[Federal Register Volume 71, Number 92 (Friday, May 12, 2006)]
[Rules and Regulations]
[Pages 27606-27610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-4369]


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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

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

ACTION: Direct final rule.

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SUMMARY: The Health Resources and Services Administration (HRSA) and 
the Food and Drug Administration (FDA) are amending their regulations 
to consider as part of an organ those blood

[[Page 27607]]

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 are governed by the 
regulations pertaining to organs. The regulation of other recovered 
blood vessels remains 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). We are issuing these amendments directly as a final rule 
because they are noncontroversial, and there is little likelihood that 
we will receive any significant adverse comments. Elsewhere in this 
issue of the Federal Register, we are publishing a companion proposed 
rule under our usual procedures for notice and comment in the event 
that we receive any significant adverse comments on the direct final 
rule. 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: This rule is effective September 25, 2006. Submit written or 
electronic comments on the direct final rule by July 26, 2006. If we 
receive no comments during the specified comment period, we intend to 
publish a confirmation document on or before the effective date of this 
direct final rule confirming that the direct final rule will go into 
effect on September 25, 2006. If we receive any significant adverse 
comments during the comment period, we intend to withdraw this direct 
final rule before its effective date by publication of a document in 
the Federal Register.

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 X 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 are amending 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 will 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 will 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. 
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. HRSA 
will 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 apply. 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

[[Page 27608]]

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 transferring jurisdiction over 
blood vessels intended for use in organ transplantation from FDA to 
HRSA. The direct final rule does not affect regulation of blood vessels 
intended for transplantation but not involving organ transplantation. 
Jurisdiction over such blood vessels remains with FDA. Ordinarily, non-
organ transplant uses have a different risk/benefit assessment and the 
current FDA requirements are appropriate for these blood vessels.

III. Legal Authority

    We are issuing 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 issuing 
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 Direct Final Rule

    To transfer from FDA to HRSA jurisdiction over blood vessels 
intended for use in organ transplantation, we are amending 21 CFR 
1271.3(d), 42 CFR 121.2, and 42 CFR 121.7 as follows.

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 direct final rule adds Sec.  1271.3(d)(8), 
excluding 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 
direct final rule, blood vessels intended for other uses 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 direct final 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 are 
required to be in compliance with HRSA provisions for donor screening 
and testing. The labeling provision is a distinct requirement in order 
for such blood vessels to fall under the regulation governing the 
operation of the OPTN. Any OPTN labeling policies, whether voluntary or 
enforceable, supplement this requirement.

C. 42 CFR 121.7

    In 42 CFR 121.7, we are redesignating paragraph (e) as paragraph 
(f), and adding a new paragraph (e). Under 42 CFR 121.7(e), a blood 
vessel intended for use in organ transplantation is 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 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. Rulemaking Action

    In the Federal Register of November 21, 1997 (62 FR 62466), FDA 
described its procedures on when and how the agency will employ direct 
final rulemaking. We have determined that this rule is appropriate for 
direct final rulemaking because we believe that it includes only 
noncontroversial amendments and we anticipate no significant adverse 
comments.

[[Page 27609]]

 Consistent with FDA's procedures on direct final rulemaking, FDA and 
HRSA are publishing elsewhere in this issue of the Federal Register a 
companion proposed rule to amend FDA's and HRSA's regulations to 
include as organs those blood vessels recovered with organs that are 
intended for use in organ transplantation; and to exclude such blood 
vessels from the definition of HCT/Ps. The companion proposed rule 
provides a procedural framework within which the rule may be finalized 
in the event that the direct final rule is withdrawn because of any 
significant adverse comments. The comment period for the direct final 
rule runs concurrently with the companion proposed rule. Any comments 
received in response to the companion proposed rule will be considered 
as comments regarding the direct final rule.
    We are providing a comment period of 75 days after date of 
publication in the Federal Register. If we receive any significant 
adverse comments, we intend to withdraw this direct final rule action 
before its effective date by publication of a notice in the Federal 
Register. A significant adverse comment is defined as a comment that 
explains why the rule would be inappropriate, including challenges to 
the rule's underlying premise or approach, or would be ineffective or 
unacceptable without a change. In determining whether an adverse 
comment is significant and warrants terminating a direct final 
rulemaking, we will consider whether the comment raises an issue 
serious enough to warrant a substantive response in a notice-and-
comment process in accordance with section 553 of the Administrative 
Procedure Act (5 U.S.C. 553). Comments that are frivolous, 
insubstantial, or outside the scope of the rule will not be considered 
significant or adverse under this procedure. A comment recommending a 
regulation change in addition to those in the rule would not be 
considered a significant adverse comment unless the comment states why 
the rule would be ineffective without the additional change. In 
addition, if a significant adverse comment applies to an amendment, 
paragraph, or section of this rule and that provision can be severed 
from the remainder of the rule, we may adopt as final those provisions 
of the rule that are not the subjects of a significant adverse comment.
    If any significant adverse comments are received during the comment 
period, FDA will publish, before the effective date of this direct 
final rule, a document withdrawing the direct final rule. If we 
withdraw the direct final rule, any comments received will be applied 
to the proposed rule and will be considered in developing a final rule 
using the usual notice-and-comment procedures.
    If FDA and HRSA receive no significant adverse comments during the 
specified comment period, FDA and HRSA intend to publish a confirmation 
document, before the effective date of the direct final rule, 
confirming the effective date.

VI. Analysis of Impacts

    FDA and HRSA have examined the impacts of the final 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 direct final rule is not a significant regulatory action as 
defined by the Executive order.
    Under the Regulatory Flexibility Act, agencies 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 preserve, store, and transplant such blood vessels, FDA and 
HRSA certify that the direct final rule will not have a significant 
economic impact on a substantial number of small entities.
    Under section 202(a) of the Unfunded Mandates Reform Act of 1995, 
agencies prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``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 direct final 
rule to result in any 1-year expenditure that would meet or exceed this 
amount.

VII. Paperwork Reduction Act of 1995

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

VIII. 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.

IX. Federalism

    FDA and HRSA have analyzed this direct final 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.

X. 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.

List of Subjects

21 CFR 1271

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

42 CFR 121

    Healthcare, Hospitals, Reporting and recordkeeping requirements.

0
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, 21 CFR 
part 1271 and 42 CFR part 121 are amended as follows:

[[Page 27610]]

21 CFR Chapter I

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

0
1. The authority citation for 21 CFR part 1271 continues to read as 
follows:

    Authority:  42 U.S.C. 216, 243, 263a, 264, 271.

0
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

0
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).

0
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 are intended 
for use in organ transplantation and labeled ``For use in organ 
transplantation only.''
* * * * *

0
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 Administration.

    Dated: February 8, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy, Food and Drug Administration.
[FR Doc. 06-4369 Filed 5-11-06; 8:45 am]
BILLING CODE 4160-01-S