Notices. Notice
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BILLING CODE 4140-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: The Development of C-6 and C-8 Modified cAMP-Derivatives for the Treatment of Cancer AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S.
Patent Application No. 07/198,489 filed May 23, 1988, entitled “Use of 8-Cl-cAMP as Anticancer Drug” [HHS Reference No. E-132-1988/0-US-01], PCT Application filed May 19, 1989 [HHS Reference No. E-132-1988/0-PCT-02], U.S. Patent Application No. 07/896,452 filed June 4, 1992, entitled “Use of 8-Cl-cAMP as Anticancer Drug” [HHS Reference No. E-132-1988/0-US-04], U.S. Patent 5,792,752 filed October 27, 1994 and issued August 11, 1998, entitled “Use of 8-Cl-cAMP as Anticancer Drug” [HHS Reference No.
E-132-1988/0-US-05], U.S. Patent 5,902,794 filed September 22, 1997 and issued May 11, 1999, entitled “Use of 8-Cl-cAMP as Anticancer Drug” [HHS Reference No. E-132-1988/0-US-06] and Canadian Patent Application No. 133572 filed May 19, 1989, entitled “Use of 8-Cl-cAMP as Anticancer Drug” [HHS Reference No. E-132-1988/0-CA-03], to Kuhnil Pharm. Co. Ltd., which has offices in Seoul, Republic of Korea. The patent rights in these inventions have been assigned and/or exclusively licensed to the Government of the United States of America.
The prospective exclusive license territory may be worldwide, and the field of use may be limited to the treatment of cancer with 8-Cl-cAMP. This notice replaces the Prospective Grant notice published in the **Federal Register** on Tuesday, May 9, 2006 (71 FR 26979). DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before July 17, 2006 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to:
David A. Lambertson, PhD., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone:
(301)435-4632; Facsimile:
(301)402-0220; E-mail: *lambertsond@od.nih.gov* . SUPPLEMENTARY INFORMATION: Cyclic AMP
(cAMP)is a natural biological product with a number of regulatory functions at physiological levels. At higher than physiological concentrations, cAMP has the ability to inhibit the aberrant growth of malignant cells. Because cAMP is a natural product involved in normal biological function, this inhibition occurs without causing significant toxicity. However, this is not a feasible method for treating cancer *in vivo* because of potential interference with the physiological role of cAMP. C-6 and C-8 modified cAMP derivatives also inhibit the growth of malignant cells. One such derivative, 8-Cl-cAMP, has effectively decreased tumor growth *in vitro* and *in vivo* . Specifically, 8-Cl-cAMP showed the ability to decrease tumor growth in leukemia mouse models and xenografts of human tumors. Because of the low toxicity associated with 8-Cl-cAMP, this compound has promise as an anti-cancer agent, particularly with regard to hematological malignancies. The prospective 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 exclusive license may be granted unless within sixty
(60)days from the date of this published notice, the 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. Applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted 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. Dated: May 10, 2006. David R. Sadowski, Acting Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6-7435 Filed 5-15-06; 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); Announcement of the Availability of the Genistein and Soy Formula Expert Panel Reports; Request for Public Comment AGENCY: National Institute for Environmental Health Sciences (NIEHS); National Institutes of Health (NIH), HHS. ACTION: Request for comments. SUMMARY: CERHR announces the availability of the genistein and soy formula expert panel reports on the CERHR Web site ( *http://cerhr.niehs.nih.gov* ) or in print from CERHR (see ADDRESSES below). These expert panel reports are evaluations of the reproductive and developmental toxicity of genistein and soy formula conducted by a 14-member expert panel composed of scientists from the federal government, universities, and private organizations. CERHR invites the submission of public comments on these expert panel reports. DATES: The final genistein and soy formula expert panel reports are presently available and written public comments on these reports should be received by July 5, 2006. ADDRESSES: Public comments 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 (mail),
(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 is a phytoestrogen found in some legumes, especially soybeans. Phytoestrogens are non-steriodal, estrogenic compounds that occur naturally in some plants. In plants, nearly all genistein is linked to a sugar molecule and this genistein-sugar complex is called genistin. Genistein and genistin are 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. CERHR selected genistein and soy formula for expert panel evaluation because of
(1)the availability of reproductive and developmental toxicity studies in laboratory animals and humans,
(2)the availability of information on exposures in infants and women of reproductive age, and
(3)public concern for effects on infant or child development. The CERHR convened an expert panel on March 15-17, 2006, to review and revise the draft expert panel reports and reach conclusions regarding whether exposure to genistein or soy formula is a hazard to human development or reproduction. The expert panel also identified data gaps and research needs. Prior to the meeting, CERHR solicited public comment on the draft expert panel reports ( **Federal Register** Vol. 70, No. 241 pp. 74834-74835). Following receipt of public comments on the genistein and soy formula expert panel reports, CERHR staff will prepare NTP-CERHR monographs on each of these substances. NTP-CERHR monographs are divided into four major sections:
(1)The NTP Brief which 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)any public comments received on that report. The NTP Brief is based on the expert panel report, public comments on that report, and any new information that became available after the expert panel meeting. Request for Comments CERHR invites written public comments on the genistein expert panel report and on the soy formula expert panel report. Written comments should be sent to Dr. Michael Shelby at the address provided 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). All comments received will be posted on the CERHR Web site and will be included in the NTP-CERHR monograph on the chemical. The NTP will consider all public comments during preparation of the NTP Brief. Background Information on CERHR The NTP established CERHR in June 1998 [ **Federal Register,** 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 ( *http://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. The formal evaluation process was published in the **Federal Register** notice July 16, 2001 (Vol. 66, No. 136, pp. 37047-37048) and is available on the CERHR Web site under “About CERHR” or in printed copy from CERHR. Dated: May 8, 2006. Samuel H. Wilson, Deputy Director, National Institute of Environmental Health Sciences and the National Toxicology Program. [FR Doc. E6-7434 Filed 5-15-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HOMELAND SECURITY Citizenship and Immigration Services Agency Information Collection Activities; Extension of a Currently Approved Information Collection; Comment Request ACTION: 30-Day Notice of Information Collection Under Review: Request for Premium Processing Service; Form I-907. OMB Control No. 1615-0048. The Department of Homeland Security, U.S. Citizenship and Immigration Services (USCIS) has submitted the following information collection request to the Office of Management and Budget
(OMB)for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection was previously published in the **Federal Register** on March 9, 2006, at 71 FR 12212, allowing for a 60-day public comment period. USCIS did not receive any comments for this information collection. The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until June 15, 2006. This process is conducted in accordance with 5 CFR 1320.10. Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Department of Homeland Security (DHS), USCIS, Director, Regulatory Management Division, Clearance Office, 111 Massachusetts Avenue, 3rd floor, Washington, DC 20529. Comments may also be submitted to DHS via facsimile to 202-272-8352 or via e-mail at *rfs.regs@dhs.gov.* When submitting comments by e-mail please make sure to add OMB Control Number 1615-0048 in the subject box. Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1)Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2)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;
(3)Enhance the quality, utility, and clarity of the information to be collected; and
(4)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. Overview of This Information Collection
(1)*Type of Information Collection:* Extension of a currently approved information collection.
(2)*Title of the Form/Collection:* Application for Premium Processing Service.
(3)*Agency form number, if any, and the applicable component of the Department of Homeland Security sponsoring the collection:* Form I-907. U.S. Citizenship and Immigration Services.
(4)*Affected public who will be asked or required to respond, as well as a brief abstract: Business or other for profit.* The data collected on this form will be used by USCIS to process the petitioner's/applicant's request for premium processing. The form serves the purpose of standardizing requests for premium processing, and will ensure that basic information required to assess eligibility is provided by petitioners/applicants.
(5)*An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: Filed by mail:* 77,000 responses at 30 minutes (.50) per response; *Filed electronically:* 3,000 responses at 20 minutes (.333) per response.
(6)*An estimate of the total public burden (in hours) associated with the collection:* 39,500 burden hours. If you have additional comments, suggestions, or need a copy of the proposed information collection instrument with instructions, or additional information, please visit the USCIS Web site at: *http://uscis.gov/graphics/formsfee/forms/pra/index.htm.* If additional information is required contact: USCIS, Regulatory Management Division, 111 Massachusetts Avenue, 3rd Floor, Washington, DC 20529,
(202)272-8377. Dated: May 10, 2006. Richard A. Sloan, Director, Regulatory Management Division, U.S. Citizenship and Immigration Services. [FR Doc. E6-7369 Filed 5-15-06; 8:45 am] BILLING CODE 4410-10-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Draft National Bald Eagle Management Guidelines; Extension of Public Comment Period AGENCY: Fish and Wildlife Service, Interior ACTION: Notice of availability; extension of comment period. SUMMARY: We, the U.S. Fish and Wildlife Service (the Service), are extending the comment for the draft National Bald Eagle Management Guidelines. We are also extending the comment period on the proposed rule re-opening the public comment period on the proposal to remove the bald eagle from the List of Threatened and Endangered Wildlife under the Endangered Species Act, and on the proposed rule to establish a regulatory definition of “disturb” under the Bald and Golden Eagle Protection Act, via two additional notices published separately in the Proposed Rules section of today's issue of the **Federal Register** . Comments previously submitted need not be resubmitted as they have been incorporated into the public record and will be fully considered in the final guidelines. DATES: The public comment period is extended to June 19, 2006. Any comments received after the closing date may not be considered in the final guidelines. ADDRESSES: Copies of the Draft National Bald Eagle Management Guidelines can be obtained by writing to U.S. Fish and Wildlife Service, Division of Migratory Bird Management, 4401 North Fairfax Drive, Mail Stop MBSP-4107, Arlington, VA 22203. The draft guidelines may also be obtained via the Internet at: *http://www.fws.gov/migratorybirds/baldeagle.html.* Written comments can be sent to the mailing address above, or e-mailed to *BaldEagle_ManagementGuidelines@fws.gov.* All comments must include the name and full mailing address of the person submitting the comments. All comments received, including names and addresses, will become part of the public record. You may inspect comments by appointment during normal business hours at the address above. FOR FURTHER INFORMATION CONTACT: Eliza Savage, Division of Migratory Bird Management, (see ADDRESSES section); or via e-mail at: *Eliza_Savage@fws.gov;* telephone:
(703)358-2329; or facsimile:
(703)358-2217. SUPPLEMENTARY INFORMATION: Background On February 16, 2006, in anticipation of possible removal (delisting) of the bald eagle in the 48 contiguous States from the List of Endangered and Threatened Wildlife under the Endangered Species Act
(ESA)(16 U.S.C. 1531 *et seq.* ), the U.S. Fish and Wildlife Service (the Service) published a Notice of Availability of draft National Bald Eagle Management Guidelines (71 FR 8309). The Service concurrently proposed two other related actions:
(1)a proposed regulatory definition of “disturb” under the Bald and Golden Eagle Protection Act (BGEPA) (71 FR 8265, February 16, 2006); and
(2)a re-opening of the comment period on our proposal to remove the bald eagle from the list of threatened and endangered species under the ESA (71 FR 8238, February 16, 2006). Due to the complexity of these related actions, we are extending the comment period for each action for an additional 30 days. Dated: May 10, 2006. Marshall P. Jones, Jr., Acting Director, Fish and Wildlife Service. [FR Doc. 06-4605 Filed 5-12-06; 1:17 pm]
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- 5 CFR 1320.10
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