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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0119
ICR Reference No:
201610-0910-010
Status:
Historical Inactive
Previous ICR Reference No:
201409-0910-010
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CROSS CENTER
Title:
Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies; 21 CFR Part 58
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Comment filed on proposed rule and continue
Conclusion Date:
05/18/2017
Retrieve Notice of Action (NOA)
Date Received in OIRA:
02/02/2017
Terms of Clearance:
OMB files this comment in accordance with 5 CFR 1320.11( c ). This OMB action is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. This action has no effect on any current approvals. If OMB has assigned this ICR a new OMB Control Number, the OMB Control Number will not appear in the active inventory. For future submissions of this information collection, reference the OMB Control Number provided. The agency will resubmit this collection when the final rule is issued.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2017
36 Months From Approved
01/31/2018
Responses
36,150
0
36,150
Time Burden (Hours)
1,304,157
0
1,304,157
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
US Code:
21 USC 81, 387e, 387j, 387k
Name of Law: FFDCA
US Code:
21 USC 360, 360b–360f, 360h– 360j
Name of Law: FFDCA
US Code:
21 USC 360ccc
Name of Law: FFDCA
US Code:
21 USC 371, 379e
Name of Law: FFDCA
US Code:
42 USC 216, 262, 263b–263n
Name of Law: PHS Act
US Code:
21 USC 342, 346, 346a, 348
Name of Law: FFDCA
US Code:
21 USC 351, 352, 353, 355
Name of Law: FFDCA
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0910-AG47
Proposed rulemaking
81 FR 58342
08/24/2016
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
4
IC Title
Form No.
Form Name
Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies - 21 CFR Part 58
ONE TIME RECORDKEEPING Burden resulting from new regulations
ONE TIME REPORTING Burdens resulting from new regulations
RECURRING Burden from proposed new regulations
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Changing Regulations
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
The information collection is being revised by rulemaking. Proposed changes are discussed in the agency's supporting statement.
Annual Cost to Federal Government:
$0
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
02/02/2017
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