37816 Federal Register / Vol. 83, No. 149 / Thursday, August 2, 2018 / Notices 

Dated: July 27, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16537 Filed 8–1–18; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2657] 

Advancing the Development of 

Pediatric Therapeutics 5: Advancing 

Pediatric Pharmacovigilance; Public 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Division of Pediatric and 

Maternal Health, Office of Surveillance 

and Epidemiology, and Office of 

Pediatric Therapeutics, Food and Drug 

Administration (FDA or the Agency) are 

announcing a public workshop entitled 

‘‘Advancing the Development of 

Pediatric Therapeutics 5: Advancing 

Pediatric Pharmacovigilance.’’ The 

purpose of this 1-day workshop is to 

provide a forum to gather information 

on the latest developments in pediatric 

pharmacovigilance from the perspective 

of various stakeholders and to expand 

the conversation to include the utility 

and challenges of emerging 

pharmacovigilance tools, including 

specific challenges associated with 

pediatric data tools. 

DATES: The public workshop will be 

held on Friday, September 14, 2018, 

from 8 a.m. to 5 p.m. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public workshop will 

be held at FDAWhite Oak Campus, 

10903 New Hampshire Ave. Bldg. 31 

Conference Center, the Great Room (Rm. 

1503A), 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. 

FOR FURTHER INFORMATION CONTACT: For 

questions regarding the workshop, 

contact Denise Pica-Branco, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–1732, 

denise.picabranco@fda.hhs.gov; or 

Meshaun Payne, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–6668, 

meshaun.payne@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Drugs and biologics (products) receive 

marketing approval only after 

undergoing premarket review and upon 

establishment of safety and efficacy 

through adequate and well-controlled 

clinical trials. Because all safety issues 

related to a product may not be detected 

in the premarket phase, FDA receives 

and analyzes postmarket safety 

information to determine if events 

reported in the postmarketing period are 

likely to be related to exposure to a 

product. When FDA determines that 

reported postmarketing events are likely 

related to a product, FDA can introduce 

labeling changes and other activities to 

inform the professional and lay public. 


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Federal Register / Vol. 83, No. 149 / Thursday, August 2, 2018 / Notices 37817 

FDA receives reports through the 

MedWatch website (https://

www.fda.gov/Safety/MedWatch/ 

HowToReport/default.htm), which are 

then entered into the FDA Adverse 

Event Reporting System for subsequent 

analysis. Because the volume of reports 

is large and because reporting entities 

(product manufacturers and the 

professional or lay public) need only 

suspect a possible link between product 

exposure and an adverse event, FDA 

employs specific tools and strategies to 

assess postmarket safety reports and 

potential signals that arise from review 

of these reports. The process for receipt 

and assessment of such postmarket 

safety information is referred to as 

pharmacovigilance. 

FDA has a specific regulatory 

mandate to perform pediatric 

pharmacovigilance and to present or 

make available the results of such 

pediatric pharmacovigilance to the 

Pediatric Advisory Committee. 

II. Topics for Discussion at the Public 

Workshop 

In this workshop, FDA will gather 

information on the latest developments 

in pediatric pharmacovigilance from the 

perspective of various stakeholders and 

expand the conversation to include the 

utility and challenges of emerging 

pharmacovigilance tools, including 

specific challenges associated with 

pediatric data tools. 

III. Participation in the Public 

Workshop 

Registration: Persons interested in 

attending this public workshop must 

register online at https://

www.eventbrite.com/e/advancing-thedevelopment-of-pediatric-therapeutics5-adept5-tickets-46654530958 by 

Thursday, September 6, 2018, midnight 

Eastern Time. Please provide complete 

contact information for each attendee, 

including name, title, affiliation, 

address, email, and telephone. Onsite 

registration will not be available. 

Registration for onsite participation or 

via webcast is free and based on space 

availability, with priority given to early 

registrants. 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 you need special accommodations 

due to a disability, please contact 

Denise Pica-Branco (denise.picabranco@

fda.hhs.gov) or Meshaun Payne 

(meshaun.payne@fda.hhs.gov) no later 

than Thursday, September 6, 2018. 

Streaming Webcast of the Public 

Workshop: Webcast information will be 

provided after participants have 

registered for the workshop. 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. 

Dated: July 27, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16524 Filed 8–1–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–2126] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food and Drug 

Administration’s Research and 

Evaluation Survey for the Public 

Education Campaign on Tobacco 

Among the Lesbian Gay Bisexual 

Transgender Community 

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 FDA’s Research 

and Evaluation Survey for the Public 

Education Campaign on Tobacco 

(RESPECT) among the Lesbian Gay 

Bisexual Transgender (LGBT). 

DATES: Submit either electronic or 

written comments on the collection of 

information by October 1, 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 October 1, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of October 1, 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– 

2015–N–2126 for ‘‘Food and Drug 

Administration’s (FDA’s) Research and 

Evaluation Survey for the Public 

Education Campaign on Tobacco 

(RESPECT) among LGBT.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 


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