSES: You may submit comments, identified by RIN 0906AA62, by any 
of the following methods:
     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.
     E-mail: jburdick@hrsa.gov. Include RIN 0906AA62 in the 
subject line of the message.
     Fax: 301-594-6095.
     Mail: Jim Burdick, M.D., Director, Division of 
Transplantation, Healthcare Systems Bureau, Health Resources and 
Services Administration (HRSA), 5600 Fishers Lane, Room 12C-06, 
Rockville, Maryland 20857.
     Hand Delivery/Courier: Jim Burdick, M.D., Director, 
Division of Transplantation, Healthcare Systems Bureau, Health 
Resources and Services Administration (HRSA), 5600 Fishers Lane, Room 
12C-06, Rockville, Maryland 20857.
    Instructions: All submissions received must include the agency name 
and Regulatory Information Number (RIN) for this rulemaking. All 
comments received will be posted without change to http://www.hrsa.gov/
, including any personal information provided. For detailed 
instructions on submitting comments and additional information on the 
rulemaking process, see the ``Public Participation'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    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 (HRSA), 
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: Jim Burdick, M.D. at the above 
address; telephone number (301) 443-7577.

SUPPLEMENTARY INFORMATION:

Adding Intestines to the Definition of Organs Covered by the Rules 
Governing the Operation of the Organ Procurement and Transplantation 
Network (OPTN)

    Based upon a review of intestinal transplants, the Secretary 
believes that intestines should now be included within the definition 
of organs covered by the rules governing the operation of the OPTN (42 
CFR part 121) (hereinafter the final rule). This notice sets forth the 
history of intestinal transplants, the factors that have persuaded the 
Department of the advisability of including intestines within the ambit 
of the regulations governing the operation of the OPTN, and the 
anticipated consequences of this proposal.
    The first successful intestinal transplant was performed in 1989. 
Intestinal transplantation may be considered for patients with 
irreversible intestinal failure due to surgery, trauma, or acquired or 
congenital disease who cannot be managed through the intravenous 
delivery of nutrients, also referred to as total parenteral nutrition 
(TPN). Although intestinal transplants have been performed for years, 
considerable morbidity and mortality have limited widespread clinical 
use. Complications are frequent and include acute and chronic 
rejection, lymphoproliferative disease, and serious infections such as 
cytomegalovirus disease. For patients who received intestinal 
transplants in the United States from January 2000 through June 2002, 
one-year graft and patient survival rates were 67 percent and 81 
percent respectively for adults, and 58 percent and 65 percent 
respectively for pediatric recipients. Despite the shortcomings, the 
number of candidates for intestinal transplants and the number of 
intestinal

[[Page 70766]]

transplants performed annually is increasing.
    The OPTN first adopted voluntary intestinal organ allocation 
policies and began to maintain a list of patients waiting for 
intestinal transplants in 1993. On December 31, 1993, only 43 
candidates were listed on the intestinal transplant waiting list, 
compared to 169 candidates on this list on October 24, 2003. The number 
of intestinal transplants performed annually has more than tripled from 
34 transplants in 1993 to 109 transplants in 2002. However, the volume 
of transplants per transplant center is relatively small. Ten 
transplant centers performed one or more intestinal transplants in 
2002; only five of these centers performed ten or more transplants. 
Overall median waiting time was 319 days for patients added to the 
intestinal transplant waiting list in 2001.
    According to the OPTN, intestinal organ allocation may include the 
stomach, small and/or large intestine, or any portion of the 
gastrointestinal tract as determined by the medical needs of individual 
patients (OPTN Policy 3.11). OPTN voluntary policies are available at 
http://www.optn.org/policiesandbylaws/policies.asp. In addition to 
allocation for isolated intestinal transplants, the OPTN addresses 
allocation of the liver-intestine combination and multiple organs.
    The nature of the regulatory framework governing the operation of 
the OPTN underlies the importance of including intestines within the 
definition of organs covered by the final rule. Under the final rule, 
the OPTN must submit proposed policies for review and approval by the 
Secretary. 42 CFR 121.4. Upon consideration of public comments on 
proposed policies that are considered significant, the Secretary will 
determine whether to make such proposed policies enforceable in 
accordance with Sec.  121.10 of the final rule. Any transplant hospital 
that fails to comply with any allocation policy approved as enforceable 
by the Secretary under this process will be subject to the enforcement 
sanctions delineated in Sec.  121.10 of the rule, including termination 
from the Medicare and Medicaid programs.
    The Secretary is legally obliged, as part of his responsibilities 
in administering the Medicare and Medicaid programs, to require 
hospitals that transplant organs to comply with the rules and 
requirements of the OPTN as a condition of their participation in 
Medicare and Medicaid. 42 U.S.C. 1320b-8(a)(1)(B). Because intestines 
are not included within the final rule's definition of organs, the 
Secretary cannot currently make any intestinal allocation policy 
enforceable. If intestines are added as covered organs under the final 
rule as proposed here, the Secretary could take appropriate enforcement 
actions against a transplant hospital for failing to comply with the 
OPTN's intestinal allocation policy if such a policy has been approved 
as enforceable by the Secretary under the process outlined above. This 
enforcement authority is particularly significant given that many 
recipients of transplanted intestines receive such organs together with 
other organs covered under the final rule. It is necessary to ensure 
that intestinal organ allocation, whether pertaining to isolated 
intestinal transplants or combined/multi-organ transplants, is 
consistent with the goal of an equitable national system for organ 
allocation, as described in the final rule. Enforcing allocation for 
organs currently covered under the final rule, such as livers, would be 
difficult in instances in which intestines are transplanted together 
with such organs if intestinal allocation is not subject to the 
Secretary's enforcement authority.
    As the field of intestinal transplantation evolves, it will become 
more critical that intestinal organ allocation keeps pace with advances 
in the field; that policy development include performance indicators to 
assess whether the goals of an equitable transplant system are being 
achieved; that the Secretary has the authority to make those policies 
enforceable; and that patients and physicians have timely access to 
accurate data that will assist them in making decisions regarding 
intestinal transplantation. Upon consideration of the foregoing 
factors, and in order to achieve the most equitable and medically 
effective use of donated organs, the Secretary announces his conclusion 
that intestines should explicitly be added to the definition of organs 
covered by the final rule.

Public Participation

    Additional information on the submission of comments and/or the 
rulemaking process can be obtained from the Director, Division of 
Policy Review and Coordination, Health Resources and Services 
Administration (HRSA), 5600 Fishers Lane, Room 14A-11, Rockville, 
Maryland 20857.

Soliciting Public Comment as to Whether Any Other Organs Should Be 
Covered by the Rules Governing the Operation of the OPTN

    The Secretary also invites public comment as to the advisability of 
including any other organ within the ambit of the final rule. In 
addition to intestines, there may be other organs not currently covered 
under the final rule that, as a result of factors such as medical 
advances, a growing demand for transplantation, and concerns about 
equitable allocation, should be considered for inclusion under the 
final rule.

Including Intestines Within the Definition of Human Organs Covered by 
Section 301 of NOTA

    The Secretary further proposes including intestines within the 
definition of human organs covered by section 301, as amended, of the 
National Organ Transplant Act (NOTA) (hereinafter section 301), which 
prohibits the purchase or sale of human organs for human 
transplantation. Specifically, section 301, as amended, provides as 
follows:

Prohibition of Organ Purchases

(a) Prohibition

    It shall be unlawful for any person to knowingly acquire, receive, 
or otherwise transfer any human organ for valuable consideration for 
use in human transplantation if the transfer affects interstate 
commerce.

(b) Penalties

    Any person who violates subsection (a) of this section shall be 
fined not more than $50,000 or imprisoned not more than five years, or 
both.

(c) Definitions

    For purposes of subsection (a) of this section:
    (1) The term ``human organ'' means the human (including fetal) 
kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, 
and skin or any subpart thereof and any other human organ (or any 
subpart thereof, including that derived from a fetus) specified by the 
Secretary of Health and Human Services by regulation.
    (2) The term ``valuable consideration'' does not include the 
reasonable payments associated with the removal, transportation, 
implantation, processing, preservation, quality control, and storage of 
a human organ or the expenses of travel, housing, and lost wages 
incurred by the donor of a human organ in connection with the donation 
of the organ.
    (3) The term ``interstate commerce'' has the meaning prescribed for 
it by section 321(b) of Title 21.

42 U.S.C. 274e. When it originally enacted NOTA, Congress defined the 
term ``human organ,'' within the

[[Page 70767]]

meaning of this section as ``the human kidney, liver, heart, lung, 
pancreas, bone marrow, cornea, eye, bone, and skin and any other human 
organ specified by the Secretary of Health and Human Services by 
regulation.'' NOTA, Pub. L. 98-507, Title III, section 301, 98 Stat. 
2346-2347 (1984). This section was subsequently amended by Congress to 
include fetal organs, as well as subparts of the specified organs. Pub. 
L. 100-607, Title IV, section 407, 102 Stat. 3116 (1988).
    As set forth by statute, Congress authorized the Secretary to add 
additional organs to the definition of ``human organ'' covered by 
section 301 through rulemaking in order to include the transplantation 
of additional human organs within section 301's prohibition. Through 
this notice, the Secretary proposes to add intestines to the list of 
human organs covered by section 301. The Secretary proposes adding a 
new section to part 121 to effectuate this addition, which section 301 
authorizes the Secretary to make by rulemaking.

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). 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.
    Executive Order 12866 requires that all regulations reflect 
consideration of alternatives, of costs, of benefits, of incentives, of 
equity, and of available information. Regulations must meet certain 
standards, such as avoiding an unnecessary burden. Regulations which 
are ``significant'' because of cost, adverse effects on the economy, 
inconsistency with other agency actions, effects on the budget, or 
novel legal or policy issues, require special analysis.
    The Secretary has determined that no resources are required to 
implement the requirements in this 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. Since independent and 
hospital-based organ procurement organizations (OPOs) are not 
considered small rural hospitals, because OPOs generally service large 
geographical areas, a regulatory flexibility analysis under the RFA and 
a rural impact analysis under section 1102(b) of the Act are not 
required.
    The Secretary has also determined that this proposed rule does not 
meet the criteria for a major rule as defined by Executive Order 12866 
and would have no 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 and on the private sector such as 
to require consultation under the Unfunded Mandates Reform Act of 1995.
    Nor on the basis of family well-being will the provisions of this 
rule affect the following family elements: 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.
    As stated above, this proposed rule would modify the regulations 
governing the OPTN and section 301 of NOTA based on legal authority.

Impact of the New Rule

    This proposed rule would have the effect of including transplanted 
human intestines within the ambit of the regulations governing the 
operation of the OPTN, and would include transplanted human intestines 
within the prohibition set forth at section 301 of NOTA. If 
implemented, the proposals set forth in this rule would authorize the 
Secretary to take enforcement actions against entities violating OPTN 
policies pertaining to the transplantation of intestines once such 
policies are approved as enforceable by the Secretary. In addition, if 
this proposal is implemented, individuals violating section 301 of NOTA 
with respect to intestinal transplants would be subject to criminal 
penalties.

Paperwork Reduction Act of 1995

    The amendments proposed in this notice of proposed rulemaking will 
not impose any additional data collection requirements beyond those 
already imposed under the current final rule, which have been approved 
by the Office of Management and Budget (OMB No. 0915-0157). The 
currently approved data collection includes worksheets and burden for 
intestinal transplants.

List of Subjects in 42 CFR Part 121

    Health care, Hospitals, Organ transplantation, Reporting and 
recordkeeping requirements.

    Dated: March 1, 2005.
Elizabeth M. Duke,
Administrator, Health Resources and Services Administration.
    Approved: May 20, 2005.
Michael O. Leavitt,
Secretary.

    Editorial Note: This document was received at the Office of the 
Federal Register November 18, 2005.

    Accordingly, 42 CFR part 121 is proposed to be amended as set forth 
below:

PART 121--ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK

    1. The authority citation for part 121 is revised 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. Amend Sec.  121.1 as follows:
    a. Revise paragraph (a) by replacing the phrase ``this part apply'' 
with the phrase ``this part, with the exception of Sec.  121.13, 
apply.''
    b. Redesignate paragraph (b) as paragraph (c).
    c. Add a new paragraph (b).
    The revision reads as follows:


Sec.  121.1  Applicability.

* * * * *
    (b) The provisions of Sec.  121.13 apply to the prohibition set 
forth in section 301 of the National Organ Transplant Act, as amended.
* * * * *
    3. Revise the definition of ``organ'' in Sec.  121.2 to read as 
follows:


Sec.  121.2  Definitions.

* * * * *
    Organ means a human kidney, liver, heart, lung, pancreas, or 
intestine.
* * * * *
    4. Add a new Sec.  121.13 to read as follows:


Sec.  121.13  Definition of Human Organ Under section 301 of the 
National Organ Transplant Act, as amended.

    ``Human organ,'' as covered by section 301 of the National Organ 
Transplant

[[Page 70768]]

Act, as amended, means the human (including fetal) kidney, liver, 
heart, lung, pancreas, bone marrow, cornea, eye, bone, skin, and 
intestine (or any subpart thereof).

[FR Doc. 05-23149 Filed 11-22-05; 8:45 am]
BILLING CODE 4160-15-P