General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions

Forms and Documents

Document Name	Status
Form FDA 5009 OTC User Fee Program Form	Unchanged
ACNU FinalRule_SupportingStatement_2024.docx Supporting Statement A	2024-12-19

IC Document Collections

IC ID	Document Title	Status
5943	Format & content for new OTC drug products (included FDA recommendations on statutory requirements) Other-Statutory Authority	Unchanged
273204	(RULE) ACNU statement	New
273203	(RULE) Disclosure of information on the principal display panel or within Drug Facts Labeling	New
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: 202412-0910-011
Status: Received in OIRA	Previous ICR Reference No: 202212-0910-002
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	Date Submitted to OIRA: 12/26/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	02/28/2026
Responses	29,130	29,118
Time Burden (Hours)	134,268	134,124
Cost Burden (Dollars)	0	0

---

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:
0910-AH62	Final or interim final rulemaking	89 FR 105288	12/26/2024

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
(RULE) ACNU statement
(RULE) Disclosure of information on the principal display panel or within Drug Facts Labeling
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

	Total Request	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	29,130	29,118	0	0	12	0
Annual Time Burden (Hours)	134,268	134,124	0	0	144	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: Publication of ACNU final rule increases ICR by 144 hours and 12 disclosures 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: 12/26/2024

---