[Federal Register Volume 87, Number 154 (Thursday, August 11, 2022)]
[Rules and Regulations]
[Pages 49523-49524]
[FR Doc No: 2022-17286]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2022-0673]
RIN 1625-AA00

Safety Zone; Grosse Pointe Farms Fireworks, Lake St. Clair,
Grosse Pointe Farms, MI

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone for
certain navigable waters within Lake St. Clair in Grosse Pointe Farms,
MI. The safety zone is needed to protect personnel, vessels, and the
marine environment from potential hazards during a fireworks event.
Entry of vessels or persons into this zone is prohibited unless
specifically authorized by the Captain of the Port (COTP) Detroit.

DATES: This rule is effective from 9:30 p.m. on September 3, 2022,
through 10:30 p.m. on September 4, 2022.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2022-0673 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Ms. Tracy Girard, U.S. Coast Guard;<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so is impracticable. The Coast
Guard did not receive notice of the fireworks with sufficient time to
undergo notice and comment. We must establish this safety zone by
September 3, 2022 in order to protect the public form the hazards
associated with a fireworks event.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable because immediate action is needed to
respond to the potential safety hazards associated with a fireworks
display.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Detroit
(COTP) has determined that potential hazards associated with fireworks
starting September 3, 2022, will be a safety concern for anyone within
a 250-yard radius of the fireworks location. This rule is needed to
protect personnel, vessels, and the marine environment in the navigable
waters within the safety zone while fireworks show is being displayed.

IV. Discussion of the Rule

    This rule establishes a safety zone from 9:30 p.m. through 10:30
p.m. on September 3, 2022. In the case of inclement weather on
September 3, 2022, this safety zone will be enforced from 10 p.m. to
10:30 p.m. on September 4, 2022. The safety zone will cover all
navigable waters within a 250 yard radius of location 42[deg] 24.51' N
082[deg]52.97' W (WGS 84). The duration of the zone is intended to
protect personnel, vessels, and the marine environment in these
navigable waters while the fireworks show is being displayed. No vessel
or person will be permitted to enter the safety zone without obtaining
permission from the COTP or a designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. Vessel traffic
will be able to safely transit around this safety zone which will
impact a small designated area of the Lake St. Clair for less than an
hour during the night when vessel traffic is normally low. Moreover,
the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM
marine channel 16 about the zone, and the rule would allow vessels to
seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions

concerning its provisions or options for compliance, please call or
email the person listed in the FOR FURTHER INFORMATION CONTACT section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone lasting less then an hour that will prohibit entry within
250 yard radius of 42[deg] 24.51' N 082[deg]52.97' W (WGS 84). It is
categorically excluded from further review under paragraph L[60] of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A
Record of Environmental Consideration supporting this determination is
available in the docket. For instructions on locating the docket, see
the ADDRESSES section of this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and record
keeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.2.

0
2. Add Sec.  165.T09-0673 to read as follows:

Sec.  165.T09-0673  Safety Zones; Grosse Pointe Farms Fireworks, Lake
St. Clair, Grosse Pointe, MI.

    (a) Location. This safety zone is established to encompass all U.S.
navigable waters of Lake St. Clair within a 250-yard radius of 42[deg]
24.51' N 082[deg]52.97' W (WGS 84).
    (b) Enforcement period. The safety zone described in paragraph (a)
will be enforced from 9:30 p.m. to 10:30 p.m. on September 3, 2022. In
the case of inclement weather on September 3, 2022, this safety zone
will be enforced from 9:30 p.m. through 10:30 p.m. on September 4,
2022.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, entry into, transiting, or anchoring within these safety
zones is prohibited unless authorized by the COTP Detroit or a
designated on-scene representative.
    (2) The safety zones are closed to all vessel traffic, except as
may be permitted by the COTP Detroit or a designated on-scene
representative.
    (3) The ``on-scene representative'' of the COTP Detroit is any
Coast Guard commissioned, warrant or petty officer or a federal, state,
or local law enforcement officer designated by the COTP Detroit to act
on his behalf.
    (4) Vessel operators desiring to enter or operate within the safety
zones must contact the COTP Detroit or an on-scene representative to
obtain permission to do so. The COTP Detroit or an on-scene
representative may be contacted via VHF Channel 16. Vessel operators
given permission to enter or operate in the safety zone must comply
with all directions given to them by the COTP Detroit or an on-scene
representative.

    Dated: August 5, 2022.
Brad W. Kelly,
Captain, U. S. Coast Guard, Captain of the Port Detroit.
[FR Doc. 2022-17286 Filed 8-10-22; 8:45 am]
BILLING CODE 9110-04-P


MAY 06 2003 MEMORANDUM SUBJECT: Review of Insect Resistance Management considerations associated with Pioneer and Dow Agroscience's proposed EUPs for Bacillus thuringiensis PS149B1 in corn. EPA Reg. Nos. 29964 EUP L, 29964 EUP U, 68467 EUP I, 68467 EUP T. DP Barcodes: D288786, D288789, D288852, D288855. Cases: 067211, 067212, 065381, 065383. Submission: S630869, S630878, S631040, S631056. MRID#: 457904 09,  10.

TO: Mike Mendelsohn, Regulatory Action Leader Microbial Pesticides Branch Biopesticides and Pollution Prevention Division ( 7511C)

FROM: Alan Reynolds, Entomologist / s/ Microbial Pesticides Branch Biopesticides and Pollution Prevention Division ( 7511C)

THROUGH: Sharlene Matten, Ph. D., Biologist / s/ Alan Reynolds for/ Microbial Pesticides Branch Biopesticides and Pollution Prevention Division ( 7511C)

ACTION REQUESTED AND BACKGROUND BPPD has been asked to review the Insect Resistance Management ( IRM) considerations with the proposed Experimental Use Permits ( EUP) for PS149B1 insect control protein ( derived from Bacillus thuringiensis Cry34/ 35 Ab1; hereafter referred to as Cry34/ 35 corn) requested by Pioneer ( EPA Reg. Nos. 29964 EUP L and 29964 EUP U) and Dow AgroSciences ( EPA Reg. Nos. 68467 EUP I and 68467 EUP T). Each company is proposing to test two separate vectors: 17662 and 17658. Cry34/ 35 corn is targeted against western corn rootworm ( Diabrotica virgifera virgifera, WCRW) and northern corn rootworm ( Diabrotica berberi, NCRW).

The proposed acreage for the Pioneer EUPs is 623.9 ( 29964 EUP L) and 622.4 ( 29964 EUP U), planted in 18 states and Puerto Rico. Each of the two proposed Dow EUPs will cover 393.5 acres planted in 15 states and Puerto Rico. The total acreage for all four EUPs is 2033.3. The IRM portion of the submission consists of a " Section G" ( Experimental Protocol for each EUP, a " Trait Durability" plan for the EUP ( MRID# 457904 09), and field efficacy data ( MRID# 457904 10). 2 CONCLUSIONS AND RECOMMENDATIONS 1. For the EUPs, a specific refuge requirement is not necessary. The threat of resistance to Cry34/ 35 corn should be minimal for the EUPs because: 1) the EUPs are for limited acreage ( 2033 total acres); 2) the acreage will consist of small plots ( most < 5 acres) scattered over 19 states and Puerto Rico; and 3) the EUPs are for one year only. However, for full Section 3 registration involving larger acreage, structured refuge should be required to mitigate the potential for the development of resistance. Dow's submitted " Trait Durability" plan ( MRID# 457904 09) is acceptable for the EUPs.

2. It is recommended that for a full commercial Section 3 registration of Cry34/ 35 corn, the registrants submit an Insect Resistance Management ( IRM) plan that fully addresses all pertinent topics: refuge ( size, proximity, and structure), dose, IRM research, cross resistance, monitoring, remedial action, grower education, and compliance.

3. The IRM related experimental objectives for the EUPs as proposed by Dow in their " Trait Durability" plan are acceptable. The areas of study include: model sensitivity analyses, dose evaluation, pest biology ( larval movement), monitoring ( susceptibility analysis and determining levels of " unexpected damage"), grower education, and compatibility with existing corn refuge strategies. However, the " Section G" ( proposed experimental program) reports do not describe these objectives ( other than dose investigation), so it is unclear exactly what IRM research will be undertaken.

4. Field efficacy data submitted by Dow ( MRID# 457904 10) showed that Cry34/ 35 corn significantly reduced root damage versus non transgenic corn ( determined with the Iowa State Linear Scale). Root ratings for Cry34/ 35 corn were 0.07 to 0.18 ( indicating 7  18% of one root node eaten  very minor feeding damage) while the non transgenic corn ratings were 1.22 to 1.28 ( indicating 1.22  1.28 root nodes eaten).

INSECT RESISTANCE MANAGEMENT The details of the IRM strategy and research goals for the EUPs were contained in a report (" Trait Durability and Experimental Use of Transgenic Maize Expressing the Insecticidal Crystalline Proteins Cry34Ab1 and Cry35Ab1") ( MRID# 457904 09) submitted by Dow and in the Proposed Experimental Program (" Section G") for each EUP. It is noted that the " Section G" reports submitted by both Dow and Pioneer describe the same IRM objectives.

Dow's " Trait Durability" submission argues that selection pressure for resistance to Cry34/ 35 corn should be insignificant for the experimental period. The reviewers agree with this assessment, given that the EUP is for one year and will involve limited acreage in small plots. The total acreage for all four EUPs is 2033.3, planted across 19 states and Puerto Rico. Most of the 3 experimental plots will be less than five acres ( the largest plots will be 40 acres). In addition, plots will be surrounded by border rows of corn, which will serve as de facto refuge. After harvest, plots will be demarcated and monitored for volunteer corn.

Considering these factors, a refuge plan should not be necessary for the EUPs. However, for full FIFRA Section 3 registration or larger acreage requests, structured refuge should be required to mitigate the potential for the development of resistance. A full IRM plan should be submitted with a Section 3 registration request to address the following areas: refuge ( size, proximity, and structure), dose, IRM research, cross resistance, monitoring, remedial action, grower education, and compliance.

The August 27 29, 2002 SAP addressed IRM for CRW protected transgenic corn. Although the meeting was held in the context of MON 863 ( a Monsanto registered hybrid), much of the discussion was relevant to general CRW IRM. Dow and Pioneer should address/ incorporate the August 2002 SAP report recommendations on CRW IRM as appropriate for Cry34/ 35 corn.

As part of the experimental program for the EUPs, Dow has proposed to conduct research on a number of IRM related topics ( detailed Dow's " Trait Durability" plan). The major areas of research include: model sensitivity analyses, dose evaluation, pest biology ( larval movement), monitoring ( susceptibility analysis and determining levels of " unexpected damage"), grower education, and compatibility with existing corn refuge strategies. These research topics should aid the registrants in developing a sound IRM plan for Cry34/ 35 corn. However, it is noted that the " Section G" ( proposed experimental program) reports for each EUP indicate that IRM research will focus only on investigation of dose ( other research areas are not described). It is unclear from the Section G reports whether the other research topics described in the " Trait Durability" study will investigated as part of the EUPs.

Separate from their EUP submission, Dow has provided details of their plan to evaluate high dose with Cry34/ 35 corn ( described in a confidential handout from Dow and personal communication with N. Storer). The reviewers have evaluated this plan and agree with Dow's approach for assessing dose in Cry34/ 35 corn.

FIELD EFFICACY OF CRY34/ 35 CORN As part of their submission, Dow has submitted the data from a field efficacy study to evaluate the performance of Cry34/ 35 corn ( MRID# 457904 10). Efficacy was evaluated for six events  three from vector 17662 ( 68467 EUP T) and two from vector 17658 ( 68467 EUP I). The other tested event is not part of the proposed EUPs.

The study was conducted in two locations ( York, Nebraska and Rochelle, Illinois) during the 2002 growing season. Plots of Cry34/ 35 and control ( non transgenic) corn were artificially infested with 500 ( Rochelle) or 1000 ( York) WCRW eggs. After the larvae were given sufficient time to pupate, the roots were unearthed and assessed for rootworm feeding damage using the 4 Iowa State Linear Scale ( Oleson 1998). The Linear Scale assigns a numerical score to each plant's root system: whole numbers indicate full root nodes eaten and decimals indicate the percentage of a single node eaten ( e. g. 1.25 would indicate one complete node and 25% of another node eaten).

The results showed that Cry34/ 35 corn sustained very little feeding damage: root scores were 0.07  0.18 ( 7 to 18% of one node eaten) with no significant difference between the six tested events. Control plant root scores were 1.22  1.28 ( one full node and 22 to 28% of a second node eaten), which was significantly greater feeding damage than experienced by the Cry34/ 35 corn, despite reported " moderate" insect pressure from the artificial infestation. Given these results, Cry34/ 35 corn should be effective in preventing damage from rootworm feeding.

Reference:

Oleson, 1998. Linear scale for evaluating corn rootworm larval injury. Poster presentation given at the Annual Meeting of the Entomological Society of America.


[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Notices]
[Pages 36790-36792]
[FR Doc No: 2017-16516]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-2531]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for CINQAIR 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 the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human
biological product.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by October
6, 2017. 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 5, 2018.
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 October 6, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of October 6, 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.

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-2016-E-2531 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; CINQAIR.'' 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.
     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: 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 biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological 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 biological 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 biologic product CINQAIR
(reslizumab). CINQAIR is indicated for add-on maintenance treatment of
patients with severe asthma aged 18 years and older, and with an
eosinophilic phenotype. Subsequent to this approval, the USPTO received
a patent term restoration application for CINQAIR (U.S. Patent No.
RE39,548) from UCB Celltech, and the USPTO requested FDA's assistance
in determining this patent's eligibility for patent term restoration.
In a letter dated September 26, 2016, FDA advised the USPTO that this
human biological product had undergone a regulatory review period and
that the approval of CINQAIR 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
CINQAIR is 5,685 days. Of this time, 5,325 days occurred during the
testing phase of the regulatory review period, while 360 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 (21 U.S.C. 355(i)) became effective: August 31,
2000. The applicant claims February 15, 2008, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was August 31, 2000,
which was 30 days after FDA receipt of the first IND.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): March 30, 2015. FDA has verified the
applicant's claim that the biologics license application (BLA) for
CINQAIR (BLA 761033) was initially submitted on March 30, 2015.
    3. The date the application was approved: March 23, 2016. FDA has
verified the applicant's claim that BLA 761033 was approved on March
23, 2016.
    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 application for patent extension,
this applicant seeks 1,660 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 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 be timely (see DATES) and 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.
    Submit petitions electronically to http://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: August 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16516 Filed 8-4-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 181 (Friday, September 18, 2015)]
[Notices]
[Page 56479]
[FR Doc No: 2015-23488]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2015-0672]

Commercial Fishing Safety Advisory Committee; Vacancies

AGENCY: Coast Guard, Department of Homeland Security.

ACTION: Request for applications.

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

SUMMARY: The Coast Guard seeks applications for membership on the
Commercial Fishing Safety Advisory Committee. The Commercial Fishing
Safety Advisory Committee provides advice and makes recommendations to
the Coast Guard and the Department of Homeland Security on various
matters relating to the safe operation of commercial fishing industry
vessels.

DATES: Completed applications should reach the Coast Guard on or before
November 17, 2015.

ADDRESSES: Applicants should send a cover letter expressing interest in
an appointment to the Commercial Fishing Safety Advisory Committee that
identifies which membership category the applicant is applying under,
along with a resume detailing the applicant's experience via one of the
following methods:
     By mail: Commandant (CG-CVC), Attn: Fishing Vessel Safety,
U.S. Coast Guard Stop 7501, 2703 Martin Luther King Jr Ave. SE.,
Washington, DC 20593-7501.
     By fax:<PHONE_NUMBER>.
     By email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Mr. Jack Kemerer, Alternate Designated
Federal Officer, telephone at<PHONE_NUMBER>, fax at<PHONE_NUMBER>, or
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Commercial Fishing Safety Advisory
Committee is a federal advisory committee under the Federal Advisory
Committee Act, title 5 United States Code Appendix. The Coast Guard
chartered the Commercial Fishing Safety Advisory Committee to provide
advice on issues related to the safety of commercial fishing industry
vessels regulated under chapter 45 of title 46, U.S.C., which includes
uninspected fish catching vessels, fish processing vessels, and fish
tender vessels. (See 46 U.S.C. 4508.)
    The Commercial Fishing Safety Advisory Committee meets at least
once a year. It may also meet for other extraordinary purposes. Its
subcommittees or working groups may communicate throughout the year to
prepare for meetings or develop proposals for the committee as a whole
to address specific tasks.
    Each member serves for a term of three years. An individual may be
appointed to a term as a member more than once, but not more than two
terms consecutively. All members serve at their own expense and receive
no salary from the Federal Government, although travel reimbursement
and per diem may be provided for called meetings.
    The Coast Guard will consider applications for six (06) positions
that expire or become vacant in May 2016 in the following categories:
    (a) Commercial Fishing Industry representatives (four positions);
    (b) General Public, (one position) particularly a person familiar
with issues affecting fishing communities and families of fishermen;
and
    (c) A Naval Architect and Marine Engineer representative of
commercial fishing vessels (one position).
    If you are selected as a member from the general public, you will
be appointed and serve as a Special Government Employee as defined in
section 202(a) of title 18, United States Code. As a candidate for
appointment as Special Government Employee, applicants are required to
complete a Confidential Financial Disclosure Report (OGE Form 450).
Coast Guard may not release the reports or the information in them to
the public except under an order issued by a Federal court or as
otherwise provided under the Privacy Act (5 U.S.C. 552a). Applicants
can obtain this form by going to the Web site of the Office of
Government Ethics (www.oge.gov), or by contacting the individual listed
in FOR FURTHER INFORMATION. Applications for a member from the general
public which are not accompanied by a completed OGE Form 450 will not
be considered.
    Registered lobbyists are not eligible to serve on federal advisory
committees in an individual capacity. See ``Revised Guidance on
Appointment of Lobbyist to Federal Advisory Committees, Boards and
Commission'' (79 CFR 47482, August 13, 2014). The position we list for
a member from the general public would be someone appointed in their
individual capacity and would be designated as a Special Government
Employee as defined in 202(a), title 18, U.S.C. Registered lobbyists
are lobbyists required to comply with provisions contained in the
Lobbying Disclosure Act of 1995 (Pub. L. 104-65, as amended by title II
of Pub. L. 110-81).
    The Department of Homeland Security does not discriminate in
selection of Committee members on the basis of race, color, religion,
sex, national origin, political affiliation, sexual orientation, gender
identity, marital status, disability and genetic information, age,
membership in an employee organization, or any other non-merit factor.
The Department of Homeland Security strives to achieve a widely diverse
candidate pool for all of its recruitment actions.
    If you are interested in applying to become a member of the
Committee, send your cover letter and resume to Mr. Jack Kemerer,
Commercial Fishing Safety Advisory Committee Alternate Designated
Federal Officer, via one of the transmittal methods in the ADDRESSES
section by the deadline in the DATES section. Indicate the position you
wish to fill and specify your area of expertise, knowledge, and
experience that qualify you for that position on the Commercial Fishing
Safety Advisory Committee.
    To visit our online docket, go to http://www.regulations.gov, enter
the docket number for this notice (USCG-2015-0672) in the Search box,
and click ``Search''. Please do not post your resume or OGE Form 450 on
this site.

    Dated: September 11, 2015.
V.B. Gifford, Jr.,
Captain, U.S. Coast Guard, Director of Inspections and Compliance.
[FR Doc. 2015-23488 Filed 9-17-15; 8:45 am]
BILLING CODE 9110-04-P