83 FR 37816 - Advancing the Development of Pediatric Therapeutics 5: Advancing Pediatric Pharmacovigilance; Public Workshop
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 149 (August 2, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 149 (August 2, 2018)
| Page Range | 37816-37817 | |
| FR Document | 2018-16524 |
[Federal Register Volume 83, Number 149 (Thursday, August 2, 2018)] [Notices] [Pages 37816-37817] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-16524] ----------------------------------------------------------------------- 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, [email protected]; 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, [email protected]. 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. [[Page 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-the-development-of-pediatric-therapeutics-5-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 ([email protected]) or Meshaun Payne ([email protected]) 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
![Federal Register / Vol. 83, No. 149 / Thursday, August 2, 2018 / Notices 37817
FDA receives reports through the Streaming Webcast of the Public be submitted on or before October 1,
MedWatch website (https:// Workshop: Webcast information will be 2018. The https://www.regulations.gov
www.fda.gov/Safety/MedWatch/ provided after participants have electronic filing system will accept
HowToReport/default.htm), which are registered for the workshop. If you have comments until midnight Eastern Time
then entered into the FDA Adverse never attended a Connect Pro event at the end of October 1, 2018. Comments
Event Reporting System for subsequent before, test your connection at https:// received by mail/hand delivery/courier
analysis. Because the volume of reports collaboration.fda.gov/common/help/en/ (for written/paper submissions) will be
is large and because reporting entities support/meeting_test.htm. To get a considered timely if they are
(product manufacturers and the quick overview of the Connect Pro postmarked or the delivery service
professional or lay public) need only program, visit https://www.adobe.com/ acceptance receipt is on or before that
suspect a possible link between product go/connectpro_overview. date.
exposure and an adverse event, FDA FDA has verified the website
Electronic Submissions
employs specific tools and strategies to addresses in this document, as of the
assess postmarket safety reports and date this document publishes in the Submit electronic comments in the
potential signals that arise from review Federal Register, but websites are following way:
of these reports. The process for receipt subject to change over time. • Federal eRulemaking Portal:
and assessment of such postmarket https://www.regulations.gov. Follow the
Dated: July 27, 2018.
safety information is referred to as instructions for submitting comments.
Leslie Kux, Comments submitted electronically,
pharmacovigilance.
Associate Commissioner for Policy. including attachments, to https://
FDA has a specific regulatory
[FR Doc. 2018–16524 Filed 8–1–18; 8:45 am] www.regulations.gov will be posted to
mandate to perform pediatric
pharmacovigilance and to present or BILLING CODE 4164–01–P the docket unchanged. Because your
make available the results of such comment will be made public, you are
pediatric pharmacovigilance to the solely responsible for ensuring that your
DEPARTMENT OF HEALTH AND comment does not include any
Pediatric Advisory Committee. HUMAN SERVICES confidential information that you or a
II. Topics for Discussion at the Public third party may not wish to be posted,
Workshop Food and Drug Administration such as medical information, your or
In this workshop, FDA will gather [Docket No. FDA–2015–N–2126] anyone else’s Social Security number, or
information on the latest developments confidential business information, such
Agency Information Collection as a manufacturing process. Please note
in pediatric pharmacovigilance from the
Activities; Proposed Collection; that if you include your name, contact
perspective of various stakeholders and
Comment Request; Food and Drug information, or other information that
expand the conversation to include the
Administration’s Research and identifies you in the body of your
utility and challenges of emerging
Evaluation Survey for the Public comments, that information will be
pharmacovigilance tools, including
Education Campaign on Tobacco posted on https://www.regulations.gov.
specific challenges associated with
pediatric data tools.
Among the Lesbian Gay Bisexual • If you want to submit a comment
Transgender Community with confidential information that you
III. Participation in the Public do not wish to be made available to the
AGENCY: Food and Drug Administration,
Workshop public, submit the comment as a
HHS.
Registration: Persons interested in written/paper submission and in the
ACTION: Notice. manner detailed (see ‘‘Written/Paper
attending this public workshop must
register online at https:// SUMMARY: The Food and Drug Submissions’’ and ‘‘Instructions’’).
www.eventbrite.com/e/advancing-the- Administration (FDA or Agency) is Written/Paper Submissions
development-of-pediatric-therapeutics- announcing an opportunity for public
Submit written/paper submissions as
5-adept5-tickets-46654530958 by comment on the proposed collection of
follows:
Thursday, September 6, 2018, midnight certain information by the Agency.
• Mail/Hand Delivery/Courier (for
Eastern Time. Please provide complete Under the Paperwork Reduction Act of
written/paper submissions): Dockets
contact information for each attendee, 1995 (PRA), Federal Agencies are
Management Staff (HFA–305), Food and
including name, title, affiliation, required to publish notice in the
Drug Administration, 5630 Fishers
address, email, and telephone. Onsite Federal Register concerning each
Lane, Rm. 1061, Rockville, MD 20852.
registration will not be available. proposed collection of information, • For written/paper comments
Registration for onsite participation or including each proposed extension of an submitted to the Dockets Management
via webcast is free and based on space existing collection of information, and Staff, FDA will post your comment, as
availability, with priority given to early to allow 60 days for public comment in well as any attachments, except for
registrants. Early registration is response to the notice. This notice information submitted, marked and
recommended because seating is solicits comments on FDA’s Research identified, as confidential, if submitted
limited; therefore, FDA may limit the and Evaluation Survey for the Public as detailed in ‘‘Instructions.’’
number of participants from each Education Campaign on Tobacco Instructions: All submissions received
organization. Registrants will receive (RESPECT) among the Lesbian Gay must include the Docket No. FDA–
confirmation when they have been Bisexual Transgender (LGBT). 2015–N–2126 for ‘‘Food and Drug
daltland on DSKBBV9HB2PROD with NOTICES
accepted. DATES: Submit either electronic or Administration’s (FDA’s) Research and
If you need special accommodations written comments on the collection of Evaluation Survey for the Public
due to a disability, please contact information by October 1, 2018. Education Campaign on Tobacco
Denise Pica-Branco (denise.picabranco@ ADDRESSES: You may submit comments (RESPECT) among LGBT.’’ Received
fda.hhs.gov) or Meshaun Payne as follows. Please note that late, comments, those filed in a timely
(meshaun.payne@fda.hhs.gov) no later untimely filed comments will not be manner (see ADDRESSES), will be placed
than Thursday, September 6, 2018. considered. Electronic comments must in the docket and, except for those
VerDate Sep<11>2014 17:06 Aug 01, 2018 Jkt 244001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\02AUN1.SGM 02AUN1](https://thefederalregister.org/doc/83_FR_37965/page/2.svg)
Document Created: 2018-08-02 01:28:43
Document Modified: 2018-08-02 01:28:43
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public workshop. | |
| 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. | |
| 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, [email protected]; 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, [email protected] | |
| FR Citation | 83 FR 37816 |
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