Availability of Draft Toxicological Profile, 52535-52536 [2010-21298]

Download as PDF Federal Register / Vol. 75, No. 165 / Thursday, August 26, 2010 / Notices The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) debarring Su Van Ho for a period of 15 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Ho was convicted of three felonies under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Ho was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of July 15, 2010, Mr. Ho failed to respond. Mr. Ho’s failure to respond constitutes a waiver of his right to a hearing concerning this action. DATES: This order is effective August 26, 2010. ADDRESSES: Submit applications for termination of debarment to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Kenny Shade, Division of Compliance Policy (HFC–230), Office of Enforcement, Office of Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240–632–6844. SUPPLEMENTARY INFORMATION: mstockstill on DSKH9S0YB1PROD with NOTICES SUMMARY: I. Background Section 306(b)(1)(C) of the act (21 U.S.C. 335a(b)(1)(C)) permits FDA to debar an individual from importing an article of food or offering such an article for import into the United States if FDA finds, as required by section 306(b)(3)(A) of the act (21 U.S.C. 335a(b)(3)(A)), that the individual has been convicted of a felony for conduct relating to the importation into the United States of any food. On August 4, 2009, the United States District Court for the Central District of California accepted Mr. Ho’s guilty plea and entered judgment against him for the offenses of: Smuggling, Causing an Act to be Done in violation of 18 U.S.C. 545, Concealing a Material Fact by Trick or Device in violation of 18 U.S.C. 1001(a)(1) and Receipt of an Adulterated Food and Delivery Thereof for Pay in violation of 21 U.S.C. 331(c), 333(a)(1), and 342(a)(3). FDA’s finding that debarment is appropriate is based on the three felony convictions referenced herein for conduct relating to the importation into the United States of any food. The factual basis for those convictions is as follows: Between at least January 1, VerDate Mar<15>2010 20:12 Aug 25, 2010 Jkt 220001 2003, through September 16, 2004, Mr. Ho owned and operated VincentSeafood and Trading, a frozen seafood import and distribution business. On or about August 20, 2004, in violation of 18 U.S.C. 545 and 2(b), Mr. Ho knowingly and willfully, with the intent to defraud the United States, did pass and cause to be passed through the customshouse a fraudulent commercial invoice that falsely described 610 cartons of Frozen Silk Worm as ‘‘Frozen Dade’’ fish and 461 cartons of Pineapple Brand Betel Nut as ‘‘Frozen Palmnut.’’ On or about September 16, 2004, in violation of 18 U.S.C. 1001(a)(1), Mr. Ho knowingly and willfully concealed and covered up by trick, scheme, or device a material fact. Specifically, he was ordered by FDA to export or destroy 118 cartons of frozen Featherback fish from import shipment N08–0026008–0 that contained Salmonella bacteria, with verification of such exportation or destruction by FDA. Mr. Ho concealed and covered up the material fact that he had improperly sold 103 cartons of the contaminated Featherback fish from import shipment N08–0026008–0 by a trick, scheme, or device in which he substituted 103 cartons of Featherback fish from other, unrelated import shipments and presented the substitute cartons of fish to FDA for verified exportation or destruction as the contaminated fish from import shipment N08–0026008–0. Between on or about January 17, 2004, and September 16, 2004, in violation of 21 U.S.C. 331(c), 333(a)(1), and 342(a)(3), Mr. Ho received in interstate commerce and delivered in exchange for payment an adulterated food, namely, frozen Featherback fish from import shipment N08–0026008–0 that was contaminated with Salmonella bacteria. As a result of his conviction, on June 10, 2010, FDA sent Mr. Ho a notice by certified mail proposing to debar him for a period of 15 years from importing articles of food or offering such articles for import into the United States. The proposal was based on a finding under section 306(b)(1)(C) of the act that Mr. Ho was convicted of three felonies under Federal law for conduct relating to the importation into the United States of an article of food, and a determination, after consideration of the factors set forth in section 306(c)(3) of the act (21 U.S.C. 335a(c)(3)), that the full periods of debarment shall run consecutively as provided by section 306(c)(2)(A)(iii) of the act (21 U.S.C. 335a(c)(2)(A)(iii)). The proposal also offered Mr. Ho an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 52535 failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Mr. Ho failed to respond within the timeframe prescribed by regulation and has, therefore, waived his opportunity for a hearing and waived any contentions concerning his debarment (21 CFR part 12). II. Findings and Order Therefore, the Director, Office of Enforcement, Office of Regulatory Affairs, under section 306(b)(1)(C) of the act, and under authority delegated to the Director (Staff Manual Guide 1410.35), finds that Mr. Su Van Ho has been convicted of three felonies under Federal law for conduct relating to the importation of an article of food into the United States and that the full periods of debarment shall run consecutively under section 306(c)(2) of the act (21 U.S.C. 335a(c)(2)). As a result of the foregoing finding, Mr. Ho is debarred for a period of 15 years from importing articles of food or offering such articles for import into the United States, effective (see DATES). Pursuant to section 301(cc) of the act (21 U.S.C. 331(cc)), the importing or offering for import into the United States of an article of food by, with the assistance of, or at the direction of Mr. Ho is a prohibited act. Any application by Mr. Ho for termination of debarment under section 306(d)(1) of the act should be identified with Docket No. FDA–2010–N–0213 and sent to the Division of Dockets Management (see ADDRESSES). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by 21 CFR 10.20(j). Publicly available submissions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: August 12, 2010. Howard R. Sklamberg, Director, Office of Enforcement, Office of Regulatory Affairs. [FR Doc. 2010–21258 Filed 8–25–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Toxic Substances and Disease Registry [ATSDR–266] Availability of Draft Toxicological Profile Agency for Toxic Substances and Disease Registry (ATSDR), AGENCY: E:\FR\FM\26AUN1.SGM 26AUN1 52536 Federal Register / Vol. 75, No. 165 / Thursday, August 26, 2010 / Notices other confidential information should be submitted in response to this notice. Department of Health and Human Services (DHHS). ACTION: Notice of availability. This notice announces, for review and comment, the availability of one new draft toxicological profile on unregulated hazardous substances that was prepared for the Department of Defense (DOD). All toxicological profiles issued as ‘‘Drafts for Public Comment’’ represent ATSDR’s best efforts to provide important toxicological information on priority hazardous substances. We are seeking public comments and additional information or reports on studies about the health effects of royal demolition explosive (RDX), chemical name hexahydro-1,3,5-trinitro-1,3,5-triazine, also known as cyclonite, for review and potential inclusion in the profile. ATSDR remains committed to providing a public comment period for these documents as a means to best serve public health and our stakeholders. SUMMARY: To be considered, comments on this draft toxicological profile must be received not later than November 19th, 2010. Comments received after the close of the public comment period will be considered at the discretion of ATSDR, based upon what is deemed to be in the best interest of the general public. DATES: Requests for printed copies of the draft toxicological profile should be sent via e-mail to cdcinfo@cdc.gov, or to Ms. Olga Dawkins, Division of Toxicology and Environmental Medicine, Agency for Toxic Substances and Disease Registry, Mailstop F–62, 1600 Clifton Road, NE., Atlanta, Georgia 30333. Electronic access to this document is also available at the ATSDR Web site: https:// www.atsdr.cdc.gov/toxpro2.html. Written comments and other data submitted in response to this notice and to the draft RDX toxicological profile should bear the docket control number ATSDR–XXX. Send one copy of all comments and three copies of all supporting documents to the attention of Ms. Nickolette Roney, Division of Toxicology and Environmental Medicine, Agency for Toxic Substances and Disease Registry, Mailstop F–62, 1600 Clifton Road, NE., Atlanta, Georgia 30333, by the end of the comment period. Electronic comments may be sent via e-mail to: tppubliccomments@cdc.gov. Please include RDX in the subject line of the e-mail. Because all public comments regarding ATSDR toxicological profiles are available for public inspection, no confidential business information or mstockstill on DSKH9S0YB1PROD with NOTICES ADDRESSES: VerDate Mar<15>2010 20:12 Aug 25, 2010 Jkt 220001 Ms. Olga Dawkins, Division of Toxicology and Environmental Medicine, Agency for Toxic Substances and Disease Registry, Mailstop F–62, 1600 Clifton Road, NE., Atlanta, Georgia 30333, telephone (770) 488–3315. Electronic access to this document is also available at the ATSDR Web site: https:// www.atsdr.cdc.gov/toxpro2.html. Comments and other data submitted in response to this notice and the draft toxicological profile should bear the docket control number ATSDR–266. FOR FURTHER INFORMATION CONTACT: The Superfund Amendments and Reauthorization Act (SARA) of 1986 (Pub. L. 99–499) amended the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund). Section 211 of SARA also amended Title 10 of the U.S. Code, creating the Defense Environmental Restoration Program. Section 2704(a) of Title 10 of the U.S. Code directs the Secretary of Defense to notify the Secretary of DHHS of not less than 25 of the most commonly found unregulated hazardous substances at defense facilities. The Secretary of DHHS is to prepare toxicological profiles of these substances. Each profile is to include an examination, summary, and interpretation of available toxicological information and epidemiologic evaluations. This information is used to ascertain the level of significant human exposure for the substance and the associated health effects. The toxicological profile includes a determination of whether adequate information on the health effects of each substance is available or is in the process of being developed. When adequate information is not available, ATSDR, in cooperation with the National Toxicology Program (NTP), may plan a program of research designed to determine these health effects. Although a number of key studies for this substance were identified and evaluated during the draft profile development process, this Federal Register notice seeks to solicit any additional studies, particularly unpublished data and ongoing studies. These studies will be evaluated for possible addition to the profile now or in the future. The draft toxicological profile will be made available to the public on or about August 20, 2010. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00033 Fmt 4703 Sfmt 9990 Hazardous substance RDX .......................................... CAS No. 121–82–4 Dated: August 20, 2010. Kenneth Rose, Director, Office of Policy, Planning, and Evaluation, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry. [FR Doc. 2010–21298 Filed 8–25–10; 8:45 am] BILLING CODE 4163–70–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Research Resources; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Center for Research Resources Initial Review Group, Comparative Medicine Review Committee CMRC. Date: October 14, 2010. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Washington/Rockville, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: Bonnie B. Dunn, PhD, Scientific Review Officer, National Center for Research Resources, or National Institutes of Health, 6701 Democracy Blvd., 1 Democracy Plaza, Room 1074, MSC 4874, Bethesda, MD 20892–4874. 301–435–0824. dunnbo@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical Technology; 93.389, Research Infrastructure, 93.306, 93.333; 93.702, ARRA Related Construction Awards., National Institutes of Health, HHS) Dated: August 20, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–21312 Filed 8–25–10; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\26AUN1.SGM 26AUN1

Agencies

[Federal Register Volume 75, Number 165 (Thursday, August 26, 2010)]
[Notices]
[Pages 52535-52536]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-21298]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[ATSDR-266]


Availability of Draft Toxicological Profile

AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR),

[[Page 52536]]

Department of Health and Human Services (DHHS).

ACTION: Notice of availability.

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

SUMMARY: This notice announces, for review and comment, the 
availability of one new draft toxicological profile on unregulated 
hazardous substances that was prepared for the Department of Defense 
(DOD). All toxicological profiles issued as ``Drafts for Public 
Comment'' represent ATSDR's best efforts to provide important 
toxicological information on priority hazardous substances. We are 
seeking public comments and additional information or reports on 
studies about the health effects of royal demolition explosive (RDX), 
chemical name hexahydro-1,3,5-trinitro-1,3,5-triazine, also known as 
cyclonite, for review and potential inclusion in the profile. ATSDR 
remains committed to providing a public comment period for these 
documents as a means to best serve public health and our stakeholders.

DATES: To be considered, comments on this draft toxicological profile 
must be received not later than November 19th, 2010. Comments received 
after the close of the public comment period will be considered at the 
discretion of ATSDR, based upon what is deemed to be in the best 
interest of the general public.

ADDRESSES: Requests for printed copies of the draft toxicological 
profile should be sent via e-mail to cdcinfo@cdc.gov, or to Ms. Olga 
Dawkins, Division of Toxicology and Environmental Medicine, Agency for 
Toxic Substances and Disease Registry, Mailstop F-62, 1600 Clifton 
Road, NE., Atlanta, Georgia 30333. Electronic access to this document 
is also available at the ATSDR Web site: https://www.atsdr.cdc.gov/toxpro2.html.
    Written comments and other data submitted in response to this 
notice and to the draft RDX toxicological profile should bear the 
docket control number ATSDR-XXX. Send one copy of all comments and 
three copies of all supporting documents to the attention of Ms. 
Nickolette Roney, Division of Toxicology and Environmental Medicine, 
Agency for Toxic Substances and Disease Registry, Mailstop F-62, 1600 
Clifton Road, NE., Atlanta, Georgia 30333, by the end of the comment 
period. Electronic comments may be sent via e-mail to: 
tppubliccomments@cdc.gov. Please include RDX in the subject line of the 
e-mail. Because all public comments regarding ATSDR toxicological 
profiles are available for public inspection, no confidential business 
information or other confidential information should be submitted in 
response to this notice.

FOR FURTHER INFORMATION CONTACT: Ms. Olga Dawkins, Division of 
Toxicology and Environmental Medicine, Agency for Toxic Substances and 
Disease Registry, Mailstop F-62, 1600 Clifton Road, NE., Atlanta, 
Georgia 30333, telephone (770) 488-3315. Electronic access to this 
document is also available at the ATSDR Web site: https://www.atsdr.cdc.gov/toxpro2.html. Comments and other data submitted in 
response to this notice and the draft toxicological profile should bear 
the docket control number ATSDR-266.

SUPPLEMENTARY INFORMATION: The Superfund Amendments and Reauthorization 
Act (SARA) of 1986 (Pub. L. 99-499) amended the Comprehensive 
Environmental Response, Compensation, and Liability Act (CERCLA or 
Superfund). Section 211 of SARA also amended Title 10 of the U.S. Code, 
creating the Defense Environmental Restoration Program. Section 2704(a) 
of Title 10 of the U.S. Code directs the Secretary of Defense to notify 
the Secretary of DHHS of not less than 25 of the most commonly found 
unregulated hazardous substances at defense facilities. The Secretary 
of DHHS is to prepare toxicological profiles of these substances. Each 
profile is to include an examination, summary, and interpretation of 
available toxicological information and epidemiologic evaluations. This 
information is used to ascertain the level of significant human 
exposure for the substance and the associated health effects. The 
toxicological profile includes a determination of whether adequate 
information on the health effects of each substance is available or is 
in the process of being developed. When adequate information is not 
available, ATSDR, in cooperation with the National Toxicology Program 
(NTP), may plan a program of research designed to determine these 
health effects.
    Although a number of key studies for this substance were identified 
and evaluated during the draft profile development process, this 
Federal Register notice seeks to solicit any additional studies, 
particularly unpublished data and ongoing studies. These studies will 
be evaluated for possible addition to the profile now or in the future.
    The draft toxicological profile will be made available to the 
public on or about August 20, 2010.

------------------------------------------------------------------------
                    Hazardous substance                        CAS No.
------------------------------------------------------------------------
RDX........................................................     121-82-4
------------------------------------------------------------------------


    Dated: August 20, 2010.
Kenneth Rose,
Director, Office of Policy, Planning, and Evaluation, National Center 
for Environmental Health/Agency for Toxic Substances and Disease 
Registry.
[FR Doc. 2010-21298 Filed 8-25-10; 8:45 am]
BILLING CODE 4163-70-P
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