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Notice

Draft Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the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: Revision 1; Availability

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance entitled “Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the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 Start Printed Page 75437Consumer Protection Act: Revision 1.” This revised draft guidance is intended to assist industry in complying with the labeling requirements for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application established by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. The revision of the draft guidance changes the date on which FDA intends to begin enforcing these labeling requirements. Separate guidance, issued by the Center for Food Safety and Applied Nutrition on complying with the labeling requirements for dietary supplements, is announced elsewhere in this issue of the Federal Register.

DATES:

You can submit written or electronic comments on this revised draft guidance, or any guidance, at any time (see 21 CFR 10.115(g)(5)).

ADDRESSES:

Submit written requests for single copies of the revised draft guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the revised draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the revised draft guidance document.

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FOR FURTHER INFORMATION CONTACT:

Walter Ellenberg, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5488, Silver Spring, MD 20993, 301-796-2090.

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SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a revised draft guidance 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: Revision 1.” 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. The law also amended the act to add section 502(x) (21 U.S.C. 352(x)), which requires the label of an OTC drug product marketed in the United States without an approved application to include a domestic address or domestic telephone number through which the product's manufacturer, packer, or distributor may receive reports of serious adverse events associated with its use.

In the Federal Register of January 2, 2008 (73 FR 196), FDA issued a draft guidance document containing questions and answers relating to the new labeling requirements under Public Law 109-462 for OTC drugs marketed without an approved application. Although interested parties can comment on any guidance at any time, to ensure that the agency considered comments on the draft guidance before beginning work on the final version of the guidance, FDA requested that interested parties submit comments by March 3, 2008. FDA is still working to finalize the guidance.

Because the agency is still in the process of finalizing the guidance, FDA is issuing this revised draft guidance to notify industry that it intends to exercise enforcement discretion with regard to these labeling requirements for an additional 1-year period. The draft guidance issued on January 2, 2008, stated that FDA intended to begin enforcing the requirements of section 502(x) of the act for OTC drug products marketed without an approved application that are labeled on or after January 1, 2009. The revised draft guidance remains identical to the draft guidance issued on January 2, 2008, with respect to all topics except that it states that FDA intends to begin enforcing the labeling requirements of section 502(x) of the act for OTC drug products marketed without an approved application that are labeled on or after January 1, 2010.

This revised draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirement of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval.

To comply with this requirement, FDA's notice in the Federal Register announcing the availability of the draft guidance gave notice of the proposed collections of information in the draft guidance. The notice included an analysis and burden estimate for these proposed collections of information and provided 60 days for public comment under the PRA. Because this revised draft guidance makes no change, other than to change the date on which FDA intends to begin enforcing the labeling requirements of section 502(x) of the act for OTC drug products marketed without an approved application, FDA is not providing a revised PRA analysis and burden estimate in this notice.

III. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the revised draft guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov.

IV. Electronic Access

Persons with access to the Internet may obtain the document at http://www.fda.gov/​cder/​guidance/​index.htm.

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Start Printed Page 75438

Dated: December 5, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.

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[FR Doc. E8-29301 Filed 12-8-08; 11:15 am]

BILLING CODE 4160-01-S