[Federal Register: April 28, 2008 (Volume 73, Number 82)]
[Notices]
[Page 22959-22960]
[DOCID:fr28ap08-63]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0226]

Risk Communication Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Risk Communication Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on effective risk communication.
    Date and Time: The meeting will be held on May 15, 2008, from 8
a.m. to 5 p.m. and May 16, 2008, from 8 a.m. to 2 p.m.
    Addresses: Submit electronic comments and information to http://
www.regulations.gov . Comments are to be identified with the docket
number found in brackets in the heading of this document. Written
comments should be submitted to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, by close of business on June 16, 2008. All
comments received will be posted without change, including any personal
information provided. Comments received on or before May 8, 2008, will
be provided to the committee before or at the meeting; comments
received after that time will still be considered in preparing the
report that was specified in the FDA Amendments Act of 2007 (see docket
and committee background for further information).
    Location: Hilton Washington DC/Rockville Hotel & Executive Meeting
Center, 1750 Rockville Pike, Rockville, MD, 20852-1699.
    Contact Person: Lee L. Zwanziger, Office of the Commissioner,
Office of Planning (HFP-60), Food and Drug Administration, 5600 Fishers
Lane (for express delivery: rm. 15-22), Rockville, MD, 20857, 301-827-
2895, FAX:<PHONE_NUMBER>, Food and Drug Administration, or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area), code<PHONE_NUMBER>. Please call the Information Line
for up-to-date information on this meeting. A notice in the Federal
Register about last minute modifications that affect 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 and call the appropriate advisory committee hot line/
phone line to learn about possible modifications before coming to the
meeting.
    Agenda: On May 15, 2008, the committee will meet for presentations
and discussion of direct-to-consumer (DTC) advertising, including how
it relates to communicating to subsets of the general population, such
as the elderly, children, and racial and ethnic minority communities,
and increased access to health information and decreased health
disparities for these populations. On May 16, 2008, the committee will
discuss studying the appropriateness of including, in televised DTC
ads, a statement encouraging consumers to report negative side effects
of prescription drugs to MedWatch, as is currently required for print
DTC prescription drug ads.
    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 http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2008 and scroll down to the appropriate advisory committee
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before May
8, 2008. Written submissions may also be made to the docket at the
address above (see the docket for further information on topics of
particular interest for comment in connection with this meeting). Oral
presentations from the public will be scheduled between approximately 1
p.m. and 2 p.m. on May 15th and between 10:30 a.m. and 11:30 a.m. on
May 16th. Those desiring to make formal oral presentations should
notify the contact person on or before May 8,

2008, and should 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. 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 May 9, 2008.
    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
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Lee L. Zwanziger 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 http://www.fda.gov/oc/advisory/
default.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: April 18, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-9177 Filed 4-25-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 79, Number 58 (Wednesday, March 26, 2014)]
[Notices]
[Page 16801]
[FR Doc No: 2014-06611]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0477]

Center for Devices and Radiological Health: Standard Operating
Procedure for Level 1, Immediately in Effect Guidance Documents on
Premarket Data Issues; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the Standard Operating Procedure (SOP) for Level 1,
Immediately in Effect (IIE) Guidance Documents on Premarket Data
Issues. The SOP describes the Center for Devices and Radiological
Health's (CDRH's or the Center's) process to clarify and more quickly
inform stakeholders when CDRH has changed its expectations relating to,
or otherwise has new scientific information that could affect data
submitted as part of an Investigational Device Exemption (IDE) or
premarket submission, including a Premarket Notification (510(k)), a
Premarket Approval (PMA), a Humanitarian Device Exemption (HDE), or
combination products containing a device constituent part for which
CDRH has jurisdiction that needs to be disseminated in a timely manner.

DATES: Submit either electronic or written comments on this SOP at any
time. General comments on Agency SOP documents are welcome at any time.

ADDRESSES: See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the SOP. Submit electronic comments on the SOP to
http://www.regulations.gov. Submit written comments to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Philip Desjardins, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5452, Silver Spring, MD 20993-0002, 301-
796-5678<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The Task Force on the Utilization of Science in Regulatory Decision
Making (the Task Force) published a Preliminary Report and
Recommendations in August 2010. In the report, the Task Force noted
that when new scientific information changes CDRH's regulatory
thinking, it has been challenging for the Center to communicate the
change and its basis to all affected parties in a meaningful and timely
manner. The Task Force recommended that the Center make use of more
rapid tools for broad communication on regulatory matters, including
establishing a standard practice for communicating to all manufacturers
of a particular group of devices for which the Center has changed its
regulatory expectations on the basis of new scientific information.
    Currently, manufacturers typically learn of changes CDRH implements
regarding what data or how to gather specific data in support of an IDE
or premarket submission at the time of or soon after a decision is made
through individual engagement with the Center, often not until after
they have prepared that submission. Reviewers may implement these
changes, such as requesting new clinical data or using a new test
method, on a case-by-case basis, with immediate supervisory concurrence
when it is necessary to protect the public health. For example, a
reviewer may request that sponsors test their implantable device for
durability because new data demonstrate that this type of device is
prone to failure due to premature wear and tear of the technology.
Although CDRH may issue a detailed guidance document, the document may
not be published until a year or more after a Branch- or Division-level
decision has been made to request the information because of the
resource constraints in developing guidance documents.
    CDRH believes that timely communication with industry about changes
in premarket regulatory expectations is important. FDA's Good Guidance
Practices regulation provides a mechanism for communicating and
implementing certain changes in regulatory expectations quickly,
without requiring prior public comment. Under 21 CFR 10.115(g)(2), FDA
may issue a Level 1, IIE Guidance Document when prior public
participation is not ``feasible or appropriate.'' Under these
circumstances, CDRH intends to use the procedures described in Sec.
10.115(g)(2) to issue guidance documents addressing changes in
premarket regulatory expectations. CDRH has developed this SOP to
facilitate issuance of such guidance documents.
    On September 5, 2013 (78 FR 54655), CDRH issued a draft SOP that
meets the Center's needs and addresses concerns raised regarding an
original ``Notice to Industry Letters'' proposal (July 21, 2011, 76 FR
43693). Interested persons were invited to comment by October 21, 2013.
Three comments were received with suggestions pertaining to the
administrative process and policies regarding IIE guidances. In
response to these comments, FDA revised the SOP to clarify the
processes and policies as appropriate. This document will supersede the
``Draft Standard Operating Procedure for Level 1, Immediately in Effect
Guidance Documents on Premarket Data Issues'' issued on September 5,
2013.

II. Electronic Access

    Persons interested in obtaining a copy of the SOP may do so by
using the Internet. The Standard Operating Procedure for Level 1,
Immediately in Effect Guidance Documents on Premarket Data Issues is
available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM259172.pdf. The SOP is
also available from http://www.regulations.gov and can be located using
the docket number found in brackets in the heading of this document.

III. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: March 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-06611 Filed 3-25-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: April 12, 2007 (Volume 72, Number 70)]
[Notices]
[Page 18472-18473]
[DOCID:fr12ap07-52]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application Accepted for Filing and Soliciting Motions
to Intervene, Protests, and Comments

April 6, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 12780-000
    c. Date filed: February 28, 2007.
    d. Applicant: Fairhaven OPT Ocean Power, LLC.
    e. Name of Project: Fairhaven OPT Wave Power Project.
    f. Location: The project would be located in the Pacific Ocean in
Humbolt County, California.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)--825(r).
    h. Applicant Contacts: Charles F. Dunleavy, Fairhaven OPT Ocean
Power, LLC, 1590 Reed Road, Pennington, NJ 08534, phone: (609)-730-
0400.
    i. FERC Contact: Robert Bell,<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426. Comments, protests, and
interventions may be filed electronically via the Internet in lieu of
paper; see 18 CFR 385.2001(a)(1)(iii) and the instructions on the
Commission's web site under the ``e-Filing'' link. The Commission
strongly encourages electronic filings. Please include the project
number (P-12770-000) on any comments or motions filed.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Description of Project: The proposed project would consist of:
(1) 40 to 80 Power Buoys having a total installed capacity of 20
megawatts, (2) a proposed 300-foot-long, 69 kilovolt transmission line,
and (3) appurtenant facilities. The project is estimated to have an
average annual generation of 1.534 gigawatt-hours, which would be sold
to a local utility.
    l. Locations of Applications: A copy of the application is
available for inspection and reproduction at the Commission in the
Public Reference Room, located at 888 First Street NE., Room 2A,
Washington DC 20426, or by calling<PHONE_NUMBER>. This filing may also
be viewed on the Commission's Web site at http://www.ferc.gov using the

``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy is

also available for inspection and reproduction at the address in item h
above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Competing Preliminary Permit: Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR
4.30(b) and 4.36.
    o. Competing Development Application: Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30(b) and 4.36.
    p. Notice of Intent: A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    q. Proposed Scope of Studies under Permit: A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation

of a development application to construct and operate the project.
    r. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210,
385.211, 385.214. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper; See 18 CFR 385.2001 (a)(1)(iii) and
the instructions on the Commission's web site under ``e-filing'' link.
The Commission strongly encourages electronic filing.
    s. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'',''COMPETING APPLICATION'' OR
``MOTION TO INTERVENE'', as applicable, and the Project Number of the
particular application to which the filing refers. Any of the above-
named documents must be filed by providing the original and the number
of copies provided by the Commission's regulations to: The Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. A copy of any motion to intervene must also be
served upon each representative of the Applicant specified in the
particular application.
    t. Agency Comments: Federal, State, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Philis J. Posey,
Acting Secretary.
 [FR Doc. E7-6920 Filed 4-11-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 202 (Friday, October 22, 2021)]
[Notices]
[Pages 58656-58658]
[FR Doc No: 2021-23041]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0751; FRL-9076-01-OCSPP]

Pesticide Registration Review; Interim Decisions and Case
Closures for Several Pesticides; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's interim
registration review decisions for the following chemicals:
Amicarbazone; aminopyralid; azadirachtin, cold pressed neem oil and
clarified hydrophobic neem oil; benzoic acid; endothall and salts;
ethofumesate; fluoxastrobin; forchlorfenuron; gamma-cyhalothrin;
inorganic halides; ipconazole; L-lactic acid; lambda-cyhalothrin;
metam/MITC; metconazole; myclobutanil; novaluron; picloram; prometon;
prothioconazole; and pyrasulfotole. In addition, it announces the
closure of the registration review case for propazine.

FOR FURTHER INFORMATION CONTACT: For pesticide specific information,
contact: The Chemical Review Manager for the pesticide of interest
identified in the Table in Unit IV.
    For general information on the registration review program,
contact: Melanie Biscoe, Pesticide Re-evaluation Division (7508P),
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(703) 305-7106; email address: [email protected].

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, farm worker, 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. If you have any questions
regarding the applicability of this action to a particular entity,
consult the pesticide specific contact person listed in the Table in
Unit IV.

B. How can I get copies of this document and other related information?

    The dockets these cases, identified by the docket identification
(ID) number for the specific pesticide of interest provided in the
Table in Unit IV., are available at http://www.regulations.gov or at
the Office of Pesticide Programs Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency Docket Center (EPA/DC), West
William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW,
Washington, DC 20460-0001. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OPP Docket is<PHONE_NUMBER>.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

II. Background

    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. As part of the registration review process,
the Agency has completed interim decisions for all pesticides listed in
the Table in Unit IV. 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.

III. Authority

    EPA is conducting its registration review of the chemicals listed
in the Table in Unit IV pursuant to section 3(g) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) 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.

IV. What action is the Agency taking?

    Pursuant to 40 CFR 155.58, this notice announces the availability
of EPA's interim registration review decisions for the pesticides shown
in the following table. The interim registration review decisions are
supported by rationales included in the docket established for each
chemical.

                            Table--Registration Review Interim Decisions Being Issued
----------------------------------------------------------------------------------------------------------------
                                                                                Chemical review manager
 Registration review case name and No.                   Docket ID No.                  and contact information
----------------------------------------------------------------------------------------------------------------
Amicarbazone, Case Number 7262.........  EPA-HQ-OPP-2015-0400                          Samantha Thomas,
                                                                                [email protected],
<PHONE_NUMBER>.
Aminopyralid, Case Number 7267.........  EPA-HQ-OPP-2013-0749                          Rachel Stephenson,
                                                                                [email protected],<PHONE_NUMBER>.
Azadirachtin, Cold Pressed Neem Oil,     EPA-HQ-OPP-2008-0632                          Joseph Mabon,
 and Clarified Hydrophobic Neem Oil,                                                    [email protected],
 Case Number 6021.<PHONE_NUMBER>.
Benzoic Acid, Case Number 5107.........  EPA-HQ-OPP-2010-0692                          Megan Snyderman,
                                                                                [email protected],
<PHONE_NUMBER>.
Endothall and Salts, Case Number 2245..  EPA-HQ-OPP-2015-0591                          Robert Little,
                                                                                [email protected],
<PHONE_NUMBER>.
Ethofumesate, Case Number 2265.........  EPA-HQ-OPP-2015-0406                          James Douglass,
                                                                                [email protected],
<PHONE_NUMBER>.
Fluoxastrobin, Case Number 7044........  EPA-HQ-OPP-2015-0295                          Rachel Fletcher,
                                                                                [email protected],
<PHONE_NUMBER>.
Forchlorfenuron, Case Number 7057......  EPA-HQ-OPP-2014-0641                          Srijana Shrestha,
                                                                                [email protected]
                                                                                ,<PHONE_NUMBER>.
Gamma-cyhalothrin, Case Number 7437....  EPA-HQ-OPP-2010-0479                          Darius Stanton,
                                                                                [email protected],
<PHONE_NUMBER>.
Inorganic halides, Case Number 4051....  EPA-HQ-OPP-2009-0168                          Erin Dandridge,
                                                                                [email protected],
<PHONE_NUMBER>.
Ipconazole, Case Number 7041...........  EPA-HQ-OPP-2015-0590                          Alex Hazlehurst,
                                                                                [email protected],<PHONE_NUMBER>.
L-lactic Acid, Case Number 6062........  EPA-HQ-OPP-2020-0552                          SanYvette Williams,
                                                                                [email protected],<PHONE_NUMBER>.
Lambda-cyhalothrin, Case number 7408...  EPA-HQ-OPP-2010-0480                          Darius Stanton,
                                                                                [email protected],
<PHONE_NUMBER>.
Metam/MITC, Case Number 2390 & 2405....  EPA-HQ-OPP-2013-0140 & EPA-HQ-OPP-2013-0242   Tiffany Green,
                                                                                [email protected],
<PHONE_NUMBER>.
Metconazole, Case Number 7049..........  EPA-HQ-OPP-2015-0013                          Samantha Thomas,
                                                                                [email protected],
<PHONE_NUMBER>.
Myclobutanil, Case Number 7006.........  EPA-HQ-OPP-2015-0053                          Anitha Kisanga,
                                                                                [email protected],
<PHONE_NUMBER>.
Novaluron Case Number 7615.............  EPA-HQ-OPP-2015-0171                          Robert Little,
                                                                                [email protected],
<PHONE_NUMBER>.
Picloram, Case Number 0096.............  EPA-HQ-OPP-2013-0740                          Andy Muench,
                                                                                [email protected],
<PHONE_NUMBER>.
Prometon, Case Number 2545.............  EPA-HQ-OPP-2013-0068                          Carolyn Smith,
                                                                                [email protected],
<PHONE_NUMBER>.
Prothioconazole, Case Number 7054......  EPA-HQ-OPP-2015-0474                          Rachel Eberius,
                                                                                [email protected],
<PHONE_NUMBER>.
Pyrasulfotole, Case Number 7272........  EPA-HQ-OPP-2016-0391                          James Douglass,
                                                                                [email protected],
<PHONE_NUMBER>.
----------------------------------------------------------------------------------------------------------------

    The proposed interim registration review decisions for the
chemicals in the table above were posted to the docket and the public
was invited to submit any comments or new information. EPA addressed
the comments or information received during the 60-day comment period
for the proposed interim decisions in the discussion for each pesticide
listed in the table. Comments from the 60-day comment period that were
received may or may not have affected the Agency's interim decision.
Pursuant to 40 CFR 155.58(c), the registration review case docket for
the chemicals listed in the Table will remain open until all actions
required in the interim decision have been completed.
    This document also announces the closure of the registration review
case for propazine (Case Number 0230, Docket ID Number EPA-HQ-OPP-2013-
0250) because the last U.S. registrations for these pesticides have
been canceled.
    Background on the registration review program is provided at:
http://www.epa.gov/pesticide-reevaluation.

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

    Dated: October 18, 2021.
Mary Elissa Reaves,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2021-23041 Filed 10-21-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: March 21, 2008 (Volume 73, Number 56)]
[Notices]
[Page 15253-15254]
[DOCID:fr21mr08-126]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2007-29251]

Agency Information Collection Activities; Emergency Approval of a
New Information Collection: Commercial Vehicle Driver Survey: Truck
Driver Hours of Service and Fatigue Management

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

ACTION: Notice and request for information.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, this
notice announces that the Information Collection Request (ICR)
abstracted below has been forwarded to the Office of Management and
Budget (OMB) to request an emergency approval process. FMCSA requested
approval of this ICR not later than 30 days from the date of
publication of this notice. The purpose of this information collection
is to analyze the impact of the new Hours-of-Service regulations on
drivers and the effects of these regulations on driver fatigue as well
as to acquire general demographic information regarding the commercial
motor vehicle driving population.

DATES: Please send your comments by April 21, 2008. OMB must receive
your comments by this date in order to act quickly on the ICR.

ADDRESSES: You may submit comments to the Office of Information and
Regulatory Affairs, Office of Management and Budget, 725 Seventeenth
Street, NW., Washington, DC 20503, Attention: DOT/FMCSA Desk Officer.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Carroll, Senior
Transportation Specialist,<PHONE_NUMBER><EMAIL_ADDRESS>MC-
RRR Federal Motor Carrier Safety Administration,

6th Floor, West Building, 1200 New Jersey Ave., SE., Washington, DC
20590. Requests for additional information or copies of the information
collection instrument and instructions should be directed to Dr.
Michelle Yeh, Engineering Psychologist,<PHONE_NUMBER>,
<EMAIL_ADDRESS>Human Factors Division, Volpe National
Transportation Systems Center, 55 Broadway, Cambridge, MA 02124. Office
hours are from 9 a.m. to 5 p.m., Monday through Friday, except Federal
holidays.

SUPPLEMENTARY INFORMATION:
    Title: Commercial Vehicle Driver Survey: Truck Driver Hours of
Service and Fatigue Management.
    OMB Control Number: 2126-XXXX.
    Type of Request: New information collection.
    Respondents: Commercial motor vehicle drivers.
    Estimated Number of Respondents: 1728 respondents.
    Estimated Time per Response: 15 minutes.
    Expiration Date: N/A. This is a new information collection.
    Frequency of Response: One-time.
    Estimated Total Annual Burden: 432 hours [1728 respondents x 15
minutes = 432].
    Background: The Federal Motor Carrier Safety Administration (FMCSA)
needs a better understanding of the commercial motor vehicle driving
population and the perceived effect of its new Hours-of-Service rule.
This rule, adopted in August 2005, was intended to align truck drivers'
schedules with the normal 24-hour circadian cycle and provide drivers
with better opportunities to obtain more restorative sleep. The Hours-
of-Service rule is intended to minimize the occurrence of operational
errors on the road. However, in July, 2007, two provisions of the
Hours-of-Service rule were vacated by the United States Court of
Appeals for the District of Columbia Circuit (the Court). The Court
held that FMCSA had failed to provide an opportunity to comment on the
methodology of its operator-fatigue model, and that it failed to
explain the elements of that methodology. Because the model is the
basis for the cost-benefit analysis which supports the increase of
driving time from 10 to 11 hours and of the 34-hour restart, the Court
vacated those two provisions. The Court subsequently stayed its mandate
for three months, until December 27, 2007.
    FMCSA would like to analyze, in great detail, the impact of the
2005 Hours-of-Service regulations on drivers. Related to this issue is
truck driver fatigue. Fatigue mitigation has been a high priority in
the Department of Transportation and the FMSCA for many years. The 2005
Hours-of-Service regulations required drivers to take two additional
hours off duty every day, allowing them to obtain the 7-8 hours of
sleep that most people need to maintain alertness. An understanding of
whether the rules are perceived to be having the desired effect on
driver sleep is needed. Additionally, understanding drivers' napping
habits and other solutions for coping with fatigue would provide input
for future solutions and policies to better accommodate these issues.
    FMCSA would also like to obtain information on the commercial motor
vehicle driving population. Driver-related factors are an important
consideration in commercial motor vehicle crashes, but there is no
central nationwide source of information describing the population of
drivers holding a Commercial Drivers License (CDL). An estimate of the
number of commercial drivers and particular subsets of drivers (e.g.,
short-haul, regional, long-haul) is needed and would benefit FMCSA in
assessing the impacts of future initiatives, policies, and rules and
the improvement of its safety programs.
    The goals of this survey are to obtain commercial motor vehicle
drivers' opinions on the new Hours-of-Service regulations and the
effects of these regulations on driver fatigue and to acquire general
demographic information regarding the commercial motor vehicle driving
population. Data for this project will be collected via driver
interviews and from a one-time, hard copy, mailed survey. Drivers will
provide information regarding the nature of their work, experience, and
employment history, their perceptions regarding the effect of the
Hours-of-Service regulations, and methods for coping with fatigue. The
results of the information collection will be summarized and made
available to the public. It will be used to inform future initiatives,
policies, and rules; develop a picture of the commercial vehicle driver
population for use in future FMCSA research; and contribute to the
general literature regarding fatigue management.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (1) Whether the proposed
collection is necessary for the performance of FMCSA's functions; (2)
the accuracy of the estimated burden; (3) ways for the FMCSA to enhance
the quality, usefulness, and clarity of the collected information; and
(4) ways that the burden could be minimized without reducing the
quality of the collected information.

    Issued On: March 14, 2008.
Terry Shelton,
Associate Administrator for Research and Information Technology.
 [FR Doc. E8-5720 Filed 3-20-08; 8:45 am]

BILLING CODE 4910-EX-P


[Federal Register: July 17, 2008 (Volume 73, Number 138)]
[Notices]
[Page 41067]
[DOCID:fr17jy08-65]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD08-5-000]

Compliance Workshop; Notice of Comment Period for Workshop on
Regulatory Compliance

July 10, 2008.
    As announced at the Workshop on Regulatory Compliance held July 8,
2008, the Commission is providing the opportunity for written comments
to be filed in this proceeding until July 22, 2008.
    The Commission encourages electronic submission 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 comments
to the Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-16303 Filed 7-16-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 164 (Thursday, August 23, 2018)]
[Notices]
[Page 42758]
[FR Doc No: 2018-18237]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Certification:
Airmen Other Than Flight Crewmembers, Subpart C, Aircraft Dispatchers
and App. A Aircraft Dispatcher

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. This collection involves the information that each
applicant for an aircraft dispatcher certificate or FAA approval of an
aircraft dispatcher course must submit to the FAA. These applications,
reports and training course materials are provided to the local Flight
Standards District Office of the FAA that oversees the certificates and
FAA approvals.
    The collection is necessary for the FAA to determine qualification
and the ability of the applicant to safely dispatch aircraft. Without
this collection of information, applicants for a certificate or course
approval would not be able to receive certification or approval. The
collection of information for those who choose to train aircraft
dispatcher applicants is to protect the applicants by ensuring that
they are properly trained.

DATES: Written comments should be submitted by October 22, 2018.

ADDRESSES: Send comments to the FAA at the following address: Barbara
Hall, Federal Aviation Administration, ASP-110, 10101 Hillwood Parkway,
Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: Barbara Hall by email at:
[email protected]; phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0648.
    Title: Certification: Airmen Other Than Flight Crewmembers, Subpart
C, Aircraft Dispatchers and App. A Aircraft Dispatcher.
    Form Numbers: There are no forms associated with this collection.
    Type of Review: This is a renewal of a collection.
    Background: This collection involves the information that each
applicant for an aircraft dispatcher certificate or FAA approval of an
aircraft dispatcher course must submit to the FAA to comply with 14 CFR
part 65, subpart C and Appendix A. These applications, reports and
training course materials are provided to the responsible Flight
Standards Office of the FAA that oversees the certificates and FAA
approvals.
    This collection involves the knowledge testing that each applicant
for an aircraft dispatcher certificate must successfully complete or
information required to obtain FAA approval of an aircraft dispatcher
course in order to comply with 14 CFR part 65, subpart C and Appendix
A. These applications, reports and training course materials are
provided to the responsible Flight Standards Office of the FAA which
oversees the certificates and FAA approvals.
    The collection is necessary for the FAA to determine qualification
and the ability of the applicant to safely dispatch aircraft. Without
this collection of information, applicants for a certificate or course
approval would not be able to receive certification or approval. The
collection of information for those who choose to train aircraft
dispatcher applicants is to protect the applicants by ensuring that
they are properly trained.
    Respondents: 1,288.
    Frequency: On occasion.
    Estimated Average Burden per Response: 4.8 hours.
    Estimated Total Annual Burden: 6,337.99 hours.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC, on August 16, 2018.
Jonathan Haupt,
Manager, IT Strategy and Investment Portfolio Branch, ASP-120.
[FR Doc. 2018-18237 Filed 8-22-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)]
[Rules and Regulations]
[Pages 56163-56165]
[FR Doc No: 2017-25189]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0933; Product Identifier 2017-SW-051-AD; Amendment
39-19106; AD 2017-24-02]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters Deutschland GmbH
Helicopters

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for Airbus
Helicopters Deutschland GmbH (Airbus Helicopters) Model MBB-BK 117 D-2
helicopters. This AD requires amending the rotorcraft flight manual to
establish a minimum airspeed limitation for the autopilot cruise height
mode. This AD is prompted by two reports of uncommanded helicopter
climbs and descents. The actions of this AD are intended to address an
unsafe condition on these products.

DATES: This AD becomes effective December 13, 2017.
    The Director of the Federal Register approved the incorporation by
reference of certain documents listed in this AD as of December 13,
2017.
    We must receive comments on this AD by January 29, 2018.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0933; or in person at the Docket Operations Office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The AD docket

contains this AD, the European Aviation Safety Agency AD, any
incorporated by reference service information, the economic evaluation,
any comments received, and other information. The street address for
the Docket Operations Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.
    For service information identified in this final rule, contact
Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at
http://www.helicopters.airbus.com/Web site/en/ref/Technical-
Support_73.html. You may review the referenced service information at
the FAA, Office of the Regional Counsel, Southwest Region, 10101
Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. It is also available
on the Internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2017-0933.

FOR FURTHER INFORMATION CONTACT: George Schwab, Aviation Safety
Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA,
10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>;
email [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not provide you with notice and an opportunity to
provide your comments prior to it becoming effective. However, we
invite you to participate in this rulemaking by submitting written
comments, data, or views. We also invite comments relating to the
economic, environmental, energy, or federalism impacts that resulted
from adopting this AD. The most helpful comments reference a specific
portion of the AD, explain the reason for any recommended change, and
include supporting data. To ensure the docket does not contain
duplicate comments, commenters should send only one copy of written
comments, or if comments are filed electronically, commenters should
submit them only one time. We will file in the docket all comments that
we receive, as well as a report summarizing each substantive public
contact with FAA personnel concerning this rulemaking during the
comment period. We will consider all the comments we receive and may
conduct additional rulemaking based on those comments.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
No. 2017-0146, dated August 10, 2017, to correct an unsafe condition
for Airbus Helicopters Model MBB-BK 117 D-2 helicopters. EASA advises
that two incidents of uncommanded helicopter climbs and descents have
been reported following activation of the autopilot cruise height
(CRHT) mode concurrently with the ground trajectory command in hover
mode (GTCH). EASA advises this condition, if not detected and
corrected, could lead to temporary loss of control of the helicopter or
injury to the helicopter's occupants. To address this unsafe condition,
EASA requires a minimum airspeed limitation of 40 knots for the
autopilot CRHT mode. Since the rotorcraft cannot enter GTCH mode at
speeds above 40 knots, under this limitation, CRHT mode will not be
engaged concurrently with GTCH mode. EASA considers its AD interim
action, pending an autopilot software upgrade to prevent further
occurrences.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Germany and are approved for operation in the United States. Pursuant
to our bilateral agreement with Germany, EASA, its technical
representative, has notified us of the unsafe condition described in
the EASA AD. We are issuing this AD because we evaluated all
information provided by EASA and determined the unsafe condition exists
and is likely to exist or develop on other helicopters of these same
type designs.

Related Service Information Under 1 CFR Part 51

    We reviewed Airbus Helicopters BK117 D-2 Flight Manual Temporary
Revision No. 1, dated March 28, 2017, for Model BK117 D-2 helicopters,
and Airbus Helicopters BK117 D-2 (Helionix Step 2) Flight Manual
Temporary Revision No. 1, dated March 28, 2017, for Model BK117 D-2
helicopters with Helionix Step 2. These temporary revisions establish a
minimum airspeed limitation of 40 knots for the autopilot CRHT mode.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

AD Requirements

    This AD requires, within 10 hours time-in-service, revising the
Operating Limitations section of the rotorcraft flight manual by adding
a minimum airspeed limitation for the autopilot of 40 knots when CRHT
mode is engaged.

Interim Action

    We consider this AD to be an interim action. The design approval
holder is currently developing a modification that will address the
unsafe condition identified in this AD. Once this modification is
developed, approved, and available, we might consider additional
rulemaking.

Costs of Compliance

    We estimate that this AD affects 16 helicopters of U.S. Registry
and that labor costs average $85 per work-hour. Based on these
estimates, we expect that making the required changes to the rotorcraft
flight manual will require 0.5 work-hour and no parts are needed for a
cost of $43 per helicopter and $688 for the U.S. fleet.

FAA's Justification and Determination of the Effective Date

    Providing an opportunity for public comments prior to adopting
these AD requirements would delay implementing the safety actions
needed to correct this known unsafe condition. Therefore, we find that
the risk to the flying public justifies waiving notice and comment
prior to the adoption of this rule because the required corrective
actions must be accomplished within 10 hours time-in-service.
    Since an unsafe condition exists that requires the immediate
adoption of this AD, we determined that notice and opportunity for
prior public comment before issuing this AD are impracticable and
contrary to the public interest and that good cause exists to make this
AD effective in less than 30 days.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on

products identified in this rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
Government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed, I certify that this AD:
    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);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2017-24-02 Airbus Helicopters Deutschland GmbH: Amendment 39-19106;
Docket No. FAA-2017-0933; Product Identifier 2017-SW-051-AD.

(a) Applicability

    This AD applies to Airbus Helicopters Deutschland GmbH (Airbus
Helicopters) Model MBB-BK 117 D-2 helicopters, certificated in any
category.

(b) Unsafe Condition

    This AD defines the unsafe condition as a helicopter making an
uncommanded climb or descent. This condition could result in loss of
helicopter control.

(c) Effective Date

    This AD becomes effective December 13, 2017.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    Within 10 hours time-in-service, revise the Operating
limitations section of the Rotorcraft Flight Manual by adding the
information in Figure 1 to paragraph (e) of this AD under Autopilot
Limitations. Inserting Airbus Helicopters BK117 D-2 Flight Manual
Temporary Revision No. 1, dated March 28, 2017, or Airbus
Helicopters BK117 D-2 (Helionix Step 2) Flight Manual Temporary
Revision No. 1, dated March 28, 2017, into the RFM is acceptable for
compliance with this AD.

                        Figure 1 to Paragraph (e)
------------------------------------------------------------------------

------------------------------------------------------------------------
                 Operating limitations of the autopilot

Minimum airspeed with CRHT mode engaged..........................  40 kt
------------------------------------------------------------------------

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, Rotorcraft Standards
Branch, FAA, may approve AMOCs for this AD. Send your proposal to:
George Schwab, Aviation Safety Engineer, Safety Management Section,
Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth,
TX 76177; telephone<PHONE_NUMBER>; email [email protected].
    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office, before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    The subject of this AD is addressed in European Aviation Safety
Agency (EASA) AD 2017-0146, dated August 10, 2017. You may view the
EASA AD on the Internet at http://www.regulations.gov by searching
for and locating it in Docket No. FAA-2017-0933.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 2210, Autopilot
System.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Airbus Helicopters BK117 D-2 Flight Manual Temporary
Revision No. 1, dated March 28, 2017.
    (ii) Airbus Helicopters BK117 D-2 (Helionix Step 2) Flight
Manual Temporary Revision No. 1, dated March 28, 2017.
    (3) For service information identified in this AD, contact
Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or
at http://www.helicopters.airbus.com/Website/en/ref/Technical-Support_73.html.
    (4) You may review a copy of the service information at the FAA,
Office of the Regional Counsel, Southwest Region, 10101 Hillwood
Pkwy., Room 6N-321, Fort Worth, TX 76177.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Fort Worth, Texas, on November 9, 2017.
Scott A. Horn,
Deputy Director for Regulatory Operations, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2017-25189 Filed 11-27-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Pages 30947-30949]
[FR Doc No: 2021-12148]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-E-1325 and FDA-2020-E-1324]

Determination of Regulatory Review Period for Purposes of Patent
Extension; WAKIX

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined the regulatory review period for WAKIX and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by August 9, 2021.
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 December 7, 2021. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 9, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 9, 2021. 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.

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 Nos.
FDA-2020-E-1325 and FDA-2020-E-1324 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; WAKIX.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 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 human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, 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 human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, WAKIX
(pitolisant hydrochloride). WAKIX is indicated for the treatment of
excessive daytime sleepiness in adult patients with narcolepsy.
Subsequent to this approval, the USPTO received patent term restoration
applications for WAKIX (U.S. Patent Nos. 8,207,197 and 8,486,947) from
Bioprojet, and the USPTO requested FDA's assistance in determining the
patent's eligibility for patent term restoration. In a letter dated May
26, 2020, FDA advised the USPTO that this human drug product had
undergone a regulatory review period and that the approval of WAKIX
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
WAKIX is 505 days. Of this time, 261 days occurred during the testing
phase of the regulatory review period, while 244 days occurred during
the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
March 29, 2018. The applicant claims February 27, 2018, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was March 29, 2018,
which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: December 14,
2018. FDA has verified the applicant's claim that the new drug
application (NDA) for WAKIX (NDA 211150) was initially submitted on
December 14, 2018.
    3. The date the application was approved: August 14, 2019. FDA has
verified the applicant's claim that NDA 211150 was approved on August
14, 2019.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 389 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to:

Must be timely (see DATES), must be filed in accordance with Sec.
10.20, must contain sufficient facts to merit an FDA investigation, and
must certify that a true and complete copy of the petition has been
served upon the patent applicant. (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.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: June 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12148 Filed 6-9-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 112 (Monday, June 11, 2018)]
[Rules and Regulations]
[Page 26841]
[FR Doc No: 2018-12426]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2018-0481]

Drawbridge Operation Regulation; Hudson River, Troy and Green
Island, New York

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Highway (Green Island) Bridge
across the Hudson River, mile 152.7, at Troy and Green Island, New
York. This temporary deviation is necessary to allow the bridge to
remain in the closed-to-navigation position to facilitate deck
replacement.

DATES: This deviation is effective from 12:01 a.m. on June 19, 2018, to
11:59 p.m. on September 6, 2018.

ADDRESSES: The docket for this deviation, USCG-2018-0481 is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Judy Leung-Yee, Bridge Management
Specialist, First District Bridge Branch, U.S. Coast Guard, telephone
212-514-4336, email [email protected].

SUPPLEMENTARY INFORMATION: The New York State Department of
Transportation, the bridge owner, requested a temporary deviation from
the normal operating schedule of the bridge to facilitate deck
replacement. The Highway (Green Island) Bridge across the Hudson River,
mile 152.7, has a vertical clearance in the closed position of 29 feet
at mean high water. The existing bridge operating regulations are
listed at 33 CFR 117.791(e).
    Under this temporary deviation, the Highway (Green Island) Bridge
shall remain in the closed position from 12:01 a.m. on June 19, 2018 to
11:59 p.m. on July 13, 2018, and from 12:01 a.m. on August 17, 2018 to
11:59 p.m. on September 6, 2018.
    The waterway is transited by commercial and recreational traffic.
The bridge owner and contractor notified known commercial vessel
operators that transit the area and there were no objections to this
temporary deviation. Vessels able to pass under the bridge in the
closed position may do so at any time. The bridge will not be able to
open for emergencies and there is no immediate alternate route for
vessels to pass.
    The Coast Guard will inform the users of the waterways through our
Local and Broadcast Notices to Mariners of the change in operating
schedule for the bridge so that vessel operators can arrange their
transits to minimize any impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: June 5, 2018.
C.J. Bisignano,
Supervisory Bridge Management Specialist, First Coast Guard District.
[FR Doc. 2018-12426 Filed 6-8-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: November 24, 2009 (Volume 74, Number 225)]
[Notices]
[Page 61347-61348]
[DOCID:fr24no09-47]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2009-0089; FRL-8984-4]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Unregulated Contaminant
Monitoring in Public Water Systems (Renewal); EPA ICR No. 2192.03, OMB
Control No. 2040-0270

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that an Information
Collection Request (ICR) has been forwarded to the Office of Management
and Budget (OMB) for review and approval. This is a request to renew an
existing approved collection. The ICR, which is abstracted below,
describes the nature of the information collection and its estimated
burden and cost.

DATES: Additional comments may be submitted on or before December 24,
2009.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OW-
2009-0089 to (1) EPA online using http://www.regulations.gov (our
preferred method), by e-mail to<EMAIL_ADDRESS>or by mail to: EPA
Docket Center, Environmental Protection Agency, Water Docket, United
States Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave., NW., Washington, DC 20460, Attention Docket ID No.
EPA-HQ-OW-2009-0089, and (2) OMB by mail to: Office of Information and
Regulatory Affairs, Office of Management and Budget (OMB), Attention:
Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Brenda D. Parris, Technical Support
Center, Office of Ground Water and Drinking Water, United States
Environmental Protection Agency, Office of Water, 26 West Martin Luther
King Drive (MS 140), Cincinnati, OH 45268, telephone<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>For general information, contact
the Safe Drinking Water Hotline. Callers within the United States may
reach the Hotline at<PHONE_NUMBER>. The Hotline is open Monday through
Friday, excluding legal holidays, from 10 a.m. to 4 p.m., Eastern Time.

SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On June 9, 2009, (74 FR 27312) EPA sought comments on this ICR
pursuant to 5 CFR 1320.8(d). EPA received no comments during the
comment period. Any additional comments on this ICR should be submitted
to EPA and OMB within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OW-2009-0089, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Water Docket,
EPA West, Room 3334, 1301 Constitution Avenue, NW., Washington, DC. The
Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal holidays. The telephone number
for the Reading Room is<PHONE_NUMBER>, and the telephone number for the
Water Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA
receives them and without change, unless the comment contains
copyrighted material, confidential business information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://
www.regulations.gov.
    Title: Unregulated Contaminant Monitoring in Public Water Systems
(Renewal).
    ICR numbers: EPA ICR No. 2192.03, OMB Control No. 2040-0270.
    ICR Status: This ICR is scheduled to expire on November 30, 2009.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information, unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, are displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: The Safe Drinking Water Act (SDWA), as amended in 1996,
directs EPA to establish criteria for a program to monitor not more
than 30 unregulated contaminants every five years. EPA published the
first group of contaminants in the Unregulated Contaminant Monitoring
Regulation (i.e., UCMR 1), which established a revised approach for
UCMR implementation, in the Federal Register dated September 17, 1999,
(64 FR 50556). EPA published the second group of contaminants in UCMR
2, in the Federal Register dated January 4, 2007, (72 FR 367). This
regulation met the SDWA requirement by identifying 25 new priority
contaminants to be monitored during the UCMR 2 cycle of 2007-2011.
    Under UCMR 2, Assessment Monitoring uses more common analytical
method technologies used by drinking water laboratories. All public

water systems (PWSs) serving more than 10,000 people, and 800
representative PWSs serving fewer than 10,001 people are required to
monitor for the 10 ``List 1'' contaminants during a 12-month period
between January 2008-December 2010. Screening Survey monitoring uses
more specialized analytical method technologies not as widely used by
drinking water laboratories. All PWSs serving more than 100,000 people,
320 representative PWSs serving 10,001-100,000 people, and 480
representative PWSs serving fewer than 10,001 people are required to
monitor for the 15 ``List 2'' contaminants during a 12-month period
between January 2008-December 2010.
    This notice proposes renewal of the currently approved UCMR 2 ICR
(OMB Control No. 2040-0270), which covers the period of 2007-2009. This
ICR renewal accounts for activities over a three-year period (2010-
2012), as is customary. Note that the complete five-year UCMR 2 cycle
of 2007-2011 overlaps with the applicable ICR renewal period only
during 2010 and 2011. Public water systems will only be involved in
active monitoring during 2010 (i.e., one-third of this ICR period),
with reporting continuing into 2011 for some.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 5.8
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Public water systems.
    Estimated Number of Respondents: 1,694 (1,638 PWSs and 56 State
primacy agencies).
    Frequency of Response: On Occasion.
    Estimated Total Annual Hour Burden: 9,761.
    Estimated Total Annual Cost: $3,250,616 includes an estimated labor
cost of $387,096 and $2,863,520 for capital and operation & maintenance
costs.
    Changes in the Estimates: There is decrease of 30,625 hours in the
total estimated burden currently identified in the OMB Inventory of
Approved ICR Burdens. This decrease is due to the fact that the
complete five-year UCMR 2 cycle of 2007-2011 overlaps with the
applicable ICR renewal period only during 2010 and 2011. In this time,
there will be fewer PWSs participating and the schedule of activities
will have changed.

    Dated: November 16, 2009.
John Moses,
Director, Collection Strategies Division.
[FR Doc. E9-28145 Filed 11-23-09; 8:45 am]

BILLING CODE 6560-50-P