Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans

ICR 201009-0910-004

OMB: 0910-0672

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2010-09-01
IC Document Collections
IC ID
Document
Title
Status
194533
New
194532
New
194531
New
ICR Details
0910-0672 201009-0910-004
Historical Active
HHS/FDA
Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 12/05/2010
Retrieve Notice of Action (NOA) 09/10/2010
  Inventory as of this Action Requested Previously Approved
12/31/2013 36 Months From Approved
810 0 0
10,120 0 0
1,950 0 0

The final rule amends FDA regulations governing safety reporting requirements for human drug and biologcal products subject to IND's. The revisions will improve the the utility of IND safety reports.

US Code: 21 USC 312 Name of Law: FD&C Act
  
US Code: 21 USC 312.32(b) Name of Law: null

0910-AG13 Final or interim final rulemaking 75 FR 59935 09/29/2010

Yes

3
IC Title Form No. Form Name
320.31(d)
312.32(c)(1)(ii)
312.32(c)(1)(iv)

  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 810 0 810 0 0 0
Annual Time Burden (Hours) 10,120 0 10,120 0 0 0
Annual Cost Burden (Dollars) 1,950 0 1,950 0 0 0
No
No
This final rule amends parts 312 and 320 of FDA regulations by revising the requirements for IND safety reporting and for bioavailability and bioequivalence studies. Some of the burden if covered under other existing packages.

$83,955,000
No
No
No
No
No
Uncollected
Eliazabeth Berbakos 3018271482

  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.
09/10/2010


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