Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies

ICR 202312-0910-006

OMB: 0910-0119

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2023-12-19
IC Document Collections
ICR Details
0910-0119 202312-0910-006
Received in OIRA 202011-0910-010
HHS/FDA CROSS CENTER
Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies
Extension without change of a currently approved collection   No
Regular 12/19/2023
  Requested Previously Approved
36 Months From Approved 02/29/2024
36,150 36,150
1,304,157 1,304,157
0 0

The good laboratory practice (GLP) regulations are intended to assure the quality and integrity of the safety data submitted to FDA in support of the approval of regulated products. The required information will help assure that only safe products are approved for marketing. Respondents to the collection are those submitting applications to FDA for research or marketing permits.

US Code: 21 USC 301 et seq. Name of Law: Food Drug and Cosmetic Act
  
None

Not associated with rulemaking

  88 FR 53492 08/08/2023
88 FR 82906 11/27/2023
Yes

1
IC Title Form No. Form Name
Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies

  Total Request 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 36,150 36,150 0 0 0 0
Annual Time Burden (Hours) 1,304,157 1,304,157 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$1,099,502
No
    Yes
    No
No
No
No
No
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.
12/19/2023


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