83 FR 62326 - Evaluating the Therapeutic Potential of Cannabinoids: How To Conduct Research Within the Current Regulatory Framework

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 232 (December 3, 2018)

Page Range		62326-62327
FR Document		2018-26127

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.

Federal Register, Volume 83 Issue 232 (Monday, December 3, 2018)

[Federal Register Volume 83, Number 232 (Monday, December 3, 2018)]
[Notices]
[Pages 62326-62327]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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

62326 Federal Register / Vol. 83, No. 232 / Monday, December 3, 2018 / Notices

revision to a currently approved significantly reduces the cost of performance reporting needs. The
collection OMB # 0990–0275. The performance data collection and ability to monitor and evaluate
revised data collection activities seeks reporting. To collect program performance in this manner, and to
to further streamline the current management and performance data for work towards continuous program
questions grantees are asked by all OMH-funded projects, grantee data improvement are basic functions that
reducing the number of questions, and collection via the Uniform Data Set, OMH must be able to accomplish in
reduce the cost of the data collection UDS (original data collection system) order to carry out its mandate with the
system by using a more cost efficient was first approved by OMB on June 7, most effective and appropriate use of
alternative to the Performance Data 2004 (OMB No. 0990–275). resources.
Need and Proposed Use of the
System, (PDS) web-based portal. The Likely Respondents: Respondents for
Information: The clearance is needed to
overall reduction in questions will continue performance data collection to this data collection include the project
reduce the number of burden hours on enable OMH to comply with Federal directors for OMH-funded projects and/
grantees. The movement from a reporting requirements, monitor, and or the date entry persons for each OMH-
customized web-based portal to evaluate performance by enabling the funded project. Affected public includes
reporting using commercial, off-the efficient collection of performance- non-profit institutions, State, Local, or
shelf software (i.e., a spreadsheet) oriented data tied to OMH-wide Tribal Governments.
ANNUALIZED BURDEN HOUR TABLE
Number of Average
Forms Respondents Number of Total burden
responses per burden per
(If necessary) (If necessary) respondents hours
respondents response

Performance Reporting Template ..... Non-profit institutions, State, Local, 130 4 45/60 390
or Tribal Governments.

Total ........................................... ........................................................... 130 4 45/60 390

Terry Clark, would constitute a clearly unwarranted Information is also available on the
Paperwork Reduction Act Reports Clearance invasion of personal privacy. Institute’s/Center’s home page: https://
Officer, Office of the Secretary. www.ninr.nih.gov/aboutninr/nacnr, where an
Name of Committee: National Advisory agenda and any additional information for
[FR Doc. 2018–26122 Filed 11–30–18; 8:45 am] Council for Nursing Research. the meeting will be posted when available.
BILLING CODE 4150–29–P Date: January 29–30, 2019.
(Catalogue of Federal Domestic Assistance
Open: January 29, 1:00 p.m. to 4:30 p.m. Program Nos. 93.361, Nursing Research,
Agenda: Discussion of Program Policies National Institutes of Health, HHS)
DEPARTMENT OF HEALTH AND and Issues.
HUMAN SERVICES Place: National Institutes of Health, Dated: November 27, 2018.
Natcher Building, 45 Center Drive, Room D, Sylvia L. Neal,
National Institutes of Health Bethesda, MD 20892. Program Analyst, Office of Federal Advisory
Closed: January 30, 2019, 9:00 a.m. to 1:00 Committee Policy.
National Institute of Nursing Research; p.m. [FR Doc. 2018–26113 Filed 11–30–18; 8:45 am]
Notice of Meeting Agenda: To review and evaluate grant
BILLING CODE 4140–01–P
applications.
Pursuant to section 10(d) of the Place: National Institutes of Health,
Federal Advisory Committee Act, as Natcher Building, 45 Center Drive, Room D,
amended, notice is hereby given of a Bethesda, MD 20892. DEPARTMENT OF HEALTH AND
meeting of the National Advisory Contact Person: Marguerite Littleton HUMAN SERVICES
Council for Nursing Research. Kearney, Ph.D., RN, FAAN, Director Division
of Extramural Science Programs, National National Institutes of Health
The meeting will be open to the
Institute of Nursing Research, National
public as indicated below, with Institutes of Health, 6701 Democracy Evaluating the Therapeutic Potential of
attendance limited to space available. Boulevard, Room 708, Bethesda, MD 20892, Cannabinoids: How To Conduct
Individuals who plan to attend and 301–402–7932, marguerite.kearnet@nih.gov. Research Within the Current
need special assistance, such as sign Any interested person may file written Regulatory Framework
language interpretation or other comments with the committee by forwarding
reasonable accommodations, should the statement to the Contact Person listed on AGENCY: National Institutes of Health,
notify the Contact Person listed below this notice. The statement should include the HHS.
in advance of the meeting. name, address, telephone number and when ACTION: Notice.
The meeting will be closed to the applicable, the business or professional
public in accordance with the affiliation of the interested person. SUMMARY: This workshop on December
provisions set forth in sections In the interest of security, NIH has 8, 2018, sponsored by the National
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., instituted stringent procedures for entrance Center for Complementary and
khammond on DSK30JT082PROD with NOTICES

onto the NIH campus. All visitor vehicles,
as amended. The grant applications and Integrative Health (NCCIH), a
including taxicabs, hotel, and airport shuttles
the discussions could disclose will be inspected before being allowed on
component of the National Institutes of
confidential trade secrets or commercial campus. Visitors will be asked to show one Health (NIH), will bring together
property such as patentable material, form of identification (for example, a researchers, governmental officials, and
and personal information concerning government-issued photo ID, driver’s license, industry representatives to discuss the
individuals associated with the grant or passport) and to state the purpose of their processes and issues related to
applications, the disclosure of which visit. conducting cannabinoid research.

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Federal Register / Vol. 83, No. 232 / Monday, December 3, 2018 / Notices 62327

DATES: The meeting will be held on the purpose of U.S. Government Dear Mr. Caligur,
December 8, 2018, from 8:00 a.m. to procurement. This is in response to your request of June
5:30 p.m. (EST). 11, 2018 requesting a final determination
DATES: The final determination was
regarding the country of origin of the Airlift
ADDRESSES: The meeting will be issued on November 23, 2018. A copy PTTD Brace (‘‘Airlift’’) on behalf of DJO, LLC
videocast. A link to the videocast will of the final determination is attached. (‘‘DJO’’) pursuant to subpart B of Part 177,
be posted on the NCCIH website, Any party-at-interest, as defined in 19 U.S. Customs and Border Protection (‘‘CBP’’)
https://nccih.nih.gov/node/12170, once CFR 177.22(d), may seek judicial review Regulations (19 C.F.R. § 177.21, et seq.). As
available. of this final determination within a domestic producer of merchandise, DJO is
January 2, 2019 a party-at-interest within the meaning of 19
FOR FURTHER INFORMATION CONTACT: For C.F.R. § 177.22(d) and is entitled to request
information concerning this meeting, FOR FURTHER INFORMATION CONTACT: Joy
this final determination.
see the NCCIH website, https:// Marie Virga, Valuation and Special You requested confidential treatment for
nccih.nih.gov/node/12170, or contract Programs Branch, Regulations and certain information contained in your
Dr. Angela Arensdorf, Science Policy Rulings, Office of Trade (202) 325–1511. submission and in the file. Pursuant to 19
Analyst, Office of Policy, Planning, and SUPPLEMENTARY INFORMATION: Notice is C.F.R. § 177.2(b)(7), the identified
Evaluation, National Center for hereby given that on 11/23/18, CBP information has been bracketed and will be
Complementary and Integrative Health, issued a final determination concerning redacted in the public version of this ruling.
9000 Rockville Pike, Building 31, Suite Airlift PTTD Brace, which may be FACTS:
2B11, Bethesda, MD 20892, telephone: offered to the United States Government DJO is a global provider of orthopedic
301–827–8277; email: under an undesignated government devices, including a broad range of products
angela.arensdorf@nih.gov. procurement contract. The final used for rehabilitation, pain management and
SUPPLEMENTARY INFORMATION: This determination, HQ H299701, was issued physical therapy. The Airlift, one of the items
at the request of DJO, LLC, under that DJO develops, is designed for the
workshop will be an all-day meeting
procedures set forth at 19 CFR part 177, treatment of posterior tibial tendon
held on December 8, 2018 and will dysfunction (‘‘PTTD’’), or for early signs and
bring together representatives from the subpart B, which implements Title III of
symptoms of the adult acquired flat foot. A
NIH, FDA, DEA, academia, and industry the Trade Agreements Act of 1979, as sample of the finished article and
to discuss the issues related to amended (19 U.S.C. 2511–18). In the photographs of the components were
conducting research with cannabinoids. final determination, CBP concluded that submitted with your request. The Airlift is
The goals of this meeting are to gain an the aircell produced in Mexico imparts essentially a brace that covers the ankle and
understanding of how to navigate this the final product with its essential foot. Depending on the severity of the
character. Further, the assembly patient’s condition, the Airlift can be
regulatory space, discuss future research
operations completed in Mexico prescribed for use as part of a conservative
opportunities, and foster collaborations. treatment to stabilize the foot and ankle to
The focus of this workshop will be on permanently attach the various parts to
help prevent further degeneration. It can also
the state of the science and working each other so that they lose their
be prescribed for use post-surgically and
within current regulations. This meeting individual identities and become part of during rehabilitation. The Airlift is produced
will NOT discuss challenging or the completed Airlift. Therefore, the in three sizes for both the left and right foot
changing current Federal laws, policies country of origin for purposes of U.S. with varying dimensions, but all have the
or regulations. Government procurement of the Airlift same structure and composition and are
PTTD Brace is Mexico. manufactured using the process described
Dated: November 23, 2018. Section 177.29, CBP Regulations (19 below. Foot support and ankle stabilization
David Shurtleff, CFR 177.29), provides that notice of are provided by the Airlift’s integrated aircell
Acting Director, National Center for final determinations shall be published and semi-rigid shells. The aircell, located
Complementary and Integrative Health, in the Federal Register within 60 days under the foot arch, is integral to preventing
National Institutes of Health. and rehabilitating flat foot. The aircell is
of the date the final determination is
[FR Doc. 2018–26127 Filed 11–30–18; 8:45 am] adjustable using a hand bulb, which is
issued. Section 177.30, CBP Regulations included with the brace. When inflated, the
BILLING CODE 4140–01–P (19 CFR 177.30), provides that any aircell can accommodate variances in arch
party-at-interest, as defined in 19 CFR shapes and heights. The semi-rigid shells are
177.22(d), may seek judicial review of a anatomically designed to the shape of the
final determination within 30 days of ankle for secure support and stabilization.
DEPARTMENT OF HOMELAND publication of such determination in the These shells help realign the ankle and
SECURITY Federal Register. support the patient. The Airlift uses a rear
entry design which allows the patient to slip
U.S. Customs and Border Protection Dated: November 23, 2018. his or her foot into the back of the brace. Two
Alice A. Kipel, hook and loop straps secure the brace and
Notice of Issuance of Final Executive Director, Regulations and Rulings, can be used to adjust fit. These design
Determination Concerning Airlift PTTD Office of Trade. elements eliminate the need for lacing,
Brace improve patient compliance and make the
HQ H299701 Airlift easier to put on than custom braces.
AGENCY: U.S. Customs and Border November 23, 2018 The Airlift is produced from the following
Protection, Department of Homeland OT:RR:CTF:VS: H299701 JMV
components: a form assembly from [country
Security. A], a springloaded valve from [country B], a
CATEGORY: Origin hand bulb from [country A], an aircell from
ACTION: Notice of final determination.
Matthew M. Caligur Mexico, tubing from [country C], a pneumatic
khammond on DSK30JT082PROD with NOTICES

SUMMARY: This document provides Baker & Hostetler, LLP coupler from [country D], an elbow from
811 Main St., Suite 1100 [country D], resin polyether from [country D],
notice that U.S. Customs and Border Houston, TX 77002–6111 colorant from [country D], foam from
Protection (‘‘CBP’’) has issued a final [country C], polyurethane laminate from
RE: U.S. Government Procurement; Title III,
determination concerning the country of Trade Agreements Act of 1979 (19 U.S.C. [country D], and polyurethane film from
origin of the Airlift PTTD Brace. CBP § 2511); Subpart B, Part 177, CBP [country D]. Production of the Airlift takes
has concluded that the country of origin Regulations; Country of Origin of Airlift place at DJO’s facility in Tijuana, Mexico.
of the Airlift PTTD Brace is Mexico for PTTD Brace DJO produces the aircells in Mexico using

VerDate Sep<11>2014 16:52 Nov 30, 2018 Jkt 247001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\03DEN1.SGM 03DEN1

Document Created: 2018-12-01 00:56:13
Document Modified: 2018-12-01 00:56:13

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		The meeting will be held on December 8, 2018, from 8:00 a.m. to 5:30 p.m. (EST).
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]
FR Citation		83 FR 62326

83 FR 62326 - Evaluating the Therapeutic Potential of Cannabinoids: How To Conduct Research Within the Current Regulatory Framework

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 232 (December 3, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health