Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices 2461 

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 5 years 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 § 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 

§ 60.30, including but not limited to: 

must be timely (see DATES), must be 

filed in accordance with § 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: January 11, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00684 Filed 1–16–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

[FWS–R1–ES–2017–N135; FF01EWFW00– 

FXES111601M000] 

Marine Mammal Protection Act; Stock 

Assessment Report for the Northern 

Sea Otter in Washington 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Notice of availability; request 

for comments. 

SUMMARY: In accordance with the 

Marine Mammal Protection Act of 1972, 

as amended, and its implementing 

regulations, we, the U.S. Fish and 

Wildlife Service, have developed a draft 

revised marine mammal stock 

assessment report for the northern sea 

otter stock in the State of Washington. 

We now make the draft stock 

assessment report available for public 

review and comment. 

DATES: We will consider comments that 

are received or postmarked on or before 

April 17, 2018. 

ADDRESSES: If you wish to review the 

draft revised stock assessment report for 

the northern sea otter stock in 

Washington, you may obtain a copy 

from our website at http://www.fws.gov/ 

wafwo. Alternatively, you may contact 

the Washington Fish and Wildlife 

Office, 510 Desmond Dr., Suite 102, 

Lacey, WA 98503 (telephone: 360–753– 

9440). If you wish to comment on the 

stock assessment report, you may 

submit your comments in writing by 

any one of the following methods: 

• U.S. mail: State Supervisor, at the 

above address; 

• Hand delivery: Washington Fish 

and Wildlife Office at the above address; 

• Fax: 360–753–9565; or 

• Email: fw1_waseaottersar@fws.gov. 

FOR FURTHER INFORMATION CONTACT: 

Deanna Lynch, at the above street 

address, by telephone (360–753–9545), 

or by email (deanna_lynch@fws.gov). 

Persons who use a telecommunications 

device for the deaf (TDD) may call the 

Federal Relay Service at 800–877–8339. 

SUPPLEMENTARY INFORMATION: We 

announce the availability for review and 

comment of a draft revised marine 

mammal stock assessment report (SAR) 

for the northern sea otter (Enhydra lutris 

kenyoni) stock in the State of 

Washington. 

Background 

Under the Marine Mammal Protection 

Act of 1972, as amended (MMPA; 16 

U.S.C. 1361 et seq.), and its 

implementing regulations in the Code of 

Federal Regulations (CFR) at 50 CFR 

part 18, the U.S. Fish and Wildlife 

Service (Service) regulates the taking; 

import; and, under certain conditions, 

possession; transportation; purchasing; 

selling; and offering for sale, purchase, 

or export, of marine mammals. One of 

the goals of the MMPA is to ensure that 

stocks of marine mammals occurring in 

waters under U.S. jurisdiction do not 

experience a level of human-caused 

mortality and serious injury that is 

likely to cause the stock to be reduced 

below its optimum sustainable 

population (OSP) level. OSP is defined 

under the MMPA as ‘‘the number of 

animals which will result in the 

maximum productivity of the 

population or the species, keeping in 

mind the carrying capacity of the habitat 

and the health of the ecosystem of 

which they form a constituent element’’ 

(16 U.S.C. 1362(9)). 

To help accomplish the goal of 

maintaining marine mammal stocks at 

their OSPs, section 117 of the MMPA 

requires the Service and the National 

Marine Fisheries Service (NMFS) to 

prepare a SAR for each marine mammal 

stock that occurs in waters under U.S. 

jurisdiction. A SAR must be based on 

the best scientific information available; 

therefore, we prepare it in consultation 

with established regional scientific 

review groups established under 117(d) 

of the MMPA. Each SAR must include: 

1. A description of the stock and its 

geographic range; 

2. A minimum population estimate, 

current and maximum net productivity rate, 

and current population trend; 

3. An estimate of the annual human-caused 

mortality and serious injury by source and, 

for a strategic stock, other factors that may be 

causing a decline or impeding recovery of the 

stock; 

4. A description of commercial fishery 

interactions; 

5. A categorization of the status of the 

stock; and 

6. An estimate of the potential biological 

removal (PBR) level. 

The MMPA defines the PBR as ‘‘the 

maximum number of animals, not 

including natural mortalities, that may 

be removed from a marine mammal 

stock while allowing that stock to reach 

or maintain its [OSP]’’ (16 U.S.C. 

1362(20)). The PBR is the product of the 

minimum population estimate of the 

stock (Nmin); one-half the maximum 

theoretical or estimated net productivity 

rate of the stock at a small population 

size (Rmax); and a recovery factor (Fr) of 

between 0.1 and 1.0, which is intended 

to compensate for uncertainty and 

unknown estimation errors. This can be 

written as: 

PBR = (Nmin)(1⁄2 of the Rmax)(Fr) 

Section 117 of the MMPA also 

requires the Service and NMFS to 

review the SARs (a) at least annually for 

stocks that are specified as strategic 

stocks, (b) at least annually for stocks for 

which significant new information is 

available, and (c) at least once every 3 

years for all other stocks. If our review 

of the status of a stock indicates that it 

has changed or may be more accurately 

determined, then the SAR must be 

revised accordingly. 

A strategic stock is defined in the 

MMPA as a marine mammal stock ‘‘(A) 

for which the level of direct humancaused mortality exceeds the [PBR] 

level; (B) which, based on the best 

available scientific information, is 


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2462 Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices 

declining and is likely to be listed as a 

threatened species under the 

Endangered Species Act of 1973, [as 

amended] (16 U.S.C. 1531 et seq.) [the 

‘‘ESA’’], within the foreseeable future; 

or (C) which is listed as a threatened 

species or endangered species under the 

[ESA], or is designated as depleted 

under [the MMPA]’’ 16 U.S.C. 1362(19). 

Stock Assessment Report History for 

the Northern Sea Otter in Washington 

The Washington sea otter SAR was 

last revised in August 2008. The 

Washington sea otter is not a strategic 

stock, thus the Service is required to 

review the stock assessment at least 

once every 3 years. The Service 

reviewed the Washington sea otter SAR 

in 2011 and concluded that a revision 

was not warranted because the status of 

the stock had not changed, nor could it 

be more accurately determined. 

However, upon review in 2016, the 

Service determined that revision was 

warranted because of changes in 

population estimates and distribution. 

Summary of Draft Revised Stock 

Assessment Report for the Northern Sea 

Otter in the State of Washington 

The following table summarizes some 

of the information contained in the draft 

revised SAR for northern sea otters in 

Washington State, which includes the 

stock’s Nmin, Rmax, Fr, PBR, annual 

estimated human-caused mortality and 

serious injury, and status. After 

consideration of any public comments 

we receive, the Service will revise and 

finalize the SAR, as appropriate. We 

will publish a notice of availability and 

summary of the final SAR, including 

responses to submitted comments. 

SUMMARY—DRAFT STOCK ASSESSMENT REPORT FOR THE NORTHERN SEA OTTER IN WASHINGTON STATE

Stock Nmin Rmax Fr PBR Annual estimated human-caused 

mortality and serious injury Stock status 

Northern Sea Otter 

(Washington 

State).

1,806 0.20 0.1 18 Figures by specific source, where 

known, are provided in the SAR.

Non-Strategic. 

Public Availability of Comments 

Before including your address, phone 

number, email address, or other 

personal identifying information in your 

comment, you should be aware that 

your entire comment—including your 

personal identifying information—may 

be made publicly available at any time. 

While you can ask us in your comment 

to withhold your personal identifying 

information from public review, we 

cannot guarantee that we will be able to 

do so. 

References 

In accordance with the MMPA, we 

include in this notice a list of the 

information sources and public reports 

upon which we based the SAR: 

Bigg, M.A. and I.B. MacAskie. 1978. Sea 

otters re-established in British Columbia. J. 

Mammalogy 59 (4):874–876. 

Department Fisheries and Oceans, Canada 

(DFO). 2015. Trends in the abundance and 

distribution of sea otters (Enhydra lutris) in 

British Columbia updated with 2013 

survey results. DFO Can. Sci. Advis. Sec. 

Sci. Advis. Rep. 2015/043. 

DeMaster, D.P., C. Marzin, and R.J. Jameson. 

1996. Estimating the historical abundance 

of sea otters in California. Endangered 

Species Update 13(12):79–81. 

Estes, J.A. 1990. Growth and equilibrium in 

sea otter populations. J. Anim. Ecol. 

59:358–401. 

Hatfield, B.B., J.A. Ames, J.A. Estes, M.T. 

Tinker, A.B. Johnson, M.M Staelder, and 

M.D. Harris. 2011. Sea otter mortality in 

fish and shellfish traps: estimated potential 

impacts and exploring possible solutions. 

Endangered Species Research 13:219–229. 

Hatfield, B.B. and J.A. Estes. 2000. 

Preliminary results of an evaluation of the 

potential threat to sea otters posed by the 

nearshore finfish trap fishery. 

Unpublished, 6 pp. + appendices. 

Jameson, R.J., K.W. Kenyon, A.M. Johnson, 

and H.M. Wight. 1982. History and status 

of translocated sea otter populations in 

North America. Wildl. Soc. Bull. 10:100– 

107. 

Jameson, R.J., K.W. Kenyon, S.Jeffries and 

G.R. VanBlaricom. 1986. Status of a 

translocated sea otter and its habitat in 

Washington. Murrelet 67:84–87. 

Jameson, R.J. 1996. Status reports: West Coast 

translocation projects, Oregon and 

Washington. The Otter Raft No. 55, Page 8. 

Jameson, R.J., and S. Jeffries. 1999. Results of 

the 1999 Survey of the Washington Sea 

Otter 

Population. Unpublished Report. 5 pp. 

Jeffries, S., D. Lynch, and S. Thomas. 2016. 

Results of the 2016 Survey of the 

Reintroduced Sea Otter Population in 

Washington State. Unpublished Report. 9 

pp. Copies may be obtained from the 

Washington Department of Fish and 

Wildlife or U.S. Fish and Wildlife Service’s 

Washington Fish and Wildlife Office. 

Laidre, K., R.J. Jameson, S.J. Jeffries, and E. 

Gurarie. 2011. Updated estimates of 

carrying capacity for sea otters in 

Washington state. Unpublished final 

contract report, December 31, 2011, 12 pp. 

+ appendix. 

Lance, M.M., S.A. Richardson, and H. Allen. 

2004. State of Washington sea otter 

recovery plan. WDFW, Olympia WA. 91 

pp. 

Riedman, M.L., and J.A. Estes. 1990. The sea 

otter (Enhydra lutris): behavior, ecology, 

and natural history. U.S. Fish and Wildlife 

Service, Washington, DC, Biological Report 

90(14). 126 pp. 

Scheffer, V.B. 1940. The sea otter on the 

Washington coast. Pacific Northwest 

Quarterly, 3:370–388. 

Taylor, B.L., M. Scott, J. Heyning, and J. 

Barlow. 2003. Suggested guidelines for 

recovery factors for endangered marine 

mammals. NOAA Technical Memorandum 

NOAA–TM–NMFS–SWFSC–354, 

September 2003. 6 pp. 

Wilson, D.E., M.A. Bogan, R.L. Brownell, Jr., 

A.M. Burdin, and M.K. Maminov. 1991. 

Geographic variation in sea otters, Enhydra 

lutris. J. Mammal. 72(1):22–36. 

Authority 

The authority for this action is the 

Marine Mammal Protection Act of 1972, 

as amended (16 U.S.C. 1361 et seq.). 

Dated: November 30, 2017. 

James W. Kurth, 

Deputy Director, U.S. Fish and Wildlife 

Service, Exercising the Authority of the 

Director, U.S. Fish and Wildlife Service. 

[FR Doc. 2018–00672 Filed 1–16–18; 8:45 am] 

BILLING CODE 4333–15–P 

DEPARTMENT OF THE INTERIOR 

Bureau of Indian Affairs 

[189A2100DD/AAKC001030/ 

A0A501010.999900 253G] 

Indian Gaming; Approval of an 

Amendment to a Tribal-State Class III 

Gaming Compact in the State of 

Washington 

AGENCY: Bureau of Indian Affairs, 

Interior. 

ACTION: Notice. 

SUMMARY: The Puyallup Tribe of the 

Puyallup Reservation negotiated the 

Fifth Amendment to the Tribal-State 

Compact for Class III Gaming between 

the Puyallup Indian Tribe and the State 

of Washington governing Class III 


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