Identification Of Priority Data Needs for Six Priority Hazardous Substances, 73828-73830 [E7-25213]

Download as PDF 73828 Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Notices Conference Center, 9751 Washingtonian Blvd., Gaithersburg, MD 20878. Contact Person: Anyone wishing to obtain a roster of members, agenda or minutes of the non-confidential portions of this meeting should contact Mrs. Bonnie Campbell, Committee Management Officer, Office of Extramural Research, Education and Priority Populations, AHRQ, 540 Gaither Road, Room 2038, Rockville, Maryland 20850, Telephone (301) 427– 1554. Agenda items for this meeting are subject to change as priorities dictate. Dated: December 19, 2007. Carolyn M. Clancy, Director. [FR Doc. 07–6216 Filed 12–27–07; 8:45 am] BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Toxic Substances and Disease Registry [ATSDR–237] Identification Of Priority Data Needs for Six Priority Hazardous Substances Agency for Toxic Substances and Disease Registry (ATSDR), U.S. Department of Health and Human Services (HHS). ACTION: Request for public comments on the identification of priority data needs for six priority hazardous substances and an ongoing call for voluntary research proposals. AGENCY: SUMMARY: This notice makes available for public comment the priority data needs for six priority hazardous substances (see Table 1) as part of the continuing development and implementation of the ATSDR Substance-Specific Applied Research Program (SSARP). The notice also serves as a continuous call for voluntary research proposals. The exposure and toxicity priority data needs in this notice were distilled from the data needs identified in ATSDR’s toxicological profiles by the logical scientific approach described in a decision guide published in the Federal Register on September 11, 1989 (54 FR 37618). The priority data needs represent essential information to improve the database for conducting public health assessments. Research to address these priority data needs will help to determine the types or levels of exposure that may present significant risks of adverse health effects in people exposed to the hazardous substances. The priority data needs identified in this notice reflect the opinion of ATSDR, in consultation with other federal programs, about the research needed pursuant to ATSDR’s authority under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (Superfund), or CERCLA, as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA) [42 U.S.C. 9604(i)]. The needs identified here do not represent the priority data needs for any other agency or program. Consistent with Section 104(i)(12) of CERCLA as amended [42 U.S.C. 9604(i)(12)], nothing in this research program shall be construed to delay or otherwise affect or impair the President, the Administrator of ATSDR, or the Administrator of the Environmental Protection Agency (EPA) from exercising any authority regarding any other provision of law, including the Toxic Substances Control Act of 1976 (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act of 1972 (FIFRA), or the response and abatement authorities of CERCLA. ATSDR worked with other federal programs to determine common substance-specific data needs and mechanisms to implement research that may include authorities under TSCA and FIFRA, private-sector voluntarism, or the direct use of CERCLA funds. When deciding the type of research that should be done, ATSDR considers the recommendations of the Interagency Testing Committee (ITC) established under Section 4(e) of TSCA. Federally funded projects that collect information from 10 or more respondents and that are funded by cooperative agreements are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act. If the proposed project involves research on human subjects, the applicants must comply with Department of Health and Human Services regulations (45 CFR part 46) regarding the protection of human subjects. The applicants must assure that the project will be subject to initial and continuing review by the appropriate institutional review committees. Overall, by providing additional scientific information for the risk assessment process, data generated from this research will support other researchers who are conducting human health assessments involving these six substances. Table 1 presents the priority data needs for six priority substances. The six substances are included in the ATSDR Priority List of Hazardous Substances (70 FR 72840, December 7, 2005). ATSDR invites comments from the public on the individual priority data needs and the priority data needs documents for these substances. After considering the comments, ATSDR will publish the final priority data needs for each substance. These priority data needs will be addressed by the mechanisms described in the ‘‘Implementation of Substance-Specific Applied Research Program’’ section of this Federal Register Notice. TABLE 1.—SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR SIX PRIORITY HAZARDOUS SUBSTANCES Substance Priority data needs Aluminum ........................................................................... Cresol ................................................................................. mstockstill on PROD1PC66 with NOTICES Diazinon ............................................................................. Dichloropropenes ............................................................... Guthion ............................................................................... Phenol ................................................................................ (1) 14 Exposure levels in humans living near hazardous waste sites. Exposure levels in children. Dose-response data for acute-duration(1) oral exposure. Exposure levels in humans living near hazardous waste sites. Exposure levels in children. Dose-response data for acute-duration(1) oral exposure. Developmental toxicity data for oral exposure. Dose-response data for acute-duration(1) inhalation exposure. Immunotoxicity battery via inhalation exposure. Studies of developmental toxicity via oral exposure neurodevelopmental toxicity. Exposure levels in humans living near hazardous waste sites. Exposure levels in children. Two-year oral carcinogenicity bioassay. days or less. VerDate Aug<31>2005 22:27 Dec 27, 2007 Jkt 214001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 E:\FR\FM\28DEN1.SGM 28DEN1 with emphasis on Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Notices mstockstill on PROD1PC66 with NOTICES Note: Consult the priority data needs documents for details on how these priority data needs were determined. Voluntary Research. 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 in this notice by submitting a letter of intent to ATSDR (see ADDRESSES section of this notice). A TriAgency Superfund Applied Research Committee (TASARC), comprised of scientists from ATSDR, the National Toxicology Program (NTP), and EPA, will review all proposals. The substance-specific priority data needs were based on, and determined from, information in corresponding ATSDR toxicological profiles. Background technical information and justification for the priority data needs in this notice are in the priority data needs documents. These documents are available on ATSDR’s Web site at http://www.atsdr.cdc.gov/pdns/. Printed copies of these documents are also available for review by requesting them in writing from ATSDR (see ADDRESSES section of this notice). DATES: Comments concerning the priority data needs for the six substances must be received by 90 days from the publication date. Regarding ATSDR’s call for voluntary research proposals, the agency considers voluntary research crucial to the continuing development of SSARP and believes this effort should be an open and continuous one. Therefore, privatesector organizations are encouraged to volunteer to conduct research to address the identified priority data needs until ATSDR announces that other research has been initiated for a specific priority data need. ADDRESSES: The priority data needs documents are available on ATSDR’s Web site at http://www.atsdr.cdc.gov/ pdns/. Submit comments to Nickolette Roney, Applied Toxicology Branch, Division of Toxicology and Environmental Medicine, ATSDR, 1600 Clifton Road, NE., Mailstop F–32, Atlanta, Georgia 30333; e-mail: NRoney@cdc.gov. Information about pertinent ongoing or completed research that may fill priority data needs cited in this notice should be similarly addressed. Also, use the same address to request printed copies of the priority data needs documents and to submit proposals to conduct voluntary research. FOR FURTHER INFORMATION CONTACT: Nickolette Roney, Applied Toxicology Branch, Division of Toxicology and Environmental Medicine, ATSDR, 1600 VerDate Aug<31>2005 22:27 Dec 27, 2007 Jkt 214001 Clifton Road, NE., Mailstop F–32, Atlanta, Georgia 30333; e-mail: NRoney@cdc.gov; telephone: (770) 488– 3332; fax: (770) 488–4178. SUPPLEMENTARY INFORMATION: Background CERCLA, as amended by SARA [42 U.S.C. 9604(i)], requires that ATSDR (1) Develop jointly with EPA a list of hazardous substances found at National Priorities List (NPL) sites (in order of priority), (2) prepare toxicological profiles of these substances, and (3) ensure the initiation of a research program to address identified priority data needs associated with the substances. SSARP was initiated in 1991. A list of priority data needs for 38 priority hazardous substances was announced in the Federal Register on October 17, 1991 (56 FR 52178). The list was subsequently revised, based on public comments, and was published in final form on November 16, 1992 (57 FR 54150). In 1997, after releasing for public comment, ATSDR finalized the priority data needs for a second list of 12 substances that priority data needs list was announced in the Federal Register on July 30, 1997 (62 FR 40820). ATSDR then identified priority data needs for a third list of 10 hazardous substances; this list was released as a draft for public comment and published in its final form on April 29, 2003 (68 FR 22704). On September 8, 2006, ATSDR released priority data needs for two hazardous substances as a draft for public comment (71 FR 53102). This ATSDR SSARP supplies the necessary information to improve the database to conduct public health assessments. This link between research and public health assessments, and the process for distilling priority data needs for ranked hazardous substances from the data needs identified in associated ATSDR toxicological profiles, are described in the ATSDR ‘‘Decision Guide for Identifying Substance-Specific Data Needs Related to Toxicological Profiles’’ (54 FR 37618, September 11, 1989). Implementation of Substance-Specific Applied Research Program In Section 104(i)(5)(D), CERCLA states that it is the sense of Congress that the costs for conducting this research program should be borne by the manufacturers and processors of the hazardous substances found under the Toxic Substances Control Act of 1976 (TSCA); by registrants under the Federal Insecticide, Fungicide, and Rodenticide Act of 1972 (FIFRA); or by cost recovery from responsible parties under CERCLA. PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 73829 To execute this statutory intent, ATSDR developed a plan whereby parts of SSARP are being conducted through regulatory mechanisms (TSCA/FIFRA), private-sector voluntarism, and the direct use of CERCLA funds. CERCLA also requires that ATSDR consider recommendations of the Interagency Testing Committee, established under Section 4(e) of TSCA, on the types of research to be done. ATSDR actively participates on this committee. The mechanisms for implementing SSARP are discussed next. The status of SSARP in addressing priority data needs of the first 60 priority hazardous substances through these mechanisms was described in a Federal Register Notice on December 13, 2005 (70 FR 73749). A. TSCA/FIFRA In developing and implementing SSARP, ATSDR and EPA established procedures to identify those priority data needs of common interest to multiple Federal programs. Where practicable, these data needs will be addressed through a program of toxicologic testing under TSCA or FIFRA. This part of the research will be conducted according to established TSCA/FIFRA procedures and guidelines. B. Private-Sector Voluntarism As part of SSARP, on February 7, 1992, ATSDR announced a set of proposed procedures for conducting voluntary research (57 FR 4758). Revisions based on public comments were published on November 16, 1992 (57 FR 54160). ATSDR strongly encourages private-sector organizations to propose research to address priority data needs at any time until ATSDR announces that research has already been initiated for a specific priority data need. Private-sector organizations may volunteer to conduct research to address specific priority data needs identified in this notice by submitting a letter of intent. The letter of intent should be a brief statement (1–2 pages) that identifies the priority data need(s) to be filled and the methods to be used. TASARC will review these proposals and recommend to ATSDR the voluntary research projects that should be pursued- and how they should be conducted-with the volunteer organizations. ATSDR will enter into only those voluntary research projects that lead to high-quality, peerreviewed scientific work. Additional details regarding the process for voluntary research are in the Federal Register Notices cited in this section. E:\FR\FM\28DEN1.SGM 28DEN1 73830 Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Notices C. CERCLA Those priority data needs that are not addressed by TSCA/FIFRA or initial voluntarism will be considered for funding by ATSDR through its CERCLA budget. Much of this research program is envisioned to be unique to CERCLA— for example, research on substances not regulated by other programs or research needs specific to public health assessments. A current example of the direct use of CERCLA funds is a cooperative agreement with the Minority Health Professions Foundation (MHPF) that supports the MHPF’s Environmental Health, Health Services, and Toxicology Research Program. Mechanisms to address these priority data needs may include a second call for voluntarism. Again, scientific peer review of study protocols and results would occur for all research conducted under this auspice. Substance-Specific Priority Data Needs Table 1 identifies the priority data needs. ATSDR encourages private-sector organizations and other governmental programs to use ATSDR’s priority data needs to plan their research activities. Dated: December 19, 2007. Ken Rose, Director, Office of Policy, Planning and Evaluation, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry. [FR Doc. E7–25213 Filed 12–27–07; 8:45 am] BILLING CODE 4163–70–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–222 and CMS– R–268] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS) 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 mstockstill on PROD1PC66 with NOTICES AGENCY: VerDate Aug<31>2005 22:27 Dec 27, 2007 Jkt 214001 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. 1. Type of Information Collection Request: Extension of currently approved collection; Title of Information Collection: Independent Rural Health Center/Freestanding Federally Qualified Health Center Cost Report and Supporting Regulations 42 CFR 413.20 AND 42 CFR 413.24; Use: Providers of service in the Medicare program are required to submit annual information to achieve reimbursement for health care services rendered to Medicare beneficiaries. The Form CMS– 222 cost report is needed to determine the amount of reasonable cost due to the providers for furnishing medical services to Medicare beneficiaries; Form Number: CMS–222 (OMB# 0938–0107); Frequency: Yearly; Affected Public: Business or other for-profit and Not-forprofit institutions; Number of Respondents: 3,159; Total Annual Responses: 3,159; Total Annual Hours: 157,950. 2. Type of Information Collection Request: Revision of currently approved collection; Title of Information Collection: Survey Tool for http:// www.medicare.gov and http:// www.cms.hhs.gov; Use: The purpose of this submission is to request a revision of 0938–0756 (CMS-R–268) to continue to collect information from Internet users as they exit from the Websites Medicare.gov and CMS.hhs.gov. As part of the revised collection we are combining the content from the collection 0938–0900 that was discontinued on 5/31/2007. The packages are being combined to eliminate a duplication of effort. We are requesting a three-year clearance, so that the feedback received through the survey can be used continually to update and improve the sites. To ensure that we gather information about user reactions to the Websites, we have developed a survey tool that users can complete when they exit either site or by accessing a link on the bottom bar on the page. The responses on this survey tool will help CMS to make appropriate changes to the Websites in the future. The survey tool contains questions about the information that visitors are seeking from the sites, the degree to which either site was useful to them, the improvements that they would like to see in the sites, and their general comments. Form Number: CMS–R–268 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 (OMB# 0938–0756); Frequency: On occasion; Affected Public: Individuals and households, Private sector— Business or other for-profit; Number of Respondents: 7,000; Total Annual Responses: 7,000; Total Annual Hours: 1,167. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS’ Web Site address at http://www.cms.hhs.gov/ PaperworkReductionActof1995, or Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call the Reports Clearance Office on (410) 786– 1326. To be assured consideration, comments and recommendations for the proposed information collections must be received at the address below, no later than 5 p.m. on February 26, 2008. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—C, Attention: Bonnie L Harkless, Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. Dated: December 20, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7–25289 Filed 12–27–07; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–7007–N] Medicare Program; Request for Nominations for the Advisory Panel on Medicare Education Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: SUMMARY: This notice requests nominations for individuals to serve on the Advisory Panel on Medicare Education (the Panel) to fill current vacancies and vacancies that will become available in 2008. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on the effectiveness of consumer education strategies concerning the Medicare program. E:\FR\FM\28DEN1.SGM 28DEN1

Agencies

[Federal Register Volume 72, Number 248 (Friday, December 28, 2007)]
[Notices]
[Pages 73828-73830]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-25213]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[ATSDR-237]


Identification Of Priority Data Needs for Six Priority Hazardous 
Substances

AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR), U.S. 
Department of Health and Human Services (HHS).

ACTION: Request for public comments on the identification of priority 
data needs for six priority hazardous substances and an ongoing call 
for voluntary research proposals.

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

SUMMARY: This notice makes available for public comment the priority 
data needs for six priority hazardous substances (see Table 1) as part 
of the continuing development and implementation of the ATSDR 
Substance-Specific Applied Research Program (SSARP). The notice also 
serves as a continuous call for voluntary research proposals.
    The exposure and toxicity priority data needs in this notice were 
distilled from the data needs identified in ATSDR's toxicological 
profiles by the logical scientific approach described in a decision 
guide published in the Federal Register on September 11, 1989 (54 FR 
37618). The priority data needs represent essential information to 
improve the database for conducting public health assessments. Research 
to address these priority data needs will help to determine the types 
or levels of exposure that may present significant risks of adverse 
health effects in people exposed to the hazardous substances.
    The priority data needs identified in this notice reflect the 
opinion of ATSDR, in consultation with other federal programs, about 
the research needed pursuant to ATSDR's authority under the 
Comprehensive Environmental Response, Compensation, and Liability Act 
of 1980 (Superfund), or CERCLA, as amended by the Superfund Amendments 
and Reauthorization Act of 1986 (SARA) [42 U.S.C. 9604(i)]. The needs 
identified here do not represent the priority data needs for any other 
agency or program.
    Consistent with Section 104(i)(12) of CERCLA as amended [42 U.S.C. 
9604(i)(12)], nothing in this research program shall be construed to 
delay or otherwise affect or impair the President, the Administrator of 
ATSDR, or the Administrator of the Environmental Protection Agency 
(EPA) from exercising any authority regarding any other provision of 
law, including the Toxic Substances Control Act of 1976 (TSCA) and the 
Federal Insecticide, Fungicide, and Rodenticide Act of 1972 (FIFRA), or 
the response and abatement authorities of CERCLA.
    ATSDR worked with other federal programs to determine common 
substance-specific data needs and mechanisms to implement research that 
may include authorities under TSCA and FIFRA, private-sector 
voluntarism, or the direct use of CERCLA funds.
    When deciding the type of research that should be done, ATSDR 
considers the recommendations of the Interagency Testing Committee 
(ITC) established under Section 4(e) of TSCA. Federally funded projects 
that collect information from 10 or more respondents and that are 
funded by cooperative agreements are subject to review by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act. If the 
proposed project involves research on human subjects, the applicants 
must comply with Department of Health and Human Services regulations 
(45 CFR part 46) regarding the protection of human subjects. The 
applicants must assure that the project will be subject to initial and 
continuing review by the appropriate institutional review committees. 
Overall, by providing additional scientific information for the risk 
assessment process, data generated from this research will support 
other researchers who are conducting human health assessments involving 
these six substances.
    Table 1 presents the priority data needs for six priority 
substances. The six substances are included in the ATSDR Priority List 
of Hazardous Substances (70 FR 72840, December 7, 2005). ATSDR invites 
comments from the public on the individual priority data needs and the 
priority data needs documents for these substances. After considering 
the comments, ATSDR will publish the final priority data needs for each 
substance. These priority data needs will be addressed by the 
mechanisms described in the ``Implementation of Substance-Specific 
Applied Research Program'' section of this Federal Register Notice.

    Table 1.--Substance-Specific Priority Data Needs for Six Priority
                          Hazardous Substances
------------------------------------------------------------------------
             Substance                       Priority data needs
------------------------------------------------------------------------
Aluminum..........................  Exposure levels in humans living
                                     near hazardous waste sites.
                                    Exposure levels in children.
                                    Dose-response data for acute-
                                     duration\(1)\ oral exposure.
Cresol............................  Exposure levels in humans living
                                     near hazardous waste sites.
                                    Exposure levels in children.
                                    Dose-response data for acute-
                                     duration\(1)\ oral exposure.
Diazinon..........................  Developmental toxicity data for oral
                                     exposure.
Dichloropropenes..................  Dose-response data for acute-
                                     duration\(1)\ inhalation exposure.
                                    Immunotoxicity battery via
                                     inhalation exposure.
Guthion...........................  Studies of developmental toxicity
                                     via oral exposure with emphasis on
                                     neurodevelopmental toxicity.
Phenol............................  Exposure levels in humans living
                                     near hazardous waste sites.
                                    Exposure levels in children.
                                    Two-year oral carcinogenicity
                                     bioassay.
------------------------------------------------------------------------
\(1)\ 14 days or less.



[[Page 73829]]

    Note: Consult the priority data needs documents for details on 
how these priority data needs were determined.

    Voluntary Research. 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 
in this notice by submitting a letter of intent to ATSDR (see ADDRESSES 
section of this notice). A Tri-Agency Superfund Applied Research 
Committee (TASARC), comprised of scientists from ATSDR, the National 
Toxicology Program (NTP), and EPA, will review all proposals.
    The substance-specific priority data needs were based on, and 
determined from, information in corresponding ATSDR toxicological 
profiles. Background technical information and justification for the 
priority data needs in this notice are in the priority data needs 
documents. These documents are available on ATSDR's Web site at http://
www.atsdr.cdc.gov/pdns/. Printed copies of these documents are also 
available for review by requesting them in writing from ATSDR (see 
ADDRESSES section of this notice).

DATES: Comments concerning the priority data needs for the six 
substances must be received by 90 days from the publication date. 
Regarding ATSDR's call for voluntary research proposals, the agency 
considers voluntary research crucial to the continuing development of 
SSARP and believes this effort should be an open and continuous one. 
Therefore, private-sector organizations are encouraged to volunteer to 
conduct research to address the identified priority data needs until 
ATSDR announces that other research has been initiated for a specific 
priority data need.

ADDRESSES: The priority data needs documents are available on ATSDR's 
Web site at http://www.atsdr.cdc.gov/pdns/. Submit comments to 
Nickolette Roney, Applied Toxicology Branch, Division of Toxicology and 
Environmental Medicine, ATSDR, 1600 Clifton Road, NE., Mailstop F-32, 
Atlanta, Georgia 30333; e-mail: NRoney@cdc.gov. Information about 
pertinent ongoing or completed research that may fill priority data 
needs cited in this notice should be similarly addressed. Also, use the 
same address to request printed copies of the priority data needs 
documents and to submit proposals to conduct voluntary research.

FOR FURTHER INFORMATION CONTACT: Nickolette Roney, Applied Toxicology 
Branch, Division of Toxicology and Environmental Medicine, ATSDR, 1600 
Clifton Road, NE., Mailstop F-32, Atlanta, Georgia 30333; e-mail: 
NRoney@cdc.gov; telephone: (770) 488-3332; fax: (770) 488-4178.

SUPPLEMENTARY INFORMATION:

Background

    CERCLA, as amended by SARA [42 U.S.C. 9604(i)], requires that ATSDR 
(1) Develop jointly with EPA a list of hazardous substances found at 
National Priorities List (NPL) sites (in order of priority), (2) 
prepare toxicological profiles of these substances, and (3) ensure the 
initiation of a research program to address identified priority data 
needs associated with the substances.
    SSARP was initiated in 1991. A list of priority data needs for 38 
priority hazardous substances was announced in the Federal Register on 
October 17, 1991 (56 FR 52178). The list was subsequently revised, 
based on public comments, and was published in final form on November 
16, 1992 (57 FR 54150). In 1997, after releasing for public comment, 
ATSDR finalized the priority data needs for a second list of 12 
substances that priority data needs list was announced in the Federal 
Register on July 30, 1997 (62 FR 40820). ATSDR then identified priority 
data needs for a third list of 10 hazardous substances; this list was 
released as a draft for public comment and published in its final form 
on April 29, 2003 (68 FR 22704). On September 8, 2006, ATSDR released 
priority data needs for two hazardous substances as a draft for public 
comment (71 FR 53102).
    This ATSDR SSARP supplies the necessary information to improve the 
database to conduct public health assessments. This link between 
research and public health assessments, and the process for distilling 
priority data needs for ranked hazardous substances from the data needs 
identified in associated ATSDR toxicological profiles, are described in 
the ATSDR ``Decision Guide for Identifying Substance-Specific Data 
Needs Related to Toxicological Profiles'' (54 FR 37618, September 11, 
1989).

Implementation of Substance-Specific Applied Research Program

    In Section 104(i)(5)(D), CERCLA states that it is the sense of 
Congress that the costs for conducting this research program should be 
borne by the manufacturers and processors of the hazardous substances 
found under the Toxic Substances Control Act of 1976 (TSCA); by 
registrants under the Federal Insecticide, Fungicide, and Rodenticide 
Act of 1972 (FIFRA); or by cost recovery from responsible parties under 
CERCLA. To execute this statutory intent, ATSDR developed a plan 
whereby parts of SSARP are being conducted through regulatory 
mechanisms (TSCA/FIFRA), private-sector voluntarism, and the direct use 
of CERCLA funds.
    CERCLA also requires that ATSDR consider recommendations of the 
Interagency Testing Committee, established under Section 4(e) of TSCA, 
on the types of research to be done. ATSDR actively participates on 
this committee.
    The mechanisms for implementing SSARP are discussed next. The 
status of SSARP in addressing priority data needs of the first 60 
priority hazardous substances through these mechanisms was described in 
a Federal Register Notice on December 13, 2005 (70 FR 73749).

A. TSCA/FIFRA

    In developing and implementing SSARP, ATSDR and EPA established 
procedures to identify those priority data needs of common interest to 
multiple Federal programs. Where practicable, these data needs will be 
addressed through a program of toxicologic testing under TSCA or FIFRA. 
This part of the research will be conducted according to established 
TSCA/FIFRA procedures and guidelines.

B. Private-Sector Voluntarism

    As part of SSARP, on February 7, 1992, ATSDR announced a set of 
proposed procedures for conducting voluntary research (57 FR 4758). 
Revisions based on public comments were published on November 16, 1992 
(57 FR 54160). ATSDR strongly encourages private-sector organizations 
to propose research to address priority data needs at any time until 
ATSDR announces that research has already been initiated for a specific 
priority data need. Private-sector organizations may volunteer to 
conduct research to address specific priority data needs identified in 
this notice by submitting a letter of intent.
    The letter of intent should be a brief statement (1-2 pages) that 
identifies the priority data need(s) to be filled and the methods to be 
used. TASARC will review these proposals and recommend to ATSDR the 
voluntary research projects that should be pursued- and how they should 
be conducted-with the volunteer organizations. ATSDR will enter into 
only those voluntary research projects that lead to high-quality, peer-
reviewed scientific work. Additional details regarding the process for 
voluntary research are in the Federal Register Notices cited in this 
section.

[[Page 73830]]

C. CERCLA

    Those priority data needs that are not addressed by TSCA/FIFRA or 
initial voluntarism will be considered for funding by ATSDR through its 
CERCLA budget. Much of this research program is envisioned to be unique 
to CERCLA--for example, research on substances not regulated by other 
programs or research needs specific to public health assessments. A 
current example of the direct use of CERCLA funds is a cooperative 
agreement with the Minority Health Professions Foundation (MHPF) that 
supports the MHPF's Environmental Health, Health Services, and 
Toxicology Research Program.
    Mechanisms to address these priority data needs may include a 
second call for voluntarism. Again, scientific peer review of study 
protocols and results would occur for all research conducted under this 
auspice.

Substance-Specific Priority Data Needs

    Table 1 identifies the priority data needs. ATSDR encourages 
private-sector organizations and other governmental programs to use 
ATSDR's priority data needs to plan their research activities.

    Dated: December 19, 2007.
Ken Rose,
Director, Office of Policy, Planning and Evaluation, National Center 
for Environmental Health/Agency for Toxic Substances and Disease 
Registry.
[FR Doc. E7-25213 Filed 12-27-07; 8:45 am]
BILLING CODE 4163-70-P