[Federal Register Volume 75, Number 112 (Friday, June 11, 2010)]
[Notices]
[Pages 33312-33313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-14047]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0256]
Indexing Structured Product Labeling for Human Prescription Drug
and Biological Products; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration's (FDA's) Center for Drug
Evaluation and Research (CDER) and Center for Biologics Evaluation and
Research (CBER) are indexing certain categories of information in
product labeling for use as terms to search repositories of approved
prescription medical product structured product labeling (SPL). FDA has
previously identified pharmacologic class as a top priority for
indexing of product labeling information. FDA is now announcing that
medical product indications is another category of product labeling
information that the agency has identified as a high priority for
indexing. CDER and CBER are announcing the establishment of a public
docket to provide an opportunity for interested parties to share
information, research, and ideas on the FDA indexing process.
DATES: Submit either electronic or written comments by August 10,
2010.
ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in the brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Colleen E. Brennan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6439, Silver Spring, MD 20993-0002, 301-
796-2316; or Denise S[aacute]nchez, Center for Biologics Evaluation and
Research, Food and Drug Administration, 1401 Rockville Pike, suite
200N, Rockville, MD 20852, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
As part of the effort to advance medical informatics to support the
safe use of medical products, CDER and CBER are using the SPL format to
index labeling information for human prescription drug and biological
products. SPL is a document markup standard approved by Health Level
Seven adopted by FDA as a mechanism for exchanging product information
by using extensible markup language. Indexing refers to the insertion
of machine-readable tags that do not appear in actual printed labeling,
but enable users with clinical decision support tools and electronic
prescribing systems to rapidly search and sort product information.
This is an important step toward the creation of a fully automated
health information exchange system.
Indexed labeling can help prevent prescription errors and enhance
the safe use of medical products. For example, among other benefits,
the SPL indexing can enable a hospital's computer system to help detect
that products prescribed by the hospital to treat a patient's injury do
not adversely interact with other products that the patient is taking.
It is important that this indexing be done consistently to enable
comprehensive searches to find all relevant information, including
appropriate synonyms.
In recent years, FDA pilot-tested the addition of SPL indexing to
human prescription drug and biological product labeling. Based on that
experience, feedback from industry, and feedback from other SPL users,
FDA's approach will be to index product labeling information and link
an indexed SPL file to the content of labeling SPL file available in
the official SPL public access repository. Considering FDA's available
resources, we have instituted a phased implementation of indexing for
certain categories for all human prescription drug and biological
product labeling. Indexing information on the pharmacologic class and
indications categories of product labeling is being undertaken by the
agency, as resources permit (see more information below). As the phased
implementation proceeds, all human prescription drug and biological
product labeling may be linked to certain key indexing.
For additional information, including the guidance for industry
``Indexing Structured Product Labeling,'' refer to the FDA Data
Standards Council Web page on SPL at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. FDA will update
the Data Standards Council Web site to include all SPL indexing and
their related terminologies as they are developed.
When the indexing of pharmacologic class and indications is
complete, FDA intends to index other categories of product labeling
information using a phased implementation process. The types and
priority order of indexing of subsequent categories will be determined
based on public input and agency priorities.
II. Indexing Pharmacologic Class
In June 2008, FDA issued the guidance for industry ``Indexing
Structured Product Labeling.'' This guidance states the agency's
intention to index product labeling information, as resources permit,
and identifies pharmacologic class as a top indexing priority. As part
of its review and label
[[Page 33313]]
approval process, FDA identifies the established pharmacologic class
for each approved medical product if appropriate. An established
pharmacologic class is one that FDA has determined is scientifically
valid and clinically meaningful according to the principles outlined in
the guidance for industry and review staff ``Labeling for Human
Prescription Drugs and Biological Products--Determining Established
Pharmacologic Class for Use in the Highlights of Prescribing
Information,'' published in October 2009.
For SPL indexing, the established pharmacologic class is
represented by an established pharmacologic class term or phrase. FDA
also uses the Department of Veterans Affairs National Drug File
Reference Terminology to identify other scientifically valid and
clinically meaningful SPL indexing terms for each active ingredient
that are representative of mechanism of action, physiologic effect, and
chemical structure.
On the FDA Data Standards Council Web site, FDA has posted a
Microsoft Excel spreadsheet containing a list of proposed established
pharmacologic classes and indexing concepts completed to date for each
active ingredient associated with approved human prescription drug and
biological products.\1\
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\1\ See http://www.fda.gov/ForIndustry/DataStandards/StructuredProductfxsp0;Labeling/ucm162549.htm.
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III. Indexing Indications Information
FDA has determined that another high priority for indexing of
product labeling information, as resources permit, is the medical
product indications category.
With indexing of indications, the goal is to determine terms or
phrases that represent the recognized disease or condition,
manifestation of a recognized disease or condition, or symptoms
associated with a recognized disease or condition that accurately
capture the approved indication appearing in the Indications section of
labeling. The current intent is to index the basic indication concepts
without the more specific usage and limitations of use information.
Criteria are under development to determine the appropriate level of
granularity and consistency in the choice of concepts indexed.
After consideration of existing alternatives including the National
Library of Medicine's Clinical Observations Recording and Encoding
(CORE) subset of Systematized Nomenclature of Medicine Clinical Terms
(SNOMED CT), FDA chose the Veterans Health Administration and Kaiser
Permanente (VA/KP) Problem List subset of SNOMED CT as the terminology
for SPL indexing of product labeling information on indication.\2\
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\2\ FDA News: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108642.htm
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SNOMED CT is a comprehensive clinical terminology that includes
expressions for body structures, clinical findings, procedures, and
hundreds of thousands of other clinical concepts. More information on
SNOMED CT is available at http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html.
IV. Request for Comments
FDA is establishing an open docket for comments to obtain public
input on the indexing process. Representatives of the human
prescription drug and biological product industries, health care
providers, and other health care professionals are particularly
encouraged to participate and submit comments.
FDA is asking for comment on all aspects of indexing the content of
labeling. In particular, FDA is asking for comments on the following:
1. FDA is currently indexing pharmacologic class and indications.
When indexing of these categories is complete, FDA plans to index
additional labeling information categories. For example, warnings and
precautions, other adverse reactions, drug interactions, pediatric, or
pregnancy information may be useful categories of information for
future indexing. Other categories may also be identified. Please
comment on the subsequent labeling categories that should be indexed by
FDA as well as the priority order for indexing these categories.
2. For each indexing category, FDA will develop a series of
principles to ensure the consistent assignment of indexing concepts.
Please comment on the type of principles that may be useful for this
task.
3. FDA chose the VA/KP Problem List subset of SNOMED CT as the
indexing terminology for indications for the following reasons:
The VA/KP Problem List is the named SPL data standard
terminology for indexing the medical condition.\3\
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\3\ SNOMED CT VA/KP subset: http://www.nlm.nih.gov/research/umls/Snomed/snomed_problem_list.html
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The subset represents conditions at a level of
discreteness that are clinically relevant.
Please comment on the use of the VA/KP Problem List for the
indexing of indications.
4. For indications, the degree of complexity indexed is limited by
FDA's intention to first capture the main focus of the indication as a
single existing concept using the 01312010 version of the SNOMED CT VA/
KP Problem List subset. Additional indication modifiers found in
approved product labeling such as disease severity or chronicity will
not always be indexed. Please comment on this approach.
5. FDA will use the SPL standard to disseminate indexing
information. Once entered into the SPL file, the indexed elements will
be available for uploading into computer systems for sorting and other
data manipulations. We believe this approach is more user friendly than
the Microsoft Excel spreadsheet format we are currently using to
showcase pharmacologic class on the Data Standards Web site. Please
comment on this approach to make SPL indexing information available to
interested parties.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments 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.
Dated: June 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-14047 Filed 6-10-10; 8:45 am]
BILLING CODE 4160-01-S