81_FR_44159 81 FR 44030 - Request for Public Comment: 60-Day Information Collection: Application for Participation in the IHS Scholarship Program

81 FR 44030 - Request for Public Comment: 60-Day Information Collection: Application for Participation in the IHS Scholarship Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service

Federal Register Volume 81, Issue 129 (July 6, 2016)

Page Range44030-44032
FR Document2016-16008

In compliance the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to comment on the information collection titled, ``Application for Participation in the IHS Scholarship Program,'' Office of Management and Budget (OMB) Control No. 0917-0006. IHS is requesting OMB to approve an extension for this collection, which expires on September 30, 2016.

Federal Register, Volume 81 Issue 129 (Wednesday, July 6, 2016)
[Federal Register Volume 81, Number 129 (Wednesday, July 6, 2016)]
[Notices]
[Pages 44030-44032]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-16008]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Indian Health Service


Request for Public Comment: 60-Day Information Collection: 
Application for Participation in the IHS Scholarship Program

AGENCY: Indian Health Service, HHS.

ACTION: Notice and request for comments. Request for extension of 
approval.

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

SUMMARY: In compliance the Paperwork Reduction Act of 1995, the Indian 
Health Service (IHS) invites the general public to comment on the 
information collection titled, ``Application for Participation in the 
IHS Scholarship Program,'' Office of Management and Budget (OMB) 
Control No. 0917-0006. IHS is requesting OMB to approve an extension 
for this collection, which expires on September 30, 2016.

DATES: Comment Due Date: September 6, 2016. Your comments regarding 
this information collection are best assured

[[Page 44031]]

of having full effect if received within 60 days of the date of this 
publication.

ADDRESSES: Send your written comments, requests for more information on 
the collection, or requests to obtain a copy of the data collection 
instrument and instructions to Mr. Robert Pittman by one of the 
following methods:
     Mail: Robert E. Pittman, BPharm, MPH, Acting Chief, 
Scholarship Branch Director, Division of Health Professions Support, 
Indian Health Service, 5600 Fishers Lane, Mail Stop: OHR 11E53A, 
Rockville, MD 20857.
     Phone: (301) 443-6197.
     Email: [email protected].
     Fax: 301-443-6048.

SUPPLEMENTARY INFORMATION: This previously approved information 
collection project was last published in the Federal Register (78 FR 
49532) on August 14, 2013 and allowed 30 days for public comment. No 
public comment was received in response to the notice. The purpose of 
this notice is to allow 60 days for public comment. A copy of the 
supporting statement is available at www.regulations.gov (see Docket ID 
IHS-2016-0005).
    Information Collection: Title: ``Application for Participation in 
the IHS Scholarship Program,'' OMB Control No. 0917-0006. Type of 
Information Collection Request: Extension of the currently approved 
information collection ``Application for Participation in the IHS 
Scholarship Program,'' OMB Control No. 0917-0006. Form Number(s): IHS-
856-3, IHS-856-5 through 856-19, IHS-856-21 through 856-24, IHS-817, 
and IHS-818 are retained for use by the IHS Scholarship Program (IHSSP) 
as part of this current information collection request. Reporting forms 
are found on the IHS Web site at www.ihs.gov/scholarship. Need and Use 
of Information Collection: The IHS Scholarship Branch needs this 
information for program administration and uses the information to: 
solicit, process, and award IHS Pre-graduate, Preparatory, and/or 
Health Professions Scholarship recipients; monitor the academic 
performance of recipients; and to place recipients at payback sites. 
The IHSSP application is electronically available on the internet at 
the IHS Web site at: https://www.ihs.gov/scholarship/applynow/. 
Affected Public: Individuals, not-for-profit institutions and State, 
local or Tribal Governments. Type of Respondents: Students pursuing 
health care professions.
    The table below provides: Types of data collection instruments, 
Estimated number of respondents, Number of responses per respondent, 
Annual number of responses, Average burden hour per response, and Total 
annual burden hours.

----------------------------------------------------------------------------------------------------------------
                                                  Responses      Total                                  Annual
  Data collection instrument(s)      Number of       per         annual    Burden hour per response     burden
                                    respondents   respondent    response               *                hours
----------------------------------------------------------------------------------------------------------------
Faculty/Employer Evaluation (IHS-         1,500            2        3,000  0.42 (25 min)...........        1,250
 856-3).
Delinquent Federal Debt (IHS-856-         1,500            1        1,500  0.13 (8 min)............          200
 5).
Course Curriculum Verification            1,500            1        1,500  0.70 (42 min)...........        1,050
 (IHS-856-6).
Verification of Acceptance or               350            1          350  0.13 (8 min)............           47
 Decline of Award (IHS-856-7).
Recipient's Initial Program               1,200            1        1,200  0.13 (8 min)............          160
 Progress Report (IHS-856-8).
Notification of Academic Problem             50            1           50  0.13 (8 min)............            7
 (IHS-856-9).
Change of Status (IHS-856-10)....            50            1           50  .045 (25 min)...........           21
Request for Approval of Deferment            20            1           20  0.13 (8 min)............            3
 (IHS-856-11).
Preferred Placement (IHS-856-12).           150            1          150  0.50 (30 min)...........           75
Notice of Impending Graduation              120            1          120  0.17 (10 min)...........           20
 (IHS-856-13).
Notification of Deferment Program            20            1           20  0.13 (8 min)............            3
 (IHS-856-14).
Placement Update (IHS-856-15)....           120            1          120  0.18 (11 min)...........           22
Annual Status Report (IHS-856-16)           200            1          200  0.25 (15 min)...........           50
Extern Site Preference Request              300            1          300  0.13 (8 min)............           40
 (IHS-856-17).
Request for Extern Travel                   150            1          150  0.10 (6 min)............           15
 Reimbursement (IHS-856-18).
Lost Stipend Payment (IHS-856-19)            50            1           50  0.13 (8 min)............            7
Summer School Request (IHS-856-             100            1          100  0.10 (6 min)............           10
 21).
Change of Name or Address (IHS-              20            1           20  0.13 (8 min)............            3
 856-22).
Request for Credit Validation                30            1           30  0.10 (6 min)............            3
 (IHS-856-23).
Faculty/Advisor Evaluation (IHS-          1,500            2        3,000  0.42 (25 min)...........        1,250
 856-24).
Scholarship Program Agreement               175            1          175  0.16 (10 min)...........           29
 (IHS-817).
Health Professions Contract (IHS-           225            1          225  0.16 (10 min)...........           38
 818).
                                  ------------------------------------------------------------------------------
    Total........................  ............  ...........       12,580  ........................        4,303
----------------------------------------------------------------------------------------------------------------
* For ease of understanding, burden hours are also provided in actual minutes.

    There are no direct costs to respondents other than their time to 
voluntarily complete the forms and submit them for consideration. The 
estimated cost in time to respondents, as a group, is $46,386 [4,303 
burden hours x $10.78 per hour (2016 GS-3 hourly base pay rate)]. This 
total dollar amount is based upon the number of burden hours per data 
collection instrument, rounded to the nearest dollar.
    Requests for Comments: Your written comments and/or suggestions are 
invited on one or more of the following points:
    (a) Whether the information collection activity is necessary to 
carry out an agency function;
    (b) whether the agency processes the information collected in a 
useful and timely fashion;
    (c) the accuracy of the public burden estimate (the estimated 
amount of time needed for individual respondents to provide the 
requested information);
    (d) whether the methodology and assumptions used to determine the 
estimates are logical;
    (e) ways to enhance the quality, utility, and clarity of the 
information being collected; and
    (f) ways to minimize the public burden through the use of 
automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology.
    Comment Due Date: Comments regarding this information collection 
are best assured of having full effect if received within 60 days of 
the date of this publication.


[[Page 44032]]


    Dated: June 24, 2016.
Elizabeth A. Fowler,
 Deputy Director for Management Operations, Indian Health Service.
[FR Doc. 2016-16008 Filed 7-5-16; 8:45 am]
 BILLING CODE 4165-16-P



                                             44030                         Federal Register / Vol. 81, No. 129 / Wednesday, July 6, 2016 / Notices

                                             registration, obtain accreditations for                  raising activities in connection with the             sponsor or co-sponsors that would best
                                             continuing education units as                            Forum. [Co-sponsor] will make clear to                fulfill OHRP’s mission. Evaluation may
                                             appropriate and handle all logistical                    donors that any gift will go solely                   include the following criteria:
                                             support leading up to and at the forum;                  toward defraying the sponsorship                         • Qualifications and capability to
                                               • Provide travel expenses for                          expenses of the event, not to OHRP.                   fulfill co-sponsorship responsibilities;
                                             additional academic faculty;                                                                                      • Suitability of the location of the
                                               • Duplicate all forum materials and                    6. Promotional Activity                               proposed event in terms of the overall
                                             prepare participant notebook as                             [Co-sponsor] will not use the event                geographical distribution of OHRP–
                                             appropriate;                                             primarily as a vehicle to sell or promote             RCFs;
                                               • Distribute and collect from speakers                 products or services. [Co-sponsor] will                  • Interests in human research
                                             signed authorization forms (wording                      ensure that any incidental promotional                protections that complement and
                                             and format provided by OHRP) that                        activity does not imply that OHRP                     promote OHRP’s interests and agenda;
                                             permit OHRP to retain and re-use                         endorses any of its products or services.                • Creativity and innovations related
                                             speakers’ presentations as well as any                   [Co-sponsor] will make reasonable                     to the human research protections
                                             video recordings of the presentations                    efforts, subject to OHRP review, to                   topics proposed to cover;
                                             obtained in the course of the Forum for                  segregate any incidental promotional                     • Creativity in enhancing the
                                             educational purposes;                                    activity from the main activities of the              conference, including ideas for
                                               • Provide OHRP with copies of the                      event.                                                improving the event based on prior
                                             speakers’ slide presentations (slides and                                                                      RCFs;
                                             any associated video recordings), as
                                                                                                      7. Event Publicity and Endorsements                      • Potential for reaching, generating,
                                             well as any video-recordings of                             [Co-sponsor] will not use the name of              and engaging attendees from diverse key
                                             conference presentations obtained in the                 OHRP or any of its components, except                 stakeholders;
                                             course of the Forum, no later than 4                     in factual publicity for the specific                    • Availability and description of
                                             months after the RCF;                                    event. Factual publicity includes dates,              facilities needed to support the RCF;
                                               • Produce and share with OHRP a                        times, locations, purposes, agendas,                     • Availability of administrative
                                             summary and evaluation report as well                    fees, and speakers involved with the                  expertise, experience, and support
                                             as the list of participants with their                   event. Such factual publicity shall not               (including accounting and event
                                             email information.                                       imply that the involvement of OHRP in                 management) for the logistics of hosting
                                                                                                      the event serves as an endorsement of                 events of a similar scale.
                                             3. Registration Fees and Other Charges                   the general policies, activities, or                  FOR FURTHER INFORMATION CONTACT:
                                                [Co-sponsor] has established a                        products of [co-sponsor]; where                       OHRP-EDU@HHS.GOV or call OHRP’s
                                             tentative registration fee schedule,                     confusion could result, publicity should              Division of Education and Development
                                             $[Amount] for the 1-day conference;                      be accompanied by a disclaimer to the                 (DED) at 240–453–6900.
                                             $[Amount] for the 1-day workshop; and                    effect that no endorsement by OHRP is                   Dated: June 29, 2016.
                                             $[Amount] when registering for both                      intended. [Co-sponsor] will clearly state             Karen DeSalvo,
                                             conference and workshop. These                           on the agenda that OHRP did not                       Acting Assistant Secretary for Health.
                                             registration fees are no higher than                     provide funding for the breaks and
                                                                                                                                                            [FR Doc. 2016–16004 Filed 7–5–16; 8:45 am]
                                             necessary for [co-sponsor] to recover its                lunch at the forum. [Co-sponsor] will
                                                                                                                                                            BILLING CODE 4150–36–P
                                             share of the costs for co-sponsoring this                state on the agenda which organization
                                             event and may be lowered, as the                         provided the funding for the breaks and
                                             arrangements for the forum event are                     lunch at the forum. [Co-sponsor] will                 DEPARTMENT OF HEALTH AND
                                             made and expenses are incurred.                          clear all publicity materials for the event
                                                HHS staff will be serving as faculty                                                                        HUMAN SERVICES
                                                                                                      with OHRP to ensure compliance with
                                             members and resource people. There is                    this paragraph.                                       Indian Health Service
                                             no attendance fee for HHS staff.
                                                [Co-sponsor] does not intend to sell                  8. Records
                                                                                                                                                            Request for Public Comment: 60-Day
                                             educational materials pertaining to this                    Records concerning the event shall                 Information Collection: Application for
                                             event.                                                   account fully and accurately for the                  Participation in the IHS Scholarship
                                                                                                      financial commitments and                             Program
                                             4. Independently Sponsored Portions of
                                                                                                      expenditures of OHRP and [co-sponsor].
                                             Event                                                                                                          AGENCY: Indian Health Service, HHS.
                                                                                                      Such records shall reflect, at a
                                                [Co-sponsor] may decide to                            minimum, the amounts, sources, and                    ACTION:Notice and request for
                                             independently provide food for lunch                     uses of all funds.                                    comments. Request for extension of
                                             and/or at breaks for the Workshop/Event                                                                        approval.
                                             attendees as a discrete portion of the                   9. Public Availability
                                             event. The workshop/event agenda will                       This co-sponsorship agreement, as                  SUMMARY:   In compliance the Paperwork
                                             indicate that this portion of the event is               well as the financial records described               Reduction Act of 1995, the Indian
                                             independently sponsored by [co-                          in paragraph 8, shall be publicly                     Health Service (IHS) invites the general
                                             sponsor]. OHRP staff and resources will                  available upon request.                               public to comment on the information
                                             not be used to develop, promote, or                                                                            collection titled, ‘‘Application for
                                                                                                      10. Co-sponsorship Guidance                           Participation in the IHS Scholarship
                                             otherwise support this portion of the
                                             event.                                                      OHRP and [co-sponsor] will abide by                Program,’’ Office of Management and
                                                                                                                                                            Budget (OMB) Control No. 0917–0006.
ehiers on DSK5VPTVN1PROD with NOTICES




                                                                                                      the legal memorandum of August 8,
                                             5. Fund Raising                                          2002, ‘‘Co-Sponsorship Guidance,’’                    IHS is requesting OMB to approve an
                                                [Co-sponsor] will make clear in any                   issued by the HHS Designated Agency                   extension for this collection, which
                                             solicitation for funds to cover its share                Ethics Official.                                      expires on September 30, 2016.
                                             of the event costs that it, not OHRP, is                    Evaluation Criteria: After engaging in             DATES: Comment Due Date: September
                                             asking for the funds. [Co-sponsor] will                  exploratory discussions with potential                6, 2016. Your comments regarding this
                                             not imply that OHRP endorses any fund                    co-sponsors, OHRP will select the co-                 information collection are best assured


                                        VerDate Sep<11>2014   15:04 Jul 05, 2016   Jkt 238001   PO 00000   Frm 00045   Fmt 4703   Sfmt 4703   E:\FR\FM\06JYN1.SGM   06JYN1


                                                                                    Federal Register / Vol. 81, No. 129 / Wednesday, July 6, 2016 / Notices                                                                                      44031

                                             of having full effect if received within                                  comment was received in response to                                          The IHS Scholarship Branch needs this
                                             60 days of the date of this publication.                                  the notice. The purpose of this notice is                                    information for program administration
                                             ADDRESSES: Send your written                                              to allow 60 days for public comment. A                                       and uses the information to: solicit,
                                             comments, requests for more                                               copy of the supporting statement is                                          process, and award IHS Pre-graduate,
                                             information on the collection, or                                         available at www.regulations.gov (see                                        Preparatory, and/or Health Professions
                                             requests to obtain a copy of the data                                     Docket ID IHS–2016–0005).                                                    Scholarship recipients; monitor the
                                             collection instrument and instructions                                       Information Collection: Title:                                            academic performance of recipients; and
                                             to Mr. Robert Pittman by one of the                                       ‘‘Application for Participation in the                                       to place recipients at payback sites. The
                                             following methods:                                                        IHS Scholarship Program,’’ OMB                                               IHSSP application is electronically
                                               • Mail: Robert E. Pittman, BPharm,                                      Control No. 0917–0006. Type of                                               available on the internet at the IHS Web
                                             MPH, Acting Chief, Scholarship Branch                                     Information Collection Request:
                                                                                                                                                                                                    site at: https://www.ihs.gov/scholarship/
                                             Director, Division of Health Professions                                  Extension of the currently approved
                                                                                                                                                                                                    applynow/. Affected Public: Individuals,
                                             Support, Indian Health Service, 5600                                      information collection ‘‘Application for
                                                                                                                                                                                                    not-for-profit institutions and State,
                                             Fishers Lane, Mail Stop: OHR 11E53A,                                      Participation in the IHS Scholarship
                                                                                                                                                                                                    local or Tribal Governments. Type of
                                             Rockville, MD 20857.                                                      Program,’’ OMB Control No. 0917–0006.
                                                                                                                                                                                                    Respondents: Students pursuing health
                                               • Phone: (301) 443–6197.                                                Form Number(s): IHS–856–3, IHS–856–
                                               • Email: Robert.Pittman@ihs.gov.                                        5 through 856–19, IHS–856–21 through                                         care professions.
                                               • Fax: 301–443–6048.                                                    856–24, IHS–817, and IHS–818 are                                                The table below provides: Types of
                                             SUPPLEMENTARY INFORMATION: This                                           retained for use by the IHS Scholarship                                      data collection instruments, Estimated
                                             previously approved information                                           Program (IHSSP) as part of this current                                      number of respondents, Number of
                                             collection project was last published in                                  information collection request.                                              responses per respondent, Annual
                                             the Federal Register (78 FR 49532) on                                     Reporting forms are found on the IHS                                         number of responses, Average burden
                                             August 14, 2013 and allowed 30 days                                       Web site at www.ihs.gov/scholarship.                                         hour per response, and Total annual
                                             for public comment. No public                                             Need and Use of Information Collection:                                      burden hours.

                                                                                                                                                      Number                  Responses                Total            Burden                  Annual
                                                                       Data collection instrument(s)                                                     of                       per                 annual           hour per                 burden
                                                                                                                                                    respondents               respondent             response         response *                 hours

                                             Faculty/Employer Evaluation (IHS–856–3) .....................................                                      1,500                         2           3,000   0.42   (25 min) ....             1,250
                                             Delinquent Federal Debt (IHS–856–5) ...........................................                                    1,500                         1           1,500   0.13   (8 min) ......              200
                                             Course Curriculum Verification (IHS–856–6) .................................                                       1,500                         1           1,500   0.70   (42 min) ....             1,050
                                             Verification of Acceptance or Decline of Award (IHS–856–7) .......                                                   350                         1             350   0.13   (8 min) ......               47
                                             Recipient’s Initial Program Progress Report (IHS–856–8) .............                                              1,200                         1           1,200   0.13   (8 min) ......              160
                                             Notification of Academic Problem (IHS–856–9) .............................                                            50                         1              50   0.13   (8 min) ......                7
                                             Change of Status (IHS–856–10) ....................................................                                    50                         1              50   .045   (25 min) ....                21
                                             Request for Approval of Deferment (IHS–856–11) ........................                                               20                         1              20   0.13   (8 min) ......                3
                                             Preferred Placement (IHS–856–12) ...............................................                                     150                         1             150   0.50   (30 min) ....                75
                                             Notice of Impending Graduation (IHS–856–13) .............................                                            120                         1             120   0.17   (10 min) ....                20
                                             Notification of Deferment Program (IHS–856–14) ..........................                                             20                         1              20   0.13   (8 min) ......                3
                                             Placement Update (IHS–856–15) ...................................................                                    120                         1             120   0.18   (11 min) ....                22
                                             Annual Status Report (IHS–856–16) ..............................................                                     200                         1             200   0.25   (15 min) ....                50
                                             Extern Site Preference Request (IHS–856–17) .............................                                            300                         1             300   0.13   (8 min) ......               40
                                             Request for Extern Travel Reimbursement (IHS–856–18) ............                                                    150                         1             150   0.10   (6 min) ......               15
                                             Lost Stipend Payment (IHS–856–19) .............................................                                       50                         1              50   0.13   (8 min) ......                7
                                             Summer School Request (IHS–856–21) ........................................                                          100                         1             100   0.10   (6 min) ......               10
                                             Change of Name or Address (IHS–856–22) ..................................                                             20                         1              20   0.13   (8 min) ......                3
                                             Request for Credit Validation (IHS–856–23) ..................................                                         30                         1              30   0.10   (6 min) ......                3
                                             Faculty/Advisor Evaluation (IHS–856–24) ......................................                                     1,500                         2           3,000   0.42   (25 min) ....             1,250
                                             Scholarship Program Agreement (IHS–817) ..................................                                           175                         1             175   0.16   (10 min) ....                29
                                             Health Professions Contract (IHS–818) .........................................                                      225                         1             225   0.16   (10 min) ....                38

                                                  Total .........................................................................................   ......................   ....................        12,580   ...........................      4,303
                                                * For ease of understanding, burden hours are also provided in actual minutes.


                                                There are no direct costs to                                             (a) Whether the information collection                                       (e) ways to enhance the quality,
                                             respondents other than their time to                                      activity is necessary to carry out an                                        utility, and clarity of the information
                                             voluntarily complete the forms and                                        agency function;                                                             being collected; and
                                             submit them for consideration. The                                          (b) whether the agency processes the                                         (f) ways to minimize the public
                                             estimated cost in time to respondents, as                                 information collected in a useful and                                        burden through the use of automated,
                                             a group, is $46,386 [4,303 burden hours
                                                                                                                       timely fashion;                                                              electronic, mechanical, or other
                                             × $10.78 per hour (2016 GS–3 hourly
                                                                                                                         (c) the accuracy of the public burden                                      technological collection techniques or
                                             base pay rate)]. This total dollar amount
                                             is based upon the number of burden                                        estimate (the estimated amount of time                                       other forms of information technology.
ehiers on DSK5VPTVN1PROD with NOTICES




                                             hours per data collection instrument,                                     needed for individual respondents to                                           Comment Due Date: Comments
                                             rounded to the nearest dollar.                                            provide the requested information);                                          regarding this information collection are
                                                Requests for Comments: Your written                                      (d) whether the methodology and                                            best assured of having full effect if
                                             comments and/or suggestions are                                           assumptions used to determine the                                            received within 60 days of the date of
                                             invited on one or more of the following                                   estimates are logical;                                                       this publication.
                                             points:


                                        VerDate Sep<11>2014       15:04 Jul 05, 2016         Jkt 238001      PO 00000        Frm 00046        Fmt 4703      Sfmt 4703        E:\FR\FM\06JYN1.SGM         06JYN1


                                             44032                         Federal Register / Vol. 81, No. 129 / Wednesday, July 6, 2016 / Notices

                                               Dated: June 24, 2016.                                  epitopes that are sterically hindered                   Contact Information: Requests for
                                             Elizabeth A. Fowler,                                     from recognition by larger antibodies,                copies of the patent application or
                                             Deputy Director for Management Operations,               but without loss of specificity in                    inquiries about licensing, research
                                             Indian Health Service.                                   antigen-binding.                                      collaborations, and co-development
                                             [FR Doc. 2016–16008 Filed 7–5–16; 8:45 am]                  Researchers at the National Cancer                 opportunities should be sent to John D.
                                             BILLING CODE 4165–16–P
                                                                                                      Institute’s Laboratory of Molecular                   Hewes, Ph.D., email: john.hewes@
                                                                                                      Biology (NCI LMB) have developed an                   nih.gov.
                                                                                                      immunological platform that includes
                                                                                                      the development of a shark V–NAR                        Dated: June 28, 2016.
                                             DEPARTMENT OF HEALTH AND
                                             HUMAN SERVICES                                           antibody phage display library, isolation             John D. Hewes,
                                                                                                      of specific antibodies that bind to                   Technology Transfer Specialist, Technology
                                             National Institutes of Health                            several tumor and viral antigens from                 Transfer Center, National Cancer Institute.
                                                                                                      the library, and the development of the               [FR Doc. 2016–15898 Filed 7–5–16; 8:45 am]
                                             Government-Owned Inventions;                             specific antibodies for treatment of                  BILLING CODE 4140–01–P
                                             Availability for Licensing                               cancer or viral infection. Specific
                                             AGENCY:    National Institutes of Health,                antibody targets for binders include
                                             HHS.                                                     tumor-specific antigens (GPC3 [Clone                  DEPARTMENT OF HEALTH AND
                                                                                                      F1], PD1 [Clone A1], HER2 [Clones A6/                 HUMAN SERVICES
                                             ACTION:   Notice.
                                                                                                      A7]), and viral antigens (MERS [Clones
                                             SUMMARY:     The invention listed below is               A3, A7, A8, B4, and B5] and SARS                      National Institutes of Health
                                             co-owned by an agency of the U.S.                        [Clone O1]).
                                             Government and is available for                             Anti-glypican 3 (GPC3) V–NAR, Clone                National Institute of Allergy and
                                             licensing and/or co-development in the                   F1, is an antibody of immediate interest              Infectious Diseases; Notice of Closed
                                             U.S. in accordance with 35 U.S.C. 209                    since it has already shown specific                   Meeting
                                             and 37 CFR part 404 to achieve                           binding to GPC3-expressing tumor cells
                                             expeditious commercialization of                         in vitro. Thus, anti-GPC3 V–NAR                         Pursuant to section 10(d) of the
                                             results of federally-funded research and                 represents a viable candidate for                     Federal Advisory Committee Act, as
                                             development. Foreign patent                              development of an antibody-toxin/drug                 amended (5 U.S.C. App.), notice is
                                             applications are filed on selected                       conjugate (ADC and immunotoxin), a
                                                                                                                                                            hereby given of the following meeting.
                                             inventions to extend market coverage                     bispecific antibody or a chimeric
                                                                                                      antigen receptor (CAR) against GPC3-                    The meeting will be closed to the
                                             for companies and may also be available                                                                        public in accordance with the
                                             for licensing and/or co-development.                     expressing tumor cells.
                                                                                                         Potential Commercial Applications:                 provisions set forth in sections
                                             ADDRESSES: Invention Development and                     • Therapeutic Uses                                    552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                             Marketing Unit, Technology Transfer                      Æ Use as unconjugated antibodies                      as amended. The grant applications and
                                             Center, National Cancer Institute, 9609                  Æ Use as targeting moieties for                       the discussions could disclose
                                             Medical Center Drive, Mail Stop 9702,                       immunoconjugates such as CARs,                     confidential trade secrets or commercial
                                             Rockville, MD 20850–9702.                                   ADCs, Immunoconjugates, bispecific                 property such as patentable material,
                                             FOR FURTHER INFORMATION CONTACT:                            antibodies, etc.
                                                                                                      • Diagnostic agent for detecting and                  and personal information concerning
                                             Information on licensing and co-
                                                                                                         monitoring target-expressing                       individuals associated with the grant
                                             development research collaborations,
                                                                                                         malignancies                                       applications, the disclosure of which
                                             and copies of the U.S. patent
                                             applications listed below may be                            Value Proposition:                                 would constitute a clearly unwarranted
                                             obtained by contacting: Attn. Invention                  • Potential to be first to market with                invasion of personal privacy.
                                             Development and Marketing Unit,                             high specificity and binding to targets              Name of Committee: National Institute of
                                             Technology Transfer Center, National                        resulting in less non-specific cell                Allergy and Infectious Diseases Special
                                             Cancer Institute, 9609 Medical Center                       killing, therefore fewer potential side-           Emphasis Panel; Opportunities for
                                             Drive, Mail Stop 9702, Rockville, MD                        effects for the patient                            Collaborative Research at the NIH Clinical
                                             20850–9702, Tel. 240–276–5515 or                         • Small size of antibodies enhances                   Center (U01).
                                             email ncitechtransfer@mail.nih.gov. A                       stability, solubility, and target                    Date: August 2, 2016.
                                             signed Confidential Disclosure                              recognition                                          Time: 10:00 a.m. to 5:00 p.m.
                                                                                                         Development Stage:                                   Agenda: To review and evaluate grant
                                             Agreement may be required to receive                     • In-vitro data—Shark/Human anti-
                                             copies of the patent applications.                                                                             applications.
                                                                                                         GPC3 chimera can bind to GPC3-                       Place: National Institutes of Health, 5601
                                             SUPPLEMENTARY INFORMATION:                                  positive tumor cells                               Fishers Lane, Rockville, MD 20892
                                             Technology description follows.                          • In-vivo testing
                                                Title of Invention: Shark Antibodies                                                                        (Telephone Conference Call).
                                                                                                         Inventor(s): Mitchell Ho (NCI), et al.
                                             that Target Tumor and Viral Antigens.                                                                            Contact Person: Frank S. De Silva, Ph.D.,
                                                                                                         Intellectual Property: US Provisional
                                                Description of Technology: Shark V–                                                                         Scientific Review Officer, Scientific Review
                                                                                                      Application 62/334,194 (HHS Reference
                                             NAR (Variable New Antigen Receptor)                                                                            Program, Division of Extramural Activities,
                                                                                                      No. E–113–2016/0–US–01) filed May
                                             antibodies are an emerging class of                                                                            Room #3E72A National Institutes of Health/
                                                                                                      10, 2016 entitled ‘‘Variable New
                                             therapeutic candidates. As single                                                                              NIAID, 5601 Fishers Lane, MSC 9823,
                                                                                                      Antigen Receptor (VNAR) Antibodies
                                             domain (heavy chain) antibodies with                                                                           Rockville, MD 20892–9823, (240) 669–5023,
                                                                                                      and Antibody Conjugates Targeting
                                                                                                                                                            fdesilva@niaid.nih.gov.
ehiers on DSK5VPTVN1PROD with NOTICES




                                             an extensive antigen-binding repertoire,                 Tumor and Viral Antigens’’.
                                             shark V–NAR antibodies may provide                          Collaboration Opportunity:                         (Catalogue of Federal Domestic Assistance
                                             advantages over traditional antibodies.                  Researchers at the NCI seek parties                   Program Nos. 93.855, Allergy, Immunology,
                                             Specifically, the smaller size of shark V–               interested in licensing or co-developing              and Transplantation Research; 93.856,
                                             NAR antibodies may provide increased                     shark V–NAR antibodies and/or                         Microbiology and Infectious Diseases
                                             solubility, thermal stability, refolding                 conjugates for cancer therapeutics and/               Research, National Institutes of Health, HHS)
                                             capacity, and the ability to recognize                   or diagnostics.


                                        VerDate Sep<11>2014   15:04 Jul 05, 2016   Jkt 238001   PO 00000   Frm 00047   Fmt 4703   Sfmt 4703   E:\FR\FM\06JYN1.SGM   06JYN1



Document Created: 2016-07-06 07:56:18
Document Modified: 2016-07-06 07:56:18
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 and request for comments. Request for extension of approval.
FR Citation81 FR 44030 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR