[Federal Register Volume 77, Number 99 (Tuesday, May 22, 2012)]
[Notices]
[Page 30293]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-12323]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2012-0005]


Recommendations for the Identification of Hepatitis C Virus (HCV) 
Chronic Infection

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), located 
within the Department of Health and Human Services (HHS) announces 
draft recommendations for identification of persons with HCV chronic 
infection, available for public comment. The recommendations are 
intended to increase the proportion of persons with chronic HCV who are 
diagnosed, provided appropriate prevention services, and linked to 
needed care and treatment. Public comment will be used to inform the 
final recommendations. The Recommendations may be found at http://www.regulations.gov, Docket No. CDC-2012-0005.

DATES: Written comments must be received on or before June 8th, 2012.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2012-
0005, by any of the following methods:
     Internet: Access the Federal eRulemaking portal at http://www.regulations.gov. Follow the instructions for submitting comments.
     Mail: Division of Viral Hepatitis, National Center for 
HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease 
Control and Prevention, 1600 Clifton Road, NE., Mailstop G-37, Atlanta, 
Georgia 30333.
    Instructions: All submissions received must include the agency name 
and docket number for this notice. All relevant comments will be posted 
without change to http://www.regulations.gov including any personal 
information provided.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov, Docket No. CDC-
2012-0005.

FOR FURTHER INFORMATION CONTACT: Rebecca Morgan, Division of Viral 
Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB 
Prevention, Centers for Disease Control and Prevention, 1600 Clifton 
Road, Mailstop G-37, Atlanta, Georgia 30333. You may also call 404-718-
8596 or send an email to [email protected].

SUPPLEMENTARY INFORMATION: 
    Hepatitis C virus infection is a contagious liver disease that 
ranges in severity from a mild illness lasting a few weeks to a 
serious, lifelong illness. It results from infection with the hepatitis 
C virus (HCV), which is spread primarily through contact with the blood 
of an infected individual. In approximately 75%-85% of persons, HCV 
persists as a chronic infection, which places infected persons at risk 
for liver cirrhosis, liver cancer or hepatocellular carcinoma (HCC), 
and complications involving other organ systems that develop over the 
decades following onset of infection. HCV infection status is 
determined by a blood test.
    In the United States an estimated 2.7-3.9 million persons are 
living with HCV infection. Cirrhosis, HCC and HCV-related mortality 
have been increasing among persons infected with HCV, and these 
outcomes are projected to increase significantly in the coming decades. 
HCV-infected persons who are aware of their infection can benefit from 
health services to prevent additional harm to the liver (e.g., 
hepatitis A virus and hepatitis B virus vaccination), medical 
monitoring, and behavioral changes (e.g., reductions in alcohol use). 
Further, anti-viral therapies can clear HCV from the system (i.e., a 
virologic cure) and halt disease progression for many patients living 
with HCV infection.
    CDC is seeking public comment on these Recommendations, 
particularly concerning the following questions:
    (1) Are there other data, evidence, or studies to consider 
regarding:
    a. The burden of HCV infection morbidity, and mortality in the 
populations for whom testing is recommended?
    b. The number of persons living with HCV who are unaware of their 
infection status?
    c. The benefits and harms of HCV testing, care and treatment?
    d. The cost effectiveness of the proposed recommendations?
    e. Settings in a community where testing should be targeted?
    (2) Are there other factors, e.g., other scientific studies not 
referenced, which should be considered in the development of the 
Recommendations?
    (3) Are there any other comments about the utility of the 
information?

    Dated: May 15, 2012.
Tanja Popovic,
Deputy Associate Director for Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2012-12323 Filed 5-18-12; 11:15 am]
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