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

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT FINAL 0572 6-22-2015.doc Supporting Statement A	2015-06-22

IC Document Collections

IC ID	Document Title	Status
6295	Labeling Requirements	Modified

ICR Details

OMB Control No: 0910-0572	ICR Reference No: 201506-0910-012
Status: Historical Active	Previous ICR Reference No: 201204-0910-001
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: 12/02/2015
	Date Received in OIRA: 06/23/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2018	36 Months From Approved	12/31/2015
Responses	197	0	105
Time Burden (Hours)	659,753	0	351,645
Cost Burden (Dollars)	0	0	0

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Abstract: Section 201.57(a) requires that prescription drug labeling for new and more recently approved prescription drug products include "Highlights of Prescribing Information." Highlights provides a concise extract of the most important information required under § 201.57(c) (the Full Prescribing Information (FPI)), as well as certain additional information important to prescribers. Section 201.57(b) requires a table of contents to prescribing information, entitled "Full Prescribing Information: Contents," consisting of a list of each heading and subheading along with its identifying number to facilitate health care practitioners' use of labeling information. Section 201.57(c) specifies the contents of the FPI. Section 201.57(d) mandates the minimum specifications for the format of prescription drug labeling and establishes minimum requirements for key graphic elements such as bold type, bullet points, type size, and spacing. Older drugs not subject to the revised labeling content and format requirements in § 201.57 are subject to labeling requirements at § 201.80. Section 201.80(f)(2) requires that within 1 year, any FDA-approved patient labeling be referenced in the "Precautions" section of the labeling of older products and either accompany or be reprinted immediately following the labeling.

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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:
	80 FR 2943	01/21/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 30686	05/29/2015
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	197	105	0	0	92	0
Annual Time Burden (Hours)	659,753	351,645	0	0	308,108	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: The increase to the estimate is in light of an increased number of NDAs/BLAs received by FDA in the 2011-2014 period compared to 2008-2010.

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Annual Cost to Federal Government: $146,125,000

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: 06/23/2015

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