83_FR_35807 83 FR 35662 - Meeting of the President's Council on Sports, Fitness, and Nutrition

83 FR 35662 - Meeting of the President's Council on Sports, Fitness, and Nutrition

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 145 (July 27, 2018)

Page Range35662-35663
FR Document2018-16056

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the President's Council on Sports, Fitness, and Nutrition (PCSFN) will hold its annual meeting. The meeting will be open to the public.

Federal Register, Volume 83 Issue 145 (Friday, July 27, 2018)
[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Pages 35662-35663]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-16056]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the President's Council on Sports, Fitness, and 
Nutrition

AGENCY: President's Council on Sports, Fitness, and Nutrition, Office 
of the Assistant Secretary for Health, Office of the Secretary, 
Department of Health and Human Services.

ACTION: Notice of meeting.

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

SUMMARY: As stipulated by the Federal Advisory Committee Act, the U.S. 
Department of Health and Human Services (HHS) is hereby giving notice 
that the President's Council on Sports, Fitness, and Nutrition (PCSFN) 
will hold its annual meeting. The meeting will be open to the public.

DATES: The meeting will be held on September 21, 2018, from 9:30 a.m. 
to 12:30 p.m.

ADDRESSES: Newseum, Knight Conference Center 7th Floor, 555 
Pennsylvania Ave. NW, Washington, DC 20001.

FOR FURTHER INFORMATION CONTACT: Ms. Holli M. Richmond, Executive 
Director, Office of the President's Council on Sports, Fitness, and 
Nutrition, Tower Building, 1101 Wootton Parkway, Suite 560, Rockville, 
MD 20852, (240) 276-9567. Information about PCSFN, including details 
about the upcoming meeting, can be obtained at www.fitness.gov.

SUPPLEMENTARY INFORMATION: The primary functions of the PCSFN include 
(1) advising the President, through the Secretary, concerning progress 
made in carrying out the provisions of Executive Order 13265, as 
amended by Executive Order 13824, and recommending to the President, 
through the Secretary, actions to accelerate such progress; (2) 
recommending to the Secretary a national strategy to expand children's 
participation in youth sports, encourage regular physical activity, 
including active play and promote good nutrition for all Americans. 
Recommendations may address, but are not necessarily limited to, 
increasing awareness of the benefits of participation in sports and 
regular physical activity, as well as the importance of good nutrition; 
promoting private and public sector strategies to increase 
participation in sports, encourage regular physical activity, and 
improve nutrition; developing metrics that gauge youth sports 
participation and physical activity to inform efforts that will improve 
participation in sports and regular physical activity among young 
Americans; and establishing a national and local strategy to recruit 
volunteers who will encourage and support youth participation in sports 
and regular physical activity, through coaching, mentoring, teaching, 
or administering athletic and nutritional programs. The Council's 
performance of these functions shall take into account the Department 
of Health and Human Services' Physical Activity Guidelines for 
Americans, including consideration for youth with disabilities.
    The Council shall meet, at a minimum, one time per fiscal year. The 
meeting will be held to (1) assess ongoing Council activities; and, (2) 
discuss and plan future projects and programs. The agenda for the 
planned meeting is being developed and will be posted at 
www.fitness.gov when it has been finalized.
    The meeting that is scheduled to be held on September 21, 2018, is 
open to the public and the media. Every effort will be made to provide 
reasonable accommodations for persons with disabilities and/or special 
needs who wish to attend the meeting. Persons with disabilities and/or 
special needs should call (240) 276-9567 no later than close of 
business Monday, September 10, 2018, to request accommodations. Members 
of the public who wish to attend the meeting are asked to pre-register 
by sending an email to

[[Page 35663]]

rsvp.fitness@hhs.gov or by calling (240) 276-9567. Registration for 
public attendance must be completed before close of business Wednesday, 
September 12, 2018.

    Dated: July 12, 2018.
Holli M. Richmond,
Executive Director, Office of the President's Council on Sports, 
Fitness, and Nutrition, U.S. Department of Health and Human Services.
[FR Doc. 2018-16056 Filed 7-26-18; 8:45 am]
BILLING CODE 4150-35-P



                                              35662                            Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices

                                              the party to whom FDA will send the                      from locations, and monitoring product                9567. Information about PCSFN,
                                              invoice for any fees that are assessed                   disposition. The direct hours spent on                including details about the upcoming
                                              under this section.                                      each such recall will be billed at the                meeting, can be obtained at
                                                                                                       appropriate hourly rate shown in table                www.fitness.gov.
                                              C. How much will this fee be?
                                                                                                       2 of this document.                                   SUPPLEMENTARY INFORMATION: The
                                                 The fee is based on the number of
                                              direct hours spent on such                               V. How must the fees be paid?                         primary functions of the PCSFN include
                                              reinspections, including time spent                                                                            (1) advising the President, through the
                                                                                                         An invoice will be sent to the                      Secretary, concerning progress made in
                                              conducting the physical surveillance                     responsible party for paying the fee after
                                              and/or compliance reinspection at the                                                                          carrying out the provisions of Executive
                                                                                                       FDA completes the work on which the                   Order 13265, as amended by Executive
                                              facility, or whatever components of                      invoice is based. Payment must be made
                                              such an inspection are deemed                                                                                  Order 13824, and recommending to the
                                                                                                       within 90 days of the invoice date in                 President, through the Secretary, actions
                                              necessary, making preparations and                       U.S. currency by check, bank draft, or
                                              arrangements for the reinspection,                                                                             to accelerate such progress; (2)
                                                                                                       U.S. postal money order payable to the                recommending to the Secretary a
                                              traveling to and from the facility,                      order of the Food and Drug
                                              preparing any reports, analyzing any                                                                           national strategy to expand children’s
                                                                                                       Administration. Detailed payment                      participation in youth sports, encourage
                                              samples or examining any labels if                       information will be included with the
                                              required, and performing other activities                                                                      regular physical activity, including
                                                                                                       invoice when it is issued.                            active play and promote good nutrition
                                              as part of the OAI reinspection until the
                                              facility is again determined to be in                    VI. What are the consequences of not                  for all Americans. Recommendations
                                              compliance. The direct hours spent on                    paying these fees?                                    may address, but are not necessarily
                                              each such reinspection will be billed at                   Under section 743(e)(2) of the FD&C                 limited to, increasing awareness of the
                                              the appropriate hourly rate shown in                     Act, any fee that is not paid within 30               benefits of participation in sports and
                                              table 2 of this document.                                days after it is due shall be treated as a            regular physical activity, as well as the
                                                                                                       claim of the U.S. Government subject to               importance of good nutrition; promoting
                                              IV. Fees for Non-Compliance With a                                                                             private and public sector strategies to
                                              Recall Order Under Section 743(a)(1)(B)                  provisions of subchapter II of chapter 37
                                                                                                       of title 31, United States Code.                      increase participation in sports,
                                              A. What will cause this fee to be                                                                              encourage regular physical activity, and
                                                                                                         Dated: July 24, 2018.                               improve nutrition; developing metrics
                                              assessed?
                                                                                                       Leslie Kux,                                           that gauge youth sports participation
                                                 The fee will be assessed for not                      Associate Commissioner for Policy.                    and physical activity to inform efforts
                                              complying with a recall order under
                                                                                                       [FR Doc. 2018–16069 Filed 7–26–18; 8:45 am]           that will improve participation in sports
                                              section 423(d) (21 U.S.C. 350l(d)) or
                                                                                                       BILLING CODE 4164–01–P                                and regular physical activity among
                                              section 412(f) of the FD&C Act (21
                                                                                                                                                             young Americans; and establishing a
                                              U.S.C. 350a(f)) to cover food recall
                                                                                                                                                             national and local strategy to recruit
                                              activities associated with such order
                                                                                                       DEPARTMENT OF HEALTH AND                              volunteers who will encourage and
                                              performed by the Secretary (and by
                                                                                                       HUMAN SERVICES                                        support youth participation in sports
                                              delegation, FDA) (section 743(a)(1)(B) of
                                                                                                                                                             and regular physical activity, through
                                              the FD&C Act). Non-compliance may                        Meeting of the President’s Council on
                                              include the following: (1) Not initiating                                                                      coaching, mentoring, teaching, or
                                                                                                       Sports, Fitness, and Nutrition                        administering athletic and nutritional
                                              a recall as ordered by FDA; (2) not
                                              conducting the recall in the manner                      AGENCY:  President’s Council on Sports,               programs. The Council’s performance of
                                              specified by FDA in the recall order; or                 Fitness, and Nutrition, Office of the                 these functions shall take into account
                                              (3) not providing FDA with requested                     Assistant Secretary for Health, Office of             the Department of Health and Human
                                              information regarding the recall, as                     the Secretary, Department of Health and               Services’ Physical Activity Guidelines
                                              ordered by FDA.                                          Human Services.                                       for Americans, including consideration
                                                                                                                                                             for youth with disabilities.
                                              B. Who will be responsible for paying                    ACTION: Notice of meeting.                               The Council shall meet, at a
                                              this fee?                                                SUMMARY:   As stipulated by the Federal               minimum, one time per fiscal year. The
                                                Section 743(a)(1)(B) of the FD&C Act                   Advisory Committee Act, the U.S.                      meeting will be held to (1) assess
                                              states that the fee is to be paid by the                 Department of Health and Human                        ongoing Council activities; and, (2)
                                              responsible party for a domestic facility                Services (HHS) is hereby giving notice                discuss and plan future projects and
                                              (as defined in section 415(b) of the                     that the President’s Council on Sports,               programs. The agenda for the planned
                                              FD&C Act) and an importer who does                       Fitness, and Nutrition (PCSFN) will                   meeting is being developed and will be
                                              not comply with a recall order under                     hold its annual meeting. The meeting                  posted at www.fitness.gov when it has
                                              section 423 or under section 412(f) of                   will be open to the public.                           been finalized.
                                              the FD&C Act. In other words, the party                                                                           The meeting that is scheduled to be
                                                                                                       DATES: The meeting will be held on
                                              paying the fee would be the party that                                                                         held on September 21, 2018, is open to
                                                                                                       September 21, 2018, from 9:30 a.m. to                 the public and the media. Every effort
                                              received the recall order.                               12:30 p.m.                                            will be made to provide reasonable
                                              C. How much will this fee be?                            ADDRESSES: Newseum, Knight                            accommodations for persons with
                                                The fee is based on the number of                      Conference Center 7th Floor, 555                      disabilities and/or special needs who
                                              direct hours spent on taking action in                   Pennsylvania Ave. NW, Washington, DC                  wish to attend the meeting. Persons
amozie on DSK3GDR082PROD with NOTICES1




                                              response to the firm’s failure to comply                 20001.                                                with disabilities and/or special needs
                                              with a recall order. Types of activities                 FOR FURTHER INFORMATION CONTACT: Ms.                  should call (240) 276–9567 no later than
                                              could include conducting recall audit                    Holli M. Richmond, Executive Director,                close of business Monday, September
                                              checks, reviewing periodic status                        Office of the President’s Council on                  10, 2018, to request accommodations.
                                              reports, analyzing the status reports and                Sports, Fitness, and Nutrition, Tower                 Members of the public who wish to
                                              the results of the audit checks,                         Building, 1101 Wootton Parkway, Suite                 attend the meeting are asked to pre-
                                              conducting inspections, traveling to and                 560, Rockville, MD 20852, (240) 276–                  register by sending an email to


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                                                                               Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices                                                 35663

                                              rsvp.fitness@hhs.gov or by calling (240)                    The patent rights in these inventions                Dated: July 20, 2018.
                                              276–9567. Registration for public                        have been assigned to the Government                  Michael A. Shmilovich,
                                              attendance must be completed before                      of the United States of America. The                  Senior Licensing and Patenting Manager,
                                              close of business Wednesday,                             prospective patent license will be                    National Heart, Lung, and Blood Institute,
                                              September 12, 2018.                                      granted worldwide and in a field of use               Office of Technology Transfer and
                                                                                                       not broader than radiotherapeutics for                Development.
                                                Dated: July 12, 2018.
                                              Holli M. Richmond,                                       somatostatin-receptor expressing                      [FR Doc. 2018–16065 Filed 7–26–18; 8:45 am]

                                              Executive Director, Office of the President’s
                                                                                                       neuroendocrine tumors.                                BILLING CODE 4140–01–P

                                              Council on Sports, Fitness, and Nutrition,                  The invention pertains to a
                                              U.S. Department of Health and Human                      radiotherapeutic against neuroendocrine
                                              Services.                                                                                                      DEPARTMENT OF HEALTH AND
                                                                                                       tumors that express somatostatin
                                                                                                                                                             HUMAN SERVICES
                                              [FR Doc. 2018–16056 Filed 7–26–18; 8:45 am]              receptor. Radionuclide therapies
                                              BILLING CODE 4150–35–P                                   directed against tumors that express                  National Institutes of Health
                                                                                                       somatostatin receptors (SSTRs) have
                                                                                                       proven effective for the treatment of                 National Cancer Institute; Notice of
                                              DEPARTMENT OF HEALTH AND                                 advanced, low- to intermediate-grade                  Closed Meetings
                                              HUMAN SERVICES                                           neuroendocrine tumors. The subject
                                                                                                                                                               Pursuant to section 10(d) of the
                                                                                                       radiotherapeutic covered by the subject
                                              National Institutes of Health                                                                                  Federal Advisory Committee Act, as
                                                                                                       patent estate includes a somatostatin
                                                                                                                                                             amended, notice is hereby given of the
                                              Prospective Grant of Exclusive Patent                    (SST) peptide derivative like octreotate
                                                                                                                                                             following meetings.
                                              License: Radiotherapeutics Against                       (TATE), conjugated to an Evans Blue
                                                                                                                                                               The meetings will be closed to the
                                              Somatostatin-Receptor Expressing                         (EB) analog, and further chelated via
                                                                                                                                                             public in accordance with the
                                              Neuroendocrine Tumors                                    DOTA to therapeutic radionuclide
                                                                                                       177Lu, a beta emitter. The EB analog
                                                                                                                                                             provisions set forth in sections
                                              AGENCY:    National Institutes of Health,                                                                      552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                                                                       reversibly binds to circulating serum                 as amended. The grant applications and
                                              HHS.                                                     albumin and improves the                              the discussions could disclose
                                              ACTION:   Notice.                                        pharmacokinetics of SST peptide                       confidential trade secrets or commercial
                                                                                                       derivatives and reduce peptide-receptor               property such as patentable material,
                                              SUMMARY:   The National Heart, Lung and
                                                                                                       radionuclide therapy toxicity. EB analog              and personal information concerning
                                              Blood Institute (NHLBI), National
                                                                                                       conjugated to octreotate (EB-                         individuals associated with grant
                                              Institutes of Health, Department of
                                                                                                       DOTATATE) has been shown by the                       applications, the disclosure of which
                                              Health and Human Services, is
                                                                                                       inventors to provide reversible albumin               would constitute a clearly unwarranted
                                              contemplating the grant of an exclusive
                                                                                                       binding in vivo and extended half-life in             invasion of personal privacy.
                                              patent license to Molecular Targeting
                                                                                                       circulation. When EB-TATE is slowly
                                              Technologies, Inc. (MTTI); a Delaware                                                                            Name of Committee: National Cancer
                                                                                                       released into the tumor
                                              corporation, with its principle place of                                                                       Institute Special Emphasis Panel; U01 SEP:
                                                                                                       microenvironment, tumor uptake and
                                              business in West Chester, Pennsylvania,                                                                        Glycobiologists Alliance for Cancer Research.
                                                                                                       internalization into SSTR positive                      Date: August 30, 2018.
                                              to practice the inventions embodied in
                                              the patent application listed in the                     tumors resulted in delivery of                          Time: 10:00 a.m. to 5:00 p.m.
                                              SUPPLEMENTARY INFORMATION section of
                                                                                                       radioactive particles and tumor cell                    Agenda: To review and evaluate grant
                                              this notice.                                             killing. EB-TATE displayed significantly              applications.
                                                                                                       more favorable pharmacokinetics than                    Place: National Cancer Institute, Shady
                                              DATES: Only written comments and/or                                                                            Grove, 9609 Medical Center Drive, Room
                                                                                                       TATE alone by achieving higher tumor
                                              applications for a license which are                                                                           7W102, Rockville, MD 20850 (Telephone
                                                                                                       to non-tumor penetration as evidenced
                                              received by the NHLBI Office of                                                                                Conference Call).
                                                                                                       by positron emission tomography.                        Contact Person: Shakeel Ahmad, Ph.D.,
                                              Technology Transfer and Development
                                              August 27, 2018 will be considered.                         This notice is made in accordance                  Scientific Review Officer, Research
                                                                                                       with 35 U.S.C. 209 and 37 CFR part 404.               Technology and Contract Review Branch,
                                              ADDRESSES: Requests for copies of the
                                                                                                       The prospective exclusive patent license              Division of Extramural Activities, National
                                              patent applications, inquiries, and                                                                            Cancer Institute, NIH, 9609 Medical Center
                                              comments relating to the contemplated                    will be royalty bearing and may be
                                                                                                                                                             Drive, Room 7W102, Bethesda, MD 20892–
                                              exclusive patent license should be                       granted unless within fifteen (15) days               9750, 240–276–6349, ahmads@mail.nih.gov.
                                              directed to: Michael Shmilovich, Esq.,                   from the date of this published notice,
                                                                                                                                                               Name of Committee: National Cancer
                                              Senior Licensing and Patent Manager,                     the NHLBI receives written evidence                   Institute Special Emphasis Panel; NCI
                                              31 Center Drive, Room 4A29, MSC2479,                     and argument that establishes that the                Program Project IV (P01).
                                              Bethesda, MD 20892–2479, phone                           grant of the license would not be                       Date: September 27–28, 2018.
                                              number 301–435–5019, or shmilovm@                        consistent with the requirements of 35                  Time: 4:00 p.m. to 5:00 p.m.
                                              mail.nih.gov.                                            U.S.C. 209 and 37 CFR part 404.                         Agenda: To review and evaluate grant
                                                                                                                                                             applications.
                                              SUPPLEMENTARY INFORMATION: The                              Complete applications for a license in               Place: Bethesda North Marriott Hotel &
                                              following and all continuing U.S. and                    the prospective field of use that are                 Conference Center, 5701 Marinelli Road,
                                              foreign patents/patent applications                      timely filed in response to this notice               North Bethesda, MD 20852.
                                              thereof are the intellectual properties to               will be treated as objections to the grant              Contact Person: Sanita Bharti, Ph.D.,
                                              be licensed under the prospective                        of the contemplated exclusive patent                  Scientific Review Officer, Research Program
amozie on DSK3GDR082PROD with NOTICES1




                                                                                                       license.                                              Review Branch, Division of Extramural
                                              agreement to MTTI: HHS Ref. E–150–
                                                                                                                                                             Activities, National Cancer Institute, NIH,
                                              2016–1–PCT–01, International Patent                         Comments and objections submitted                  9609 Medical Center Drive, Room 7W122,
                                              Application PCT/US2017/054863 filed                      to this notice will not be made available             Bethesda, MD 20892–9750, 240–276–5909,
                                              October 3, 2017, entitled ‘‘Chemical                     for public inspection and, to the extent              sanitab@mail.nih.gov.
                                              Conjugates of Evans Blue Derivatives                     permitted by law, will not be released                (Catalogue of Federal Domestic Assistance
                                              and Their Use As Radiotherapy And                        under the Freedom of Information Act,                 Program Nos. 93.392, Cancer Construction;
                                              Imaging Agents.’’                                        5 U.S.C. 552.                                         93.393, Cancer Cause and Prevention



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Document Created: 2018-07-27 04:06:09
Document Modified: 2018-07-27 04:06:09
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 of meeting.
DatesThe meeting will be held on September 21, 2018, from 9:30 a.m. to 12:30 p.m.
ContactMs. Holli M. Richmond, Executive Director, Office of the President's Council on Sports, Fitness, and Nutrition, Tower Building, 1101 Wootton Parkway, Suite 560, Rockville, MD 20852, (240) 276-9567. Information about PCSFN, including details about the upcoming meeting, can be obtained at www.fitness.gov.
FR Citation83 FR 35662 

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