OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

Certification to Accompany Drug, Biological Product, and Device Applications or Submissions

ICR 201412-0910-013 · OMB 0910-0616 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Form FDA 3674 BE Supplements/Amendments Form New Repair queued
Form FDA 3674 Original Applications Form New Available
Form FDA 3674 New Marketing Applications (includes PMAs, HDEs, Supplements and 510(k)s expected to contain clinical data) Form New Repair queued
Form FDA 3674 Clinical Amendments to Marketing Applications Form New Repair queued
Form FDA 3674 New Marketing Applications/Resubmissions (NDA/BLA) Form Modified Available
Form FDA 3674 Clinical Protocol Amendments (IND) Form Modified Repair queued
Form FDA 3674 New Applications (IND) Form Modified Repair queued
Form FDA 3674 Efficacy Supplements/Resubmissions Form Modified Repair queued
Form FDA 3674 Clinical Amendments to Marketing Applications Form Modified Repair queued
Form FDA 3674 New Marketing Applications/Resubmissions (NDA/BLA) Form Modified Available
Form FDA 3674 Clinical Protocol Amendments (IND) Form Modified Available
Form FDA 3674 New Applications (IND) Form Modified Available
SUPPORTING STATEMENT FINAL 12-19-14.doc Supporting Statement A Uploaded 2014-12-19 Available
IC Document Collections
IC IDCollectionTypeStatusForm
214358 BE Supplements/Amendments Form New
214357 Original Applications Form New
214356 New Marketing Applications (includes PMAs, HDEs, Supplements and 510(k)s expected to contain clinical data) Form New
214355 Efficacy Supplements/Resubmissions (BLA Only) Other-Guidance New
214353 Clinical Amendments to Marketing Applications Form New
199621 New Marketing Applications/Resubmissions (NDA/BLA) Form Modified
199620 Clinical Protocol Amendments (IND) Form Modified
199619 New Applications (IND) Form Modified
199618 Efficacy Supplements/Resubmissions Form Modified
199617 Clinical Amendments to Marketing Applications Form Modified
199616 New Marketing Applications/Resubmissions (NDA/BLA) Form Modified
183055 Clinical Protocol Amendments (IND) Form Modified
183054 New Applications (IND) Form Modified
ICR Details
0910-0616 201412-0910-013
Historical Active 201109-0910-006
HHS/FDA CBER
Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
Extension without change of a currently approved collection   No
Regular
Approved with change 02/09/2015
Retrieve Notice of Action (NOA) 12/30/2014
  Inventory as of this Action Requested Previously Approved
02/28/2018 36 Months From Approved 02/28/2015
20,712 0 19,353
7,119 0 6,881
0 0 0
This ICR collects information submitted to FDA with new investigational and marketing applications/submissions and certain additional submissions to such applications for human drugs, biological products, and devices. Respondents submit information as provided under statutory requirements that sponsors/applicants/submitters have complied with the certification provisions in the law with regard to any applicable clinical trials referenced in the investigational or marketing applications/submissions with which the certification is submitted. FDA has developed Form FDA 3674 to facilitate this certification and assist with correlating the clinical trials contained in the applications/submissions to FDA with the information contained in the ClinicalTrials.gov data bank.
US Code: 42 USC 282 Name of Law: Public Health Service Act
   PL: Pub.L. 110 - 85 VIII Name of Law: Food and Drug Administration Amendments Act of 2007
  
None
Not associated with rulemaking
  79 FR 38905 07/09/2014
79 FR 75819 12/19/2014
No
  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 20,712 19,353 0 0 1,359 0
Annual Time Burden (Hours) 7,119 6,881 0 0 238 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The increase in burden reflects a change in the overall number of research and marketing applications/submissions received by FDA since the previous estimate.
$0
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 [email protected]
  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.
12/30/2014