80_FR_79292 80 FR 79049 - Announcement of Intent To Establish the 2018 Physical Activity Guidelines Advisory Committee and Solicitation of Nominations for Appointment to the Committee Membership

80 FR 79049 - Announcement of Intent To Establish the 2018 Physical Activity Guidelines Advisory Committee and Solicitation of Nominations for Appointment to the Committee Membership

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 243 (December 18, 2015)

Page Range79049-79050
FR Document2015-31837

The U.S. Department of Health and Human Services (HHS) announces the intent to establish a Physical Activity Guidelines Advisory Committee (Committee). It is planned for the Committee to be established in calendar year 2016. This notice also serves to announce that an invitation is being extended for nominations of qualified candidates to be considered for appointment as a member of the Committee.

Federal Register, Volume 80 Issue 243 (Friday, December 18, 2015)
[Federal Register Volume 80, Number 243 (Friday, December 18, 2015)]
[Notices]
[Pages 79049-79050]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-31837]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Announcement of Intent To Establish the 2018 Physical Activity 
Guidelines Advisory Committee and Solicitation of Nominations for 
Appointment to the Committee Membership

AGENCY: Office of Disease Prevention and Health Promotion, Office of 
the Assistant Secretary for Health, Office of the Secretary, Department 
of Health and Human Services.

ACTION: Notice.

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

SUMMARY: The U.S. Department of Health and Human Services (HHS) 
announces the intent to establish a Physical Activity Guidelines 
Advisory Committee (Committee). It is planned for the Committee to be 
established in calendar year 2016. This notice also serves to announce 
that an invitation is being extended for nominations of qualified 
candidates to be considered for appointment as a member of the 
Committee.

DATES: Nominations for membership on the Committee must be submitted by 
6:00 p.m. ET on Friday, February 5, 2016.

ADDRESSES: Nominations should be submitted by email to 
[email protected]. This address can be accessed online at the 
following address: www.health.gov/paguidelines. Nominations may also be 
sent to the following address: Richard D. Olson, M.D., M.P.H., 
Designated Program Official, 2018 Physical Activity Guidelines Advisory 
Committee; HHS/OASH/ODPHP; 1101 Wootton Parkway, Suite LL-100; 
Rockville, MD 20852; Telephone: (240) 453-8280.

FOR FURTHER INFORMATION CONTACT: Designated Program Official, 2018 
Physical Activity Guidelines Advisory Committee, Richard D. Olson and/
or Alternate Designated Program Official, Katrina L. Piercy, Ph.D., 
R.D., HHS/OASH/ODPHP; 1101 Wootton Parkway, Suite LL-100; Rockville, MD 
20852; Telephone: (240) 453-8280. Additional information is available 
at www.health.gov/paguidelines.

SUPPLEMENTARY INFORMATION:
    Purpose: The inaugural Physical Activity Guidelines for Americans 
(PAG), issued in 2008, represents the first major federal review of the 
benefits of physical activity. The PAG provides science-based advice on 
how physical activity can help promote health and reduce the risk of 
chronic disease. The PAG serves as the benchmark and primary, 
authoritative voice of the federal government for providing science-
based guidance on physical activity, fitness, and health in the United 
States. Five years after the first edition of the PAG was released, 
ODPHP, in collaboration with the Centers for Disease Control and 
Prevention (CDC), the National Institutes of Health (NIH), and the 
President's Council on Fitness, Sports, and Nutrition (PCFSN) led 
development of the PAG Midcourse Report: Strategies to Increase 
Physical Activity Among Youth. The 2nd edition of the Physical Activity 
Guidelines will build upon the 1st edition and provide a foundation for 
federal recommendations and education for physical activity programs 
for Americans, including those at risk for chronic disease.
    The Committee will be established as a discretionary federal 
advisory committee and governed by the provisions of the Federal 
Advisory Committee Act (FACA), Public Law 92-463, as amended (5 U.S.C., 
App.). The work of the Committee will be solely advisory in nature and 
time-limited. Formation of the Committee is necessary and in the public 
interest. The Committee will examine the current PAG, take into 
consideration new scientific evidence and current resource documents, 
and then develop a scientific advisory report to be submitted to the 
Secretary of HHS that outlines its science-based recommendations and 
rationale. The scientific report will be used by the federal government 
to develop the 2nd edition of the Physical Activity Guidelines for 
Americans. The Committee's duties do not include developing the policy, 
a draft of the policy, or determining how future policy might be 
implemented by the federal government. For those interested in 
reviewing the Physical Activity Guidelines for Americans, the 2008 
Advisory Committee Scientific Report, or the PAG Midcourse Report, they 
are available at www.health.gov/paguidelines.
    The Committee is expected to begin meeting in summer of 2016. The 
Committee is expected to meet approximately five times during the 
course of its operation. Pursuant to FACA, all meetings of the full 
Committee will be open to the public.
    Individuals selected for appointment to the Committee will be 
invited to serve as members until the charter expires or the Committee 
accomplishes its mission. In keeping with FACA, the charter will expire 
two years from the date it is established. The Committee will operate 
until its report is delivered to the Secretary or the charter expires, 
whichever comes first. There will be no

[[Page 79050]]

stipend authorized to be paid to the members for performance of their 
official duties. However, Committee members will be authorized to 
receive per diem and reimbursement for travel expenses incurred for 
attending public meetings.
    Structure: It is proposed that the Committee will consist of 11-17 
members; one or two members will be selected to serve as the Chair, 
Vice Chair, and/or Co-Chairs. To be eligible for consideration of 
appointment to the Committee, individuals should be knowledgeable of 
current scientific research in human physical activity and be respected 
and published experts in their fields. They should be familiar with the 
purpose, communication, and application of federal physical activity 
guidelines and have demonstrated interest in the public's health and 
well-being through their research and/or educational endeavors. 
Expertise is sought in specific specialty areas related to physical 
activity and health promotion or disease prevention, including but not 
limited to: Health promotion and chronic disease prevention; bone, 
joint, and muscle health and performance; obesity and weight 
management; physical activity and risk of musculoskeletal injury; 
physical activity and cognition; physical activity within specific 
settings, such as preschool/childcare, schools (e.g., activity breaks, 
physical education), or the community/built environment; physical 
activity dose-response; sedentary behavior; behavior change; systematic 
reviews; and special populations including children, older adults, 
individuals with disabilities, or women who are pregnant.
    Nominations: HHS will consider nominations, including self-
nominations, for Committee membership of individuals qualified to carry 
out the above-mentioned tasks. The following information should be 
included in the package of material submitted for each individual being 
nominated for consideration: (1) The name, address, daytime telephone 
number, and email address of the nominator and the individual being 
nominated; (2) a letter of nomination that clearly states the name and 
affiliation of the nominee, the basis for the nomination (i.e., 
specific attributes which qualify the nominee for service in this 
capacity), and a statement from the nominee that the nominee is willing 
to serve as a member of the Committee; and (3) a current copy of the 
nominee's curriculum vitae (CV) no more than 10 pages in length. 
Inclusion of the following is requested in the CV: (1) Current and/or 
past grant awards; (2) publications showing both breadth and experience 
in areas of specialization; (3) paid and non-paid board and advisory 
appointments; and (4) education and occupational history.
    All nominations must include the required information. Incomplete 
nominations will not be processed for consideration. Federal employees 
should not be nominated for consideration of appointment to this 
Committee.
    Equal opportunity practices regarding membership appointments to 
the Committee will be aligned with HHS policies. When possible, every 
effort will be made to ensure that the Committee is a diverse group of 
individuals with representation from various geographic locations, 
racial and ethnic minorities, all genders, and persons with 
disabilities. Individuals will be appointed to serve as members of the 
Committee to represent balanced viewpoints of the scientific evidence, 
not to represent the viewpoints of any specific group.
    Members of the Committee will be classified as special government 
employees (SGEs) during their term of appointment to the Committee, and 
as such are subject to the ethical standards of conduct for federal 
employees. Upon entering the position and annually throughout the term 
of appointment, members of the Committee will be required to complete 
and submit a report of their financial holdings, consultancies, and 
research grants and/or contracts. The purpose of this report is to 
determine if the individual has any interest and/or activities in the 
private sector that may conflict with performance of their official 
duties as a member of the Committee.

    Dated: December 15, 2015.
Don Wright,
Deputy Assistant Secretary for Health, Office of Disease Prevention and 
Health Promotion.
[FR Doc. 2015-31837 Filed 12-17-15; 8:45 am]
 BILLING CODE 4150-32-P



                                                                              Federal Register / Vol. 80, No. 243 / Friday, December 18, 2015 / Notices                                           79049

                                                    2. The date the application was                       DEPARTMENT OF HEALTH AND                              science-based guidance on physical
                                                  initially submitted with respect to the                 HUMAN SERVICES                                        activity, fitness, and health in the
                                                  human drug product under section                                                                              United States. Five years after the first
                                                  505(b) of the FD&C Act: May 22, 2012.                   Announcement of Intent To Establish                   edition of the PAG was released,
                                                  FDA has verified the applicant’s claim                  the 2018 Physical Activity Guidelines                 ODPHP, in collaboration with the
                                                  that the new drug application (NDA) for                 Advisory Committee and Solicitation of                Centers for Disease Control and
                                                  XTANDI (NDA 203–415) was initially                      Nominations for Appointment to the                    Prevention (CDC), the National
                                                  submitted on May 22, 2012.                              Committee Membership                                  Institutes of Health (NIH), and the
                                                                                                                                                                President’s Council on Fitness, Sports,
                                                    3. The date the application was                       AGENCY:  Office of Disease Prevention
                                                                                                                                                                and Nutrition (PCFSN) led development
                                                  approved: August 31, 2012. FDA has                      and Health Promotion, Office of the
                                                                                                                                                                of the PAG Midcourse Report: Strategies
                                                  verified the applicant’s claim that NDA                 Assistant Secretary for Health, Office of             to Increase Physical Activity Among
                                                  203–415 was approved on August 31,                      the Secretary, Department of Health and               Youth. The 2nd edition of the Physical
                                                  2012.                                                   Human Services.                                       Activity Guidelines will build upon the
                                                                                                          ACTION: Notice.                                       1st edition and provide a foundation for
                                                    This determination of the regulatory
                                                  review period establishes the maximum                   SUMMARY:   The U.S. Department of                     federal recommendations and education
                                                  potential length of a patent extension.                 Health and Human Services (HHS)                       for physical activity programs for
                                                  However, the USPTO applies several                      announces the intent to establish a                   Americans, including those at risk for
                                                  statutory limitations in its calculations               Physical Activity Guidelines Advisory                 chronic disease.
                                                                                                                                                                   The Committee will be established as
                                                  of the actual period for patent extension.              Committee (Committee). It is planned
                                                                                                                                                                a discretionary federal advisory
                                                  In its application for patent extension,                for the Committee to be established in
                                                                                                                                                                committee and governed by the
                                                  this applicant seeks 101 days of patent                 calendar year 2016. This notice also
                                                                                                                                                                provisions of the Federal Advisory
                                                  term extension.                                         serves to announce that an invitation is              Committee Act (FACA), Public Law 92–
                                                                                                          being extended for nominations of                     463, as amended (5 U.S.C., App.). The
                                                  III. Petitions                                          qualified candidates to be considered                 work of the Committee will be solely
                                                                                                          for appointment as a member of the                    advisory in nature and time-limited.
                                                    Anyone with knowledge that any of
                                                                                                          Committee.                                            Formation of the Committee is
                                                  the dates as published are incorrect may
                                                  submit either electronic or written                     DATES: Nominations for membership on                  necessary and in the public interest. The
                                                  comments and ask for a redetermination                  the Committee must be submitted by                    Committee will examine the current
                                                  (see DATES). Furthermore, any interested                6:00 p.m. ET on Friday, February 5,                   PAG, take into consideration new
                                                  person may petition FDA for a                           2016.                                                 scientific evidence and current resource
                                                  determination regarding whether the                     ADDRESSES:    Nominations should be                   documents, and then develop a
                                                  applicant for extension acted with due                  submitted by email to                                 scientific advisory report to be
                                                  diligence during the regulatory review                  PAGACnominations@hhs.gov. This                        submitted to the Secretary of HHS that
                                                                                                          address can be accessed online at the                 outlines its science-based
                                                  period. To meet its burden, the petition
                                                                                                          following address: www.health.gov/                    recommendations and rationale. The
                                                  must be timely (see DATES) and contain
                                                                                                          paguidelines. Nominations may also be                 scientific report will be used by the
                                                  sufficient facts to merit an FDA                                                                              federal government to develop the 2nd
                                                  investigation. (See H. Rept. 857, part 1,               sent to the following address: Richard D.
                                                                                                          Olson, M.D., M.P.H., Designated                       edition of the Physical Activity
                                                  98th Cong., 2d sess., pp. 41–42, 1984.)                                                                       Guidelines for Americans. The
                                                  Petitions should be in the format                       Program Official, 2018 Physical Activity
                                                                                                          Guidelines Advisory Committee; HHS/                   Committee’s duties do not include
                                                  specified in 21 CFR 10.30.                                                                                    developing the policy, a draft of the
                                                                                                          OASH/ODPHP; 1101 Wootton Parkway,
                                                    Submit petitions electronically to                                                                          policy, or determining how future
                                                                                                          Suite LL–100; Rockville, MD 20852;
                                                  http://www.regulations.gov at Docket                                                                          policy might be implemented by the
                                                                                                          Telephone: (240) 453–8280.
                                                  No. FDA–2013–S–0610. Submit written                                                                           federal government. For those interested
                                                                                                          FOR FURTHER INFORMATION CONTACT:                      in reviewing the Physical Activity
                                                  petitions (two copies are required) to the              Designated Program Official, 2018
                                                  Division of Dockets Management (HFA–                                                                          Guidelines for Americans, the 2008
                                                                                                          Physical Activity Guidelines Advisory                 Advisory Committee Scientific Report,
                                                  305), Food and Drug Administration,                     Committee, Richard D. Olson and/or
                                                  5630 Fishers Lane, Rm. 1061, Rockville,                                                                       or the PAG Midcourse Report, they are
                                                                                                          Alternate Designated Program Official,                available at www.health.gov/
                                                  MD 20852. Petitions that have not been                  Katrina L. Piercy, Ph.D., R.D., HHS/                  paguidelines.
                                                  made publicly available on http://                      OASH/ODPHP; 1101 Wootton Parkway,                        The Committee is expected to begin
                                                  www.regulations.gov may be viewed in                    Suite LL–100; Rockville, MD 20852;                    meeting in summer of 2016. The
                                                  the Division of Dockets Management                      Telephone: (240) 453–8280. Additional                 Committee is expected to meet
                                                  between 9 a.m. and 4 p.m., Monday                       information is available at                           approximately five times during the
                                                  through Friday.                                         www.health.gov/paguidelines.                          course of its operation. Pursuant to
                                                    Dated: December 14, 2015.                             SUPPLEMENTARY INFORMATION:                            FACA, all meetings of the full
                                                                                                             Purpose: The inaugural Physical                    Committee will be open to the public.
                                                  Leslie Kux,
                                                                                                          Activity Guidelines for Americans                        Individuals selected for appointment
                                                  Associate Commissioner for Policy.                      (PAG), issued in 2008, represents the                 to the Committee will be invited to
                                                  [FR Doc. 2015–31824 Filed 12–17–15; 8:45 am]
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                                                                                                          first major federal review of the benefits            serve as members until the charter
                                                  BILLING CODE 4164–01–P                                  of physical activity. The PAG provides                expires or the Committee accomplishes
                                                                                                          science-based advice on how physical                  its mission. In keeping with FACA, the
                                                                                                          activity can help promote health and                  charter will expire two years from the
                                                                                                          reduce the risk of chronic disease. The               date it is established. The Committee
                                                                                                          PAG serves as the benchmark and                       will operate until its report is delivered
                                                                                                          primary, authoritative voice of the                   to the Secretary or the charter expires,
                                                                                                          federal government for providing                      whichever comes first. There will be no


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                                                  79050                       Federal Register / Vol. 80, No. 243 / Friday, December 18, 2015 / Notices

                                                  stipend authorized to be paid to the                    publications showing both breadth and                 attendance limited to space available.
                                                  members for performance of their                        experience in areas of specialization; (3)            Individuals who plan to attend and
                                                  official duties. However, Committee                     paid and non-paid board and advisory                  need special assistance, such as sign
                                                  members will be authorized to receive                   appointments; and (4) education and                   language interpretation or other
                                                  per diem and reimbursement for travel                   occupational history.                                 reasonable accommodations, should
                                                  expenses incurred for attending public                     All nominations must include the                   notify the Contact Person listed below
                                                  meetings.                                               required information. Incomplete                      in advance of the meeting.
                                                     Structure: It is proposed that the                   nominations will not be processed for                    The meeting will be closed to the
                                                  Committee will consist of 11–17                         consideration. Federal employees                      public in accordance with the
                                                  members; one or two members will be                     should not be nominated for                           provisions set forth in sections
                                                  selected to serve as the Chair, Vice                    consideration of appointment to this                  552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
                                                  Chair, and/or Co-Chairs. To be eligible                 Committee.                                            as amended. The grant applications and
                                                  for consideration of appointment to the                    Equal opportunity practices regarding
                                                                                                                                                                the discussions could disclose
                                                  Committee, individuals should be                        membership appointments to the
                                                                                                                                                                confidential trade secrets or commercial
                                                  knowledgeable of current scientific                     Committee will be aligned with HHS
                                                                                                                                                                property such as patentable material,
                                                  research in human physical activity and                 policies. When possible, every effort
                                                                                                                                                                and personal information concerning
                                                  be respected and published experts in                   will be made to ensure that the
                                                  their fields. They should be familiar                                                                         individuals associated with the grant
                                                                                                          Committee is a diverse group of
                                                  with the purpose, communication, and                                                                          applications, the disclosure of which
                                                                                                          individuals with representation from
                                                  application of federal physical activity                                                                      would constitute a clearly unwarranted
                                                                                                          various geographic locations, racial and
                                                  guidelines and have demonstrated                                                                              invasion of personal privacy.
                                                                                                          ethnic minorities, all genders, and
                                                  interest in the public’s health and well-               persons with disabilities. Individuals                   Name of Committee: National Advisory
                                                  being through their research and/or                     will be appointed to serve as members                 Council for Nursing Research.
                                                  educational endeavors. Expertise is                     of the Committee to represent balanced                   Date: January 26–27, 2016.
                                                  sought in specific specialty areas related              viewpoints of the scientific evidence,                   Open: January 26, 2016, 1:00 p.m. to 4:45
                                                  to physical activity and health                         not to represent the viewpoints of any                p.m.
                                                  promotion or disease prevention,                                                                                 Agenda: Discussion of Program Policies
                                                                                                          specific group.
                                                  including but not limited to: Health                       Members of the Committee will be                   and Issues.
                                                  promotion and chronic disease                                                                                    Place: National Institutes of Health, Porter
                                                                                                          classified as special government
                                                  prevention; bone, joint, and muscle                                                                           Neuroscience Research Center, Building 35A,
                                                                                                          employees (SGEs) during their term of
                                                                                                                                                                Convent Drive, Room 620/630, Bethesda, MD
                                                  health and performance; obesity and                     appointment to the Committee, and as                  20892.
                                                  weight management; physical activity                    such are subject to the ethical standards                Closed: January 27, 2016, 9:00 a.m. to 1:00
                                                  and risk of musculoskeletal injury;                     of conduct for federal employees. Upon                p.m.
                                                  physical activity and cognition; physical               entering the position and annually                       Agenda: To review and evaluate grant
                                                  activity within specific settings, such as              throughout the term of appointment,                   applications.
                                                  preschool/childcare, schools (e.g.,                     members of the Committee will be                         Place: National Institutes of Health, Porter
                                                  activity breaks, physical education), or                required to complete and submit a                     Neuroscience Research Center, Building 35A,
                                                  the community/built environment;                        report of their financial holdings,                   Convent Drive, Room 620/630, Bethesda, MD
                                                  physical activity dose-response;                        consultancies, and research grants and/               20892.
                                                  sedentary behavior; behavior change;                    or contracts. The purpose of this report                 Contact Person: Ann R. Knebel, DNSC, RN,
                                                  systematic reviews; and special                         is to determine if the individual has any             FAAN, Deputy Director, National Institute of
                                                  populations including children, older                   interest and/or activities in the private             Nursing Research, National Institutes of
                                                  adults, individuals with disabilities, or               sector that may conflict with                         Health, 31 Center Drive, Building 31, Room
                                                  women who are pregnant.                                 performance of their official duties as a             5B05, Bethesda, MD 20892, 301–496–8230,
                                                     Nominations: HHS will consider                       member of the Committee.                              knebelar@mail.nih.gov.
                                                  nominations, including self-                                                                                     Any interested person may file written
                                                  nominations, for Committee                                 Dated: December 15, 2015.                          comments with the committee by forwarding
                                                  membership of individuals qualified to                  Don Wright,                                           the statement to the Contact Person listed on
                                                  carry out the above-mentioned tasks.                    Deputy Assistant Secretary for Health, Office         this notice. The statement should include the
                                                  The following information should be                     of Disease Prevention and Health Promotion.           name, address, telephone number and when
                                                  included in the package of material                     [FR Doc. 2015–31837 Filed 12–17–15; 8:45 am]          applicable, the business or professional
                                                  submitted for each individual being                     BILLING CODE 4150–32–P                                affiliation of the interested person.
                                                  nominated for consideration: (1) The                                                                             In the interest of security, NIH has
                                                  name, address, daytime telephone                                                                              instituted stringent procedures for entrance
                                                                                                          DEPARTMENT OF HEALTH AND                              onto the NIH campus. All visitor vehicles,
                                                  number, and email address of the
                                                                                                          HUMAN SERVICES                                        including taxicabs, hotel, and airport shuttles
                                                  nominator and the individual being
                                                                                                                                                                will be inspected before being allowed on
                                                  nominated; (2) a letter of nomination                                                                         campus. Visitors will be asked to show one
                                                  that clearly states the name and                        National Institutes of Health
                                                                                                                                                                form of identification (for example, a
                                                  affiliation of the nominee, the basis for                                                                     government-issued photo ID, driver’s license,
                                                                                                          National Institute of Nursing Research;
                                                  the nomination (i.e., specific attributes                                                                     or passport) and to state the purpose of their
                                                                                                          Notice of Meeting
                                                  which qualify the nominee for service in                                                                      visit.
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                                                  this capacity), and a statement from the                  Pursuant to section 10(d) of the                       Information is also available on the
                                                  nominee that the nominee is willing to                  Federal Advisory Committee Act, as                    Institute’s/Center’s home page: www.nih.gov/
                                                  serve as a member of the Committee;                     amended (5 U.S.C. App.), notice is                    ninr/aadvisory.html, where an agenda and
                                                  and (3) a current copy of the nominee’s                 hereby given of a meeting of the                      any additional information for the meeting
                                                  curriculum vitae (CV) no more than 10                   National Advisory Council for Nursing                 will be posted when available.
                                                  pages in length. Inclusion of the                       Research.                                             (Catalogue of Federal Domestic Assistance
                                                  following is requested in the CV: (1)                     The meeting will be open to the                     Program Nos. 93.361, Nursing Research,
                                                  Current and/or past grant awards; (2)                   public as indicated below, with                       National Institutes of Health, HHS)



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Document Created: 2015-12-18 01:38:40
Document Modified: 2015-12-18 01:38:40
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.
DatesNominations for membership on the Committee must be submitted by 6:00 p.m. ET on Friday, February 5, 2016.
ContactDesignated Program Official, 2018 Physical Activity Guidelines Advisory Committee, Richard D. Olson and/ or Alternate Designated Program Official, Katrina L. Piercy, Ph.D., R.D., HHS/OASH/ODPHP; 1101 Wootton Parkway, Suite LL-100; Rockville, MD 20852; Telephone: (240) 453-8280. Additional information is available at www.health.gov/paguidelines.
FR Citation80 FR 79049 

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