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14896 Federal Register / Vol. 71, No. 57 / Friday, March 24, 2006 / Notices 

duties to the funding agency for 

approval. The supervisory plan must be 

designed to ensure the scientific 

integrity of the Respondent’s research 

contribution. Respondent agreed to 

ensure that a copy of the supervisory 

plan is also submitted to ORI by the 

institution. Respondent agreed that she 

will not participate in any PHSsupported research until such a 

supervisory plan is submitted to ORI. 

FOR FURTHER INFORMATION CONTACT: 

Director, Division of Investigative 

Oversight, Office of Research Integrity, 

1101 Wootton Parkway, Suite 750, 

Rockville, MD 20852, (240) 453–8800. 

Chris B. Pascal, 

Director, Office of Research Integrity. 

[FR Doc. 06–2843 Filed 3–23–06; 8:45 am] 

BILLING CODE 4150–31–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

National Institute for Occupational 

Safety and Health; Changes to the 

NIOSH–IREP Lung Cancer Risk Model 

Under the Energy Employees 

Occupational Illness Compensation 

Program Act of 2000 

Authority: 42 CFR 81.12, 67 FR 22311– 

22312. 

AGENCY: Centers for Disease Control and 

Prevention, HHS. 

ACTION: Notice for public comment; 

change to a scientific element 

underlying the determination of 

probability of causation under the 

Energy Employees Occupational Illness 

Compensation Program Act of 2000. 

SUMMARY: The National Institute for 

Occupational Safety and Health 

(NIOSH) has changed a guideline for 

determining the probability of causation 

under the Energy Employees 

Occupational Illness Compensation 

Program Act of 2000 (EEOICPA) for 

energy employees with cancers of the 

lung, trachea, or bronchus. The change 

affects only the NIOSH-Interactive 

RadioEpidemiological Program (IREP) 

cancer risk model termed ‘‘Lung (162).’’ 

The new guideline, which became 

effective on February 28, 2006, with the 

introduction of NIOSH–IREP Version 

5.5, requires the use of both a National 

Institutes of Health (NIH)–IREP lung 

model implemented by NIH in 2003 and 

the original NIOSH–IREP lung model 

implemented by NIOSH in 2002. 

NIOSH–IREP Version 5.5 calculates 

separately the probability of causation 

produced under each model for each 

cancer of the lung, trachea, or bronchus. 

The result from the model that produces 

the higher probability of causation at the 

upper 99th percentile credibility limit is 

reported as the probability of causation 

result of record for the claim. NIOSH– 

IREP Version 5.5 also incorporates a 

bias correction factor for random errors 

in dosimetry for those energy workers 

who had not smoked cigarettes (‘‘never 

smokers’’) and who were exposed to 

radon. This correction was previously 

applied to smokers, but had been 

inadvertently omitted for never 

smokers. These changes may result in 

the Department of Labor (DOL) 

calculating higher probability of 

causation determinations for select 

cases of cancer of the lung, trachea, or 

bronchus among previously decided 

and current EEOICPA cancer claims. 

The changes cannot result in any lower 

probability of causation determinations. 

Although this change to the NIOSH– 

IREP lung cancer risk model took effect 

February 28, 2006, NIOSH will fully 

consider all comments received 

regarding this change and may 

reconsider this change or consider 

further revisions to the lung cancer risk 

model based on public comment. 

DATES: NIOSH must receive public 

comments on this change on or before 

May 23, 2006. 

ADDRESSES: Comments may be 

submitted by mail or e-mail. Mail 

comments concerning this change to 

Larry Elliott, Director, Office of 

Compensation Analysis and Support, 

National Institute for Occupational 

Safety and Health, 4676 Columbia 

Parkway, Mailstop C–46, Cincinnati, OH 

45226. Submit electronic comments, 

titled ‘‘NIOSH–IREP Lung Cancer 

Model’’, to OCAS@CDC.GOV. 

FOR FURTHER INFORMATION CONTACT: 

Larry Elliott, Director, Office of 

Compensation Analysis and Support, 

National Institute for Occupational 

Safety and Health, 4676 Columbia 

Parkway, Mailstop C–46, Cincinnati, OH 

45226, Telephone: (513) 533–6800 (This 

is not a toll-free number). 

SUPPLEMENTARY INFORMATION: 

I. Solicitation of Public Comments 

NIOSH invites public comments on 

this change to the NIOSH–IREP lung 

cancer risk model. NIOSH will fully 

consider comments received regarding 

this change and, based on such 

comments, may reconsider this change 

or consider further revisions to the lung 

cancer risk model, as appropriate. 

Additional details regarding this change 

to NIOSH–IREP, including PDF copies 

of all relevant documents provided to 

the Advisory Board on Radiation and 

Worker Health, can be accessed via the 

NIOSH/OCAS ‘‘Probability of 

Causation—NIOSH–IREP’’ Web page at 

http://www.cdc.gov/niosh/ocas/ 

ocasirep.html. 

II. Summary of Changes to the 

Guidelines for Determining Probability 

of Causation for Cancers of the Lung, 

Trachea, or Bronchus as Effected in the 

February 28, 2006, Implementation of 

NIOSH–IREP Version 5.5 

Under HHS regulations at 42 CFR part 

81, NIOSH developed and maintains 

NIOSH–IREP. This computerized set of 

cancer risk models is used by DOL to 

calculate the statistical probability that 

the cancer or cancers of an energy 

employee covered under EEOICPA were 

at least as likely as not caused by 

exposure to ionizing radiation incurred 

by the employee while in the 

performance of duty for U.S. nuclear 

weapons programs. 

HHS regulations also provide for 

NIOSH to add, modify, or replace cancer 

risk models as necessary on the basis of 

new evidence and/or improved 

scientific understanding. Accordingly, 

on February 28, 2006, NIOSH modified 

its cancer risk model ‘‘Lung (162)’’ to 

incorporate new evidence concerning 

the radiogenicity of lung cancer and its 

relationship with cigarette smoking and 

to make a minor technical correction 

concerning radon exposure. 

NIOSH evaluated new interpretations 

of the interaction between cigarette 

smoking and ionizing radiation and the 

effects of age at exposure and age at 

diagnosis with respect to the 

development of cancers of the lung, 

trachea, or bronchus. In conjunction 

with this evaluation, NIOSH also 

reviewed a new lung cancer risk model 

implemented in 2003 by the National 

Cancer Institute for use in a separate 

version of IREP known as ‘‘NIH–IREP’’ 

and compared it to the model in 

NIOSH–IREP. 

The NIH lung cancer risk model relies 

less on a multiplicative interaction than 

does the NIOSH model to account for 

the interaction between cigarette 

smoking and ionizing radiation in the 

development of lung cancer. The NIH 

model also adjusts risk for age at 

exposure and age at diagnosis, whereas 

the NIOSH model does not take into 

account these age-dependent factors. In 

terms of probability of causation, the 

NIH model is generally more favorable 

to smokers for some exposure profiles 

than the NIOSH model, whereas the 

NIOSH model is generally more 

favorable to nonsmokers for some 

exposure profiles. Other probability of 

causation calculation differences 

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Federal Register / Vol. 71, No. 57 / Friday, March 24, 2006 / Notices 14897 

between the models vary with the 

circumstances of each individual claim 

and are more difficult to generalize. In 

summary, however, the same inputs 

entered into NIH–IREP and the previous 

version of NIOSH–IREP for a cancer of 

the lung, trachea, or bronchus could 

produce different probabilities of 

causation for some exposure profiles. 

The NIOSH review also included 

consideration of recommendations 

submitted by four internationallyrecognized outside experts. The experts 

recruited by NIOSH were: David J. 

Brenner, PhD, Professor of Radiation 

Oncology and Public Health, Columbia 

University School of Public Health; 

Faith G. Davis, PhD, Professor of 

Epidemiology and Biostatistics, 

University of Illinois at Chicago, School 

of Public Health; David B. Richardson, 

PhD, Assistant Professor of 

Epidemiology, University of North 

Carolina School of Public Health; and 

Jonathan M. Samet, MD, MS, Professor 

and Chairman, Department of 

Epidemiology, Johns Hopkins 

University School of Public Health. 

Each expert reviewed the issue 

independently, considering the 

appropriateness of the NIOSH and NIH 

models and any alternatives to the use 

of these models. The only general 

consensus among all four reviewers was 

that none recommended the exclusive 

retention of the NIOSH lung model. 

Beyond this, there was a diversity of 

opinion as to how to properly 

characterize and model the interaction 

between cigarette smoking and ionizing 

radiation. 

In accordance with the experts’ 

opinions, NIOSH concluded that the 

current state of scientific knowledge 

does not support the exclusive use of 

either of the two IREP lung cancer risk 

models, and that the most reasonable 

option within the context of 

compensation was to reprogram 

NIOSH–IREP to run both the NIOSH 

and the NIH lung cancer risk models 

separately for each relevant EEOICPA 

case, and then to select the model that 

produces the higher probability of 

causation result for application to the 

case. The programming was 

accomplished and implemented on 

February 28, 2006, with the installation 

of NIOSH–IREP Version 5.5, which 

replaced NIOSH–IREP Version 5.4. 

NIOSH–IREP Version 5.5 also 

incorporates a bias correction factor in 

the NIOSH lung model for random 

errors in dosimetry for ‘‘never smokers’’ 

who were exposed to radon. Due to a 

programming oversight, this correction 

had been inadvertently omitted for 

never smokers and was applied only to 

smokers in earlier versions of NIOSH– 

IREP. NIOSH–IREP Version 5.5 corrects 

this error. 

The changes introduced in NIOSH– 

IREP Version 5.5 on February 28, 2006, 

pertain only to the NIOSH–IREP cancer 

risk model termed ‘‘Lung (162)’’ and 

apply only to cancers of the lung, 

trachea, or bronchus. NIOSH will 

review all relevant previously 

completed claims that have not been 

compensated to identify those for which 

the new guidelines are applicable, and 

will re-evaluate the claims using the 

new guidelines. NIOSH will also apply 

the new guidelines to all currently 

active claims and any future cases. 

Application of these new guidelines 

may result in DOL calculating higher 

probability of causation determinations 

for select lung, trachea, or bronchus 

cases among previously decided and 

current EEOICPA cancer claims. As 

noted above, the changes cannot result 

in any lower probability of causation 

determinations. 

III. Summary of Recommendations of 

the Advisory Board on Radiation and 

Worker Health 

Under 42 CFR 81.12, NIOSH is 

required to obtain the review of the 

Board before making changes to 

NIOSH–IREP that would have a 

substantial effect on probability of 

causation calculations. NIOSH notified 

the Advisory Board on Radiation and 

Worker Health (ABRWH) of its intent to 

re-evaluate the NIOSH–IREP lung 

cancer risk model and to review the 

NIH–IREP lung cancer risk model as a 

possible alternative model during a 

meeting of the Board on December 15, 

2004. After the NIOSH review and 

evaluation was completed, NIOSH 

presented information describing and 

proposing the current NIOSH–IREP 

change to the Board, including a 

summary of the NIOSH evaluation and 

the expert reviews discussed above. The 

Board considered the change and voted 

unanimously to support it during the 

October 19, 2005, meeting of the Board 

in Knoxville, Tennessee. The motion to 

support the change included a provision 

that NIOSH should revisit the issue in 

approximately one year to determine if 

new evidence might warrant 

consideration of a single lung cancer 

risk model. 

The Director, National Institute for 

Occupational Safety and Health 

(NIOSH), has been delegated the 

authority to sign Federal Register 

notices for CDC that pertain to NIOSH 

programmatic matters. 

Dated: March 17, 2006. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health (NIOSH), Centers for 

Disease Control and Prevention (CDC). 

[FR Doc. E6–4314 Filed 3–23–06; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control; Special 

Emphasis Panel: Centers for 

Agricultural Disease and Injury 

Research, Education and Prevention, 

Program Announcement Number 06– 

057 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the following meeting: 

Name: Disease, Disability, and Injury 

Prevention and Control Special Emphasis 

Panel (SEP): Centers for Agricultural Disease 

and Injury Research, Education and 

Prevention, Program Announcement Number 

06–057. 

Times and Dates: 8 a.m.–5 p.m., May 1, 

2006 (Closed). 

8 a.m.–5 p.m., May 2, 2006 (Closed). 

8 a.m.–5 p.m., May 3, 2006 (Closed). 

8 a.m.–5 p.m., May 4, 2006 (Closed). 

8 a.m.–5 p.m., May 5, 2006 (Closed). 

Place: Residence Inn, 1456 Duke Street, 

Alexandria, VA 22314 telephone 703–548– 

5474. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in section 552b(c) (4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

Matters To Be Discussed: The meeting will 

include the review, discussion, and 

evaluation of applications received in 

response to Centers for Agricultural Disease 

and Injury Research, Education and 

Prevention, Program Announcement Number 

06–057. 

For Further Information Contact: Steve 

Olenchock, Ph.D., Scientific Review 

Administrator, National Institute for 

Occupational Safety and Health, CDC, 1095 

Willowdale Road, MS 1119, Morgantown, 

WV 26505, Telephone 304–285–6271. 

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 CDC and the Agency for Toxic 

Substances and Disease Registry.