National Institute of Environmental Health Sciences (NIEHS); National Toxicology Program (NTP); Request for Information (NOT-ES-09-001): Ongoing Research and Research Needs for Biological Effects of Exposure to Bisphenol A (BPA), 62505-62506 [E8-25053]

Download as PDF Federal Register / Vol. 73, No. 204 / Tuesday, October 21, 2008 / Notices The proposed Order will expire in 20 years. By direction of the Commission. Donald S. Clark, Secretary [FR Doc. E8–24931 Filed 10–20–08: 8:45 am] BILLING CODE 6750–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES mstockstill on PROD1PC66 with NOTICES SUMMARY: This notice announces the meeting date for the 25th meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. No. 92–463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT). Meeting Date: November 12, 2008, from 8:30 a.m. to 2:45 p.m. (Eastern) ADDRESSES: Hubert H. Humphrey building (200 Independence Avenue, SW., Washington, DC 20201), Room 800. SUPPLEMENTARY INFORMATION: The meeting will include updates on the Healthcare Information Technology Standards Panel, the Certification Commission for Healthcare Information Technology, and hospital health information technology adoption rates. Final reports on the Electronic Health Records, Chronic Care, Consumer Empowerment, Quality, and Personalized Healthcare Workgroups will also be presented. Finally, an update on the AHIC Successor organization will be heard. For further information, visit https:// www.hhs.gov/healthit/ahic.html. A Web cast of the Community meeting will be available on the NIH Web site at: https:// www.videocast.nih.gov/. If you have special needs for the meeting, please contact (202) 690–7151. Dated: October 15, 2008. Judith Sparrow, Director, American Health Information Community, Office of Programs and Coordination, Office of the National Coordinator for Health Information Technology. [FR Doc. E8–24991 Filed 10–20–08; 8:45 am] VerDate Aug<31>2005 17:06 Oct 20, 2008 Jkt 217001 National Institutes of Health (NIH). Meeting announcement. BILLING CODE 4150–45–P National Institute of Environmental Health Sciences (NIEHS); National Toxicology Program (NTP); Request for Information (NOT–ES–09–001): Ongoing Research and Research Needs for Biological Effects of Exposure to Bisphenol A (BPA) AGENCY: Office of the National Coordinator for Health Information Technology; American Health Information Community Meeting ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: Request for information. SUMMARY: The NIEHS Division of Extramural Research and Training (DERT) and the NTP are seeking input on a number of key research areas that have been identified in recent evaluations of bisphenol A (BPA). Information provided will be used to help focus future research and testing activities on BPA. This Request for Information (RFI) is for planning purposes only and should not be construed as a funding opportunity or grant program. The NIEHS and NTP welcome input from the lay public, environmental health researchers, healthcare professionals, educators, policy makers, industry, and others with an interest in BPA. DATES: Please respond online at the Bisphenol A Request for Information Web page by December 1, 2008, at https://ntp.niehs.nih.gov/go/rfibpa. FOR FURTHER INFORMATION CONTACT: Other correspondence regarding this RFI should be directed to either (1) Dr. Jerry Heindel, DERT Program Administrator, NIEHS, P.O. Box 12233, MD EC–23, Research Triangle Park, NC 27709, (phone) 919–541–0781, (e-mail) heindelj@niehs.nih.gov or (2) Dr. Paul Foster, NTP Acting Toxicology Branch Chief, NIEHS, P.O. Box 12233, MD EC– 34, Research Triangle Park, NC 27709, (phone) 919–541–2513, (e-mail) foster2@niehs.nih.gov. SUPPLEMENTARY INFORMATION: Background 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 was established as a cooperative effort to (1) Coordinate toxicology testing programs within the federal government, (2) strengthen the science base in toxicology, (3) develop improved testing methods, and (4) provide information about potentially toxic chemicals to health, regulatory, and research agencies, scientific and medical communities, and the public. To meet these goals, NTP designs and conducts PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 62505 large-scale laboratory animal research and testing programs and analyzes and reports its findings to assess potential hazards to human health from exposure to environmental agents. The NTP also carries out formal review and literature analysis activities. The NIEHS mission is to understand the complex relationship between environmental risk factors and human biology within affected individuals and populations and to use this knowledge to prevent illness, reduce disease, and promote health. To accomplish this, the NIEHS supports research and professional development in environmental health sciences, environmental clinical research, and environmental public health. These extramural research and development activities are managed through NIEHS/ DERT. Recently, both the NTP and NIEHS/ DERT conducted assessments related to understanding the potential human health and environmental risks posed by BPA. The NTP evaluation was conducted through its Center for the Evaluation of Risks to Human Reproduction (CERHR) and focused on whether current exposures may pose health risks to human reproduction and development. The final results of this evaluation were released on September 3, 2008, as the NTP–CERHR Monograph on Bisphenol A. The monograph and details of this evaluation are available at https://cerhr.niehs.nih.gov/chemicals/ bisphenol/bisphenol.html. The NIEHS workshop, ‘‘Bisphenol A: An Examination of the Relevance of Ecological, In Vitro and Laboratory Animal Studies for Assessing Risks to Human Health’’ (for consensus statement see vom Saal et al., Reproductive Toxicol. 2007. 24:131– 138) was co-sponsored with a number of other organizations and was broader in scope compared to the NTP–CERHR evaluation as it included consideration of ecological effects and human health effects not directly related to development or reproduction. The NTP and NIEHS review activities resulted in a number of research recommendations to better characterize the sources and levels of human exposures to BPA and to help determine what, if any, adverse health effects might result from such exposures. Similarly, a number of research needs have been identified by the Food and Drug Administration in its draft assessment of BPA in food contact applications (https://www.fda.gov/ ohrms/dockets/ac/ oc08.html#Scienceboard see ‘‘Science Board to the Food and Drug E:\FR\FM\21OCN1.SGM 21OCN1 62506 Federal Register / Vol. 73, No. 204 / Tuesday, October 21, 2008 / Notices mstockstill on PROD1PC66 with NOTICES Administration’’ meeting information for September 16, 2008). Currently the NTP is pursuing studies of absorption, distribution, metabolism, and excretion (ADME) in experimental animals (rodents and non human primates) as well as the kinetics associated with these processes, following exposures to BPA from the perinatal period through adulthood, over a wide range of doses, by multiple routes of administration. These studies have been identified as high priority needs in all recent reviews and reflect the general lack of information on concentrations of BPA in blood and target tissues in animal studies reporting effects of ‘‘low’’ doses of BPA on various aspects of development. In addition to ADME studies, other areas of research have been suggested to better characterize possible hazards associated with BPA exposures in humans. They include studies to (1) Examine pathways of human exposures, (2) identify cellular targets for BPA at low and high doses for consistency with an estrogenic mechanism of action, (3) identify interactions with other estrogenic substances including naturally occurring hormones, and (4) investigate further the ‘‘low’’ dose effects reported in experimental animals. The findings from the ADME studies and the information collected as a result of this RFI will be analyzed and considered for use in the further development of NTP and NIEHS/DERT research and testing programs on BPA. Information Requested The NTP and NIEHS/DERT request information on the following: • Ongoing or planned research activities that you are aware of related to this RFI. • Specific data needs for any or all of the priority areas identified below. • Suggestions for beneficial research collaborations. To aid in the development of a listing of prioritized data needs, a summary listing of the research needs identified in the NTP CERHR evaluation, the NIEHS co-sponsored workshop, or the draft FDA assessment are included below. This list may be used as a starting point for developing a prioritized listing of research needs related to the health effects of BPA. 1. Studies of the concentrations of BPA and metabolites in human blood, urine, breast milk, amniotic fluid, placenta and other tissues, particularly in infants and young children, where appropriate. 2. More complete assessment of sources of human exposure to BPA. VerDate Aug<31>2005 17:06 Oct 20, 2008 Jkt 217001 3. In vitro studies examining interactions of BPA with multiple cellular targets (toxicity pathways) across a range of concentrations, and comparing these results with similar studies of other known estrogenic agents and combinations of estrogenic agents with BPA. 4. Studies of gestational and lactational exposure of experimental animals to ‘‘low’’ doses of BPA regarding effects on development and onset of adult disease including: a. The sensitivity of the developing brain to BPA induced structural, functional, and biochemical alterations. b. The relevance to primates of diminished estrogen-dependent brain and behavioral sexual dimorphisms in rodents exposed to BPA during development. c. Confirmation of rodent studies reporting behavioral effects following BPA exposure during development related to the dopaminergic systems such as novelty-seeking, socio-sexual behaviors, and response to addictive drugs. d. The susceptibility of the mammary gland and prostate gland to alterations in development from exposures to BPA. e. The predilection of BPA-induced changes in mammary gland and prostate gland development to neoplasia later in life. 5. The robustness and biologic basis for altered puberty following BPA exposure in multiple species. 6. The potential for effects on the immune system. 7. The potential for metabolic disruptions leading to obesity, diabetes, or other metabolic diseases. 8. The potential for disruptions to the male reproductive tract including effects on sperm quantity and quality. 9. The potential for aneuploidy or chromosomal disruption to female germ cells and for proliferative and/or cystic changes to the ovary and uterus later in life. 10. Other areas not previously identified. All responses to information requested within this RFI are optional. The information collected will be analyzed and considered for use in the further development of NTP and NIEHS/DERT research and testing programs on BPA. 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 and shall not be construed as a solicitation for applications nor as an obligation on the part of the Government. The PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Government will not pay for the preparation of any information submitted or for the Government’s use of that information. 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: October 7, 2008. Samuel H. Wilson, Acting Director, National Institute of Environmental Health Sciences and National Toxicology Program. [FR Doc. E8–25053 Filed 10–20–08; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Statement of Organization, Functions, and Delegations of Authority Part C (Centers for Disease Control and Prevention) of the statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (45 FR 67772–76, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 73 FR 46300–46301, dated August 8, 2008) is amended to reflect the reorganization of the Coordinating Center for Infectious Diseases at the Centers for Disease Control and Prevention. Section C–B, Organization and Functions, is hereby amended as follows: Delete in its entirety the functional statement for the Strategic Business Unit (CVA2) and insert the following: Strategic Business Unit (CVA2). The mission of the Strategic Business Unit (SBU) is to support CCID programs and staff through the efficient, professional, and timely delivery of critical public health mission-support services. In carrying out its mission, the SBU performs the following functions: (1) Provides direct and daily management and execution of domestic travel processing for federal employees, Commissioned Corps, and all CDCinvited guests; (2) provides direct and daily management and execution of the administrative aspects of human resources across CCTD, including training and administration of policies and guidelines developed by the Atlanta Human Resources Center, Department of Health and Human Services (HHS), E:\FR\FM\21OCN1.SGM 21OCN1

Agencies

[Federal Register Volume 73, Number 204 (Tuesday, October 21, 2008)]
[Notices]
[Pages 62505-62506]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-25053]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Institute of Environmental Health Sciences (NIEHS); 
National Toxicology Program (NTP); Request for Information (NOT-ES-09-
001): Ongoing Research and Research Needs for Biological Effects of 
Exposure to Bisphenol A (BPA)

AGENCY: National Institutes of Health (NIH).

ACTION: Request for information.

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

SUMMARY: The NIEHS Division of Extramural Research and Training (DERT) 
and the NTP are seeking input on a number of key research areas that 
have been identified in recent evaluations of bisphenol A (BPA). 
Information provided will be used to help focus future research and 
testing activities on BPA. This Request for Information (RFI) is for 
planning purposes only and should not be construed as a funding 
opportunity or grant program. The NIEHS and NTP welcome input from the 
lay public, environmental health researchers, healthcare professionals, 
educators, policy makers, industry, and others with an interest in BPA.

DATES: Please respond online at the Bisphenol A Request for Information 
Web page by December 1, 2008, at https://ntp.niehs.nih.gov/go/rfibpa.

FOR FURTHER INFORMATION CONTACT: Other correspondence regarding this 
RFI should be directed to either (1) Dr. Jerry Heindel, DERT Program 
Administrator, NIEHS, P.O. Box 12233, MD EC-23, Research Triangle Park, 
NC 27709, (phone) 919-541-0781, (e-mail) heindelj@niehs.nih.gov or (2) 
Dr. Paul Foster, NTP Acting Toxicology Branch Chief, NIEHS, P.O. Box 
12233, MD EC-34, Research Triangle Park, NC 27709, (phone) 919-541-
2513, (e-mail) foster2@niehs.nih.gov.

SUPPLEMENTARY INFORMATION: 

Background

    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 was established as a 
cooperative effort to (1) Coordinate toxicology testing programs within 
the federal government, (2) strengthen the science base in toxicology, 
(3) develop improved testing methods, and (4) provide information about 
potentially toxic chemicals to health, regulatory, and research 
agencies, scientific and medical communities, and the public. To meet 
these goals, NTP designs and conducts large-scale laboratory animal 
research and testing programs and analyzes and reports its findings to 
assess potential hazards to human health from exposure to environmental 
agents. The NTP also carries out formal review and literature analysis 
activities.
    The NIEHS mission is to understand the complex relationship between 
environmental risk factors and human biology within affected 
individuals and populations and to use this knowledge to prevent 
illness, reduce disease, and promote health. To accomplish this, the 
NIEHS supports research and professional development in environmental 
health sciences, environmental clinical research, and environmental 
public health. These extramural research and development activities are 
managed through NIEHS/DERT.
    Recently, both the NTP and NIEHS/DERT conducted assessments related 
to understanding the potential human health and environmental risks 
posed by BPA. The NTP evaluation was conducted through its Center for 
the Evaluation of Risks to Human Reproduction (CERHR) and focused on 
whether current exposures may pose health risks to human reproduction 
and development. The final results of this evaluation were released on 
September 3, 2008, as the NTP-CERHR Monograph on Bisphenol A. The 
monograph and details of this evaluation are available at https://
cerhr.niehs.nih.gov/chemicals/bisphenol/bisphenol.html. The NIEHS 
workshop, ``Bisphenol A: An Examination of the Relevance of Ecological, 
In Vitro and Laboratory Animal Studies for Assessing Risks to Human 
Health'' (for consensus statement see vom Saal et al., Reproductive 
Toxicol. 2007. 24:131-138) was co-sponsored with a number of other 
organizations and was broader in scope compared to the NTP-CERHR 
evaluation as it included consideration of ecological effects and human 
health effects not directly related to development or reproduction.
    The NTP and NIEHS review activities resulted in a number of 
research recommendations to better characterize the sources and levels 
of human exposures to BPA and to help determine what, if any, adverse 
health effects might result from such exposures. Similarly, a number of 
research needs have been identified by the Food and Drug Administration 
in its draft assessment of BPA in food contact applications (https://
www.fda.gov/ohrms/dockets/ac/oc08.html#Scienceboard see ``Science Board 
to the Food and Drug

[[Page 62506]]

Administration'' meeting information for September 16, 2008).
    Currently the NTP is pursuing studies of absorption, distribution, 
metabolism, and excretion (ADME) in experimental animals (rodents and 
non human primates) as well as the kinetics associated with these 
processes, following exposures to BPA from the perinatal period through 
adulthood, over a wide range of doses, by multiple routes of 
administration. These studies have been identified as high priority 
needs in all recent reviews and reflect the general lack of information 
on concentrations of BPA in blood and target tissues in animal studies 
reporting effects of ``low'' doses of BPA on various aspects of 
development.
    In addition to ADME studies, other areas of research have been 
suggested to better characterize possible hazards associated with BPA 
exposures in humans. They include studies to (1) Examine pathways of 
human exposures, (2) identify cellular targets for BPA at low and high 
doses for consistency with an estrogenic mechanism of action, (3) 
identify interactions with other estrogenic substances including 
naturally occurring hormones, and (4) investigate further the ``low'' 
dose effects reported in experimental animals.
    The findings from the ADME studies and the information collected as 
a result of this RFI will be analyzed and considered for use in the 
further development of NTP and NIEHS/DERT research and testing programs 
on BPA.

Information Requested

    The NTP and NIEHS/DERT request information on the following:
     Ongoing or planned research activities that you are aware 
of related to this RFI.
     Specific data needs for any or all of the priority areas 
identified below.
     Suggestions for beneficial research collaborations.
    To aid in the development of a listing of prioritized data needs, a 
summary listing of the research needs identified in the NTP CERHR 
evaluation, the NIEHS co-sponsored workshop, or the draft FDA 
assessment are included below. This list may be used as a starting 
point for developing a prioritized listing of research needs related to 
the health effects of BPA.
    1. Studies of the concentrations of BPA and metabolites in human 
blood, urine, breast milk, amniotic fluid, placenta and other tissues, 
particularly in infants and young children, where appropriate.
    2. More complete assessment of sources of human exposure to BPA.
    3. In vitro studies examining interactions of BPA with multiple 
cellular targets (toxicity pathways) across a range of concentrations, 
and comparing these results with similar studies of other known 
estrogenic agents and combinations of estrogenic agents with BPA.
    4. Studies of gestational and lactational exposure of experimental 
animals to ``low'' doses of BPA regarding effects on development and 
onset of adult disease including:
    a. The sensitivity of the developing brain to BPA induced 
structural, functional, and biochemical alterations.
    b. The relevance to primates of diminished estrogen-dependent brain 
and behavioral sexual dimorphisms in rodents exposed to BPA during 
development.
    c. Confirmation of rodent studies reporting behavioral effects 
following BPA exposure during development related to the dopaminergic 
systems such as novelty-seeking, socio-sexual behaviors, and response 
to addictive drugs.
    d. The susceptibility of the mammary gland and prostate gland to 
alterations in development from exposures to BPA.
    e. The predilection of BPA-induced changes in mammary gland and 
prostate gland development to neoplasia later in life.
    5. The robustness and biologic basis for altered puberty following 
BPA exposure in multiple species.
    6. The potential for effects on the immune system.
    7. The potential for metabolic disruptions leading to obesity, 
diabetes, or other metabolic diseases.
    8. The potential for disruptions to the male reproductive tract 
including effects on sperm quantity and quality.
    9. The potential for aneuploidy or chromosomal disruption to female 
germ cells and for proliferative and/or cystic changes to the ovary and 
uterus later in life.
    10. Other areas not previously identified.
All responses to information requested within this RFI are optional. 
The information collected will be analyzed and considered for use in 
the further development of NTP and NIEHS/DERT research and testing 
programs on BPA. 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 and shall not be 
construed as a solicitation for applications nor 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. 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: October 7, 2008.
Samuel H. Wilson,
Acting Director, National Institute of Environmental Health Sciences 
and National Toxicology Program.
[FR Doc. E8-25053 Filed 10-20-08; 8:45 am]
BILLING CODE 4140-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.