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

ICR 201610-0910-008

OMB: 0910-0672

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2016-10-24
ICR Details
0910-0672 201610-0910-008
Historical Active 201311-0910-005
HHS/FDA CDER
Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
Extension without change of a currently approved collection   No
Regular
Approved without change 01/23/2017
Retrieve Notice of Action (NOA) 10/24/2016
  Inventory as of this Action Requested Previously Approved
01/31/2020 36 Months From Approved 01/31/2017
1,361 0 810
16,724 0 10,120
0 0 1,950

The information collection supports agency rulemaking. Burden reflects that otherwise captured under OMB Control Nos. 0910-0014, "Investigational New Drug Regulations," and 0910-0291, "MedWatch: FDA’s Medical Products Reporting Program." FDA will incorporate the burden under the instant collection into these collections accordingly.

US Code: 21 USC 321, 331, 351, 352, 353 et al. Name of Law: FD&C Act; Investigational New Drug Application
   US Code: 21 USC 321, 351, 352, 355, 371 Name of Law: FD&C At; Bioavailability and Bioequivalence Requirements
  
None

Not associated with rulemaking

  81 FR 14860 03/18/2016
81 FR 73115 10/24/2016
No

  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 1,361 810 0 0 551 0
Annual Time Burden (Hours) 16,724 10,120 0 0 6,604 0
Annual Cost Burden (Dollars) 0 1,950 0 0 -1,950 0
No
No
Fluctuations in burden explained in Q15 of the agency supporting statement.

$0
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  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.
10/24/2016


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