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

ICR 200809-0910-001

OMB: 0910-0616

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0616 200809-0910-001
Historical Active 200712-0910-002
Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
Extension without change of a currently approved collection   No
Approved without change 10/21/2008
Retrieve Notice of Action (NOA) 09/08/2008
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
10/31/2011 36 Months From Approved 10/31/2008
54,782 0 54,782
24,420 0 24,420
0 0 0

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.

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

Not associated with rulemaking

  73 FR 11926 03/05/2008
73 FR 50024 08/25/2008

  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

Jonnalynn Capezzuto 3018274659


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.

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