Meeting of the Advisory Committee on Blood Safety and Availability, 28619-28620 [2010-12326]
Download as PDF
<![CDATA[
emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 98 / Friday, May 21, 2010 / Notices
instruments, including product lines
adjacent to the 3Q GC-MS and ICP-MS
businesses. As a result, Bruker has a
significant existing global infrastructure
that will enable it to quickly support
additional business expansion and
replace the loss of competition posed by
Agilent’s acquisition of Varian.
Pursuant to the Consent Agreement,
Inficon will receive the assets necessary
to replicate Agilent’s Micro GC
instrument business, and Bruker will
receive the assets necessary to replicate
Varian’s 3Q GC-MS and ICP-MS
instrument businesses. In addition to
ensuring that the employees of the
relevant businesses will continue their
employment with the acquirers, the
Consent Agreement requires Agilent to
provide Inficon and Bruker with access
to additional Agilent employees who
may be needed to facilitate the
transition of the assets associated with
each of the Products. The Consent
Agreement also requires Agilent to
transfer all relevant intellectual property
and all contracts and confidential
business information associated with
each of the Products. Combined, these
provisions ensure that Inficon and
Bruker fully and immediately restore
the competition that will be eliminated
by the acquisition.
The Commission may appoint an
interim monitor to oversee the
divestiture of the Products at any time
after the Consent Agreement has been
signed. In order to ensure that the
Commission remains informed about
the status of the proposed divestitures,
the proposed Consent Agreement
requires the parties to file periodic
reports with the Commission until the
divestiture is accomplished. If the
Commission determines that Agilent has
not fully complied with its obligations
under the Decision and Order within
ten days after the date the Decision and
Order becomes final, the Commission
may appoint a divestiture trustee to
divest the Micro GC, 3Q GC-MS, and
ICP-MS assets to a Commissionapproved acquirer.
The purpose of this analysis is to
facilitate public comment on the
Consent Agreement, and it is not
intended to constitute an official
interpretation of the proposed Decision
and Order or to modify its terms in any
way.
By direction of the Commission.
Donald S. Clark
Secretary.
[FR Doc. 2010–12183 Filed 5–20–10; 11:55 am]
BILLING CODE 6750–01–S
VerDate Mar<15>2010
16:40 May 20, 2010
Jkt 220001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Advisory Committee on
Blood Safety and Availability
AGENCY: Department of Health and
Human Services, Office of the Secretary.
ACTION: Notice.
SUMMARY: As stipulated by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Services is hereby giving notice that the
Advisory Committee on Blood Safety
and Availability (ACBSA) will hold a
meeting. The meeting will be open to
the public.
DATES: The meeting will take place
Thursday, June 10 and Friday, June 11,
2010, from 8:30 a.m. to 5 p.m.
ADDRESSES: The Universities at Shady
Grove, 9630 Gudelsky Drive, Rockville,
Maryland 20850, Phone: 301–738–6000.
FOR FURTHER INFORMATION CONTACT: Jerry
A. Holmberg, PhD, Executive Secretary,
Advisory Committee on Blood Safety
and Availability, Office of Public Health
and Science, Department of Health and
Human Services, 1101 Wootton
Parkway, Suite 250, Rockville, MD
20852, (240) 453–8803, FAX (240) 453–
8456, e-mail ACBSA@hhs.gov.
SUPPLEMENTARY INFORMATION: The
Advisory Committee on Blood Safety
and Availability (ACBSA) provides
advice to the Secretary and the Assistant
Secretary for Health on a range of policy
issues that impact (1) Definition of
public health parameters around safety
and availability of the blood supply and
blood products, (2) broad public health,
ethical and legal issues related to
transfusion and transplantation safety,
and (3) the implications for safety and
the availability of various economic
factors affecting product cost and
supply.
Current Food and Drug
Administration (FDA) policy
recommends that men who have had
sex with another man (MSM) even one
time since 1977 should be deferred
indefinitely from donating blood. The
deferral of MSM began prior to the
availability of tests for HIV in early
1985. The deferral has existed in its
current form since September 1985.
This and other related FDA policies are
designed to address the major sources of
known risk to the blood supply as well
as the theoretical risk of emerging
infectious disease (EID) transmission.
FDA has reviewed the policy
periodically, most recently at a meeting
of the FDA Blood Products Advisory
Committee in 2000 and in an FDAsponsored public scientific workshop in
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
28619
2006. After considering both public
discussions FDA retained its policy.
FDA has noted its commitment to
continue to review its donor deferral
recommendations.
Data from the Centers for Disease
Control and Prevention (CDC) indicate
that HIV and other blood borne
pathogens are not randomly distributed
in the population, but are concentrated
within specific subgroups, including
those whose sex partners have risk
behavior(s) associated with a higher
prevalence of transfusion transmitted
diseases (TTDs). MSM have an
increased incidence and prevalence of
several currently recognized
transfusion-transmitted diseases (e.g.
HBV, HIV, syphilis, and CMV). There is
a theoretical concern that MSM
populations may also be at increased
risk for other unrecognized transfusiontransmitted agents.
Although today’s blood supply is
screened using highly sensitive tests,
screening tests can be falsely negative
during the ‘‘window period,’’ defined as
the interval between the time when an
infected individual may transmit the
disease and the time when screening
tests become positive. A period of
deferral is needed after high-risk
exposure to prevent false negative tests
from ‘‘window period’’ collections.
Deferral of donors with high-risk
exposure depends upon reliable
responses to a donor questionnaire,
which are never 100 percent accurate.
Therefore, despite highly sensitive
testing and current deferral policies,
failures to identify infected donors may
occur.
In addition, unsuitable blood may be
released inadvertently through
inventory control errors. This increased
risk is believed to be primarily related
to human errors resulting in the release
of infected units from quarantine. This
is based on the assumption that due to
higher infectious disease prevalence in
MSM, greater numbers of infected units
would be collected, leading to a small
overall increase in quarantine release
errors. These quarantine release errors
would likely be reduced if
computerized inventory controls were
in place in all blood facilities.
At the June 10–11, 2010 meeting, the
HHS ACBSA will hear presentations
and engage in deliberations on the
current MSM deferral policy.
Specifically, the ACBSA will be asked
to discuss the following: what are the
most important factors (e.g. societal,
scientific, and economic) to consider in
making a policy change; is the currently
available scientific information
including risk assessments sufficient to
support a policy change at this time;
E:\FR\FM\21MYN1.SGM
21MYN1
28620
Federal Register / Vol. 75, No. 98 / Friday, May 21, 2010 / Notices
what studies, if any, are needed before
implementing a policy change; what
monitoring tools or surveillance
activities would need to be in place
before implementing a policy change;
what additional safety measures, if any,
are needed to assure blood safety under
a revised deferral policy?
The public will have opportunity to
present their views to the Committee on
the second day. A public comment
session has been scheduled for June 11,
2010. Comments will be limited to five
minutes per speaker and must be
pertinent to the discussion. Preregistration is required for participation
in the public comment session. Any
member of the public who would like to
participate in this session should
contact the Executive Secretary no later
than June 8, 2010. It is requested that
those who wish to have printed material
distributed to the Committee provide
thirty (30) copies of the document to be
distributed to the Executive Secretary,
ACBSA, prior to close of business June
8, 2010. If it is not possible to provide
30 copies of the material to be
distributed, then individuals are
requested to provide at a minimum one
(1) copy of the document(s) to be
distributed prior to the close of business
June 8, 2010. It also is requested that
any member of the public who wishes
to provide comments to the Committee
utilizing electronic data projection
submit the necessary material to the
Executive Secretary prior to close of
business June 8, 2010. Electronic
comments must adhere to disability
accessibility guidelines (Section 508
compliance).
Dated: May 4, 2010.
Jerry A. Holmberg,
Executive Secretary, Advisory Committee on
Blood Safety and Availability.
[FR Doc. 2010–12326 Filed 5–20–10; 8:45 am]
BILLING CODE 4150–41–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30 Day–10–10BT]
emcdonald on DSK2BSOYB1PROD with NOTICES
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
VerDate Mar<15>2010
16:40 May 20, 2010
Jkt 220001
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
National Quitline Data Warehouse—
New—National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Tobacco use remains the leading
preventable cause of disease and death
in the United States, resulting in
approximately 440,000 deaths annually
and contributing to $92 billion annually
in lost worker productivity. Although
the prevalence of current smoking
among adults decreased significantly
since its peak in the 1960s, overall
smoking prevalence among U.S. adults
has remained virtually unchanged
during the past five years. Large
disparities in smoking prevalence
continue to exist among members of
racial/ethnic minority groups and
individuals of low socioeconomic
status.
The National Tobacco Control
Program (NTCP) was established by
CDC to help reduce tobacco-related
disease, disability, and death. The NTCP
provides funding for state Quitlines,
which provide telephone-based tobacco
cessation services to help tobacco users
quit. Quitlines overcome many of the
barriers to tobacco cessation classes and
traditional clinics because they are free
and available at the caller’s
convenience. Quitline services in all
states can be accessed through a toll-free
national portal number at 1–800–QUIT–
NOW. According to CDC’s Best
Practices for Comprehensive Tobacco
Control, approximately six to eight
percent of tobacco users potentially can
be reached successfully by Quitlines;
however, currently, only one to two
percent of tobacco users contact
Quitlines.
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
With funding authorized by the
American Recovery and Reinvestment
Act of 2009 (ARRA), CDC has provided
additional support for the expansion of
tobacco Quitline services. CDC is
therefore requesting OMB approval to
establish a National Quitline Data
Warehouse (NDQW), and to collect
information from the 50 states, the
District of Columbia, Puerto Rico, and
Guam. The principal information
collection will be based on a uniform
Minimum Data Set (MDS) developed
collaboratively by the North American
Quitline Consortium and other tobacco
control organizations.
Quitline service providers will use a
common interview instrument to collect
information from all callers. A oneminute interview will be conducted
with callers who contact the Quitline to
obtain information on another person’s
behalf. Callers who contact the Quitline
to obtain information or services for
themselves will be asked to participate
in a 10-minute interview. A random
sample of callers who receive a Quitline
service will be asked to participate in a
short, voluntary follow-up interview
seven months after intake.
In addition, to monitor and evaluate
the expenditure of Recovery Act
funding, CDC will collect a quarterly
report about each Quitline program from
the designated Tobacco Control
Manager. These reports will be used to
quantify improvements in the capacity
of the Quitlines to assist tobacco users
over time.
The information collected in the
NQDW will be used to determine the
role Quitlines play in promoting tobacco
use cessation, measure the number of
tobacco users being served by state
Quitlines, determine reach of Quitlines
to high-risk populations (e.g., racial and
ethnic minorities and the medically
underserved), measure the number
using each state Quitline who quit,
determine whether some combinations
of services contribute to higher quit
rates than others, and improve the
timeliness, access to, and quality of data
collected by Quitlines.
Information will be collected
electronically for a two-year period.
There are no costs to respondents other
than their time. The total estimated
annualized burden hours are 90,563.
E:\FR\FM\21MYN1.SGM
21MYN1
]]>Agencies
[Federal Register Volume 75, Number 98 (Friday, May 21, 2010)]
[Notices]
[Pages 28619-28620]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-12326]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Advisory Committee on Blood Safety and
Availability
AGENCY: Department of Health and Human Services, Office of the
Secretary.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: As stipulated by the Federal Advisory Committee Act, the U.S.
Department of Health and Human Services is hereby giving notice that
the Advisory Committee on Blood Safety and Availability (ACBSA) will
hold a meeting. The meeting will be open to the public.
DATES: The meeting will take place Thursday, June 10 and Friday, June
11, 2010, from 8:30 a.m. to 5 p.m.
ADDRESSES: The Universities at Shady Grove, 9630 Gudelsky Drive,
Rockville, Maryland 20850, Phone: 301-738-6000.
FOR FURTHER INFORMATION CONTACT: Jerry A. Holmberg, PhD, Executive
Secretary, Advisory Committee on Blood Safety and Availability, Office
of Public Health and Science, Department of Health and Human Services,
1101 Wootton Parkway, Suite 250, Rockville, MD 20852, (240) 453-8803,
FAX (240) 453-8456, e-mail ACBSA@hhs.gov.
SUPPLEMENTARY INFORMATION: The Advisory Committee on Blood Safety and
Availability (ACBSA) provides advice to the Secretary and the Assistant
Secretary for Health on a range of policy issues that impact (1)
Definition of public health parameters around safety and availability
of the blood supply and blood products, (2) broad public health,
ethical and legal issues related to transfusion and transplantation
safety, and (3) the implications for safety and the availability of
various economic factors affecting product cost and supply.
Current Food and Drug Administration (FDA) policy recommends that
men who have had sex with another man (MSM) even one time since 1977
should be deferred indefinitely from donating blood. The deferral of
MSM began prior to the availability of tests for HIV in early 1985. The
deferral has existed in its current form since September 1985. This and
other related FDA policies are designed to address the major sources of
known risk to the blood supply as well as the theoretical risk of
emerging infectious disease (EID) transmission. FDA has reviewed the
policy periodically, most recently at a meeting of the FDA Blood
Products Advisory Committee in 2000 and in an FDA-sponsored public
scientific workshop in 2006. After considering both public discussions
FDA retained its policy. FDA has noted its commitment to continue to
review its donor deferral recommendations.
Data from the Centers for Disease Control and Prevention (CDC)
indicate that HIV and other blood borne pathogens are not randomly
distributed in the population, but are concentrated within specific
subgroups, including those whose sex partners have risk behavior(s)
associated with a higher prevalence of transfusion transmitted diseases
(TTDs). MSM have an increased incidence and prevalence of several
currently recognized transfusion-transmitted diseases (e.g. HBV, HIV,
syphilis, and CMV). There is a theoretical concern that MSM populations
may also be at increased risk for other unrecognized transfusion-
transmitted agents.
Although today's blood supply is screened using highly sensitive
tests, screening tests can be falsely negative during the ``window
period,'' defined as the interval between the time when an infected
individual may transmit the disease and the time when screening tests
become positive. A period of deferral is needed after high-risk
exposure to prevent false negative tests from ``window period''
collections. Deferral of donors with high-risk exposure depends upon
reliable responses to a donor questionnaire, which are never 100
percent accurate. Therefore, despite highly sensitive testing and
current deferral policies, failures to identify infected donors may
occur.
In addition, unsuitable blood may be released inadvertently through
inventory control errors. This increased risk is believed to be
primarily related to human errors resulting in the release of infected
units from quarantine. This is based on the assumption that due to
higher infectious disease prevalence in MSM, greater numbers of
infected units would be collected, leading to a small overall increase
in quarantine release errors. These quarantine release errors would
likely be reduced if computerized inventory controls were in place in
all blood facilities.
At the June 10-11, 2010 meeting, the HHS ACBSA will hear
presentations and engage in deliberations on the current MSM deferral
policy. Specifically, the ACBSA will be asked to discuss the following:
what are the most important factors (e.g. societal, scientific, and
economic) to consider in making a policy change; is the currently
available scientific information including risk assessments sufficient
to support a policy change at this time;
[[Page 28620]]
what studies, if any, are needed before implementing a policy change;
what monitoring tools or surveillance activities would need to be in
place before implementing a policy change; what additional safety
measures, if any, are needed to assure blood safety under a revised
deferral policy?
The public will have opportunity to present their views to the
Committee on the second day. A public comment session has been
scheduled for June 11, 2010. Comments will be limited to five minutes
per speaker and must be pertinent to the discussion. Pre-registration
is required for participation in the public comment session. Any member
of the public who would like to participate in this session should
contact the Executive Secretary no later than June 8, 2010. It is
requested that those who wish to have printed material distributed to
the Committee provide thirty (30) copies of the document to be
distributed to the Executive Secretary, ACBSA, prior to close of
business June 8, 2010. If it is not possible to provide 30 copies of
the material to be distributed, then individuals are requested to
provide at a minimum one (1) copy of the document(s) to be distributed
prior to the close of business June 8, 2010. It also is requested that
any member of the public who wishes to provide comments to the
Committee utilizing electronic data projection submit the necessary
material to the Executive Secretary prior to close of business June 8,
2010. Electronic comments must adhere to disability accessibility
guidelines (Section 508 compliance).
Dated: May 4, 2010.
Jerry A. Holmberg,
Executive Secretary, Advisory Committee on Blood Safety and
Availability.
[FR Doc. 2010-12326 Filed 5-20-10; 8:45 am]
BILLING CODE 4150-41-P
