Nominations to the Report on Carcinogens; Request for Information, 57868-57869 [2013-22890]

Download as PDF 57868 Federal Register / Vol. 78, No. 183 / Friday, September 20, 2013 / Notices Special Emphasis Panel, PAR–11–043 NIDDK Program Project: Responses to Bariatric Surgery. Date: December 11, 2013. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Ann A. Jerkins, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 759, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, 301–594–2242, jerkinsa@niddk.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: September 13, 2013. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–22891 Filed 9–19–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: Oral Treatment of Hemophilia AGENCY: National Institutes of Health, HHS. ACTION: Notice. This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an Exclusive Patent License to ProGenetics, LLC, a company having its headquarters in Blacksburg, Virginia, to practice the inventions embodied in U.S. Patent No. 7,220,718, issued 27 February 2007 (HHS Ref. No. E–281– 2001/0–US–03]), European Patent Application No. 02756904.5 (HHS Ref. No. E281–2001/0–EP–04), filed August 2, 2002, and U.S. Patent No. 7,867,974, issued 11 January 2011 (HHS Ref. No. E–281–2001/0–US–05), entitled respectively, ‘‘Oral Treatment of Hemophilia’’ and ‘‘Induction of Tolerance by Oral administration of Factor VIII and Treatment of Hemophilia’’. The patent rights in these inventions have been assigned to or exclusively licensed to the Government of the United States of America. The prospective Exclusive Patent License territory may be ‘‘worldwide’’, and the mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:24 Sep 19, 2013 Jkt 229001 field of use may be limited to: ‘‘Treatment of Hemophilia A and B and immunotolerization using oral delivery methods’’. DATES: Only written comments and/or applications for a license received by the NIH Office of Technology Transfer on or before October 21, 2013 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, comments and other materials relating to the contemplated Exclusive Patent License should be directed to: Vince Contreras, Ph.D., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435–4711; Facsimile: (301) 402– 0220; Email: vince.contreras@nih.gov. A signed confidentiality nondisclosure agreement will be required to receive copies of any patent applications that have not been published or issued by the United States Patent and Trademark Office or the World Intellectual Property Organization. SUPPLEMENTARY INFORMATION: This technology relates to therapeutic methods of arresting bleeding episodes in a subject having hemophilia A or B, by orally administering an effective amount of the appropriate clotting factor, sufficient to induce oral tolerance and supply exogenous clotting factor to the subject. Roughly 20,000 people in the U.S. have hemophilia with over 200 new patients born every year. Currently there is no cure for hemophilia and treatment generally involves intravenous infusion of missing clotting factors derived from concentrated preparations of donated blood plasma which can be expensive and result in generating inhibitory antibodies. The current technology provides a rapid, inexpensive oral treatment for individuals suffering from hemophilia A or B by utilizing a high quantity source of clotting factors produced in milk. The prospective worldwide Exclusive Patent License will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license may be granted unless, within thirty (30) 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 part 404. Complete applications for a license in the prospective field of use that are filed in response to this notice will be treated as objections to the grant of the contemplated Exclusive Patent License. Comments and objections submitted in PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 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. Dated: September 16, 2013. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2013–22875 Filed 9–19–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Nominations to the Report on Carcinogens; Request for Information National Toxicology Program (NTP) Office of the Report on Carcinogens (ORoC) requests information on 20 substances, mixtures, and exposure circumstances (collectively referred to as ‘‘substances’’) nominated for possible review for future editions of the Report on Carcinogens (RoC). DATES: The deadline for receipt of information is October 18, 2013. ADDRESSES: Information can be submitted electronically on the ORoC nomination page (https:// ntp.niehs.nih.gov/go/rocnom) or to lunn@niehs.nih.gov. FOR FURTHER INFORMATION CONTACT: Dr. Ruth Lunn, Director, ORoC, DNTP, NIEHS, P.O. Box 12233, MD K2–14, Research Triangle Park, NC 27709; telephone (919) 316–4637; FAX: (301) 480–2970; lunn@niehs.nih.gov. Courier address: NIEHS, Room 2138, 530 Davis Drive, Morrisville, NC 27560. SUPPLEMENTARY INFORMATION: Request for Information: The NTP requests information on the 20 substances listed below that have been nominated for possible review for future editions of the RoC (for more information, see https:// ntp.niehs.nih.gov/go/rocnom). Specifically, the NTP requests information on each substance for the following topics: (1) data on current production, use patterns, and human exposure; (2) information about published, ongoing, or planned studies related to evaluating carcinogenicity; (3) scientific issues important for assessing carcinogenicity of the substance; and (4) names of scientists with expertise or knowledge about the substance. Please include any available bibliographic citations for the information. The NTP will use this information for identifying SUMMARY: E:\FR\FM\20SEN1.SGM 20SEN1 Federal Register / Vol. 78, No. 183 / Friday, September 20, 2013 / Notices nominated substances to propose for formal evaluation for the RoC. mstockstill on DSK4VPTVN1PROD with NOTICES 20 Substances Nominated to the RoC* • Aloe vera whole leaf extract (Aloe barbadensis Miller) • 2-Butoxyethanol (CAS No. 111–76– 2) • Chlorothalonil (2,4,5,6-tetrachloroisophthalonitrile) (CAS No. 1897–45–6) • Coconut diethanolamide (CAS No. 68603–42–9) • Cobalt (metal) (CAS No. 7440–48–4) • Decalin (CAS No. 91–17–8) • Ginkgo biloba extract • Goldenseal root powder (Hydrastis canadensis) • Kava kava extract • 2-Methylimidazole (CAS No. 693– 98–1) • 4-Methylimidazole (CAS No. 822– 36–6) • Methyl isobutyl ketone (CAS No. 108–10–1) • Nickel nanoparticles • Nitro polycyclic aromatic hydrocarbons (PAH) as a class • Perfluorooctanoic acids (PFOA) (CAS No. 335–67–1) • Polyacrylates • Pulegone (CAS No. 89–82–7) • Tetralin (CAS No. 119–64–2) • Tris-(1,3-dichloro-2-propyl) phosphate (chlorinated Tris, TDCPP) (CAS No. 13674–87–8) • Wood smoke * Nominations to the RoC may seek to list a new substance in the report, reclassify the listing status of a substance already listed, or remove a listed substance. Information can be submitted electronically on the ORoC nomination page (https://ntp.niehs.nih.gov/go/ rocnom) or by email to lunn@ niehs.nih.gov. If submitting by email, please include the submitter’s name, affiliation, mailing address, phone, email, and sponsoring organization (if any) with the document. Written information received in response to this notice will be posted on the NTP Web site, and the submitter will be identified by name, affiliation, and/or sponsoring organization. Responses to this request for information are voluntary. This request for information is for planning purposes only and is not a solicitation for applications or an obligation on the part of the U.S. Government to provide support for any ideas identified in response to it. Please note that the U.S. Government will not pay for the preparation of any information submitted or for its use. No proprietary, classified, confidential, or sensitive information should be included in your response. VerDate Mar<15>2010 17:24 Sep 19, 2013 Jkt 229001 Background Information on the RoC: The RoC is a congressionally mandated, science-based, public health report that identifies agents, substances, mixtures, or exposures (collectively called ‘‘substances’’) in our environment that pose a cancer hazard for people in the United States. The NTP prepares the RoC on behalf of the Secretary of Health and Human Services. The NTP follows an established, four-part process for preparation of the RoC (https:// ntp.niehs.nih.gov/go/rocprocess). Published biennially, each edition of the RoC is cumulative and consists of substances newly reviewed in addition to those listed in previous editions. The 12th RoC, the latest edition, was published on June 10, 2011 (available at https://ntp.niehs.nih.gov/go/roc12). The 13th RoC is under development. Dated: September 16, 2013. John R. Bucher, Associate Director, National Toxicology Program. [FR Doc. 2013–22890 Filed 9–19–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [OMB Control Number 1615–NEW; Form I– 407] Agency Information Collection Activities: Record of Abandonment of Lawful Permanent Resident Status; Existing Collection in Use Without an OMB Control Number ACTION: 60-day notice. The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) invites the general public and other Federal agencies to comment on this proposed collection in use without an OMB Control Number. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e. the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments. DATES: Comments are encouraged and will be accepted for 60 days until November 19, 2013. ADDRESSES: All submissions received must include the OMB Control Number SUMMARY: PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 57869 1615–NEW in the subject box, the agency name and Docket ID USCIS– 2013–0005. To avoid duplicate submissions, please use only one of the following methods to submit comments: (1) Online. Submit comments via the Federal eRulemaking Portal Web site at www.regulations.gov under e-Docket ID number USCIS–2013–0005; (2) Email. Submit comments to USCISFRComment@uscis.dhs.gov; (3) Mail. Submit written comments to DHS, USCIS, Office of Policy and Strategy, Chief, Regulatory Coordination Division, 20 Massachusetts Avenue NW., Washington, DC 20529–2140. SUPPLEMENTARY INFORMATION: Comments Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at https://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of https://www.regulations.gov. Note: The address listed in this notice should only be used to submit comments concerning this information collection. Please do not submit requests for individual case status inquiries to this address. If you are seeking information about the status of your individual case, please check ‘‘My Case Status’’ online at: https://egov.uscis.gov/cris/ Dashboard.do, or call the USCIS National Customer Service Center at 1–800–375–5283. 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 E:\FR\FM\20SEN1.SGM 20SEN1

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[Federal Register Volume 78, Number 183 (Friday, September 20, 2013)]
[Notices]
[Pages 57868-57869]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22890]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Nominations to the Report on Carcinogens; Request for Information

SUMMARY: National Toxicology Program (NTP) Office of the Report on 
Carcinogens (ORoC) requests information on 20 substances, mixtures, and 
exposure circumstances (collectively referred to as ``substances'') 
nominated for possible review for future editions of the Report on 
Carcinogens (RoC).

DATES: The deadline for receipt of information is October 18, 2013.

ADDRESSES: Information can be submitted electronically on the ORoC 
nomination page (https://ntp.niehs.nih.gov/go/rocnom) or to 
lunn@niehs.nih.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Ruth Lunn, Director, ORoC, DNTP, 
NIEHS, P.O. Box 12233, MD K2-14, Research Triangle Park, NC 27709; 
telephone (919) 316-4637; FAX: (301) 480-2970; lunn@niehs.nih.gov. 
Courier address: NIEHS, Room 2138, 530 Davis Drive, Morrisville, NC 
27560.

SUPPLEMENTARY INFORMATION:
    Request for Information: The NTP requests information on the 20 
substances listed below that have been nominated for possible review 
for future editions of the RoC (for more information, see https://ntp.niehs.nih.gov/go/rocnom). Specifically, the NTP requests 
information on each substance for the following topics: (1) data on 
current production, use patterns, and human exposure; (2) information 
about published, ongoing, or planned studies related to evaluating 
carcinogenicity; (3) scientific issues important for assessing 
carcinogenicity of the substance; and (4) names of scientists with 
expertise or knowledge about the substance. Please include any 
available bibliographic citations for the information. The NTP will use 
this information for identifying

[[Page 57869]]

nominated substances to propose for formal evaluation for the RoC.

20 Substances Nominated to the RoC*

     Aloe vera whole leaf extract (Aloe barbadensis Miller)
     2-Butoxyethanol (CAS No. 111-76-2)
     Chlorothalonil (2,4,5,6-tetrachloro-isophthalonitrile) 
(CAS No. 1897-45-6)
     Coconut diethanolamide (CAS No. 68603-42-9)
     Cobalt (metal) (CAS No. 7440-48-4)
     Decalin (CAS No. 91-17-8)
     Ginkgo biloba extract
     Goldenseal root powder (Hydrastis canadensis)
     Kava kava extract
     2-Methylimidazole (CAS No. 693-98-1)
     4-Methylimidazole (CAS No. 822-36-6)
     Methyl isobutyl ketone (CAS No. 108-10-1)
     Nickel nanoparticles
     Nitro polycyclic aromatic hydrocarbons (PAH) as a class
     Perfluorooctanoic acids (PFOA) (CAS No. 335-67-1)
     Polyacrylates
     Pulegone (CAS No. 89-82-7)
     Tetralin (CAS No. 119-64-2)
     Tris-(1,3-dichloro-2-propyl) phosphate (chlorinated Tris, 
TDCPP) (CAS No. 13674-87-8)
     Wood smoke
    * Nominations to the RoC may seek to list a new substance in the 
report, reclassify the listing status of a substance already listed, or 
remove a listed substance.
    Information can be submitted electronically on the ORoC nomination 
page (https://ntp.niehs.nih.gov/go/rocnom) or by email to 
lunn@niehs.nih.gov. If submitting by email, please include the 
submitter's name, affiliation, mailing address, phone, email, and 
sponsoring organization (if any) with the document. Written information 
received in response to this notice will be posted on the NTP Web site, 
and the submitter will be identified by name, affiliation, and/or 
sponsoring organization.
    Responses to this request for information are voluntary. This 
request for information is for planning purposes only and is not a 
solicitation for applications or an obligation on the part of the U.S. 
Government to provide support for any ideas identified in response to 
it. Please note that the U.S. Government will not pay for the 
preparation of any information submitted or for its use. No 
proprietary, classified, confidential, or sensitive information should 
be included in your response.
    Background Information on the RoC: The RoC is a congressionally 
mandated, science-based, public health report that identifies agents, 
substances, mixtures, or exposures (collectively called ``substances'') 
in our environment that pose a cancer hazard for people in the United 
States. The NTP prepares the RoC on behalf of the Secretary of Health 
and Human Services. The NTP follows an established, four-part process 
for preparation of the RoC (https://ntp.niehs.nih.gov/go/rocprocess). 
Published biennially, each edition of the RoC is cumulative and 
consists of substances newly reviewed in addition to those listed in 
previous editions. The 12th RoC, the latest edition, was published on 
June 10, 2011 (available at https://ntp.niehs.nih.gov/go/roc12). The 
13th RoC is under development.

    Dated: September 16, 2013.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2013-22890 Filed 9-19-13; 8:45 am]
BILLING CODE 4140-01-P
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