Proposed Collection; 60-Day Comment Request; Generic Clearance To Conduct Voluntary Customer/Partner Surveys (NLM), 34599-34600 [2018-15490]
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Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; or Office of Communication,
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Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist the office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Richard Lostritto, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4132,
Silver Spring, MD 20993, 301–796–
1697, Richard.Lostritto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of April 19,
2018 (83 FR 17420), FDA announced the
availability of a draft guidance for
industry entitled ‘‘Metered Dose Inhaler
and Dry Powder Inhaler Drug
Products—Quality Considerations; Draft
Guidance for Industry.’’ Interested
persons were originally given until June
18, 2018, to comment on the draft
guidance. The Agency believes that
reopening the comment period for an
additional 60 days from the date of
publication of this notice will allow
adequate time for interested persons to
submit comments without significantly
delaying Agency decision making on
these important issues.
II. Electronic Access
daltland on DSKBBV9HB2PROD with NOTICES
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, or https://
www.regulations.gov.
Dated: July 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–15508 Filed 7–19–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT:
Chris Kornak, 240–627–3705,
chris.kornak@nih.gov. Licensing
information and copies of the U.S.
patent applications listed below may be
obtained by communicating with the
indicated licensing contact at the
Technology Transfer and Intellectual
Property Office (TTIPO), 5601 Fishers
Lane, Suite 6D, MSC 9804, Rockville,
MD 20892, tel: 301–496–2644, fax: 240–
627–3117. A signed Confidential
Disclosure Agreement will be required
to receive copies of unpublished patent
applications.
SUPPLEMENTARY INFORMATION:
Technology description follows.
SUMMARY:
Inhibition of CD300f Function on
Dendritic Cells Promotes Tumor
Destruction
Description of Technology: Cancer
immunotherapy aims to enhance the
ability of a patient’s own immune
response to destroy tumors. The
magnitude of the immune response is
determined by the balance between
immune activating signals and negative
inhibitory signals. Checkpoint receptors
are negative regulators that normally
deliver inhibitory signals which limit
immune activation. Blockade of
immune checkpoints represents an
effective strategy to enhance the
immune response against cancer cells.
NIAID researchers have discovered
that blocking CD300f function in
dendritic cells markedly enhances their
ability to phagocytose and process
apoptotic tumor cells, leading to
substantial inhibition of tumor growth.
In this light, CD300f may be viewed as
a dendritic cell checkpoint receptor
analogous to T cell checkpoint receptors
like PD–1 and CTLA–4. As a result,
inhibiting CD300f function on dendritic
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34599
cells could be a promising anti-cancer
therapy, especially in the settings where
blocking of T cell checkpoint receptors
has been ineffective.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404, as well as for further
development and evaluation under a
research collaboration.
Potential Commercial Applications:
• Cancer immunotherapy
Competitive Advantages:
• A novel approach
Development Stage:
• Pre-Clinical
• Proof-of-concept studies in mouse
models
Inventors: John E. Coligan, Konrad
Krzewski, Linjie Tian, Ha-Na Lee, all of
NIAID, NIH.
Publications: Tian, L. et al., Enhanced
efferocytosis by dendritic cells underlies
memory T-cell expansion and
susceptibility to autoimmune disease in
CD300f-deficient mice. Cell Death and
Differ (2016) 23, 1086–1096.
Intellectual Property: HHS Reference
No. E–257–2016/0—U.S. Patent
Application No. 62/408,596 filed on 10/
14/2016;—PCT/US2017/056192 filed on
10/11/2017.
Licensing Contact: Chris Kornak, 240–
627–3705, Chris.Kornak@nih.gov.
Collaborative Research Opportunity:
The Technology Transfer and
Intellectual Property Office (TTIPO) is
not seeking parties interested in
collaborative research to further develop
the technology.
Dated: July 9, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2018–15489 Filed 7–19–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Generic Clearance To
Conduct Voluntary Customer/Partner
Surveys (NLM)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
SUMMARY:
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Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices
National Library of Medicine (NLM)
will publish periodic summaries of
propose projects to be submitted to the
Office of Management and Budget
(OMB) for review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: David Sharlip, National Library
of Medicine, Building 38A, Room
B2N12, 8600 Rockville Pike, Bethesda,
MD 20894, or call non-toll-free number
301–827–6361 or Email your request to
sharlipd@mail.nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
SUPPLEMENTARY INFORMATION: Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: written
comments and/or suggestions from the
public and affected agencies are invited
to address one or more of the following
points: (1) Whether the proposed
minimum, necessary elements in
improving the delivery of information
include: (1) Development of easy-to-use
access and delivery mechanisms that
promote the public’s understanding of
health information, drawing on research
in lay terminology, graphical and
multimedia presentations; (2) assisting
those providing health information to
the public to make effective use of
electronic services through internet
connections, training, and other means,
with an emphasis on those serving
minority groups, low income
populations, and seniors; (3) promoting
integrations of NLM services with other
electronic services covering regional,
state, or local health information; and
(4) conducting and supporting research,
development, and evaluation of the
public’s health information needs,
information seeking behavior and
learning styles, information systems that
meet the public’s needs, and the impact
of access to information.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
750.
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Proposed Collection Title: Generic
Clearance to Conduct Voluntary
Customer/Partner Surveys (NLM), 0925–
0476, Expiration Date 09/30/2018,
EXTENSION, National Library of
Medicine (NLM), National Institutes of
Health (NIH).
Need and Use of Information
Collection: In 1994, the NLM was
designated a ‘‘Federal Reinvention
Laboratory’’ with a major objective of
improving its methods of delivering
information to the public. At a
ESTIMATED ANNUALIZED BURDEN HOURS
Table A.12–1
Estimates of annual burden hours
Number of
respondents
Annual
frequency
per response
Average time
per response
(minutes/hour)
Total
burden hours
Type of collection
Type of respondents
Customer Satisfaction Surveys ............................
Focus Groups .......................................................
Usability and Pilot Testing ....................................
Interviews or Small Discussion Groups ................
General Public ..............
Health Professionals ....
Librarians ......................
Health Educators ..........
1,000
500
500
500
1
1
1
1
20/60
15/60
20/60
15/60
333
125
167
125
Total ...............................................................
.......................................
2,500
2,500
........................
750
Dated: July 3, 2018.
David Sharlip,
Project Clearance Liaison, National Library
of Medicine, National Institutes of Health.
[FR Doc. 2018–15490 Filed 7–19–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
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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 on
Alcohol Abuse and Alcoholism Special
Emphasis Panel; Review of RFA–AA–18–
011—Interaction of HIV Infection and
Alcohol Abuse on Central Nervous System
Morbidity.
Date: August 27, 2018.
Time: 2:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
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Alcoholism, 6700 B Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Ranga Srinivas, Ph.D.,
Chief Extramural Project Review Branch,
National Institute on Alcohol Abuse and
Alcoholism, National Institutes of Health,
5365 Fishers Lane, Room 2085, Rockville,
MD 20852, (301) 451–2067, srinivar@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.271, Alcohol Research
Career Development Awards for Scientists
and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
Training; 93.273, Alcohol Research Programs;
93.891, Alcohol Research Center Grants;
93.701, ARRA Related Biomedical Research
and Research Support Awards., National
Institutes of Health, HHS)
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[Federal Register Volume 83, Number 140 (Friday, July 20, 2018)]
[Notices]
[Pages 34599-34600]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15490]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Generic Clearance To
Conduct Voluntary Customer/Partner Surveys (NLM)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995 to provide opportunity for public comment on proposed data
collection projects, the
[[Page 34600]]
National Library of Medicine (NLM) will publish periodic summaries of
propose projects to be submitted to the Office of Management and Budget
(OMB) for review and approval.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, or
request more information on the proposed project, contact: David
Sharlip, National Library of Medicine, Building 38A, Room B2N12, 8600
Rockville Pike, Bethesda, MD 20894, or call non-toll-free number 301-
827-6361 or Email your request to [email protected]. Formal
requests for additional plans and instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: written comments and/or suggestions
from the public and affected agencies are invited to address one or
more of the following points: (1) Whether the proposed collection of
information is necessary for the proper performance of the function of
the agency, including whether the information will have practical
utility; (2) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) Ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) Ways
to minimize the burden of the collection of information on those who
are to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Proposed Collection Title: Generic Clearance to Conduct Voluntary
Customer/Partner Surveys (NLM), 0925-0476, Expiration Date 09/30/2018,
EXTENSION, National Library of Medicine (NLM), National Institutes of
Health (NIH).
Need and Use of Information Collection: In 1994, the NLM was
designated a ``Federal Reinvention Laboratory'' with a major objective
of improving its methods of delivering information to the public. At a
minimum, necessary elements in improving the delivery of information
include: (1) Development of easy-to-use access and delivery mechanisms
that promote the public's understanding of health information, drawing
on research in lay terminology, graphical and multimedia presentations;
(2) assisting those providing health information to the public to make
effective use of electronic services through internet connections,
training, and other means, with an emphasis on those serving minority
groups, low income populations, and seniors; (3) promoting integrations
of NLM services with other electronic services covering regional,
state, or local health information; and (4) conducting and supporting
research, development, and evaluation of the public's health
information needs, information seeking behavior and learning styles,
information systems that meet the public's needs, and the impact of
access to information.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 750.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Table A.12-1 Estimates of annual burden hours
-----------------------------------------------------------------------------------------------------------------
Annual Average time
Type of collection Type of Number of frequency per per response Total burden
respondents respondents response (minutes/hour) hours
----------------------------------------------------------------------------------------------------------------
Customer Satisfaction Surveys. General Public.. 1,000 1 20/60 333
Focus Groups.................. Health 500 1 15/60 125
Professionals.
Usability and Pilot Testing... Librarians...... 500 1 20/60 167
Interviews or Small Discussion Health Educators 500 1 15/60 125
Groups.
---------------------------------------------------------------
Total..................... ................ 2,500 2,500 .............. 750
----------------------------------------------------------------------------------------------------------------
Dated: July 3, 2018.
David Sharlip,
Project Clearance Liaison, National Library of Medicine, National
Institutes of Health.
[FR Doc. 2018-15490 Filed 7-19-18; 8:45 am]
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