National Heart, Lung, and Blood Institute; Notice of Closed Meeting, 43770-43771 [2017-19858]

Download as PDF 43770 Federal Register / Vol. 82, No. 180 / Tuesday, September 19, 2017 / Notices Dated: September 14, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. I. Background [FR Doc. 2017–19928 Filed 9–18–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–3998] Flavor Developer and Manufacturer Site Tours Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA), Center for Tobacco Products (CTP), is announcing an invitation for participation in its voluntary Flavor Developer and Manufacturer Site Tours Program. This program is intended to give CTP staff an opportunity to visit companies that develop and/or manufacture flavors (including flavor mixtures) that are sold to tobacco product manufacturers in order to gain a better understanding of the development, testing, and production of flavors and flavor mixtures used in the manufacturing of tobacco products. The site tours in this program are not intended as regulatory inspections. The purpose of this notice is to invite parties interested in participating in the Flavor Developer and Manufacturer Site Tours Program to submit requests to CTP. DATES: Submit either an electronic or written request for participation in this program by November 20, 2017. See section IV of this document for information on requests for participation. SUMMARY: If your company is interested in offering a site visit, please submit a request either electronically to https://www.regulations.gov or in writing to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Karla Price, Office of Science, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993–0002, 1–877–287–1373, email: AskCTP@fda.hhs.gov. SUPPLEMENTARY INFORMATION: asabaliauskas on DSKBBXCHB2PROD with NOTICES ADDRESSES: VerDate Sep<11>2014 17:12 Sep 18, 2017 Jkt 241001 The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) was enacted on June 22, 2009, amending the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by, among other things, adding a new chapter (chapter IX) granting FDA the authority to regulate tobacco product manufacturing, distribution, and marketing (Pub. L. 111–31). The Tobacco Control Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. On May 10, 2016, FDA published a final rule entitled ‘‘Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products’’ (81 FR 28974), which became effective on August 8, 2016. Under this rule, all products that meet the statutory definition of ‘‘tobacco product’’ set forth in section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), including components and parts, but excluding accessories of newly deemed products, are now subject to chapter IX of the FD&C Act. CTP’s Office of Science is conducting the Flavor Developer and Manufacturer Site Tours Program to provide its staff an opportunity to visit companies that develop and/or manufacture flavors (including flavor mixtures) that are sold to tobacco product manufacturers. Flavor developers and manufacturers are regulated by FDA if they, among other things, manufacture products that meet the statutory definition of a ‘‘tobacco product’’ set forth in section 201(rr) of the FD&C Act. The site tours will aid the Agency in gaining a better understanding of the development, testing, and production of flavors and flavor mixtures used in the manufacturing of tobacco products. The goal for the Flavor Developer and Manufacturer Site Tours Program is for CTP staff to gain firsthand exposure to how flavors are developed, tested, and produced. II. Description of Flavor Developer and Manufacturer Site Tours Program In the Flavor Developer and Manufacturer Site Tours Program, small groups of CTP staff will observe the operations of flavor developers and manufacturers, including the development, testing, and production of flavors that can be used by tobacco PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 product manufacturers. The site tours in this program are not intended as regulatory inspections; rather, the program is meant to educate CTP staff and improve their understanding of flavors used in the manufacturing of tobacco products. It is anticipated that the site tours will take place in 2018. III. Site Selection CTP hopes to be able to tour small, medium, and large flavor developers and manufacturers, as well as companies that develop and/or manufacture flavors that are used for different categories of tobacco products (e.g., cigarettes, cigars, smokeless tobacco, waterpipe tobacco, e-liquids). Final site selections will be based on the availability of funds and resources for the relevant fiscal year as well as the desire to visit a wide variety of flavor developers and manufacturers. All FDA travel expenses associated with the Flavor Developer and Manufacturer site tours will be the responsibility of FDA. IV. Requests for Participation To aid in site selection, your request for participation should include the following information: • A description of your company, including the size of the organization; • A list of the flavors your company develops and/or manufactures and the categories of tobacco product (e.g., cigarettes, cigars, smokeless tobacco, waterpipe tobacco, e-liquids) for which your flavors are typically used; • The physical address(es) of the site(s) for which you are submitting a request; and • A proposed 1-day tour agenda. Identify requests for participation with the docket number found in brackets in the heading of this document. Received requests are available for public examination in the Dockets Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday. Dated: September 14, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–19900 Filed 9–18–17; 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 Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as E:\FR\FM\19SEN1.SGM 19SEN1 Federal Register / Vol. 82, No. 180 / Tuesday, September 19, 2017 / Notices amended, notice is hereby given of a meeting of the Clinical Trials Review Committee. 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. Name of Committee: Heart, Lung, and Blood Initial Review Group; Clinical Trials Review Committee. Date: October 26, 2017. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Garden Inn Bethesda, 7301 Waverly Street, Bethesda, MD 20814. Contact Person: Keary A Cope, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7190, Bethesda, MD 20892–7924, 301–827– 7912, copeka@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: September 13, 2017. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–19858 Filed 9–18–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health asabaliauskas on DSKBBXCHB2PROD with NOTICES 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, October 30, 2018, 8:00 a.m. to October 30, 2018, 5:00 p.m., Hotel Palomar, 2121 P Street NW., Washington, DC, 20036 which was published in the Federal Register on September 1, 2017, 82FR41631. This meeting is being amended to correct the meeting date from October 30, 2018 to October 30, 2017. The meeting is closed to the public. VerDate Sep<11>2014 17:12 Sep 18, 2017 Jkt 241001 Dated: September 13, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–19862 Filed 9–18–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; 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 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 Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; NIDDK KUH Fellowship Review. Date: October 6, 2017. Time: 8:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Xiaodu Guo, MD, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7023, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–4719, guox@extra.niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Clinical Small Business Applications. Date: October 13, 2017. Time: 3:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Ryan G. Morris, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National institutes of Health, ROOM 7015, 6707 Democracy Boulevard, Bethesda, MD 20892–2542, 301–594–4721, ryan.morris@nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; NIDDK Pilot and Feasibility Clinical Trial (R21). PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 43771 Date: October 26, 2017. Time: 1:00 p.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Jason D. Hoffert, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7343, 6707 Democracy Boulevard, Bethesda, MD 20892–2542, 301–496–9010, hoffertj@niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; D2D Renewal. Date: October 30, 2017. Time: 3:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: MIchele L. Barnard, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7353, 6707 Democracy Boulevard, Bethesda, MD 20892–2542, (301) 594–8898, barnardm@extra.niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; NIDDK Research Project Grants. Date: October 31, 2017. Time: 3:00 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Elena Sanovich, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, ROOM 7351, 6707 Democracy Boulevard, Bethesda, MD 20892–2542, 301–594–8886, sanoviche@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: September 13, 2017. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–19860 Filed 9–18–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center For Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Center for Scientific E:\FR\FM\19SEN1.SGM 19SEN1

Agencies

[Federal Register Volume 82, Number 180 (Tuesday, September 19, 2017)]
[Notices]
[Pages 43770-43771]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19858]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Heart, Lung, and Blood Institute; Notice of Closed 
Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as

[[Page 43771]]

amended, notice is hereby given of a meeting of the Clinical Trials 
Review Committee.
    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.

    Name of Committee: Heart, Lung, and Blood Initial Review Group; 
Clinical Trials Review Committee.
    Date: October 26, 2017.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Hilton Garden Inn Bethesda, 7301 Waverly Street, 
Bethesda, MD 20814.
    Contact Person: Keary A Cope, Ph.D., Scientific Review Officer, 
Office of Scientific Review/DERA, National Heart, Lung, and Blood 
Institute, 6701 Rockledge Drive, Room 7190, Bethesda, MD 20892-7924, 
301-827-7912, copeka@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: September 13, 2017.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-19858 Filed 9-18-17; 8:45 am]
 BILLING CODE 4140-01-P

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