46170 Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices 

suggestion and will implement the 

revision. 

We also received comment that some 

users have experienced ‘‘timing out’’ 

while completing Form FDA 3500B 

online and requested that any time limit 

for completing online forms be 

extended. We were not aware of this 

issue and will investigate to see whether 

it relates to the online functionality of 

the form. If so, we will make the 

necessary adjustments. 

While we are especially appreciative 

of the comments received in response to 

our notice, we continue to welcome 

feedback at all times regarding ways we 

might improve the MedWatch Program 

and the associated forms. In addition to 

the revisions discussed previously, on 

our own initiative we are now including 

burden associated with written 

submissions under § 329.100(c)(2) (21 

CFR 329.100(c)(2)) that request a 

temporary waiver from the electronic 

reporting requirements associated with 

postmarket adverse drug events under 

section 760 of the FD&C Act. While we 

expect few such waiver requests, we 

retain a placeholder for one respondent 

annually, and we estimate it takes 1 

hour to complete the request. 

We therefore estimate the burden for 

the information collection as follows. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA center or 21 CFR section and/or FDA form Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Center for Biologics Evaluation and Research/Center 

for Drug Evaluation and Research: 

Form 3500 ............................................................ 14,727 1 14,727 0.66 (40 minutes) .. 9,720 

Form 3500A (§§ 310.305, 314.80, 314.98, 

600.80, and 1271.350).

599 98 58,702 1.21 ........................ 71,029 

Form 3500A (§ 310.305 outsourcing facilities) ..... 50 2 100 1.21 ........................ 121 

Center for Devices and Radiological Health: 

Form 3500 ............................................................ 5,233 1 5,233 0.66 (40 minutes) ... 3,454 

Form 3500A (part 803) ......................................... 2,277 296 673,992 1.21 ........................ 815,530 

Center for Food Safety and Applied Nutrition: 

Form 3500 ............................................................ 1,793 1 1,793 0.66 (40 minutes) ... 1,183 

Form 3500A .......................................................... 1,659 1 1,659 1.21 ........................ 2,007 

Center for Tobacco Products: 

Form 3500 ............................................................ 39 1 39 0.66 (40 minutes) ... 26 

All Centers: 

Form 3500B .......................................................... 13,750 1 13, 750 0.46 (28 minutes) .. 6,325 

Written requests for temporary waiver under 

§ 329.100(c)(2): 

1 1 1 1 ............................. 1 

Total ...................................................................... ........................ ........................ ........................ ................................ 909,396 

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

While we retain the currently 

approved estimate for the information 

collection, as noted previously we have 

added burden associated with written 

submissions under § 329.100. 

Dated: September 4, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19742 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–2018–N–3010] 

Evidence-Based Treatment Decision in 

Transplantation: Patient Individualized 

Treatment; Choosing the Right 

Regimen for the Right Patient; Public 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following public 

workshop entitled ‘‘Evidence-Based 

Treatment Decision in Transplantation: 

Patient Individualized Treatment; 

Choosing the Right Regimen for the 

Right Patient.’’ This public workshop is 

intended to discuss potential candidate 

biomarkers to determine organ 

transplant patients’ immunologic risk 

for organ rejection or tolerance. The 

public workshop will include 

discussion of the biomarker 

qualification process and how it could 

be used to develop biomarkers for use 

in clinical trials in transplantation, to 

develop new drugs to address unmet 

needs, and in clinical practice to guide 

patient treatment selection. Speakers 

will be patients who will provide 

perspective on the challenges of living 

with a transplant, managing 

immunosuppression and perspectives 

on tolerability, adherence, and risk that 

may inform patient-reported outcome 

(PRO) and patient-focused drug 

development. 

DATES: The public workshop will be 

held on September 27, 2018, from 8:30 

a.m. to 6 p.m. and September 28, 2018, 

from 8 a.m. to 12:30 p.m. Submit either 

electronic or written comments on this 

public workshop by November 19, 2018. 

See the SUPPLEMENTARY INFORMATION

section for registration date and 

information. 

ADDRESSES: The public workshop will 

be held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503, sections B and C), Silver Spring, 

MD 20993. Entrance for the public 

workshop participants (non-FDA 

employees) is through Building 1 where 

routine security check procedures will 

be performed. For parking and security 

information, please refer to https://

www.fda.gov/AboutFDA/ 

WorkingatFDA/BuildingsandFacilities/ 

WhiteOakCampusInformation/ 

ucm241740.htm. 

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 19, 2018. The 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices 46171 

https://www.regulations.gov electronic 

filing system will accept comments 

until midnight Eastern Time at the end 

of November 19, 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– 

2018–N–3010 for ‘‘Evidence-Based 

Treatment Decision in Transplantation: 

Patient Individualized Treatment; 

Choosing the Right Regimen for the 

Right Patient.’’ 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: 

Derek Alberding or Ramou Pratt, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993, 240–402–0963, derek.alberding@

fda.hhs.gov, or 301–796–3928, 

ramou.pratt@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing a public 

workshop entitled ‘‘Evidence-Based 

Treatment Decision in Transplantation: 

Patient Individualized Treatment; 

Choosing the Right Regimen for the 

Right Patient.’’ This public workshop is 

intended for academic experts, industry, 

healthcare providers, patients, other 

U.S. Government Agencies, and other 

stakeholders. 

II. Topics for Discussion at the Public 

Workshop 

Presentations and discussions will 

cover identifying potential candidate 

biomarkers that could: 

• Be considered for the biomarker 

qualification process 

• be used in identifying patients at 

high immunologic risk or low 

immunologic risk 

• be used in clinical trials to develop 

drugs to address unmet individual 

needs in transplantation 

• be used to make appropriate 

immunosuppressive regimen treatment 

decisions 

In addition, patient speakers will 

provide perspectives on: 

• Challenges of living with a 

transplant, 

• managing immunosuppression, and 

• tolerability, adherence, and risk of 

therapy. 

The goal of these presentations is to 

inform PRO and patient-focused drug 

development. 

III. Participating in the Public 

Workshop 

Registration: Registration is free and 

based on space availability, with 

priority given to early registrants. 

Persons interested in attending this 

public workshop must register by 

September 14, 2018, midnight Eastern 

Time. To register, please provide 

complete contact information for each 

attendee, including name, title, 

affiliation, address, email, and 

telephone to 

TransplantationWorkshop2018@

fda.hhs.gov. 

Early registration is recommended 

because seating is limited; therefore, 

FDA may limit the number of 

participants from each organization. 

Registrants will receive confirmation 

when they have been accepted. If time 

and space permit, onsite registration on 

the day of the public workshop will be 

provided beginning at 7:30 a.m. We will 

let registrants know if registration closes 

before the day of the public workshop. 

If you need special accommodations 

due to a disability, please contact Derek 

Alberding or Ramou Pratt (see FOR

FURTHER INFORMATION CONTACT) no later 

than September 13, 2018. 

Requests for Oral Presentations: 

During online registration you may 

indicate if you wish to present during a 

public comment session and which 

topic(s) you wish to address. We will do 

our best to accommodate requests to 

make public comments. Individuals and 


daltland on DSKBBV9HB2PROD with NOTICES
46172 Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices 

organizations with common interests are 

urged to consolidate or coordinate their 

presentations, and request time for a 

joint presentation, or submit requests for 

designated representatives to participate 

in the focused sessions. Following the 

close of registration, we will determine 

the amount of time allotted to each 

presenter and the approximate time 

each oral presentation is to begin, and 

will select and notify participants by 

September 14, 2018. All requests to 

make oral presentations must be 

received by September 10, 2018. If 

selected for presentation, any 

presentation materials must be emailed 

to TransplantationWorkshop2018@

fda.hhs.gov (see FOR FURTHER

INFORMATION CONTACT) no later than 

September 19, 2018. No commercial or 

promotional material will be permitted 

to be presented or distributed at the 

public workshop. 

Streaming Webcast of the Public 

Workshop: This public workshop will 

also be webcast at https://

collaboration.fda.gov/ebtd092018/. 

If you have never attended a Connect 

Pro event before, test your connection at 

https://collaboration.fda.gov/common/ 

help/en/support/meeting_test.htm. To 

get a quick overview of the Connect Pro 

program, visit https://www.adobe.com/ 

go/connectpro_overview. FDA has 

verified the website addresses in this 

document, as of the date this document 

publishes in the Federal Register, but 

websites are subject to change over time. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

workshop is available, it will be 

accessible at https://

www.regulations.gov. It may be viewed 

at the Dockets Management Staff (see 

ADDRESSES). A link to the transcript will 

also be available on the internet at 

https://www.fda.gov/Drugs/NewsEvents/ 

ucm605761.htm. 

Dated: September 6, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19816 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–2018–N–3308] 

Oncologic Drugs Advisory Committee; 

Notice of Meeting; Establishment of a 

Public Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Oncologic Drugs 

Advisory Committee. The general 

function of the committee is to provide 

advice and recommendations to FDA on 

regulatory issues. The meeting will be 

open to the public. FDA is establishing 

a docket for public comment on this 

document. 

DATES: The meeting will be held on 

October 10, 2018, from 8 a.m. to 1 p.m. 

ADDRESSES: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Answers to commonly asked questions 

including information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: https://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2018–N–3308. 

The docket will close on October 9, 

2018. Submit either electronic or 

written comments on this public 

meeting by October 9, 2018. Please note 

that late, untimely filed comments will 

not be considered. Electronic comments 

must be submitted on or before October 

9, 2018. The https://www.regulations.

gov electronic filing system will accept 

comments until midnight Eastern Time 

at the end of October 9, 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. 

Comments received on or before 

October 1, 2018, will be provided to the 

committee. Comments received after 

that date will be taken into 

consideration by FDA. 

You may submit comments 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–N–3308 for ‘‘Oncologic Drugs 

Advisory Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments.’’ 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.’’ 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. 


daltland on DSKBBV9HB2PROD with NOTICES