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

Forms and Documents

Document Name	Status
0119 GLP PRIA for PR Aug 2016.pdf Supplementary Document	2017-02-02
0119 Supporting Statement for GLP PR published 24 Aug 2016.pdf Supporting Statement A	2017-02-02

IC Document Collections

IC ID	Document Title	Status
5731	Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies - 21 CFR Part 58	Unchanged
225546	RECURRING Burden from proposed new regulations	New
225545	ONE TIME RECORDKEEPING Burden resulting from new regulations	New
224150	ONE TIME REPORTING Burdens resulting from new regulations	New

ICR Details

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
	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

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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.

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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

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG47	Proposed rulemaking	81 FR 58342	08/24/2016

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
ONE TIME REPORTING Burdens resulting from new regulations
Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies - 21 CFR Part 58
RECURRING Burden from proposed new regulations
ONE TIME RECORDKEEPING Burden resulting from new regulations

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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.

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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

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Common Form ICR:  No

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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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