59724 Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Notices 

people, caregivers, and health 

professionals (physicians and nonphysicians). The annual reporting 

burden is as follows: Estimated Number 

of Respondents: 630. Estimated Number 

of Responses per Respondent: 1. 

Average Burden Hours Per Response: 

0.37. Estimated Total Annual Burden 

Hours Requested: 234. The annualized 

cost to respondents is estimated at: 

$5,680. There are no Capital Costs to 

report. There are no Operating or 

Maintenance Costs to report. 

Type of respondents 

Estimated 

number of 

respondents 

Estimated 

number of 

responses per 

respondent 

Average burden 

hours per 

response 

Estimated total 

annual burden 

hours 

requested 

Older adults ................................................................................................... 260 1 .37 97 

Non-physician health professionals and caregivers ...................................... 310 1 .35 107 

Physicians ...................................................................................................... 60 1 .5 30 

Total ........................................................................................................ ........................ ........................ .......................... 234 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address one or more of the following 

points: (1) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) Evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Minimize the burden 

of the collection of information on those 

who are to respond, including the use 

of appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact: Megan Homer, 

Writer/Editor, Office of 

Communications and Public Liaison, 

NIH, Building 31C Room 5C27, 9000 

Rockville Pike, Bethesda, MD 20892, or 

call non-toll-free number 301–496–1752 

or E-mail your request, including your 

address to: homerm@mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: September 22, 2010. 

Lynn Hellinger, 

Director of Management, National Institutes 

of Health. 

[FR Doc. 2010–24277 Filed 9–27–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Transfusion-Transmitted 

Retrovirus and Hepatitis Virus Rates 

and Risk Factors: Improving the Safety 

of the U.S. Blood Supply Through 

Hemovigilance 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Heart, Lung, and Blood 

Institute (NHLBI), the National 

Institutes of Health (NIH), will publish 

periodic summaries of proposed 

projects to the Office of Management 

and Budget (OMB) for review and 

approval. 

Proposed Collection: Title: 

Transfusion-transmitted retrovirus and 

hepatitis virus rates and risk factors: 

Improving the safety of the U.S. blood 

supply through hemovigilance. Type of 

Information Collection Request: NEW. 

Need and Use of Information Collection: 

Information on current risk factors in 

blood donors as assessed using 

analytical study designs is largely 

unavailable in the U.S. Studies of risk 

factor profiles among HIV-infected 

donors were funded by the CDC for 

approximately 10 years after 

implementation of serologic screening 

in the mid-1980s, whereas studies of 

HTLV- and HCV-seropositive (and 

indeterminate) donors, funded by NIH, 

were conducted in the early 1990s, but 

unfortunately, none of these studies is 

ongoing. Infection trend analyses have 

been conducted by the American Red 

Cross (ARC). The findings show 

continued HIV risk with the prevalence 

of HIV in first time donors hovering 

around 10 per 100,000 donations in 

each of the last 10 years and the 

incidence in repeat donors increasing 

from 1.49 per 100,000 person-years in 

1999–2000 to 2.16 per 100,000 personsyears in 2007–2008. While the 

prevalence of HCV in first time donors 

decreased over this time interval from 

345 to 163 per 100,000 donations, the 

incidence in repeat donors did not 

decrease and evidence of incident 

infection in first time donors increased. 

Moreover specific age, gender and race/ 

ethnicity groups were over-represented. 

Significantly increased incidence of 

both HIV and HCV were observed in 

2007/2008 compared to 2005/2006. 

Similar analyses for HBV have shown 

an incidence in all donors of 3.4 per 

100,000 person-years which is lower 

than earlier estimates, but remains 

higher than for HIV and HCV. 

This project represents a collaborative 

pilot research study that will include a 

comprehensive interview study of viral 

infection positive blood donors at the 

American Red Cross (ARC), Blood 

Systems Inc. (BSI) and New York Blood 

Center (NYBC) in order to identify the 

current predominant risk factors for 

virus positive donations and will also 

establish a donor biovigilance capacity 

that currently does not exist in the U.S. 

At this time it is not easy to integrate 

risk factor data and disease marker 

surveillance information within or 

across different blood collection 

organizations because common 

interview procedures and laboratory 

confirmation procedures are not being 

used and so we cannot easily tabulate 

and analyze behavioral risks or viral 

infections in U.S. blood donors. This 

creates the potential for gaps in our 

understanding of absolute incidence 

and prevalence as well as risks that 

could lead to transfusion-transmitted 

disease. Combined data are critical for 

appropriate national surveillance 

efforts. For example, this information 

could be used to target educational 

interventions to reduce donations from 

persons with high risk behaviors. This 

is particularly important in the case of 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Notices 59725 

behaviors associated with incident 

(recently acquired) infections because 

these donations have the greatest 

potential transmission risk because they 

could be missed during routine testing. 

As part of the project a comprehensive 

research-quality biovigilance database 

will be created that integrates existing 

operational information on blood 

donors, disease marker testing and 

blood components collected by 

participating organizations into a 

research database. The combined 

database will capture infectious disease 

and risk factor information on nearly 

60% of all blood donors and donations 

in the country. Following successful 

completion of the risk factor interviews 

and research database development, the 

biovigilance network pilot can be 

expanded to include additional blood 

centers and/or re-focused on other 

safety threats as warranted, such as 

XMRV. This pilot biovigilance network 

will thereby establish a standardized 

process for integration of information 

across blood collection organizations. 

The Specific Aims are to: 

(1) Define consensus infectious 

disease testing classification algorithms 

for HIV, HCV, HBV, and HTLV that can 

be used to consistently classify donation 

testing results across blood collection 

organizations in the U.S. This will allow 

for better estimates of infection disease 

marker prevalence and incidence in the 

U.S. 

(2) Determine current behavioral risk 

factors associated with prevalent and 

incident (when possible) HIV, HCV, 

HBV and HTLV infections in blood 

donors, including parenteral and sexual 

risks, across the participating blood 

collection organizations using a casecontrol study design. 

(3) Determine nationallyrepresentative infectious disease marker 

prevalence and incidence for HIV, HCV, 

HBV, and HTLV overall and by 

demographic characteristics of donors. 

This will be accomplished by forming 

research databases from operational data 

at BSI and NYBC into formats that can 

be combined with the ARC research 

database. 

(4) Analyze integrated risk factor and 

infectious marker testing data together 

because when taken together these may 

show that blood centers are not 

achieving the same degree of success in 

educational efforts to prevent donation 

by donors with risk behaviors across all 

demographic groups. 

Frequency of Response: Once. 

Affected Public: Individuals. Type of 

Respondents: Adult blood donors. The 

annual reporting burden is a follows: 

Estimated Number of Respondents: 

4150; Estimated Number of Responses 

per Respondent: 1; Average Burden of 

Hours per Response: 0.58 and Estimated 

Total Annual Burden Hours Requested: 

2407. The annualized cost to 

respondents is estimated at: $43,326 

(based on $18 per hour). There are no 

Capital Costs to report. There are no 

Operating or Maintenance Costs to 

report. 

Tables 1–1 and 1–2: Estimate of 

Requested Burden Hours and Dollar 

Value of Burden Hours 

TABLE 1–1—ESTIMATES OF HOUR BURDEN

Type of respondents Number of 

respondents 

Frequency of 

response 

Average time 

per response 

Annual hour 

burden 

Cases ............................................................................................................... 1650 1 0.58 957 

Controls ............................................................................................................ 2500 1 0.58 1450 

Total .......................................................................................................... 4150 ........................ ........................ 2407 

TABLE 1–2—ANNUALIZED COST TO RESPONDENTS

Type of respondents Number of 

respondents 

Frequency of 

response 

Average time 

per response 

Hourly 

wage rate 

Respondent 

cost 

Cases ........................................................................................... 1650 1 0.58 $18 17,226 

Controls ........................................................................................ 2500 1 0.58 18 26,100 

Total ...................................................................................... 4150 ........................ ........................ ................ 43,326 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address one or more of the following 

points: (1) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) Evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Minimize the burden 

of the collection of information on those 

who are to respond, including the use 

of appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Ms Elizabeth 

Wagner, Project Officer, NHLBI, Two 

Rockledge Center, Room 9030, 6701 

Rockledge Drive, Bethesda, MD 20892– 

7950, or call 301–451–9491, or E-mail 

your request to 

elizabeth.wagner@nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: September 16, 2010. 

Ms. Elizabeth Wagner, 

NHLBI Project Officer, NHLBI, National 

Institutes of Health. 

[FR Doc. 2010–24278 Filed 9–27–10; 8:45 am] 

BILLING CODE 4140–01–P 


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