[Federal Register Volume 84, Number 174 (Monday, September 9, 2019)]
[Notices]
[Pages 47308-47309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19346]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3840]


Electronic Submissions; Data Standards; Support for Unified Code 
for Units of Measure

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
its adoption of the most current set of the Unified Code for Units of 
Measure (UCUM) codes. The UCUM is a terminology standard that contains 
a system of coding units of measure used in science and medicine. UCUM 
offers a single coding system for units of measure that does not 
contain ambiguities amongst electronic communication, and assigns a 
concise semantics to each defined unit. FDA is encouraging sponsors and 
applicants to use UCUM standard for drug establishment registration and 
drug listing, as well as for content of product labeling provided in 
regulatory submissions to the Center for Biologics Evaluation and 
Research and the Center for Drug Evaluation and Research.

ADDRESSES: You may submit either electronic or written comments at any 
time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-N-3840 for ``Electronic Submissions; Data Standards; Support 
for Unified Code for Units of Measure.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure laws. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Chenoa Conley, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1117, Silver Spring, MD 20993-0002, 301-
796-0035, [email protected], or Stephen Ripley, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION: On May 23, 2005, the Secretary of the

[[Page 47309]]

Department of Health and Human Services announced the adoption of the 
Health Level 7 (HL7) units of measure standard by all U.S. Federal 
Agencies, which had been developed under the Consolidated Health 
Informatics (CHI) initiative (see 70 FR 76287, December 23, 2005 
(available at https://www.govinfo.gov/content/pkg/FR-2005-12-23/pdf/05-24289.pdf). The CHI initiative was a Federal government-wide 
collaborative effort intended to implement health care information 
interoperability standards to enable the Federal government to more 
efficiently exchange electronic health care information. The UCUM units 
of standard measure is found in HL7 Vocabulary Table 0396 (https://www.hl7.org/special/committees/vocab/table_0396/index.cfm).
    UCUM is a mature standard in the Interoperability Standards 
Advisory (ISA) (https://www.healthit.gov/isa/representing-units-measure-use-numerical-references-and-values). The ISA process 
represents the model by which the Office of the National Coordinator 
for Health Information Technology coordinates the identification, 
assessment, and public awareness of interoperability standards and 
implementation specifications that can be used by the health care 
industry to address specific interoperability needs, including, but not 
limited to, interoperability for clinical, public health, and research 
purposes.
    FDA currently supports the use of UCUM codes (available at http://unitsofmeasure.org/trac/) in certain structured product labeling (SPL) 
submissions, such as labeling and electronic drug establishment 
registration and drug listing requirements. The SPL web page provides a 
list of UCUM names FDA currently accepts (available at https://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm168397.htm).
    Technical Specification for creating electronic files using UCUM 
for units of measure is provided in the Structured Product Labeling 
Implementation Guide for FDA Drug Establishment Registration and Drug 
Listing, which can be found on the FDA Structured Product Labeling 
Resources web page (https://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm).
    Although FDA currently supports the UCUM standard, the FDA Data 
Standards Catalog will be updated to announce immediate implementation 
of the UCUM standard. After receiving comments, the Agency may consider 
further actions regarding the adoption of the UCUM standard and/or its 
implementation date.

    Dated: September 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19346 Filed 9-6-19; 8:45 am]
 BILLING CODE 4164-01-P