Announcement of Final Priority Data Needs for Six Priority Hazardous Substances, 55240-55242 [E9-25776]

Download as PDF 55240 Federal Register / Vol. 74, No. 206 / Tuesday, October 27, 2009 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects Title: State Self-Assessment Review and Report. OMB No.: 0970–0223. Description: Section 454(15)(A) of the Social Security Act, as amended by the Personal Responsibility and Work Opportunity Reconciliation Act of 1996, requires each State to annually assess the performance of its child support enforcement program in accordance with standards specified by the Secretary of the Department of Health and Human Services, and to provide a report of the findings to the Secretary. This information is required to determine if States are complying with Federal child support mandates and providing the best services possible. The report is also intended to be used as a management tool to help States evaluate their programs and assess performance. Respondents: State Child Support Enforcement Agencies or the Department/Agency/Bureau responsible for Child Support Enforcement in each State. ANNUAL BURDEN ESTIMATES Number of respondents Instrument pwalker on DSK8KYBLC1PROD with NOTICES Self-assessment report .................................................................................... Estimated Total Annual Burden Hours: ........................................................... In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments 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) 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. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: October 21, 2009. Robert Sargis, Reports Clearance Officer. [FR Doc. E9–25734 Filed 10–26–09; 8:45 am] BILLING CODE 4184–01–P VerDate Nov<24>2008 16:45 Oct 26, 2009 Jkt 220001 Agency for Toxic Substances and Disease Registry [ATSDR–255] Announcement of Final 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: Notice. SUMMARY: This notice announces the final 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). This 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 information essential to improving 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 six hazardous substances. The priority data needs announced in this notice reflect the opinion of ATSDR, in consultation with other federal programs, about the research Frm 00060 Fmt 4703 Sfmt 4703 Average burden hours per response 1 4 54 216 DEPARTMENT OF HEALTH AND HUMAN SERVICES PO 00000 Number of responses per respondent Total burden hours 216 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), 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. Table 1 presents the priority data needs for six priority substances included in the ATSDR Priority List of Hazardous Substances (73 FR 12178, March 6, 2008). ATSDR initially announced these priority data needs in the Federal Register on December 28, 2007 (72 FR 73828), and the public had 90 days to comment on them. EPA, the National Institute of Environmental Health Sciences (NIEHS)/National Toxicology Program (NTP), the National Institute for Occupational Safety and Health (NIOSH), and the U.S. Food and E:\FR\FM\27OCN1.SGM 27OCN1 Federal Register / Vol. 74, No. 206 / Tuesday, October 27, 2009 / Notices Drug Administration/National Center for Toxicological Research (FDA/NCTR) reviewed the six priority data needs and accompanying documents. The mechanisms described in the ‘‘Implementation of Substance-Specific 55241 Applied Research Program’’ section of this Federal Register Notice will address these data needs. TABLE 1—SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR SIX PRIORITY HAZARDOUS SUBSTANCES Substance Priority data needs Aluminum ................................................... Cresol ......................................................... Diazinon ..................................................... Dichloropropenes ....................................... Guthion ...................................................... Phenol ........................................................ pwalker on DSK8KYBLC1PROD with NOTICES 1 14 Exposure levels in humans living near hazardous waste sites. Exposure levels in children. Exposure levels for adults and children who do not live near hazardous waste sites (as controls). 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, with emphasis on neurodevelopmental toxicity. Exposure levels in humans living near hazardous waste sites. Exposure levels in children. days or less. 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, available on ATSDR’s Web site at http://www.atsdr.cdc.gov/ pdns/. Printed copies are also available by written request from ATSDR (see ADDRESSES section of this notice). 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, NTP, EPA, FDA, and NIOSH, will review all proposals. DATES: The ATSDR voluntary research program is a continuous program, and private-sector organizations can volunteer to fill identified data needs until ATSDR announces that other research has been initiated for a specific data need. ADDRESSES: The priority data needs are available on ATSDR’s Web site at http://www.atsdr.cdc.gov/pdns/. Private-sector organizations interested in volunteering to conduct research to fill identified priority data needs should write to Nickolette Roney, Applied Toxicology Branch, Division of Toxicology and Environmental Medicine, ATSDR, 1600 Clifton Road, NE., Mailstop F–62, Atlanta, GA 30333; e-mail: NRoney@cdc.gov. Use the same address for sending information about pertinent ongoing or completed research that may fill priority data needs cited in VerDate Nov<24>2008 16:45 Oct 26, 2009 Jkt 220001 this notice and for requesting printed copies of the priority data needs documents. FOR FURTHER INFORMATION CONTACT: Nickolette Roney, Applied Toxicology Branch, Division of Toxicology and Environmental Medicine, ATSDR, 1600 Clifton Road, NE., Mailstop F–62, Atlanta, GA 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 (in order of priority) found at National Priorities List (NPL) sites, (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. The SSARP was initiated in 1991. On November 16, 1992 (57 FR 54150), priority data needs for 38 priority hazardous substances were published in the Federal Register in final form, after release for public comment. On July 30, 1997 (62 FR 40820), after releasing for public comment, ATSDR finalized the priority data needs for a second list of 12 substances. ATSDR identified priority data needs for a third list of 10 hazardous substances, published in its final form on April 29, 2003 (68 FR 22704), after release for public comment. On January 9, 2009 (74 FR 900), priority data needs for two hazardous substances were published in final form after release for public comment. On December 28, 2007 (72 FR 73828), ATSDR released for public PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 comment the priority data needs for the six hazardous substances that are the subject of this final notice. ATSDR SSARP supplies the necessary information to improve the database for conducting public health assessments. The link between research and public health assessments and the process for distilling priority data needs 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 the SubstanceSpecific Applied Research Program In Section 104(i)(5)(D), CERCLA states that Congress believes the costs for conducting this research program should be borne by the manufacturers and processors of the hazardous substances 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, for the types of research to be done. ATSDR actively participates on this committee. Federally funded projects that collect information from 10 or more respondents and are funded by cooperative agreements are subject to E:\FR\FM\27OCN1.SGM 27OCN1 55242 Federal Register / Vol. 74, No. 206 / Tuesday, October 27, 2009 / Notices 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. A. TSCA/FIFRA In developing and implementing SSARP, ATSDR and EPA established procedures to identify 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. pwalker on DSK8KYBLC1PROD with NOTICES review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act. If the proposed project is research involving human subjects, the applicants must comply with Department of Health and Human Services regulations (45 CFR part 46) and, if applicable, Food and Drug Administration regulations (21 CFR parts 50 and 56), regarding the protection of human subjects. The applicants must ensure that the project will be subject to initial and continuing review by the appropriate institutional review boards. Overall, by providing additional scientific information for the risk assessment process, data generated from this research will support other researchers conducting human health assessments involving these substances. Below are the mechanisms for implementing SSARP. 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). Dated: October 21, 2009. Ken Rose, Director, Office of Policy, Planning, and Evaluation, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry. [FR Doc. E9–25776 Filed 10–26–09; 8:45 am] 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 National Institutes of Health VerDate Nov<24>2008 16:45 Oct 26, 2009 Jkt 220001 C. CERCLA Those priority data needs 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. Mechanisms to address these priority data needs may include a second call for voluntarism. Again, scientific peer review of study protocols and results is a requirement for all research conducted under this auspice. ATSDR encourages private-sector organizations and other governmental programs to use ATSDR’s priority data needs to plan their research activities. BILLING CODE 4163–70–P National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Alcohol Abuse and Alcoholism Special Emphasis Panel; AA–1 and AA–4 Study Sections Members Conflict. Date: November 10, 2009. Frm 00062 Fmt 4703 Dated: October 19, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–25623 Filed 10–26–09; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES PO 00000 Time: 3 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5635 Fishers Lane, Bethesda, MD 20892. (Telephone Conference Call.) Contact Person: Lorraine Gunzerath, PhD, MBA, Scientific Review Officer, National Institute on Alcohol Abuse and Alcoholism, Office of Extramural Activities, Extramural Project Review Branch, 5635 Fishers Lane, Room 2121, Bethesda, MD 20892–9304, 301– 443–2369, Igunzera@mail.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the securing of meeting attendees. (Catalogue of Federal Domestic Assistance Program Nos. 93.271, Alcohol Research Career Development Awards for Scientists and Clinicians; 93.272, Alcohol National Research Service Awards for Research Training; 93.273, Alcohol Research Programs; 93.891, Alcohol Research Center Grants; 93.701, ARRA Related Biomedical Research and Research Support Awards, National Institutes of Health, HHS) Sfmt 4703 Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflicts in Language and Cognition. Date: November 12, 2009. Time: 3:30 p.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Dana Jeffrey Plude, PhD, Scientific Review Officer, Center for E:\FR\FM\27OCN1.SGM 27OCN1

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[Federal Register Volume 74, Number 206 (Tuesday, October 27, 2009)]
[Notices]
[Pages 55240-55242]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25776]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[ATSDR-255]


Announcement of Final 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: Notice.

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

SUMMARY: This notice announces the final 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). This 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 information essential to 
improving 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 six hazardous 
substances.
    The priority data needs announced 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), 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.
    Table 1 presents the priority data needs for six priority 
substances included in the ATSDR Priority List of Hazardous Substances 
(73 FR 12178, March 6, 2008). ATSDR initially announced these priority 
data needs in the Federal Register on December 28, 2007 (72 FR 73828), 
and the public had 90 days to comment on them. EPA, the National 
Institute of Environmental Health Sciences (NIEHS)/National Toxicology 
Program (NTP), the National Institute for Occupational Safety and 
Health (NIOSH), and the U.S. Food and

[[Page 55241]]

Drug Administration/National Center for Toxicological Research (FDA/
NCTR) reviewed the six priority data needs and accompanying documents. 
The mechanisms described in the ``Implementation of Substance-Specific 
Applied Research Program'' section of this Federal Register Notice will 
address these data needs.

              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.
                                                                   Exposure levels for adults and children who
                                                                    do not live near hazardous waste sites (as
                                                                    controls).
                                                                   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.
----------------------------------------------------------------------------------------------------------------
\1\ 14 days or less.

    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, available on ATSDR's Web site at http://www.atsdr.cdc.gov/pdns/. Printed copies are also available by written request from ATSDR 
(see ADDRESSES section of this notice).
    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, NTP, EPA, FDA, 
and NIOSH, will review all proposals.

DATES: The ATSDR voluntary research program is a continuous program, 
and private-sector organizations can volunteer to fill identified data 
needs until ATSDR announces that other research has been initiated for 
a specific data need.

ADDRESSES: The priority data needs are available on ATSDR's Web site at 
http://www.atsdr.cdc.gov/pdns/. Private-sector organizations interested 
in volunteering to conduct research to fill identified priority data 
needs should write to Nickolette Roney, Applied Toxicology Branch, 
Division of Toxicology and Environmental Medicine, ATSDR, 1600 Clifton 
Road, NE., Mailstop F-62, Atlanta, GA 30333; e-mail: NRoney@cdc.gov. 
Use the same address for sending information about pertinent ongoing or 
completed research that may fill priority data needs cited in this 
notice and for requesting printed copies of the priority data needs 
documents.

FOR FURTHER INFORMATION CONTACT: Nickolette Roney, Applied Toxicology 
Branch, Division of Toxicology and Environmental Medicine, ATSDR, 1600 
Clifton Road, NE., Mailstop F-62, Atlanta, GA 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 (in order 
of priority) found at National Priorities List (NPL) sites, (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.
    The SSARP was initiated in 1991. On November 16, 1992 (57 FR 
54150), priority data needs for 38 priority hazardous substances were 
published in the Federal Register in final form, after release for 
public comment. On July 30, 1997 (62 FR 40820), after releasing for 
public comment, ATSDR finalized the priority data needs for a second 
list of 12 substances. ATSDR identified priority data needs for a third 
list of 10 hazardous substances, published in its final form on April 
29, 2003 (68 FR 22704), after release for public comment. On January 9, 
2009 (74 FR 900), priority data needs for two hazardous substances were 
published in final form after release for public comment. On December 
28, 2007 (72 FR 73828), ATSDR released for public comment the priority 
data needs for the six hazardous substances that are the subject of 
this final notice.
    ATSDR SSARP supplies the necessary information to improve the 
database for conducting public health assessments. The link between 
research and public health assessments and the process for distilling 
priority data needs 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 the Substance-Specific Applied Research Program

    In Section 104(i)(5)(D), CERCLA states that Congress believes the 
costs for conducting this research program should be borne by the 
manufacturers and processors of the hazardous substances 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, 
for the types of research to be done. ATSDR actively participates on 
this committee. Federally funded projects that collect information from 
10 or more respondents and are funded by cooperative agreements are 
subject to

[[Page 55242]]

review by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act. If the proposed project is research involving human 
subjects, the applicants must comply with Department of Health and 
Human Services regulations (45 CFR part 46) and, if applicable, Food 
and Drug Administration regulations (21 CFR parts 50 and 56), regarding 
the protection of human subjects. The applicants must ensure that the 
project will be subject to initial and continuing review by the 
appropriate institutional review boards. Overall, by providing 
additional scientific information for the risk assessment process, data 
generated from this research will support other researchers conducting 
human health assessments involving these substances.
    Below are the mechanisms for implementing SSARP. 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 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.

C. CERCLA

    Those priority data needs 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.
    Mechanisms to address these priority data needs may include a 
second call for voluntarism. Again, scientific peer review of study 
protocols and results is a requirement for all research conducted under 
this auspice.
    ATSDR encourages private-sector organizations and other 
governmental programs to use ATSDR's priority data needs to plan their 
research activities.

    Dated: October 21, 2009.
Ken Rose,
Director, Office of Policy, Planning, and Evaluation, National Center 
for Environmental Health/Agency for Toxic Substances and Disease 
Registry.
[FR Doc. E9-25776 Filed 10-26-09; 8:45 am]
BILLING CODE 4163-70-P