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, 72417-72418 [2011-30205]
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Dated: November 17, 2011.
Elaine L. Baker,
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Office, Centers for Disease Control and
Prevention.
[FR Doc. 2011–30233 Filed 11–22–11; 8:45 am]
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National Health and Nutrition
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Centers for Disease Control and
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ACTION:
Notice.
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Phone: (301) 458–4371,
Fax: (301) 458–4028,
E-Mail: NHANESgenetics@cdc.gov.
FOR FURTHER INFORMATION CONTACT:
Juliana K. Cyril,
Deputy Director, Office of Science Quality,
Office of the Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2011–30204 Filed 11–22–11; 8:45 am]
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72417
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2011–0011]
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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (DHHS).
ACTION: Extension of the public
comment period.
AGENCY:
On September 21, 2011, the
Centers for Disease Control and
Prevention (CDC), located within the
Department of Health and Human
Services (HHS), published a notice in
the Federal Register requesting public
comment on the draft ‘‘Public Health
Service (PHS) Guideline for Reducing
Transmission of Human
Immunodeficiency Virus (HIV),
Hepatitis B Virus (HBV), and Hepatitis
C Virus (HCV) through Solid Organ
Transplantation’’ (76 FR 58517). Written
and electronic comments were to be
received on or before November 21,
2011. However, HHS/CDC has received
requests for a 30 day extension of the
comment period. In consideration of
those requests, HHS/CDC is extending
the comment period by 30 days to
December 23, 2011.
CDC also published 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
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 December 23,
2011.
ADDRESSES: Written comments may be
submitted electronically or by mail. To
SUMMARY:
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sroberts on DSK5SPTVN1PROD with NOTICES
72418
Federal Register / Vol. 76, No. 226 / Wednesday, November 23, 2011 / Notices
download an electronic version of the
Guideline, go to https://
www.regulations.gov, Docket CDC–
2011–0011. You may submit written
comments electronically at this Web
site. Please follow directions at https://
www.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
Promotion, National Center for
Emerging and Zoonotic Infectious
Diseases, Centers for Disease Control
and Prevention, (CDC), 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, 30333.
All written materials identified will be
available for public inspection Monday
through Friday, except for legal
holidays, from 9 a.m. until 5 p.m.,
Eastern Standard Time, at 1600 Clifton
Road, NE., Atlanta, Georgia 30333.
Please call ahead to (404) 639–4000 and
ask for a representative from the Office
of Blood, Organ and Other Tissue Safety
to schedule your visit. All relevant
comments received will be posted
publicly at this Web site without
change, including any personal or
proprietary information.
FOR FURTHER INFORMATION CONTACT:
Debbie Seem, Division of Healthcare
Quality Promotion, National Center for
Emerging and Zoonotic Diseases,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE.,
Mailstop A–07, Atlanta, Georgia, 30329–
4018; Telephone: (404) 639–4000.
SUPPLEMENTARY INFORMATION: Since
2008, HHS/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. The 2011 draft Guideline
updates the previous recommendations
about HIV and also 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
VerDate Mar<15>2010
17:03 Nov 22, 2011
Jkt 226001
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 draft 2011 Guideline also
identifies important gaps in the
literature where further research is
needed.
HHS/CDC worked with the University
of Pennsylvania’s Health System Center
for Evidence-based Practice (CEP) and
sought input in each phase of the
Guideline’s development from subject
matter experts in HIV and hepatitis
through formation of a Guideline Expert
Panel to develop the new Guideline.
HHS/CDC also formed a Guideline
Review Committee to provide feedback
on the draft Guideline
recommendations. Members of the
Review Committee included
representation from public health,
regulatory, transplant infectious disease
and other stakeholders. This new Draft
Guideline will not be a federal rule or
regulation.
Juliana K. Cyril,
Deputy Director, Office of Science Quality,
Office of the Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2011–30205 Filed 11–22–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Statement of Organization, Functions,
and Delegations of Authority;
Administration on Developmental
Disabilities
Administration for Children
and Families, HHS.
ACTION: Notice.
AGENCY:
Statement of Organization,
Functions, and Delegations of
Authority. The Administration for
Children and Families (ACF) has
reorganized the Office of the Assistant
Secretary (OAS) and the Administration
on Developmental Disabilities (ADD).
This reorganization realigns the
President’s Committee for People with
Intellectual Disabilities Staff within the
OAS and moves the function to ADD as
a result of the Charter Amendment for
PCPID governed by Public Law 92–463
signed by the Secretary, HHS, on May
9, 2011.
SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Sharon Lewis, Commissioner,
Administration on Developmental
Disabilities, 200 Independence Avenue
SW., Washington, DC 20201, (202) 690–
6590.
This notice amends Part K of the
Statement of Organization, Functions
and Delegations of Authority of the
Department of Health and Human
Services (HHS), Administration for
Children and Families (ACF) as follows:
Chapter KA, Office of the Assistant
Secretary (OAS) last amended, 75 FR
60471–60473, September 30, 2010, and
Chapter KC, Administration on
Developmental Disabilities (ADD) last
amended 75 FR 63186–63187, October
14, 2010.
I. Under Chapter, KA, Amend the Office
of the Assistant Secretary as Follows
A. Delete KA.10 Organization in its
entirety and replace with the following:
KA.10 Organization. The Office of the
Assistant Secretary for Children and
Families is headed by the Assistant
Secretary for Children and Families who
reports directly to the Secretary and
consists of:
Office of the Assistant Secretary for
Children and Families (KA)
Executive Secretariat Office (KAF)
Office of Human Services Emergency
Preparedness and Response (KAG)
Office of the Deputy Assistant Secretary
and Inter-Departmental Liaison for
Early Childhood Development (KAH)
B. Delete KA.20 Functions B in Its
entirety.
II. Under Chapter, KC, Administration
on Developmental Disabilities, Delete in
Its Entirety and Replace With the
Following
KC.00 Mission. The Administration
on Developmental Disabilities (ADD)
advises the Secretary, through the
Assistant Secretary for Children and
Families, on matters relating to
individuals with developmental
disabilities and their families. ADD
serves as the focal point in the
Department to support and encourage
the provision of quality services to
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assists states, through the design and
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continuing state plan, in increasing the
independence, productivity and
community inclusion of individuals
with developmental disabilities. These
state plans make optimal use of existing
Federal and state resources for the
provision of services and supports to
these individuals and their families to
achieve these outcomes. ADD works
E:\FR\FM\23NON1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 226 (Wednesday, November 23, 2011)]
[Notices]
[Pages 72417-72418]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30205]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2011-0011]
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: Extension of the public comment period.
-----------------------------------------------------------------------
SUMMARY: On September 21, 2011, the Centers for Disease Control and
Prevention (CDC), located within the Department of Health and Human
Services (HHS), published a notice in the Federal Register requesting
public comment on the draft ``Public Health Service (PHS) Guideline for
Reducing Transmission of Human Immunodeficiency Virus (HIV), Hepatitis
B Virus (HBV), and Hepatitis C Virus (HCV) through Solid Organ
Transplantation'' (76 FR 58517). Written and electronic comments were
to be received on or before November 21, 2011. However, HHS/CDC has
received requests for a 30 day extension of the comment period. In
consideration of those requests, HHS/CDC is extending the comment
period by 30 days to December 23, 2011.
CDC also published 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 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 December 23,
2011.
ADDRESSES: Written comments may be submitted electronically or by mail.
To
[[Page 72418]]
download an electronic version of the Guideline, go to https://www.regulations.gov, Docket CDC-2011-0011. You may submit written
comments electronically at this Web site. Please follow directions at
https://www.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
Promotion, National Center for Emerging and Zoonotic Infectious
Diseases, Centers for Disease Control and Prevention, (CDC), 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, 30333. All
written materials identified will be available for public inspection
Monday through Friday, except for legal holidays, from 9 a.m. until 5
p.m., Eastern Standard Time, at 1600 Clifton Road, NE., Atlanta,
Georgia 30333. Please call ahead to (404) 639-4000 and ask for a
representative from the Office of Blood, Organ and Other Tissue Safety
to schedule your visit. All relevant comments received will be posted
publicly at this Web site without change, including any personal or
proprietary information.
FOR FURTHER INFORMATION CONTACT: Debbie Seem, Division of Healthcare
Quality Promotion, National Center for Emerging and Zoonotic Diseases,
Centers for Disease Control and Prevention, 1600 Clifton Road NE.,
Mailstop A-07, Atlanta, Georgia, 30329-4018; Telephone: (404) 639-4000.
SUPPLEMENTARY INFORMATION: Since 2008, HHS/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. The 2011
draft Guideline updates the previous recommendations about HIV and also
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 draft
2011 Guideline also identifies important gaps in the literature where
further research is needed.
HHS/CDC worked with the University of Pennsylvania's Health System
Center for Evidence-based Practice (CEP) and sought input in each phase
of the Guideline's development from subject matter experts in HIV and
hepatitis through formation of a Guideline Expert Panel to develop the
new Guideline. HHS/CDC also formed a Guideline Review Committee to
provide feedback on the draft Guideline recommendations. Members of the
Review Committee included representation from public health,
regulatory, transplant infectious disease and other stakeholders. This
new Draft Guideline will not be a federal rule or regulation.
Juliana K. Cyril,
Deputy Director, Office of Science Quality, Office of the Associate
Director for Science, Centers for Disease Control and Prevention.
[FR Doc. 2011-30205 Filed 11-22-11; 8:45 am]
BILLING CODE 4163-18-P
