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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these regulations (as amended in 66 FR 31146) should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities.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 | |
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Legal Deadline:
None |
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Timetable:
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| 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 | |
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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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