45942 Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices 

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: 

Moon Hee V. Choi, 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: 

AADPAC@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 be asked 

to discuss new drug application (NDA) 

210730, for oliceridine 1 milligram/ 

milliliter injection, submitted by 

Trevena, Inc., for the management of 

moderate-to-severe acute pain in adult 

patients for whom an intravenous 

opioid is warranted. The committee will 

also be asked to discuss the efficacy and 

safety data and benefit-risk 

considerations. 

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 3, 2018, will be provided to the 

committee. Oral presentations from the 

public will be scheduled between 

approximately 1 p.m. and 2 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 September 25, 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 26, 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 Moon Hee V. 

Choi (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 4, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19667 Filed 9–10–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–0286] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry: Formal Meetings Between the 

Food and Drug Administration and 

Biosimilar Biological Product 

Sponsors or Applicants 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) 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. 

DATES: Fax written comments on the 

collection of information by October 11, 

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 0910–0802. 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: Formal 

Meetings between the Food and Drug 

Administration and Biosimilar 

Biological Product Sponsors or 

Applicants. 

OMB Control No. 0910–0802— 

Extension. 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices 45943 

This information collection supports 

the above captioned Agency guidance. 

The Biologics Price Competition and 

Innovation Act of 2009, the Biosimilar 

User Fee Act of 2012, and the recent 

passage of the Biosimilar User Fee 

Amendments of 2017 (BsUFA II) under 

Title IV of the FDA Reauthorization Act 

of 2017, authorize user fees for 

biosimilar biological products. FDA has 

committed to meeting certain 

performance goals in connection with 

the reauthorized biosimilar user fee 

program. To provide recommendations 

to industry on formal meetings between 

FDA and sponsors or applicants relating 

to the development and review of 

biosimilar biological products regulated 

by the Center for Drug Evaluation and 

Research (CDER) or the Center for 

Biologics Evaluation and Research 

(CBER) and assist sponsors and 

applicants in generating and submitting 

meeting requests and the associated 

meeting packages to FDA for biosimilar 

biological products, we developed 

guidance for industry entitled ‘‘Formal 

Meetings Between FDA and Biosimilar 

Biological Products Sponsors or 

Applicants.’’ The guidance describes 

our current thinking on how we intend 

to interpret and apply certain provisions 

of BsUFA II and provides information 

on specific performance goals for the 

management of meetings associated 

with the development and review of 

biosimilar biological products. The 

guidance document includes two types 

of information collection: (1) The 

submission of a meeting request 

containing certain information and (2) 

the submission of the information 

package(s) that accompany the meeting 

request. 

A. Request for a Meeting 

Under the guidance, a sponsor or 

applicant interested in meeting with 

CDER or CBER should submit a meeting 

request to the sponsor’s or applicant’s 

application (i.e., investigational new 

drug application, biologics license 

application). If there is no application, 

a sponsor or applicant should submit 

the request to either the appropriate 

CDER division director, with a copy 

sent to the division’s chief of project 

management staff, or to the division 

director of the appropriate product 

office within CBER, but only after first 

contacting the appropriate review 

division or the Biosimilars Program 

staff, CDER, Office of New Drugs to 

determine to whom the request should 

be directed, how it should be submitted, 

and the appropriate format for the 

request and to arrange for confirmation 

of receipt of the request. Under the 

guidance, FDA requests that sponsors 

and applicants incorporate certain 

information in the meeting request, 

including: 

1. Product name, 

2. application number (if applicable), 

proposed proper name or proper name 

(post licensure), 

4. structure, 

5. reference product name, 

6. proposed indication(s) or context of 

product development, 

7. meeting type being requested (the 

rationale for requesting the meeting type 

should be included), 

8. a brief statement of the purpose of 

the meeting, including a brief 

background of the issues underlying the 

agenda. It can also include a brief 

summary of completed or planned 

studies and clinical trials or data the 

sponsor or applicant intends to discuss 

at the meeting, the general nature of the 

critical questions to be asked, and where 

the meeting fits in the overall 

development plans. 

9. a list of specific objectives/ 

outcomes expected from the meeting, 

10. a proposed agenda, including 

times required for each agenda item, 

11. a list of questions grouped by 

discipline and a brief explanation of the 

context and purpose of each question, 

12. a list of all individuals with their 

titles and affiliations who will attend 

the requested meeting from the 

requestor’s organization and 

consultants, 

13. a list of FDA staff, if known, or 

disciplines asked to participate in the 

requested meeting, 

14. suggested dates and times for the 

meeting, and 

15. the proposed format of the 

meeting (i.e., face to face meeting, 

teleconference, or videoconference). 

This information will be used by FDA 

to determine the utility of the meeting, 

to identify FDA staff necessary to 

discuss proposed agenda items, and to 

schedule the meeting. 

B. Information Package 

FDA requests that a sponsor or 

applicant submit a meeting package to 

the appropriate review division with the 

meeting request. FDA recommends that 

the information packages generally 

include: 

1. Product name and application 

number (if applicable), 

2. proposed proper name or proper 

name (post licensure), 

3. structure, 

4. reference product name, 

5. proposed indication(s) or context of 

product development, 

6. dosage form, route of 

administration, dosing regimen 

(frequency and duration), and 

presentation(s), 

7. a list of all sponsor’s or applicant’s 

attendees and consultants with their 

titles and affiliations who will attend 

the requested meeting, 

8. background that includes a brief 

history of the development program and 

the status of product development (e.g., 

chemistry, manufacturing, and controls; 

nonclinical; and clinical, including any 

development outside the United States, 

as applicable), 

9. a brief statement summarizing the 

purpose of the meeting, 

10. the proposed agenda, 

11. a list of questions for discussion 

grouped by discipline and with a brief 

summary for each question to explain 

the need or context for the question, and 

12. data to support discussion 

organized by discipline and question. 

The purpose of the meeting package is 

to provide FDA staff the opportunity to 

adequately prepare for the meeting, 

including the review of relevant data 

concerning the product. 

Description of Respondents: A 

sponsor or applicant for a biosimilar 

biological product who requests a 

formal meeting with FDA regarding the 

development and review of a biosimilar 

biological product. 

In the Federal Register of June 18, 

2018 (83 FR 28234), we published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. No comments were 

received. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

GFI: Formal meetings between FDA and biosimilar 

biological product sponsors or applicants 

Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

CDER Meeting Requests ..................................................... 36 2.5 89 15 1,335 

CBER Meeting Requests ..................................................... 2 1 2 15 30 

CDER Information Packages ............................................... 29 2.2 64 30 1,920 


daltland on DSKBBV9HB2PROD with NOTICES
45944 Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

GFI: Formal meetings between FDA and biosimilar 

biological product sponsors or applicants 

Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

CBER Information Packages ............................................... 2 2 4 30 120 

Total .............................................................................. ........................ ........................ ........................ ........................ 3,405 

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

Since last OMB approval, there has 

been an increase in meeting requests 

with CDER and a corresponding 

increase in the number of information 

packages. Accordingly, we have 

adjusted our estimate upward by six 

respondents to CDER meeting requests. 

We attribute this change to an increase 

in biosimilar product development. 

Dated: September 4, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19674 Filed 9–10–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–3151] 

Postapproval Changes to Drug 

Substances; 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 

‘‘Postapproval Changes to Drug 

Substances.’’ This draft guidance 

provides recommendations to holders of 

approved new drug applications, 

abbreviated new drug applications, new 

animal drug applications, abbreviated 

new animal drug applications, and 

holders of drug master files and 

veterinary master files who may want to 

make a change to the drug substance 

manufacturing process during the drug 

product application postapproval 

period. The draft guidance applies to 

synthetic drug substances and the 

synthetic steps involved in the 

preparation of semisynthetic drug 

substances. The draft guidance covers 

facility, scale, and equipment changes 

associated with all steps of drug 

substance manufacturing; specification 

changes to starting materials, raw 

materials, intermediates, and the 

unfinished and final drug substance; 

synthetic manufacturing process 

changes; changes in the source of drug 

substance; and change to container 

closure system of the drug substance. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by November 13, 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– 

2018–D–3151 for ‘‘Postapproval 

Changes to Drug Substances.’’ 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 

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 


daltland on DSKBBV9HB2PROD with NOTICES