General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form FDA 5009 OVER-THE-COUNTER MONOGRAPH USER FEE COVER SHEET	Form	Unchanged	Available
Form FDA 5009 OTC User Fee Program	Form	Unchanged	Repair queued
0340 OTC Drug Labeling SSA 2022 REV.docx	Supporting Statement A	Uploaded 2022-12-19	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5943	Format & content for new OTC drug products (included FDA recommendations on statutory requirements)	Other-Statutory Authority	Modified
250630	Domestic Address or Phone Number Labeling Requirement (21 U.S.C. 352(x)) and Recommendation to Clarify its Purpose	Other-Guidance	Removed
244708	OTC User Fee Program	Form	Unchanged	OVER-THE-COUNTER MONOGRAPH USER FEE COVER SHEET
244708	OTC User Fee Program	Form	Unchanged
209796	Format and Content Requirements; exemptions and deferrals		Unchanged

ICR Details

OMB Control No: 0910-0340	ICR Reference No: 202212-0910-002
Status: Historical Active	Previous ICR Reference No: 202112-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/02/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 12/19/2022
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	29,118	0	8,760
Time Burden (Hours)	134,124	0	98,495
Cost Burden (Dollars)	0	0	1,950,000

---

Abstract: Drugs and drug products not labeled in compliance with applicable statutory and regulatory requirements may be misbranded and subject to enforcement action under the Federal Food, Drug, and Cosmetic Act. This information collection sets forth labeling required by the applicable authorities and supports FDA implementation of the attendant reporting, recordkeeping, and disclosure activities.

---

Authorizing Statute(s): US Code: 21 USC 321; 352 Name of Law: FD&C Act; Prohibited acts; misbranded drugs
   PL: Pub.L. 109 - 462 760 Name of Law: Dietary Supplement and Nonprescription Drug Consumer Protection Act
  

Citations for New Statutory Requirements: PL: Pub.L. 116 - 136 Subpart F, Part I Name of Law: CARES Act; OTC Drug Review

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 55440	09/09/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 76200	12/13/2022
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 3

table that charts list of burden

IC Title	Form No.	Form Name
Domestic Address or Phone Number Labeling Requirement (21 U.S.C. 352(x)) and Recommendation to Clarify its Purpose
Format & content for new OTC drug products (included FDA recommendations on statutory requirements)
Format and Content Requirements; exemptions and deferrals
OTC User Fee Program	FDA 5009	OVER-THE-COUNTER MONOGRAPH USER FEE COVER SHEET

---

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	29,118	8,760	0	0	20,358	0
Annual Time Burden (Hours)	134,124	98,495	0	0	35,629	0
Annual Cost Burden (Dollars)	0	1,950,000	0	0	-1,950,000	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 changes to the organization of IC elements and removal cost data elements that are included 12b of our supporting statement. The summary of burden table now includes burden we attribute to recommendations discussed in agency guidance regarding statutory labeling requirements. We have also adjusted our estimate of the annual number of responses and corresponding hours to reflect and upward fluctuation of annual new drug product labeling. Cumulatively these modifications result in an increase of 20,358 responses and 35,629 hours annually.

---

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? Yes

---

Common Form ICR:  No

---

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: 12/19/2022

---