National Center for Advancing Translational Sciences; Amended Notice of Meeting, 46024 [2019-18895]

Download as PDF 46024 Federal Register / Vol. 84, No. 170 / Tuesday, September 3, 2019 / Notices Dated: August 28, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of August 2, 2019, FDA published a notice of availability with a 60-day comment period to request comments on the draft guidance for industry and FDA staff entitled ‘‘Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.’’ The Agency has received a request for a 30-day extension of the comment period. The request conveyed concern that the current 60-day comment period does not allow sufficient time to develop a meaningful or thoughtful response. FDA has considered the request and is extending the comment period for the notice of availability for 30 days, until October 31, 2019. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying guidance on these important issues. II. Significance of Guidance FDA is issuing this draft guidance consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. khammond on DSKBBV9HB2PROD with NOTICES III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/ device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1500059 to identify the guidance you are requesting. VerDate Sep<11>2014 18:55 Aug 30, 2019 Jkt 247001 [FR Doc. 2019–18929 Filed 8–30–19; 8:45 am] Dated: August 27, 2019. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy. BILLING CODE 4164–01–P [FR Doc. 2019–18902 Filed 8–30–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Mental Health Services Research Committee, November 7, 2019, 8:00 a.m. to November 7, 2019 p.m., 05:00 p.m., The Dupont Hotel, 1500 New Hampshire Avenue NW, Washington, DC 20036 which was published in the Federal Register on August 201, 2019, 84 FR 43150. This notice is to amend the date of the Mental Health Service Research Committee (SERV) meeting from November 7, 2019 to November 8, 2019. The meeting times and location remain the same. The meeting is closed to the public. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Advancing Translational Sciences; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Cures Acceleration Network Review Board, September 19, 2019, 11:00 a.m. to 4:30 p.m., PORTER NEUROSCIENCE RESEARCH CENTER, Building 35A, 35 Convent Drive, Bethesda, MD 20892 which was published in the Federal Register on June 27, 2019, 84 FR 30744 Pg. 30744. This meeting notice is amended to change the start time from 11:00 a.m. to 10:00 a.m. The meeting is open to the public. Dated: August 27, 2019. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. Dated: August 27, 2019. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–18901 Filed 8–30–19; 8:45 am] [FR Doc. 2019–18895 Filed 8–30–19; 8:45 am] BILLING CODE 4140–01–P BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health Office of the Director, National Institutes of Health; Amended Notice of Meeting Center for Scientific Review; Notice of Closed Meetings Notice is hereby given of a change in the meeting of the Council of Councils, September 6, 2019, 08:15 a.m. to 04:00 p.m., National Institutes of Health, The Natcher Building, Building 45, Room E, 45 Center Drive, Bethesda, MD 20892 which was published in the Federal Register on February 08, 2019, 84 FR 2890. The meeting notice is amended to change the open and closed session meeting times as follows: The morning open session will change from 8:15 a.m.–12:00 p.m. to 8:00 a.m.–12:00 p.m.; the closed session will change from 12:00 p.m.–1:30 p.m. to 12:00 p.m.– 12:45 p.m.; and the afternoon open session will change from 1:30 p.m.–4:00 p.m. to 12:45 p.m.–4:15 p.m. The meeting is partially closed to the public. PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Biological Chemistry and Macromolecular Biophysics Integrated E:\FR\FM\03SEN1.SGM 03SEN1

Agencies

[Federal Register Volume 84, Number 170 (Tuesday, September 3, 2019)]
[Notices]
[Page 46024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18895]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Center for Advancing Translational Sciences; Amended 
Notice of Meeting

    Notice is hereby given of a change in the meeting of the Cures 
Acceleration Network Review Board, September 19, 2019, 11:00 a.m. to 
4:30 p.m., PORTER NEUROSCIENCE RESEARCH CENTER, Building 35A, 35 
Convent Drive, Bethesda, MD 20892 which was published in the Federal 
Register on June 27, 2019, 84 FR 30744 Pg. 30744.
    This meeting notice is amended to change the start time from 11:00 
a.m. to 10:00 a.m. The meeting is open to the public.

    Dated: August 27, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-18895 Filed 8-30-19; 8:45 am]
BILLING CODE 4140-01-P
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