Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation, 10922-10925 [07-1131]
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Federal Register / Vol. 72, No. 47 / Monday, March 12, 2007 / Rules and Regulations
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DEPARTMENT OF HEALTH AND
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Food and Drug Administration
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[Docket No. 2006N–0051]
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Blood Vessels Recovered With Organs
and Intended for Use in Organ
Transplantation
Issued in Burlington, Massachusetts, on
March 2, 2007.
Robert J. Ganley,
Acting Manager, Engine and Propeller
Directorate, Aircraft Certification Service.
[FR Doc. E7–4140 Filed 3–9–07; 8:45 am]
BILLING CODE 4910–13–P
AGENCIES: Food and Drug
Administration, Health Resources and
Services Administration, HHS.
ACTION: Final rule.
SUMMARY: The Food and Drug
Administration (FDA) and the Health
Resources and Services Administration
(HRSA) are amending their regulations
to include 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, or
cellular or tissue-based products (HCT/
Ps) (FDA regulation). The purpose of
this final rule is to amend the
regulations so that blood vessels
recovered with organs and intended for
use in organ transplantation, and
labeled as such, are governed by the
regulations pertaining to organs. The
regulation of other recovered blood
vessels remains unchanged. We (HRSA
and FDA) believe that this change will
eliminate the 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).
DATES:
This rule is effective on April 11,
2007.
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FOR FURTHER INFORMATION CONTACT:
For information regarding FDA’s rule:
´
Denise Sanchez, 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.
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SUPPLEMENTARY INFORMATION:
I. Introduction
HRSA oversees transplantation of
organs through the Organ Procurement
and Transplantation Network (OPTN),
which sets policies related to the
procurement, transplantation, and
allocation of human organs (see 42 CFR
part 121). FDA currently regulates blood
vessels. However, FDA does not regulate
vascularized human organs (see 21 CFR
1270.3(j)(4) and 1271.3(d)(1)). FDA’s
jurisdiction over blood vessels intended
for use in organ transplantation overlaps
with HRSA’s oversight of the OPTN.
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. Blood vessels
intended for use in organ
transplantation are recovered with
human organs by Organ Procurement
Organizations (OPOs) and stored for use
at transplant centers. Both OPOs and
transplant centers are already subject to
HRSA oversight because of their organ
procurement and transplantation
activities. The application of both HRSA
and FDA regulatory requirements to
these facilities in relation to organs and
blood vessels procured for use in organ
transplantation is not supported by a
need for such dual oversight. In order to
avoid the duplication of efforts and
reduce the burden on affected facilities,
this final rule transfers from FDA to
HRSA jurisdiction over blood vessels
intended and labeled for use in organ
transplantation. This final rule does not
affect the regulation of blood vessels
intended for transplantation that do not
involve organ transplantation.
Jurisdiction over such blood vessels
remains with FDA.
Under this final rule, 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 OPTN policies
established under 42 CFR part 121. To
be regulated under HRSA requirements,
such blood vessels intended for use in
organ transplantation must be labeled
‘‘For use in organ transplantation only.’’
However, they are not required to be
attached to the organ(s), transplanted
simultaneously with such organ(s) to
the same recipient, or transplanted with
the organ(s) from the same donor. For
example, 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
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Federal Register / Vol. 72, No. 47 / Monday, March 12, 2007 / Rules and Regulations
recipient of an organ from a different
donor. Such blood vessels intended and
labeled for use in organ transplantation
may be used in these ways when the use
is consistent with HRSA requirements.
hsrobinson on PROD1PC76 with RULES
II. Background
In the Federal Register of May 12,
2006, we published a direct final rule
and a companion proposed rule (71 FR
27606 and 27649, respectively) to revise
HRSA’s definition of ‘‘organ’’ to include
blood vessels recovered from an organ
donor during the same recovery
procedure of such organ(s) and intended
and labeled for use in organ
transplantation; and to exclude such
blood vessels from FDA’s definition of
human cells, tissues, or cellular or
tissue-based products (HCT/Ps) (21 CFR
1271.3(d)). The direct final rule
amended the regulations so that blood
vessels intended and labeled for use in
organ transplantation were under the
same regulatory scheme as organs,
thereby making blood vessels intended
and labeled for use in organ
transplantation readily available to meet
organ transplant needs. Such direct final
rule would become effective unless we
received significant adverse comment.
We published a companion proposed
rule to provide a procedural framework
within which the rule could be finalized
in the event we received any significant
adverse comments regarding the direct
final rule, and the direct final rule had
to be withdrawn.
We received comments from health
care professionals and a nonprofit
organization. Among the comments
received, one comment fully supported
the rulemaking. Another comment
concerned the use and tracking of blood
vessels recovered from a deceased organ
donor but not transplanted with the
recovered organ, and questioned the
transfer of regulatory responsibility for
such blood vessels from FDA to HRSA.
Another comment suggested that the
rulemaking distinguish between organ
transplant recipients based on the type
of their organ donor (living, nonrelated;
living, related; or deceased) and use
these distinctions to define who may
receive the blood vessels addressed in
the rulemaking. The comments received
and our responses to the comments are
discussed in section IV of this
document. Because we received
significant adverse comment in
response to the rulemaking, we
published a notice in the Federal
Register of September 14, 2006 (71 FR
54198), withdrawing the direct final
rule.
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III. Highlights of the Final Rule
To transfer from FDA to HRSA
jurisdiction over blood vessels intended
for use in organ transplantation, the
final rule amends 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
exclude certain articles from the
definition of HCT/Ps. This final rule
adds § 1271.3(d)(8), excluding from the
definition of HCT/Ps blood vessels
intended for use in organ
transplantation. 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 will not be used for other purposes.
Under the final rule, blood vessels
intended for other uses remain subject
to 21 CFR part 1271.
B. 42 CFR 121.2
Under 42 CFR 121.2, ‘‘Organ’’ means
a human kidney, liver, heart, lung, or
pancreas. This 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 required in order
for such blood vessels to fall under this
regulatory program. 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
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determines that the blood vessel is not
needed for the transplantation of that
organ. This allocation priority assures
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.
IV. Comments on the Proposed Rule
and HRSA and FDA Responses
(Comment 1) One comment supported
the proposed rule. The comment stated
that the Organ Procurement and
Transplantation Network/United
Network for Organ Sharing (OPTN/
UNOS) Board of Directors has approved
a policy to provide guidance for the
recovery, use, and storage of deceased
donor vascular allografts. The comment
also stated that the OPTN/UNOS policy
does not result in undue burden to the
transplant community and is consistent
with the provisions of the proposed
rule.
(Response) We appreciate the
supportive comment. One of our reasons
for the proposed rule is to eliminate the
burden of dual oversight, by FDA and
HRSA, of those blood vessels used in
organ transplantation. The policy
discussed in the comment is OPTN/
UNOS Policy 5.7.1 OPTN/UNOS Policy
5.7 addresses practices for blood vessel
recovery, storage, and transplant by
transplant centers and OPOs. The policy
will only be implemented once this
final rule goes into effect.
(Comment 2) One comment stated
that patients would be better protected
under the existing regulatory scheme.
The comment questioned the safety of
transplanting blood vessels recovered
from a deceased organ donor into third
party recipients who received organs
from other donors. The comment
explained that use of blood vessels in
these recipients poses disease
transmission and human leukocyte
antigen (HLA) sensitization risks that
jeopardize patient safety. The comment
also stated that the OPTN and organ
transplant programs lack adequate
tracking and traceability mechanisms
for such blood vessels.
(Response) We acknowledge that the
use of blood vessels poses disease
transmission and HLA sensitization
risks in third party recipients. The
intent of this rule is to facilitate the
successful completion of life-saving
organ transplants in medical procedures
1 See https://www.optn.org/PoliciesandBylaws2/
policies/pdfs/policy_17.pdf. (FDA and HRSA have
verified the Web site address, but the agencies are
not responsible for subsequent changes to the Web
site after this document publishes in the Federal
Register).
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hsrobinson on PROD1PC76 with RULES
where the vasculature of the donated
organ is inadequate, or to salvage a graft
that would otherwise be lost. It is up to
the organ transplant surgeon to assess
the risks and benefits of, and
alternatives to, using a particular vessel
to accomplish or modify an organ
transplant. Moreover, the risks of
disease transmission and HLA
sensitization would apply even if FDA
retained jurisdiction over these blood
vessels as HCT/Ps. FDA regulations, like
HRSA policies, reduce, but cannot
entirely eliminate, the risk of disease
transmission, and FDA tissue
regulations do not address HLA
sensitization. In addition, the OPTN has
long-established mechanisms for
tracking of organs from the donor to the
recipient, which require the reporting of
transplant outcomes. HRSA intends to
monitor the use and outcomes of these
vessels used in organ transplantation,
and to work with the OPTN to modify
policies governing their use as needed.
(Comment 3) One comment suggested
that the rulemaking should distinguish
between organ recipients based on the
type of their organ donor (living,
nonrelated; living, related; or deceased)
and use these distinctions to define the
types of transplant recipients who may
receive these vessels for organ
transplant use. The comment asked
whether a surgeon may use vessels from
a deceased donor to repair a thrombosed
renal artery in the recipient of a living
donor kidney.
(Response) We decline to make these
suggested changes to the rulemaking.
The language in 42 CFR 121.7(e)
establishes a priority allocation for use
of vessels with organs from the same
donor. If vessels are not needed for this
use, the rule does not preclude vessels
recovered from deceased donors and
labeled ‘‘For use in organ
transplantation only’’ from being
transplanted into recipients of organs
from living donors, either to perform the
initial transplant of the organ or to later
modify the organ transplant. The
situation described in the comment
would be an example of the use of such
vessels to modify a transplant.
V. 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
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‘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 reevaluation of the level of regulation that
is necessary to prevent disease
transmission involving blood vessels
intended for use in organ
transplantation.
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). The
agencies believe that this final rule is
not a significant regulatory action under
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 from FDA to
HRSA of jurisdiction over the blood
vessels described in the rule 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 final
rule will not have a significant
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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 $122
million, using the most current (2005)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this final rule to result in any 1-year
expenditure that would meet or exceed
this amount.
VII. The Paperwork Reduction Act of
1995
This 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
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. Effective Date
This final rule is effective on April 11,
2007.
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.
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42 CFR Part 121
§ 121.7
Healthcare, Hospitals, Reporting and
recordkeeping requirements.
I 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:
*
Identification of organ recipient.
10925
*
*
*
*
(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.
*
*
*
*
*
PART 1271—HUMAN CELLS, TISSUES,
AND CELLULAR AND TISSUE-BASED
PRODUCTS
Dated: December 8, 2006.
Elizabeth M. Duke,
Administrator, Health Resources and Services
Administration.
II chemicals acetone, ethyl ether, 2butanone, and toluene shall be exempt
from CSA chemical recordkeeping and
reporting requirements.
DATES: This Final Rule is effective
March 12, 2007.
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, Ph.D., Chief,
Drug & Chemical Evaluation Section,
Office of Diversion Control, Drug
Enforcement Administration,
Washington, DC 20537, telephone (202)
307–7183.
SUPPLEMENTARY INFORMATION:
I. Background
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:
Dated: February 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy, Food and
Drug Administration.
[FR Doc. 07–1131 Filed 3–9–07; 8:45 am]
BILLING CODE 4160–01–S
21 CFR Chapter I
I
I
§ 1271.3 How does FDA define important
terms in this part?
DEPARTMENT OF JUSTICE
*
Drug Enforcement Administration
*
*
*
*
(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:
I
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:
I
§ 121.2
Definitions
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*
*
*
*
*
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.’’
*
*
*
*
*
I 5. Section 121.7 is amended by
redesignating paragraph (e) as paragraph
(f) and by adding paragraph (e) to read
as follows:
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21 CFR Part 1310
[Docket No. DEA–137F3]
RIN 1117–AA31
Exemption of Chemical Mixtures
Drug Enforcement
Administration (DEA), U.S. Department
of Justice.
ACTION: Final rule.
AGENCY:
SUMMARY: On December 15, 2004, the
Drug Enforcement Administration
(DEA) published a Final Rule corrected
January 4, 2005) that implemented new
regulations concerning chemical
mixtures that contain any of the 27
listed chemicals. The Final Rule added
a new provision not previously raised
by DEA in any proposed rulemaking.
This newly introduced provision
exempted domestic and import
transactions in chemical mixtures that
are regulated solely due to the presence
of the List II solvent chemicals acetone,
ethyl ether, 2-butanone, or toluene from
the Controlled Substances Act (CSA)
recordkeeping and reporting
requirements. Because this exemption
was not previously proposed in any
rulemaking, DEA implemented this
exemption on an interim basis and
requested public comment on this
exemption provision.
Based upon a review of all comments,
DEA is finalizing this exemption. As
such, domestic and import transactions
in chemical mixtures containing the List
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Historical Legal Status of Chemical
Mixtures
The Chemical Diversion and
Trafficking Act of 1988 (CDTA), (Pub. L.
100–690) created the definition of
‘‘chemical mixture’’ (21 U.S.C. 802(40)),
and exempted chemical mixtures from
regulatory control. The CDTA
established 21 U.S.C. 802(39)(A)(vi), as
amended by Title VII of Public Law
109–177, to exclude ‘‘any transaction in
a chemical mixture’’ from the definition
of a ‘‘regulated transaction.’’ The
exemption of all chemical mixtures,
however, provided traffickers with an
unregulated source for obtaining listed
chemicals for use in the illicit
manufacture of controlled substances.
To remedy this situation, the
Domestic Chemical Diversion Control
Act of 1993 (Pub. L. 103–200) (DCDCA),
enacted in April 1994, subjected
chemical mixtures containing listed
chemicals to CSA regulatory
requirements, unless specifically
exempted by regulation. The DCDCA,
therefore, subjected all regulated
chemical mixtures to recordkeeping,
reporting, and security requirements of
the CSA. Additionally, the DCDCA
added a registration requirement for
handlers of regulated List I chemical
mixtures.
The DCDCA, however, also amended
21 U.S.C. 802(39)(A)(vi), as amended by
Title VII of Public Law 109–177, to
provide the Attorney General with the
authority to establish regulations
exempting chemical mixtures from the
definition of a ‘‘regulated transaction’’
‘‘based on a finding that the mixture is
formulated in such a way that it cannot
be easily used in the illicit production
of a controlled substance and that the
listed chemical or chemicals contained
in the mixture cannot be readily
recovered’’ (21 U.S.C. 802(39)(A)(vi) as
amended by Title VII of Pub. L. 109–
177). This authority has been delegated
to the Administrator of DEA by 28 CFR
0.100 and redelegated to the Deputy
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]]>Agencies
[Federal Register Volume 72, Number 47 (Monday, March 12, 2007)]
[Rules and Regulations]
[Pages 10922-10925]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-1131]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1271
[Docket No. 2006N-0051]
RIN 0910-AF65
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: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) and the Health
Resources and Services Administration (HRSA) are amending their
regulations to include 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, or cellular or tissue-
based products (HCT/Ps) (FDA regulation). The purpose of this final
rule is to amend the regulations so that blood vessels recovered with
organs and intended for use in organ transplantation, and labeled as
such, are governed by the regulations pertaining to organs. The
regulation of other recovered blood vessels remains unchanged. We (HRSA
and FDA) believe that this change will eliminate the 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).
DATES: This rule is effective on April 11, 2007.
FOR FURTHER INFORMATION CONTACT:
For information regarding FDA's rule: Denise S[aacute]nchez, 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
HRSA oversees transplantation of organs through the Organ
Procurement and Transplantation Network (OPTN), which sets policies
related to the procurement, transplantation, and allocation of human
organs (see 42 CFR part 121). FDA currently regulates blood vessels.
However, FDA does not regulate vascularized human organs (see 21 CFR
1270.3(j)(4) and 1271.3(d)(1)). FDA's jurisdiction over blood vessels
intended for use in organ transplantation overlaps with HRSA's
oversight of the OPTN.
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. Blood
vessels intended for use in organ transplantation are recovered with
human organs by Organ Procurement Organizations (OPOs) and stored for
use at transplant centers. Both OPOs and transplant centers are already
subject to HRSA oversight because of their organ procurement and
transplantation activities. The application of both HRSA and FDA
regulatory requirements to these facilities in relation to organs and
blood vessels procured for use in organ transplantation is not
supported by a need for such dual oversight. In order to avoid the
duplication of efforts and reduce the burden on affected facilities,
this final rule transfers from FDA to HRSA jurisdiction over blood
vessels intended and labeled for use in organ transplantation. This
final rule does not affect the regulation of blood vessels intended for
transplantation that do not involve organ transplantation. Jurisdiction
over such blood vessels remains with FDA.
Under this final rule, 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 OPTN policies established under
42 CFR part 121. To be regulated under HRSA requirements, such blood
vessels intended for use in organ transplantation must be labeled ``For
use in organ transplantation only.'' However, they are not required to
be attached to the organ(s), transplanted simultaneously with such
organ(s) to the same recipient, or transplanted with the organ(s) from
the same donor. For example, 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
[[Page 10923]]
recipient of an organ from a different donor. Such blood vessels
intended and labeled for use in organ transplantation may be used in
these ways when the use is consistent with HRSA requirements.
II. Background
In the Federal Register of May 12, 2006, we published a direct
final rule and a companion proposed rule (71 FR 27606 and 27649,
respectively) to revise HRSA's definition of ``organ'' to include blood
vessels recovered from an organ donor during the same recovery
procedure of such organ(s) and intended and labeled for use in organ
transplantation; and to exclude such blood vessels from FDA's
definition of human cells, tissues, or cellular or tissue-based
products (HCT/Ps) (21 CFR 1271.3(d)). The direct final rule amended the
regulations so that blood vessels intended and labeled for use in organ
transplantation were under the same regulatory scheme as organs,
thereby making blood vessels intended and labeled for use in organ
transplantation readily available to meet organ transplant needs. Such
direct final rule would become effective unless we received significant
adverse comment. We published a companion proposed rule to provide a
procedural framework within which the rule could be finalized in the
event we received any significant adverse comments regarding the direct
final rule, and the direct final rule had to be withdrawn.
We received comments from health care professionals and a nonprofit
organization. Among the comments received, one comment fully supported
the rulemaking. Another comment concerned the use and tracking of blood
vessels recovered from a deceased organ donor but not transplanted with
the recovered organ, and questioned the transfer of regulatory
responsibility for such blood vessels from FDA to HRSA. Another comment
suggested that the rulemaking distinguish between organ transplant
recipients based on the type of their organ donor (living, nonrelated;
living, related; or deceased) and use these distinctions to define who
may receive the blood vessels addressed in the rulemaking. The comments
received and our responses to the comments are discussed in section IV
of this document. Because we received significant adverse comment in
response to the rulemaking, we published a notice in the Federal
Register of September 14, 2006 (71 FR 54198), withdrawing the direct
final rule.
III. Highlights of the Final Rule
To transfer from FDA to HRSA jurisdiction over blood vessels
intended for use in organ transplantation, the final rule amends 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 exclude certain articles from
the definition of HCT/Ps. This final rule adds Sec. 1271.3(d)(8),
excluding from the definition of HCT/Ps blood vessels intended for use
in organ transplantation. 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 will not be used for other purposes. Under the
final rule, blood vessels intended for other uses remain subject to 21
CFR part 1271.
B. 42 CFR 121.2
Under 42 CFR 121.2, ``Organ'' means a human kidney, liver, heart,
lung, or pancreas. This 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 required in order for such blood vessels to
fall under this regulatory program. 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 assures 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.
IV. Comments on the Proposed Rule and HRSA and FDA Responses
(Comment 1) One comment supported the proposed rule. The comment
stated that the Organ Procurement and Transplantation Network/United
Network for Organ Sharing (OPTN/UNOS) Board of Directors has approved a
policy to provide guidance for the recovery, use, and storage of
deceased donor vascular allografts. The comment also stated that the
OPTN/UNOS policy does not result in undue burden to the transplant
community and is consistent with the provisions of the proposed rule.
(Response) We appreciate the supportive comment. One of our reasons
for the proposed rule is to eliminate the burden of dual oversight, by
FDA and HRSA, of those blood vessels used in organ transplantation. The
policy discussed in the comment is OPTN/UNOS Policy 5.7.\1\ OPTN/UNOS
Policy 5.7 addresses practices for blood vessel recovery, storage, and
transplant by transplant centers and OPOs. The policy will only be
implemented once this final rule goes into effect.
---------------------------------------------------------------------------
\1\ See https://www.optn.org/PoliciesandBylaws2/policies/pdfs/
policy_17.pdf. (FDA and HRSA have verified the Web site address,
but the agencies are not responsible for subsequent changes to the
Web site after this document publishes in the Federal Register).
---------------------------------------------------------------------------
(Comment 2) One comment stated that patients would be better
protected under the existing regulatory scheme. The comment questioned
the safety of transplanting blood vessels recovered from a deceased
organ donor into third party recipients who received organs from other
donors. The comment explained that use of blood vessels in these
recipients poses disease transmission and human leukocyte antigen (HLA)
sensitization risks that jeopardize patient safety. The comment also
stated that the OPTN and organ transplant programs lack adequate
tracking and traceability mechanisms for such blood vessels.
(Response) We acknowledge that the use of blood vessels poses
disease transmission and HLA sensitization risks in third party
recipients. The intent of this rule is to facilitate the successful
completion of life-saving organ transplants in medical procedures
[[Page 10924]]
where the vasculature of the donated organ is inadequate, or to salvage
a graft that would otherwise be lost. It is up to the organ transplant
surgeon to assess the risks and benefits of, and alternatives to, using
a particular vessel to accomplish or modify an organ transplant.
Moreover, the risks of disease transmission and HLA sensitization would
apply even if FDA retained jurisdiction over these blood vessels as
HCT/Ps. FDA regulations, like HRSA policies, reduce, but cannot
entirely eliminate, the risk of disease transmission, and FDA tissue
regulations do not address HLA sensitization. In addition, the OPTN has
long-established mechanisms for tracking of organs from the donor to
the recipient, which require the reporting of transplant outcomes. HRSA
intends to monitor the use and outcomes of these vessels used in organ
transplantation, and to work with the OPTN to modify policies governing
their use as needed.
(Comment 3) One comment suggested that the rulemaking should
distinguish between organ recipients based on the type of their organ
donor (living, nonrelated; living, related; or deceased) and use these
distinctions to define the types of transplant recipients who may
receive these vessels for organ transplant use. The comment asked
whether a surgeon may use vessels from a deceased donor to repair a
thrombosed renal artery in the recipient of a living donor kidney.
(Response) We decline to make these suggested changes to the
rulemaking. The language in 42 CFR 121.7(e) establishes a priority
allocation for use of vessels with organs from the same donor. If
vessels are not needed for this use, the rule does not preclude vessels
recovered from deceased donors and labeled ``For use in organ
transplantation only'' from being transplanted into recipients of
organs from living donors, either to perform the initial transplant of
the organ or to later modify the organ transplant. The situation
described in the comment would be an example of the use of such vessels
to modify a transplant.
V. 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. Sec. 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.
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). The agencies believe
that this final rule is not a significant regulatory action under 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
from FDA to HRSA of jurisdiction over the blood vessels described in
the rule 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 final 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 $122 million, using the most current (2005) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
VII. The Paperwork Reduction Act of 1995
This 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 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. Effective Date
This final rule is effective on April 11, 2007.
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.
[[Page 10925]]
42 CFR Part 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:
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: December 8, 2006.
Elizabeth M. Duke,
Administrator, Health Resources and Services Administration.
Dated: February 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy, Food and Drug Administration.
[FR Doc. 07-1131 Filed 3-9-07; 8:45 am]
BILLING CODE 4160-01-S
