[Federal Register Volume 78, Number 119 (Thursday, June 20, 2013)]
[Notices]
[Pages 37270-37271]
[FR Doc No: 2013-14716]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2011-0092]

Qualification of Drivers; Exemption Applications; Vision

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

ACTION: Notice of renewal of exemptions; request for comments.

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SUMMARY: FMCSA announces its decision to renew the exemptions from the
vision requirement in the Federal Motor Carrier Safety Regulations for
24 individuals. FMCSA has statutory authority to exempt individuals
from the vision requirement if the exemptions granted will not
compromise safety. The Agency has concluded that granting these
exemption renewals will provide a level of safety that is equivalent to
or greater than the level of safety maintained without the exemptions
for these commercial motor vehicle (CMV) drivers.

DATES: This decision is effective June 28, 2013. Comments must be
received on or before July 22, 2013.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) numbers: Docket No. [Docket No. FMCSA-2011-
0092], using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and
5 p.m., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number for this notice. Note that DOT posts all comments
received without change to http://www.regulations.gov, including any
personal information included in a comment. Please see the Privacy Act
heading below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The Federal Docket Management System (FDMS) is
available 24 hours each day, 365 days each year. If you want
acknowledgment that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgement

page that appears after submitting comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the Federal Docket
Management System (FDMS) published in the Federal Register on January
17, 2008 (73 FR 3316).

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>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.
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the vision requirements in 49 CFR 391.41(b)(10), which applies to
drivers of CMVs in interstate commerce, for a two-year period if it
finds ``such exemption would likely achieve a level of safety that is
equivalent to or greater than the level that would be achieved absent
such exemption.'' The procedures for requesting an exemption (including
renewals) are set out in 49 CFR part 381.

Exemption Decision

    This notice addresses 24 individuals who have requested renewal of
their exemptions in accordance with FMCSA procedures. FMCSA has
evaluated these 24 applications for renewal on their merits and decided
to extend each exemption for a renewable two-year period. They are:

Keith E. Allstot (WA)
Christopher L. Bagby (VA)
Jan M. Bernath (OH)
Joseph L. Butler (IN)
Shawn Carroll (OK)
Erik R. Davis (GA)
Walter C. Dean, Sr. (AL)
John C. DiMassa (WA)
John E. Edler, III (DE)
Saul E. Fierro (AZ)
Mark T. Gileau (CT)
Robert A. Goerl, Jr. (PA)
Peter D. Gouge (IA)
Eric M. Grayson (KY)
Alan D. Harberts (IA)
Thomas M. Harris (MI)
Paul M. Hinkson (TN)
Ellie L. Murphree (AL)
Michael P. Passmore (FL)
Wendell S. Sehen (OH)
Gary E. Valentine (OH)
Kevin W. Van Arsdol (CO)
Charles Van Dyke (WI)
Harlon C. VanBlaricom (MN)

    The exemptions are extended subject to the following conditions:
(1) That each individual has a physical examination every year (a) by
an ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the requirements in 49 CFR 391.41(b)(10),
and (b) by a medical examiner who attests that the individual is
otherwise physically qualified under 49 CFR 391.41; (2) that each
individual provides a copy of the ophthalmologist's or optometrist's
report to the medical examiner at the time of the annual medical
examination; and (3) that each individual provide a copy of the annual
medical certification to the employer for retention in the driver's
qualification file and retains a copy of the certification on his/her
person while driving for presentation to a duly authorized Federal,
State, or local enforcement official. Each exemption will be valid for
two years unless rescinded earlier by FMCSA. The exemption will be
rescinded if: (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 before it was 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.

Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application for additional two year periods. In accordance with 49
U.S.C. 31136(e) and 31315, each of the 24 applicants has satisfied the
entry conditions for obtaining an exemption from the vision
requirements (76 FR 25766; 76 FR 37885). Each of these 24 applicants
has requested renewal of the exemption and has submitted evidence
showing that the vision in the better eye continues to meet the
requirement specified at 49 CFR 391.41(b)(10) and that the vision
impairment is stable. In addition, a review of each record of safety
while driving with the respective vision deficiencies over the past two
years indicates each applicant continues to meet the vision exemption
requirements.
    These factors provide an adequate basis for predicting each
driver's ability to continue to drive safely in interstate commerce.
Therefore, FMCSA concludes that extending the exemption for each
renewal applicant for a period of two years is likely to achieve a
level of safety equal to that existing without the exemption.

Request for Comments

    FMCSA will review comments received at any time concerning a
particular driver's safety record and determine if the continuation of
the exemption is consistent with the requirements at 49 U.S.C. 31136(e)
and 31315. However, FMCSA requests that interested parties with
specific data concerning the safety records of these drivers submit
comments by July 22, 2013.
    FMCSA believes that the requirements for a renewal of an exemption
under 49 U.S.C. 31136(e) and 31315 can be satisfied by initially
granting the renewal and then requesting and evaluating, if needed,
subsequent comments submitted by interested parties. As indicated
above, the Agency previously published notices of final disposition
announcing its decision to exempt these 24 individuals from the vision
requirement in 49 CFR 391.41(b)(10). The final decision to grant an
exemption to each of these individuals was made on the merits of each
case and made only after careful consideration of the comments received
to its notices of applications. The notices of applications stated in
detail the qualifications, experience, and medical condition of each
applicant for an exemption from the vision requirements. That
information is available by consulting the above cited Federal Register
publications.
    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315, FMCSA will take immediate steps to revoke the
exemption of a driver.

    Issued on: June 12, 2013.
 Larry W. Minor,
 Associate Administrator for Policy.
[FR Doc. 2013-14716 Filed 6-19-13; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 76, Number 162 (Monday, August 22, 2011)]
[Notices]
[Page 52377]
[FR Doc No: 2011-21481]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

Colorado Wyoming Reserve Co., Grant Life Sciences, Inc., NOXSO
Corp., Omni Medical Holdings, Inc., and TSI, Inc., Order of Suspension
of Trading

August 18, 2011.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Colorado Wyoming Reserve Company because it has not filed any periodic
reports since the period ended March 31, 2007.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Grant Life Sciences, Inc. because it has not filed any periodic reports
since the period ended March 31, 2008.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
NOXSO Corp. because it has not filed any periodic reports since the
period ended December 31, 2004.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Omni Medical Holdings, Inc. because it has not filed any periodic
reports since the period ended December 31, 2005.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
TSI, Inc. because it has not filed any periodic reports since the
period ended September 30, 2004.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed companies. Therefore, it is ordered,
pursuant to Section 12(k) of the Securities Exchange Act of 1934, that
trading in the securities of the above-listed companies is suspended
for the period from 9:30 a.m. EDT on August 18, 2011 through 11:59 p.m.
EDT on August 31, 2011.

By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2011-21481 Filed 8-18-11; 4:15 pm]
BILLING CODE 8011-01-P


1Memorandum of November 18, 2002, from Lydia Wegman and Peter Tsirigotis, " 2002 Base Year Emission Inventory SIP Planning: 8 hr Ozone, PM2.5 and Regional Haze Programs." This document is available at the following web site: http:// www. epa. gov/ ttn/ oarpg/ meta. 442.1.2002baseinv. pdf. 8/ 8/ 05 alternative PREAMBLE SUMMARY:

3. What baseline year should be required for the emissions inventory for the RFP requirement? We are using the 2002 inventory as the baseline inventory for the ROP requirement for areas designated nonattainment in 2004 primarily because of timing concerns related to attainment dates and when data is collected and compiled. However, in response to several comments, we are allowing States the option of justifying the use of an alternative baseline inventory year for RFP.

**************

PREAMBLE DETAIL:

3. What baseline year should be required for the emissions inventory for the RFP requirement? [ Section VI. I. 4. of June 2, 2003 proposed rule ( 68 FR 32833); § 51.909 of the draft regulatory text; § 51.910( d) of the final regulatory text.] a. Background The baseline inventory for RFP ( under subpart 2) is used as the starting point for the determination of a target level of emissions for the future year RFP and as the baseline from which creditable reductions are determined. We designated ozone nonattainment areas in April 2004. Under the " Consolidated Emissions Reporting Rule" ( 67 FR 39602, June 10, 2002) revised emissions inventories are required for the years 2002 and 2005; therefore, we proposed to require use of the 2002 inventory as the baseline inventory for the RFP requirement. This would be the most recent inventory available at the time of designation. We issued a memorandum identifying 2002 as the anticipated emissions inventory base year for the SIP planning process to address the 8 hour ozone and the PM2.5 standards. 1 b. Summary of Final Rule As set forth in our proposed rule, for areas designated nonattainment for the 8 hour ozone NAAQS with an effective date of June 15, 2004, we are requiring States to use the 2002 inventory as the baseline inventory for the RFP requirement. As noted in the proposal, the inventory for the 2002 calendar year 2E. g., where the effective date of designation to nonattainment for an area for the 8 hour ozone NAAQS is after June 1, 2007 but before June 1, 2010, the baseline inventory will be for calendar year 2005. would be the most recently available inventory at the time of designation in 2004. However, in response to several comments, we are allowing States the option of justifying the use of an alternative baseline inventory year for RFP. To justify an alternative, the State would have to demonstrate how the alternative year meets the CAA's provisions for RFP and why the use of the 2002 baseline year is impracticable. We believe that for multi state nonattainment areas, the several States must agree on a single baseline. The baseline emissions inventory is calculated as of the effective date of an area's nonattainment designation using the most recent calendar year for which a complete inventory is required to be submitted to EPA under subpart A of this part. Under subpart A, States are required to submit a comprehensive inventory on 3 year cycles within 17 months after the close of the reporting period. Thus, the 2002 inventory was due 17 months after the December 31, 2002 close of the reporting period, i. e., was due by June 1, 2004. For those areas designated nonattainment for the 8 hour ozone NAAQS effective June 15, 2004 ( 69 FR 23858, April 30, 2004), the baseline emissions inventory shall be based on the calendar year 2002 because the 2002 inventory was due under subpart A of this part prior to the time of designation. For areas with an effective nonattainment designation in the future, the baseline inventory will be for the calendar year of the most recent triennial inventory as of the date of designation. 2 c. Comments and responses Comment: Some commenters agreed there is a reasonable basis to select 2002 as the date of emissions inventories for purpose of establishing creditable reductions from the inventory. States are not required by the CAA to adopt the year of the nonattainment designation for the 8 hour standard as the basis for their planning, even though that was the case under the 1990 CAA Amendments. The commenter claims there are a variety of measures that would be implemented after 2002 that local jurisdictions would like to be able to account for as new emissions reductions in their modeling demonstrations. The commenter claims that this in part is justified on the basis of the 1997 revisions to the ozone NAAQS, including maximum achievable control technology ( MACT) reductions and NOx SIP Call/ 126 rule reductions. The commenter thus believes that reductions between these years " should count." In addition, this was the most recent quality assured/ quality controlled inventory used to support the States' recommendations for proposed nonattainment designations on July 15, 2003. Even if EPA allows States to show that air quality improved between 2001 2003 for purposes of final designations, it will be on the basis of reductions from these earlier inventories. Several commenters recommended that the baseline year ( starting the 6 year period for RFP) be set for the year in which designations were made ( i. e., 2004).

Comment: Response: The EPA has decided to establish 2002 as the baseline year for RFP SIPs in conformity with both the language of the CAA and the inventory year cycle. Of reasonable importance is the need to maintain consistency with the periodic inventory for use in various milestone considerations such as RFP, milestone compliance demonstration, attainment, and contingency plans. In addition, there should be little if any difference in the result in terms of emissions reductions needed to demonstrate timely attainment. If we use 2002, the baseline may be higher but areas can take credit for any 2002 2004 emission reductions from federally enforceable control measures. If we use 2004, the baseline may be lower but areas can't take credit for measures that produce emissions reductions between 2002 2004. Depending on the area, the difference should be minimal in terms of the difference in the amount of reductions needed to reach attainment and what new measures are necessary to get there. Also, EPA selected this baseline year at the request of many States to allow areas to take credit for emissions reductions achieved in the 2002 2004 period as a result of numerous recently adopted Federal and State measures. We believe it is reasonable to select an inventory year for which States were already required to produce an inventory rather than requiring States to produce an additional inventory ( e. g., for 2004) that is not otherwise required. Moreover, requiring the use of an inventory for the designation year would cause delay, as it would take the States 1 2 years after the end of 2004 to produce the inventory which would be the basis for selecting controls to achieve the necessary reductions. However, we are allowing States the option of justifying the use of an alternative later baseline emission inventory, provided it meets the requirement of the CAA's RFP provisions.

Comment: Another commenter referred to EPA's proposal language regarding the RFP SIP that would have required submission of the RFP plan within 2 years after designation. They stated that EPA is missing the point in that the attainment and RFP submission dates established in subpart 2 are to allow States a sufficient amount of time to achieve the mandated goals. That commenter referred to another alternative that would amend the proposal to require a 1990, rather than 2002 baseline for those areas not having a previously approved 15 percent RFP plan. They further commented that although a 1990 baseline would not eliminate the planning burden associated with this requirement, it would go far towards minimizing the necessary additional work.

Response: We disagree with the commenters who urged use of the 1990 inventories. Use of the 1990 baseline would be unreasonable now since it would have to be substantially recalculated due to changes in emission calculating methodologies. Furthermore, a 1990 inventory was only required for nonattainment areas as of enactment of the 1990 CAA Amendments and therefore may not exist for a number of areas that are currently designated nonattainment for the 8 hour standard. Finally, we believe that reliance on emission reductions that may have occurred well before 8 hour designations and classifications should not be counted as making progress toward attainment.

Comment: Another commenter noted that the 18 percent reduction for serious areas would have to be achieved by 2008. This is 6 years after the base year. The commenter noted that the 2 years that would remain after SIP submission ( from the proposed SIP due date of 2006 until 2008) would be totally inadequate to achieve either the 15 percent reduction in VOCs or the 18 percent reduction in VOCs and/ or NOx. The commenter noted the CAA provides for submission of RFP plans within 3 years ( from 1990) in section 182( b)( 1)( A) and 4 years in section 182( c)( 2).

Response: The final rule reflects a change from the proposal to allow submission of the RFP plan up to 3 years from the date of designation.

Comment: A comment on draft regulatory text § 51.909 noted that EPA specified various program milestone dates, which were derived from the relationship of these dates to the expected date of initial designation. The commenter recommends deleting all such specific date references from the regulation, to avoid the need for revising regulations if the initial designations are not concluded as expected. This should be replaced by a generic approach, for example by requiring the most recent year's data to be used as the baseline in the second sentence of § 51.909. Deleting the calendar specific dates would not change the result if the designations occur as planned, yet would allow for more recent data to be used if factors beyond the agency's control create a delay in designations. This approach also will allow the regulation to apply to future area designation changes, such as areas that are redesignated nonattainment at some point in the future. Such specific dates are more appropriately included as examples in agency guidance or within the preamble of a final rule with a discussion of how they are derived. The regulation itself should retain only the generic relationship between the 3We note that even though the draft regulatory text was structured to place the specification of the baseline year for RFP ( as well as for attainment demonstrations) in § 51.909, the final rule places the RFP baseline year requirement in § 51.910. milestone and the effective date of designation, which is the approach taken elsewhere in the rule. Response: Because the designations have already taken effect at this point, we believe removing the 2002 specification may only be confusing to some. The final version of rule ( now § 51.910( d)) provides specificity regarding the appropriate baseline year for subsequent nonattainment designations. 3 **************

REGULATORY TEXT: from Sect. 51.910:

( d) What is the baseline emissions inventory for RFP plans? ( 1) A baseline emissions inventory is required for the RFP plan required under this section. ( 2) The baseline emissions inventory shall be determined at the time of designation for the 8 hour NAAQS and shall be the emissions inventory for the most recent calendar year for which a complete inventory is required to be submitted to EPA under the provisions of subpart A of this part or a more recent alternative baseline emissions inventory provided the State demonstrates that the baseline inventory meets the CAA provisions for RFP and demonstrates why the inventory required under subpart A of this part would be impracticable to use.


[Federal Register Volume 75, Number 4 (Thursday, January 7, 2010)]
[Notices]
[Page 1002]
[FR Doc No: X10-300107]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension: Rule 15c3-4; SEC File No. 270-441; OMB Control No. 3235-
0497.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget a request for extension of the previously approved
collection of information discussed below.
    Rule 15c3-4 (17 CFR 240.15c3-4) (the ``Rule'') under the Securities
Exchange Act of 1934 (17 U.S.C. 78a et seq.) (the ``Exchange Act'')
requires certain broker-dealers that are registered with the Commission
as OTC derivatives dealers to establish, document, and maintain a
system of internal risk management controls. The Rule sets forth the
basic elements for an OTC derivatives dealer to consider and include
when establishing, documenting, and reviewing its internal risk
management control system, which are designed to, among other things,
ensure the integrity of an OTC derivatives dealer's risk measurement,
monitoring, and management process, to clarify accountability at the
appropriate organizational level, and to define the permitted scope of
the dealer's activities and level of risk. The Rule also requires that
management of an OTC derivatives dealer must periodically review, in
accordance with written procedures, the OTC derivatives dealer's
business activities for consistency with its risk management
guidelines.
    The staff estimates that that the average amount of time a new OTC
derivatives dealer will spend establishing and documenting its risk
management control system is 2,000 hours and that, on average, an
registered OTC derivatives dealer will spend approximately 200 hours
each year to maintain (e.g., reviewing and updating) its risk
management control system. Currently, four firms are registered with
the Commission as OTC derivatives dealers. The staff estimates that
approximately one additional OTC derivatives dealer may become
registered within the next three years. Accordingly, the staff
estimates the total annualized burden associated with Rule 15c3-4 for
five OTC derivatives dealers will be approximately 1,567 hours
annually.\1\
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    \1\ ((One new OTC derivatives dealer x 2,000 hours to establish
and document its internal risk management control system) + (One new
OTC derivatives dealer x 200 hours to maintain an internal risk
management control system x (3 years/2)) + (Four registered OTC
derivatives dealers x 200 hours to maintain an internal risk
management control system x 3 years))/3 years = 1,567 hours.
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    The staff believes that the cost of complying with Rule 15c3-4 will
be approximately $258 per hour.\2\ This per hour cost is based upon an
annual average hourly salary for a compliance manager who would be
responsible for ensuring compliance with the requirements of Rule 15c3-
4. Accordingly, the total annualized cost for all affected OTC
derivatives dealers is estimated to be $404,200.\3\
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    \2\ The $258 per hour salary figure for a Compliance Manager is
from SIFMA's Management & Professional Earnings in the Securities
Industry 2008, modified by Commission staff to account for an 1,800-
hour work-year and multiplied by 5.35 to account for bonuses, firm
size, employee benefits and overhead.
    \3\ 1,567 hours x $258 = $404,200.
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    The records required to be made by OTC derivatives dealers pursuant
to the Rule and the results of the periodic reviews conducted under
paragraph (d) of Rule 15c3-4 must be preserved under Rule 17a-4 of the
Exchange Act (17 CFR 240.17a-4) for a period of not less than three
years, the first two years in an accessible place. The Commission will
not generally publish or make available to any person notice or reports
received pursuant to the Rule. The statutory basis for the Commission's
refusal to disclose such information to the public is the exemption
contained in Section (b)(4) of the Freedom of Information Act, 5 U.S.C.
552, which essentially provides that the requirement of public
dissemination does not apply to commercial or financial information
which is privileged or confidential.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Comments should be directed to: (i) Desk Officer for the Securities
and Exchange Commission Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503 or by sending an email to: (i)
<EMAIL_ADDRESS>and (ii) Charles Boucher, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Shirley
Martinson, 6432 General Green Way, Alexandria, Virginia 22312 or send
an e-mail to<EMAIL_ADDRESS>Comments must be submitted to OMB
within 30 days of this notice.

    Dated: December 30, 2009.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-2 Filed 1-6-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 38 (Wednesday, February 26, 2020)]
[Notices]
[Pages 11091-11093]
[FR Doc No: 2020-03860]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5570]

Recommendations for Clinical Laboratory Improvement Amendments of
1988 Waiver Applications for Manufacturers of In Vitro Diagnostic
Devices; Guidance for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Recommendations for
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver
Applications for Manufacturers of In Vitro Diagnostic Devices.'' FDA
has updated this guidance to implement the waiver improvements section
of the 21st Century Cures Act (the Cures Act), which requires FDA to
revise ``Section V. Demonstrating Insignificant Risk of an Erroneous
Result--Accuracy'' of the guidance ``Recommendations for Clinical
Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications
for Manufacturers of In Vitro Diagnostic Devices'' (``2008 CLIA Waiver
Guidance'') that was issued on January 30, 2008. The remainder of the
2008 CLIA Waiver Guidance, with exception of technical edits for
consistency with the newly amended section V, has not been
substantively changed. This final guidance provides additional and
updated approaches for demonstrating that a test meets the statutory
criteria for waiver and includes FDA's revised thinking regarding ``the
appropriate use of comparable performance between a waived user and a
moderately complex laboratory user to demonstrate accuracy.''

DATES: The announcement of the guidance is published in the Federal
Register on February 26, 2020.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-5570 for ``Recommendations for Clinical Laboratory
Improvement Amendments of 1988 (CLIA) Waiver Applications for
Manufacturers of In Vitro Diagnostic Devices.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Recommendations for Clinical Laboratory Improvement Amendments of
1988 (CLIA) Waiver Applications for Manufacturers of In Vitro
Diagnostic Devices'' to the Office of Policy, Guidance and Policy
Development, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002 or to the Office of Communication, Outreach and
Development, Center for Biologics Evaluation and Research (CBER), Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to

assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Peter Tobin, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3435, Silver Spring, MD 20993-0002,<PHONE_NUMBER> or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This final guidance revises the guidance titled ``Recommendations
for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver
Applications for Manufacturers of In Vitro Diagnostic Devices'' (``2008
CLIA Waiver Guidance'') that was issued on January 30, 2008, to
implement section 3057 of the Cures Act (Pub. L. 114-255), which
requires FDA to revise ``Section V. Demonstrating Insignificant Risk of
an Erroneous Result--Accuracy'' of the 2008 CLIA Waiver Guidance. The
remainder of the 2008 CLIA Waiver Guidance, with exception of technical
edits for consistency with the newly amended section V, has not been
substantively changed. This update provides additional approaches for
demonstrating that a test meets the criteria in 42 U.S.C. 263a(d)(3)(A)
and includes FDA's revised thinking regarding ``the appropriate use of
comparable performance between a waived user and a moderately complex
laboratory user to demonstrate accuracy.''
    The Secretary of Health and Human Services has delegated to FDA the
authority to determine whether particular tests are ``simple'' and have
``an insignificant risk of an erroneous result'' under CLIA and thus
are eligible for CLIA waiver (69 FR 22849, April 27, 2004). The Centers
for Medicare & and Medicaid Services is responsible for oversight of
clinical laboratories, which includes issuing Certificates of Waiver.
CLIA requires that clinical laboratories obtain a certificate before
accepting materials derived from the human body for laboratory tests
(42 U.S.C. 263a(b)).
    The 2008 CLIA Waiver Guidance describes recommendations for device
manufacturers about study design and analysis for CLIA Waiver by
Application to support an FDA determination as to whether the device
meets the statutory criteria for waiver.
    On November 29, 2017, FDA issued a draft guidance titled ``Select
Updates for Recommendations for Clinical Laboratory Improvement
Amendments of 1988 Waiver Applications for Manufacturers of In Vitro
Diagnostic Devices.'' This draft guidance proposed additional
approaches for demonstrating that a test meets the criteria in 42
U.S.C. 263a(d)(3)(A). On November 29, 2018, FDA issued a revised draft
guidance by the same title, which appeared in the Federal Register of
November 29, 2018 (83 FR 61391), after considering comments received on
the draft guidance issued November 29, 2017. This document revises
section V of the guidance ``Recommendations for Clinical Laboratory
Improvement Amendments of 1988 (CLIA) Waiver Applications for
Manufacturers of In Vitro Diagnostic Devices,'' issued on January 30,
2008.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Recommendations for Clinical Laboratory
Improvement Amendments of 1988 (CLIA) Waiver Applications for
Manufacturers of In Vitro Diagnostic Devices.'' It does not establish
any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. This guidance document is also available at
https://www.regulations.gov. Persons unable to download an electronic
copy of ``Recommendations for Clinical Laboratory Improvement
Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In
Vitro Diagnostic Devices'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 16046 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in
the following FDA regulations and guidance have been approved by OMB as
listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
      21 CFR part or guidance               Topic               No.
------------------------------------------------------------------------
50, 56............................  Protection of Human        0910-0755
                                     Subjects: Informed
                                     Consent;
                                     Institutional
                                     Review Boards.
54................................  Financial Disclosure       0910-0396
                                     by Clinical
                                     Investigators.
803...............................  Medical Device             0910-0437
                                     Reporting.
809...............................  Medical Device             0910-0485
                                     Labeling
                                     Regulations.
812...............................  Investigational            0910-0078
                                     Device Exemption.
``Recommendations for Clinical      CLIA Waiver                0910-0598
 Laboratory Improvement Amendments   Applications.
 of 1988 (CLIA) Waiver
 Applications for Manufacturers of
 In Vitro Diagnostic Devices''.
``Administrative Procedures for     CLIA Categorizations       0910-0607
 Clinical Laboratory Improvement
 Amendments of 1988
 Categorization''.
``Requests for Feedback and         Q-submissions.......       0910-0756
 Meetings for Medical Device
 Submissions: The Q-Submission
 Program''.
------------------------------------------------------------------------

    Dated: February 21, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03860 Filed 2-25-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 143 (Thursday, July 27, 2023)]
[Notices]
[Pages 48479-48480]
[FR Doc No: 2023-15873]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2023-0002; Internal Agency Docket No. FEMA-B-2353]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice.

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

SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP).

DATES: Comments are to be submitted on or before October 25, 2023.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location https://hazards.fema.gov/femaportal/prelimdownload and the
respective Community Map Repository address listed in the tables below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
https://msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-2353, to
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance
and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC
20472,<PHONE_NUMBER>, or (email) [email protected].

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
[email protected]; or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location
https://hazards.fema.gov/femaportal/prelimdownload and the respective
Community Map Repository address listed in the tables. For communities
with multiple ongoing Preliminary studies, the studies can be
identified by the unique project number and Preliminary FIRM date
listed in the tables. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at https://msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Nicholas A. Shufro,
Deputy Assistant Administrator for Risk Management, Federal Emergency
Management Agency, Department of Homeland Security.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
            Hunterdon County, New Jersey (All Jurisdictions)
          Project: 18-02-0007S Preliminary Date: April 02, 2021
------------------------------------------------------------------------
Town of Clinton........................  Municipal Building, 43 Leigh
                                          Street, Clinton, NJ 08809.
Township of Clinton....................  Clinton Municipal Building,
                                          1225 Route 31 South, Lebanon,
                                          NJ 08833.
Township of Franklin...................  Franklin Municipal Building,
                                          202 Sidney Road, Pittstown, NJ
                                          08867.
Township of Raritan....................  Raritan Municipal Building, One
                                          Municipal Drive, Flemington,
                                          NJ 08822.
Township of Readington.................  Readington Municipal Building,
                                          509 Route 523, Whitehouse
                                          Station, NJ 08889.
------------------------------------------------------------------------
             Somerset County, New Jersey (All Jurisdictions)
          Project: 18-02-0007S Preliminary Date: March 26, 2021
------------------------------------------------------------------------
Township of Branchburg.................  Municipal Building, Engineering
                                          Department, 1077 US Highway
                                          202 North, Branchburg, NJ
                                          08876.
Township of Bridgewater................  Municipal Building, 100 Commons
                                          Way, Bridgewater, NJ 08807.
------------------------------------------------------------------------

[FR Doc. 2023-15873 Filed 7-26-23; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 77, Number 178 (Thursday, September 13, 2012)]
[Notices]
[Page 56697]
[FR Doc No: 2012-22487]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67802; File No. 4-652]

Technology and Trading Roundtable

AGENCY: Securities and Exchange Commission.

ACTION: Notice of roundtable discussion; date change.

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

SUMMARY: The Securities and Exchange Commission will host a one day
roundtable entitled ``Technology and Trading: Promoting Stability in
Today's Markets'' to discuss ways to promote stability in markets that
rely on highly automated systems. The market technology roundtable,
which was scheduled for September 14, 2012, will now be held on October
2, 2012. The roundtable at the Securities and Exchange Commission's
Washington, DC headquarters is open to the public and will be webcast.
As previously announced, the event will begin with a discussion on
preventing errors, focusing on current best practices and practical
constraints for creating, deploying and operating mission-critical
systems, including those used to automatically generate and route
orders, match trades, confirm transactions, and disseminate data. The
afternoon session will focus on error response, with experts discussing
how the market might employ independent filters, objective tests, and
other real-time processes or crisis-management procedures to detect,
limit, and possibly terminate erroneous market activities when they
occur, thereby limiting the impact of such errors.

DATES: The roundtable discussion will take place on October 2, 2012.
The Commission will accept comments regarding issues addressed at the
roundtable until October 23, 2012.

FOR FURTHER INFORMATION CONTACT: Arisa Tinaves, Special Counsel, at
(202) 551-5676, Division of Trading and Markets, Securities and
Exchange Commission, 100 F Street NE., Washington, DC 20549-7010.

    By the Commission.
    Dated: September 7, 2012
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-22487 Filed 9-12-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 19 (Monday, February 1, 2021)]
[Notices]
[Pages 7774-7775]
[FR Doc No: 2021-02018]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2020-0052]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

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

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to exempt three individuals from
the requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs) that interstate commercial motor vehicle (CMV) drivers have
``no established medical history or clinical diagnosis of epilepsy or
any other condition which is likely to cause loss of consciousness or
any loss of ability to control a CMV.'' The exemptions enable these
individuals who have had one or more seizures and are taking anti-
seizure medication to operate CMVs in interstate commerce.

DATES: The exemptions were applicable on January 11, 2021. The
exemptions expire on January 11, 2023.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>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 Dockets Operations,<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/docket?D=FMCSA-2020-0052 and choose the document to review. If you do
not have access to the internet, you may view the docket online by
visiting Dockets Operations in Room W12-140 on the ground floor of the
DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590-
0001, between 9 a.m. and 5 p.m. ET, Monday through Friday, except
Federal holidays. To be sure someone is there to help you, please call
(202) 366-9317 or<PHONE_NUMBER> before visiting Dockets Operations.

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 December 11, 2020, FMCSA published a notice announcing receipt
of applications from three individuals requesting an exemption from the
epilepsy and seizure disorders prohibition in 49 CFR 391.41(b)(8) and
requested comments from the public (85

FR 8022). The public comment period ended on January 11, 2021, and one
comments was received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting exemptions to these individuals would achieve
a level of safety equivalent to, or greater than, the level that would
be achieved by complying with Sec.  391.41(b)(8).
    The physical qualification standard for drivers regarding epilepsy
found in Sec.  391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist medical examiners (MEs) in determining whether
drivers with certain medical conditions are qualified to operate a CMV
in interstate commerce.
---------------------------------------------------------------------------

    \1\ These criteria may be found in APPENDIX A TO PART 391--
MEDICAL ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8),
paragraphs 3, 4, and 5, which is available on the internet at
https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
---------------------------------------------------------------------------

III. Discussion of Comments

    FMCSA received one comments in this proceeding. The comment
received was outside the scope of this notice.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statute also allows the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-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 2007 recommendations of the Agency's Medical Expert Panel
(MEP). The Agency conducted an individualized assessment of each
applicant's medical information, including the root cause of the
respective seizure(s) and medical information about the applicant's
seizure history, the length of time that has elapsed since the
individual's last seizure, the stability of each individual's treatment
regimen and the duration of time on or off of anti-seizure medication.
In addition, the Agency reviewed the treating clinician's medical
opinion related to the ability of the driver to safely operate a CMV
with a history of seizure and each applicant's driving record found in
the Commercial Driver's License Information System for commercial
driver's license (CDL) holders, and interstate and intrastate
inspections recorded in the Motor Carrier Management Information
System. For non-CDL holders, the Agency reviewed the driving records
from the State Driver's Licensing Agency (SDLA). A summary of each
applicant's seizure history was discussed in the December 11, 2020,
Federal Register notice (85 FR 80222) and will not be repeated in this
notice.
    These three applicants have been seizure-free over a range of eight
to 19 years while taking anti-seizure medication and maintained a
stable medication treatment regimen for the last 2 years. In each case,
the applicant's treating physician verified his or her seizure history
and supports the ability to drive commercially.
    The Agency acknowledges the potential consequences of a driver
experiencing a seizure while operating a CMV. However, the Agency
believes the drivers granted this exemption have demonstrated that they
are unlikely to have a seizure and their medical condition does not
pose a risk to public safety.
    Consequently, FMCSA finds that in each case exempting these
applicants from the epilepsy and seizure disorder prohibition in Sec.
391.41(b)(8) 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 remain seizure-free and maintain a stable treatment
during the 2-year exemption period; (2) each driver must submit annual
reports from their treating physicians attesting to the stability of
treatment and that the driver has remained seizure-free; (3) each
driver must undergo an annual medical examination by a certified ME, as
defined by Sec.  390.5; 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 keep a copy of 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 three exemption applications,
FMCSA exempts the following drivers from the epilepsy and seizure
disorder prohibition, Sec.  391.41(b)(8), subject to the requirements
cited above:

Dylan C. Hill (KS)
James R. Satterlee (MI)
Robert G. Schauer, III (IA)

    In accordance with 49 U.S.C. 31315(b), each exemption will be valid
for 2 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(b).

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2021-02018 Filed 1-29-21; 8:45 am]
BILLING CODE 4910-EX-P