[Federal Register Volume 81, Number 120 (Wednesday, June 22, 2016)]
[Rules and Regulations]
[Pages 40512-40518]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14721]
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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: Final rule.
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SUMMARY: The Food and Drug Administration (FDA or Agency or we) is
issuing this final 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. This final rule is 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: This rule is effective August 22, 2016.
ADDRESSES: 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 final rule 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: Jessica T. Walker, 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:
Table of Contents
I. Executive Summary
A. Purpose of the Final Rule
B. Summary of the Major Provisions of the Final Rule
C. Legal Authority
D. Costs and Benefits
II. Background
A. Need for the Regulation/History of This Rulemaking
B. Summary of Comments to the Proposed Rule
C. General Overview of the Final Rule
III. Legal Authority
IV. Comments on the Proposed Rule and FDA Response
A. Introduction
B. Description of General Comments and FDA Response
[[Page 40513]]
C. Purpose and Scope of the Final Rule (Sec. 1271.1)
D. Donor Screening (Sec. 1271.75)
E. Exceptions From the Requirement of Determining Donor
Eligibility (Sec. 1271.90)
F. Labeling Requirements (Sec. 1271.370)
V. Effective Date
VI. Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
I. Executive Summary
A. Purpose of the Final Rule
FDA is issuing this final rule to amend certain regulations
regarding donor eligibility, including the screening and testing of
donors of particular HCT/Ps, and related labeling. We are finalizing
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.
B. Summary of the Major Provisions of the Final Rule
FDA is amending 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 rulemaking
redesignates 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 final rule also requires 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 labeling is to
help ensure that physicians have specific and accurate information to
provide to recipients for use in making informed medical decisions.
C. Legal Authority
FDA has authority for this rulemaking under 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.
D. Costs and Benefits
Because this rule imposes no additional regulatory burdens, the
costs associated with this rule are expected to be minimal.
II. Background
A. Need for the Regulation/History of This Rulemaking
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 HCT/Ps 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 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 HCT/Ps 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), we 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
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 certain 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
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 (72 FR 33667), in the final rule entitled ``Human Cells, Tissues,
and Cellular and Tissue-Based Products; Donor Screening and Testing,
and Related Labeling'' (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 expressed
concerns that the exception added by
[[Page 40514]]
the 2007 final rule does not fully address the need for access to
cryopreserved embryos. The stakeholders have raised concerns that the
current regulations still unduly restrict the use of embryos that were
originally intended for personal reproductive use, and therefore impose
limitations on individuals and couples involved in family building. In
response to these concerns, FDA published the proposed rule ``Revisions
to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular
and Tissue-Based Products'' in the Federal Register of December 31,
2014 (79 FR 78744). The proposed rule intended to increase access to
embryos for reproductive use by expanding the current exceptions to the
prohibitions on use under Sec. 1271.90, providing HCT/P establishments
with the flexibility to make available any embryo originally formed for
reproductive use for a specific individual or couple and now intended
for reproductive use in a directed or anonymous donation, provided that
specific criteria are met, including requirements for labeling.
B. Summary of Comments to the Proposed Rule
We received approximately 10 comment letters on the proposed rule
by the close of the comment period. We received comments from academia,
professional organizations, and individuals. The comments were balanced
between those expressing support for the proposed rule and those
raising concerns about how the proposed exception will impact public
health. They addressed the following topics: Purpose and scope of the
final rule, donor screening, exceptions from the requirement of
determining donor eligibility, and labeling requirements.
C. General Overview of the Final Rule
FDA is adopting as final, without material change, the proposed
rule to amend certain regulations regarding donor eligibility and
related labeling.
We are making revisions to the following FDA regulations:
1. 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 adding 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 amending 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.'' The heading for Sec. 1271.90 will
read ``Are there other exceptions and what labeling requirements
apply?'' We made this change for clarity; the new heading will 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 will make the language more consistent.
The beginning of Sec. 1271.90(a)(3) will read, ``Cryopreserved cells
or tissue for reproductive use, other than embryos, originally excepted
. . . .''
Changing current Sec. 1271.90(a)(4) by replacing
``exempt'' with ``excepted''.
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 removing
``paragraph (a)'' and adding in its place ``paragraphs (a) and (b)'' 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 of the
gametes, not just before cryopreservation of the embryos.
2. Section 1271.90(b)
We are redesignating the current Sec. 1271.90(b) to Sec.
1271.90(c), and adding a new Sec. 1271.90(b) entitled ``Exceptions for
reproductive use.'' Under finalized 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 will not be prohibited from making
available for reproductive use such embryos for reproductive purposes
in accordance with this section. The 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 adding 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.
3. Section 1271.90(c)
Under Sec. 1271.90(c), HCT/P establishments must prominently label
an HCT/P described in Sec. 1271.90(a) and (b). 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.
The nonsubstantive change to Sec. 1271.90(c)(2) clarifies 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 change to Sec. 1271.90(c)(6) includes ``recovery
or'' before the word ``cryopreservation''. Thus, the 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 change is made to recognize that
some testing and screening activities may take place even before
recovery of HCT/Ps, not just before cryopreservation.
4. Amendment 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 redesignates the
current labeling requirements under Sec. 1271.90(b) to Sec.
1271.90(c), we are amending Sec. 1271.370(b)(4) to revise the
reference from Sec. 1271.90(b) to Sec. 1271.90(c).
III. Legal Authority
FDA is issuing this final rule under the authority of section 361
of the 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
[[Page 40515]]
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
final rule incorporates 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.
IV. Comments on the Proposed Rule and FDA Response
A. Introduction
We received approximately 10 comment letters on the proposed rule
by the close of the comment period, each containing one or more
comments on one or more issues. We received comments from academia,
professional organizations, and individual consumers.
We describe and respond to the comments in sections IV.B through
IV.F. We have numbered each comment to help distinguish among different
comments. We have grouped similar comments together under the same
number, and, in some cases, we have separated different issues
discussed in the same comment and designated them as distinct comments
for purposes of our responses. The number assigned to each comment is
purely for organizational purposes and does not signify the comment's
value or importance or the order in which the comments were received.
B. Description of General Comments and FDA Response
Several comments made general remarks supporting the proposed rule
without focusing on a particular proposed provision. In the following
paragraphs, we discuss and respond to such general comments.
(Comment 1) There were several comments that were in support of the
proposed rule and suggested that we provide even more guidance on donor
eligibility, screening, and testing of donors of reproductive cells.
One suggestion was that FDA's donor eligibility, screening, and testing
requirements closely parallel American Society of Reproductive
Medicine/Society for Assisted Reproductive Technology guidelines.
(Response) FDA acknowledges and appreciates the supportive
comments. We appreciate the interest in additional guidance for the
screening and testing of donors of reproductive cells. We continue to
review existing regulations with respect to providing additional
guidance or modifying these regulations as appropriate, in the future.
(Comment 2) One comment asked if the final rule would be applied
retrospectively to embryos formed and cryopreserved on or after May 25,
2005.
(Response) Yes, the final rule applies to embryos formed and
cryopreserved on or after May 25, 2005.
C. Purpose and Scope of the Final Rule (Sec. 1271.1)
(Comment 3) One comment noted that preventing the spread of
communicable disease protects the population and the family receiving
the donation. Two comments suggested that the proposed rule conflicts
with FDA regulations that serve to prevent the introduction,
transmission, and spread of communicable disease. One comment expressed
concern that the proposed rule appears to relax the testing
requirements for donors and conflicts with the PHS Act, specifically
section 361, that provides FDA with the authority to make and enforce
regulations ``to prevent the introduction, transmission, or spread of
communicable diseases from foreign countries into the States or
possessions, or from State or possession into any other State or
possession'' (42 U.S.C. 264(a)). This commenter's interpretation of the
proposed rule is that it removes the requirement for reproductive
tissue donors to be tested, and only requires reproductive tissue donor
testing ``when possible.'' According to the comment, FDA seems to posit
informed consent as an adequate response to the health risks faced by
recipients of donated embryos. The commenter would like FDA to strike
the qualifier ``when possible'' from the text of the proposed rule
because the commenter believes this approach would provide a greater
level of protection to the recipient than the proposed rule and
preserve FDA's intention of relaxing the current donor eligibility
regulations in the interest of family building.
(Response) As stated previously, we consider it necessary that
establishments take appropriate measures to prevent the use of HCT/Ps
from donors infected with communicable diseases. Part 1271 requires
HCT/P establishments to screen and test donors for relevant
communicable disease agents and diseases, and to maintain records. Part
1271 also requires for most HCT/Ps that the donor must be determined to
be eligible, based on the results of screening and testing for relevant
communicable disease agents and diseases. We have retained the
qualifier ``when possible'' in Sec. 1271.90(a)(4) to 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 in a directed or anonymous
donation, provided that specific criteria are met, including
requirements for labeling.
The final rule provides for the continued applicability of labeling
requirements for embryos intended for reproductive use that would be
excepted from the prohibition on use. The rule requires prominent
labeling that describes the donor eligibility status of the individual
donors whose gametes were used to form the embryo. The required
labeling will provide information to the treating physician to permit
discussion of the potential risks of communicable disease with the
recipient.
D. Donor Screening (Sec. 1271.75)
(Comment 4) Some of the comments expressed concern about the risk
of accepting an unscreened donation. Another comment noted that
eligibility of the HCT/P donor must be assessed prior to usage to
ensure the safety of recipients, their offspring, and the public as a
whole; and furthermore, ensuring the proper screening of the donor's
HCT/P enables the control of the spread of disease.
(Response) We agree that the proper screening of HCT/P donors
minimizes the risk of introducing, transmitting, or spreading
communicable diseases. As stated in the proposed rule, we consider it
necessary to require establishments to take appropriate measures to
prevent the use of HCT/Ps from infected donors. Part 1271 requires HCT/
P establishments to screen and test donors for relevant communicable
disease agents and diseases, and to maintain records. Part 1271 also
requires, for most HCT/Ps, that donor 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
[[Page 40516]]
tests reactive for a particular communicable disease, or who possesses
clinical evidence of, or risk factors for, a communicable disease agent
and disease, would be considered ineligible, and cells or tissues from
that donor would not ordinarily be used.
(Comment 5) A few comments expressed the belief that the proposed
rule will allow for better genetic profiling. One of those comments
stated that labeling will make it easier to identify particular
genotypes for research. Another comment stated that genetically
profiling all donors and to the extent possible all embryos will reduce
the risk of recipients of embryos giving birth to children with serious
genetic disorders. The commenter asked FDA to require establishments to
genetically screen all donors and the embryo when possible.
(Response) These comments address a topic that is outside the scope
of this rulemaking.
E. Exceptions From the Requirement of Determining Donor Eligibility
(Sec. 1271.90)
(Comment 6) One comment sought transparency as to which embryos are
excepted and requested specific examples of how the rule provides
additional flexibility to make embryos available for directed and
anonymous donation. Specifically, the commenter asked whether donation
would be allowed when the embryo was originally intended for transfer
to a sexually intimate partner, where one of the gamete providers
(either a directed or anonymous donor) would be considered ineligible
based on screening and testing.
(Response) The rulemaking provides additional flexibility to make
embryos available when there have been changes in the original plans
for use of the embryos. Under finalized 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 will not be prohibited from making
available for reproductive use such embryos for reproductive purposes
in accordance with this section. The 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 change we are making 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.
(Comment 7) One comment recommends that the term ``embryos formed
for autologous use'' not be used in conjunction with embryos. The
commenter reasons that after a sperm or oocyte form an embryo, the
embryo should not be considered autologous, given the definition at
Sec. 1271.3(a).
(Response) We agree with the comment and are not adopting, as part
of the final rule, the term ``embryos formed for autologous use''.
Likewise, we are not adopting, as part of the final rule, the reference
to Sec. 1271.90(a)(1) in Sec. 1271.90(a)(4).
F. Labeling Requirements (Sec. 1271.370)
(Comment 8) Several comments were in support of labeling because it
allows the physician to fully discuss the risks of any communicable
disease and it allows the patient to make a fully informed decision.
One commenter noted that factors affecting decisions of an HCT/P
recipient may outweigh the expert advice of medical doctors. Another
comment referenced Sec. 1271.90(c)(6) of the proposed rule (embryo
labeling requirements) that states establishments are required to
``advise recipients that screening and testing of the donor(s) were not
performed at the time of recovery or cryopreservation of the
reproductive cells or tissues, but have been performed subsequently.''
The comment further states that ``Description of the Proposed Rule''
provides that these labeling requirements are ``based on the
expectation that a physician will be closely involved in the decision
of the 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.''
The comment asked that FDA revise the rule to expressly require
establishments to counsel recipients on the risk of disease.
(Response) We agree that the recipients should be fully informed
about the risk of communicable disease before accepting an embryo for
implantation; however, we decline to make the suggested change. As
stated in the preamble of the proposed rule, 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. Further, we expect that a recipient would be fully informed
of the risks involved in using an embryo for reproductive purposes as
finalized under Sec. 1271.90(b) even when the donor eligibility
requirements under part 1271, subpart C are not met.
(Comment 9) One comment suggested that while a labeling requirement
that is tiered according to the risks may mitigate the risks, it does
not go far enough in abolishing the risks.
(Response) As described under proposed Sec. 1271.90(c)(2) through
(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 labeled as applicable. We acknowledge that
the labeling requirement will not abolish all risks of implanting those
embryos. Rather, as stated in the proposed rule, the required labeling
would provide information to the treating physician to permit
discussion of the potential risks of communicable diseases with the
recipient. Our expectation is that the recipient will become fully
informed of the risk when the donor eligibility requirements under part
1271, subpart C are not met, so that the recipient can make a well
informed decision about receiving the embryo.
V. Effective Date
This rule is effective August 22, 2016.
VI. Economic Analysis of Impacts
We have examined the impacts of the final 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 us 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). We
have
[[Page 40517]]
developed a comprehensive Economic Analysis of Impacts that assesses
the impacts of the final rule. We believe that this final rule is not a
significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us 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 certify that the rule will not have a significant
economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to 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 $146
million, using the most current (2015) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in an
expenditure in any year that meets or exceeds this amount.
This rule amends certain regulations regarding donor eligibility
and labeling related to the screening and testing of donors of
particular HCT/Ps. The final rule will 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 final rule will 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
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 final 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 for a specific individual or couple, while continuing to emphasize
the applicability of the donor eligibility screening and testing
requirements for individual gamete donors. The final rule will provide
HCT/P establishments with the flexibility to make embryos originally
intended for reproductive use for a specific individual or couple now
available for directed or anonymous donation, provided that specific
criteria are met. Consistent with current regulations, the 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 rule imposes no additional
regulatory burdens, the costs associated with this rule are expected to
be minimal.
VII. Analysis of Environmental Impact
We have 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.
VIII. Paperwork Reduction Act of 1995
The labeling requirements contained in this final rule are not
subject to review by the Office of Management and Budget (OMB) because
they do not constitute a ``collection of information'' 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 final 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 concludes that these
requirements in this document are not subject to review by OMB because
they do not constitute a ``collection of information'' under the PRA.
IX. Federalism
We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has 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, we conclude 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.
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 authority
delegated to the Commissioner of Food and Drugs, 21 CFR part 1271 is
amended as follows:
PART 1271--HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED
PRODUCTS
0
1. The authority citation for 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 paragraph (a)(3) introductory text;
0
c. Revise paragraph (a)(4);
0
d. Redesignate paragraph (b) as paragraph (c);
0
e. Add a new paragraph (b);
0
f. Revise newly designated paragraph (c) introductory text;
0
g. Revise newly designated paragraph (c)(2); and
0
h. Revise newly designated paragraph (c)(6).
The revisions and additions 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 paragraph
(a)(2) of this section at the time of recovery or 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
[[Page 40518]]
use under Sec. 1271.45(c) even when the applicable donor eligibility
requirements under subpart C of this part 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:
* * * * *
(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.
Sec. 1271.370
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: June 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14721 Filed 6-21-16; 8:45 am]
BILLING CODE 4164-01-P