Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products

Forms and Documents

Document Name	Status
0572 Rx labeling for drugs and biologics SSA 2018 Ext.pdf Supporting Statement A	2018-12-05

IC Document Collections

IC ID	Document Title	Status
6295	Labeling Requirements	Modified

ICR Details

OMB Control No: 0910-0572	ICR Reference No: 201810-0910-004
Status: Active	Previous ICR Reference No: 201506-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/28/2019
	Date Received in OIRA: 12/06/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2022	36 Months From Approved	12/31/2018
Responses	541	0	197
Time Burden (Hours)	1,258,907	0	659,753
Cost Burden (Dollars)	0	0	0

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Abstract: The information collection supports agency regulations governing the content and format of labeling for human prescription drug and biological products. Respondents to the collection are sponsors of new drug and biological product applications.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 34596	07/20/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 58776	11/21/2018
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Labeling Requirements

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ICR Summary of Burden

	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	541	197	0	0	344	0
Annual Time Burden (Hours)	1,258,907	659,753	0	0	599,154	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 12/06/2018

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