Prescription Drug Product Labeling; Medication Guide Requirements

Forms and Documents

Document Name	Status
0393 PMGs SSA 2019 Ext.pdf Supporting Statement A	2019-09-09

IC Document Collections

IC ID	Document Title	Status
6050	Content and Format of a Medication Guide	Modified
205325	Distributing and Dispensing a Medication Guide to Patients	Modified
188594	Distributor Provides Medication Guide to Dispenser	Unchanged
187331	Exemptions and Deferrals	Unchanged
187330	Supplements and Other Changes to an Approved Application	Modified

ICR Details

OMB Control No: 0910-0393	ICR Reference No: 201908-0910-014
Status: Active	Previous ICR Reference No: 201510-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Prescription Drug Product Labeling; Medication Guide Requirements
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: 10/08/2019
	Date Received in OIRA: 09/10/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2022	36 Months From Approved	10/31/2019
Responses	507,957,217	0	507,957,166
Time Burden (Hours)	27,491,378	0	27,486,670
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports agency regulations pertaining to patient labeling for certain drug products. Specifically, regulations in 21 CFR part 208 describe requirements for Medications guides and enables the agency to determine whether the labeling for certain prescription drug products that pose a serious and significant public health concern comply with current safety regulations.

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Authorizing Statute(s): US Code: 21 USC 301 et seq. Name of Law: Food, Drug, and Cosmetic Act
  

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 54110	10/26/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 43608	08/21/2019
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Distributor Provides Medication Guide to Dispenser
Distributing and Dispensing a Medication Guide to Patients
Supplements and Other Changes to an Approved Application
Exemptions and Deferrals
Content and Format of a Medication Guide

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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	507,957,217	507,957,166	0	0	51	0
Annual Time Burden (Hours)	27,491,378	27,486,670	0	0	4,708	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 information collection reflects an upward adjustment in the number of respondents, which we attribute to an increase in submissions we have received over the past few years. We have also corrected a calculation error in our annual third-party disclosure burden. These adjustments result in an overall increase of 51 annual responses and 4,708 annual hours.

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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: 09/10/2019

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