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HHS/FDA | RIN: 0910-AF90 | Publication ID: Fall 2008 |
Title: Exceptions or Alternatives To Labeling Requirements for Products Held by the Strategic National Stockpile | |
Abstract: FDA issued 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 FDA 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 FDA 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: Long-Term Actions |
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 |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: Federal, State |
Federalism: Yes | |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Tiffany J. Brown Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200N (HFM-17), Rockville, MD 20852-1448 Phone:301 827-6210 |