Prescription Drug Product Labeling; Medication Guide Requirements

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0393 Patient Medication Guides SSA 2022 EXT.docx	Supporting Statement A	Uploaded 2022-10-31	Repair queued
PDUFA User Fee Schedule 87 FR 61063 Oct 7 2022.pdf	Supplementary Document	Uploaded 2022-10-24	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
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		Removed

ICR Details

OMB Control No: 0910-0393	ICR Reference No: 202210-0910-010
Status: Historical Active	Previous ICR Reference No: 201908-0910-014
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 with change	Conclusion Date: 02/07/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 10/31/2022
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2026	36 Months From Approved	02/28/2023
Responses	503,758,169	0	507,957,217
Time Burden (Hours)	27,263,874	0	27,491,378
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:
	87 FR 16199	03/22/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 61040	10/07/2022
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

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

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ICR Summary of Burden

table that charts list 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	503,758,169	507,957,217	0	0	-4,199,048	0
Annual Time Burden (Hours)	27,263,874	27,491,378	0	0	-227,504	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 a downward adjustment in the number of respondents, which we attribute to a decrease in submissions we have received over the past few years. We have also adjusted the number of third-party respondents to reflect the current estimate of pharmacies to 88,000. As noted in Question 8 above, we have removed the burden we attribute to reporting associated with supplements and other changes to approved ANDAs, NDAs, and BLAs (21 CFR 314.70(b)(3)(ii) and 601.12(f)), as this burden is accounted for in other approved collections. Cumulatively these adjustments result in an overall decrease of 4,199,048 responses and 227,504 hours annually.

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Annual Cost to Federal Government: $1,001,407

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? No

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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: 10/31/2022

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