[Federal Register Volume 84, Number 36 (Friday, February 22, 2019)]
[Notices]
[Pages 5681-5682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02907]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2014-0012]


Information for Providers To Share With Male Patients and Parents 
Regarding Male Circumcision and the Prevention of HIV Infection, 
Sexually Transmitted Infections, and Other Health Outcomes

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

ACTION: Notice.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), within 
the Department of Health and Human Services (HHS), announces the 
availability of ``Information for Providers to Share with Male Patients 
and Parents Regarding Male Circumcision and the Prevention of HIV 
infection, Sexually Transmitted Infections, and other Health 
Outcomes.''

FOR FURTHER INFORMATION CONTACT: Division of HIV/AIDS, National Centers 
for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for 
Disease Control and Prevention, 1600 Clifton Road NE, MS D-21, Atlanta, 
Georgia 30329; phone: 404-639-5200; email: [email protected].

SUPPLEMENTARY INFORMATION: On December 2, 2014, CDC published a notice 
in the Federal Register (79 FR 71433) requesting public comment on a 
draft document titled Recommendations for Providers Counseling Male 
Patients and Parents Regarding Male Circumcision and the Prevention of 
HIV Infection, STIs, and Other Health Outcomes (referred to as The 
Initial Draft Document). On August 30, 2018, the title was changed to 
Information for Providers to Share with Male Patients and Parents 
Regarding Male Circumcision and the Prevention of HIV infection, 
Sexually Transmitted Infections, and other Health Outcomes to better 
align with the content in the final version of the document.
    The intent of this document is to assist health care providers in 
the United States who share information with men and parents of male 
infants, children and adolescents for their use in decision making 
about male circumcision as it relates to the prevention of human 
immunodeficiency virus (HIV) infection, sexually transmitted infections 
(STIs), and other health outcomes. Such decision making is made in the 
context of not only health considerations, but also other social, 
cultural, ethical, and religious factors. Although observational and 
ecologic data have been accumulating about infant male circumcision for 
many years, clinical trials conducted between 2005-2010 have 
demonstrated safety and significant efficacy of voluntary adult male 
circumcision performed by clinicians for reducing the risk of 
acquisition of human immunodeficiency virus (HIV) by a male during 
penile-vaginal sex (``heterosexual sex''). Three randomized clinical 
trials conducted in Kenya, Uganda, and South Africa \1\ \2\ \3\ showed 
that adult male circumcision reduced HIV infection risk by 50-60%. 
These trials also found that adult circumcision reduced the risk of men 
acquiring two common sexually transmitted infections (STIs), herpes 
simplex virus type-2 (HSV-2) and types of human papilloma virus (HPV) 
that can cause penile and other anogenital cancers. Since the release 
of these trial data, various medical professional organizations have 
updated their information about adult male and infant male 
circumcision.
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    \1\ Bailey RC, Moses S, Parker CB, et al. Male circumcision for 
HIV prevention in young men in Kisumu, Kenya: a randomised 
controlled trial. Lancet. 2007; 369 (9562):643-656.
    \2\ Auvert B, Taljaard D, Lagarde E, Sobngwi-Tambekou J, Sitta 
R, Puren A. Randomized, controlled intervention trial of male 
circumcision for reduction of HIV infection risk: the ANRS 1265 
Trial. PLoS Med. 2005;2(11):e298.
    \3\ Gray RH, Kigozi G, Serwadda D, et al. Male circumcision for 
HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet. 
2007; 369 (9562): 657-666.
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    Initial comment period. The initial comment period was open for 
public and peer review during December 2, 2014--January 16, 2015.
    Public comments (initial comment period). CDC received 3,234 
comments on the Initial Draft Document from the public, including but 
not limited to

[[Page 5682]]

individuals (e.g., parents and physicians) and representatives of 
professional medical and community-based organizations. A summary of 
public comments and responses to comments, including changes are noted 
in the Summary of Public Comments and CDC Responses to Public Comments 
for Information for Providers Counseling Male Patients and Parents 
Regarding Male Circumcision and the Prevention of HIV infection, 
Sexually Transmitted Infections, and other Health Outcomes. This 
document is in the docket at: www.regulations.gov and at https://www.cdc.gov/hiv/pdf/risk/MC-HISA-Public-Comments-and-Responses.pdf.
    Peer Review comments (initial comment period). Peer reviewers were 
asked to review the Initial Draft Document and its companion document, 
Background, Methods, and Synthesis of Scientific Information Used to 
Inform the `Recommendations for Providers Counseling Male Patients and 
Parents Regarding Male Circumcision and the Prevention of HIV 
infection, STIs, and other Health Outcomes.' On August 30, 2018, the 
title of this companion document was changed to Background, Methods, 
and Synthesis of Scientific Information Used to Inform `Information for 
Providers to Share with Male Patients and Parents Regarding Male 
Circumcision and the Prevention of HIV Infection, Sexually Transmitted 
Infections, and other Health Outcomes' to better align with the content 
in the final document.
    CDC considers these documents to be highly influential scientific 
assessments (HISA) as defined by the Office of Management and Budget's 
(OMB) directive, Final Information Quality Bulletin for Peer Review, 
dated December 15, 2004. HISA documents are subject to peer review.
    Peer reviewers evaluated the appropriateness of the methods and of 
the interpretation of findings, including generalizability of the 
evidence to the United States. Peer review comments were received from 
three physician peer reviewers. A copy of peer review comments, CDC 
responses, and changes are noted in the documents titled: Peer Review 
Comments and CDC Responses for Peer Review Comments and CDC Responses 
for ``Information for Providers to Share with Male Patients and Parents 
Regarding Male Circumcision and the Prevention of HIV infection, 
Sexually Transmitted Infections, and other Health Outcomes'' and 
``Background, Methods, and Synthesis of Scientific Information Used to 
Inform `Information for Providers to Share with Male Patients and 
Parents Regarding Male Circumcision and the Prevention of HIV 
Infection, Sexually Transmitted Infections, and other Health Outcomes.' 
These documents are in the public docket at www.regulations.gov and at 
https://www.cdc.gov/hiv/pdf/risk/MC-HISA-Round-1-Peer-Review-Comments-and-Responses.pdf.
    Second comment period. The second comment period was opened during 
September 15-30, 2016, for peer review only.
    Peer Review comments (second comment period). Peer Reviewers 
reviewed and commented on a revised copy of the Initial Draft Document. 
Peer Reviewers were asked to limit their comments only to changes that 
were made as a result of the initial comment period.
    Comments were received from two peer reviewers. A summary of peer 
review comments, CDC responses, and changes made are noted in the 
Summary of Peer Review Comments and CDC Responses to Second Round of 
Peer Review Comments for Information for Providers to Share with Male 
Patients and Parents Regarding Male Circumcision and the Prevention of 
HIV Infection, Sexually Transmitted Infections, and other Health 
Outcomes are in the public docket at www.regulations.gov and at https://www.cdc.gov/hiv/pdf/risk/MC-HISA-Round-2-Peer-Review-Comments-and-Responses.pdf.
    All comments were carefully reviewed and considered in the 
development of the final version of the document found in the public 
docket at www.regulations.gov and at https://www.cdc.gov/hiv/risk/male-circumcision.html.

    Dated: February 14, 2019.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2019-02907 Filed 2-21-19; 8:45 am]
 BILLING CODE 4163-18-P