83_FR_57711 83 FR 57490 - Evaluating the Pressor Effects of Drugs; Public Workshop

83 FR 57490 - Evaluating the Pressor Effects of Drugs; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 221 (November 15, 2018)

Page Range57490-57491
FR Document2018-24961

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.

Federal Register, Volume 83 Issue 221 (Thursday, November 15, 2018) 
[Federal Register Volume 83, Number 221 (Thursday, November 15, 2018)]
[Notices]
[Pages 57490-57491]
From the Federal Register Online  [www.thefederalregister.org]
[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: Norman.Stockbridge@fda.hhs.gov.

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: sarah.supsiri@duke.edu) 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

57490 Federal Register / Vol. 83, No. 221 / Thursday, November 15, 2018 / Notices Jeffrey M. Zirger, address: CMS, Office of Strategic Security Act (the Act) requires the Acting Lead, Information Collection Review Operations and Regulatory Affairs, Secretary of HHS every three years to Office, Office of Scientific Integrity, Office Division of Regulations Development, assess the quality and efficiency effects of Science, Centers for Disease Control and Attention: Document Identifier/OMB of the use of endorsed measures in Prevention. Control Number llll, Room C4–26– specific Medicare quality reporting and [FR Doc. 2018–24969 Filed 11–14–18; 8:45 am] 05, 7500 Security Boulevard, Baltimore, incentive programs. This request is for BILLING CODE 4163–18–P Maryland 21244–1850. review and approval of a survey and To obtain copies of a supporting qualitative interview guide for the home statement and any related forms for the health setting, which CMS proposes to DEPARTMENT OF HEALTH AND proposed collection(s) summarized in use to address critical needs regarding HUMAN SERVICES this notice, you may make your request the impact of use of quality and using one of following: efficiency measures in the home health Centers for Medicare & Medicaid 1. Access CMS’ website address at setting, including the burden they Services website address at https://www.cms.gov/ impose on home health agencies. [Document Identifier: CMS–10688] Regulations-and-Guidance/Legislation/ CMS plans to use the findings from PaperworkReductionActof1995/PRA- surveys and qualitative interviews for Agency Information Collection Listing.html. multiple purposes. The qualitative Activities: Proposed Collection; 2. Email your request, including your interviews and standardized survey will Comment Request address, phone number, OMB number, inform CMS about the impact of AGENCY: Centers for Medicare & and CMS document identifier, to measures used to assess care in HHAs. Medicaid Services, HHS. Paperwork@cms.hhs.gov. The surveys will help CMS understand 3. Call the Reports Clearance Office at whether the use of performance ACTION: Notice. (410) 786–1326. measures has been associated with SUMMARY: The Centers for Medicare & FOR FURTHER INFORMATION CONTACT: changes in HHA behavior—namely, Medicaid Services (CMS) is announcing William Parham at (410) 786–4669. what quality improvements (QI) an opportunity for the public to SUPPLEMENTARY INFORMATION: investments HHAs are making and comment on CMS’ intention to collect whether adoption of QI changes is information from the public. Under the Contents associated with higher performance on Paperwork Reduction Act of 1995 (the This notice sets out a summary of the the measures. The survey will help CMS PRA), federal agencies are required to use and burden associated with the identify characteristics associated with publish notice in the Federal Register following information collections. More high performance, which, if understood, concerning each proposed collection of detailed information can be found in could be used to leverage improvements information (including each proposed each collection’s supporting statement in care among lower-performing HHAs. extension or reinstatement of an existing and associated materials (see The survey and interviews, assuming collection of information) and to allow ADDRESSES). approval by August 2019, would be 60 days for public comment on the fielded from fall 2019 through spring proposed action. Interested persons are CMS–10688 Home Health (HH) 2020. Form Number: CMS–10688 (OMB invited to send comments regarding our National Provider Survey control number: 0938–NEW); burden estimates or any other aspect of Under the PRA (44 U.S.C. 3501– Frequency: Yearly; Affected Public: this collection of information, including 3520), federal agencies must obtain Private Sector (Business or other for- the necessity and utility of the proposed approval from the Office of Management profits, Not-for-Profit Institutions); information collection for the proper and Budget (OMB) for each collection of Number of Respondents: 1,040; Total performance of the agency’s functions, information they conduct or sponsor. Annual Responses: 1,040; Total Annual the accuracy of the estimated burden, The term ‘‘collection of information’’ is Hours: 1,040. (For policy questions ways to enhance the quality, utility, and defined in 44 U.S.C. 3502(3) and 5 CFR regarding this collection contact Noni clarity of the information to be 1320.3(c) and includes agency requests Bodkin at 410–786–7837.) collected, and the use of automated or requirements that members of the Dated: November 9, 2018. collection techniques or other forms of public submit reports, keep records, or William N. Parham, III, information technology to minimize the provide information to a third party. Director, Paperwork Reduction Staff, Office information collection burden. Section 3506(c)(2)(A) of the PRA of Strategic Operations and Regulatory DATES: Comments must be received by requires federal agencies to publish a Affairs. January 14, 2019. 60-day notice in the Federal Register [FR Doc. 2018–24951 Filed 11–14–18; 8:45 am] ADDRESSES: When commenting, please concerning each proposed collection of BILLING CODE 4120–01–P reference the document identifier or information, including each proposed OMB control number. To be assured extension or reinstatement of an existing consideration, comments and collection of information, before DEPARTMENT OF HEALTH AND recommendations must be submitted in submitting the collection to OMB for HUMAN SERVICES any one of the following ways: approval. To comply with this 1. Electronically. You may send your requirement, CMS is publishing this Food and Drug Administration comments electronically to http:// notice. [Docket No. FDA–2018–N–3692] khammond on DSK30JT082PROD with NOTICES www.regulations.gov. Follow the Information Collection instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ Type of Information Collection Evaluating the Pressor Effects of to find the information collection Request: New collection (Request for a Drugs; Public Workshop document(s) that are accepting new OMB control number); Title of AGENCY: Food and Drug Administration, comments. Information Collection: Home Health HHS. 2. By regular mail. You may mail (HH) National Provider Survey; Use: ACTION: Notice of public workshop. written comments to the following Section 1890A(a)(6) of the Social VerDate Sep<11>2014 16:53 Nov 14, 2018 Jkt 247001 PO 00000 Frm 00092 Fmt 4703 Sfmt 4703 E:\FR\FM\15NON1.SGM 15NON1

Federal Register / Vol. 83, No. 221 / Thursday, November 15, 2018 / Notices 57491 SUMMARY: The Food and Drug II. Topics for Discussion at the Public evaluating-pressor-effects-drugs- Administration (FDA, the Agency, or Workshop ambulatory-blood-pressure-monitoring- we) is announcing a public workshop Topics for discussion during this studies. entitled ‘‘Evaluating the Pressor Effects meeting include: Dated: November 9, 2018. of Drugs.’’ This public workshop is • Risk associated with blood pressure Leslie Kux, convened by the Duke-Robert J. change Associate Commissioner for Policy. Margolis, MD, Center for Health Policy • Aspects and FDA analyses related [FR Doc. 2018–24961 Filed 11–14–18; 8:45 am] at Duke University and supported by a to ambulatory blood pressure BILLING CODE 4164–01–P cooperative agreement with FDA. The monitoring purpose of this public workshop is to • Evaluating a drug’s effect on blood bring the stakeholder community pressure and understanding the optimal together to discuss the premarketing DEPARTMENT OF HOMELAND regulatory approach to assigning risk SECURITY assessment of a drug’s effect on blood pressure. Elevated blood pressure is III. Participating in the Public [Docket No.: DHS–2018–0063] known to increase the risk of stroke, Workshop heart attack, and death. The effect of a Registration: To register for the public First Responders Community of drug on blood pressure may therefore be workshop, please visit the following Practice (FRCoP) an important consideration in benefit- website: https://healthpolicy.duke.edu/ AGENCY: Science and Technology risk assessment. Agency staff will events/evaluating-pressor-effects-drugs- Directorate, Department of Homeland present findings related to the use of ambulatory-blood-pressure-monitoring- Security. ambulatory blood pressure monitoring studies. Please provide complete contact ACTION: 30-Day Notice of Information to assess treatment effects. information for each attendee, including Collection; request for comment. (Re- DATES: The public workshop will be name, title, affiliation, address, email, instatement of a Currently Approved held on Monday, February 4, 2019 from and telephone. Collection, 1640–0016). 8:30 a.m. to 5 p.m. See the Registration is free and based on SUPPLEMENTARY INFORMATION section for space availability, with priority given to SUMMARY: The Department of Homeland registration date and information. early registrants. Persons interested in Security (DHS), Science and Technology attending this public workshop must (S&T) is proposing to reinstate OMB ADDRESSES: The public workshop will register by Thursday, January 31, 2019, 1640–0016, an information collection, be held at 1777 F Street NW, midnight Eastern Time. There will be no by inviting the public to comment on Washington, DC 20006. For additional onsite registration. Early registration is the collection: First Responders travel and hotel information, please recommended because seating is Community of Practice (FRCoP) User refer to the following website: https:// limited; therefore, FDA may limit the Registration Page (DHS Form 10059 (9/ healthpolicy.duke.edu/events/ number of participants from each 09)). The FRCoP web based tool collects evaluating-pressor-effects-drugs- organization. Registrants will receive profile information from first responders ambulatory-blood-pressure-monitoring- confirmation when they have been and select authorized non-first studies. accepted. If you are unable to attend the responder users to facilitate networking FOR FURTHER INFORMATION CONTACT: meeting in person, you can register to and formation of online communities. Norman Stockbridge, Center for Drug view a live webcast of the meeting. All users are required to authenticate Evaluation and Research, Food and Duke-Margolis will post on its website prior to entering the site. In addition, Drug Administration, 10903 New if registration closes before the day of the tool provides members the Hampshire Ave., Bldg. 22, Rm. 4166, the public meeting. capability to create wikis, discussion Silver Spring, MD 20903, 301–796– If you need special accommodations threads, blogs, documents, etc., allowing 2240, email: Norman.Stockbridge@ due to a disability, please contact Sarah them to enter and upload content in fda.hhs.gov. Supsiri at the Duke-Margolis Center for accordance with the site’s Rules of Health Policy (202–791–9561, email: Behavior. Members are able to SUPPLEMENTARY INFORMATION: sarah.supsiri@duke.edu) no later than participate in threaded discussions and November 29, 2018. comment on other members’ content. I. Background Streaming webcast of the public The FRCoP program is responsible for FDA is announcing a public workshop: This public workshop will be providing a collaborative environment workshop regarding FDA’s assessment webcast live. Persons interested in for the first responder community to of the pressor effects of drugs. Elevated viewing the live webcast may register share information, best practices, and blood pressure is known to increase the ahead of the event by visiting https:// lessons learned. The Homeland Security risk of stroke, heart attack, and death. healthpolicy.duke.edu/events/ Act of 2002 established this The effect of a drug on blood pressure evaluating-pressor-effects-drugs- requirement. Interested persons may may therefore be an important ambulatory-blood-pressure-monitoring- receive a copy of the collection by consideration in benefit-risk assessment. studies. The live webcast will also be contacting the DHS S&T Paperwork Following FDA’s announcement in the available at the website above on the Reduction Act (PRA) Coordinator. Federal Register of the availability of a day of the event without preregistration. DATES: Comments are encouraged and draft guidance for industry entitled Archived video footage will be available accepted until December 17, 2018. ‘‘Assessment of Pressor Effects of at the Duke-Margolis website following khammond on DSK30JT082PROD with NOTICES ADDRESSES: You may submit comments, Drugs’’ (May 31, 2018, 83 FR 25013), the workshop. identified by docket number DHS– FDA is convening this public meeting in All event materials will be provided 2018–0063, at: collaboration with the Duke-Margolis to registered attendees via email prior to • Federal eRulemaking Portal: http:// Center for Health Policy to discuss the the workshop and will be publicly www.regulations.gov. Please follow the Agency’s current thinking with expert available at the Duke-Margolis Center instructions for submitting comments. stakeholders and to consider public for Health Policy website https:// • Mail and hand delivery or comments. healthpolicy.duke.edu/events/ commercial delivery: Science and VerDate Sep<11>2014 16:53 Nov 14, 2018 Jkt 247001 PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 E:\FR\FM\15NON1.SGM 15NON1


Document Created: 2018-11-15 04:00:01
Document Modified: 2018-11-15 04:00:01
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of public workshop.
DatesThe 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.
ContactNorman 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]
FR Citation83 FR 57490 
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