Advisory Council on Alzheimer's Research, Care, and Services; Request for Nominations, 14804-14805 [2012-6083]
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Federal Register / Vol. 77, No. 49 / Tuesday, March 13, 2012 / Notices
tracking the results of pre-donation
testing; (3) the period within which a
potential MSM donor would need to
return to complete an actual blood
donation; (4) concern that pre-donation
testing of only MSM could be seen as
discriminatory; and (5) the residual
impact on safety due to window period
donations that would not be reduced by
pre-testing.
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(b) Post-Donation Testing
In a post-donation testing strategy,
MSM who are presently deferred, but
who would be eligible to donate during
the pilot under modified deferral
criteria would have a unit of blood
drawn. This unit would be segregated
from other units and placed in a
separate quarantine. The donor would
be asked to return for ‘‘post-donation
testing’’ within a specified period
following the donation that would
exceed the ‘‘window period’’ for
transfusion-transmissible infections but
be within the expiration dating period
of the unit of blood (i.e., within 14 to
42 days post-donation for red blood
cells or from 14 days to within one year
for plasma for transfusion). For donors
who continue to meet acceptance
criteria and have negative ‘‘postdonation test’’ results, the unit would be
released for transfusion. Such
collections would be most applicable to
repeat plasma donations given the
longer shelf life of frozen plasma,
providing greater flexibility for the time
of ‘‘post-donation testing’’ of the donor.
Also, plasma for transfusion could be
collected at the time of ‘‘post-donation
testing’’ initiating a new quarantine for
a new collection.
Placing units drawn from MSM
donors in quarantine until qualifying
‘‘post-donation testing’’ results are
obtained would address the issue of
recent (i.e. ‘‘incident’’) infections.
Infectious units would be entered into a
quarantine portion of the blood bank
inventory prior to the availability of
screening test results. However, if more
infectious units are drawn and placed in
inventory, these units would be subject
to quarantine release errors.
There could be the same or similar
unanswered questions for the postdonation testing strategy as are outlined
above under the pre-donation testing
strategy. In addition, blood
establishments would need to maintain
stratified and potentially larger
quarantine inventories and would incur
the costs of discarding all units in
quarantine for which a donor failed to
return for ‘‘post-donation testing.’’
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(c) Combined Pre-Donation and PostDonation Testing
Under this scenario, an MSM donor
seeking to donate under modified
deferral criteria would be screened with
a questionnaire and asked to give a predonation testing sample. Assuming the
blood sample is negative for infectious
markers, and the donor meets all other
eligibility criteria, the donor would be
invited to return within a defined
period to donate a unit of blood. This
unit would be placed in quarantine and
the donor again would be asked to
return, this time for post-donation
testing also within a specified time
period.
This strategy would provide the
strictest control over any increase in risk
to the blood supply. Both incident and
prevalent infection concerns would be
addressed. However, this scenario
would require a potential donor meeting
the candidate MSM acceptability
criteria to make three appearances at a
blood collection facility within
specified time periods in order to have
a donation released for transfusion.
Blood establishments would face
challenging logistic issues in conducting
such a study concurrently with normal,
highly standardized blood collection
operations.
(3) Input is requested on the data that
should be gathered and the criteria used
to evaluate the results of the pilot
operational study. For example, should
MSM donors and non-MSM donors be
asked to participate in surveys on their
understanding of the donor screening
questions, their specific sexual
behaviors and their motivations to
donate blood? Should the study
outcome be based on observed markers
of transfusion-transmitted infections in
MSM donors compared with other
donors? Should MSM donors with
positive screening tests be interviewed
to better understand their risk factors,
their understanding of the donor
questionnaire and their motivations to
donate if they did not appropriately selfdefer or disclose their risk?
Requested RFI Responses:
Please comment on each of the above
scenarios, or propose additional pilot
operational study designs for
consideration. In your response, please
address each of the following:
• Revised criteria that should be
considered to permit blood donation
by MSM
• Blood safety considerations and safety
mitigations that should be considered
• Impact on blood establishment
operations
• Staff training and staff perceptions
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• Tracking of pre-donation and/or postdonation test results
• Inventory management
• Donor perceptions regarding the
possible changes in deferral policy
within the operational study scenarios
(including both MSM and non-MSM
donors)
• Public reaction, if any, and impact on
blood drives
• Potential venues where the study
could be conducted
• Study costs
• Willingness of blood organizations to
participate in a pilot study
• Data elements that should be gathered
during the study, including those that
may be associated with future
emerging infections
• Criteria for evaluation of the study
results and conclusions
• Expected timeframe for each proposed
study.
Dated: March 8, 2012.
Richard Henry,
Deputy Director, Blood Safety & Availability.
[FR Doc. 2012–6091 Filed 3–12–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Advisory Council on Alzheimer’s
Research, Care, and Services; Request
for Nominations
Office of the Assistant
Secretary for Planning and Evaluation;
Department of Health and Human
Services.
ACTION: Request for Nominations.
AGENCY:
HHS is soliciting nominations
for a new, non-Federal member of the
Advisory Council on Alzheimer’s
Research, Care, and Services to fill the
position of ‘‘representative of a state
public health department.’’
Nominations should include the
nominee’s contact information (current
mailing address, email address, and
telephone number) and current
curriculum vitae or resume.
DATES: Submit nominations by email or
USPS mail before COB on April 4, 2012.
ADDRESSES: Nominations should be sent
to Helen Lamont at
helen.lamont@hhs.gov; Helen Lamont,
Ph.D., Office of the Assistant Secretary
for Planning and Evaluation, Room 424E
Humphrey Building, Department of
Health and Human Services, 200
Independence Avenue SW.,
Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT:
Helen Lamont (202) 690–7996,
helen.lamont@hhs.gov.
SUMMARY:
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Federal Register / Vol. 77, No. 49 / Tuesday, March 13, 2012 / Notices
The
Advisory Council on Alzheimer’s
Research, Care, and Services meets
quarterly to discuss programs that
impact people with Alzheimer’s disease
and related dementias and their
caregivers. The Advisory Council makes
recommendations about ways to reduce
the financial impact of Alzheimer’s
disease and related dementias and to
improve the health outcomes of people
with these conditions. The Advisory
Council provides feedback on the
National Plan to Address Alzheimer’s
Disease. On an annual basis, the
Advisory Council shall evaluate the
implementation of the
recommendations through an updated
national plan.
The Advisory Council consists of
designees from Federal agencies
including the Centers for Disease
Control and Prevention, Administration
on Aging, Centers for Medicare and
Medicaid Services, Indian Health
Service, Office of the Director of the
National Institutes of Health, National
Science Foundation, Department of
Veterans Affairs, Food and Drug
Administration, Agency for Healthcare
Research and Quality, and the Surgeon
General. The Advisory Council also
consists of 12 non-federal members
selected by the Secretary who are
Alzheimer’s patient advocates (2),
Alzheimer’s caregivers (2), health care
providers (2), representatives of State
health departments (2), researchers with
Alzheimer’s-related expertise in basic,
translational, clinical, or drug
development science (2), and voluntary
health association representatives (2).
Members serve for overlapping 4 year
terms, except that any member
appointed to fill a vacancy for an
unexpired term shall be appointed for
the remainder of such term. A member
may serve after the expiration of the
member’s term until a successor has
taken office. Members serve as Special
Government Employees. This
announcement is seeking nominations
for a ‘‘representative of a state public
health department’’ who is not a Federal
employee.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Sherry Glied,
Assistant Secretary for Planning and
Evaluation.
[FR Doc. 2012–6083 Filed 3–12–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention (CDC)
Request for Nominations of
Candidates to Serve on the Advisory
Committee on Immunization Practices
(ACIP)
The CDC is soliciting nominations for
membership on the ACIP. The ACIP
consists of 15 experts in fields
associated with immunization, who are
selected by the Secretary of the U. S.
Department of Health and Human
Services to provide advice and guidance
to the Secretary, the Assistant Secretary
for Health, and the CDC on the control
of vaccine-preventable diseases. The
role of the ACIP is to provide advice
that will lead to a reduction in the
incidence of vaccine preventable
diseases in the United States, and an
increase in the safe use of vaccines and
related biological products. The
committee also establishes, reviews, and
as appropriate, revises the list of
vaccines for administration to children
eligible to receive vaccines through the
Vaccines for Children (VFC) Program.
Nominations are being sought for
individuals who have expertise and
qualifications necessary to contribute to
the accomplishments of the committee’s
objectives. Nominees will be selected
based on expertise in the field of
immunization practices; multidisciplinary expertise in public health;
expertise in the use of vaccines and
immunologic agents in both clinical and
preventive medicine; knowledge of
vaccine development, evaluation, and
vaccine delivery; or knowledge about
consumer perspectives and/or social
and community aspects of
immunization programs. Federal
employees will not be considered for
membership. Members may be invited
to serve for four-year terms. The next
cycle of selection of candidates will
begin in the fall of 2012, for selection of
potential nominees to replace members
whose terms will end on June 30, 2013.
Selection of members is based on
candidates’ qualifications to contribute
to the accomplishment of ACIP
objectives (https://www.cdc.gov/
vaccines/recs/acip). The U.S.
Department of Health and Human
Services policy stipulates that
committee membership be balanced in
terms of points of view represented and
the committee’s function. Consideration
is given to a broad representation of
geographic areas within the U.S., as well
as gender, race, ethnicity, and persons
with disabilities. Nominees must be
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14805
U.S. citizens, and cannot be full-time
employees of the U.S. Government.
Candidates should submit the
following items:
• Current curriculum vitae, including
complete contact information
(telephone numbers, fax number,
mailing address, email address)
• At least one letter of
recommendation from person(s) not
employed by the U.S. Department of
Health and Human Services. Candidates
may submit letter(s) from current HHS
employees if they wish, but at least one
letter must be submitted by a person not
employed by HHS.
Nominations should be submitted
(postmarked or received) by November
16, 2012 (for consideration for term
beginning July 2013.) All files must be
submitted electronically as email
attachments to:
• Ms. Stephanie Thomas, c/o ACIP
Secretariat, SThomas5@cdc.gov.
• Nominations may be submitted by
the candidate or by the person/
organization recommending the
candidate.
The Director, Management Analysis
and Services Office, 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.
Dated: March 6, 2012.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2012–6071 Filed 3–12–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Clinical Laboratory Improvement
Advisory Committee, Centers for
Disease Control and Prevention:
Notice of Charter Renewal
This gives notice under the Federal
Advisory Committee Act (Pub. L. 92–
463) of October 6, 1972, that the Clinical
Laboratory Improvement Advisory
Committee, Centers for Disease Control
and Prevention (CDC), Department of
Health and Human Services (HHS), has
been renewed for a 2-year period
through February 19, 2014.
For information, contact May Chu,
Ph.D., Designated Federal Officer,
Clinical Laboratory Improvement
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]]>Agencies
[Federal Register Volume 77, Number 49 (Tuesday, March 13, 2012)]
[Notices]
[Pages 14804-14805]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6083]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Advisory Council on Alzheimer's Research, Care, and Services;
Request for Nominations
AGENCY: Office of the Assistant Secretary for Planning and Evaluation;
Department of Health and Human Services.
ACTION: Request for Nominations.
-----------------------------------------------------------------------
SUMMARY: HHS is soliciting nominations for a new, non-Federal member of
the Advisory Council on Alzheimer's Research, Care, and Services to
fill the position of ``representative of a state public health
department.'' Nominations should include the nominee's contact
information (current mailing address, email address, and telephone
number) and current curriculum vitae or resume.
DATES: Submit nominations by email or USPS mail before COB on April 4,
2012.
ADDRESSES: Nominations should be sent to Helen Lamont at
helen.lamont@hhs.gov; Helen Lamont, Ph.D., Office of the Assistant
Secretary for Planning and Evaluation, Room 424E Humphrey Building,
Department of Health and Human Services, 200 Independence Avenue SW.,
Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT: Helen Lamont (202) 690-7996,
helen.lamont@hhs.gov.
[[Page 14805]]
SUPPLEMENTARY INFORMATION: The Advisory Council on Alzheimer's
Research, Care, and Services meets quarterly to discuss programs that
impact people with Alzheimer's disease and related dementias and their
caregivers. The Advisory Council makes recommendations about ways to
reduce the financial impact of Alzheimer's disease and related
dementias and to improve the health outcomes of people with these
conditions. The Advisory Council provides feedback on the National Plan
to Address Alzheimer's Disease. On an annual basis, the Advisory
Council shall evaluate the implementation of the recommendations
through an updated national plan.
The Advisory Council consists of designees from Federal agencies
including the Centers for Disease Control and Prevention,
Administration on Aging, Centers for Medicare and Medicaid Services,
Indian Health Service, Office of the Director of the National
Institutes of Health, National Science Foundation, Department of
Veterans Affairs, Food and Drug Administration, Agency for Healthcare
Research and Quality, and the Surgeon General. The Advisory Council
also consists of 12 non-federal members selected by the Secretary who
are Alzheimer's patient advocates (2), Alzheimer's caregivers (2),
health care providers (2), representatives of State health departments
(2), researchers with Alzheimer's-related expertise in basic,
translational, clinical, or drug development science (2), and voluntary
health association representatives (2). Members serve for overlapping 4
year terms, except that any member appointed to fill a vacancy for an
unexpired term shall be appointed for the remainder of such term. A
member may serve after the expiration of the member's term until a
successor has taken office. Members serve as Special Government
Employees. This announcement is seeking nominations for a
``representative of a state public health department'' who is not a
Federal employee.
Sherry Glied,
Assistant Secretary for Planning and Evaluation.
[FR Doc. 2012-6083 Filed 3-12-12; 8:45 am]
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