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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0230
ICR Reference No:
201207-0910-003
Status:
Historical Active
Previous ICR Reference No:
200904-0910-004
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Adverse Drug Experience Reporting
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
08/15/2012
Retrieve Notice of Action (NOA)
Date Received in OIRA:
07/05/2012
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2015
36 Months From Approved
08/31/2012
Responses
415,226
0
411,509
Time Burden (Hours)
7,312,076
0
7,089,086
Cost Burden (Dollars)
47,000
0
46,962
Abstract:
Sections 201, 502, 505, and 701 of the Federal Food, Drug, and Cosmetic Act require that marketed drugs be safe and effective. In order to know whether drugs that are not safe and effective are on the market, FDA must be promptly informed of adverse experiences occasioned by the use of marketed drugs. In order to help ensure this, FDA issued regulations at 21 CFR 310.305 and 314.80 to impose reporting and recordkeeping requirements on the drug industry that would enable FDA to take action necessary for protection of the public health from adverse drug experiences.
Authorizing Statute(s):
US Code:
21 USC 310
Name of Law: FFDCA
US Code:
21 USC 314
Name of Law: FFDCA
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
77 FR 16232
05/21/2012
30-day Notice:
Federal Register Citation:
Citation Date:
77 FR 38303
06/27/2012
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
5
IC Title
Form No.
Form Name
Adverse Drug Event Recordkeeping -- 314.80(i)
Adverse Drug Experience Reporting -- 310.305(c)(5)
Adverse Event Recordkeeping -- 310.305(f)
Adverse Event Reporting -- 314.80(c)(2)
Adverse Event Reporting--314.80(c)(1)(iii)
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
415,226
411,509
0
0
3,717
0
Annual Time Burden (Hours)
7,312,076
7,089,086
0
0
222,990
0
Annual Cost Burden (Dollars)
47,000
46,962
0
0
38
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Annual Cost to Federal Government:
$225,450,000
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Johnny Vilela 301 796-3792 juanmanuel.vilela@fda.hhs.gov
Common Form ICR:
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Certification Date:
07/05/2012
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