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, 58517-58518 [2011-24189]
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58517
Federal Register / Vol. 76, No. 183 / Wednesday, September 21, 2011 / Notices
Dated: September 13, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2011–24187 Filed 9–20–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–0920–0792]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington
DC or by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Proposed Project
Environmental Health Specialists
Network (EHS–NET) Program, OMB
0920–0792, expiration 10/31/2011—
Revision—National Center for
Environmental Health (NCEH), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
The CDC is requesting OMB approval
for three additional years to use this
generic clearance for a research program
focused on identifying the
environmental causes of foodborne
illness. This revision will provide OMB
clearance for EHS–Net data collections
conducted in 2011 through 2014 (a
maximum of 3 annually). The program
is revising the generic information
collection request (ICR) to reduce the
number of respondent groups, reduce
the number of studies conducted and
the estimated burden, and collect more
generalizable data.
Reducing foodborne illness first
requires identification and
understanding of the environmental
factors that cause these illnesses. We
need to know how and why food
becomes contaminated with foodborne
illness pathogens. This information can
then be used to determine effective food
safety prevention methods. The purpose
of this food safety research program is
to identify and understand
environmental factors associated with
foodborne illness and outbreaks. This
program will continue to involve up to
3 data collections a year. This program
is conducted by the Environmental
Health Specialists Network (EHS–Net), a
collaborative project of CDC, FDA,
USDA, and six state/local sites (CA,
NYC, NY, MN, RI, and TN).
Environmental factors associated with
foodborne illness include both food
safety practices (e.g., inadequate
cleaning practices) and the factors in the
environment associated with those
practices (e.g., worker and retail food
establishment characteristics). To
understand these factors, we need to
continue to collect data from those who
prepare food (i.e., food workers) and on
the environments in which the food is
prepared (i.e., retail food establishment
kitchens). Thus, our respondents will be
retail food establishment food workers.
For each data collection, we will
collect data in approximately 480 retail
food establishments. For each data
collection, we will collect data from a
maximum 1,440 workers. Each
respondent will respond only once and
the average burden per response will be
approximately 30 minutes. We will
conduct up to 3 data collections a year.
The maximum annual interview/survey
burden for all 3 data collections will be
2,160 hours.
We expect a worker response rate of
approximately 70 percent. Thus, for
each data collection, we will need to
conduct a recruiting screener with
approximately 2,057 worker
respondents to obtain the needed
number of respondents. Each
respondent will respond only once and
the average burden per response will be
3 minutes. As we plan to conduct up to
3 data collections annually, the
maximum annual recruiting screener
burden will be 309 hours. The total
maximum annual burden will be 2,469
hours. There is no cost to the
respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Retail food workers ...................................
Retail food workers ...................................
Interview/survey ........................................
Recruiting screener ..................................
Dated: September 15, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2011–24181 Filed 9–20–11; 8:45 am]
wreier-aviles on DSK7SPTVN1PROD with NOTICES
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Notice of availability and
request for public comment.
Centers for Disease Control and
Prevention
SUMMARY:
[Docket No. CDC–2011–0011]
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (DHHS).
Jkt 223001
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per response (in
hours)
ACTION:
AGENCY:
15:20 Sep 20, 2011
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6,171
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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
VerDate Mar<15>2010
Number of
responses per
respondent
Number of
respondents
Type of respondents
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With this notice, the Centers
for Disease Control and Prevention
(CDC), located within the Department of
Health and Human Services (HHS)
requests public comment on the draft
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 (Draft Guideline). The
Draft Guideline can be found at https://
www.regulations.gov under Docket No.
CDC–2011–0011.
E:\FR\FM\21SEN1.SGM
21SEN1
58518
Federal Register / Vol. 76, No. 183 / Wednesday, September 21, 2011 / Notices
Also found at the docket is 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 Draft
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 November 21,
2011.
Written comments may be
submitted electronically or by mail. You
may also submit written comments
electronically to: https://
www.regulations.gov. Comments must
be identified by Docket No. CDC–2011–
0011. Please follow directions at https://
wwww.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
Quality Promotion, National Center for
Emerging and Zoonotic Infectious
Diseases, Centers for Disease Control
and Prevention, 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, 30329.
All written materials identified by
Docket No. CDC–2011–0011 will be
available for public inspection Monday
through Friday, except for legal
holidays, from 9 a.m. until 5 p.m.,
Eastern Daylight Time, at 1600 Clifton
Road, NE., Atlanta, Georgia 30333.
wreier-aviles on DSK7SPTVN1PROD with NOTICES
ADDRESSES:
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 public
comments will be reviewed and
considered prior to finalizing the Draft
Guideline. All relevant comments
received will be posted publicly without
change, including any personal or
proprietary information provided. To
download an electronic version of the
Draft Guideline, access https://
www.regulations.gov, Docket No. CDC–
2011–0011.
FOR FURTHER INFORMATION CONTACT:
Debbie Seem, Division of Healthcare
Quality Promotion, National Center for
Emerging and Zoonotic Infectious
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, 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 (1994
Guideline). The 2011 Draft Guideline
updates the previous recommendations
for HIV, 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 2011 Draft
Guideline also identifies important gaps
in the literature where further research
is needed.
CDC worked with the University of
Pennsylvania’s Health System Center for
Evidence-based Practice (CEP) and
sought input in each phase of the Draft
Guideline’s development from subject
matter experts in HIV and hepatitis
through formation of a Guideline Expert
Panel to develop the new Draft
Guideline. CDC also formed a Guideline
Review Committee to provide feedback
on the Draft Guideline
recommendations. Members of the
Review Committee included
representatives from public health, the
regulatory arena, transplant infectious
disease experts, and other stakeholders.
This new Draft Guideline will not be a
federal rule or regulation.
Dated: September 13, 2011.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2011–24189 Filed 9–20–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Temporary Assistance for Needy
Families/National Directory of New
Hires Match Results Report.
OMB No.: 0970–0311.
Description: Section 453(j)(3) of the
Social Security Act (the Act) allows for
matching between the National
Directory of New Hires (maintained by
the Federal Office of Child Support
Enforcement (OCSE)) and State TANF
Agencies for purposes of carrying out
responsibilities under programs funded
under part A of Title IV of the Act. To
assist OCSE and Office of Family
Assistance (OFA) in measuring savings
to the TANF program attributable to the
use of NDNH data matches, the State
TANF Agencies have agreed to provide
OCSE with a written description of the
performance outputs and outcomes
attributable to the State TANF Agency’s
use of NDNH match results. This
information will help OCSE
demonstrate how the NDNH supports
the OCSE’s mission and strategic goals.
Respondents: State TANF Agencies.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
TANF/NDNH Match Results Report ................................................................
VerDate Mar<15>2010
15:20 Sep 20, 2011
Jkt 223001
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
40
E:\FR\FM\21SEN1.SGM
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21SEN1
Average
burden hours
per response
0.17
Total burden
hours *
27.20
]]>Agencies
[Federal Register Volume 76, Number 183 (Wednesday, September 21, 2011)]
[Notices]
[Pages 58517-58518]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24189]
-----------------------------------------------------------------------
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: Notice of availability and request for public comment.
-----------------------------------------------------------------------
SUMMARY: With this notice, the Centers for Disease Control and
Prevention (CDC), located within the Department of Health and Human
Services (HHS) requests public comment on the draft 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 (Draft Guideline). The Draft
Guideline can be found at https://www.regulations.gov under Docket No.
CDC-2011-0011.
[[Page 58518]]
Also found at the docket is 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 Draft 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 November 21,
2011.
ADDRESSES: Written comments may be submitted electronically or by mail.
You may also submit written comments electronically to: https://www.regulations.gov. Comments must be identified by Docket No. CDC-
2011-0011. Please follow directions at https://wwww.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
Quality Promotion, National Center for Emerging and Zoonotic Infectious
Diseases, Centers for Disease Control and Prevention, 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, 30329. All
written materials identified by Docket No. CDC-2011-0011 will be
available for public inspection Monday through Friday, except for legal
holidays, from 9 a.m. until 5 p.m., Eastern Daylight 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 public comments
will be reviewed and considered prior to finalizing the Draft
Guideline. All relevant comments received will be posted publicly
without change, including any personal or proprietary information
provided. To download an electronic version of the Draft Guideline,
access https://www.regulations.gov, Docket No. CDC-2011-0011.
FOR FURTHER INFORMATION CONTACT: Debbie Seem, Division of Healthcare
Quality Promotion, National Center for Emerging and Zoonotic Infectious
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, 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 (1994
Guideline). The 2011 Draft Guideline updates the previous
recommendations for HIV, 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 2011 Draft Guideline also identifies important
gaps in the literature where further research is needed.
CDC worked with the University of Pennsylvania's Health System
Center for Evidence-based Practice (CEP) and sought input in each phase
of the Draft Guideline's development from subject matter experts in HIV
and hepatitis through formation of a Guideline Expert Panel to develop
the new Draft Guideline. CDC also formed a Guideline Review Committee
to provide feedback on the Draft Guideline recommendations. Members of
the Review Committee included representatives from public health, the
regulatory arena, transplant infectious disease experts, and other
stakeholders. This new Draft Guideline will not be a federal rule or
regulation.
Dated: September 13, 2011.
Tanja Popovic,
Deputy Associate Director for Science, Centers for Disease Control and
Prevention.
[FR Doc. 2011-24189 Filed 9-20-11; 8:45 am]
BILLING CODE 4163-18-P
