2011-24189. 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.

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.

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 [phone] 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: [phone].

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.