[Federal Register Volume 84, Number 174 (Monday, September 9, 2019)]
[Notices]
[Pages 47308-47309]
[FR Doc No: 2019-19346]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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_ADDRESS>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

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


[Federal Register Volume 79, Number 101 (Tuesday, May 27, 2014)]
[Notices]
[Pages 30230-30231]
[FR Doc No: 2014-12096]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2014-0033]

Reports, Forms, and Recordkeeping Requirements

AGENCY: National Highway Traffic Safety Administration (NHTSA), U.S.
Department of Transportation (DOT).

ACTION: Notice and request for public comments on a proposed collection
of information.

-----------------------------------------------------------------------

SUMMARY: Before a Federal agency can collect certain information from
the public, it must receive approval from the Office of Management and
Budget (OMB). Under procedures established by the Paperwork Reduction
Act of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of information. NHTSA invites
public comments about our intention to request OMB approval for a new
collection of information. The collection involves eligibility,
demographic, scheduling preferences, and debriefing questionnaires. The
information will be used to recruit participants for a research study
that focuses on driver response with various automatic transmission
gear selector designs during routine and emergency simulated driving
scenarios.

DATES: Written comments must be received on or before July 28, 2014.

ADDRESS: You may submit comments identified by the Docket No. NHTSA-
2014-0033 through one of the following methods:
    Federal eRulemaking Portal: Go to http://www.regulations.gov.
Follow the instructions for submitting comments on the electronic
docket site by clicking ``Help'' or ``FAQs.''
    Mail or Hand Delivery: Docket Management Facility, M-30, U.S.
Department of Transportation, 1200 New Jersey Avenue SE., West Building
Ground Floor, Room W12-140, Washington, DC 20590. Hand delivered
documents accepted between 9 a.m. and 5 p.m. Eastern Time, Monday
through Friday, except Federal Holidays. Telephone:<PHONE_NUMBER>.
    Fax:<PHONE_NUMBER>
    Instructions: Each submission must include the Agency name and the
Docket number for this proposed collection of information. Note that
all comments received will be posted without change to http://www.regulations.gov, including any personal information provided.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000
    (65 FR 19477-78) or you may visit http://www.dot.gov/privacy.html.

FOR FURTHER INFORMATION CONTACT: For background documents, contact Lisa
Gavin, Office of Crash Avoidance Standards (NVS-121), U.S. Department
of Transportation, National Highway Traffic Safety Administration, West
Building, W43-432, 1200 New Jersey Avenue SE., Washington, DC 20590.
Ms. Gavin can be reached at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. OMB has promulgated regulations describing what must be
included in such a document. Under OMB's regulation (at 5 CFR
1320.8(d)), an agency must request public comment on the following:
    (i) Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
    (ii) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (iii) How to enhance the quality, utility, and clarity of the
information to be collected;
    (iv) How to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses.
    In compliance with these requirements, NHTSA asks for public
comments on the following proposed collection of information:
    Title: Recruitment and Debriefing of Human Subjects for Research
Related to Motor Vehicle Gear Selection Controls
    Type of Request: New information collection.
    OMB Control Number: 2127-New.

    Form Number: N/A.
    Requested Expiration Date of Approval: Upon completion of the
study.
    Abstract: The introduction of electronically-controlled
transmissions has allowed much greater freedom in the design of driver
interfaces, with the result that drivers are being confronted with new
and different types of gear selector controls--joysticks, push buttons,
rotary knobs, etc. This information collection is incidental to the
recruitment of participants for human-factors studies designed to
measure the ability of drivers to adapt to unfamiliar types of gear-
selection controls. There is no known published usability research
related to these new types of driver interfaces.
    The proposed studies will examine driver response to non-
traditional gear selector configurations in routine and emergency
simulated driving scenarios, noting driver confusion, distraction and
unintended consequences due to the unconventional gear selector
configuration. The research method consists of driving simulations to
collect objective and subjective data about six different gear selector
types. Approximately 500 drivers will respond to the request for
participants. It is estimated that of the 500 respondents, 360 will
ultimately be recruited and participate. The estimated burden hours
were calculated for the pre and post experiment questionnaires and for
performing the driving tasks for the 500 respondents accordingly.
    Participants will be tested individually in a driving simulator
located at the Volpe National Transportation Systems Center (Volpe
Center), which will conduct this research under an Intra-Agency
Agreement (IAA) with NHTSA. The information being collected consists of
that required for scheduling appointments and for balancing the subject
sample across age groups, gender, and previous driving experience with
various motor vehicle gear selector configurations. The experimental
data will contain the demographic and past-experience descriptors for
each participant, but no personally identifiable information. During or
after the experimental sessions, participants may be queried regarding
their perceptions and preferences about various aspects of gear-
selection controls.
    Description of the Need for the Information and Proposed Use of the
Information: The collection of information consists of: (1) An
eligibility questionnaire, (2) a demographic questionnaire; (3)
scheduling preferences; and (4) post-experiment questionnaires. The
information to be collected will be used to:
     Eligibility questionnaire will be used to obtain self-
reported driving history information. Individuals interested in
participating in the study will be asked to provide information about
their driving history (e.g., years of driving experience, daily driving
usage, familiarity with different types of gear selectors). Individuals
will be excluded from participating in the experiment if they do not
have a valid driver license.
     Demographic questionnaire will be used to obtain
demographic information to confirm that the study group includes
participants from various age groups and both genders.
     Scheduling preferences will be used to establish a
convenient time for the participants to visit the Volpe Center.
     Post-experiment questionnaire will be used to gather
information about drivers' beliefs and attitude towards each gear
selector configuration tested, and to explore respondent knowledge of
how a motor vehicle will likely respond when shifted to positions other
than Drive at highway speed. These questionnaires will also be used to
assess perceived usability of the various gear selector configurations
in terms of acceptance and satisfaction, as well as willingness to have
a particular gear selector configuration in their vehicle.
    Respondents: drivers with a valid driver license.
    Estimated Number of Respondents: 500.
    Estimated Number of Respondents Selected: 360.
    Estimated Total Annual Burden: 595 hours (1 hour and 38 minutes per
selected respondent and 3 minutes per respondent not selected.)
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for the agency's performance of
its functions; (b) the accuracy of the estimated burden; (c) ways for
the agency to enhance the quality, utility and clarity of the
information to be collected; and (d) ways that the burden could be
minimized without reducing the quality of the collected information.
The agency will summarize your comments and the agency's responses in
the request for OMB clearance of this information collection.

    Authority: The Paperwork Reduction Act of 1995, 44 U.S.C. chap.
35; 49 U.S.C. 30181-83; under authority delegated in 49 CFR 1.95

Claude H. Harris,
Acting Associate Administrator for Rulemaking.
[FR Doc. 2014-12096 Filed 5-23-14; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register: February 27, 2009 (Volume 74, Number 38)]
[Notices]
[Page 8930-8931]
[DOCID:fr27fe09-56]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER09-687-000]

Florida MSW LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

February 20, 2009.
    This is a supplemental notice in the above-referenced proceeding of
Florida MSW LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC, 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to

intervene or protest must serve a copy of that document on the
Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is March 12, 2009.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC, 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
 [FR Doc. E9-4165 Filed 2-26-09; 8:45 am]

BILLING CODE 6717-01-P