[Federal Register Volume 78, Number 219 (Wednesday, November 13, 2013)]
[Proposed Rules]
[Pages 67983-67984]
[FR Doc No: 2013-26919]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 121

[Docket No. FAA-2013-0944]

Proposed Legal Interpretation

AGENCY: Federal Aviation Administration (FAA)

ACTION: Proposed legal interpretation.

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SUMMARY: The FAA is proposing to clarify the qualification requirements
for the pilot assigned as second in command on a flight in part 121
operations that requires three or more pilots and the pilot who
provides relief to the assigned second in command during the en route
cruise portion of the flight.

DATES: Comments must be received on or before January 13, 2014.

ADDRESSES: You may send comments identified by Docket Number FAA-2013-
0944 using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue SE., Room W12-140,
West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Bring comments to Docket
Operations 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.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Sara Mikolop, Attorney, Regulations
Division, Office of the Chief Counsel, Federal Aviation Administration,
800 Independence Avenue SW., Washington, DC 20591; telephone: 202-267-
3073.

SUPPLEMENTARY INFORMATION: The Federal Aviation Administration's Office
of the Chief Counsel has received multiple requests for a legal
interpretation regarding (1) the qualification requirements for both an
assigned SIC on a part 121 flight requiring three or more pilots and
(2) the qualification requirements for the pilot who relieves the
assigned second in command (SIC) during the en route cruise portion of
a flight. This proposed legal interpretation addresses the
qualification requirements for the assigned SIC and the pilot relieving
the assigned SIC. The agency is seeking comments on this proposed legal
interpretation because, while the existing interpretations with respect
to the requirements of Sec.  121.432(a) are clear, these
interpretations may not be consistently applied and the agency is
considering whether they are still appropriate.
    Part 121 requires a minimum of two pilots for every operation and
states that ``the certificate holder shall designate one pilot as pilot
in command and the other second in command.'' See 14 CFR 121.385(c).
However, certain part 121 operations require more than two pilots due
to the operating rules that address pilot flight duty and rest,
limiting the amount of time a pilot may be aloft or at the controls.
See 14 CFR part 121, subparts R and S. By assigning one or more
additional pilots to a long range flight, a certificate holder can
ensure that the assigned pilot in command (PIC) and assigned SIC may
each have an opportunity to rest during the flight if needed or if
required to comply with the flight duty and rest requirements of part
121.
    In those instances in which a part 121 operation requires three or
more pilots, Sec.  121.432(a) \1\ establishes additional qualification
standards for the assigned SIC. Section 121.432(a) requires a pilot who
serves as SIC of an operation that requires three or more pilots to
meet all PIC qualification requirements except for PIC operating
experience. See Legal Interpretation 1978-27. The agency explained in
the preamble to the provision now codified at Sec.  121.432(a) that
this provision is not limited to one particular aspect of PIC
qualification. See 35 FR 84, 87 (Jan. 3, 1970); Legal Interpretation
1978-27. Rather, it covers broad PIC qualification requirements,
inclusive of PIC proficiency checks. See 30 FR 6725, 6725 (May 18,
1965) (requiring the second in command in a crew requiring three or
more pilots to complete the same semi-annual proficiency checks as the
pilot in command); 34 FR 6112, 6113 (April 4, 1969) (proposing
121.432(c), the predecessor to 121.432(a), to remove the repetitious
stating of requirements for the second in command of a crew of three or
more pilots); 35 FR 84, 87 (Jan. 3, 1970); Legal Interpretation 1978-27
(discussing regulatory history of Sec.  121.432(a) including
requirements for PIC proficiency checks in Sec.  121.441).
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    \1\ Section 121.432(a) states, ``Except in the case of operating
experience under Sec.  121.434, a pilot who serves as second in
command of an operation that requires three or more pilots must be
fully qualified to act as pilot in command of that operation.''
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    The assigned SIC is a required flightcrew member and as such may
only leave his or her duty station for purposes of rest during the en
route cruise portion of the flight, if relief is provided by a pilot
who meets the requirements identified in Sec.  121.543(b)(3)(ii) to act
as SIC of the aircraft during the en route cruise portion of the
flight.\2\ See 42 FR 37417, 37420 (July 21, 1977). Once a relief pilot
assumes the responsibilities of the assigned SIC, the relief pilot
becomes a ``required'' flightcrew member within the meaning of Sec.
121.543 and must remain at that duty station until relief is provided
in accordance with Sec.  121.543(b)(3)(ii).
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    \2\ Section 121.543(b)(3)(ii) allows a required flightcrew
member to leave the assigned duty station if the crewmember is
taking a rest and relief is provided, ``In the case of the assigned
second in command, by a pilot qualified to act as second in command
of that aircraft during en route operations. However, the relief
pilot need not meet the recent experience requirements of Sec.
121.439(b).'' The agency notes that the requirements for PIC relief
are independent from the requirements for SIC relief. Requirements
for PIC relief for purposes of rest during the en route cruise
portion of the flight can be found in a separate paragraph, Sec.
121.543(b)(3)(i). An assigned PIC may only be relieved by a pilot
who holds an ATP and appropriate type rating. See 14 CFR
121.543(b)(3)(i). Further, the PIC relief pilot may be either a
fully qualified PIC or an SIC qualified to act as PIC en route. See
id. An SIC qualified to act as PIC en route means an SIC who has
completed all PIC qualification requirements except for the
following: 6-month recurrent training required by Sec.
121.433(c)(1)(iii); the operating experience required by Sec.
121.434; the takeoffs and landings required by Sec.  121.439; the
line check required by Sec.  121.440; and the 6-month proficiency
check or simulator training required by Sec.  121.441(a)(1). See id.
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    To relieve the assigned SIC during the en route portion of a flight
(the only time the assigned SIC may leave their duty station), a pilot
must meet the part 121 SIC qualification requirements, except for the
recency of experience requirement in Sec.  121.439 (three takeoffs and
landings within 90 days). See Sec.  121.543(b)(3)(ii). In contrast with
Sec.  121.432(a), which adds PIC qualification requirements to serve as
the assigned SIC in a crew of three or more pilots, the relief pilot
requirements in Sec.  121.543(b)(3)(ii) do not identify any additional
qualification requirements for service as SIC en route. Accordingly,
the pilot relieving the assigned SIC during the en route portion of the
flight need not meet the additional SIC qualification requirements
identified Sec.  121.432(a).
    Finally, the agency notes that Sec.  121.543(b)(3)(ii) does not
serve as a substitute for the qualification requirements in Sec.
121.432(a), applicable to the assigned SIC of a part 121 operation that
requires three or more pilots. Thus, the exception to the recency
requirement in Sec.  121.543(b)(3)(ii) applies only to a pilot who
relieves the SIC during the en route cruise portion of the flight.

    Issued in Washington, DC, on November 4, 2013.
Mark W. Bury,
Assistant Chief Counsel for International Law, Legislation and
Regulations.
[FR Doc. 2013-26919 Filed 11-12-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: August 4, 2009 (Volume 74, Number 148)]
[Notices]
[Page 38659-38660]
[DOCID:fr04au09-63]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-E-0551]

Determination of Regulatory Review Period for Purposes of Patent
Extension; XIENCE V EECSS

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for XIENCE V EECSS and is publishing this
notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of Patents and Trademarks, Department of Commerce, for the
extension of a patent which claims that medical device.

ADDRESSES:  Submit written comments and petitions to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of Patents and Trademarks may award (half
the testing phase must be subtracted as well as any time that may have
occurred before the patent was issued), FDA's determination of the
length of a regulatory review period for a medical device will include
all of the testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA recently approved for marketing the medical device, XIENCE V
EECSS. XIENCE V EECSS is indicated for improving coronary luminal
diameter in patients with symptomatic heart disease due to de novo
native coronary artery lesions (length = 28 millimeters (mm)) with
reference vessel diameters of 2.5 mm to 4.25 mm. Subsequent to this
approval, the Patent and Trademark Office received a patent term
restoration application for XIENCE V EECSS (U.S. Patent No. 5,451,233)
from Abbott Cardiovascular Systems, Inc., and the Patent and Trademark
Office requested

FDA's assistance in determining this patent's eligibility for patent
term restoration. In a letter dated February 18, 2009, FDA advised the
Patent and Trademark Office that this medical device had undergone a
regulatory review period and that the approval of XIENCE V EECSS
represented the first permitted commercial marketing or use of the
product. Thereafter, the Patent and Trademark Office requested that FDA
determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
XIENCE V EECSS is 1,157 days. Of this time, 759 days occurred during
the testing phase of the regulatory review period, while 398 days
occurred during the approval phase. These periods of time were derived
from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)) involving this
device became effective: May 4, 2005. FDA has verified the applicant's
claim that the date the investigational device exemption (IDE) required
under section 520(g) of the act for human tests to begin became
effective on May 4, 2005.
    2. The date an application was initially submitted with respect to
the device under section 515 of the act (21 U.S.C. 360e): June 1, 2007.
The applicant claims the premarket approval application (PMA) XIENCE V
EECSS (PMA 70015) was submitted in three modules and that Module 1 was
initially submitted on July 14, 2006. The applicant claims July 14,
2006, as the date PMA 70015 was initially submitted. It is FDA's
position that the approval phase begins when the marketing application
is complete. A review of FDA records indicates that PMA 70015 was
submitted as a complete application on June 1, 2007, which is
considered to be the initially submitted date for PMA 70015.
    3. The date the application was approved: July 2, 2008. FDA has
verified the applicant's claim that PMA 70015 was approved on July 2,
2008.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 937 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments and ask for a redetermination
by October 5, 2009. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by February 1,
2010. To meet its burden, the petition must contain sufficient facts to
merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d
sess., pp. 41-42, 1984.) Petitions should be in the format specified in
21 CFR 10.30.
    Comments and petitions should be submitted to the Division of
Dockets Management. Three copies of any mailed information are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Comments and petitions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 8, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-18530 Filed 8-3-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 82, Number 206 (Thursday, October 26, 2017)]
[Notices]
[Pages 49632-49634]
[FR Doc No: 2017-23223]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5818]

Pharmacy Compounding Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Pharmacy Compounding Advisory
Committee (PCAC). The general function of the committee is to provide
advice on scientific, technical, and medical issues concerning drug
compounding under the Federal Food, Drug, and Cosmetic Act (the FD&C
Act), and, as required, any other product for which FDA has regulatory
responsibility, and to make appropriate recommendations to the Agency.
The meeting will be open to the public.

DATES: The meeting will be held on November 20, 2017, from 8:30 a.m. to
5 p.m. and November 21, 2017, from 8:30 a.m. to 11:30 a.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions, including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2017-N-5818. The docket will close on November
17, 2017. Submit either electronic or written comments on this public
meeting by November 17, 2017. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before November 17, 2017. The https://www.regulations.gov
electronic filing system will accept comments until midnight Eastern
Time at the end of November 17, 2017. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.
    Comments received on or before November 3, 2017, will be provided
to the committee. Comments received after that date will be taken into
consideration by the Agency.
    You may submit comments 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-N-5818 for ``Pharmacy Compounding Advisory Committee; Notice
of Meeting; Establishment of a Public Docket; Request for Comments.''
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.

FOR FURTHER INFORMATION CONTACT: Cindy Chee, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, Fax:
301-847-8533, email: [email protected], or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting

cannot always be published quickly enough to provide timely notice.
Therefore, you should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the
appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Background: Section 503A of the FD&C Act (21 U.S.C. 353a) describes
the conditions that must be satisfied for human drug products
compounded by a licensed pharmacist in a State licensed pharmacy or a
Federal facility, or a licensed physician, to be exempt from the
following three sections of the FD&C Act: (1) Section 501(a)(2)(B) (21
U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice
(CGMP)); (2) section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the
labeling of drugs with adequate directions for use); and (3) section
505 (21 U.S.C. 355) (concerning the approval of human drug products
under new drug applications (NDAs) or abbreviated new drug applications
(ANDAs)).
    The Drug Quality and Security Act added a new section 503B to the
FD&C Act (21 U.S.C. 353b), which created a new category of compounders
termed ``outsourcing facilities.'' Under section 503B of the FD&C Act,
outsourcing facilities are defined, in part, as facilities that meet
certain conditions described in section 503B, including registration
with FDA as an outsourcing facility. If these conditions are satisfied,
a drug product compounded for human use by or under the direct
supervision of a licensed pharmacist in an outsourcing facility is
exempt from three sections of the FD&C Act: (1) Section 502(f)(1)
(concerning the labeling of drugs with adequate directions for use);
(2) section 505 (concerning the approval of human drug products under
NDAs or ANDAs); and (3) section 582 (21 U.S.C. 360eee-1) (concerning
the drug supply chain security requirements). Outsourcing facilities
are not exempt from CGMP requirements in section 501(a)(2)(B) of the
FD&C Act.
    One of the conditions that must be satisfied to qualify for the
exemptions under section 503A of the FD&C Act is that a bulk drug
substance (active pharmaceutical ingredient) used in a compounded drug
product must meet one of the following criteria: (1) Complies with the
standards of an applicable United States Pharmacopoeia (USP) or
National Formulary (NF) monograph, if a monograph exists, and the USP
chapter on pharmacy compounding; (2) if an applicable monograph does
not exist, is a component of a drug approved by the Secretary of Health
and Human Services (the Secretary); or (3) if such a monograph does not
exist and the drug substance is not a component of a drug approved by
the Secretary, appears on a list developed by the Secretary through
regulations issued by the Secretary (the ``503A Bulks List'') (see
section 503A(b)(1)(A)(i) of the FD&C Act).
    Another condition that must be satisfied to qualify for the
exemptions under section 503A of the FD&C Act is that the compounded
drug product is not a drug product identified by the Secretary by
regulation as a drug product that presents demonstrable difficulties
for compounding that reasonably demonstrate an adverse effect on the
safety or effectiveness of that drug product (see section 503A(b)(3)(A)
of the FD&C Act).
    A condition that must be satisfied to qualify for the exemptions in
section 503B of the FD&C Act is that the compounded drug is not
identified (directly or as part of a category of drugs) on a list,
published by the Secretary by regulation, of drugs or categories of
drugs that present demonstrable difficulties for compounding that are
reasonably likely to lead to an adverse effect on the safety or
effectiveness of the drug or category of drugs, taking into account the
risks and benefits to patients, or the drug is compounded in accordance
with all applicable conditions identified on the list as conditions
that are necessary to prevent the drug or category of drugs from
presenting such demonstrable difficulties (see section 503B(a)(6)(A)
and (B) of the FD&C Act).
    FDA intends to discuss with the committee bulk drug substances
nominated for inclusion on the 503A Bulks List and drug products
nominated for inclusion on the list of drug products that present
demonstrable difficulties for compounding under sections 503A and 503B
(``Difficult to Compound List'').
    Agenda: The committee intends to discuss six bulk drug substances
nominated for inclusion on the section 503A Bulks List. FDA will
discuss the following nominated bulk drug substances: astragalus, L-
citrulline, pregnenolone, 7-keto dehydroepiandrosterone (DHEA),
epigallocatechin gallate (EGCg), and resveratrol. The chart below
identifies the use(s) FDA reviewed for each of the six bulk drug
substances being discussed at this advisory committee meeting. The
nominators of these substances will be invited to make a short
presentation supporting the nomination.

------------------------------------------------------------------------
               Drug                             Uses reviewed
------------------------------------------------------------------------
Astragalus........................  Allergic rhinitis, asthma, diabetes,
                                     herpes simplex keratitis, wound
                                     healing.
L-citrulline......................  Hyperammonaemia due to cycle
                                     disorders.
Pregnenolone......................  Rheumatoid arthritis,
                                     hypercholesterolemia, manic and
                                     depressive symptoms of bipolar
                                     disorder and bipolar disorder with
                                     substance abuse (dual diagnosis),
                                     positive and negative symptoms of
                                     schizophrenia.
7-keto dehydroepiandrosterone.....  Weight loss, Raynaud's phenomena.
Epigallocatechin gallate..........  Treatment of obesity, wound healing,
                                     corneal neovascularization, non-
                                     alcoholic fatty liver disease,
                                     cardiac hypertrophy, diabetes (type
                                     1 & 2), Parkinson's disease.
Resveratrol.......................  Treatment of older adults with
                                     impaired glucose tolerance, pain.
------------------------------------------------------------------------

    The committee also intends to discuss liposome drug products and
drug products produced using hot melt extrusion technology for
inclusion on the Difficult to Compound List. Drug products produced
``by extrusion or nanotechnology'' were nominated for inclusion on the
Difficult to Compound List. The nominators will be invited to make a
short presentation supporting the nomination.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the

appropriate advisory committee meeting link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see the
ADDRESSES section) on or before November 3, 2017, will be provided to
the committee. Oral presentations from the public will be scheduled
between approximately 9:35 a.m. and 9:45 a.m., 10:55 a.m. and 11:05
a.m., 12 noon and 12:10 p.m., 2:05 p.m. and 2:15 p.m., 3:25 p.m. and
3:35 p.m., and 4:30 p.m. and 4:40 p.m. on November 20, 2017, and
between approximately 9:40 a.m. and 9:50 a.m. and 11:10 a.m. and 11:20
a.m. on November 21, 2017. Those individuals interested in making
formal oral presentations should notify the contact person and submit a
brief statement of the general nature of the evidence or arguments they
wish to present, the names and addresses of proposed participants, and
an indication of the approximate time requested to make their
presentation on or before October 26, 2017. Time allotted for each
presentation may be limited. If the number of registrants requesting to
speak is greater than can be reasonably accommodated during the
scheduled open public hearing session, FDA may conduct a lottery to
determine the speakers for the scheduled open public hearing session.
The contact person will notify interested persons regarding their
request to speak by October 27, 2017.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Cindy Chee at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: October 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-23223 Filed 10-25-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: March 17, 2006 (Volume 71, Number 52)]
[Notices]
[Page 13825]
[DOCID:fr17mr06-54]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP05-286-003]

Northwest Pipeline Corporation; Notice of Compliance Filing

March 10, 2006.
    Take notice that on February 28, 2006, Northwest Pipeline
Corporation (Northwest) tendered for filing as part of its FERC Gas
Tariff, Third Revised Volume No. 1, Second Substitute Original Sheet
No. 271-B, to be effective May 23, 2005.
    Northwest states that a copy of this filing has been served upon
each person designated on the official service list.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed in accordance with the provisions of section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-3885 Filed 3-16-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 82 (Monday, April 29, 2019)]
[Notices]
[Pages 18069-18070]
[FR Doc No: 2019-08604]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2019-0006; OMB No. 1660-0040]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Standard Flood Hazard Determination Form

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice and request for comments.

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SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public to take this opportunity to comment on a
reinstatement, without change, of a previously approved information
collection for which approval has expired. In accordance with the
Paperwork Reduction Act of 1995, this notice seeks comments concerning
this form which is used by regulated lending institutions, federal
agency lenders, the Federal National Mortgage Association, the Federal
Home Loan Mortgage Corporation, and the Government National Mortgage
Association. Federally regulated lending institutions complete this
form when making, increasing, extending, renewing or purchasing each
loan for the purpose of determining whether flood insurance is required
and available. FEMA is responsible for maintaining the form and making
it available.

DATES: Comments must be submitted on or before June 28, 2019.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at www.regulations.gov under Docket ID
FEMA-2019-0006. Follow the instructions for submitting comments.
    (2) Mail. Submit written comments to Docket Manager, Office of
Chief Counsel, DHS/FEMA, 500 C Street SW, 8NE, Washington, DC 20472-
3100.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available via the link in the footer of
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Susan Bernstein, Insurance Specialist,
FIMA, Marketing and Outreach Branch,<PHONE_NUMBER>. You may contact the
Information Management Division for copies of the proposed collection
of information at email address: [email protected].

SUPPLEMENTARY INFORMATION: Section 1365 of the National Flood Insurance
Act of 1968 (NFIA) (42 U.S.C. 4104b), as added by Section 528 of the
National Flood Insurance Reform Act of 1994 (Pub. L. 103-325, title V),
requires that FEMA develop a standard hazard determination form for
recording the determination of whether a structure is located within an
identified Special Flood Hazard Area and whether flood insurance is
available. Regulated lending institutions, federal agency lenders, the
Federal National Mortgage Association, the Federal Home Loan Mortgage
Corporation, and the Government National Mortgage Association must
complete this form for any loan made, increased, extended, renewed or
purchased by these entities. The requirement for federally regulated
lending institutions to determine whether a building or mobile home
securing a loan is located in an area having special flood hazards and
whether flood insurance is available has been in effect since the
enactment of the Flood Disaster Protection Act of 1973, although the
use of a standard form was not required until the enactment of the
Section 1365 of the NFIA. The establishment of the Standard Flood
Hazard Determination form has enabled lenders to provide consistent
information.
    This information collection expired on 30 November 2018. FEMA is
requesting a reinstatement, without change, of a previously approved
information collection for which approval has expired.

Collection of Information

    Title: Standard Flood Hazard Determination Form.
    Type of Information Collection: Reinstatement, without change, of a
previously approved information collection for which approval has
expired.
    OMB Number: 1660-0040.
    Form Titles and Numbers: FEMA Form 086-0-32, Standard Flood Hazard
Determination Form.
    Abstract: This form is used by regulated lending institutions,
federal agency lenders, the Federal National

Mortgage Association, the Federal Home Loan Mortgage Corporation, and
the Government National Mortgage Association. Federally regulated
lending institutions complete this form when making, increasing,
extending, renewing or purchasing each loan for the purpose is of
determining whether flood insurance is required and available. FEMA is
responsible for maintaining the form and making it available.
    Affected Public: Business and other for-profit; and Individuals or
Households.
    Estimated Number of Respondents: 26,616,265.
    Estimated Number of Responses: 26,616,265.
    Estimated Total Annual Burden Hours: 8,783,367.
    Estimated Total Annual Respondent Cost: $209,044,145.
    Estimated Respondents' Operation and Maintenance Costs: 0.
    Estimated Respondents' Capital and Start-Up Costs: 0.
    Estimated Total Annual Cost to the Federal Government: 0.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

Tammi Hines,
Acting Records Management Branch Chief, Office of the Chief
Administrative Officer, Mission Support, Federal Emergency Management
Agency, Department of Homeland Security.
[FR Doc. 2019-08604 Filed 4-26-19; 8:45 am]
 BILLING CODE 9111-52-P


[Federal Register Volume 80, Number 240 (Tuesday, December 15, 2015)]
[Notices]
[Pages 77621-77623]
[FR Doc No: 2015-31473]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP16-12-000]

Tennessee Gas Pipeline Company, L.L.C.; Notice of Intent To
Prepare an Environmental Assessment for the Proposed Southwest
Louisiana Supply Project and Request for Comments on Environmental
Issues

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental assessment (EA) that will
discuss the environmental impacts of the Southwest Louisiana Supply
Project (Project) involving construction and operation of facilities by
Tennessee Gas Pipeline Company, L.L.C. (Tennessee) in Madison,
Franklin, Richland, and Rapides Parishes, Louisiana. The Commission
will use this EA in its decision-making process to determine whether
the project is in the public convenience and necessity.
    This notice announces the opening of the scoping process the
Commission will use to gather input from the public and interested
agencies on the project. You can make a difference by providing us with
your specific comments or concerns about the project. Your comments
should focus on the potential environmental effects, reasonable
alternatives, and measures to avoid or lessen environmental impacts.
Your input will help the Commission staff determine what issues they
need to evaluate in the EA. To ensure that your comments are timely and
properly recorded, please send your comments so that the Commission
receives them in Washington, DC on or before January 11, 2016.
    If you sent comments on this project to the Commission before the
opening of this docket on October 26, 2015, you will need to file those
comments in Docket No. CP16-12-000 to ensure they are considered as
part of this proceeding.
    This notice is being sent to the Commission's current environmental
mailing list for this project. State and local government
representatives should notify their constituents of this proposed
project and encourage them to comment on their areas of concern.
    If you are a landowner receiving this notice, a pipeline company
representative may contact you about the acquisition of an easement to
construct, operate, and maintain the proposed facilities. The company
would seek to negotiate a mutually acceptable agreement. However, if
the Commission approves the project, that approval conveys with it the
right of eminent domain. Therefore, if easement negotiations fail to
produce an agreement, the pipeline company could initiate condemnation
proceedings where compensation would be determined in accordance with
state law.
    Tennessee provided landowners with a fact sheet prepared by the
FERC entitled ``An Interstate Natural Gas Facility On My Land? What Do
I Need To Know?'' This fact sheet addresses a number of typically asked
questions, including the use of eminent domain and how to participate
in the Commission's proceedings. It is also available for viewing on
the FERC Web site (www.ferc.gov).

Public Participation

    For your convenience, there are three methods you can use to submit
your comments to the Commission. The Commission encourages electronic
filing of comments and has expert staff available to assist you at
(202) 502-8258 or<EMAIL_ADDRESS>Please carefully

follow these instructions so that your comments are properly recorded.
    (1) You can file your comments electronically using the eComment
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. This is an easy method for submitting brief,
text-only comments on a project;
    (2) You can file your comments electronically by using the eFiling
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. With eFiling, you can provide comments in a
variety of formats by attaching them as a file with your submission.
New eFiling users must first create an account by clicking on
``eRegister.'' If you are filing a comment on a particular project,
please select ``Comment on a Filing'' as the filing type; or
    (3) You can file a paper copy of your comments by mailing them to
the following address. Be sure to reference the project docket number
(CP16-12-000) with your submission: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE., Room 1A,
Washington, DC 20426.

Summary of the Proposed Project

    The purpose of the Southwest Louisiana Supply Project is to provide
295,000 dekatherms per day of firm natural gas capacity to Tennessee's
800 Line. The Southwest Louisiana Supply Project would consist of
construction and modification of the following facilities:
     Construction of a new 2.4-mile-long, 30-inch-diameter
lateral pipeline to be known as the Delhi North Lateral and two new
meter station interconnects to be known as the Midcontinent Express
Pipeline Meter Station (MEP Meter Station) and the Gulf Crossing
Pipeline Meter Station (Gulf Crossing Meter Station) in Madison Parish,
Louisiana;
     construction of a new 1.4-mile-long-30-inch-diameter
lateral pipeline to be known as the Delhi South Latera, three new meter
station interconnects to be known as the Enable Midstream Partners
Meter Station (Enable Meter Station), the Gulf South Pipeline Meter
Station (Gulf South Meter Station), and the Tiger Pipeline Meter
Station (Tiger Meter Station) in Franklin and Richland Parishes,
Louisiana;
     construction of a new compressor station to be known as
the Delhi Compressor Station 836A in Franklin, Parish, Louisiana; and
     modifications at the Alexandria Compressor Station,
including turbine replacement in Rapides Parish, Louisiana.
    The general location of the project facilities is shown in appendix
1.\1\
---------------------------------------------------------------------------

    \1\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of appendices were sent to all those
receiving this notice in the mail and are available at www.ferc.gov
using the link called ``eLibrary'' or from the Commission's Public
Reference Room, 888 First Street NE., Washington, DC 20426, or call
(202) 502-8371. For instructions on connecting to eLibrary, refer to
the last page of this notice.
---------------------------------------------------------------------------

Land Requirements for Construction

    Construction of the proposed facilities would disturb approximately
108.4 acres of land for the aboveground facilities and the pipeline.
Following construction, Tennessee would maintain about 76.5 acres for
permanent operation of the project's facilities; the remaining acreage
would be restored and revert to former uses.

The EA Process

    The National Environmental Policy Act (NEPA) requires the
Commission to take into account the environmental impacts that could
result from an action whenever it considers the issuance of a
Certificate of Public Convenience and Necessity. NEPA also requires us
\2\ to discover and address concerns the public may have about
proposals. This process is referred to as ``scoping.'' The main goal of
the scoping process is to focus the analysis in the EA on the important
environmental issues. By this notice, the Commission requests public
comments on the scope of the issues to address in the EA. We will
consider all filed comments during the preparation of the EA.
---------------------------------------------------------------------------

    \2\ ``We,'' ``us,'' and ``our'' refer to the environmental staff
of the Commission's Office of Energy Projects.
---------------------------------------------------------------------------

    In the EA we will discuss impacts that could occur as a result of
the construction and operation of the proposed project under these
general headings:
     Geology and soils;
     land use;
     water resources, fisheries, and wetlands;
     cultural resources;
     vegetation and wildlife;
     air quality and noise;
     endangered and threatened species;
     public safety; and
     cumulative impacts
    We will also evaluate reasonable alternatives to the proposed
project or portions of the project, and make recommendations on how to
lessen or avoid impacts on the various resource areas.
    The EA will present our independent analysis of the issues. The EA
will be available in the public record through eLibrary. Depending on
the comments received during the scoping process, we may also publish
and distribute the EA to the public for an allotted comment period. We
will consider all comments on the EA before making our recommendations
to the Commission. To ensure we have the opportunity to consider and
address your comments, please carefully follow the instructions in the
Public Participation section, beginning on page 2.
    With this notice, we are asking agencies with jurisdiction by law
and/or special expertise with respect to the environmental issues of
this project to formally cooperate with us in the preparation of the
EA.\3\ Agencies that would like to request cooperating agency status
should follow the instructions for filing comments provided under the
Public Participation section of this notice.
---------------------------------------------------------------------------

    \3\ The Council on Environmental Quality regulations addressing
cooperating agency responsibilities are at Title 40, Code of Federal
Regulations, Part 1501.6.
---------------------------------------------------------------------------

Consultations Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, we are using this notice to initiate consultation
with the applicable State Historic Preservation Office (SHPO), and to
solicit their views and those of other government agencies, interested
Indian tribes, and the public on the project's potential effects on
historic properties.\4\ We will define the project-specific Area of
Potential Effects (APE) in consultation with the SHPO as the project
develops. On natural gas facility projects, the APE at a minimum
encompasses all areas subject to ground disturbance (examples include
construction right-of-way, contractor/pipe storage yards, compressor
stations, and access roads). Our EA for this project will document our
findings on the impacts on historic properties and summarize the status
of consultations under section 106.
---------------------------------------------------------------------------

    \4\ The Advisory Council on Historic Preservation's regulations
are at Title 36, Code of Federal Regulations, Part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.
---------------------------------------------------------------------------

Environmental Mailing List

    The environmental mailing list includes federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American Tribes; other
interested parties; and local libraries

and newspapers. This list also includes all affected landowners (as
defined in the Commission's regulations) who are potential right-of-way
grantors, whose property may be used temporarily for project purposes,
or who own homes within certain distances of aboveground facilities,
and anyone who submits comments on the project. We will update the
environmental mailing list as the analysis proceeds to ensure that we
send the information related to this environmental review to all
individuals, organizations, and government entities interested in and/
or potentially affected by the proposed project.
    If we publish and distribute the EA, copies of the EA will be sent
to the environmental mailing list for public review and comment. If you
would prefer to receive a paper copy of the document instead of the CD
version or would like to remove your name from the mailing list, please
return the attached Information Request (appendix 2).

Becoming an Intervenor

    In addition to involvement in the EA scoping process, you may want
to become an ``intervenor'' which is an official party to the
Commission's proceeding. Intervenors play a more formal role in the
process and are able to file briefs, appear at hearings, and be heard
by the courts if they choose to appeal the Commission's final ruling.
An intervenor formally participates in the proceeding by filing a
request to intervene. Instructions for becoming an intervenor are in
the ``Document-less Intervention Guide'' under the ``e-filing'' link on
the Commission's Web site. Motions to intervene are more fully
described at http://www.ferc.gov/resources/guides/how-to/intervene.asp.

Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site at www.ferc.gov using the ``eLibrary'' link. Click on the
eLibrary link, click on ``General Search'' and enter the docket number,
excluding the last three digits in the Docket Number field (i.e., CP16-
12-000). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.
    Finally, public meetings or site visits will be posted on the
Commission's calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along with other related information.

    Dated: December 9, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-31473 Filed 12-14-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: August 11, 2009 (Volume 74, Number 153)]
[Notices]
[Page 40180]
[DOCID:fr11au09-69]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project Nos. 2403-056; 2312-019; 2721-020]

Penobscot River Restoration Trust; Notice of Availability of
Draft Environmental Assessment

August 4, 2009.
    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's regulations, 18 CFR Part
380 (Order No. 486, 52 FR 47879) the Office of Energy Projects has
reviewed an application filed on November 7, 2008, to surrender the
project licenses for the Veazie, Great Works, and Howland Hydroelectric
Projects, located on the Penobscot and Piscataquis Rivers in Penobscot
County, Maine. A draft environmental assessment (DEA) has been prepared
as part of staff's review. The DEA finds that approval of the
application would not constitute a major federal action significantly
affecting the quality of the human environment.
    A copy of the DEA is on file with the Commission and is available
for public inspection. The DEA may also be viewed on the Commission's
Web site at http://www.ferc.gov using the ``eLibrary'' link. Enter the
docket number (P-2403, P-2312, or P-2721) excluding the last three
digits in the docket number field to access the document. For
assistance, contact FERC Online Support at<EMAIL_ADDRESS>or toll-free at 1-866-208-3372, or for TTY,<PHONE_NUMBER>.
    Any comments should be filed by September 3, 2009, and should be
addressed to the Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Room 1-A, Washington, DC 20426. Please reference the
project name and project number (P-2232) on all comments. Comments may
be filed electronically via Internet in lieu of paper. The Commission
strongly encourages electronic filings. See 18 CFR 385.2001(a)(1)(iii)
and the instructions on the Commission's Web site under the ``eFiling''
link. For further information, contact Christopher Yeakel at (202) 502-
8132.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
 [FR Doc. E9-19135 Filed 8-10-09; 8:45 am]

BILLING CODE 6717-01-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact:

Hope Johnson<PHONE_NUMBER>

OAT AGRIO CO., LTD.

EPA Company No. 11581

5F8408

	EPA has received a pesticide petition (5F8408) from OAT AGRIO CO.,
LTD., 1-3-1 Kanda Ogawa-machi, Chiyoda-ku, Tokyo 101-0052, Japan
proposing, pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.

	1. by establishing a tolerance for residues of

	Flutianil,
(Z)-2-[2-fluoro-5-(trifluoromethyl)phenylthio]-2-[3-(2-methoxyphenyl)-1,
3-thiazolidin-2-ylidene]acetonitrile, including its metabolites and
degradates, in or on apple, fruit at 0.2 ppm, apple, juice at 0.03 ppm,
apple, wet pomace at 2 ppm, cantaloupe at 0.07 ppm, cherry, fruit at 0.4
ppm, cucumber at 0.02 ppm, grape, fruit at 0.7 ppm, grape, juice at 0.2
ppm, grape, raisins at 0.3 ppm, squash at 0.03 ppm, and strawberry,
fruit at 0.3 ppm. EPA has determined that the petition contains data or
information regarding the elements set forth in section 408 (d)(2) of
FDDCA; however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data supports granting of the
petition. Additional data may be needed before EPA rules on the
petition.

A.	Residue Chemistry

Plant metabolism.

The plant metabolism of flutianil is adequately understood in four
diverse crops: apple, cucumber, grape and lettuce. The parent compound,
flutianil, accounted for the majority of residues extracted in all
crops. The metabolism of flutianil in plants is understood for the
purposes of the proposed tolerances.

Analytical method.

The following analytical method was used for apple, cantaloupe, cherry,
cucumber, squash and strawberry samples:  residues were extracted with
acetonitrile/water solution and the aqueous sample was cleaned up by
liquid/liquid partition with hexane. The organic phase was concentrated
and further cleaned up using a silica gel column. Quantitation was
achieved by GC/MSD in selective ion monitoring mode.

The lowest level of method validation (LLMV) in the apple study was 0.01
ppm. Based on recoveries of samples fortified at the LLMV, the limit of
detection (LOD) and limit of quantitation (LOQ) were calculated as 0.001
ppm and 0.0037 ppm, respectively for the apple RAC, 0.002 ppm and 0.0046
ppm for apple juice, and as 0.0003 ppm and 0.00076 ppm, respectively,
for apple wet pomace.

The LLMV in the cantaloupe study was 0.010 ppm. Based on recoveries of
samples fortified at the LLMV, the LOD and LOQ were calculated as 0.001
ppm and 0.0038 ppm, respectively.

For the cherry study, the LLMV was 0.010 ppm.

Based on recoveries of samples fortified at the LLMV, the LOD and LOQ
were calculated as 0.0009 ppm and 0.0027 ppm, respectively in the
cucumber study. The LLMV in the cucumber study was 0.01 ppm.

In the squash study, the LLMV in this study was 0.01 ppm. Based on
recoveries of samples fortified at the LLMV, LOD and LOQ were calculated
as 0.001 ppm and 0.0030 ppm, respectively.

The LOD was determined to be 0.0025 ppm for strawberry, and the LOQ was
0.0076 ppm. The LLMV was 0.010 ppm for strawberry.

In the grape RAC and PC study, the analytical method was as follows:
flutianil residues were analyzed and quantified in grapes, grape juice
and raisins by gas chromatography after extraction and cleanup.
Flutianil metabolite OC-56635 residues were analyzed and quantified in
grapes, grape juice and raisins by high performance liquid
chromatography with tandem mass spectral detection (LCMS/MS). A LOQ of
0.01 mg/kg was determined for flutianil and OC-56635 in grapes and grape
juice. A LOQ of 0.10 mg/kg was determined for flutianil and OC-56635 in
raisins. The limit of detection was set at 30% of the LOQ.

Magnitude of residues.

Apple

Foliar applications of flutianil (V-10118, a 5EC formulation) at a rate
of approximately 0.04 lb ai/A each were made 4 times (~7 day retreatment
interval), for a total of approximately 0.16 lb ai/A in the apple
magnitude of residues study. The results from the trials show that the
maximum residues in/on apple were 0.095 ppm. V-10118 was also applied at
5X the application rate (approximately 0.2 lb ai/A) at three sites to
provide apples for processing into juice and wet pomace. The results
from the trials show that the maximum residues in/on apple juice to be
0.016 ppm and wet pomace to be 1 ppm.

Cantaloupe

For cantaloupes, foliar applications of V-10118 at a rate of
approximately 0.04 lb ai/A each were made 5 times (~7 day retreatment
interval), for a total of approximately 0.20 lb ai/A.  The results from
the trials show that the maximum residues in/on cantaloupe were 0.042
ppm.

Cherry

Foliar applications of V-10118 at a rate of approximately 0.04 lb ai/A
each were made 4 times (~7 day retreatment interval), for a total of
approximately 0.16 lb ai/A for cherry.  Five applications were made at
the Washington site for a total of approximately 0.20 lb ai/A due to a
delay in crop maturity. The results from the trials show that the
maximum residues in/on cherry were 0.26 ppm.

Cucumber

For cucumbers, six trials were conducted in the field and two trials
were conducted in the greenhouse.  Foliar applications of V-10118 at a
rate of approximately 0.04 lb ai/A each were made 5 times (~7 day
retreatment interval), for a total of approximately 0.20 lb ai/A. The
maximum residues in/on cucumber were 0.014 ppm.

Grape

Foliar applications of flutianil at a rate of approximately 0.09 lb
ai/ha each were made 5 times (~7 day retreatment interval), for a total
of approximately 0.49 lb ai/ha in the grape residue study.  Flutianil
residues in treated grape samples ranged from <LOQ to 0.4977 ppm.
OC-56635 residues in treated grape samples ranged from <LOQ to 0.0536
ppm.  For grape raisins and juice, flutianil was also applied at 5X the
application rate (approximately 0.49 lb ai/ha per application) at one
site to provide grapes for processing into juice and raisins.
Flutianil residues in grape juice were found with a maximum residue of
0.2059 ppm. Flutianil residues in raisins were found with a maximum
residue of 0.2993 ppm.   OC-56635 residues in grape juice were found
with a maximum residue of 0.0187 ppm.  OC-56635 residues in raisins were
found with a maximum residue of <LOQ.

Squash

For squash (summer), the trials were conducted foliar applications of
V-10118 at a rate of approximately 0.04 lb ai/A each were made 5 times
(~7 day retreatment interval), for a total of approximately 0.20 lb
ai/A.  The results from the trials show that the maximum residue in/on
summer squash is 0.021 ppm.

Strawberry

For strawberries, trials foliar applications of V-10118 at a rate of
approximately 0.04 lb ai/A each were made 5 times (~7 day retreatment
interval), for a total of approximately 0.20 lb ai/A.

At the Florida trial, one additional application was needed to allow the
fruit to ripen for a total of approximately 0.24 lb ai/A.  At the
Colorado trial, two additional applications were needed to obtain fruit
for harvest for a total of approximately 0.28 lb ai/A. The results from
the trials show that the maximum residues in/on strawberry were 0.24
ppm.

B. Toxicological Profile

1. Acute toxicity.

Technical flutianil shows low acute toxicity (Toxicity Category IV) via
the oral, dermal and inhalation routes of exposure. Flutianil has a very
low acute oral (LD50: >5,000 mg/kg bw), dermal (LD50: >5,000 mg/kg bw)
and inhalation toxicity (LC50: >5.17 mg/L air) in male and female rats.
Flutianil shows no irritation to the eye or skin and shows no skin
sensitization potential under the conditions of the guinea pig
maximization test. There were no acute neurotoxicity concerns.

2. Genotoxicity.

Flutianil was tested for its genotoxic potential in a battery of four in
vitro or in vivo studies covering all required end-points (gene
mutations, chromosomal aberrations). There was no evidence of
genotoxicity.

3. Reproductive and developmental toxicity.

Flutianil shows no evidence of primary developmental or reproductive
effects. In the prenatal developmental toxicity studies in rats and
rabbits and in the two-generation reproduction study in rats, neither
fetal toxicity nor maternal toxicity was present. There was no evidence
to suggest that Flutianil possessed a teratogenic potential in either
species.

4. Subchronic toxicity.

The subchronic toxicity of Flutianil was investigated in 90-day toxicity
studies via the oral route in mouse, rat and dog and via inhalation and
dermal routes in 28-day toxicity studies in the rat. Rats, dogs, and
mice tolerated the chemical in excess of the limit dose without
mortalities or clinical signs.  The NOAEL for oral studies were 1387
mg/kg, 1271 mg/kg, and 1000 mg/kg in mouse, rat and dog respectively.
The NOEL in the rat for dermal exposure was >1000 mg/kg and for
inhalation was 14.4 mg/kg (100 mg/m3).

5. Chronic toxicity.

The chronic toxicity of Flutianil was evaluated in the dog, rat, and
mouse. Oncogenic potential was evaluated in rats and mice. The NOAEL
from the one-year feeding study in the dog was 1000 mg/kg bw/day. The
NOAEL for the rat was 249 mg/kg, the highest dose evaluated.  The NOAEL
in the oncogenic mouse study was 1063 mg/kg bw/day.  No flutianil
induced carcinogenicity was observed. Flutianil is not likely to be
carcinogenic, based on rat and mouse bioassays as well as negative in
vivo and in vitro mutagenic effects.

6. Animal metabolism.

The elimination of flutianil was very rapid with over 90% being
eliminated in the first 24 hours with little absorbed material.
Absorption of [14C]-flutianil was low and biotransformation of absorbed
radioactivity was rapid, giving rise to an extensive range and number of
metabolites. The number and nature of metabolites and difference in
radio-profiles for animals dosed with [trifluoromethyl-14C] and
[2-methoxyphenyl-U-14C] labelled flutianil suggested that cleavage of
the molecule was a significant process in the metabolic pathway.  This
was observed in both the rat and goat metabolism studies.

7. Metabolite toxicology.

One major soil metabolite was evaluated in a 28-day study which showed a
NOAEL of 1380 mg/kg, which was similar to parent flutianil.
Mutagenicity testing (in vitro bacterial reverse mutation and mouse
lymphoma gene mutation and in vivo mouse micronucleus) was conducted
with three major metabolites and all were negative.

8. Endocrine disruption.

The toxicology database for Flutianil is current and complete. Studies
in this database include evaluation of the potential effects on
reproduction and development and an evaluation of the pathology of the
endocrine organs following short- or long-term exposure. No endocrine
disruption is expected to be present following exposure to Flutianil.

9. Immunotoxicity.

Flutianil was evaluated in a 28-day dietary immunotoxicity study.  The
NOEL was greater than 1251 mg/kg.  There was no effect on immune
function.

B.	Toxicological Endpoints

A summary of the toxicological endpoints for flutianil used for human
risk assessment is shown in the following table:

Doses and Toxicological Endpoints for Flutianil

Exposure/Scenario	Dose Used in Risk Assessment, Interspecies,
Intraspecies and any Traditional UF	FQPA SF and Level of

Concern for Risk Assessment	Study and Toxicological Effects

Acute Dietary (females 13-49 years of age)	Not selected	NA	No
toxicological endpoint attributable to a single exposure was identified
in the available toxicology studies.

Acute Dietary (General population including infants and children)	Not
selected	NA	No toxicological endpoint attributable to a single exposure
was identified in the available toxicology studies.

Chronic Dietary (All populations)	NOAEL = 249 mg/kg/day

UF = 100

Chronic RfD = 2.49 mg/kg/day	FQPA SF = 1x

cPAD = Chronic RfD 	Combined Chronic Toxicity/

Carcinogenicity Study in Rat

(MRID No. 49490550)

LOAEL = Not identified

NOAEL male: 249 mg/kg

Incidental Oral Short-Term

(1 – 30 days)	NOAEL =1000 mg/kg/day

UF = 100	LOC for MOE = 100	Developmental Toxicity in Rabbit

(MRID No. 49490545)

LOAEL = Not identified

NOAEL = 1000 mg/kg

Incidental Oral Intermediate-Term (1 - 6 months)	NOAEL = 1271 mg/kg/day

UF = 100	LOC for MOE = 100	Subchronic Oral Toxicity in Rat

(MRID No. 49490537)

LOAEL = Not identified

NOAEL 1271 mg/kg

Dermal (All durations)	NA	NA	No systemic toxicity was identified in the
dermal 28-day study; Highest Dose Tested was 1,000 mg/kg/day.

Inhalation (All durations)	NOAEL =14.4 mg/kg/day

UF = 100	LOC for MOE = 100

Residential

LOC for MOE = 100

Occupational	28-Day Inhalation Toxicity in Rat (MRID No. 49490541)

LOAEL = 1000 mg/m3 based on organ weight changes and histopathological
changes in liver and thyroid. (144 mg/kg conversion)

Cancer (oral, dermal, inhalation)	Classification: “Not likely to be
carcinogenic in humans.''

UF = uncertainty factor, FQPA SF = any additional safety factor retained
due to concerns unique to the FQPA, NOAEL = no observed adverse effect
level, LOAEL = lowest observed adverse effect level, PAD = population
adjusted dose (a = acute, c = chronic) RfD = reference dose, MOE =
margin of exposure, LOC = level of concern, NA = Not Applicable

C.	Exposure Assessment

	1. 	Dietary Exposure

	a.	Acute exposure

Acute dietary risk assessments are performed for a food-use pesticide if
a toxicological study has indicated the possibility of an effect of
concern occurring as a result of a one day or single exposure. An acute
risk assessment was not performed. No toxicological endpoint
attributable to a single (acute) dietary exposure was identified.

	b.	Chronic exposure

A chronic dietary risk assessment was conducted for flutianil use on
apple, cantaloupe, cherry, cucumber, grape, squash and strawberry at the
proposed tolerances using the Dietary Exposure Evaluation Model
(DEEM-FCID™, Version 4.02) which uses food translations based on
EPA/USDA FCID recipe set as of August 2014. The chronic dietary risk
estimates are below HED’s level of concern for the general U.S.
population and all population subgroups. The most highly exposed
population subgroups (0.1% of the RfD) were children 1-2 years old and
children 3-5 years old.

Summary of Chronic Dietary (Food + Drinking Water) Exposure and Risk for
Flutianil

Population Subgroup

Exposure (mg/kg bw/day)

Percent of RfD1

US population

0.000414	0.0%

All infants ( < 1 year old)

0.000901	0.0%

Children (1-2 years old)	0.002257	0.1%

Children (3-5 years old)	0.001446	0.1%

Children (6-12 years old)	0.000642	0.0%

Youth (13-19 years old)	0.000239	0.0%

Adults (20-49 years old)	0.000243	0.0%

Adults (50+ years old)	0.000304	0.8%

Females (13-49 years old)	0.000272	0.0%

	1 RfD = 2.49 mg/kg/day

	c.	Cancer

In accordance with the EPA Final Guidelines for Carcinogen Risk
Assessment, flutianil may be classified as “Not likely to be
carcinogenic in humans” and is not expected to pose a cancer risk to
humans. Animal evidence demonstrates the lack of carcinogenic effects in
both sexes in well-designed and well-conducted studies in rats and mice.

	2.	Non-dietary exposure

	a.	Occupational exposure

Flutianil is formulated a 5% emulsifiable concentrate to be applied to
strawberry, cantaloupe, cucumber, summer squash, apple, cherry, and
grape using groundboom or airblast spray equipment. The potential
exposures and associated risks for handlers mixing, loading and applying
flutianil and for workers re-entering treated areas are based on the
proposed label for GATTEN® fungicide (flutianil 5% liquid formulation).
The maximum application rate is 0.04 lb ai/acre. A maximum of four to
five applications are allowed per year, depending upon crop, with a
7-day application interval.

Short- and intermediate-term dermal and inhalation exposures are
predicted for occupational handlers mixing, loading, and applying
flutianil. Since flutianil-specific exposure data are not available,
handler scenarios were assessed using the EPA Occupational Pesticide
Handler Unit Exposure Surrogate Reference Table - Revised March 2013.
The occupational handler exposure and risk estimates for flutianil are
listed below.

Occupational Handler Exposure & Risk Estimates for Flutianil

Short- & Intermediate-Term Exposure	Unit Exposure1 (mg/lb ai handled)
Application Rate

(lb ai/A)	Units Treated2 (A/day)	Average Daily Dose3 (mg ai/kg bw/day)
Short- & Intermediate-Term MOE4

Mixer/Loader – Liquids – Open Loading for Airblast Application

Dermal	0.0376	0.04	40	0.000158	8,000,000

Inhalation	0.000219	0.04	40	0.00000438	3,300,000

Mixer/Loader – Liquids – Open Loading for Groundboom Application

Dermal	0.0376	0.04	80	0.000316	4,000,000

Inhalation	0.000219	0.04	80	0.00000876	1,600,000

Applicator – Liquids – Airblast

Dermal	1.59	0.04	40	0.00668	190,000

Inhalation	0.00471	0.04	40	0.0000942	150,000

Applicator – Liquids – Groundboom

Dermal	0.0161	0.04	80	0.000135	9,400,000

Inhalation	0.00471	0.04	80	0.000188	76,000

1 Unit Exposure (UE) = mg ai/lb ai handled from Occupational Pesticide
Handler Unit Exposure Surrogate Reference Table - Revised March 2013.
PPE = long-sleeve shirt, long pants, socks, shoes, gloves.

2 Units Treated taken from Science Advisory Council for Exposure,
Standard Operating Procedure 9.1, Standard Values for Daily Acres
Treated in Agriculture, Rev. 25, September 2001.

3 Average Daily Dose (ADD) = Unit Exposure x Application Rate x Units
Treated x Absorption Factor ÷ Body Weight (80 kg).  Dermal absorption
factor = 21%, inhalation absorption factor = 100%.

4 Margin of Exposure (MOE) = NOAEL (mg/kg/day) ÷ ADD (mg/kg/day);
NOAELdermal = 1271 mg/kg/day, NOAELinhalation = 14.4 mg/kg/day for all
durations.

Short- and intermediate-term dermal exposures are predicted for
post-application exposure to workers performing typical agricultural
tasks.  Since flutianil-specific exposure data are not available,
post-application scenarios were assessed using Science Advisory Council
for Exposure (ExpoSAC) Policy 3 – Revised March 2013. The occupational
post-application exposure and risk estimates for flutianil are listed
below.

Occupational Post-Application Exposure & Risk Estimates for Flutianil

Short- & Intermediate-Term Exposure	Crop

Activity	Transfer Coefficient1 (cm2/hr)	Application Rate

(lb ai/A)	Average Daily Dose2 (mg ai/kg bw/day)	Short- &
Intermediate-Term MOE3

Dermal	Strawberry

Hand Harvest	1,100	0.04	0.0026	490,000

Dermal	Cantaloupe, Cucumber, Summer Squash

Hand Set Irrigation	1,900	0.04	0.0045	280,000

Dermal	Apple, Cherry

Thinning Fruit	3,600	0.04	0.0085	150,000

Dermal	Grapes

Tying/Training, Hand Harvest, Leaf Pulling	10,100	0.04	0.024	53,000

1 Transfer Coefficient from   HYPERLINK
"http://www.epa.gov/pesticides/science/exposac-policy-3-march2013.pdf"
Science Advisory Council for Exposure (ExpoSAC) Policy 3 – Revised
March 2013 .  PPE = long-sleeve shirt, long pants, socks, shoes.

3 Average Daily Dose (ADD) = Transfer Coefficient (TC) x Dislodgeable
Foliar Residue (DFR) x Duration * Absorption Factor ÷ Body Weight
(80 kg).  DFR = 25% * Application Rate, Duration = 8 hrs/day, Dermal
Absorption Factor = 21%.

4 Margin of Exposure (MOE) = NOAEL (mg/kg/day) ÷ ADD (mg/kg/day);
NOAELdermal = 1271 mg/kg/day for all durations.

All occupational handler and post-application exposures from
agricultural applications of flutianil result in MOEs greater than 100
and therefore do not exceed HED’s level of concern.

	b.	Residential (Non-occupational) exposure and risk

There are no proposed uses of flutianil which would lead to direct
exposure to resident, either through mixing, loading and application, or
due to post application exposure; however, there are potential indirect
post-application exposures to adults and children due to drift onto
residential lawns from agricultural applications.  These indirect
post-application scenarios were assessed based on the proposed label for
GATTEN® fungicide (flutianil 5% liquid formulation) using draft
Residential Exposure Assessment Standard Operating Procedures - Addenda
1: Consideration of Spray Drift (November 1, 2013). The greatest
indirect residential exposure potential is from groundboom application
to cantaloupe, cucumber, summer squash or strawberries. The residential
post-application exposure and risk estimates for flutianil are listed
below.

Residential Exposure & Risk Estimates for Flutianil

Short- & Intermediate-Term Exposure	Lifestage	Drift Application Rate1
(lb ai/A)	Average Daily Dose2 (mg ai/kg bw/day)	Short- &
Intermediate-Term MOE3

High Contact Lawn

Dermal	Adult	0.0075	0.00059	2,200,000

Dermal	1 to <2 years	0.0075	0.0012	1,100,000

Hand-to Mouth

Incidental Oral	1 to <2 years	0.0075	0.00011	11,000,000

Object-to-Mouth

Incidental Oral	1 to <2 years	0.0075	0.0000035	370,000,000

Soil Ingestion

Incidental Oral	1 to <2 years	0.0075	0.00000025	5,000,000,000

D.  	Cumulative Effects

Cumulative effects from substances with a common mechanism of toxicity:
Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency consider
“available information” concerning the cumulative effects of a
particular pesticide's residues and “other substances that have a
common mechanism of toxicity.”

Unlike other pesticides for which EPA has followed a cumulative risk
approach based on a common mechanism of toxicity, EPA has not made a
common mechanism of toxicity finding as to flutianil and any other
substances, and flutianil does not appear to produce a toxic metabolite
produced by other substances. Therefore for the purposes of this
tolerance action, EPA has not assumed that flutianil has a common
mechanism of toxicity with other substances.

E. 	Safety Factor for Infants and Children

In general, Section 408 of the FFDCA provides that EPA shall apply an
additional ten-fold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal toxicity
and the completeness of the database on toxicity and exposure unless EPA
determines that a different margin of safety will be safe for infants
and children. Margins of safety are incorporated into EPA risk
assessments either directly through use of a MOE analysis or through
using uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk to humans.

Prenatal developmental toxicity studies in rabbits and rats showed no
qualitative/qualitative evidence of increased susceptibility in
offspring.  The 2-generation reproduction study in rats did not show
evidence of qualitative/qualitative evidence of increased susceptibility
in offspring.

The toxicology database for flutianil is complete. The data are
sufficient for endpoint selection for exposure/risk assessment scenarios
and for evaluation of the requirements under the Food Quality Protection
Act (FQPA). Evidence of quantitative and qualitative susceptibility of
offspring was not observed, and therefore, the FQPA 10x safety factor
was reduced to 1x.

F. 	Aggregate Risks and Determination of Safety

The proposed uses are the first uses proposed for flutianil in the
United States.

Acute risk

An acute risk assessment was not performed. No toxicological endpoint
attributable to a single (acute) dietary exposure was identified.
Therefore, acute risk from flutianil exposure to is not expected.

Chronic risk

Using the exposure assumptions described in this unit for chronic
exposure, it was concluded that exposure to flutianil from food and
water will utilize 0.0% of the RfD for the U.S. population, and 0.1% of
the RfD for children 1-2 years old and children 3-5 years old, the
subpopulations at greatest exposure. Based on the use pattern, chronic
residential exposure to residues of flutianil is not expected.
Therefore, the aggregate exposure is not expected to exceed 100% of the
RfD.

Short-term risk

Short-term aggregate exposure takes into account residential exposure
plus chronic exposure to food and water. There are no proposed uses of
flutianil which would lead to direct exposure to resident, either
through mixing, loading and application or due to post application
exposure; however, there are potential indirect post-application
exposures to adults and children due to drift onto residential lawns
from agricultural applications.  Short-term aggregate exposure is not
expected to exceed the Agency's level of concern.

Intermediate-term risk

Intermediate-term aggregate exposure takes into account non-dietary,
non-occupational exposure plus chronic exposure to food and water.
Intermediate-term aggregate exposure is not expected to exceed the
Agency's level of concern.

Cancer risk

Flutianil should be classified as, “Not likely to be carcinogenic in
humans.'' Flutianil is not expected to pose a cancer risk.

Determination of safety

Based on these risk assessments, it is concluded that there is a
reasonable certainty that no harm will result to the general population
and to infants and children from aggregate exposure to flutianil
residues.

G.	 International Tolerances

Tolerances have been established in Japan for the following crops:
eggplant (0.2 ppm), cucumber (including gherkin (0.2 ppm)), pumpkin
(including squash (0.05 ppm)), watermelon (0.05 ppm), melons (0.05 ppm)
and strawberry (0.5 ppm).  Tolerances have been established in Korea for
the following crops:  green and red pepper (0.5 ppm), strawberry (0.3
ppm), melon (0.05 ppm), watermelon (0.05 ppm), cucumber (0.05 ppm),
Korean melon (0.05 ppm) and sweet pepper (0.5 ppm).

Page   PAGE  1  of   NUMPAGES   10


[Federal Register Volume 80, Number 205 (Friday, October 23, 2015)]
[Notices]
[Pages 64434-64435]
[FR Doc No: 2015-27017]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2015-0634]

Collection of Information Under Review by Office of Management
and Budget; OMB Control Number: 1625-0014

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding an Information Collection Request (ICR),
abstracted below, to the Office of Management and Budget (OMB), Office
of Information and Regulatory Affairs (OIRA), requesting approval of a
revision to the following collection of information: 1625-0014, Request
for Designation and Exemption of Oceanographic Research Vessels. Our
ICR describe the information we seek to collect from the public. Review
and comments by OIRA ensure we only impose paperwork burdens
commensurate with our performance of duties.

DATES: Comments must reach the Coast Guard and OIRA on or before
November 23, 2015.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2015-0634] to the Coast Guard using the Federal
eRulemaking Portal at http://www.regulations.gov. Alternatively, you
may submit comments to OIRA using one of the following means:
    (1) Email<EMAIL_ADDRESS>    (2) Mail: OIRA, 725 17th Street NW., Washington, DC 20503,
attention Desk Officer for the Coast Guard.
    (3) Fax:<PHONE_NUMBER>. To ensure your comments are received in a
timely manner, mark the fax, attention Desk Officer for the Coast
Guard.
    A copy of the ICR is available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
COMMANDANT (CG-612), ATTN: PAPERWORK REDUCTION ACT MANAGER, U.S. COAST
GUARD, 2703 MARTIN LUTHER KING JR. AVE. SE., STOP 7710, WASHINGTON, DC
20593-7710.

FOR FURTHER INFORMATION CONTACT: Contact Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection. The Coast Guard invites comments on whether
this ICR should be granted based on the Collection being necessary for
the proper performance of Departmental functions. In particular, the
Coast Guard would appreciate comments addressing: (1) The practical
utility of the Collection; (2) the accuracy of the estimated burden of
the Collection; (3) ways to enhance the quality, utility, and clarity
of information subject to the Collection; and (4) ways to minimize the
burden of the Collection on respondents, including the use of automated
collection techniques or other forms of information technology. These
comments will help OIRA determine whether to approve the ICR referred
to in this Notice.
    We encourage you to respond to this request by submitting comments
and related materials. Comments to Coast Guard or OIRA must contain the
OMB Control Number of the ICR. They must also contain the docket number
of this request, [USCG-2015-0634], and must be received by November 23,
2015.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at http://www.regulations.gov and
can be viewed by following that Web site's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    OIRA posts its decisions on ICRs online at http://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice
of Action on each ICR will become available via a hyperlink in the OMB
Control Number: 1625-0014 .

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard published the 60-day notice (80 FR 45669, July 31, 2015)
required by 44 U.S.C. 3506(c)(2). That Notice elicited no comments.
Accordingly, no changes have been made to the Collection.

Information Collection Request

    1. Title: Request for Designation and Exemption of Oceanographic
Research Vessels.
    OMB Control Number: 1625-0014.
    Summary: This collection requires submission of specific
information about a vessel in order for the vessel to be designated as
an Oceanographic Research Vessel (ORV).
    Need: Title 46 U.S.C. 2113 authorizes the Secretary of the
Department of Homeland Security to exempt Oceanographic Research
Vessels (ORV), by regulation, from provisions of Subtitle II, of Title
46, Shipping, of the United States Code, concerning maritime safety and
seaman's welfare laws. This information is necessary to ensure a vessel
qualifies for the designation of ORV under 46 CFR part 3 and 46 CFR
part 14, subpart D.
    Forms: N/A.
    Respondents: Owners or operators of certain vessel.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden has decreased from 51
hours to 25 hours a year due to a decrease in the estimated annual
number of respondents.

    Authority:  The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: October 18, 2015.
Thomas P. Michelli,
U.S. Coast Guard, Deputy Chief Information Officer.
[FR Doc. 2015-27017 Filed 10-22-15; 8:45 am]
BILLING CODE 9110-04-P