Notices. Joint notice and request for comment
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/register/2005/12/13/05-23958A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 6560-50-S FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB SUMMARY: Background Notice is hereby given of the final approval of a proposed information collection by the Board of Governors of the Federal Reserve System (Board) under OMB delegated authority, as per 5 CFR 1320.16 (OMB Regulations on Controlling Paperwork Burdens on the Public). Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information.
Copies of the OMB 83-Is and supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. FOR FURTHER INFORMATION CONTACT: Federal Reserve Board Clearance Officer—Michelle Long—Division of Research and Statistics, Board of Governors of the Federal Reserve System, Washington, DC 20551 (202-452-3829).
OMB Desk Officer-Mark Menchik—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503, or e-mail to *mmenchik@omb.eop.gov.* *Final approval under OMB delegated authority of the revision, without extension, of the following reports:* *Report titles:* Report of Changes in Organizational Structure, Report of Changes in FBO Organizational Structure. *Agency form number:* FR Y-10, FR Y-10F, and FR Y-10S. *OMB control number:* 7100-0297. *Frequency:* Event-generated. *Reporters:* Bank holding companies (BHCs), foreign banking organizations (FBOs), and state member banks unaffiliated with a BHC. *Annual reporting hours:* 18,004 hours. *Estimated average hours per response:* 1 hour. *Number of respondents:* 5,510. *General description of report:* This information collection is mandatory (12 U.S.C. 248(a)(1), 602, 611a, 1843(k), 1844(c)(1)(A), 3106(a) and 12 CFR 211.13(c), 225.5(b), and 225.87).
Individual respondent data are not considered as confidential. However, a company may request confidential treatment pursuant to sections (b)(4) and (b)(6) of the Freedom of Information Act (5 U.S.C. 552(b)(4) and (b)(6)). *Abstract:* The FR Y-10 is an event-generated report filed by top-tier domestic BHCs, including financial holding companies (FHCs), and state member banks unaffiliated with a BHC or FHC, to capture changes in their regulated investments and activities. The Federal Reserve uses the data to monitor structure information on subsidiaries and regulated investments of these entities engaged in both banking and nonbanking activities.
The FR Y-10F is an event-generated report filed by FBOs, including FHCs, to capture changes in their regulated investments and activities. The Federal Reserve uses the data to ensure compliance with U.S. banking laws and regulations and to determine the risk profile of the FBO structure. *Current action:* On September 29, 2005, the Federal Reserve published a notice soliciting comments on the proposed supplement (70 FR 56897). The comment period ended on November 28, 2005. The Federal Reserve received one general comment letter; however, the proposal is unchanged from the one the Board initially approved.
In the comment letter, a small commercial bank generally questioned the usefulness of the proposed supplement for supervisory purposes. As described in the initial **Federal Register** notice, the data would be used to enhance the Federal Reserve's ability to compare regulatory data to market data and to increase the Federal Reserve's effectiveness in assessing banking organizations' compliance with the Sarbanes-Oxley Act of 2002 (SOX). Although the commenter asserted that the Federal Reserve was trying to make non-public organizations comply with SOX, non-public organizations are only required to check two boxes indicating that they have no data to report.
Therefore, SOX compliance would not be required and the burden for non-public organizations should be minimal. As proposed, the Federal Reserve will add a Supplement to the Reports of Changes in Organizational Structure (FR Y-10S) to enhance the Federal Reserve's ability to compare regulatory data to market data and to increase the Federal Reserve's effectiveness in assessing banking organizations' compliance with Sarbanes-Oxley Act of 2002 (SOX). The initial collection of this data will be as of December 31, 2005.
The FR Y-10S panel will comprise top-tier BHCs, FBOs, and state member banks that are not controlled by a BHC. All of these organizations currently file either the FR Y-10 or FR Y-10F. However, FBOs will not be required to report data for Schedule B. Board of Governors of the Federal Reserve System, December 7, 2005. Jennifer J. Johnson, Secretary of the Board. [FR Doc. E5-7239 Filed 12-12-05; 8:45 am] BILLING CODE 6210-01-P DEPARTMENT OF THE TREASURY Office of the Comptroller of the Currency FEDERAL RESERVE SYSTEM FEDERAL DEPOSIT INSURANCE CORPORATION Agency Information Collection Activities:
Proposed Collection; Comment Request AGENCIES: Office of the Comptroller of the Currency (OCC), Treasury; Board of Governors of the Federal Reserve System (Board); and Federal Deposit Insurance Corporation (FDIC). ACTION: Joint notice and request for comment. SUMMARY: In accordance with the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the OCC, the Board, and the FDIC (the “agencies”) may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget
(OMB)control number. The Federal Financial Institutions Examination Council (FFIEC), of which the agencies are members, has approved the agencies' publication for public comment of a proposal to extend, without revision, the Country Exposure Report (FFIEC 009) and the Country Exposure Information Report (FFIEC 009a), which are currently approved information collections. At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the FFIEC should modify the reports. The agencies will then submit the reports to OMB for review and approval. DATES: Comments must be submitted on or before February 13, 2006. ADDRESSES: Interested parties are invited to submit written comments to any or all of the agencies. All comments, which should refer to the OMB control number, will be shared among the agencies. *OCC:* You should direct your comments to: Communications Division, Office of the Comptroller of the Currency, Public Information Room, Mail stop 1-5, Attention: 1557-0100, 250 E Street, SW., Washington, DC 20219. In addition, comments may be sent by fax to 202-874-4448, or by electronic mail to *regs.comments@occ.treas.gov.* You can inspect and photocopy the comments at the OCC's Public Information Room, 250 E Street, SW., Washington, DC 20219. You can make an appointment to inspect the comments by calling 202-874-5043. *Board:* You may submit comments, identified by FFIEC 009, by any of the following methods: • *Agency Web Site: http://www.federalreserve.gov.* Follow the instructions for submitting comments on the *http://www.federalreserve.gov/generalinfo/foia/ProposedRegs.cfm.* • *Federal eRulemaking Portal: http://www.regulations.gov.* Follow the instructions for submitting comments. • *E-mail: regs.comments@federalreserve.gov.* Include docket number in the subject line of the message. • *FAX:* 202-452-3819 or 202-452-3102. • *Mail:* Jennifer J. Johnson, Secretary, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue, NW., Washington, DC 20551. All public comments are available from the Board's Web site at *http://www.federalreserve.gov/generalinfo/foia/ProposedRegs.cfm* as submitted, except as necessary for technical reasons. Accordingly, your comments will not be edited to remove any identifying or contact information. Public comments may also be viewed electronically or in paper in Room MP-500 of the Board's Martin Building (20th and C Streets, NW.) between 9 a.m. and 5 p.m. on weekdays. *FDIC:* You may submit written comments, which should refer to “Country Exposure Reports, 3064-0017,” by any of the following methods: • *Agency Web Site: http://www.fdic.gov/regulations/laws/federal/propose.html.* Follow the instructions for submitting comments on the FDIC Web site. • *Federal eRulemaking Portal: http://www.regulations.gov.* Follow the instructions for submitting comments. • *E-mail: Comments@FDIC.gov.* • *Mail:* Robert E. Feldman, Executive Secretary, Attention: Comments, FDIC, 550 17th Street, NW., Washington, DC 20429. • *Hand Delivery/Courier:* Guard station at the rear of the 550 17th Street Building (located on F Street) on business days between 7 a.m. and 5 p.m. *Public Inspection:* All comments received will be posted without change to *http://www.fdic.gov/regulations/laws/federal/propose/html* including any personal information provided. Comments may be inspected at the FDIC Public Information Center, Room 100, 801 17th Street, NW., Washington, DC, between 9 a.m. and 4:30 p.m. on business days. A copy of the comments may also be submitted to the OMB desk officer for the agencies: By mail to U.S. Office of Management and Budget, 725 17th Street, NW., #10235, Washington, DC 20503 or by facsimile to 202-395-6974, Attention: Federal Banking Agency Desk Officer. FOR FURTHER INFORMATION CONTACT: Additional information or a copy of the collection may be requested from: *OCC:* Mary Gottlieb, OCC Clearance Officer, or Camille Dixon, 202-874-5090, Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, 250 E Street, SW., Washington, DC 20219. *Board:* Michelle Long, Federal Reserve Board Clearance Officer, 202-452-3829, Division of Research and Statistics, Board of Governors of the Federal Reserve System, 20th and C Streets, NW., Washington, DC 20551. Telecommunications Device for the Deaf
(TDD)users may call 202-263-4869, Board of Governors of the Federal Reserve System, 20th and C Streets, NW., Washington, DC 20551. *FDIC:* Leneta G. Gregorie, Counsel, 202-898-3719, Legal Division, Federal Deposit Insurance Corporation, 550 17th Street, NW., Washington, DC 20429. SUPPLEMENTARY INFORMATION: Proposal To Extend for Three Years, Without Revision, the Following Currently Approved Collections of Information *Report Title:* Country Exposure Report and Country Exposure Information Report. *Form Number:* FFIEC 009 and FFIEC 009a. *Frequency of Response:* Quarterly. *Affected Public:* Business or other for profit. OCC *OMB Number:* 1557-0100. *Estimated Number of Respondents:* 21 (FFIEC 009); 21 (FFIEC 009a). *Estimated Average Time per Response:* 70 burden hours (FFIEC 009); 5.25 burden hours (FFIEC 009a). *Estimated Total Annual Burden:* 5,880 burden hours (FFIEC 009); 441 burden hours (FFIEC 009a). Board *OMB Number:* 7100-0035. *Estimated Number of Respondents:* 29 (FFIEC 009); 16 (FFIEC 009a). *Estimated Average Time per Response:* 70 burden hours (FFIEC 009); 5.25 burden hours (FFIEC 009a). *Estimated Total Annual Burden:* 8,120 burden hours (FFIEC 009); 336 burden hours (FFIEC 009a). FDIC *OMB Number:* 3064-0017. *Estimated Number of Respondents:* 21 (FFIEC 009); 21 (FFIEC 009a). *Estimated Average Time per Response:* 70 burden hours (FFIEC 009); 5.25 burden hours (FFIEC 009a). *Estimated Total Annual Burden:* 5,880 burden hours (FFIEC 009); 441 burden hours (FFIEC 009a). General Description of Reports These information collections are mandatory: 12 U.S.C. 161 and 1817 (national banks), 12 U.S.C. 248(a), 1844(c), and 3906 (state member banks and bank holding companies); and 12 U.S.C. 1817 and 1820 (insured state nonmember commercial and savings banks). The FFIEC 009 information collection is given confidential treatment (5 U.S.C. 552(b)(4) and (b)(8)). The FFIEC 009a information collection is not given confidential treatment. Abstract The Country Exposure Report (FFIEC 009) is filed quarterly with the agencies and provides information on international claims of U.S. banks and bank holding companies that is used for supervisory and analytical purposes. The information is used to monitor country exposure of banks to determine the degree of risk in their portfolios and the possible impact on U.S. banks of adverse developments in particular countries. The Country Exposure Information Report (FFIEC 009a) is a supplement to the FFIEC 009 and provides publicly available information on material foreign country exposures (all exposures to a country in excess of 1 percent of total assets or 20 percent of capital, whichever is less) of U.S. banks and bank holding companies that file the FFIEC 009 report. As part of the Country Exposure Information Report, reporting institutions must also furnish a list of countries in which they have lending exposures above 0.75 percent of total assets or 15 percent of total capital, whichever is less. Request for Comment *Comments are invited on:* a. Whether the information collections are necessary for the proper performance of the agencies' functions, including whether the information has practical utility; b. The accuracy of the agencies' estimates of the burden of the information collections, including the validity of the methodology and assumptions used; c. Ways to enhance the quality, utility, and clarity of the information to be collected; d. Ways to minimize the burden of information collections on respondents, including through the use of automated collection techniques or other forms of information technology; and e. Estimates of capital or start up costs and costs of operation, maintenance, and purchase of services to provide information. Comments submitted in response to this notice will be shared among the agencies. All comments will become a matter of public record. Written comments should address the accuracy of the burden estimates and ways to minimize burden including the use of automated collection techniques or the use of other forms of information technology as well as other relevant aspects of the information collection request. Dated: November 22, 2005. Stuart Feldstein, Assistant Director, Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency. Board of Governors of the Federal Reserve System, December 1, 2005. Jennifer J. Johnson, Secretary of the Board. Dated at Washington, DC, this 5th day of December, 2005. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary. [FR Doc. E5-7276 Filed 12-12-05; 8:45 am] BILLING CODE 4810-33-P; 6210-01-P; 6714-01-P FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 *et seq.* ) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at *http://www.ffiec.gov/nic/* . Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than January 6, 2006. **A. Federal Reserve Bank of New York** (Jay Bernstein, Bank Supervision Officer) 33 Liberty Street, New York, New York 10045-0001: *1. Community Partners Bancorp* , Middletown, New Jersey; to become a bank holding company by acquiring 100 percent of the voting shares of The Town Bank, Westfield, New Jersey, and thereby indirectly acquire voting shares of Two River Community Bank, Middletown, New Jersey. **B. Federal Reserve Bank of St. Louis** (Glenda Wilson, Community Affairs Officer) 411 Locust Street, St. Louis, Missouri 63166-2034: *1. Illinois Bancshares, Inc.* , Karnak, Illinois; to become a bank holding company by acquiring 96.5 percent of the voting shares of The First State Bank of Grand Chain, Grand Chain, Illinois. **C. Federal Reserve Bank of Minneapolis** (Jacqueline G. King, Community Affairs Officer) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291: *1. Beulah Bancorporation* , Sioux Falls, South Dakota; to acquire 100 percent of the voting shares of Valley Bank & Trust, Mapleton, Iowa. Board of Governors of the Federal Reserve System, December 8, 2005. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E5-7262 Filed 12-12-05; 8:45 am] BILLING CODE 6210-01-S GENERAL SERVICES ADMINISTRATION Federal Travel Regulation; Notice of GSA Bulletin FTR 05-08 AGENCY: Office of Governmentwide Policy, General Services Administration (GSA). ACTION: Notice of a bulletin. SUMMARY: This notice announces GSA Federal Travel Regulation
(FTR)Bulletin 05-08. This Bulletin informs agencies that in accordance with the OMB Circular A-123 (revised), Appendix B, issued August 5, 2005, new travel charge card policies and guidance are issued to Executive Branch departments and agencies in order to help reduce the risk of fraud, misuse, and late payments. OMB Circular A-123 (revised), Appendix B is effective October 1, 2005. Bulletin FTR 05-08 may be found at *www.gsa.gov/ftrbulletins* . An amendment to the FTR on the use of the government issued travel charged card is forthcoming. DATES: The bulletin announced in this notice is effective December 2, 2005. FOR FURTHER INFORMATION CONTACT: For clarification of content, contact General Services Administration, Office of Governmentwide Policy, Office of Travel, Transportation and Asset Management, at
(202)501-1777. Please cite Bulletin FTR 05-08. SUPPLEMENTARY INFORMATION: A. Background OMB Circular A-123 (revised), Appendix B, establishes guidance for Executive branch agencies for improving the management of government charge card programs. The requirements in OMB Circular A-123 (revised), Appendix B pertain to the use of charge card programs by agencies and their employees and must be included in internal agency regulations, procedures, and training materials. Bulletin FTR 05-08 serves as guidance to agencies on implementing those policies and guidelines that are related to the official travel charge card. B. Procedures Bulletins regarding Federal travel expenses are located on the Internet at *www.gsa.gov/ftrbulletins* as Federal Travel Regulation
(FTR)bulletins. Dated: December 2, 2005. Becky Rhodes, Deputy Associate Administrator. [FR Doc. E5-7259 Filed 12-12-05; 8:45 am] BILLING CODE 6820-14-S DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: OS-0990-New [60-day notice]] Office of the Secretary; Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Office of the Secretary, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:
(1)The necessity and utility of the proposed information collection for the proper performance of the agency's functions;
(2)the accuracy of the estimated burden;
(3)ways to enhance the quality, utility, and clarity of the information to be collected; and
(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. *Type of Information Collection Request:* New collection. *Title of Information Collection:* Evaluation of the Office for Human Research Protections
(OHRP)Education Program Activities. *Form/OMB No.:* OS-0990-New. *Use:* The OHRP Evaluation of Education Activites project will evaluate the outcomes of OHRP's educational (and outreach) activites and identify opportunities for improvements, based on information obtained on the research communities' education needs related to protection of human research subjects. *Frequency:* Reporting on occasion. *Affected Public:* State, local, or tribal governments, Federal Government, business or other for-profit, not-for-profit institutions. *Annual Number of Respondents:* 6,598. *Total Annual Responses:* 1. *Average Burden Per Response:* 1 hour. *Total Annual Hours:* 900. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access the HHS Web site address at *http://www.hhs.gov/oirm/infocollect/pending/* or e-mail your request, including your address, phone number, OMB number, and OS document identifier, to *naomi.cook@hhs.gov,* or call the Reports Clearance Office on
(202)690-6162. Written comments and recommendations for the proposed information collections must be mailed within 60 days of this notice directly to the OS Paperwork Clearance Officer designated at the following address: Department of Health and Human Services, Office of the Secretary, Assistant Secretary for Budget, Technology, and Finance, Office of Information and Resource Management, Attention: Naomi Cook (0990-New) Room 531-H, 200 Independence Avenue, SW., Washington, DC 20201. Date: December 2, 2005. Robert E. Polson, Office of the Secretary, Paperwork Reduction Act Reports Clearance Officer. [FR Doc. E5-7251 Filed 12-12-05; 8:45 am] BILLING CODE 4168-17-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary [Document Identifier: OS-4040-0004 (Formerly OMB-0348-0043) [30-day notice] Grants.gov Program Management Office; Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Office of the Secretary, Grants.gov Program Management Office, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Grants.gov Program Management Office, one of the 26 E-Government initiatives, managed by the Department of Health and Human Services is publishing the following summary of proposed collection for public comment. Interested individuals are invited to send comments regarding any aspect of this collection of information or any other aspect of this collection of information, including any of the following subjects:
(1)The necessity and utility of the proposed information collection for the proper performance of the agency's functions;
(2)the accuracy of the estimated burden;
(3)ways to enhance the quality, utility, and clarity of the information to be collected; and
(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. *Type of Information Collection Request:* Regular, Revision of a currently approved collection; *Title of Information Collection:* SF-424 Application for Federal Assistance; *Form/OMB No.:* OS-4040-0004 (Formerly OMB-0348-0043); The SF-424 Application for Federal Assistance (OMB control number 0348-0043) was cleared by OMB for emergency use on July 31, 2003, **Federal Register** notice [68 FR 44974]. OMB has since assigned the responsibility for this government-wide standard form to the Grants.gov Program Management Office and therefore the SF-424 Application for Federal Assistance OMB control number was changed in April 2005 from 0348-0043 to 4040-0004. A 60-day **Federal Register** Notice was published on September 15, 2005 [Vol. 70. No. 178]. *Use:* In the **Federal Register** notice published April 8, 2003 [68 FR 17090], OMB proposed to establish a government-wide standard set of data elements and definitions for grant-related applications. After consultation with the public, OMB added four data elements to the existing Standard Form 424 (SF-424), Application for Federal Assistance data elements and established the data as the standard core data set for use on both paper and electronic applications. After obtaining emergency clearance, July 31, 2003, **Federal Register** notice, [68 FR 44974], use of the standard data elements was implemented through the electronic grants application process of Grants.gov, and was deployed in October 2003 as part of the implementation of the Federal Financial Assistance Management Improvement Act of 1999 (Pub. L. 106-107). OMB recognized that a transition period would be needed to provide agencies time to adapt their application forms and systems to the SF-424 core data set and to phase out the use of the old forms. OMB committed to a one-year transition period and further committed to reevaluate the data set at the end of the transition period. Following the expiration of the transition period, a cross-agency working group recommended revisions to the SF-424 core data set and form. Based on these recommendations, the Grants.gov Program office now proposes the addition of the following three new standard data elements to the SF-424 data set and form: Requesting entity's Province to collect non-US geographic subdivision data for international address purposes, if applicable. Requesting entity's Point of Contact's Organizational Affiliation, if applicable. Requesting entity's Point of Contact's Title, if applicable. The Grants.gov Program office further proposes deletion of the requesting entity's designation of construction or non-construction type of submission data element. Also proposed are non-data collection related changes, *i.e.* , renaming of data elements. These changes are presented in the supporting statement found on the HHS Web site at *http://www.hhs.gov/oirm/infocollect/pending* . Federal agencies will not be required to collect all of the information included in the data set. The agency will identify the data that must be provided by applicants through instructions that will accompany the application package. The efforts to address potential future revisions to the SF-424A and SF-424C budget forms and categories and to evaluate the SF-424B and SF-424D assurance language are separate efforts to be undertaken by the Public Law 106/107 working groups and have no impact upon the proposed revisions to the SF-424 data set or form. An estimate of the total burden was submitted during the first information collection package for the SF-424 on April 8, 2003, **Federal Register** notice [68 FR 17090]. The estimate has been updated based on the Paperwork Reduction Act Worksheets (OMB 83-C) received from the agencies. Collectively, the agencies plan to receive 142,223 applications annually and estimate that it takes applicants one hour on average to complete each application. Cumulatively, the agencies report the total burden to applicants to be 146,758 hours. *Frequency:* Recordkeeping, Reporting, on occasion. *Affected:* Federal, State, Local and Tribal governments; farms; non-profit institutions, and other for-profit. *Total Annual Respondents:* 77,576. *Total Annual Responses:* 142,223. *Average Burden Per Response:* 1 hour. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access the HHS Web site address at *http://www.hhs.gov/oirm/infocollect/pending/* or e-mail your request, including your address, phone number, OMB number, and OS document identifier, to *naomi.cook@hhs.gov* , or call the Reports Clearance Office on
(202)690-6162. Written comments and recommendations for the proposed information collections must be mailed within 30 days of this notice directly to the Desk Officer at the address below: *OMB Desk Officer:* Katherine Astrich, OMB Human Resources and Housing Branch, Attention: (OMB 4040-0004), New Executive Office Building, Room 10235, Washington, DC 20503. Date: December 2, 2005. Robert E. Polson, Office of the Secretary, Paperwork Reduction Act Reports Clearance Officer. [FR Doc. E5-7252 Filed 12-12-05; 8:45 am] BILLING CODE 4157-17-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Toxic Substances and Disease Registry [ATSDR-215] Update on the Status of the Superfund Substance-Specific Applied Research Program **Editorial Note:** FR Doc. 05-23361 was originally published at page 71506 in the issue of Tuesday, November 29, 2005. The corrected document is republished below in its entirety, due to printing errors. AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR), U.S. Department of Health and Human Services (HHS). ACTION: Notice. SUMMARY: This Notice provides the status of ATSDR's Superfund-mandated Substance-Specific Applied Research Program (SSARP) which was last updated in a **Federal Register** notice in 2002 (67 FR 4836). Authorized by the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA, also known as the Superfund statute), as amended by the Superfund Amendments and Reauthorization Act of 1986
(SARA)[42 U.S.C. 9604 (i)], this research program was initiated on October 17, 1991. At that time, a list of priority data needs for 38 priority hazardous substances frequently found at waste sites was announced in the **Federal Register** (56 FR 52178). The list was subsequently revised based on public comments and published in final form on November 16, 1992 (57 FR 54150). The 38 substances, each of which is found on ATSDR's Priority List of Hazardous Substances (68 FR 63098, November 7, 2003), are aldrin/dieldrin, arsenic, benzene, beryllium, cadmium, carbon tetrachloride, chloroethane, chloroform, chromium, cyanide, p,p'-DDT,DDE,DDD, di(2-ethylhexyl) phthalate, lead, mercury, methylene chloride, nickel, polychlorinated biphenyl compounds (PCBs), polycyclic aromatic hydrocarbons (PAHs—includes 15 substances), selenium, tetrachloroethylene, toluene, trichloroethylene, vinyl chloride, and zinc. On July 30, 1997, priority data needs for 12 additional hazardous substances frequently found at waste sites were determined and announced in the **Federal Register** (62 FR 40820). The 12 substances, each of which is included in ATSDR's Priority List of Hazardous Substances, are chlordane, 1,2-dibromo-3-chloropropane, di-n-butyl phthalate, disulfoton, endrin (includes endrin aldehyde), endosulfan (alpha-, beta-, and endosulfan sulfate), heptachlor (includes heptachlor epoxide), hexachlorobutadiene, hexachlorocyclohexane (alpha-, beta-, delta- and gamma-), manganese, methoxychlor, and toxaphene. More recently, priority data needs for 10 additional hazardous substances frequently found at waste sites were determined and announced in the **Federal Register** (68 FR 22704). The ten substances, each of which is included in ATSDR's Priority List of Hazardous Substances, are asbestos, benzidine, chlorinated dibenzo-p-dioxins, 1,2-dibromoethane, 1,2-dichloroethane, 1,1-dichloroethene, ethylbenzene, pentachlorophenol, 1,1,2,2-tetrachloroethane, and total xylenes. Currently, the priority data needs for acrolein and barium are being identified and will be reported in a future **Federal Register** notice. To date, 270 priority data needs have been identified for the 60 hazardous substances, and 86 priority data needs have been filled (Table 1). ATSDR fills these research needs through U.S. Environmental Protection Agency
(EPA)regulatory mechanisms (test rules), private-sector voluntarism, and the direct use of CERCLA funds. Additional priority data needs are being addressed through collaboration with the National Toxicology Program (NTP), by ATSDR's Great Lakes Human Health Effects Research Program, and other Agency programs. Priority data needs documents describing ATSDR's rationale for prioritizing research needs for each substance are available. See ADDRESSES section of this Notice. This Notice also serves as a continuous call for voluntary research proposals. Private-sector organizations may volunteer to conduct research to address specific priority data needs identified in this Notice by indicating their interest through submission of a letter of intent to ATSDR (see ADDRESSES section of this Notice). A Tri-Agency Superfund Applied Research Committee (TASARC) composed of scientists from ATSDR, National Institute of Environmental Health Sciences (NIEHS)/NTP, and the EPA, will review all proposed voluntary research studies. DATES: ATSDR provides updates on the status of its Substance-Specific Applied Research Program approximately every three years or sooner, as needed. ATSDR considers the voluntary research effort to be important to the continuing implementation of the SSARP. Therefore, the Agency strongly encourages private-sector organizations to volunteer at any time to conduct research to fill data needs until ATSDR announces that other research mechanisms are in place to address those specific data needs. ADDRESSES: Private-sector organizations interested in volunteering to conduct research can write to Yee-Wan Stevens, M.S., Applied Toxicology Branch, Division of Toxicology and Environmental Medicine, ATSDR, 1600 Clifton Road, NE., Mailstop F-32, Atlanta, Georgia 30333, e-mail: *YStevens@cdc.gov.* Information about pertinent ongoing or completed research that may fill priority data needs cited in this Notice should be similarly addressed. Other Requirements: Projects that involve the collection of information from ten or more individuals and funded by cooperative agreement will be subject to review by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act. FOR FURTHER INFORMATION CONTACT: Yee-Wan Stevens, M.S., Applied Toxicology Branch, Division of Toxicology and Environmental Medicine, ATSDR, 1600 Clifton Road, NE., Mailstop F-32, Atlanta, Georgia 30333, telephone:
(770)488-3325, fax:
(770)488-4178. SUPPLEMENTARY INFORMATION: Background CERCLA as amended by SARA [42 U.S.C. 9604(i)] requires that ATSDR
(1)jointly with the EPA, develop and prioritize a list of hazardous substances found at National Priorities List
(NPL)sites,
(2)prepare toxicological profiles for these substances, and
(3)assure the initiation of a research program, in conjunction with NTP, to address identified data needs associated with the substances. Before starting such a program, ATSDR will consider recommendations of the InterAgency Testing Committee on the type of research that should be done. This committee was established under section 4(e) of the Toxic Substances Control Act of 1976 [15 U.S.C. 2604(e)](TSCA). The major goals of the ATSDR SSARP are
(1)to address the substance-specific information needs of the public and scientific community, and
(2)to supply information necessary to improve the database used to conduct comprehensive public health assessments of populations living near hazardous waste sites. We anticipate that the information will help to establish linkages between levels of contaminants in the environment and levels in human tissue and organs associated with adverse health effects. Once such links have been established, strategies to mitigate potentially harmful exposures can be developed. This program will also provide data that can be generalized to other substances or areas of science, including risk assessment of chemicals, thus creating a scientific information base for addressing a broader range of data needs. ATSDR encourages the use of *in vitro* assessment methods and other innovative tools for filling priority data needs. For example, the Agency believes that physiologically based pharmacokinetic
(PBPK)modeling could serve as a valuable tool in predicting across route similarities (or differences) in toxicological responses to hazardous substances. Therefore, on a case-by-case basis, a priority data need can be filled using existing data and modeling. In addition, ATSDR is a member of NTP's InterAgency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and supports development, validation, and acceptance of alternative toxicological test methods that reduce, refine, and replace the use of animals, as appropriate. CERCLA section 104(i)(5)(D) states that it is the sense of Congress that the costs for conducting this research program “be borne by the manufacturers and processors of the hazardous substance in question,” as required in TSCA and the Federal Insecticide, Fungicide, and Rodenticide Act of 1972 [7 U.S.C. 136 et seq.] (FIFRA), or by cost recovery from responsible parties under CERCLA. To execute this statutory intent, ATSDR developed a plan whereby parts of the SSARP are being conducted via the regulatory mechanisms referenced (TSCA/FIFRA), private-sector voluntarism, and the direct use of CERCLA funds. The TASARC, composed of scientists from ATSDR, NIEHS/NTP, and EPA, has been set up to:
(1)Advise ATSDR on the assignment of priorities for mechanisms to address data needs,
(2)Coordinate knowledge of research activities to avoid duplication of research in other programs and under other authorities,
(3)Advise ATSDR on issues of science related to substance-specific data needs, and
(4)Maintain a scheduled forum that provides an overall review of the ATSDR SSARP. TASARC has met 12 times since the initiation of the SSARP. It has guided referral of priority data needs to EPA and the associated development of test rules through TSCA. In addition, it has endorsed the proposals of several private-sector organizations to conduct voluntary research. Furthermore, TASARC has become a forum for other federal agencies to bring forth their research agendas. For example, it has coordinated research efforts on hazardous pollutants with the Office of Air and Radiation, EPA. TASARC has developed testing guidelines for immunotoxicity; and has endorsed the use of decision-support methodologies such as physiologically based pharmacokinetic
(PBPK)modeling and benchmark-dose modeling, where appropriate. Additional priority data needs are being addressed through collaborative research efforts with NTP, by ATSDR's Great Lakes Human Health Effects Research Program, and other Agency programs. Criteria for Evaluating Status of Priority Data Needs To update the activities covered under the SSARP, criteria for evaluating the status of the priority data needs were developed. Based on these criteria and the review of the current literature, a priority data need can be filled, or unchanged. The criteria for evaluating the status of the priority data needs are described below. General Criteria A priority data need is filled: • If it has been referred to one of the implementation mechanisms and research has been initiated (Exception: priority data needs referred to EPA [i.e., included in the EPA/ATSDR test rule] and/or ATSDR Voluntary Research Program remain as priority data needs until the studies have been completed, peer reviewed and accepted by ATSDR), OR • If an updated ATSDR toxicological profile contains relevant new studies, or if other relevant, peer-reviewed, and publicly available new studies (not included in the toxicological profile) have been identified since the finalization of the priority data needs document; and based on such studies, it is generally agreed that a priority data need has been filled. Furthermore, in the event a priority data need is considered filled, it does not necessarily mean that the study has been completed and that ATSDR has accepted the data. It does, however, indicate that the Agency no longer considers it a priority to initiate additional studies at this time. A priority data need remains unchanged: • If no mechanism or information has been identified to address the priority data need, or • If the priority data need is included in the ATSDR/EPA test rule under development and/or ATSDR Voluntary Research Program, or it is associated with a pilot substance in EPA's Voluntary Children's Chemical Evaluation Program. Specific Criteria Examples of specific criteria for two categories of priority data needs are described below. • Epidemiologic studies—A priority data need is filled if multiple new studies assessing key health end points are available in ATSDR's updated toxicological profile and/or ongoing studies have been identified, e.g., human health studies supported by ATSDR's Great Lakes Human Health Effects Research Program or the Minority Health Professions Foundation Research Program. In some cases, ATSDR indicates that it will continue to evaluate new data as they become available to determine whether additional studies are needed. • Exposure levels in humans (adults and/or children)—A priority data need is filled if
(a)there are current and adequate biomonitoring data for exposed populations associated with health effects (from published or ongoing studies), or
(b)there are reference range data (e.g., the Centers for Disease Control and Prevention's Third National Report on Human Exposure to Environmental Chemicals, with data from a random sample of participants from the National Health and Nutrition Examination Survey [NHANES] ) or generally agreed upon background population levels. In the latter case, ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. It should be noted that for some of the chemicals listed in the National Report, the measurements are reported as below the limit of detection
(LOD)for those chemicals. However, the LODs for all the chemicals monitored are available in the Report, and therefore, these data can be considered as estimates of background exposure levels. In updating the SSARP, the status of the priority data needs may change as new information becomes available. Further, during the literature review, new studies may be identified suggesting other effects of concern, such as those related to endocrine disruptors and children's health, which were not included in the original list of priority data needs. In such cases, additional priority data needs may be added to the research agenda. For example, in addressing issues relating to children's health, ATSDR considers it a priority to obtain data on exposure levels in children; therefore, when such information is available, it is used to fill this additional priority data need (e.g., cadmium, chlordane, chlorinated dibenzo-p-dioxins, DDT, lead, and pentachlorophenol, see Table 1). In contrast, the Agency may consider a previously identified priority data need to no longer be a priority to fill at this time and thus be deleted from the list of priority data needs. However, it remains a data need for the Agency. For example, as a result of reevaluation of the database for di-n-butyl phthalate, two of its previously identified priority data needs, i.e., immunotoxicity and neurotoxicty studies via oral exposure are no longer considered to be priority data needs. This is due to the fact that the immune system does not appear to be a target for di-n-butyl phthalate toxicity and that additional neurotoxicty studies do not seem necessary because of the lack of effects seen in long-term neurotoxicty studies. In addition, under the Agency's Voluntary Research Program, the Halogenated Solvents Industry Alliance, Inc.
(HSIA)proposed to fill a trichloroethylene priority data need (dose-response data for intermediate-duration, oral exposure) by conducting PBPK modeling to obtain the data for oral exposure using existing inhalation data. However, ATSDR is concerned that, based on the existing data for this exposure duration, it is not clear if the most sensitive end point for oral exposure is the same as that for inhalation exposure. Therefore, the Agency believes it is prudent not to consider it a priority to conduct a PBPK study to obtain the oral data at this time pending evaluation of additional information. This is reflected in Table 1 from which this priority data need has been deleted. Update of Activities in the SSARP An update of the activities associated with the mechanisms for implementing the ATSDR Substance-Specific Applied Research Program (SSARP) is discussed below. A. TSCA/FIFRA In developing and implementing the SSARP, ATSDR, NIEHS/NTP, and EPA have identified a subset of priority data needs for substances of mutual interest to the federal programs. These priority data needs are being addressed through a program of toxicological testing under TSCA according to established procedures and guidelines. On several occasions when ATSDR identified priority data needs for oral exposure, other agencies needed inhalation data. In response, ATSDR considers proposals to conduct inhalation studies in conjunction with physiologically based pharmacokinetic
(PBPK)studies in lieu of oral studies. ATSDR expects that inhalation data derived from these studies can be used with PBPK modeling to address its oral toxicity priority data needs. Currently, an EPA/ATSDR test rule, under development, includes eight ATSDR substances, *i.e.* , benzene, chloroethane, cyanide (hydrogen cyanide and sodium cyanide), methylene chloride, tetrachloroethylene, toluene and trichloroethylene, and addresses 13 ATSDR priority data needs (Table 2). The test rule is presently undergoing ATSDR and EPA final review and is anticipated to be available for public comment in Spring 2006. At least seven metals included in the ATSDR's SSARP (arsenic, beryllium, chromium, manganese, mercury, nickel, and selenium, associated with 21 priority data needs) (Table 2) have been forwarded to EPA through TASARC for toxicity testing. The EPA is currently developing a risk assessment framework for metals. Once the framework has been adopted, the EPA will solicit testing proposals for these metals and pursue appropriate testing mechanisms at a later date. B. Private-Sector Voluntarism As part of the Substance-Specific Applied Research Program (SSARP), ATSDR announced a set of proposed procedures for conducting voluntary research in the **Federal Register** (57 FR 4758) on February 7, 1992. Revisions based on public comments were published on November 16, 1992 (57 FR 54160). Private-sector organizations are encouraged to volunteer to conduct research to fill specific priority data needs at no expense to ATSDR. All study protocols and final reports are subjected to ATSDR's external peer review, and ATSDR accepts the study results based on the peer reviewers' recommendation and the industry groups' satisfactory response to the reviewers' comments. To date, ATSDR has established memoranda of understanding with four industry groups. Through the voluntary research efforts of these organizations, at least 15 research needs (12 priority data needs and 3 data needs) for methylene chloride, tetrachloroethylene (perchloroethylene), trichloroethylene, polychlorinated biphenyl compounds [PCBs], and vinyl chloride have been or are being filled (Table 2). Industry groups which conducted studies under the Voluntary Research Program include: *The American Chemistry Council (ACC* ) [formerly the Chemical Manufacturers Association (CMA)] ATSDR accepted the ACC studies “Vinyl chloride: Combined inhalation two-generation reproduction and developmental toxicity study in CD rats.” General Electric Company
(GE)GE conducted studies on polychlorinated biphenyls including “An assessment of the chronic toxicity and oncogenicity of Aroclors 1016, 1242, 1254, and 1260 administered in diet to rats,” “PCB congener analyses,” and “Metabolite detection as a tool for determining naturally occurring aerobic PCB biodegradation.” Although these studies do not specifically address ATSDR's *priority* data needs for PCBs, they do address other Agency research needs for these substances. Halogenated Solvents Industry Alliance, Inc.
(HSIA)To date, ATSDR has entered into five MOUs with HSIA to conduct studies to fill priority data needs for methylene chloride, tetrachloroethylene and trichloroethylene. In addition, in 2002, HSIA signed a letter of agreement with ATSDR stating that HSIA volunteers to conduct studies to fill ATSDR's remaining priority data needs for tetrachloroethylene (perchloroethylene) and trichloroethylene. These studies are being done in conjunction with the EPA/ATSDR test rule and EPA's Voluntary Children's Chemical Evaluation Program. In some cases, HSIA first conducted a study via inhalation which was followed by route extrapolation via PBPK modeling to obtain data for oral exposure. This is because, for specific chemicals, EPA requires inhalation data while ATSDR has determined that ingestion of contaminated environmental media is the primary exposure route at hazardous waste sites. HSIA studies accepted by ATSDR include: Addressing priority data needs for methylene chloride with physiologically based pharmacokinetic modeling” which evaluates acute- and subchronic-duration toxicity and developmental toxicity via oral exposure. “Methylene chloride: 28 day inhalation toxicity study in the rat to assess potential immunotoxicity.” “Immunotoxic potential of orally administered dichloromethane from immunotoxicty studies conducted by the inhalation route.” (PBPK modeling) “Trichloroethylene: Inhalation developmental toxicity study in CD rats.” HSIA will conduct PBPK modeling to obtain data for oral exposure based on the inhalation data. “Trichloroethylene (TCE): Immunotoxicity potential in CD rats following a 4-week vapor inhalation exposure.” The final report of the study is undergoing ATSDR's external peer review. Pending ATSDR's acceptance of the inhalation study, HSIA will conduct PBPK modeling to obtain data for oral exposure based on the inhalation data. “Perchloroethylene: Study of effects on embryo-fetal development in CD rats by inhalation administration.” HSIA will conduct PBPK modeling to obtain data for oral exposure based on the inhalation data. Electric Power Research Institute, Inc.
(EPRI)In addition to the substance-specific MOUs described above, ATSDR also signed an MOU with EPRI to conduct a study “Validation of test methods for assessing neurodevelopment in children.” In this particular case, ATSDR and three other federal agencies (the Food and Drug Administration, EPA, and NIEHS) were also funding partners. C. CERCLA-Funded Research (Minority Health Professions Foundation Research Program) During FY 1992, ATSDR announced a $4 million cooperative agreement program with the Minority Health Professions Foundation
(MHPF)to support substance-specific investigations. A not-for-profit Internal Revenue Code 501(c)(3) organization, the MHPF comprises 11 minority health professions schools at historically black colleges and universities. The MHPF mission is to research health problems that disproportionately affect poor and minority citizens. The purpose of the cooperative agreement was to address substance-specific data needs for priority hazardous substances identified by ATSDR. In addition, the agreement strengthened the environmental health research opportunities for scientists and students at MHPF member institutions and enhanced existing disciplinary capacities to conduct research in toxicology and environmental health. The MHPF published a report, “Environmental Health and Toxicology Research Program: Meeting Environmental Health Challenges Through Research, Education, and Service,” that describes the research findings and other successes from the first 5 years of the program. In the first five year project period that concluded during FY 1997, nine priority data needs for 21 priority hazardous substances and 22 other research needs for these and other substances were addressed. Research initiated in the second 5-year project period included studies to address 10 additional priority data needs for chlordane, di-n-butyl phthalate, lead, manganese, the polycylic aromatic hydrocarbons (PAHs), zinc, and eight other research needs. To date, 14 priority data needs have been filled through this cooperative agreement (Table 1). During 2003, ATSDR announced a new five year cooperative agreement program with the MHPF. The purpose of the program is to apply findings from the previous ten year environmental health and Toxicology Research Program and to improve public health and environmental medicine in low-income and minority communities. The new program builds on earlier efforts and expands the Program's public environmental health impact on affected communities. Activities across the following four research and environmental public health focus areas were funded to initiate this new program: substance-specific toxicology research, environmental exposure assessment, community-based environmental health education, and environmental health education for primary-care providers. No additional priority data needs are being addressed under this new program. To date, Program research findings and other activities have resulted in the publication of more than 50 manuscripts in peer-reviewed journals. The institutions which have received awards and their respective studies are listed in Table 2. D. National Toxicology Program
(NTP)Section 104(i)(5) of CERCLA directs the administrator of ATSDR (in consultation with the administrator of EPA and agencies and programs of the Public Health Service) to assess whether adequate information on the health effects of priority hazardous substances found at NPL sites is available. Where adequate information is not available, ATSDR, in cooperation with the National Toxicology Program (NTP), is required to assure the initiation of a program of research designed to determine these health effects (and techniques for developing methods to determine such health effects). ATSDR continues to collaborate with NTP to address priority data needs of mutual interest. Chemicals for which NTP has conducted studies (or is in the process of conducting studies) to fill ATSDR's priority data needs include carbon tetrachloride, 1,1-dichloroethene, di-n-butyl phthalate, disulfoton, and heptachlor (Table 2). E. Great Lakes Human Health Effects Research Program Some of the priority data needs identified in the SSARP have been independently identified as research needs through the ATSDR Great Lakes Human Health Effects Research Program, a separate research program. In support of the Great Lakes Critical Programs Act of 1990, ATSDR announced in Fiscal Year 1992 the availability of $2 million for a grant program to conduct research on the potential for short- and long-term adverse health effects from consumption of contaminated fish from the Great Lakes basin. Research undertaken through this program is intended to build on and amplify the results of past and ongoing fish consumption research in the Great Lakes basin. The ATSDR-supported research projects focus on known high-risk populations to define further the human health consequences of exposure to persistent toxic substances
(PTSs)identified in the Great Lakes basin. These at-risk populations include sport anglers; African Americans, Asians and other non-English speaking populations; pregnant women; fetuses, nursing infants, and children of mothers who consume contaminated Great Lakes sport fish; the elderly, and the urban poor. To date, the research activities of the ATSDR Great Lakes Human Health Effects Research Program have resulted in 70 publications in peer-reviewed journals. Currently, 14 priority data needs for 24 priority hazardous substances (including 15 PAHs) identified in the SSARP are being addressed through this program. The institutions which have received awards and their respective studies are listed in Table 2. F. Other ATSDR Programs In its role as a public health agency addressing environmental health, ATSDR may collect human data to validate substance-specific exposure and toxicity findings. The need for additional information on levels of contaminants in humans has been identified, and remains as a priority data need for 59 of the 60 priority substances (Table 1). In some cases, ATSDR anticipates obtaining this information through exposure and health effects studies, and through establishing and using substance-specific subregistries of people within the Agency's National Exposure Registry who have potentially been exposed to these substances. Regarding the priority data need for exposure subregistries, the list of the 60 priority hazardous substances in the SSARP was forwarded to ATSDR's Division of Health Studies for consideration as potential candidates for subregistries of exposed persons, based on criteria described in its 1994 document, “National Exposure Registry: Policies and Procedures Manual (Revised),” Agency for Toxic Substances and Disease Registry, Public Health Service, U.S. Department of Health and Human Services, Atlanta, Georgia, NTIS Publication No. PB95-154571. Currently, ATSDR has established exposure subregistries for benzene, dioxin, 1,1,1-trichloroethane (not included in the SSARP), trichloroethylene, and tremolite asbestos. G. Conclusion The results of the research conducted via the SSARP are expected to provide information necessary to improve the database used to conduct comprehensive public health assessments of populations living near hazardous waste sites. The information will enable the Agency to establish linkages between levels of contaminants in the environment and levels in human tissue and organs associated with adverse health effects, ultimately helping to determine methods for interdicting exposure and mitigating toxicity. This program will also provide data that can be generalized to other substances or areas of science, including risk assessment of chemicals, thus creating a scientific information base for addressing a broader range of data needs. The Agency plans to provide an update on the status of this research program approximately every three years or sooner, as needed. Dated: November 17, 2005. Kenneth Rose, Acting Director, Office of Policy, Planning, and Evaluation, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry. Table 1.—ATSDR's Substance-Specific Priority Data Needs for 60 Priority Hazardous Substances Substances PDN ID 1 PDN description Program 2 Status change 3 Comments 4 Aldrin/Dieldrin 1A Dose-response data in animals for intermediate-duration oral exposure Filled An MRL was derived in the 2000 updated ATSDR toxicological profile. 1B Bioavailability from soil 1C Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers This priority data need, previously addressed in a study in the Great Lakes Research Program, is no longer investigated in that study. 1D Potential candidate for subregistry of exposed persons ATSDR Arsenic 2A Comparative toxicokinetic studies to determine if an appropriate animal species can be identified EPA 2B Half-lives in surface water, groundwater EPA 2C Bioavailability from soil EPA 2D Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers G. Lakes Filled In addition to the data from the Great Lakes Research Program, background level data are available in ATSDR's 1993 toxicological profile, and at least seven ATSDR studies that evaluated urine arsenic levels and potential adverse health effects are available. Also, additional studies are available in ATSDR's 2000 updated toxicological profile. Asbestos 3A Epidemiologic studies of individuals occupationally exposed to asbestos levels lower than those experienced before the institution of current occupational standards governing the use of asbestos, but higher than current levels in the general population. These studies should be performed in conjunction with the immunotoxicity studies 3B Immunotoxicity studies of individuals occupationally exposed to asbestos 3C Development of human and rat lung retention models to aid in extrapolating between rat and human data 3D Improved analytical methods for screening samples and determining the chemical structure of asbestos fibers. Also, techniques are needed to normalize studies in which different analytical methods were employed 3E Exposure levels, fiber size distribution, and asbestos fiber type in areas with natural geologic deposits of friable asbestos and at hazardous waste sites. Also, techniques for estimating air levels of asbestos from soil concentrations and activity scenarios 3F Exposure levels in humans living near hazardous waste sites and in other populations, such as humans living in areas with naturally high levels of friable asbestos 3G Potential candidate for subregistry of exposed persons ATSDR Filled ATSDR established registry to follow the health of people who were exposed to asbestos in Libby, Montana. The name of the registry is the Tremolite Asbestos Registry (TAR). Benzene 4A Dose-response data in animals for acute- and intermediate-duration oral exposure. The subchronic study should include an extended reproductive organ histopathology EPA Reproductive toxicity study is the only component of this PDN that is included in the EPA/ATSDR test rule. 4B Prenatal developmental toxicity study via oral exposure EPA Previously planned study in the MHPF Research Program to address this priority data need was canceled. 4C Neurotoxicology battery of tests via oral exposure EPA 4D Epidemiologic studies on the health effects of benzene (Special emphasis end points include immunotoxicity) Filled Based on an evaluation of the data in ATSDR's 1997 updated toxicological profile. ATSDR will continue to evaluate new data as they become available to determine if additional studies are needed. 4E Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers Filled Reference range concentrations are available (Ashley *et al.* 1992, 1994; Needham *et al.* 1995), and at least one ATSDR study that evaluated blood benzene levels and potential adverse health effects is available. ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. Benzidine 5A Dose-response data for acute- and intermediate-duration exposure via the oral route (the study of intermediate-duration exposure should include evaluation of reproductive and endocrine organ histopathology, lymphoid tissues histopathology as well as examination of relevant blood components, and nervous system histopathology) 5B Exposure levels in humans living near hazardous waste sites 5C Exposure levels in children 5D Potential candidate for subregistry of exposed persons ATSDR Beryllium 6A Dose-response data in animals for acute- and intermediate-duration inhalation exposures. The subchronic study should include extended reproductive organ histopathology EPA 6B Prenatal developmental toxicity study via inhalation exposure EPA 6C Environmental fate in air; factors affecting bioavailability in air EPA 6D Analytical methods to determine environmental speciation Filled Based on an evaluation of the data in ATSDR's 2000 updated toxicological profile. 6E Immunotoxicology battery of tests following oral exposure EPA 6F Exposure levels in humans (adults) living near hazardous waste sites and other populations, such as exposed workers Filled Reference range concentrations in urine are available (Paschal *et al.* 1998, CDC 2005). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. 6G Exposure levels in children Filled Reference range concentrations in urine are available (CDC 2005). 6H Potential candidate for subregistry of exposed persons ATSDR Cadmium 7A Analytical methods for biological tissues and fluids and environmental media Filled Based on an evaluation of the data in ATSDR's 1999 updated toxicological profile. 7B Exposure levels in humans (adults) living near hazardous waste sites and other populations, such as exposed workers G. Lakes Filled In addition to the data from the Great Lakes Research Program, reference range concentrations in blood and urine are available (CDC 2005), and at least nine ATSDR studies that evaluated blood and urine cadmium levels and potential adverse health effects are available. 7C Exposure levels in children Filled Reference range concentrations in blood and urine are available (CDC 2005). Carbon tetrachloride 8A Dose-response data in animals for chronic oral exposure. The study should include extended reproductive organ and nervous tissue histopathology 8B Immunotoxicology battery of tests via oral exposure NTP Filled NTP dose-finding study and one study in ATSDR's 1994 updated toxicological profile addressed the priority data need. 8C Half-life in soil Filled One study in ATSDR's 1994 updated toxicological profile provided information on half-life in soil. 8D Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers Filled Reference range concentrations in blood are available (Ashley *et al.* 1992, 1994; Needham *et al.* 1995). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. 8E Potential candidate for subregistry of exposed persons ATSDR Chlordane 9A Oral multigenerational studies to evaluate reproductive toxicity MHPF Filled Availability of studies in the MHPF Research Program. 9B Bioavailability studies following ingestion of contaminated media 9C Exposure levels in humans (adults) living near hazardous waste sites and other populations potentially exposed to chlordane Filled Reference range concentrations in serum are available (CDC 2005). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. 9D Exposure levels in children Filled Reference range concentrations in serum are available (CDC 2005). 9E Potential candidate for subregistry of exposed persons ATSDR Chlorinated dibenzo-p-dioxins
(CDDs)10A Studies via oral exposure designed to assess childhood susceptibility 10B Comparative toxicokinetic studies examining the relative absorption of CDDs across exposure routes and the relative contribution of each exposure route to total body burdens 10C Exposure levels in humans (adults) living near hazardous waste sites Filled Reference range concentrations in serum are available (CDC 2005). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. 10D Exposure levels in children Filled Reference range concentrations in serum are available (CDC 2005). Chloroethane 11A Dose-response data in animals for acute- and intermediate-duration oral exposures. The subchronic study should include an evaluation of immune and nervous system tissues, and extended reproductive organ histopathology EPA 11B Dose-response data in animals for chronic inhalation exposures. The study should include an evaluation of nervous system tissues EPA 11C Potential candidate for subregistry of exposed persons ATSDR Chloroform 12A Dose-response data in animals for intermediate-duration oral exposure Filled An MRL was derived in ATSDR's 1997 updated toxicological profile. 12B Epidemiologic studies on the health effects of chloroform (Special emphasis end points include cancer, neurotoxicity, reproductive and developmental toxicity, hepatotoxicity, and renal toxicity) Filled Based on an evaluation of the data in ATSDR's 1997 updated toxicological profile. ATSDR will continue to evaluate new data as they become available to determined if additional studies are needed. 12C Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers Filled Reference range concentrations in blood are available (Ashley *et al.* 1992, 1994; and Needham *et al.* 1995). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. 12D Potential candidate for subregistry of exposed persons ATSDR Chromium 13A Dose-response data in animals for acute-duration exposure to chromium
(VI)and
(III)via oral exposure and for intermediate-duration exposure to chromium
(VI)via oral exposure EPA 13B Multigeneration reproductive toxicity study via oral exposure to chromium
(III)and
(VI)EPA 13C Immunotoxicology battery of tests following oral exposure to chromium
(III)and
(VI)EPA 13D Prenatal developmental toxicity study via oral exposure to chromium
(III)and
(VI)EPA 13E Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers G. Lakes Filled In addition to the data from the Great Lakes Research Program, reference range concentrations in urine are available (Paschal *et al.* 1998). Also, at least two ATSDR studies that evaluated urine chromium levels and potential adverse health effects are available. Cyanide 14A Dose-response data in animals for acute- and intermediate-duration exposures via inhalation. The subchronic study should include extended reproductive organ histopathology and evaluation of neurobehavioral and neuropathological end points EPA 14B Prenatal developmental toxicity study via oral exposure EPA 14C Evaluation of the environmental fate of cyanide in soil Filled A study addressing the priority data need was submitted by industry to EPA in response to EPA's solicitation for proposals for test rule making. Scientists from EPA and ATSDR reviewed the study and considered that this research need is no longer a priority. 14D Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers 14E Potential candidate for subregistry of exposed persons ATSDR 1,2-dibromo-3-chloropropane 15A Dose-response data in animals for acute-duration exposure via the oral route (including reproductive organ histopathology) 15B Dose-response data in animals for chronic-duration exposure via the oral route (including reproductive organ histopathology) 15C Prenatal developmental toxicity study via oral exposure 15D Immunotoxicology testing battery via oral exposure Previously planned study in the MHPF Research Program to address this priority data need was canceled. 15E Neurotoxicology testing battery via oral exposure Previously planned study in the MHPF Research Program to address this priority data need was canceled. 15F Exposure levels in humans living near hazardous waste sites and other exposed populations, such as exposed workers 15G Potential candidate for subregistry of exposed persons ATSDR 1,2-Dibromoethane 16A Dose-response data in animals for acute- and intermediate-duration exposure by the oral route (the study of intermediate-duration exposure should include evaluation of neuropathology and observation for overt signs of neurotoxicity) 16B Multigeneration reproductive toxicity studies via oral exposure 16C Developmental toxicity studies via oral exposure 16D Immunotoxicity battery studies via oral exposure 16E Exposure levels in humans living near hazardous waste sites and in other populations, such as workers exposed to 1, 2-dibromoethane 16F Exposure levels in children 16G Potential candidate for subregistry of exposed persons ATSDR 1,2-Dichloroethane 17A Dose-response data in animals for acute-duration (14-day) exposure by the inhalation route, including a comparison of young and adult animals 17B Dose-response data in animals for acute-duration (14-day) exposure by the oral route, including a comparison of young and adult animals 17C Dose-response data in animals for intermediate-duration exposure by the inhalation route (the study should be performed in conjunction with the neurotoxicology battery of tests) 17D Neurotoxicology battery of tests following inhalation exposure 17E Neurotoxicology battery of tests following oral exposure 17F Dose-response data in animals for chronic-duration exposure by the oral route 17G Prenatal developmental toxicity data for inhalation exposure (assessment of developmental cardiotoxicity and neurotoxicity) 17H Prenatal developmental toxicity data for oral exposure (assessment of developmental cardiotoxicity and neurotoxicity) 17I Additional analyses and studies for comparative toxicokinetics across species, ages, routes, and durations 17J Children's susceptibility 17K Exposure levels in humans living near hazardous waste sites 17L Exposure levels in children 17M Potential candidate for subregistry of exposed persons ATSDR 1,1-Dichloroethene 18A Dose-response data in animals for acute-duration exposure by the inhalation route NTP Filled Availability of ongoing NTP study. 18B Dose-response data in animals for chronic-duration exposure by the inhalation route NTP Filled Availability of ongoing NTP study. 18C Dose-response data in animals for acute- and intermediate-duration exposure by the oral route 18D Carcinogenicity studies in two species following inhalation exposure 18E Reproductive toxicity studies assessing male and female end points following inhalation exposure 18F Prenatal developmental toxicity studies following oral exposure 18G Immunotoxicology battery of tests following oral exposure 18H Battery of neurobehavioral tests following inhalation exposure 18I Children's susceptibility 18J Exposure levels in humans living near hazardous waste sites 18K Exposure levels in children 18L Potential candidate for subregistry of exposed persons ATSDR DDT 19A Dose-response data in animals for chronic-duration oral exposure 19B Comparative toxicokinetic study (across routes/species) 19C Bioavailability and bioaccumulation from soil 19D Epidemiologic studies on the health effects of DDT, DDD, and DDE (Special emphasis end points include immunotoxicity, and reproductive and developmental toxicity) G. Lakes Filled In addition to the data from the Great Lakes Research Program, multiple studies in ATSDR's 2000 updated toxicological profile are available. 19E Exposure levels in humans (adults) living near hazardous waste sites and other populations, such as exposed workers G. Lakes Filled In addition to the data from the Great Lakes Research Program, reference range concentrations in serum are available (CDC 2005). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. 19F Exposure levels in children Filled Reference range concentrations in serum are available (CDC 2005). 19G Potential candidate for subregistry of exposed persons ATSDR Di (2-ethylhexyl) phthalate 20A Epidemiologic studies on the health effects of DEHP (Special emphasis end points include cancer) 20B Dose-response data in animals for acute- and intermediate-duration oral exposures. The subchronic study should include an extended histopathologic evaluation of the immunologic and neurologic systems This research need remains as a priority data need because the previously developed MRL for acute-duration (1993 toxicological profile) was withdrawn. However, a new MRL for intermediate-duration was derived in ATSDR's 2002 updated Toxicological Profile. Therefore, this priority data need is considered partially filled because additional adequate acute-duration data for deriving an MRL are still lacking. 20C Multigeneration reproductive toxicity study via oral exposure This research need is reassigned as a priority data need based on an evaluation of the data in ATSDR's 2002 updated toxicological profile. Also, the NTP Center for the Evaluation of Risks to Human Reproduction Expert Panel Report (October 2000) has identified critical data needs for reproductive toxicity. 20D Comparative toxicokinetic studies (Studies designed to examine how primates metabolize and distribute DEHP as compared with rodents via oral exposure) Filled The existing database provides adequate information to fill this priority data need based on ATSDR's reevaluation of the published data. 20E Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers 20F Potential candidate for subregistry of exposed persons ATSDR Di-n-butyl phthalate 21A Dose-response data in animals for acute-duration exposure via the oral route NTP Filled Availability of an NTP study. 21B Dose-response data in animals for chronic-duration exposure via the oral route 21C Carcinogenicity studies via oral exposure 21D In vivo genotoxicity studies MHPF Filled Availability of a study in the MHPF Research Program. 21E Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers 21F Environmental fate of di-n-butyl phthalate in environmental media 21G Bioavailability in contaminated environmental media near hazardous waste sites 21H Potential candidate for subregistry of exposed persons ATSDR Disulfoton 22A Immunotoxicology testing battery following oral exposure NTP Filled Availability of ongoing NTP study. 22B Exposure levels of disulfoton in tissues/fluids for populations living near hazardous waste sites and other populations, such as exposed workers 22C Disulfoton should be considered as a potential candidate for a subregistry of exposed persons ATSDR Endosulfan (α, β, and sulfate) 23A Acute-duration oral exposure studies 23B Data on sensitive neurologic end point following oral exposure 23C Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers 23D Data on the bioavailability of endosulfan from soil 23E Potential candidate for subregistry of exposed persons ATSDR Endrin/endrin aldehyde 24A Dose-response animal data for acute oral exposure to endrin 24B Multigeneration reproductive toxicity studies via oral exposure to endrin 24C Accurately describe the toxicokinetics of endrin and its degradation products and identify the animal species to be used as the most appropriate model for human exposure 24D Exposure levels for endrin and its degradation products in humans living near hazardous waste sites 24E Accurately describe the environmental fate of endrin, including environmental breakdown products and rates, media half-lives, and chemical and physical properties of the breakdown products that help predict mobility and volatility 24F Potential candidate for subregistry of exposed persons ATSDR Ethylbenzene 25A Dose-response data for acute-duration exposure by the inhalation route 25B Dose-response data for chronic-duration exposure by the inhalation route 25C Dose-response data for acute- and intermediate-duration exposure by the oral route; the study of intermediate-duration exposure should include an evaluation of clinical signs of neurotoxicity and histopathology of reproductive organs, endocrine glands, and nervous system 25D Multigeneration toxicity study examining reproductive end points and indicators of endocrine disruption following inhalation exposure 25E Prenatal developmental study with continued assessment of offspring during postnatal development following oral exposure 25F Studies for comparative toxicokinetics 25G Exposure levels in humans living near hazardous waste sites 25H Exposure levels in children 25I Potential candidate for subregistry of exposed persons ATSDR Heptachlor/heptachlor epoxide 26A Dose-response animal data for acute- and intermediate-duration oral exposures, including immunopathology 26B Multigeneration reproductive toxicity studies via the oral route of exposure NTP Filled Availability of publication “The effects of perinatal/juvenile heptachlor exposure on adult immune and reproductive system function in rats” by Smialowicz et al. (2001), Toxicological Sciences 61:164-175. 26C Prenatal developmental toxicity studies via the oral route of exposure Filled Based on ATSDR's review of the literature, i.e., Smialowicz et al. (2001), Toxicological Sciences 61:164-175 and Moser et al.
(2001)Toxicological Sciences 60 (2):315-326. 26D Exposure levels in humans (adults) living near hazardous waste sites and other populations, such as exposed workers Filled Reference range concentrations in serum are available (CDC 2005). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. 26E Exposure levels in children Filled Reference range concentrations in serum are available (CDC 2005). 26F Bioavailability from contaminated air, water, and soil and bioaccumulation potential 26G Potential candidate for subregistry of exposed persons ATSDR Hexachlorobutadiene 27A Dose-response data in animals for acute-duration exposure via the oral route 27B Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers 27C Environmental fate studies that determine the extent to which hexachlorobutadiene volatilizes from soil, and studies that determine the reactions and rates which drive degradation in soil 27D Bioavailability studies in soil and plants 27E Potential candidate for subregistry of exposed persons ATSDR Hexachlorocyclohexane (α, β and γ) 28A Dose-response data for chronic-duration oral exposure Filled An MRL was derived in ATSDR's 1999 updated toxicological profile. 28B Mechanistic studies on the neurotoxicity, hepatotoxicity, reproductive toxicity, and immunotoxicity of hexachlorocyclohexane 28C Exposure levels in humans (adults) living near hazardous waste sites and other populations, such as exposed workers Filled Reference range concentrations in serum are available (CDC 2005). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. 28D Exposure levels in children Filled Reference range concentrations in serum are available (CDC 2005). 28E Potential candidate for subregistry of exposed persons ATSDR Lead 29A Mechanistic studies on the neurotoxic effects of lead MHPF Filled Multiple studies (at least 13 publications from the MHPF Research Program + numerous studies in ATSDR's 1999 updated toxicological profile) are available. 29B Analytical methods for tissue levels MHPF Filled A publication from the MHPF Research Program and numerous studies in ATSDR's 1999 toxicological profile are available. 29C Exposure levels in humans (adults) near hazardous waste sites and other populations, such as exposed workers MHPF G. Lakes Filled In addition to the data from Great Lakes Research Program and MHPF Research Program, reference range concentrations in blood and urine are available (CDC 2005; Paschal et al. 1998), and at least 19 ATSDR studies that evaluated blood lead levels and potential adverse health effects are available. 29D Exposure levels in children Filled Reference range concentrations in blood and urine are available (CDC 2005). Manganese 30A Dose-response data for acute- and intermediate-duration oral exposures (the subchronic study should include reproductive histopathology and an evaluation of immunologic parameters including manganese effects on plaque-forming cells (SRBC), surface markers (D4:D8 ratio), and delayed hypersensitivity reactions) MHPF EPA Filled Availability of studies in the MHPF Research Program. 30B Toxicokinetic studies on animals to investigate uptake and absorption, relative uptake of differing manganese compounds, metabolism of manganese, and interaction of manganese with other substances following oral exposure MHPF EPA Filled Availability of studies in the MHPF Research Program. 30C Epidemiological studies on the health effects of manganese (Special emphasis end points include neurologic, reproductive, developmental, immunologic, and cancer) Filled Based on an evaluation of the data in ATSDR's 2000 updated toxicological profile. ATSDR will continue to evaluate new data as they become available to determine if additional studies are needed. 30D Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers 30E Relative bioavailability of different manganese compounds and bioavailability of manganese from soil EPA. Mercury 31A Multigeneration reproductive toxicity study via oral exposure MHPF Filled Availability of publications from the MHPF Research Program. 31B Dose-response data in animals from chronic-duration oral exposure Filled An MRL was derived in ATSDR's 1999 updated toxicological profile. 31C Immunotoxicology battery of tests via oral exposure EPA. 31D Exposure levels in humans (adults) living near hazardous waste sites and other populations, such as exposed workers G. Lakes Filled In addition to the data from the Great Lakes Research Program, background levels data are available in ATSDR's 1997 updated toxicological profile, and multiple ATSDR studies that evaluated blood, urine, hair mercury levels and potential adverse health effects are available. Also, reference range concentrations in blood and urine are available (CDC 2005). 31E Exposure levels in children Filled Reference range concentrations in blood and urine are available (CDC 2005). 31F Potential candidate for subregistry of exposed persons ATSDR. Methoxychlor 32A Evaluate neurologic effects after long-term, low-level oral exposure Filled Based on an evaluation of the data in ATSDR's 2000 updated toxicological profile. 32B Exposure levels of methoxychlor and primary metabolites in humans living near hazardous waste sites and those individuals with the potential to ingest it 32C Evaluate the fate, transport, and levels of the degradation products of methoxychlor in soil 32D Potential candidate for subregistry of exposed persons ATSDR. Methylene chloride 33A Dose-response data in animals for acute- and intermediate-duration oral exposure. The subchronic study should include extended reproductive organ histopathology, neuropathology, and immunopathology EPA Vol Res Filled ATSDR accepted HSIA's toxicity study for acute- and intermediate-duration exposure duration in February 1997. Also, ATSDR accepted HSIA's immunotoxicity study via inhalation in November 2000 and the oral data obtained via PBPK modeling conducted by HSIA based on the immunotoxicity data from the inhalation study. Neurotoxicity screening battery testing remains in the ATSDR/EPA test rule under development. 33B Prenatal developmental toxicity study via the oral route Vol Res Filled ATSDR accepted HSIA's study in February 1997. 33C Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers Filled Reference range concentrations in blood are available (Ashley *et al.* 1992, 1994; Needham *et al.* 1995). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. 33D Potential candidate for subregistry of exposed persons ATSDR. Nickel 34A Epidemilogic studies on the health effects of nickel (Special emphasis end points include reproductive toxicity) Filled Based on at least two relevant studies in ATSDR's 1997 updated toxicological profile. ATSDR will continue to evaluate new data as they become available to determine if additional studies are needed. 34B Prenatal development toxicity study via the oral route EPA Filled In ATSDR's 1997 updated toxicological profile, a study confirming the results of two previous studies is available. 34C Dose-response data in animals for acute- and intermediate-duration oral exposures EPA. 34D Neurotoxicology battery of tests via oral exposure EPA. 34E Bioavailability of nickel from soil EPA. 34F Exposure levels in humans (adults) living near hazardous waste sites and other populations, such as exposed workers G. Lakes Filled Based on availability of the data from the Great Lakes Research Program and an evaluation of ATSDR's 1997 updated toxicological profile. 34G Potential candidate for subregistry of exposed persons ATSDR. Pentachlorophenol 35A Comparative toxicokinetic studies 35B Exposure levels in humans (adults) living near hazardous waste sites Filled Reference range concentrations in urine are available (CDC 2005). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. 35C Exposure levels in children Filled Reference range concentrations in urine are available (CDC 2005). 35D Potential candidate for subregistry of exposed persons ATSDR. Polychlorinated biphenyls
(PCBs)36A Dose-response data in animals for acute- and intermediate-duration oral exposure G. Lakes Although an MRL for intermediate-exposure duration was derived in ATSDR's 2000 updated toxicological profile, an MRL for acute-exposure duration is still lacking. 36B Biodegradation of PCBs in water; bioavailability of PCBs in air, water, and soil 36C Dose-response data in animals for acute- and intermediate-duration inhalation exposures. The subchronic study should include extended reproductive organ histopathology 36D Epidemiologic studies on the health effects of PCBs (Special emphasis end points include immunotoxicity, gastrointestinal toxicity, liver toxicity, kidney toxicity, thyroid toxicity, and reproductive/developmental toxicity) G. Lakes Filled In addition to the data from the Great Lakes Research Program, multiple studies in ATSDR's 2000 updated toxicological profile are available. 36E Exposure levels in humans (adults) living near hazardous waste sites and other populations, such as exposed workers G. Lakes Filled In addition to the data from the Great Lakes Research Program, background levels data are available (ATSDR's 1997 updated toxicological profile, Needham *et al.* 1996, and CDC 2005). Also, multiple ATSDR studies that evaluated blood and breast milk PCB levels and potential adverse health effects are available. 36F Exposure levels in children Filled Reference range concentrations in serum are available (CDC 2005). 36G Potential candidate for subregistry of exposed persons ATSDR. 36H 5 Chronic toxicity and oncogenicity via oral exposure Vol Res Filled ATSDR accepted the final report of the GE study in October 1997. 36I 5 Aerobic PCB biodegradation in sediment Vol Res Filled ATSDR accepted the final report of the GE study in July 1999. 36J 5 PCB congener analysis Vol Res G. Lakes Filled ATSDR accepted the final report of the GE study in October 1997. Also, data from the Great Lakes Research Program are available. Polycyclic aromatic hydrocarbons
(PAHs)(Includes 15 substances) 37A Dose-response data in animals for intermediate-duration oral exposures. The subchronic study should include extended reproductive organ histopathology and immunopathology MHPF Filled MRLs for four PAHs were derived in ATSDR's 1995 updated toxicological profile. A publication from the MHPF Research Program addressing this priority data need is available. 37B Prenatal developmental toxicity study via inhalation or oral exposure MHPF Filled Data from the MHPF Research Program including a publication are available. 37C Mechanistic studies on PAHs, on how mixtures of PAHs can influence the ultimate activation of PAHs, and on how PAHs affect rapidly proliferating tissues MHPF Filled In addition to publications from the MHPF Research Program, studies are available in ATSDR's 1995 updated toxicological profile. 37D Dose-response data in animals for acute- and intermediate-duration inhalation exposures. The subchronic study should include extended reproductive organ histopathology and immunopathology MHPF Filled Data from the MHPF Research Program including one publication are available. 37E Epidemiologic studies on the health effects of PAHs (Special emphasis end points include cancer, dermal, hemolymphatic, and hepatic toxicity) Filled Multiple studies in ATSDR's 1995 updated toxicological profile are available. ATSDR will continue to evaluate new data as they become available to determine if additional studies are needed. 37F Exposure levels in humans (adults) living near hazardous waste sites and other populations, such as exposed workers G. Lakes Filled Based on data from the Great Lakes Research Program and an evaluation of the ATSDR 1995 updated toxicological profile. Also, reference range concentrations in urine are available (CDC 2005). The Agency continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. 37G Exposure levels in children Filled Reference range concentrations in urine are available (CDC 2005). 37H Potential candidate for subregistry of exposed persons ATSDR. Selenium 38A Dose-response data in animals for acute-duration oral exposure EPA. 38B Immunotoxicology battery of tests via oral exposure EPA. 38C Epidemiologic studies on the health effects of selenium (Special emphasis end points include cancer, reproductive and developmental toxicity, hepatotoxicity, and adverse skin effects) Filled Based on an evaluation of ATSDR's 2001 updated toxicological profile. ATSDR will continue to evaluate new data as they become available to determine if additional studies are needed. 38D Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers G. Lakes Filled In addition to the data from the Great Lakes Research Program, reference range concentrations in serum are available (NHANES III). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. 38E Potential candidate for subregistry of exposed persons ATSDR 1,1,2,2-Tetrachloroethane 39A Prenatal developmental toxicity study by the oral route 39B Immunotoxicity battery following oral exposure 39C Mammalian in vivo genotoxicity assays 39D Exposure levels in humans living near hazardous waste sites 39E Exposure levels in children 39F Potential candidate for subregistry of exposed persons ATSDR Tetrachloroethylene 40A Dose-response data in animals for acute-duration oral exposure, including neuropathology and demeanor, and immunopathology Filled An MRL was derived in the ATSDR 1997 updated toxicological profile. 40B Multigeneration reproductive toxicity study via oral exposure Vol Res HSIA's inhalation study was accepted by ATSDR and included in ATSDR's 1997 updated toxicological profile. However, ATSDR has identified ingestion of contaminated environmental media to be the primary exposure route for this chemical at waste sites. HSIA will obtain the oral data from the inhalation study by conducting PBPK modeling. 40C Dose-response data in animals for intermediate-duration oral exposure, including neuropathology, and immunopathology EPA. Vol Res HSIA will obtain oral data for intermediate-duration toxicity and neurotoxicity by PBPK modeling based on existing inhalation data. Also, it will conduct an inhalation immunotoxicity study, followed by PBPK modeling to obtain oral data. 40D Prenatal developmental toxicity study via oral exposure Vol Res HSIA's developmental toxicity study via inhalation was accepted by ATSDR. However, ATSDR has identified ingestion of contaminated environmental media to be the primary exposure route for this chemical at waste sites. HSIA will obtain the oral data from the inhalation study by conducting PBPK modeling. 40E Developmental neurotoxicity study via oral exposure EPA Vol Res 40F Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers Filled Reference range concentrations in blood are available (Ashley *et al.* 1992, 1994; Needham *et al.* 1995). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. 40G Potential candidate for subregistry of exposed persons ATSDR Toluene 41A Dose-response data in animals for acute- and intermediate-duration oral exposures. The subchronic study should include an extended histopathologic evaluation of the immune system Filled Availability of MRLs for acute- and intermediate-exposure durations in ATSDR's 2000 updated toxicological profile. 41B Comparative toxicokinetic studies (Characterization of absorption, distribution, and excretion via oral exposure) Filled Based on evaluation of the data in ATSDR's 2000 updated toxicological profile. 41C Neurotoxicology battery of tests via oral exposure EPA MHPF A publication for acute exposure but not longer term exposure is available in the MHPF Research Program. Also, this priority data need is included in the EPA/ATSDR test rule. 41D Mechanism of toluene-induced neurotoxicity Filled Multiple studies in ATSDR's 1994 and 2000 updated toxicological profiles are available. 41E Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers Filled Reference range concentrations in blood are available (Ashley *et al.* 1992, 1994; Needham *et al.* 1995), and additional data in ATSDR's 2000 updated toxicological profile are available. ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. 41F Potential candidate for subregistry of exposed persons ATSDR Toxaphene 42A Identify the long-term health consequences of exposure to environmental toxaphene via oral exposure 42B Conduct additional immunotoxicity studies for chronic-duration via oral route of exposure 42C Conduct additional neurotoxicity studies for chronic-duration via oral route of exposure 42D Exposure levels in humans living in areas near hazardous waste sites with toxaphene and in those individuals with the potential to ingest it 42E Potential candidate for subregistry of exposed persons ATSDR Trichloroethylene 43A Dose-response data in animals for acute-duration oral exposure Filled An MRL was derived in ATSDR's 1997 updated toxicological profile. 43B Neurotoxicology battery of tests via the oral route EPA MHPF Vol Res A publication for acute exposure but not longer term exposure is available in the MHPF Research Program. Also, this priority data need is included in the EPA/ATSDR test rule and ATSDR's Voluntary Research Program. 43C Immunotoxicology battery of tests via oral route Vol Res HSIA has completed an inhalation immunotoxicity study which is undergoing ATSDR peer review. HSIA will obtain oral data via PBPK modeling based on the inhalation data. 43D Prenatal developmental toxicity study via oral exposure Vol Res ATSDR has accepted HSIA's final report for an inhalation developmental toxicity study. HSIA will use PBPK modeling to obtain data for oral exposure based on the results of its inhalation study. 43E Developmental neurotoxicity study via oral exposure EPA Vol Res 43F Epidemiologic studies on the health effects of trichloroethylene (Special emphasis end points include cancer, hepatotoxicity, renal toxicity, developmental toxicity, and neurotoxicity) Filled Based on evaluation of the data in ATSDR's 1997 updated toxicological profile. ATSDR will continue to evaluate new data as they become available to determine if additional studies are needed. 43G Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers Filled Reference range concentrations in blood are available (Ashley *et al.* 1992, 1994; Needham *et al.* 1995). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. Vinyl chloride 44A Dose-response data in animals for acute-duration inhalation exposure Filled An MRL was derived in ATSDR's 1997 updated toxicological profile. 44B Multigeneration reproductive toxicity study via inhalation Vol Res Filled ATSDR accepted the final report of ACC's study in November 2000. 44C Dose-response data in animals for chronic-duration inhalation exposure 44D Mitigation of vinyl chloride-induced toxicity 44E Prenatal developmental toxicity study via inhalation Vol Res Filled ATSDR accepted the final report of ACC's study in November 2000. 44F Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers 44G Potential candidate for subregistry of exposed persons ATSDR. Xylenes 45A Dose-response data for chronic-duration exposure by the oral route. This study should be done in conjunction with the neurotoxicology battery of tests 45B Neurotoxicology battery of tests following oral exposure 45C Two-generation reproductive study following oral exposure 45D Developmental toxicity study that includes neurodevelopmental end points following oral exposure 45E Exposure levels in humans living near hazardous waste sites 45F Exposure levels in children 45G Potential candidate for subregistry of exposed persons ATSDR. Zinc 46A Dose-response data in animals for acute- and intermediate-duration oral exposures. The subchronic study should include an extended histopathologic evaluation of the immunologic and neurologic systems MHPF Filled Availability of ongoing studies in the MHPF Research Program. 46B Multigeneration reproductive toxicity study via oral exposure MHPF Filled Availability of ongoing studies in the MHPF Research Program. 46C Carcinogenicity testing (2-year bioassay) via oral exposure 46D Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers This priority data need, previously anticipated to be addressed under the voluntary research program, is not being investigated under any of the ATSDR research programs. 46E Potential candidate for subregistry of exposed persons ATSDR. 1 Priority data need identification number. 2 Programs addressing priority data needs. ATSDR = ATSDR's Division of Health Studies; EPA = U.S. Environmental Protection Agency; G. Lakes = Great Lakes Human Health Effects Research Program; MHPF = Minority Health Professions Foundation; NTP = National Toxicology Program; Vol Res = Voluntary research. 3 PDN can be *filled* or remain unchanged based on reevaluation of the database using criteria developed by ATSDR. 4 ACC = American Chemistry Council; Ashley *et al.* 1992 = Ashley DL, Bonin MA, Cardinali FL, *et al.* Anal Chem
(1992)64:1021-29; Ashley *et al.* 1994 = Ashley DL, Bonin MA, Cardinali FL *et al.* , Clin Chem
(1994)40/7:1401-4; ATSDR studies = Studies conducted by ATSDR's Division of Health Studies; GE = General Electric Company; HSIA = Halogenated Solvents Industry Alliance, Inc.; MHPF = Minority Health Professions Foundation; MRL = Minimal Risk Level; CDC 2005 = The third National Report on Human Exposure to Environmental Chemicals, prepared by the National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA; Needham *et al.* 1995 = Needham LL, Hill RH Jr, Ashley DL, Pirkle JL, and Sampson EJ. Environ Health Perspect 103(Suppl 3):89-94; Needham *et al.* 1996 = Needham LL, Patterson DG Jr, Burse VW, Paschal DC, Turner WE, and Hill VW Jr. Toxicol Ind Health 12:507-513; NHANES III = The Third National Health and Nutrition Examination Survey, conducted by the National Center for Health Statistics, Centers for Disease Control and Prevention, Atlanta, GA; NTP = National Toxicology Program; Paschal *et al.* 1998 = Paschal DC, Ting BC, Morrow JC, *et al.* Environ Res, Section A 76: 53-59; PBPK modeling = physiologically based pharmacokinetic modeling; Toxicological profile = ATSDR's toxicological profiles for the Agency's priority hazardous substances. 5 Not a priority data need. Table 2.—Groups Which Are Addressing/Have Addressed ATSDR's Substance-Specific Priority Data Needs
(PDNs)Program Firm, institution, agency, or consortium Substance PDN ID Voluntarism American Chemistry Council Vinyl chloride 44B, 44E General Electric Company PCBs 36H * , 36I * , 36J * Halogenated Solvents Industry Alliance, Inc Methylene chloride 33A, 33B Tetrachloroethylene 40B, 40C, 40D, 40E Trichloroethylene 43B, 43C, 43D, 43E Minority Health Professions Foundation Florida A & M University Lead 29A The King/Drew Medical Center of the Charles R. Drew University of Medicine and Science Lead 29B, 29C Meharry Medical College PAHs 37A, 37B, 37C, 37D Morehouse School of Medicine Lead 29C Texas Southern University Di-n-butyl phthalate 21D Lead 29A Toluene 41C Trichloroethylene 43B Tuskegee University Chlordane 9A Mercury 31A Zinc 46A, 46B Xavier University Manganese 30A, 30B Zinc 46A Great Lakes Human Health Effects Research Program Michigan State University DDT/DDE 19D, 19E Lead 29C Mercury 31D PCBs 36D, 36E, 36J * Selenium 38D New York State Health Department DDT/DDE 19E Lead 29C Mercury 31D PCBs 36D, 36E, 36J * State University of New York at Albany PCBs 36E State University of New York at Buffalo DDT/DDE 19D, 19E Lead 29C Mercury 31D PCBs 36D, 36E, 36J * State University of New York at Oswego DDT/DDE 19D, 19E Lead 29C Mercury 31D PCBs 36D, 36E, 36J * University of Illinois at Chicago DDT/DDE 19D, 19E Lead 29C Mercury 31D PCBs 36D, 36E, 36J * University of Illinois at Urbana-Champaign DDT/DDE 19D, 19E Lead 29C Mercury 31D PCBs 36D, 36E, 36J * University of Wisconsin-Milwaukee DDT/DDE 19D, 19E Lead 29C Mercury 31D PCBs 36A, 36D, 36E, 36J * Selenium 38D Wisconsin Department of Health and Social Services—5 State Consortium Arsenic 2D Cadmium 7B Chromium 13E DDT/DDE 19D, 19E Lead 29C Mercury 31D Nickel 34F PAHs 37F PCBs 36D, 36E, 36J * Environmental Protection Agency TSCA/FIFRA EPA/ATSDR Test Rule Benzene 4A, 4B, 4C Chloroethane 11A, 11B Cyanide (hydrogen cyanide and sodium cyanide) 14A, 14B Methylene chloride 33A Tetrachloroethylene 40C, 40E Toluene 41C Trichloroethylene 43B, 43E Metals Testing Task Force (TASARC) Arsenic 2A, 2B, 2C Beryllium 6A, 6B, 6C, 6E Chromium 13A, 13B, 13C, 13D Manganese 30A, 30B, 30E Mercury 31C Nickel 34B, 34C, 34D, 34E Selenium 38A, 38B National Toxicology Program National Institute of Environmental Health Sciences Carbon tetrachloride 8B 1,1-dichloroethene 18A, 18B Di-n-butyl phthalate 21A Disulfoton 22A Heptachlor 26B * Not priority data needs. **Editorial Note:** FR Doc. 05-23361 was originally published at page 71506 in the issue of Tuesday, November 29, 2005. The corrected document is republished in its entirety, due to printing errors. [FR Doc. R5-23361 Filed 12-12-05; 8:45 am] BILLING CODE 1505-01-D DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-06-0556] 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 404-639-4766 or send comments to Seleda Perryman, CDC Assistant 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 should be received within 60 days of this notice. Proposed Project Assisted Reproductive Technology
(ART)Program Reporting System—Extension—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description Section 2(a) of Public Law 102-493 (known as the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA), 42 U.S.C. 263a-1(a)) requires that each ART program shall annually report to the Secretary through the Centers for Disease Control and Prevention—(1) pregnancy success rates achieved by such ART program, and
(2)the identity of each embryo laboratory used by such ART program and whether the laboratory is certified or has applied for such certification under this Act. The Act defines ART as all treatments and procedures that include the handling of human oocytes and sperm or embryos for the purpose of establishing a pregnancy. The Centers for Disease Control and Prevention seeks to extend approval of a reporting system for the Assisted Reproductive Technology
(ART)Program from the Office of Management and Budget
(OMB)for a period of 3 years. The reporting system includes all ART cycles initiated by any of the approximately 400 ART programs in the United States, and covers the pregnancy outcome of each cycle as well as a number of data items deemed important to explain variability in success rates across ART programs and across individuals. An ART cycle is started when a woman begins taking medication to stimulate the ovaries to develop eggs or starts ovarian monitoring with the intent of having embryos transferred. Data will be collected through a Web-based data collection system, developed by Westat in consultation with CDC, that complies with FCSRCA requirements. In developing the definition of pregnancy success rates and the list of data items to be reported, CDC has consulted with representatives of the Society for Assisted Reproductive Technology (SART), the American Society for Reproductive Medicine (ASRM), and RESOLVE, the National Infertility Association (a national, nonprofit consumer organization), as well as a variety of individuals with expertise and interest in this field. The average annual cost to each ART program responding to the survey, including data entry and validation, is estimated to be $6,720. Estimated Annualized Burden Table Respondents Number of respondents Number of responses per respondent Average burden per response (in hrs.) Total burden (in hours) ART Programs (data entry) *400 *288 37/60 71,040 ART Programs (selected for data validation) **40 **83 23/60 1,273 Total 72,313 *Approximately 400 ART programs (respondents) reported data in 2002. The average number of ART cycles (responses) per ART program was 288. **Approximately 10% of the ART programs are selected for validation. An average of 83 ART cycles per ART program were selected for validation in 2002. Dated: December 7, 2005. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E5-7258 Filed 12-12-05; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers For Disease Control and Prevention [60Day-06-06AI] 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 404-639-4766 or send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email 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 should be received within 60 days of this notice. Proposed Project Metropolitan Atlanta Stillbirth Management Survey: Knowledge, Attitudes and Practice Patterns from Obstetricians, new collection, National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC). Background and Brief Description The U.S. Congress House Report 108-792 (joint conference report for the Fiscal Year 2005 omnibus appropriations bill) provides specific funding to devise a comprehensive strategy for expanding existing birth defects surveillance systems to incorporate surveillance data on all intrauterine fetal deaths of 20 or more week's gestation into the Metropolitan Atlanta Congenital Defects Program (MACDP). Stillbirth is largely an understudied adverse pregnancy outcome even though it accounts for nearly one half of all perinatal mortality. There is currently no nationally accepted definition of what constitutes a stillbirth, and there are no universally recommended, standardized stillbirth evaluation protocols in use for the evaluation of fetal deaths. The proposed survey has been designed to evaluate and assess the knowledge, attitudes and practice management patterns of obstetricians in the metropolitan Atlanta area regarding stillbirths in general, as well as in their medical practice. This information will be used to identify prevailing deficiencies leading to incomplete and inaccurate reporting of data relative to stillbirths, and to develop targeted awareness and educational strategies for participating MACDP facilities. Ongoing, accurate and reliable population-based registries of stillbirths are essential for conducting epidemiologic studies on the causes of and risk factors for this pregnancy outcome. This survey will be mailed to randomly selected obstetricians whose practices serve residents of the 5 counties comprising metropolitan Atlanta. This survey will be conducted once and will take approximately 2-3 months to collect the data. NCBDDD is requesting OMB clearance for 1
(one)year. There is no cost to the survey respondents except for the time necessary to complete the survey. Estimated Annualized Burden Table Respondents
(type)Respondents (number) Number of responses per respondent Average burden per response (in hrs.) Total burden (in hrs.) Obstetricians 600 1 30/60 300 Total 600 300 Dated: December 7, 2005. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E5-7260 Filed 12-12-05; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0479] International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Butorphanol; Delta-9-tetrahydrocannabinol (Dronabinol); Gamma-Hydroxybutyric Acid; Ketamine; Khat; Tramadol; Zopiclone; Buprenorphine; Oripavine AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is requesting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of nine drug substances. These comments will be considered in preparing a response from the United States to the World Health Organization
(WHO)regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs. This notice requesting comments is required by the Controlled Substances Act (CSA). DATES: Submit written or electronic comments by January 12, 2006. ADDRESSES: Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: James R. Hunter, Center for Drug Evaluation and Research (HFD-9), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5563, e mail: *hunterj@cder.FDA.gov* . SUPPLEMENTARY INFORMATION: The United States is a party to the 1971 Convention on Psychotropic Substances. Article 2 of the Convention on Psychotropic Substances provides that if a party to the convention or WHO has information about a substance, which in its opinion may require international control or change in such control, it shall so notify the Secretary General of the United Nations and provide the Secretary General of the United Nations with information in support of its opinion. The CSA (21 U.S.C. 811 *et seq.* ) (Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970) provides that when WHO notifies the United States under Article 2 of the Convention on Psychotropic Substances that it has information that may justify adding a drug or other substances to one of the schedules of the convention, transferring a drug or substance from one schedule to another, or deleting it from the schedules, the Secretary of State must transmit the notice to the Secretary of the Department of Health and Human Services (the Secretary of HHS). The Secretary of HHS must then publish the notice in the **Federal Register** and provide opportunity for interested persons to submit comments that will be considered by HHS in its preparation of the scientific and medical evaluations of the drug or substance. I. WHO Notification The Secretary of HHS received the following notices from WHO: Ref: C.L.29.2005 WHO Questionnaire for Collection of Information for Review of Dependence-Producing Psychoactive Substances The WHO presents its compliments and has the pleasure of informing Member States and Associate Members that the Thirty-fourth Expert Committee on Drug Dependence will meet from March 28 to 31, 2006 to review the following substances: 1. Butorphanol
(INN)2. Dronabinol
(INN)1 1 Including its stereo-isomers. 3. Gamma-hydroxybutyric acid 4. Ketamine
(INN)5. Khat (Catha edulis Forsk) 6. Tramadol
(INN)7. Zopiclone
(INN)As a follow-up for the thirty-third meeting of the Expert Committee on Drug Dependence, final decisions will be taken for buprenorphine
(INN)and oripavine (INN). One of the essential elements of the established review procedure is for the Secretariat to collect relevant information from Member States to prepare a Critical Review Report for submission to the Expert Committee on Drug Dependence. WHO invites Member States to collaborate, as in the past, in this process by providing pertinent information mentioned in the attached questionnaire concerning substances listed above. Further clarification on any of the above items can be obtained from Quality Assurance and Safety: Medicines, Department of Medicines Policy and Standards, WHO, Geneva, to which replies should be sent not later than January 3, 2006. WHO takes this opportunity to renew to Member States and Associate Members the assurance of its highest consideration. GENEVA, October 27, 2005 If statistical information requested is not readily available, a brief descriptive answer would be appreciated. Please attach copies of relevant study reports and other background information as appropriate. 1. BUTORPHANOL
(INN)1. LEGITIMATE USE OF THE SUBSTANCE 1.1 Is the substance currently registered as a medical product? (Yes/No) If “yes,” since when (year of marketing)? 19___ Please indicate trade name(s), dosage form(s) with strength(s) and indication(s): Trade Name Dosage Form Strength(s) Indication(s) 1.2 If the answer to 1.1 is “no,” is there other legitimate use of the substance? (Yes/No) If “yes,” please describe the purpose of use. 1.3 If there is legitimate use of the substance, how is the substance supplied? (Imported/Manufactured in the country) 2. ABUSE OF THE SUBSTANCE 2.1 Is the substance abused or misused 2 in your country? (Yes/No/No Information) 2 In this questionnaire, “abuse or misuse” refers to use of the substance other than for medical or scientific purposes. 2.2 If “yes,” any information on the extent of abuse? 2.3 Any information on the extent of public health or social problems associated with the abuse of the substance (statistics on cases of overdose deaths, dependence, etc.)? 3. ILLICIT ACTIVITIES INVOLVING THE SUBSTANCE 3.1 Any information on the nature and extent of illicit activities involving the substance (clandestine manufacture, smuggling, diversion, seizure, etc.)? 4. IMPACT OF SCHEDULING 4.1 If butorphanol is placed under international control, do you think that its availability for medical use will be affected? (Yes/No) 4.2 If “yes,” how do you think the transfer will impact its medical availability? 2. DRONABINOL
(INN)AND ITS STEREO-ISOMERS 1. LEGITIMATE USE OF THE SUBSTANCE 1.1 Is the substance currently registered as a medical product? (Yes/No) If “yes,” since when (year of marketing)? 19___ Please indicate trade name(s), dosage form(s) with strength(s) and indication(s): Trade Name Dosage Form Strength(s) Indication(s) 1.2 If the answer to 1.1 is “no,” is there other legitimate use of the substance? (Yes/No) If “yes,” please describe the purpose of use. 1.3 If there is legitimate use of the substance, how is the substance supplied? (Imported/Manufactured in the country) 2. ABUSE OF THE SUBSTANCE 2.1 Is the substance abused or misused in your country? (Yes/No/No information) 2.2 If “yes,” any information on the extent of abuse? 2.3 Any information on the extent of public health or social problems associated with the abuse of the substance (statistics on cases of overdose deaths, dependence, etc.)? 3. ILLICIT ACTIVITIES INVOLVING THE SUBSTANCE 3.1 Any information on the nature and extent of illicit activities involving the substance (clandestine manufacture, smuggling, diversion, seizure, etc.)? 3. GAMMA-HYDROXYBUTYRIC ACID
(GHB)1. LEGITIMATE USE OF THE SUBSTANCE 1.1 Is the substance currently registered as a medical product? (Yes/No) If “yes,” since when (year of marketing)? 19___ Please indicate trade name(s), dosage form(s) with strength(s) and indication(s): Trade Name Dosage Form Strength(s) Indication(s) 1.2 If the answer to 1.1 is “no,” is there other legitimate use of the substance? (Yes/No) If “yes,” please describe the purpose of use. 1.3 If there is legitimate use of the substance, how is the substance supplied? (Imported/Manufactured in the country) 2. ABUSE OF THE SUBSTANCE 2.1 Is the substance abused or misused in your country? (Yes/No/No information) 2.2 If “yes,” any information on the extent of abuse? 2.3 Any information on the extent of public health or social problems associated with the abuse of the substance (statistics on cases of overdose deaths, dependence, etc.)? 3. ILLICIT ACTIVITIES INVOLVING THE SUBSTANCE 3.1 Any information on the nature and extent of illicit activities involving the substance (clandestine manufacture, smuggling, diversion, seizure, etc.)? 4. IMPACT OF TRANSFER TO SCHEDULE II or III OF THE CONVENTION ON PSYCHOTROPIC SUBSTANCES, 1971, ON MEDICAL AVAILABILITY 4.1 If gamma-hydroxybutyric acid is transferred from Schedule IV of the Convention on Psychotropic Substances, 1971, to either Schedule II or III of the Convention on Psychotropic Substances, do you think that its availability for medical use will be affected? (Yes/No) 4.2 If “yes,” how do you think the transfer will impact its medical availability? 4. KETAMINE
(INN)1. LEGITIMATE USE OF THE SUBSTANCE 1.1 Is the substance currently registered as a medical product? (Yes/No) If “yes,” since when (year of marketing)? 19___ Please indicate trade name(s), dosage form(s) with strength(s) and indication(s): Trade Name Dosage Form Strength(s) Indication(s) 1.2 If the answer to 1.1 is “no,” is there other legitimate use of the substance? (Yes/No) If “yes,” please describe the purpose of use. 1.3 If there is legitimate use of the substance, how is the substance supplied? (Imported/Manufactured in the country) 2. ABUSE OF THE SUBSTANCE 2.1 Is the substance abused or misused in your country? (Yes/No/No information) 2.2 If “yes,” any information on the extent of abuse? 2.3 Any information on the extent of public health or social problems associated with the abuse of the substance (statistics on cases of overdose deaths, dependence, etc.)? 3. ILLICIT ACTIVITIES INVOLVING THE SUBSTANCE 3.1 Any information on the nature and extent of illicit activities involving the substance (clandestine manufacture, smuggling, diversion, seizure, etc.)? 4. IMPACT OF SCHEDULING 4.1 If ketamine is placed under international control, do you think that its availability for medical use will be affected? (Yes/No) 4.2 If “yes,” how do you think the transfer will impact its medical availability? 5. KHAT (CATHA EDULIS Forsk.) 1. LEGITIMATE USE OF THE SUBSTANCE 1.1 Is the substance currently registered as a medical product? (Yes/No) If “yes,” since when (year of marketing)? 19___ Please indicate trade name(s), dosage form(s) with strength(s) and indication(s): Trade Name Dosage Form Strength(s) Indication(s) 1.2 If the answer to 1.1 is “no,” is there other legitimate use of the substance? (Yes/No) If “yes,” please describe the purpose of use. 1.3 If there is legitimate use of the substance, how is the substance supplied? (Imported/Manufactured in the country) 2. ABUSE OF THE SUBSTANCE 2.1 Is the substance abused or misused in your country? (Yes/No/No information) 2.2 If “yes,” any information on the extent of abuse? 2.3 Any information on the extent of public health or social problems associated with the abuse of the substance (statistics on cases of overdose deaths, dependence, etc.)? 3. ILLICIT ACTIVITIES INVOLVING THE SUBSTANCE 3.1 Any information on the nature and extent of illicit activities involving the substance (clandestine manufacture, smuggling, diversion, seizure, etc.)? 4. IMPACT OF SCHEDULING 4.1 If khat is placed under international control, do you think that its availability for medical use will be affected? (Yes/No) 4.2 If “yes,” how do you think the transfer will impact its medical availability? 6. TRAMADOL
(INN)1. LEGITIMATE USE OF THE SUBSTANCE 1.1 Is the substance currently registered as a medical product? (Yes/No) If “yes,” since when (year of marketing)? 19___ Please indicate trade name(s), dosage form(s) with strength(s) and indication(s): Trade Name Dosage Form Strength(s) Indication(s) 1.2 If the answer to 1.1 is “no,” is there other legitimate use of the substance? (Yes/No) If “yes,” please describe the purpose of use. 1.3 If there is legitimate use of the substance, how is the substance supplied? (Imported/Manufactured in the country) 2. ABUSE OF THE SUBSTANCE 2.1 Is the substance abused or misused in your country? (Yes/No/No information) 2.2 If “yes,” any information on the extent of abuse? 2.3 Any information on the extent of public health or social problems associated with the abuse of the substance (statistics on cases of overdose deaths, dependence, etc.)? 3. ILLICIT ACTIVITIES INVOLVING THE SUBSTANCE 3.1 Any information on the nature and extent of illicit activities involving the substance (clandestine manufacture, smuggling, diversion, seizure, etc.)? 4. IMPACT OF SCHEDULING 4.1 If tramadol is placed under international control, do you think that its availability for medical use will be affected? (Yes/No) 4.2 If “yes,” how do you think the transfer will impact its medical availability? 7. ZOPICLONE
(INN)1. LEGITIMATE USE OF THE SUBSTANCE 1.1 Is the substance currently registered as a medical product? (Yes/No) If “yes,” since when (year of marketing)? 19___ Please indicate trade name(s), dosage form(s) with strength(s) and indication(s): Trade Name Dosage Form Strength(s) Indication(s) 1.2 If the answer to 1.1 is “no,” is there other legitimate use of the substance? (Yes/No) If “yes,” please describe the purpose of use. 1.3 If there is legitimate use of the substance, how is the substance supplied? (Imported/Manufactured in the country) 2. ABUSE OF THE SUBSTANCE 2.1 Is the substance abused or misused in your country? (Yes/No/No information) 2.2 If “yes,” any information on the extent of abuse? 2.3 Any information on the extent of public health or social problems associated with the abuse of the substance (statistics on cases of overdose deaths, dependence, etc.)? 3. ILLICIT ACTIVITIES INVOLVING THE SUBSTANCE 3.1 Any information on the nature and extent of illicit activities involving the substance (clandestine manufacture, smuggling, diversion, seizure, etc.)? 4. IMPACT OF SCHEDULING 4.1 If zopiclone is placed under international control, do you think that its availability for medical use will be affected? (Yes/No) 4.2 If “yes,” how do you think the transfer will impact its medical availability? 8. BUPRENORPHINE
(INN)1. IMPACT OF TRANSFER TO SCHEDULE I OF THE SINGLE CONVENTION ON NARCOTIC DRUGS, 1961, ON MEDICAL AVAILABILITY 1.1 If buprenorphine is transferred from Schedule III of the Convention on Psychotropic Substances, 1971, to Schedule I of the Single Convention on Narcotic Drugs, 1961, do you think that its availability for medical use will be affected? (Yes/No) 1.2 If “yes,” how do you think the transfer will impact its medical availability? II. Background Butorphanol is classified as a synthetic opiate partial agonist analgesic. It is marketed in the United States for the management of pain as an injectable and as a nasal spray solution. It is controlled domestically in Schedule IV of the CSA and is not controlled internationally under the Psychotropic Convention or the Single Convention on Narcotic Drugs. Synthetic *delta* -9-tetrahydrocannabinol ( *delta* -9-THC), or dronabinol, is the active component of the drug product Marinol, which is marketed in the United States as an antiemetic in the setting of cancer chemotherapy and for treatment of AIDS wasting syndrome. Marinol is currently controlled in Schedule III of the CSA, and the drug substance dronabinol (which is the synthetic equivalent of the natural active component of marijuana, *delta* -9-THC) is controlled in Schedule I of the CSA. The drug substance dronabinol, including its isomers, is controlled internationally in Schedule II of the Psychotropic Convention. Gamma-hydroxybutyric acid
(GHB)is classified as a central nervous system depressant. In 2002, FDA approved a GHB-containing product, Xyrem, for the treatment of cataplexy associated with narcolepsy. Xyrem was approved under the regulations in 21 CFR part 314, subpart H (21 CFR 314.520), and the product labeling contained a comprehensive risk management program, which includes restricted distribution of the drug through a central pharmacy. Xyrem is controlled domestically in Schedule III of the CSA, while bulk GHB and all other material containing GHB is controlled in Schedule I. In addition, illicit use of Xyrem is subject to Schedule I penalties of the CSA. GHB is controlled internationally in Schedule IV of the Psychotropic Convention. Ketamine is classified as a rapid-acting general anesthetic agent used for short diagnostic and surgical procedures that do not require skeletal muscle relaxation. It is marketed in the United States as an injectable. Ketamine is controlled domestically in Schedule III of the CSA. It is not controlled internationally under the Psychotropic Convention or the Single Convention on Narcotic Drugs. Khat (or qat) refers to the leaves and young shoots of the plant Cathia edulis Forsk. The principal psychoactive substances contained in khat leaves are cathinone and cathine. Cathinone (α-ketoamphetamine) is a monoamine alkaloid that is controlled domestically and internationally in Schedule I. The DEA published a final rule on January 14, 1993 (58 FR 4316), that results in the placement of any material that contains cathinone into Schedule I, which includes khat. Cathine, also a monoamine alkaloid, is controlled domestically in Schedule IV of the CSA and internationally in Schedule III drug under the Convention on Psychotropic Substances. In 1980, WHO classified khat as a drug of abuse that can produce mild to moderate psychic dependence, however khat is not controlled internationally under the Psychotropic Convention or the Single Convention on Narcotic Drugs. Tramadol is a centrally acting synthetic analgesic. At least two complementary mechanisms of action appear applicable: binding of parent and metabolite to mu-opioid receptors and inhibition of the reuptake of norepinephrine and serotonin. It is marketed in the United States for the treatment of moderate to moderately severe pain. Cases of abuse and dependence of tramadol have been reported. It is not controlled in the United States under the CSA or controlled internationally under the Psychotropic Convention or the Single Convention on Narcotic Drugs. Zopiclone is classified as a nonbenzodiazepine hypnotic. The pure enantiomer (optical isomer) of zopiclone, eszopiclone, is marketed in the United States for the treatment of insomnia. The precise mechanism of action of eszopiclone as a hypnotic is unknown, but its effect is believed to result from its interaction with gamma-aminobutyric acid (GABA)-receptor complexes at binding domains located close to or allosterically coupled to benzodiazepine receptors. Eszopiclone and zopiclone are controlled domestically in Schedule IV of the CSA and are not controlled internationally under the Psychotropic Convention or Single Convention on Narcotic Drugs. Buprenorphine is a semisynthetic opium derivative with partial mu-opioid receptor agonist activity. In the United States, buprenorphine is available as a parenteral product marketed for the relief of moderate to severe pain, as a sublingual single-entity tablet, and as a sublingual combination tablet with naloxone. The sublingual tablets are used for the treatment of opiate addiction. Buprenorphine is controlled domestically in Schedule III of the CSA as a narcotic and is controlled internationally in Schedule III of the Psychotropic Convention. Oripavine is a phenanthrene alkaloid contained in the species of the Papaver plant. It is a chemical derivative of thebaine, a naturally-occurring substance found in the opium plant. Oripavine is controlled domestically in Schedule II of the CSA because it is a derivative of thebaine, opium, and other opiates. Oripavine is not under international control. III. Opportunity to Submit Domestic Information As required by section 201(d)(2)(A) of the CSA (21 U.S.C. 811(d)(2)(A)), FDA, on behalf of HHS, invites interested persons to submit comments regarding the nine named drugs. Any comments received will be considered by HHS when it prepares a scientific and medical evaluation of these drugs. HHS will forward a scientific and medical evaluation of these drugs to WHO, through the Secretary of State, for WHO's consideration in deciding whether to recommend international control/decontrol of any of these drugs. Such control could limit, among other things, the manufacture and distribution (import/export) of these drugs and could impose certain recordkeeping requirements on them. HHS will not now make any recommendations to WHO regarding whether any of these drugs should be subjected to international controls. Instead, HHS will defer such consideration until WHO has made official recommendations to the Commission on Narcotic Drugs, which are expected to be made in early 2006. Any HHS position regarding international control of these drugs will be preceded by another **Federal Register** notice soliciting public comments as required by section 201(d)(2)(B) of the CSA. IV. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding the drugs. The abbreviated comment period is necessary to allow sufficient time to prepare and submit the domestic information package by the deadline imposed by WHO. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: December 5, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05-23958 Filed 12-12-05; 8:45 am]
Connectionstraces to 14
Traces to 14 documents
U.S. Code
- Enumerated powers§ 248
- Public information; agency rules, opinions, orders, records, and proceedings§ 552
- Reports to Comptroller of the Currency§ 161
- Assessments§ 1817
- Definitions§ 1841
- Acquisition of bank shares or assets§ 1842
- Interests in nonbanking organizations§ 1843
- Response authorities§ 9604
- Manufacturing and processing notices§ 2604
- Definitions§ 136
- Assisted reproductive technology programs§ 263a–1
- Authority and criteria for classification of substances§ 811
5 references not yet in our index
- 5 CFR 1320.16
- 12 CFR 225
- Pub. L. 106-107
- Pub. L. 102-493
- 21 CFR 314
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