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, 5681-5682 [2019-02907]

Download as PDF 5681 Federal Register / Vol. 84, No. 36 / Friday, February 22, 2019 / Notices include worksites, schools, universities, hospitals, senior meal programs, food banks, and restaurants. The information collection will occur via the SRCP Partner Cost Survey, in which respondents will be asked about a key set of sodium reduction activities that were developed based on a pilot study with eight partners as part of the evaluation of SRCP Round 2. Activities include: Establishing nutrition guidelines, developing lower sodium products or recipes, preparing lowersodium food, promoting lower-sodium foods, and attending additional meetings. We will request participation from all SRCP partners via email and offer a $50 gift card as an incentive. Complete surveys will be returned to CDC’s data collection contractor by email. The estimated burden per response is one hour. The insights to be gained from this data collection will be critical to understanding the full costs of implementing community-based sodium reduction strategies. Estimates will be considered preliminary and not externally generalizable but can provide a basis for future planning and evaluation. Understanding the costs to partners is important for program planning to support program longevity and sustainability. For example, CDC can use findings to provide guidance or technical assistance to entities that are interested in population-based strategies for reducing sodium consumption. Results will also be disseminated to other state and local organizations to inform planning and sustainability of other community-based public health initiatives. OMB approval is requested for one year. CDC estimates that information will be collected from 44 of the SRCP’s community partners (50% response rate). Participation is voluntary and there are no costs to respondents other than their time. The estimated annualized burden hours are 44. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondents Form name Partner Program Manager .............................. SRCP Partner Cost Survey ........................... Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2019–03100 Filed 2–21–19; 8:45 am] BILLING CODE 4163–18–P 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 Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: 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 SUMMARY: VerDate Sep<11>2014 16:52 Feb 21, 2019 Jkt 247001 Road NE, MS D–21, Atlanta, Georgia 30329; phone: 404–639–5200; email: circumcision@cdc.gov. 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 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 44 Number of responses per respondent Average burden per response (in hours) 1 1 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. 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 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, SobngwiTambekou 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. E:\FR\FM\22FEN1.SGM 22FEN1 5682 Federal Register / Vol. 84, No. 36 / Friday, February 22, 2019 / Notices individuals (e.g., parents and physicians) and representatives of professional medical and communitybased 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-HISAPublic-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 VerDate Sep<11>2014 16:52 Feb 21, 2019 Jkt 247001 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-HISARound-1-Peer-Review-Comments-andResponses.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-HISARound-2-Peer-Review-Comments-andResponses.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/malecircumcision.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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Board of Scientific Counselors, National Institute for Occupational Safety and Health: Notice of Charter Renewal Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of charter renewal. AGENCY: PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through February 3, 2021. SUMMARY: FOR FURTHER INFORMATION CONTACT: Alberto Garcia, M.S., Executive Secretary, BSC, NIOSH, CDC, 555 Ridge Avenue, MS–R5, Cincinnati, OH 45213, telephone (513) 841–4596, fax (513) 841–4506. The Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Sherri Berger, Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2019–03008 Filed 2–21–19; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–18–18AQQ] Agency Forms Undergoing Paperwork Reduction Act Review In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled ‘‘HIV prevention among Latina transgender women: Evaluation of a Locally Developed Intervention (ChiCAS)’’ to the Office of Management and Budget (OMB) for review and approval. CDC previously published a ‘‘Proposed Data Collection Submitted for Public Comment and Recommendations’’ notice on August 23, 2018 to obtain comments from the public and affected agencies. CDC did not receive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments. CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that: E:\FR\FM\22FEN1.SGM 22FEN1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: circumcision@cdc.gov.

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.