81 FR 22998 - National Center for Advancing Translational Sciences; Notice of Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 75 (April 19, 2016)

Page Range		22998-22999
FR Document		2016-08992

Federal Register, Volume 81 Issue 75 (Tuesday, April 19, 2016)

[Federal Register Volume 81, Number 75 (Tuesday, April 19, 2016)]
[Notices]
[Pages 22998-22999]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-08992]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Center for Advancing Translational Sciences; Notice of 
Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), notice is hereby given of meetings of the 
National Center for Advancing Translational Sciences.
    The meetings 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 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: Cures Acceleration Network Review Board.
    Date: May 12, 2016.
    Time: 8:30 a.m. to 2:45 p.m.
    Agenda: Report from the Institute Director.
    Place: National Institutes of Health, Building 31, Conference 
Room 10, 31 Center Drive, Bethesda, MD 20892.
    Contact Person: Anna L. Ramsey-Ewing, Ph.D., Executive 
Secretary, National Center for Advancing Translational Sciences, 1 
Democracy Plaza, Room 1072, Bethesda, MD 20892, 301-435-0809, 
[email protected].

    Name of Committee: National Center for Advancing Translational 
Sciences Advisory Council.
    Date: May 12, 2016.
    Open: 8:30 a.m. to 2:45 p.m.
    Agenda: Report from the Institute Director and other staff.
    Place: National Institutes of Health, Building 31, Conference 
Room 10, 31 Center Drive, Bethesda, MD 20892.
    Closed: 3:00 p.m. to 4:30 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Building 31, Conference 
Room 10, 31 Center Drive, Bethesda, MD 20892.
    Contact Person: Anna L. Ramsey-Ewing, Ph.D., Executive 
Secretary, National Center for Advancing Translational Sciences, 1 
Democracy Plaza, Room 1072, Bethesda, MD 20892, 301-435-0809, 
[email protected].


[[Page 22999]]


(Catalogue of Federal Domestic Assistance Program Nos. 93.859, 
Pharmacology, Physiology, and Biological Chemistry Research; 93.350, 
B--Cooperative Agreements; 93.859, Biomedical Research and Research 
Training, National Institutes of Health, HHS)

    Dated: April 13, 2016.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-08992 Filed 4-18-16; 8:45 am]
 BILLING CODE 4140-01-P

22998 Federal Register / Vol. 81, No. 75 / Tuesday, April 19, 2016 / Notices

ACTION: Notice. Advancement Office, The National DEPARTMENT OF HEALTH AND
Institute of Diabetes and Digestive and HUMAN SERVICES
SUMMARY: This notice, in accordance Kidney Diseases on or before May 4,
with 35 U.S.C. 209(c)(1) and 37 CFR 2016 will be considered. National Institutes of Health
part 404.7, that the National Institutes of
Health, Department of Health and ADDRESSES: Requests for copies of the National Center for Advancing
Human Services, is contemplating the patent application, patents, inquiries, Translational Sciences; Notice of
grant of an exclusive patent license to comments, and other materials relating Meetings
practice the following inventions to the contemplated exclusive license
Pursuant to section 10(d) of the
embodied in the following patent should be directed to: Betty Tong, Ph.D.,
Federal Advisory Committee Act, as
applications, entitled ‘‘CB1 receptor Sr. Licensing and Patenting Manager,
amended (5 U.S.C. App.), notice is
mediating compounds’’: Technology Advancement Office, The
hereby given of meetings of the National
1. U.S. Provisional Patent Application National Institute of Diabetes and Center for Advancing Translational
No.: 61/991,333, HHS Ref. No.: E– Digestive and Kidney Diseases, 12A Sciences.
140–2014/0–US–01, Filed: May 09, South Drive, Bethesda, MD 20892; The meetings will be open to the
2014. Email: betty.tong@nih.gov. A signed public as indicated below, with
2. PCT Application No.: PCT/US2015/ confidentiality non-disclosure attendance limited to space available.
029946, HHS Ref. No.: E–140–2014/ agreement will be required to receive Individuals who plan to attend and
0–PCT–02, Filed: May 08, 2015. copies of any patent applications that need special assistance, such as sign
3. U.S. Provisional Patent Application have not been published by the United language interpretation or other
No.: 61/725,949, HHS Ref. No.: E– States Patent and Trademark Office or reasonable accommodations, should
282–2012/0–US–01, Filed: the World Intellectual Property notify the Contact Person listed below
November 13, 2012. Organization. in advance of the meeting.
4. PCT Application No.: PCT/US2013/ The meetings will be closed to the
069686, HHS Ref. No.: E–282–2012/ SUPPLEMENTARY INFORMATION: This public in accordance with the
0–PCT–02, Filed: November 12, technology, and its corresponding provisions set forth in sections
2013. patent applications, is directed to 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
5. U.S. Patent Application No.: 14/ methods of treating fibrosis, obesity and as amended. The grant applications and
442,383, HHS Ref. No.: E–282– associated diseases such as type 2 the discussions could disclose
2012/0–US–03, Filed: May 12, diabetes by administering an agent that confidential trade secrets or commercial
2015. reduces appetite, body weight, hepatic property such as patentable material,
6. Canadian Patent Application No.: steatosis, and insulin resistance. This and personal information concerning
2889697, HHS Ref. No.: E–282– technology may be useful as a means for individuals associated with the grant
2012/0–CA–04, Filed: April 27, treating various fibrotic diseases and applications, the disclosure of which
2015. metabolic syndromes without serious would constitute a clearly unwarranted
7. European Patent Application No.: adverse neuropsychiatric side effects. invasion of personal privacy.
13802153.0, HHS Ref. No.: E–282– The prospective exclusive license will Name of Committee: Cures Acceleration
2012/0–EP–05, Filed: June 01, 2015. be royalty bearing and will comply with Network Review Board.
8. Indian Patent Application No.: 3733/ the terms and conditions of 35 U.S.C. Date: May 12, 2016.
DELNP/2015, HHS Ref. No.: E–282– 209 and 37 CFR part 404.7. The Time: 8:30 a.m. to 2:45 p.m.
2012/0–IN–06, Filed: May 01, 2015. prospective exclusive license may be Agenda: Report from the Institute Director.
9. Japanese Patent Application No.: granted unless within fifteen (15) days Place: National Institutes of Health,
2015–542015, HHS Ref. No.: E– Building 31, Conference Room 10, 31 Center
from the date of this published notice, Drive, Bethesda, MD 20892.
282–2012/0–JP–07, Filed: May 11, the Technology Advancement Office Contact Person: Anna L. Ramsey-Ewing,
2015. receives written evidence and argument Ph.D., Executive Secretary, National Center
10. Chinese Patent Application No.: that establishes that the grant of the for Advancing Translational Sciences, 1
201380069389.9, HHS Ref. No.: E– license would not be consistent with the Democracy Plaza, Room 1072, Bethesda, MD
282–2012/0–CN–08, Filed: July 3, requirements of 35 U.S.C. 209 and 37 20892, 301–435–0809, anna.ramseyewing@
2015. CFR part 404.7. nih.gov.
11. US Provisional Application No.: 62/ Name of Committee: National Center for
171,179, HHS Ref. No.: E–282– Properly filed competing applications Advancing Translational Sciences Advisory
2012/1–US–01, Filed: June 04, for a license in response to this notice Council.
2015. will be treated as objections to the Date: May 12, 2016.
contemplated license. Comments and Open: 8:30 a.m. to 2:45 p.m.
to Kalytera Therapeutics Inc., Agenda: Report from the Institute Director
(‘‘Kalytera’’), a company incorporated objections submitted in response to this
and other staff.
under the laws of Delaware and having notice will not be made available for
Place: National Institutes of Health,
an office in Hermosa Beach, California. public inspection and, to the extent Building 31, Conference Room 10, 31 Center
The patent rights in these inventions permitted by law, will not be released Drive, Bethesda, MD 20892.
have been assigned to the United States under the Freedom of Information Act, Closed: 3:00 p.m. to 4:30 p.m.
of America. This license may be 5 U.S.C. 552. Agenda: To review and evaluate grant
applications.
worldwide. The field of use may be Dated: April 13, 2016.
mstockstill on DSK4VPTVN1PROD with NOTICES

Place: National Institutes of Health,
limited to the use of the Licensed Patent Anna Amar, Building 31, Conference Room 10, 31 Center
Rights to the development of select Acting Deputy Director, Technology Drive, Bethesda, MD 20892.
compounds from the patents listed Advancement Office, National Institute of Contact Person: Anna L. Ramsey-Ewing,
above. Diabetes and Digestive and Kidney Diseases, Ph.D., Executive Secretary, National Center
National Institutes of Health. for Advancing Translational Sciences, 1
DATES: Only written comments and/or Democracy Plaza, Room 1072, Bethesda, MD
applications for a license which are [FR Doc. 2016–08986 Filed 4–18–16; 8:45 am] 20892, 301–435–0809, anna.ramseyewing@
received by the Technology BILLING CODE 4140–01–P nih.gov.

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Federal Register / Vol. 81, No. 75 / Tuesday, April 19, 2016 / Notices 22999

(Catalogue of Federal Domestic Assistance Proposed Project: Opioid Drugs in treatment plan, any prenatal support
Program Nos. 93.859, Pharmacology, Maintenance and Detoxification provided to the patient, justification of
Physiology, and Biological Chemistry Treatment of Opioid Dependence—42 unusually large initial doses, changes in
Research; 93.350, B—Cooperative CFR part 8 (OMB No. 0930–0206) and a patient’s dosage schedule, justification
Agreements; 93.859, Biomedical Research Opioid Treatment Programs (OTPs)— of unusually large daily doses, the
and Research Training, National Institutes of Revision rationale for decreasing a patient’s clinic
Health, HHS) attendance, and documentation of
42 CFR part 8 establishes a
Dated: April 13, 2016. certification program managed by physiologic dependence.
David Clary, SAMHSA’s Center for Substance Abuse The rule also includes requirements
Program Analyst, Office of Federal Advisory Treatment (CSAT). The regulation that OTPs and accreditation
Committee Policy. requires that Opioid Treatment organizations disclose information. For
[FR Doc. 2016–08992 Filed 4–18–16; 8:45 am] Programs (OTPs) be certified. example, 42 CFR 8.12(e)(1) requires that
‘‘Certification’’ is the process by which a physician explain the facts concerning
BILLING CODE 4140–01–P
SAMHSA determines that an OTP is the use of opioid drug treatment to each
qualified to provide opioid treatment patient. This type of disclosure is
under the Federal opioid treatment considered to be consistent with the
DEPARTMENT OF HEALTH AND
standards established by the Secretary common medical practice and is not
HUMAN SERVICES
of Health and Human Services. To considered an additional burden.
Substance Abuse and Mental Health become certified, an OTP must be Further, the rule requires, under Sec.
accredited by a SAMHSA-approved 8.4(i)(1) that accreditation organizations
Services Administration
accreditation body. The regulation also shall make public their fee structure;
Agency Information Collection provides standards for such services as this type of disclosure is standard
Activities: Proposed Collection; individualized treatment planning, business practice and is not considered
increased medical supervision, and a burden.
Comment Request
assessment of patient outcomes. This A number of changes have been made
In compliance with section submission seeks continued approval of to the forms. Forms have been reworded
3506(c)(2)(A) of the Paperwork the information collection requirements for clarification, updated with current
in the regulation and of the forms used SAMHSA mailing and web-submission
Reduction Act of 1995 concerning
in implementing the regulation. information, and a few additional fields
opportunity for public comment on SAMHSA currently has approval for
proposed collections of information, the have been provided for clarity and for
the Application for Certification to Use
Substance Abuse and Mental Health providers to best explain their services
Opioid Drugs in a Treatment Program
Services Administration (SAMHSA) (e.g., expanding the former global
Under 42 CFR 8.11 (Form SMA–162);
will publish periodic summaries of patient census in the SMA–162 to
the Application for Approval as
proposed projects. To request more request patient census by drug type—
Accreditation Body Under 42 CFR 8.3(b)
information on the proposed projects or methadone, buprenorphine, naltrexone,
(Form SMA–163); and the Exception
to obtain a copy of the information or other) and the needs of their patients
Request and Record of Justification
Under 42 CFR 8.12 (Form SMA–168), (e.g., including urinalysis results on the
collection plans, call the SAMHSA
which may be used by physicians when SMA–168 and adding ‘‘weather crisis’’
Reports Clearance Officer on (240) 276–
there is a patient care situation in which as a standard option for physician
1243. justification of the requested exception).
the physician must make a treatment
Comments are invited on: (a) Whether Amendments also include the removal
decision that differs from the treatment
the proposed collections of information of information pertaining to faxing the
regimen required by the regulation.
are necessary for the proper Form SMA–168 is a simplified, forms to SAMHSA, as this is no longer
performance of the functions of the standardized form to facilitate the an acceptable form of submission. The
agency, including whether the documentation, request, and approval burden hours have increased slightly
information shall have practical utility; process for exceptions. (by 28% or approximately 639 hours)
(b) the accuracy of the agency’s estimate SAMHSA believes that the due to an increase in the number of
of the burden of the proposed collection recordkeeping requirements in the facilities accredited and certified by
of information; (c) ways to enhance the regulation are customary and usual SAMHSA since the previous
quality, utility, and clarity of the practices within the medical and submissions of these forms. The forms
information to be collected; and (d) rehabilitative communities and has not are available online with a unique
ways to minimize the burden of the calculated a response burden for them. feature for both the SMA–162 and
collection of information on The recordkeeping requirements set SMA–168 that pre-populates certain
respondents, including through the use forth in 42 CFR 8.4, 8.11, and 8.12 information within the form. This in
of automated collection techniques or include maintenance of the following: 5- turn reduces the program’s time spent
year retention by accreditation bodies of filling out the forms as well as the staff
other forms of information technology.
certain records pertaining to time spent on processing it.
accreditation, and documentation by an The tables that follow summarize the
OTP of the following: A patient’s annual reporting burden associated with
medical examination when admitted to the regulation, including burden
mstockstill on DSK4VPTVN1PROD with NOTICES

treatment, a patient’s history, a associated with the forms.
ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR ACCREDITATION BODIES
Number of Responses/ Total Hours/ Total
42 CFR citation Purpose respondents respondent responses response hours

8.3(b)(1–11) ......... Initial approval (SMA–163) ................ 1 1 1 6.00 6.00

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Document Created: 2016-04-19 00:15:49
Document Modified: 2016-04-19 00:15:49

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
Dates		May 12, 2016.
FR Citation		81 FR 22998

81 FR 22998 - National Center for Advancing Translational Sciences; Notice of Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 75 (April 19, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health