Announcement of Final Priority Data Needs for Two Priority Hazardous Substances, 900-902 [E9-189]

Download as PDF 900 Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices Act, may be found in the FTC’s privacy policy, at (http://www.ftc.gov/ftc/ privacy.shtm). FOR FURTHER INFORMATION CONTACT: Requests for additional information or copies of the proposed information requirements should be sent to Stephen Ecklund, Investigator, Division of Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Ave., N.W., Washington, D.C. 20580, (202) 3262841. Under the PRA, 44 U.S.C. 3501-3521, Federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. ‘‘Collection of information’’ means agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. 44 U.S.C. 3502(3); 5 CFR 1320.3(c). As required by the PRA, the FTC is providing this opportunity for public comment before requesting that OMB extend the existing paperwork clearance for the regulations noted herein. 44 U.S.C. 3506(c)(2)(A). On October 10, 2008, the Commission sought public comments concerning the proposed collection of information. See 73 FR 60286. No comments were received. Pursuant to the OMB regulations that implement the PRA (5 CFR Part 1320), the Commission is providing this second opportunity for public comment while seeking OMB clearance for the FPLA regulations. All comments should be filed as prescribed in the ADDRESSES section above, and must be received on or before February 9, 2009. The FPLA, 15 U.S.C. 1451-1461, was enacted to eliminate consumer deception concerning product size representations and package content information. The regulations that implement the FPLA, 16 CFR Parts 500 - 503, establish requirements for the manner and form of labeling applicable to manufacturers, packagers, and distributors of ‘‘consumer commodities.’’2 Section 4 of the FPLA specifically requires packages or labels to be marked with: (1) A statement of identity; (2) a net quantity of contents mstockstill on PROD1PC66 with NOTICES SUPPLEMENTARY INFORMATION: 2 ‘‘Consumer commodity’’ means any article, product, or commodity of any kind or class which is customarily produced or distributed for sale through retail sales agencies or instrumentalities for consumption by individuals, or use by individuals for purposes of personal care or in the performance of services ordinarily rendered within the household, and which usually is consumed or expended in the course of such consumption or use.’’ 16 CFR 500.2(c). For the precise scope of the term’s coverage see 16 CFR 500.2(c); 503.2; 503.5. See also (http://www.ftc.gov/os/statutes/fpla/ outline.html). VerDate Nov<24>2008 17:55 Jan 08, 2009 Jkt 217001 disclosure; and (3) the name and place of business of a company that is responsible for the product. Estimated annual hours burden: 7,570,740 total burden hours (solely relating to disclosure3) As in the past, Commission staff has used Census data4 to estimate the number of companies subject to the FPLA. Staff conservatively estimates5 that approximately 757,074 manufacturers, packagers, distributors, and retailers of consumer commodities make disclosures at an average burden of ten hours per entity, for a total disclosure burden of 7,570,740 hours. Estimated annual cost burden: $158,985,540 (solely relating to labor costs) The estimated annual labor cost burden associated with the FPLA disclosure requirements consists of an estimated hour of managerial and/or professional time per covered entity (at an estimated average hourly rate of $55), plus two hours of specialized clerical support6 (at an estimated average hourly rate of $25), and seven hours of clerical time per covered entity (at an estimated average hourly rate of $15), for a total of $158,985,540 ($210 blended labor cost per covered entity x 757,074 entities).7 3 To the extent that the FPLA-implementing regulations require sellers of consumer commodities to keep records that substantiate ‘‘cents off,’’ ‘‘introductory offer,’’ and/or ‘‘economy size’’ claims, staff believes that most, if not all, of the records that sellers maintain would be kept in the ordinary course of business, regardless of the legal mandates. 4 Staff has drawn upon the U.S. Census Bureau’s 2002 economic census, the most recent census available providing data for purposes of staff’s instant estimates. See (http://www.census.gov/econ/ census02/guide/SUBSUMM.HTM) and (http:// www.census.gov/prod/ec02/ec0231sg1.pdf) (Table 2). 5 Although the estimates are non-rounded figures, they remain estimates as they are the sum total of projected industry codes subject to the FPLA. But, even allowing for industries that may apply, the Census data do not separately break out nonhousehold products from household use and, accordingly, overstate what is actually subject to the FPLA. 6 ‘‘Specialized clerical support’’ consists of graphic design specialists, working by computer to design the appearance and layout of product packaging, including appropriate display of the disclosures required by the FPLA regulations. 7 Based generally on the National Compensation Survey: Occupational Earnings in the United States, 2007, U.S. Department of Labor, Bureau of Labor Statistics (August 2008) (‘‘BLS National Compensation Survey’’) (citing the mean hourly earnings for management occupations, legal occupations/lawyers, and assorted clerical positions), available at (http://www.bls.gov/ncs/ocs/ sp/nctb0300.pdf). Clerical estimates are derived from the above source data, applying roughly a midrange of mean hourly rates for potentially applicable clerical types, e.g., computer operators, data entry and information processing workers. PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 Total capital and start-up costs are de minimis. For many years, the packaging and labeling activities that require capital and start-up costs have been performed by covered entities in the ordinary course of business independent of the FPLA and implementing regulations. Similarly, firms provide in the ordinary course of business the information that the statute and regulations require be placed on packages and labels. William Blumenthal General Counsel FR Doc. E9–178 Filed 1–8–09: 8:45 am] Billing code 6750–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Toxic Substances and Disease Registry [ATSDR–249] Announcement of Final Priority Data Needs for Two 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 two 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 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 E:\FR\FM\09JAN1.SGM 09JAN1 Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices 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, the National Toxicology Program (NTP), and EPA 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 from now 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–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. TABLE 1—SUBSTANCE-SPECIFIC PRI- FOR FURTHER INFORMATION CONTACT: ORITY DATA NEEDS FOR TWO PRI- Nickolette Roney, Applied Toxicology ORITY HAZARDOUS SUBSTANCES Branch, Division of Toxicology and Environmental Medicine, ATSDR, 1600 Substance Priority data needs Clifton Road, NE., Mailstop F–32, Atlanta, Georgia 30333; e-mail: Acrolein .......... Exposure levels in humans NRoney@cdc.gov; telephone: (770) 488– living near hazardous 3332; fax: (770) 488–4178. waste sites and other popSUPPLEMENTARY INFORMATION: ulations. mstockstill on PROD1PC66 with NOTICES (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 acrolein and barium, two priority substances included in the ATSDR Priority List of Hazardous Substances (73 FR 12178, March 6, 2008). These priority data needs were initially announced by ATSDR in the Federal Register on September 8, 2006 (71 FR 53102). The public was invited to comment on these data needs for these two substances during a 90-day period. No public comments were received. These priority data needs and accompanying documents were reviewed by EPA and the National Institute of Environmental Health Sciences (NIEHS), and will be addressed by the mechanisms described in the ‘‘Implementation of Substance-Specific Applied Research Program’’ section of this Federal Register Notice. Barium ............ Exposure levels in children. Dose-response data for chronic duration 1 via inhalation exposure. Dose-response data for acute duration 2 via oral exposure. 1 365 2 14 days or more. days or less. VerDate Nov<24>2008 16:16 Jan 08, 2009 Jkt 217001 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) PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 901 ensure the initiation of a research program to address identified priority data needs associated with the substances. The SSARP was initiated in 1991. A list of priority data needs for 38 priority hazardous substances was announced for public comment in the Federal Register on October 17, 1991 (56 FR 52178) 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 and 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 (71 FR 53102), ATSDR released for public comment the priority data needs for the two hazardous substances that are the subject of this final notice. The ATSDR SSARP supplies the necessary information to improve the database to conduct 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 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 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, 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 that are funded by E:\FR\FM\09JAN1.SGM 09JAN1 902 Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices 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 ensure 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 two substances. 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). mstockstill on PROD1PC66 with NOTICES 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 VerDate Nov<24>2008 16:16 Jan 08, 2009 Jkt 217001 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. 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 Association of Minority Health Professions Schools (AMHPS) that supports the AMHPS Environmental Health, Health Services, and Toxicology Research programs. 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. ATSDR encourages private-sector organizations and other governmental programs to use ATSDR’s priority data needs to plan their research activities. Dated: January 6, 2009. Ken Rose, Director, Office of Policy, Planning, and Evaluation, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry. [FR Doc. E9–189 Filed 1–8–09; 8:45 am] BILLING CODE 4163–70–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–R–262, CMS– 10142 and CMS–R–137] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services. 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), 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 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 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 function; (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: Revision of a currently approved collection; Title of Information Collection: CY 2010 Plan Benefit Package (PBP) and Formulary Submission for Medicare Advantage (MA) Plans and Prescription Drug Plans (PDP) Use: Under the Medicare Modernization Act (MMA), Medicare Advantage (MA) and Prescription Drug Plan (PDP) organizations are required to submit plan benefit packages for all Medicare beneficiaries residing in their service area. The plan benefit package submission consists of the formulary file, Plan Benefit Package (PBP) software, and supporting documentation as necessary. MA and PDP organizations will generate a formulary to illustrate their list of drugs, including information on prior authorization, step therapy, tiering, and quantity limits. Additionally, the PBP software will be used to describe their organization’s plan benefit packages, including information on premiums, cost sharing, authorization rules, and supplemental benefits. CMS uses the formulary and PBP data to review and approve the plan benefit packages proposed by each MA and PDP organization. CMS requires that MA and PDP organizations submit a completed formulary and PBP as part of the annual bidding process. During this process, organizations prepare their proposed plan benefit packages for the upcoming contract year and submit them to CMS for review and approval. Based on operational changes and policy clarifications to the Medicare program and continued input and feedback by the industry, CMS has made the necessary changes to the plan benefit package submission. Form Number: CMS–R–262 (OMB# 0938–0763); Frequency: Yearly; Affected Public: Business or other for-profits b. Not-forprofit institutions; Number of Respondents: 475; Total Annual Responses: 4987.5; Total Annual Hours: 12112.5. 2. Type of Information Collection Request: Revision of a currently approved collection; Title of E:\FR\FM\09JAN1.SGM 09JAN1

Agencies

[Federal Register Volume 74, Number 6 (Friday, January 9, 2009)]
[Notices]
[Pages 900-902]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-189]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[ATSDR-249]


Announcement of Final Priority Data Needs for Two 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 two 
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 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

[[Page 901]]

(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 acrolein and barium, 
two priority substances included in the ATSDR Priority List of 
Hazardous Substances (73 FR 12178, March 6, 2008). These priority data 
needs were initially announced by ATSDR in the Federal Register on 
September 8, 2006 (71 FR 53102). The public was invited to comment on 
these data needs for these two substances during a 90-day period. No 
public comments were received. These priority data needs and 
accompanying documents were reviewed by EPA and the National Institute 
of Environmental Health Sciences (NIEHS), and 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 Two Priority
                          Hazardous Substances
------------------------------------------------------------------------
               Substance                       Priority data needs
------------------------------------------------------------------------
Acrolein...............................  Exposure levels in humans
                                          living near hazardous waste
                                          sites and other populations.
                                         Exposure levels in children.
                                         Dose-response data for chronic
                                          duration \1\ via inhalation
                                          exposure.
Barium.................................  Dose-response data for acute
                                          duration \2\ via oral
                                          exposure.
------------------------------------------------------------------------
\1\ 365 days or more.
\2\ 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, the National 
Toxicology Program (NTP), and EPA 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 from now 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-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.

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.
    The SSARP was initiated in 1991. A list of priority data needs for 
38 priority hazardous substances was announced for public comment in 
the Federal Register on October 17, 1991 (56 FR 52178) 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 and 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 (71 FR 53102), ATSDR released for public 
comment the priority data needs for the two hazardous substances that 
are the subject of this final notice.
    The ATSDR SSARP supplies the necessary information to improve the 
database to conduct 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 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 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, 
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 that are funded by

[[Page 902]]

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 ensure 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 two substances.
    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 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 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 Association of Minority Health Professions Schools 
(AMHPS) that supports the AMHPS Environmental Health, Health Services, 
and Toxicology Research programs.
    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.
    ATSDR encourages private-sector organizations and other 
governmental programs to use ATSDR's priority data needs to plan their 
research activities.

    Dated: January 6, 2009.
Ken Rose,
Director, Office of Policy, Planning, and Evaluation, National Center 
for Environmental Health/Agency for Toxic Substances and Disease 
Registry.
 [FR Doc. E9-189 Filed 1-8-09; 8:45 am]
BILLING CODE 4163-70-P