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

Forms and Documents

Document Name	Status
Form FDA 3674 BE Supplements/Amendments Form	New
Form FDA 3674 Original Applications Form	New
Form FDA 3674 New Marketing Applications (includes PMAs, HDEs, Supplements and 510(k)s expected to contain clinical data) Form	New
Form FDA 3674 Clinical Amendments to Marketing Applications Form	New
Form FDA 3674 New Marketing Applications/Resubmissions (NDA/BLA) Form	Modified
Form FDA 3674 Clinical Protocol Amendments (IND) Form	Modified
Form FDA 3674 New Applications (IND) Form	Modified
Form FDA 3674 Efficacy Supplements/Resubmissions Form	Modified
Form FDA 3674 Clinical Amendments to Marketing Applications Form	Modified
Form FDA 3674 New Marketing Applications/Resubmissions (NDA/BLA) Form	Modified
Form FDA 3674 Clinical Protocol Amendments (IND) Form	Modified
Form FDA 3674 New Applications (IND) Form	Modified
SUPPORTING STATEMENT FINAL 12-19-14.doc Supporting Statement A	2014-12-19

IC Document Collections

IC ID	Document Title	Status
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

OMB Control No: 0910-0616	ICR Reference No: 201412-0910-013
Status: Historical Active	Previous ICR Reference No: 201109-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/09/2015
	Date Received in OIRA: 12/30/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2018	36 Months From Approved	02/28/2015
Responses	20,712	0	19,353
Time Burden (Hours)	7,119	0	6,881
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): 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
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 38905	07/09/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 75819	12/19/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 13

IC Title	Form No.	Form Name
Efficacy Supplements/Resubmissions (BLA Only)	3674	Certification of Compliance
New Marketing Applications (includes PMAs, HDEs, Supplements and 510(k)s expected to contain clinical data)	FDA 3674	Certification of Compliance
BE Supplements/Amendments	FDA 3674	Certification of Compliance
Original Applications	FDA 3674	Certification of Compliance
New Applications (IND)	FDA 3674	Certification of Compliance
Clinical Protocol Amendments (IND)	FDA 3674	Certification of Compliance
New Marketing Applications/Resubmissions (NDA/BLA)	FDA 3674	Certification of Compliance
Clinical Amendments to Marketing Applications	FDA 3674	Certification of Compliance
Efficacy Supplements/Resubmissions	FDA 3674	Certification of Compliance
New Applications (IND)	FDA 3674	Certification of Compliance
Clinical Protocol Amendments (IND)	FDA 3674	Certification of Complicance
New Marketing Applications/Resubmissions (NDA/BLA)	FDA 3674	Certification of Compliance
Clinical Amendments to Marketing Applications	FDA 3674	Certification of Compliance

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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	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

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: The increase in burden reflects a change in the overall number of research and marketing applications/submissions received by FDA since the previous estimate.

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Annual Cost to Federal Government: $0

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

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Common Form ICR:  No

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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: 12/30/2014

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