[Federal Register Volume 83, Number 206 (Wednesday, October 24, 2018)]
[Notices]
[Pages 53737-53738]
[FR Doc No: 2018-23230]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2018-0202]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to exempt 39 individuals from the
prohibition in the Federal Motor Carrier Safety Regulations (FMCSRs)
against persons with insulin-treated diabetes mellitus (ITDM) from
operating a commercial motor vehicle (CMV) in interstate commerce. The
exemptions enable these individuals with ITDM to operate CMVs in
interstate commerce.

DATES: The exemptions were applicable on September 15, 2018. The
exemptions expire on September 15, 2020.

FOR FURTHER INFORMATION CONTACT:  Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov.
Insert the docket number, FMCSA-2018-0202, in the keyword box, and
click ``Search.'' Next, click the ``Open Docket Folder'' button and
choose the document to review. If you do not have access to the
internet, you may view the docket online by visiting the Docket
Management Facility in Room W12-140 on the Ground Floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9
a.m. and 5 p.m., ET., Monday through Friday, except Federal holidays.

B. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On August 15, 2018, FMCSA published a notice announcing receipt of
applications from 39 individuals requesting an exemption from diabetes
requirement in 49 CFR 391.41(b)(3) and requested comments from the
public (83 FR 40642). The public comment period ended on September 14,
2018, and no comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).
    The physical qualification standard for drivers regarding diabetes
found in 49 CFR 391.41(b)(3) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control.

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for up to five years from the diabetes standard in 49 CFR 391.41(b)(3)
if the exemption is likely to achieve an equivalent or greater level of
safety than would be achieved without the exemption. The exemption
allows the applicants to operate CMVs in interstate commerce. FMCSA
grants exemptions from the FMCSRs for a two-year period to align with
the maximum duration of a driver's medical certification.
    The Agency's decision regarding these exemption applications is
based on the program eligibility criteria and an individualized
assessment of information submitted by each applicant. The
qualifications,

experience, and medical condition of each applicant were stated and
discussed in detail in the August 15, 2018, Federal Register notice (83
FR 40642) and will not be repeated in this notice.
    These 39 applicants have had ITDM over a range of 1 to 59 years.
These applicants report no severe hypoglycemic reactions resulting in
loss of consciousness or seizure, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning symptoms, in the past 12 months and no recurrent (two
or more) severe hypoglycemic episodes in the past five years. In each
case, an endocrinologist verified that the driver has demonstrated a
willingness to properly monitor and manage his/her diabetes mellitus,
received education related to diabetes management, and is on a stable
insulin regimen. These drivers report no other disqualifying
conditions, including diabetes related complications. Each meets the
vision requirement at 49 CFR 391.41(b)(10).
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is
likely to achieve a level of safety equal to that existing without the
exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption are provided to the
applicants in the exemption document and includes the following: (1)
Each driver must submit a quarterly monitoring checklist completed by
the treating endocrinologist as well as an annual checklist with a
comprehensive medical evaluation; (2) each driver must report within
two business days of occurrence, all episodes of severe hypoglycemia,
significant complications, or inability to manage diabetes; also, any
involvement in an accident or any other adverse event in a CMV or
personal vehicle, whether or not it is related to an episode of
hypoglycemia; (3) each driver must provide a copy of the
ophthalmologist's or optometrist's report to the Medical Examiner at
the time of the annual medical examination; and (4) each driver must
provide a copy of the annual medical certification to the employer for
retention in the driver's qualification file, or keeping a copy in his/
her driver's qualification file if he/she is self-employed. The driver
must also have a copy of the exemption when driving, for presentation
to a duly authorized Federal, State, or local enforcement official.

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based upon its evaluation of the 39 exemption applications, FMCSA
exempts the following drivers from the diabetes requirement in 49 CFR
391.41(b)(10), subject to the requirements cited above:

Jeffrey L. Barton (KS)
Michael J. Beattie (TN)
Timothy W. Beeny (KY)
Joseph A. Bradley (IN)
Harold B. Bryan (ID)
Javis B. Cruz (NM)
Matthew A. Cunningham (NY)
Victor J. Da-Chao (MD)
Timothy S. Danley (TX)
Richard G. Dattler, Jr. (OR)
Ellen M. Diggs (KS)
Marven J. Finken (MN)
Randie S. Fisher, Jr. (MO)
Jason J. Fleisch (PA)
Ryan M. Galusha (NY)
Raymond M. Hamlin (ME)
Steven L. Hare, Jr. (NC)
Joshua R. Hedges (MO)
Vicky L. Hill (WA)
Charles O. Hudson (TN)
James A. Keebaugh (PA)
Rein R. Kori (TN)
Thomas C. McGee (SC)
Anton Means (IL)
Andrew P. Metze (SC)
Christopher J. Misner (MI)
Mohamed S. Mohamed (MA)
Eugene G. Mueller (WI)
Reginald J. Pokorny (NE)
Vernon C. Read (CA)
John W. Rosenthal (ID)
Steven A. Santamaria (IL)
Ricky J. Sawyer (AL)
Justin G. Simpson (OH)
Jacob H. Turner (AR)
Chad E. Vanscoy (OH)
Phillip M. Woods (MI)
Robert W. Youdath (OH)
Brian D. Zoll (OH)

    In accordance with 49 U.S.C. 31136(e) and 31315, each exemption
will be valid for two years from the effective date unless revoked
earlier by FMCSA. The exemption will be revoked if the following
occurs: (1) The person fails to comply with the terms and conditions of
the exemption; (2) the exemption has resulted in a lower level of
safety than was maintained prior to being granted; or (3) continuation
of the exemption would not be consistent with the goals and objectives
of 49 U.S.C. 31136(e) and 31315.

    Issued on: October 15, 2018.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2018-23230 Filed 10-23-18; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 86, Number 68 (Monday, April 12, 2021)]
[Notices]
[Pages 18969-18970]
[FR Doc No: 2021-07393]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for electronic review at the Commission in the Public
Reference Room or may be viewed on the Commission's website at http://www.ferc.gov using the eLibrary link. Enter the docket number,
excluding the last three digits, in the docket number field to access
the document. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.

------------------------------------------------------------------------
                                                        Presenter or
            Docket Nos.                File date          requester
------------------------------------------------------------------------
Prohibited:
    1. CP16-10-000, CP16-10-005,         3-24-2021  FERC Staff.\1\
     CP16-10-006, CP16-10-007,
     CP16-10-008, CP16-13-000,
     CP16-13-003, CP19-14-000,
     CP19-14-001, CP19-477-000,
     CP21-12-000, CP21-57-000.
    2. CP16-10-000, CP16-10-005,         3-24-2021  FERC Staff.\2\
     CP16-10-006, CP16-10-007,
     CP16-10-008, CP16-13-000,
     CP16-13-003, CP19-14-000,
     CP19-14-001, CP19-477-000,
     CP21-12-000, CP21-57-000.
    3. CP16-10-000, CP16-10-005,         3-24-2021  FERC Staff \3\
     CP16-10-006, CP16-10-007,
     CP16-10-008, CP16-13-000,
     CP16-13-003, CP19-14-000,
     CP19-14-001, CP19-477-000,
     CP21-12-000, CP21-57-000.
Exempt:
    1. ER21-1111-000, ER21-1112-         3-17-2021  South Carolina
     000, ER21-1114-000, ER21-1115-                  Senator Tom Davis.
     000, ER21-1116-000, ER21-1117-
     000, ER21-1118-000, ER21-1119-
     000, ER21-1120-000, ER21-1121-
     000, ER21-1125-000, ER21-1128-
     000.
    2. CP17-458-000...............       3-17-2021  U.S. Representative
                                                     Tom Cole.
    3. ER21-1111-000, ER21-1112-         3-18-2021  South Carolina
     000, ER21-1114-000, ER21-1115-                  Representative
     000, ER21-1116-000, ER21-1117-                  Nathan Ballentine.
     000, ER21-1118-000, ER21-1119-
     000, ER21-1120-000, ER21-1121-
     000, ER21-1125-000, ER21-1128-
     000.
    4. P-405-106, P-405-121.......       3-18-2021  Maryland Senator
                                                     Stephen S. Hershey,
                                                     Jr.
    5. CP21-57-000................       3-26-2021  U.S. Congress.\4\

    6. CP20-466-000...............       3-29-2021  FERC Staff.\5\
    7. CP16-9-000.................       3-30-2021  U.S. Senator John
                                                     Barrasso.
------------------------------------------------------------------------
\1\ Memorandum regarding ex parte communication from July 2020 with an
  individual.
\2\ Memorandum regarding ex parte communication from July 2020 with Ms.
  Elaine Werner.
\3\ Memorandum regarding ex parte communication from July 2020 with Mr.
  Alex Abrams of Wisconsin.
\4\ U.S. Senators Tim Kaine and Mark R. Warner.
\5\ Memorandum dated March 29, 2021, regarding a listening session
  entitled Landowners and Communities Affected by Infrastructure
  Development.

    Dated: April 4, 2021.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2021-07393 Filed 4-9-21; 8:45 am]
BILLING CODE 6717-01-P


gas) may be loaded in an inaccessible manner. The requirements of this
paragraph do not apply to Class 9, articles of Identification Numbers
UN0012, UN0014, or UN0055 also meeting the requirements of Sec.
173.63(b), and Limited or Excepted Quantity material.
* * * * *
    (e) * * *
    (1) Class 3, PG III (unless the substance is also labeled
CORROSIVE), Class 6.1 (unless the substance is also labeled for any
hazard class or division except FLAMMABLE LIQUID), Division 6.2, Class
7 (unless the hazardous material meets the definition of another hazard
class), Class 9, articles of Identification Numbers UN0012, UN0014, or
UN0055 also meeting the requirements of Sec.  173.63(b), and those
marked as a Limited Quantity or Excepted Quantity material.
* * * * *
    (f) * * *

    Note 1:  * * *

    b. Division 6.1 (unless the substance is also labeled for any
hazard class or division except FLAMMABLE LIQUID)
* * * * *
    d. Class 9, Limited Quantity or Excepted Quantity material.
    e. Articles of Identification Numbers UN0012, UN0014, or UN0055
also meeting the requirements of Sec.  173.63(b).
* * * * *

PART 176--CARRIAGE BY VESSEL

0
36. The authority citation for part 176 is revised to read as follows:

    Authority:  49 U.S.C. 5101-5128; 49 CFR 1.81 and 1.97.

0
37. In Sec.  176.905, paragraph (i) is revised to read as follows:

Sec.  176.905  Stowage of motor vehicles or mechanical equipment.

* * * * *
    (i) Exceptions--A vehicle or mechanical equipment is excepted from
the requirements of this subchapter if any of the following are met:
    (1) The vehicle or mechanical equipment has an internal combustion
engine using liquid fuel that has a flashpoint less than 38 [deg]C
(100[emsp14][deg]F), the fuel tank is empty, and the engine is run
until it stalls for lack of fuel;
    (2) The vehicle or mechanical equipment has an internal combustion
engine using liquid fuel that has a flashpoint of 38 [deg]C (100
[deg]F) or higher, the fuel tank contains 418 L (110 gallons) of fuel
or less, and there are no fuel leaks in any portion of the fuel system;
    (3) The vehicle or mechanical equipment is stowed in a hold or
compartment designated by the administration of the country in which
the vessel is registered as specially designed and approved for
vehicles and mechanical equipment and there are no

signs of leakage from the battery, engine, fuel cell, compressed gas
cylinder or accumulator, or fuel tank, as appropriate. For vehicles
with batteries connected and fuel tanks containing gasoline transported
by U.S. vessels, see 46 CFR 70.10-1 and 90.10-38;
    (4) The vehicle or mechanical equipment is electrically powered
solely by wet electric storage batteries (including nonspillable
batteries) or sodium batteries; or
    (5) The vehicle or mechanical equipment is equipped with liquefied
petroleum gas or other compressed gas fuel tanks, the tanks are
completely emptied of liquefied or compressed gas and the positive
pressure in the tank does not exceed 2 bar (29 psig), the line from the
fuel tank to the regulator and the regulator itself is drained of all
traces of liquefied or compressed gas, and the fuel shut-off valve is
closed.
* * * * *

PART 178--SPECIFICATIONS FOR PACKAGINGS

0
38. The authority citation for part 178 continues to read as follows:

     Authority:  49 U.S.C. 5101-5128; 49 CFR 1.81 and 1.97.

0
39. In Sec.  178.601, paragraphs (l) introductory text, (l)(1), and
(l)(2) introductory text are revised to read as follows:

Sec.  178.601  General requirements.

* * * * *
    (l) Record retention. Following each design qualification test and
each periodic retest on a packaging, a test report must be prepared.
    (1) The test report must be maintained at each location where the
packaging is manufactured, certified, and a design qualification test
or periodic retest is conducted as follows:

------------------------------------------------------------------------
           Responsible party                         Duration
------------------------------------------------------------------------
Person manufacturing the packaging.....  As long as manufactured and two
                                          years thereafter.
Person performing design testing.......  Design test maintained for a
                                          single or composite packaging
                                          for six years after the test
                                          is successfully performed and
                                          for a combination packaging or
                                          packaging intended for
                                          infectious substances for
                                          seven years after the test is
                                          successfully performed.
Person performing periodic retesting...  Performance test maintained for
                                          a single or composite
                                          packaging for one year after
                                          the test is successfully
                                          performed and for a
                                          combination packaging or
                                          packaging intended for
                                          infectious substances for two
                                          years after the test is
                                          successfully performed.
------------------------------------------------------------------------

    (2) The test report must be made available to a user of a packaging
or a representative of the Department upon request. The test report, at
a minimum, must contain the following information:
* * * * *

0
40. In Sec.  178.801, paragraph (l) is revised to read as follows:

Sec.  178.801  General requirements.

* * * * *
    (l) Record retention. Following each design qualification test and
each periodic retest on an IBC, a test report must be prepared.
    (1) The test report must be maintained at each location where the
packaging is manufactured, certified, and a design qualification test
or periodic retest is conducted as follows:

------------------------------------------------------------------------
           Responsible party                         Duration
------------------------------------------------------------------------
Person manufacturing the packaging.....  As long as manufactured and two
                                          years thereafter.
Person performing design testing.......  Design test maintained for a
                                          single or composite packaging
                                          for six years after the test
                                          is successfully performed and
                                          for a combination packaging or
                                          packaging intended for
                                          infectious substances for
                                          seven years after the test is
                                          successfully performed.
Person performing periodic retesting...  Performance test maintained for
                                          a single or composite
                                          packaging for one year after
                                          the test is successfully
                                          performed and for a
                                          combination packaging or
                                          packaging intended for
                                          infectious substances for two
                                          years after the test is
                                          successfully performed.
------------------------------------------------------------------------

    (2) The test report must be made available to a user of a packaging
or a representative of the Department upon request. The test report, at
a minimum, must contain the following information:
    (i) Name and address of test facility;
    (ii) Name and address of the person certifying the IBC;
    (iii) A unique test report identification;
    (iv) Date of test report;
    (v) Manufacturer of the IBC;
    (vi) Description of the IBC design type (e.g., dimensions,
materials, closures, thickness, representative service equipment,
etc.);
    (viii) Maximum IBC capacity;
    (ix) Characteristics of test contents;
    (x) Test descriptions and results (including drop heights,
hydrostatic pressures, tear propagation length, etc.); and
    (xi) The signature of the person conducting the test, and name of
the person responsible for testing.

0
41. In Sec.  178.955, paragraph (i) introductory text, (i)(1), and
(i)(2) introductory text are revised to read as follows:

Sec.  178.955  General Requirements.

* * * * *
    (i) Record retention. Following each design qualification test and
each periodic retest on a Large Packaging, a test report must be
prepared.
    (1) The test report must be maintained at each location where the
packaging is manufactured, certified, and a design qualification test
or periodic retest is conducted as follows:

------------------------------------------------------------------------
           Responsible party                         Duration
------------------------------------------------------------------------
Person manufacturing the packaging.....  As long as manufactured and two
                                          years thereafter.

Person performing design testing.......  Design test maintained for a
                                          single or composite packaging
                                          for six years after the test
                                          is successfully performed and
                                          for a combination packaging or
                                          packaging intended for
                                          infectious substances for
                                          seven years after the test is
                                          successfully performed.
Person performing periodic retesting...  Performance test maintained for
                                          a single or composite
                                          packaging for one year after
                                          the test is successfully
                                          performed and for a
                                          combination packaging or
                                          packaging intended for
                                          infectious substances for two
                                          years after the test is
                                          successfully performed.
------------------------------------------------------------------------

    (2) The test report must be made available to a user of a Large
Packaging or a representative of the Department of Transportation upon
request. The test report, at a minimum, must contain the following
information:
* * * * *

    Issued in Washington, DC, on October 17, 2013 under authority
delegated in 49 CFR part 1.97.
Cynthia L. Quarterman,
Administrator, Pipeline and Hazardous Materials Safety Administration.
[FR Doc. 2013-24714 Filed 10-30-13; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 87, Number 116 (Thursday, June 16, 2022)]
[Notices]
[Pages 36369-36372]
[FR Doc No: 2022-13015]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2021-0051]

Agency Information Collection Activities; Submission to the
Office of Management and Budget for Review and Approval; National
Survey of Pedestrian and Bicyclist Attitudes, Knowledge, and Behaviors

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

ACTION: Notice and request for comments on a reinstatement with
modification of a previously approved collection of information.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (PRA),
this notice announces that the Information Collection Request (ICR)
abstracted below will be submitted to the Office of Management and
Budget (OMB) for review. The ICR describes the nature of the
information collection and its expected burden. The ICR is for a
reinstatement with modification of a previously approved collection of
information for a one-time voluntary survey regarding knowledge,
attitudes, and behaviors associated with speeding. A Federal Register
notice with a 60-day comment period soliciting public comments on the
following information collection was published on April 4, 2022. NHTSA
received two comments, which we address below.

DATES: Comments must be submitted on or before July 18, 2022.

ADDRESSES: Written comments and recommendations for the proposed
information collection, including suggestions for reducing burden,
should be submitted to the Office of Management and Budget at
www.reginfo.gov/public/do/PRAMain. To find this particular information
collection, select ``Currently under Review--Open for Public Comment''
or use the search function. Comments may also be sent by mail to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, 725 17th Street NW, Washington, DC 20503, Attention: Desk
Officer for Department of Transportation, National Highway Traffic
Safety Administration, or by email at [email protected], or
fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For additional information or access
to background documents, contact Kristie Johnson, Ph.D., Office of
Behavioral Safety Research (NPD-310),<PHONE_NUMBER>,
[email protected], National Highway Traffic Safety
Administration, W46-498, 1200 New Jersey Avenue SE, Washington, DC
20590. Please identify the relevant collection of information by
referring to its OMB Control Number 2127-0684.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501 et seq.), a
Federal agency must receive approval from the Office of Management and
Budget (OMB) before it collects certain information from the public and
a person is not required to respond to a collection of information by a
Federal agency unless the collection displays a valid OMB control
number. In compliance with these requirements, this notice announces
that the following information collection request will be submitted to
OMB.
    A Federal Register notice with a 60-day comment period soliciting
public comments on the following information collection was published
on April 4, 2022 (Federal Register/Vol. 87, No. 64/pp. 19576-19579).
NHTSA received one comment and one letter in support. Steven Morris
provided remarks about ebikes, but no mention of the proposed survey or
general traffic safety. The letter in support of the survey was
submitted by the National Association of Mutual Insurance Companies
(NAMIC).
    Mr. Morris takes issue with the prohibition on using ebikes on an
Ohio National Forest Service bicycle trail system. He also supplied a
photo of his ebike contending that they do no more damage than regular
bikes to the trails. His remarks did not mention the proposed survey.
In NAMIC's letter addressed to NHTSA Administrator Steven Cliff,
``NAMIC supports NHTSA's proposed collection of information as
necessary and appropriate and believes that the information surveyed
will have significant practical utility.'' They further believe that
the survey effort will provide valuable information to help their
members work with NHTSA, State legislators and regulars, and law
enforcement agencies to improve pedestrian and bicyclist safety. NAMIC
recognizes the importance of the collection citing recent statistics
from NHTSA and the Governors Highway Safety Administration of the
rising number of vulnerable road user deaths.
    Comments on the proposed information collection are appreciated.
Thank you to NAMIC for providing thoughtful commentary as to the
importance of conducting the National Survey of Pedestrian and
Bicyclist Attitudes, Knowledge, and Behaviors.
    Title: National Survey of Pedestrian and Bicyclist Attitudes,
Knowledge, and Behaviors.
    OMB Control Number: 2127-0684.
    Form Numbers: NHTSA Forms 1148, 1613, 1614, 1615, 1616, 1617, 1618.
    Type of Request: Reinstatement with modification of a previously
approved information collection (OMB Control No. 2127-0684).
    Type of Review Requested: Regular.
    Requested Expiration Date of Approval: 3 years from date of
approval.
    Summary of the Collection of Information: NHTSA is seeking approval
to conduct a National Survey of Pedestrian and Bicyclist Attitudes,
Knowledge, and Behaviors by web and mail among a national probability
sample of 7,500 adults (and 150 adults for a pilot survey), age 18 and
older to obtain up-to-date information about bicyclist and pedestrian
attitudes and behaviors. Participation by respondents would be
voluntary. Survey topics include the extent to which Americans engage
in walking and bicycling activity, their attitudes toward and
experience with various facilities, road conditions, and technologies,
and their opinions on pedestrian and bicycling safety topics.

    In conducting the proposed research, the survey would use computer-
assisted web interviewing (i.e., a programmed, self-administered web
survey) to minimize recording errors, as well as optical mark
recognition and image scanning for the paper and pencil survey to
facilitate ease of use and data accuracy. A Spanish-language survey
option would be used to minimize language barriers to participation.
Surveys would be conducted with respondents using an address-based
sampling design that encourages respondents to complete the survey
online. Although web-based interviewing would be the primary data
collection mode, a paper questionnaire would be sent to households that
do not respond to the web invitations. This collection only requires
respondents to report their answers; there are no record-keeping costs
to the respondents.
    Description of the Need for the Information and Proposed Use of the
Information: NHTSA was established by the Highway Safety Act of 1970
and its mission is to reduce the number of deaths, injuries, and
economic losses resulting from motor vehicle crashes on the Nation's
highways. To further this mission, NHTSA is authorized to conduct
research as a foundation for the development of traffic safety
programs. Title 23, United States Code, Section 403, gives the
Secretary of Transportation (NHTSA by delegation) authorization to use
funds appropriated to conduct research and development activities,
including demonstration projects and the collection and analysis of
highway and motor vehicle safety data and related information, with
respect to all aspects of highway and traffic safety systems and
conditions relating to vehicle, highway, driver, passenger,
motorcyclist, bicyclist, and pedestrian characteristics; accident
causation and investigations; and human behavioral factors and their
effect on highway and traffic safety. Pedestrian safety and bicyclist
safety are two of multiple behavioral areas for which NHTSA has
developed comprehensive programs to meet its injury reduction goals.
The major components of pedestrian and bicyclist safety programs are
education, enforcement, and outreach.
    NHTSA encourages walking and bicycling as alternate modes of
transportation to motor vehicle travel; however, pedestrians and
bicyclists are among the most vulnerable road users. Motor vehicle
crashes in 2019 accounted for 6,205 pedestrian fatalities and 846
bicyclist and other cyclist fatalities.\1\ That same year, 76,000
pedestrians and 49,000 bicyclists were injured in traffic crashes.
Moreover, increasing safe walking and bicycling behavior is promoted as
a positive contributor to the quality of life. But an increase in
walking and bicycling often means an increase in exposure to potential
risk of collision with motor vehicles, underscoring the need to have in
place aggressive pedestrian and bicyclist safety programs to reduce
injuries and fatalities. This in turn requires periodic data collection
to assess whether the programs continue to be responsive to the
public's information needs, behavioral intentions, attitudes, physical
environment, and other factors that contribute to safety while walking
or bicycling.
---------------------------------------------------------------------------

    \1\ National Center for Statistics and Analysis. (2021, March).
Quick facts 2019 (Report No. DOT HS 813 124). National Highway
Traffic Safety Administration. https://crashstats.nhtsa.dot.gov/Api/Public/ViewPublication/813124.
---------------------------------------------------------------------------

    The National Survey of Pedestrian and Bicyclist Attitudes,
Knowledge, and Behaviors was conducted on two previous occasions--first
in 2002 and again in 2012. Those surveys provided program planners and
community leaders with detailed information on walking and bicycling
behavior, level of support for facilities assisting those activities
and awareness of safety issues. Since it has been ten years since NHTSA
last conducted the survey, the information needs updating, especially
given recent programs and initiatives to increase walking and
bicycling, as well as the emergence of new technologies including e-
bikes, e-scooters, and fitness trackers. This project will provide that
update by conducting the 2022 National Survey of Bicyclist and
Pedestrian Attitudes and Behaviors. In the 2022 survey, NHTSA intends
to examine the extent to which Americans engage in walking and
bicycling activity, their attitudes towards and experience with various
facilities, road conditions, and technologies, and their opinions on
pedestrian and bicycling safety topics. Furthermore, NHTSA plans to
assess whether self-reported behaviors, attitudes, and perceptions
regarding walking and bicycling have changed over time since the
administration of the prior national surveys. NHTSA will use the
findings to assist States, localities, and communities in developing
and refining walking and bicycling safety programs that will aid in
their efforts to reduce pedestrian and bicyclist crashes and injuries.
    NHTSA will use the information to produce a technical report that
presents the results of the study. The technical report will provide
aggregate (summary) statistics and tables as well as the results of
statistical analysis of the information, but it will not include any
personally identifiable information. The technical report will be
shared with State highway offices, local governments, and those who
develop traffic safety communications that aim to reduce pedestrian and
bicyclist crashes.
    Affected Public: Participants will be U.S. adults (18 years old and
older). Businesses are ineligible for the sample and would not be
interviewed.
    Estimated Number of Respondents: 7,650.
    Participation in this study will be voluntary. For the main survey
collection, 7,500 participants will be sampled from all 50 States and
the District of Columbia using address data from the most recent U.S.
Postal Service (USPS) computerized Delivery Sequence File (DSF) of
residential addresses. An estimated 22,943 households will be contacted
and have the study described to them. No more than one respondent will
be selected per household.
    Prior to the main survey, a pilot survey will be administered to
test the survey and the mailing protocol and procedures. Participation
in this study will be voluntary with 150 participants sampled from all
50 States and the District of Columbia using address data from the most
recent USPS computerized DSF of residential addresses. An estimated 459
households will be contacted and have the study described to them. No
more than one respondent will be selected per household.
    Frequency of Collection: The study will be conducted one time
during the three-year period for which NHTSA is requesting approval,
with a small pilot study occurring several months before the study's
full launch. This study is part of a tracking and trending study to
measure changes over time. The last study was administered in 2012.
    Estimated Total Annual Burden Hours: NHTSA estimates the total
burden of this information collection by estimating the burden to those
who NHTSA contacts but do not respond (non-responders) and those who
respond and are eligible for participation (eligible respondents or
actual participants). As virtually all households have at least one
adult 18 or older, all households are eligible to participate and, as
such, no burden is calculated for ineligible respondents. The estimated
time to contact 22,943 potential participants (actual participants and
non-responders) for the

survey and 459 potential participants (actual participants and non-
responders) for the pilot is one minute per person per contact attempt.
Contact attempts will be made in five waves with fewer potential
participants contacted in each subsequent wave. NHTSA estimates that
7,500 people will respond to the survey request and 150 will respond to
the pilot. The estimated time to contact (1 minute) and complete the
survey (20 minutes) for 7,500 participants and 150 pilot participants
is 21 minutes per person. Table 1 provides a description for each of
the forms used in the survey protocol as well as their mailing wave.
Details of the burden hours for each wave in the pilot and full survey
are included in Tables 2 and 3 below. When rounded up to the nearest
whole hour for each data collection effort, the total estimated annual
burden is 4,182 hours for the project activities. Table 4 provides
total burden hours associated with each form.

        Table 1--NHTSA Form Number, Description, and Mailing Wave
------------------------------------------------------------------------
                                                                Mailing
        NHTSA form No.                   Description              wave
------------------------------------------------------------------------
1148.........................  Questionnaire--National Survey       3, 5
                                of Pedestrian and Bicyclist
                                Attitudes, Knowledge, and
                                Behaviors (English).
1613.........................  Questionnaire--National Survey       3, 5
                                of Pedestrian and Bicyclist
                                Attitudes, Knowledge, and
                                Behaviors (Spanish).
1614.........................  Initial Invitation Letter.....          1
1615.........................  Reminder Postcard #1..........          2
1616.........................  Cover Letter included with 1st          3
                                mailing of the paper survey.
1617.........................  Reminder Postcard #2..........          4
1618.........................  Cover Letter included with 2nd          5
                                mailing of the paper survey.
------------------------------------------------------------------------

                                                    Table 2--Estimated Total Burden for Pilot Survey
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Estimated
                                           Number of                                 burden per   Frequency of    Number of   Burden hours  Total burden
        Mailing wave (form No.)            contacts          Participant type        sample unit     burden     sample units        *          hours *
                                                                                (in minutes)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Wave 1 (NHTSA Form 1614)...............           459  Contacted potential                     1             1           409             7            25
                                                        participant--Non-
                                                        respondent.
                                                       Recruited participant--                21             1            50            18
                                                        Eligible respondent.
Wave 2 (NHTSA Form 1615)...............           409  Contacted potential                     1             1           379             7            18
                                                        participant--Non-
                                                        respondent.
                                                       Recruited participant--                21             1            30            11
                                                        Eligible respondent.
                                                                                ---------------------------------------------------------------------
Wave 3 (NHTSA Forms 1148, 1613, 1616)..           379  Contacted potential                     1             1           341             6            20
                                                        participant--Non-
                                                        respondent.
                                                       Recruited participant--                21             1            38            14
                                                        Eligible respondent.
Wave 4 (NHTSA Form 1617)...............           341  Contacted potential                     1             1           322             6            13
                                                        participant--Non-
                                                        respondent.
                                                       Recruited participant--                21             1            19             7
                                                        Eligible respondent.
Wave 5 (NHTSA Forms 1148, 1613, 1618)..           322  Contacted potential                     1             1           309             6            11
                                                        participant--Non-
                                                        respondent.
                                                       Recruited participant--                21             1            13             5
                                                        Eligible respondent.
                                                                                ---------------------------------------------------------------------
    Total..............................  ............  ...........................  ............  ............  ............  ............            87
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Rounded up to the nearest hour.

                                             Table 3--Estimated Total Burden for Main Data Collection Survey
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Estimated
                                           Number of                                 burden per   Frequency of    Number of   Burden hours  Total burden
        Mailing wave (form No.)            contacts          Participant type        sample unit     burden     sample units        *          hours *
                                                                                (in minutes)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Wave 1 (NHTSA Form 1614)...............        22,943  Contacted potential                     1             1        20,443           341         1,216
                                                        participant--Non-
                                                        respondent.
                                                       Recruited participant--                21             1         2,500           875
                                                        Eligible respondent.
Wave 2 (NHTSA Form 1615)...............        20,443  Contacted potential                     1             1        18,943           316           841
                                                        participant--Non-
                                                        respondent.
                                                       Recruited participant--                21             1         1,500           525
                                                        Eligible respondent.
Wave 3 (NHTSA Forms 1148, 1613, 1616)..        18,943  Contacted potential                     1             1        17,049           285           948
                                                        participant--Non-
                                                        respondent.
                                                       Recruited participant--                21             1         1,894           663
                                                        Eligible respondent.
Wave 4 (NHTSA Form 1617)...............        17,049  Contacted potential                     1             1        16,102           269           601
                                                        participant--Non-
                                                        respondent.
                                                       Recruited participant--                21             1           947           332
                                                        Eligible respondent.

Wave 5 (NHTSA Forms 1148, 1613, 1618)..        16,102  Contacted potential                     1             1        15,443           258           489
                                                        participant--Non-
                                                        respondent.
                                                                                ---------------------------------------------------------------------
                                                       Recruited participant--                21             1           659           231
                                                        Eligible respondent.
                                                                                ---------------------------------------------------------------------
    Total..............................  ............  ...........................  ............  ............  ............  ............         4,095
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Rounded up to the nearest hour.

          Table 4--Estimated Total Burden by NHTSA Form for the Pilot and Main Data Collection Surveys
----------------------------------------------------------------------------------------------------------------
                                                                    Burden per      Burden per
             Information collection                  Number of       response       respondent     Total burden
                                                     responses       (minutes)       (minutes)         hours
----------------------------------------------------------------------------------------------------------------
NHTSA Forms 1148 and 1613.......................           7,650              20              20           2,550
NHTSA Form 1614.................................        * 23,850               1               1           * 398
NHTSA Form 1615.................................          20,852               1               1             348
NHTSA Form 1616.................................          19,322               1               1             322
NHTSA Form 1617.................................          17,390               1               1             290
NHTSA Form 1618.................................          16,424               1               1             274
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............           4,182
----------------------------------------------------------------------------------------------------------------
* Rounded up based on individual waves.

    Estimated Total Annual Burden Cost: Participation in this study is
voluntary, and there are no costs to respondents beyond the time spent
completing the questionnaires.
    Public Comments Invited: You are asked to comment on any aspects of
this information collection, including (a) 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; (b) the accuracy of the Department's estimate
of the burden of the proposed information collection; (c) ways to
enhance the quality, utility and clarity of the information to be
collected; and (d) 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, e.g., permitting
electronic submission of responses.
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter
35, as amended; 49 CFR 1.49; and DOT Order 1351.29.

Nanda Narayanan Srinivasan,
Associate Administrator, Research and Program Development.
[FR Doc. 2022-13015 Filed 6-15-22; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 86, Number 206 (Thursday, October 28, 2021)]
[Notices]
[Pages 59738-59741]
[FR Doc No: 2021-23501]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1584]

Authorization of Emergency Use of Certain Medical Devices During
COVID-19; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of Emergency Use Authorizations (EUAs) (the Authorizations)
for certain medical devices related to the Coronavirus Disease 2019
(COVID-19) public health emergency. FDA has issued the Authorizations
listed in this document under the Federal Food, Drug, and Cosmetic Act
(FD&C Act). These Authorizations contain, among other things,
conditions on the emergency use of the authorized products. The
Authorizations follow the February 4, 2020, determination by the
Secretary of Health and Human Services (HHS) that there is a public
health emergency that has a significant potential to affect national
security or the health and security of U.S. citizens living abroad, and
that involves the virus that causes COVID-19, and the subsequent
declarations on February 4, 2020, March 2, 2020, and March 24, 2020,
that circumstances exist justifying the authorization of emergency use
of in vitro diagnostics for detection and/or diagnosis of the virus
that causes COVID-19, personal respiratory protective devices, and
medical devices, including alternative products used as medical
devices, respectively, subject to the terms of any authorization issued
under the FD&C Act. These Authorizations, which include an explanation
of the reasons for issuance, are listed in this document, and can be
accessed on FDA's website from the links indicated.

DATES: These Authorizations are effective on their date of issuance.

ADDRESSES: Submit written requests for single copies of an EUA to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the Authorization may be sent.

See the SUPPLEMENTARY INFORMATION section for electronic access to the
Authorization.

FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to
strengthen the public health protections against biological, chemical,
radiological, or nuclear agent or agents. Among other things, section
564 of the FD&C Act allows FDA to authorize the use of an unapproved
medical product or an unapproved use of an approved medical product in
certain situations. With this EUA authority, FDA can help ensure that
medical countermeasures may be used in emergencies to diagnose, treat,
or prevent serious or life-threatening diseases or conditions caused by
a biological, chemical, radiological, or nuclear agent or agents when
there are no adequate, approved, and available alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
A determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces, including personnel operating under the
authority of title 10 or title 50 of the U.S. Code, of attack with (A)
a biological, chemical, radiological, or nuclear agent or agents; or
(B) an agent or agents that may cause, or are otherwise associated
with, an imminently life-threatening and specific risk to U.S. military
forces; \1\ (3) a determination by the Secretary of HHS that there is a
public health emergency, or a significant potential for a public health
emergency, that affects, or has a significant potential to affect,
national security or the health and security of U.S. citizens living
abroad, and that involves a biological, chemical, radiological, or
nuclear agent or agents, or a disease or condition that may be
attributable to such agent or agents; or (4) the identification of a
material threat by the Secretary of Homeland Security pursuant to
section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-
6b) sufficient to affect national security or the health and security
of U.S. citizens living abroad.
---------------------------------------------------------------------------

    \1\ In the case of a determination by the Secretary of Defense,
the Secretary of HHS shall determine within 45 calendar days of such
determination, whether to make a declaration under section 564(b)(1)
of the FD&C Act, and, if appropriate, shall promptly make such a
declaration.
---------------------------------------------------------------------------

    Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Under section 564(h)(1) of the FD&C Act, revisions to
an authorization shall be made available on the internet website of
FDA. Section 564 of the FD&C Act permits FDA to authorize the
introduction into interstate commerce of a drug, device, or biological
product intended for use when the Secretary of HHS has declared that
circumstances exist justifying the authorization of emergency use.
Products appropriate for emergency use may include products and uses
that are not approved, cleared, or licensed under section 505, 510(k),
512, or 515 of the FD&C Act (21 U.S.C. 355, 360(k), 360b, or 360e) or
section 351 of the PHS Act (42 U.S.C. 262), or conditionally approved
under section 571 of the FD&C Act (21 U.S.C. 360ccc). FDA may issue an
EUA only if, after consultation with the HHS Assistant Secretary for
Preparedness and Response, the Director of the National Institutes of
Health, and the Director of the Centers for Disease Control and
Prevention (to the extent feasible and appropriate given the applicable
circumstances), FDA \2\ concludes: (1) That an agent referred to in a
declaration of emergency or threat can cause a serious or life-
threatening disease or condition; (2) that, based on the totality of
scientific evidence available to FDA, including data from adequate and
well-controlled clinical trials, if available, it is reasonable to
believe that (A) the product may be effective in diagnosing, treating,
or preventing (i) such disease or condition; or (ii) a serious or life-
threatening disease or condition caused by a product authorized under
section 564, approved or cleared under the FD&C Act, or licensed under
section 351 of the PHS Act, for diagnosing, treating, or preventing
such a disease or condition caused by such an agent; and (B) the known
and potential benefits of the product, when used to diagnose, prevent,
or treat such disease or condition, outweigh the known and potential
risks of the product, taking into consideration the material threat
posed by the agent or agents identified in a declaration under section
564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no
adequate, approved, and available alternative to the product for
diagnosing, preventing, or treating such disease or condition; (4) in
the case of a determination described in section 564(b)(1)(B)(ii), that
the request for emergency use is made by the Secretary of Defense; and
(5) that such other criteria as may be prescribed by regulation are
satisfied. No other criteria for issuance have been prescribed by
regulation under section 564(c)(4) of the FD&C Act.
---------------------------------------------------------------------------

    \2\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
---------------------------------------------------------------------------

II. Electronic Access

    An electronic version of this document and the full text of the
Authorizations are available on the internet and can be accessed from
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

III. The Authorizations

    Having concluded that the criteria for the issuance of the
following Authorizations under section 564(c) of the FD&C Act are met,
FDA has authorized the emergency use of the following products for
diagnosing, treating, or preventing COVID-19 subject to the terms of
each Authorization. The Authorizations in their entirety, including any
authorized fact sheets and other written materials, can be accessed
from the FDA web page entitled ``Emergency Use Authorization,''
available at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
The lists that follow include Authorizations issued from June 1, 2021,
through September 10, 2021, and we have included explanations of the
reasons for their issuance, as required by section 564(h)(1) of the
FD&C Act. In addition, the EUAs that

have been reissued can be accessed from FDA's web page: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
    FDA is hereby announcing the following Authorizations for molecular
diagnostic and antigen tests for COVID-19, excluding multianalyte
tests: \3\
---------------------------------------------------------------------------

    \3\ As set forth in the EUAs for these products, FDA has
concluded that: (1) SARS-CoV-2, the virus that causes COVID-19, can
cause a serious or life-threatening disease or condition, including
severe respiratory illness, to humans infected by this virus; (2)
based on the totality of scientific evidence available to FDA, it is
reasonable to believe that the products may be effective in
diagnosing COVID-19, and that the known and potential benefits of
the products, when used for diagnosing COVID-19, outweigh the known
and potential risks of such products; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
products.
---------------------------------------------------------------------------

     OraSure Technologies, Inc.'s InteliSwab COVID-19 Rapid
Test Pro, issued June 4, 2021;
     OraSure Technologies, Inc's InteliSwab COVID-19 Rapid
Test, issued June 4, 2021;
     OraSure Technologies, Inc's InteliSwab COVID-19 Rapid Test
Rx, issued June 4, 2021;
     Roche Molecular Systems' cobas SARS-CoV-2 Nucleic acid
test for use on the cobas LIAT System (cobas SARS-CoV-2), issued June
17, 2021;
     WREN Laboratories LLC's WREN Laboratories COVID-19 PCR
Test DTC, issued June 17, 2021;
     BioGX, Inc.'s BioGX Xfree COVID-19 Direct RT-PCR, issued
June 29, 2021;
     Ellume Limited's Ellume.lab COVID Antigen Test, issued
July 8, 2021;
     Thermo Fisher Scientific Inc's TaqPath COVID-19 RNase P
Combo Kit 2.0, issued July 8, 2021;
     GenBody Inc.'s GenBody COVID-19 Ag, issued July 13, 2021;
     PHASE Scientific International, Ltd.'s INDICAID COVID-19
Rapid Antigen Test, issued July 28, 2021;
     Life Technologies Corporation's (a part of Thermo Fisher
Scientific, Inc.) TaqPath COVID-19 Fast PCR Combo Kit 2.0, issued July
30, 2021;
     Access Bio, Inc.'s CareStart COVID-19 Antigen Home Test,
issued August 2, 2021;
     Life Technologies Corporation's (a part of Thermo Fisher
Scientific, Inc.) TaqPath COVID-19 MS2 Combo Kit 2.0, issued August 2,
2021;
     QIAGEN GmbH's QIAreach SARS-CoV-2 Antigen Test, issued
August 5, 2021;
     Cleveland Clinic Robert J. Tomsich Pathology and
Laboratory Medicine Institute's SelfCheck COVID-19 TaqPath Multiplex
PCR, issued August 9, 2021;
     STS Lab Holdco's Amazon Multi-Target SARS-CoV-2 Real-Time
RT-PCR DTC Test (``Amazon Multi-Target DTC Test''), issued August 11,
2021;
     STS Lab Holdco's Amazon Multi-Target SARS-CoV-2 Real-Time
RT-PCR Test (``Amazon Multi-Target Test''), issued August 11, 2021;
     The Mount Sinai Hospital, Center for Clinical
Laboratories' Mount Sinai SARS-CoV-2 Assay, issued August 23, 2021;
     Becton, Dickinson and Company's BD Veritor At-Home COVID-
19 Test, issued August 24, 2021;
     Empire City Laboratories' ECL COVID TEST SYSTEM, issued
August 25, 2021;
     Empire City Laboratories' ECL COVID TEST SYSTEM-1, issued
August 25, 2021; and
     Yale School of Public Health, Department of Epidemiology
of Microbial Diseases' SalivaDirect for use with DTC Kits, issued
August 27, 2021.
    FDA is hereby announcing the following Authorizations for serology
tests: \4\
---------------------------------------------------------------------------

    \4\ As set forth in the EUAs for these products, unless
otherwise noted in this document, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the products may be effective
in diagnosing recent or prior infection with SARS-CoV-2 by
identifying individuals with an adaptive immune response to the
virus that causes COVID-19, and that the known and potential
benefits of the products when used for such use, outweigh the known
and potential risks of the products; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
products.
---------------------------------------------------------------------------

     Diabetomics, Inc.'s CovAb SARS-CoV-2 Ab Test, issued June
4, 2021;
     Siemens Healthcare Diagnostics Inc.'s ADVIA Centaur SARS-
CoV-2 IgG (sCOVG), issued June 17, 2021;
     Access Bio, Inc.'s CareStart EZ COVID-19 IgM/IgG, issued
June 24, 2021;
     Bio-Rad Laboratories' BioPlex 2200 SARS-CoV-2 IgG, issued
July 1, 2021;
     Ortho-Clinical Diagnostics, Inc.'s VITROS Immunodiagnostic
Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in
combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2
IgG Quantitative Calibrator, issued July 9, 2021; \5\
---------------------------------------------------------------------------

    \5\ As set forth in this EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the product may be effective
in diagnosing recent or prior infection with SARS-CoV-2 by aiding in
identifying individuals with an adaptive immune response to the
virus that causes COVID-19, and that the known and potential
benefits of the product when used for such use, outweigh the known
and potential risks of the product; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
product.
---------------------------------------------------------------------------

     Ortho-Clinical Diagnostics, Inc.'s VITROS Immunodiagnostic
Products Anti-SARS-CoV-2 Total N Reagent Pack used in combination with
the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody
Calibrators, issued July 22, 2021; \6\
---------------------------------------------------------------------------

    \6\ As set forth in this EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the product may be effective
in diagnosing recent or prior infection with SARS-CoV-2 by aiding in
identifying individuals with an adaptive immune response to the
virus that causes COVID-19, and that the known and potential
benefits of the product when used for such use, outweigh the known
and potential risks of the product; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
product.
---------------------------------------------------------------------------

     LumiraDx UK Ltd.'s LumiraDx SARS-CoV-2 Ab Test, issued
August 2, 2021; and
     InBios International, Inc.'s SCoV-2 Detect IgG Rapid Test,
issued August 24, 2021.
    FDA is hereby announcing the following Authorizations for
multianalyte in vitro diagnostics:
     Exact Sciences Laboratories' COVID-Flu Multiplex Assay,
issued July 1, 2021 \7\ and
---------------------------------------------------------------------------

    \7\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the COVID-Flu Multiplex Assay
may be effective in diagnosing COVID-19 through the simultaneous
detection and differentiation of SARS-CoV-2, influenza A virus, and/
or influenza B virus nucleic acids and that the known and potential
benefits of the COVID-Flu Multiplex Assay when used for diagnosing
COVID-19, outweigh the known and potential risks of the COVID-Flu
Multiplex Assay; and (3) there is no adequate, approved, and
available alternative to the emergency use of the COVID-Flu
Multiplex Assay.
---------------------------------------------------------------------------

     Cepheid's Xpert Xpress CoV-2/Flu/RSV plus, issued
September 10, 2021.\8\
---------------------------------------------------------------------------

    \8\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the Xpert Xpress CoV-2/Flu/RSV
plus may be effective in diagnosing COVID-19 through the
simultaneous detection and differentiation of nucleic acid from
SARS-CoV-2 virus, influenza A, influenza B and respiratory syncytial
virus (RSV) and that the known and potential benefits of the Xpert
Xpress CoV-2/Flu/RSV plus when used for diagnosing COVID-19,
outweigh the known and potential risks of the Xpert Xpress CoV-2/
Flu/RSV plus; and (3) there is no adequate, approved, and available
alternative to the emergency use of the Xpert Xpress CoV-2/Flu/RSV
plus.
---------------------------------------------------------------------------

    FDA is hereby announcing the following Authorizations for other
medical devices:

     WREN Laboratories LLC's WREN Laboratories COVID-19 Saliva
Test Collection Kit DTC, issued June 17, 2021; \9\
---------------------------------------------------------------------------

    \9\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the WREN Laboratories COVID-19 Saliva Test Collection Kit DTC
may be effective in diagnosing COVID-19 by serving as an appropriate
means to collect and transport human specimens so that an authorized
laboratory can detect SARS-CoV-2 RNA from the self-collected human
specimen, and that the known and potential benefits of the WREN
Laboratories COVID-19 Saliva Test Collection Kit DTC when used for
such use, outweigh the known and potential risks of the WREN
Laboratories COVID-19 Saliva Test Collection Kit DTC; and (3) there
is no adequate, approved, and available alternative to the emergency
use of the WREN Laboratories COVID-19 Saliva Test Collection Kit
DTC.
---------------------------------------------------------------------------

     Tidal Medical Technologies LLC's InSee incentive
spirometer accessory, issued June 30, 2021; \10\
---------------------------------------------------------------------------

    \10\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the InSee COVID-19 may be effective in treating respiratory
conditions in patients with COVID-19 in hospital settings by
quantitatively tracking patient usage of Vyaire Medical's AirLife
incentive spirometer, and that the known and potential benefits of
the InSee when used for treating COVID-19, outweigh the known and
potential risks of InSee; and (3) there is no adequate, approved,
and available alternative to the emergency use of the InSee for
treating COVID-19 for such use.
---------------------------------------------------------------------------

     Everlywell, Inc.'s Everlywell COVID-19 & Flu Test Home
Collection Kit, issued July 1, 2021; \11\
---------------------------------------------------------------------------

    \11\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the Everlywell COVID-19 & Flu Test Home Collection Kit may be
effective in diagnosing COVID-19, by serving as an appropriate means
to collect and transport human specimens so that an authorized
laboratory can detect SARS-CoV-2 influenza A and/or influenza B
nucleic acids from the home collected human specimen and that the
known and potential benefits of the Everlywell COVID-19 & Flu Test
Home Collection Kit when used for diagnosing COVID-19, outweigh the
known and potential risks of the Everlywell COVID-19 & Flu Test Home
Collection Kit; and (3) there is no adequate, approved, and
available alternative to the emergency use of the Everlywell COVID-
19 & Flu Test Home Collection Kit.
---------------------------------------------------------------------------

     Becton, Dickinson and Company's BD Vacutainer Plus Citrate
Plasma Tubes (UK Manufacturing Site), issued July 22, 2021; \12\
---------------------------------------------------------------------------

    \12\ FDA is using the term ``UK Manufacturing Site'' to
differentiate the authorized version from the FDA-cleared version of
these products that are also manufactured by Becton, Dickinson and
Company. As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing
Site) may be effective in aiding in the identification and treatment
of coagulopathy in patients, including patients with known or
suspected COVID-19, by collecting, transporting, and storing blood
specimens for coagulation testing, and that the known and potential
benefits of the BD Vacutainer Plus Citrate Plasma Tubes (UK
Manufacturing Site) when used for such use, outweigh the known and
potential risks of the BD Vacutainer Plus Citrate Plasma Tubes (UK
Manufacturing Site); and (3) there is no adequate, approved, and
available alternative to the emergency use of the BD Vacutainer Plus
Citrate Plasma Tubes (UK Manufacturing Site).
---------------------------------------------------------------------------

     Kwokman Diagnostics, LLC's Kwokman Diagnostics COVID-19
Home Collection Kit, issued August 13, 2021; \13\ and
---------------------------------------------------------------------------

    \13\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the Kwokman Diagnostics COVID-19 Home Collection Kit may be
effective in diagnosing COVID-19, by serving as an appropriate means
to collect and transport human specimens so that an authorized
laboratory can detect SARS-CoV-2 RNA from the home-collected human
specimen, and that the known and potential benefits of the Kwokman
Diagnostics COVID-19 Home Collection Kit when used for such use,
outweigh the known and potential risks of the Kwokman Diagnostics
COVID-19 Home Collection Kit; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
Kwokman Diagnostics COVID-19 Home Collection Kit.
---------------------------------------------------------------------------

     Yale School of Public Health, Department of Epidemiology
of Microbial Diseases' SalivaDirect DTC Saliva Collection Kit, issued
August 27, 2021.\14\
---------------------------------------------------------------------------

    \14\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the SalivaDirect DTC Saliva Collection Kit may be effective in
diagnosing COVID-19, by serving as an appropriate means to collect
and transport human specimens so that an authorized laboratory can
detect SARS-CoV-2 RNA from the self-collected human specimen, and
that the known and potential benefits of the SalivaDirect DTC Saliva
Collection Kit when used for such use, outweigh the known and
potential risks of the SalivaDirect DTC Saliva Collection Kit; and
(3) there is no adequate, approved, and available alternative to the
emergency use of the SalivaDirect DTC Saliva Collection Kit.

    Dated: October 22, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23501 Filed 10-27-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 61 (Wednesday, March 30, 2016)]
[Notices]
[Pages 17760-17761]
[FR Doc No: 2016-07144]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2015-0083, Notice 2]

Decision That Nonconforming Model Year 2014 Mercedes-Benz SLK
Class Passenger Cars Are Eligible for Importation

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

ACTION: Grant of petition.

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

SUMMARY: This document announces a decision by the National Highway
Traffic Safety Administration that certain model year (MY) 2014
Mercedes-Benz SLK Class passenger cars (PCs) that were not originally
manufactured to comply with all applicable Federal Motor Vehicle Safety
Standards (FMVSS) are eligible for importation into the United States
because they are substantially similar to vehicles originally
manufactured for sale in the United States and certified by their
manufacturer as complying with the safety standards (the U.S. certified
version of the MY 2014 Mercedes-Benz SLK Class PC), and they are
capable of being readily altered to conform to the standards.

DATES: This decision became effective on March 25, 2016.

ADDRESSES: For further information contact George Stevens, Office of
Vehicle Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS shall be
refused admission into the United States unless NHTSA has decided that
the motor vehicle is substantially similar to a motor vehicle
originally manufactured for importation into and sale in the United
States, certified as required under 49 U.S.C. 30115, and of the same
model year as the model of the motor vehicle to be compared, and is
capable of being readily altered to conform to all applicable FMVSS.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notice
in the Federal Register of each petition that it receives, and affords
interested persons an opportunity to comment on the petition. At the
close of the comment period, NHTSA decides, on the basis of the
petition and any comments that it has received, whether the vehicle is
eligible for importation. The agency then publishes this decision in
the Federal Register.
    J.K. Technologies, LLC, of Baltimore, Maryland (JK) (Registered
Importer# RI-90-006), petitioned NHTSA to decide whether MY 2014
Mercedes-Benz SLK Class PCs are eligible for importation into the
United States. NHTSA published a notice of the petition on February 16,
2016 (81 FR 7889) to afford an opportunity for public comment. No
comments were received in response to this petition. The reader is
referred to the receipt notice for a thorough description of the
petition.

NHTSA'S Conclusions

    NHTSA has reviewed the petition and has concluded that the vehicles
covered by the petition are substantially similar to MY 2014 Mercedes-
Benz SLK Class PC's and are capable of being readily altered to comply
with all applicable FMVSS.
    NHTSA has also determined that any RI who imports or modifies one
of these vehicles must include in the statement of conformity and
associated documents (referred to as a ``conformity package'') it
submits to NHTSA under 49 CFR 592.6(d) additional specific proof to
confirm that the vehicle was manufactured to conform to, or was
successfully altered to conform to, FMVSS No. 101, Controls and
Displays, FMVSS No. 138, Tire Pressure Monitoring Systems, FMVSS No.
208 Occupant Crash Protection and FMVSS No. 301 Fuel System Integrity.
This proof must include detailed descriptions of all modifications made
to achieve conformity with those standards, including a detailed
description of systems in place (if any) on the vehicle at the time it
was delivered to the RI and a similarly detailed description of the
systems in place after the vehicle is altered, including photographs of
all required labeling. The description must also include parts assembly
diagrams and associated part numbers for all components that were
removed from or installed on the vehicle, a description of how any
computer programming changes were completed, and a description of how
compliance was verified after alterations were completed. Photographs
(e.g., monitor print screen captures) or report printouts, as
practicable, must be submitted as proof that any computer reprogramming
was carried out successfully.
    In addition to the information specified above, each conformity
package must also include evidence showing how the RI verified that the
changes it made in loading or reprograming vehicle software to achieve
conformity with each separate FMVSS, did not also cause the vehicle to
fall out of compliance with any other applicable FMVSS.

Decision

    Accordingly, on the basis of the foregoing, NHTSA hereby decides
that MY 2014 Mercedes-Benz SLK Class passenger cars that were not
originally manufactured to comply with all applicable FMVSS, are
substantially similar to MY 2014 Mercedes-Benz SLK Class passenger cars
manufactured for importation into and/or sale in the United States, and
certified under 49 U.S.C. 30115, and are capable of being readily
altered to conform to all applicable Federal Motor Vehicle Safety
Standards.

Vehicle Eligibility Number for Subject Vehicles

    The importer of a vehicle admissible under any final decision must
indicate on the form HS-7 accompanying entry the appropriate vehicle
eligibility number indicating that the vehicle is eligible for entry.
VSP-581 is the vehicle eligibility number assigned to vehicles
admissible under this notice of final decision.

    Authority:  49 U.S.C. 30118, 30120: delegations of authority at
49 CFR 1.95 and 501.8.

Jeffrey M. Giuseppe,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2016-07144 Filed 3-29-16; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 76, Number 137 (Monday, July 18, 2011)]
[Notices]
[Page 42123]
[FR Doc No: 2011-17988]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP11-506-000]

Texas Eastern Transmission, LP; Notice of Request Under Blanket
Authorization

    Take notice that on July 1, 2011, Texas Eastern Transmission, LP
(Texas Eastern), filed an application pursuant to sections 157.205,
157.208, and 157.210 of the Commission's regulations, requesting
authorization to uprate the existing electric compressor unit at its
Kosciusko Compressor Station from 12,500 horsepower (hp) to 16,875 hp
and effectively increase the certificated capacity at the Kosciusko
Compressor Station by 4,375 hp from 47,500 hp to 51,875 hp, all as more
fully set forth in the application which is on file with the
Commission. The filing may also be viewed on the web at http://www.ferc.gov using the ``eLibrary'' link. Enter the docket number
excluding the last three digits in the docket number field to access
the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    Any questions regarding this prior notice should be directed to
Lisa A. Connolly, General Manager, Rates & Certificates, Texas Eastern
Transmission, LP, P.O. Box 1642, Houston, Texas 77251-1642, or
telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>or by e-mail
<EMAIL_ADDRESS>    Any person may, within 60 days after the issuance of the instant
notice by the Commission, file pursuant to Rule 214 of the Commission's
Procedural Rules (18 CFR 385.214) a motion to intervene or notice of
intervention. Any person filing to intervene or the Commission's staff
may, pursuant to section 157.205 of the Commission's Regulations under
the NGA (18 CFR 157.205) file a protest to the request. If no protest
is filed within the time allowed therefore, the proposed activity shall
be deemed to be authorized effective the day after the time allowed for
protest. If a protest is filed and not withdrawn within 30 days after
the time allowed for filing a protest, the instant request shall be
treated as an application for authorization pursuant to section 7 of
the NGA.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a) (1) (iii) and the instructions on the Commission's Web
site (http://www.ferc.gov) under the ``e-Filing'' link. Persons unable
to file electronically should submit an original and 14 copies of the
protest or intervention to the Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426.

    Dated: July 12, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-17988 Filed 7-15-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 98 (Monday, May 21, 2012)]
[Notices]
[Page 30003]
[FR Doc No: 2012-12187]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Commission Staff Attendance

    The Federal Energy Regulatory Commission (Commission) hereby gives
notice that members of the Commission's staff may attend the following
meeting related to the transmission planning activities of the
Southwest Power Pool, Inc. (SPP):

Strategic Planning Committee Task Force on Order 1000

    May 18, 2012, 8:00 a.m.-3 p.m. CDT.
    The above-referenced meeting will be held at: AEP Offices, 1201 Elm
Street, 8th Floor, Dallas, TX 75201.
    The above-referenced meeting is open to stakeholders.
    Further information may be found at www.spp.org.
    The discussions at the meetings described above may address matters
at issue in the following proceedings:

Docket No. ER09-35-001, Tallgrass Transmission, LLC
Docket No. ER09-36-001, Prairie Wind Transmission, LLC
Docket No. ER09-548-001, ITC Great Plains, LLC
Docket No. ER11-4105-000, Southwest Power Pool, Inc.
Docket No. EL11-34-001, Midwest Independent Transmission System
Operator, Inc.
Docket No. ER11-3967-002, Southwest Power Pool, Inc.
Docket No. ER11-3967-003, Southwest Power Pool, Inc.
Docket No. ER12-1179-000, Southwest Power Pool, Inc.
Docket No. ER12-1415-000, Southwest Power Pool, Inc.
Docket No. ER12-1460-000, Southwest Power Pool, Inc.
Docket No. ER12-1610-000, Southwest Power Pool, Inc.

    For more information, contact Luciano Lima, Office of Energy
Markets Regulation, Federal Energy Regulatory Commission at (202) 502-
6210 or<EMAIL_ADDRESS>
    Dated: May 15, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-12187 Filed 5-18-12; 8:45 am]
BILLING CODE 6717-01-P