[Federal Register Volume 79, Number 250 (Wednesday, December 31, 2014)]
[Proposed Rules]
[Pages 78744-78749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30528]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1271
[Docket No. FDA-2014-N-1484]
Revisions to Exceptions Applicable to Certain Human Cells,
Tissues, and Cellular and Tissue-Based Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing
this proposed rule to amend certain regulations regarding donor
eligibility, including the screening and testing of donors of
particular human cells, tissues, and cellular and tissue-based products
(HCT/Ps), and related labeling. FDA is proposing this action in
response to our enhanced understanding in this area and in response to
comments from stakeholders regarding the importance of embryos to
individuals and couples seeking access to donated embryos.
DATES: Submit either electronic or written comments on the proposed
rule by March 31, 2015.
ADDRESSES: You may submit comments by any of the following methods:
[[Page 78745]]
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Docket No.
FDA-2014-N-1484 for this rulemaking. All comments received may be
posted without change to http://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Comments'' heading 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.regulations.gov 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: Melissa Segal, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
SUPPLEMENTARY INFORMATION:
Executive Summary
Purpose of the Regulatory Action
FDA is issuing this proposed rule to amend certain regulations
regarding donor eligibility, including the screening and testing of
donors of particular HCT/Ps, and related labeling. We are proposing
these changes in response to our enhanced understanding in this area
and in response to comments from stakeholders regarding the importance
of embryos to individuals and couples seeking access to donated
embryos.
FDA is proposing this rulemaking under the authority of section 361
of the Public Health Service Act (PHS Act) (42 U.S.C. 264). Under
section 361 of the PHS Act, FDA may issue and enforce regulations
necessary to prevent the introduction, transmission, or spread of
communicable disease between the States or from foreign countries into
the States.
Summary of the Major Provisions of the Regulatory Action
FDA is proposing to amend existing regulations to provide
additional flexibility to HCT/P establishments to make available for
reproductive use embryos originally intended for reproductive use for a
specific individual or couple when those embryos are subsequently
intended for directed or anonymous donation. Specifically, this
proposed rulemaking would redesignate the current Title 21 of the Code
of Federal Regulations (CFR) 1271.90(b) (Sec. 1271.90(b)) to new Sec.
1271.90(c), and would insert a new Sec. 1271.90(b) entitled
``Exceptions for Reproductive Use'' to clarify that if an embryo was
originally intended for reproductive use for a specific individual or
couple, its use for directed or anonymous donation, would not be
prohibited under Sec. 1271.45(c), even when the applicable donor
eligibility requirements under part 1271, subpart C, are not met. FDA
also clarifies that we are not creating an exception for deficiencies
that occurred in making the donor eligibility determination for either
the oocyte donor or the semen donor as required under Sec. 1271.45(b),
or for deficiencies in performing donor screening or testing, as
required under Sec. Sec. 1271.75, 1271.80, and 1271.85.
The proposed rule also would require appropriate labeling for
embryos that would describe the donor eligibility status of the
individual donors whose gametes were used to form the embryo. The
content of the labeling is not different from that required under
current regulations. Consistent with current regulations, the intent of
the proposed labeling is to help ensure that physicians have specific
and accurate information to provide to recipients for use in making
informed medical decisions.
Costs and Benefits
The proposed rule would ensure that any related costs and burdens
are kept to a minimum.
I. Background
Under the authority of section 361 of the PHS Act, by delegation
from the Surgeon General and the Secretary of Health and Human
Services, FDA may make and enforce regulations necessary to prevent the
introduction, transmission, or spread of communicable diseases.
Communicable diseases include, but are not limited to, those
transmitted by viruses, bacteria, fungi, parasites, and transmissible
spongiform encephalopathy agents. Certain diseases are transmissible
through implantation, transplantation, infusion, or transfer of HCT/Ps
derived from donors infected with those diseases. To prevent the
introduction, transmission, or spread of such communicable diseases, we
consider it necessary to require establishments to take appropriate
measures to prevent the use of cells or tissues from infected donors.
FDA regulates HCT/Ps intended for implantation, transplantation,
infusion, or transfer into a human recipient under part 1271 that was
issued under the authority of section 361 of the PHS Act. Part 1271
requires HCT/P establishments to screen and test donors for relevant
communicable disease agents and diseases, to prepare and follow written
standard operating procedures for the prevention of the spread of
communicable diseases, and to maintain records. Part 1271 also requires
that for most HCT/Ps, the cell or tissue donor must be determined to be
eligible, based on the results of screening and testing for relevant
communicable disease agents and diseases. In most cases, a donor who
tests reactive for a particular communicable disease, or who possesses
clinical evidence of, or risk factors for, communicable disease agents
and diseases, would be considered ineligible, and cells or tissues from
that donor would not ordinarily be used.
FDA has published three final rules that make up part 1271. In the
Federal Register of January 19, 2001 (66 FR 5447), FDA published
regulations requiring HCT/P establishments to register and list their
HCT/Ps with FDA (registration final rule). In the Federal Register of
May 25, 2004 (69 FR 29786), we published regulations requiring most
cell and tissue donors to be tested and screened for relevant
communicable disease agents and diseases (donor eligibility final
rule). In the Federal Register of November 24, 2004 (69 FR 68612), we
published regulations requiring HCT/P establishments to follow current
good tissue practice (CGTP), which governs the methods used in, and the
facilities and controls used for, the manufacture of HCT/Ps,
recordkeeping, and the establishment of a quality program (CGTP final
rule). These regulations apply to HCT/Ps recovered on or after May 25,
2005.
As part of our ongoing effort to implement our framework for
regulating HCT/Ps, in the Federal Register of May 25, 2005 (70 FR
29949), we issued an interim final rule entitled ``Human Cells,
Tissues, and Cellular and Tissue-Based Products; Donor Screening and
[[Page 78746]]
Testing, and Related Labeling'' (2005 interim final rule), which had an
effective date simultaneous with publication. This interim final rule
was then adopted without change in the Federal Register of June 19,
2007, in the final rule entitled ``Human Cells, Tissues, and Cellular
and Tissue-Based Products; Donor Screening and Testing, and Related
Labeling'' (72 FR 33667) (2007 final rule). The 2007 final rule amended
regulations regarding the screening and testing of donors of HCT/Ps,
timing of specimen collection, record retention requirements, and
related labeling requirements in response to public comments concerning
the importance of cryopreserved embryos to individuals seeking access
to donated embryos. The 2007 final rule also added an exception to the
donor eligibility requirements in Sec. 1271.90(a)(4) for cryopreserved
embryos that, while originally exempt from the donor eligibility
requirements because the donors were sexually intimate partners, are
later intended for directed or anonymous donation.
In recent years, industry and the medical community have raised
concerns that the current regulations restrict the use of embryos that
were intended for personal reproductive use and therefore impose
limitations on individuals and couples involved in family building. In
response to these concerns, we are proposing this rulemaking to clarify
and further develop the current exceptions to the donor eligibility
requirements. If finalized, the proposed rule will provide HCT/P
establishments with the flexibility to make available any embryos
originally formed for reproductive use for a specific individual or
couple and now intended for reproductive use, provided that specific
criteria are met, including requirements for labeling.
II. Description of the Proposed Rule
The proposed rule is intended to allow the use of all embryos for
reproductive use by expanding the current exceptions to the prohibition
on use under Sec. 1271.90. This proposal is in response to our
enhanced understanding in this area and to increase the options for
individuals and couples seeking access to these HCT/Ps.
A. Current Exceptions to Prohibition on Use
As set forth in the donor eligibility final rule, an HCT/P must not
be implanted, transplanted, infused, or transferred until the donor has
been determined to be eligible (Sec. 1271.45(c)) based on the results
of donor screening (Sec. 1271.75) and testing (Sec. Sec. 1271.80 and
1271.85) for relevant communicable disease agents and diseases. These
donor eligibility requirements apply to all donors of HCT/Ps, including
donors of reproductive cells or tissues. In the case of an embryo or of
cells derived from an embryo, a donor eligibility determination is
required for both the oocyte donor and the semen donor (Sec.
1271.45(b)).
Section 1271.90(a) contains exceptions from the requirement of
determining donor eligibility for the following HCT/Ps: (1) Cells and
tissues for autologous use; (2) reproductive cells or tissue donated by
a sexually intimate partner of the recipient for reproductive use; (3)
cryopreserved cells or tissues for reproductive use that are for
autologous use or donated by a sexually intimate partner and are
subsequently intended for directed donation; and (4) a cryopreserved
embryo that is formed from gametes of sexually intimate partners and is
subsequently intended for directed or anonymous donation.
The 2007 final rule added the Sec. 1271.90(a)(4) exception to
allow for directed or anonymous donation of cryopreserved embryos
originally intended for use by a sexually intimate partner, without the
need for a donor eligibility determination. This exception addresses
the situation where sexually intimate partners who were not screened
and tested at the time of cryopreservation of their embryos later wish
to make a directed or anonymous donation of their cryopreserved
embryos. As explained in the preamble to the 2005 interim final rule,
we recognize that because the embryos were intended for use in a
sexually intimate relationship, the donors would not have been required
to be screened and tested for communicable disease agents and diseases
at the time that the oocytes and semen were recovered. While the 2005
interim final rule recommended that appropriate measures be taken to
screen and test the semen and oocyte donors before transfer of the
embryo to a recipient, the rule also specifically stated that ``[I]f
screening and testing of the semen and oocyte donors are not performed,
this rule would not prohibit the transfer of the embryo into a
recipient'' (70 FR 29949 at 29951).
The Agency provided additional guidance on this point in the
guidance entitled, ``Guidance for Industry: Eligibility Determination
for Donors of Human Cells, Tissues, and Cellular and Tissue-Based
Products (HCT/Ps)'' dated August 2007. The guidance states that, as in
other cases involving directed donations of reproductive tissue, the
regulatory language in Sec. 1271.90(a)(4) allows for the use of
embryos from a directed, ineligible donor. In the guidance, FDA also
clarified that we intend to apply this policy to a sexually intimate
couple's cryopreserved embryos where one of the gametes is from a
qualified (i.e., eligible) third party gamete donor, and the other
gamete is from the sexually intimate partner of the intended recipient.
As specifically stated in the guidance in section VIII.A, ``. . .
although FDA requires appropriate screening and testing when possible,
if appropriate screening and testing are not possible (e.g., because
one of the donors is unavailable), you may still transfer the embryo
into a recipient.'' In this proposed rulemaking, our intent is to
expand this exception beyond the current exception in Sec. 1271.90(a)
for reproductive cells or tissue donated by a sexually intimate partner
of the recipient for reproductive use. Under this proposed rule, an
embryo, originally intended for reproductive use for a specific
individual or couple, may be subsequently used for directed or
anonymous donation even when the applicable donor eligibility
requirements under part 1271, subpart C are not met. As stated in the
new Sec. 1271.90(b), nothing in this paragraph creates an exception
for deficiencies that occurred in making the donor eligibility
determination for either the oocyte donor or the semen donor as
required under Sec. 1271.45(b), or for deficiencies in performing
donor screening or testing, as required under Sec. Sec. 1271.75,
1271.80, and 1271.85.
B. Continued Obligations Under HCT/P Regulations
As discussed previously, this proposed rule would clarify and
further develop the current exceptions to the prohibition on use and
provide greater accommodation to individuals and couples wanting access
to embryos intended for reproductive use, while continuing to emphasize
the applicability of the donor eligibility screening and testing
requirements for individual gamete donors. FDA reminds industry of its
continued obligations under part 1271, subpart C to determine donor
eligibility based on the results of donor screening (Sec. 1271.75) and
testing (Sec. Sec. 1271.80 and 1271.85). Establishments must also
continue to comply with part 1271 requirements applicable to
reproductive HCT/Ps to prevent the introduction, transmission, or
spread of communicable disease.
[[Page 78747]]
C. Labeling Requirements
This proposed rule describes the continued applicability of
labeling requirements for embryos intended for reproductive use that
would be excepted from the prohibition on use. This proposed rule would
require prominent labeling that describes the donor eligibility status
of the individual donors whose gametes were used to form the embryo.
The required labeling would provide information to the treating
physician to permit discussion of the potential risks of communicable
diseases with the recipient. We expect that a recipient would be fully
informed of the risks involved in using an embryo for reproductive
purposes as described under proposed Sec. 1271.90(b) even when the
donor eligibility requirements under part 1271, subpart C are not met.
Specifically, under proposed Sec. 1271.90(c)(2) through (c)(6), an
embryo originally intended for reproductive use for a specific
individual or couple that is subsequently intended for directed or
anonymous donation must be prominently labeled with the following
statements as they are applicable:
``NOT EVALUATED FOR INFECTIOUS SUBSTANCES'';
``WARNING: Advise recipient of communicable disease
risk'';
the BIOHAZARD legend shown in Sec. 1271.3(h);
``WARNING: Reactive test results for (name of disease
agent or disease)'';
``Advise recipient that screening and testing of the
donor(s) were not performed at the time of recovery or cryopreservation
of the reproductive cells or tissue, but have been performed
subsequently.''
The proposed labeling requirements are based on the expectation
that a physician will be closely involved in the decision to use an
embryo and the recognition that physicians are under legal and ethical
obligations that require them to discuss the risks of communicable
disease transmission stemming from the use of HCT/Ps. FDA relies on
physicians to meet these obligations when discussing procedures
involving HCT/Ps with recipients. FDA expects that HCT/P establishments
will take appropriate measures to screen and test the semen and oocyte
donor(s) before making available for reproductive use the embryo
excepted under proposed Sec. 1271.90(b). For this reason, proposed
Sec. 1271.90(b) also specifically states that ``[N]othing in this
paragraph creates an exception for deficiencies that occurred in making
the donor eligibility determination for either the oocyte donor or the
semen donor as required under Sec. 1271.45(b), or for deficiencies in
performing donor screening or testing, as required under Sec. Sec.
1271.75, 1271.80, and 1271.85.''
III. Proposed Revisions to FDA Regulations
We are proposing revisions to the following FDA regulations:
A. Proposed Amendments to Sec. 1271.90
Section 1271.90 sets forth exceptions where HCT/P establishments
are not required to make a donor eligibility determination under Sec.
1271.50 or to perform donor screening or testing under Sec. Sec.
1271.75, 1271.80, and 1271.85. We are proposing to add language to the
exceptions listed in this section to provide clarity and update the
regulation by allowing for an embryo originally intended for
reproductive use for a specific individual or couple, to be
subsequently used for directed or anonymous donation, even when the
donor eligibility requirements under part 1271, subpart C are not met.
We are proposing to amend Sec. 1271.90 as follows:
Changing the heading of this section by deleting ``from
the requirement of determining donor eligibility,'' and inserting
``other'' before ``exceptions.'' If this change is finalized, the
heading for Sec. 1271.90 would read ``Are there other exceptions and
what labeling requirements apply?'' We made this change for clarity;
the new heading would be more accurate.
Changing Sec. 1271.90(a)(3) by replacing ``exempt'' with
``excepted,'' which is the term used in the introductory title for this
provision. Thus, this change would make the language more consistent.
If this change is finalized, the beginning of Sec. 1271.90(a)(3) would
read, ``Cryopreserved cells or tissues for reproductive use, other than
embryos, originally excepted. . . .''
Changing current Sec. 1271.90(a)(4) by replacing
``exempt'' with ``excepted,'' and by adding ``(a)(1) and'' before
``(a)(2)'' to clarify that as proposed, Sec. 1271.90(a)(4) would refer
to a cryopreserved embryo formed for autologous use and the
reproductive cells or tissue were donated by a sexually intimate
partner of the recipient for reproductive use. If this change is
finalized, Sec. 1271.90(a)(4) would read, ``A cryopreserved embryo,
originally excepted under paragraphs (a)(1) and (a)(2). . . .''
Redesignating current Sec. 1271.90(b) as Sec. 1271.90(c)
and adding a new paragraph (b) to Sec. 1271.90.
Changing newly designated Sec. 1271.90(c) by adding ``and
(b)'' after ``(a)'' in the introductory text, revising Sec.
1271.90(c)(2) to replace ``(b)(6)'' with ``(c)(6)'', and by adding
``recovery or'' before ``cryopreservation'' in new Sec. 1271.90(c)(6)
to clarify that some testing and screening activities may take place
before recovery, not just before cryopreservation.
B. Proposed Sec. 1271.90(b)
We are proposing to redesignate the current Sec. 1271.90(b) to
Sec. 1271.90(c), and insert a new Sec. 1271.90(b) entitled
``Exceptions for Reproductive Use.'' Under proposed Sec. 1271.90(b),
an embryo originally intended for reproductive use for a specific
individual or couple that is subsequently intended for directed or
anonymous donation is excepted from the prohibition on use under Sec.
1271.45(c) even when the applicable donor eligibility requirements
under part 1271, subpart C are not met. Accordingly, when an
establishment fails to comply with applicable donor eligibility
requirements under part 1271, subpart C, the establishment would not be
prohibited from making available for reproductive use such embryos for
reproductive purposes in accordance with this section. The proposed
exception from the prohibition on use does not create an exception for
deficiencies that occurred in making the donor eligibility
determination for either the oocyte donor or the semen donor as
required under Sec. 1271.45(b), or for deficiencies in performing
donor screening or testing, as required under Sec. Sec. 1271.75,
1271.80, and 1271.85.
We note that the language we are proposing to add to the exceptions
currently listed in Sec. 1271.90 is additive. It creates an additional
exception for the use of certain reproductive HCT/Ps that are not
currently excepted, but it does not impact or restrict the exceptions
currently provided for in the regulations.
C. Proposed Sec. 1271.90(c)
Under proposed Sec. 1271.90(c), HCT/P establishments must
prominently label an HCT/P described in paragraphs (a) and (b) of this
section as required in paragraph (c). The labeling requirements are
intended to help ensure that physicians have specific and accurate
information to provide to recipients for use in making informed medical
decisions.
If finalized, the nonsubstantive change to Sec. 1271.90(c)(2)
would clarify that the labeling requirements contained in Sec.
1271.90(c)(2) do not apply to reproductive cells or tissue labeled in
accordance with Sec. 1271.90(c)(6). The proposed change to Sec.
1271.90(c)(6) would include ``recovery or'' before the word
``cryopreservation''. Thus, the
[[Page 78748]]
proposed Sec. 1271.90(c)(6) provision requires HCT/P establishments to
prominently label an HCT/P described in Sec. 1271.90(a)(3) or (a)(4)
with ``Advise recipient that screening and testing of the donor(s) were
not performed at the time of recovery or cryopreservation of the
reproductive cells or tissue, but have been performed subsequently''
for HCT/Ps described in Sec. 1271.90(a)(3) or (a)(4). This proposed
change is made to recognize that some testing and screening activities
may take place even before recovery of HCT/Ps, not just before
cryopreservation.
D. Proposed Amendments to Sec. 1271.370
Section 1271.370 sets forth labeling requirements in addition to
those that apply under Sec. Sec. 1271.55, 1271.60, 1271.65, and
1271.90. Because, as discussed previously, this rule is proposing to
redesignate the current labeling requirements under Sec. 1271.90(b) to
Sec. 1271.90(c), we are proposing to amend Sec. 1271.370(b)(4) to
revise the reference from Sec. 1271.90(b) to Sec. 1271.90(c).
IV. Legal Authority
FDA is proposing this rulemaking under the authority of section 361
of the PHS Act. Under section 361 of the PHS Act, FDA may issue and
enforce regulations necessary to prevent the introduction,
transmission, or spread of communicable disease between the States or
from foreign countries into the States. It is important to recognize
that HCT/Ps recovered in one State may be sent to another for
processing, and then shipped for use throughout the United States, or
beyond. FDA has been involved in many recalls where HCT/Ps processed in
a single establishment have been distributed in many States. In any
event, intrastate transactions affecting interstate communicable
disease transmission may also be regulated under section 361 of the PHS
Act. (See Louisiana v. Mathews, 427 F. Supp. 174, 176 (E.D. La. 1977);
Independent Turtle Farmers of Louisiana, Inc. v. United States of
America, et al., 2010 U.S. Dist. LEXIS 31117). This rulemaking proposes
changes in response to our enhanced understanding of the uses of
certain types of HCT/Ps in specific situations and in response to
comments from stakeholders regarding the importance of embryos to
individuals and couples seeking access to donated embryos.
V. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct 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). This proposed rule is not a significant regulatory action as
defined by Executive Order 12866.
The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the costs associated with this rule are
expected to be minimal, we propose to certify that this 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 $141 million, using the most current (2013) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in a 1-year expenditure that would meet or
exceed this amount.
This rule proposes to amend certain regulations regarding donor
eligibility and labeling related to the screening and testing of donors
of particular HCT/Ps. The proposed rule would provide additional
flexibility to HCT/P establishments to make available for reproductive
use embryos originally intended for reproductive use for a specific
individual or couple and subsequently intended for directed or
anonymous donation. Specifically, the proposed rule would clarify that
if an embryo was originally intended for reproductive use for a
specific individual or couple, its use for directed or anonymous
donation would not be prohibited under Sec. 1271.45(c), even when the
applicable donor eligibility requirements under part 1271, subpart C
are not met. This proposed exception from prohibition for use would not
create an exception for deficiencies that occurred in making the donor
eligibility determination for either the oocyte donor or the semen
donor as required under Sec. 1271.45(b), or for deficiencies in
performing donor screening or testing, as required under Sec. Sec.
1271.75, 1271.80, and 1271.85. The proposed rule also requires
appropriate labeling that describes the donor eligibility status of the
individual donors whose gametes were used to form the embryo.
This rule will provide greater accommodation of individuals and
couples wanting access to embryos originally intended for reproductive
use, while continuing to emphasize the applicability of the donor
eligibility screening and testing requirements for individual gamete
donors. If finalized, the proposed rule will provide HCT/P
establishments with the flexibility to make available embryos
originally intended for reproductive use, provided that specific
criteria are met. Consistent with current regulations, the proposed
labeling requirements will help ensure that physicians have specific
and accurate information to provide to recipients for use in making
informed medical decisions. Because this proposed rule would impose no
additional regulatory burdens, the costs associated with this rule are
expected to be minimal. FDA requests comment on this conclusion.
VI. Environmental Impact
The Agency has determined under 21 CFR 25.30(h) 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.
VII. Federalism
FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule, if finalized, would 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, the Agency tentatively concludes that the proposed 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.
VIII. The Paperwork Reduction Act of 1995
The labeling requirements contained in this proposed rule are not
subject to review by the Office of Management and Budget (OMB) because
they do not constitute a ``collection of information''
[[Page 78749]]
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). Rather, the requirement to label HCT/Ps in accordance with the
proposed rule is a ``public disclosure of information originally
supplied by the Federal government to the recipient for the purpose of
disclosure to the public'' (5 CFR 1320.3(c)(2)). Therefore, FDA
tentatively concludes that these proposed requirements in this document
are not subject to review by OMB because they do not constitute a
``collection of information'' under the PRA.
IX. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov.
List of Subjects in 21 CFR Part 1271
Biologics, Drugs, Human cells and tissue-based products, Medical
devices, Reporting and recordkeeping requirements.
Therefore, under the Public Health Service Act and under the
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 1271 be amended as follows:
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. In Sec. 1271.90:
0
a. Revise the heading;
0
b. Revise paragraphs (a)(3) and (a)(4) by removing ``exempt'' and by
adding in its place ``excepted'';
0
c. Revise paragraph (a)(4) by removing ``paragraph'' and by adding in
its place ``paragraphs ''; and by adding ``(a)(1) and'' before
``(a)(2)'';
0
d. Redesignate paragraph (b) as paragraph (c);
0
e. Add a new paragraph (b);
0
f. Revise newly designated paragraph (c) by removing ``paragraph'' and
by adding in its place ``paragraphs'' and by adding ``and (b)'' after
``(a)'' in the introductory text;
0
g. Revise newly designated paragraph (c)(2) by removing ``(b)(6)'' and
by adding in its place ``(c)(6)''; and
0
h. Revise newly designated paragraph (c)(6) by adding ``recovery or''
before ``cryopreservation''.
The revisions read as follows:
Sec. 1271.90 Are there other exceptions and what labeling
requirements apply?
(a) * * *
(3) Cryopreserved cells or tissue for reproductive use, other than
embryos, originally excepted under paragraphs (a)(1) or (a)(2) of this
section at the time of donation, that are subsequently intended for
directed donation, provided that
* * * * *
(4) A cryopreserved embryo, originally excepted under paragraphs
(a)(1) and (a)(2) of this section at the time of cryopreservation, that
is subsequently intended for directed or anonymous donation. When
possible, appropriate measures should be taken to screen and test the
semen and oocyte donors before transfer of the embryo to the recipient.
(b) Exceptions for Reproductive Use. An embryo originally intended
for reproductive use for a specific individual or couple that is
subsequently intended for directed or anonymous donation for
reproductive use is excepted from the prohibition on use under Sec.
1271.45(c) even when the applicable donor eligibility requirements
under part 1271, subpart C are not met. Nothing in this paragraph
creates an exception for deficiencies that occurred in making the donor
eligibility determination for either the oocyte donor or the semen
donor as required under Sec. 1271.45(b), or for deficiencies in
performing donor screening or testing, as required under Sec. Sec.
1271.75, 1271.80, and 1271.85.
(c) Required labeling. As applicable, you must prominently label an
HCT/P described in paragraphs (a) and (b) of this section as follows:
(1) * * *
(2) ``NOT EVALUATED FOR INFECTIOUS SUBSTANCES,'' unless you have
performed all otherwise applicable screening and testing under
Sec. Sec. 1271.75, 1271.80, and 1271.85. This paragraph does not apply
to reproductive cells or tissue labeled in accordance with paragraph
(c)(6) of this section.
* * * * *
(6) ``Advise recipient that screening and testing of the donor(s)
were not performed at the time of recovery or cryopreservation of the
reproductive cells or tissue, but have been performed subsequently,''
for paragraphs (a)(3) or (a)(4) of this section.
* * * * *
0
3. Amend Sec. 1271.370(b)(4) by removing ``Sec. 1271.90(b)'' and by
adding in its place ``Sec. 1271.90(c)''.
Dated: December 23, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30528 Filed 12-30-14; 8:45 am]
BILLING CODE 4164-01-P