83_FR_10781 83 FR 10733 - Bright Futures Periodicity Schedule Updates

83 FR 10733 - Bright Futures Periodicity Schedule Updates

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Service Administration

Federal Register Volume 83, Issue 48 (March 12, 2018)

Page Range10733-10734
FR Document2018-04834

Effective December 21, 2017, HRSA updated the HRSA-supported guidelines for infants, children, and adolescents for purposes of health insurance coverage for preventive services, as set out in the Bright Futures Periodicity Schedule. This notice serves as an announcement of the decision to update these guidelines as listed below. Please see https://mchb.hrsa.gov/maternal-child-health-topics/ child-health/bright-futures.html for additional information.

Federal Register, Volume 83 Issue 48 (Monday, March 12, 2018)
[Federal Register Volume 83, Number 48 (Monday, March 12, 2018)]
[Notices]
[Pages 10733-10734]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-04834]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Service Administration


Bright Futures Periodicity Schedule Updates

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

ACTION: Notice.

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

SUMMARY: Effective December 21, 2017, HRSA updated the HRSA-supported 
guidelines for infants, children, and adolescents for purposes of 
health insurance coverage for preventive services, as set out in the 
Bright Futures Periodicity Schedule. This notice serves as an 
announcement of the decision to update these guidelines as listed 
below. Please see https://mchb.hrsa.gov/maternal-child-health-topics/child-health/bright-futures.html for additional information.

FOR FURTHER INFORMATION CONTACT: Bethany D. Miller, LCSW-C, M.Ed., 
HRSA/Maternal and Child Health Bureau by calling (301) 495-5156 or 
emailing BMiller@hrsa.gov.

SUPPLEMENTARY INFORMATION: The Bright Futures program has been funded 
by HRSA since 1990. A primary focus of this program is for the funding 
recipient to maintain and update the Bright Futures Guidelines for 
Health Supervision of Infants, Children and Adolescents, a set of 
materials and tools that provide theory-based and evidence-driven 
guidance for all preventive care screenings and well-child visits. One 
component of these tools is the Bright Futures Periodicity Schedule, a 
chart

[[Page 10734]]

that outlines the recommended screenings, assessments, physical 
examinations, and procedures to be delivered during preventive checkups 
at each age milestone. The Bright Futures Periodicity Schedule has 
become the accepted schedule within the United States for preventive 
health services through the course of a child's development.
    Section 2713 of the Public Health Service Act requires that non-
grandfathered group health plans and health insurance issuers offering 
group or individual health insurance coverage provide coverage for 
certain preventive health services in four identified areas without 
cost sharing. Section 2713(a)(3) describes such services for infants, 
children, and adolescents as ``evidence-informed preventive care and 
screenings provided for in the comprehensive guidelines supported by 
HRSA.'' HHS, along with the Departments of Treasury and Labor, issued 
an Interim Final Rule (IFR) on July 19, 2010 (75 FR 41726-41760) that 
identified two specific charts as the comprehensive guidelines 
supported by HRSA for infants, children, and adolescents to be covered 
by insurance without cost sharing by non-grandfathered group health 
plans and health insurance issuers: (1) The Bright Futures Periodicity 
Schedule and (2) the Recommended Uniform Screening Panel (RUSP) of the 
Advisory Committee on Heritable Disorders in Newborns and Children. The 
IFR provided that future changes to these comprehensive guidelines are 
considered to be issued for purposes of Section 2713 on the date of 
acceptance by the HRSA Administrator or, if applicable, adoption by the 
Secretary.
    On December 21, 2017, the HRSA Administrator accepted the proposed 
2017 updates to the Bright Futures Periodicity Schedule. Therefore, all 
non-grandfathered group health plans and health insurance issuers 
offering group or individual health insurance coverage must cover the 
services and screenings listed on the updated Bright Futures 
Periodicity Schedule for plan years (in the individual market, policy 
years) beginning on or after December 21, 2018.
    The updated 2017 Bright Futures Periodicity schedule can be 
accessed at the following link: https://mchb.hrsa.gov/maternal-child-health-topics/child-health/bright-futures.html.

    Dated: February 27, 2018.
George Sigounas,
Administrator.
[FR Doc. 2018-04834 Filed 3-9-18; 8:45 am]
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                                                                           Federal Register / Vol. 83, No. 48 / Monday, March 12, 2018 / Notices                                                   10733

                                             do not wish to be made available to the                    Docket: For access to the docket to                subject to review by the Office of
                                             public, submit the comment as a                         read background documents or the                      Management and Budget (OMB) under
                                             written/paper submission and in the                     electronic and written/paper comments                 the Paperwork Reduction Act of 1995
                                             manner detailed (see ‘‘Written/Paper                    received, go to https://                              (44 U.S.C. 3501–3520). The collections
                                             Submissions’’ and ‘‘Instructions’’).                    www.regulations.gov and insert the                    of information in 21 CFR part 514 have
                                                                                                     docket number, found in brackets in the               been approved under OMB control
                                             Written/Paper Submissions                               heading of this document, into the                    numbers 0910–0032 and 0910–0699; 21
                                                Submit written/paper submissions as                  ‘‘Search’’ box and follow the prompts                 CFR part 511 have been approved under
                                             follows:                                                and/or go to the Dockets Management                   OMB control number 0910–0117.
                                                • Mail/Hand delivery/Courier (for                    Staff, 5630 Fishers Lane, Rm. 1061,
                                                                                                                                                           IV. Electronic Access
                                             written/paper submissions): Dockets                     Rockville, MD 20852.
                                             Management Staff (HFA–305), Food and                       You may submit comments on any                       Persons with access to the internet
                                             Drug Administration, 5630 Fishers                       guidance at any time (see 21 CFR                      may obtain the draft guidance at either
                                             Lane, Rm. 1061, Rockville, MD 20852.                    10.115(g)(5)).                                        http://www.fda.gov/AnimalVeterinary/
                                                • For written/paper comments                            Submit written requests for single                 GuidanceComplianceEnforcement/
                                             submitted to the Dockets Management                     copies of the guidance to the Policy and              GuidanceforIndustry/default.htm or
                                             Staff, FDA will post your comment, as                   Regulations Staff (HFV–6), Center for                 https://www.regulations.gov.
                                             well as any attachments, except for                     Veterinary Medicine, Food and Drug                      Dated: March 6, 2018.
                                             information submitted, marked and                       Administration, 7500 Standish Pl.,                    Leslie Kux,
                                             identified, as confidential, if submitted               Rockville, MD 20855. Send one self-
                                                                                                                                                           Associate Commissioner for Policy.
                                             as detailed in ‘‘Instructions.’’                        addressed adhesive label to assist that
                                                                                                                                                           [FR Doc. 2018–04885 Filed 3–9–18; 8:45 am]
                                                                                                     office in processing your requests. See
                                                Instructions: All submissions received                                                                     BILLING CODE 4164–01–P
                                                                                                     the SUPPLEMENTARY INFORMATION section
                                             must include the Docket No. FDA–
                                                                                                     for electronic access to the draft
                                             2018–D–0626 for ‘‘Proprietary Names
                                                                                                     guidance document.
                                             for New Animal Drugs.’’ Received                                                                              DEPARTMENT OF HEALTH AND
                                                                                                     FOR FURTHER INFORMATION CONTACT: Tom
                                             comments will be placed in the docket                                                                         HUMAN SERVICES
                                             and, except for those submitted as                      Modric, Center for Veterinary Medicine
                                             ‘‘Confidential Submissions,’’ publicly                  (HFV–216), Food and Drug                              Health Resources and Service
                                             viewable at https://www.regulations.gov                 Administration, 7519 Standish Pl.,                    Administration
                                             or at the Dockets Management Staff                      Rockville, MD 20855, 240–402–5853,
                                             between 9 a.m. and 4 p.m., Monday                       tomislav.modric@fda.hhs.gov.                          Bright Futures Periodicity Schedule
                                             through Friday.                                         SUPPLEMENTARY INFORMATION:                            Updates
                                                • Confidential Submissions—To                        I. Background                                         AGENCY: Health Resources and Service
                                             submit a comment with confidential                         FDA is announcing the availability of              Administration (HRSA), Department of
                                             information that you do not wish to be                  a draft guidance for industry #240                    Health and Human Services (HHS).
                                             made publicly available, submit your                    entitled ‘‘Proprietary Names for New                  ACTION: Notice.
                                             comments only as a written/paper                        Animal Drugs.’’ CVM evaluates
                                             submission. You should submit two                                                                             SUMMARY:   Effective December 21, 2017,
                                                                                                     proprietary names as a part of the new                HRSA updated the HRSA-supported
                                             copies total. One copy will include the                 animal drug approval process. Selecting
                                             information you claim to be confidential                                                                      guidelines for infants, children, and
                                                                                                     a proprietary name is a critical element              adolescents for purposes of health
                                             with a heading or cover note that states                in the design and development of drug
                                             ‘‘THIS DOCUMENT CONTAINS                                                                                      insurance coverage for preventive
                                                                                                     product labeling because end users may                services, as set out in the Bright Futures
                                             CONFIDENTIAL INFORMATION.’’ The                         rely, in part, on the proprietary name to
                                             Agency will review this copy, including                                                                       Periodicity Schedule. This notice serves
                                                                                                     identify which product, among                         as an announcement of the decision to
                                             the claimed confidential information, in                thousands of available products, is
                                             its consideration of comments. The                                                                            update these guidelines as listed below.
                                                                                                     intended for a given animal.                          Please see https://mchb.hrsa.gov/
                                             second copy, which will have the
                                             claimed confidential information                        II. Significance of Guidance                          maternal-child-health-topics/child-
                                             redacted/blacked out, will be available                    This level 1 draft guidance is being               health/bright-futures.html for additional
                                             for public viewing and posted on                        issued consistent with FDA’s good                     information.
                                             https://www.regulations.gov. Submit                     guidance practices regulation (21 CFR                 FOR FURTHER INFORMATION CONTACT:
                                             both copies to the Dockets Management                   10.115). The draft guidance, when                     Bethany D. Miller, LCSW–C, M.Ed.,
                                             Staff. If you do not wish your name and                 finalized, will represent the current                 HRSA/Maternal and Child Health
                                             contact information to be made publicly                 thinking of FDA on ‘‘Proprietary Names                Bureau by calling (301) 495–5156 or
                                             available, you can provide this                         for New Animal Drugs.’’ It does not                   emailing BMiller@hrsa.gov.
                                             information on the cover sheet and not                  establish any rights for any person and               SUPPLEMENTARY INFORMATION: The Bright
                                             in the body of your comments and you                    is not binding on FDA or the public.                  Futures program has been funded by
                                             must identify this information as                       You can use an alternative approach if                HRSA since 1990. A primary focus of
                                             ‘‘confidential.’’ Any information marked                it satisfies the requirements of the                  this program is for the funding recipient
                                             as ‘‘confidential’’ will not be disclosed               applicable statutes and regulations. This             to maintain and update the Bright
                                             except in accordance with 21 CFR 10.20                  is not a significant regulatory action                Futures Guidelines for Health
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                                             and other applicable disclosure law. For                subject to Executive Order 12866.                     Supervision of Infants, Children and
                                             more information about FDA’s posting                                                                          Adolescents, a set of materials and tools
                                             of comments to public dockets, see 80                   III. Paperwork Reduction Act of 1995                  that provide theory-based and evidence-
                                             FR 56469, September 18, 2015, or access                    This draft guidance refers to                      driven guidance for all preventive care
                                             the information at: https://www.gpo.gov/                previously approved collections of                    screenings and well-child visits. One
                                             fdsys/pkg/FR-2015-09-18/pdf/2015-                       information found in FDA regulations.                 component of these tools is the Bright
                                             23389.pdf.                                              These collections of information are                  Futures Periodicity Schedule, a chart


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                                             10734                         Federal Register / Vol. 83, No. 48 / Monday, March 12, 2018 / Notices

                                             that outlines the recommended                           DEPARTMENT OF HEALTH AND                                Agenda: To review and evaluate personal
                                             screenings, assessments, physical                       HUMAN SERVICES                                        qualifications and performance, and
                                             examinations, and procedures to be                                                                            competence of individual investigators.
                                                                                                     National Institutes of Health                           Place: Residence Inn Bethesda, 7335
                                             delivered during preventive checkups at
                                                                                                                                                           Wisconsin Avenue, Bethesda, MD 20814.
                                             each age milestone. The Bright Futures                                                                          Contact Person: Alan P. Koretsky, Ph.D.,
                                             Periodicity Schedule has become the                     Eunice Kennedy Shriver National
                                                                                                                                                           Scientific Director, Division of Intramural
                                             accepted schedule within the United                     Institute of Child Health & Human                     Research, National Institute of Neurological
                                             States for preventive health services                   Development; Amended Notice of                        Disorders and Stroke, NIH, 35 Convent Drive,
                                             through the course of a child’s                         Meeting                                               Room 6A 908, Bethesda, MD 20892, (301)
                                             development.                                                                                                  435–2232, koretskya@ninds.nih.gov.
                                                                                                       Notice is hereby given of a change in               (Catalogue of Federal Domestic Assistance
                                                Section 2713 of the Public Health                    the meeting of the National Institute of              Program Nos. 93.853, Clinical Research
                                             Service Act requires that non-                          Child Health and Human Development                    Related to Neurological Disorders; 93.854,
                                             grandfathered group health plans and                    Special Emphasis Panel, March 2, 2018,                Biological Basis Research in the
                                             health insurance issuers offering group                 8:30 a.m. to March 2, 2018, 5:00 p.m.,                Neurosciences, National Institutes of Health,
                                             or individual health insurance coverage                 Hilton Washington/Rockville, 1750                     HHS).
                                             provide coverage for certain preventive                 Rockville Pike, Rockville, MD, 20852                    Dated: March 6, 2018.
                                             health services in four identified areas                which was published in the Federal                    Sylvia l. Neal,
                                             without cost sharing. Section 2713(a)(3)                Register on February 6, 2018, 83 FR
                                             describes such services for infants,                                                                          Program Analyst, Office of Federal Advisory
                                                                                                     5265.                                                 Committee Policy.
                                             children, and adolescents as ‘‘evidence-
                                             informed preventive care and screenings                   The meeting date has changed from                   [FR Doc. 2018–04951 Filed 3–9–18; 8:45 am]
                                             provided for in the comprehensive                       March 2, 2018 from 8:30 a.m. to 5:00                  BILLING CODE 4140–01–P

                                             guidelines supported by HRSA.’’ HHS,                    p.m. to March 13, 2018 from 10:30 a.m.
                                             along with the Departments of Treasury                  to 3:30 p.m. The meeting is closed to the
                                             and Labor, issued an Interim Final Rule                 public.                                               DEPARTMENT OF HEALTH AND
                                             (IFR) on July 19, 2010 (75 FR 41726–                      Dated: March 6, 2018.
                                                                                                                                                           HUMAN SERVICES
                                             41760) that identified two specific                     Michelle Trout,                                       National Institutes of Health
                                             charts as the comprehensive guidelines                  Program Analyst, Office of Federal Advisory
                                             supported by HRSA for infants,                          Committee Policy.                                     Proposed Collection; 60-Day Comment
                                             children, and adolescents to be covered                 [FR Doc. 2018–04949 Filed 3–9–18; 8:45 am]            Request; Generic Clearance for the
                                             by insurance without cost sharing by                    BILLING CODE 4140–01–P                                Collection of Qualitative Feedback on
                                             non-grandfathered group health plans                                                                          Agency Service Delivery (National
                                             and health insurance issuers: (1) The                                                                         Institute of Nursing Research)
                                             Bright Futures Periodicity Schedule and                 DEPARTMENT OF HEALTH AND
                                             (2) the Recommended Uniform                             HUMAN SERVICES                                        AGENCY:   National Institutes of Health,
                                             Screening Panel (RUSP) of the Advisory                                                                        HHS.
                                             Committee on Heritable Disorders in                     National Institutes of Health                         ACTION:   Notice.
                                             Newborns and Children. The IFR
                                                                                                     National Institute of Neurological                    SUMMARY:   In compliance with the
                                             provided that future changes to these
                                                                                                     Disorders and Stroke; Notice of Closed                requirement of the Paperwork
                                             comprehensive guidelines are
                                                                                                     Meeting                                               Reduction Act of 1995 to provide
                                             considered to be issued for purposes of
                                                                                                                                                           opportunity for public comment on
                                             Section 2713 on the date of acceptance
                                                                                                       Pursuant to section 10(d) of the                    proposed data collection projects, the
                                             by the HRSA Administrator or, if
                                                                                                     Federal Advisory Committee Act, as                    National Institute of Nursing Research
                                             applicable, adoption by the Secretary.
                                                                                                     amended, notice is hereby given of a                  (NINR) will publish periodic summaries
                                                On December 21, 2017, the HRSA                                                                             of propose projects to be submitted to
                                             Administrator accepted the proposed                     meeting of the Board of Scientific
                                                                                                     Counselors, National Institute of                     the Office of Management and Budget
                                             2017 updates to the Bright Futures                                                                            (OMB) for review and approval.
                                             Periodicity Schedule. Therefore, all                    Neurological Disorders and Stroke.
                                                                                                                                                           DATES: Comments regarding this
                                             non-grandfathered group health plans                      The meeting will be closed to the
                                                                                                     public as indicated below in accordance               information collection are best assured
                                             and health insurance issuers offering
                                                                                                     with the provisions set forth in sections             of having their full effect if received
                                             group or individual health insurance
                                                                                                     552b(c)(6), Title 5 U.S.C., as amended                within 60 days of the date of this
                                             coverage must cover the services and
                                                                                                     for the review, discussion, and                       publication.
                                             screenings listed on the updated Bright
                                             Futures Periodicity Schedule for plan                   evaluation of individual intramural                   FOR FURTHER INFORMATION CONTACT: To
                                             years (in the individual market, policy                 programs and projects conducted by the                obtain a copy of the data collection
                                             years) beginning on or after December                   National Institute of Neurological                    plans and instruments, submit
                                             21, 2018.                                               Disorders and Stroke, including                       comments in writing, or request more
                                                The updated 2017 Bright Futures                      consideration of personnel                            information on the proposed project,
                                             Periodicity schedule can be accessed at                 qualifications and performance, and the               contact: Diana Finegold, Division of
                                             the following link: https://                            competence of individual investigators,               Science Policy and Public Liaison,
                                             mchb.hrsa.gov/maternal-child-health-                    the disclosure of which would                         NINR, NIH, 31 Center Drive, Building
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                                             topics/child-health/bright-futures.html.                constitute a clearly unwarranted                      31, Suite B1B55, Bethesda, MD 20892,
                                                                                                     invasion of personal privacy.                         by phone at (301) 496–0209 or email
                                              Dated: February 27, 2018.                                                                                    your request, including your address to:
                                             George Sigounas,                                          Name of Committee: Board of Scientific
                                                                                                     Counselors, National Institute of                     diana.finegold@nih.gov. Formal
                                             Administrator.                                                                                                requests for additional plans and
                                                                                                     Neurological Disorders and Stroke.
                                             [FR Doc. 2018–04834 Filed 3–9–18; 8:45 am]                Date: April 15–17, 2018.                            instruments must be requested in
                                             BILLING CODE 4165–15–P                                    Time: 6:00 p.m. to 12:00 p.m.                       writing.


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Document Created: 2018-11-01 08:51:40
Document Modified: 2018-11-01 08:51:40
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.
ContactBethany D. Miller, LCSW-C, M.Ed., HRSA/Maternal and Child Health Bureau by calling (301) 495-5156 or emailing [email protected]
FR Citation83 FR 10733 

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