Federal Register / Vol. 83, No. 3 / Thursday, January 4, 2018 / Notices 533 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Michelle Sollenberger, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1673, 

Silver Spring, MD 20993–0002, 240– 

402–0981. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Good ANDA Submission Practices.’’ 

This draft guidance is intended to assist 

applicants preparing to submit ANDAs 

to FDA. It highlights common, recurring 

deficiencies that may lead to a delay in 

the approval of an ANDA. This draft 

guidance also makes recommendations 

to applicants on how to avoid these 

deficiencies so that applicants can 

submit ANDAs that may be approved in 

the first review cycle. This draft 

guidance has been developed as part of 

FDA’s ‘‘Drug Competition Action Plan,’’ 

which, in coordination with the Generic 

Drug User Fee Amendments (GDUFA I 

and II) (Pub. L. 112–144 and Pub. L. 

115–52, respectively) and other FDA 

activities, is expected to increase 

competition in the market for 

prescription drugs, facilitate entry of 

high-quality and affordable generic 

drugs, and improve public health. 

In conjunction with this draft 

guidance, FDA is issuing a Good ANDA 

Assessment Practices Manual of Policies 

and Procedures, which establishes good 

ANDA assessment practices for the 

Office of Generic Drugs and the Office 

of Pharmaceutical Quality to increase 

their operational efficiency and 

effectiveness. This draft guidance and 

the Manual of Policies and Procedures 

are intended to build upon the success 

of the GDUFA program and to help 

reduce the number of review cycles for 

an ANDA to attain approval. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on good ANDA submission practices. It 

does not establish any rights for any 

person and is not binding on FDA or the 

public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. This draft guidance is not 

subject to Executive Order 12866. 

II. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information that are subject to review by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). The 

collections of information in the draft 

guidance have been approved under 

OMB control numbers 0910–0001 and 

0910–0786. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.regulations.gov. 

Dated: December 26, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–28435 Filed 1–3–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

[FWS–R1–ES–2017–N161; 

FXES11140100000–189–FF01E00000] 

Proposed Graysmarsh Safe Harbor 

Agreement for the Taylor’s 

Checkerspot Butterfly, Clallam County, 

Washington 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Notice of availability; request 

for comments. 

SUMMARY: Graysmarsh, LLC, hereafter 

referred to as the applicant, has applied 

to the U.S. Fish and Wildlife Service 

(Service, us) for an enhancement of 

survival permit (permit) pursuant to the 

Endangered Species Act of 1973, as 

amended. The permit application 

includes a draft safe harbor agreement 

(SHA). The permit would authorize 

incidental take of the endangered 

Taylor’s checkerspot butterfly. We have 

prepared a draft environmental action 

statement (EAS) for our preliminary 

determination that the SHA and permit 

decision may be eligible for categorical 

exclusion under the National 

Environmental Policy Act (NEPA). We 

invite the public to review and 

comment on the permit application, 

draft SHA, and the draft EAS. 

DATES: To ensure consideration, please 

send your written comments by 

February 5, 2018. 

ADDRESSES: You may view or download 

copies of the draft SHA, and draft EAS 

and obtain additional information on 

the internet at http://www.fws.gov/ 

wafwo/ or obtain hard copies or a CD– 

ROM by calling the phone number 

listed below. You may submit 

comments or requests for more 

information by any of the following 

methods: 

• Email: wfwocomments@fws.gov. 

Include ‘‘Graysmarsh SHA’’ in the 

subject line of the message. 

• U.S. Mail: Mark Ostwald, U.S. Fish 

and Wildlife Service, Washington Fish 

and Wildlife Office, 510 Desmond 

Drive, Southeast, Suite 102, Lacey, WA 

98503. 

• In-Person Drop-off, Viewing, or 

Pickup: Call 360–753–9564 to make an 

appointment (necessary for viewing/ 

pickup only) during regular business 


ethrower on DSK3G9T082PROD with NOTICES
534 Federal Register / Vol. 83, No. 3 / Thursday, January 4, 2018 / Notices 

hours at Washington Fish and Wildlife 

Office (address above). 

FOR FURTHER INFORMATION CONTACT: 

Mark Ostwald, U.S. Fish and Wildlife 

Service (by mail at the address in 

ADDRESSES), telephone 360–753–9564. 

If you use a telecommunications device 

for the deaf (TDD), please call the 

Federal Relay Service at 800–877–8339. 

SUPPLEMENTARY INFORMATION: 

Graysmarsh, LLC, hereafter referred to 

as the applicant, has applied to the U.S. 

Fish and Wildlife Service (Service, us) 

for an enhancement of survival permit 

(permit) pursuant to section 10(a)(1)(A) 

of the Endangered Species Act of 1973 

(16 U.S.C. 1531 et seq.; ESA), as 

amended. The permit application 

includes a draft safe harbor agreement 

(SHA), which covers 1,105 acres 

managed by the applicant in Clallam 

County, Washington. The proposed term 

of the permit and the SHA is 50 years. 

The permit would authorize incidental 

take of the endangered Taylor’s 

checkerspot butterfly (Euphydryas 

editha taylori (TCB)) in exchange for 

habitat conservation actions that are 

expected to provide a net conservation 

benefit for the species. We have 

prepared a draft environmental action 

statement (EAS) for our preliminary 

determination that the SHA and permit 

decision may be eligible for categorical 

exclusion under the National 

Environmental Policy Act (43 U.S.C. 

4321 et seq.; NEPA). We invite the 

public to review and comment on the 

permit application, draft SHA, and the 

draft EAS. 

Background 

SHAs are intended to encourage 

private or other non-Federal property 

owners to implement beneficial 

conservation actions for species listed 

under the ESA. SHA permit holders are 

assured that they will not be subject to 

increased property use restrictions as a 

result of their proactive actions to 

benefit listed species. Incidental take of 

listed species is authorized under a SHA 

permit pursuant to the provisions of 

section 10(a)(1)(A) of the ESA. For an 

applicant to receive a permit through an 

SHA, the applicant must submit an 

application form that includes the 

following: 

(1) The common and scientific names 

of the listed species for which the 

applicant requests incidental take 

authorization; 

(2) A description of how incidental 

take of the listed species pursuant to the 

SHA is likely to occur, both as a result 

of management activities and as a result 

of the return to baseline; and 

(3) A description of how the SHA 

complies with the requirements of the 

Service’s Safe Harbor policy. 

For the Service to issue a permit, we 

must determine that: 

(1) The take of listed species will be 

incidental to an otherwise lawful 

activity and will be in accordance with 

the terms of the SHA; 

(2) The implementation of the terms 

of the SHA is reasonably expected to 

provide a net conservation benefit to the 

covered species by contributing to its 

recovery, and the SHA otherwise 

complies with the Service’s Safe Harbor 

Policy (64 FR 32717, June 17, 1999); 

(3) The probable direct and indirect 

effects of any authorized take will not 

appreciably reduce the likelihood of 

survival and recovery in the wild of any 

listed species; 

(4) Implementation of the terms of the 

SHA is consistent with applicable 

Federal, state, and tribal laws and 

regulations; 

(5) Implementation of the terms of the 

SHA will not be in conflict with any 

ongoing conservation or recovery 

programs for listed species covered by 

the permit; and 

(6) The applicant has shown 

capability for and commitment to 

implementing all of the terms of the 

SHA. 

The Service’s Safe Harbor Policy (64 

FR 32717) and the Safe Harbor 

Regulations (68 FR 53320, 69 FR 24084) 

provide important terms and concepts 

for developing SHAs. The Service’s Safe 

Harbor policy and regulations are 

available at the following website: 

http://www.fws.gov/endangered/lawspolicies/regulations-and-policies.html. 

Proposed Action 

The applicant has submitted a draft 

SHA for the TCB that covers 

approximately 1,105 acres of land 

(enrolled property) in Clallam County, 

Washington. The enrolled property is 

primarily operated as a commercial 

lavender and berry farm (‘‘u-pick 

farm’’), and a private recreational area 

and homestead. There are also some 

non-agricultural areas of mowed 

grasslands, marsh, and forest. 

The applicant worked closely with 

the Service to establish the baseline and 

develop the SHA. Habitat surveys for 

the TCB have shown there are 40.5 acres 

of TCB baseline habitat within the 

enrolled property. The baseline habitat 

contains three habitat types: Upland 

grass and forb occupied by the covered 

species (15.3 acres), and a buffer 

consisting of emergent marsh/wetland 

(18.7 acres) and beach upland (6.5 

acres). For specific details about 

baseline conditions, see the draft SHA. 

Within the 40.5 acres, the applicant 

will perform habitat management 

activities for the benefit of the TCB. 

Within the area occupied by the TCB, 

the applicant will maintain and 

potentially enhance habitat. This will 

include annual hand removal of Scotch 

broom (Cytisus scoparius) until it is 

considered eradicated. Additional nondesirable vegetation may also be 

removed if necessary. Plantings of 

certain vegetation to benefit the TCB 

may also occur. The applicant will 

maintain fencing and signage to impede 

illegal public trespass onto baseline 

habitat. 

The applicant will conduct annual 

surveys of the TCB during its flight 

period and also monitor the status of 

baseline habitat relative to the metrics 

described in the SHA. Additional 

monitoring will also include 

observations regarding public access, 

describing any research and data 

collection, and any emerging issues that 

could influence the success of the SHA. 

The applicant will monitor and report 

in years 1, 3, and 5 of the SHA, and 

every 3 years thereafter (except for adult 

TCB surveys, which will be conducted 

annually). 

These activities will require the 

applicant to enter habitat occupied by 

the TCB as needed over the course of 

the year, but mainly during the spring 

flight season for the TCB. Depending on 

the timing, these activities could result 

in take of TCB larva and possibly adult 

butterflies, mainly as a result of 

inadvertent trampling. Continued 

removal of Scotch broom and other 

invasive plant species and the planting 

of target host plants could result in 

temporary disturbance of TCB habitat 

and also result in take if TCB is present 

in the affected areas. The timing and 

extent of these activities will occur in a 

manner to minimize incidental take. 

There is also a low potential for take of 

TCB to occur within other areas of the 

property as a result of interactions 

between agricultural activities and adult 

butterflies. Examples of the potential for 

incidental take include inadvertent 

harm during routine agricultural 

operations, mainly associated with 

annual seeding (plowing and disking) of 

barley, mowing lawns, moving and 

replacing irrigation lines, and managing 

and harvesting berries. 

National Environmental Policy Act 

Compliance 

The development of the draft SHA 

and the proposed issuance of an 

enhancement of survival permit is a 

Federal action that triggers the need for 

compliance with the NEPA (42 U.S.C. 

4321 et seq.). We have prepared a draft 


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Federal Register / Vol. 83, No. 3 / Thursday, January 4, 2018 / Notices 535 

EAS to analyze the impacts of permit 

issuance and implementation of the 

SHA on the human environment in 

comparison to the no-action alternative. 

We have made a preliminary 

determination that issuing the permit 

and implementing the SHA would have 

minor or negligible impacts to the 

environment, and thus the proposed 

SHA and permit actions are eligible for 

categorical exclusion under NEPA. The 

basis for our preliminary determination 

is contained in the EAS, which is 

available for public review (see 

ADDRESSES). 

Public Comments 

You may submit your comments and 

materials by one of the methods listed 

in the ADDRESSES section. We request 

data, new information, or comments 

from the public, other concerned 

governmental agencies, Tribes, the 

scientific community, industry, or any 

other interested party via this notice on 

our proposed Federal action. 

Public Availability of Comments 

All comments and materials we 

receive become part of the public record 

associated with this action. Before 

including your address, phone number, 

email address, or other personal 

identifying information in your 

comments, 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. All comments received from 

organizations, businesses, or individuals 

representing organizations or businesses 

are available for public inspection in 

their entirety. Comments and materials 

we receive will be available for public 

inspection by appointment, during 

normal business hours, at our office (see 

ADDRESSES). 

Next Step 

The Service will evaluate the permit 

application, draft SHA, and public 

comments submitted thereon to 

determine whether the permit 

application meets the requirements of 

section 10(a)(1)(A) of the ESA and 

NEPA regulations. The final NEPA and 

permit determinations will not be 

completed until after the end of the 30- 

day comment period and full 

consideration of all comments received 

during the comment period. If we 

determine that all requirements are met, 

we will issue the applicant an 

enhancement of survival permit under 

section 10(a)(1)(A) of the ESA. 

Authority 

We provide this notice pursuant to 

section 10(c) of the ESA (16 U.S.C. 1531 

et seq.), its implementing regulations 

(50 CFR 17.22), and NEPA (42 U.S.C. 

4321 et seq.) and its implementing 

regulations (40 CFR 1506.6). 

Theresa E. Rabot, 

Deputy Regional Director, Pacific Region, U.S. 

Fish and Wildlife Service. 

[FR Doc. 2017–28490 Filed 1–3–18; 8:45 am] 

BILLING CODE 4333–15–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

[Docket No. FWS–HQ–IA–2017–0095; 

FXIA16710900000–178–FF09A30000] 

Endangered Species Receipt of Permit 

Applications 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Notice of receipt of permit 

applications. 

SUMMARY: We, the U.S. Fish and 

Wildlife Service, invite the public to 

comment on applications to conduct 

certain activities with foreign 

endangered species, marine mammals, 

or both. With some exceptions, the 

Endangered Species Act (ESA) prohibit 

activities with listed species unless 

Federal authorization is acquired that 

allows such activities. The ESA also 

requires that we invite public comment 

before issuing these permits. 

DATES: We must receive comments by 

February 5, 2018. 

ADDRESSES: Document availability: The 

applications, as well as any comments 

and other materials that we receive, will 

be available for public inspection online 

in Docket No. FWS–HQ–IA–2017–0095 

at http://www.regulations.gov. 

Submitting Comments: You may 

submit comments by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments 

on Docket No. FWS–HQ–IA–2017–0095. 

• U.S. mail or hand-delivery: Public 

Comments Processing, Attn: Docket No. 

FWS–HQ–IA–2017–0095; U.S. Fish and 

Wildlife Service Headquarters, MS: 

BPHC; 5275 Leesburg Pike, Falls 

Church, VA 22041–3803. 

When submitting comments, please 

indicate the name of the applicant and 

the PRT# at the beginning of your 

comment. We will post all comments on 

http://www.regulations.gov. This 

generally means that we will post any 

personal information you provide us 

(see SUPPLEMENTARY INFORMATION for 

more information). 

FOR FURTHER INFORMATION CONTACT: 

Joyce Russell, 703–358–2280. 

SUPPLEMENTARY INFORMATION: 

I. Public Comment Procedures 

A. How do I comment on submitted 

applications? 

You may submit your comments and 

materials by one of the methods listed 

under Submitting Comments in the 

ADDRESSES section. We will not 

consider comments sent by email or fax, 

or to an address not in the ADDRESSES

section. 

Please make your requests or 

comments as specific as possible, 

confine your comments to issues for 

which we seek comments in this notice, 

and explain the basis for your 

comments. Include sufficient 

information with your comments to 

allow us to authenticate any scientific or 

commercial data you include. 

The comments and recommendations 

that will be most useful and likely to 

influence agency decisions are: (1) 

Those supported by quantitative 

information or studies; and (2) Those 

that include citations to, and analyses 

of, the applicable laws and regulations. 

We will not consider or include in our 

administrative record comments we 

receive after the close of the comment 

period (see DATES or comments 

delivered to an address other than those 

listed above in ADDRESSES). 

B. May I review comments submitted by 

others? 

Comments, including names and 

street addresses of respondents, will be 

available for public review at the street 

address listed under ADDRESSES. The 

public may review documents and other 

information applicants have sent in 

support of the application unless our 

allowing viewing would violate the 

Privacy Act or Freedom of Information 

Act. 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. 

C. Who will see my comments? 

If you submit a comment via http://

www.regulations.gov, your entire 

comment, including any personal 

identifying information, will be posted 


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