[Federal Register: February 19, 2008 (Volume 73, Number 33)]
[Notices]
[Page 9158-9159]
[DOCID:fr19fe08-101]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-05-22727, FMCSA-05-23099]

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
8 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 March 15, 2008. Comments must be
received on or before March 20, 2008.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-05-22727, FMCSA-05-23099,
using any of the following methods.
     Federal eRulemaking Portal: Go to http://www.regulations.gov.
 Follow the online 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 online.
    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 19477-78; Apr. 11, 2000).
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 8 individuals who have requested a renewal of
their exemption in accordance with FMCSA procedures. FMCSA has
evaluated these 8 applications for renewal on their merits and decided
to extend each exemption for a renewable two-year period. They are:

John R. Alger
Gene Bartlett, Jr.
Marland L. Brassfield
Billy R. Jeffries
John P. Rodrigues
Robert V. Sloan
Gary N. Wilson
William B. Wilson

    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 8 applicants has satisfied the
entry conditions for obtaining an exemption from the vision
requirements (70 FR 71884; 71 FR 4632; 71 FR 4194; 71 FR 13450). Each
of these 8 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 20, 2008.
    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 8 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: February 11, 2008.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. E8-2982 Filed 2-15-08; 8:45 am]

BILLING CODE 4910-EX-P


[Federal Register Volume 87, Number 67 (Thursday, April 7, 2022)]
[Notices]
[Pages 20435-20436]
[FR Doc No: 2022-07395]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0055]

M7(R2) Addendum: Application of the Principles of the ICH M7
Guideline to Calculation of Compound-Specific Acceptable Intakes;
International Council for Harmonisation; Draft Guidance for Industry;
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 draft guidance for industry entitled ``M7(R2)
Addendum: Application of the Principles of the ICH M7 Guideline to
Calculation of Compound-Specific Acceptable Intakes; International
Council for Harmonisation; Draft Guidance for Industry.'' The draft
guidance was prepared under the auspices of the International Council
for Harmonisation of Technical Requirements for Pharmaceuticals for
Human Use (ICH). The draft guidance adds monographs for seven new
compounds to the M7 Guideline which outlines considerations for
assessment and control of DNA reactive (mutagenic) impurities to limit
potential carcinogenic risk. The compounds are: Acetaldehyde,
dibromoethane, epichlorohydrin, ethyl bromide, formaldehyde, styrene,
and vinyl acetate. The addendum is intended to update the M7 Guideline
in line with the ICH process for its maintenance and includes other
revisions.

DATES: Submit either electronic or written comments on the draft
guidance by May 9, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2022-D-0055 for ``M7(R2) Addendum: Application of the Principles of
the ICH M7 Guideline to Calculation of Compound-Specific Acceptable
Intakes.'' 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,<PHONE_NUMBER>.
     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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002, or 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 requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:

    Regarding the guidance: Aisar Atrakchi, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 4118, 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>.
    Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6364, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The Food and Drug Administration (FDA or Agency) is announcing the
availability of a draft guidance for industry entitled ``M7(R2)
Addendum: Application of the Principles of the ICH M7 Guideline to
Calculation of Compound-Specific Acceptable Intakes; International
Council for Harmonisation; Draft Guidance for Industry.'' The draft
guidance was prepared under the auspices of ICH. ICH has the mission of
achieving greater regulatory harmonization worldwide to ensure that
safe, effective, high-quality medicines are developed, registered, and
maintained in the most resource-efficient manner.
    By harmonizing the regulatory requirements in regions around the
world, ICH guidelines have substantially reduced duplicative clinical
studies, prevented unnecessary animal studies, standardized the
reporting of important safety information, standardized marketing
application submissions, and made many other improvements in the
quality of global drug development and manufacturing and the products
available to patients.
    The six Founding Members of the ICH are the FDA; the Pharmaceutical
Research and Manufacturers of America; the European Commission; the
European Federation of Pharmaceutical Industries Associations; the
Japanese Ministry of Health, Labour, and Welfare; and the Japanese
Pharmaceutical Manufacturers Association. The Standing Members of the
ICH Association include Health Canada and Swissmedic. Additionally, the
Membership of ICH has expanded to include other regulatory authorities
and industry associations from around the world (refer to https://www.ich.org/).
    ICH works by involving technical experts from both regulators and
industry parties in detailed technical harmonization work and the
application of a science-based approach to harmonization through a
consensus-driven process that results in the development of ICH
guidelines. The regulators around the world are committed to
consistently adopting these consensus-based guidelines, realizing the
benefits for patients and for industry.
    As a Founding Regulatory Member of ICH, FDA plays a major role in
the development of each of the ICH guidelines, which FDA then adopts
and issues as guidance for industry. FDA's guidance documents do not
establish legally enforceable responsibilities. Instead, they describe
the Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited.
    In September 2021, the ICH Assembly endorsed the draft guideline
entitled ``M7(R2) Addendum: Application of the Principles of the ICH M7
Guideline to Calculation of Compound-Specific Acceptable Intakes'' and
agreed that the guideline should be made available for public comment.
The draft guideline is the product of the Safety Expert Working Group
of the ICH. Comments about this draft will be considered by FDA and the
Safety Expert Working Group.
    The draft guidance adds monographs for seven new compounds to the
M7 Guideline which outlines considerations for assessment and control
of DNA reactive (mutagenic) impurities to limit potential carcinogenic
risk. The compounds are: Acetaldehyde, dibromoethane, epichlorohydrin,
ethyl bromide, formaldehyde, styrene, and vinyl acetate. The addendum
is intended to update the M7 Guideline in line with the ICH process for
its maintenance and includes other revisions.
    This draft guidance has been left in the original ICH format. It
contains only a list of revisions to the M7(R1) Guideline as well as
the monographs for seven new compounds submitted for public
consultation. The final guidance will include a complete, integrated
M7(R2) Guideline and Addendum and will be reformatted and edited to
conform with FDA's good guidance practices regulation (21 CFR 10.115)
and style before publication.
    The draft guidance, when finalized, will represent the current
thinking of FDA on ``M7(R2) Assessment and Control of DNA Reactive
(Mutagenic) Impurities in Pharmaceuticals To Limit Potential
Carcinogenic Risk'' and its Addendum. 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.

II. Paperwork Reduction Act of 1995

    While this draft guidance contains no collection of information it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR parts 312 and 314 have been approved under OMB
control numbers 0910-0014 and 0910-0001, and the collection of
information under 21 CFR parts 210 and 211 have been approved under OMB
control number 0910-0139.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

    Dated: April 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-07395 Filed 4-6-22; 8:45 am]
BILLING CODE 4164-01-P