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HHS/FDA

RIN: 0910-AG05

Publication ID: Fall 2008

Title: Biological Products; Reporting of Biological Product Deviations in Manufacturing (Section 610 Review)
Abstract: Section 600.14 (21 CFR 600.14) requires licensed manufacturers of biological products to report to FDA biological product deviations in manufacturing. Section 606.170 requires licensed manufacturers of blood and blood components including Source Plasma, unlicensed registered establishments, and transfusion services to report to FDA biological product deviations in manufacturing. Under section 610 of the Regulatory Flexibility Act, FDA has undertaken a review of these regulations in parts 600 and 606 under section 610. The purpose of this review was to determine whether the regulations in parts 600 and 606 should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities.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 on the following: 1) The continued need for the regulations; 2) the nature of complaints or comments received concerning the regulations; 3) the complexity of the regulations; 4) the extent to which a regulation in parts 600 or 606 overlaps, duplicates, or conflicts with other Federal rules, and to the extent feasible, with State and local government rules; and 5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations. FDA did not receive any comments during the review process of these regulations under section 610 review, therefore these regulations will continue without change. The section 610 review has been carried out along with a regulations review under section 5 of Executive Order 12866, which calls for agencies to periodically review existing regulations to determine whether any should be modified or eliminated so as to make the agency's regulatory program more effective in achieving its goals, less burdensome, or in great alignment with the President's priorities and the principles set forth in the Executive order.
Agency: Department of Health and Human Services(HHS)	Priority: Info./Admin./Other
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Completed Actions
Major: No	Unfunded Mandates: No
RFA Section 610 Review: Section 610 Review
CFR Citation: 21 CFR 600.14 21 CFR 606.170
Legal Authority: 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 360 21 USC 360i 21 USC 360j 21 USC 371 21 USC 374 42 USC 216 42 USC 262 and 263 42 USC 263a 42 USC 264 42 USC 300aa-25

Legal Deadline: None

Timetable:

Action	Date	FR Cite
Begin Review	05/05/2008
End Review	11/03/2008

Regulatory Flexibility Analysis Required: No	Government Levels Affected: None
Federalism: No
Included in the Regulatory Plan: No
RIN Data Printed in the FR: Yes
Agency Contact: Stephen M. Ripley Team Leader Department of Health and Human Services Food and Drug Administration Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200N (HFM-17), Rockville, MD 20852-1448 Phone:301 827-6210