Notices. Notice for public comment

3,453 words·~16 min read·/register/2006/01/19/06-452

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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. 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: *http://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. 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 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 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. 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 Centers for Disease Control and Prevention National Task Force on Fetal Alcohol Syndrome and Fetal Alcohol Effect: 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)announces the following federal advisory committee 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 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. 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 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. 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 ATSDR. Dated: January 10, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6-529 Filed 1-18-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0010] Able Laboratories, Inc.; Withdrawal of Approval of 43 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is withdrawing approval of 43 abbreviated new drug applications (ANDAs) held by Able Laboratories, Inc. (Able Labs), One Able Dr., Cranbury, NJ 08512. The drug products are no longer marketed, and Able Labs has requested that the approval of the applications be withdrawn. DATES: Effective January 19, 2006. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The applications listed in the table in this document are no longer marketed, and Able Labs has requested that FDA withdraw approval of the applications. The company has also, by its request, waived its opportunity for a hearing. Application No. Drug 40-390 Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 milligrams (mg)/325 mg/40 mg 40-394 Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/500 mg/40 mg 40-402 Phentermine Hydrochloride

(HCl)Tablets USP, 37.5 mg 40-403 Phentermine HCL Capsules USP, 30 mg (powder) 40-413 Methocarbamol Tablets USP, 500 mg and 750 mg 40-421 Carisoprodol Tablets USP, 350 mg 40-427 Phentermine HCl Capsules USP, 30 mg (beads) 40-449 Promethazine HCl Suppositories USP, 50 mg 40-464 Hydrocodone Bitartrate and Acetaminophen Tablets USP, 7.5 mg/325 mg and 10 mg/325 mg 40-469 Hydrocodone Bitartrate and Acetaminophen Tablets USP, 7.5 mg/750 mg 40-473 Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg 40-474 Hydrocodone Bitartrate and Acetaminophen Tablets USP, 7.5 mg/650 mg 40-476 Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/650 mg 40-477 Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/500 mg 40-478 Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/325 mg 40-483 Bethanechol Chloride Tablets USP, 10 mg 40-485 Bethanechol Chloride Tablets USP, 25 mg 40-490 Hydrocodone Bitartrate and Acetaminophen Tablets USP, 7.5 mg/500 mg 40-492 Bethanechol Chloride Tablets USP, 5 mg 40-497 Phentermine HCl Capsules USP, 15 mg 40-504 Promethazine HCl Suppositories USP, 12.5 mg and 25 mg 40-509 Bethanechol Chloride Tablets USP, 50 mg 40-529 Methamphetamine HCl Tablets USP, 5 mg 40-539 Theophylline Extended-Release Tablets, 600 mg 40-543 Theophylline Extended-Release Tablets, 400 mg 40-546 Theophylline Extended-Release Tablets, 450 mg 40-548 Theophylline Extended-Release Tablets, 300 mg 40-558 Promethazine HCl Tablets USP, 12.5 mg, 25 mg, and 50 mg 40-559 Hydroxyzine HCl Tablets USP, 10 mg 40-562 Hydroxyzine HCl Tablets USP, 25 mg 40-563 Hydroxyzine HCl Tablets USP, 50 mg 76-114 Indomethacin Extended-Release Capsules USP, 75 mg 76-121 Lithium Carbonate Capsules USP, 300 mg 76-382 Lithium Carabonate Extended-Release Tablets USP, 300 mg 76-462 Metronidazole Extended-Release Tablets, 750 mg 76-505 Metronidazole Capsules, 375 mg 76-519 Metronidazole Tablets USP, 250 mg and 500 mg 76-528 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg 76-544 Naproxen Sodium Tablets USP, 275 mg and 550 mg 76-666 Indomethacin Capsules USP, 25 mg and 50 mg 76-814 Dextroamphetamine Sulfate Extended-Release Capsules, 5 mg, 10 mg, and 15 mg 76-823 Lithium Carbonate Capsules USP, 150 mg, 300 mg, and 600 mg 76-907 Atenolol Tablets USP, 25 mg, 50 mg, and 100 mg Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the Director, Center for Drug Evaluation and Research, by the Commissioner of Food and Drugs, approval of the applications listed in the table in this document, and all amendments and supplements thereto, is hereby withdrawn, effective January 19, 2006. Dated: January 4, 2006. Douglas C. Throckmorton, Deputy Director, Center for Drug Evaluation and Research. [FR Doc. E6-506 Filed 1-18-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service Chief Executive Officer Retention Survey AGENCY: Indian Health Service, HHS. SUMMARY: The Department of Health and Human Services, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Indian Health Service

(IHS)is providing a 60-day advance opportunity for public comment on a proposed extension of current information collection activity to be submitted to the Office of Management and Budget for review. Proposed Collection *Title:* 0917-NEW, “Indian Health Service Chief Executive Officer Retention Survey”. *Type of Information Collection Request:* New Collection. *Form Number:* None. *Forms:* The IHS Chief Executive Officer Retention Survey. *Need and Use of Information Collection:* The National Council of Chief Executive Officers (NCCEO) was established to ensure that the IHS Service Unit Chief Executive Officers

(CEO)effectively participate in the establishment and implementation of strategies to achieve the IHS mission. Part of their responsibility (as stated in their Charter) includes: ongoing recruitment, development, and retention of professional CEOs. The NCCEO's purpose is to ensure that the IHS Service Unit CEO and their Tribal CEO counterparts effectively participate in the establishment and implementation of an agency strategy to achieve the IHS mission. The current Executive Committee is actively addressing recruitment, retention and succession planning for their constituents, the IHS CEOs. To enhance their ability to be effective in this challenging task, the NCCEO needs to know more about IHS CEOs and the issues that affect retention and recruitment including the competitive influences of private sector health care delivery systems. The chosen method to obtain this critical information from the CEOs of IHS, Tribal and Urban facilities is by electronic survey. The goal of the IHS is to raise the health status of American Indians and Alaska Natives to the highest possible level. To meet this goal, the IHS is committed to providing high quality health services to the eligible service population. An important factor in improving the quality of services is: ensuring that our clinics and hospitals recruit and retain the best possible CEO reasonably available. The proposed survey is designed to ascertain current demographics: age, gender, years of experience, education, pay compared to complexity of facilities, job satisfaction and retirement eligibility. *Affected Public:* Individuals. *Type of Respondents:* Individuals. The table below provides the estimated burden hours for this information collection: Estimated Burden Hours Data collection instrument Estimated number of respondents Responses per respondent Average burden hour per response * Total annual burden hrs CEO Retention Survey 120 1 0.15 (10 mins) 20 *For ease of understanding, burden hours are also provided in actual minutes. There are no Capital Costs, Operating Costs and/or Maintenance Costs to report. *Request For Comments:* Your written comments and/or suggestions are invited on one or more of the following points:

(a)Whether the information collection activity is necessary to carry out an agency function;

(b)whether the agency processes the information collected in a useful and timely fashion;

(c)the accuracy of public burden estimate (the estimated amount of time needed for individual respondents to provide the requested information);

(d)whether the methodology and assumptions used to determine the estimate are logical;

(e)ways to enhance the quality, utility, and clarity of the information being collected; and

(f)ways to minimize the public burden through the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. *Send Comment and Requests for Further Information:* Send your written comments and requests for more information on the proposed collection or requests to obtain a copy of the data collection instruments(s) and instructions to: Mrs. Chris Rouleau, IHS Reports Clearance Officer, 801 Thompson Avenue, TMP Suite 450, Rockville, MD 20852.1601, call non-toll free

(301)443-5938, send via facsimile to

(301)443-2316, or send your E-mail requests, comments, and return address: *crouleau@hqe.ihs.gov.* *Comment Due Date:* Your 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: January 12, 2006. Charles W. Grim, Assistant Surgeon General, Director, Indian Health Service. [FR Doc. 06-452 Filed 1-18-06; 8:45 am]

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