National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Announcement of the Availability of the Bisphenol A Expert Panel Report; Request for Public Comment, 67730-67731 [E7-23234]

Download as PDF 67730 Federal Register / Vol. 72, No. 230 / Friday, November 30, 2007 / Notices Avenue, SW., Room 450G, Washington, DC 20201; 202–205–3815; fax: 202–690– 7412; e-mail address: leigh.sawyer@hhs.gov. Pursuant to section 319M of the Public Health Service Act (42 U.S.C. 247d–7f) as added by section 402 of the Pandemic and All-Hazards Preparedness Act (Pub. L. 109–417) the Secretary of Health and Human Services is required to establish the National Biodefense Science Board and hold the inaugural meeting of the Board prior to December 19, 2007. The Board shall provide expert advice and guidance to the Secretary on scientific, technical and other matters of special interest to the Department of Health and Human Services regarding current and future chemical, biological, nuclear, and radiological (CBRN) agents, whether naturally occurring, accidental, or deliberate. The agenda will include topics related to current and future challenges to national preparedness related to CBRN agents, and will include discussions regarding matters that the Board will consider in greater depth. A tentative schedule will be made available on December 2, 2007 at the NBSB Web site, https://www.hhs.gov/aspr/omsph/nbsb. Any member of the public interested in presenting oral comments at the meeting may notify the Contact person listed on this notice by December 10, 2007. Interested individuals and representatives of an organization may submit a letter of intent and a brief description of the organization represented. Both printed and electronic copies are requested for the record. In addition, any interested person may file written comments with the committee. All written comments must be received prior to December 10, 2007 and should be sent by e-mail with ‘‘NBSB Public Comment’’ as the subject line or by regular mail to the Contact person listed above. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the designated Contact person by December 10, 2007. rwilkins on PROD1PC63 with NOTICES SUPPLEMENTARY INFORMATION: Dated: November 26, 2007. RADM W. Craig Vanderwagen, Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services. [FR Doc. 07–5885 Filed 11–29–07; 8:45 am] BILLING CODE 4150–37–M VerDate Aug<31>2005 16:27 Nov 29, 2007 Jkt 214001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting Dated: November 19, 2007. James Scanlon, Deputy Assistant Secretary for Planning and Evaluation (SDP), Office of the Assistant Secretary for Planning and Evaluation. [FR Doc. 07–5876 Filed 11–29–07; 8:45 am] Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting. BILLING CODE 4151–05–M Name: National Committee on Vital and Health Statistics (NCVHS). Time and Date: November 27, 2007 9 a.m.– 3:45 p.m. November 28, 2007 10 a.m.–3 p.m. Place: Hilton Embassy Row Hotel, 2015 Massachusetts Avenue NW., Washington, DC, 202–265–1600. Status: Open. Purpose: At this meeting the Committee will hear presentations and hold discussions on several health data policy topics. On the morning and afternoon of the first day the Committee will hear updates from the Department and status reports from its subcommittees as well as a presentation from the Robert Graham Center on harmonizing primary care standards. On the morning of the second day the Committee will hear an update from the Office of the National Coordinator for Health Information Technology (ONCHIT) followed by Committee actions on selected topics from the subcommittees. In the afternoon there will be a follow up discussion to the ONCHIT presentation and an update from the subcommittees on current and planned activities. There will be a short discussion of future agendas before the meeting adjourns. The times shown above are for the full Committee meeting. Subcommittee breakout sessions are scheduled for late in the afternoon of the first day in the morning prior to the full Committee meeting on the second day. Agendas for these breakout sessions will be posted on the NCVHS Web site (URL below) when available. National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Announcement of the Availability of the Bisphenol A Expert Panel Report; Request for Public Comment FOR FURTHER INFORMATION CONTACT: Substantive program information as well as summaries of meetings and a roster of committee members may be obtained from Marjorie S. Greenberg, Executive Secretary, NCVHS, National Center for Health Statistics, Centers for Disease Control and Prevention, 3311 Toledo Road, Room 2402, Hyattsville, Maryland 20782, telephone (301) 458– 4245. Information also is available on the NCVHS home page of the HHS Web Site: https://www.ncvhs.hhs.gov/, where further information including an agenda will be posted when available. Should you require reasonable accommodation, please contact the CDC Office of Equal Employment Opportunity on (301) 458–4EEO (4336) as soon as possible. PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute of Environmental Health Sciences (NIEHS); National Institutes of Health (NIH). AGENCY: Announcement of report availability and request for comment. ACTION: SUMMARY: CERHR announces the availability of the final bisphenol A expert panel report on November 26, 2007, from the CERHR Web site (https:// cerhr.niehs.nih.gov) or in print from CERHR (see ADDRESSES below). The expert panel report is an evaluation of the reproductive and developmental toxicity of bisphenol A conducted by an independent, 12-member expert panel composed of scientists from the public and private sectors convened by CERHR. CERHR invites the submission of public comments on this report (see SUPPLEMENTARY INFORMATION below). The expert panel met twice in public session (March 5–7, 2007 and August 6– 8, 2007) to review and revise the draft expert panel report and reach conclusions regarding whether exposure to bisphenol A is a hazard to human development or reproduction. The expert panel also identified data gaps and research needs. The final bisphenol A expert panel report will be available for public comment on November 26, 2007. Written public comments on this report should be received by January 25, 2008. DATES: Comments on the expert panel report and any other correspondence should be sent to Dr. Michael D. Shelby, CERHR Director, NIEHS, P.O. Box 12233, MD EC–32, Research Triangle Park, NC 27709, fax: (919) 316–4511, or e-mail: shelby@niehs.nih.gov. Courier address: CERHR, 79 T.W. Alexander Drive, Building 4401, Room 103, Research Triangle Park, NC 27709. ADDRESSES: SUPPLEMENTARY INFORMATION: E:\FR\FM\30NON1.SGM 30NON1 Federal Register / Vol. 72, No. 230 / Friday, November 30, 2007 / Notices Background Bisphenol A (CAS RN: 80–5–07) is a high production volume chemical used in the production of epoxy resins, polyester resins, polysulfone resins, polyacrylate resins, polycarbonate plastics, and flame retardants. Polycarbonate plastics are used in food and drink packaging; resins are used as lacquers to coat metal products such as food cans, bottle tops, and water supply pipes. Some polymers used in dental sealants and tooth coatings contain bisphenol A. Exposure to the general population can occur through direct contact to bisphenol A or by exposure to food or drink that has been in contact with a material containing bisphenol A. CERHR selected this chemical for evaluation because of (1) high production volume, (2) widespread human exposure, (3) evidence of reproductive toxicity in laboratory animal studies, and (4) public concern. The CERHR convened an expert panel on March 5–7, 2007, and on August 6– 8, 2007, to review and revise the draft and interim draft expert panel reports and reach conclusions regarding whether exposure to bisphenol A is a hazard to human development or reproduction. The expert panel also identified data gaps and research needs. CERHR solicited public comments on drafts of the expert panel report several times (FR, December 12, 2006, Vol. 71, No. 238 pp. 74534–74536; FR, April 2, 2007, Vol. 72, No. 62 pp. 15695–15696; FR, May 1, 2007, Vol. 72, No. 83 pp. 23833–23834). Following receipt of public comments on the final bisphenol A expert panel report, CERHR staff will prepare the NTP–CERHR monograph. NTP–CERHR monographs are divided into four major sections: (1) The NTP Brief that provides the NTP’s interpretation of the potential for the chemical to cause adverse reproductive and/or developmental effects in exposed humans, (2) a roster of expert panel members, (3) the final expert panel report, and (4) public comments received on that report. The NTP Brief is based on the expert panel report, public comments on that report, public and peer review comments on the draft NTP Brief, and any new, relevant information that becomes available after the expert panel meetings. rwilkins on PROD1PC63 with NOTICES Request for Comments CERHR invites written public comments on the bisphenol A expert panel report. Written comments should be sent to Dr. Michael Shelby (see ADDRESSES above). Persons submitting written comments are asked to include VerDate Aug<31>2005 16:27 Nov 29, 2007 Jkt 214001 their name and contact information (affiliation, mailing address, telephone and facsimile numbers, e-mail, and sponsoring organization, if any). Any comments received will be posted on the CERHR Web site and included in the NTP CERHR monograph on this chemical. All public comments will be considered by the NTP during preparation of the NTP Brief (see ‘‘Background’’ above). Background Information on CERHR The NTP established the CERHR in June 1998 [FR, December 14, 1998 (Vol. 63, No. 239, pp. 68782)]. CERHR is a publicly accessible resource for information about adverse reproductive and/or developmental health effects associated with exposure to environmental and/or occupational exposures. Expert panels conduct scientific evaluations of agents selected by CERHR in public forums. CERHR invites the nomination of agents for review or scientists for its expert registry. Information about CERHR and the nomination process can be obtained from its Web site (https:// cerhr.niehs.nih.gov) or by contacting Dr. Shelby (see ADDRESSES above). CERHR selects chemicals for evaluation based upon several factors including production volume, potential for human exposure from use and occurrence in the environment, extent of public concern, and extent of data from reproductive and developmental toxicity studies. CERHR follows a formal, multi-step process for review and evaluation of selected chemicals. A description of the evaluation process is available on the CERHR Web site under ‘‘About CERHR’’ or in printed copy from CERHR. Dated: November 15, 2007. Samuel H. Wilson, Acting Director, National Institute of Environmental Health Sciences and National Toxicology Program. [FR Doc. E7–23234 Filed 11–29–07; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Amendment to January 26, 2007 Declaration Under the Public Readiness and Emergency Preparedness Act Office of the Assistant Secretary for Preparedness and Response (ASPR), HHS. AGENCY: Amendment (to the January 26, 2007 Declaration under the Public ACTION: PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 67731 Readiness and Emergency Preparedness Act). SUMMARY: Declaration pursuant to section 319F–3 of the Public Health Service Act (42 U.S.C. 247d–6d) to provide targeted liability protections for pandemic countermeasures based on a credible risk that avian influenza viruses spread and evolve into strains capable of causing a pandemic of human influenza. Amendment: Whereas, the H7 and H9 subtypes of avian influenza viruses are viewed as likely candidates to evolve into an influenza virus strain capable of causing a pandemic of human influenza; and Whereas, in accordance with section 319F–3(b)(6) of the Public Health Service Act (42 U.S.C. 247d–6d(b)) (‘‘the Act’’), I have considered the desirability of encouraging the design, development, clinical testing or investigation, manufacturing and product formulation, labeling, distribution, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of these additional medical countermeasures with respect to the category of diseases and population described in sections II and IV of the declaration published in Federal Register on February 1, 2007 (72 FR 4710) (‘‘the Original Declaration’’); Therefore, pursuant to section 319F– 3(b) of the Act, I have determined there is a credible risk that the spread of the H7 and H9 subtypes of avian influenza viruses and resulting disease could in the future constitute a public health emergency. In order to reflect the addition of medical countermeasures specific to the H7 and H9 subtypes of influenza viruses, the Original Declaration is hereby amended as follows: First ‘‘whereas’’ clause, first sentence, insert ‘‘H7 and H9 vaccines’’ following ‘‘(H5N1).’’ Second ‘‘whereas’’ clause, first sentence, insert ‘‘H7 and H9’’ following ‘‘H5N1’’ to read ‘‘Whereas an H5N1, [H7 and H9] avian influenza viruse[s] may evolve into strain[s] * * *.’’ In Section I, paragraph 2, first sentence insert ‘‘H7 and H9’’ following ‘‘(H5N1)’’ to read ‘‘* * * pandemic countermeasure influenza A (H5N1, [H7 and H9]) vaccine[s].’’ In Section I, paragraph 2, third sentence insert ‘‘H7 and H9’’ following ‘‘(H5N1)’’ to read ‘‘* * * pandemic countermeasure influenza A (H5N1, [H7 and H9]) vaccine[s] * * *.’’ In Section II, paragraph 1, insert ‘‘or an H7 or H9’’ following ‘‘(H5N1).’’ E:\FR\FM\30NON1.SGM 30NON1

Agencies

[Federal Register Volume 72, Number 230 (Friday, November 30, 2007)]
[Notices]
[Pages 67730-67731]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-23234]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Toxicology Program (NTP); Center for the Evaluation of 
Risks to Human Reproduction (CERHR); Announcement of the Availability 
of the Bisphenol A Expert Panel Report; Request for Public Comment

AGENCY: National Institute of Environmental Health Sciences (NIEHS); 
National Institutes of Health (NIH).

ACTION: Announcement of report availability and request for comment.

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

SUMMARY: CERHR announces the availability of the final bisphenol A 
expert panel report on November 26, 2007, from the CERHR Web site 
(https://cerhr.niehs.nih.gov) or in print from CERHR (see ADDRESSES 
below). The expert panel report is an evaluation of the reproductive 
and developmental toxicity of bisphenol A conducted by an independent, 
12-member expert panel composed of scientists from the public and 
private sectors convened by CERHR. CERHR invites the submission of 
public comments on this report (see SUPPLEMENTARY INFORMATION below). 
The expert panel met twice in public session (March 5-7, 2007 and 
August 6-8, 2007) to review and revise the draft expert panel report 
and reach conclusions regarding whether exposure to bisphenol A is a 
hazard to human development or reproduction. The expert panel also 
identified data gaps and research needs.

DATES: The final bisphenol A expert panel report will be available for 
public comment on November 26, 2007. Written public comments on this 
report should be received by January 25, 2008.

ADDRESSES: Comments on the expert panel report and any other 
correspondence should be sent to Dr. Michael D. Shelby, CERHR Director, 
NIEHS, P.O. Box 12233, MD EC-32, Research Triangle Park, NC 27709, fax: 
(919) 316-4511, or e-mail: shelby@niehs.nih.gov. Courier address: 
CERHR, 79 T.W. Alexander Drive, Building 4401, Room 103, Research 
Triangle Park, NC 27709.

SUPPLEMENTARY INFORMATION:

[[Page 67731]]

Background

    Bisphenol A (CAS RN: 80-5-07) is a high production volume chemical 
used in the production of epoxy resins, polyester resins, polysulfone 
resins, polyacrylate resins, polycarbonate plastics, and flame 
retardants. Polycarbonate plastics are used in food and drink 
packaging; resins are used as lacquers to coat metal products such as 
food cans, bottle tops, and water supply pipes. Some polymers used in 
dental sealants and tooth coatings contain bisphenol A. Exposure to the 
general population can occur through direct contact to bisphenol A or 
by exposure to food or drink that has been in contact with a material 
containing bisphenol A. CERHR selected this chemical for evaluation 
because of (1) high production volume, (2) widespread human exposure, 
(3) evidence of reproductive toxicity in laboratory animal studies, and 
(4) public concern.
    The CERHR convened an expert panel on March 5-7, 2007, and on 
August 6-8, 2007, to review and revise the draft and interim draft 
expert panel reports and reach conclusions regarding whether exposure 
to bisphenol A is a hazard to human development or reproduction. The 
expert panel also identified data gaps and research needs. CERHR 
solicited public comments on drafts of the expert panel report several 
times (FR, December 12, 2006, Vol. 71, No. 238 pp. 74534-74536; FR, 
April 2, 2007, Vol. 72, No. 62 pp. 15695-15696; FR, May 1, 2007, Vol. 
72, No. 83 pp. 23833-23834).
    Following receipt of public comments on the final bisphenol A 
expert panel report, CERHR staff will prepare the NTP-CERHR monograph. 
NTP-CERHR monographs are divided into four major sections: (1) The NTP 
Brief that provides the NTP's interpretation of the potential for the 
chemical to cause adverse reproductive and/or developmental effects in 
exposed humans, (2) a roster of expert panel members, (3) the final 
expert panel report, and (4) public comments received on that report. 
The NTP Brief is based on the expert panel report, public comments on 
that report, public and peer review comments on the draft NTP Brief, 
and any new, relevant information that becomes available after the 
expert panel meetings.

Request for Comments

    CERHR invites written public comments on the bisphenol A expert 
panel report. Written comments should be sent to Dr. Michael Shelby 
(see ADDRESSES above). Persons submitting written comments are asked to 
include their name and contact information (affiliation, mailing 
address, telephone and facsimile numbers, e-mail, and sponsoring 
organization, if any). Any comments received will be posted on the 
CERHR Web site and included in the NTP CERHR monograph on this 
chemical. All public comments will be considered by the NTP during 
preparation of the NTP Brief (see ``Background'' above).

Background Information on CERHR

    The NTP established the CERHR in June 1998 [FR, December 14, 1998 
(Vol. 63, No. 239, pp. 68782)]. CERHR is a publicly accessible resource 
for information about adverse reproductive and/or developmental health 
effects associated with exposure to environmental and/or occupational 
exposures. Expert panels conduct scientific evaluations of agents 
selected by CERHR in public forums.
    CERHR invites the nomination of agents for review or scientists for 
its expert registry. Information about CERHR and the nomination process 
can be obtained from its Web site (https://cerhr.niehs.nih.gov) or by 
contacting Dr. Shelby (see ADDRESSES above). CERHR selects chemicals 
for evaluation based upon several factors including production volume, 
potential for human exposure from use and occurrence in the 
environment, extent of public concern, and extent of data from 
reproductive and developmental toxicity studies.
    CERHR follows a formal, multi-step process for review and 
evaluation of selected chemicals. A description of the evaluation 
process is available on the CERHR Web site under ``About CERHR'' or in 
printed copy from CERHR.

    Dated: November 15, 2007.
Samuel H. Wilson,
Acting Director, National Institute of Environmental Health Sciences 
and National Toxicology Program.
 [FR Doc. E7-23234 Filed 11-29-07; 8:45 am]
BILLING CODE 4140-01-P
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