Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements

Docket ID: FDA-2008-N-0334
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
The final rule would amend FDA's postmarketing safety reporting regulations for human drug and biological products to require that mandatory safety reports submitted to the Agency be transmitted in an electronic format that FDA can process, review, and archive. The rule will allow the Agency to review safety reports more quickly, to identify emerging safety problems, and disseminate safety information more rapidly in support of FDA's public health mission. The amendments also would be a key element in harmonizing FDA's postmarketing safety reporting regulations with international and International Harmonization Standards standards for the electronic submission of safety information.
RIN: 0910-AF96
Impacts and Effects: None
CFR Citation: 21 CFR 310.305,21 CFR 314.80,21 CFR 314.98,21 CFR 329.100 (new),21 CFR 600.2,21 CFR 600.80,21 CFR 600.81
Priority: Other Significant
UA and Regulatory Plan Information open glossary dialog  
Publication Period: Fall 2014
Agenda Stage of Rulemaking: Completed Action
Major Rule: No
Legal Authorities: 21 USC 321, 21 USC 331, 21 USC 351 to 353, 21 USC 355 to 355a, 21 USC 356 to 356c, 21 USC 360, 21 USC 371, 21 USC 374, 21 USC 375, 21 USC 379k-l, 21 USC 379aa, 21 USC 381, 42 USC 241, 42 USC 262, 42 USC 264, ...
Legal Deadlines: None
Government Levels Affected: No
Federalism Implications: No
Unfunded Mandates: No
Requires Regulatory Flexibility Analysis: Business
Small Entities Affected: No
International Impacts: No
Included in Regulatory Plan: No
ActionDateFR Citation
ANPRM11/05/199863 FR 59746
ANPRM Comment Period End02/03/1999
NPRM08/21/200974 FR 42184
NPRM Comment Period End11/19/2009
Final Action06/10/201479 FR 33072
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Short Title: Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements
Keyword(s): Stephen Ripley
Type: Rulemaking
Docket Status: OPEN
Center: CDER
Docket Item Code: N

Primary Documents

View All  (7)
Comment Period Closed
Nov 19, 2009 11:59 PM ET
Proposed Rule
Posted: 08/21/2009
ID: FDA-2008-N-0334-0001
Comment Period Closed
Posted: 05/27/2015
ID: FDA-2008-N-0334-0015
Comment Period Closed
Posted: 09/08/2014
ID: FDA-2008-N-0334-0013
Comment Period Closed
Posted: 09/08/2014
ID: FDA-2008-N-0334-0014
Comment Period Closed
Posted: 08/14/2014
ID: FDA-2008-N-0334-0012

Supporting Documents

View All  (2)
Comments Not Accepted
Supporting & Related Material
Posted: 06/10/2014
ID: FDA-2008-N-0334-0011


View All  (7)

Comments Received*
Regulatory Timeline
Pre Rule
Current Stage
Proposed Rule
Current Stage
Final Rule
Current Stage
Current Stage
Agency Contact
Reena Raman
Regulatory Counsel
301 796-7577
301 847-8440 (Fax)
Center for Drug Evaluation and Research, WO 51, Room 6238, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002
Silver Spring, MD 20993-0002
*This count refers to the total comment/submissions received on this docket, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.