82_FR_33273 82 FR 33136 - Advisory Committee on Heritable Disorders in Newborns and Children

82 FR 33136 - Advisory Committee on Heritable Disorders in Newborns and Children

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Service Administration

Federal Register Volume 82, Issue 137 (July 19, 2017)

Page Range33136-33137
FR Document2017-15113

In accordance with the Federal Advisory Committee Act, notice is hereby given that a meeting is scheduled for the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC). This meeting will be open to the public but advance registration is required. Please register online at http://www.achdncmeetings.org/ by 12:00 p.m. ET on August 1, 2017. Information about the ACHDNC can be obtained by accessing the following Web site: https://www.hrsa.gov/ advisorycommittees/mchbadvisory/heritabledisorders/index.html.

Federal Register, Volume 82 Issue 137 (Wednesday, July 19, 2017)
[Federal Register Volume 82, Number 137 (Wednesday, July 19, 2017)]
[Notices]
[Pages 33136-33137]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-15113]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Service Administration


Advisory Committee on Heritable Disorders in Newborns and 
Children

AGENCY: Health Resources and Service Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice of meeting.

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

SUMMARY: In accordance with the Federal Advisory Committee Act, notice 
is hereby given that a meeting is scheduled for the Advisory Committee 
on Heritable Disorders in Newborns and Children (ACHDNC). This meeting 
will be open to the public but advance registration is required. Please 
register online at http://www.achdncmeetings.org/ by 12:00 p.m. ET on 
August 1, 2017. Information about the ACHDNC can be obtained by 
accessing the following Web site: https://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders/index.html.

DATES: The meeting will be held on August 3, 2017, 9:30 a.m. to 5:00 
p.m. ET and August 4, 2017, 9:30 a.m. to 3:00 p.m. ET. Meeting times 
may be revised; please check the Committee's Web site for updates.

ADDRESSES: This meeting will be held in-person at 5600 Fishers Lane, 
5th Floor Pavilion, Rockville, MD 20857. The meeting will also be 
accessible via Webcast. Instructions on accessing the meeting via 
Webcast will be provided upon registration. Please note that 5600 
Fishers Lane requires security screening on entry. Visitors must 
provide a driver's license, passport, or other form of government-
issued photo identification to be granted entry into the facility. Non-
US citizens planning to attend in person will need to provide 
additional information to HRSA by July 24, 2017, 12:00 p.m. EDT. Please 
see contact information below.

FOR FURTHER INFORMATION CONTACT: Anyone requesting information 
regarding the ACHDNC should contact Ann Ferrero, Maternal and Child 
Health Bureau (MCHB), HRSA, in one of three ways: (1) Send a request to 
the following address: Ann Ferrero, MCHB, HRSA 5600 Fishers Lane, Room 
18N100C, Rockville, MD 20857; (2) call 301-443-3999; or (3) send an 
email to: [email protected].

SUPPLEMENTARY INFORMATION: The ACHDNC provides advice to the Secretary 
of HHS on the development of newborn screening activities, 
technologies, policies, guidelines, and programs for effectively 
reducing morbidity and mortality in newborns and children having, or at 
risk for, heritable disorders. In addition, ACHDNC's recommendations 
regarding inclusion of additional conditions and inherited disorders 
for screening which have been adopted by the Secretary are then 
included in the Recommended Uniform Screening Panel (RUSP). Conditions 
listed on the RUSP constitute part of the comprehensive preventive 
health guidelines supported by HRSA for infants and children under 
section 2713 of the Public Health Service Act, codified at 42 U.S.C. 
300gg-13. Under this provision, non-grandfathered health plans are 
required to cover screenings included in the HRSA-supported 
comprehensive guidelines without charging a co-payment, co-insurance, 
or deductible for plan years (i.e., policy years) beginning on or after 
the date that is 1 year from the Secretary's adoption of the condition 
for screening.

[[Page 33137]]

    The meeting agenda will include: (1) Presentations and discussion 
on the processes states use to identify and follow up on out of range 
newborn screening results; (2) a presentation on phase one of the 
spinal muscular atrophy evidence review; (3) presentations on newborn 
screening topics such as the clinical and public health impact of 
Critical Congenital Heart Defects, quality measures in newborn 
screening, and a review of newborn screening technology; and (4) 
updates from the Laboratory Standards and Procedures workgroup, Follow-
up and Treatment workgroup, and Education and Training workgroup. The 
Committee will not be voting on a proposed addition of a condition to 
the RUSP. Agenda items are subject to change. The final meeting agenda 
will be available 2 days prior to the meeting on the Committee's Web 
site: http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders.
    Members of the public will have the opportunity to provide 
comments. All comments are part of the official Committee record. To 
submit written comments or request time for an oral comment at the 
meeting, please register online by 12:00 p.m. on July 28, 2017, at 
http://www.achdncmeetings.org/. To ensure all individuals who have 
registered and requested time for oral comments are accommodated, the 
allocated time for comments may be limited. Individuals associated with 
groups or who plan to provide comments on similar topics may be asked 
to combine their comments and present them through a single 
representative. No audiovisual presentations are permitted. Written 
comments should identify the individual's name, address, email, 
telephone number, professional or organization affiliation, background 
or area of expertise (i.e., parent, family member, researcher, 
clinician, public health) and the topic/subject matter.
    Individuals who plan to attend and need special assistance, such as 
sign language interpretation or other reasonable accommodations, should 
notify Ann Ferrero using the address and phone number above at least 10 
days prior to the meeting.

Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2017-15113 Filed 7-18-17; 8:45 am]
BILLING CODE 4165-15-P



                                                    33136                                 Federal Register / Vol. 82, No. 137 / Wednesday, July 19, 2017 / Notices

                                                    Expenditures. While separate in terms                                      used for Federal oversight of Title III                        provided on the second page, to reflect
                                                    of the data gathered, the financial                                        Programs and Title VII Ombudsman                               changes made during the 2016
                                                    review and certification of funds                                          Program expenditures.                                          reauthorization of the OAA.
                                                    processes that are completed to generate                                      In addition to renewing OMB
                                                                                                                                                                                                ACL estimates the burden of this
                                                    the information gathered on these forms                                    approval of these data collection
                                                                                                                               instruments, minor changes are being                           collection of information as follows: 56
                                                    are generally done at the same time by
                                                                                                                               proposed to the LTCO Expenditures                              State Agencies on Aging respond
                                                    the States. To reduce burden, these
                                                    forms are being presented together for                                     Certification and an accompanying                              annually, and it takes each agency an
                                                    renewal since both are issued under the                                    document which provides specific                               average of one half (1⁄2) hour per State
                                                    same Program Instruction, and they                                         statutory references related to                                agency per year to complete each form
                                                    have the same due date to ACL.                                             Ombudsman program minimum                                      for a total of twenty-eight hours for all
                                                       The Certification of Maintenance of                                     funding, non-supplanting requirements                          state agencies annually. The half hour
                                                    Effort under Title III and Certification of                                and state authorization to expend Title                        estimate is based on prior years’
                                                    Long-Term Care Ombudsman (LTCO)                                            III–B funds on Ombudsman activities.                           experience with States in completing
                                                    Program Expenditures provide                                               Specifically, changes include making                           these forms.
                                                    statutorily required information                                           the reference to the Fiscal Year at the                          The proposed data collection tools
                                                    regarding each state’s contribution to                                     bottom of the form a fillable field to                         may be found on the ACL Web site for
                                                    programs funded under the Older                                            allow the date to be changed annually;                         review at: https://www.acl.gov/sites/
                                                    Americans Act and compliance with                                          listing the ‘‘Administration for                               default/files/programs/2017-06/
                                                    legislative requirements, pertinent                                        Community Living (ACL)’’ as the
                                                                                                                                                                                              MOE%20and%20LTCO%
                                                    Federal regulations, and other                                             intended recipient of the completed
                                                                                                                                                                                              20Certification%202017%20-
                                                    applicable instructions and guidelines                                     form; and updating statutory language
                                                    issued by ACL. This information will be                                    references (i.e., Section 306(a)(9))                           %20FINAL.pdf.

                                                                                                                                                                                             Responses
                                                                                                                                                                             Number of           per           Hours per        Annual burden
                                                                                  Respondent/data collection activity                                                       respondents      respondent        response            hours
                                                                                                                                                                                               (/year)

                                                    Certification on Maintenance of Effort under Title III .......................................                                     56                 1                ⁄
                                                                                                                                                                                                                           12             28
                                                    Certification of Long-Term Care Ombudsman Program Expenditures ...........                                                         56                 1                ⁄
                                                                                                                                                                                                                           12             28

                                                         Total ..........................................................................................................            112                  2                1              56



                                                      Dated: July 11, 2017.                                                    https://www.hrsa.gov/                                          Rockville, MD 20857; (2) call 301–443–
                                                    Mary Lazare,                                                               advisorycommittees/mchbadvisory/                               3999; or (3) send an email to: AFerrero@
                                                    Acting Administrator and Assistant Secretary                               heritabledisorders/index.html.                                 hrsa.gov.
                                                    for Aging.                                                                 DATES: The meeting will be held on                             SUPPLEMENTARY INFORMATION:       The
                                                    [FR Doc. 2017–14962 Filed 7–18–17; 8:45 am]                                August 3, 2017, 9:30 a.m. to 5:00 p.m.                         ACHDNC provides advice to the
                                                    BILLING CODE 4154–01–P                                                     ET and August 4, 2017, 9:30 a.m. to 3:00                       Secretary of HHS on the development of
                                                                                                                               p.m. ET. Meeting times may be revised;                         newborn screening activities,
                                                                                                                               please check the Committee’s Web site                          technologies, policies, guidelines, and
                                                    DEPARTMENT OF HEALTH AND                                                   for updates.                                                   programs for effectively reducing
                                                    HUMAN SERVICES                                                             ADDRESSES: This meeting will be held                           morbidity and mortality in newborns
                                                                                                                               in-person at 5600 Fishers Lane, 5th                            and children having, or at risk for,
                                                    Health Resources and Service
                                                                                                                               Floor Pavilion, Rockville, MD 20857.                           heritable disorders. In addition,
                                                    Administration
                                                                                                                               The meeting will also be accessible via                        ACHDNC’s recommendations regarding
                                                    Advisory Committee on Heritable                                            Webcast. Instructions on accessing the                         inclusion of additional conditions and
                                                    Disorders in Newborns and Children                                         meeting via Webcast will be provided                           inherited disorders for screening which
                                                                                                                               upon registration. Please note that 5600                       have been adopted by the Secretary are
                                                    AGENCY: Health Resources and Service                                       Fishers Lane requires security screening                       then included in the Recommended
                                                    Administration (HRSA), Department of                                       on entry. Visitors must provide a                              Uniform Screening Panel (RUSP).
                                                    Health and Human Services (HHS).                                           driver’s license, passport, or other form                      Conditions listed on the RUSP
                                                    ACTION: Notice of meeting.                                                 of government-issued photo                                     constitute part of the comprehensive
                                                                                                                               identification to be granted entry into                        preventive health guidelines supported
                                                    SUMMARY:   In accordance with the                                          the facility. Non-US citizens planning to                      by HRSA for infants and children under
                                                    Federal Advisory Committee Act, notice                                     attend in person will need to provide                          section 2713 of the Public Health
                                                    is hereby given that a meeting is                                          additional information to HRSA by July                         Service Act, codified at 42 U.S.C. 300gg-
                                                    scheduled for the Advisory Committee                                       24, 2017, 12:00 p.m. EDT. Please see                           13. Under this provision, non-
                                                                                                                               contact information below.
asabaliauskas on DSKBBXCHB2PROD with NOTICES




                                                    on Heritable Disorders in Newborns and                                                                                                    grandfathered health plans are required
                                                    Children (ACHDNC). This meeting will                                       FOR FURTHER INFORMATION CONTACT:                               to cover screenings included in the
                                                    be open to the public but advance                                          Anyone requesting information                                  HRSA-supported comprehensive
                                                    registration is required. Please register                                  regarding the ACHDNC should contact                            guidelines without charging a co-
                                                    online at http://                                                          Ann Ferrero, Maternal and Child Health                         payment, co-insurance, or deductible for
                                                    www.achdncmeetings.org/ by 12:00 p.m.                                      Bureau (MCHB), HRSA, in one of three                           plan years (i.e., policy years) beginning
                                                    ET on August 1, 2017. Information                                          ways: (1) Send a request to the following                      on or after the date that is 1 year from
                                                    about the ACHDNC can be obtained by                                        address: Ann Ferrero, MCHB, HRSA                               the Secretary’s adoption of the
                                                    accessing the following Web site:                                          5600 Fishers Lane, Room 18N100C,                               condition for screening.


                                               VerDate Sep<11>2014       18:49 Jul 18, 2017         Jkt 241001       PO 00000        Frm 00097       Fmt 4703       Sfmt 4703   E:\FR\FM\19JYN1.SGM   19JYN1


                                                                                 Federal Register / Vol. 82, No. 137 / Wednesday, July 19, 2017 / Notices                                                    33137

                                                       The meeting agenda will include: (1)                  DEPARTMENT OF HEALTH AND                                 Mr. Mirchandani has entered into a
                                                    Presentations and discussion on the                      HUMAN SERVICES                                        Voluntary Settlement Agreement with
                                                    processes states use to identify and                                                                           ORI, in which he voluntarily agreed,
                                                    follow up on out of range newborn                        Office of the Secretary                               beginning on June 29, 2017:
                                                    screening results; (2) a presentation on                                                                          (1) That if within two (2) years from
                                                                                                             Findings of Research Misconduct                       the effective date of the Agreement,
                                                    phase one of the spinal muscular
                                                    atrophy evidence review; (3)                             AGENCY:   Office of the Secretary, HHS                Respondent receives or applies for U.S.
                                                    presentations on newborn screening                       ACTION:   Notice.                                     Public Health Service (PHS) support,
                                                                                                                                                                   Respondent agrees to have his research
                                                    topics such as the clinical and public
                                                                                                             SUMMARY:    Notice is hereby given that               supervised for a period of one (1) year,
                                                    health impact of Critical Congenital
                                                                                                             the Office of Research Integrity (ORI)                beginning on the date of his
                                                    Heart Defects, quality measures in                                                                             employment in a position in which he
                                                                                                             has taken final action in the following
                                                    newborn screening, and a review of                       case:                                                 receives or applies for PHS support, and
                                                    newborn screening technology; and (4)                       Alec Mirchandani, Florida Atlantic                 agrees to notify his employer(s)/
                                                    updates from the Laboratory Standards                    University: Based on the report of the                institution(s) of the terms of this
                                                    and Procedures workgroup, Follow-up                      inquiry conducted by Florida Atlantic                 supervision. Respondent agrees that
                                                    and Treatment workgroup, and                             University (FAU), the Respondent’s                    prior to the submission of an
                                                    Education and Training workgroup. The                    admission, and analysis conducted by                  application for PHS support for a
                                                    Committee will not be voting on a                        ORI, ORI found that Mr. Alec                          research project on which the
                                                    proposed addition of a condition to the                  Mirchandani, former post-baccalaureate                Respondent’s participation is proposed
                                                    RUSP. Agenda items are subject to                        research volunteer in the Center for                  and prior to Respondent’s participation
                                                    change. The final meeting agenda will                    Complex Systems and Brain Sciences,                   in any capacity on PHS-supported
                                                    be available 2 days prior to the meeting                 Florida Atlantic University (FAU),                    research, Respondent shall ensure that a
                                                    on the Committee’s Web site: http://                     engaged in research misconduct in                     plan for supervision of Respondent’s
                                                    www.hrsa.gov/advisorycommittees/                         research supported by National Institute              duties is submitted to ORI for approval.
                                                    mchbadvisory/heritabledisorders.                         of Mental Health (NIMH), National                     The supervision plan must be designed
                                                                                                             Institutes of Health (NIH), grant 1 R15               to ensure the scientific integrity of
                                                       Members of the public will have the                   MH099590–01A1.                                        Respondent’s research contribution.
                                                    opportunity to provide comments. All                        ORI found that Respondent engaged                  Respondent agrees that he shall not
                                                    comments are part of the official                        in research misconduct by knowingly                   participate in any PHS-supported
                                                    Committee record. To submit written                      and intentionally: (1) Fabricating the                research until such a supervision plan is
                                                    comments or request time for an oral                     results of the T-maze behavioral                      submitted to and approved by ORI.
                                                    comment at the meeting, please register                  experiment for control mice, (2)                      Respondent agrees to maintain
                                                    online by 12:00 p.m. on July 28, 2017,                   falsifying the laboratory and vivarium                responsibility for compliance with the
                                                    at http://www.achdncmeetings.org/. To                    entry logs in an effort to cover up his               agreed upon supervision plan.
                                                    ensure all individuals who have                          actions, and (3) reporting the fabricated                (2) To exclude himself voluntarily
                                                    registered and requested time for oral                   and falsified data to his laboratory                  from serving in any advisory capacity to
                                                    comments are accommodated, the                           supervisors.                                          PHS including, but not limited to,
                                                    allocated time for comments may be                          Specifically, ORI found that                       service on any PHS advisory committee,
                                                    limited. Individuals associated with                     Respondent knowingly and                              board, and/or peer review committee, or
                                                    groups or who plan to provide                            intentionally:                                        as a consultant for a period of one (1)
                                                    comments on similar topics may be                           • Fabricated the results that he                   year, beginning with the effective date
                                                                                                             recorded for the T-maze behavioral                    of the Agreement.
                                                    asked to combine their comments and
                                                                                                             experiment in three of the five TMZ                   FOR FURTHER INFORMATION CONTACT:
                                                    present them through a single
                                                                                                             control mice on the laboratory data                   Director, Office of Research Integrity,
                                                    representative. No audiovisual
                                                                                                             sheets and white board on fourteen (14)               1101 Wootton Parkway, Suite 750,
                                                    presentations are permitted. Written                     of the sixteen (16) eligible days in June
                                                    comments should identify the                                                                                   Rockville, MD 20852, (240) 453–8200.
                                                                                                             2016, to make it appear as though he
                                                    individual’s name, address, email,                       had conducted the experiments;                        Kathryn M. Partin,
                                                    telephone number, professional or                           • Falsified the animal transfer logs on            Director, Office of Research Integrity.
                                                    organization affiliation, background or                  twelve (12) of the sixteen (16) eligible              [FR Doc. 2017–15159 Filed 7–18–17; 8:45 am]
                                                    area of expertise (i.e., parent, family                  days in June 2016, to make it appear as               BILLING CODE 4150–31–P
                                                    member, researcher, clinician, public                    though he had conducted the
                                                    health) and the topic/subject matter.                    experiments;
                                                       Individuals who plan to attend and                       • Fabricated the times he recorded on              DEPARTMENT OF HEALTH AND
                                                                                                             the laboratory data sheets on fourteen                HUMAN SERVICES
                                                    need special assistance, such as sign
                                                    language interpretation or other                         (14) of the sixteen (16) eligible days in
                                                                                                             June 2016, to make it appear as though                National Institutes of Health
                                                    reasonable accommodations, should
                                                                                                             he had conducted the experiments;
                                                    notify Ann Ferrero using the address                        • incorporated and recorded the                    National Institute of Allergy and
                                                    and phone number above at least 10                                                                             Infectious Diseases; Notice of Closed
asabaliauskas on DSKBBXCHB2PROD with NOTICES




                                                                                                             fabricated and falsified data with his
                                                    days prior to the meeting.                               previous data in his laboratory notebook              Meeting
                                                    Jason E. Bennett,                                        and reported the results to his                         Pursuant to section 10(d) of the
                                                    Director, Division of the Executive Secretariat.
                                                                                                             laboratory supervisor and principal                   Federal Advisory Committee Act, as
                                                                                                             investigator, such that the experimental              amended (5 U.S.C. App.), notice is
                                                    [FR Doc. 2017–15113 Filed 7–18–17; 8:45 am]
                                                                                                             control data (five animals) for                       hereby given of the following meeting.
                                                    BILLING CODE 4165–15–P
                                                                                                             experiments conducted from January                      The meeting will be closed to the
                                                                                                             2016–June 30, 2016, were not accurately               public in accordance with the
                                                                                                             represented.                                          provisions set forth in sections


                                               VerDate Sep<11>2014   18:49 Jul 18, 2017   Jkt 241001   PO 00000   Frm 00098   Fmt 4703   Sfmt 4703   E:\FR\FM\19JYN1.SGM   19JYN1



Document Created: 2017-07-19 06:17:47
Document Modified: 2017-07-19 06:17:47
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 August 3, 2017, 9:30 a.m. to 5:00 p.m. ET and August 4, 2017, 9:30 a.m. to 3:00 p.m. ET. Meeting times may be revised; please check the Committee's Web site for updates.
ContactAnyone requesting information regarding the ACHDNC should contact Ann Ferrero, Maternal and Child Health Bureau (MCHB), HRSA, in one of three ways: (1) Send a request to
FR Citation82 FR 33136 

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