Revisions to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products, 40512-40518 [2016-14721]
Download as PDF
<![CDATA[
40512
Federal Register / Vol. 81, No. 120 / Wednesday, June 22, 2016 / Rules and Regulations
Authority: 15 U.S.C. 77e, 77f, 77g, 77h, 77j,
77k, 77s, 77z–2, 77z–3, 77aa(25), 77aa(26),
77ddd, 77eee, 77ggg, 77hhh, 77iii, 77jjj,
77nnn, 77sss, 78c, 78i, 78j, 78j–3, 78l, 78m,
78n, 78n–1, 78o, 78u–5, 78w, 78ll, 78 mm,
80a–8, 80a–9, 80a–20, 80a–29, 80a–30, 80a–
31(c), 80a–37, 80a–38(a), 80a–39, 80b–11 and
7201 et seq. 18 U.S.C. 1350; Sec. 953(b), Pub.
L. 111–203, 124 Stat. 1904; Sec. 102(a)(3),
Pub. L. 112–106, 126 Stat. 309; and Sec.
84001, Pub. L. 114–94, 129 Stat. 1312.
*
*
*
§ 229.1100
*
*
[Amended]
2. Amend § 229.1100 in paragraph (a)
by removing ‘‘(§§ 229.1100 through
229.1123)’’ and adding in its place
‘‘(§§ 229.1100 through 229.1125)’’.
■
§ 229.1104
[Amended]
3. Amend § 229.1104 in paragraph
(e)(2) by adding ‘‘in response to Rule
15Ga–1’’ after ‘‘(as that term is defined
in Section 15G(a) of the Securities
Exchange Act of 1934)’’.
■
§ 229.1105
[Amended]
4. Amend § 229.1105 in paragraph
(a)(3)(ii) by removing ‘‘135 days after’’
and adding in its place ‘‘135 days of’’.
■
§ 229.1115
[Amended]
§ 230.456
[Amended]
9. Amend § 230.456 in paragraph
(c)(3) by removing ‘‘post-effective
amendment or’’.
■
PART 239—FORMS PRESCRIBED
UNDER THE SECURITIES ACT OF 1933
10. The authority citation for part 239
continues to read, in part, as follows:
■
Authority: 15 U.S.C. 77c, 77f, 77g, 77h, 77j,
77s, 77z–2, 77z–3, 77sss, 78c, 78l, 78m, 78n,
78o(d), 78o–7 note, 78u–5, 78w(a), 78ll,
78mm, 80a–2(a), 80a–3, 80a–8, 80a–9, 80a–
10, 80a–13, 80a–24, 80a–26, 80a–29, 80a–30,
80a–37, and Sec. 71003 and Sec. 84001, Pub.
L. 114–94, 129 Stat. 1312, unless otherwise
noted.
§ 239.45
[Amended]
11. Amend Form SF–3 (referenced in
§ 239.45) in Note 2 of Notes to the
‘‘Calculation of Registration Fee’’ Table
(‘‘Fee Table’’) by removing ‘‘in a posteffective amendment to the registration
statement or’’.
■
PART 249—FORMS, SECURITIES
EXCHANGE ACT OF 1934
12. The authority citation for part 249
continues to read, in part, as follows:
■
5. Amend § 229.1115 in Instruction 1
to Item 1115 by removing ‘‘, 3 and 5 to
Item 1114’’ and adding in its place ‘‘and
4 to Item 1114(b)’’.
Authority: 15 U.S.C. 78a et seq. and 7201
et seq.; 12 U.S.C. 5461 et seq.; and 18 U.S.C.
1350, unless otherwise noted.
§ 229.1125
*
■
[Amended]
6. Amend Appendix to § 229.1125—
Schedule AL in Item 4(i) and Item 4(j)
by removing all references to ‘‘loan’’ and
adding in their place ‘‘lease’’; and
removing all references to ‘‘loans’’ and
adding in their place ‘‘leases’’.
■
PART 230—GENERAL RULES AND
REGULATIONS, SECURITIES ACT OF
1933
7. The authority citation for part 230
continues to read, in part, as follows:
■
Authority: 15 U.S.C. 77b, 77b note, 77c,
77d, 77d note, 77f, 77g, 77h, 77j, 77r, 77s,
77z–3, 77sss, 78c, 78d, 78j, 78l, 78m, 78n,
78o, 78o–7 note, 78t, 78w, 78ll(d), 78mm,
80a–8, 80a–24, 80a–28, 80a–29, 80a–30, and
80a–37, and Pub. L. 112–106, sec. 201(a), 126
Stat. 313 (2012), unless otherwise noted.
sradovich on DSK3TPTVN1PROD with RULES
*
*
§ 230.405
*
*
*
[Amended]
8. Amend § 230.405 in paragraph (1)(i)
of the definition of an Ineligible issuer,
by removing the phrase ‘‘General
Instruction I.A.4 of Form S–3’’ and
adding in its place ‘‘General Instruction
I.A.2 of Form SF–3’’
■
VerDate Sep<11>2014
16:06 Jun 21, 2016
Jkt 238001
*
§ 249.308
*
*
*
[Amended]
13. Amend Form 8–K (referenced in
§ 249.308) by amending Item 6.05 to
remove ‘‘Form S–3 (17 CFR 239.13)’’
and add in its place ‘‘Form SF–3 (17
CFR 239.45)’’.
■
§ 249.312
[Amended]
14. Amend Form 10–D (referenced in
§ 249.312) by amending Item 1 in Part
I:
■ a. to remove all references to the
phrase ‘‘Item 1121(a) and (b)’’ and
replacing them with the phrase ‘‘Item
1121(a), (b) and (c)’’; and
■ b. to remove the phrase ‘‘17 CFR
229.1121(a) and (b)’’ and add in its
place ‘‘17 CFR 1121(a), (b) and (c)’’.
■
Dated: June 16, 2016.
Brent J. Fields,
Secretary.
[FR Doc. 2016–14730 Filed 6–21–16; 8:45 am]
BILLING CODE 8011–01–P
PO 00000
Frm 00036
Fmt 4700
Sfmt 4700
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.
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 tissuebased 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 https://
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:
SUMMARY:
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
E:\FR\FM\22JNR1.SGM
22JNR1
Federal Register / Vol. 81, No. 120 / Wednesday, June 22, 2016 / Rules and Regulations
C. Purpose and Scope of the Final Rule
(§ 1271.1)
D. Donor Screening (§ 1271.75)
E. Exceptions From the Requirement of
Determining Donor Eligibility (§ 1271.90)
F. Labeling Requirements (§ 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.
sradovich on DSK3TPTVN1PROD with RULES
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) (§ 1271.90(b)) to new
§ 1271.90(c), and would insert a new
§ 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 § 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 § 1271.45(b), or
for deficiencies in performing donor
screening or testing, as required under
§§ 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
VerDate Sep<11>2014
16:06 Jun 21, 2016
Jkt 238001
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
PO 00000
Frm 00037
Fmt 4700
Sfmt 4700
40513
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 TissueBased 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
§ 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
E:\FR\FM\22JNR1.SGM
22JNR1
40514
Federal Register / Vol. 81, No. 120 / Wednesday, June 22, 2016 / Rules and Regulations
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 § 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.
sradovich on DSK3TPTVN1PROD with RULES
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 § 1271.90
Section 1271.90 sets forth exceptions
where HCT/P establishments are not
required to make a donor eligibility
determination under § 1271.50 or to
perform donor screening or testing
under §§ 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
VerDate Sep<11>2014
16:06 Jun 21, 2016
Jkt 238001
subsequently used for directed or
anonymous donation, even when the
donor eligibility requirements under
part 1271, subpart C are not met.
We are amending § 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 § 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 § 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 § 1271.90(a)(3) will read,
‘‘Cryopreserved cells or tissue for
reproductive use, other than embryos,
originally excepted . . . .’’
• Changing current § 1271.90(a)(4) by
replacing ‘‘exempt’’ with ‘‘excepted’’.
• Redesignating current § 1271.90(b)
as § 1271.90(c) and adding a new
paragraph (b) to § 1271.90.
• Changing newly designated
§ 1271.90(c) by removing ‘‘paragraph
(a)’’ and adding in its place ‘‘paragraphs
(a) and (b)’’ in the introductory text,
revising § 1271.90(c)(2) to replace
‘‘(b)(6)’’ with ‘‘(c)(6)’’, and by adding
‘‘recovery or’’ before ‘‘cryopreservation’’
in new § 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
§ 1271.90(b) to § 1271.90(c), and adding
a new § 1271.90(b) entitled ‘‘Exceptions
for reproductive use.’’ Under finalized
§ 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
§ 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
PO 00000
Frm 00038
Fmt 4700
Sfmt 4700
donor or the semen donor as required
under § 1271.45(b), or for deficiencies in
performing donor screening or testing,
as required under §§ 1271.75, 1271.80,
and 1271.85.
We note that the language we are
adding to the exceptions currently listed
in § 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 § 1271.90(c), HCT/P
establishments must prominently label
an HCT/P described in § 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
§ 1271.90(c)(2) clarifies that the labeling
requirements contained in
§ 1271.90(c)(2) do not apply to
reproductive cells or tissue labeled in
accordance with § 1271.90(c)(6). The
change to § 1271.90(c)(6) includes
‘‘recovery or’’ before the word
‘‘cryopreservation’’. Thus, the
§ 1271.90(c)(6) provision requires HCT/
P establishments to prominently label
an HCT/P described in § 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 § 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 § 1271.370
Section 1271.370 sets forth labeling
requirements in addition to those that
apply under §§ 1271.55, 1271.60,
1271.65, and 1271.90. Because, as
discussed previously, this rule
redesignates the current labeling
requirements under § 1271.90(b) to
§ 1271.90(c), we are amending
§ 1271.370(b)(4) to revise the reference
from § 1271.90(b) to § 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
E:\FR\FM\22JNR1.SGM
22JNR1
Federal Register / Vol. 81, No. 120 / Wednesday, June 22, 2016 / Rules and Regulations
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.
sradovich on DSK3TPTVN1PROD with RULES
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
VerDate Sep<11>2014
16:06 Jun 21, 2016
Jkt 238001
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
(§ 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
PO 00000
Frm 00039
Fmt 4700
Sfmt 4700
40515
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 § 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 (§ 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
E:\FR\FM\22JNR1.SGM
22JNR1
40516
Federal Register / Vol. 81, No. 120 / Wednesday, June 22, 2016 / Rules and Regulations
sradovich on DSK3TPTVN1PROD with RULES
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
(§ 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 § 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
§ 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
VerDate Sep<11>2014
16:06 Jun 21, 2016
Jkt 238001
determination for either the oocyte
donor or the semen donor as required
under § 1271.45(b), or for deficiencies in
performing donor screening or testing,
as required under §§ 1271.75, 1271.80,
and 1271.85.
We note that the change we are
making to the exceptions currently
listed in § 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 § 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 § 1271.90(a)(1) in
§ 1271.90(a)(4).
F. Labeling Requirements (§ 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
§ 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
PO 00000
Frm 00040
Fmt 4700
Sfmt 4700
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 § 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 § 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
E:\FR\FM\22JNR1.SGM
22JNR1
sradovich on DSK3TPTVN1PROD with RULES
Federal Register / Vol. 81, No. 120 / Wednesday, June 22, 2016 / Rules and Regulations
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
§ 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 § 1271.45(b), or
for deficiencies in performing donor
screening or testing, as required under
§§ 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
VerDate Sep<11>2014
16:06 Jun 21, 2016
Jkt 238001
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
PO 00000
Frm 00041
Fmt 4700
Sfmt 4700
40517
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
1. The authority citation for part 1271
continues to read as follows:
■
Authority: 42 U.S.C. 216, 243, 263a, 264,
271.
2. In § 1271.90:
a. Revise the heading;
b. Revise paragraph (a)(3) introductory
text;
■ c. Revise paragraph (a)(4);
■ d. Redesignate paragraph (b) as
paragraph (c);
■ e. Add a new paragraph (b);
■ f. Revise newly designated paragraph
(c) introductory text;
■ g. Revise newly designated paragraph
(c)(2); and
■ h. Revise newly designated paragraph
(c)(6).
The revisions and additions read as
follows:
■
■
■
§ 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
E:\FR\FM\22JNR1.SGM
22JNR1
40518
Federal Register / Vol. 81, No. 120 / Wednesday, June 22, 2016 / Rules and Regulations
use under § 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 § 1271.45(b), or
for deficiencies in performing donor
screening or testing, as required under
§§ 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
§§ 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.
§ 1271.370
3. Amend § 1271.370(b)(4) by
removing ‘‘§ 1271.90(b)’’ and by adding
in its place ‘‘§ 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
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9772]
RIN 1545–BN15
Modification of Treatment of Certain
Health Organizations
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations.
sradovich on DSK3TPTVN1PROD with RULES
AGENCY:
This document contains final
regulations that provide guidance to
Blue Cross and Blue Shield
organizations, and certain other
organizations, on computing and
applying the medical loss ratio and the
SUMMARY:
VerDate Sep<11>2014
16:06 Jun 21, 2016
Jkt 238001
consequences for not meeting the
medical loss ratio threshold. The final
regulations reflect the enactment of a
technical correction to section 833(c)(5)
of the Internal Revenue Code by the
Consolidated and Further Continuing
Appropriations Act of 2015. The final
regulations affect Blue Cross and Blue
Shield organizations, and certain other
organizations involved in providing
health insurance.
DATES: Effective Date: These regulations
are effective on June 22, 2016.
Applicability Date: For the date of
applicability, see § 1.833–1(e).
FOR FUTHER INFORMATION CONTACT:
Rebecca L. Baxter, at (202) 317–6995
(not a toll-free number).
SUPPLEMENTARY INFORMATION:
Background
This Treasury decision contains final
regulations that amend 26 CFR part 1
under section 833 of the Internal
Revenue Code (the Code). Section 833(a)
provides that Blue Cross and Blue
Shield organizations, and certain other
organizations involved in providing
health insurance as described in section
833(c), are entitled to: (1) Treatment as
stock insurance companies for purposes
of sections 831 through 835 (related to
taxation of non-life insurance
companies generally); (2) a special
deduction determined under section
833(b); and (3) computation of unearned
premium reserves under section
832(b)(4) based on 100 percent, and not
80 percent, of unearned premiums for
purposes of determining ‘‘insurance
company taxable income’’ under section
832.
Section 833(c)(5) was added to the
Code by section 9016 of the Patient
Protection and Affordable Care Act
(Pub. L. 111–148, 124 Stat. 119) (the
Affordable Care Act), effective for
taxable years beginning after December
31, 2009. Section 833(c)(5), as enacted
by the Affordable Care Act, provided
that section 833 did not apply to any
organization unless the organization’s
medical loss ratio (MLR) for the taxable
year was at least 85 percent. For
purposes of section 833, an
organization’s MLR was its percentage
of total premium revenue expended on
reimbursement for clinical services
provided to enrollees under its policies
during such taxable year (as reported
under section 2718 of the Public Health
Service Act (42 U.S.C. 300gg–18)).
Section 2718 of the Public Health
Service Act (PHSA) was added by
section 1001 and amended by section
10101 of the Affordable Care Act.
Section 2718 of the PHSA is
administered by the Department of
PO 00000
Frm 00042
Fmt 4700
Sfmt 4700
Health and Human Services. Section
2718(a) of the PHSA requires a health
insurance issuer to submit a report for
each plan year to the Secretary of the
Department of Health and Human
Services concerning the percentage of
total premium revenue, after accounting
for collections or receipts for risk
adjustment and risk corridors and
payments of reinsurance, that the issuer
expends: (1) On reimbursement for
clinical services provided to enrollees
under such coverage; (2) for activities
that improve health care quality; and (3)
on all other non-claims costs, excluding
federal and state taxes and licensing or
regulatory fees.
Section 2718(b) of the PHSA requires
that a health insurance issuer offering
group or individual health insurance
coverage, with respect to each plan year,
provide an annual rebate to each
enrollee under such coverage, on a pro
rata basis, if the ratio of the amount of
the premium revenue the issuer
expends on costs for reimbursement for
clinical services provided to enrollees
under such coverage and for activities
that improve health care quality to the
total amount of premium revenue
(excluding federal and state taxes and
licensing or regulatory fees and after
accounting for payments or receipts for
risk adjustment, risk corridors, and
reinsurance under sections 1341, 1342,
and 1343 of the Affordable Care Act (42
U.S.C. 18061, 18062, and 18063)) for the
plan year is less than a prescribed
percentage. Section 2718(b)(1)(B)(ii) of
the PHSA provides that beginning on
January 1, 2014, the medical loss ratio
computed under section 2718(b) of the
PHSA shall be based on expenses and
premium revenues for each of the
previous three years of the plan.
The Department of Health and Human
Services published in the Federal
Register (75 FR 74864) an interim final
rule under section 2718 of the PHSA on
December 1, 2010, an interim final rule
and final rule on December 7, 2011 (76
FR 76596 and 76574), and a final rule
on May 16, 2012 (77 FR 28790). These
rules implementing section 2718 of the
PHSA are codified at 45 CFR part 158
(HHS Regulations).
On December 6, 2010, the Treasury
Department and the IRS published
Notice 2010–79 (2010–49 I.R.B. 809),
which provided interim guidance and
transitional relief to organizations under
section 833(c)(5). The interim guidance
applied to an organization’s first taxable
year beginning after December 31, 2009.
The interim guidance provided that
for purposes of determining whether an
organization’s percentage of total
premium revenue expended on
reimbursement for clinical services
E:\FR\FM\22JNR1.SGM
22JNR1
]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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
