Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices 46173 

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: 

Lauren D. Tesh, 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: 

ODAC@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 

biologics license application 761088 for 

CT–P10, a proposed biosimilar to 

Genentech, Inc.’s RITUXAN (rituximab), 

submitted by Celltrion, Inc. The 

proposed indications (uses) for this 

product are for the treatment of adult 

patients with (1) relapsed or refractory, 

low-grade or follicular, CD20-positive, 

B-cell Non-Hodgkin’s Lymphoma (NHL) 

as a single agent; (2) previously 

untreated follicular, CD20-positive, Bcell NHL in combination with first-line 

chemotherapy and, in patients 

achieving a complete or partial response 

to CT–P10 in combination with 

chemotherapy, as single-agent 

maintenance therapy; and (3) nonprogressing (including stable disease), 

low-grade, CD20-positive, B-cell NHL as 

a single agent after first-line 

cyclophosphamide, vincristine, and 

prednisone. 

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 ADDRESSES) on or before 

October 1, 2018, will be provided to the 

committee. Oral presentations from the 

public will be scheduled between 

approximately 11 a.m. and 12 noon. 

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 September 24, 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 

September 25, 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 Lauren D. Tesh 

(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: September 6, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19741 Filed 9–11–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4853] 

Receipt of Notice That a Patent 

Infringement Complaint Was Filed 

Against a Biosimilar Applicant 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing 

notice that an applicant for a proposed 

biosimilar product notified FDA that a 

patent infringement action was filed in 

connection with the applicant’s 

biologics license application (BLA). 

Under the Public Health Service Act 

(PHS Act), an applicant for a proposed 

biosimilar product or interchangeable 

product must notify FDA within 30 days 

after the applicant was served with a 

complaint in a patent infringement 

action described under the PHS Act. 

FDA is required to publish notice of the 

complaint in the Federal Register. 

FOR FURTHER INFORMATION CONTACT: 

Angela Hoague, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6257, 

Silver Spring, MD 20993–0002, 301– 

348–3915, angela.hoague@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Biologics Price Competition and 

Innovation Act of 2009 (BPCI Act) was 

enacted as part of the Patient Protection 

and Affordable Care Act (Pub. L. 111– 

148) on March 23, 2010. The BPCI Act 

amended the PHS Act and created an 

abbreviated licensure pathway for 

biological products shown to be 

biosimilar to, or interchangeable with, 

an FDA-licensed biological reference 


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46174 Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices 

product. Section 351(k) of the PHS Act 

(42 U.S.C. 262(k)), added by the BPCI 

Act, describes the requirements for a 

BLA for a proposed biosimilar product 

or a proposed interchangeable product 

(351(k) BLA). Section 351(l) of the PHS 

Act, also added by the BPCI Act, 

describes certain procedures for 

exchanging patent information and 

resolving patent disputes between a 

351(k) BLA applicant and the holder of 

the BLA reference product. If a 351(k) 

applicant is served with a complaint for 

a patent infringement described in 

section 351(l)(6) of the PHS Act, the 

applicant is required to provide the FDA 

with notice and a copy of the complaint 

within 30 days of service. FDA is 

required to publish notice of a 

complaint received under section 

351(l)(6)(C) of the PHS Act in the 

Federal Register. 

FDA received notice of the following 

complaint under section 351(l)(6)(C) of 

the PHS Act: Genentech, Inc. and City 

of Hope v. Amgen Inc., 1:18–cv–00924– 

GMS (D. Del., filed July 2, 2018). 

FDA has only a ministerial role in 

publishing notice of a complaint 

received under section 351(l)(6)(C) of 

the PHS Act, and does not perform a 

substantive review of the complaint. 

Dated: September 6, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19811 Filed 9–11–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0429] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance on 

Meetings With Industry and 

Investigators on the Research and 

Development of Tobacco Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on ‘‘Guidance on 

Meetings with Industry and 

Investigators on the Research and 

Development of Tobacco Products.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 13, 2018. 

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 November 13, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of November 13, 2018. 

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– 

2012–D–0429 for ‘‘Guidance on 

Meetings with Industry and 

Investigators on the Research and 

Development of Tobacco Products.’’ 

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: 

Amber Sanford, Office of Operations, 


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