Federal Register / Vol. 75, No. 98 / Friday, May 21, 2010 / Notices 28619 

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 

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 

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; 


emcdonald on DSK2BSOYB1PROD with NOTICES
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] 

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 

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. 

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. 


emcdonald on DSK2BSOYB1PROD with NOTICES