E9-3917. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement ...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA). Elsewhere in this issue of the Federal Register, FDA is announcing that a proposed collection of information regarding dietary supplement labeling requirements and recommendations has been submitted for OMB review.

DATES:

Fax written comments on the collection of information by March 26, 2009.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: [phone], or e-mailed to [e-mail]. All comments should be identified with the title “Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers.” Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Elizabeth Berbakos, Office of Information Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-3792.

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers

On December 22, 2006, the President signed into law the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109-462, 120 Stat. 3469). This law amends the Federal Food, Drug, and Cosmetic Act (the act) with respect to serious adverse event reporting for dietary supplements and nonprescription drugs marketed without an approved application.

Section 502(x) of the act (21 U.S.C. 352(x)), which was added by Public Law 109-462, requires the label of a nonprescription drug product marketed without an approved application in the United States to include a domestic address or domestic telephone number through which a responsible person may receive a report of a serious adverse event associated with the product. In the Federal Register of January 2, 2008 (73 FR 196), FDA announced the availability of a draft guidance document entitled “Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.” In the Federal Register of December 11, 2008 (73 FR 75436), FDA published a notice of availability of a revised version of the same draft guidance document. The guidance document contains questions and answers relating to the labeling requirement and provides guidance to industry on the following topics: (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.

Title: Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers.

Description of Respondents: Respondents to this collection of information are manufacturers, packers, and distributors whose name (under section 502(b)(1) of the act (21 U.S.C. 352(b)(1))) appears on the label of a nonprescription drug product marketed in the United States without an approved application.

Burden Estimate: FDA is requesting public comment on the estimated one-time reporting burden from these respondents, as required by 502(x) of the act and described in the guidance “Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers.” The estimates for one-time reporting are based on FDA's knowledge of nonprescription drug product labeling in the United States, whether or not marketed under an approved application.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden ¹

	No. of Respondents	Frequency per Response	Total Responses	Hours per Response	Total Hours
Domestic address or telephone number labeling requirement (21 U.S.C. 502(x)) and recommendation to clarify its purpose	200	500	100,000	4	400,000
1 There are no capital costs or maintenance and operating costs associated with this collection of information.

As indicated in Table 1 of this document, we estimate that approximately 200 manufacturers will revise approximately 100,000 labels to add a full domestic address and a domestic telephone number, and should they choose to adopt the guidance's recommendation, to add a statement identifying the purpose of the domestic address or telephone number. FDA believes that designing the label change should not take longer than 4 hours per label. Automated printing of the labels should only require a few seconds per label. This estimate accounts for the possibility that every manufacturer will make label revision, which is unlikely. Because the majority of over-the-counter drug product labels currently have a domestic telephone number that satisfies the requirement, we believe many manufacturers will opt not to adopt the guidance's recommendation to add a statement identifying the purpose of the address or telephone number, significantly reducing the number of total responses. However, assuming that all labels are revised, estimate a one-time reporting burden for this information collection of 400,000 hours.

In the Federal Register of January 2, 2008 (73 FR 196), FDA published a notice of availability for the original draft guidance that also gave notice of the proposed collections of information in the draft guidance, included an analysis and burden estimate for those proposed collections of information, and provided 60 days for public comment under the PRA. FDA did not revise the PRA burden analysis and estimate when it issued the revised draft guidance in December 2008 because the revisions did not affect them.

FDA received one comment on the proposed collections of information, stating that the time involved in revising labels would be significantly longer than the typical timeframe to implement labeling changes because the volume of labels required to be revised at one time might exceed manufacturers' labeling revision capacity. Several comments requested that FDA extend the date of its enforcement discretion. In response to comments, in December 2008, FDA published a notice of availability of the revised draft guidance for industry. The revised draft guidance was identical to the first draft guidance, with the exception that, in the revised draft guidance, FDA stated its intention to exercise enforcement discretion until January 1, 2010. As a result, any label revision made as a result of this guidance would likely be made contemporaneously with other scheduled label revisions, minimizing the burden to industry.

Dated: February 17, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.