Medication Guides for Prescription Drug Products: 21 CFR part 208

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
E-D.pdf	Public Comments	Uploaded 2026-07-27	Repair queued
E-C.pdf	Public Comments	Uploaded 2026-07-27	Repair queued
E-A.pdf	Public Comments	Uploaded 2026-07-27	Repair queued
PPLA Comment Letter FDA-2025-N-6869-Final 7-24-26.pdf	Public Comments	Uploaded 2026-07-27	Repair queued
E-B.pdf	Public Comments	Uploaded 2026-07-27	Repair queued
0393 Patient Medication Guides SSA 2026 - 30D response.docx	Supporting Statement A	Uploaded 2026-08-05	Repair queued
0393 Patient Medication Guides SSA 2026 - Reinstatement.docx	Supporting Statement A	Uploaded 2026-07-01	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
6050	Content and Format of Medication Guide		Modified
281295	Mfr. provides PMG or means to produce to distributers & authorized dispensers		New
205325	Dispensing Medication Guide to patient		Modified
188594	Distributor provides Medication Guide or means to produce to Dispenser		Modified
187331	Exemptions and Deferrals		Unchanged

ICR Details

OMB Control No: 0910-0393	ICR Reference No: 202607-0910-001
Status: Active	Previous ICR Reference No: 202210-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Medication Guides for Prescription Drug Products: 21 CFR part 208
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/07/2026
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/01/2026
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2029	36 Months From Approved
Responses	508,587,951	0	0
Time Burden (Hours)	4,325,499	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports agency regulations pertaining to information communicated to patients through Patient Medication Guides found in 21 CFR part 208. Respondents to the information collection are sponsors of prescription drug products and authorized dispensers of prescription drug products who are required to provide the information upon dispensing the prescription drug product. FDA reviews the information as part of new drug marketing and biologic license applications submitted by product sponsors.

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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:
	91 FR 3511	01/27/2026
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 40000	07/01/2026
Did the Agency receive public comments on this ICR? Yes

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

table that charts list of burden

IC Title	Form No.	Form Name
Content and Format of Medication Guide
Dispensing Medication Guide to patient
Distributor provides Medication Guide or means to produce to Dispenser
Exemptions and Deferrals
Mfr. provides PMG or means to produce to distributers & authorized dispensers

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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	508,587,951	0	0	0	4,829,782	503,758,169
Annual Time Burden (Hours)	4,325,499	0	0	0	-22,938,375	27,263,874
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: $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: 07/01/2026

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