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

agencies to provide services in 

intergovernmental cases. 

Respondents: All state and tribal CSE 

agencies. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per 

response 

Total 

burden hours 

Intergovernmental Reference Guide: State Profile Guidance—(States and 

Territories) .................................................................................................... 54 18 0.3 291.6

Intergovernmental Reference Guide: Tribal Profile Guidance ........................ 62 18 0.3 334.8 

Total .......................................................................................................... ........................ ........................ ........................ 626.4 

Estimated Total Annual Burden 

Hours: 626.4 hours. 

In compliance with the requirements 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Administration, 

Office of Planning, Research and 

Evaluation, 330 C Street SW, 

Washington, DC 20201, Attn: ACF 

Reports Clearance Officer. Email 

address infocollection@acf.hhs.gov. All 

requests should be identified by the title 

of the information collection. 

The department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and, (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Report Clearance Officer. 

[FR Doc. 2017–28443 Filed 1–3–18; 8:45 am] 

BILLING CODE 4184–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–6854] 

Good Abbreviated New Drug 

Application Submission Practices; 

Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Good 

ANDA Submission Practices.’’ This 

guidance is intended to assist applicants 

preparing to submit to FDA abbreviated 

new drug applications (ANDAs). This 

draft guidance highlights common, 

recurring deficiencies that may lead to 

a delay in the approval of an ANDA. It 

also makes recommendations to 

applicants on how to avoid these 

deficiencies with the goal of minimizing 

the number of review cycles necessary 

for approval. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 5, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–D–6854 for ‘‘Good ANDA 

Submission Practices.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 


ethrower on DSK3G9T082PROD with NOTICES
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 


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