National Heart, Lung, and Blood Institute; Notice of Closed Meetings, 38035-38036 [2019-16615]

Download as PDF Federal Register / Vol. 84, No. 150 / Monday, August 5, 2019 / Notices jspears on DSK3GMQ082PROD with NOTICES III. Identification of HPHCs Is an Ongoing Effort FDA recognizes that there may be constituents that are ‘‘harmful or potentially harmful’’ that FDA neither included on the established HPHC list nor proposed to be added to that list per table 1. The criteria described previously in the April 2012 notice and the additional criterion described in this document generally depend on a chemical or chemical compound being studied and identified by FDA or another regulatory entity as having adverse effects that are relevant to cancer, cardiovascular, respiratory, developmental, or reproductive effects. That a constituent has not been so identified by FDA or other entities could be because it has not been adequately studied or has not yet been systematically reviewed. Consistent with our obligations under section 904(e) of the FD&C Act, FDA intends to continue: • Our efforts to review other disease outcomes to assess whether additional chemicals or chemical compounds in tobacco products or tobacco smoke, including chemicals or chemical compounds in the emissions from the range of tobacco products now deemed to be subject to chapter IX of the FD&C Act, are harmful or potentially harmful constituents that contribute to the risk of other diseases; • Our consideration of whether additional or different criteria should be selected to help identify other classes of harmful or potentially harmful chemicals and chemical compounds for inclusion on the HPHC established list and whether individual constituents should be added; and • Our efforts to review new information to determine if it would be appropriate to remove one or more of the constituents that appear on the HPHC established list, or to add additional constituents to the list. IV. Request for Comments and Information FDA is soliciting public comment on this notice, including scientific and other information on the following topics: • The additional criterion FDA is proposing to use when determining whether a constituent should be added to the HPHC established list; • Whether any chemicals or chemical compounds not listed in table 1 should be included because they are harmful or potentially harmful, including supporting scientific or other information; and • Whether any of the chemicals or chemical compounds listed in table 1, VerDate Sep<11>2014 18:42 Aug 02, 2019 Jkt 247001 including as a result of the proposed criterion, should not be included because they are not harmful or potentially harmful, including supporting scientific or other information. Interested persons may submit to the Dockets Management Staff (see ADDRESSES) either electronic or written comments regarding this document. V. References The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https:// www.regulations.gov. References without asterisks are not on public display at https://www.regulations.gov because they have copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time. 1. Laino, T., C. Tuma, A. Curioni, et al., ‘‘A Revisited Picture of the Mechanism of Glycerol Dehydration,’’ Journal of Physical Chemistry A, 115(15):3592–3595, 2011. https://doi.org/10.1021/jp201078e. 2. Sleiman, M., J. Logue, V. Montesinos, et al., ‘‘Emissions from Electronic Cigarettes: Key Parameters Affecting the Release of Harmful Chemicals,’’ Environmental Science & Technology, (50)9644–9651, 2016. https:// doi.org/10.1021/acs.est.6b01741. 3. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Vol. 77, at 482 (2000). https://monographs.iarc.fr/wpcontent/uploads/2018/06/mono77.pdf. *4. Borghardt, J.M., C. Kloft, and A. Sharma, ‘‘Inhaled Therapy in Respiratory Disease: The Complex Interplay of Pulmonary Kinetic Processes,’’ Canadian Respiratory Journal, 2018, doi:10.1155/2018/ 2732017. https://downloads.hindawi.com/ journals/crj/2018/2732017.pdf. 5. Dionex Corporation, ‘‘Determination of Ethylene Glycol and Diethylene Glycol in a Sorbitol Solution,’’ Application Note 246, LPN 2505, Sunnyvale, CA, 2016. https:// assets.thermofisher.com/TFS-Assets/CMD/ Application-Notes/AN-246-IC-EthyleneDiethylene-Glycol-Sorbitol-LPN2505-EN.pdf. 6. Hutzler, C., M. Paschke, S. Kruschinski, et al., ‘‘Chemical Hazards Present in Liquids and Vapors of Electronic Cigarettes,’’ Archives of Toxicology, 88(7): 1295–1308, 2014. https://doi.org/10.1007/s00204-0141294-7. 7. Diethylene Glycol Poisoning (Cal. Poison Control System) Dec. 21, 2012, available at https://calpoison.org/news/diethylene-glycolpoisoning (last accessed on October 10, 2018). PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 38035 8. Schep, L.J., R.J. Slaughter, W.A. Temple, and D. M. Beasley, ‘‘Diethylene Glycol Poisoning’’ Clinical Toxicology, 47(6):525– 535 at 526, 2009. https://doi.org/10.1080/ 15563650903086444. 9. Devoti, E., E. Marta E. Belotti, et al., ‘‘Diethylene Glycol Poisoning from Transcutaneous Absorption,’’ American Journal of Kidney Diseases, 65(4):603–606, 2015. https://doi.org/10.1053/j.ajkd.2014.07. 032. *10. National Industrial Chemicals Notification and Assessment Scheme, Existing Hazard Assessment Report, Diethylene Glycol (DEG), Australian Government Department of Health and Ageing (June 2009). https:// www.nicnas.gov.au/__data/assets/word_doc/ 0018/37323/Diethylene-glycol-DEG-hazardassessment.docx. *11. Health Council of the Netherlands. ‘‘Diethylene glycol; Health-based recommended occupational exposure limit.’’ https://www.healthcouncil.nl/documents/ advisory-reports/2007/10/17/diethyleneglycol. 12. Sanina Y., ‘‘Remote Consequences of Chronic Inhalation of Diethylene Glycol,’’ Gigiena I Sanitariia (1968). *13. FDA Guidance for Industry, ‘‘Testing of Glycerin for Diethylene Glycol,’’ May 2007, available at https://www.fda.gov/ regulatory-information/search-fda-guidancedocuments/testing-glycerin-diethylene-glycol. *14. August 2, 1996, CDC Morbidity and Mortality Weekly Report. https:// www.cdc.gov/mmwr/PDF/wk/mm4530.pdf. *15. Varlet, V. et al., ‘‘Toxicity Assessment of Refill Liquids for Electronic Cigarettes,’’ International Journal of Environmental Research and Public Health 2015, 12, 4796– 4815. https://www.mdpi.com/1660-4601/12/ 5/4796. *16. FDA Memorandum, ‘‘Evaluation of ECigarettes,’’ from B. Westenberger, CDER/ OPS/OTR, to M. Levy, Center for Drug Evaluation and Research, Office of Compliance, May 4, 2009. Dated: July 30, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–16658 Filed 8–2–19; 8:45 am] BILLING CODE 4164–01–P 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 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 E:\FR\FM\05AUN1.SGM 05AUN1 38036 Federal Register / Vol. 84, No. 150 / Monday, August 5, 2019 / Notices 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; Opportunities for Collaborative Research at the NIH Clinical Center. Date: September 4, 2019. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Office of Scientific Review/DERA, National Heart, Lung and Blood Institute, 6701 Rockledge Drive, Bethesda, MD 20879 (Telephone Conference Call). Contact Person: William J. Johnson, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7178, Bethesda, MD 20892–7924, 301–827– 7938, johnsonwj@nhlbi.nih.gov. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Risk (DECIPHeR). Date: September 13, 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/DERA, 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. (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 30, 2019. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–16615 Filed 8–2–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration jspears on DSK3GMQ082PROD with NOTICES Center for Mental Health Services; Notice of Meeting Pursuant to Public Law 92–463, notice is hereby given for the meeting of the Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Mental Health Services National Advisory Council (CMHS NAC) on August 21, 2019. VerDate Sep<11>2014 18:42 Aug 02, 2019 Jkt 247001 The meeting is open to the public and will include consideration of minutes from the April 22, 2019 SAMHSA CMHS NAC meeting; updates from the CMHS Director; and discussion on Children’s School Based/Mental Health, Civil Commitment, and Suicide. The meeting will be held in Rockville, Maryland and can also be accessed virtually. Attendance by the public will be limited to the space available. Interested persons may present data, information, or views, orally or in writing, on issues pending before the Council. Individuals interested in sending written submissions or making public comments, must forward them and notify the contact person on or before August 14, 2019. Up to three minutes will be allotted for each presentation. Registration is required to participate during this meeting. To attend in person, virtually, or to obtain the callin number and access code, submit written or brief oral comments, or request special accommodations for persons with disabilities, please register on-line at: https:// snacregister.samhsa.gov/ MeetingList.aspx or communicate with the CMHS NAC Designated Federal Officer; Pamela Foote. Meeting information and a roster of Council members may be obtained by accessing the SAMHSA website at: https://www.samhsa.gov/about-us/ advisory-councils/cmhs-nationaladvisory-council or by contacting the CMHS NAC Designated Federal Officer; Pamela Foote. Council Name: Substance Abuse and Mental Health Services Administration Center for Mental Health Services National Advisory Council. Date/Time/Type: Wednesday, August 21, 2019, 9:00 a.m. to 4:00 p.m., EDT, (OPEN). Place: SAMHSA, 5600 Fishers Lane, Room 5A02, Rockville, Maryland 20857. Contact: Pamela Foote, Designated Federal Officer, CMHS National Advisory Council, 5600 Fishers Lane, Room 14E53C, Rockville, Maryland 20857, Telephone: (240) 276–1279, Fax: (301) 480–8491, Email: pamela.foote@ samhsa.hhs.gov. Carlos Castillo, Committee Management Officer, Substance Abuse and Mental Health Services Administration. [FR Doc. 2019–16694 Filed 8–2–19; 8:45 am] BILLING CODE 4162–20–P PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 DEPARTMENT OF HOMELAND SECURITY [Docket No. CISA–2019–0006] Office of Bombing Prevention Training and Conference Forms Infrastructure Security Division (ISD), Cybersecurity and Infrastructure Security Agency (CISA), Department of Homeland Security (DHS). ACTION: 60-Day notice and request for comments; Revision, 1670–0031. 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. SUMMARY: DATES: Comments are due by October 4, 2019. You may submit comments, identified by docket number CISA– 2019–0006, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Please follow the instructions for submitting comments. • Email: dhsobptaskings@ HQ.DHS.GOV. Please include docket number CISA–2019–0006 in the subject line of the message. • Mail: Written comments and questions about this Information Collection Request should be forwarded to DHS/CISA/ISD/OBP, ATTN: 1670– 0031, 245 Murray Lane SW, Mail Stop 0609, Washington, DC 20598–0609. 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–2019–0006. 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 ADDRESSES: E:\FR\FM\05AUN1.SGM 05AUN1

Agencies

[Federal Register Volume 84, Number 150 (Monday, August 5, 2019)]
[Notices]
[Pages 38035-38036]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16615]


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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 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

[[Page 38036]]

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; Opportunities for Collaborative Research at 
the NIH Clinical Center.
    Date: September 4, 2019.
    Time: 1:00 p.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Office of Scientific Review/DERA, National Heart, Lung 
and Blood Institute, 6701 Rockledge Drive, Bethesda, MD 20879 
(Telephone Conference Call).
    Contact Person: William J. Johnson, Ph.D., Scientific Review 
Officer, Office of Scientific Review/DERA, National Heart, Lung, and 
Blood Institute, 6701 Rockledge Drive, Room 7178, Bethesda, MD 
20892-7924, 301-827-7938, [email protected].

    Name of Committee: National Heart, Lung, and Blood Institute 
Special Emphasis Panel; Disparities Elimination through Coordinated 
Interventions to Prevent and Control Heart and Lung Disease Risk 
(DECIPHeR).
    Date: September 13, 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/DERA, National Heart, Lung, and Blood 
Institute, National Institutes of Health, 6701 Rockledge Drive, Room 
7185, Bethesda, MD 20892, 301-827-7953, [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 30, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-16615 Filed 8-2-19; 8:45 am]
BILLING CODE 4140-01-P
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