[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19138-19139]
[FR Doc No: 2017-08355]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2016-0123]

Reports, Forms and Record Keeping Requirements Agency Information
Collection Activity Under OMB Review

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Notice and request for comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, this
notice announces that the Information Collection Request (ICR)
abstracted below has been forwarded to the Office of Management and
Budget (OMB) for review and comment. The ICR describes the nature of
the information collections and their expected burden.

DATES: Comments must be submitted on or before May 25, 2017.

ADDRESSES: Send comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget, 725 17th Street NW.,

Washington, DC 20503, Attention: NHTSA Desk Officer.

FOR FURTHER INFORMATION CONTACT: For additional information or access
to background documents, contact John Kindelberger, Office of
Regulatory Analysis and Evaluation, National Highway Traffic Safety
Administration, 1200 New Jersey Avenue SE., NSA-310, Washington, DC
20590. Mr. Kindelberger's telephone number is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Before a Federal agency can collect certain
information from the public, it must receive approval from the Office
of Management and Budget (OMB). In compliance with these requirements,
this notice announces that the following information collection request
has been forwarded to OMB. A Federal Register notice requesting
comments on the following information collection was published on
December 21, 2016 (81 FR 93728). The agency received no comments on
that notice.
    Title: Tire Pressure Monitoring System--Outage Rate and Repair
Costs (TPMS-ORRC).
    OMB Number: 2127-0626.
    Type of Request: Revision of a currently approved collection.
    Abstract: Improperly inflated tires pose a safety risk, increasing
the chance of skidding, hydroplaning, longer stopping distances, and
crashes due to flat tires and blowouts. Section 13 of the
Transportation Recall Enhancement, Accountability, and Documentation
(TREAD) Act, which Congress passed on November 1, 2000, directed NHTSA
to conduct rulemaking actions to revise and update the Federal motor
vehicle safety standards for tires, to improve labeling on tires, and
to require a system in new motor vehicles that warns the operator when
a tire is significantly underinflated.
    Tire Pressure Monitoring Systems (TPMS) were mandated in Federal
Motor Vehicle Safety Standard (FMVSS) No. 138, so that drivers are
warned when the pressure in one or more of the vehicle's tires has
fallen to 25 percent or more below the placard pressure, or a minimum
level of pressure specified in the standard, whichever pressure is
higher, and may be informed about which of the four tires is
underinflated. As of September 1, 2007, after a phase-in period
beginning on October 5, 2005, TPMS was required on all new light
vehicles (i.e., passenger cars, trucks, multipurpose passenger
vehicles, and buses with a gross vehicle weight rating of 10,000 pounds
or less, except those vehicles with dual wheels on an axle).
    Executive Order 12866 requires Federal agencies to evaluate their
existing regulations and programs and measure their effectiveness in
achieving their objectives. Since the phase-in of TPMS, there has been
only one evaluation of TPMS. The TPMS-SS (OMB #2127-0626) was conducted
in 2011, as a special study through the infrastructure of the National
Automotive Sampling System (NASS), to collect nationally representative
data on how effective TPMS was in reducing underinflation in the on-
road fleet of passenger vehicles. Analysis of the survey results
indicated that direct TPMS is 55.6-percent effective at preventing
severe underinflation as defined in FMVSS No. 138. However,
effectiveness was substantially lower in vehicles that were 6-7 years
old at the time of the survey. One explanation as to why this is true
was the possibility that the drivers of these older vehicles were not
taking all the maintenance actions (e.g., adding TPMS sensors to new
replacement tires, replacing non-functioning sensors on current tires,
having the system properly re-set when needed) that were needed to
insure the vehicles had functioning TPMS. Relevant data are needed to
examine why the effectiveness of TPMSs in older vehicles is reduced and
what can be done to increase it. This was the original goal of the
TPMS-ORRC and is still a goal.
    Additionally, on December 4, 2015, the Fixing America's Surface
Transportation (FAST) Act (Pub. L. 114-94) was signed into law. An
amendment (Section 24115) directs the Secretary of Transportation to
update the standard on tire pressure monitoring systems, FMVSS No. 138,
to ensure that they cannot be overridden, reset or recalibrated in a
way that will prevent the system from identifying a tire that is
significantly underinflated. The Act also states that the revised
requirements shall not contain any provision that has the effect of
prohibiting the availability of direct or indirect tire pressure
monitoring systems. Data are needed to help inform the required
rulemaking. For this purpose, the design of the TPMS-ORRC field survey
has been changed from a convenience sample to a probability sample,
allowing nationally representative estimates; this revision also adds a
module for indirect TPMS.
    Affected Public: Individuals and businesses.
    Estimated Total Annual Burden: 1,352 hours.
    Comments are Invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including: Whether the information will have practical
utility; the accuracy of the Department's estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended and 49 CFR 1.95.

Joseph M. Kolly,
Acting Associate Administrator, National Center for Statistics and
Analysis.
[FR Doc. 2017-08355 Filed 4-24-17; 8:45 am]
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[Federal Register: October 21, 2009 (Volume 74, Number 202)]
[Notices]
[Page 54055-54056]
[DOCID:fr21oc09-63]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0473]

Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Cardiac Allograft Gene
Expression Profiling Test Systems; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the special controls guidance document entitled ``Class
II Special Controls Guidance Document: Cardiac Allograft Gene
Expression Profiling Test Systems.'' This guidance document describes a
means by which cardiac allograft gene expression profiling test systems
may comply with the requirement of special controls for class II
devices. It includes recommendations for validation of performance
characteristics and recommendations for product labeling. Elsewhere in
this issue of the Federal Register, FDA is publishing a final rule
codifying the classification of cardiac allograft gene expression
profiling test systems into class II (special controls), and
establishing this guidance document as the special control for this
device.

DATES: Submit electronic or written comments on this guidance at any
time. General comments on agency guidance documents are welcome at any
time.

ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Class II Special Controls Guidance Document:
Cardiac Allograft Gene Expression Profiling Test Systems'' to the
Division of Small Manufacturers, International, and Consumer
Assistance, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request, or fax your request to 301-847-
8149. See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the guidance.
    Submit electronic comments to http://www.regulations.gov. Submit
written comments concerning this guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Kellie B. Kelm, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5625, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing
a final rule codifying the classification of cardiac allograft gene
expression profiling test systems into class II (special controls)
under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360c(f)(2)) and establishing this guidance
document as the special control for cardiac allograft gene expression
profiling test systems classified under that regulation. Section
513(f)(2) of the act provides that any person who submits a premarket
notification under section 510(k) of the act (21 U.S.C. 360(k)) for a
device that has not previously been classified may, within 30 days
after receiving an order classifying the device in class III under
section 513(f)(1), request FDA to classify the device under the
criteria set forth in section 513(a)(1). FDA shall, within 60 days of
receiving such a request, classify the device by written order. This
classification shall be the initial classification of the device.
Within 30 days after the issuance of an order classifying the device,
FDA must publish a notice in the Federal Register announcing such
classification. Under this authority, on August 26, 2008, FDA by order
classified into class II, subject to this special control guidance
document, the XDx AlloMap Test.

II. Significance of Special Controls Guidance Documents

    FDA believes that adherence to the recommendations described in
this guidance document, in addition to the general controls, will
provide reasonable assurance of the safety and effectiveness of cardiac
allograft gene expression profiling test systems classified under Sec.
862.1163 (21 CFR 862.1163). In order to be classified as a class II
device under Sec.  862.1163, a cardiac allograft gene expression
profiling test system must comply with the requirement of special
controls; manufacturers must address the issues requiring special
controls as identified in the guidance documents, either by following
the recommendations in the guidance documents or by some other means
that provides equivalent assurances of safety and effectiveness.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
using the Internet. To receive ``Class II Special Controls Guidance
Document: Cardiac Allograft Gene Expression Profiling Test Systems,''
you may either send an e-mail request to<EMAIL_ADDRESS>to receive
an electronic copy of the document or send a fax request to 301-847-
8149 to receive a hard copy. Please use the document number 1686 to
identify the guidance you are requesting.
    CDRH maintains an entry on the Internet for easy access to
information including text, graphics, and files that may be downloaded
to a personal computer with Internet access. Updated on a regular
basis, the CDRH home page includes device safety alerts, Federal
Register reprints, information on premarket submissions (including
lists of approved applications and manufacturers' addresses), small
manufacturer's assistance, information on video conferencing and
electronic submissions, Mammography Matters, and other device-oriented
information. The CDRH Web site may be accessed at http://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    Elsewhere in this issue of the Federal Register, FDA is publishing
a final rule establishing as special controls for the cardiac allograft
gene expression profiling test systems the guidance document that is
the subject of this notice. The preamble to that rule addresses the
application of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520) to the information collection provisions referenced in this
guidance document.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified 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: October 9, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-25313 Filed 10-20-09; 8:45 am]

BILLING CODE 4160-01-S