OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 201411-0910-004 · OMB 0910-0770 · Historical Active

Forms and Documents
Document
Name
Status
Form
 Unchanged
Form
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Form
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Form
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Form
 Unchanged
Supporting Statement A
2014-11-07
IC Document Collections
IC ID
Document
Title
Status
211827 Unchanged
211825 Unchanged
211824 Unchanged
211823 Unchanged
211822 Unchanged
ICR Details
0910-0770 201411-0910-004
Historical Active 201406-0910-005
HHS/FDA CDER
Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements - Final Rule
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 02/03/2015
Retrieve Notice of Action (NOA) 11/10/2014
  Inventory as of this Action Requested Previously Approved
02/28/2018 36 Months From Approved
13 0 0
13 0 0
0 0 0
FDA is requiring that all postmarketing safety reports for human drugs and biological products be submitted in electronic format. Requiring submission of these reports in electronic format will expedite access to safety information and facilitate international harmonization and exchange of this information. This, in turn, will lead to more efficient reviews of safety data and enhance our ability to rapidly disseminate safety information to health care providers, consumers, applicants, sponsors, and other regulatory authorities in support of FDA's public health mission. In addition, the Agency will recognize a significant cost savings by converting the safety reporting system from a paper submission process to an all electronic system that would increase the accuracy of information and reduce the need for manual data entry. The final rule will expedite the identification of emerging safety problems, improve the speed and efficiency of industry and agency operations, and further the international harmonization of safety reporting.
US Code: 21 USC 356,356a,b,c,360,371,374,375 Name of Law: FD&C Act
   US Code: 21 USC 379k-l,379aa, and 381 Name of Law: FD&C Act
   US Code: 42 USC 241, 261, 264 Name of Law: PHS Act
   US Code: 21 USC 321,331,351,352,353,355,355a Name of Law: FD&C Act
  
None
0910-AF96 Final or interim final rulemaking 79 FR 33072 06/10/2014
Yes
5
IC Title Form No. Form Name
310.305(e)(2) 3500A MedWatch
314.80(g)(2) 3500A MedWatch
329.100(c)(2) 3500A MedWatch
600.80(h)(2) 3500A MedWatch
600.81(b)(2) 3500A MedWatch
  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 13 0 0 13 0 0
Annual Time Burden (Hours) 13 0 0 13 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
The information collection request revises the currently approved collection under OMB Control No. 0910-0770. The "Stage of Rulemaking" was mistakenly entered in ROCIS as a Proposed Rule, and should have been entered as a Final Rule. There are no other changes to this information collection request
$0
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov
  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
11/10/2014