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| HHS/FDA | RIN: 0910-AG18 | Publication ID: 2012 |
| Title: Electronic Distribution of Prescribing Information for Human Drugs Including Biological Products | |
| Abstract: This rule would require electronic package inserts for human drug and biological prescription products with limited exceptions, in lieu of paper, which is currently used. These inserts contain prescribing information intended for healthcare practitioners. This would ensure that the information accompanying the product is the most up-to-date information regarding important safety and efficacy issues about these products. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Economically Significant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
| Major: Yes | Unfunded Mandates: Private Sector |
| CFR Citation: 21 CFR 201.100; 21 CFR 201.306; 21 CFR 201.310; 21 CFR 606.121; 21 CFR 606.122; 21 CFR 610.60; 21 CFR 610.61; ... (To search for a specific CFR, visit the Code of Federal Regulations.) | |
| Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 | |
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Legal Deadline:
None |
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Timetable:
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| Additional Information: Includes Retrospective Review under E.O. 13563. | |
| 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: Megan Clark-Velez Policy Analyst Department of Health and Human Services Food and Drug Administration Office of Policy, WO 32, Room 4249, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-9301 Email: megan.clark@fda.hhs.gov |
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