Exchange of Letters Between Dr. Murray M. Lumpkin, Deputy Commissioner, International Programs, Food and Drug Administration and Mr. Martin Heraghty, Assistant Secretary General, Department of Agriculture, Fisheries and Food of Ireland Concerning Certification Requirements for Caseins, Caseinates, and Mixtures Thereof Exported From Ireland to the United States, 14407-14413 [2011-6079]

Download as PDF Federal Register / Vol. 76, No. 51 / Wednesday, March 16, 2011 / Notices jlentini on DSKJ8SOYB1PROD with NOTICES 801, 803, and 807, 809, and 820 (21 CFR parts 201, 207, 211, 600, 601, 606, 607, 610, 660, 801, 803, 807, 809, and 820). The collections of information in §§ 606.121, 606.122, and 610.40 have been approved under OMB Control No. 0910–0116; § 610.2 has been approved under OMB Control No. 0910–0206; §§ 600.12(e) and 600.80 have been approved under OMB Control No. 0910–0308; §§ 601.2(a), 601.12, 610.60 through 610.65, 610.67, 660.2(c), 660.28(a) and (b), 660.35(a), 660.35(c) through (g), 660.35(i) through (m), 660.45, and 660.55(a) and (b) have been approved under OMB Control No. 0910–0338; §§ 803.20, 803.50, and 803.53 have been approved under OMB Control No. 0910–0437; and §§ 600.14 and 606.171 have been approved under OMB Control No. 0910–0458. The current good manufacturing practice regulations for finished pharmaceuticals (part 211) have been approved under OMB Control No. 0910–0139; §§ 820.181 and 820.184 have been approved under OMB Control No. 0910–0073; the establishment registration regulations (parts 207, 607, and 807) have been approved under OMB Control Nos. 0910–0045, 0910– 0052, and 0910–0387; and the labeling regulations (parts 201, 801, and 809) have been approved under OMB Control Nos. 0910–0537, 0910–0572, and 0910–0485. VerDate Mar<15>2010 18:34 Mar 15, 2011 Jkt 223001 Dated: February 25, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–6055 Filed 3–15–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0109] Exchange of Letters Between Dr. Murray M. Lumpkin, Deputy Commissioner, International Programs, Food and Drug Administration and Mr. Martin Heraghty, Assistant Secretary General, Department of Agriculture, Fisheries and Food of Ireland Concerning Certification Requirements for Caseins, Caseinates, and Mixtures Thereof Exported From Ireland to the United States AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is providing notice of exchange of letters between Dr. Murray M. Lumpkin, Deputy Commissioner, International and Special Programs, FDA and Mr. Martin Heraghty, Assistant Secretary General, Department of Agriculture, Fisheries and Food (DAFF), concerning certification requirements for caseins, SUMMARY: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 14407 caseinates, and mixtures thereof exported from Ireland to the United States. The mutual goals of FDA and DAFF in establishing certification requirements for caseins, caseinates, and mixtures thereof exported from Ireland to the United States are to assure that contaminated products will not be imported into the United States and to minimize the need for extensive FDA audit sampling of these products from Ireland. DAFF and FDA have a history of cooperation on this issue and it is, therefore, desirable that the two Agencies continue to cooperate to maintain and improve consumer protection. The agreement became effective November 10, 2010. FOR FURTHER INFORMATION CONTACT: David P. Kelly, Office of International Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 3404, Silver Spring, MD 20993–0002, 301–796–8373, Fax: 301–595–7941. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which states that all written agreements and understandings between FDA and others shall be published in the Federal Register, the Agency is publishing notice of this agreement. DATES: Dated: March 10, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. BILLING CODE 4160–01–P E:\FR\FM\16MRN1.SGM 16MRN1 VerDate Mar<15>2010 Federal Register / Vol. 76, No. 51 / Wednesday, March 16, 2011 / Notices 16:56 Mar 15, 2011 Jkt 223001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4725 E:\FR\FM\16MRN1.SGM 16MRN1 EN16MR11.008</GPH> jlentini on DSKJ8SOYB1PROD with NOTICES 14408 VerDate Mar<15>2010 16:56 Mar 15, 2011 Jkt 223001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4725 E:\FR\FM\16MRN1.SGM 16MRN1 14409 EN16MR11.009</GPH> jlentini on DSKJ8SOYB1PROD with NOTICES Federal Register / Vol. 76, No. 51 / Wednesday, March 16, 2011 / Notices VerDate Mar<15>2010 Federal Register / Vol. 76, No. 51 / Wednesday, March 16, 2011 / Notices 16:56 Mar 15, 2011 Jkt 223001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4725 E:\FR\FM\16MRN1.SGM 16MRN1 EN16MR11.010</GPH> jlentini on DSKJ8SOYB1PROD with NOTICES 14410 VerDate Mar<15>2010 16:56 Mar 15, 2011 Jkt 223001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4725 E:\FR\FM\16MRN1.SGM 16MRN1 14411 EN16MR11.011</GPH> jlentini on DSKJ8SOYB1PROD with NOTICES Federal Register / Vol. 76, No. 51 / Wednesday, March 16, 2011 / Notices VerDate Mar<15>2010 Federal Register / Vol. 76, No. 51 / Wednesday, March 16, 2011 / Notices 16:56 Mar 15, 2011 Jkt 223001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4725 E:\FR\FM\16MRN1.SGM 16MRN1 EN16MR11.012</GPH> jlentini on DSKJ8SOYB1PROD with NOTICES 14412 Federal Register / Vol. 76, No. 51 / Wednesday, March 16, 2011 / Notices BILLING CODE 4160–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] Risk Mitigation Strategies To Address Potential Procoagulant Activity in Immune Globulin Intravenous Products; Public Workshop AGENCY: Food and Drug Administration, HHS. jlentini on DSKJ8SOYB1PROD with NOTICES ACTION: Notice of public workshop. The Food and Drug Administration (FDA), in cooperation with the National Heart, Lung, and Blood Institute, and the Plasma Protein Therapeutics Association, are jointly cosponsoring a public workshop on risk mitigation strategies to address procoagulant activity that may be present in some Immune Globulin Intravenous (IGIV) products. The purposes of the public workshop are to identify the most likely causes of IGIV-associated thrombotic events, to determine which procoagulant proteins may be causative, and to identify relevant, feasible tests that could be used to assess levels and/ or activity of these proteins in IGIV products. The public workshop will feature presentations by national and international experts from government, academic institutions, and industry. Dates and Time: The public workshop will be held on May 17, 2011, from 8:30 VerDate Mar<15>2010 16:56 Mar 15, 2011 Jkt 223001 a.m. to 5 p.m. and May 18, 2011, from 8 a.m. to 11:30 a.m. Location: The public workshop will be held at the Universities at Shady Grove Conference Center, Building II, Multipurpose Room, 9630 Gudelsky Dr., Rockville, MD 20850. Please visit https://www.shadygrove.umd.edu/about/ visit for directions, visitor parking, and public transportation information. Contact Person: Rhonda Dawson, Center for Biologics Evaluation and Research (HFM–302), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6129, FAX: 301–827–2843, email: rhonda.dawson@fda.hhs.gov. Registration: Mail or fax your registration information (including name, title, firm name, address, telephone and fax numbers) to the contact person by April 26, 2011. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space available basis beginning at 7:30 a.m. If you need special accommodations due to a disability, please contact Rhonda Dawson at least 7 days in advance of the workshop. SUPPLEMENTARY INFORMATION: The following topics will be discussed at the public workshop: (1) Epidemiology of thrombotic events in IGIV recipients; (2) pathophysiology of arterial and venous thrombosis in this context; (3) research to identify specific procoagulant proteins that can co-purify with IGIV; (4) partitioning of coagulation factors during IGIV purification; (5) the role of PO 00000 Frm 00045 Fmt 4703 Sfmt 9990 activated Coagulation Factor XIa in IGIV-associated thrombosis; (6) test methods for screening IGIV products; (7) ancillary animal models; and (8) standards development for thrombin generation tests. On the first day of the public workshop, the epidemiology and potential causes of historically observed IGIV-associated thrombotic adverse events, as well as biochemical identification of procoagulant proteins that co-purify with IGIV will be discussed. In addition, methods and relevance of both broad and specific tests to screen IGIV products for procoagulant activity will be addressed, and limitations in test methodologies and validation needs will be identified. On the second day of the public workshop, preliminary results of IGIV product testing for procoagulant activity will be presented and discussed, followed by a summary of the meeting. Transcripts: Transcripts of the public workshop may be requested in writing from the Freedom of Information Office (HFI–35), Food and Drug Administration, 5600 Fishers Lane, rm. 6–30, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page. A transcript of the public workshop will be available on the Internet at https://www.fda.gov/ BiologicsBloodVaccines/NewsEvents/ WorkshopsMeetingsConferences/ TranscriptsMinutes/default.htm. Dated: March 10, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–6084 Filed 3–15–11; 8:45 am] BILLING CODE 4160–01–P E:\FR\FM\16MRN1.SGM 16MRN1 EN16MR11.013</GPH> [FR Doc. 2011–6079 Filed 3–15–11; 8:45 am] 14413

Agencies

[Federal Register Volume 76, Number 51 (Wednesday, March 16, 2011)]
[Notices]
[Pages 14407-14413]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6079]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0109]


Exchange of Letters Between Dr. Murray M. Lumpkin, Deputy 
Commissioner, International Programs, Food and Drug Administration and 
Mr. Martin Heraghty, Assistant Secretary General, Department of 
Agriculture, Fisheries and Food of Ireland Concerning Certification 
Requirements for Caseins, Caseinates, and Mixtures Thereof Exported 
From Ireland to the United States

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is providing notice of 
exchange of letters between Dr. Murray M. Lumpkin, Deputy Commissioner, 
International and Special Programs, FDA and Mr. Martin Heraghty, 
Assistant Secretary General, Department of Agriculture, Fisheries and 
Food (DAFF), concerning certification requirements for caseins, 
caseinates, and mixtures thereof exported from Ireland to the United 
States.
    The mutual goals of FDA and DAFF in establishing certification 
requirements for caseins, caseinates, and mixtures thereof exported 
from Ireland to the United States are to assure that contaminated 
products will not be imported into the United States and to minimize 
the need for extensive FDA audit sampling of these products from 
Ireland. DAFF and FDA have a history of cooperation on this issue and 
it is, therefore, desirable that the two Agencies continue to cooperate 
to maintain and improve consumer protection.

DATES: The agreement became effective November 10, 2010.

FOR FURTHER INFORMATION CONTACT: David P. Kelly, Office of 
International Programs, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, rm. 3404, Silver Spring, MD 20993-0002, 301-
796-8373, Fax: 301-595-7941.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which 
states that all written agreements and understandings between FDA and 
others shall be published in the Federal Register, the Agency is 
publishing notice of this agreement.

    Dated: March 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
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[FR Doc. 2011-6079 Filed 3-15-11; 8:45 am]
BILLING CODE 4160-01-C
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