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, 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices 46175 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Guidance on Meetings With Industry 

and Investigators on the Research and 

Development of Tobacco Products 

OMB Control Number 0910–0731— 

Extension 

The Family Smoking Prevention and 

Tobacco Control Act (Pub. L. 111–31) 

offers tobacco product manufacturers 

several pathways to obtain an order 

from FDA to authorize the marketing of 

a new tobacco product before it may be 

introduced or delivered into interstate 

commerce. To provide assistance with 

these pathways to market products, FDA 

will meet with tobacco product 

manufacturers, importers, researchers, 

and investigators (or their 

representatives) when appropriate. This 

guidance is intended to assist persons 

who seek meetings with FDA relating to 

their research to inform the regulation of 

tobacco products, or to support the 

development or marketing of tobacco 

products. The original guidance issued 

in 2012 was revised for updating and 

clarity in July 2016. 

In the guidance, the Agency 

discusses, among other things: 

• What information FDA 

recommends persons include in a 

meeting request; 

• How and when to submit a request; 

and 

• What information FDA 

recommends persons submit prior to a 

meeting. 

This guidance describes two 

collections of information: (1) The 

submission of a meeting request 

containing certain information and (2) 

the submission of an information 

package in advance of the meeting. The 

purpose of this proposed information 

collection is to allow FDA to conduct 

meetings with tobacco manufacturers, 

importers, researchers, and investigators 

in an effective and efficient manner. 

FDA issued this guidance and the 

revisions consistent with FDA’s good 

guidance practices regulations (21 CFR 

10.115). 

Meeting Requests: The guidance sets 

forth FDA’s recommendations for 

materials to be included in a request for 

a meeting with FDA to discuss the 

research and development of tobacco 

products. In the guidance, FDA 

recommends that the following 

information be included in the meeting 

request: 

1. Product name and FDA-assigned 

Submission Tracking Number (if 

applicable); 

2. Product category (e.g., cigarettes, 

smokeless tobacco) (if applicable); 

3. Product use (indicate for consumer 

use or for further manufacturing); 

4. Contact information for the 

authorized point of contact for the 

company requesting the meeting; 

5. The topic of the meeting being 

requested (e.g., a new tobacco product 

application, an application for 

permission to market a modified risk 

tobacco product, or investigational use 

of a new tobacco product); 

6. A brief statement of the purpose of 

the meeting, which could include a 

discussion of the types of studies or data 

to be discussed at the meeting, the 

general nature of the primary questions 

to be asked, and where the meeting fits 

in the overall product development 

plans; 

7. A preliminary list of the specific 

objectives/outcomes expected from the 

meeting; 

8. A preliminary proposed agenda, 

including an estimate of the time 

needed and a designated speaker for 

each agenda item; 

9. A preliminary list of specific 

questions, grouped by discipline (e.g., 

chemistry, clinical, nonclinical); 

10. A list of all individuals who will 

attend the meeting on behalf of the 

tobacco product manufacturer, importer, 

researcher, or investigator, including 

titles and responsibilities; 

11. The date on which the meeting 

information package will be received by 

FDA; and 

12. Suggested format of the meeting 

(e.g., conference call, in-person meeting 

at FDA offices, video conference, or 

written response) and suggested dates 

and times for the meeting. Meetings are 

usually scheduled for 1 hour. 

This information will be used by the 

Agency to: (1) Determine the utility of 

the meeting, (2) identify Agency staff 

necessary to discuss proposed agenda 

items, and (3) schedule the meeting. 

Meeting Information Packages: An 

individual submitting a meeting 

information package to FDA in advance 

of a meeting should provide summary 

information relevant to the product and 

supplementary information pertaining 

to any issue raised by the individual or 

FDA to be discussed at the meeting. As 

stated in the guidance, FDA 

recommends that meeting information 

packages generally include updates of 

information that was submitted with the 

meeting request and, as applicable: 

1. Product composition and design 

data summary; 

2. Manufacturing and process control 

data summary; 

3. Nonclinical data summary; 

4. Clinical data summary; 

5. Behavioral and product use data 

summary; 

6. User and nonuser perception data 

summary; and 

7. Investigational plans for studies 

and surveillance of the tobacco product, 

including a summary of proposed study 

protocols containing the following 

information (as applicable): 

a. Study objective(s); 

b. Study hypotheses; 

c. Study design; 

d. Study population (inclusion/ 

exclusion criteria, comparison group(s)); 

e. Human subject protection 

information, including Institutional 

Review Board information; 

f. Primary and secondary endpoints 

(definition and success criteria); 

g. Sample size calculation; 

h. Data collection procedures; 

i. Duration of follow up and baseline 

and follow up assessments, and 

j. Data analysis plan(s). 


daltland on DSKBBV9HB2PROD with NOTICES
46176 Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices 

The purpose of the information 

package is to provide Agency staff the 

opportunity to adequately prepare for 

the meeting, including the review of 

relevant data concerning the product. In 

the Agency’s experience, reviewing 

such information is critical to achieving 

a productive meeting. If the information 

package was previously submitted in 

the meeting request, it should be 

revised, as applicable, so that the 

information reflects the most current 

and accurate information available. 

FDA estimates the burden of this 

collection of information 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 

Total hours 

Meeting Requests 

Combining and Sending Meeting Request Letters for Manufacturers, Importers, and Researchers .......................... 83 1 83 10 830 

Meeting Information Packages 

Combining and Submitting Meeting Information Packages 

for Manufacturers, Importers, and Researchers .............. 83 1 83 18 1,494 

Total .............................................................................. ........................ ........................ ........................ ........................ 2,324 

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

FDA’s estimate of the number of 

respondents for meeting requests in 

table 1 is based on the number of 

meeting requests received and projected 

over the next 3 years. FDA estimates 

that 83 preapplication meetings will be 

requested. 

The hours per response for combining 

and sending meeting request letters are 

estimated at 10 hours each, and the total 

burden hours for meeting requests are 

expected to be 830 hours. Based on 

FDA’s experience, the Agency expects it 

will take respondents this amount of 

time to prepare, gather, copy, and 

submit brief statements about the 

product and a description of the 

purpose and details of the meeting. 

FDA’s estimates that 83 respondents 

will compile meeting information 

packages and submit to FDA at 18 hours 

per response. Based on FDA’s 

experience, the Agency expects that it 

will take respondents 1,494 hours (83 

respondents × 18 hours) to gather, copy, 

and submit brief statements about the 

product, a description of the details of 

the anticipated meeting, and data and 

information that generally would 

already have been generated for the 

planned research and/or product 

development. 

The total number of burden hours for 

this collection of information is 

estimated to be 2,324 hours (830 hours 

to prepare and submit meeting requests 

and 1,494 hours to prepare and submit 

information packages). 

Our estimated burden for the 

information collection reflects an 

overall increase of 16 respondents and 

448 hours. We attribute this adjustment 

to an increase in the number of industry 

meetings as the premarket tobacco 

application compliance deadlines will 

come due in the next 3 years. 

Dated: September 4, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19743 Filed 9–11–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Healthcare Delivery 

and Methodologies Integrated Review Group; 

Clinical Management of Patients in 

Community-based Settings Study Section. 

Date: September 27–28, 2018. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Warwick Denver, 1776 Grant Street, 

Denver, CO 80203. 

Contact Person: Martha L Hare, Ph.D., RN, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3154, 

MSC 7770, Bethesda, MD 20892, (301) 451– 

8504, harem@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Hypertension and Microcirculation. 

Date: October 2, 2018. 

Time: 8:00 a.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road NW, 

Washington, DC 20015. 

Contact Person: Katherine M. Malinda, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4140, 

MSC 7814, Bethesda, MD 20892, 301–435– 

0912, Katherine_Malinda@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Dental, Microbiology and Oral 

Biology. 

Date: October 3, 2018. 

Time: 12:00 p.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Baljit S Moonga, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4214, 

MSC 7806, Bethesda, MD 20892, 301–435– 

1777, moongabs@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR–17– 

094: Maximizing Investigators’ Research 

Award (R35). 

Date: October 10–11, 2018. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 


daltland on DSKBBV9HB2PROD with NOTICES