[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