[Federal Register Volume 83, Number 17 (Thursday, January 25, 2018)]
[Proposed Rules]
[Pages 3447-3449]
[FR Doc No: 2018-01296]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 112, 117, and 507

[Docket No. FDA-2017-D-0397]

Considerations for Determining Whether a Measure Provides the
Same Level of Public Health Protection as the Corresponding Requirement
in 21 CFR Part 112 or the Preventive Controls Requirements in Part 117
or 507; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
announcing the availability of a draft guidance for industry entitled
``Considerations for Determining Whether a Measure Provides the Same
Level of Public Health Protection as the Corresponding Requirement in
21 CFR 112 or the Preventive Controls Requirements in Part 117 or
507.'' The draft guidance describes FDA's current thinking on the
concept of ``same level of public health protection'' (SLPHP), and
FDA's expectations for how an SLPHP evaluation should be conducted and
an SLPHP determination should be reached. The draft guidance identifies
certain points to consider that a competent authority, a farm, a
facility, an importer, or other relevant entity should take into
consideration when evaluating whether a measure that is different from
that required under (part 112) 21 CFR part 112 or the preventive
controls requirements in (part 117 or part 507) 21 CFR part 117 or 507
meets the SLPHP threshold under the foreign supplier verification
program (FSVP) regulation (21 CFR part 1, subpart L) or under part 112.

DATES: Submit either electronic or written comments on the draft
guidance by May 25, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-0397 for ``Considerations for Determining Whether a Measure
Provides the Same Level of Public Health Protection as the
Corresponding Requirement in 21 CFR 112 or the Preventive Controls
Requirements in Part 117 or 507.'' Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Center for Food Safety and Applied Nutrition (HFS-300), Food and
Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Ritu Nalubola, Office of Policy, Food
and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD
20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft guidance for industry
entitled ``Considerations for Determining Whether a Measure Provides
the Same Level of Public Health Protection as the Corresponding
Requirement in 21 CFR 112 or the Preventive Controls Requirements in
Part 117 or 507.'' We are issuing the draft guidance consistent with
FDA's good guidance practices regulation (21 CFR 10.115). The draft
guidance, when finalized, will represent the current thinking of FDA on
this topic. It does not establish any rights for

any person and is not binding on FDA or the public. You can use an
alternate approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.
    The draft guidance relates to four of the seven foundational rules
that we have established in Title 21 of the Code of Federal Regulations
(21 CFR) as part of our implementation of the FDA Food Safety
Modernization Act (FSMA) (Pub. L. 111-353). Table 1 lists these four
rules.

                    Table 1--The Four Foundational FSMA Rules Relevant to the Draft Guidance
----------------------------------------------------------------------------------------------------------------
  Title and abbreviations for the          Regulatory
      purpose of this document            codification                           Publication
----------------------------------------------------------------------------------------------------------------
Current Good Manufacturing           21 CFR part 117.......  80 FR 55908, September 17, 2015.
 Practice, Hazard Analysis, and
 Risk-Based Preventive Controls for
 Human Food (PC for Human Food
 regulation).
Current Good Manufacturing           21 CFR part 507.......  80 FR 56170, September 17, 2015.
 Practice, Hazard Analysis, and
 Risk-Based Preventive Controls for
 Food for Animals (PC for Animal
 Food regulation).
Standards for the Growing,           21 CFR part 112.......  80 FR 74354, November 27, 2015.
 Harvesting, Packing, and Holding
 of Produce for Human Consumption
 (Produce Safety regulation).
Foreign Supplier Verification        21 CFR part 1, subpart  80 FR 74226, November 27, 2015.
 Programs for Importers of Food for   L.
 Humans and Animals (FSVP
 regulation).
----------------------------------------------------------------------------------------------------------------

    The FSVP regulation requires, in relevant part, that importers
develop, maintain, and follow an FSVP that provides adequate assurances
that the foreign supplier of a food is using processes and procedures
that provide the SLPHP as those required under part 112 or the
preventive controls requirements in part 117 or part 507, respectively,
if any is applicable. As incorporated in 21 CFR 1.502(a), this means
that importers may import food consistent with the FSVP regulation even
if their foreign supplier uses a process or procedure that varies in
some way from the processes and procedures required under the
applicable requirements in these regulations, provided that the
importer follows an FSVP that provides adequate assurance that the
processes or procedures that the supplier uses provide the SLPHP as
those required under the relevant FDA requirement. Similarly, a
provision in the FSVP requirements for dietary supplements, in 21 CFR
1.511(c), also requires that foreign supplier verification activities
performed under that section must provide adequate assurances that a
supplier is producing the dietary supplement in accordance with
processes and procedures that provide the same level of public health
protection as those required under 21 CFR part 111 (the dietary
supplement current good manufacturing practice regulations). In
addition, the Produce Safety regulation includes certain provisions
whereby farms may use measures different from those required under part
112, provided all relevant requirements are met, including that those
measures must provide the SLPHP as the corresponding FDA-established
requirement (Sec. Sec.  112.12, 112.49, and 112.171-182 (Subpart P--
Variances)).
    The draft guidance describes FDA's current thinking on
considerations relevant to SLPHP determinations, specifically in
relation to the FSVP, PC for Human Food, PC for Animal Food, and
Produce Safety regulations. The draft guidance identifies certain
points to consider that a competent authority, a farm, a facility, an
importer, or other relevant entity should take into consideration when
evaluating whether a measure that is different from that required under
part 112 or the preventive controls requirements in part 117 or 507
meets the SLPHP threshold under the FSVP or Produce Safety regulations.
In addition, FDA expects to apply these same points in our own
evaluations of whether a measure that is different from that required
under the applicable provisions of these regulations provides the same
level of public health protection as the corresponding requirement.
    These points are intended to provide a general framework for
evaluating the adequacy of a measure to provide the necessary level of
public health protection that FDA determined is appropriate by
establishing the corresponding requirement. We rely on an overarching
principle that an SLPHP determination should be supported by sound
scientific evidence that is analyzed by competent individuals, taking
into account any unique measure-specific considerations. There are
different scenarios under which an SLPHP evaluation may be conducted,
and we recognize that an evaluation of a measure's level of public
health protection compared to the corresponding FDA requirement can
vary widely, including with respect to the scope of evaluation and the
entity that conducts the evaluation. Although the points to consider
can be flexibly used, as appropriate and applicable, considering the
specific circumstances applicable to the measure and the context for
its evaluation, we expect using these points will help achieve
consistency in the application of the concept of SLPHP across different
circumstances and by different entities. As we implement the FSMA
rules, FDA will also consider what, if any, training may be necessary
for our personnel to better understand and apply these points, and help
ensure consistency in our evaluations for SLPHP determinations.

II. The Paperwork Reduction Act of 1995

    This draft 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 part 117 have been approved under OMB
control number 0910-0751. The collections of information in part 507
have been approved under OMB control number 0910-0789. The collections
of information in part 112 have been approved under OMB control number
0910-0816. The collections of information in part 1, subpart L, have
been approved under OMB control number 0910-0752.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either http://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.

    Dated: January 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01296 Filed 1-24-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 69 (Monday, April 11, 2016)]
[Notices]
[Pages 21339-21341]
[FR Doc No: 2016-08280]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2015-0762; FRL-9943-48]

Registration Review; Conventional, Biopesticide and Antimicrobial
Dockets Opened for Review and Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: With this document, EPA is opening the public comment period
for several registration reviews. Registration review is EPA's periodic
review of pesticide registrations to ensure that each pesticide
continues to satisfy the statutory standard for registration, that is,
the pesticide can perform its intended function without unreasonable
adverse effects on human health or the environment. Registration review
dockets contain information that will assist the public in
understanding the types of information and issues that the Agency may
consider during the course of registration reviews. Through this
program, EPA is ensuring that each pesticide's registration is based on
current scientific and other knowledge, including its effects on human
health and the environment.

DATES: Comments must be received on or before June 10, 2016.

ADDRESSES: Submit your comments identified by the docket identification
(ID) number for the specific pesticide of interest provided in the
table in Unit III. A., 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 pesticide specific information
contact: The person identified as a contact in the table in Unit III.A.
Also include the docket ID number listed in the table in Unit III.A.
for the pesticide of interest.
    For general information contact: Richard Dumas, Pesticide Re-
Evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, farmworker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action.

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

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their

location, cultural practices, or other factors, may have atypical or
disproportionately high and adverse human health impacts or
environmental effects from exposure to the pesticides discussed in this
document, compared to the general population.

II. Authority

    EPA is initiating its reviews of the pesticides identified in this
document pursuant to section 3(g) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136a(g)) and the
Procedural Regulations for Registration Review at 40 CFR part 155,
subpart C., Section 3(g) of FIFRA provides, among other things, that
the registrations of pesticides are to be reviewed every 15 years.
Under FIFRA, a pesticide product may be registered or remain registered
only if it meets the statutory standard for registration given in FIFRA
section 3(c)(5) (7 U.S.C. 136a(c)(5)). When used in accordance with
widespread and commonly recognized practice, the pesticide product must
perform its intended function without unreasonable adverse effects on
the environment; that is, without any unreasonable risk to man or the
environment, or a human dietary risk from residues that result from the
use of a pesticide in or on food.

III. Registration Reviews

 A. What action is the Agency taking?

    As directed by FIFRA section 3(g), EPA is reviewing the pesticide
registrations identified in the table in this unit to assure that they
continue to satisfy the FIFRA standard for registration--that is, they
can still be used without unreasonable adverse effects on human health
or the environment. A pesticide's registration review begins when the
Agency establishes a docket for the pesticide's registration review
case and opens the docket for public review and comment. At present,
EPA is opening registration review dockets for the cases identified in
the following table.

                                   Table--Registration Review Dockets Opening
----------------------------------------------------------------------------------------------------------------
Registration review case name and No.                 Docket ID No.                           Contact
----------------------------------------------------------------------------------------------------------------
1,2-Benzisothiazol-3(2H)-one,2-butyl-  EPA-HQ-OPP-2015-0736                        Rachel Ricciardi,
 (BBIT), 5017<EMAIL_ADDRESS><PHONE_NUMBER>.
Bacillus popilliae, 4102.............  EPA-HQ-OPP-2016-0043                        Kathleen Martin,
<EMAIL_ADDRESS><PHONE_NUMBER>.
Brodifacoum, 2755....................  EPA-HQ-OPP-2015-0767                        Ricardo Jones,
<EMAIL_ADDRESS>(703)
                                                                                347-0493.
Bromadiolone, 2760...................  EPA-HQ-OPP-2015-0768                        Ricardo Jones,
<EMAIL_ADDRESS>(703)
                                                                                347-0493.
Derivatives of benzoic acid, 4013....  EPA-HQ-OPP-2015-0597                        Moana Appleyard,
<EMAIL_ADDRESS><PHONE_NUMBER>.
Difenacoum, 7630.....................  EPA-HQ-OPP-2015-0769                        Nicole Zinn
<EMAIL_ADDRESS>(703)
                                                                                308-7075.
Difethialone, 7603...................  EPA-HQ-OPP-2015-0770                        Nicole Zinn
<EMAIL_ADDRESS>(703)
                                                                                308-7075.
Ethofumesate, 2265...................  EPA-HQ-OPP-2015-0406                        Jordan Page,
<EMAIL_ADDRESS>(703)
                                                                                347-0467.
Fluometuron, 0049....................  EPA-HQ-OPP-2015-0746                        Linsey Walsh,
<EMAIL_ADDRESS>(703)
                                                                                347-8030.
Inorganic chlorates, 4049............  EPA-HQ-OPP-2016-0080                        Brittany Pruitt,
<EMAIL_ADDRESS><PHONE_NUMBER>.
Inorganic polysulfides, 4054.........  EPA-HQ-OPP-2016-0102                        Katherine St. Clair,
<EMAIL_ADDRESS><PHONE_NUMBER>.
Metaldehyde, 0576....................  EPA-HQ-OPP-2015-0649                        Leigh Rimmer,
<EMAIL_ADDRESS>(703)
                                                                                347-0553.
Methyl Eugenol, 6203.................  EPA-HQ-OPP-2015-0542                        Cheryl Greene,
<EMAIL_ADDRESS>(703)
                                                                                308-0352.
Pentachloronitrobenzene, 0128........  EPA-HQ-OPP-2015-0348                        Veronica Dutch,
<EMAIL_ADDRESS><PHONE_NUMBER>.
Triadimefon, 2700....................  EPA-HQ-OPP-2016-0114                        Christina Motilall,
<EMAIL_ADDRESS><PHONE_NUMBER>.
Triadimenol, 7008....................  EPA-HQ-OPP-2016-0114                        Christina Motilall,
<EMAIL_ADDRESS><PHONE_NUMBER>.
----------------------------------------------------------------------------------------------------------------

B. Docket Content

    1. Review dockets. The registration review dockets contain
information that the Agency may consider in the course of the
registration review. The Agency may include information from its files
including, but not limited to, the following information:
     An overview of the registration review case status.
     A list of current product registrations and registrants.
     Federal Register notices regarding any pending
registration actions.
     Federal Register notices regarding current or pending
tolerances.
     Risk assessments.
     Bibliographies concerning current registrations.
     Summaries of incident data.
     Any other pertinent data or information.
    Each docket contains a document summarizing what the Agency
currently knows about the pesticide case and a preliminary work plan
for anticipated data and assessment needs. Additional documents provide
more detailed information. During this public comment period, the
Agency is asking that interested persons identify any additional
information they believe the Agency should consider during the
registration reviews of these pesticides. The Agency identifies in each
docket the areas where public comment is specifically requested, though
comment in any area is welcome.
    2. Other related information. More information on these cases,
including the active ingredients for each case, may be located in the
registration review schedule on the Agency's Web site at https://www.epa.gov/pesticide-reevaluation/registration-review-schedules.
Information on the Agency's registration review program and its
implementing regulation may be seen at http://www.epa.gov/pesticide-reevaluation/registration-review-process.
    3. Information submission requirements. Anyone may submit data or
information in response to this document. To be considered during a
pesticide's registration review, the

submitted data or information must meet the following requirements:
     To ensure that EPA will consider data or information
submitted, interested persons must submit the data or information
during the comment period. The Agency may, at its discretion, consider
data or information submitted at a later date.
     The data or information submitted must be presented in a
legible and useable form. For example, an English translation must
accompany any material that is not in English and a written transcript
must accompany any information submitted as an audiographic or
videographic record. Written material may be submitted in paper or
electronic form.
     Submitters must clearly identify the source of any
submitted data or information.
     Submitters may request the Agency to reconsider data or
information that the Agency rejected in a previous review. However,
submitters must explain why they believe the Agency should reconsider
the data or information in the pesticide's registration review.
    As provided in 40 CFR 155.58, the registration review docket for
each pesticide case will remain publicly accessible through the
duration of the registration review process; that is, until all actions
required in the final decision on the registration review case have
been completed.

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

    Dated: March 31, 2016.
Yu-Ting Guilaran,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2016-08280 Filed 4-8-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: June 9, 2010 (Volume 75, Number 110)]
[Notices]
[Page 32767-32769]
[DOCID:fr09jn10-51]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0008; FRL-8828-7]

Pesticide Products; Registration Applications

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces receipt of applications to register new
uses for pesticide products containing currently registered active
ingredients, pursuant to the provisions of section 3(c) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. EPA is
publishing this notice of such applications, pursuant to section
3(c)(4) of FIFRA.

DATES: Comments must be received on or before July 9, 2010.

ADDRESSES: Submit your comments, identified by the docket
identification (ID) number specified within Unit II. of the
SUPPLEMENTARY INFORMATION, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).

Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket the ID number
specified for the pesticide of interest as shown in the registration
application summaries. EPA's policy is that all comments received will
be included in the docket without change and may be made available on-
line at http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: A contact person is listed at the end
of each registration application summary and may be contacted by
telephone or e-mail. The mailing address for each contact person listed
is: Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have 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 the 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 this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
If you are commenting in a docket that addresses multiple products,
please indicate to which registration number(s) your comment applies.
     ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
     iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
     viii. Make sure to submit your comments by the comment period
deadline identified.

II. Registration Applications

    EPA received applications as follows to register pesticide products
containing currently registered active ingredients pursuant to the
provisions of section 3(c) of FIFRA, and is publishing this notice of
such applications pursuant to section 3(c)(4) of FIFRA. Notice of
receipt of these applications does not imply a decision by the Agency
on the applications.
     1. Registration Number/File Symbol: 2647-718, 264-719, 264-850.
Docket Number: EPA-HQ-OPP-2009-0682. Company name and address: Bayer
CropScience, P.O. Box 12014, 2 T.W. Alexander Drive, Research Triangle
Park, NC 27709. Active ingredient: Spiromesifen. Proposed Uses: Pea,
dry seed; and Peppermint and Spearmint tops. Contact: Jennifer Gaines,
(703) 305-5967<EMAIL_ADDRESS>     2. Registration Number/File Symbol: 265-1034, 10308-32. Docket
Number: EPA-HQ-OPP-2008-0771. Company name and address: Valent U.S.A.
Corporation, 1600 Riviera Avenue, Suite 200, Walnut Creek, CA 94596.
Active ingredient: Clothianidin. Proposed Use: Mustard seed. Contact:
Kable Bo Davis,<PHONE_NUMBER><EMAIL_ADDRESS>     3. Registration Number/File Symbol: 352-IGI. Docket Number: EPA-
HQ-OPP-2009-0261. Company name and address: E.I. du Pont de Nemours and
Company, DuPont Crop Protection,

Stine-Haskell Research Center, P.O. Box 30, Newark, DE 19714. Active
ingredient: Chlorantraniliprole. Proposed Uses: Seed treatment on head
and leaf lettuce and spinach. Contact: Kable Bo Davis,<PHONE_NUMBER>;
<EMAIL_ADDRESS>     4. Registration Number/File Symbol: 10163-247, 10163-301. Docket
Number: EPA-HQ-OPP-2010-0343. Company name and address: The Gowan
Company, P.O. Box 5569, Yuma, AZ 85366-5569. Active ingredient:
Flutolanil. Proposed Uses: Brassica leafy vegetables; Cucurbit; and
Ginseng. Contact: Lisa Jones,<PHONE_NUMBER><EMAIL_ADDRESS>     5. Registration Number/File Symbol: 71711-6, 71711-7, 71711-25,
71711-27. Docket Number: EPA-HQ-OPP-2010-0426. Company name and
address: Nichino America, Inc., 4550 New Linden Hill Road, Suite 501,
Wilmington, DE 19808. Active ingredient: Pyraflufen-ethyl. Proposed
Uses: Grapes; Hops; Olive trees; Pistachio; Pome fruit (crop group 11);
Pomegranates; Stone fruit (crop group 12); and Tree nut (crop group
14). Contact: James M. Stone,<PHONE_NUMBER><EMAIL_ADDRESS>     6. Registration Number/File Symbol: 264-1025, 264-1026, 71711-26.
Docket Number: EPA-HQ-OPP-2007-0099. Company name and address: Bayer
CropScience LP, P.O. Box 12014, 2 T.W. Alexander Drive, Research
Triangle Park, NC 27709. Active ingredient: Flubendiamide. Proposed
Uses:: Legume; Soybean. Contact: Carmen Rodia,<PHONE_NUMBER>;
<EMAIL_ADDRESS>
List of Subjects

    Environmental protection, Pesticides and pest.

    Dated: May 28, 2010.
 Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

[FR Doc. 2010-13688 Filed 6-8-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Notices]
[Pages 20662-20663]
[FR Doc No: 2013-07949]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Preparation for International Cooperation on Cosmetics
Regulation; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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

    The Food and Drug Administration (FDA or we) is announcing a public
meeting entitled, ``International Cooperation on Cosmetics Regulation
(ICCR)--Preparation for ICCR-7 Meeting.'' The purpose of the meeting is
to invite public input on various topics pertaining to the regulation
of cosmetics. We may use this input to help us prepare for the ICCR-7
meeting that will be held in Japan on July 8 to 10, 2013.

DATES: Date and Time: The meeting will be held on May 8, 2013, from 2
p.m. to 4 p.m.
    Location: The meeting will be held at the Food and Drug
Administration, University Station Building, 4300 River Rd., Conference
Room 3172 (third floor), College Park, MD 20740.
    Contact Person: If you intend to participate in the meeting, you
should register with Maria Rossana (Rosemary) Cook, Office of Cosmetics
and Colors, Food and Drug Administration, 4300 River Rd., College Park,
MD 20740, by email<EMAIL_ADDRESS>or Fax:<PHONE_NUMBER>.
    Registration and Requests for Oral Presentations: Send registration
information (including your name, title, firm name, address, telephone
number, fax number, and email address), written material, and requests
to make an oral presentation, to the contact person by April 22, 2013.
    If you need special accommodations due to a disability, please
contact Maria Rossana (Rosemary) Cook (see Contact Person) by May 1,
2013.
    You may present data, information, or views orally or in writing,
on issues pending at the public meeting. Time allotted for oral
presentations may be limited to 10 minutes or less for each presenter.
If you wish to make an oral presentation, you should notify the contact
person by April 22, 2013, and submit a brief statement of the general
nature of the evidence or arguments that you wish to present, your
name, address, telephone number, fax number, and email address, and
indicate the approximate amount of time you need to make your
presentation.

    Transcripts: As soon as a transcript is available, it will be
accessible at http://www.regulations.gov. It also may be viewed at the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD. A transcript will also be
available in either hardcopy or on CD-ROM, after submission of a
Freedom of Information request. You should send written requests for a
hardcopy or CD-ROM transcript to the Division of Freedom of
Information, (ELEM-1029), Food and Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD 20857.
    The purpose of the multilateral framework on the ICCR is to pave
the way for the removal of regulatory obstacles to international trade
while maintaining global consumer protection.
    ICCR is a voluntary international group of cosmetics regulatory
authorities from the United States, Japan, the European Union, and
Canada. These regulatory authority members will enter into constructive
dialogue with their relevant cosmetics industry trade associations and
public advocacy groups. Currently, the ICCR members are: Health Canada;
the European Directorate General for Health and Consumers; the Ministry
of Health, Labor and Welfare of Japan; and the U.S. Food and Drug
Administration. All decisions made by consensus will be compatible with
the laws, policies, rules, regulations, and directives of the
respective administrations and governments. Members will implement and/
or promote actions or documents within their own jurisdictions and seek
convergence of regulatory policies and practices. Successful
implementation will need input from stakeholders.
    You may present data, information, or views orally or in writing on
issues pending at the public meeting. Time allotted for oral
presentations may be limited to 10 minutes or less for each presenter.
If you wish to make an oral presentation, you should notify the contact
person by April 22, 2013, and submit a brief statement of the general
nature of the evidence or arguments that you wish to present, your
name, address, telephone number, fax number, and email address, and
indicate the approximate time you need to make your presentation. If
you need special accommodations due to a disability, please contact
Maria Rossana (Rosemary) Cook (see Contact Person) by May 1, 2013.
    We will make the agenda for the public meeting available on the
Internet at: http://www.fda.gov/Cosmetics/InternationalActivities/ConferencesMeetingsWorkshops/InternationalCooperationonCosmeticsRegulationsICCR/default.htm. We may
use the information that you provide to us during the public meeting to
help us prepare for the July 8 to 10, 2013 ICCR-7 meeting.

    Dated: April 1, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07949 Filed 4-4-13; 8:45 am]
BILLING CODE 4160-01-P


0154 04 010\ process vent reduction mem. doc 1 MEMORANDUM TO: Randy McDonald, U. S. Environmental Protection Agency, OAQPS/ Sector Policies and Programs Division, Coatings and Chemicals Group ( C504 04)

FROM: Roy Oommen and Danny Greene, ERG DATE: June 2006 SUBJECT: Process Vent Emission Reduction and Control Cost Estimates 1.0 INTRODUCTION The purpose of this memorandum is to present the analyses used to estimate the hazardous air pollutant ( HAP) emissions, emission reductions, and costs associated with controlling uncontrolled process vent streams at hazardous organic NESHAP ( HON) sources.

These uncontrolled streams are classified in the HON regulation as Group 2 process vents.

Section 2 presents the data used to estimate baseline emissions from uncontrolled process vents.

Section 3 presents the methodologies used to estimate emission reductions and control costs.

2.0 BASELINE DATA Baseline process vent data on existing HON facilities were collected by the American Chemistry Council ( ACC) through a voluntary survey and provided to EPA. The ACC data contained site specific information for the base year 1999 for 104 of the 238 existing HON facilities. Information from all the facilities was then combined into one database. The data fields in the database are presented in Table 2 1.

The ACC survey requested that process vent information be identified as either controlled or uncontrolled. However, many respondents did not provide this information. Such process vents were grouped into a third category, unspecified process vents. 0154 04 010\ process vent reduction mem. doc 2 3.0 EMISSION REDUCTION AND CONTROL COST ESTIMATES For this analysis, both uncontrolled vent streams and unspecified vent streams were categorized as Group 2 streams. This assumption regarding the unspecified streams provides the most conservative estimate of costs. Additionally, this analysis was conducted only for process vent streams that contained at least one HAP with a high lifetime cancer risk, as well as other specific pollutants of interest. Collectively, these HAP are referred as HAPs listed in Table 38 of the proposed rule.

Table 2 1. Data Fields in Process Vents Database Source ID HON Facility ID Chemical Manufacturing Process Unit ID ( CMPU_ ID)

Latitude Longitude Emission Type HAP Name CAS Number Emission Rate ( kg/ yr)

Stack Height Stack Diameter Stack Velocity Stack Temperature Each process vent was identified based on the process unit associated with it, as well as by unique longitude and latitude, stack height, stack diameter, stack velocity, and stack temperature.

3.1 Emission Reductions Emission reductions were calculated assuming that each Group 2 vent stream would be controlled using a combustion device. This was the control method used in the HON, and no other controls were identified that would achieve greater emission reductions than combustion.

The destruction efficiency for combustion devices was assumed to be 98 percent, based on 0154 04 010\ process vent reduction mem. doc 3 analyses done for the HON. The annual emissions reductions of each from controlling each Group 2 stream was calculated using the following equation:

ER = ( 0.98)(( EHAP)( H)( 1/ 1000)

where:

C ER is the emission reduction of each HAP in the vent stream ( Megagrams per hour),

C EHAP is the process vent HAP emission rate ( kilograms per hour),

C H is the hours of operation per year.

3.2 Cost The capital and annual cost estimates from controlling Group 2 streams were calculated using the methodology in the HON, i. e., using the total resource effectiveness ( TRE) concept.

The TRE index is a measure of how costly a particular process vent is to control ( the higher the TRE index, the more costly the control). For each process vent, the TRE was calculated using the following equation from the HON regulation:

where:

C EHAP is the process vent HAP emission rate ( kilograms per hour),

C Qs is the volumetric flow rate ( standard cubic meters per minute, scmm) of the process vent at a standard temperature of 20 ° C,

C HT is the net heating value ( mega Joules per standard cubic meter, MJ/ scm) of the process vent stream,

C ETOC is the emission rate ( kg/ hr) of total organic carbon ( TOC), minus methane and ethane of the process vent, and C a, b, c, and d are coefficients for nonhalogenated and halogenated vent streams ( taken from table 1 of subpart G of part 63). 0154 04 010\ process vent reduction mem. doc 4 The volumetric flowrate was not provided in the survey responses. However, it could be estimated using the stack diameter and the stack velocity from the following equation:

Qs = (  *( Sd) 2/ 4)( Sv)

where:

C Sd is the stack diameter ( meters)

C Sv is the stack gas velocity ( meters/ second)

Because sufficient data ( total speciated organic emissions) were not available for each process vent to estimate heating value, each vent stream was assigned an average heating value, as provided in the HON background information document ( BID) of 14.6 mega Joules per standard cubic meter ( MJ/ scm). The TOC emission rate for each process vent was estimated by dividing the HAP emissions by an average HAP to VOC ratio from the HON BID, 0.78. The nonhalogenated and halogenated vent stream coefficients ( included in Attachment A) were assigned based on whether the vent stream contained a halogenated HAP.

Using the TRE values, the total annual costs ( TAC) of control were estimated using the following equation:

TAC = ( HAP emission reduction)($ 3,000/ TRE)( TRE)

This equation is based on TRE value of 1.0 corresponding to a cost effectiveness value of approximately $ 3,000 per Mg of HAP reduced, as discussed in the HON BID.

The total capital investment ( TCI) was estimated using the annualized capital costs and the capital recovery factor. The annualized capital costs were estimated by assuming that the annualized capital costs account for 40 percent of the TAC. This assumption was based on costs calculated for model process vent streams in the HON BID. The annualized capital costs are also equal to the TCI multiplied by the capital recovery factor ( CRF). The capital recovery factor ( 0.1097) was calculated using the following equation:

CRF = ( i( 1+ i) n)/(( 1+ i) n 1) 0154 04 010\ process vent reduction mem. doc 5 where:

i = the interest rate ( 7 percent was used for this analysis), and n = repayment period ( years).

For this analysis, the interest rate chosen was 7 percent and the repayment period was 15 years.

Attachment B presents the summary of costs and emission reductions for process vent streams with Table 38 HAP. Table B 1 contains results for unspecified process vent streams. Table B 2 contains results for uncontrolled process vent streams.

4.0 REFERENCES 1. Hazardous Air Pollutant Emissions From Process Units in the Synthetic Organic Chemical Manufacturing Industry Background Information for Proposed Standards, Volume 1C Model Emission Sources, Emission Standards Division, U. S. Environmental Protection Agency, Office of Air and Radiation, Office of Air Quality Planning and Standards, Research Triangle Park, NC, November 1992. 0154 04 010\ process vent reduction mem. doc 6 Attachment A Coefficients for Total Resource Effectiveness Nonhalogenated and Halogenated Vent Streams Coeffecient Halogenated Non halogenated a 3.995 1.935 b 0.052 0.366 c  0.001769  0.007687 d 0.00097 0.000733 0154 04 010\ process vent reduction mem. doc 7 Attachment B Emissions, Emission Reductions, and Control Cost Estimates for Uncontrolled and Unspecified Process Vents


[Federal Register Volume 82, Number 237 (Tuesday, December 12, 2017)]
[Notices]
[Pages 58469-58470]
[FR Doc No: 2017-26700]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 32935; 812-14820]

Calvert Research and Management and Calvert ETF Trust

December 6, 2017.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice.

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

    Notice of an application for an order under section 6(c) of the
Investment Company Act of 1940 (the ``Act'') for an exemption from
sections 2(a)(32), 5(a)(1), 22(d), and 22(e) of the Act and rule 22c-1
under the Act, under sections 6(c) and 17(b) of the Act for an
exemption from sections 17(a)(1) and 17(a)(2) of the Act, and under
section 12(d)(1)(J) for an exemption from sections 12(d)(1)(A) and
12(d)(1)(B) of the Act. The requested order would permit (a) index-
based series of certain open-end management investment companies
(``Funds'') to issue shares redeemable in large aggregations only
(``Creation Units''); (b) secondary market transactions in Fund shares
to occur at negotiated market prices rather than at net asset value
(``NAV''); (c) certain Funds to pay redemption proceeds, under certain
circumstances, more than seven days after the tender of shares for
redemption; (d) certain affiliated persons of a Fund to deposit
securities into, and receive securities from, the Fund in connection
with the purchase and redemption of Creation Units; and (e) certain
registered management investment companies and unit investment trusts
outside of the same group of investment companies as the Funds (``Funds
of Funds'') to acquire shares of the Funds.

Applicants: Calvert Research and Management (the ``Initial Adviser''),
a Massachusetts business trust, that is registered as an investment
adviser under the Investment Advisers Act of 1940 and Calvert ETF Trust
(the ``Trust''), a Massachusetts business trust that intends to
register under the Act as an open-end management investment company
with multiple series.

Filing Date: The application was filed on September 20, 2017 and
amended on November 14, 2017.

Hearing or Notification of Hearing: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on January 2, 2018, and should be accompanied by proof of
service on applicants, in the form of an affidavit, or for lawyers, a
certificate of service. Pursuant to rule 0-5 under the Act, hearing
requests should state the nature of the writer's interest, any facts
bearing upon the desirability of a hearing on the matter, the reason
for the request, and the issues contested. Persons who wish to be
notified of a hearing may request notification by writing to the
Commission's Secretary.

ADDRESSES: Secretary, Securities and Exchange Commission, 100 F Street
NE, Washington, DC 20549-1090; Applicants: 1825 Connecticut Avenue NW,
Suite 400, Washington, DC 20009.

FOR FURTHER INFORMATION CONTACT: Courtney S. Thornton, Senior Counsel,
at<PHONE_NUMBER>, or Robert H. Shapiro, Branch Chief, at (202) 551-
6821 (Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's website by searching for the file number, or for an
applicant using the Company name box, at http://www.sec.gov/search/search.htm or by calling<PHONE_NUMBER>.

Summary of the Application

    1. Applicants request an order that would allow Funds to operate as
index exchange traded funds (``ETFs'').\1\ Fund shares will be
purchased and redeemed at their NAV in Creation Units only. All orders
to purchase Creation Units and all redemption requests will be placed
by or through an ``Authorized Participant'', which will have signed a
participant agreement with the Distributor. Shares will be listed and
traded individually on a national securities exchange, where share
prices will be based on the current bid/offer market. Any order
granting the requested relief would be subject to the

terms and conditions stated in the application.
---------------------------------------------------------------------------

    \1\ Applicants request that the order apply to the new series of
the Trust, any additional series of the Trust, and any other open-
end management investment company or series thereof (each, included
in the term ``Fund''), each of which will operate as an ETF and will
track a specified index comprised of domestic or foreign equity and/
or fixed income securities (each, an ``Underlying Index''). Any Fund
will (a) be advised by the Initial Adviser or an entity controlling,
controlled by, or under common control with the Initial Adviser or
any successor thereto (each, an ``Adviser'') and (b) comply with the
terms and conditions of the application. For purposes of the
requested Order, ``successor'' is limited to an entity that results
from a reorganization into another jurisdiction or a change in the
type of business organization.
---------------------------------------------------------------------------

    2. Each Fund will hold investment positions selected to correspond
generally to the performance of an Underlying Index. Certain of the
Funds will track an Underlying Index that is compiled, created,
sponsored, or maintained by an affiliated person, as defined in section
2(a)(3) of the Act (``Affiliated Person''), or an affiliated person of
an Affiliated Person (``Second-Tier Affiliate''), of the Trust or a
Fund, of the Adviser, of any sub-adviser to or promoter of a Fund, or
of the Distributor (each a ``Self-Indexing Fund'').\2\
---------------------------------------------------------------------------

    \2\ Each Self-Indexing Fund will post on its website the
identities and quantities of the investment positions that will form
the basis for the Fund's calculation of its NAV at the end of the
day. Applicants believe that requiring Self-Indexing Funds to
maintain full portfolio transparency will help address, together
with other protections, conflicts of interest with respect to such
Funds.
---------------------------------------------------------------------------

    3. Shares will be purchased and redeemed in Creation Units and
generally on an in-kind basis. Except where the purchase or redemption
will include cash under the limited circumstances specified in the
application, purchasers will be required to purchase Creation Units by
depositing specified instruments (``Deposit Instruments''), and
shareholders redeeming their shares will receive specified instruments
(``Redemption Instruments''). The Deposit Instruments and the
Redemption Instruments will each correspond pro rata to the positions
in the Fund's portfolio (including cash positions) except as specified
in the application.
    4. Because shares will not be individually redeemable, applicants
request an exemption from section 5(a)(1) and section 2(a)(32) of the
Act that would permit the Funds to register as open-end management
investment companies and issue shares that are redeemable in Creation
Units only.
    5. Applicants also request an exemption from section 22(d) of the
Act and rule 22c-1 under the Act as secondary market trading in shares
will take place at negotiated prices, not at a current offering price
described in a Fund's prospectus, and not at a price based on NAV.
Applicants state that (a) secondary market trading in shares does not
involve a Fund as a party and will not result in dilution of an
investment in shares, and (b) to the extent different prices exist
during a given trading day, or from day to day, such variances occur as
a result of third-party market forces, such as supply and demand.
Therefore, applicants assert that secondary market transactions in
shares will not lead to discrimination or preferential treatment among
purchasers. Finally, applicants represent that share market prices will
be disciplined by arbitrage opportunities, which should prevent shares
from trading at a material discount or premium from NAV.
    6. With respect to Funds that effect creations and redemptions of
Creation Units in kind and that are based on certain Underlying Indexes
that include foreign securities, applicants request relief from the
requirement imposed by section 22(e) in order to allow such Funds to
pay redemption proceeds within fifteen calendar days following the
tender of Creation Units for redemption. Applicants assert that the
requested relief would not be inconsistent with the spirit and intent
of section 22(e) to prevent unreasonable, undisclosed or unforeseen
delays in the actual payment of redemption proceeds.
    7. Applicants request an exemption to permit Funds of Funds to
acquire Fund shares beyond the limits of section 12(d)(1)(A) of the
Act; and the Funds, and any principal underwriter for the Funds, and/or
any broker or dealer registered under the Exchange Act, to sell shares
to Funds of Funds beyond the limits of section 12(d)(1)(B) of the Act.
The application's terms and conditions are designed to, among other
things, help prevent any potential (i) undue influence over a Fund
through control or voting power, or in connection with certain
services, transactions, and underwritings, (ii) excessive layering of
fees, and (iii) overly complex fund structures, which are the concerns
underlying the limits in sections 12(d)(1)(A) and (B) of the Act.
    8. Applicants request an exemption from sections 17(a)(1) and
17(a)(2) of the Act to permit persons that are Affiliated Persons, or
Second Tier Affiliates, of the Funds, solely by virtue of certain
ownership interests, to effectuate purchases and redemptions in-kind.
The deposit procedures for in-kind purchases of Creation Units and the
redemption procedures for in-kind redemptions of Creation Units will be
the same for all purchases and redemptions and Deposit Instruments and
Redemption Instruments will be valued in the same manner as those
investment positions currently held by the Funds. Applicants also seek
relief from the prohibitions on affiliated transactions in section
17(a) to permit a Fund to sell its shares to and redeem its shares from
a Fund of Funds, and to engage in the accompanying in-kind transactions
with the Fund of Funds.\3\ The purchase of Creation Units by a Fund of
Funds directly from a Fund will be accomplished in accordance with the
policies of the Fund of Funds and will be based on the NAVs of the
Funds.
---------------------------------------------------------------------------

    \3\ The requested relief would apply to direct sales of shares
in Creation Units by a Fund to a Fund of Funds and redemptions of
those shares. Applicants are not seeking relief from section 17(a)
for, and the requested relief will not apply to, transactions where
a Fund could be deemed an Affiliated Person, or a Second-Tier
Affiliate, of a Fund of Funds because an Adviser or an entity
controlling, controlled by or under common control with an Adviser
provides investment advisory services to that Fund of Funds.
---------------------------------------------------------------------------

    9. Section 6(c) of the Act permits the Commission to exempt any
persons or transactions from any provision of the Act if such exemption
is necessary or appropriate in the public interest and consistent with
the protection of investors and the purposes fairly intended by the
policy and provisions of the Act. Section 12(d)(1)(J) of the Act
provides that the Commission may exempt any person, security, or
transaction, or any class or classes of persons, securities, or
transactions, from any provision of section 12(d)(1) if the exemption
is consistent with the public interest and the protection of investors.
Section 17(b) of the Act authorizes the Commission to grant an order
permitting a transaction otherwise prohibited by section 17(a) if it
finds that (a) the terms of the proposed transaction are fair and
reasonable and do not involve overreaching on the part of any person
concerned; (b) the proposed transaction is consistent with the policies
of each registered investment company involved; and (c) the proposed
transaction is consistent with the general purposes of the Act.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-26700 Filed 12-11-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 135 (Monday, July 19, 2021)]
[Proposed Rules]
[Pages 37939-37941]
[FR Doc No: 2021-15221]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-0536; Airspace Docket No. 21-ASO-20]
RIN 2120-AA66

Proposed Establishment of Class D Airspace, and Amendment of
Class E Airspace; Gulf Shores, AL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish Class D airspace and amend
Class E airspace extending upward from 700 feet above the surface for
Jack Edwards National Airport, Gulf Shores, AL, as a new air traffic
control tower will service the airport. This action would also update
the airport's name and geographic coordinates under the existing Class
E airspace. Controlled airspace is necessary for the safety and
management of instrument flight rules (IFR) operations in the area.

DATES: Comments must be received on or before September 2, 2021.

ADDRESSES: Send comments on this proposal to: The U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001;
Telephone:<PHONE_NUMBER>, or<PHONE_NUMBER>. You must identify the
Docket No. FAA-2020-0536; Airspace Docket No. 21-ASO-20, at the
beginning of your comments. You may also submit comments through the
internet at https://www.regulations.gov.
    FAA Order 7400.11E, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed on line 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:  John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Avenue, College Park, GA 30337; 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 would establish Class D airspace and amend

Class E airspace for Jack Edwards National Airport, Gulf Shores, AL.

Comments Invited

    Interested persons are invited to comment on this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (Docket No. FAA-
2020-0536 and Airspace Docket No. 21-ASO-20) and be submitted in
triplicate to DOT Docket Operations (see ADDRESSES section for the
address and phone number). You may also submit comments through the
internet at https://www.regulations.gov.
    Persons wishing the FAA to acknowledge receipt of their comments on
this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2020-0536; Airspace Docket No. 21-ASO-20''. The postcard
will be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this document may be changed in light of the
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined between 8:00 a.m. and
4:30 p.m., Monday through Friday, except federal holidays, at the
office of the Eastern Service Center, Federal Aviation Administration,
Room 350, 1701 Columbia Avenue, College Park, GA 30337.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend 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 Proposal

    The FAA proposes an amendment to 14 CFR part 71 to establish Class
D airspace for Jack Edwards National Airport, Gulf Shores, AL, as a new
air traffic control tower will service the airport. Also, an airspace
evaluation resulted in increasing the radius of the existing Class E
airspace extending upward from 700 feet above the surface to 6.8 miles
from 6.5 miles. In addition, the FAA proposes to update the name and
geographic coordinates of the airport to coincide with the FAA's
aeronautical database. Finally, the city name would be removed from the
airspace header under the existing Class E airspace to comply with the
7400.M.
    Class D and Class E airspace designations are published in
Paragraphs 5000, and 6005, respectively, 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 D and E airspace designations
listed in this document will be published subsequently in the Order.
    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 proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
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
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 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 Federal Aviation
Administration Order 7400.11E, Airspace Designations and Reporting
Points, dated July 21, 2020, and effective September 15, 2020, is
amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

ASO AL D Gulf Shores, AL [New]

Jack Edwards National Airport, AL
    (Lat. 30[deg]17'23' W'' N, long. 87[deg]40'18'' W)

    That airspace extending upward from the surface to and including
2,000 feet MSL, within a 4.3-mile radius of Jack Edwards National
Airport, excluding that airspace within Restricted Area R-2908. This
Class D airspace area is effective during the specific dates and
times established in advance by a Notice to Airmen. The effective
date and time will thereafter be continuously published in the Chart
Supplement.

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

* * * * *

ASO AL E5 Gulf Shores, AL [Amended]

Jack Edwards National Airport, AL
    (Lat. 30[deg]17'23' W'' N, long. 87[deg]40'18'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.8-mile radius of Jack Edwards National Airport, excluding
that airspace within Restricted Area R-2908.

    Issued in College Park, Georgia, on July 13, 2021.
Matthew N. Cathcart,
Manager, Airspace & Procedures Team North, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2021-15221 Filed 7-16-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 250 (Wednesday, December 30, 2015)]
[Proposed Rules]
[Pages 81475-81477]
[FR Doc No: 2015-32764]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Parts 1910, 1915, and 1926

[Docket No. OSHA-H005C-2006-0870-0353]
RIN 1218-AB76

Occupational Exposure to Beryllium

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Proposed rule; notice of informal public hearing.

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SUMMARY: OSHA is scheduling an informal public hearing on its proposed
rule ``Occupational Exposure to Beryllium and Beryllium Compounds.''
The proposed rule was published in the Federal Register on August 7,
2015 and the 90-day public comment period ended on November 5, 2015.
This document describes the procedures that will govern this hearing.

DATES: Informal public hearing. The hearing will begin on February 29,
2016 at 2 p.m. If necessary, the hearing will continue from 9:30 a.m.
to 5:00 p.m., local time, on subsequent days, in Washington, DC.

ADDRESSES: Informal public hearing. The Washington, DC hearing will be
held in Room N4437 A, B, C, D at the Frances Perkins Building, U.S.
Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210.
    Notice of Intention to appear at the hearing: Interested persons
who intend to present testimony or question witnesses at the hearing
must submit (transmit, send, postmark, deliver) a notice of intention
to appear, by January 29, 2016.
    Hearing testimony and documentary evidence. Interested persons who
request more than 10 minutes to present testimony or intend to submit
documentary evidence at the hearing must submit (transmit, send,
postmark, deliver) the full text of their testimony and all documentary
evidence by January 29, 2016.
    Methods of submission. All submissions must include the Agency name
and the docket number for this rulemaking (OSHA-H005C-2006-0870-0353).
Notices of intention to appear, hearing testimony, and documentary
evidence may be submitted by any of the following methods:
    Federal eRulemaking Portal: http://www.regulations.gov. Follow the
instructions online for electronically submitting materials, including
attachments;
    Fax: If your written submission does not exceed 10 pages, including
attachments, you may fax it to the OSHA Docket Office at (202) 693-
1648; or
    Regular mail, express delivery, hand delivery, and messenger or
courier service: Submit your materials to the OSHA Docket Office,
Docket No. OSHA-H005C-2006-0870-0353, U.S. Department of Labor, Room N-
2625, 200 Constitution Avenue NW., Washington, DC 20210; telephone
(202) 693-2350 (TTY number:<PHONE_NUMBER>). Deliveries (express mail,
hand delivery, and messenger or courier service) are accepted during
the OSHA Docket Office's normal hours of operation, 8:15 a.m. to 4:45
p.m., E.T.
    Instructions: All submission must include the Agency name and
docket number for this rulemaking (OSHA-H005C-2006-0870-0353). All
submissions, including any personal information, are placed in the
public docket without change and may be available online at http://www.regulations.gov. Therefore, OSHA cautions you about submitting
certain personal information such as social security numbers and birth
dates. Because of security-related procedures, the use of regular mail
may cause a significant delay in the receipt of your submissions. For
information about security-related procedures for submitting materials
by express delivery, hand delivery, messenger, or courier service,
please contact the OSHA Docket Office. For additional information on
submitting notices of intention to appear, hearing testimony, or
documentary evidence, see the SUPPLEMENTARY INFORMATION section of this
notice.
    Docket: To read or download comments, notices of intention to
appear, and other material in the docket, go to Docket No. OSHA-H005C-
2006-

0870-0353 at http://www.regulations.gov. All documents in the docket
are listed in the http://www.regulations.gov index; however, some
copyrighted material is not publicly available to read or download
through the Web site. All submissions and other material in the docket
are available for public inspection and copying in the OSHA Docket
Office. For information on reading or downloading materials in the
docket and obtaining materials not available through the Web site,
please contact the OSHA Docket Office.
    Electronic copies of this Federal Register notice are available at
http://www.regulations.gov. This notice, as well as new releases and
other relevant information, also is available at OSHA's Web site at
http://www.osha.gov.

FOR FURTHER INFORMATION CONTACT: Press inquiries: Kimberly Darby,
Office of Communications, Room N-3647, U.S. Department of Labor, 200
Constitution Avenue NW., Washington, DC 20210; telephone<PHONE_NUMBER>.
    Technical information: Maureen Ruskin, OSHA, Office of Chemical
Hazards-Metals, Room N-3718, U.S. Department of Labor, 200 Constitution
Avenue NW., Washington DC 20210; telephone<PHONE_NUMBER>.
    Hearing inquiries: Gretta Jameson, OSHA, Office of Communications,
Room N-3647; 200 Constitution Avenue NW., Washington, DC 20210;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On August 7, 2015, OSHA published a proposed
rule to amend its existing exposure limits for occupational exposure in
general industry to beryllium and beryllium compounds (80 FR 47565).
The proposed rule would promulgate a substance-specific standard for
general industry, regulating occupational exposure to beryllium and
beryllium compounds. OSHA accepted comments concerning the proposed
rule during the comment period, which ended on November 5, 2015.
Commenters shared information and suggestions on a variety of topics,
and the Non-Ferrous Founders' Society also requested that OSHA schedule
an informal public hearing on the proposed rule.
    Informal public hearing--purpose, rules and procedures. OSHA
invites interested persons to participate in this rulemaking by
providing oral testimony and documentary evidence at the informal
public hearing. OSHA also welcomes presentation of data and documentary
evidence that will provide the Agency with the best available evidence
to use in developing the final rule.
    Pursuant to 29 CFR 1911.15(a) and 5 U.S.C. 553(c), members of the
public have an opportunity at the informal public hearing to provide
oral testimony and evidence on issues raised by the proposal. An
administrative law judge (ALJ) will preside over the hearing and will
resolve any procedural matters relating to the hearing.
    OSHA's regulation governing public hearings (29 CFR 1911.15)
establishes the purpose and procedures of informal public hearings.
Although the presiding officer of the hearing is an ALJ and questioning
of witnesses is allowed on crucial issues, the proceeding is largely
informal and essentially legislative in purpose. Therefore, the hearing
provides interested persons with an opportunity to make oral
presentations in the absence of rigid procedures that could impede or
protract the rulemaking process. The hearing is not an adjudicative
proceeding subject to the Federal rules of evidence. Instead, it is an
informal administrative proceeding convened for the purpose of
gathering and clarifying information. Accordingly, questions of
relevance, procedure, and participation generally will be resolved in
favor of developing a clear, accurate, and complete record.
    Conduct of the hearing will conform to 29 CFR 1911.15. In addition,
pursuant to 29 CFR 1911.4, the Assistant Secretary may, on reasonable
notice, issue additional or alternative procedures to expedite the
proceedings, to provide greater procedural protections to interested
persons, or to further any other good cause consistent with applicable
law. Although the ALJ presiding over the hearing makes no decision or
recommendation on the merits of the proposal, the ALJ has the
responsibility and authority necessary to ensure that the hearing
progresses at a reasonable pace and in an orderly manner. To ensure a
full and fair hearing, the ALJ has the power to regulate the course of
the proceedings; dispose of procedural requests, objections, and
comparable matters; confine presentations to matters pertinent to the
issues the proposed rule raises; use appropriate means to regulate the
conduct of persons present at the hearing; question witnesses and
permit others to do so; limit the time for such questioning; and leave
the record open for a reasonable time after the hearing for the
submission of additional data, evidence, comments, and arguments from
those who participated in the hearing (29 CFR 1911.16).
    If you submit scientific or technical studies or other results of
scientific research, OSHA requests (but is not requiring) that you also
provide the following information where it is available: (1)
Identification of the funding source(s) and sponsoring organization(s)
of the research; (2) the extent to which the research findings were
reviewed by a potentially affected party prior to publication or
submission to the docket, and identification of any such parties; and
(3) the nature of any financial relationships (e.g., consulting
agreements, expert witness support, or research funding) between
investigators who conducted the research and any organization(s) or
entities having an interest in the rulemaking. If you are submitting
comments or testimony on the Agency's scientific or technical analyses,
OSHA requests that you disclose: (1) The nature of any financial
relationships you may have with any organization(s) or entities having
an interest in the rulemaking; and (2) the extent to which your
comments or testimony were reviewed by an interested party before you
submitted them. Disclosure of such information is intended to promote
transparency and scientific integrity of data and technical information
submitted to the record. This request is consistent with Executive
Order 13563, issued on January 18, 2011, which instructs agencies to
ensure the objectivity of any scientific and technological information
used to support their regulatory actions. OSHA emphasizes that all
material submitted to the rulemaking record will be considered by the
Agency to develop the final rule and supporting analyses. At the close
of the hearing, the ALJ will establish a 45-day post-hearing comment
period for interested persons who filed a timely notice of intention to
appear at the hearing. During the first 30 days of the post-hearing
period, those persons may submit final briefs, arguments, summations,
and additional data and information to OSHA. During the remaining 15
days, they may only submit final briefs, arguments, and summations.
    Notice of intention to appear at the hearing. Interested persons
who intend to participate in and provide oral testimony or documentary
evidence at the hearing must file a written notice of intention to
appear prior to the hearing. To testify or question witnesses at the
hearing, interested persons must submit (transmit, send, postmark,
deliver) their notice by January 29, 2016. The notice must provide the
following information:
     Name, address, email address, and telephone number of each
individual who will give oral testimony;

     Name of the establishment or organization each individual
represents, if any;
     Occupational title and position of each individual
testifying;
     Approximate amount of time required for each individual's
testimony;
     A brief statement of the position each individual will
take with respect to the issues raised by the proposed rule; and
     A brief summary of documentary evidence each individual
intends to present.
    Participants who need projectors and other special equipment for
their testimony must contact Gretta Jameson at OSHA's Office of
Communications, telephone<PHONE_NUMBER>, no later than one week before
the hearing begins.
    OSHA emphasizes that the hearing is open to the public; however,
only individuals who file a notice of intention to appear may question
witnesses and participate fully at the hearing. If time permits, and at
the discretion of the ALJ, an individual who did not file a notice of
intention to appear may be allowed to testify at the hearing, but for
no more than 10 minutes.
    Hearing testimony and documentary evidence. Individuals who request
more than 10 minutes to present their oral testimony at the hearing or
who will submit documentary evidence at the hearing must submit
(transmit, send, postmark, deliver) the full text of their testimony
and all documentary evidence no later than January 29, 2016.
    The Agency will review each submission and determine if the
information it contains warrants the amount of time the individual
requested for the presentation. If OSHA believes the requested time is
excessive, the Agency will allocate an appropriate amount of time for
the presentation. The Agency also may limit to 10 minutes the
presentation of any participant who fails to comply substantially with
these procedural requirements, and may request that the participant
return for questioning at a later time. Before the hearing, OSHA will
notify participants of the time the Agency will allow for their
presentation and, if less than requested, the reasons for its decision.
In addition, before the hearing, OSHA will provide the hearing
procedures and hearing schedule to each participant who filed a notice
of intention to appear.
    Certification of the hearing record and Agency final determination.
Following the close of the hearing and the post-hearing comment
periods, the ALJ will certify the record to the Assistant Secretary of
Labor for Occupational Safety and Health. The record will consist of
all of the written comments, oral testimony, and documentary evidence
received during the proceeding. The ALJ, however, will not make or
recommend any decisions as to the content of the final standard.
Following certification of the record, OSHA will review all the
evidence received into the record and will issue the final rule based
on the record as a whole.

Authority and Signature

    This document was prepared under the direction of David Michaels,
Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and
Health, U.S. Department of Labor, 200 Constitution Avenue NW.,
Washington, DC 20210, pursuant to section 6(b) of the Occupational
Safety and Health Act of 1970 (29 U.S.C. 655(b)), Secretary of Labor's
Order 1-2012 (77 FR 3912), and 29 CFR part 1911.

    Signed at Washington, DC, on December 23, 2015.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2015-32764 Filed 12-29-15; 8:45 am]
 BILLING CODE 4510-26-P


[Federal Register Volume 78, Number 185 (Tuesday, September 24, 2013)]
[Notices]
[Page 58599]
[FR Doc No: 2013-22999]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2013-42]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number involved and must be received on or before October 15, 2013.

ADDRESSES: You may send comments identified by Docket Number FAA-2013-
0680 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue, SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Theresa White, ANM-113,
Standardization Branch, Transport Airplane Directorate, Federal
Aviation Administration, 1601 Lind Avenue SW., Renton, WA 98057; email:
<EMAIL_ADDRESS>(425) 227-2956; Andrea Copeland, ARM-208,
Office of Rulemaking, Federal Aviation Administration, 800 Independence
Avenue SW., Washington, DC 20591; email<EMAIL_ADDRESS>(202)
267-3664.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on August 23, 2013.
Brenda D. Courtney,
Acting Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2013-0680.
    Petitioner: Jamco America Inc.
    Section of 14 CFR Affected:
    25.785(d), 25.807(c)(1), 25.807(c)(5), 25.809(f)(1), 25.813(b),
25.857(e), and 25.1447(c)(1).
    Description of Relief Sought:
    The petitioner requests relief to allow interior modifications to a
Dubai Air Wing Boeing Model 747-412F (Freighter), serial number 28032,
to increase the number of persons carried on the upper deck from 8 to a
maximum of 19. Fifteen will be qualified as supernumeraries occupying
the main deck with access to the main deck cargo compartment in flight
and during taxi, takeoff, and landing. The petitioner proposes to use
the exit on the main deck of the airplane for emergency evacuation.

[FR Doc. 2013-22999 Filed 9-23-13; 8:45 am]
BILLING CODE 4910-13-P