Document ID: FDA-2014-N-1484-0001
Agency: fda
Document Type: Proposed Rule
Title: Revisions to Exceptions Applicable to Certain Human Cells Tissues and Cellular and Tissue-Based Products
Posted Date: 2014-12-31T05:00Z

[Federal Register Volume 79, Number 250 (Wednesday, December 31, 2014)]
[Proposed Rules]
[Pages 78744-78749]
From the Federal Register Online via the Government Printing 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