Bright Futures Periodicity Schedule Updates, 10733-10734 [2018-04834]
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Federal Register / Vol. 83, No. 48 / Monday, March 12, 2018 / Notices
do not wish to be made available to the
public, submit the comment as a
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manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
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Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
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• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–0626 for ‘‘Proprietary Names
for New Animal Drugs.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
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• Confidential Submissions—To
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with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
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both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
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information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
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Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT: Tom
Modric, Center for Veterinary Medicine
(HFV–216), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5853,
tomislav.modric@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry #240
entitled ‘‘Proprietary Names for New
Animal Drugs.’’ CVM evaluates
proprietary names as a part of the new
animal drug approval process. Selecting
a proprietary name is a critical element
in the design and development of drug
product labeling because end users may
rely, in part, on the proprietary name to
identify which product, among
thousands of available products, is
intended for a given animal.
II. Significance of Guidance
This level 1 draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the current
thinking of FDA on ‘‘Proprietary Names
for New Animal Drugs.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
is not a significant regulatory action
subject to Executive Order 12866.
III. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
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10733
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 514 have
been approved under OMB control
numbers 0910–0032 and 0910–0699; 21
CFR part 511 have been approved under
OMB control number 0910–0117.
IV. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: March 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–04885 Filed 3–9–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Service
Administration
Bright Futures Periodicity Schedule
Updates
Health Resources and Service
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
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/childhealth/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 evidencedriven guidance for all preventive care
screenings and well-child visits. One
component of these tools is the Bright
Futures Periodicity Schedule, a chart
SUMMARY:
E:\FR\FM\12MRN1.SGM
12MRN1
amozie on DSK30RV082PROD with NOTICES
10734
Federal Register / Vol. 83, No. 48 / Monday, March 12, 2018 / Notices
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 nongrandfathered 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 ‘‘evidenceinformed 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-healthtopics/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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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Amended Notice of
Meeting
Notice is hereby given of a change in
the meeting of the National Institute of
Child Health and Human Development
Special Emphasis Panel, March 2, 2018,
8:30 a.m. to March 2, 2018, 5:00 p.m.,
Hilton Washington/Rockville, 1750
Rockville Pike, Rockville, MD, 20852
which was published in the Federal
Register on February 6, 2018, 83 FR
5265.
The meeting date has changed from
March 2, 2018 from 8:30 a.m. to 5:00
p.m. to March 13, 2018 from 10:30 a.m.
to 3:30 p.m. The meeting is closed to the
public.
Dated: March 6, 2018.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Alan P. Koretsky, Ph.D.,
Scientific Director, Division of Intramural
Research, National Institute of Neurological
Disorders and Stroke, NIH, 35 Convent Drive,
Room 6A 908, Bethesda, MD 20892, (301)
435–2232, koretskya@ninds.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS).
Dated: March 6, 2018.
Sylvia l. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–04951 Filed 3–9–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
BILLING CODE 4140–01–P
Proposed Collection; 60-Day Comment
Request; Generic Clearance for the
Collection of Qualitative Feedback on
Agency Service Delivery (National
Institute of Nursing Research)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
National Institutes of Health
ACTION:
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meeting
SUMMARY:
[FR Doc. 2018–04949 Filed 3–9–18; 8:45 am]
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Board of Scientific
Counselors, National Institute of
Neurological Disorders and Stroke.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in sections
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Institute of Neurological
Disorders and Stroke, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, National Institute of
Neurological Disorders and Stroke.
Date: April 15–17, 2018.
Time: 6:00 p.m. to 12:00 p.m.
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National Institutes of Health,
HHS.
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
National Institute of Nursing Research
(NINR) will publish periodic summaries
of propose projects to be submitted to
the Office of Management and Budget
(OMB) for review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Diana Finegold, Division of
Science Policy and Public Liaison,
NINR, NIH, 31 Center Drive, Building
31, Suite B1B55, Bethesda, MD 20892,
by phone at (301) 496–0209 or email
your request, including your address to:
diana.finegold@nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
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[Federal Register Volume 83, Number 48 (Monday, March 12, 2018)]
[Notices]
[Pages 10733-10734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04834]
-----------------------------------------------------------------------
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 [email protected].
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]
BILLING CODE 4165-15-P
