[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Notices]
[Pages 60909-60911]
[FR Doc No: 2015-25642]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1622]

Submitting Food Canning Establishment Registration Form and Food
Process Filing Forms to the Food and Drug Administration in Electronic
or Paper Format: Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a guidance entitled ``Submitting Form FDA 2541 (Food
Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA
2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic
or Paper Format: Guidance for Industry.'' This guidance describes the
administrative procedures to be used by commercial processors that
manufacture, process, or pack acidified foods (``AF'') and/or thermally
processed low-acid foods packaged in hermetically sealed containers
(historically referred to as ``low-acid canned foods'' or ``LACF'').
These changes include new registration and food process filing forms
and a new ``smart form'' system for electronic submission of the
process filing forms. Registration and process filing are required by
the AF and LACF provisions of our regulations. This guidance also
provides general information about how to use FDA's systems for
electronic submission of the applicable forms. In addition, this
guidance describes administrative procedures for voluntary registration
and voluntary submissions when a commercial processor has determined
that its product is not an acidified food or a low-acid canned food,
and is therefore not subject to our regulations for AF and LACF.
Further, this guidance describes a voluntary process whereby, upon
request, we review data and other information that relate to a new
processing method or new equipment.

DATES: Submit either electronic or written comments on FDA guidances at
any time.

ADDRESSES: You may submit comments as follows:
    Electronic Submissions: Submit electronic comments in the following
way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2013-D-1622 for Submitting Food Canning Establishment Registration
Form and Food Process Filing Forms to the Food and Drug Administration
in Electronic or Paper Format: Guidance for Industry; Availability.
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets

Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance entitled
``Submitting Form FDA 2541 (Food Canning Establishment Registration)
and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process
Filing Forms) to FDA in Electronic or Paper Format: Guidance for
Industry'' to Office of Food Safety, Center for Food Safety and Applied
Nutrition (HFS-HFS-302), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive
labels to assist that office in processing your request. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
guidance.

FOR FURTHER INFORMATION CONTACT: Susan Brecher, Center for Food Safety
and Applied Nutrition (HFS-302), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry
entitled ``Submitting Form FDA 2541 (Food Canning Establishment
Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g
(Food Process Filing Forms) to FDA in Electronic or Paper Format:
Guidance for Industry.'' This guidance is being issued consistent with
our good guidance practices regulation (21 CFR 10.115). The guidance
represents our current thinking on this topic. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.
    This guidance supersedes the previous guidance entitled ``Guidance
for Industry: Submitting Form FDA 2541 (Food Canning Establishment
Registration) and Forms FDA 2541a and FDA 2541c (Food Process Filing
Forms) to FDA in Electronic or Paper Format.'' Among other things, it
provides guidance on administrative procedures related to new process
filing forms (Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g)
that will replace the current process filing forms (Forms FDA 2541a and
2541c). The process filing regulations in 21 CFR 108.25(c)(2) and
108.35(c)(2) currently specify Form FDA 2541a (food canning
establishment process filing for all methods except aseptic) or Form
FDA 2541c (food canning establishment process filing for aseptic
systems). We intend to update these regulations to specify the new form
numbers, and to provide information about how to access the online
system for electronic submission of these forms, as soon as possible.
    This guidance describes: (1) Administrative procedures relating to
the registration requirements of 21 CFR 108.25(c)(1) (for AF) using
Form FDA 2541 in both electronic and paper format; (2) administrative
procedures relating to the registration requirements of Sec.
108.35(c)(1) (for LACF) using Form FDA 2541 in both electronic and
paper format; (3) administrative procedures relating to the process
filing requirements of Sec.  108.25(c)(2) (for AF) using Form FDA 2541e
in both electronic and paper format; (4) administrative procedures
relating to the process filing requirements of Sec.  108.35(c)(2) (for
LACF) using Forms FDA 2541d, FDA 2541f, and FDA 2541g in both
electronic and paper format; (5) administrative procedures for
voluntary registration and voluntary process filing submissions when a
commercial processor has determined that its product is not an
acidified food (or a low-acid canned food), and is therefore not
subject to 21 CFR part 113, 21 CFR part 114, or part 108; and (6) a
voluntary process whereby, upon request, we review data and other
information that relate to a new processing method or new equipment.
    In the Federal Register of January 14, 2014 (79 FR 2448), we made
available a draft guidance entitled ``Guidance for Industry: Submitting
Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA
2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms)
to FDA in Electronic or Paper Format'' and gave interested parties an
opportunity to submit comments by March 17, 2014, for us to consider
before beginning work on the final version of the guidance. We received
a few comments on the draft guidance, largely directed to the specific
content of the forms discussed in the guidance rather than to the
procedures described in the guidance, and have not made any
modifications to the final guidance as a result of these comments. We
have, however, modified the content of the forms where appropriate. We
have deleted information, which we had included in the draft guidance,
explaining how the draft guidance would eventually supersede previous
administrative guidance associated with previous editions of the forms,
which are now obsolete. We also have modified the Appendix of the final
guidance to include additional resources--e.g., instructions for
submitting process filing forms electronically. The guidance announced
in this notice finalizes the draft guidance dated January 2014.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in parts 108, 113, and 114 have been
approved under OMB control number 0910-0037. The collections of
information related to 21 CFR 1.230 through 1.233 and section 415 of
the Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 350d) have been approved under OMB control number 0910-0502.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/FoodGuidances, http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/AcidifiedLACF/default.htm or http://www.regulations.gov. Use the FDA
Web site listed in the previous sentence to find the most current
version of the guidance.

    Dated: October 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25642 Filed 10-7-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: February 5, 2009 (Volume 74, Number 23)]
[Notices]
[Page 6211-6212]
[DOCID:fr05fe09-75]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2000-7006; FMCSA-2006-26066; FMCSA-2006-25246]

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
19 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 1, 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-2000-7006; FMCSA-2006-26066;
FMCSA-2006-25246, 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 19 individuals who have requested a renewal
of their exemption in accordance with FMCSA procedures. FMCSA has
evaluated these 19 applications for renewal on their merits and decided
to extend each exemption for a renewable two-year period. They are:
Kreis C. Baldridge, James L. Baynes, Daniel H. Bungartz, Steven J.
Clark, Donald D. Daniels, Michael A. Fouch, Thanh V. Ha, Carl A.
Lohrbach, James E. Menz, Jeffrey L. Olson, Chris H. Pederson, Timmy J.
Pottebaum, Donnie Riggs, Luis H. Sanchez, Phillip L. Smith, Randall S.
Surber, Brian S. Tuttle, Ernest W. Waff, Joseph W. Wigley.
    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 19 applicants has satisfied the
entry conditions for obtaining an exemption from the vision
requirements (65 FR 20245; 65 FR 57230; 67 FR 57266; 69 FR 52741; 71 FR
55820; 71 FR 63379; 72 FR 1050; 72 FR 180; 72 FR 9397). Each of these
19 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
under49 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 19 individuals from the vision
requirement in49 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. E9-2453 Filed 2-4-09; 8:45 am]

BILLING CODE 4910-EX-P


[Federal Register Volume 84, Number 42 (Monday, March 4, 2019)]
[Notices]
[Page 7358]
[FR Doc No: 2019-03760]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CD19-6-000]

Notice of Preliminary Determination of a Qualifying Conduit
Hydropower Facility and Soliciting Comments and Motions To Intervene:
City and County of Denver, Colorado

    On February 19, 2019, as supplemented on February 25, 2019, the
City and County of Denver, Colorado, filed a notice of intent to
construct a qualifying conduit hydropower facility, pursuant to section
30 of the Federal Power Act (FPA). The proposed Northwater Treatment
Plant Hydropower Facility Project would have a total installed capacity
of up to 950 kilowatts (kW), and would be located within the currently
unconstructed Headworks Building of the Northwater Treatment Plant near
Golden in Jefferson County, Colorado.
    Applicant Contact: Peter McCormick, NTP Design Manager, 1600 W 12th
Ave, Denver, Colorado 80204, Phone No.<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>    FERC Contact: Christopher Chaney, Phone No.<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>    Qualifying Conduit Hydropower Facility Description: The proposed
project would consist of: (1) One 450-kW turbine-generator unit, with a
second up to 500-kW turbine-generator unit planned in the future, and
(2) appurtenant facilities. The proposed project would have an
estimated annual generation of up to 2,600 megawatt-hours.
    A qualifying conduit hydropower facility is one that is determined
or deemed to meet all of the criteria shown in the table below.

                          Table 1--Criteria for Qualifying Conduit Hydropower Facility
----------------------------------------------------------------------------------------------------------------
              Statutory provision                                 Description                    Satisfies (Y/N)
----------------------------------------------------------------------------------------------------------------
FPA 30(a)(3)(A)...............................  The conduit the facility uses is a tunnel,                    Y
                                                 canal, pipeline, aqueduct, flume, ditch, or
                                                 similar manmade water conveyance that is
                                                 operated for the distribution of water for
                                                 agricultural, municipal, or industrial
                                                 consumption and not primarily for the
                                                 generation of electricity.
FPA 30(a)(3)(C)(i)............................  The facility is constructed, operated, or                     Y
                                                 maintained for the generation of electric
                                                 power and uses for such generation only the
                                                 hydroelectric potential of a non-federally
                                                 owned conduit.
FPA 30(a)(3)(C)(ii)...........................  The facility has an installed capacity that                   Y
                                                 does not exceed 5 megawatts.
FPA 30(a)(3)(C)(iii)..........................  On or before August 9, 2013, the facility is                  Y
                                                 not licensed, or exempted from the licensing
                                                 requirements of Part I of the FPA.
----------------------------------------------------------------------------------------------------------------

    Preliminary Determination: The proposed Northwater Treatment Plant
Hydropower Facility Project will not interfere with the primary purpose
of the conduit, which is to transport water for municipal use.
Therefore, based upon the above criteria, Commission staff
preliminarily determines that the proposal satisfies the requirements
for a qualifying conduit hydropower facility, which is not required to
be licensed or exempted from licensing.
    Comments and Motions to Intervene: Deadline for filing comments
contesting whether the facility meets the qualifying criteria is 30
days from the issuance date of this notice.
    Deadline for filing motions to intervene is 30 days from the
issuance date of this notice.
    Anyone may submit comments or a motion to intervene in accordance
with the requirements of Rules of Practice and Procedure, 18 CFR
385.210 and 385.214. Any motions to intervene must be received on or
before the specified deadline date for the particular proceeding.
    Filing and Service of Responsive Documents: All filings must (1)
bear in all capital letters the COMMENTS CONTESTING QUALIFICATION FOR A
CONDUIT HYDROPOWER FACILITY or MOTION TO INTERVENE, as applicable; (2)
state in the heading the name of the applicant and the project number
of the application to which the filing responds; (3) state the name,
address, and telephone number of the person filing; and (4) otherwise
comply with the requirements of sections 385.2001 through 385.2005 of
the Commission's regulations.\1\ All comments contesting Commission
staff's preliminary determination that the facility meets the
qualifying criteria must set forth their evidentiary basis.
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    \1\ 18 CFR 385.2001-2005 (2018).
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    The Commission strongly encourages electronic filing. Please file
motions to intervene and comments using the Commission's eFiling system
at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE, Washington, DC 20426. A copy of all other filings in
reference to this application must be accompanied by proof of service
on all persons listed in the service list prepared by the Commission in
this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
    Locations of Notice of Intent: Copies of the notice of intent can
be obtained directly from the applicant or such copies can be viewed
and reproduced at the Commission in its Public Reference Room, Room 2A,
888 First Street NE, Washington, DC 20426. The filing may also be
viewed on the web at http://www.ferc.gov/docs-filing/elibrary.asp using
the eLibrary link. Enter the docket number (i.e., CD19-6) in the docket
number field to access the document. For assistance, call toll-free 1-
866-208-3676 or email<EMAIL_ADDRESS>For TTY, call (202)
502-8659.

    Dated: February 26, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-03760 Filed 3-1-19; 8:45 am]
BILLING CODE 6717-01-P


 Page 1 of 2 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM SUBJECT: Pentachlorophenol: Risk Assessment and Science Support Branch's Preliminary Risk Assessments and Science Chapters In Support of The Reregistration Eligibility Decision FROM: Norm Cook, Chief Risk Assessment and Science Support Branch Antimicrobials Division ( 7510C)

TO: Connie Welch, Chief Regulatory Management Branch II ( RMB II) Antimicrobials Division ( 7510C)

Pesticide Chemical 63001 No.:

Chemical Name: Pentachlorophenol Case: 2505 Introduction With this cover memo the Risk Assessment and Science Support Branch ( RASSB) is forwarding Preliminary Risk Assessments ( PRAs) for human and environmental risks with Science Chapters in Page 2 of 2 support of the Antimicrobials Division's ( AD's) Reregistration Eligibility Decision ( RED) for Pentachlorophenol. In an effort to avoid duplication RASSB has not developed an Executive Summary for creosote since the PRAs for human and environmental risks are presented in detail in their Science Chapters, which can be found under Attachments 8 and 11, respectively. The following Science Chapters are included as attachments to this memo:

Science Chapters Appendix 1: Use Profile Appendix 2: Product Chemistry Appendix 3: Human Exposure Appendix 4: Review of Worker Exposure Study for Pentachlorophenol Appendix 5: Toxicology Appendix 6: Epidemiology Appendix 7: Human Risk Characterization Appendix 8: Dietary Exposure and Risk Appendix 9: Environmental Fate Appendix 10: Environmental Exposure/ Modeling Appendix 11: Ecological Effects and Environmental Risk Characterization


[Federal Register Volume 75, Number 240 (Wednesday, December 15, 2010)]
[Notices]
[Pages 78279-78281]
[FR Doc No: 2010-31449]

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SECURITIES AND EXCHANGE COMMISSION

Release No. 34-63487; File No. SR-CHX-2010-23]

Self-Regulatory Organizations; Chicago Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
To Extend Pilot Program Related to Clearly Erroneous Execution
Transactions

December 9, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\, and Rule 19b-4 \2\ thereunder, notice is hereby given
that on December 7, 2010, the Chicago Stock Exchange, Inc. (``CHX'' or
the ``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in

Items I and II below, which Items have been prepared by the CHX. CHX
has filed this proposal pursuant to Exchange Act Rule 19-4(f)(6) \3\
which is effective upon filing with the Commission.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    CHX proposes to amend its rules to extend the pilot program related
to clearly erroneous transactions. The text of this proposed rule
change is available on the Exchange's Web site at http://www.chx.com
and in the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the CHX included statements
concerning the purpose of and basis for the proposed rule changes and
discussed any comments it received regarding the proposal. The text of
these statements may be examined at the places specified in Item IV
below. The CHX has prepared summaries, set forth in sections A, B and C
below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    In September, 2010, CHX obtained Commission approval of a filing
amending its rules relating to clearly erroneous transactions on a
pilot basis until December 10, 2010.\4\ The proposed rule change merely
extends the duration of the pilot program until April 11, 2011.
Extending the pilot for an additional four months will allow the
Commission more time to consider the impact of the pilot program.
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    \4\ See Securities Exchange Act Release No. 34-62886 (September
10, 2010), 75 FR 56613 (September 16, 2010) approving SR-CHX-2010-
13.
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2. Statutory Basis
    Approval of the rule change proposed in this submission is
consistent with the requirements of the Act and the rules and
regulations thereunder that are applicable to a national securities
exchange, and, in particular, with the requirements of Section 6(b) of
the Act.\5\ In particular, the proposed change is consistent with
Section 6(b)(5) of the Act,\6\ because it would promote just and
equitable principles of trade, remove impediments to, and perfect the
mechanism of, a free and open market and a national market system, and,
in general, protect investors and the public interest. The proposed
rule change is also designed to support the principles of Section
11A(a)(1) \7\ of the Act in that it seeks to assure fair competition
among brokers and dealers and among exchange markets. The Exchange
believes that the proposed rule meets these requirements in that it
promotes transparency and uniformity across markets concerning reviews
of potentially clearly erroneous executions in various contexts,
including reviews in the context of a Multi-Stock Event involving
twenty or more securities and reviews resulting from a Trigger Trade
and any executions occurring immediately after a Trigger Trade but
before a trading pause is in effect on the Exchange. Further, the
Exchange believes that the proposed changes enhance the objectivity of
decisions made by the Exchange with respect to clearly erroneous
executions.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
    \7\ 15 U.S.C. 78k-1(a)(1).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \8\ and Rule 19b-
4(f)(6)(iii) thereunder.\9\ The Exchange has asked the Commission to
waive the 30-day operative delay so that the proposal may become
operative immediately upon filing. The Commission believes that waiving
the 30-day operative delay is consistent with the protection of
investors and the public interest because such waiver will allow the
pilot program to continue uninterrupted and help ensure uniformity
among the national securities exchanges and FINRA with respect to the
treatment of clearly erroneous transactions.\10\ Accordingly, the
Commission waives the 30-day operative delay requirement and designates
the proposed rule change as operative upon filing with the Commission.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires that a self-regulatory organization submit to
the Commission written notice of its intent to file the proposed
rule change, along with a brief description and text of the proposed
rule change, at least five business days prior to the filing of the
proposed rule change, or such shorter time as designated by the
Commission. The Commission notes that the Exchange has satisfied
this requirement.
    \10\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form http://www.sec.gov/rules/sro.shtml; or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-CHX-2010-23 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-CHX-2010-23. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site http://www.sec.gov/rules/sro.shtml.
Copies of the submission, all subsequent amendments, all written
statements

with respect to the proposed rule change that are filed with the
Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street, NE., Washington,
DC 20549, on official business days between the hours of 10 a.m. and 3
p.m. Copies of such filing also will be available for inspection and
copying at the principal office of the Exchange. All comments received
will be posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make publicly available. All submissions
should refer to File Number SR-CHX-2010-23 and should be submitted on
or before January 5, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-31449 Filed 12-14-10; 8:45 am]
BILLING CODE 8011-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

								OFFICE OF PREVENTION, PESTICIDES

									AND TOXIC SUBSTANCES

MEMORANDUM						 27 March 2007

SUBJECT:	Chloropicrin:  HED Response to Comments Submitted to the Agency
				Concerning the Product Chemistry Chapter for the Reregistration
Eligibility Decision [RED] Document, D268927 dated 10 October 2004.

		DP Barcode: D305341

			Chloropicrin Docket ID Number:  EPA-HQ-OPP-2006-0661

			DP Barcode: D305330, PC Code: 081501

FROM:	P. Yvonne Barnes, Chemist

		Reregistration Branch II

Health Effects Division (7509P)

THROUGH:	Alan Nielsen, Branch Senior Scientist

		Reregistration Branch II

Health Effects Division (7509P), and

William Hazel, Chief

Reregistration Branch II

Health Effects Division (7509P)

TO:		Elissa Reaves and Charles Smith, Risk Assessors

		Reregistration Branch II

		Health Effects Division (7509P)

In the Federal Register of November 29, 2006 the EPA issued a notice
announcing the availability of EPA's human health and environmental fate
and effects risk assessments and related documents for the fumigant,
chloropicrin. Following closure of the comment period the primary
registrant (and data provider), Ashta Chemicals Incorporated, sent a
letter to the Agency with comments to the decision document. The
following memo is the Health Effects Division’s response to the Ashta
Chemicals Incorporated comments.

Executive Summary

Chloropicrin [trichloronitromethane] is a non-selective soil and space
commodity fumigant used for the control of weeds, nematodes, insects,
rodents, and certain fungi. It is also a warning agent for use with
odorless fumigants, such as methyl bromide. Chloropicrin is a FIFRA
List-A reregistration chemical. The Chloropicrin Reregistration Standard
dated 12/07/1981 and Guidance Document dated 09/1982 required additional
generic and product-specific product chemistry data concerning
chloropicrin.

A generic Data Call-In Notice (DCI) was issued 09/28/1990 to the
manufacturers of chloropicrin. Only the Great Lakes and Niklor technical
products were registered at the time of the Reregistration Standard. The
reregistration of chloropicrin is being supported by the Chloropicrin
Manufacturers’ Task Force (CMTF) including members Niklor Chemical
Company; Ashta Chemicals Incorporated; Trinity Manufacturing, Angus
Chemical Company; Great Lakes Chemical Corporation; Soil Chemical
Corporation Products; TRICAL; Arysta Life Science North America, and Dow
Agrosciences LLC.

Ashta Chemicals, Incorporated has responded to several product chemistry
deficiencies below:

1)  Ashta chemicals Comment

UV/VISIBLE ABSORPTION STUDY

In the Risk Assessment EPA requested a UV/Visible absorption study.  EPA
had not previously requested this study for chloropicrin. However, the
CMTF has identified an existing recently completed study. The study will
be submitted shortly.

HED Response(s)

This is an Office of Pesticide Programs and Toxic Substances, OPPTS
830.7050, guideline data requirement for the technical grade of the
active ingredient [TGAI] or the pure active ingredient [PAI]. This study
must be submitted to the Agency.

2)  Ashta chemicals Comment

OXIDIZING/REDUCion ACTION and VISCOSITY

In the Risk Assessment EPA has asked from information from our company
on the Oxidizing Reduction and Viscosity.  For these two data
requirements our company will rely on a study previously submitted by
Niklor Chemical, MRID # 43434601.

HED Response(s)

HED concurs with Ashta Chemical’s reference to an acceptable study
such that no additional information is required.

3)  Ashta chemicals Comment

FLAMMABILITY/STORAGE STABILITY and CORROSION CHARACTERISTICS

In the Risk Assessment EPA has asked for information from our company on
Flammability, Storage Stability and Corrosion Characteristics. For these
data requirements our company will rely on a study previously submitted
by Niklor Chemical, MRID # 00013198.

HED Response(s)

HED concurs with Ashta Chemical’s reference to an acceptable study
such that no additional information is required.

4)  Ashta chemicals Comment

ENFORCEMENT ANALYTICAL METHOD

In the Risk Assessment EPA has asked for information from our company on
Enforcement Analytical Method. Additional information concerning the
Enforcement Analytical Method was provided to the Agency in a letter to
Walter I. Waldrop dated July 10, 1995. In the letter we discussed a lack
of a certified chloropicrin standard as explained earlier in this
letter.

HED Response(s)

HED concurs with Ashta Chemical’s reference to an acceptable
Enforcement Analytical Method such that no additional information is
required. A copy of the letter dated 10 July 1995 was attached to your
response letter dated 28 February 2007.

A sample of the chloropicrin used for characterization in MRID 43091402
must be submitted to the USEPA Laboratory.

Samples should be sent to: Chief, EPA Analytical Laboratory,
Environmental Science Center, 701 Maples Road, Fort Meade, Maryland
20755-5350, Telephone Number: (410) 305 - 2931. Analytical standards
must be replenished as requested by the Repository.

5)  Ashta chemicals Comment

	CERTIFIED CHLOROPICRIN REFERENCE STANDARD

For several of the studies EPA has a raised question because of a
certified chloropicrin reference was not used to generate the product
chemistry data.

HED Response(s)

HED concurs with Ashta Chemicals that no additional information is
required pursuant to the analysis reported to EPA (MRID 43091402).

Health Effects Division Recommendation(s)

The CMTF should consider sending a sample to the National Institute of
Standards and Technology (NIST) to become part of the National Reference
Standard Database if practical.

Health Effects Division Conclusion(s)

Provided that the registrant submits the data required and certifies
that the suppliers of beginning materials and the manufacturing
processes have not changed since the last comprehensive product
chemistry review or submits new complete updated product chemistry data
packages,  HED has no objections to the reregistration of chloropicrin
with respect to product chemistry data requirements.

 PAGE

Page   PAGE  4  of   NUMPAGES  4


[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Notices]
[Pages 62555-62556]
[FR Doc No: 2016-21716]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2015-0117]

Denial of Exemption Applications; Epilepsy and Seizure Disorders

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

ACTION: Notice of denial.

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

SUMMARY: FMCSA announces its decision to deny applications from seven
individuals who requested an exemption from the Federal Motor Carrier
Safety Regulations (FMCSRs) prohibiting persons with a clinical
diagnosis of epilepsy or any other condition that is likely to cause a
loss of consciousness or any loss of ability to operate a commercial
motor vehicle (CMV) from operating CMVs in interstate commerce.

FOR FURTHER INFORMATION CONTACT: Christine A. Hydock, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-224,
Washington, DC 20590-0001. Office hours are 8:30 a.m. to 5 p.m., e.t.,
Monday through Friday, except Federal holidays. If you have questions
regarding viewing or submitting material to the docket, contact Docket
Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/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.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to http://www.regulations.gov, as described in
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at http://www.dot.gov/privacy.

II. Background

    On August 12, 2015, FMCSA published a notice announcing receipt of
applications from 12 individuals requesting an exemption from the
prohibition against persons with a clinical diagnosis of epilepsy or
any other condition that is likely to cause a loss of consciousness or
any loss of ability to operate a CMV in interstate commerce and
requested comments from the public (80 FR 48406). The public comment
period closed on September 11, 2015, and one comment was received.
    FMCSA has evaluated the eligibility of these applicants and
concluded that granting seven of the 12 exemptions would not provide a
level of safety that would be equivalent to or greater than, the level
of safety that would be obtained by complying with the regulation 49
CFR 391.41(b)(8). A final notice announcing the decision to grant five
of the 12 exemptions and providing a response to the one comment
received was published on June 13, 2016 (FR 81 38262).

III. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the Federal epilepsy standard for a renewable two-year period if
it finds ``such exemption is likely achieve a level of safety that is
equivalent to or greater than the level that would be achieved absent
such exemption.''
    The Agency's decision regarding these exemption applications is
based on an individualized assessment of each applicant's medical
information, including the root cause of the respective seizure(s) and
medical information about the applicant's seizure history, the length
of time that has elapsed since the individual's last seizure, the
stability of each individual's treatment regimen and the duration of
time on or off of anti-seizure medication. The Agency considered the
2007 recommendations of the Agency's Medical Expert Panel (MEP). The
January 15, 2013 Federal Register notice (78 FR 3069) provides the
current MEP recommendations which is the criteria the Agency uses to
make decisions regarding seizure exemptions.

IV. Conclusion

    The Agency has determined that these seven applicants do not
satisfy the criteria eligibility or meet the terms and conditions for a
Federal exemption and granting these exemptions would not provide a
level of safety that would be equivalent to or greater than, the level
of safety that would be obtained by complying with the regulation 49
CFR 391.41(b)(8). Therefore, the applicants in this notice have been
denied an exemption from the physical qualification standards in 49 CFR
391.41(b)(8).
    Each applicant has, prior to this notice, received a letter of
final disposition regarding his/her exemption request. Those decision
letters fully outlined the basis for the denial and constitutes final
action by the Agency. This notice summarizes the Agency's recent
denials as required under 49 U.S.C. 31315(b)(4) by periodically
publishing names and reasons for denial. The following drivers were
listed previously in Federal Register

Notice FMCSA-2015-0117 published on August 12, 2015:
    Nicholes Arroyo--Mr. Arroyo has a history of epilepsy. His last
seizure was in 2014. He takes anti-seizure medication. He does not meet
the MEP guidelines at this time.
    Kevin Scott Brelsford--Mr. Brelsford has a history of epilepsy. His
last seizure was in 2010. He takes anti-seizure medication. He does not
meet the MEP guidelines at this time.
    Donald Adin Horst--Mr. Horst has a history of a single provoked
seizure in 2009 as the result of a subdural hematoma. He takes anti-
seizure medication. He does not meet the MEP guidelines at this time.
    Bradley Jolley--Mr. Jolley has a history of a epilepsy. Mr. Jolley
did not provide enough medical information to determine the date of his
last seizure. He takes anti-seizure medication. He does not meet the
MEP guidelines at this time.
    Charles Ray Paul--Mr. Paul has a history of epilepsy. His last
seizure was in 2006, and his medical documentation notes that he
experiences stereotypical auras. He takes anti-seizure medication. He
does not meet the MEP guidelines at this time.
    Eric Lee Troendle--Mr. Troendle has a history of a brain tumor. His
last seizure was in 2014. He takes anti-seizure medication. He does not
meet the MEP guidelines at this time.
    Brian J. Underwood--Mr. Underwood has a history of epilepsy. His
last seizure was in 2003. Mr. Underwood did not provide enough medical
information to determine the last change in his anti-seizure
medication. He does not meet the MEP guidelines at this time.

    Issued on: August 26, 2016.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016-21716 Filed 9-8-16; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 77, Number 90 (Wednesday, May 9, 2012)]
[Notices]
[Pages 27234-27235]
[FR Doc No: 2012-11179]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0427]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Inspection by Accredited Persons
Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 the Inspection by Accredited
Persons Program Under the Medical Device User Fee and Modernization Act
of 2002.

DATES: Submit either electronic or written comments on the collection
of information by July 9, 2012.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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.

Inspection by Accredited Persons Program Under the Medical Device User
Fee and Modernization Act of 2002--(OMB Control Number 0910-0510)--
Extension

    The Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
(Pub. L. 107-250) was signed into law on October 26, 2002. Section 201
of MDUFMA adds a new paragraph (g) to section 704 of the Federal, Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 374), directing FDA to
accredit third parties (accredited persons) to conduct inspections of
eligible manufacturers of class II or class III devices. This is a
voluntary program. FDA has a guidance document that provides
information for those interested in participating in this program. The
guidance is entitled ``Implementation of the Inspection by Accredited
Persons Program Under the Medical Device User Fee and Modernization Act
of 2002; Accreditation Criteria.''
    FDA based these estimates on conversations with industry, trade
association representatives, and internal FDA estimates. Once an
organization is accredited, it will not be required to reapply.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                  Section of the FD&C act/activity                      Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
704(g) Request for Accreditation...................................               1                1                1               80               80
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: May 3, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-11179 Filed 5-8-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 171 (Wednesday, September 8, 2021)]
[Rules and Regulations]
[Pages 50244-50245]
[FR Doc No: 2021-19272]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0161; Airspace Docket No. 21-ASW-5]
RIN 2120-AA66

Amendment of Class E Airspace; Yoakum, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends the Class E airspace extending upward from
700 feet above the surface at Yoakum Municipal Airport, Yoakum, TX. The
FAA is proposing this action as the result of an airspace review caused
by the decommissioning of the Yoakum non-directional beacon (NDB).

DATES: Effective 0901 UTC, December 2, 2021. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.11 and
publication of conforming amendments.

ADDRESSES: FAA Order 7400.11E, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11E at NARA, email
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Rebecca Shelby, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends the Class E airspace extending upward from 700 feet above
the surface at Yoakum Municipal Airport, Yoakum, TX, to support
instrument flight rule operations at this airport.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (86 FR 14026; March 12, 2021) for Docket No. FAA-2021-0161 to
amend the Class E airspace extending upward from 700 feet above the
surface at Yoakum Municipal Airport, Yoakum, TX. Interested parties
were invited to participate in this rulemaking effort by submitting
written comments on the

proposal to the FAA. No comments were received.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11E, dated July 21, 2020, and effective September 15,
2020, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11E, Airspace Designations and
Reporting Points, dated July 21, 2020, and effective September 15,
2020. FAA Order 7400.11E is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11E lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to 14 CFR part 71 amends the Class E airspace
extending upward from 700 feet above the surface within a 6.3-mile
(decreased from 7.2-mile) radius of Yoakum Municipal Airport, Yoakum,
TX; and updating geographic coordinates of the airport to coincide with
the FAA's aeronautical database.
    This action is the result of an airspace review due to the
decommissioning of the Yoakum NDB which provided navigation information
for the instrument procedures at this airport.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5.a. This airspace action is not expected
to cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11E,
Airspace Designations and Reporting Points, dated July 21, 2020, and
effective September 15, 2020, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASW TX E5 Yoakum, TX [Amended]

Yoakum Municipal Airport, TX
    (Lat. 29[deg]18'47'' N, long. 97[deg]08'18'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.3-mile radius of Yoakum Municipal Airport.

    Issued in Fort Worth, Texas, on September 1, 2021.
Martin A. Skinner,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2021-19272 Filed 9-7-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 218 (Tuesday, November 10, 2020)]
[Notices]
[Page 71650]
[FR Doc No: 2020-24895]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[FRL-10016-76-OW]

Meeting of the National Drinking Water Advisory Council

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of a public meeting.

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

SUMMARY: The U.S. Environmental Protection Agency's (EPA) Office of
Ground Water and Drinking Water is announcing a virtual meeting of the
National Drinking Water Advisory Council (NDWAC or Council) as
authorized under the Safe Drinking Water Act (SDWA). The purpose of the
meeting is to allow EPA to present an overview of Safe Drinking Water
Act programs for fiscal year 2021 and to receive input from Council
members. Additional details will be provided in the meeting agenda,
which will be posted on EPA's website at https://www.epa.gov/ndwac
prior to the meeting.

DATES: The meeting will be held on December 2, 2020, from 1 p.m. to 5
p.m., eastern time.

ADDRESSES: This will be a virtual meeting. There will be no in-person
gathering for this meeting.

FOR FURTHER INFORMATION CONTACT: Elizabeth Corr, NDWAC Designated
Federal Officer, Office of Ground Water and Drinking Water (Mail Code
4601), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue
NW, Washington, DC 20460; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Attending the Meeting: The meeting will be open to the general
public. The meeting agenda and information on how to register for and
attend the meeting online will be provided on EPA's website at https://www.epa.gov/ndwac prior to the meeting.
    Oral Statements: EPA will allocate 25 minutes for the public to
present oral comments during the meeting. Oral statements will be
limited to five minutes per person during the public comment period. It
is preferred that only one person present a statement on behalf of a
group or organization. Persons interested in presenting an oral
statement should send an email to Elizabeth Corr, at
<EMAIL_ADDRESS>by noon, eastern time, on November 24, 2020.
    Written Statements: Any person who wishes to file a written
statement can do so before or after the Council meeting. Send written
statements by email to<EMAIL_ADDRESS>or see the FOR FURTHER
INFORMATION CONTACT section if sending statements by mail. Written
statements received by noon, eastern time, on November 24, 2020, will
be distributed to all members of the Council prior to the meeting.
Statements received after that time will become part of the permanent
file for the meeting and will be forwarded to the Council members after
conclusion of the meeting.
    Accessibility: For information on access or services for
individuals with disabilities, or to request accommodations for a
disability, please contact Elizabeth Corr by email at
<EMAIL_ADDRESS>or by phone at<PHONE_NUMBER>, preferably at
least 10 days prior to the meeting to allow as much time as possible to
process your request.
    National Drinking Water Advisory Council: The NDWAC was created by
Congress on December 16, 1974, as part of the Safe Drinking Water Act
(SDWA) of 1974, Public Law 93-523, 42 U.S.C. 300j-5, and is operated in
accordance with the provisions of the Federal Advisory Committee Act
(FACA), 5 U.S.C. App. 2. The NDWAC was established to advise, consult
with, and make recommendations to the EPA Administrator on matters
relating to activities, functions, policies, and regulations under the
SDWA. General information concerning the NDWAC is available at: https://www.epa.gov/ndwac.

Jennifer L. McLain,
Director, Office of Ground Water and Drinking Water.
[FR Doc. 2020-24895 Filed 11-9-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 204 (Wednesday, October 22, 2014)]
[Notices]
[Pages 63120-63121]
[FR Doc No: 2014-24586]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2014-0558; FRL-9916-22]

Proposed Removal of Certain Inert Ingredients From Approved
Chemical Substance List for Pesticide Products

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA is proposing to remove certain chemical substances from
the current listing of inert ingredients approved for use in pesticide
products because the inert ingredients are no longer used in any
registered pesticide product.

DATES: Comments must be received on or before November 21, 2014.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2014-0558, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For general information contact: Cameo
G. Smoot, Field and External Affairs Division (7506P), Office of
Pesticide Programs, Environmental Protection Agency; 1200 Pennsylvania
Ave. NW., Washington DC 20460-0001; telephone number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>    For chemical listing inquiries contact: Kerry B. Leifer,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington
DC 20460-0001; telephone number<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you engage in
activities related to the registration of pesticide products, including
but not limited to, the use of approved inert ingredients used in
registered pesticide products. Potentially affected entities may
include, but are not limited to, engaging in the formulation and
preparation of agricultural and household pest control chemicals or
pesticide and other agricultural and household pest control chemicals
or inert manufacturers and those who make proprietary inert ingredient
formulations or pesticide and other agricultural chemical manufacturing
generally identified by the North American Industrial Classification
System (NAICS). You may also be affected by this action if you are a
consumer or user of pesticides, or if you are exposed to pesticides.
    This listing is not intended to be exhaustive, but rather provides
a guide for readers to help determine whether this document applies to
them and which entities are likely to be affected by this action. Other
types of entities not listed in this unit could also be affected. The
NAICS code 325320 has been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult either person

listed under FOR FURTHER INFORMATION CONTACT.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit CBI information to EPA through
regulations.gov or email. Contact Kerry Leifer, email address:
<EMAIL_ADDRESS>to discuss options for submitting CBI to the
Agency.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Discussion

    EPA maintains a list of chemical substances that have been approved
for use as inert ingredients in pesticide products. Inert ingredients
on this list do not need further approval prior to inclusion in a
pesticide formulation for a non-food use. These individual formulations
are subject to data requirements in 40 CFR part 158, regardless of
whether the inert ingredient is on the approved list. If an application
for registration of a pesticide product includes inert ingredients not
on the approved list, the inert ingredient will need approval and
require payment of a fee in accordance with section 33 of FIFRA, 7
U.S.C. 136w-8.
    EPA is considering removing from this list a set of 72 chemical
substances that are no longer being used as an inert ingredient in a
pesticide product. Some of the 72 chemical substances are a subset of a
larger list of 371 inert ingredients that were the subject of two
petitions submitted to EPA in 2006 (see docket) requesting that the
Agency require that the identities of hazardous ingredients identified
in the petitions be disclosed on pesticide products containing those
ingredients. EPA is taking this action, fulfilling a commitment as
described in an EPA May 22, 2014 amended response to the petitioners
(see docket). EPA would remove from the approved list those inert
ingredients listed in the petitions that are no longer being used in
pesticide products.
    The list of 72 inert ingredients was generated by an Agency
evaluation of pesticide product compositional information to determine
which of those 371 chemical substances listed as inert ingredients on
the EPA-approved list are in use or not in use in currently registered
pesticide formulations. The list of chemical substances that are no
longer being used as an inert ingredient is available in the docket for
this action, under docket ID number EPA-HQ-OPP-2014-0558 at http://www.regulations.gov.
    Once an inert ingredient is removed from the list, any proposed
future use of the inert ingredient would need to be supported by data
provided to and reviewed by the EPA as part of a new inert ingredient
submission request. The type of data needed to evaluate a new inert
ingredient may include, among others, studies to evaluate potential
carcinogenicity, adverse reproductive effects, developmental toxicity,
genotoxicity as well as environmental effects associated with any
chemical substance that is persistent or bioaccumulative. Information
regarding the inert ingredient approval process may be found at http://www2.epa.gov/pesticide-registration/guidance-documents-inert-ingredients.
    EPA suggests that pesticide registrants review their records to
ensure that the chemical substances, listed by chemical name and
Chemical Abstracts Service Registry Number, listed in the docket for
this action are, in fact, no longer used as inert ingredients in their
registered pesticide products. While EPA has endeavored to prepare an
accurate list, if a pesticide registrant is aware of a registered
product containing any of the 72 chemical substances, that registrant
should contact the Agency directly, using the contact listed under FOR
FURTHER INFORMATION CONTACT (Chemical Listing Inquiries).
    Similarly, producers of proprietary mixtures currently approved for
use as inert ingredients in pesticide products should also review their
records to ensure that the chemical substances listed in the docket for
this action are, in fact, not currently used in their proprietary
mixtures.
    After the close of the comment period, EPA will consider all
comments received and determine appropriate action.

    Authority: 7 U.S.C. 136 et seq.

    Dated: October 7, 2014.
James Jones,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2014-24586 Filed 10-21-14; 8:45 am]
BILLING CODE 6560-50-P


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, D.C.

Issued by the Department of Transportation on April 5, 2006

NOTICE OF ACTION TAKEN -- DOCKET OST-2006-23702

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Joint Applicants:  AEROVIAS de MEXICO, S.A. de C.V.  (Aeromexico) and
Date Filed:  January 23, 2006

	                 TRANSPORTES AEROMAR, S.A. de C.V. (Transportes
Aeromar)

Relief requested:  Exemption from 49 USC § 41301 to permit Aeromexico
to conduct scheduled foreign air transportation of persons, property,
and mail between Monterrey and Reynosa, Mexico, on the one hand, and
Corpus Christi, Texas, on the other hand.  These services would be
conducted only through a code-share arrangement with Transportes
Aeromar, on flights operated by Transportes Aeromar.

Statement of authorization under 14 CFR Part 212 to permit Transportes
Aeromar to display the Aeromexico designator code (AM) on flights
operated by Transportes Aeromar between Monterrey and Reynosa, Mexico,
on the one hand, and Corpus Christi, Texas, on the other hand.

If renewal, date and citation of last action:  New authority.

Applicant representatives:  William C. Evans,<PHONE_NUMBER> (Aeromexico)

                                            Herbert A. Rosenthal,
202-785-9773 (Transportes Aeromar)

DOT analyst:  Robert J. Finamore,<PHONE_NUMBER>

Responsive pleadings:  None.

DISPOSITION

Action:  Approved in part (Monterrey-Corpus Christi), remainder
(Reynosa-Corpus Christi) deferred.

Action date:  April 5, 2006

Effective dates of authority granted:  Aeromexico’s exemption
authority is effective from April 5, 2006, through

April 5, 2007.  Transportes Aeromar’s statement of authorization is
effective for an indefinite duration.

Basis for approval (bilateral agreement/reciprocity): United
States-Mexico Air Transport Services Agreement.

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations of our standard exemption and
codeshare conditions (attached).  In addition, Aeromexico shall adhere
to the otherwise applicable terms, conditions, and limitations of its
foreign air carrier permit (Order 91-5-25).  The exemption authority
granted to Aeromexico to serve the Monterrey-Corpus Christi market is
limited to operations conducted only through a code-share arrangement
with Transportes Aeromar, on flights operated by Transportes Aeromar.

Action taken by:   Paul L. Gretch, Director, Office of International
Aviation

________________________________________________________________________
________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) the applicant was qualified to perform its proposed
operations; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

FOREIGN CARRIER EXEMPTION CONDITIONS
 			ATTACHMENT

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

1) Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

2) Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its International Principal Security Inspector (IPSI) to advise
the IPSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served;

3) Comply with the requirements for minimum insurance coverage contained
in 14 CFR Part 205, and, prior to the commencement of any operations
under this authority, file evidence of such coverage, in the form of a
completed OST Form 6411, with the Federal Aviation Administration’s
Program Management Branch (AFS-260), Flight Standards Service (any
changes to, or termination of, insurance also shall be filed with that
office);

4) Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

5) Conform to the airworthiness and airman competency requirements of
its Government for international air services;

6) Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

7) Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: a) based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or b) based on
a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term “international air transportation” means “international
transportation” as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

8) Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

9) Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department’s
rules governing charters (including 14 CFR Parts 212 and 380); and

11) Comply with such other reasonable terms, conditions, and limitations
required by the public interest as may be prescribed by the Department,
with all applicable orders or regulations of other U.S. agencies and
courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

 05/2004

Aeromexico/Transportes Aeromar Code-Share Conditions (OST-2006-23702)

The codeshare operations authorized here are subject to the following
conditions:

(a)  The statement of authorization will remain in effect only as long
as (i) Aeromexico and Transportes Aeromar continue to hold the necessary
underlying authority to operate the codeshare services at issue, and
(ii) the codeshare agreement providing for the codeshare operations
remains in effect.

(b) Aeromexico and/or Transportes Aeromar must promptly notify the
Department if the codeshare agreement providing for the codeshare
operations is no longer effective or the carriers decide to cease
operating any or all of the approved codeshare services.    We expect
this notification to be received within 10 days of such
non-effectiveness or of such decision.  Such notices should be filed in
docket OST-2006-23702.

(c)  The codesharing operations conducted under this authority must
comply with 14 C.F.R. Part 257 and with any amendments to the
Department’s regulations concerning codeshare arrangements that may be
adopted.  Notwithstanding any provisions in the contract between the
carriers, our approval here is expressly conditioned upon the
requirements that the subject foreign air transportation be sold in the
name of the carrier holding out such service in computer reservation
systems and elsewhere; that the carrier selling such transportation
(i.e., the carrier shown on the ticket) accept responsibility for the
entirety of the codeshare journey for all obligations established in its
contract of carriage with the passenger; and that the passenger
liability of the operating carrier be unaffected.

(d)  The authority granted here is specifically conditioned so that
neither Aeromexico nor Transportes Aeromar shall give any force or
effect to any contractual provisions between themselves that are
contrary to these conditions.

We may amend, modify, or revoke this authority at any time without
hearing, at our discretion.

 The Reynosa airport is not currently assessed under the Transportation
Security Administration’s Foreign Airports Assessment Program.  For
this reason, we shall defer action at this time on the Reynosa-Corpus
Christi portion of this application.


[Federal Register Volume 76, Number 42 (Thursday, March 3, 2011)]
[Notices]
[Pages 11789-11790]
[FR Doc No: 2011-4778]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0478]

Albert Poet: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
permanently debarring Albert Poet, MD from providing services in any
capacity to a person that has an approved or pending drug product
application. We base this order on a finding that Dr. Poet was
convicted of felonies under Federal law for conduct relating to the
regulation of a drug product under the FD&C Act. Dr. Poet was given
notice of the proposed permanent debarment and an opportunity to
request a hearing within the timeframe prescribed by regulation. Dr.
Poet failed to respond. Dr. Poet's failure to respond constitutes a
waiver of his right to a hearing concerning this action.

DATES: This order is effective March 3, 2011.

ADDRESSES: Submit applications for special termination of debarment to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Division of Compliance
Policy (HFC-230), Office of Enforcement, Office of Regulatory

Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B))
requires debarment of an individual if FDA finds that the individual
has been convicted of a felony under Federal law for conduct otherwise
relating to the regulation of any drug product under the FD&C Act.
    On September 28, 2007, the U.S. District Court District of New
Jersey entered judgment against Dr. Poet for 13 counts of mail fraud in
violation of 18 U.S.C. 2 and 1341 and 1 count of causing a drug to be
misbranded while it was held for sale after shipment in interstate
commerce with the intent to defraud or mislead in violation of 21
U.S.C. 331(k), 333(a)(2), and 352(i)(3).
    FDA's finding that debarment is appropriate is based on the felony
convictions referenced herein for conduct relating to the regulation of
a drug product. The factual basis for those convictions is as follows:
During 2003-2004, Dr. Poet was a physician licensed to practice
medicine in the State of New Jersey. Dr. Poet owned and operated the
Shore Laser Center and PEAU, both located in New Jersey. As part of his
practice, Dr. Poet injected patients with BOTOX, a Botulinum Toxin Type
A drug.
    From on or about December 4, 2003, through in or about December
2004, Dr. Poet knowingly and willfully devised a scheme and artifice to
defraud and to obtain money and property by means of false and
fraudulent pretenses, representations, and promises. He maintained a
Web site and placed regular advertisements in local newspapers offering
BOTOX treatments at his office. Between December 4, 2003, and November
8, 2004, Dr. Poet placed 13 orders for a total of 26 vials of TRI-
Toxin, a Botulinum Toxin Type A drug manufactured by Toxin Research
International, Inc. TRI-Toxin was labeled ``For Research Purposes Only,
Not for Human Use.'' Dr. Poet injected many of the approximately 130
patients who sought BOTOX treatments with unapproved TRI-Toxin between
January 1, 2004, and December 1, 2004. As part of his scheme to
defraud, Dr. Poet did not inform most of his patients receiving the
TRI-Toxin injections that they were receiving injections of a product
not approved by FDA. Dr. Poet charged patients the same price for the
cheaper, unapproved TRI-Toxin and the approved BOTOX. For purposes of
executing the scheme and artifice, Dr. Poet knowingly and willfully
caused the TRI-Toxin to be delivered by private and commercial
interstate carrier.
    As a result of his convictions, on December 13, 2010, FDA sent Dr.
Poet a notice by certified mail proposing to permanently debar him from
providing services in any capacity to a person that has an approved or
pending drug product application. The proposal was based on a finding,
under section 306(a)(2)(B) of the FD&C Act, that Dr. Poet was convicted
of felonies under Federal law for conduct relating to the regulation of
a drug product under the FD&C Act. The proposal also offered Dr. Poet
an opportunity to request a hearing, providing him 30 days from the
date of receipt of the letter in which to file the request, and advised
him that failure to request a hearing constituted a waiver of the
opportunity for a hearing and of any contentions concerning this
action. Dr. Poet failed to respond within the timeframe prescribed by
regulation and has, therefore, waived his opportunity for a hearing and
waived any contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement, Office of
Regulatory Affairs, under section 306(a)(2)(B) of the FD&C Act, under
authority delegated to the Director (Staff Manual Guide 1410.35), finds
that Albert Poet has been convicted of a felony under Federal law for
conduct relating to the regulation of a drug product under the FD&C
Act.
    As a result of the foregoing finding, Dr. Poet is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application under sections 505, 512,
or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section
351 of the Public Health Service Act (42 U.S.C. 262) (see DATES) (see
sections 306(c)(1)(B) and (c)(2)(A)(ii), and 201(dd) of the FD&C Act
(21 U.S.C. 321(dd))). Any person with an approved or pending drug
product application who knowingly employs or retains as a consultant or
contractor, or otherwise uses the services of Dr. Poet, in any capacity
during Dr. Poet's debarment, will be subject to civil money penalties
(section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Dr. Poet
provides services in any capacity to a person with an approved or
pending drug product application during his period of debarment he will
be subject to civil money penalties (section 307(a)(7) of the FD&C
Act). In addition, FDA will not accept or review any abbreviated new
drug applications submitted by or with the assistance of Dr. Poet
during his period of debarment (section 306(c)(1)(B) of the FD&C Act).
    Any application by Dr. Poet for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No. FDA-2010-N-0478 and sent to the Division of Dockets
Management (see ADDRESSES). All such submissions are to be filed in
four copies. The public availability of information in these
submissions is governed by 21 CFR 10.20(j).
    Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 16, 2011.
Howard Sklamberg,
Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-4778 Filed 3-2-11; 8:45 am]
BILLING CODE 4160-01-P