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

Forms and Documents

Document Name	Status
Form FDA 3674 Supplements/Amendments Form and Instruction	New
Form FDA 3674 Original Applications Form and Instruction	New
Form FDA 3674 New Marketing Applications for CDRH Form and Instruction	New
Form FDA 3674 Efficacy Supplements/Resubmissions for CDER and CBER Form and Instruction	New
Form FDA 3674 Clinical Amendments to Marketing Applications for CDER and CBER Form and Instruction	New
Form FDA 3674 New Marketing Applications/Resubmissions (NDA/BLA) for CDER and CBER Form and Instruction	New
Form FDA 3674 Clinical Protocol Amendments (IND) for CDER and CBER Form and Instruction	Modified
Form FDA 3674 New Applications (IND) for CDER and CBER Form and Instruction	Modified
Supporting_Statement_Final.doc Supporting Statement A	2011-12-06

IC Document Collections

IC ID	Document Title	Status
199621	Supplements/Amendments Form and Instruction	New
199620	Original Applications Form and Instruction	New
199619	New Marketing Applications for CDRH Form and Instruction	New
199618	Efficacy Supplements/Resubmissions for CDER and CBER Form and Instruction	New
199617	Clinical Amendments to Marketing Applications for CDER and CBER Form and Instruction	New
199616	New Marketing Applications/Resubmissions (NDA/BLA) for CDER and CBER Form and Instruction	New
183055	Clinical Protocol Amendments (IND) for CDER and CBER Form and Instruction	Modified
183054	New Applications (IND) for CDER and CBER Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0616	ICR Reference No: 201109-0910-006
Status: Historical Active	Previous ICR Reference No: 200809-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/27/2012
	Date Received in OIRA: 09/30/2011
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for three years. In future submissions, the agency must provide a clear explanation of the source of the program change. OMB will return requests as improperly submitted if the explanation is unclear. In addition, the agency must submit any ICR revisions associated with guidance in a timely manner. If OMB approval is not requested or provided prior to the effective date of a guidance containing new information collections or revisions to existing collections, any information collected as a result of the guidance must be reported to OMB as a violation of the PRA.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2015	36 Months From Approved	02/29/2012
Responses	19,353	0	54,782
Time Burden (Hours)	6,881	0	24,420
Cost Burden (Dollars)	0	0	0

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Abstract: Sponsors of investigational new drug applications (IND) and marketing applications (NDA, BLA, PMA, 510k, HDE) are required, under the Food and Drug Administration Amendments Act of 2007, to certify that all applicable requirements have been met. Sponsors of applicable clinical trials are required to submit information to the publicly-accessible clinical trials data bank, ClinicalTrials.gov.

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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:
	76 FR 26305	05/06/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 59401	09/26/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
New Applications (IND) for CDER and CBER	FDA 3674	Certification of Compliance, under 42 U.S.C. 282(j)(5)(B), with Requirements of Clinical Trials.gov Data Bank (42 U.S.C. 282(j))
Clinical Protocol Amendments (IND) for CDER and CBER	FDA 3674	Certification of Compliance, under 42 U.S.C. 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C. 282(j))
New Marketing Applications/Resubmissions (NDA/BLA) for CDER and CBER	FDA 3674	Certification of Compliance, under 42 U.S.C. 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C. 282(j))
Clinical Amendments to Marketing Applications for CDER and CBER	FDA 3674	Certification of Compliance, under 42 U.S.C. 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C. 282(j))
Efficacy Supplements/Resubmissions for CDER and CBER	FDA 3674	Certification of Compliance, under 42 U.S.C. 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C. 282(j))
New Marketing Applications for CDRH	FDA 3674	Certification of Compliance, under 42 U.S.C. 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C. 282(j))
Original Applications	FDA 3674	Certification of Compliance, under 42 U.S.C. 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C. 282(j))
Supplements/Amendments	FDA 3674	Certification of Compliance, under 42 U.S.C. 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C. 282(j))

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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	19,353	54,782	0	-35,429	0	0
Annual Time Burden (Hours)	6,881	24,420	0	-17,539	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The decrease in burden (a program change) reflects changes made based on certain applications/submissions either removed from the burden calculations made in the original estimates or new applications/submissions added to the burden calculations. Those applications/submissions removed include those we currently have determined do not typically require that a certification form accompany the application/submission, as described in our January 2009 Guidance. In this guidance, we eliminated annual reports and labeling supplements from the list of applications/submissions that required a certification.

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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: 09/30/2011

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