National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Availability of the Draft NTP Brief on Di-(2-ethylhexyl) phthalate; Request for Public Comments, 32365-32366 [E6-8677]

Download as PDF cprice-sewell on PROD1PC66 with NOTICES Federal Register / Vol. 71, No. 107 / Monday, June 5, 2006 / Notices Monoclonal Antibodies’’. Inventor(s): Dimiter S. Dimitrov (NCI) and Mei-Yun Zhang (SAIC). 2. U.S. Patent Application, S/N 60/ 506,946 (E–316–2003/0–US–01), PCT/ US2004/31878 (E–316–2003/0–PCT–02) entered the national stage filing on March 29, 2006 in USA (E–316–2003/0– US–03), in Canada (E–316–2003/0–CA– 04), in Europe (E–316–2003/0–EP–05), and in Australia (E–316–2003/0–AU– 06), entitled: ‘‘Immunoglobulins With Potent and Broad Antiviral Activity’’. Inventor(s): Dimiter S. Dimitrov (NCI) and Mei-Yun Zhang (SAIC) to Virosys Pharmaceuticals Inc. (hereafter Virosys) having a place of business in Los Altos Hills, California, and Profectus Biosciences, Inc. (hereafter Profectus) having a place of business in Baltimore, Maryland. The patent rights in these inventions have been assigned to the United States of America. DATES: Only written comments and/or application for a license, which are received by the NIH Office of Technology Transfer on or before August 4, 2006 will be considered. ADDRESSES: Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Sally Hu, Ph.D., M.B.A., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; E-mail: hus@od.nih.gov; Telephone: (301) 435–5606; Facsimile: (301) 402– 0220. SUPPLEMENTARY INFORMATION: The first invention (E–144–2002/1–PCT–02) describes two single chain fragment variable (scFv) clones, designated M6 and M9 that were selected from phagedisplayed X5 scFv mutants library by panning the library against gp12089.6/IIIB– CD4 complex using the alternating antigen panning strategy (AAP). M6 and M9 are stable and have significant improved binding activities to gp120IIIB. Both scFvs inhibit more efficiently membrane fusion of HIV mediated by envelop glycoproteins of primary HIV isolates with a broader spectrum compared to other antibodies such as X5, indicating that the scFv form may be a more proper form compared to the Fab form for HIV–1 neutralizing antibodies to inhibit virus infection and transmission. Furthermore, scFv is a single molecule almost half the size of Fab, which makes it more suitable for constructing bivalent and multivalent antibodies and antibody fusion proteins. M6 and M9 are cross-reactive with HIV– 1 isolates so that these antibodies could be directly used for therapy of HIV–1 infected individuals. In addition, these VerDate Aug<31>2005 15:33 Jun 02, 2006 Jkt 208001 antibodies can also be used for screening of peptide phage display libraries, libraries of Envs, and in general as tools for development of HIV vaccines and therapeutics. The second invention (E–316–2003) describes methods of inhibiting viral infection, such as HIV–1, by administering a fusion protein comprising a small size, single chain Fv (scFv) antibody-binding domain joined to an Fc region by a long flexible linker. In particular, scFv M6 or M9, and their complex with two-domain soluble CD4 are joined to Fc by a long flexible linker to provide a new agent for the inhibition of HIV infection or immunotherapy of HIV-infected individuals. The Fc region provides stability, long half-life, and biological effector functions. The scFvFc fragment provides antigen recognition and neutralizing activity. The small size of the scFv-Fc fusion molecule provides easy access to conserved viral epitopes exposed before or during viral entry. In addition, these fusion molecules exhibit neutralization activity that is higher than that of whole IgGs, and comparable to or better than that of scFv. Thus, this invention may offer a novel approach to treat and prevent HIV–1 infection and/or AIDS, is related to invention E–144–2002/1, and may strengthen the company’s portfolio of technologies being developed. The prospective co-exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective co-exclusive license may be granted unless, within 60 days from the date of this published Notice, NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7. The field of use may be limited to the development of human monoclonal antibodies for use as a therapeutic or preventative in HIV infection either alone or in combination with other compounds. Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 32365 Dated: May 26, 2006. David R. Sadowski, Acting Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6–8680 Filed 6–2–06; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Availability of the Draft NTP Brief on Di-(2-ethylhexyl) phthalate; Request for Public Comments National Institute for 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 Brief for di-(2ethylhexyl)phthalate (DEHP). The draft NTP Brief is 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 the peer review and finalization of the NTP Brief. DATES: Written comments on the draft NTP Brief for DEHP should be received by July 5, 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 DEHP (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. On October 10–12, 2005, CERHR convened an expert panel to conduct an updated evaluation of the potential reproductive and developmental toxicities of DEHP. E:\FR\FM\05JNN1.SGM 05JNN1 32366 Federal Register / Vol. 71, No. 107 / Monday, June 5, 2006 / Notices The expert panel report was released for public comment on November 21, 2005 (Federal Register Vol. 70, No. 220, pp. 69567, November 16, 2005). Following this public comment period, CERHR staff prepared the draft NTP Brief for DEHP 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 Brief for DEHP will be included in the CERHR Monograph for DEHP. The draft NTP Brief for DEHP and related background materials, including the DEHP expert panel report and previously received public comments, are available on the CERHR Web site (https:// cerhr.niehs.nih.gov see Di–(2– ethylhexyl)phthalate under ‘‘CERHR Reports & Monographs’’). cprice-sewell on PROD1PC66 with NOTICES Request for Comments The NTP invites written public comments on the draft NTP Brief for DEHP. Any comments received will be posted on the CERHR Web site and considered during the peer review and finalization of the NTP Brief for DEHP. 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 July 5, 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 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 VerDate Aug<31>2005 15:33 Jun 02, 2006 Jkt 208001 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: May 25, 2006. Samuel H. Wilson, Deputy Director, National Institute of Environmental Health Sciences and National Toxicology Program. [FR Doc. E6–8677 Filed 6–2–06; 8:45 am] BILLING CODE 4140–01–P U.S. Coast Guard Headquarters, 2100 Second Street, SW., Washington, DC 20593–0001. FOR FURTHER INFORMATION CONTACT: For questions on this notice, contact Mr. Gould, Assistant to the Executive Director, telephone 202–372–1409, fax 202–372–1926, or e-mail mgould@comdt.uscg.mil. Notice of these meetings is given under the Federal Advisory Committee Act, 5 U.S.C. App. 2 (Pub. L. 92–463, 86 Stat. 770, as amended). SUPPLEMENTARY INFORMATION: Tentative Agendas Tuesday, June 20, 2006 DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG–2006–24935] Merchant Marine Personnel Advisory Committee; Notice of Open Teleconference Meetings Coast Guard, DHS. Notice of meetings. AGENCY: ACTION: SUMMARY: This notice announces teleconferences of the Merchant Marine Personnel Advisory Committee (MERPAC). The Federal Advisory Committee Act (Pub. L. 92–463, 86 Stat. 770) requires that public notice of these meetings be announced in the Federal Register. The purpose of these teleconferences is for MERPAC to discuss and prepare comments to the docket on the joint Transportation Security Administration’s (TSA) and Coast Guard’s Transportation Worker’s Identification Credential (TWIC) proposed rule and on the Coast Guard’s Merchant Mariner Credential (MMC) proposed rule. MERPAC provides advice and makes recommendations to the Coast Guard on matters related to the training, qualification, licensing, certification, and fitness of seamen serving in the U.S. merchant marine. DATES: The teleconference calls will take place on Tuesday, June 20th, 2006, from 12 p.m. until 3 p.m., and on Thursday, June 29th, 2006, from 12 p.m. until 3 p.m. These meetings may adjourn early if all business is finished. ADDRESSES: Members of the public may participate by dialing 1–202–366–3920, pass code 6934 on June 20th, and by dialing 1–202–366–3920, pass code 7124 on June 29th. Public participation is welcomed; however, the number of teleconference lines is limited and available on a first-come, first-served basis. Members of the public may also participate by coming to Room 1208, PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 12 p.m.–12:05 p.m.: Welcome and Opening Remarks—MERPAC Chairman Andrew McGovern. 12:05 p.m.–2:30 p.m.: Open discussion and solicitation of comments to the docket of the Transportation Security Administration’s (TSA) Transportation Worker’s Identification Credential (TWIC) proposed rules and of the Coast Guard’s Merchant Mariner Credential (MMC) proposed rules. 2:30 p.m.–3 p.m.: Public comment period. 3 p.m.: Meeting adjourned. Thursday, June 29, 2006 12 p.m.–12:05 p.m.: Welcome and Opening Remarks—MERPAC Chairman Andrew McGovern. 12:05 p.m.–2:30 p.m.: Open discussion and solicitation of comments to the docket of the Transportation Security Administration’s (TSA) Transportation Worker’s Identification Credential (TWIC) proposed rules and of the Coast Guard’s Merchant Mariner Credential (MMC) proposed rules. 2:30 p.m.–2:45 p.m.: Public comment period. 2:45 p.m.–3 p.m.: MERPAC votes on and delivers official recommendations to the Coast Guard. 3 p.m.: Meeting adjourned. Procedural All meetings are open to the public. Please note that the meetings may adjourn early if all business is finished. At the Chair’s discretion, members of the public may make oral presentations during the meetings. If you would like to make an oral presentation at a meeting, please notify Mr. Gould no later than June 13, 2006. Information on Services for Individuals With Disabilities For information on facilities or services for individuals with disabilities E:\FR\FM\05JNN1.SGM 05JNN1

Agencies

[Federal Register Volume 71, Number 107 (Monday, June 5, 2006)]
[Notices]
[Pages 32365-32366]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-8677]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Toxicology Program (NTP); Center for the Evaluation of 
Risks to Human Reproduction (CERHR); Availability of the Draft NTP 
Brief on Di-(2-ethylhexyl) phthalate; Request for Public Comments

AGENCY: National Institute for 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 Brief for di-(2-ethylhexyl)phthalate (DEHP). The draft NTP Brief is 
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 the peer 
review and finalization of the NTP Brief.

DATES: Written comments on the draft NTP Brief for DEHP should be 
received by July 5, 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

    DEHP (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. On October 10-
12, 2005, CERHR convened an expert panel to conduct an updated 
evaluation of the potential reproductive and developmental toxicities 
of DEHP.

[[Page 32366]]

The expert panel report was released for public comment on November 21, 
2005 (Federal Register Vol. 70, No. 220, pp. 69567, November 16, 2005). 
Following this public comment period, CERHR staff prepared the draft 
NTP Brief for DEHP 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 Brief for DEHP will be included in the 
CERHR Monograph for DEHP. The draft NTP Brief for DEHP and related 
background materials, including the DEHP expert panel report and 
previously received public comments, are available on the CERHR Web 
site (https://cerhr.niehs.nih.gov see Di-(2-ethylhexyl)phthalate under 
``CERHR Reports & Monographs'').

Request for Comments

    The NTP invites written public comments on the draft NTP Brief for 
DEHP. Any comments received will be posted on the CERHR Web site and 
considered during the peer review and finalization of the NTP Brief for 
DEHP. 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 July 
5, 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 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: May 25, 2006.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences 
and National Toxicology Program.
[FR Doc. E6-8677 Filed 6-2-06; 8:45 am]
BILLING CODE 4140-01-P

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