National Institute of Mental Health; Amended Notice of Meeting, 64542-64543 [2019-25312]

Download as PDF 64542 Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Dear Health Care Provider Letters: Improving Communication of Important Safety Information OMB Control Number 0910–0754— Extension This information collection supports recommendations found in the Agency guidance document entitled ‘‘Dear Health Care Provider Letters: Improving Communication of Important Safety Information.’’ The guidance provides instruction to industry and FDA staff on the content and format of Dear Health Care Provider (DHCP) letters. These letters are sent by manufacturers or distributors to health care providers to communicate an important drug warning, a change in prescribing information, or a correction of misinformation in prescription drug promotional labeling or advertising. The guidance is available from our website at: https://www.fda.gov/media/79793/ download. The guidance document gives specific instruction on what should and should not be included in DHCP letters. Some DHCP letters have been too long, have contained promotional material, or otherwise have not met the goals set forth in the applicable regulation (21 CFR 200.5). In some cases, health care providers have not been aware of important new information, and have been unable to communicate it to patients, because the letters’ content and length have made it difficult to find the relevant information. In addition, letters have sometimes been sent for the wrong reasons. In addition to content and format recommendations for each type of DHCP letter, the guidance also includes recommendations on consulting with FDA on how to develop a DHCP letter, when to send a letter, what type of letter to send, and how to assess the letter’s impact. Based on a review of FDA’s Document Archiving, Reporting, and Regulatory Tracking System for 2016— 2018, we identified 38 DHCP letters that were sent by 24 distinct sponsors during the 3-year timeframe. We estimate that we will receive approximately 13 DHCP letters annually from approximately 8 application holders. FDA professionals familiar with DHCP letters, and with the recommendations in the guidance, estimate that it should take an application holder approximately 100 hours to prepare and send DHCP letters in accordance with the guidance. In the Federal Register of August 19, 2019 (84 FR 42929), we published a 60day notice requesting public comment on the proposed collection of information. One comment was received expressing the importance of communicating safety information, for which we are appreciative. No other comments were received. We estimate the annual reporting burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Type of activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Dear Health Care Provider Letters ...................................... 8 1.625 13 100 1,300 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Based on a review of the information collection, we have reduced our burden estimate by 17 respondents with a corresponding decrease in annual hours by 1,200. We attribute the decrease to the effectiveness of the guidance. Dated: November 14, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–25333 Filed 11–21–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health khammond on DSKJM1Z7X2PROD with NOTICES National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting 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 VerDate Sep<11>2014 16:57 Nov 21, 2019 Jkt 250001 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: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Centers for AIDS Research (P30) and Developmental Centers for AIDS Research (P30). Date: December 16–17, 2019. Time: 9:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Chelsea D. Boyd, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institutes of Health, NIAID, 5601 Fishers Lane, MSC–9823, Rockville, MD 20852–9834, 240–669–2081, chelsea.boyd@ nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 Dated: November 15, 2019. Tyeshia M. Roberson, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–25306 Filed 11–21–19; 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 National Institute of Mental Health Special Emphasis Panel, November 25, 2019, 11:00 a.m. to November 25, 2019, 4:00 p.m., National Institutes of Health Neuroscience Center Building (NSC), 6001 Executive Boulevard, Rockville, MD 20852, which was published in the Federal Register on November 14, 2019, 84 FR 61920. This notice is to amend the date of the NIMH HIV/AIDS Review meeting from November 25, 2019, from 11:00 a.m.– 4:00 p.m. to December 17, 2019, from 1:00 p.m.–5:00 p.m. The meeting is closed to the public. E:\FR\FM\22NON1.SGM 22NON1 Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices Dated: November 18, 2019. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2019–25312 Filed 11–21–19; 8:45 am] National Center for Advancing Translational Sciences; Notice of Meeting BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting 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. khammond on DSKJM1Z7X2PROD with NOTICES Name of Committee: Center for Scientific Review Special Emphasis Panel; Interdisciplinary Molecular Sciences and Training Member Conflicts. Date: December 17, 2019. Time: 11:00 a.m. to 11:45 a.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Raj K. Krishnaraju, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6190, Bethesda, MD 20892, 301–435–1047, kkrishna@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: November 18, 2019. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–25301 Filed 11–21–19; 8:45 am] 16:57 Nov 21, 2019 Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Cures Acceleration Network Review Board. The meeting will be open to the public, viewing virtually by WebEx. Individuals can register to view and access the meeting by the link below. https://nih.webex.com/nih/onstage/ g.php?MTID=e546cfc8baef0 c0b50c44b24d9601d2c4. 1. Click ‘‘Register’’. On the registration form, enter your information and then click ‘‘Submit’’ to complete the required registration. 2. You will receive a personalized email with the live event link. Name of Committee: Cures Acceleration Network Review Board. Date: December 13, 2019. Time: 11:00 a.m. to 2:30 p.m. Agenda: The CAN Review Board will meet virtually to discuss updates regarding CAN programs and next steps. Place: National Institutes of Health, One Democracy Plaza, 6701 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Anna L. Ramsey-Ewing, Ph.D., Executive Secretary, National Center for Advancing, Translational Sciences, 1 Democracy Plaza, Room 1072, Bethesda, MD 20892, 301–435–0809, anna.ramseyewing@ nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.350, B—Cooperative Agreements; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) Dated: November 18, 2019. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–25302 Filed 11–21–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. BILLING CODE 4140–01–P VerDate Sep<11>2014 National Institutes of Health Jkt 250001 PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 64543 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: Center for Scientific Review Special Emphasis Panel; Member Conflict: AIDS and AIDS-Related Research. Date: December 12, 2019. Time: 11:30 a.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: John C. Pugh, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 1206, MSC 7808, Bethesda, MD 20892, (301) 435– 2398, pughjohn@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; AgingAssociated Brain Changes in Animals and Reanalysis of RDoC Data. Date: December 16, 2019. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Suzan Nadi, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5217B, MSC 7846, Bethesda, MD 20892, 301–435– 1259, nadis@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Neuroimmunology of Brain Tumor and Neuroimmunology of Brain Tumor and Viral Infection. Date: December 16, 2019. Time: 2:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Wei-Qin Zhao, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5181, MSC 7846, Bethesda, MD 20892–7846, 301– 827–7238, zhaow@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Auditory Brainstem Physiology. Date: December 16, 2019. Time: 2:30 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. E:\FR\FM\22NON1.SGM 22NON1

Agencies

[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
[Notices]
[Pages 64542-64543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25312]


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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 National 
Institute of Mental Health Special Emphasis Panel, November 25, 2019, 
11:00 a.m. to November 25, 2019, 4:00 p.m., National Institutes of 
Health Neuroscience Center Building (NSC), 6001 Executive Boulevard, 
Rockville, MD 20852, which was published in the Federal Register on 
November 14, 2019, 84 FR 61920.
    This notice is to amend the date of the NIMH HIV/AIDS Review 
meeting from November 25, 2019, from 11:00 a.m.-4:00 p.m. to December 
17, 2019, from 1:00 p.m.-5:00 p.m. The meeting is closed to the public.


[[Page 64543]]


    Dated: November 18, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-25312 Filed 11-21-19; 8:45 am]
 BILLING CODE 4140-01-P
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