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

Forms and Documents

Document Name	Status
0616 ss 8-25-08.doc Supporting Statement A	2008-08-28

IC Document Collections

IC ID	Document Title	Status
183055	Certification to Accompany Drug, Biological Product, and Device Applications or Submissions Other-Public Law	Modified
183054	Certification to Accompany Drug, Biological Product, and Device Applications or Submissions Other-Public Law	Modified

ICR Details

OMB Control No: 0910-0616	ICR Reference No: 200809-0910-001
Status: Historical Active	Previous ICR Reference No: 200712-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
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 without change	Conclusion Date: 10/21/2008
	Date Received in OIRA: 09/08/2008
Terms of Clearance: This ICR is approved for 3 years. During that time, FDA should continue to work with respondents to ensure that they understand these new requirements and when they are applicable. FDA will also continue to evaluate whether there are additional ways to minimize respondent burden with regards to routine filings which may not require certification.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2011	36 Months From Approved	10/31/2008
Responses	54,782	0	54,782
Time Burden (Hours)	24,420	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:
	73 FR 11926	03/05/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 50024	08/25/2008
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
Certification to Accompany Drug, Biological Product, and Device Applications or Submissions

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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	54,782	54,782	0	0	0	0
Annual Time Burden (Hours)	24,420	24,420	0	0	0	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:

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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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 09/08/2008

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