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HHS/FDA | RIN: 0910-AF16 | Publication ID: Spring 2006 |
Title: Distribution of Blood Derivatives by Registered Blood Establishments That Qualify as Health Care Entities; PDMA of 1987; PDA of 1992; Policies, Requirements, and Administrative Procedures | |
Abstract: FDA is proposing to amend certain limited provisions of the implementing regulations of the Prescription Drug Marketing Act (PDMA) of 1987, as modified by the Prescription Drug Amendments (PDA) of 1992 and the FDA Modernization Act of 1997. Certain provisions of that final rule that published on December 3, 1999, (64 FR 67720), do not allow a registered blood establishment that provides health care services to concurrently distribute blood derivatives. The effective date of those provisions of that rule is December 1, 2006, as published on February 23, 2004, (69 FR 8105). FDA is amending the final rule to allow a registered blood establishment that concurrently provides health care services related to its activities as a blood establishment to also distribute blood derivatives. | |
Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 203.3(q) 21 CFR 203.22(h) 21 CFR 205.3(h) | |
Legal Authority: 21 USC 351 to 353 21 USC 371 21 USC 374 |
Legal Deadline:
None |
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Timetable:
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Additional Information: Delayed effective date of portion of rule to 12/01/06, effective date of non-stayed portion of final rule, 64 FR 67720, December 3, 1999 | |
Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: No | |
Agency Contact: Kathleen E. Swisher Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200N (HFM-10), Rockville, MD 20852 Phone:301 827-0372 |