Recommendations for Providers Counseling Male Patients and Parents Regarding Male Circumcision and the Prevention of HIV Infection, STIs, and Other Health Outcomes, 71433 [2014-27814]
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Federal Register / Vol. 79, No. 231 / Tuesday, December 2, 2014 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Type of respondent
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Adult Family Member ......................................
Sample Adult ...................................................
Adult Family Member ......................................
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Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2014–28233 Filed 12–1–14; 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]
Recommendations for Providers
Counseling Male Patients and Parents
Regarding Male Circumcision and the
Prevention of HIV Infection, STIs, and
Other Health Outcomes
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), located
within the Department of Health and
Human Services (HHS), is seeking
public comment on draft
recommendations for health care
providers who deliver information and
counseling about elective male
circumcision and the prevention of HIV
and other adverse health outcomes to
male patients and parents in the United
States. The draft recommendations
include information about the health
benefits and risks of elective male
circumcision performed by health care
providers.
DATES: Written comments must be
received on or before January 16, 2015.
ADDRESSES: You may submit comments
identified by Docket Number CDC–
2014–0012 by any of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Division of HIV/AIDS
Prevention, National Center for HIV/
rljohnson on DSK3VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
15:30 Dec 01, 2014
Jkt 235001
AIDS, Viral Hepatitis, STD, and TB
Prevention, Centers for Disease Control
and Prevention, 1600 Clifton Road NE.,
Mailstop D–21, Atlanta, Georgia 30333.
Attn: Male Circumcision
Recommendations.
Instructions: All submissions received
must include the agency name and
docket number or RIN. All relevant
comments received will be posted
without change to https://
regulations.gov, including any personal
information provided. CDC will not
consider or post any comments that
contain vulgar or offensive language,
threats, personal accusations, and/or
statements intended to promote
commercial products or services, or
images. Additionally, CDC will not post
any pictures that are submitted. For
access to the docket to read the
recommendations, background
document, or comments received, go to
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Division of HIV/AIDS, National Center
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: These
recommendations are intended to assist
health care providers in the United
States who are counseling men and
parents of male infants, children and
adolescents in decision making about
male circumcision. Such decision
making is made in the context of not
only health considerations, but also
other social, cultural, ethical, and
religious factors. Although 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
PO 00000
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Number of
responses per
respondent
45,000
36,000
14,000
45,000
12,000
5,000
1
1
1
1
1
1
Average
burden per
response
(in hours)
23/60
15/60
10/60
20/60
20/60
5/60
clinical trials showed that adult male
circumcision reduced HIV infection risk
by 50–60% over time. 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, by 30%. Since the
release of these trial data, various
organizations have updated their
recommendations about adult male and
infant male circumcision.
In addition to obtaining public
comment on the draft
Recommendations, CDC considers this
document to be important information
as defined by the Office of Management
and Budget’s (OMB) 2004 Information
Quality Bulletin for Peer Review and,
therefore, subject to peer review. CDC
will share the summary of public
comments with external experts who
conduct a peer review of the evidence
on this topic. Their review will include
an evaluation of completeness,
accuracy, interpretation, and
generalizability of the evidence to the
United States and whether the evidence
is sufficient to support the draft
counseling recommendations.
After considering all public comment
and the results of the peer review, CDC
will publish a notice in the Federal
Register announcing the final
recommendations.
Dated: November 19, 2014.
Ron A. Otten,
Acting Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2014–27814 Filed 11–28–14; 4:15 pm]
BILLING CODE 4163–18–P
E:\FR\FM\02DEN1.SGM
02DEN1
]]>Agencies
[Federal Register Volume 79, Number 231 (Tuesday, December 2, 2014)]
[Notices]
[Page 71433]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-27814]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2014-0012]
Recommendations for Providers Counseling Male Patients and
Parents Regarding Male Circumcision and the Prevention of HIV
Infection, STIs, and Other Health Outcomes
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), located
within the Department of Health and Human Services (HHS), is seeking
public comment on draft recommendations for health care providers who
deliver information and counseling about elective male circumcision and
the prevention of HIV and other adverse health outcomes to male
patients and parents in the United States. The draft recommendations
include information about the health benefits and risks of elective
male circumcision performed by health care providers.
DATES: Written comments must be received on or before January 16, 2015.
ADDRESSES: You may submit comments identified by Docket Number CDC-
2014-0012 by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: Division of HIV/AIDS Prevention, National Center for
HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease
Control and Prevention, 1600 Clifton Road NE., Mailstop D-21, Atlanta,
Georgia 30333. Attn: Male Circumcision Recommendations.
Instructions: All submissions received must include the agency name
and docket number or RIN. All relevant comments received will be posted
without change to https://regulations.gov, including any personal
information provided. CDC will not consider or post any comments that
contain vulgar or offensive language, threats, personal accusations,
and/or statements intended to promote commercial products or services,
or images. Additionally, CDC will not post any pictures that are
submitted. For access to the docket to read the recommendations,
background document, or comments received, go to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Division of HIV/AIDS, National Center
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: These recommendations are intended to assist
health care providers in the United States who are counseling men and
parents of male infants, children and adolescents in decision making
about male circumcision. Such decision making is made in the context of
not only health considerations, but also other social, cultural,
ethical, and religious factors. Although 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 showed that adult male circumcision reduced
HIV infection risk by 50-60% over time. 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, by 30%. Since the release of these trial
data, various organizations have updated their recommendations about
adult male and infant male circumcision.
In addition to obtaining public comment on the draft
Recommendations, CDC considers this document to be important
information as defined by the Office of Management and Budget's (OMB)
2004 Information Quality Bulletin for Peer Review and, therefore,
subject to peer review. CDC will share the summary of public comments
with external experts who conduct a peer review of the evidence on this
topic. Their review will include an evaluation of completeness,
accuracy, interpretation, and generalizability of the evidence to the
United States and whether the evidence is sufficient to support the
draft counseling recommendations.
After considering all public comment and the results of the peer
review, CDC will publish a notice in the Federal Register announcing
the final recommendations.
Dated: November 19, 2014.
Ron A. Otten,
Acting Deputy Associate Director for Science, Centers for Disease
Control and Prevention.
[FR Doc. 2014-27814 Filed 11-28-14; 4:15 pm]
BILLING CODE 4163-18-P
