Guidance for Industry on Labeling for Products Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Act: Questions and Answers

Forms and Documents

Document Name	Status
Supporting Statement A - 0910-0641.doc Supporting Statement A	2012-07-24

IC Document Collections

IC ID	Document Title	Status
188840	Domestic address or phone number labeling requirement (21 U.S.C. 502(x)) and recommendation to clarify its purpose	Modified

ICR Details

OMB Control No: 0910-0641	ICR Reference No: 201207-0910-011
Status: Historical Inactive	Previous ICR Reference No: 201207-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Guidance for Industry on Labeling for Products Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Act: Questions and Answers
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Improperly submitted and continue	Conclusion Date: 10/15/2012
	Date Received in OIRA: 07/27/2012
Terms of Clearance: In accordance with the terms of 5 CFR 1320, this information collection is improperly submitted. Previous terms of clearance require FDA to accurately classify the burden related to third party disclosure. The Agency does not appear to have done so. We also note that the underlying Guidance document should be uploaded as part of the collection.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2012	36 Months From Approved	10/31/2012
Responses	100,000	0	100,000
Time Burden (Hours)	400,000	0	400,000
Cost Burden (Dollars)	0	0	0

---

Abstract: The guidance provides information on: (1) The meaning of "domestic address" for purposes of the labeling requirements of section 502(x) of the act; (2) FDA's recommendation for the use of an introductory statement before the domestic address or telephone number that is required to appear on the product label under section 502(x) of the act; and (3) FDA's intent regarding enforcing the labeling requirements of section 502(x) of the act. Public Law 109-462 also requires certain postmarketing safety reports for dietary supplements.

---

Authorizing Statute(s): PL: Pub.L. 109 - 462 760 Name of Law: DSNDCPA
  

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:
	77 FR 28604	05/15/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 43841	07/26/2012
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
Domestic address or phone number labeling requirement (21 U.S.C. 502(x)) and recommendation to clarify its purpose

---

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:

---

Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 07/27/2012

---