[Federal Register Volume 76, Number 46 (Wednesday, March 9, 2011)]
[Notices]
[Pages 12963-12964]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-5352]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Request for Information (NOT-ES-11-007): Needs and Approaches for 
Assessing the Human Health Impacts of Exposure to Mixtures

AGENCY: National Institutes of Health (NIH), HHS.

ACTION: Request for information.

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SUMMARY: The National Institute of Environmental Health Sciences 
(NIEHs), the Division of Extramural Research and Training (DERT) and 
the National Toxicology Program (NTP) seek input for identification of 
key research areas in mixtures. Information provided will be used in 
planning a workshop for late summer 2011 to help inform the development 
of intramural and extramural research efforts that address the combined 
health effects of multiple environmental exposures (``mixtures''). This 
request for information (RFI) is for planning purposes only and should 
not be construed as a funding opportunity or grant program. Input from 
all interested parties is welcome including the lay public, 
environmental health researchers, health professionals, educators, 
policy makers, industry, and others. Please respond on-line at the 
Mixtures Request for Information Web page (http://ntp.niehs.nih.gov/go/rfimix) by April 15, 2011.

DATES: Please respond online at the Mixtures Request for Information 
Web page (http://ntp.niehs.nih.gov/go/rfimix) by April 15, 2011.

FOR FURTHER INFORMATION CONTACT: Other correspondence regarding this 
RFI should be directed to either (1) Dr. Danielle Carlin, DERT Program 
Administrator, NIEHS, P.O. Box 12233, MD K3-04, Research Triangle Park, 
NC 27709, (telephone) 919-541-1409, (e-mail) <a href="/cdn-cgi/l/email-protection#fa999b889693949e90ba94939f9289d4949392d49d958c"><span class="__cf_email__" data-cfemail="036062716f6a6d6769436d6a666b702d6d6a6b2d646c75">[email protected]</span></a> or 
(2) Dr. Cynthia Rider, NTP Toxicologist, NIEHS, P.O. Box 12233, MD K2-
12, Research Triangle Park, NC 27709, (telephone) 919-541-7638, (e-
mail) <a href="/cdn-cgi/l/email-protection#91e3f8f5f4e3f2e7d1fff8f4f9e2bffff8f9bff6fee7"><span class="__cf_email__" data-cfemail="3a48535e5f48594c7a54535f524914545352145d554c">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

Background

    The NIEHS mission is to reduce the burden of human illness and 
disability by understanding how the environment influences the 
development and progression of human disease. To accomplish this, the 
NIEHS supports research and professional development in environmental 
health sciences, clinical research, and public health.
    DERT plans, directs and evaluates the NIEHS grant program, which 
supports research and research training in environmental health. It 
develops program priorities and recommends funding levels to assure 
maximum utilization of available resources in attainment of NIEHS 
objectives. Through cooperative relationships with NIH and with public 
and private institutions and organizations, DERT maintains an awareness 
of national research efforts and assesses the need for research and 
research training in environmental health.
    The NTP is an interagency program whose mission is to evaluate 
agents of public health concern by developing and applying tools of 
modern toxicology and molecular biology. The NTP designs and conducts 
laboratory studies and testing programs and analyzes its findings to 
assess potential hazards to human health from exposure to environmental 
substances. The NTP also carries out formal review and literature 
analysis activities.
    The evaluation of human health effects from multiple environmental 
exposures represents a special challenge to the research community due 
to the

[[Page 12964]]

inherent complexity of the topic. The term ``mixture'' can be broadly 
interpreted and can refer to a substance with variable composition or 
to mixtures resulting from combined exposures. For the purposes of this 
RFI, ``mixtures'' pertains to any set of multiple environmental 
exposures (chemical or non-chemical) that may contribute jointly to 
adverse human health outcomes, irrespective of whether people are 
exposed to the substances at the same/different times or through 
similar/distinct sources or routes.
    Continuous human exposure to complex and dynamic mixtures precludes 
directly testing the toxicity of each possible exposure combination. 
Therefore, predictive models of mixture toxicity must be developed and 
validated in order to characterize the hazard associated with complex 
exposures. In order to develop these models, a better understanding is 
required of both the composition of real-world exposures and the 
fundamental principles of chemical interactions. Combinatorial or 
statistical approaches are needed to address the potential interactions 
of complex exposures. Moreover, these approaches should be used to move 
beyond assessment of individual chemicals and further our understanding 
of the impacts of realistic exposures.
    Information gathered through this RFI will be used in planning a 
workshop on mixtures to be held in late summer 2011. The date and 
location have not yet been determined, but when set, will be announced 
in the Federal Register. The overarching goals of this workshop are to 
foster discussion on the approaches, infrastructure, and resources 
needed to make progress and to identify new scientific opportunities by 
applying innovative tools to the field of mixtures research. 
Additionally, the workshop should provide opportunities for development 
of collaborations and foster multidisciplinary interactions among the 
mixtures scientific community. The workshop will bring together experts 
from multiple disciplines including, but not limited to, exposure 
assessment, risk assessment, biostatistics, toxicology, biology, 
regulatory science, and epidemiology.

Information Requested

    DERT and the NTP request information on the challenges and 
potential solutions in mixtures research. Responses to any or all of 
the questions below are invited from interested individuals/groups, 
including, but not limited to, the environmental health research 
community, health professionals, educators, policy makers, industry, 
and the public.
    <bullet> What are the underlying scientific knowledge gaps for 
assessing the effects of mixtures on human health?
    <bullet> What are the scientific issues encountered in performing 
risk assessments of mixtures that can be addressed by new research?
    <bullet> What types of scientific data (e.g., mechanistic, 
epidemiological) are needed to address these underlying knowledge gaps?
    <bullet> What are the new technologies and innovative approaches 
that could be leveraged to address these underlying knowledge gaps?
    All responses to information requested in this RFI are optional. 
The information collected will be analyzed and considered for use in 
the further development of the workshop. The summarized data (without 
identifiers) may appear in future reports. Although the NIH will 
provide safeguards to prevent the release of identifying information, 
there is no guarantee of confidentiality. This RFI is for planning 
purposes only and shall not be construed as a solicitation for 
applications or as an obligation on the part of the Government. The 
Government will not pay for the preparation of any information 
submitted or for the Government's use of that information. 
Acknowledgement of receipt of responses will be provided through the 
Web site (http://ntp.niehs.nih.gov/go/rfimix), but respondents will not 
be notified of the Government's assessment of the information received. 
No basis for claims against the Government shall arise as a result of 
responses to this RFI, or in the Government's use of such information 
as part of its evaluation process.

    Dated: February 28, 2011.
Linda S. Birnbaum,
Director, National Institute of Environmental Health Sciences and 
National Toxicology Program.
[FR Doc. 2011-5352 Filed 3-8-11; 8:45 am]
BILLING CODE 4140-01-P


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