Evaluating the Therapeutic Potential of Cannabinoids: How To Conduct Research Within the Current Regulatory Framework, 62326-62327 [2018-26127]

Download as PDF 62326 Federal Register / Vol. 83, No. 232 / Monday, December 3, 2018 / Notices revision to a currently approved collection OMB # 0990–0275. The revised data collection activities seeks to further streamline the current questions grantees are asked by reducing the number of questions, and reduce the cost of the data collection system by using a more cost efficient alternative to the Performance Data System, (PDS) web-based portal. The overall reduction in questions will reduce the number of burden hours on grantees. The movement from a customized web-based portal to reporting using commercial, off-the shelf software (i.e., a spreadsheet) significantly reduces the cost of performance data collection and reporting. To collect program management and performance data for all OMH-funded projects, grantee data collection via the Uniform Data Set, UDS (original data collection system) was first approved by OMB on June 7, 2004 (OMB No. 0990–275). Need and Proposed Use of the Information: The clearance is needed to continue performance data collection to enable OMH to comply with Federal reporting requirements, monitor, and evaluate performance by enabling the efficient collection of performanceoriented data tied to OMH-wide performance reporting needs. The ability to monitor and evaluate performance in this manner, and to work towards continuous program improvement are basic functions that OMH must be able to accomplish in order to carry out its mandate with the most effective and appropriate use of resources. Likely Respondents: Respondents for this data collection include the project directors for OMH-funded projects and/ or the date entry persons for each OMHfunded project. Affected public includes non-profit institutions, State, Local, or Tribal Governments. ANNUALIZED BURDEN HOUR TABLE Performance Reporting Template ..... Non-profit institutions, State, Local, or Tribal Governments. 130 4 45/60 390 Total ........................................... ........................................................... 130 4 45/60 390 [FR Doc. 2018–26122 Filed 11–30–18; 8:45 am] BILLING CODE 4150–29–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Nursing Research; Notice of Meeting khammond on DSK30JT082PROD with NOTICES Average burden per response Respondents (If necessary) Terry Clark, Paperwork Reduction Act Reports Clearance Officer, Office of the Secretary. Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Council for Nursing Research. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the 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 VerDate Sep<11>2014 16:52 Nov 30, 2018 Jkt 247001 Number of respondents Number of responses per respondents Forms (If necessary) would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Advisory Council for Nursing Research. Date: January 29–30, 2019. Open: January 29, 1:00 p.m. to 4:30 p.m. Agenda: Discussion of Program Policies and Issues. Place: National Institutes of Health, Natcher Building, 45 Center Drive, Room D, Bethesda, MD 20892. Closed: January 30, 2019, 9:00 a.m. to 1:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Natcher Building, 45 Center Drive, Room D, Bethesda, MD 20892. Contact Person: Marguerite Littleton Kearney, Ph.D., RN, FAAN, Director Division of Extramural Science Programs, National Institute of Nursing Research, National Institutes of Health, 6701 Democracy Boulevard, Room 708, Bethesda, MD 20892, 301–402–7932, marguerite.kearnet@nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 Total burden hours Information is also available on the Institute’s/Center’s home page: https:// www.ninr.nih.gov/aboutninr/nacnr, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.361, Nursing Research, National Institutes of Health, HHS) Dated: November 27, 2018. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–26113 Filed 11–30–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Evaluating the Therapeutic Potential of Cannabinoids: How To Conduct Research Within the Current Regulatory Framework AGENCY: National Institutes of Health, HHS. ACTION: Notice. This workshop on December 8, 2018, sponsored by the National Center for Complementary and Integrative Health (NCCIH), a component of the National Institutes of Health (NIH), will bring together researchers, governmental officials, and industry representatives to discuss the processes and issues related to conducting cannabinoid research. SUMMARY: E:\FR\FM\03DEN1.SGM 03DEN1 Federal Register / Vol. 83, No. 232 / Monday, December 3, 2018 / Notices The meeting will be held on December 8, 2018, from 8:00 a.m. to 5:30 p.m. (EST). ADDRESSES: The meeting will be videocast. A link to the videocast will be posted on the NCCIH website, https://nccih.nih.gov/node/12170, once available. DATES: For information concerning this meeting, see the NCCIH website, https:// nccih.nih.gov/node/12170, or contract Dr. Angela Arensdorf, Science Policy Analyst, Office of Policy, Planning, and Evaluation, National Center for Complementary and Integrative Health, 9000 Rockville Pike, Building 31, Suite 2B11, Bethesda, MD 20892, telephone: 301–827–8277; email: angela.arensdorf@nih.gov. SUPPLEMENTARY INFORMATION: This workshop will be an all-day meeting held on December 8, 2018 and will bring together representatives from the NIH, FDA, DEA, academia, and industry to discuss the issues related to conducting research with cannabinoids. The goals of this meeting are to gain an understanding of how to navigate this regulatory space, discuss future research opportunities, and foster collaborations. The focus of this workshop will be on the state of the science and working within current regulations. This meeting will NOT discuss challenging or changing current Federal laws, policies or regulations. FOR FURTHER INFORMATION CONTACT: Dated: November 23, 2018. David Shurtleff, Acting Director, National Center for Complementary and Integrative Health, National Institutes of Health. [FR Doc. 2018–26127 Filed 11–30–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection khammond on DSK30JT082PROD with NOTICES Notice of Issuance of Final Determination Concerning Airlift PTTD Brace the purpose of U.S. Government procurement. DATES: The final determination was issued on November 23, 2018. A copy of the final determination is attached. Any party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial review of this final determination within January 2, 2019 FOR FURTHER INFORMATION CONTACT: Joy Marie Virga, Valuation and Special Programs Branch, Regulations and Rulings, Office of Trade (202) 325–1511. SUPPLEMENTARY INFORMATION: Notice is hereby given that on 11/23/18, CBP issued a final determination concerning Airlift PTTD Brace, which may be offered to the United States Government under an undesignated government procurement contract. The final determination, HQ H299701, was issued at the request of DJO, LLC, under procedures set forth at 19 CFR part 177, subpart B, which implements Title III of the Trade Agreements Act of 1979, as amended (19 U.S.C. 2511–18). In the final determination, CBP concluded that the aircell produced in Mexico imparts the final product with its essential character. Further, the assembly operations completed in Mexico permanently attach the various parts to each other so that they lose their individual identities and become part of the completed Airlift. Therefore, the country of origin for purposes of U.S. Government procurement of the Airlift PTTD Brace is Mexico. Section 177.29, CBP Regulations (19 CFR 177.29), provides that notice of final determinations shall be published in the Federal Register within 60 days of the date the final determination is issued. Section 177.30, CBP Regulations (19 CFR 177.30), provides that any party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial review of a final determination within 30 days of publication of such determination in the Federal Register. Dated: November 23, 2018. Alice A. Kipel, Executive Director, Regulations and Rulings, Office of Trade. AGENCY: HQ H299701 November 23, 2018 This document provides notice that U.S. Customs and Border Protection (‘‘CBP’’) has issued a final determination concerning the country of origin of the Airlift PTTD Brace. CBP has concluded that the country of origin of the Airlift PTTD Brace is Mexico for OT:RR:CTF:VS: H299701 JMV CATEGORY: Origin Matthew M. Caligur Baker & Hostetler, LLP 811 Main St., Suite 1100 Houston, TX 77002–6111 RE: U.S. Government Procurement; Title III, Trade Agreements Act of 1979 (19 U.S.C. § 2511); Subpart B, Part 177, CBP Regulations; Country of Origin of Airlift PTTD Brace U.S. Customs and Border Protection, Department of Homeland Security. ACTION: Notice of final determination. SUMMARY: VerDate Sep<11>2014 16:52 Nov 30, 2018 Jkt 247001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 62327 Dear Mr. Caligur, This is in response to your request of June 11, 2018 requesting a final determination regarding the country of origin of the Airlift PTTD Brace (‘‘Airlift’’) on behalf of DJO, LLC (‘‘DJO’’) pursuant to subpart B of Part 177, U.S. Customs and Border Protection (‘‘CBP’’) Regulations (19 C.F.R. § 177.21, et seq.). As a domestic producer of merchandise, DJO is a party-at-interest within the meaning of 19 C.F.R. § 177.22(d) and is entitled to request this final determination. You requested confidential treatment for certain information contained in your submission and in the file. Pursuant to 19 C.F.R. § 177.2(b)(7), the identified information has been bracketed and will be redacted in the public version of this ruling. FACTS: DJO is a global provider of orthopedic devices, including a broad range of products used for rehabilitation, pain management and physical therapy. The Airlift, one of the items that DJO develops, is designed for the treatment of posterior tibial tendon dysfunction (‘‘PTTD’’), or for early signs and symptoms of the adult acquired flat foot. A sample of the finished article and photographs of the components were submitted with your request. The Airlift is essentially a brace that covers the ankle and foot. Depending on the severity of the patient’s condition, the Airlift can be prescribed for use as part of a conservative treatment to stabilize the foot and ankle to help prevent further degeneration. It can also be prescribed for use post-surgically and during rehabilitation. The Airlift is produced in three sizes for both the left and right foot with varying dimensions, but all have the same structure and composition and are manufactured using the process described below. Foot support and ankle stabilization are provided by the Airlift’s integrated aircell and semi-rigid shells. The aircell, located under the foot arch, is integral to preventing and rehabilitating flat foot. The aircell is adjustable using a hand bulb, which is included with the brace. When inflated, the aircell can accommodate variances in arch shapes and heights. The semi-rigid shells are anatomically designed to the shape of the ankle for secure support and stabilization. These shells help realign the ankle and support the patient. The Airlift uses a rear entry design which allows the patient to slip his or her foot into the back of the brace. Two hook and loop straps secure the brace and can be used to adjust fit. These design elements eliminate the need for lacing, improve patient compliance and make the Airlift easier to put on than custom braces. The Airlift is produced from the following components: a form assembly from [country A], a springloaded valve from [country B], a hand bulb from [country A], an aircell from Mexico, tubing from [country C], a pneumatic coupler from [country D], an elbow from [country D], resin polyether from [country D], colorant from [country D], foam from [country C], polyurethane laminate from [country D], and polyurethane film from [country D]. Production of the Airlift takes place at DJO’s facility in Tijuana, Mexico. DJO produces the aircells in Mexico using E:\FR\FM\03DEN1.SGM 03DEN1

Agencies

[Federal Register Volume 83, Number 232 (Monday, December 3, 2018)]
[Notices]
[Pages 62326-62327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26127]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Evaluating the Therapeutic Potential of Cannabinoids: How To 
Conduct Research Within the Current Regulatory Framework

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This workshop on December 8, 2018, sponsored by the National 
Center for Complementary and Integrative Health (NCCIH), a component of 
the National Institutes of Health (NIH), will bring together 
researchers, governmental officials, and industry representatives to 
discuss the processes and issues related to conducting cannabinoid 
research.

[[Page 62327]]


DATES: The meeting will be held on December 8, 2018, from 8:00 a.m. to 
5:30 p.m. (EST).

ADDRESSES: The meeting will be videocast. A link to the videocast will 
be posted on the NCCIH website, https://nccih.nih.gov/node/12170, once 
available.

FOR FURTHER INFORMATION CONTACT: For information concerning this 
meeting, see the NCCIH website, https://nccih.nih.gov/node/12170, or 
contract Dr. Angela Arensdorf, Science Policy Analyst, Office of 
Policy, Planning, and Evaluation, National Center for Complementary and 
Integrative Health, 9000 Rockville Pike, Building 31, Suite 2B11, 
Bethesda, MD 20892, telephone: 301-827-8277; email: 
[email protected].

SUPPLEMENTARY INFORMATION: This workshop will be an all-day meeting 
held on December 8, 2018 and will bring together representatives from 
the NIH, FDA, DEA, academia, and industry to discuss the issues related 
to conducting research with cannabinoids. The goals of this meeting are 
to gain an understanding of how to navigate this regulatory space, 
discuss future research opportunities, and foster collaborations. The 
focus of this workshop will be on the state of the science and working 
within current regulations. This meeting will NOT discuss challenging 
or changing current Federal laws, policies or regulations.

    Dated: November 23, 2018.
David Shurtleff,
Acting Director, National Center for Complementary and Integrative 
Health, National Institutes of Health.
[FR Doc. 2018-26127 Filed 11-30-18; 8:45 am]
BILLING CODE 4140-01-P

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