81 FR 51921 - Request for Public Comment on the Proposed Changes to the NIH Guidelines for Human Stem Cell Research and the Proposed Scope of an NIH Steering Committee's Consideration of Certain Human-Animal Chimera Research

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 151 (August 5, 2016)

The National Institutes of Health (NIH) is requesting public comment on a proposal to amend Section IV and Section V of the NIH Guidelines for Human Stem Cell Research and on the proposed scope of certain human-animal chimera research that will be considered internally by an NIH steering committee to provide programmatic input to the director of the relevant NIH Institute(s) or Center(s) or equivalent NIH officials responsible for funding decisions.

[Federal Register Volume 81, Number 151 (Friday, August 5, 2016)]
[Notices]
[Pages 51921-51923]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-18601]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Request for Public Comment on the Proposed Changes to the NIH 
Guidelines for Human Stem Cell Research and the Proposed Scope of an 
NIH Steering Committee's Consideration of Certain Human-Animal Chimera 
Research

SUMMARY: The National Institutes of Health (NIH) is requesting public 
comment on a proposal to amend Section IV and Section V of the NIH 
Guidelines for Human Stem Cell Research and on the proposed scope of 
certain human-animal chimera research that will be considered 
internally by an NIH steering committee to provide programmatic input 
to the director of the relevant NIH Institute(s) or Center(s) or 
equivalent NIH officials responsible for funding decisions.

DATES: Written comments must be received by the NIH on or before 
September 6, 2016 in order to be considered.

ADDRESSES: Public comments may be entered at: http://grants.nih.gov/grants/rfi/rfi.cfm?ID=57. Comments may also be mailed to: Office of 
Science Policy, National Institutes of Health, 6705 Rockledge Drive, 
Suite 750, Bethesda, MD 20892, 301-496-9838. Comments will be made 
publicly available. Comments received, including any

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personal information, will be posted without change to http://grants.nih.gov/grants/rfi/responses_57.cfm.

SUPPLEMENTARY INFORMATION: On July 7, 2009, the NIH issued the NIH 
Guidelines for Human Stem Cell Research (``Guidelines'') 74 FR 32170 
(July 7, 2009) to implement Executive Order 13505 (March 9, 2009), as 
it pertains to NIH-funded stem cell research, to establish policy and 
procedures under which the NIH will fund such research, and help ensure 
that NIH-funded research in this area is ethically responsible, 
scientifically worthy, and conducted in accordance with applicable law.
    Since the Guidelines were issued in 2009, growing knowledge and 
advancement of stem cell biology has created new research 
opportunities. Some scientists are exploring strategies for growing 
human tissue and organs in animals through the introduction of human 
pluripotent cells into early stage embryos of non-human vertebrate 
animals. These experimental designs raise questions regarding where the 
human cells might go in the developing animal and how they might 
function, such as whether the human cells might contribute to the 
central nervous system and affect the cognition of the animal.
    While considering these issues, on September 23, 2015, the NIH 
issued a funding moratorium (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-158.html) on ``NIH Research Involving Introduction of 
Human Pluripotent Cells into Non-Human Vertebrate Animal Pre-
Gastrulation Embryos.'' The NIH subsequently held a workshop with 
experts on November 6, 2015, to review the state of the science and 
discuss animal welfare issues.
    The workshop illustrated that while there are significant 
challenges to creating chimeric models, there is clear interest and 
potential in producing animal models with human tissues or organs for 
studying human development, disease pathology, and eventually organ 
transplantation. In the interest of moving the field forward while 
preserving the NIH's opportunity to provide continuing assessment and 
oversight of this emerging area of research, the NIH has decided to 
establish a steering committee to provide programmatic input to the 
director of the relevant NIH Institute(s) or Center(s) (or equivalent 
NIH official responsible for funding decisions) on certain human-animal 
chimera research proposals. The committee will be composed of federal 
employees. The committee is expected to consider and offer the director 
of the relevant NIH Institute(s) or Center(s) (or equivalent NIH 
official responsible for funding decisions) programmatic input on 
factors, such as, (1) the characteristics of the human cells to be 
introduced (including potency and any modifications of those cells); 
(2) characteristics of the recipient animal (e.g., species, stage of 
development, and any modifications that affect location or function of 
human cells); (3) other data relevant to the likely effects on the 
animal (e.g., changes in cognition, behavior, or physical appearance); 
(4) planned monitoring (including animal welfare assessments); and (5) 
any staging of proposed research (e.g., assessing the outcome of a 
particular experiment before conducting a further experiment). This 
internal programmatic work will be conducted independent of, and in 
addition to, the usual peer review procedures for research at the NIH. 
The relevant IC director(s) will consider the input from the steering 
committee, in addition to other NIH programmatic input, as well as the 
funding recommendations and evaluations of the initial Scientific 
Review Group and the relevant Institute or Center's Advisory Council or 
Board. The committee will also monitor trends in this general field of 
research and the use of new technologies, and may provide such analysis 
and advice to the NIH leadership.
    The NIH also proposes to revise the Guidelines to expand the 
existing prohibition on introducing human pluripotent stem cells into 
blastocyst stage nonhuman primate embryos to include pre-blastocyst 
stage nonhuman primate embryos; and to expand the prohibition on 
research involving the breeding of animals where the introduction of 
hESCs or human induced pluripotent stem cells may contribute to the 
germ line to include any human cells that may result in the formation 
of human gametes.
    Therefore, NIH is requesting public comment on:
    (1) The following proposed changes to the Guidelines.
    Sections IV and V of the Guidelines currently state:

    IV. Research Using hESCs and/or Human Induced Pluripotent Stem 
Cells That, Although the Cells May Come From Eligible Sources, Is 
Nevertheless Ineligible for NIH Funding

    This section governs research using hESCs and human induced 
pluripotent stem cells, i.e., human cells that are capable of 
dividing without differentiating for a prolonged period in culture, 
and are known to develop into cells and tissues of the three primary 
germ layers. Although the cells may come from eligible sources, the 
following uses of these cells are nevertheless ineligible for NIH 
funding, as follows:
    A. Research in which hESCs (even if derived from embryos donated 
in accordance with these Guidelines) or human induced pluripotent 
stem cells are introduced into non-human primate blastocysts.
    B. Research involving the breeding of animals where the 
introduction of hESCs (even if derived from embryos donated in 
accordance with these Guidelines) or human induced pluripotent stem 
cells may contribute to the germ line.

    V. Other Research Not Eligible for NIH Funding

    A. NIH funding of the derivation of stem cells from human 
embryos is prohibited by the annual appropriations ban on funding of 
human embryo research (Section 509, Omnibus Appropriations Act, 
2009, Pub. L. 111-8, 3/11/09), otherwise known as the Dickey 
Amendment.
    B. Research using hESCs derived from other sources, including 
somatic cell nuclear transfer, parthenogenesis, and/or IVF embryos 
created for research purposes, is not eligible for NIH funding.

    The NIH is proposing to amend the Guidelines as follows:

    IV. Research Not Eligible for NIH Funding:
    A. Research in which human pluripotent stem cells are introduced 
into non-human primate embryos up through the end of the blastocyst 
stage, is not eligible for funding.
    B. Research involving the breeding of animals where the 
introduction of human cells may contribute to the germ line, is not 
eligible for funding.
    C. NIH funding of the derivation of stem cells from human 
embryos is prohibited by the annual appropriations limitations on 
the funding of human embryo research (see e.g. Section 508, Omnibus 
Appropriations Act, 2016, Pub. L.114-113, 12/18/15), otherwise known 
as the Dickey Amendment.
    D. Research using hESCs derived from other sources, including 
somatic cell nuclear transfer, parthenogenesis, and/or IVF embryos 
created for research purposes, is not eligible for NIH funding.

    (2) The NIH is also requesting public comment on the proposed scope 
of research (e.g., grant applications, contract proposals, intramural 
research protocols, etc.) to be considered by an NIH steering committee 
to provide programmatic input to the director of the relevant Institute 
or Center (or equivalent NIH official responsible for funding 
decisions). The NIH proposes the scope of research include research in 
which:
    a. Human pluripotent cells are introduced into non-human vertebrate 
embryos, up through the end of the gastrulation stage, or
    b. human cells are introduced into post-gastrulation non-human 
mammals (excluding rodents), such that there could be either a 
substantial contribution or a substantial functional

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modification to the animal brain by the human cells.
    While the NIH seeks public comment on the proposed changes to the 
Guidelines, and on the proposed scope for an NIH steering committee's 
consideration of certain research, NOT-OD-15-158 will remain in effect.

    Dated: July 28, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016-18601 Filed 8-4-16; 8:45 am]
 BILLING CODE 4140-01-P