Time and Extent Applications for Nonprescription Drug Products

Forms and Documents

Document Name	Status
0688 Supporting Statement 11-29-2023.docx Supporting Statement A	2023-11-29

IC Document Collections

IC ID	Document Title	Status
197086	Time and Extent Application; Reporting Activities Other-Guidance	Modified

ICR Details

OMB Control No: 0910-0688	ICR Reference No: 202305-0910-005
Status: Received in OIRA	Previous ICR Reference No: 202010-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Time and Extent Applications for Nonprescription Drug Products
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/14/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2023
Responses	1	9
Time Burden (Hours)	862	7,756
Cost Burden (Dollars)	0	0

---

Abstract: This information collection supports certain FDA regulations in 21 CFR part 330 regarding over-the-counter (OTC) human drugs and associated guidance. Specifically, our regulations in §§ 330.14 and 330.15 (21 CFR 330.14 and 330.15), established additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded. However, these regulations are not reflective of more-recently enacted statutory provisions that govern the regulation of OTC human drugs marketed without approved new drug applications, under the OTC drug review process, and accordingly, these regulations will be withdrawn. These regulations provided that OTC drug products introduced into the U.S. market after the OTC drug review began in 1972 and OTC drug products without any marketing experience in the United States could be evaluated under the OTC monograph system if the conditions (e.g., active ingredients) met certain ‘‘time and extent’’ criteria outlined in the regulations. The regulation in 21 CFR 330.14 allowed a sponsor to submit certain information to the Agency in a time and extent application (TEA) for use to determination the eligibility of a condition for consideration in the OTC monograph system.

---

Authorizing Statute(s): US Code: 21 USC 301 et seq. Name of Law: FFDCA
  

Citations for New Statutory Requirements: US Code: 21 USC 355g Name of Law: Federal Food, Drug and Cosmetic Act

---

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:
	88 FR 53497	08/08/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 85642	12/08/2023
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Time and Extent Application; Reporting Activities

---

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	1	9	-8	0	0	0
Annual Time Burden (Hours)	862	7,756	-6,894	0	0	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: As a result of the statutory provision, we anticipate no TEA submissions. For purposes of burden calculation, we assume one respondent as a placeholder. Our estimated burden for the information collection reflects, as a result of the statutory provision, a program change decrease of 6,894 hours and a corresponding decrease of 8 responses.

---

Annual Cost to Federal Government: $1,146

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

---

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: 12/14/2023

---