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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. 

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. 

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. 

BILLING CODE 4160–01–P 


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[FR Doc. 2011–6079 Filed 3–15–11; 8:45 am] 

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. 

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 

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 

http://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 

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 http://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] 

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