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
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.
0616 ss 8-25-08.doc
Certification to Accompany Drug, Biological Product, and Device Applications or Submissions