[Federal Register Volume 76, Number 183 (Wednesday, September 21, 2011)]
[Notices]
[Pages 58517-58518]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-24189]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2011-0011]
Public Health Service Guideline for Reducing Transmission of
Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and
Hepatitis C Virus (HCV) Through Solid Organ Transplantation
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (DHHS).
ACTION: Notice of availability and request for public comment.
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SUMMARY: With this notice, the Centers for Disease Control and
Prevention (CDC), located within the Department of Health and Human
Services (HHS) requests public comment on the draft Public Health
Service Guideline for Reducing Transmission of Human Immunodeficiency
Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV)
through Solid Organ Transplantation (Draft Guideline). The Draft
Guideline can be found at http://www.regulations.gov under Docket No.
CDC-2011-0011.
[[Page 58518]]
Also found at the docket is a supporting document for reference,
the Evidence Report. The Evidence Report includes primary evidence,
studies, and data tables that were used by the Guideline authors in
developing the recommendations in the Guideline.
The Draft Guideline is for use by organ procurement organizations
(OPOs); transplant centers, including physicians, nurses,
administrators, and clinical coordinators; laboratory personnel
responsible for testing and storing donor and recipient specimens; and
persons responsible for developing, implementing, and evaluating
infection prevention and control programs for OPOs and transplant
centers. This Draft Guideline provides evidence-based recommendations
for reducing unexpected transmission of HIV, HBV and HCV from deceased
and living organ donors.
DATES: Written comments must be received on or before November 21,
2011.
ADDRESSES: Written comments may be submitted electronically or by mail.
You may also submit written comments electronically to: http://www.regulations.gov. Comments must be identified by Docket No. CDC-
2011-0011. Please follow directions at http://wwww.regulations.gov to
submit comments.
You may also submit written comments to the following address:
Office of Blood, Organ, and Other Tissue Safety, Division of Healthcare
Quality Promotion, National Center for Emerging and Zoonotic Infectious
Diseases, Centers for Disease Control and Prevention, Attn: Public
Health Service Guideline for Reducing Transmission of Human
Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C
Virus (HCV) through Solid Organ Transplantation, Docket No. CDC-2011-
0011, 1600 Clifton Rd, NE., Mailstop A-07, Atlanta, Georgia, 30329. All
written materials identified by Docket No. CDC-2011-0011 will be
available for public inspection Monday through Friday, except for legal
holidays, from 9 a.m. until 5 p.m., Eastern Daylight Time, at 1600
Clifton Road, NE., Atlanta, Georgia 30333. Please call ahead to (404)
639-4000 and ask for a representative from the Office of Blood, Organ
and Other Tissue Safety to schedule your visit. All public comments
will be reviewed and considered prior to finalizing the Draft
Guideline. All relevant comments received will be posted publicly
without change, including any personal or proprietary information
provided. To download an electronic version of the Draft Guideline,
access http://www.regulations.gov, Docket No. CDC-2011-0011.
FOR FURTHER INFORMATION CONTACT: Debbie Seem, Division of Healthcare
Quality Promotion, National Center for Emerging and Zoonotic Infectious
Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road
NE., Mailstop A-07, Atlanta, Georgia, 30329-4018; Telephone: (404) 639-
4000.
SUPPLEMENTARY INFORMATION: Since 2008, CDC has collaborated with state
and federal agencies, national partners, academicians, public and
private health professionals, the transplant field, public health
organizations, and other partners to revise and expand the 1994
Guidelines for Preventing Transmission of Human Immunodeficiency Virus
(HIV) through Transplantation of Human Tissue and Organs (1994
Guideline). The 2011 Draft Guideline updates the previous
recommendations for HIV, includes recommendations to reduce disease
transmission of HBV and HCV, and addresses issues such as donor risk
assessment, donor screening, HBV- and HCV-infected donors and
transplantation, recipient informed consent, recipient screening, donor
and recipient specimen collection and storage, and tracking and
reporting of HIV, HBV, and HCV. As with the 1994 Guideline, the
recommendations address adult and pediatric donors who are living or
deceased, as well as transplant candidates and recipients. In addition
to summarizing current scientific knowledge about solid organ
transplant safety, the 2011 Draft Guideline also identifies important
gaps in the literature where further research is needed.
CDC worked with the University of Pennsylvania's Health System
Center for Evidence-based Practice (CEP) and sought input in each phase
of the Draft Guideline's development from subject matter experts in HIV
and hepatitis through formation of a Guideline Expert Panel to develop
the new Draft Guideline. CDC also formed a Guideline Review Committee
to provide feedback on the Draft Guideline recommendations. Members of
the Review Committee included representatives from public health, the
regulatory arena, transplant infectious disease experts, and other
stakeholders. This new Draft Guideline will not be a federal rule or
regulation.
Dated: September 13, 2011.
Tanja Popovic,
Deputy Associate Director for Science, Centers for Disease Control and
Prevention.
[FR Doc. 2011-24189 Filed 9-20-11; 8:45 am]
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