83_FR_58483 83 FR 58260 - Meeting of the Advisory Committee on Infant Mortality

83 FR 58260 - Meeting of the Advisory Committee on Infant Mortality

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Service Administration

Federal Register Volume 83, Issue 223 (November 19, 2018)

Page Range58260-58261
FR Document2018-25105

The Advisory Committee on Infant Mortality (ACIM) has scheduled a public meeting.

Federal Register, Volume 83 Issue 223 (Monday, November 19, 2018)
[Federal Register Volume 83, Number 223 (Monday, November 19, 2018)]
[Notices]
[Pages 58260-58261]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-25105]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Service Administration


Meeting of the Advisory Committee on Infant Mortality

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

ACTION: Notice.

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SUMMARY: The Advisory Committee on Infant Mortality (ACIM) has 
scheduled a public meeting.

DATES: December 4, 2018, 9:00 a.m.-5:00 p.m. ET and December 5, 2018, 
9:00 a.m.-3:30 p.m. ET.

ADDRESSES: This meeting will be held in-person and by webinar. The 
address for the meeting is 5600 Fishers Lane, Room 5W11, Rockville, 
Maryland 20857. Instructions on how to access the meeting via webcast 
will be provided upon registration.
    Information about ACIM and the agenda for this meeting can be found 
on the ACIM website at https://www.hrsa.gov/advisory-committees/infant-mortality/index.html. While this meeting is open to the public, advance 
registration is required. Registration information and information 
about the ACIM can be obtained by accessing: https://www.hrsa.gov/advisory-committees/infant-mortality/index.html.

FOR FURTHER INFORMATION CONTACT: David S. de la Cruz, Ph.D., MPH, 
Designated Federal Official (DFO), at HRSA, Maternal and Child Health 
Bureau (MCHB), 5600 Fishers Lane, Rockville, Maryland 20857; 301-443-
0543; or [email protected].

SUPPLEMENTARY INFORMATION: ACIM provides advice and recommendations to 
the Secretary of HHS (Secretary) on HHS programs and activities that 
focus on reducing infant mortality and improving the health status of 
infants and pregnant women and factors affecting the continuum of care 
with respect to maternal and child health care. ACIM focuses on 
outcomes before, during, and following pregnancy and childbirth, 
strategies to coordinate a myriad of federal, state, local, and private 
programs, efforts that are designed to deal with the health and social 
problems impacting infant mortality, and the implementation of the 
federal Healthy Start Program.
    The meeting agenda is being finalized and tentatively includes 
updates on HRSA, MCHB, and the Healthy Start Program, an introduction 
of members, a briefing on infant mortality and health disparity data in 
the U.S., and future topic areas for ACIM to discuss. Agenda items are 
subject to changes as priorities dictate. The final meeting agenda will 
be available 2 days prior to the meeting on the ACIM website: https://
www.hrsa.gov/advisory-committees/Infant-Mortality/index.html. Refer to 
the ACIM website for any updated information concerning the meeting.
    Members of the public will have the opportunity to provide comments 
on the afternoon of December 5, 2018. Written comments must be 
submitted via email to the DFO, David S. de la Cruz, by 12:00 p.m. ET 
on Tuesday, November 20, 2018, at [email protected]. Please indicate if 
your comments will be written only or if you are requesting to present 
your comments in person during the meeting. All comments (oral and 
written) will be part of the official meeting record. To ensure all 
individuals who have requested time for oral comments are accommodated, 
the allocated time for each comment will be limited to no more than 3 
minutes. More complete/longer comments should be submitted in writing. 
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

[[Page 58261]]

presentations are permitted. Comments should identify the individual's 
name, address, email, telephone number, professional or organization 
affiliation, background or area of expertise (e.g., parent, family 
member, researcher, clinician, public health, etc.), and the topic/
subject matter. Oral comments must be presented in-person and not via 
phone/webinar.
    Individuals who plan to attend and need special assistance or 
another reasonable accommodation should notify David S. de la Cruz at 
the address and phone number listed above at least 10 days prior to the 
meeting. Since this meeting occurs in a federal government building, 
attendees must go through a security check to enter the building. Non-
U.S. Citizen attendees must notify HRSA of their planned attendance at 
least 10 business days prior to the meeting in order to facilitate 
their entry into the building. All attendees are required to present 
government-issued identification prior to entry.

Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2018-25105 Filed 11-16-18; 8:45 am]
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                                               58260                      Federal Register / Vol. 83, No. 223 / Monday, November 19, 2018 / Notices

                                               (ASRs); (4) FDA-verified status of open                    In 2018, MEPS–IC, available at                     information and information about the
                                               PMRs/PMCs reported in                                   www.meps.ahrq.gov, published the                      ACIM can be obtained by accessing:
                                               § 314.81(b)(2)(vii) or § 601.70 ASRs; (5)               annual 2017 average total single                      https://www.hrsa.gov/advisory-
                                               the status of closed PMRs/PMCs; and (6)                 premium per enrolled employee at                      committees/infant-mortality/index.html.
                                               the distribution of the status by fiscal                private-sector establishments that                    FOR FURTHER INFORMATION CONTACT:
                                               year of establishment 2 (FY2011 to                      provide health insurance. The figure                  David S. de la Cruz, Ph.D., MPH,
                                               FY2017) for PMRs and PMCs open at                       published was $6,368. This figure is                  Designated Federal Official (DFO), at
                                               the end of FY2017, or those closed                      divided by 12 months to determine the                 HRSA, Maternal and Child Health
                                               within FY2017. Additional information                   cost per month of $530.67. The $530.67                Bureau (MCHB), 5600 Fishers Lane,
                                               about PMRs/PMCs is provided on FDA’s                    figure is increased or decreased by the               Rockville, Maryland 20857; 301–443–
                                               website at https://www.fda.gov/Drugs/                   percentage change reported by the most                0543; or dcruz@hrsa.gov.
                                               GuidanceCompliance                                      recent KFF Employer Health Benefits                   SUPPLEMENTARY INFORMATION: ACIM
                                               RegulatoryInformation/Post-marketing                    Survey, available at www.kff.org. The                 provides advice and recommendations
                                               PhaseIVCommitments/default.htm.                         percentage increase from 2017 to 2018                 to the Secretary of HHS (Secretary) on
                                                 Dated: November 13, 2018.                             was 3.0 percent. By adding this                       HHS programs and activities that focus
                                               Leslie Kux,                                             percentage increase, the calculated                   on reducing infant mortality and
                                                                                                       average monthly cost of a health                      improving the health status of infants
                                               Associate Commissioner for Policy.
                                                                                                       insurance policy for a 12-month period                and pregnant women and factors
                                               [FR Doc. 2018–25128 Filed 11–16–18; 8:45 am]
                                                                                                       is $546.59.                                           affecting the continuum of care with
                                               BILLING CODE 4164–01–P                                     Therefore, the Secretary announces
                                                                                                                                                             respect to maternal and child health
                                                                                                       that the revised average cost of a health
                                                                                                                                                             care. ACIM focuses on outcomes before,
                                                                                                       insurance policy under the VICP is
                                               DEPARTMENT OF HEALTH AND                                                                                      during, and following pregnancy and
                                                                                                       $546.59 per month. In accordance with
                                               HUMAN SERVICES                                                                                                childbirth, strategies to coordinate a
                                                                                                       § 100.2, the revised amount was
                                                                                                                                                             myriad of federal, state, local, and
                                               Health Resources and Services                           effective upon its delivery by the
                                                                                                                                                             private programs, efforts that are
                                               Administration                                          Secretary to the Court. Such notice was
                                                                                                                                                             designed to deal with the health and
                                                                                                       delivered to the Court on November 13,
                                                                                                                                                             social problems impacting infant
                                               National Vaccine Injury Compensation                    2018.
                                                                                                                                                             mortality, and the implementation of
                                               Program: Revised Amount of the                           Dated: November 13, 2018.                            the federal Healthy Start Program.
                                               Average Cost of a Health Insurance                      George Sigounas,                                         The meeting agenda is being finalized
                                               Policy                                                  Administrator.                                        and tentatively includes updates on
                                               AGENCY: Health Resources and Services                   [FR Doc. 2018–25087 Filed 11–16–18; 8:45 am]          HRSA, MCHB, and the Healthy Start
                                               Administration (HRSA), Department of                    BILLING CODE 4165–15–P                                Program, an introduction of members, a
                                               Health and Human Services (HHS).                                                                              briefing on infant mortality and health
                                               ACTION: Notice.                                                                                               disparity data in the U.S., and future
                                                                                                       DEPARTMENT OF HEALTH AND                              topic areas for ACIM to discuss. Agenda
                                               SUMMARY:    HRSA is publishing an                       HUMAN SERVICES                                        items are subject to changes as priorities
                                               updated monetary amount of the                                                                                dictate. The final meeting agenda will
                                               average cost of a health insurance policy               Health Resources and Service                          be available 2 days prior to the meeting
                                               as it relates to the National Vaccine                   Administration                                        on the ACIM website: https://
                                               Injury Compensation Program (VICP).                                                                           www.hrsa.gov/advisory-committees/
                                               SUPPLEMENTARY INFORMATION: Section                      Meeting of the Advisory Committee on
                                                                                                                                                             Infant-Mortality/index.html. Refer to the
                                               100.2 of VICP’s implementing regulation                 Infant Mortality
                                                                                                                                                             ACIM website for any updated
                                               (42 CFR part 100) states that the revised               AGENCY: Health Resources and Service                  information concerning the meeting.
                                               amount of an average cost of a health                   Administration (HRSA), Department of                     Members of the public will have the
                                               insurance policy, as determined by the                  Health and Human Services (HHS).                      opportunity to provide comments on the
                                               Secretary of HHS (the Secretary), is                    ACTION: Notice.                                       afternoon of December 5, 2018. Written
                                               effective upon its delivery by the                                                                            comments must be submitted via email
                                               Secretary to the United States Court of                 SUMMARY:   The Advisory Committee on                  to the DFO, David S. de la Cruz, by
                                               Federal Claims (the Court), and will be                 Infant Mortality (ACIM) has scheduled a               12:00 p.m. ET on Tuesday, November
                                               published periodically in a notice in the               public meeting.                                       20, 2018, at dcruz@hrsa.gov. Please
                                               Federal Register. This figure is                        DATES: December 4, 2018, 9:00 a.m.–                   indicate if your comments will be
                                               calculated using the most recent                        5:00 p.m. ET and December 5, 2018,                    written only or if you are requesting to
                                               Medical Expenditure Panel Survey-                       9:00 a.m.–3:30 p.m. ET.                               present your comments in person
                                               Insurance Component (MEPS–IC) data                      ADDRESSES: This meeting will be held                  during the meeting. All comments (oral
                                               available as the baseline for the average               in-person and by webinar. The address                 and written) will be part of the official
                                               monthly cost of a health insurance                      for the meeting is 5600 Fishers Lane,                 meeting record. To ensure all
                                               policy. This baseline is adjusted by the                Room 5W11, Rockville, Maryland                        individuals who have requested time for
                                               annual percentage increase/decrease                     20857. Instructions on how to access the              oral comments are accommodated, the
                                               obtained from the most recent annual                    meeting via webcast will be provided                  allocated time for each comment will be
                                               Kaiser Family Foundation (KFF)                                                                                limited to no more than 3 minutes. More
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                                                                                                       upon registration.
                                               Employer Health Benefits Survey or                        Information about ACIM and the                      complete/longer comments should be
                                               other authoritative source that may be                  agenda for this meeting can be found on               submitted in writing. Individuals
                                               more accurate or appropriate.                           the ACIM website at https://                          associated with groups or who plan to
                                                                                                       www.hrsa.gov/advisory-committees/                     provide comments on similar topics
                                                 2 The establishment date is the date of the formal

                                               FDA communication to the applicant that included
                                                                                                       infant-mortality/index.html. While this               may be asked to combine their
                                               the final FDA-required (PMR) or -requested (PMC)        meeting is open to the public, advance                comments and present them through a
                                               postmarketing study or clinical trial.                  registration is required. Registration                single representative. No audiovisual


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                                                                          Federal Register / Vol. 83, No. 223 / Monday, November 19, 2018 / Notices                                                 58261

                                               presentations are permitted. Comments                   Health Services Corps Scholarship                     Human Research Protections, 1101
                                               should identify the individual’s name,                  Program (42 U.S.C. 254o(b)(1)(A))’’ and               Wootton Parkway, Suite 200, Rockville,
                                               address, email, telephone number,                       ‘‘National Research Service Award                     MD 20852.
                                               professional or organization affiliation,               Program (42 U.S.C. 288(c)(4)(B)).’’ This                 Comments received, including any
                                               background or area of expertise (e.g.,                  interest rate will be applied to overdue              personal information, will be posted
                                               parent, family member, researcher,                      debt until the Department of Health and               without change to http://
                                               clinician, public health, etc.), and the                Human Services publishes a revision.                  www.regulations.gov.
                                               topic/subject matter. Oral comments                       Dated: October 10, 2018.                            FOR FURTHER INFORMATION CONTACT:
                                               must be presented in-person and not via                                                                       Irene Stith-Coleman, Ph.D., Office for
                                                                                                       David C. Horn,
                                               phone/webinar.                                                                                                Human Research Protections, 1101
                                                  Individuals who plan to attend and                   Director, Office of Financial Policy and
                                                                                                       Reporting.                                            Wootton Parkway, Suite 200, Rockville,
                                               need special assistance or another
                                                                                                       [FR Doc. 2018–25204 Filed 11–16–18; 8:45 am]          MD 20852, 240–453–6900; email
                                               reasonable accommodation should
                                                                                                                                                             Irene.Stith-Coleman@hhs.gov.
                                               notify David S. de la Cruz at the address               BILLING CODE 4150–04–P
                                               and phone number listed above at least                                                                        SUPPLEMENTARY INFORMATION:
                                               10 days prior to the meeting. Since this                                                                      I. Background
                                               meeting occurs in a federal government                  DEPARTMENT OF HEALTH AND
                                               building, attendees must go through a                   HUMAN SERVICES                                        A. Overview
                                               security check to enter the building.                                                                            OHRP, Office of the Assistant
                                                                                                       Activities Deemed Not To Be
                                               Non-U.S. Citizen attendees must notify                                                                        Secretary for Health, is announcing the
                                                                                                       Research: Public Health Surveillance,
                                               HRSA of their planned attendance at                                                                           availability of a draft guidance
                                                                                                       2018 Requirements
                                               least 10 business days prior to the                                                                           document entitled ‘‘Activities Deemed
                                               meeting in order to facilitate their entry              AGENCY:  The Office for Human Research                Not to Be Research: Public Health
                                               into the building. All attendees are                    Protections, Office of the Assistant                  Surveillance, 2018 Requirements.’’ This
                                               required to present government-issued                   Secretary for Health, Office of the                   guidance document applies to activities
                                               identification prior to entry.                          Secretary, HHS.                                       that are conducted or supported by
                                                                                                       ACTION: Notice of availability.                       HHS. It is intended to help entities
                                               Amy P. McNulty,
                                                                                                                                                             determine whether a planned activity
                                               Acting Director, Division of the Executive              SUMMARY:  The Office for Human                        constitutes a public health surveillance
                                               Secretariat.
                                                                                                       Research Protections (OHRP), Office of                activity deemed not to be research
                                               [FR Doc. 2018–25105 Filed 11–16–18; 8:45 am]
                                                                                                       the Assistant Secretary for Health, is                under the 2018 Requirements (the
                                               BILLING CODE 4165–15–P
                                                                                                       announcing the availability of a draft                revised subpart A of 45 CFR part 46,
                                                                                                       guidance document entitled, ‘‘Activities              effective July 19, 2018). The draft
                                                                                                       Deemed Not to Be Research: Public                     guidance document, when finalized,
                                               DEPARTMENT OF HEALTH AND
                                                                                                       Health Surveillance, 2018                             will represent OHRP’s current thinking
                                               HUMAN SERVICES
                                                                                                       Requirements.’’                                       on this topic. OHRP obtained input from
                                               Office of the Secretary                                 DATES:  Submit written comments by                    HHS agencies and the Common Rule
                                                                                                       December 19, 2018.                                    departments and agencies in developing
                                               Notice of Interest Rate on Overdue                                                                            the draft guidance document.
                                                                                                       ADDRESSES: Submit written requests for
                                               Debts
                                                                                                       a single copy of the draft guidance                   II. Electronic Access
                                                 Section 30.18 of the Department of                    document entitled ‘‘Activities Deemed                    Persons with access may obtain the
                                               Health and Human Services’ claims                       Not to Be Research: Public Health                     draft guidance documents on OHRP’s
                                               collection regulations (45 CFR part 30)                 Surveillance, 2018 Requirements,’’ to                 website at https://www.hhs.gov/ohrp/
                                               provides that the Secretary shall charge                the Division of Policy and Assurances,                regulations-and-policy/requests-for-
                                               an annual rate of interest, which is                    Office for Human Research Protections,                comments/index.html.
                                               determined and fixed by the Secretary                   1101 Wootton Parkway, Suite 200,
                                               of the Treasury after considering private               Rockville, MD 20852. Send one self-                     Dated: November 8, 2018.
                                               consumer rates of interest on the date                  addressed adhesive label to assist that               Julie Kaneshiro,
                                               that the Department of Health and                       office in processing your request, or fax             Deputy Director, Office for Human Research
                                               Human Services becomes entitled to                      your request to 240–453–6909. See the                 Protections.
                                               recovery. The rate cannot be lower than                 SUPPLEMENTARY INFORMATION section for                 [FR Doc. 2018–25202 Filed 11–16–18; 8:45 am]
                                               the Department of Treasury’s current                    information on electronic access to the               BILLING CODE 4150–36–P
                                               value of funds rate or the applicable rate              draft guidance documents.
                                               determined from the ‘‘Schedule of                          You may submit comments identified
                                               Certified Interest Rates with Range of                  by docket ID number HHS–OS–OPHS–                      DEPARTMENT OF HEALTH AND
                                               Maturities’’ unless the Secretary waives                2018–0015 (Activities Deemed Not to Be                HUMAN SERVICES
                                               interest in whole or part, or a different               Research: Public Health Surveillance,
                                               rate is prescribed by statute, contract, or             2018 Requirements), by one of the                     National Biodefense Science Board
                                               repayment agreement. The Secretary of                   following methods:                                    Public Teleconference
                                               the Treasury may revise this rate                          • Federal eRulemaking Portal: http://              AGENCY:  Office of the Assistant
                                                                                                       www.regulations.gov. Enter the docket
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                                               quarterly. The Department of Health and                                                                       Secretary for Preparedness and
                                               Human Services publishes this rate in                   ID number and click on ‘‘Search.’’ On                 Response (ASPR), Department of Health
                                               the Federal Register.                                   the next page, click the ‘‘Comment                    and Human Services (HHS).
                                                 The current rate of 101⁄8%, as fixed by               Now’’’’ action and follow the                         ACTION: Notice.
                                               the Secretary of the Treasury, is certified             instructions.
                                               for the quarter ended September 30,                        • Mail/Hand delivery/Courier [For                  SUMMARY: As stipulated by the Federal
                                               2018. This rate is based on the Interest                paper, disk, or CD–ROM submissions]:                  Advisory Committee Act, the
                                               Rates for Specific Legislation, ‘‘National              Irene Stith-Coleman, Ph.D., Office for                Department of Health and Human


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Document Created: 2018-11-17 02:47:34
Document Modified: 2018-11-17 02:47:34
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.
DatesDecember 4, 2018, 9:00 a.m.-5:00 p.m. ET and December 5, 2018, 9:00 a.m.-3:30 p.m. ET.
ContactDavid S. de la Cruz, Ph.D., MPH, Designated Federal Official (DFO), at HRSA, Maternal and Child Health Bureau (MCHB), 5600 Fishers Lane, Rockville, Maryland 20857; 301-443- 0543; or [email protected]
FR Citation83 FR 58260 

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