[Federal Register: January 18, 2008 (Volume 73, Number 13)]
[Rules and Regulations]
[Page 3387]
[DOCID:fr18ja08-4]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

Human Cells, Tissues, and Cellular and Tissue-Based Products

CFR Correction

    In Title 21 of the Code of Federal Regulations, Parts 800 to 1299,
revised as of April 1, 2007, in part 1271, on page 718, Sec.  1271.22
is reinstated to read as follows:

Sec.  1271.22  How and where do I register and submit an HCT/P list?

    (a) You must use Form FDA 3356 for:
    (1) Establishment registration,
    (2) HCT/P listings, and
    (3) Updates of registration and HCT/P listing.
    (b) You may obtain Form FDA 3356:
    (1) By writing to the Center for Biologics Evaluation and Research
(HFM-775), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448, Attention: Tissue Establishment Registration
Coordinator;
    (2) By contacting any Food and Drug Administration district office;
    (3) By calling the CBER Voice Information System at 1-800-835-4709
or<PHONE_NUMBER>; or
    (4) By connecting to http://www.fda.gov/opacom/morechoices/fdaforms/cber.html
 on the Internet.

    (c)(1) You may submit Form FDA 3356 to the Center for Biologics
Evaluation and Research (HFM-775), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448, Attention: Tissue
Establishment Registration Coordinator; or
    (2) You may submit Form FDA 3356 electronically through a secure
web server at http://www.fda.gov/cber/tissue/tisreg.htm.

[69 FR 68681, Nov. 24, 2004]
[FR Doc. 08-55500 Filed 1-17-08; 8:45 am]

BILLING CODE 1505-01-D


[Federal Register Volume 79, Number 137 (Thursday, July 17, 2014)]
[Notices]
[Pages 41737-41740]
[FR Doc No: 2014-16796]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0008]

Qualification of Drivers; Exemption Applications; Vision

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

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

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SUMMARY: FMCSA announces receipt of applications from 5 individuals for
exemption from the vision requirement for operating a commercial motor
vehicle (CMV) in the Federal Motor Carrier Safety Regulations. The
applicants are unable to meet the vision requirement in one eye for
various reasons. The exemptions will allow these individuals to operate
CMVs in interstate commerce without meeting the prescribed vision
requirement in one eye. At the end of the comment period, the Agency
will grant exemptions to the applicants listed herein if there are no
adverse comments that indicate the driver's ability will not achieve a
level of safety equivalent to or greater than the level of safety that
would be obtained by complying with the regulations. All comments will
be reviewed and evaluated by FMCSA. Some individuals appearing in this
notice may not receive exemptions based on comments received during the
comment period. Individuals not granted an exemption may either be
published at a future date based on further evaluation or may not be
deemed to meet the aforementioned level of safety if granted an
exemption. These individuals will be published in a quarterly notice of
exemption denials. As always, any adverse comments received after the
exemption is granted will be evaluated, and if they indicate that the
driver is not achieving a level of safety equivalent to or greater than
the level of safety that would be obtained by complying with the
regulation, the exemption will be revoked. When granted, the exemptions
will allow these individuals with vision deficiencies in one eye to
operate in interstate commerce.

DATES: Comments must be received on or before August 18, 2014. All
comments will be investigated by FMCSA. The exemptions will be issued
the day after the comment period closes.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2014-0008 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: 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 numbers for this notice. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    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 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 grant an exemption
from the Federal Motor Carrier Safety Regulations for a 2-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 2-year period. The 5 individuals listed in
this notice have recently requested such an exemption from the vision
requirement in 49 CFR 391.41(b)(10), which applies to drivers of CMVs
in interstate commerce. Accordingly, the Agency has evaluated the
qualifications of each applicant to determine whether granting an
exemption will achieve the required level of safety mandated by
statute.

Qualifications of Applicants

Christopher D. Bolomey

    Mr. Bolomey, 40, has strabismus, a cataract, and optic nerve damage
in his right eye due to a traumatic incident during childhood. The
visual acuity in his right eye is light perception, and in his left
eye, 20/20. Following an examination in 2014, his optometrist stated,
``Needs to be checked for Federal DOT exemption. No changes to vision.
Snce [sic] LEE [sic] 12-31-2013 . . . Pass for DOT or Fed Driving w/
[sic] correcton [sic].'' Mr. Bolomey reported that he has driven
tractor-trailer combinations for 10 years, accumulating 875,500 miles.
He holds a Class A CDL from Missouri. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Leamon V. Manchester

    Mr. Manchester, 46, has complete loss of vision in his left eye due
to a traumatic incident during childhood. The visual acuity in his
right eye is 20/20, and in his left eye, no light perception. Following
an examination in 2014, his ophthalmologist stated, ``Mr. Manchester
[sic] vision status meets the requirements to operate a commercial
motor vehicle.'' Mr. Manchester reported that he has driven straight
trucks for 20 years, accumulating 1.75 million miles, and tractor-
trailer combinations for 20 years, accumulating 2 million miles. He
holds an operator's license from Louisiana. His driving record for the
last 3 years shows no crashes and no convictions for moving violations
in a CMV.

Leverne F. Schulte Jr.

    Mr. Schulte, 57, has a large corneal scar resulting in poor vision
in his right eye due to a traumatic incident during childhood. The
visual acuity in his right eye is light perception, and in his left
eye, 20/20. Following an examination in 2014, his optometrist stated,
``I examined Mr. Schulte on April 3, 2014. He wanted to get an
interstate CDL. Currently he has intrastate license only. He has a
history of an injury to his right cornea . . . Since he is presently
driving in the state and has no trouble [sic] I don't see any danger in
him driving across the state line.'' Mr. Schulte reported that he has
driven straight trucks for 21 years, accumulating 42,000 miles, and
tractor-trailer combinations for 37 years, accumulating 277,500 miles.
He holds a Class A CDL from Ohio. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Clark D. Workman

    Mr. Workman, 56, has had Coats' disease and a branch retinal artery
occlusion resulting in a macular scar in his left eye since 2009. The
visual acuity in his right eye is 20/20, and in his left eye, 20/70.
Following an examination in 2014, his optometrist stated, ``I certify
in my medical opinion the Mr [sic] Workman has sufficient vision to
perform the driving tasks required to operate a commercial vehicle.''
Mr. Workman reported that he has driven straight trucks for 36 years,
accumulating 72,000 miles, and tractor-trailer combinations for 38
years, accumulating 190,000 miles. He holds a Class A CDL from Idaho.
His driving record for the last 3 years shows no crashes and no
convictions for moving violations in a CMV.

Paul M. Wooton

    Mr. Wooton, 36, has a macular scar in his left eye due to a
traumatic incident during childhood. The visual acuity in his right eye
is 20/20, and in his left eye, 20/70. Following an examination in 2014,
his ophthalmologist stated, ``I have recommended that he is safely
about to operate [sic] the commercial motor vehicle as he has good
peripheral vision and fairly decent central vision with the left eye.''
Mr. Wooton reported that he has driven straight trucks for 5 years,
accumulating 150,000 miles, and tractor-trailer combinations for 2
years, accumulating 150,000 miles. He holds a Class DA CDL from
Kentucky. His driving record for the last 3 years shows no crashes and
no convictions for moving violations in a CMV.
    FMCSA has evaluated the eligibility of the 5 applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(10). Absent the receipt of comments indicating that a
driver's ability would not achieve the aforementioned level of safety,
the Agency will grant the drivers an exemption the day after the
comment period closes.

Vision and Driving Experience of the Applicants

    The vision requirement in the FMCSRs provides:
    A person is physically qualified to drive a commercial motor
vehicle if that person has distant visual acuity of at least 20/40
(Snellen) in each eye without corrective lenses or visual acuity
separately corrected to 20/40 (Snellen) or better with corrective
lenses, distant binocular acuity of at least 20/40 (Snellen) in both
eyes with or without corrective lenses, field of vision of at least
70[deg] in the horizontal meridian in each eye, and the ability to
recognize the colors of traffic signals and devices showing red, green,
and amber (49 CFR 391.41(b)(10)).
    MCSA recognizes that some drivers do not meet the vision
requirement but have adapted Ftheir driving to accommodate their vision
limitation and demonstrated their ability to drive safely. The 5
exemption applicants listed in this notice are in this category. They
are unable to meet the vision requirement in one eye for various
reasons, and in most cases their eye conditions were not recently
developed. Four of the applicants were either born with their vision
impairments or have had them since childhood. The one individual that
sustained his vision condition as an adult has had it for 5 years.
    Although each applicant has one eye which does not meet the vision
requirement in 49 CFR 391.41(b)(10), each has at least 20/40 corrected
vision in the other eye, and in a doctor's opinion, has sufficient
vision to perform all the tasks necessary to operate a CMV. Doctors'
opinions are supported by the applicants' possession of valid
commercial driver's licenses (CDLs) or non-CDLs to operate CMVs. Before
issuing CDLs, States subject drivers to knowledge and skills tests
designed to

evaluate their qualifications to operate a CMV.
    All of these applicants satisfied the testing requirements for
their State of residence. By meeting State licensing requirements, the
applicants demonstrated their ability to operate a CMV, with their
limited vision, to the satisfaction of the State.
    While possessing a valid CDL or non-CDL, these 5 drivers have been
authorized to drive a CMV in intrastate commerce, even though their
vision disqualified them from driving in interstate commerce. The
qualifications, experience, and medical condition of each applicant is
stated and discussed in detail above.

Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the vision requirement in 49 CFR 391.41(b)(10) if the exemption is
likely to achieve an equivalent or greater level of safety than would
be achieved without the exemption. Without the exemption, applicants
will continue to be restricted to intrastate driving. With the
exemption, applicants can drive in interstate commerce. Thus, our
analysis focuses on whether an equal or greater level of safety is
likely to be achieved by permitting each of these drivers to drive in
interstate commerce as opposed to restricting him or her to driving in
intrastate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered the medical reports about the applicants' vision as well as
their driving records and experience with the vision deficiency.
    To qualify for an exemption from the vision requirement, FMCSA
requires a person to present verifiable evidence that he/she has driven
a commercial vehicle safely with the vision deficiency for the past 3
years. Recent driving performance is especially important in evaluating
future safety, according to several research studies designed to
correlate past and future driving performance. Results of these studies
support the principle that the best predictor of future performance by
a driver is his/her past record of crashes and traffic violations.
Copies of the studies may be found at Docket Number FMCSA-1998-3637.
    FMCSA believes it can properly apply the principle to monocular
drivers, because data from the Federal Highway Administration's (FHWA)
former waiver study program clearly demonstrate the driving performance
of experienced monocular drivers in the program is better than that of
all CMV drivers collectively (See 61 FR 13338, 13345, March 26, 1996).
The fact that experienced monocular drivers demonstrated safe driving
records in the waiver program supports a conclusion that other
monocular drivers, meeting the same qualifying conditions as those
required by the waiver program, are also likely to have adapted to
their vision deficiency and will continue to operate safely.
    The first major research correlating past and future performance
was done in England by Greenwood and Yule in 1920. Subsequent studies,
building on that model, concluded that crash rates for the same
individual exposed to certain risks for two different time periods vary
only slightly (See Bates and Neyman, University of California
Publications in Statistics, April 1952). Other studies demonstrated
theories of predicting crash proneness from crash history coupled with
other factors. These factors--such as age, sex, geographic location,
mileage driven and conviction history--are used every day by insurance
companies and motor vehicle bureaus to predict the probability of an
individual experiencing future crashes (See Weber, Donald C.,
``Accident Rate Potential: An Application of Multiple Regression
Analysis of a Poisson Process,'' Journal of American Statistical
Association, June 1971). A 1964 California Driver Record Study prepared
by the California Department of Motor Vehicles concluded that the best
overall crash predictor for both concurrent and non-concurrent events
is the number of single convictions. This study used 3 consecutive
years of data, comparing the experiences of drivers in the first 2
years with their experiences in the final year.
    Applying principles from these studies to the past 3-year record of
the 5 applicants, none of the drivers were involved in crashes or
convicted of moving violations in a CMV. All the applicants achieved a
record of safety while driving with their vision impairment,
demonstrating the likelihood that they have adapted their driving
skills to accommodate their condition. As the applicants' ample driving
histories with their vision deficiencies are good predictors of future
performance, FMCSA concludes their ability to drive safely can be
projected into the future.
    FMCSA believes that the applicants' intrastate driving experience
and history provide an adequate basis for predicting their ability to
drive safely in interstate commerce. Intrastate driving, like
interstate operations, involves substantial driving on highways on the
interstate system and on other roads built to interstate standards.
Moreover, driving in congested urban areas exposes the driver to more
pedestrian and vehicular traffic than exists on interstate highways.
Faster reaction to traffic and traffic signals is generally required
because distances between them are more compact. These conditions tax
visual capacity and driver response just as intensely as interstate
driving conditions. The veteran drivers in this proceeding have
operated CMVs safely under those conditions for at least 3 years, most
for much longer. Their experience and driving records lead us to
believe that each applicant is capable of operating in interstate
commerce as safely as he/she has been performing in intrastate
commerce. Consequently, FMCSA finds that exempting these applicants
from the vision requirement in 49 CFR 391.41(b)(10) is likely to
achieve a level of safety equal to that existing without the exemption.
For this reason, the Agency is granting the exemptions for the 2-year
period allowed by 49 U.S.C. 31136(e) and 31315 to the 5 applicants
listed in this notice.
    We recognize that the vision of an applicant may change and affect
his/her ability to operate a CMV as safely as in the past. As a
condition of the exemption, therefore, FMCSA will impose requirements
on the 5 individuals consistent with the Grandfathering provisions
applied to drivers who participated in the Agency's vision waiver
program.
    Those requirements are found at 49 CFR 391.64(b) and include the
following: (1) That each individual be physically examined every year
(a) by an ophthalmologist or optometrist who attests that the vision in
the better eye continues to meet the requirement 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, or keep a copy in his/her driver's
qualification file if he/she is self-employed. The driver must have a
copy of the certification when driving, for presentation to a duly
authorized Federal, State, or local enforcement official.
    In accordance with 49 U.S.C. 31136(e) and 31315, each exemption
will be valid for 2 years unless revoked earlier by FMCSA. The
exemption will be revoked 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 and 31315.

Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. The Agency will consider all comments
received before the close of business August 18, 2014. Comments will be
available for examination in the docket at the location listed under
the ADDRESSES section of this notice. The Agency will file comments
received after the comment closing date in the public docket, and will
consider them to the extent practicable.
    In addition to late comments, FMCSA will also continue to file, in
the public docket, relevant information that becomes available after
the comment closing date. Interested persons should monitor the public
docket for new material.

Submitting Comments

    You may submit your comments and material online or by fax, mail,
or hand delivery, but please use only one of these means. FMCSA
recommends that you include your name and a mailing address, an email
address, or a phone number in the body of your document so that FMCSA
can contact you if there are questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov and
in the search box insert the docket number FMCSA-2014-0008 and click
the search button. When the new screen appears, click on the blue
``Comment Now!'' button on the right hand side of the page. On the new
page, enter information required including the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. If you submit your comments by mail or
hand delivery, submit them in an unbound format, no larger than 8\1/2\
by 11 inches, suitable for copying and electronic filing. If you submit
comments by mail and would like to know that they reached the facility,
please enclose a stamped, self-addressed postcard or envelope.
    We will consider all comments and material received during the
comment period and may change this proposed rule based on your
comments. FMCSA may issue a final rule at any time after the close of
the comment period.

Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble, To submit your comment online, go to http://www.regulations.gov and in the search box insert the docket number
FMCSA-2014-0008 and click ``Search.'' Next, click ``Open Docket
Folder'' and you will find all documents and comments related to the
proposed rulemaking.

    Issued on: July 10, 2014.
Larry W. Minor,
 Associate Administrator for Policy.
[FR Doc. 2014-16796 Filed 7-16-14; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 76, Number 131 (Friday, July 8, 2011)]
[Notices]
[Pages 40349-40350]
[FR Doc No: 2011-17136]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings No. 2

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP11-2006-001.
    Applicants: Equitrans, L.P.
    Description: Equitrans, L.P. submits tariff filing per 154.203:
Removal of Non-Conforming Agreement Compliance Filing to be effective
7/9/2011.
    Filed Date: 06/09/2011.
    Accession Number: 20110609-5105.
    Comment Date: 5 p.m. Eastern Time on Friday, June 24, 2011.

    Docket Numbers: RP10-713-002.
    Applicants: Enbridge Offshore Pipelines (UTOS) LLC.
    Description: Enbridge Offshore Pipelines (UTOS) LLC submits tariff
filing per 154.203: Resubmittal in Compliance with Order to be
effective 6/5/2010.
    Filed Date: 06/16/2011.
    Accession Number: 20110616-5071.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 28, 2011.

    Docket Numbers: RP11-2177-001.
    Applicants: Texas Gas Transmission, LLC.
    Description: Texas Gas Transmission, LLC submits tariff filing per
154.205(b): RP11-2177-000 Amendment Filing to be effective 7/7/2011.
    Filed Date: 06/16/2011.
    Accession Number: 20110616-5057.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 28, 2011.

    Docket Numbers: CP05-357-010.
    Applicants: Cheniere Creole Trail Pipeline, L.P.
    Description: Cheniere Creole Trail Pipeline, L.P. submits Cost and
Revenue Study.
    Filed Date: 06/17/2011.
    Accession Number: 20110617-5178.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 28, 2011.

    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed on or before 5 p.m. Eastern time on the specified comment
date. Anyone filing a protest must serve a copy of that document on all
the parties to the proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons
unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC

Online service, please e-mail<EMAIL_ADDRESS>or call (866)
208-3676 (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 21, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-17136 Filed 7-7-11; 8:45 am]
BILLING CODE 6717-01-P