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)
National Institutes of Health
Federal Register Volume 81, Issue 151 (August 5, 2016)
| Page Range | 51921-51923 | |
| FR Document | 2016-18601 |
[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] ----------------------------------------------------------------------- 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 [[Page 51922]] 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 [[Page 51923]] 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
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DEPARTMENT OF HEALTH AND Place: National Institutes of Health, 6701 Name of Committee: National Institute of
HUMAN SERVICES Rockledge Drive, Bethesda, MD 20892 Allergy and Infectious Diseases Special
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This notice is being published less than 15 5C100, 5601 Fishers Lane, Rockville, MD
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amended (5 U.S.C. App.), notice is limitations imposed by the review and Contact Person: Lynn Rust, Ph.D.,
hereby given of the following meetings. funding cycle. Scientific Review Officer, Scientific Review
The meetings will be closed to the Name of Committee: Center for Scientific Program, Division of Extramural Activities,
public in accordance with the Review Special Emphasis Panel; PAR14–066: Room 3G42A National Institutes of Health/
provisions set forth in sections SPF Macaque Colonies. NIAID, 5601 Fishers Lane, MSC 9823,
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the discussions could disclose Agenda: To review and evaluate grant (Catalogue of Federal Domestic Assistance
confidential trade secrets or commercial applications. Program Nos. 93.855, Allergy, Immunology,
Place: National Institutes of Health, 6701 and Transplantation Research; 93.856,
property such as patentable material, Rockledge Drive, Bethesda, MD 20892 Microbiology and Infectious Diseases
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individuals associated with the grant Contact Person: Shiv A. Prasad, Ph.D.,
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Review Special Emphasis Panel; Member This notice is being published less than 15 [FR Doc. 2016–18550 Filed 8–4–16; 8:45 am]
Conflict: AIDS and AIDS Related Research. days prior to the meeting due to the timing BILLING CODE 4140–01–P
Date: August 9, 2016. limitations imposed by the review and
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DEPARTMENT OF HEALTH AND
Program Nos. 93.306, Comparative Medicine; HUMAN SERVICES
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Scientific Review Officer, Center for Request for Public Comment on the
Scientific Review, National Institutes of Dated: August 1, 2016. Proposed Changes to the NIH
Health, 6701 Rockledge Drive, Room 5218, Anna Snouffer, Guidelines for Human Stem Cell
MSC 7852, Bethesda, MD 20892, 301–435– Deputy Director, Office of Federal Advisory Research and the Proposed Scope of
1775, rubertm@csr.nih.gov. Committee Policy. an NIH Steering Committee’s
This notice is being published less than 15 [FR Doc. 2016–18548 Filed 8–4–16; 8:45 am] Consideration of Certain Human-
days prior to the meeting due to the timing
BILLING CODE 4140–01–P Animal Chimera Research
limitations imposed by the review and
funding cycle. SUMMARY: The National Institutes of
Name of Committee: Center for Scientific
DEPARTMENT OF HEALTH AND Health (NIH) is requesting public
Review Special Emphasis Panel; PAR Panel: comment on a proposal to amend
Methods for HIV Prevention Packages. HUMAN SERVICES
Section IV and Section V of the NIH
Date: August 9, 2016. Guidelines for Human Stem Cell
Time: 11:00 a.m. to 1:00 p.m. National Institutes of Health
Agenda: To review and evaluate grant
Research and on the proposed scope of
applications. National Institute of Allergy and certain human-animal chimera research
Place: National Institutes of Health, 6701 Infectious Diseases; Notice of Closed that will be considered internally by an
Rockledge Drive, Bethesda, MD 20892 Meeting NIH steering committee to provide
(Telephone Conference Call). programmatic input to the director of
Pursuant to section 10(d) of the
Contact Person: Shalanda A. Bynum, the relevant NIH Institute(s) or Center(s)
Ph.D., MPH, Scientific Review Officer, Center Federal Advisory Committee Act, as
or equivalent NIH officials responsible
for Scientific Review, National Institutes of amended (5 U.S.C. App.), notice is
for funding decisions.
Health, 6701 Rockledge Drive, Room 3206, hereby given of the following meeting.
The meeting will be closed to the DATES: Written comments must be
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This notice is being published less than 15 provisions set forth in sections September 6, 2016 in order to be
days prior to the meeting due to the timing 552b(c)(4) and 552b(c)(6), title 5 U.S.C., considered.
limitations imposed by the review and as amended. The grant applications and ADDRESSES: Public comments may be
funding cycle. the discussions could disclose entered at: http://grants.nih.gov/grants/
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Applications.
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![Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices 51923
modification to the animal brain by the DEPARTMENT OF HOMELAND reallocate Coast Guard inspection
human cells. SECURITY resources from lower risk, fixed interval
While the NIH seeks public comment activities to higher risk activities prior
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Guidelines, and on the proposed scope [Docket No. USCG–2016–0640] The Coast Guard will periodically
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OD–15–158 will remain in effect. Outer Continental Shelf Risk-Based or are due for a Coast Guard regulatory
Dated: July 28, 2016. Resource Allocation Methodology inspection to assign an inspection
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AGENCY: Coast Guard, DHS. For example, under this methodology
Deputy Director, National Institutes of Health.
ACTION: Notice of availability and Coast Guard inspection resources
[FR Doc. 2016–18601 Filed 8–4–16; 8:45 am]
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BILLING CODE 4140–01–P
Certificate of Compliance inspection of
SUMMARY: The Coast Guard announces a lower risk stacked MODU may be
the availability of an interim risk based reallocated to conduct a higher risk
DEPARTMENT OF HEALTH AND resource allocation methodology for inspection of any MODU or OCS facility
HUMAN SERVICES inspections of certain Outer Continental with a drilling rig prior to
Shelf (OCS) units in the Eighth Coast commencement of drilling.
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Pursuant to section 10(d) of the the trial period, the methodology will be conducted outreach to the offshore
Federal Advisory Committee Act, as finalized within D8 and submitted to Operators’ Committee at its annual
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the discussions could disclose
2016–0640 or view documents Comments
confidential trade secrets or commercial
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property such as patentable material, We encourage you to submit
available in the docket using the Federal
and personal information concerning comments (or related material) on the
eRulemaking Portal at http://
individuals associated with the grant interim risk based resource allocation
www.regulations.gov. See the ‘‘Public
applications, the disclosure of which methodology for inspection of OCS
Participation and Request for
would constitute a clearly unwarranted units in the D8 AOR. We will consider
Comments’’ portion of the
invasion of personal privacy. all submissions and may adjust our
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Name of Committee: National Heart, Lung, action based on your comments,
further instructions on submitting
and Blood Institute, Special Emphasis Panel, although we do not anticipate a written
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and Resources Research, National Institutes upon the risk based matrix created for online docket at http://
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mstockstill on DSK3G9T082PROD with NOTICES
of Health, HHS)
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Dated: July 29, 2016. Federal Register (76 FR 39885) by the instructions. Additionally, if you go to
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[FR Doc. 2016–18549 Filed 8–4–16; 8:45 am] Safety and Environmental Enforcement We accept anonymous comments. All
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Document Created: 2016-08-05 06:43:44
Document Modified: 2016-08-05 06:43:44
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | Written comments must be received by the NIH on or before September 6, 2016 in order to be considered. | |
| FR Citation | 81 FR 51921 |
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