[Federal Register Volume 76, Number 35 (Tuesday, February 22, 2011)]
[Notices]
[Pages 9849-9852]
[FR Doc No: 2011-3825]

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

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Privacy Act of 1974: System of Records

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

ACTION: Notice to establish a new system of records.

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

SUMMARY: FMCSA proposes to establish the system of records called
``Medical Exemption Program'' in compliance with the terms of the
Privacy Act of 1974 (5 U.S.C. 552a). FMCSA has established the Medical
Exemption

Program to support the paper-based Federal Vision Exemption Program
(FVEP), the paper-based Federal Diabetes Exemption Program (FDEP), and
the web-based Med-Ex application managed by the FMCSA Office of Medical
Programs. Medical Exemption Program is maintained by MANILA Consulting
Group, Inc. (MANILA), an FMCSA contractor. The mission of the FMCSA
Office of Medical Programs is to improve the safety of U.S. roadways by
disseminating and implementing the medical regulations, guidelines, and
policies that ensure commercial motor vehicle (CMV) drivers engaged in
interstate commerce are physically qualified to do so. Only authorized
DOT personnel with a specific ``need to know'' can access CMV driver
exemption information in Medical Exemption Program. A request from any
other individual or entity (e.g., a law firm) for CMV driver exemption
information in Medical Exemption Program is treated as a Freedom of
Information Act (FOIA) request by FMCSA and processed accordingly.
FMCSA performs routine audits of the Medical Exemption Program to
ensure that privacy and security objectives are met.
    More detailed information concerning the Medical Exemption Program
system of records is located within this document. A System of Records
Notice (SORN) for the Medical Exemption Program will be published in
the Federal Register and posted on the DOT Web site. The Privacy Impact
Assessment (PIA) for the Medical Exemption Program will be located on
the DOT Web site (http://www.dot.gov/pia.html).

DATES: Effective March 24, 2011. Written comments should be submitted
on or before the effective date. If comments are received, the comments
will be considered and, where adopted, FMCSA will republish the SORN
with the changes or publish an amended SORN.

FOR SUBMITTING COMMENTS: Send comments to Pam Gosier-Cox, FMCSA Privacy
Officer, FMCSA Office of Information Technology, MC-RI, U.S. Department
of Transportation, 1200 New Jersey Avenue, SE., Washington, DC 20590 or
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Habib Azarsina, Departmental Privacy
Officer, S-80, United States Department of Transportation, Office of
the Secretary of Transportation, 1200 New Jersey Avenue, SE.,
Washington DC 20590; telephone<PHONE_NUMBER>, or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 4007 of Public Law 105-178--enacted as the Transportation
Equity Act for the 21st Century (TEA-21)--amends Section 31315 and
Section 31136(e) of Title 49 of the U.S. Code. TEA-21 allows DOT to
grant exemptions from Federal Motor Carrier Safety Regulations (FMCSR)
if DOT finds an exemption would likely achieve a level of safety that
is equivalent to, or greater than, the level that would be achieved
absent the exemption.

II. Medical Exemption Program

    The FVEP and the FDEP provide exemptions for CMV drivers who do not
meet the federal vision standard [49 CFR 391.41(b)(10)] or the federal
diabetes standard [49 CFR 391.41(b)(3)] in the FMCSR. TEA-21 gives
FMCSA broad authority to establish exemption application procedures and
the process by which exemption applications are to be managed by FMCSA
in order to minimize delays. FMCSA will continue to process diabetes
exemption applications using a paper-based system. FMCSA will use the
Med-Ex web application to process vision exemption applications. The
Medical Exemption Program is designed to perform the following in
support of the submission, review, and management of all applicants
requesting vision and diabetes exemptions:
    1. Provide CMV drivers with the option of applying for a vision
exemption electronically in order to expedite the process;
    2. Allow FMCSA to process and manage all vision and diabetes
exemption applications sent electronically or via mail; and
    3. Archive all vision and diabetes exemption program records.
    The Medical Exemption Program also allows the FMCSA Office of
Medical Programs to monitor CMV drivers for compliance with exemption
conditions and determine if CMV drivers remain eligible for an
exemption during the exemption renewal process.
    The Medical Exemption Program contains Personally Identifiable
Information (PII) concerning CMV drivers, such as name; date of birth;
Social Security Number (SSN); driver license number and issuing state;
medical evaluations from medical examiners, eye care practitioners, and
medical specialists; copies of motor vehicle records (MVR); photocopies
of driver licenses; and proof of commercial driving experience. This
PII is used to positively identify CMV drivers and to determine if CMV
drivers qualify for an exemption.

III. Privacy Act

    The Privacy Act of 1974 (5 U.S.C. 552a) governs the means by which
the United States Government collects, maintains, and uses PII in a
system of records. A ``system of records'' is a group of records under
the control of a federal agency from which information about
individuals is retrieved by name or other personal identifier. In
accordance with the Privacy Act, each federal agency must publish in
the Federal Register a System of Records Notice (SORN) identifying and
describing each system of records the agency maintains, including the
purposes for which the agency uses PII in the system, the routine uses
for which the agency discloses such information outside the agency, and
how individuals to whom a Privacy Act record pertains can exercise
their rights under the Privacy Act (e.g., to determine if the system
contains information about them).

IV. Privacy Impact Assessment

    FMCSA is publishing a Privacy Impact Assessment (PIA) for Medical
Exemption Program to coincide with the publication of the Medical
Exemption Program SORN. In accordance with 5 U.S.C. 552a(r), a report
on the establishment of this system of records has been sent to the
U.S. Congress and the Office of Management and Budget (OMB).

V. System of Records Notice

System Number:
    DOT/FMCSA 008

System Name:
    Medical Exemption Program.

Security Classification:
    Unclassified, Sensitive.

System Location:
    Medical Exemption Program databases reside at the following
locations:
     Volpe National Transportation Systems Center (Volpe
Center), U.S. Department of Transportation, Cambridge, MA 02142.
     MANILA Consulting Group, Inc. (MANILA), McLean, VA 22101.

Categories of Individuals Covered by the System of Records:
    The Medical Exemption Program includes PII from CMV drivers
applying for an exemption from the federal vision standard [49 CFR
391.41(b)(10)] or the federal diabetes standard [49 CFR 391.41(b)(3)]
in the FMCSR.

Categories of Records in Medical Exemption Program:
    FMCSA has established the Medical Exemption Program to support the
paper-based Federal Vision Exemption Program (FVEP), the paper-based
Federal Diabetes Exemption Program (FDEP), and the web-based Med-Ex
application managed by the FMCSA Office of Medical Programs.
    Federal Vision Exemption Database--A legacy database that contains
PII, including sensitive health information received from CMV drivers
applying for a vision exemption from the federal vision standard [49
CFR 391.41(b)(10)] via mail, e-mail, and fax prior to the launch of
Med-Ex. There are no external users of this database.
    Federal Diabetes Exemption Database--A database that contains PII,
including sensitive health information received from CMV drivers
applying for a diabetes exemption from the federal diabetes standard
[49 CFR 391.41(b)(3)] via mail, email, and fax. There are no external
users of this database.
    Med-Ex Application--A web-based application that collects and
stores PII, including sensitive health information from CMV drivers
applying for a vision exemption from the federal vision standard [49
CFR 391.41(b)(10)] via hardcopy applications mailed to FMCSA and
electronic applications submitted through the Med-Ex Web site.
    The Medical Exemption Program collects the following PII or
information containing PII from CMV drivers as part of the vision
exemption application process:
    A. Applicant Information
     Name
     Home address
     Home/mobile phone number
     Gender
     Date of birth
     SSN
    B. CMV Driver Information
     Driver license number and issuing state
     Driver license classification code
     Driver license date of issuance and expiration date
     Restrictions and endorsements
     Copy of valid driver license
     List of all licenses held to operate CMVs in last three
years
     Copy of motor vehicle record (MVR) covering last three
years.
    (Florida drivers must supply official copy of complete driving
record from state of Florida due to state citation and accident
reporting requirements. Indiana drivers must supply copies of accident
reports from state police in addition to MVR due to state accident
reporting requirements.)
    C. Employment Information
     Current employer name, address, and phone number
     If employed by or leased to companies, driving history and
name, address, and phone number for each company for past three years
     If self-employed, all customer names, addresses, and phone
numbers for past three years
     Dates of employment
    D. Medical Information
     Optometrist/ophthalmologist letter stating the following:
     Date of examination
     Nature, duration, and stability of vision deficiency
     Corrected and uncorrected visual acuity for each eye
     Field of vision test results for each eye
     Color vision information
     Medical opinion regarding ability to operate CMVs with
diagnosed visual deficiency
    The Medical Exemption Program collects the following PII or
information containing PII from CMV drivers as part of the diabetes
exemption application process:
    A. Applicant Information
     Name
     Home address
     Home/mobile phone number
     Gender
     Date of birth
     SSN
    B. CMV Driver Information
     Copy of valid driver license
     Copy of MVR from official state agency
     List of waivers, exemptions, and skill performance
evaluation certificates
    C. Employment Information
     Current employer name, address, and phone number
    D. Medical Information
     Medical Examination Report
     Medical Examiner's Certificate
     Endocrinologist Evaluation Checklist
     Vision Evaluation Checklist

Authority for Maintenance of the System:
    Motor Carrier Safety Act of 1984 [49 U.S.C. 31136(e)] and the
Transportation Equity Act for the 21st Century (TEA-21) (49 U.S.C.
31315)

Purpose(s):
    The purpose for maintaining vision and diabetes exemption records
in the Medical Exemption Program is to provide the FMCSA Office of
Medical Programs with sufficient information to determine if CMV
drivers are eligible for an exemption from the federal vision standard
[49 CFR 391.41(b)(10)] or the federal diabetes standard [49 CFR
391.41(b)(3)] in the FMCSR. However, some of the CMV driver information
that is collected during the exemption application process is used to
ensure that duplicate applications are not submitted. The Medical
Exemption Program also collects quarterly and annual medical monitoring
information to determine if CMV drivers that have received a diabetes
exemption are in compliance with the conditions of the exemption.
During the exemption renewal process, updated application information
is compared to application information stored in the Medical Exemption
Program to determine if CMV drivers remain eligible for a vision or
diabetes exemption.

Routine Uses of Records Maintained in the System, Including Categories
of Users and Purposes of Use:
     Information is accessed by FMCSA Office of Medical
Programs employees and FMCSA contractors responsible for processing,
monitoring, and reviewing exemption applications and by FMCSA employees
and contractors responsible for system support and maintenance.
    Some applicant information (name, age, basic information related to
applicant's medical condition, and current driver license class) is
published in the Federal Register in a notice requesting public comment
upon receipt of an exemption request (49 U.S.C. 31315).
    See DOT Prefatory Statement of General Routine Uses published in
the Federal Register on December 29, 2010 (75 FR 82132).

Disclosure to Consumer Reporting Agencies:
    None.

Policies and Practices for Storing, Retrieving, Accessing, Retaining,
and Disposing of Records:
Storage:
    Electronic records are stored in the Medical Exemption Program
databases at the Volpe Center and MANILA. Vision exemption applications
submitted via the web-based Med-Ex application are stored in a database
in a secured area within the Volpe Center located in Cambridge, MA.
Hardcopy vision exemption applications submitted via mail, email, or
fax are entered and scanned into Med-Ex and stored in a secured area at
MANILA until a disposition decision is made. MANILA destroys these
hardcopy applications after FMCSA completes the disposition of the
application. All hardcopy diabetes and vision exemption applications
are stored in locked file cabinets.

Retrievability:
    Electronic records are retrieved by using automated searches. Name,
tracking number, application status, SSN, and date of birth may be used
to retrieve records in the Medical Exemption Program.

Accessibility (Including Safeguards):
    All records in the Medical Exemption program at the Volpe Center
and MANILA are protected from unauthorized access through appropriate
administrative, physical, and technical safeguards. Electronic files
are stored in separate databases at MANILA and the Volpe Center that
are secured by password security, encryption, firewalls, and secured
operating systems and to which only authorized personnel with a
specific ``need to know'' have access. Paper files are stored in file
cabinets in a locked file room to which only authorized MANILA
personnel with a specific ``need to know'' have access. Physical access
to the Volpe Center and MANILA is restricted to authorized personnel.
All access to the electronic system and paper files is logged and
monitored. Access to electronic records is password protected, and the
scope of access for each password is limited to the official need of
each individual authorized access.

Retention and Disposal:
    The proposed Medical Exemption Program records schedule has been
submitted to the U.S. National Archives and Records Administration
(NARA) and is pending approval. Medical Exemption Program applications
with a status of accepted are assigned a disposition date of 10 years.
All other applications are assigned a disposition date of 3 years after
the application date or 30 days after a status change to deceased,
whichever occurs first. Medical Exemption Program applications are
destroyed at the end of each calendar year following the disposition
date. Hardcopy documents that have been entered and scanned into the
Med-Ex application are assigned a 30-day disposition date following the
disposition date assigned to the electronic record and destroyed at the
end of the calendar year.

System Manager Contact Information:
    Office of Medical Programs, Federal Motor Carrier Safety
Administration, U.S. Department of Transportation, 1200 New Jersey
Avenue SE., Washington, DC 20590

Notification Procedure:
    Individuals wishing to know if their records appear in this system
may make a request in writing to the System Manager. The request must
include the requester's name, mailing address, telephone number and/or
e-mail address, a description and the location of the records
requested, and verification of identity (such as a statement, under
penalty of perjury, that the requester is the individual who he or she
claims to be).

Record Access Procedure:
    Individuals seeking access to information about them in this system
should apply to the System Manager by following the same procedures as
indicated under ``Notification Procedure.''

Contesting Record Procedure:
    Individuals seeking to contest the content of information about
them in this system should apply to the System Manager by following the
same procedures as indicated under ``Notification Procedure.''

Record Source Categories:
    CMV drivers requesting a vision or diabetes exemption are
responsible for submitting the following documentation, as appropriate:
     Completed vision or diabetes exemption application.
     Copy of valid driver license.
     Copy of MVR from official state agency.
     Medical Examiner's Certificate.
     Medical Examination Report.
     Endocrinologist Evaluation Checklist.
     Vision Evaluation Checklist or letter from optometrist/
ophthalmologist.
     Letters from employers concerning employment history or
customer information if self-employed.
    For vision exemption applications, authorized MANILA personnel use
the Commercial Driver's License Information System (CDLIS) to verify
that convictions reported on MVR are accurate and up-to-date.
Convictions that are included in CDLIS but missing from MVR are
verified by requesting ticket information and police reports from CMV
drivers. CDLIS information is reviewed several times during the
application process and continues to be monitored after an exemption
has been granted.

Exemptions Claimed for the System:
    Pursuant to subsection (k)(2) of the Privacy Act (5 U.S.C. 552a),
portions of this system are exempt from the requirements of subsections
(c)(3), (d), (e)(4)(G)-(I), and (f) of the Privacy Act for the reasons
stated in DOT's Privacy Act regulations (49 CFR Part 10, Appendix, Part
II, A.8).

    Dated: February 15, 2011.
Habib Azarsina,
Departmental Privacy Officer,<PHONE_NUMBER> .
[FR Doc. 2011-3825 Filed 2-18-11; 8:45 am]
BILLING CODE 4910-9X-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my friends' lives. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

Several friends of mine have made the switch to e-cigarettes and vaporizers over a year ago. Initially, it was difficult for them to get over the initial addiction of fire-based cigarettes. However, those that dedicated themselves to it, began to notice changed after roughly 2 weeks. The changes could only be attributed to the harmful chemicals in fire-based cigarettes leaving their bodies. During the initial 2 week period, several accounts of nausea and irritability could be accounted for. After the 2 week period, there was virtually no sign of withdrawals from fire-based cigarettes. Not long after that, they noticed a lesser craving for nicotine, and thus, lowered the amount they would intake. This process repeated numerous times the the point where at least one of them used a minuscule amount of nicotine in their vapor cigarette (8mL vs the original 36mL when he started 1 year ago) His breathing has improved, his sense of smell and taste have strengthened, and his ability to exercise for longer periods before needing to catch his breath has increased greatly.

This account serves as a reminder that the chemicals in the fire-based cigarettes are what's really doing the most damage, and causing the addiction. the nicotine levels, over time, have lowered again and again. It seems nicotine is not an addictive drug. It feels more like the chemicals burned in fire-based cigarettes are what's causing the issue.

In terms of children coming into contact with nicotine (liquid or from fire-based cigarettes) is all on whether the individuals consuming the nicotine are responsible enough to keep the substances out of reach. Irresponsible consumers will always be the cause of irresponsible reactions. A responsible parent that smokes fire-based cigarettes would never leave it out where a child could reach them. A responsible parent using an e-cigarette will never leave the product within reach.

I appreciate your consideration of my request and am happy to discuss this issue with you further.