83_FR_34739 83 FR 34599 - Proposed Collection; 60-Day Comment Request; Generic Clearance To Conduct Voluntary Customer/Partner Surveys (NLM)

83 FR 34599 - Proposed Collection; 60-Day Comment Request; Generic Clearance To Conduct Voluntary Customer/Partner Surveys (NLM)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 140 (July 20, 2018)

Page Range34599-34600
FR Document2018-15490

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the 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.

Federal Register, Volume 83 Issue 140 (Friday, July 20, 2018)
[Federal Register Volume 83, Number 140 (Friday, July 20, 2018)]
[Notices]
[Pages 34599-34600]
From the Federal Register Online  [www.thefederalregister.org]
[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]
 BILLING CODE 4140-01-P



                                                                                Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices                                                 34599

                                               Drug Evaluation and Research, Food                       DEPARTMENT OF HEALTH AND                              cells could be a promising anti-cancer
                                               and Drug Administration, 10001 New                       HUMAN SERVICES                                        therapy, especially in the settings where
                                               Hampshire Ave., Hillandale Building,                                                                           blocking of T cell checkpoint receptors
                                               4th Floor, Silver Spring, MD 20993–                      National Institutes of Health                         has been ineffective.
                                               0002; or Office of Communication,                                                                                 This technology is available for
                                                                                                        Government-Owned Inventions;                          licensing for commercial development
                                               Outreach and Development, Center for
                                                                                                        Availability for Licensing                            in accordance with 35 U.S.C. 209 and 37
                                               Biologics Evaluation and Research,
                                               Food and Drug Administration, 10903                      AGENCY:    National Institutes of Health,             CFR part 404, as well as for further
                                               New Hampshire Ave., Bldg. 71, Rm.                        HHS.                                                  development and evaluation under a
                                               3128, Silver Spring, MD 20993–0002.                                                                            research collaboration.
                                                                                                        ACTION:   Notice.
                                                                                                                                                                 Potential Commercial Applications:
                                               Send one self-addressed adhesive label
                                               to assist the office in processing your                  SUMMARY:   The inventions listed below                • Cancer immunotherapy
                                               requests. The draft guidance may also be                 are owned by an agency of the U.S.                       Competitive Advantages:
                                               obtained by mail by calling CBER at 1–                   Government and are available for                      • A novel approach
                                                                                                        licensing to achieve expeditious
                                               800–835–4709 or 240–402–8010. See                                                                                 Development Stage:
                                                                                                        commercialization of results of
                                               the SUPPLEMENTARY INFORMATION section
                                                                                                        federally-funded research and                         • Pre-Clinical
                                               for electronic access to the draft                       development. Foreign patent                           • Proof-of-concept studies in mouse
                                               guidance document.                                       applications are filed on selected                       models
                                               FOR FURTHER INFORMATION CONTACT:                         inventions to extend market coverage                     Inventors: John E. Coligan, Konrad
                                               Richard Lostritto, Center for Drug                       for companies and may also be available               Krzewski, Linjie Tian, Ha-Na Lee, all of
                                               Evaluation and Research, Food and                        for licensing.                                        NIAID, NIH.
                                               Drug Administration, 10903 New                           FOR FURTHER INFORMATION CONTACT:                         Publications: Tian, L. et al., Enhanced
                                               Hampshire Ave., Bldg. 51, Rm. 4132,                      Chris Kornak, 240–627–3705,                           efferocytosis by dendritic cells underlies
                                               Silver Spring, MD 20993, 301–796–                        chris.kornak@nih.gov. Licensing                       memory T-cell expansion and
                                                                                                        information and copies of the U.S.                    susceptibility to autoimmune disease in
                                               1697, Richard.Lostritto@fda.hhs.gov.
                                                                                                        patent applications listed below may be               CD300f-deficient mice. Cell Death and
                                               SUPPLEMENTARY INFORMATION:                               obtained by communicating with the                    Differ (2016) 23, 1086–1096.
                                                                                                        indicated licensing contact at the                       Intellectual Property: HHS Reference
                                               I. Background                                                                                                  No. E–257–2016/0—U.S. Patent
                                                                                                        Technology Transfer and Intellectual
                                                 In the Federal Register of April 19,                   Property Office (TTIPO), 5601 Fishers                 Application No. 62/408,596 filed on 10/
                                               2018 (83 FR 17420), FDA announced the                    Lane, Suite 6D, MSC 9804, Rockville,                  14/2016;—PCT/US2017/056192 filed on
                                               availability of a draft guidance for                     MD 20892, tel: 301–496–2644, fax: 240–                10/11/2017.
                                                                                                        627–3117. A signed Confidential                          Licensing Contact: Chris Kornak, 240–
                                               industry entitled ‘‘Metered Dose Inhaler
                                                                                                        Disclosure Agreement will be required                 627–3705, Chris.Kornak@nih.gov.
                                               and Dry Powder Inhaler Drug                                                                                       Collaborative Research Opportunity:
                                               Products—Quality Considerations; Draft                   to receive copies of unpublished patent
                                                                                                        applications.                                         The Technology Transfer and
                                               Guidance for Industry.’’ Interested                                                                            Intellectual Property Office (TTIPO) is
                                               persons were originally given until June                 SUPPLEMENTARY INFORMATION:
                                                                                                                                                              not seeking parties interested in
                                               18, 2018, to comment on the draft                        Technology description follows.
                                                                                                                                                              collaborative research to further develop
                                               guidance. The Agency believes that                       Inhibition of CD300f Function on                      the technology.
                                               reopening the comment period for an                      Dendritic Cells Promotes Tumor                           Dated: July 9, 2018.
                                               additional 60 days from the date of                      Destruction                                           Suzanne M. Frisbie,
                                               publication of this notice will allow
                                                                                                           Description of Technology: Cancer                  Deputy Director, Technology Transfer and
                                               adequate time for interested persons to
                                                                                                        immunotherapy aims to enhance the                     Intellectual Property Office, National Institute
                                               submit comments without significantly                    ability of a patient’s own immune                     of Allergy and Infectious Diseases.
                                               delaying Agency decision making on                       response to destroy tumors. The                       [FR Doc. 2018–15489 Filed 7–19–18; 8:45 am]
                                               these important issues.                                  magnitude of the immune response is                   BILLING CODE 4140–01–P
                                               II. Electronic Access                                    determined by the balance between
                                                                                                        immune activating signals and negative
                                                 Persons with access to the internet                    inhibitory signals. Checkpoint receptors              DEPARTMENT OF HEALTH AND
                                               may obtain the draft guidance at https://                are negative regulators that normally                 HUMAN SERVICES
                                               www.fda.gov/Drugs/Guidance                               deliver inhibitory signals which limit
                                               ComplianceRegulatoryInformation/                         immune activation. Blockade of                        National Institutes of Health
                                               Guidances/default.htm, https://                          immune checkpoints represents an
                                                                                                        effective strategy to enhance the                     Proposed Collection; 60-Day Comment
                                               www.fda.gov/BiologicsBloodVaccines/                                                                            Request; Generic Clearance To
                                               GuidanceComplianceRegulatory                             immune response against cancer cells.
                                                                                                           NIAID researchers have discovered                  Conduct Voluntary Customer/Partner
                                               Information/default.htm, or https://                                                                           Surveys (NLM)
                                               www.regulations.gov.                                     that blocking CD300f function in
                                                                                                        dendritic cells markedly enhances their               AGENCY:    National Institutes of Health,
                                                 Dated: July 16, 2018.                                  ability to phagocytose and process                    HHS.
daltland on DSKBBV9HB2PROD with NOTICES




                                               Leslie Kux,                                              apoptotic tumor cells, leading to                     ACTION:   Notice.
                                               Associate Commissioner for Policy.                       substantial inhibition of tumor growth.
                                               [FR Doc. 2018–15508 Filed 7–19–18; 8:45 am]              In this light, CD300f may be viewed as                SUMMARY: In compliance with the
                                               BILLING CODE 4164–01–P
                                                                                                        a dendritic cell checkpoint receptor                  requirement of the Paperwork
                                                                                                        analogous to T cell checkpoint receptors              Reduction Act of 1995 to provide
                                                                                                        like PD–1 and CTLA–4. As a result,                    opportunity for public comment on
                                                                                                        inhibiting CD300f function on dendritic               proposed data collection projects, the


                                          VerDate Sep<11>2014   18:06 Jul 19, 2018   Jkt 244001   PO 00000   Frm 00064   Fmt 4703   Sfmt 4703   E:\FR\FM\20JYN1.SGM   20JYN1


                                               34600                                       Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices

                                               National Library of Medicine (NLM)                                        collection of information is necessary                          minimum, necessary elements in
                                               will publish periodic summaries of                                        for the proper performance of the                               improving the delivery of information
                                               propose projects to be submitted to the                                   function of the agency, including                               include: (1) Development of easy-to-use
                                               Office of Management and Budget                                           whether the information will have                               access and delivery mechanisms that
                                               (OMB) for review and approval.                                            practical utility; (2) The accuracy of the                      promote the public’s understanding of
                                               DATES: Comments regarding this                                            agency’s estimate of the burden of the                          health information, drawing on research
                                               information collection are best assured                                   proposed collection of information,                             in lay terminology, graphical and
                                               of having their full effect if received                                   including the validity of the                                   multimedia presentations; (2) assisting
                                               within 60 days of the date of this                                        methodology and assumptions used; (3)                           those providing health information to
                                               publication.                                                              Ways to enhance the quality, utility, and                       the public to make effective use of
                                                                                                                         clarity of the information to be                                electronic services through internet
                                               FOR FURTHER INFORMATION CONTACT: To
                                                                                                                         collected; and (4) Ways to minimize the                         connections, training, and other means,
                                               obtain a copy of the data collection                                      burden of the collection of information
                                               plans and instruments, submit                                                                                                             with an emphasis on those serving
                                                                                                                         on those who are to respond, including                          minority groups, low income
                                               comments in writing, or request more                                      the use of appropriate automated,
                                               information on the proposed project,                                                                                                      populations, and seniors; (3) promoting
                                                                                                                         electronic, mechanical, or other                                integrations of NLM services with other
                                               contact: David Sharlip, National Library                                  technological collection techniques or
                                               of Medicine, Building 38A, Room                                                                                                           electronic services covering regional,
                                                                                                                         other forms of information technology.                          state, or local health information; and
                                               B2N12, 8600 Rockville Pike, Bethesda,                                       Proposed Collection Title: Generic
                                               MD 20894, or call non-toll-free number                                                                                                    (4) conducting and supporting research,
                                                                                                                         Clearance to Conduct Voluntary
                                               301–827–6361 or Email your request to                                                                                                     development, and evaluation of the
                                                                                                                         Customer/Partner Surveys (NLM), 0925–
                                               sharlipd@mail.nih.gov. Formal requests                                                                                                    public’s health information needs,
                                                                                                                         0476, Expiration Date 09/30/2018,
                                               for additional plans and instruments                                                                                                      information seeking behavior and
                                                                                                                         EXTENSION, National Library of
                                               must be requested in writing.                                                                                                             learning styles, information systems that
                                                                                                                         Medicine (NLM), National Institutes of
                                               SUPPLEMENTARY INFORMATION: Section
                                                                                                                                                                                         meet the public’s needs, and the impact
                                                                                                                         Health (NIH).
                                               3506(c)(2)(A) of the Paperwork                                              Need and Use of Information                                   of access to information.
                                               Reduction Act of 1995 requires: written                                   Collection: In 1994, the NLM was                                  OMB approval is requested for 3
                                               comments and/or suggestions from the                                      designated a ‘‘Federal Reinvention                              years. There are no costs to respondents
                                               public and affected agencies are invited                                  Laboratory’’ with a major objective of                          other than their time. The total
                                               to address one or more of the following                                   improving its methods of delivering                             estimated annualized burden hours are
                                               points: (1) Whether the proposed                                          information to the public. At a                                 750.

                                                                                                                        ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                      Table A.12–1            Estimates of annual burden hours

                                                                                                                                                                                          Annual           Average time
                                                                                                                                                                        Number of                                                        Total
                                                                      Type of collection                                       Type of respondents                                      frequency          per response
                                                                                                                                                                       respondents                                                   burden hours
                                                                                                                                                                                       per response       (minutes/hour)

                                               Customer Satisfaction Surveys ............................                    General Public ..............                     1,000                 1                  20/60                 333
                                               Focus Groups .......................................................          Health Professionals ....                           500                 1                  15/60                 125
                                               Usability and Pilot Testing ....................................              Librarians ......................                   500                 1                  20/60                 167
                                               Interviews or Small Discussion Groups ................                        Health Educators ..........                         500                 1                  15/60                 125

                                                     Total ...............................................................   .......................................           2,500             2,500    ........................            750



                                                  Dated: July 3, 2018.                                                   provisions set forth in sections                                Alcoholism, 6700 B Rockledge Drive,
                                               David Sharlip,                                                            552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,                      Bethesda, MD 20892 (Telephone Conference
                                               Project Clearance Liaison, National Library                               as amended. The grant applications and                          Call).
                                               of Medicine, National Institutes of Health.                               the discussions could disclose                                    Contact Person: Ranga Srinivas, Ph.D.,
                                               [FR Doc. 2018–15490 Filed 7–19–18; 8:45 am]                               confidential trade secrets or commercial                        Chief Extramural Project Review Branch,
                                               BILLING CODE 4140–01–P                                                    property such as patentable material,                           National Institute on Alcohol Abuse and
                                                                                                                         and personal information concerning                             Alcoholism, National Institutes of Health,
                                                                                                                         individuals associated with the grant                           5365 Fishers Lane, Room 2085, Rockville,
                                               DEPARTMENT OF HEALTH AND                                                  applications, the disclosure of which                           MD 20852, (301) 451–2067, srinivar@
                                               HUMAN SERVICES                                                            would constitute a clearly unwarranted                          mail.nih.gov.
                                                                                                                         invasion of personal privacy.                                   (Catalogue of Federal Domestic Assistance
                                               National Institutes of Health                                                                                                             Program Nos. 93.271, Alcohol Research
                                                                                                                           Name of Committee: National Institute on
                                                                                                                         Alcohol Abuse and Alcoholism Special                            Career Development Awards for Scientists
                                               National Institute on Alcohol Abuse                                                                                                       and Clinicians; 93.272, Alcohol National
                                                                                                                         Emphasis Panel; Review of RFA–AA–18–
                                               and Alcoholism; Notice of Closed                                          011—Interaction of HIV Infection and                            Research Service Awards for Research
                                               Meeting
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                                                                                                                         Alcohol Abuse on Central Nervous System                         Training; 93.273, Alcohol Research Programs;
                                                                                                                         Morbidity.                                                      93.891, Alcohol Research Center Grants;
                                                 Pursuant to section 10(d) of the
                                                                                                                           Date: August 27, 2018.                                        93.701, ARRA Related Biomedical Research
                                               Federal Advisory Committee Act, as                                          Time: 2:00 p.m. to 3:00 p.m.                                  and Research Support Awards., National
                                               amended, notice is hereby given of the                                      Agenda: To review and evaluate grant                          Institutes of Health, HHS)
                                               following meeting.                                                        applications.
                                                 The meeting will be closed to the                                         Place: National Institutes of Health,
                                               public in accordance with the                                             National Institute on Alcohol Abuse and



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Document Created: 2018-07-20 01:19:07
Document Modified: 2018-07-20 01:19:07
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.
ContactTo 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.
FR Citation83 FR 34599 

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