National Heart, Lung, and Blood Institute; Notice of Closed Meetings, 32929-32930 [2019-14647]

Download as PDF Federal Register / Vol. 84, No. 132 / Wednesday, July 10, 2019 / Notices Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Risk Evaluation and Mitigation Strategies: Modifications and Revisions.’’ This guidance provides information on what types of changes to approved REMS will be considered modifications of the REMS and what types of changes will be considered revisions. (See section 505– 1(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355–1(h)).) This guidance also provides information on how REMS modifications and revisions should be submitted to FDA and how FDA intends to review and act on these submissions. If FDA determines that a REMS is necessary to ensure that the benefits of a drug outweigh its risks, FDA is authorized to require a REMS for such drugs under section 505–1 of the FD&C Act.1 Section 505–1(g) and (h) of the FD&C Act include provisions for the assessment and modification of an approved REMS. Section 505–1(h) of the FD&C Act requires FDA to review and act on proposed minor modifications, as defined in guidance, within 60 days.2 It also requires FDA to establish, through guidance, that ‘‘certain modifications’’ can be implemented following notification to FDA. (See section 505– 1(h)(2)(A)(iv) of the FD&C Act.) In addition, FDA is required to review and act on REMS modifications to conform the REMS to approved safety labeling changes, or to a safety labeling change that FDA has directed the application holder to make pursuant to section 505(o)(4) of the FD&C Act within 60 days. (See section 505–1(h)(2)(A)(iii) of the FD&C Act.) Finally, section 505– 1(g)(4)(A) of the FD&C Act specifies that proposed REMS modifications no longer require submission of a REMS assessment; instead, proposed jspears on DSK30JT082PROD with NOTICES 1 Section 505–1 of the FD&C Act applies to applications for prescription drugs submitted under subsection 505(b) (i.e., new drug applications) or (j) (i.e., abbreviated new drug applications) of the FD&C Act (21 U.S.C. 355(b) or (j), respectively) and applications under section 351 of the Public Health Service Act (i.e., biologics license applications). 2 See section 505–1(h)(2)(A)(ii) of the FD&C Act. Section 1132(c) of the Food and Drug Administration Safety and Innovation Act also provides that FDA will issue guidance that, for purposes of section 505–1(h)(2)(A) of the FD&C Act, describes the types of modifications to approved risk evaluation and mitigation strategies that are considered to be minor modifications of such strategies. VerDate Sep<11>2014 18:32 Jul 09, 2019 Jkt 247001 modifications must include an adequate rationale for the proposed changes. This guidance updates the guidance of the same name, issued April 7, 2015 (80 FR 18629), and finalizes the portion that sets forth the submission procedures for REMS revisions. FDA carefully considered all comments received, including comments on the submission procedures portion, and revised the guidance as appropriate. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Risk Evaluation and Mitigation Strategies: Modifications and Revisions.’’ 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. II. Paperwork Reduction Act of 1995 This final guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). REMS modifications are submitted to FDA as supplements to approved new drug applications (NDAs) under 21 CFR 314.70 and for abbreviated new drug applications (ANDAs) under 21 CFR 314.97, and for approved biologics license applications (BLAs) under 21 CFR 601.12. Burden hours for NDAs and ANDAs are approved by OMB under control number 0910–0001, and for BLAs under control number 0910–0338. REMS revisions are submitted to FDA as application correspondence and are also approved by OMB under control numbers 0910–0001 and 0910–0338. III. Electronic Access Dated: July 3, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–14663 Filed 7–9–19; 8:45 am] PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Library of Medicine; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the 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 materials, 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: Biomedical Informatics, Library and Data Sciences Review Committee. Date: November 14–15, 2019. Time: November 14, 2019, 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda Hyatt, 1 Metro Center, Bethesda, MD 20814. Time: November 15, 2019, 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Contact Person: Zoe E. Huang, MD, Chief Scientific Review Officer, Scientific Review Office, Extramural Programs, National Library of Medicine, NIH, 6705 Rockledge Drive, Suite 301, Bethesda, MD 20892–7968, 301–594–4937, huangz@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program No. 93.879, Medical Library Assistance, National Institutes of Health, HHS) Dated: July 3, 2019. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–14645 Filed 7–9–19; 8:45 am] BILLING CODE 4140–01–P Persons with access to the internet may obtain the guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https:// www.regulations.gov. BILLING CODE 4164–01–P 32929 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; 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. The meetings will be closed to the public in accordance with the provisions set forth in sections E:\FR\FM\10JYN1.SGM 10JYN1 32930 Federal Register / Vol. 84, No. 132 / Wednesday, July 10, 2019 / Notices jspears on DSK30JT082PROD with NOTICES 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: National Heart, Lung, and Blood Institute Special Emphasis Panel; R13 Conference Grant Review. Date: July 30, 2019. Time: 10:00 a.m. to 1:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Keith A. Mintzer, Ph.D., Scientific Review Officer, Office of Scientific Review, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Room 7186, Bethesda, MD 20892, 301–594–7947, mintzerk@ nhlbi.nih.gov. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; NHLBI Outstanding Investigator Award (OIA). Date: August 5–6, 2019. Time: August 05, 2019, 1:00 p.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: The William F. Bolger Center, 9600 Newbridge Drive, Potomac, MD 20854. Time: August 06, 2019, 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: The William F. Bolger Center, 9600 Newbridge Drive, Potomac, MD 20854. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: The William F. Bolger Center, 9600 Newbridge Drive, Potomac, MD 20854. Contact Person: Melissa E. Nagelin, Ph.D., Scientific Review Officer, Office of Scientific Review, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Room 7202, Bethesda, MD 20892, 301–435–0297, nagelinmh2@ nhlbi.nih.gov. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Stimulating Access to Research in Residency (StARR). Date: August 21, 2019. Time: 8:30 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Kristen Page, Ph.D., Scientific Review Officer, Office of Scientific Review, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Room 7185, Bethesda, MD 20892, 301–827–7953, kristen.page@nih.gov. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; VerDate Sep<11>2014 18:32 Jul 09, 2019 Jkt 247001 Continuation of Existing Grant Based Epidemiology Cohort Studies in Heart, Lung, Blood, and Sleep Diseases and Disorders. Date: August 22, 2019. Time: 2:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Room 7180, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Tony L. Creazzo, Ph.D., Scientific Review Officer, Office of Scientific Review, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Room 7180, Bethesda, MD 20892, 301–827–7913, creazzotl@ mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: July 3, 2019. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–14647 Filed 7–9–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY [Docket No. CISA–2019–0007] Cybersecurity and Infrastructure Security Agency Vulnerability Assessments Infrastructure Security Division (ISD), Cybersecurity and Infrastructure Security Agency (CISA), Department of Homeland Security (DHS). ACTION: 60-Day notice and request for comments; Revision, 1670–0035. AGENCY: DHS CISA ISD will submit the following information collection request (ICR) to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. DATES: Comments are due by September 9, 2019. ADDRESSES: You may submit comments, identified by docket number CISA– 2019–0007, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Please follow the instructions for submitting comments. • Email: IPGatewayHelpDesk@ hq.dhs.gov. Please include docket number CISA–2019–0007 in the subject line of the message. • Mail: Written comments and questions about this Information Collection Request should be forwarded SUMMARY: PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 to DHS/CISA/ISD, ATTN: 1670–0035, 245 Murray Lane SW, Mail Stop 0602, Washington, DC 20598–0602. Instructions: All submissions received must include the words ‘‘Department of Homeland Security’’ and the docket number for this action. Comments received will be posted without alteration at https://www.regulations.gov, including any personal information provided. Docket: For access to the docket and comments received, please go to www.regulations.gov and enter docket number CISA–2019–0007. Comments submitted in response to this notice may be made available to the public through relevant websites. For this reason, please do not include in your comments information of a confidential nature, such as sensitive personal information or proprietary information. If you send an email comment, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the internet. Please note that responses to this public comment request containing any routine notice about the confidentiality of the communication will be treated as public comments that may be made available to the public notwithstanding the inclusion of the routine notice. FOR FURTHER INFORMATION CONTACT: Ricky Morgan, 866–844–8163, IPGatewayHelpDesk@hq.dhs.gov. SUPPLEMENTARY INFORMATION: The Homeland Security Presidential Directive-7, the Presidential Policy Directive-21, and the National Infrastructure Protection Plan highlight the need for a centrally managed repository of infrastructure attributes capable of assessing risks and facilitating data sharing. To support this mission need, the DHS CISA ISD has developed a data collection system that contains several capabilities which support the homeland security mission in the area of critical infrastructure (CI) protection. Protective Security Advisors (PSAs) and Cyber Security Advisors (CSAs) conduct voluntary assessments on CI facilities. These assessments are webbased and are used to collect an organization’s basic, high-level information, and its dependencies. This data is then used to determine a Protective Measures Index (PMI) and a Resilience Measures Index (RMI) for the assessed organization. This information allows an organization to see how it compares to other organizations within the same sector as well as allows them to see how adjusting certain aspects E:\FR\FM\10JYN1.SGM 10JYN1

Agencies

[Federal Register Volume 84, Number 132 (Wednesday, July 10, 2019)]
[Notices]
[Pages 32929-32930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14647]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Heart, Lung, and Blood Institute; 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.
    The meetings will be closed to the public in accordance with the 
provisions set forth in sections

[[Page 32930]]

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: National Heart, Lung, and Blood Institute 
Special Emphasis Panel; R13 Conference Grant Review.
    Date: July 30, 2019.
    Time: 10:00 a.m. to 1:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Keith A. Mintzer, Ph.D., Scientific Review 
Officer, Office of Scientific Review, National Heart, Lung, and 
Blood Institute, National Institutes of Health, 6701 Rockledge 
Drive, Room 7186, Bethesda, MD 20892, 301-594-7947, 
[email protected].

    Name of Committee: National Heart, Lung, and Blood Institute 
Special Emphasis Panel; NHLBI Outstanding Investigator Award (OIA).
    Date: August 5-6, 2019.
    Time: August 05, 2019, 1:00 p.m. to 7:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: The William F. Bolger Center, 9600 Newbridge Drive, 
Potomac, MD 20854.
    Time: August 06, 2019, 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: The William F. Bolger Center, 9600 Newbridge Drive, 
Potomac, MD 20854.
    Time: 1:00 p.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: The William F. Bolger Center, 9600 Newbridge Drive, 
Potomac, MD 20854.
    Contact Person: Melissa E. Nagelin, Ph.D., Scientific Review 
Officer, Office of Scientific Review, National Heart, Lung, and 
Blood Institute, National Institutes of Health, 6701 Rockledge 
Drive, Room 7202, Bethesda, MD 20892, 301-435-0297, 
[email protected].

    Name of Committee: National Heart, Lung, and Blood Institute 
Special Emphasis Panel; Stimulating Access to Research in Residency 
(StARR).
    Date: August 21, 2019.
    Time: 8:30 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, 
MD 20814.
    Contact Person: Kristen Page, Ph.D., Scientific Review Officer, 
Office of Scientific Review, National Heart, Lung, and Blood 
Institute, National Institutes of Health, 6701 Rockledge Drive, Room 
7185, Bethesda, MD 20892, 301-827-7953, [email protected].

    Name of Committee: National Heart, Lung, and Blood Institute 
Special Emphasis Panel; Continuation of Existing Grant Based 
Epidemiology Cohort Studies in Heart, Lung, Blood, and Sleep 
Diseases and Disorders.
    Date: August 22, 2019.
    Time: 2:00 p.m. to 4:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, Room 
7180, Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Tony L. Creazzo, Ph.D., Scientific Review 
Officer, Office of Scientific Review, National Heart, Lung, and 
Blood Institute, National Institutes of Health, 6701 Rockledge 
Drive, Room 7180, Bethesda, MD 20892, 301-827-7913, 
[email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.233, 
National Center for Sleep Disorders Research; 93.837, Heart and 
Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, 
Blood Diseases and Resources Research, National Institutes of 
Health, HHS)

    Dated: July 3, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-14647 Filed 7-9-19; 8:45 am]
 BILLING CODE 4140-01-P
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