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

Forms and Documents

Document Name	Status
Supporting Statement A - 2012_revised.doc Supporting Statement A	2012-08-01

IC Document Collections

IC ID	Document Title	Status
6295	Annual Burden for Labeling Requirement in 201.56 and 201.57	Modified
188335	Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Final Rule	Removed
188334	Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Final Rule	Removed
188333	Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Final Rule	Removed

ICR Details

OMB Control No: 0910-0572	ICR Reference No: 201204-0910-001
Status: Historical Active	Previous ICR Reference No: 200901-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/15/2012
	Date Received in OIRA: 04/04/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2015	36 Months From Approved	08/31/2012
Responses	105	0	973
Time Burden (Hours)	351,645	0	471,295
Cost Burden (Dollars)	0	0	0

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Abstract: FDA regulations governing the format and content of labeling for human prescription drug and biological products requiring that the labeling of new and recently approved products contain highlights of prescribing information, a table of contents for prescribing information, reordering of certain sections, minor content changes, and minimum graphical requirements.

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Authorizing Statute(s): Statute at Large: 52 Stat. 1040 Name of Statute: null
  

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:
	76 FR 78668	12/19/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 16234	03/20/2012
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Annual Burden for Labeling Requirement in 201.56 and 201.57
Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Final Rule
Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Final Rule
Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Final Rule

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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	105	973	0	-866	-2	0
Annual Time Burden (Hours)	351,645	471,295	0	-112,952	-6,698	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The changes in burden from the information collection in the final rule are the result of reductions in the number of submissions that have occurred because 6 years have expired under the implementation plan.

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Annual Cost to Federal Government: $210,000

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: 04/04/2012

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