National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Availability of the Draft NTP Briefs on Genistein and Soy Formula; Request for Public Comments, 65537-65538 [E6-18796]

Download as PDF Federal Register / Vol. 71, No. 216 / Wednesday, November 8, 2006 / Notices cprice-sewell on PRODPC62 with NOTICES reducing the yield of the active vaccine component. Immediately available for licensing is a strain that encodes a mutated pertussis toxin, which does not have to be chemically detoxified. Application: Production of Bordatella pertussis toxin for acellular vaccine use. Inventors: Tod Merkel, Jerry Keith, and Xiaoming Yang (NIDCR). Patent Status: U.S. Patent No. 7,101,558 issued 05 Sep 2006 (HHS Reference No. E–159–1999/0-US–03). Licensing Status: Available for nonexclusive licensing. Licensing Contact: Susan Ano, Ph.D.; 301/435–5515; anos@mail.nih.gov. HSV–2 Diagnostic Description of Technology: The present invention relates to novel diagnostic methods for Herpes Simplex Virus Type 2 (HSV–2). HSV–2 infects approximately one fifth of adults in the United States and is the most common cause of genital ulceration. The invention relates to the detection of HSV–2 based on a transforming nucleic acid sequence and its protein product. This DNA sequence harbors the potential to induce the tumorigenic transformation of normal cells in in vitro and in vivo assays and thus will be useful as a means of prognostic evaluation in predicting the development of genital or cervical cancer. Current HSV–2 diagnostic tests relying on tedious viral culture and/or immunoassays that do not have the sensitivity and the specificity essential for diagnosis. Using PCR, the current invention will provide a superior method for viral detection and subtyping. Application: HSV–2 diagnostic. Inventors: Joseph A. DiPaolo (NCI–) Publication: JA DiPaolo et al. Relationship of stable integration of herpes simplex virus-2 Bg/II N subfragment Xho2 to malignant transformation of human papillomavirus-immortalized cervical keratinocytes. Int J Cancer 1998 Jun 10;76(6):865–871. Patent Status: U.S. Patent 6,617,103 issued 09 Sep 2003 (HHS Reference No. E–091–1999/0-US–03); CA Application 2,259,657 filed 30 Jun 1997 (HHS Reference No. E–091–1999/0-CA–04). Licensing Status: Available for nonexclusive or exclusive licensing. Licensing Contact: Susan Ano, Ph.D.; 301/435–5515; anos@mail.nih.gov. Collaborative Research Opportunity: The NCI Division of Basic Science is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize HSV–2 Diagnostic. Please contact Betty VerDate Aug<31>2005 15:11 Nov 07, 2006 Jkt 211001 Tong, Ph.D. at 301–594–4263 or tongb@mail.nih.gov for more information. Dated: October 24, 2006. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6–18885 Filed 11–7–06; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Availability of the Draft NTP Briefs on Genistein and Soy Formula; Request for Public Comments National Institute of Environmental Health Sciences (NIEHS); National Institutes of Health (NIH). ACTION: Request for comments. AGENCY: SUMMARY: CERHR invites the submission of public comments on the draft NTP Briefs on Genistein and Soy Formula. The draft NTP Briefs are available from the CERHR Web site (https://cerhr.niehs.nih.gov see ‘‘CERHR Reports & Monographs’’) or in hardcopy from CERHR (see ADDRESSES below). Public comments will be considered during peer review and finalization of the NTP Briefs. DATES: Written comments on the draft NTP Briefs on Genistein and Soy Formula should be received by December 8, 2006. ADDRESSES: Public comments and any other correspondence should be addressed to Dr. Michael D. Shelby, CERHR Director, NIEHS, P.O. 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 Genistein (CAS RN: 446–72–0) is a phytoestrogen found in some legumes, especially soybeans. Genistein is found in many food products, especially soybased foods such as tofu, soy milk, and soy infant formula, and in some overthe-counter dietary supplements. Soy formula is fed to infants as a supplement or replacement for human milk or cow milk. On March 15–17, 2006, CERHR convened an expert panel to conduct evaluations of the potential PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 65537 reproductive and developmental toxicities of genistein and soy formula. The expert panel reports were released for public comment on May 5, 2006 (Federal Register Vol. 71, No. 94, pp. 28368, May 16, 2006). Following this public comment period, CERHR staff prepared draft NTP Briefs on Genistein and Soy Formula that provides in plain language: • Background information on the substance(s). • Findings of the expert panel. • Discussion of any relevant data available after the expert panel meeting. • NTP’s conclusions on the potential for the substance to cause adverse reproductive and/or developmental effects in exposed humans. Upon finalization, the NTP Briefs on Genistein and Soy Formula will be included in the CERHR Monographs on Genistein and Soy Formula. The draft NTP Briefs on Genistein and Soy Formula and related background materials, including the genistein expert panel report, soy formula expert panel report, and previously received public comments, are available on the CERHR Web site (https://cerhr.niehs.nih.gov see Genistein and Soy Formula under ‘‘CERHR Reports & Monographs’’). Request for Comments The NTP invites written public comments on the draft NTP Briefs on Genistein and Soy Formula. Any comments received will be posted on the CERHR Web site and considered during the peer reviews and finalization of the NTP Brief on Genistein and the NTP Brief on Soy Formula. Persons submitting written comments are asked to include their name and contact information (affiliation, mailing address, telephone and facsimile numbers, email, and sponsoring organization, if any) and submit comments to Dr. Shelby (see ADDRESSES above) for receipt by December 8, 2006. Background Information on CERHR The NTP established CERHR in June 1998 [Federal Register, December 14, 1998 (Volume 63, Number 239, page 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. 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. Michael Shelby, CERHR Director (see ADDRESSES). CERHR selects chemicals E:\FR\FM\08NON1.SGM 08NON1 65538 Federal Register / Vol. 71, No. 216 / Wednesday, November 8, 2006 / Notices 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. Expert panels conduct scientific evaluations of agents selected by CERHR in public forums. Following these evaluations, CERHR prepares the NTP–CERHR monograph on the agent evaluated. The monograph is transmitted to appropriate Federal and State agencies and made available to the public. Dated: October 31, 2006. David A. Schwartz, Director, National Institute of Environmental Health Sciences and National Toxicology Program. [FR Doc. E6–18796 Filed 11–7–06; 8:45 am] BILLING CODE 4140–01–P Mitigation Grant Program. Grant requirements, and grants management procedures of the program are outlined in 44 CFR Part 13. DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency Collection of Information Agency Information Collection Activities: Proposed Collection; Comment Request Federal Emergency Management Agency, DHS. ACTION: Notice and request for comments. AGENCY: SUMMARY: The Federal Emergency Management Agency, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a proposed revision of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning the Hazard Mitigation Grant Program reporting requirements. SUPPLEMENTARY INFORMATION: Section 404 of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 44 U.S.C. 5170c, establishes the Hazard Title: Hazard Mitigation Grant Program Application and Reporting. Type of Information Collection: Revision of a currently approved collection. OMB Number: 1660–0076. Form Numbers: None. Abstract: Grantees administer the Hazard Mitigation Grant Program, which is a post-disaster program that contributes funds toward the cost of hazard mitigation activities in order to reduce the risk of future damage hardship, loss or suffering in any area affected by a major disaster. FEMA uses applications to provide financial assistance in the form of grant awards and, through grantee quarterly reporting, monitors grantee project activities and expenditure of funds. Affected Public: State, local or tribal government. Estimated Total Annual Burden Hours: ANNUAL BURDEN HOURS Number of respondents Frequency of responses Burden hours per respondent Annual responses Total annual burden hours (A) Data collection activities/instruments (B) (C) (D=A×B) (E=C×D) 56 56 56 56 56 18 18 18 1 1 12 5 7.5 4 40 1008 1008 1008 56 56 12,096 5,040 7,560 224 2,240 Total Burden for HMGP ...................................... cprice-sewell on PRODPC62 with NOTICES Project Narrative section 209.8(b) ............................. Benefit-Cost Determination ........................................ Environmental Review ............................................... FEMA 345, HMGP Desk Reference .......................... Annual Audit & Audit Trail Requirements .................. 56 56 .......................... 3136 27,160 Estimated Cost: The State Hazard Mitigation Office staff is usually comprised of urban and regional planners. Wage rates for urban and regional planners were determined using data from the U.S. Department of Labor, Bureau of Labor Statistics (BLS). Currently, BLS data indicate that the median hourly earnings of urban and regional planners for 2004 were $26.75 for an annualized cost of $726,530. Comments: Written comments are solicited to (a) evaluate whether the proposed data collection is necessary for the proper performance of the agency, including whether the information shall have practical utility; (b) evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) enhance the quality, utility, and VerDate Aug<31>2005 15:11 Nov 07, 2006 Jkt 211001 clarity of the information to be collected; and (d) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Comments must be submitted on or before January 8, 2007. Interested persons should submit written comments to Chief, Records Management and Privacy, Information Resources Management Branch, Information Technology Services Division, Federal Emergency Management Agency, 500 C Street, SW., Room 316, Washington, DC 20472. ADDRESSES: Policy Section, Mitigation Division, (202) 646–3321 for additional information. You may contact the Records Management Branch for copies of the proposed collection of information at facsimile number (202) 646–3347 or e-mail address: FEMAInformation-Collections@dhs.gov. Dated: November 2, 2006. John A. Sharetts-Sullivan, Chief, Records Management and Privacy Information Resources Management Branch, Information Technology Services Division, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E6–18834 Filed 11–7–06; 8:45 am] BILLING CODE 9110–41–P FOR FURTHER INFORMATION CONTACT: Contact Cecelia Rosenberg, Chief, Grants PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 E:\FR\FM\08NON1.SGM 08NON1

Agencies

[Federal Register Volume 71, Number 216 (Wednesday, November 8, 2006)]
[Notices]
[Pages 65537-65538]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-18796]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Toxicology Program (NTP); Center for the Evaluation of 
Risks to Human Reproduction (CERHR); Availability of the Draft NTP 
Briefs on Genistein and Soy Formula; Request for Public Comments

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

ACTION: Request for comments.

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

SUMMARY: CERHR invites the submission of public comments on the draft 
NTP Briefs on Genistein and Soy Formula. The draft NTP Briefs are 
available from the CERHR Web site (https://cerhr.niehs.nih.gov see 
``CERHR Reports & Monographs'') or in hardcopy from CERHR (see 
ADDRESSES below). Public comments will be considered during peer review 
and finalization of the NTP Briefs.

DATES: Written comments on the draft NTP Briefs on Genistein and Soy 
Formula should be received by December 8, 2006.

ADDRESSES: Public comments and any other correspondence should be 
addressed to Dr. Michael D. Shelby, CERHR Director, NIEHS, P.O. 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

    Genistein (CAS RN: 446-72-0) is a phytoestrogen found in some 
legumes, especially soybeans. Genistein is found in many food products, 
especially soy-based foods such as tofu, soy milk, and soy infant 
formula, and in some over-the-counter dietary supplements. Soy formula 
is fed to infants as a supplement or replacement for human milk or cow 
milk. On March 15-17, 2006, CERHR convened an expert panel to conduct 
evaluations of the potential reproductive and developmental toxicities 
of genistein and soy formula. The expert panel reports were released 
for public comment on May 5, 2006 (Federal Register Vol. 71, No. 94, 
pp. 28368, May 16, 2006). Following this public comment period, CERHR 
staff prepared draft NTP Briefs on Genistein and Soy Formula that 
provides in plain language:
     Background information on the substance(s).
     Findings of the expert panel.
     Discussion of any relevant data available after the expert 
panel meeting.
     NTP's conclusions on the potential for the substance to 
cause adverse reproductive and/or developmental effects in exposed 
humans.
    Upon finalization, the NTP Briefs on Genistein and Soy Formula will 
be included in the CERHR Monographs on Genistein and Soy Formula. The 
draft NTP Briefs on Genistein and Soy Formula and related background 
materials, including the genistein expert panel report, soy formula 
expert panel report, and previously received public comments, are 
available on the CERHR Web site (https://cerhr.niehs.nih.gov see 
Genistein and Soy Formula under ``CERHR Reports & Monographs'').

Request for Comments

    The NTP invites written public comments on the draft NTP Briefs on 
Genistein and Soy Formula. Any comments received will be posted on the 
CERHR Web site and considered during the peer reviews and finalization 
of the NTP Brief on Genistein and the NTP Brief on Soy Formula. 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 submit 
comments to Dr. Shelby (see ADDRESSES above) for receipt by December 8, 
2006.

Background Information on CERHR

    The NTP established CERHR in June 1998 [Federal Register, December 
14, 1998 (Volume 63, Number 239, page 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.
    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. Michael Shelby, CERHR Director (see ADDRESSES). CERHR 
selects chemicals

[[Page 65538]]

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. Expert panels conduct 
scientific evaluations of agents selected by CERHR in public forums. 
Following these evaluations, CERHR prepares the NTP-CERHR monograph on 
the agent evaluated. The monograph is transmitted to appropriate 
Federal and State agencies and made available to the public.

    Dated: October 31, 2006.
David A. Schwartz,
Director, National Institute of Environmental Health Sciences and 
National Toxicology Program.
[FR Doc. E6-18796 Filed 11-7-06; 8:45 am]
BILLING CODE 4140-01-P
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