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Notice

Draft Guidance for Industry on Indexing Structured Product Labeling; Availability

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Indexing Structured Product Labeling.” This guidance explains that the Center for Drug Evaluation and Research (CDER) will index structured product labeling (SPL) in the product labeling for human drugs. This guidance also makes recommendations to industry on how to request a change to the indexing information in the SPL.

DATES:

Submit written or electronic comments on the draft guidance by June 18, 2007. General comments on agency guidance documents are welcome at any time.

ADDRESSES:

Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.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 Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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.fda.gov/​dockets/​ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

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FOR FURTHER INFORMATION CONTACT:

Laurie Burke, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6462, Silver Spring, MD 20993-0002, laurie.burke@fda.hhs.gov.

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SUPPLEMENTARY INFORMATION:

I. Background

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Indexing Structured Product Labeling.” This guidance explains that FDA's CDER will index SPL in the product labeling for human drugs. This guidance also makes recommendations to industry on how to request a change to the indexing information in the SPL.

A Health Level Seven (HL7)1 standard, SPL is used for electronically exchanging the content of labeling and other regulated product information using the extensible markup language. The SPL standard enables the inclusion of indexing elements with product labeling. These machine-readable identifiers enable users, such as clinical decision support tools and electronic prescribing systems, to rapidly search and sort product information found in product labels. Indexing the SPL will greatly facilitate the efficient communication of important drug information to the public, helping create a more robust nationwide system for promoting the safe and effective use of drugs.

After completing a 6-month pilot project evaluating how best to add indexing elements, FDA determined that the most efficient strategy is for FDA, not individual applicants, to index the SPL using a phased approach. We will index the pharmacological class during the first phase. We are adding pharmacologic class first because: (1) It is important for the safe use of drugs, (2) it is necessary for making future indexing meaningful (e.g., drug interactions), and (3) this choice leverages existing FDA resources. After pharmacologic class, we will be seeking public input on which indexing elements should be added in future phases.

The draft guidance also recommends that applicants submit any questions regarding existing indexing, including any requests to add or revise an indexing element, to CDER (spl@fda.hhs.gov). Inquiries and requests will be forwarded to the appropriate FDA personnel who will consider them and make the appropriate change in the SPL.

This 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 indexing SPL. 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 requirements of the applicable statutes and regulations.

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. 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 may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

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

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Start Printed Page 12808

Dated: March 7, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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Footnotes

1.  See http://www.hl7.org. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.)

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[FR Doc. E7-4881 Filed 3-16-07; 8:45 am]

BILLING CODE 4160-01-S