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HHS/FDA RIN: 0910-AF90 Publication ID: Spring 2007 
Title: Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile 
Abstract: FDA is issuing regulations to permit FDA Center Directors to grant an exception or alternative to certain regulatory labeling provisions applicable to human drugs, biological products, or medical devices that are or will be included in the Strategic National Stockpile (SNS). Under this rule, the appropriate Center Director may grant an exception or alternative to such labeling requirements if he or she determines that compliance with such requirements could adversely affect the safety, effectiveness, or availability of specified lots, batches, or other units of human drugs, biological products, or medical devices that are or will be included in the SNS. A grant of an exception or alternative under these regulations will include any safeguards or conditions deemed appropriate by the Center Director to ensure that the labeling of such products includes information for the safe and effective use of the products given their anticipated circumstances of use. This rule will facilitate the safety, effectiveness, and availability of appropriate medical countermeasures in the event of a public health emergency. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 201    21 CFR 312    21 CFR 314    21 CFR 601    21 CFR 610    21 CFR 801    21 CFR 807    21 CFR 809    21 CFR 812    21 CFR 814   
Legal Authority: 15 USC 1451 to 1561    21 USC 321    21 USC 331    21 USC 351 to 353    21 USC 355 and 356    21 USC 358    21 USC 360    21 USC 371 to 375    21 USC 379    21 USC 381 and 382    21 USC 393    42 USC 216    42 USC 241    42 USC 262 to 264    42 USC 271   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Interim Final Rule  10/00/2007    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
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