[Federal Register Volume 73, Number 106 (Monday, June 2, 2008)]
[Notices]
[Pages 31492-31493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-12158]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0364] (formerly Docket No. 2007D-0080)


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 guidance for industry entitled ``Indexing Structured 
Product Labeling.'' This guidance explains that the Center for 
Biologics Evaluation and Research (CBER) and the Center for Drug 
Evaluation and Research (CDER) will index structured product labeling 
(SPL) in the product labeling for human drug and biologic products. 
This guidance also makes recommendations to industry on how to submit 
input regarding the indexing information in the SPL.

DATES: Submit written or electronic comments on agency guidance 
documents at any time.

ADDRESSES:  Submit written requests for single copies of the guidance 
to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring MD 20993-0003, or the 
Office of Communication, Training, and Manufacturers Assistance (HFM-
40), Center for Biologics Evaluation and Research, Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist that office in 
processing your requests. The guidance can also be obtained by mail by 
calling CBER at 1-800-835-4709 or 301-827-1800. Submit written comments 
on the 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 
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], or
     Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Indexing Structured Product Labeling.'' This guidance 
explains that CBER and CDER will index SPL in the product labeling for 
human drug and biological products. This guidance also makes 
recommendations to industry on how to submit input regarding the 
indexing information in the SPL.
    A Health Level Seven (HL7) standard, SPL enables the electronic 
exchange of 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 with clinical decision 
support tools and electronic prescribing systems to rapidly search and 
sort product information found in product labeling. Indexing the 
content of labeling with 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

[[Page 31493]]

the 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 guidance also recommends that applicants submit any questions 
regarding existing indexing, including any requests to add or revise an 
indexing element, to FDA by e-mail at [email protected]. Inquiries and 
requests will be forwarded to the appropriate FDA personnel, who will 
consider them and make any appropriate change in the SPL.
    In the Federal Register of March 19, 2007, FDA announced a draft 
version of this guidance entitled ``Indexing Structured Product 
Labeling'' (72 FR 12807). A number of comments were received, and FDA 
considered them carefully during finalization of the guidance. For 
example, applicants expressed a desire to recommend indexing terms to 
FDA; the guidance now provides advice on this topic. Applicants also 
indicated that they would like to see the indexing terms that FDA has 
selected prior to indexing. The guidance describes a high level process 
for sharing indexing terms before FDA actually indexes the SPL decision 
for a specific element, e.g., pharmacologic class. The guidance also 
clarifies various points set forth in the draft guidance that the 
public suggested needed clarification. This guidance is being issued as 
a joint CDER-CBER guidance in preparation for CBER to implement SPL in 
the future.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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

    Comments on agency guidances are welcome at any time. 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.
    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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, or http://www.fda.regulations.

    Dated: May 23, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-12158 Filed 5-30-08; 8:45 am]
BILLING CODE 4160-01-S