http://www.gpo.gov/fdsys/pkg/FR-2013-10-02/pdf/2013-24094.pdfDEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 121
RIN 0906–AB02
Change to the Definition of ‘‘Human Organ’’ Under Section 301 of the National Organ Transplant Act of 1984
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice of proposed rulemaking.
SUMMARY: This notice seeks public
comment on the proposed change in the
definition of ‘‘human organ’’ in section
301 of the National Organ and
Transplant Act of 1984, as amended,
(NOTA) to explicitly incorporate
hematopoietic stem cells (HSCs) within
peripheral blood in the definition of
‘‘bone marrow.’’ This would clarify that
the prohibition on transfers of human
organs for valuable consideration
applies to HSCs regardless of whether
they were recovered directly from bone
marrow (by aspiration) or from
peripheral blood (by apheresis). This
amendment will also conform section
301 to the provisions of the Stem Cell
Research and Therapeutic Act of 2005,
as amended.
DATES: To be considered, comments
should be submitted by December 2,
2013. Subject to consideration of the
comments submitted, the Department
intends to publish final regulations.
ADDRESSES: You may submit comments,
identified by Regulatory Information
Number RIN 0906–AB02, by any of the
following methods, but the first option
is preferred:
• Federal eRulemaking Portal: http://
www.regulations.gov. Follow the
instructions for submitting comments.
• Agency Web site: http://
www.hrsa.gov/. Follow the instructions
for submitting comments on the Agency
Web site.
• Email: SGrant@hrsa.gov. Include
RIN 0906–AB02 in the subject line of
the message.
• Fax: (301) 594–6095.
• Mail: Shelley Grant, MHSA, Branch
Chief, Blood Stem Cell Transplantation
Program, Division of Transplantation,
Healthcare Systems Bureau, Health
Resources and Services Administration,
5600 Fishers Lane, Room 12C–06,
Rockville, Maryland 20857.
Instructions: All submissions must
include the agency name and RIN for
this rulemaking. All comments received
will be posted without change to
http://www.hrsa.gov/, including any
personal information provided.
Additional information concerning the
submission of comments and/or the
rulemaking process can be obtained
from the Regulations Officer, Division of
Policy Information and Coordination,
Health Resources and Services
Administration, 5600 Fishers Lane,
Room 14–101, Rockville, Maryland
20857.
Docket: For access to the docket to
read background documents or
comments received, go to the Division
of Transplantation, Healthcare Systems
Bureau, Health Resources and Services
Administration, 5600 Fishers Lane,
Room 12C–06, Rockville, Maryland
20857, weekdays (Federal holidays
excepted) between the hours of 8:30
a.m. and 5 p.m. To schedule an
appointment to view public comments,
phone (301) 443–7757.
FOR FURTHER INFORMATION CONTACT:
Shelley Grant, MHSA, at the above
address; telephone number (301) 443–
8036.
SUPPLEMENTARY INFORMATION:
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