Revisions to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products, 78744-78749 [2014-30528]

Download as PDF 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. tkelley on DSK3SPTVN1PROD with PROPOSALS 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 VerDate Sep<11>2014 16:21 Dec 30, 2014 Jkt 235001 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 PO 00000 Frm 00019 Fmt 4702 Sfmt 4702 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. 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: SUMMARY: E:\FR\FM\31DEP1.SGM 31DEP1 Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Proposed Rules 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 tkelley on DSK3SPTVN1PROD with PROPOSALS 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 VerDate Sep<11>2014 16:21 Dec 30, 2014 Jkt 235001 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 PO 00000 Frm 00020 Fmt 4702 Sfmt 4702 78745 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 E:\FR\FM\31DEP1.SGM 31DEP1 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. tkelley on DSK3SPTVN1PROD with PROPOSALS 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 VerDate Sep<11>2014 16:21 Dec 30, 2014 Jkt 235001 (§ 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 PO 00000 Frm 00021 Fmt 4702 Sfmt 4702 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. E:\FR\FM\31DEP1.SGM 31DEP1 Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS 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 VerDate Sep<11>2014 16:21 Dec 30, 2014 Jkt 235001 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 PO 00000 Frm 00022 Fmt 4702 Sfmt 4702 78747 § 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 E:\FR\FM\31DEP1.SGM 31DEP1 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. tkelley on DSK3SPTVN1PROD with PROPOSALS 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. VerDate Sep<11>2014 17:18 Dec 30, 2014 Jkt 235001 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 PO 00000 Frm 00023 Fmt 4702 Sfmt 4702 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’’ E:\FR\FM\31DEP1.SGM 31DEP1 Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Proposed Rules 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; tkelley on DSK3SPTVN1PROD with PROPOSALS ■ ■ ■ VerDate Sep<11>2014 16:21 Dec 30, 2014 Jkt 235001 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 PO 00000 Frm 00024 Fmt 4702 Sfmt 4702 78749 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 Mine Safety and Health Administration, Labor. ACTION: Proposed rule; notice of public hearings; extension of comment period; close of record. AGENCY: 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. SUMMARY: 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. DATES: 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, ADDRESSES: E:\FR\FM\31DEP1.SGM 31DEP1

Agencies

[Federal Register Volume 79, Number 250 (Wednesday, December 31, 2014)]
[Proposed Rules]
[Pages 78744-78749]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30528]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

[Docket No. FDA-2014-N-1484]


Revisions to Exceptions Applicable to Certain Human Cells, 
Tissues, and Cellular and Tissue-Based Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing 
this proposed rule to amend certain regulations regarding donor 
eligibility, including the screening and testing of donors of 
particular human cells, tissues, and cellular and tissue-based products 
(HCT/Ps), and related labeling. FDA is proposing this action in 
response to our enhanced understanding in this area and in response to 
comments from stakeholders regarding the importance of embryos to 
individuals and couples seeking access to donated embryos.

DATES: Submit either electronic or written comments on the proposed 
rule by March 31, 2015.

ADDRESSES: You may submit comments by any of the following methods:

[[Page 78745]]

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
FDA-2014-N-1484 for this rulemaking. All comments received may be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Melissa Segal, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION: 

Executive Summary

Purpose of the Regulatory Action

    FDA is issuing this proposed rule to amend certain regulations 
regarding donor eligibility, including the screening and testing of 
donors of particular HCT/Ps, and related labeling. We are proposing 
these changes in response to our enhanced understanding in this area 
and in response to comments from stakeholders regarding the importance 
of embryos to individuals and couples seeking access to donated 
embryos.
    FDA is proposing this rulemaking under the authority of section 361 
of the Public Health Service Act (PHS Act) (42 U.S.C. 264). Under 
section 361 of the PHS Act, FDA may issue and enforce regulations 
necessary to prevent the introduction, transmission, or spread of 
communicable disease between the States or from foreign countries into 
the States.

Summary of the Major Provisions of the Regulatory Action

    FDA is proposing to amend existing regulations to provide 
additional flexibility to HCT/P establishments to make available for 
reproductive use embryos originally intended for reproductive use for a 
specific individual or couple when those embryos are subsequently 
intended for directed or anonymous donation. Specifically, this 
proposed rulemaking would redesignate the current Title 21 of the Code 
of Federal Regulations (CFR) 1271.90(b) (Sec.  1271.90(b)) to new Sec.  
1271.90(c), and would insert a new Sec.  1271.90(b) entitled 
``Exceptions for Reproductive Use'' to clarify that if an embryo was 
originally intended for reproductive use for a specific individual or 
couple, its use for directed or anonymous donation, would not be 
prohibited under Sec.  1271.45(c), even when the applicable donor 
eligibility requirements under part 1271, subpart C, are not met. FDA 
also clarifies that we are not creating an exception for deficiencies 
that occurred in making the donor eligibility determination for either 
the oocyte donor or the semen donor as required under Sec.  1271.45(b), 
or for deficiencies in performing donor screening or testing, as 
required under Sec. Sec.  1271.75, 1271.80, and 1271.85.
    The proposed rule also would require appropriate labeling for 
embryos that would describe the donor eligibility status of the 
individual donors whose gametes were used to form the embryo. The 
content of the labeling is not different from that required under 
current regulations. Consistent with current regulations, the intent of 
the proposed labeling is to help ensure that physicians have specific 
and accurate information to provide to recipients for use in making 
informed medical decisions.

Costs and Benefits

    The proposed rule would ensure that any related costs and burdens 
are kept to a minimum.

I. Background

    Under the authority of section 361 of the PHS Act, by delegation 
from the Surgeon General and the Secretary of Health and Human 
Services, FDA may make and enforce regulations necessary to prevent the 
introduction, transmission, or spread of communicable diseases. 
Communicable diseases include, but are not limited to, those 
transmitted by viruses, bacteria, fungi, parasites, and transmissible 
spongiform encephalopathy agents. Certain diseases are transmissible 
through implantation, transplantation, infusion, or transfer of HCT/Ps 
derived from donors infected with those diseases. To prevent the 
introduction, transmission, or spread of such communicable diseases, we 
consider it necessary to require establishments to take appropriate 
measures to prevent the use of cells or tissues from infected donors. 
FDA regulates HCT/Ps intended for implantation, transplantation, 
infusion, or transfer into a human recipient under part 1271 that was 
issued under the authority of section 361 of the PHS Act. Part 1271 
requires HCT/P establishments to screen and test donors for relevant 
communicable disease agents and diseases, to prepare and follow written 
standard operating procedures for the prevention of the spread of 
communicable diseases, and to maintain records. Part 1271 also requires 
that for most HCT/Ps, the cell or tissue donor must be determined to be 
eligible, based on the results of screening and testing for relevant 
communicable disease agents and diseases. In most cases, a donor who 
tests reactive for a particular communicable disease, or who possesses 
clinical evidence of, or risk factors for, communicable disease agents 
and diseases, would be considered ineligible, and cells or tissues from 
that donor would not ordinarily be used.
    FDA has published three final rules that make up part 1271. In the 
Federal Register of January 19, 2001 (66 FR 5447), FDA published 
regulations requiring HCT/P establishments to register and list their 
HCT/Ps with FDA (registration final rule). In the Federal Register of 
May 25, 2004 (69 FR 29786), we published regulations requiring most 
cell and tissue donors to be tested and screened for relevant 
communicable disease agents and diseases (donor eligibility final 
rule). In the Federal Register of November 24, 2004 (69 FR 68612), we 
published regulations requiring HCT/P establishments to follow current 
good tissue practice (CGTP), which governs the methods used in, and the 
facilities and controls used for, the manufacture of HCT/Ps, 
recordkeeping, and the establishment of a quality program (CGTP final 
rule). These regulations apply to HCT/Ps recovered on or after May 25, 
2005.
    As part of our ongoing effort to implement our framework for 
regulating HCT/Ps, in the Federal Register of May 25, 2005 (70 FR 
29949), we issued an interim final rule entitled ``Human Cells, 
Tissues, and Cellular and Tissue-Based Products; Donor Screening and

[[Page 78746]]

Testing, and Related Labeling'' (2005 interim final rule), which had an 
effective date simultaneous with publication. This interim final rule 
was then adopted without change in the Federal Register of June 19, 
2007, in the final rule entitled ``Human Cells, Tissues, and Cellular 
and Tissue-Based Products; Donor Screening and Testing, and Related 
Labeling'' (72 FR 33667) (2007 final rule). The 2007 final rule amended 
regulations regarding the screening and testing of donors of HCT/Ps, 
timing of specimen collection, record retention requirements, and 
related labeling requirements in response to public comments concerning 
the importance of cryopreserved embryos to individuals seeking access 
to donated embryos. The 2007 final rule also added an exception to the 
donor eligibility requirements in Sec.  1271.90(a)(4) for cryopreserved 
embryos that, while originally exempt from the donor eligibility 
requirements because the donors were sexually intimate partners, are 
later intended for directed or anonymous donation.
    In recent years, industry and the medical community have raised 
concerns that the current regulations restrict the use of embryos that 
were intended for personal reproductive use and therefore impose 
limitations on individuals and couples involved in family building. In 
response to these concerns, we are proposing this rulemaking to clarify 
and further develop the current exceptions to the donor eligibility 
requirements. If finalized, the proposed rule will provide HCT/P 
establishments with the flexibility to make available any embryos 
originally formed for reproductive use for a specific individual or 
couple and now intended for reproductive use, provided that specific 
criteria are met, including requirements for labeling.

II. Description of the Proposed Rule

    The proposed rule is intended to allow the use of all embryos for 
reproductive use by expanding the current exceptions to the prohibition 
on use under Sec.  1271.90. This proposal is in response to our 
enhanced understanding in this area and to increase the options for 
individuals and couples seeking access to these HCT/Ps.

A. Current Exceptions to Prohibition on Use

    As set forth in the donor eligibility final rule, an HCT/P must not 
be implanted, transplanted, infused, or transferred until the donor has 
been determined to be eligible (Sec.  1271.45(c)) based on the results 
of donor screening (Sec.  1271.75) and testing (Sec. Sec.  1271.80 and 
1271.85) for relevant communicable disease agents and diseases. These 
donor eligibility requirements apply to all donors of HCT/Ps, including 
donors of reproductive cells or tissues. In the case of an embryo or of 
cells derived from an embryo, a donor eligibility determination is 
required for both the oocyte donor and the semen donor (Sec.  
1271.45(b)).
    Section 1271.90(a) contains exceptions from the requirement of 
determining donor eligibility for the following HCT/Ps: (1) Cells and 
tissues for autologous use; (2) reproductive cells or tissue donated by 
a sexually intimate partner of the recipient for reproductive use; (3) 
cryopreserved cells or tissues for reproductive use that are for 
autologous use or donated by a sexually intimate partner and are 
subsequently intended for directed donation; and (4) a cryopreserved 
embryo that is formed from gametes of sexually intimate partners and is 
subsequently intended for directed or anonymous donation.
    The 2007 final rule added the Sec.  1271.90(a)(4) exception to 
allow for directed or anonymous donation of cryopreserved embryos 
originally intended for use by a sexually intimate partner, without the 
need for a donor eligibility determination. This exception addresses 
the situation where sexually intimate partners who were not screened 
and tested at the time of cryopreservation of their embryos later wish 
to make a directed or anonymous donation of their cryopreserved 
embryos. As explained in the preamble to the 2005 interim final rule, 
we recognize that because the embryos were intended for use in a 
sexually intimate relationship, the donors would not have been required 
to be screened and tested for communicable disease agents and diseases 
at the time that the oocytes and semen were recovered. While the 2005 
interim final rule recommended that appropriate measures be taken to 
screen and test the semen and oocyte donors before transfer of the 
embryo to a recipient, the rule also specifically stated that ``[I]f 
screening and testing of the semen and oocyte donors are not performed, 
this rule would not prohibit the transfer of the embryo into a 
recipient'' (70 FR 29949 at 29951).
    The Agency provided additional guidance on this point in the 
guidance entitled, ``Guidance for Industry: Eligibility Determination 
for Donors of Human Cells, Tissues, and Cellular and Tissue-Based 
Products (HCT/Ps)'' dated August 2007. The guidance states that, as in 
other cases involving directed donations of reproductive tissue, the 
regulatory language in Sec.  1271.90(a)(4) allows for the use of 
embryos from a directed, ineligible donor. In the guidance, FDA also 
clarified that we intend to apply this policy to a sexually intimate 
couple's cryopreserved embryos where one of the gametes is from a 
qualified (i.e., eligible) third party gamete donor, and the other 
gamete is from the sexually intimate partner of the intended recipient. 
As specifically stated in the guidance in section VIII.A, ``. . . 
although FDA requires appropriate screening and testing when possible, 
if appropriate screening and testing are not possible (e.g., because 
one of the donors is unavailable), you may still transfer the embryo 
into a recipient.'' In this proposed rulemaking, our intent is to 
expand this exception beyond the current exception in Sec.  1271.90(a) 
for reproductive cells or tissue donated by a sexually intimate partner 
of the recipient for reproductive use. Under this proposed rule, an 
embryo, originally intended for reproductive use for a specific 
individual or couple, may be subsequently used for directed or 
anonymous donation even when the applicable donor eligibility 
requirements under part 1271, subpart C are not met. As stated in the 
new Sec.  1271.90(b), nothing in this paragraph creates an exception 
for deficiencies that occurred in making the donor eligibility 
determination for either the oocyte donor or the semen donor as 
required under Sec.  1271.45(b), or for deficiencies in performing 
donor screening or testing, as required under Sec. Sec.  1271.75, 
1271.80, and 1271.85.

B. Continued Obligations Under HCT/P Regulations

    As discussed previously, this proposed rule would clarify and 
further develop the current exceptions to the prohibition on use and 
provide greater accommodation to individuals and couples wanting access 
to embryos intended for reproductive use, while continuing to emphasize 
the applicability of the donor eligibility screening and testing 
requirements for individual gamete donors. FDA reminds industry of its 
continued obligations under part 1271, subpart C to determine donor 
eligibility based on the results of donor screening (Sec.  1271.75) and 
testing (Sec. Sec.  1271.80 and 1271.85). Establishments must also 
continue to comply with part 1271 requirements applicable to 
reproductive HCT/Ps to prevent the introduction, transmission, or 
spread of communicable disease.

[[Page 78747]]

C. Labeling Requirements

    This proposed rule describes the continued applicability of 
labeling requirements for embryos intended for reproductive use that 
would be excepted from the prohibition on use. This proposed rule would 
require prominent labeling that describes the donor eligibility status 
of the individual donors whose gametes were used to form the embryo. 
The required labeling would provide information to the treating 
physician to permit discussion of the potential risks of communicable 
diseases with the recipient. We expect that a recipient would be fully 
informed of the risks involved in using an embryo for reproductive 
purposes as described under proposed Sec.  1271.90(b) even when the 
donor eligibility requirements under part 1271, subpart C are not met.
    Specifically, under proposed Sec.  1271.90(c)(2) through (c)(6), an 
embryo originally intended for reproductive use for a specific 
individual or couple that is subsequently intended for directed or 
anonymous donation must be prominently labeled with the following 
statements as they are applicable:
     ``NOT EVALUATED FOR INFECTIOUS SUBSTANCES'';
     ``WARNING: Advise recipient of communicable disease 
risk'';
     the BIOHAZARD legend shown in Sec.  1271.3(h);
     ``WARNING: Reactive test results for (name of disease 
agent or disease)'';
     ``Advise recipient that screening and testing of the 
donor(s) were not performed at the time of recovery or cryopreservation 
of the reproductive cells or tissue, but have been performed 
subsequently.''
    The proposed labeling requirements are based on the expectation 
that a physician will be closely involved in the decision to use an 
embryo and the recognition that physicians are under legal and ethical 
obligations that require them to discuss the risks of communicable 
disease transmission stemming from the use of HCT/Ps. FDA relies on 
physicians to meet these obligations when discussing procedures 
involving HCT/Ps with recipients. FDA expects that HCT/P establishments 
will take appropriate measures to screen and test the semen and oocyte 
donor(s) before making available for reproductive use the embryo 
excepted under proposed Sec.  1271.90(b). For this reason, proposed 
Sec.  1271.90(b) also specifically states that ``[N]othing in this 
paragraph creates an exception for deficiencies that occurred in making 
the donor eligibility determination for either the oocyte donor or the 
semen donor as required under Sec.  1271.45(b), or for deficiencies in 
performing donor screening or testing, as required under Sec. Sec.  
1271.75, 1271.80, and 1271.85.''

III. Proposed Revisions to FDA Regulations

    We are proposing revisions to the following FDA regulations:

A. Proposed Amendments to Sec.  1271.90

    Section 1271.90 sets forth exceptions where HCT/P establishments 
are not required to make a donor eligibility determination under Sec.  
1271.50 or to perform donor screening or testing under Sec. Sec.  
1271.75, 1271.80, and 1271.85. We are proposing to add language to the 
exceptions listed in this section to provide clarity and update the 
regulation by allowing for an embryo originally intended for 
reproductive use for a specific individual or couple, to be 
subsequently used for directed or anonymous donation, even when the 
donor eligibility requirements under part 1271, subpart C are not met.
    We are proposing to amend Sec.  1271.90 as follows:
     Changing the heading of this section by deleting ``from 
the requirement of determining donor eligibility,'' and inserting 
``other'' before ``exceptions.'' If this change is finalized, the 
heading for Sec.  1271.90 would read ``Are there other exceptions and 
what labeling requirements apply?'' We made this change for clarity; 
the new heading would be more accurate.
     Changing Sec.  1271.90(a)(3) by replacing ``exempt'' with 
``excepted,'' which is the term used in the introductory title for this 
provision. Thus, this change would make the language more consistent. 
If this change is finalized, the beginning of Sec.  1271.90(a)(3) would 
read, ``Cryopreserved cells or tissues for reproductive use, other than 
embryos, originally excepted. . . .''
     Changing current Sec.  1271.90(a)(4) by replacing 
``exempt'' with ``excepted,'' and by adding ``(a)(1) and'' before 
``(a)(2)'' to clarify that as proposed, Sec.  1271.90(a)(4) would refer 
to a cryopreserved embryo formed for autologous use and the 
reproductive cells or tissue were donated by a sexually intimate 
partner of the recipient for reproductive use. If this change is 
finalized, Sec.  1271.90(a)(4) would read, ``A cryopreserved embryo, 
originally excepted under paragraphs (a)(1) and (a)(2). . . .''
     Redesignating current Sec.  1271.90(b) as Sec.  1271.90(c) 
and adding a new paragraph (b) to Sec.  1271.90.
     Changing newly designated Sec.  1271.90(c) by adding ``and 
(b)'' after ``(a)'' in the introductory text, revising Sec.  
1271.90(c)(2) to replace ``(b)(6)'' with ``(c)(6)'', and by adding 
``recovery or'' before ``cryopreservation'' in new Sec.  1271.90(c)(6) 
to clarify that some testing and screening activities may take place 
before recovery, not just before cryopreservation.

B. Proposed Sec.  1271.90(b)

    We are proposing to redesignate the current Sec.  1271.90(b) to 
Sec.  1271.90(c), and insert a new Sec.  1271.90(b) entitled 
``Exceptions for Reproductive Use.'' Under proposed Sec.  1271.90(b), 
an embryo originally intended for reproductive use for a specific 
individual or couple that is subsequently intended for directed or 
anonymous donation is excepted from the prohibition on use under Sec.  
1271.45(c) even when the applicable donor eligibility requirements 
under part 1271, subpart C are not met. Accordingly, when an 
establishment fails to comply with applicable donor eligibility 
requirements under part 1271, subpart C, the establishment would not be 
prohibited from making available for reproductive use such embryos for 
reproductive purposes in accordance with this section. The proposed 
exception from the prohibition on use does not create an exception for 
deficiencies that occurred in making the donor eligibility 
determination for either the oocyte donor or the semen donor as 
required under Sec.  1271.45(b), or for deficiencies in performing 
donor screening or testing, as required under Sec. Sec.  1271.75, 
1271.80, and 1271.85.
    We note that the language we are proposing to add to the exceptions 
currently listed in Sec.  1271.90 is additive. It creates an additional 
exception for the use of certain reproductive HCT/Ps that are not 
currently excepted, but it does not impact or restrict the exceptions 
currently provided for in the regulations.

C. Proposed Sec.  1271.90(c)

    Under proposed Sec.  1271.90(c), HCT/P establishments must 
prominently label an HCT/P described in paragraphs (a) and (b) of this 
section as required in paragraph (c). The labeling requirements are 
intended to help ensure that physicians have specific and accurate 
information to provide to recipients for use in making informed medical 
decisions.
    If finalized, the nonsubstantive change to Sec.  1271.90(c)(2) 
would clarify that the labeling requirements contained in Sec.  
1271.90(c)(2) do not apply to reproductive cells or tissue labeled in 
accordance with Sec.  1271.90(c)(6). The proposed change to Sec.  
1271.90(c)(6) would include ``recovery or'' before the word 
``cryopreservation''. Thus, the

[[Page 78748]]

proposed Sec.  1271.90(c)(6) provision requires HCT/P establishments to 
prominently label an HCT/P described in Sec.  1271.90(a)(3) or (a)(4) 
with ``Advise recipient that screening and testing of the donor(s) were 
not performed at the time of recovery or cryopreservation of the 
reproductive cells or tissue, but have been performed subsequently'' 
for HCT/Ps described in Sec.  1271.90(a)(3) or (a)(4). This proposed 
change is made to recognize that some testing and screening activities 
may take place even before recovery of HCT/Ps, not just before 
cryopreservation.

D. Proposed Amendments to Sec.  1271.370

    Section 1271.370 sets forth labeling requirements in addition to 
those that apply under Sec. Sec.  1271.55, 1271.60, 1271.65, and 
1271.90. Because, as discussed previously, this rule is proposing to 
redesignate the current labeling requirements under Sec.  1271.90(b) to 
Sec.  1271.90(c), we are proposing to amend Sec.  1271.370(b)(4) to 
revise the reference from Sec.  1271.90(b) to Sec.  1271.90(c).

IV. Legal Authority

    FDA is proposing this rulemaking under the authority of section 361 
of the PHS Act. Under section 361 of the PHS Act, FDA may issue and 
enforce regulations necessary to prevent the introduction, 
transmission, or spread of communicable disease between the States or 
from foreign countries into the States. It is important to recognize 
that HCT/Ps recovered in one State may be sent to another for 
processing, and then shipped for use throughout the United States, or 
beyond. FDA has been involved in many recalls where HCT/Ps processed in 
a single establishment have been distributed in many States. In any 
event, intrastate transactions affecting interstate communicable 
disease transmission may also be regulated under section 361 of the PHS 
Act. (See Louisiana v. Mathews, 427 F. Supp. 174, 176 (E.D. La. 1977); 
Independent Turtle Farmers of Louisiana, Inc. v. United States of 
America, et al., 2010 U.S. Dist. LEXIS 31117). This rulemaking proposes 
changes in response to our enhanced understanding of the uses of 
certain types of HCT/Ps in specific situations and in response to 
comments from stakeholders regarding the importance of embryos to 
individuals and couples seeking access to donated embryos.

V. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). This proposed rule is not a significant regulatory action as 
defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the costs associated with this rule are 
expected to be minimal, we propose to certify that this rule will not 
have a significant economic impact on a substantial number of small 
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $141 million, using the most current (2013) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
proposed rule to result in a 1-year expenditure that would meet or 
exceed this amount.
    This rule proposes to amend certain regulations regarding donor 
eligibility and labeling related to the screening and testing of donors 
of particular HCT/Ps. The proposed rule would provide additional 
flexibility to HCT/P establishments to make available for reproductive 
use embryos originally intended for reproductive use for a specific 
individual or couple and subsequently intended for directed or 
anonymous donation. Specifically, the proposed rule would clarify that 
if an embryo was originally intended for reproductive use for a 
specific individual or couple, its use for directed or anonymous 
donation would not be prohibited under Sec.  1271.45(c), even when the 
applicable donor eligibility requirements under part 1271, subpart C 
are not met. This proposed exception from prohibition for use would not 
create an exception for deficiencies that occurred in making the donor 
eligibility determination for either the oocyte donor or the semen 
donor as required under Sec.  1271.45(b), or for deficiencies in 
performing donor screening or testing, as required under Sec. Sec.  
1271.75, 1271.80, and 1271.85. The proposed rule also requires 
appropriate labeling that describes the donor eligibility status of the 
individual donors whose gametes were used to form the embryo.
    This rule will provide greater accommodation of individuals and 
couples wanting access to embryos originally intended for reproductive 
use, while continuing to emphasize the applicability of the donor 
eligibility screening and testing requirements for individual gamete 
donors. If finalized, the proposed rule will provide HCT/P 
establishments with the flexibility to make available embryos 
originally intended for reproductive use, provided that specific 
criteria are met. Consistent with current regulations, the proposed 
labeling requirements will help ensure that physicians have specific 
and accurate information to provide to recipients for use in making 
informed medical decisions. Because this proposed rule would impose no 
additional regulatory burdens, the costs associated with this rule are 
expected to be minimal. FDA requests comment on this conclusion.

VI. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VII. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed rule, if finalized, would not contain policies that have 
substantial direct effects on the States, on the relationship between 
the National Government and the States, or on the distribution of power 
and responsibilities among the various levels of government. 
Accordingly, the Agency tentatively concludes that the proposed rule 
does not contain policies that have federalism implications as defined 
in the Executive order and, consequently, a federalism summary impact 
statement is not required.

VIII. The Paperwork Reduction Act of 1995

    The labeling requirements contained in this proposed rule are not 
subject to review by the Office of Management and Budget (OMB) because 
they do not constitute a ``collection of information''

[[Page 78749]]

under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). Rather, the requirement to label HCT/Ps in accordance with the 
proposed rule is a ``public disclosure of information originally 
supplied by the Federal government to the recipient for the purpose of 
disclosure to the public'' (5 CFR 1320.3(c)(2)). Therefore, FDA 
tentatively concludes that these proposed requirements in this document 
are not subject to review by OMB because they do not constitute a 
``collection of information'' under the PRA.

IX. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

List of Subjects in 21 CFR Part 1271

    Biologics, Drugs, Human cells and tissue-based products, Medical 
devices, Reporting and recordkeeping requirements.

    Therefore, under the Public Health Service Act and under the 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 1271 be amended as follows:

PART 1271--HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED 
PRODUCTS

0
1. The authority citation for 21 CFR part 1271 continues to read as 
follows:

    Authority: 42 U.S.C. 216, 243, 263a, 264, 271.

0
2. In Sec.  1271.90:
0
a. Revise the heading;
0
b. Revise paragraphs (a)(3) and (a)(4) by removing ``exempt'' and by 
adding in its place ``excepted'';
0
c. Revise paragraph (a)(4) by removing ``paragraph'' and by adding in 
its place ``paragraphs ''; and by adding ``(a)(1) and'' before 
``(a)(2)'';
0
d. Redesignate paragraph (b) as paragraph (c);
0
e. Add a new paragraph (b);
0
f. Revise newly designated paragraph (c) by removing ``paragraph'' and 
by adding in its place ``paragraphs'' and by adding ``and (b)'' after 
``(a)'' in the introductory text;
0
g. Revise newly designated paragraph (c)(2) by removing ``(b)(6)'' and 
by adding in its place ``(c)(6)''; and
0
h. Revise newly designated paragraph (c)(6) by adding ``recovery or'' 
before ``cryopreservation''.
    The revisions read as follows:


Sec.  1271.90  Are there other exceptions and what labeling 
requirements apply?

    (a) * * *
    (3) Cryopreserved cells or tissue for reproductive use, other than 
embryos, originally excepted under paragraphs (a)(1) or (a)(2) of this 
section at the time of donation, that are subsequently intended for 
directed donation, provided that
* * * * *
    (4) A cryopreserved embryo, originally excepted under paragraphs 
(a)(1) and (a)(2) of this section at the time of cryopreservation, that 
is subsequently intended for directed or anonymous donation. When 
possible, appropriate measures should be taken to screen and test the 
semen and oocyte donors before transfer of the embryo to the recipient.
    (b) Exceptions for Reproductive Use. An embryo originally intended 
for reproductive use for a specific individual or couple that is 
subsequently intended for directed or anonymous donation for 
reproductive use is excepted from the prohibition on use under Sec.  
1271.45(c) even when the applicable donor eligibility requirements 
under part 1271, subpart C are not met. Nothing in this paragraph 
creates an exception for deficiencies that occurred in making the donor 
eligibility determination for either the oocyte donor or the semen 
donor as required under Sec.  1271.45(b), or for deficiencies in 
performing donor screening or testing, as required under Sec. Sec.  
1271.75, 1271.80, and 1271.85.
    (c) Required labeling. As applicable, you must prominently label an 
HCT/P described in paragraphs (a) and (b) of this section as follows:
    (1) * * *
    (2) ``NOT EVALUATED FOR INFECTIOUS SUBSTANCES,'' unless you have 
performed all otherwise applicable screening and testing under 
Sec. Sec.  1271.75, 1271.80, and 1271.85. This paragraph does not apply 
to reproductive cells or tissue labeled in accordance with paragraph 
(c)(6) of this section.
* * * * *
    (6) ``Advise recipient that screening and testing of the donor(s) 
were not performed at the time of recovery or cryopreservation of the 
reproductive cells or tissue, but have been performed subsequently,'' 
for paragraphs (a)(3) or (a)(4) of this section.
* * * * *
0
3. Amend Sec.  1271.370(b)(4) by removing ``Sec.  1271.90(b)'' and by 
adding in its place ``Sec.  1271.90(c)''.

    Dated: December 23, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30528 Filed 12-30-14; 8:45 am]
BILLING CODE 4164-01-P