[Federal Register Volume 83, Number 221 (Thursday, November 15, 2018)]
[Notices]
[Pages 57490-57491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24961]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3692]


Evaluating the Pressor Effects of Drugs; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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[[Page 57491]]

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing a public workshop entitled ``Evaluating the Pressor Effects 
of Drugs.'' This public workshop is convened by the Duke-Robert J. 
Margolis, MD, Center for Health Policy at Duke University and supported 
by a cooperative agreement with FDA. The purpose of this public 
workshop is to bring the stakeholder community together to discuss the 
premarketing assessment of a drug's effect on blood pressure. Elevated 
blood pressure is known to increase the risk of stroke, heart attack, 
and death. The effect of a drug on blood pressure may therefore be an 
important consideration in benefit-risk assessment. Agency staff will 
present findings related to the use of ambulatory blood pressure 
monitoring to assess treatment effects.

DATES: The public workshop will be held on Monday, February 4, 2019 
from 8:30 a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public workshop will be held at 1777 F Street NW, 
Washington, DC 20006. For additional travel and hotel information, 
please refer to the following website: https://healthpolicy.duke.edu/events/evaluating-pressor-effects-drugs-ambulatory-blood-pressure-monitoring-studies.

FOR FURTHER INFORMATION CONTACT: Norman Stockbridge, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 4166, Silver Spring, MD 20903, 301-796-
2240, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a public workshop regarding FDA's assessment of 
the pressor effects of drugs. Elevated blood pressure is known to 
increase the risk of stroke, heart attack, and death. The effect of a 
drug on blood pressure may therefore be an important consideration in 
benefit-risk assessment. Following FDA's announcement in the Federal 
Register of the availability of a draft guidance for industry entitled 
``Assessment of Pressor Effects of Drugs'' (May 31, 2018, 83 FR 25013), 
FDA is convening this public meeting in collaboration with the Duke-
Margolis Center for Health Policy to discuss the Agency's current 
thinking with expert stakeholders and to consider public comments.

II. Topics for Discussion at the Public Workshop

    Topics for discussion during this meeting include:
     Risk associated with blood pressure change
     Aspects and FDA analyses related to ambulatory blood 
pressure monitoring
     Evaluating a drug's effect on blood pressure and 
understanding the optimal regulatory approach to assigning risk

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the 
following website: https://healthpolicy.duke.edu/events/evaluating-pressor-effects-drugs-ambulatory-blood-pressure-monitoring-studies. 
Please provide complete contact information for each attendee, 
including name, title, affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register by Thursday, January 31, 2019, midnight Eastern 
Time. There will be no onsite registration. 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 are unable to attend 
the meeting in person, you can register to view a live webcast of the 
meeting. Duke-Margolis will post on its website if registration closes 
before the day of the public meeting.
    If you need special accommodations due to a disability, please 
contact Sarah Supsiri at the Duke-Margolis Center for Health Policy 
(202-791-9561, email: [email protected]) no later than November 
29, 2018.
    Streaming webcast of the public workshop: This public workshop will 
be webcast live. Persons interested in viewing the live webcast may 
register ahead of the event by visiting https://healthpolicy.duke.edu/events/evaluating-pressor-effects-drugs-ambulatory-blood-pressure-monitoring-studies. The live webcast will also be available at the 
website above on the day of the event without preregistration. Archived 
video footage will be available at the Duke-Margolis website following 
the workshop.
    All event materials will be provided to registered attendees via 
email prior to the workshop and will be publicly available at the Duke-
Margolis Center for Health Policy website https://healthpolicy.duke.edu/events/evaluating-pressor-effects-drugs-ambulatory-blood-pressure-monitoring-studies.

    Dated: November 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24961 Filed 11-14-18; 8:45 am]
 BILLING CODE 4164-01-P


