National Institute for Occupational Safety and Health; Proposed Changes to the Dose Reconstruction Target Organ Selection for Lymphoma Under the Energy Employees Occupational Illness Compensation Program Act of 2000, 3095-3096 [E6-542]

Download as PDF Federal Register / Vol. 71, No. 12 / Thursday, January 19, 2006 / Notices public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail nvac@osophs.dhhs.gov or call 202–690– 5566. Dated: January 11, 2006. Bruce Gellin, Director, National Vaccine Program Office. [FR Doc. 06–493 Filed 1–18–06; 8:45 am] BILLING CODE 4150–44–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institute for Occupational Safety and Health; Proposed Changes to the Dose Reconstruction Target Organ Selection for Lymphoma Under the Energy Employees Occupational Illness Compensation Program Act of 2000 Authority: 42 CFR 82.32, 67 FR 22335– 22336. Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC). AGENCY: sroberts on PROD1PC70 with NOTICES ACTION: Notice for public comment. SUMMARY: The National Institute for Occupational Safety and Health (NIOSH) proposes to change the selection of target organs used in dose reconstructions NIOSH produces under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA) for energy employees with lymphoma cancers. This proposed change is in response to an evaluation by NIOSH of current scientific data on lymphoma, which revealed that the site of the radiation injury can differ from the site of the tumor or cancer origin documented in the medical files of a lymphoma cancer patient. The new process for selecting dose reconstruction target organs for energy employees with lymphoma cancers would include selecting the target organ that would have received the highest radiation dose from among relevant, possibly irradiated organs, as determined through the dose reconstruction process, when the identity of the target organ is in question. This change would result in the Department of Labor calculating higher probability of causation determinations for select lymphoma cases among previously decided and current EEOICPA cancer claims. NIOSH must receive public comments on this proposed change on DATES: VerDate Aug<31>2005 16:38 Jan 18, 2006 Jkt 208001 or before 15 days after the date of publication in the Federal Register. ADDRESSES: Mail comments concerning this proposed 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, Ohio 45226. Submit electronic comments 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: NIOSH conducts radiation dose reconstructions under EEOICPA in compliance with the dose reconstruction methods specified in HHS regulations at 42 CFR part 82. These regulations provide for NIOSH to update its dose reconstruction methods as necessary on the basis of improved scientific understanding and specify a process for deciding and implementing such updates (41 CFR 82.30–82.33). Accordingly, NIOSH is currently proposing to update its method for reconstructing radiation doses in cases involving certain lymphoma cancers. Specifically, NIOSH is proposing to change its method for identifying the target organ for which radiation doses will be reconstructed in these cases, for the reasons described below. As required for certain updates in dose reconstruction methods, NIOSH will present the proposed change to the Advisory Board on Radiation and Worker Health for its comments. NIOSH will also consider all public comments concerning this change that are received prior to the comment deadline, as specified above. NIOSH has re-examined the appropriateness of the current method of selecting dosimetry target organs for lymphoma cases in light of the current scientific knowledge on the diagnosis and etiology of the various forms of lymphoma.1 This re-examination has revealed that for many non-Hodgkin’s 1 Crowther, M. Consultant’s Report, Dose Reconstruction Project. Prepared for the National Institute for Occupational Safety and Health Office of Compensation Analysis and Support. 2005; Eckerman, K.F. Target Organs for Lymphatic and Hematopoietic Cancers Comments/Suggestions. Prepared for the National Institute for Occupational Safety and Health Office of Compensation Analysis and Support. 2005. Available online at: https:// www.cdc.gov/niosh/ocas/ocasdose.html. (This information can be found on the aforementioned Web page under the ‘‘Miscellaneous Items’’ heading in the section ‘‘Evaluation of Target Organ for Lymphomas.’’) PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 3095 lymphomas, there are two problems with NIOSH’s current target organ selection method. First, the site of occurrence of the tumor is not necessarily the site of the original radiation injury. Second, the site listed in the diagnosis may not actually be the site of primary involvement. Rather, it is common to list the site of the biopsy, which may be selected on the basis of medical considerations in terms of the clinical symptoms and condition of the patient and the ease of surgical access. Both of these problems contribute to the possibility that under current methods for select lymphoma cases, NIOSH is not certain to be basing its dose reconstruction on the organ that has the highest radiation dose and may have been the site of origin of the lymphoma of the energy employee. As a result of this re-evaluation, NIOSH proposes to modify the selection of target organs in select lymphoma cases so that the organ that would have received the highest radiation dose from among relevant, possibly irradiated organs, as determined through the dose reconstruction process, is used in the dose reconstruction. For the subset of lymphomas where tumor location is informative about the probable site of the original radiation injury (e.g. Hodgkin’s disease, lymphosarcoma, etc.), information related to the site of diagnosis would be considered in target organ selection. This proposed change pertains only to the selection of the appropriate target organ as the site of radiation injury (i.e., for calculation of effective radiation dose during the dose reconstruction process). It has no bearing on the selection of the appropriate Interactive Radiological Epidemiology Program (IREP) cancer risk model for determining probability of causation, nor does it impact the cancer risk models themselves. This proposed change in NIOSH dose reconstruction methods would be likely to have a substantial effect on certain EEOICPA cancer cases involving lymphomas. NIOSH would review all relevant completed dose reconstructions for cases that have not been compensated to identify those for which this new method is applicable, and would re-complete these dose reconstructions using this new method, and would apply this new method to all current and future cases undergoing dose reconstruction. Application of this new method would result in the Department of Labor calculating higher probability of causation determinations for select lymphoma cases among previously decided and current EEOICPA cancer claims. E:\FR\FM\19JAN1.SGM 19JAN1 3096 Federal Register / Vol. 71, No. 12 / Thursday, January 19, 2006 / Notices The proposed change may be discussed at meetings of the Advisory Board on Radiation and Worker Health on January 9, 2006 (teleconference) and January 24–26, 2006 in Oak Ridge, TN. Only after the close of the public comment period will NIOSH make a final decision regarding the proposed change. 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. 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. Dated: January 12, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6–538 Filed 1–18–06; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: January 10, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention (CDC). [FR Doc. E6–543 Filed 1–18–06; 8:45 am] BILLING CODE 4163–18–P Dated: January 10, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6–542 Filed 1–18–06; 8:45 am] Centers for Disease Control and Prevention BILLING CODE 4163–18–P 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 federal advisory committee meeting: DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Portfolio Review of Single Gene Disorders and Disability sroberts on PROD1PC70 with NOTICES 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): Portfolio Review of Single Gene Disorders and Disability. Times and Dates: 9 a.m.–5 p.m., February 10, 2006 (Closed). Place: National Center on Birth Defects and Developmental Disabilities, CDC, 12 Executive Park Drive, Atlanta, GA 30329, Telephone Number 404.498.3800. 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 and discussion of the Single Gene Disorders and Disability Team’s strategies and activities. For Further Information Contact: Esther Sumartojo, Acting Associate Director for Science and Public Health, National Center on Birth Defects and Developmental Disabilities, CDC, 1600 Clifton Road, NE., Mailstop E–87, Atlanta, GA 30333, Telephone Number 404.498.3800. VerDate Aug<31>2005 16:38 Jan 18, 2006 Jkt 208001 Developmental Disabilities, CDC, 1600 Clifton Road, NE., (E–86), Atlanta, Georgia 30333, telephone 404/498–3926, fax 404/ 498–3550. 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 CDC and Agency for Toxic Substances and Disease Registry. National Task Force on Fetal Alcohol Syndrome and Fetal Alcohol Effect: Meeting Name: National Task Force on Fetal Alcohol Syndrome and Fetal Alcohol Effect (NTFFASFAE). Times and Dates: 8:30 a.m.–4:30 p.m., February 16, 2006. 8:30 a.m.–1 p.m., February 17, 2006. Place: Embassy Suites Hotel Buckhead, 3285 Peachtree Road, NE., Atlanta, Georgia 30305, telephone 404/261–7733, fax 404/ 262–0522. Status: Open to the public, limited only by the space available. The meeting room accommodates approximately 65 people. Purpose: The Secretary is authorized by the Public Health Service Act, section 399G (42 U.S.C. Section 280f, as added by Pub. L. 105– 392), to establish a NTFFASFAE to: (1) Foster coordination among all governmental agencies, academic bodies and community groups that conduct or support Fetal Alcohol Syndrome (FAS) and Fetal Alcohol Effect (FAE) research, programs and surveillance; and (2) to otherwise meet the general needs of populations actually or potentially impacted by FAS and FAE. Matters to be Discussed: Agenda items include: (1) Discussion of the Task Force’s Post-Exposure working group activities; (2) presentations regarding prevention initiatives from other relevant health topics such as tobacco use and HIV; (3) presentation and discussion regarding evidence-based review of FAS prevention strategies; (4) Task Force next steps; (5) updates from the Interagency Coordinating Committee on FAS, CDC, and other federal agencies, and liaison members; (6) and scheduling of the next meeting. Agenda items are subject to change as priorities dictate. For Further Information Contact: Mary Kate Weber, M.P.H., Executive Secretary, National Center on Birth Defects and PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Committee on Immunization Practices: Meeting 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) announce the following Federal committee meeting. Name: Advisory Committee on Immunization Practices (ACIP). Time and Date: 8 a.m.–6:15 p.m., February 21, 2006. 8 a.m.–5 p.m., February 22, 2006. Place: Centers for Disease Control and Prevention, 1600 Clifton Road, NE., Building 19, Room 232, Atlanta, Georgia 30333. Status: Open to the public, limited only by the space available. Purpose: The committee is charged with advising the Director, CDC, on the appropriate uses of immunizing agents. In addition, under 42 U.S.C. 1396s, the committee is mandated to establish and periodically review and, as appropriate, revise the list of vaccines for administration to vaccine-eligible children through the Vaccines for Children (VFC) program, along with schedules regarding the appropriate periodicity, dosage, and contraindications applicable to the vaccines. Matters To Be Discussed: The agenda will include discussions on Rotavirus Vaccine which may include a possible VFC Vote; Human Papillomavirus Vaccine; general recommendations on immunization; Influenza; Herpes Zoster Vaccine; Tetanus Toxoid, Diphtheria Toxoid, and Acellular Pertussis (Tdap) Vaccines; and departmental updates. Agenda items are subject to change as priorities dictate. For Further Information Contact: Demetria Gardner, Epidemiology and Surveillance Division, National Immunization Program, CDC, 1600 Clifton Road, NE., (E–61), Atlanta, Georgia 30333, telephone 404/639–8096, fax 404/639–8616. E:\FR\FM\19JAN1.SGM 19JAN1

Agencies

[Federal Register Volume 71, Number 12 (Thursday, January 19, 2006)]
[Notices]
[Pages 3095-3096]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-542]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


National Institute for Occupational Safety and Health; Proposed 
Changes to the Dose Reconstruction Target Organ Selection for Lymphoma 
Under the Energy Employees Occupational Illness Compensation Program 
Act of 2000

    Authority: 42 CFR 82.32, 67 FR 22335-22336.

AGENCY: Department of Health and Human Services (HHS), Centers for 
Disease Control and Prevention (CDC).

ACTION: Notice for public comment.

-----------------------------------------------------------------------

SUMMARY: The National Institute for Occupational Safety and Health 
(NIOSH) proposes to change the selection of target organs used in dose 
reconstructions NIOSH produces under the Energy Employees Occupational 
Illness Compensation Program Act of 2000 (EEOICPA) for energy employees 
with lymphoma cancers. This proposed change is in response to an 
evaluation by NIOSH of current scientific data on lymphoma, which 
revealed that the site of the radiation injury can differ from the site 
of the tumor or cancer origin documented in the medical files of a 
lymphoma cancer patient. The new process for selecting dose 
reconstruction target organs for energy employees with lymphoma cancers 
would include selecting the target organ that would have received the 
highest radiation dose from among relevant, possibly irradiated organs, 
as determined through the dose reconstruction process, when the 
identity of the target organ is in question. This change would result 
in the Department of Labor calculating higher probability of causation 
determinations for select lymphoma cases among previously decided and 
current EEOICPA cancer claims.

DATES: NIOSH must receive public comments on this proposed change on or 
before 15 days after the date of publication in the Federal Register.

ADDRESSES: Mail comments concerning this proposed 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, Ohio 45226. Submit electronic 
comments 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: NIOSH conducts radiation dose 
reconstructions under EEOICPA in compliance with the dose 
reconstruction methods specified in HHS regulations at 42 CFR part 82. 
These regulations provide for NIOSH to update its dose reconstruction 
methods as necessary on the basis of improved scientific understanding 
and specify a process for deciding and implementing such updates (41 
CFR 82.30-82.33). Accordingly, NIOSH is currently proposing to update 
its method for reconstructing radiation doses in cases involving 
certain lymphoma cancers. Specifically, NIOSH is proposing to change 
its method for identifying the target organ for which radiation doses 
will be reconstructed in these cases, for the reasons described below. 
As required for certain updates in dose reconstruction methods, NIOSH 
will present the proposed change to the Advisory Board on Radiation and 
Worker Health for its comments. NIOSH will also consider all public 
comments concerning this change that are received prior to the comment 
deadline, as specified above.
    NIOSH has re-examined the appropriateness of the current method of 
selecting dosimetry target organs for lymphoma cases in light of the 
current scientific knowledge on the diagnosis and etiology of the 
various forms of lymphoma.\1\ This re-examination has revealed that for 
many non-Hodgkin's lymphomas, there are two problems with NIOSH's 
current target organ selection method. First, the site of occurrence of 
the tumor is not necessarily the site of the original radiation injury. 
Second, the site listed in the diagnosis may not actually be the site 
of primary involvement. Rather, it is common to list the site of the 
biopsy, which may be selected on the basis of medical considerations in 
terms of the clinical symptoms and condition of the patient and the 
ease of surgical access. Both of these problems contribute to the 
possibility that under current methods for select lymphoma cases, NIOSH 
is not certain to be basing its dose reconstruction on the organ that 
has the highest radiation dose and may have been the site of origin of 
the lymphoma of the energy employee.
---------------------------------------------------------------------------

    \1\ Crowther, M. Consultant's Report, Dose Reconstruction 
Project. Prepared for the National Institute for Occupational Safety 
and Health Office of Compensation Analysis and Support. 2005; 
Eckerman, K.F. Target Organs for Lymphatic and Hematopoietic Cancers 
Comments/Suggestions. Prepared for the National Institute for 
Occupational Safety and Health Office of Compensation Analysis and 
Support. 2005. Available online at: https://www.cdc.gov/niosh/ocas/
ocasdose.html. (This information can be found on the aforementioned 
Web page under the ``Miscellaneous Items'' heading in the section 
``Evaluation of Target Organ for Lymphomas.'')
---------------------------------------------------------------------------

    As a result of this re-evaluation, NIOSH proposes to modify the 
selection of target organs in select lymphoma cases so that the organ 
that would have received the highest radiation dose from among 
relevant, possibly irradiated organs, as determined through the dose 
reconstruction process, is used in the dose reconstruction. For the 
subset of lymphomas where tumor location is informative about the 
probable site of the original radiation injury (e.g. Hodgkin's disease, 
lymphosarcoma, etc.), information related to the site of diagnosis 
would be considered in target organ selection.
    This proposed change pertains only to the selection of the 
appropriate target organ as the site of radiation injury (i.e., for 
calculation of effective radiation dose during the dose reconstruction 
process). It has no bearing on the selection of the appropriate 
Interactive Radiological Epidemiology Program (IREP) cancer risk model 
for determining probability of causation, nor does it impact the cancer 
risk models themselves.
    This proposed change in NIOSH dose reconstruction methods would be 
likely to have a substantial effect on certain EEOICPA cancer cases 
involving lymphomas. NIOSH would review all relevant completed dose 
reconstructions for cases that have not been compensated to identify 
those for which this new method is applicable, and would re-complete 
these dose reconstructions using this new method, and would apply this 
new method to all current and future cases undergoing dose 
reconstruction. Application of this new method would result in the 
Department of Labor calculating higher probability of causation 
determinations for select lymphoma cases among previously decided and 
current EEOICPA cancer claims.

[[Page 3096]]

    The proposed change may be discussed at meetings of the Advisory 
Board on Radiation and Worker Health on January 9, 2006 
(teleconference) and January 24-26, 2006 in Oak Ridge, TN. Only after 
the close of the public comment period will NIOSH make a final decision 
regarding the proposed change.
    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: January 10, 2006.
Alvin Hall,
Director, Management Analysis and Services Office, Centers for Disease 
Control and Prevention.
 [FR Doc. E6-542 Filed 1-18-06; 8:45 am]
BILLING CODE 4163-18-P
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