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HHS/FDA RIN: 0910-AG61 Publication ID: 2012 
Title: Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents(Completion of a Section 610 Review) 
Abstract: FDA is undertaking a review of 21 CFR sections 610.40, 610.41, 610.42, 610.44, 640.67, 640.70 (as amended in 66 FR 31146) under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether these regulations (as amended in 66 FR 31146) should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities. FDA solicited comments under section 610 of the Regulatory Flexibility Act and no comments were received. FDA has concluded its review and intends to propose revisions at a later date. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
RFA Section 610 Review: Completion of a Section 610 Review 
CFR Citation: None (To search for a specific CFR, visit the Code of Federal Regulations.
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360c and 360d; 21 USC 360h and 360i; 21 USC 371 and 372; 21 USC 374; 21 USC 381; 42 USC 216; 42 USC 262 to 264; 42 USC 263; 42 USC 263a; 42 USC 264 
Legal Deadline:  None
Timetable:
Action Date FR Cite
Begin Review of Current Regulation   06/01/2011   
End Review of Current Regulation  12/30/2011   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Melissa Reisman
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville Pike,
Rockville, MD 20852
Phone:301 827-6210

 
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