National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Announcement of the Di(2-ethylhexyl)-phthalate Expert Panel Meeting and Availability of the Draft Expert Panel Report on Di(2-ethylhexyl)-phthalate; Request for Public Comment, 43870-43871 [05-15080]

Download as PDF 43870 Federal Register / Vol. 70, No. 145 / Friday, July 29, 2005 / Notices Board of Governors of the Federal Reserve System, July 25, 2005. Jennifer J. Johnson, Secretary of the Board. [FR Doc. 05–14993 Filed 7–28–05; 8:45 am] BILLING CODE 6210–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary [Document Identifier: OS–0990–New] Agency Information Collection Activities: Proposed Collection; Comment Request Office of the Secretary, Assistant Secretary for Health, Office of Public Health and Science In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), 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 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 functions; (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. Type of Information Collection Request: New Collection. Title of Information Collection: Blood Availability and Safety Information System. Form/OMB No.: OS–0990–New. Use: To assure blood supplies in the United States are safe and adequate to meet the needs of man-made and natural disasters as well as seasonal shortages a statistically accurate monitoring program is proposed. Frequency: Reporting daily. Affected Public: Not-for-profit institutions. Annual Number of Respondents: 1,000. Total Annual Responses: 36,500. Average Burden Per Response: 30 minutes. Total Annual Hours: 30,416. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections AGENCY: VerDate jul<14>2003 17:05 Jul 28, 2005 Jkt 205001 referenced above, access the HHS Web site address at https://www.hhs.gov/ oirm/infocollect/pending/ or e-mail your request, including your address, phone number, OMB number, and OS document identifier, to naomi.cook@hhs.gov, or call the Reports Clearance Office on (202) 690–6162. Written comments and recommendations for the proposed information collections must be mailed within 60 days of this notice directly to the OS Paperwork Clearance Officer designated at the following address: Department of Health and Human Services, Office of the Secretary, Assistant Secretary for Budget, Technology, and Finance, Office of Information and Resource Management, Attention: Naomi Cook (0990–New), Room 531–H, 200 Independence Avenue, SW., Washington DC 20201. Dated: July 21, 2005. Robert E. Polson, Office of the Secretary, Paperwork Reduction Act Reports Clearance Officer. [FR Doc. 05–14969 Filed 7–28–05; 8:45 am] BILLING CODE 4150–28–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Announcement of the Di(2-ethylhexyl)phthalate Expert Panel Meeting and Availability of the Draft Expert Panel Report on Di(2-ethylhexyl)-phthalate; Request for Public Comment National Institute for Environmental Health Sciences (NIEHS); National Institutes of Health (NIH). ACTION: Meeting announcement and request for comment. AGENCY: SUMMARY: The CERHR announces the availability of the draft expert panel report for di(2-ethylhexyl)-phthalate (DEHP) on August 15, 2005, from the CERHR Web site (https:// cerhr.niehs.nih.gov) or in printed text from the CERHR (see ADDRESSES below). The CERHR invites the submission of public comments on sections 1–4 of the draft expert panel report (see SUPPLEMENTARY INFORMATION below). The expert panel will meet on October 10–12, 2005, at the Holiday Inn Old Town Select in Alexandria, Virginia to review and revise the draft expert panel report and reach conclusions regarding whether exposure to DEHP is a hazard to human development or reproduction. The expert panel will also identify data gaps and research needs. CERHR expert PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 panel meetings are open to the public with time scheduled for oral public comment. Attendance is limited only by the available meeting room space. Following the expert panel meeting and completion of the expert panel report, the CERHR will post the report on its Web site and solicit public comment on it through a Federal Register notice. DATES: The expert panel meeting for DEHP will be held on October 10–12, 2005. Sections 1–4 of the draft expert panel report will be available for public comment on August 15, 2005. Written public comments on the draft report should be received by September 28, 2005. Individuals wishing to make oral public comments at the expert panel meeting are asked to contact Dr. Michael D. Shelby, CERHR Director, by September 28, 2005, and if possible, also send a copy of the statement or talking points at that time. Persons needing special assistance in order to attend are asked to contact Dr. Shelby at least 7 business days prior to the meeting. ADDRESSES: The expert panel meeting for DEHP will be held at the Holiday Inn Old Town Select Alexandria, Virginia (telephone: 703–549–6080, facsimile: 703–684–6508). Comments on the draft expert panel report and other correspondence should be addressed to Dr. Michael D. Shelby, CERHR Director, NIEHS, PO Box 12233, MD EC–32, Research Triangle Park, NC 27709 (mail), (919) 541–3455 (phone), (919) 316–4511 (fax), or shelby@niehs.nih.gov (e-mail). Courier address: CERHR, 79 T.W. Alexander Drive, Building 4401, Room 103, Research Triangle Park, NC 27709. SUPPLEMENTARY INFORMATION: Background Di(2-ethylhexyl)-phthalate (CAS RN: 117–81–7) is a high production volume chemical used as a plasticizer of polyvinyl chloride in the manufacturer of a wide variety of consumer products, such as building products, car products, clothing, food packaging, children’s products (but not in toys intended for mouthing) and in polyvinyl chloride medical devices. In 1999–2000, a NTP– CERHR expert panel evaluated DEHP and six other phthalates for reproductive and developmental toxicities. Since release of the NTP– CERHR expert panel report on DEHP in 2000, approximately 70 papers relevant to human exposure and reproductive and/or developmental toxicity of DEHP have been published. Because this is a chemical with wide human exposure and public and government interest, CERHR plans to convene an expert E:\FR\FM\29JYN1.SGM 29JYN1 Federal Register / Vol. 70, No. 145 / Friday, July 29, 2005 / Notices panel to conduct an updated evaluation of the potential reproductive and developmental toxicities of DEHP. At the expert panel meeting, the expert panel will review and revise the draft expert panel report and reach conclusions regarding whether exposure to DEHP is a hazard to human reproduction or development. Each expert panel report has the following sections: 1.0 Chemistry, Use, and Human Exposure 2.0 General Toxicological and Biological Effects 3.0 Developmental Toxicity Data 4.0 Reproductive Toxicity Data 5.0 Summary, Conclusions, and Critical Data Needs (to be prepared at expert panel meeting) anticipated that a lunch break will occur from noon–1 p.m. and the meeting will adjourn at 5–6 p.m. The meeting is expected to adjourn by noon on October 12; however, adjournment may occur earlier or later depending upon the time needed by the expert panel to complete its work. Anticipated agenda topics for each day are listed below. Request for Comments The CERHR invites written public comments on sections 1–4 of the draft expert panel report on DEHP. Any comments received will be posted on the CERHR Web site prior to the meeting and distributed to the expert panel and CERHR staff for their consideration in revising the draft report and preparing for the expert panel meeting. 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) and send them to Dr. Shelby (see ADDRESSES above) for receipt by September 28, 2005. Time is set-aside on October 10, 2005, for the presentation of oral public comments at the expert panel meeting. Seven minutes will be available for each speaker (one speaker per organization). When registering to comment orally, please provide your name, affiliation, mailing address, telephone and facsimile numbers, email and sponsoring organization (if any). If possible, also send a copy of the statement or talking points to Dr. Shelby by September 28, 2005. This statement will be provided to the expert panel to assist them in identifying issues for discussion and will be noted in the meeting record. Registration for presentation of oral comments will also be available at the meeting on October 10, 2005, from 7:30–8:30 AM. Those persons registering at the meeting are asked to bring 20 copies of their statement or talking points for distribution to the expert panel and for the record. October 11, 2005 Preliminary Agenda The meeting begins each day at 8:30 AM. On October 10 and 11, it is Background Information on the CERHR VerDate jul<14>2003 17:05 Jul 28, 2005 Jkt 205001 October 10, 2005 • Opening remarks • Oral public comments (7 minutes per speaker; one representative per group) • Review of sections 1–4 of the draft expert panel report on di (2-ethylhexyl)phthalate • Discussion of Section 5.0 Summary, Conclusions, and Critical Data Needs • Discussion of Section 5.0 Summary, Conclusions, and Critical Data Needs • Preparation of draft summaries and conclusion statements October 12, 2005 • Presentation, discussion of, and agreement on summaries, conclusions, and data needs • Closing comments Expert Panel Roster The CERHR expert panel is composed of independent scientists selected for their scientific expertise in reproductive and/or developmental toxicology and other areas of science relevant for this review. Robert J. Kavlock, Ph.D., (Chair)—U.S. Environmental Protection Agency Research Triangle Park, NC Dana Boyd Barr, Ph.D.—Centers for Disease Control & Prevention, Atlanta, GA Kim Boekelheide, MD, Ph.D.—Brown University, Providence, RI William J. Breslin, Ph.D.—Eli Lilly and Company, Greenfield, IN Patrick N. Breysse, Ph.D.—The Johns Hopkins University, Baltimore, MD Robert E. Chapin, Ph.D.—Pfizer Global Research & Development Groton, CT Kevin Gaido, Ph.D.—CIIT Centers for Health Research, Research Triangle Park, NC Ernest. Hodgson, Ph.D.—North Carolina State University, Raleigh, NC Michele Marcus, Ph.D.—Emory University, Atlanta, GA Katherine M. Shea, MD, MPH— Consultant, Chapel Hill, NC Paige L. Williams, Ph.D.—Harvard School of Public Health, Boston, MA The NTP established the NTP CERHR in June 1998 [Federal Register, PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 43871 December 14, 1998 (Volume 63, Number 239, page 68782)]. The 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 the CERHR in public forums. The 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 homepage (https:// cerhr.niehs.nih.gov) or by contacting Dr. Shelby (see ADDRESSES above). The CERHR selects chemicals for evaluation based upon several factors including production volume, potential for human exposure from use and occurrence in the environment, extent 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. The formal evaluation process was published in the Federal Register on July 16, 2001 (Volume 66, Number 136, pages 37047– 37048) and is available on the CERHR web site under ‘‘About CERHR’’ or in printed copy from the CERHR. Dated: July 22, 2005. David A. Schwartz, Director, National Institute of Environmental Health Sciences and the National Toxicology Program. [FR Doc. 05–15080 Filed 7–28–05; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration on Aging Agency Information Collection Activities; Proposed Collection; Comment Request; Fourth National Survey of Older Americans Act Title III Service Recipients Administration on Aging, HHS. Notice. AGENCY: ACTION: SUMMARY: The Administration on Aging (AoA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice E:\FR\FM\29JYN1.SGM 29JYN1

Agencies

[Federal Register Volume 70, Number 145 (Friday, July 29, 2005)]
[Notices]
[Pages 43870-43871]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-15080]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Toxicology Program (NTP); Center for the Evaluation of 
Risks to Human Reproduction (CERHR); Announcement of the Di(2-
ethylhexyl)-phthalate Expert Panel Meeting and Availability of the 
Draft Expert Panel Report on Di(2-ethylhexyl)-phthalate; Request for 
Public Comment

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

ACTION: Meeting announcement and request for comment.

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

SUMMARY: The CERHR announces the availability of the draft expert panel 
report for di(2-ethylhexyl)-phthalate (DEHP) on August 15, 2005, from 
the CERHR Web site (https://cerhr.niehs.nih.gov) or in printed text from 
the CERHR (see ADDRESSES below). The CERHR invites the submission of 
public comments on sections 1-4 of the draft expert panel report (see 
SUPPLEMENTARY INFORMATION below). The expert panel will meet on October 
10-12, 2005, at the Holiday Inn Old Town Select in Alexandria, Virginia 
to review and revise the draft expert panel report and reach 
conclusions regarding whether exposure to DEHP is a hazard to human 
development or reproduction. The expert panel will also identify data 
gaps and research needs. CERHR expert panel meetings are open to the 
public with time scheduled for oral public comment. Attendance is 
limited only by the available meeting room space. Following the expert 
panel meeting and completion of the expert panel report, the CERHR will 
post the report on its Web site and solicit public comment on it 
through a Federal Register notice.

DATES: The expert panel meeting for DEHP will be held on October 10-12, 
2005. Sections 1-4 of the draft expert panel report will be available 
for public comment on August 15, 2005. Written public comments on the 
draft report should be received by September 28, 2005. Individuals 
wishing to make oral public comments at the expert panel meeting are 
asked to contact Dr. Michael D. Shelby, CERHR Director, by September 
28, 2005, and if possible, also send a copy of the statement or talking 
points at that time. Persons needing special assistance in order to 
attend are asked to contact Dr. Shelby at least 7 business days prior 
to the meeting.

ADDRESSES: The expert panel meeting for DEHP will be held at the 
Holiday Inn Old Town Select Alexandria, Virginia (telephone: 703-549-
6080, facsimile: 703-684-6508). Comments on the draft expert panel 
report and other correspondence should be addressed to Dr. Michael D. 
Shelby, CERHR Director, NIEHS, PO Box 12233, MD EC-32, Research 
Triangle Park, NC 27709 (mail), (919) 541-3455 (phone), (919) 316-4511 
(fax), or shelby@niehs.nih.gov (e-mail). Courier address: CERHR, 79 
T.W. Alexander Drive, Building 4401, Room 103, Research Triangle Park, 
NC 27709.

SUPPLEMENTARY INFORMATION:

Background

    Di(2-ethylhexyl)-phthalate (CAS RN: 117-81-7) is a high production 
volume chemical used as a plasticizer of polyvinyl chloride in the 
manufacturer of a wide variety of consumer products, such as building 
products, car products, clothing, food packaging, children's products 
(but not in toys intended for mouthing) and in polyvinyl chloride 
medical devices. In 1999-2000, a NTP-CERHR expert panel evaluated DEHP 
and six other phthalates for reproductive and developmental toxicities. 
Since release of the NTP-CERHR expert panel report on DEHP in 2000, 
approximately 70 papers relevant to human exposure and reproductive 
and/or developmental toxicity of DEHP have been published. Because this 
is a chemical with wide human exposure and public and government 
interest, CERHR plans to convene an expert

[[Page 43871]]

panel to conduct an updated evaluation of the potential reproductive 
and developmental toxicities of DEHP.
    At the expert panel meeting, the expert panel will review and 
revise the draft expert panel report and reach conclusions regarding 
whether exposure to DEHP is a hazard to human reproduction or 
development. Each expert panel report has the following sections:

1.0 Chemistry, Use, and Human Exposure
2.0 General Toxicological and Biological Effects
3.0 Developmental Toxicity Data
4.0 Reproductive Toxicity Data
5.0 Summary, Conclusions, and Critical Data Needs (to be prepared at 
expert panel meeting)

Request for Comments

    The CERHR invites written public comments on sections 1-4 of the 
draft expert panel report on DEHP. Any comments received will be posted 
on the CERHR Web site prior to the meeting and distributed to the 
expert panel and CERHR staff for their consideration in revising the 
draft report and preparing for the expert panel meeting. 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) and send them to 
Dr. Shelby (see ADDRESSES above) for receipt by September 28, 2005.
    Time is set-aside on October 10, 2005, for the presentation of oral 
public comments at the expert panel meeting. Seven minutes will be 
available for each speaker (one speaker per organization). When 
registering to comment orally, please provide your name, affiliation, 
mailing address, telephone and facsimile numbers, email and sponsoring 
organization (if any). If possible, also send a copy of the statement 
or talking points to Dr. Shelby by September 28, 2005. This statement 
will be provided to the expert panel to assist them in identifying 
issues for discussion and will be noted in the meeting record. 
Registration for presentation of oral comments will also be available 
at the meeting on October 10, 2005, from 7:30-8:30 AM. Those persons 
registering at the meeting are asked to bring 20 copies of their 
statement or talking points for distribution to the expert panel and 
for the record.

Preliminary Agenda

    The meeting begins each day at 8:30 AM. On October 10 and 11, it is 
anticipated that a lunch break will occur from noon-1 p.m. and the 
meeting will adjourn at 5-6 p.m. The meeting is expected to adjourn by 
noon on October 12; however, adjournment may occur earlier or later 
depending upon the time needed by the expert panel to complete its 
work. Anticipated agenda topics for each day are listed below.

October 10, 2005

     Opening remarks
     Oral public comments (7 minutes per speaker; one 
representative per group)
     Review of sections 1-4 of the draft expert panel report on 
di (2-ethylhexyl)-phthalate
     Discussion of Section 5.0 Summary, Conclusions, and 
Critical Data Needs

October 11, 2005

     Discussion of Section 5.0 Summary, Conclusions, and 
Critical Data Needs
     Preparation of draft summaries and conclusion statements

October 12, 2005

     Presentation, discussion of, and agreement on summaries, 
conclusions, and data needs
     Closing comments

Expert Panel Roster

    The CERHR expert panel is composed of independent scientists 
selected for their scientific expertise in reproductive and/or 
developmental toxicology and other areas of science relevant for this 
review.

Robert J. Kavlock, Ph.D., (Chair)--U.S. Environmental Protection Agency 
Research Triangle Park, NC
Dana Boyd Barr, Ph.D.--Centers for Disease Control & Prevention, 
Atlanta, GA
Kim Boekelheide, MD, Ph.D.--Brown University, Providence, RI
William J. Breslin, Ph.D.--Eli Lilly and Company, Greenfield, IN
Patrick N. Breysse, Ph.D.--The Johns Hopkins University, Baltimore, MD
Robert E. Chapin, Ph.D.--Pfizer Global Research & Development Groton, 
CT
Kevin Gaido, Ph.D.--CIIT Centers for Health Research, Research Triangle 
Park, NC
Ernest. Hodgson, Ph.D.--North Carolina State University, Raleigh, NC
Michele Marcus, Ph.D.--Emory University, Atlanta, GA
Katherine M. Shea, MD, MPH--Consultant, Chapel Hill, NC
Paige L. Williams, Ph.D.--Harvard School of Public Health, Boston, MA

Background Information on the CERHR

    The NTP established the NTP CERHR in June 1998 [Federal Register, 
December 14, 1998 (Volume 63, Number 239, page 68782)]. The 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 the CERHR in public 
forums.
    The 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 homepage (https://cerhr.niehs.nih.gov) 
or by contacting Dr. Shelby (see ADDRESSES above). The CERHR selects 
chemicals for evaluation based upon several factors including 
production volume, potential for human exposure from use and occurrence 
in the environment, extent 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. The formal evaluation process was 
published in the Federal Register on July 16, 2001 (Volume 66, Number 
136, pages 37047-37048) and is available on the CERHR web site under 
``About CERHR'' or in printed copy from the CERHR.

    Dated: July 22, 2005.
David A. Schwartz,
Director, National Institute of Environmental Health Sciences and the 
National Toxicology Program.
[FR Doc. 05-15080 Filed 7-28-05; 8:45 am]
BILLING CODE 4140-01-P
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