14804 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. 

(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.’’ 

(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 

• 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] 

BILLING CODE 4150–41–P 

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. 

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Federal Register / Vol. 77, No. 49 / Tuesday, March 13, 2012 / Notices 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] 

BILLING CODE P 

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 (http://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 

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] 

BILLING CODE 4163–18–P 

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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