[Federal Register Volume 80, Number 93 (Thursday, May 14, 2015)]
[Notices]
[Pages 27690-27691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11596]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1349]


Electronic Study Data Submission; Data Standards; Support for the 
Logical Observation Identifiers Names and Codes

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is encouraging sponsors 
and applicants to provide Logical Observation Identifiers Names and 
Codes (LOINC) codes (available at http://loinc.org/) for clinical 
laboratory test results in investigational study data provided in 
regulatory submissions submitted to the Center for Drug Evaluation and 
Research and to the Center for Biologics Evaluation and Research. LOINC 
code is defined as electronic messages for laboratory test results and 
clinical observations. The decision to adopt LOINC for lab test results 
is part of a larger FDA effort to align the use of data standards for 
clinical research with ongoing nationwide health information technology 
initiatives. FDA invites public comment on appropriate steps the Agency 
could take to promote the use and utility of LOINC-coded clinical data 
submitted to the Agency. The LOINC common terminology will be listed in 
the FDA Data Standards Catalog that is posted to FDA's Study Data 
Standards Resources Web page at http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm.

DATES: Although you can comment on this notice at any time, to ensure 
that the Agency considers your comments submit either electronic or 
written comments by June 29, 2015.

ADDRESSES: Submit written requests for single copies of the documents 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 2201, Silver Spring, MD 20993-0002 or the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 10903 New 
Hampshire Avenue, Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. 
Send one self-addressed adhesive label to assist that office in 
processing your requests.
    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.

FOR FURTHER INFORMATION CONTACT: Ron Fitzmartin, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993-002, 301-
796-5333, [email protected], or Stephen Ripley, Center for 
Biologics Evaluation and Research, Food and Drug Administration, Bldg. 
71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    LOINC is a clinical terminology housed by the Regenstrief 
Institute, a nonprofit medical research organization associated with 
Indiana University (available at http://www.regenstrief.org/). LOINC 
was initiated in 1994 as a response to the demand for electronic 
movement of clinical data from laboratories that produce the data to 
consumers of clinical data. LOINC codes are universal identifiers for 
laboratory and other clinical observations that enable semantically 
interoperable clinical data exchange. The purpose of LOINC is to 
facilitate the exchange and pooling of clinical data for clinical care, 
outcomes management, and research.
    The laboratory portion of the LOINC database contains the 
categories of chemistry, hematology, serology, microbiology (including 
parasitology and virology), toxicology, and more. The clinical portion 
of the LOINC database includes entries for vital signs, hemodynamics, 
intake/output, EKG, obstetric ultrasound, cardiac echo, urologic 
imaging, gastroendoscopic procedures, and selected survey instruments.
    FDA is now encouraging sponsors and applicants to provide LOINC 
codes for laboratory test data in investigational studies provided in 
regulatory submissions (e.g., investigational new drug applications 
(INDs), new drug applications (NDAs), abbreviated new drug applications 
(ANDAs), biologics license applications (BLAs)) when those LOINC codes 
are available (e.g., from the clinical laboratory that performed the 
test). FDA supports LOINC-coded laboratory test results because: (1) 
LOINC is widely used among clinical laboratories, (2) LOINC-coded lab 
data make the information easier to understand and analyze, and (3) the 
currently supported exchange standard for laboratory test results in 
clinical trials, the Study Data Tabulation Model (available at http://www.cdisc.org/sdtm) already supports the exchange of LOINC codes. FDA's 
decision to adopt LOINC for lab test results is part of a larger FDA 
effort to align the use of data standards for clinical research with 
ongoing nationwide health information technology initiatives.
    FDA recognizes that there are additional steps the Agency could 
take to promote the use and utility of LOINC-coded clinical data 
submitted to the Agency. FDA invites public comment on what those 
additional steps should be, along with a suggested sequence and timing 
of those steps. For example, the Agency recognizes that the high level 
of granularity inherent in LOINC has

[[Page 27691]]

presented coding challenges and that these challenges have led to the 
creation of subsets of LOINC to help facilitate coding.
     Should FDA identify a LOINC subset for its use case?
     If yes, should FDA create its own subset or leverage 
existing subsets?
     Which LOINC subsets should FDA consider?
     What steps can FDA take to minimize the burden to sponsors 
and applicants in adopting LOINC within their organizations to support 
regulatory submissions?

II. Comments

    Interested persons may submit either electronic comments to http://www.regulations.gov or written comments regarding this notice to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: May 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11596 Filed 5-13-15; 8:45 am]
BILLING CODE 4164-01-P