[Federal Register Volume 71, Number 92 (Friday, May 12, 2006)]
[Proposed Rules]
[Pages 27649-27652]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-4370]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
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 

  Federal Register / Vol. 71, No. 92 / Friday, May 12, 2006 / Proposed 
Rules  

[[Page 27649]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

[Docket No. 2006N-0051]

Health Resources and Services Administration

42 CFR Part 121


Blood Vessels Recovered With Organs and Intended for Use in Organ 
Transplantation; Companion Document to Direct Final Rule

AGENCIES: Food and Drug Administration, Health Resources and Services 
Administration, HHS.

ACTION: Proposed rule.

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

SUMMARY: The Health Resources and Services Administration (HRSA) and 
the Food and Drug Administration (FDA) are proposing to amend their 
regulations to consider as part of an organ those blood vessels 
recovered with the organ that are intended for use in organ 
transplantation (HRSA regulation); and to exclude such blood vessels 
from the definition of human cells, tissues, and cellular and tissue-
based products (HCT/Ps) (FDA regulation). We (HRSA and FDA) are taking 
this action to provide that blood vessels recovered with organs and 
intended for use in organ transplantation will be governed by the 
regulations pertaining to organs. The regulation of other recovered 
blood vessels would remain unchanged. We believe that this change will 
eliminate the unnecessary burden resulting from an organ procurement 
organization's efforts to comply with both FDA and HRSA rules with 
respect to blood vessels (FDA jurisdiction) and organs (HRSA 
jurisdiction). This proposed rule is a companion document to the direct 
final rule published elsewhere in this issue of the Federal Register. 
We are taking this action because the proposed changes are 
noncontroversial, and we do not anticipate any significant adverse 
comments. If we receive any significant adverse comments that warrant 
terminating the direct final rule, we will consider such comments on 
the proposed rule in developing the final rule.

DATES: Submit written or electronic comments on the proposed rule by 
July 26, 2006.

ADDRESSES: You may submit comments, identified by Docket No. 2006N-
0051, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal or the agency Web site, as described in the 
Electronic Submissions portion of this paragraph. FDA will share all 
comments received with HRSA.
    Instructions: All submissions received must include the agency name 
(FDA) and Docket No. 2006N-0051 for this rulemaking. All comments 
received may be posted without change to http://www.fda.gov/ohrms/dockets/default.htm, including any personal information provided. For 
additional information on submitting comments see the ``Comments'' 
heading in section IX of the SUPPLEMENTARY INFORMATION section of this 
document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: 
    For information regarding FDA's rule: Paula S. McKeever, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.
    For information regarding HRSA's rule: Jim Burdick, Division of 
Transplantation, Healthcare Systems Bureau, Health Resources and 
Services Administration (HRSA), 5600 Fishers Lane, rm. 12C-06, 
Rockville, MD 20857, 301-443-7577.

SUPPLEMENTARY INFORMATION:

I. Introduction

    We propose to amend certain regulations to:
     Revise the definition of ``organ'' to include blood 
vessels (usually segments of iliac arteries and veins) recovered from 
an organ donor during the same recovery procedure of such organ(s) and 
intended for use in organ transplantation (hereinafter referred to as 
``blood vessels intended for use in organ transplantation''); and
     Exclude blood vessels intended for use in organ 
transplantation from the definition of human cells, tissues, and 
cellular and tissue-based products (HCT/Ps).
    By taking this action, blood vessels labeled and intended solely 
for use in organ transplantation would be subject to HRSA requirements 
in 42 CFR part 121 and any enforceable organ procurement and 
transplantation network (OPTN) policies established under 42 CFR part 
121. This action would keep blood vessels intended for use in organ 
transplantation and organs under the same regulatory scheme, making 
blood vessels intended for use in organ transplantation readily 
available to meet organ transplant needs.

II. Background

    HRSA oversees transplantation of organs through the OPTN, which 
sets policies related to the procurement, transplantation, and 
allocation of human organs. An ``organ'' is ordinarily defined as a 
bodily part that performs a function or cooperates in an activity.

[[Page 27650]]

 Vascularized human organs for transplantation are under the purview of 
HRSA and are excluded from FDA's tissue regulations in Sec. Sec.  
1270.3(j)(4) and 1271.3(d)(1) (21 CFR 1270.3(j)(4) and 1271.3(d)(1)). 
Blood vessels are currently regulated by FDA. Blood vessels are 
included in the definition of ``human tissue'' under FDA regulations in 
Sec.  1270.3(j) (applicable to tissue recovered before May 25, 2005), 
and in the definition of ``human cells, tissues, or cellular or tissue-
based products (HCT/P's)'' in Sec.  1271.3(d) (applicable to tissue 
recovered on or after May 25, 2005).
    There is a routine practice of recovering blood vessels intended 
for use in organ transplantation during organ procurement and using 
such blood vessels to connect donor organ and recipient vessels. We 
propose to regulate such blood vessels intended for use in organ 
transplantation as part of the organ under 42 CFR part 121. Therefore, 
the applicable provisions of 42 CFR part 121 would apply. We propose 
that such blood vessels do not need to be attached to the organ(s), nor 
transplanted simultaneously with such organs to the same recipient, nor 
transplanted together with the organ(s) from the same donor. 
Occasionally, blood vessels not used immediately for the 
transplantation of a donated organ are stored for a number of days and 
subsequently used to modify the organ transplant in the same recipient 
or to accomplish transplantation in the recipient of an organ from a 
different donor.
    Currently, FDA's jurisdiction over blood vessels intended for use 
in organ transplantation overlaps with HRSA's oversight of the OPTN. 
OPTN's membership compliance review activities are required under 42 
CFR 121.10(b)(1)(iii). In addition, under 42 CFR 121.10(c), the 
Secretary of Health and Human Services (the Secretary) may take actions 
against OPTN members (including, but not limited to termination of a 
transplant hospital's participation in or reimbursement under Medicare 
and Medicaid and removal of a transplant program's designation under 42 
CFR 121.9) for noncompliance with 42 CFR part 121 or enforceable OPTN 
policies (those approved by the Secretary) and for actions that 
indicate a risk to the health of patients or to the public safety. 
Because blood vessels intended for use in organ transplantation are 
recovered by organ procurement organizations (OPOs) and stored 
temporarily at transplant centers, having two Federal inspectional 
programs for such facilities without a medical or public health need 
for such dual oversight would be inefficient and burdensome.
    FDA requirements and recommendations for determining HCT/P donor 
eligibility are different than HRSA provisions for screening and 
testing organ donors. This is because of a different risk/benefit 
assessment for most HCT/P recipients than for vascularized human organ 
transplant recipients. HCT/Ps from a single donor can affect up to 100 
recipients, they are often life extending, and alternative materials 
usually exist; whereas organs from a single donor go to fewer 
recipients, are almost always life saving, and are in short supply.
    Therefore, in order to avoid duplication of efforts and reduce the 
burden on affected facilities, we are proposing to transfer 
jurisdiction over blood vessels intended for use in organ 
transplantation and labeled as such from FDA to HRSA. The proposed rule 
would not affect regulation of blood vessels intended for 
transplantation but not involving organ transplantation. Jurisdiction 
over such blood vessels would remain with FDA. Ordinarily, non-organ 
transplant uses will have a different risk/benefit assessment and the 
current FDA requirements are appropriate for these blood vessels.

III. Legal Authority

    We are proposing to issue these regulations under the authority of 
the National Organ Transplant Act as amended (NOTA) and section 361 of 
the Public Health Service Act (the PHS Act). NOTA authorizes HRSA, by 
delegation from the Secretary, to issue regulations governing the 
operation of the OPTN. NOTA, as amended, also authorizes the Secretary 
to define human organs to be covered by the OPTN. Section 374 of the 
PHS Act specifically states, ``[t]he term `organ' means the human 
kidney, liver, heart, lung, pancreas, and any other human organ (other 
than corneas and eyes) specified by the Secretary by regulation * * *'' 
(42 U.S.C. 274b(d)(2)) (emphasis supplied). Accordingly, HRSA is 
proposing to issue this regulation to modify the definition of 
``organ,'' and to make blood vessels labeled and intended for use in 
the transplantation of organs subject to regulations governing the 
operation of the OPTN. Extending the definition of organs governed by 
HRSA in 42 CFR 121.2 to add blood vessels recovered with organs that 
are intended for use in organ transplantation, and labeled as such, 
furthers the Secretary's charge under NOTA.
    Under the authority of section 361 of the PHS Act delegated to the 
Commissioner of FDA, the Department of Health and Human Services may 
make and enforce regulations necessary to prevent the introduction, 
transmission, or spread of communicable diseases between the States or 
from foreign countries into the States. This modification of FDA's 
existing regulation reflects FDA's re-evaluation of the level of 
regulation that is necessary to prevent disease transmission involving 
blood vessels intended for use in organ transplantation.

IV. Description of the Proposed Rule

    To transfer from FDA to HRSA jurisdiction over blood vessels 
intended for use in organ transplantation, we propose the following 
revisions to 21 CFR 1271.3(d), 42 CFR 121.2, and 42 CFR 121.7.

A. 21 CFR 1271.3(d)

    21 CFR 1271.3(d) defines HCT/Ps as ``articles containing or 
consisting of human cells or tissues that are intended for 
implantation, transplantation, infusion, or transfer into a human 
recipient.'' In the definition, we also identify articles not 
considered HCT/Ps. This proposed rule would add Sec.  1271.3(d)(8), in 
order to exclude blood vessels intended for use in organ 
transplantation from the definition of HCT/Ps. The rule excludes such 
blood vessels intended for use in organ transplantation only when they 
are labeled as ``For use in organ transplantation only'' to distinguish 
such vessels from blood vessels not intended for use in organ 
transplantation. By labeling such blood vessels ``For use in organ 
transplantation only'' we expect that they would not be used for other 
purposes. Under the proposal, blood vessels intended for other uses 
would remain subject to 21 CFR part 1271 (or 21 CFR part 1270, for 
tissue recovered prior to May 25, 2005).

B. 42 CFR 121.2

    Under 42 CFR 121.2, ``Organ'' means a human kidney, liver, heart, 
lung, or pancreas. This proposed rule adds to that definition ``Blood 
vessels recovered from an organ donor during the recovery of such 
organ(s) are considered part of an organ with which they are procured 
for purposes of this Part if the vessels are intended for use in organ 
transplantation and labeled ``For use in organ transplantation only.'' 
Blood vessels intended for use in organ transplantation would be 
required to be in compliance with HRSA provisions for donor screening 
and testing. The labeling provision would be a distinct requirement in 
order for such blood

[[Page 27651]]

vessels to fall under the regulation governing the operation of the 
OPTN. Any OPTN labeling policies, whether voluntary or enforceable, 
would supplement this requirement.

C. 42 CFR 121.7

    In 42 CFR 121.7, we are proposing to redesignate paragraph (e) as 
paragraph (f), and to add a new paragraph (e). Under proposed 42 CFR 
121.7(e), a blood vessel intended for use in organ transplantation 
would be subject to the allocation requirements under 42 CFR part 121 
and enforceable OPTN policies pertaining to the organ with which the 
blood vessel is procured. These provisions would apply until the 
transplant center receiving the organ determines that the blood vessel 
is not needed for the transplantation of that organ. This allocation 
priority will assure that vessels that may be necessary for the 
immediate transplantation of the organs with which they are recovered 
are made available for that use prior to being diverted to other organ 
transplant uses.

V. Analysis of Impacts

    FDA and HRSA have examined the impacts of the proposed rule under 
Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). FDA and HRSA believe 
that this proposed rule is not a significant regulatory action as 
defined by the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the agencies do not expect that the transfer 
of jurisdiction over the blood vessels described in this rule from FDA 
to HRSA will result in substantial changes in the way transplant 
hospitals and OPOs procure, store, and transplant such blood vessels, 
FDA and HRSA certify that the proposed rule will not have a significant 
economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $115 million, using the most current (2003) Implicit 
Price Deflator for the Gross Domestic Product. FDA and HRSA do not 
expect this proposed rule to result in any 1-year expenditure that 
would meet or exceed this amount.

VI. The Paperwork Reduction Act of 1995

    This proposed rule contains no collections of information. 
Therefore, clearance by OMB under the Paperwork Reduction Act of 1995 
is not required.

VII. Environmental Impact

    FDA and HRSA have determined under 21 CFR 25.30(j) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

VIII. Federalism

    FDA and HRSA have analyzed this proposed rule in accordance with 
the principles set forth in Executive Order 13132. FDA and HRSA have 
determined that the rule does not contain policies that have 
substantial direct effects on the States, on the relationship between 
the National Government and the States, or on the distribution of power 
and responsibilities among the various levels of government. 
Accordingly, FDA and HRSA have concluded that the rule does not contain 
policies that have federalism implications as defined in the Executive 
order and, consequently, a federalism summary impact statement is not 
required.

IX. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

X. Proposed Effective Date

    FDA and HRSA propose that any final rule that may issue based on 
this proposal become effective on the date of its publication in the 
Federal Register.

List of Subjects

21 CFR Part 1271

    Biologics, Communicable diseases, Drugs, HIV/AIDS, Human cells, 
tissues, and cellular and tissue-based products, Medical Devices, 
Reporting and recordkeeping requirements.

42 CFR Part 121

    Healthcare, Hospitals, Reporting and recordkeeping requirements.
    Therefore, under the Public Health Service Act and under authority 
delegated to the Commissioner of Food and Drugs and to the 
Administrator, Health Resources and Services Administration it is 
proposed that 21 CFR part 1271 and 42 CFR part 121 be amended as 
follows:

21 CFR Chapter I

PART 1271--HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED 
PRODUCTS

    1. The authority citation for 21 CFR part 1271 continues to read as 
follows:

    Authority:  42 U.S.C. 216, 243, 263a, 264, 271.
    2. Section 1271.3 is amended by adding paragraph (d)(8) to read as 
follows:


Sec.  1271.3  How does FDA define important terms in this part?

* * * * *
    (d) * * *
    (8) Blood vessels recovered with an organ, as defined in 42 CFR 
121.2, that are intended for use in organ transplantation and labeled 
``For use in organ transplantation only.''
* * * * *

42 CFR Chapter I

PART 121--ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK

    3. The authority citation for 42 CFR part 121 continues to read as 
follows:

    Authority: Sections 215, 371-376 of the Public Health Service 
Act (42 U.S.C. 216, 273-274d); and sections 1102, 1106, 1138, and 
1871 of the Social Security Act (42 U.S.C. 1302, 1306, 1320b-8 and 
1395hh).
    4. Section 121.2 is amended by adding a sentence at the end of the 
definition of ``Organ'' to read as follows:


Sec.  121.2  Definitions.

* * * * *
    Organ *** Blood vessels recovered from an organ donor during the 
recovery of such organ(s) are considered part of an organ with which 
they are procured for purposes of this part if the vessels

[[Page 27652]]

are intended for use in organ transplantation and labeled ``For use in 
organ transplantation only.''
* * * * *
    5. Section 121.7 is amended by redesignating paragraph (e) as 
paragraph (f) and by adding paragraph (e) to read as follows:


Sec.  121.7  Identification of organ recipient.

* * * * *
    (e) Blood vessels considered part of an organ. A blood vessel that 
is considered part of an organ under this part shall be subject to the 
allocation requirements and policies pertaining to the organ with which 
the blood vessel is procured until and unless the transplant center 
receiving the organ determines that the blood vessel is not needed for 
the transplantation of that organ.
* * * * *

    Dated: April 10, 2006.
Elizabeth M. Duke,
Administrator, Health Resources and Services and Administration.

    Dated: February 8, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy, Food and Drug Administration.
[FR Doc. 06-4370 Filed 5-11-06; 8:45 am]
BILLING CODE 4160-01-S