Oversight of Laboratory Developed Tests; Public Meeting; Reopening of the Comment Period, 51280-51281 [2010-20489]

Download as PDF 51280 Federal Register / Vol. 75, No. 160 / Thursday, August 19, 2010 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings emcdonald on DSK2BSOYB1PROD with NOTICES 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 meetings. The meetings 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: Center for Scientific Review Special Emphasis Panel; Member Conflict: Biology of Macromolecular Assemblies. Date: September 1, 2010. Time: 2 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Rolf Menzel, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3196, MSC 7808, Bethesda, MD 20892, 301–435– 0952, menzelro@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Cellular and Molecular Aspects of Neurodevelopment. Date: September 9, 2010. Time: 1 p.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Laurent Taupenot, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4811, MSC 7850, Bethesda, MD 20892, 301–435– 1203, taupenol@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA Panel: Investigations on Primary Immunodeficiency Diseases. Date: September 28, 2010. Time: 11 a.m. to 5 pm. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Scott Jakes, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge VerDate Mar<15>2010 17:05 Aug 18, 2010 Jkt 220001 Drive, Room 4198, MSC 7812, Bethesda, MD 20892, 301–495–1506, jakesse@mail.nih.gov. Name of Committee: Immunology Integrated Review Group; Cellular and Molecular Immunology—A Study Section. Date: September 30–October 1, 2010. Time: 8:30 a.m. to 2 p.m. Agenda: To review and evaluate grant applications. Place: The St. Regis Washington, DC, 923 16th Street, NW., Washington, DC 20006. Contact Person: David B. Winter, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, Immunology IRG, 4th Floor, Rm. 4204, 6701 Rockledge Drive, RKII, Bethesda, MD 20892, 301–435–1152, dwinter@mail.nih.gov. Name of Committee: Immunology Integrated Review Group; Transplantation, Tolerance, and Tumor Immunology Study Section. Date: September 30–October 1, 2010. Time: 8:30 a.m. to 3 p.m. Agenda: To review and evaluate grant applications. Place: The Melrose Hotel, 2430 Pennsylvania Avenue, NW., Washington, DC 20037. Contact Person: Jin Huang, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4199, MSC 7812, Bethesda, MD 20892, 301–435–1230, jh377p@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel, Nonhuman Primate Core Humoral Immunology Vaccine Laboratory. Date: September 9, 2010. Time: 12:30 p.m. to 5:30 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, 6700B Rockledge Drive, Bethesda, MD 20817 (Telephone Conference Call). Contact Person: Jay Bruce Sundstrom, PhD, Scientific Review Officer, Scientific Review Program, DEA/NIAID/NIH/DHHS, 6700B Rockledge Drvie, MSC–7616, Room 3119, Bethesda, MD 20892–7616, 301–496–2550, sundstromj@niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: August 13, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–20612 Filed 8–18–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0274] Dated: August 10, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. Oversight of Laboratory Developed Tests; Public Meeting; Reopening of the Comment Period [FR Doc. 2010–20584 Filed 8–18–10; 8:45 am] AGENCY: BILLING CODE 4140–01–P Food and Drug Administration, HHS. Notice; reopening of the comment period. ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; 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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 The Food and Drug Administration (FDA) is reopening until September 15, 2010, the comment period for the notice that published in the Federal Register of Thursday, June 17, 2010 (75 FR 34463). In the notice, FDA requested input and comments from interested stakeholders on the agency’s oversight of laboratory developed tests (LDTs). FDA is reopening the comment period to update comments and to receive any new information. DATES: Submit either electronic or written comments and information by September 15, 2010. ADDRESSES: Submit electronic comments or information to https:// www.regulations.gov. Submit written comments or information to the Division of Dockets Management (HFA– 305), Food and Drug Administration, SUMMARY: E:\FR\FM\19AUN1.SGM 19AUN1 Federal Register / Vol. 75, No. 160 / Thursday, August 19, 2010 / Notices 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Katherine Serrano, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5613, Silver Spring, MD 20993, 301–796–6652, email: Katherine.serrano@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 17, 2010 (75 FR 34463), FDA published a notice announcing a public meeting on July 19 and 20, 2010, and the opening of a public docket to seek input and comments from interested stakeholders to discuss the agency’s oversight of LDTs. Interested persons were originally given until August 15, 2010, to comment on information. II. Request for Comments Following publication of the June 17, 2010, notice, FDA received a request to allow interested persons additional time to comment. The requester asserted that the initial time period was insufficient to respond fully to FDA’s specific requests for comments and to allow potential respondents to thoroughly evaluate and address pertinent issues. III. How to Submit Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: August 13, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. Notice of accreditation and approval of Intertek USA, Inc., as a commercial gauger and laboratory. ACTION: Notice is hereby given that, pursuant to 19 CFR 151.12 and 19 CFR 151.13, Intertek USA, Inc., 16025 B Jacintoport Blvd., Channelview, TX 77015, has been approved to gauge and accredited to test petroleum and petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344–1060. The inquiry may also be sent to cbp.labhq@dhs.gov. Please reference the Web site listed below for a complete listing of CBP approved gaugers and accredited laboratories. https://cbp.gov/ xp/cgov/import/operations_support/ labs_scientific_svcs/commercial_ gaugers/. DATES: The accreditation and approval of Intertek USA, Inc., as commercial gauger and laboratory became effective on April 27, 2010. The next triennial inspection date will be scheduled for April 2013. FOR FURTHER INFORMATION CONTACT: Anthony Malana, Laboratories and Scientific Services, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue, NW., Suite 1500N, Washington, DC 20229, 202–344–1060. SUMMARY: Dated: August 9, 2010. Ira S. Reese, Executive Director, Laboratories and Scientific Services. [FR Doc. 2010–20529 Filed 8–18–10; 8:45 am] [FR Doc. 2010–20489 Filed 8–18–10; 8:45 am] BILLING CODE 9111–14–P DEPARTMENT OF HOMELAND SECURITY emcdonald on DSK2BSOYB1PROD with NOTICES Notice is hereby given that, pursuant to 19 CFR 151.12 and 19 CFR 151.13, Inspectorate America Corporation, 1150–80 Sylvan Street, Linden, NJ 07036, has been approved to gauge and accredited to test petroleum and petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquires regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344–1060. The inquiry may also be sent to cbp.labhq@dhs.gov. Please reference the Web site listed below for a complete listing of CBP approved gaugers and accredited laboratories. https://cbp.gov/xp/cgov/import/ operations_support/labs_scientific_svcs/ commercial_gaugers/ SUMMARY: The accreditation and approval of Inspectorate America Corporation, as commercial gauger and laboratory became effective on May 12, 2010. The next triennial inspection date will be scheduled for May 2013. DATES: FOR FURTHER INFORMATION CONTACT: Anthony Malana, Laboratories and Scientific Services, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue, NW., Suite 1500N, Washington, DC 20229, 202–344–1060. Dated: August 9, 2010. Ira S. Reese, Executive Director, Laboratories and Scientific Services. BILLING CODE 9111–14–P DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection U.S. Customs and Border Protection Accreditation and Approval of Intertek USA, Inc., as a Commercial Gauger and Laboratory U.S. Customs and Border Protection, Department of Homeland Security. AGENCY: 17:05 Aug 18, 2010 Corporation, as a commercial gauger and laboratory. [FR Doc. 2010–20527 Filed 8–18–10; 8:45 am] BILLING CODE 4160–01–S VerDate Mar<15>2010 51281 Jkt 220001 Accreditation and Approval of Inspectorate America Corporation, as a Commercial Gauger and Laboratory U.S. Customs and Border Protection, Department of Homeland Security. ACTION: Notice of accreditation and approval of Inspectorate America AGENCY: PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Accreditation and Approval of Saybolt LP, as a Commercial Gauger and Laboratory U.S. Customs and Border Protection, Department of Homeland Security. AGENCY: E:\FR\FM\19AUN1.SGM 19AUN1

Agencies

[Federal Register Volume 75, Number 160 (Thursday, August 19, 2010)]
[Notices]
[Pages 51280-51281]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-20489]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0274]

Oversight of Laboratory Developed Tests; Public Meeting;
Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is reopening until
September 15, 2010, the comment period for the notice that published in
the Federal Register of Thursday, June 17, 2010 (75 FR 34463). In the
notice, FDA requested input and comments from interested stakeholders
on the agency's oversight of laboratory developed tests (LDTs). FDA is
reopening the comment period to update comments and to receive any new
information.

DATES: Submit either electronic or written comments and information by
September 15, 2010.

ADDRESSES: Submit electronic comments or information to https://www.regulations.gov. Submit written comments or information to the
Division of Dockets Management (HFA-305), Food and Drug Administration,

[[Page 51281]]

5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Katherine Serrano, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 5613, Silver Spring, MD 20993, 301-796-
6652, email: Katherine.serrano@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of June 17, 2010 (75 FR 34463), FDA
published a notice announcing a public meeting on July 19 and 20, 2010,
and the opening of a public docket to seek input and comments from
interested stakeholders to discuss the agency's oversight of LDTs.
Interested persons were originally given until August 15, 2010, to
comment on information.

II. Request for Comments

Following publication of the June 17, 2010, notice, FDA received a
request to allow interested persons additional time to comment. The
requester asserted that the initial time period was insufficient to
respond fully to FDA's specific requests for comments and to allow
potential respondents to thoroughly evaluate and address pertinent
issues.

III. How to Submit Comments

Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

Dated: August 13, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-20489 Filed 8-18-10; 8:45 am]
BILLING CODE 4160-01-S

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