[Federal Register Volume 76, Number 226 (Wednesday, November 23, 2011)]
[Notices]
[Pages 72417-72418]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-30205]


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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: Extension of the public comment period.

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SUMMARY: On September 21, 2011, the Centers for Disease Control and 
Prevention (CDC), located within the Department of Health and Human 
Services (HHS), published a notice in the Federal Register requesting 
public comment on the draft ``Public Health Service (PHS) Guideline for 
Reducing Transmission of Human Immunodeficiency Virus (HIV), Hepatitis 
B Virus (HBV), and Hepatitis C Virus (HCV) through Solid Organ 
Transplantation'' (76 FR 58517). Written and electronic comments were 
to be received on or before November 21, 2011. However, HHS/CDC has 
received requests for a 30 day extension of the comment period. In 
consideration of those requests, HHS/CDC is extending the comment 
period by 30 days to December 23, 2011.
    CDC also published 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 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 December 23, 
2011.

ADDRESSES: Written comments may be submitted electronically or by mail. 
To

[[Page 72418]]

download an electronic version of the Guideline, go to http://www.regulations.gov, Docket CDC-2011-0011. You may submit written 
comments electronically at this Web site. Please follow directions at 
http://www.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 
Promotion, National Center for Emerging and Zoonotic Infectious 
Diseases, Centers for Disease Control and Prevention, (CDC), 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, 30333. All 
written materials identified will be available for public inspection 
Monday through Friday, except for legal holidays, from 9 a.m. until 5 
p.m., Eastern Standard 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 relevant comments received will be posted 
publicly at this Web site without change, including any personal or 
proprietary information.

FOR FURTHER INFORMATION CONTACT: Debbie Seem, Division of Healthcare 
Quality Promotion, National Center for Emerging and Zoonotic 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, HHS/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. The 2011 
draft Guideline updates the previous recommendations about HIV and also 
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 draft 
2011 Guideline also identifies important gaps in the literature where 
further research is needed.
    HHS/CDC worked with the University of Pennsylvania's Health System 
Center for Evidence-based Practice (CEP) and sought input in each phase 
of the Guideline's development from subject matter experts in HIV and 
hepatitis through formation of a Guideline Expert Panel to develop the 
new Guideline. HHS/CDC also formed a Guideline Review Committee to 
provide feedback on the draft Guideline recommendations. Members of the 
Review Committee included representation from public health, 
regulatory, transplant infectious disease and other stakeholders. This 
new Draft Guideline will not be a federal rule or regulation.

Juliana K. Cyril,
Deputy Director, Office of Science Quality, Office of the Associate 
Director for Science, Centers for Disease Control and Prevention.
[FR Doc. 2011-30205 Filed 11-22-11; 8:45 am]
BILLING CODE 4163-18-P