10616 Federal Register / Vol. 72, No. 46 / Friday, March 9, 2007 / Rules and Regulations 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by May 8, 2007. Filing a petition 

for reconsideration by the Administrator 

of this final rule does not affect the 

finality of this rule for the purposes of 

judicial review nor does it extend the 

time within which a petition for judicial 

review may be filed, and shall not 

postpone the effectiveness of such rule 

or action. This action may not be 

challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects 

40 CFR Part 52 

Environmental protection, Air 

pollution control, Carbon monoxide, 

Incorporation by reference, 

Intergovernmental relations, Lead, 

Nitrogen dioxide, Ozone, Particulate 

matter, Reporting and recordkeeping 

requirements, Sulfur oxides, Volatile 

organic compounds. 

40 CFR Part 70 

Administrative practice and 

procedure, Air pollution control, 

Intergovernmental relations, Operating 

permits, Reporting and recordkeeping 

requirements. 

Dated: February 27, 2007. 

John B. Askew, 

Regional Administrator, Region 7. 

■ Chapter I, Title 40 of the Code of 

Federal Regulations is amended as 

follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for Part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart AA—Missouri 

■ 2. In § 52.1320(c) the table is amended 

under Chapter 6 by revising the entry 

for ‘‘10–6.110’’ to read as follows: 

§ 52.1320 Identification of plan. 

* * * * * 

(c) * * * 

EPA-APPROVED MISSOURI REGULATIONS

Missouri citation Title State effective 

date EPA approval date Explanation 

Missouri Department of Natural Resources 

* * * * * * * 

Chapter 6—Air Quality Standards, Definitions, Sampling and Reference Methods, and Air Pollution Control Regulations for the State of 

Missouri 

* * * * * * * 

10–6.110 ................... Submission of Emission Data, Emission Fees, 

and Process Information.

12/30/06 3/9/07 [insert FR page 

number where the 

document begins].

Section (3)(D), Emissions Fees, has not 

been approved as 

part of the SIP. 

* * * * * * * 

* * * * * 

PART 70—[AMENDED] 

■ 3. The authority citation for Part 70 

continues to read as follows: 

Authority: 42 U.S.C. 7401, et seq. 

Appendix A—[Amended] 

■ 4. Appendix A to Part 70 is amended 

by adding paragraph (u) under Missouri 

to read as follows: 

Appendix A to Part 70—Approval 

Status of State and Local Operating 

Permits Programs 

* * * * * 

Missouri 

* * * * * 

(u) The Missouri Department of Natural 

Resources submitted revisions to Missouri 

rule 10 CSR 10–6.110, ‘‘Submission of 

Emission Data, Emission Fees, and Process 

Information’’ on December 11, 2006; 

approval of sections (3)(D)1., (3)(D)2.E., and 

(3)(D)2.F. effective May 8, 2007. 

* * * * * 

[FR Doc. E7–4176 Filed 3–8–07; 8:45 am] 

BILLING CODE 6560–50–P 

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: Final rule. 

SUMMARY: This Final Rule sets forth the 

Secretary’s decision to include 

intestines within the definition of 

organs covered by the regulations 

governing the operations of the Organ 

Procurement and Transplantation 


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Federal Register / Vol. 72, No. 46 / Friday, March 9, 2007 / Rules and Regulations 10617 

Network. The Secretary under the 

authority granted by section 301 of the 

National Organ Transplant Act, as 

amended, further effects a 

corresponding change to the definition 

of human organs covered in the statute 

with this Final Rule. 

DATES: This Final Rule is effective 

March 9, 2007. 

FOR FURTHER INFORMATION CONTACT: 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. 

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 Final Rule 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 Rule. 

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 

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 

esophagus, 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 

regulations. Under the final rule, the 

OPTN must submit proposed policies 

for review and approval by the Secretary 

according to the requirements of 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 42 CFR 121.10. 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 42 

CFR 121.10, 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 under 42 U.S.C. 

1320b–8(a)(1)(B). Because intestines 

currently are not included within the 

regulation’s definition of organs, the 

Secretary cannot make any intestinal 

allocation policy enforceable. The 

inclusion of intestines as covered organs 

under this Final Rule will allow the 

Secretary to take appropriate 

enforcement actions against a transplant 

hospital that fails to comply with any 

OPTN intestinal allocation policy if 

such a policy is approved by the 

Secretary. This enforcement authority is 

particularly significant given that many 

recipients of transplanted intestines 

receive such organs together with other 

organs covered under the regulations. 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. 

Enforcing the allocation for organs 

currently covered under the regulations, 

such as livers, would be difficult when 

intestines are transplanted together with 

other such organs if an 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 has 

determined that intestines should 

explicitly be added to the definition of 

organs covered by the OPTN regulations 

at 42 CFR Part 121. 

Public Participation 

The public was invited to respond to 

the Notice of Proposed Rulemaking 

(NPRM) which was published in the 

Federal Register on November 23, 2005 

(70 FR 70765–70768). The NPRM 

provided for a 60-day comment period. 

We received a total of three comments 

from the public. All three comments 

were in support of adding intestines to 

the definition of organs covered by the 

rules governing the OPTN and 

encouraged coordination with the 

Centers for Medicare and Medicaid 

Services. Consequently, this Final Rule 

is the same as the proposed rule 

published on November 23, 2005. 


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10618 Federal Register / Vol. 72, No. 46 / Friday, March 9, 2007 / Rules and Regulations 

Soliciting Public Comment as to 

Whether Any Other Organs Should Be 

Covered by the Rules Governing the 

Operation of the OPTN 

The Secretary invited public comment 

as to the advisability of including any 

other organ within the ambit of this 

final rule. The comments we received 

did not request the inclusion of any 

other organ under the OPTN 

regulations. 

Including Intestines Within the 

Definition of Human Organs Covered by 

Section 301 of NOTA 

The Secretary further invited public 

comment on 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. 

Originally as enacted section 301 of 

NOTA (Pub. L. 98–507) defined the term 

‘‘human organ’’ 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, Public Law 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, by Public Law 

100–607, section 407. 

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. Through this Final Rule, the 

Secretary adds intestines to the list of 

human organs covered by section 301. 

The Secretary adds a new section to 42 

CFR Part 121 to effectuate this change. 

The comments we received supported 

adding intestines to the definition of 

organs covered under section 301 of 

NOTA and encouraged coordination 

with the Centers for Medicare and 

Medicaid Services regarding 

implementation of the respective but 

related authorities regarding organ 

procurement and transplantation. 

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 Final 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 Final Rule does not meet the 

criteria for a major rule as defined by 

Executive Order 12866, as amended by 

Executive Order 13258, and would have 

no major effect on the economy or 

Federal expenditures. We have 

determined that the Final 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 Final 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 Final Rule will 

modify the regulations governing the 

OPTN and section 301 of NOTA based 

on legal authority. 

Impact of the New Rule 

This Final Rule will have the effect of 

including human intestines within the 

ambit of the regulations governing the 

operation of the OPTN, and will include 

transplanted human intestines within 

the changes made at section 301 of 

NOTA. The changes made in this Rule 

will 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, individuals violating section 

301 of NOTA with respect to intestinal 

transplants will be subject to criminal 

penalties. 

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 

regulations, 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 9, 2007. 

Elizabeth M. Duke, 

Administrator, Health Resources and Services 

Administration. 

Approved: November 27, 2006. 

Michael O. Leavitt, 

Secretary. 

■ Accordingly, 42 CFR part 121 is 

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. Amend paragraph (a) by removing 

the phrase ‘‘this part apply’’ and adding 

in its place the phrase ‘‘this part, with 

the exception of § 121.13, apply.’’


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Federal Register / Vol. 72, No. 46 / Friday, March 9, 2007 / Rules and Regulations 10619 

■ 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. 

* * * * * 

§ 121.2 [Amended] 

■ 3. Amend the definition of ‘‘organ’’ in 

§ 121.2 by removing the word ‘‘or’’ and 

by adding the phrase ‘‘, or intestine 

(including the esophagus, stomach, 

small and/or large intestine, or any 

portion of the gastrointestinal tract)’’

after the term ‘‘pancreas.’’

■ 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 

Act, as amended, means the human 

(including fetal) kidney, liver, heart, 

lung, pancreas, bone marrow, cornea, 

eye, bone, skin, and intestine, including 

the esophagus, stomach, small and/or 

large intestine, or any portion of the 

gastrointestinal tract. 

[FR Doc. E7–4267 Filed 3–8–07; 8:45 am] 

BILLING CODE 4160–15–P 


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