29792 Federal Register / Vol. 83, No. 123 / Tuesday, June 26, 2018 / Notices 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–N–1073 for ‘‘Antimicrobial Drugs 

Advisory Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments.’’ Received 

comments, those filed in a timely 

manner (see the ADDRESSES section), 

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.’’ FDA 

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 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 the 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: 

Kalyani Bhatt, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, Fax: 301–847–8533, email: 

AMDAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

FDA’s website at https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before coming to the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The committee will discuss 

new drug application (NDA) 210607, 

tafenoquine tablet, 100 milligram (mg), 

sponsored by 60 Degrees 

Pharmaceuticals, LLC, for the proposed 

indication of prevention of malaria in 

adults for up to 6 months of continuous 

dosing. 

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 website 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 website after 

the meeting. Background material is 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. All electronic and 

written submissions submitted to the 

Docket (see the ADDRESSES section) on 

or before July 12, 2018, will be provided 

to the committee. Oral presentations 

from the public will be scheduled 

between approximately 1:30 p.m. and 

2:30 p.m. Those individuals interested 

in making formal oral presentations 

should notify the contact person and 

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 on 

or before July 3, 2018. 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 July 5, 2018. 

Persons attending FDA’s advisory 

committee meetings are advised that 

FDA is not responsible for providing 

access to electrical outlets. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Kalyani Bhatt 

(see FOR FURTHER INFORMATION CONTACT) 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.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: June 21, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–13711 Filed 6–25–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–6209] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry: Assessing User Fees Under 

the Biosimilar User Fee Amendments 

of 2017 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 123 / Tuesday, June 26, 2018 / Notices 29793 

DATES: Fax written comments on the 

collection of information by July 26, 

2018. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0718. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Guidance for Industry: Assessing User 

Fees Under the Biosimilar User Fee 

Amendments of 2017 

OMB Control Number 0910–0718— 

Revision 

This information collection supports 

the above captioned Agency guidance 

and implementation of the Biosimilar 

User Fee Amendments of 2017 (BsUFA 

II). Under BsUFA II, FDA’s authority is 

extended to collect user fees from fiscal 

years 2018–2022 and includes a number 

of technical revisions that affect what 

fees and how fees are collected. Fees 

authorized by this legislation help fund 

the review process for biosimilar 

biological product applications and play 

an important role in expediting the 

review and approval process. 

We have developed the guidance 

document entitled ‘‘Assessing User Fees 

Under the Biosimilar User Fee 

Amendments of 2017’’ to assist industry 

in understanding when these fees are 

incurred and the process by which 

applicants can submit payments. The 

guidance also provides information on 

the consequences of failing to pay 

BsUFA II fees, as well as processes for 

submitting reconsideration and appeal 

requests. The guidance document is 

available on our website at: https://

www.fda.gov/downloads/Drugs/ 

GuidanceComplianceRegulatory

Information/Guidances/ 

UCM584984.pdf. 

In the Federal Register of November 

16, 2017 (82 FR 53505), we published a 

notice announcing availability of the 

subject guidance document, including a 

60-day notice requesting public 

comment on the information collection. 

One comment was received in response 

to the notice from a trade organization 

indicating that interested persons ‘‘have 

reviewed the draft guidance and 

appreciate(s) FDA applying the user fee 

provisions consistent with the BsUFA II 

negotiations and Commitment Letter.’’ 

In addition, and upon our own review, 

we believe it is appropriate to include 

the guidance document under the 

existing information collection 

‘‘Biosimilar User Fee Cover Sheet’’ 

currently approved under OMB control 

number 0910–0718 rather than to 

establish a new collection. FDA is 

preparing to renew OMB control 

number 0910–0718 and will include the 

guidance document accordingly. 

We estimate the burden of the 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(hours) 

Total hours 

Request for discontinuation from biological product development program ............................................................... 2 1 2 1 2 

Request to move products to discontinued section of the 

biosimilar list ..................................................................... 5 1 5 * 0.5 2.5 

Small business waiver of the BsUFA application fee .......... 1 1 1 16 16 

Small business waiver reconsiderations .............................. 1 1 1 24 24 

Small business waiver appeals ........................................... 1 1 1 12 12 

Annual Fee Determination Survey ....................................... 35 1 35 1 35 

Annual BsUFA Fees Correspondence ................................ 35 1 35 2 70 

Total .............................................................................. ........................ ........................ ........................ ........................ 161.5 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

* 30 minutes. 

Our estimate is based on the number 

of Biosimilars User Fee submissions we 

have received since establishing the 

program. 

Dated: June 21, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–13688 Filed 6–25–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Vaccine Injury Compensation 

Program; List of Petitions Received 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HRSA is publishing this 

notice of petitions received under the 

National Vaccine Injury Compensation 

Program (the Program), as required by 

the Public Health Service (PHS) Act, as 

amended. While the Secretary of HHS is 

named as the respondent in all 

proceedings brought by the filing of 

petitions for compensation under the 

Program, the United States Court of 

Federal Claims is charged by statute 

with responsibility for considering and 

acting upon the petitions. 

FOR FURTHER INFORMATION CONTACT: For 

information about requirements for 

filing petitions and the Program in 

general, contact Lisa L. Reyes, Clerk of 

Court, United States Court of Federal 


sradovich on DSK3GMQ082PROD with NOTICES