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Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 201801-0910-004 · OMB 0910-0616 · Active

Forms and Documents
DocumentTypeStatusAvailability
Form FDA 3674 BE Supplements/Amendments - ODG Form Modified Available
Form FDA 3674 New Marketing Applications (includes PMAs, HDEs, Supplements and 510(k)s expected to contain clinical data) Form Removed Available
Form FDA 3674 Clinical Amendments to Marketing Applications Form Removed Repair queued
Form FDA 3674 New Marketing Applications/Resubmissions (NDA/BLA) Form Removed Repair queued
Form FDA 3674 Clinical Protocol Amendments (IND) Form Removed Available
Form FDA 3674 New Applications (IND) Form Removed Available
0616_Supporting Statement_Jan. 2018.docx Supporting Statement A Uploaded 2018-01-18 Available
IC Document Collections
IC IDCollectionTypeStatusForm
214358 BE Supplements/Amendments - ODG Form Modified
214357 Original Applications - ODG Other-Guidance Modified
214356 New Marketing Applications (includes PMAs, HDEs, Supplements and 510(k)s expected to contain clinical data) Form Removed
214355 Efficacy Supplements/Resubmissions (BLA Only) Other-Guidance Removed
214353 Clinical Amendments to Marketing Applications Form Removed
199621 New Marketing Applications/Resubmissions (NDA/BLA) Form Removed
199620 Clinical Protocol Amendments (IND) Form Removed
199619 New Applications (IND) Form Removed
199618 Efficacy Supplements/Resubmissions - CDER and CBER Other-Guidance Modified
199617 Clinical Amendments to Marketing Applications - CDER and CBER Other-Guidance Modified
199616 New Marketing Applications/Resubmissions - CDER, CBER and CDRH Other-Guidance Modified
183055 Clinical Protocol Amendments (IND) - CDER and CBER Other-Guidance Modified
183054 New Applications (IND) - CDER and CBER Other-Guidance Modified
ICR Details
0910-0616 201801-0910-004
Active 201412-0910-013
HHS/FDA CROSS CENTER
Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
Extension without change of a currently approved collection   No
Regular
Approved without change 03/27/2018
Retrieve Notice of Action (NOA) 01/23/2018
  Inventory as of this Action Requested Previously Approved
03/31/2021 36 Months From Approved 03/31/2018
21,427 0 20,712
7,175 0 7,119
0 0 0
This ICR collects information which will be submitted to FDA with new investigational and marketing applications/submissions and certain additional submissions to such applications for human drugs, biological products, and medical devices. It will be used by the FDA to confirm that sponsors/applicants/submitters have complied with the certification provisions in section 402(j)(5)(B) of the Public Health Service Act 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 the certification process for sponsors and provide FDA a means of 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
  82 FR 44417 09/22/2017
83 FR 1363 01/11/2018
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 21,427 20,712 0 0 715 0
Annual Time Burden (Hours) 7,175 7,119 0 0 56 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
$0
No
    No
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [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.
01/23/2018