[Federal Register Volume 85, Number 157 (Thursday, August 13, 2020)]
[Notices]
[Pages 49381-49383]
[FR Doc No: 2020-17711]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0076]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Electronic Records; Electronic Signatures

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on requirements governing the
acceptance of electronic records and electronic signatures.

DATES: Submit either electronic or written comments on the collection
of information by October 13, 2020.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before October 13, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 13, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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-2011-N-0076 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Electronic Records; Electronic
Signatures.'' Received comments, those filed in a timely manner (see
ADDRESSES), 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.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Electronic Records; Electronic Signatures--21 CFR Part 11

OMB Control Number 0910-0303--Extension

    This information collection supports FDA regulations in part 11 (21
CFR part 11), which govern criteria for acceptance of electronic
records, electronic signatures, and handwritten signatures executed to
electronic records as equivalent to paper records. Under these
regulations, records and reports may be submitted to us electronically
provided that we have stated our ability to accept the records
electronically in an Agency-established public docket and that the
other requirements of part 11 are met.
    The recordkeeping provisions in Sec. Sec.  11.10, 11.30, 11.50, and
11.300 require the following standard operating procedures to ensure
appropriate use of and precautions for systems using electronic records
and signatures: (1) Sec.  11.10 specifies procedures and controls for
persons who use closed systems to create, modify, maintain, or transmit
electronic records; (2) Sec.  11.30 specifies procedures and controls
for persons who use open systems to create, modify, maintain, or
transmit electronic records; (3) Sec.  11.50 specifies procedures and
controls for persons who use electronic signatures; and (4) Sec.
11.300 specifies controls to ensure the security and integrity of
electronic signatures based upon use of identification codes in
combination with passwords. The reporting provision (Sec.  11.100)
requires persons to certify to us in writing that they will regard
electronic signatures used in their systems as the legally

binding equivalent of traditional handwritten signatures.
    The burden created by the information collection provision of this
regulation is a one-time burden associated with the creation of
standard operating procedures, validation, and certification. We
anticipate that the use of electronic media will substantially reduce
the paperwork burden associated with maintaining FDA-required records.
The respondents are businesses and other for-profit organizations,
State or local governments, Federal Agencies, and nonprofit
institutions.
    To assist respondents with the information collection we have
developed the guidance document entitled ``Guidance for Industry: Part
11, Electronic Records; Electronic Signatures--Scope and Application,''
available on our website at https://www.fda.gov/media/75414/download.
While we do not believe the guidance creates any attendant burden, it
describes the Agency's thinking regarding persons who, in fulfillment
of a requirement in a statute or another part of FDA's regulations to
maintain records or submit information to FDA, have chosen to maintain
the records or submit designated information electronically and, as a
result, have become subject to part 11. Part 11 applies to records in
electronic form that are created, modified, maintained, archived,
retrieved, or transmitted under any records requirements set forth in
Agency regulations. Part 11 also applies to electronic records
submitted to the Agency under the Federal Food, Drug, and Cosmetic Act
and the Public Health Service Act, even if such records are not
specifically identified in Agency regulations (Sec.  11.1).
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Number of
                         21 CFR section                               Number of       responses per     Total annual    Average  burden    Total hours
                                                                     respondents       respondent        responses       per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   11.100...................................................            4,500                 1            4,500                 1            4,500
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                   Number of                     Average  burden
        21 CFR section            Number of        record per     Total annual         per          Total hours
                                recordkeepers    recordkeepers       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Sec.   11.10.................            2,500                1           2,500               20          50,000
Sec.   11.30.................            2,500                1           2,500               20          50,000
Sec.   11.50.................            4,500                1           4,500               20          90,000
Sec.   11.300................            4,500                1           4,500               20          90,000
                              ----------------------------------------------------------------------------------
    Total....................  ...............  ...............  ..............  ...............         280,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.

    Dated: August 5, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17711 Filed 8-12-20; 8:45 am]
BILLING CODE 4164-01-P


FACTS Dan Giambattisto EMD Chemicals Inc.

Rona Cosmetic Business Unit 7 Skyline Drive Hawthorne, NY 10532 United States Environmental Protection Agency Human Studies Review Board, Public Meeting Washington, DC   June 2006 06/ 2006 ( DG) HRSB 2006 Page 2 What is IR3535 ® ?

° IR3535 ® is an EPA registered biopesticide with a proven record of excellent safety and efficacy against a variety of arthropods.

° It was developed in the 1970s based upon the amino acid ß alanine ° IR3535 ® has been marketed in Europe since the late 1970s, in Asia since the mid 1990s and in the US since 1999 06/ 2006 ( DG) HRSB 2006 Page 3 IR3535 ® Efficacy Anopheles Aedes aegypti Aedes albopictus Culex quinquefasciatus Phlebotomus spp Ixodes ricinus Culicoides sp.

Ixodes scapularis 06/ 2006 ( DG) HRSB 2006 Page 4 IR3535 ® : Safety EPA approved WHO recommended full specification acc. to new CIPAC procedure NRA* approved ( Australia)

° new name: APVMA =

Australian Pesticides & Veterinary Medicines Authority notified acc. to BPD ( European Union)

full dossier submitted in April 2006 06/ 2006 ( DG) HRSB 2006 Page 5 Availability in the US 06/ 2006 ( DG) HRSB 2006 Page 6 Important business considerations ° IR3535 ® is the best selling DEET alternative in the US but  .

°    .. Many more consumer product companies without the resources to file for EPA approval want to market IR3535 ®  containing insect repellent products.

° Sales of insect repellent products are seasonal in nature and a timely approval of the EMD protocols is essential for products to be on the market in 2007.

° EPA has determined that IR3535 ® safe according to the results obtained by acute toxicity, irritation & sensitization,

Repeat dose toxicity, Genotoxicity, Reproduction toxicity and ADME. 06/ 2006 ( DG) HRSB 2006 Page 7 Back up information 06/ 2006 ( DG) HRSB 2006 Page 8 more efficacy studies English name Species IR3535 ®

Lice Pediculus humanus +++

Stable flies Stomoxys calcitrans ++

Black flies Simuliidae +++

Deer flies Tabanidae ++

Sandflies Phlebotomus +++

House flies Musca domestica ++

Wasps Polistes galliens +++

IR3535 ® Efficacy 06/ 2006 ( DG) HRSB 2006 Page 9 IR3535 ® : Market experience European Market Surveillance 1996, and update 2005 Standard Text sent to Subsidiaries to be answered by their customers:

We, Company, Address, Country have been using IR3535 ® in our consumer products since        alone or in combination with the other active ingredients

During this period we had      reports of skin irritancy or adverse reactions Country No. of answers used since no. of reports France 11 1986 0,0007%

Poland 2 2001 0 Germany 3 2000 0,0013%

Switzerland 4 1992 0 UK 7 1991 0 Belgium 1 1991 0 Spain 4 1994 0 Feedback: 06/ 2006 ( DG) HRSB 2006 Page 10 Malaysia Germany Israel Spain Colombia Thailand France Vietnam IR3535 ® : Worldwide acceptance 06/ 2006 ( DG) HRSB 2006 Page 11 Availability in the US 06/ 2006 ( DG) HRSB 2006 Page 12 Availability in the US Introducing BullFrog ® Mosquito Coast ®

2006


[Federal Register Volume 79, Number 157 (Thursday, August 14, 2014)]
[Notices]
[Pages 47720-47722]
[FR Doc No: 2014-19190]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2013-0145; Notice 2]

KBC America, Inc., Grant of Petition for Decision of
Inconsequential Noncompliance

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

ACTION: Grant of Petition.

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SUMMARY: KBC America, Inc. ``KBCA'' has determined that certain
motorcycle helmets manufactured by KBC Corporation for Harley-Davidson
as Harley-Davidson brand helmets do not fully comply with paragraph
S5.6 of Federal Motor Vehicle Safety Standard (FMVSS) No. 218,
Motorcycle Helmets. KBCA has filed an appropriate report dated December
12, 2013, pursuant to 49 CFR part 573, Defect and Noncompliance
Responsibility and Reports.

ADDRESSES: For further information on this decision contact Claudia
Covell, Office of Vehicle Safety Compliance, the National Highway
Traffic Safety Administration (NHTSA), telephone<PHONE_NUMBER>,
facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    I. KBCA's Petition: Pursuant to 49 U.S.C. 30118(d) and 30120(h)
(see implementing rule at 49 CFR part 556), KBCA submitted a petition
for an exemption from the notification and remedy requirements of 49
U.S.C. Chapter 301 on the basis that this noncompliance is
inconsequential to motor vehicle safety.
    Notice of receipt of KBCA's petition was published, with a 30-day
public comment period, on June 6, 2014 in the Federal Register (79 FR
32817). One comment was received. In that comment, Harley-Davidson
Motor Company reiterated KBCA's points supporting their belief that the
noncompliance is inconsequential to

motor vehicle safety. To view the petition and all supporting documents
log onto the Federal Docket Management System (FDMS) Web site at:
http://www.regulations.gov/. Then follow the online search instructions
to locate docket number ``NHTSA-2013-0145.''
    II. Helmets Involved: Affected are approximately 566 Jet model
helmets that KBC Corporation manufactured in December 2012 for Harley
Davidson, who in turn marketed these helmets under its own brand by the
model name ``Black Label Retro \3/4\.''
    III. Noncompliance: KBCA explains that the subject helmets fail to
fully comply with the requirements of S5.6.1(e) of FMVSS No. 218 that
was in effect on the date of manufacture of these helmets because the
goggle strap holders on the rear of the helmets can obscure the DOT
certification label from view.
    IV. Rule Text: Paragraph S5.6.1(e) of FMVSS No. 218 requires in
pertinent part:

    S5.6.1 Each helmet shall be labeled permanently and legibly, in
a manner such that the label(s) can be read easily without removing
padding or any other permanent part, with the following: . . .
    (e) The symbol DOT, constituting the manufacturer's
certification that the helmet conforms to the applicable Federal
motor vehicle safety standards. This symbol shall appear on the
outer surface, in a color that contrasts with the background, in
letters at least 3/8 inch (1 cm) high, centered laterally with the
horizontal centerline of the symbol located a minimum of 1 1/8
inches (2.9 cm) and a maximum of 1 3/8 inches (3.5 cm) from the
bottom edge of the posterior portion of the helmet.

    V. Summary of KBCA's Analyses: KBCA stated its belief that the
subject noncompliance is inconsequential to motor vehicle safety for
the following reasons:

    1. KBCA believes that the subject helmets comply with the
performance requirements of FMVSS No. 218 and that neither the
presence of the strap holder nor the fact that it can obscure the
DOT label affects the helmet's ability to protect the wearer in the
event of a crash.
    2. KBCA states that other than the subject noncompliance the DOT
label on the subject helmets comply with the requirements of FMVSS
No. 218.
    3. KBCA also believes that while the DOT label is not visible
when the strap holder is fastened, a user can easily view the label
by unfastening the strap holder to confirm that the helmet has been
certified and thus complies with the requirements set forth in FMVSS
No. 218.
    4. KBCA further believes that if their company were required to
do a recall of the subject helmets, it would be likely that a very
low percentage of helmets would be returned, if any, and that in
doing so would leave the owners without a helmet while the subject
helmets are retrofitted with a new label.
    5. KBCA expressed its belief that in similar situations NHTSA
has granted petitions for inconsequential noncompliance regarding
other products that have incorrect or missing label information
required by other FMVSS's.

    KBCA has additionally informed NHTSA that it no longer manufactures
the subject helmets.
    In summation, KBCA believes that the described noncompliance of the
subject helmets is inconsequential to motor vehicle safety, and that
its petition, to exempt KBCA from providing recall notification of
noncompliance as required by 49 U.S.C. 30118 and remedying the recall
noncompliance as required by 49 U.S.C. 30120 should be granted.
    VI. NHTSA'S DECISION:
    NHTSA's Analysis of KBCA's Petition:
    Because the goggle strap on this helmet can cover the certification
label and prevents it from being easily read, KBCA acknowledges and
NHTSA agrees that the subject helmets do not comply with the following
language of Paragraph S5.6.1(e) of FMVSS No. 218:

    S5.6.1 Each helmet shall be labeled . . . in a manner such that
the label(s) can be read easily . . . with the following: . . .
    (e) The symbol DOT . . . This symbol shall appear on the outer
surface . . .

    The certification label indicates that the manufacturer has
certified the helmet to meet or exceed all requirements of FMVSS No.
218. FMVSS No. 218 requires the certification label be placed in a
specified location so that it is readily visible. Being visible to
consumers is important so that consumers can ensure motorcycle helmets
they purchase are certified to the standard. In addition, law
enforcement personnel need to be able to easily read certification
labels to enforce motorcycle helmet laws. This point was recently
discussed in a Notice of Proposed Rulemaking \1\ issued by NHTSA.
---------------------------------------------------------------------------

    \1\ 73 FR 57297 published October 2, 2008.
---------------------------------------------------------------------------

    KBCA raises several points in support of its request to be exempt
from the notification and remedy requirements for this helmet. KBCA
believes that a very low percentage of helmets would be returned if a
recall were conducted. In addition, they believe conducting a recall
would leave owners without a helmet while the subject helmets are
retrofitted with a new label. NHTSA notes that anticipating a low
recall completion rate is no justification for not conducting a
notification and remedy campaign. Furthermore, NHTSA has worked with
many manufacturers who have devised strategies to minimize customers'
inconvenience while having their recalled products remedied.
    KBCA states and NHTSA agrees that the presence of the strap holder
which obscures the DOT label does not affect the helmet's ability to
protect the wearer in the event of a crash if that helmet meets or
exceeds the performance requirements of FMVSS No. 218. In this
instance, KBCA has certified this helmet and states in their petition
that this helmet complies with all aspects of the standard other than
the aspect for which it is requesting relief.
    KBCA points out that when the goggle strap holder is unfastened,
the helmet certification label can be read easily. Consumers, who might
be asked by law enforcement personnel about the certification of this
helmet, would be able to unfasten the goggle strap holder to reveal the
certification label which conforms in content and location to the
requirements of FMVSS No. 218.
    KBCA expressed its belief that in similar situations NHTSA has
granted petitions for inconsequential noncompliance regarding other
products that have incorrect or missing label information required by
other FMVSS's. NHTSA responds that the agency determines whether a
particular noncompliance is inconsequential to motor vehicle safety
based on the specific facts of each case.
    NHTSA's Decision: In consideration of the foregoing, NHTSA has
decided that KBCA has met its burden of persuasion and that in this
instance, the subject FMVSS No. 218 noncompliance is inconsequential to
motor vehicle safety. Accordingly, KBCA's petition is hereby granted
and KBCA is exempted from the obligation of providing notification of,
and a remedy for, that noncompliance under 49 U.S.C. 30118 and 30120.
    However, a recent publication of changes to FMVSS No. 218 became
effective on May 13, 2013 and allowed helmets manufactured on or after
May 13, 2013 to display the certification label in a wider range of
locations and therefore accommodate a variety of helmet designs. Along
with the recently published changes came an emphasis on the importance
of label visibility to law enforcement. For these reasons and others,
NHTSA may not view future, similar requests for inconsequential non-
compliance as inconsequential to safety.
    NHTSA also notes that the statutory provisions (49 U.S.C. 30118(d)
and 30120(h)) that permit manufacturers to file petitions for a
determination of

inconsequentiality allows NHTSA to exempt manufacturers only from the
duties found in sections 30118 and 30120, respectively, to notify
owners, purchasers, and dealers of a defect or noncompliance and to
remedy the defect or noncompliance. Therefore, this decision only
applies to the subject helmets that KBCA no longer controlled at the
time it determined that the noncompliance existed. However, the
granting of this petition does not relieve distributors and dealers of
the prohibitions on the sale, offer for sale, or introduction or
delivery for introduction into interstate commerce of the noncompliant
helmets under their control after KBCA notified them that the subject
noncompliance existed.

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

Jeffrey M. Giuseppe,
Acting Director, Office of Vehicle Safety Compliance.
[FR Doc. 2014-19190 Filed 8-13-14; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register: February 5, 2009 (Volume 74, Number 23)]
[Notices]
[Page 6207-6209]
[DOCID:fr05fe09-73]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2002-12844; FMCSA-2002-12423; FMCSA-2004-19477]

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
5 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 February 25, 2009. Comments must be
received on or before March 9, 2009.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-02-12844; FMCSA-02-12423;
FMCSA-04-19477, 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.
    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 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 the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19476). This information is
also available at http://DocketInfo.dot.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<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 5 individuals who have requested a renewal of
their exemption in accordance with FMCSA procedures. FMCSA has
evaluated these 5 applications for renewal on their merits and decided
to extend each exemption for a renewable two-year period. They are:
Lester G. Kelley, II, Dennis R. O'Dell, Jr., Jerry W. Parker, Virgil A.
Potts, Henry A. Shelton.
    These exemptions are extended subject to the following conditions:
(1) That each individual have a physical examination every year (a) by
an ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the standard 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
provide 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
retain 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 5 applicants has satisfied the
entry conditions for obtaining an exemption from the vision
requirements (67 FR 68719; 68 FR 2629; 69 FR 71100; 72 FR 5489; 68
8794; 70 FR 8659; 69 FR 64806; 70 FR 2705). Each of these 5 applicants
has requested renewal of the exemption and has submitted evidence
showing that the vision in the better eye continues to meet the
standard 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
standards. 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 March 9, 2009.
    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 5 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 based on the merits of each
case and 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: January 29, 2009.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. E9-2435 Filed 2-4-09; 8:45 am]

BILLING CODE 4910-EX-P