78744 Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Proposed Rules 

documentation that the terms and 

conditions of the adjustment were 

established and known to the customer 

at the time of sale. This rulemaking 

would be effective for proceedings 

initiated on or after 30 days following 

the date of publication of the final rule. 

The Department invites parties to 

comment on this proposed rule and the 

proposed effective date. Further, any 

party may submit comments expressing 

its disagreement with the Department’s 

proposal and may propose an 

alternative approach. 

Classifications 

Executive Order 12866 

It has been determined that this 

proposed rule is not significant for 

purposes of Executive Order 12866. 

Paperwork Reduction Act 

This proposed rule contains no new 

collection of information subject to the 

Paperwork Reduction Act, 44 U.S.C. 

Chapter 35. 

Executive Order 13132 

This proposed rule does not contain 

policies with federalism implications as 

that term is defined in section 1(a) of 

Executive Order 13132, dated August 4, 

1999 (64 FR 43255 (August 10, 1999)). 

Regulatory Flexibility Act 

The Chief Counsel for Regulation has 

certified to the Chief Counsel for 

Advocacy of the Small Business 

Administration under the provisions of 

the Regulatory Flexibility Act, 5 U.S.C. 

605(b), that the proposed rule would not 

have a significant economic impact on 

a substantial number of small business 

entities. A summary of the need for, 

objectives of and legal basis for this rule 

is provided in the preamble, and is not 

repeated here. 

The entities upon which this 

rulemaking could have an impact 

include foreign exporters and 

producers, some of whom are affiliated 

with U.S. companies, and U.S. 

importers. Enforcement & Compliance 

currently does not have information on 

the number of entities that would be 

considered small under the Small 

Business Administration’s size 

standards for small businesses in the 

relevant industries. However, some of 

these entities may be considered small 

entities under the appropriate industry 

size standards. Although this proposed 

rule may indirectly impact small 

entities that are parties to individual 

antidumping duty proceedings, it will 

not have a significant economic impact 

on any entities. 

The proposed action is merely a 

continuation of the Department’s 

practice based on its interpretation of 

current Department regulations. If the 

proposed rule is implemented, no 

entities would be required to undertake 

additional compliance measures or 

expenditures. Rather, the regulations, 

both in their current form and in this 

proposed rulemaking, instruct the 

Department on what adjustments to 

make to export price or constructed 

export price and normal value under 

certain factual scenarios in the course of 

an antidumping duty proceeding. 

Because the proposed rule only impacts 

the way in which the Department makes 

certain calculations in antidumping 

duty proceedings, it does not directly 

impact any business entities. The 

proposed rule merely clarifies the 

regulations to better align with current 

Departmental practices. Therefore, the 

proposed rule would not have a 

significant economic impact on a 

substantial number of small business 

entities. For this reason, an Initial 

Regulatory Flexibility Analysis is not 

required and one has not been prepared. 

List of Subjects in 19 CFR Part 351 

Administrative practice and 

procedure, Antidumping, Business and 

industry, Cheese, Confidential business 

information, Countervailing duties, 

Freedom of information, Investigations, 

Reporting and recordkeeping 

requirements. 

Dated: December 19, 2014. 

Paul Piquado, 

Assistant Secretary for Enforcement and 

Compliance. 

For the reasons stated, 19 CFR part 

351 is proposed to be amended as 

follows: 

PART 351—ANTIDUMPING AND 

COUNTERVAILING DUTIES 

■ 1. The authority citation for 19 CFR 

part 351 continues to read as follows: 

Authority: 5 U.S.C. 301; 19 U.S.C. 1202 

note; 19 U.S.C. 1303 note; 19 U.S.C. 1671 et 

seq.; and 19 U.S.C. 3538. 

■ 2. In § 351.102, revise paragraph 

(b)(38) to read as follows: 

§ 351.102 Definitions. 

* * * * * 

(b) * * * 

(38) Price adjustment. ‘‘Price 

adjustment’’ means a change in the 

price charged for subject merchandise or 

the foreign like product, such as a 

discount or rebate, including, under 

certain circumstances, a change such as 

a discount or rebate that is made after 

the time of sale (see § 351.401(c)), that 

is reflected in the purchaser’s net 

outlay. 

* * * * * 

■ 3. In § 351.401, revise paragraph (c) to 

read as follows: 

§ 351.401 In general. 

* * * * * 

(c) Use of price net of price 

adjustments. In calculating export price, 

constructed export price, and normal 

value (where normal value is based on 

price), the Secretary normally will use 

a price that is net of price adjustments, 

as defined in § 351.102(b), that are 

reasonably attributable to the subject 

merchandise or the foreign like product 

(whichever is applicable). The Secretary 

generally will not consider a price 

adjustment that reduces or eliminates a 

dumping margin unless the party 

claiming such price adjustment 

demonstrates, to the satisfaction of the 

Secretary, through documentation that 

the terms and conditions of the 

adjustment were established and known 

to the customer at the time of sale. 

* * * * * 

[FR Doc. 2014–30664 Filed 12–30–14; 8:45 am] 

BILLING CODE 3510–DS–P 

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. 

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 tissuebased 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: 


tkelley on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Proposed Rules 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) (§ 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 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 TissueBased Products; Donor Screening and 


tkelley on DSK3SPTVN1PROD with PROPOSALS
78746 Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Proposed Rules 

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 

§ 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 § 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 (§ 1271.45(c)) 

based on the results of donor screening 

(§ 1271.75) and testing (§§ 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 

(§ 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 

§ 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 § 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 § 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 

§ 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 § 1271.45(b), or for 

deficiencies in performing donor 

screening or testing, as required under 

§§ 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 (§ 1271.75) and testing 

(§§ 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. 


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Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Proposed Rules 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 § 1271.90(b) even when 

the donor eligibility requirements under 

part 1271, subpart C are not met. 

Specifically, under proposed 

§ 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 

§ 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 § 1271.90(b). For this reason, 

proposed § 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 § 1271.45(b), or for 

deficiencies in performing donor 

screening or testing, as required under 

§§ 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 § 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 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 § 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 § 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 § 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 

§ 1271.90(a)(3) would read, 

‘‘Cryopreserved cells or tissues for 

reproductive use, other than embryos, 

originally excepted. . . .’’ 

• Changing current § 1271.90(a)(4) by 

replacing ‘‘exempt’’ with ‘‘excepted,’’ 

and by adding ‘‘(a)(1) and’’ before 

‘‘(a)(2)’’ to clarify that as proposed, 

§ 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, § 1271.90(a)(4) 

would read, ‘‘A cryopreserved embryo, 

originally excepted under paragraphs 

(a)(1) and (a)(2). . . .’’ 

• 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 adding ‘‘and (b)’’ after 

‘‘(a)’’ 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, not just before 

cryopreservation. 

B. Proposed § 1271.90(b) 

We are proposing to redesignate the 

current § 1271.90(b) to § 1271.90(c), and 

insert a new § 1271.90(b) entitled 

‘‘Exceptions for Reproductive Use.’’ 

Under proposed § 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 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 § 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 

proposing to add 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. 

C. Proposed § 1271.90(c) 

Under proposed § 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 § 1271.90(c)(2) would clarify 

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 

proposed change to § 1271.90(c)(6) 

would include ‘‘recovery or’’ before the 

word ‘‘cryopreservation’’. Thus, the 


tkelley on DSK3SPTVN1PROD with PROPOSALS
78748 Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Proposed Rules 

proposed § 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 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 § 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 is 

proposing to redesignate the current 

labeling requirements under 

§ 1271.90(b) to § 1271.90(c), we are 

proposing to amend § 1271.370(b)(4) to 

revise the reference from § 1271.90(b) to 

§ 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 § 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 § 1271.45(b), or for deficiencies in 

performing donor screening or testing, 

as required under §§ 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’’ 


tkelley on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Proposed Rules 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 

■ 1. The authority citation for 21 CFR 

part 1271 continues to read as follows: 

Authority: 42 U.S.C. 216, 243, 263a, 264, 

271. 

■ 2. In § 1271.90: 

■ a. Revise the heading; 

■ b. Revise paragraphs (a)(3) and (a)(4) 

by removing ‘‘exempt’’ and by adding in 

its place ‘‘excepted’’; 

■ c. Revise paragraph (a)(4) by removing 

‘‘paragraph’’ and by adding in its place 

‘‘paragraphs ’’; and by adding ‘‘(a)(1) 

and’’ before ‘‘(a)(2)’’; 

■ d. Redesignate paragraph (b) as 

paragraph (c); 

■ e. Add a new paragraph (b); 

■ 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; 

■ g. Revise newly designated paragraph 

(c)(2) by removing ‘‘(b)(6)’’ and by 

adding in its place ‘‘(c)(6)’’; and 

■ h. Revise newly designated paragraph 

(c)(6) by adding ‘‘recovery or’’ before 

‘‘cryopreservation’’. 

The revisions 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 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 § 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 § 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: 

(1) * * * 

(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. 

* * * * * 

■ 3. Amend § 1271.370(b)(4) by 

removing ‘‘§ 1271.90(b)’’ and by adding 

in its place ‘‘§ 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 

DEPARTMENT OF LABOR 

Mine Safety and Health Administration 

30 CFR Part 100 

[Docket No. MSHA–2014–0009] 

RIN 1219–AB72 

Criteria and Procedures for 

Assessment of Civil Penalties 

AGENCY: Mine Safety and Health 

Administration, Labor. 

ACTION: Proposed rule; notice of public 

hearings; extension of comment period; 

close of record. 

SUMMARY: The Mine Safety and Health 

Administration (MSHA) will hold two 

additional public hearings on the 

Agency’s proposed rule for Criteria and 

Procedures for Assessment of Civil 

Penalties. 

DATES: MSHA will hold public hearings 

on February 5, 2015, and February 12, 

2015, at the locations listed in the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Post-hearing comments must be 

received or postmarked by midnight 

Eastern Standard Time on March 12, 

2015. 

ADDRESSES: Submit comments, 

informational materials, and requests to 

speak, identified by RIN 1219–AB72 or 

Docket No. MSHA–2014–0009, by one 

of the following methods: 

• Federal E-Rulemaking Portal: 

http://www.regulations.gov. Follow the 

on-line instructions for submitting 

comments. 

• E-Mail: zzMSHA-comments@

dol.gov. Include RIN 1219–AB72 or 

Docket No. MSHA–2014–0009 in the 

subject line of the message. 

• Mail: MSHA, Office of Standards, 

Regulations, and Variances, 1100 

Wilson Boulevard, Room 2350, 

Arlington, Virginia 22209–3939. 

• Hand Delivery or Courier: MSHA, 

1100 Wilson Boulevard, Room 2350, 

Arlington, Virginia, between 9:00 a.m. 

and 5:00 p.m., Monday through Friday, 


tkelley on DSK3SPTVN1PROD with PROPOSALS