8366 Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Notices 

Dated: February 17, 2010. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2010–3756 Filed 2–23–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[60 Day–10–0639] 

Centers for Disease Control and 

Prevention Proposed Data Collections 

Submitted for Public Comment and 

Recommendations 

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 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–5960 or send 

comments to Maryam Daneshvar, CDC 

Acting Reports Clearance Officer, 1600 

Clifton Road, MS–D74, Atlanta, GA 

30333 or send an e-mail to 

omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments must be 

received within 60 days of this notice. 

Project Proposal 

EEOICPA Special Exposure Cohort 

Petitions (OMB No. 0920–0639 exp. 7/ 

31/2010)—Extension—National Institute 

for Occupational Safety and Health 

(NIOSH), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

On October 30, 2000, the Energy 

Employees Occupational Illness 

Compensation Program Act of 2000 

(EEOICPA), 42 U.S.C. 7384–7385 [1994, 

supp. 2001] was enacted. It established 

a compensation program to provide a 

lump sum payment of $150,000 and 

medical benefits as compensation to 

covered employees suffering from 

designated illnesses incurred as a result 

of their exposure to radiation, 

beryllium, or silica while in the 

performance of duty for the Department 

of Energy and certain of its vendors, 

contractors and subcontractors. This 

legislation also provided for payment of 

compensation for certain survivors of 

these covered employees. This program 

has been mandated to be in effect until 

Congress ends the funding. 

Among other duties, HHS was 

directed to establish and implement 

procedures for considering petitions by 

classes of nuclear weapons workers to 

be added to the ‘‘Special Exposure 

Cohort’’ (the ‘‘Cohort’’). In brief, 

EEOICPA authorizes HHS to designate 

such classes of employees for addition 

to the Cohort when NIOSH lacks 

sufficient information to estimate with 

sufficient accuracy the radiation doses 

of the employees, if HHS also finds that 

the health of members of the class may 

have been endangered by the radiation 

dose the class potentially incurred. HHS 

must also obtain the advice of the 

Advisory Board on Radiation and 

Worker Health (the ‘‘Board’’) in 

establishing such findings. On May 28, 

2004, HHS issued a rule that established 

procedures for adding such classes to 

the Cohort (42 CFR part 83). The rule 

was amended on July 10, 2007. 

The HHS rule authorizes a variety of 

respondents to submit petitions. 

Petitioners are required to provide the 

information specified in the rule to 

qualify their petitions for a complete 

evaluation by HHS and the Board. HHS 

has developed two forms to assist the 

petitioners in providing this required 

information efficiently and completely. 

Form A is a one-page form to be used 

by EEOICPA claimants for whom 

NIOSH has attempted to conduct dose 

reconstructions and has determined that 

available information is not sufficient to 

complete the dose reconstruction. Form 

B, accompanied by separate 

instructions, is intended for all other 

petitioners. Forms A and B can be 

submitted electronically as well as in 

hard copy. Respondent/petitioners 

should be aware that HHS is not 

requiring respondents to use the forms. 

Respondents can choose to submit 

petitions as letters or in other formats, 

but petitions must meet the 

informational requirements referenced 

above. NIOSH expects, however, that all 

petitioners for whom Form A would be 

appropriate will actually use the form, 

since NIOSH will provide it to them 

upon determining that their dose 

reconstruction cannot be completed and 

encourage them to submit the petition. 

NIOSH expects the large majority of 

petitioners for whom Form B would be 

appropriate will also use the form, since 

it provides a simple, organized format 

for addressing the informational 

requirements of a petition. 

NIOSH will use the information 

obtained through the petition for the 

following purposes: (a) Identify the 

petitioner(s), obtain their contact 

information, and establish that the 

petitioner(s) is qualified and intends to 

petition HHS; (b) establish an initial 

definition of the class of employees 

being proposed to be considered for 

addition to the Cohort; (c) determine 

whether there is justification to require 

HHS to evaluate whether or not to 

designate the proposed class as an 

addition to the Cohort (such an 

evaluation involves potentially 

extensive data collection, analysis, and 

related deliberations by NIOSH, the 

Board, and HHS); and, (d) target an 

evaluation by HHS to examine relevant 

potential limitations of radiation 

monitoring and/or dosimetry-relevant 

records and to examine the potential for 

related radiation exposures that might 

have endangered the health of members 

of the class. 

Finally, under the rule, petitioners 

may contest the proposed decision of 

the Secretary to add or deny adding 

classes of employees to the cohort by 

submitting evidence that the proposed 

decision relies on a record of either 

factual or procedural errors in the 

implementation of these procedures. 

NIOSH estimates that the time to 

prepare and submit such a challenge is 

45 minutes. Because of the uniqueness 

of this submission, NIOSH is not 

providing a form. The submission will 

typically be in the form of a letter to the 

Secretary. 

There are no costs to petitioners 

unless a petitioner chooses to purchase 

the services of an expert in dose 

reconstruction, an option provided for 

under the rule. 


pwalker on DSK8KYBLC1PROD with NOTICES
Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Notices 8367 

ESTIMATE OF ANNUALIZED BURDEN HOURS

Form name Type of respondent No. of 

respondents 

No. of 

responses per 

respondent 

Average 

burden per 

respondent 

(in hours) 

Total response 

burden hours 

Form A 83.9 ...... Petitioner using Form A .................................................... 30 1 3/60 2 

Form B 83.9 ...... Petitioner using Form B .................................................... 40 1 5 200 

Form B 83.9 ...... Petitioner submission format other than Form B (as permitted by rule).5 1 6 30 

83.18 ................. Petitioner Appealing final HHS decision (no specific form 

is required).

5 1 45/60 4 

Claimant authorizing a party to submit petition on his/her 

behalf.

20 1 3/60 1 

Total ........... ........................................................................................... 100 ........................ ........................ 237 

Dated: February 18, 2010. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2010–3702 Filed 2–23–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; REDS—II—Does PreDonation Behavioral Deferral Increase 

the Safety of the Blood Supply? 

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: REDS–II 

Does Pre-Donation Behavioral Deferral 

Increase the Safety of the Blood Supply? 

Type of Information Collection 

Request: NEW. Need and Use of 

Information Collection: While it is wellaccepted that deferrals, as part of the 

‘‘layers of safety’’ concept, increase the 

safety of the blood supply, studies with 

sufficiently large sample size to quantify 

HIV infection and other infectious 

marker rates in deferred donors are 

lacking. Evidence in support of 

increased safety is frequently inferred 

from studies conducted in other health 

care settings. For example, a small 

hospital-based case control study 

conducted in Brazil examined the 

association between infectious markers 

and body tattoos. Even though tattoos 

are not used as a criteria to determine 

blood donor eligibility in Brazil, having 

a tattoo was associated with HCV and 

also with having at least one positive 

infectious marker. (1) Significant 

associations were not independently 

observed for HIV, HBV, syphilis or 

Chagas. The authors reported an overall 

sensitivity of 11% and specificity of 

97% for the presence of a tattoo as 

indicator of having HIV, HCV, HBV, or 

syphilis infection. The researchers then 

estimated the impact on blood donor 

selection and disease marker testing 

using the results from their hospitalbased case control study. However, the 

assumptions such as disease marker 

prevalence of as much as 15% in donors 

who are deferred for tattoos and a 

prevalence of 4% of the potential donor 

base having a tattoo (2) do not represent 

current temporary deferrals in Brazil 

and do not address the most common 

behavior-related deferrals. A more 

detailed and targeted assessment of the 

value of relevant deferrals could be used 

to help inform blood donation policies 

in Brazil. 

In Brazilian blood collection centers, 

donor deferral is initiated either by the 

blood center staff, based on information 

disclosed by prospective donors, or by 

the donor through self-deferral. Either 

type of deferral occurs because of the 

belief that a donor’s behavior, 

exposures, or history represents an 

increased risk to the safety of the blood 

supply 

Although the general eligibility 

criteria are mandated by the Brazilian 

Ministry of Health, the specific criteria 

for screening potential donors and the 

procedures for implementing them may 

vary across the regional blood collection 

centers. This study will focus on sexual 

behavior deferrals and their impact on 

blood safety. The two main study aims 

are: (1) To assess infectious disease 

marker prevalence in donors who are 

deferred for higher risk sexual and noninjection drug use behavior; and (2) To 

determine if the different deferral 

classification procedures used by 

different blood centers in Brazil lead to 

a measurable difference in disease 

marker prevalence in deferred donors. 

To do this, deferred donors who agree 

to participate in this study will be asked 

to complete an audio computer assisted 

self interview (ACASI) questionnaire 

that measures two content areas (1) 

motivations for attempting to donate, (2) 

additional information on the deferral 

and other potentially undisclosed 

deferrable behaviors. A blood sample 

will be collected from the deferred 

donors and tested for the panel of 

infections currently screened for in 

Brazil (HIV, Hepatitis C, Hepatitis B, 

Human T-lymphotropic virus, syphilis, 

and Trypanosoma cruzi) using the same 

high-throughput laboratory reagents and 

procedures that are used to screen 

donations. These deferred donor marker 

rates will be compared to the marker 

rates among accepted donors with the 

same demographic characteristics. 

Marker rates in deferred donors will 

also be compared between the blood 

centers. 

Frequency of Response: Once. 

Affected Public: Individuals. Type of 

Respondents: Adult Blood Donors. The 

annual reporting burden is as follows: 

Estimated Number of Respondents: 

4,860; Estimated Number of Responses 

per Respondent: 1; Average Burden of 

Hours per Response: 0.33 (including 

administration of the informed consent 

form and questionnaire completion 

instructions); and Estimated Total 

Annual Burden Hours Requested: 1,620. 

The annualized cost to respondents is 

estimated at: $10,530 (based on $6.50 

per hour). There are no Capital Costs to 

report. There are no Operating or 

Maintenance Costs to report. 


pwalker on DSK8KYBLC1PROD with NOTICES