Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies - 21 CFR Part 58

ICR 201409-0910-010

OMB: 0910-0119

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2014-09-15
ICR Details
0910-0119 201409-0910-010
Historical Active 201107-0910-008
HHS/FDA CVM
Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies - 21 CFR Part 58
Extension without change of a currently approved collection   No
Regular
Approved without change 12/23/2014
Retrieve Notice of Action (NOA) 09/29/2014
  Inventory as of this Action Requested Previously Approved
12/31/2017 36 Months From Approved 12/31/2014
36,150 0 36,150
1,304,157 0 1,311,157
0 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 Name of Law: u.s.c.
  
None

Not associated with rulemaking

  79 FR 33755 06/12/2014
79 FR 57935 09/26/2014
Yes

1
IC Title Form No. Form Name
Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies - 21 CFR Part 58

  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 36,150 36,150 0 0 0 0
Annual Time Burden (Hours) 1,304,157 1,311,157 0 0 -7,000 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
Yes
Miscellaneous Actions
Burden reduction reflects correction of mathematical error recorded previously. This is explained in the Supporting Statement at Q.15.

$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.
09/29/2014


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