[Federal Register Volume 72, Number 52 (Monday, March 19, 2007)]
[Notices]
[Pages 12807-12808]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-4881]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0080]


Draft Guidance for Industry on Indexing Structured Product 
Labeling; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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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availability of a draft guidance for industry entitled ``Indexing 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DATES:  Submit written or electronic comments on the draft guidance by 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Division of Dockets Management (HFA-305), 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access to the draft guidance document.

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, 
[email protected].

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availability of a draft guidance for industry entitled ``Indexing 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.
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    \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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    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 ([email protected]). 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 orhttp://www.fda.gov/ohrms/dockets/default.htm.


[[Page 12808]]


    Dated: March 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-4881 Filed 3-16-07; 8:45 am]
BILLING CODE 4160-01-S