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

ICR 201109-0910-006

OMB: 0910-0616

Federal Form Document

ICR Details
0910-0616 201109-0910-006
Historical Active 200809-0910-001
HHS/FDA
Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
Revision of a currently approved collection   No
Regular
Approved with change 02/27/2012
Retrieve Notice of Action (NOA) 09/30/2011
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
02/28/2015 36 Months From Approved 02/29/2012
19,353 0 54,782
6,881 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
  
None

Not associated with rulemaking

  76 FR 26305 05/06/2011
76 FR 59401 09/26/2011
No

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))

  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
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
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.

$0
No
No
No
No
No
Uncollected
Jonnalynn Capezzuto 3018274659

  No

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.
09/30/2011


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