Format and Content Requirements for Over-the-Counter Drug Product Labeling

Forms and Documents

Document	Type	Status	Availability
0340 OTC Drug Labeling SSA 2019 Ext.pdf	Supporting Statement A	Uploaded 2019-12-05	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
5943	Format and Content Requirements for Over--the-Counter Drug Product Labeling; new OTC drug products (including sunscreen products)		Modified
209796	Format and Content Requirements; exemptions and deferrals		Modified
209795	Format and Content Requirements for Over-the-Counter Drug Product Labeling; new OTC sunscreen products		Removed

ICR Details

OMB Control No: 0910-0340	ICR Reference No: 201911-0910-009
Status: Historical Active	Previous ICR Reference No: 201612-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Format and Content Requirements for Over-the-Counter Drug Product Labeling
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: 12/31/2019
	Date Received in OIRA: 12/05/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2022	36 Months From Approved	01/31/2020
Responses	7,859	0	961
Time Burden (Hours)	94,320	0	11,523
Cost Burden (Dollars)	1,950,000	0	0

---

Abstract: The information collection supports agency regulations at 21 CFR 201.66. Respondents to the collection of information are producers or manufacturers of drug products requiring over-the-counter (OTC) labeling subject to these regulatory requirements.

---

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

Citations for New Statutory Requirements: None

---

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:
	84 FR 28555	06/21/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 61064	11/12/2019
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Format and Content Requirements for Over-the-Counter Drug Product Labeling; new OTC sunscreen products
Format and Content Requirements for Over--the-Counter Drug Product Labeling; new OTC drug products (including sunscreen products)
Format and Content Requirements; exemptions and deferrals

---

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	7,859	961	0	0	6,898	0
Annual Time Burden (Hours)	94,320	11,523	0	0	82,797	0
Annual Cost Burden (Dollars)	1,950,000	0	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 adjustments. We have adjusted our estimate to reflect an increase of 82,797 hours and a corresponding increase of 6,898 disclosures. The increase corresponds with agency data on the number of labeling reviews associated with new OTC drug product submissions. We discuss this more fully in our supporting statement at question 15.

---

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

---

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: 12/05/2019

---