Bright Futures Periodicity Schedule Updates, 10733-10734 [2018-04834]

Download as PDF 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 written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). amozie on DSK30RV082PROD with NOTICES 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 Lane, Rm. 1061, Rockville, MD 20852. • 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 between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential 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 for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this 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. VerDate Sep<11>2014 18:12 Mar 09, 2018 Jkt 244001 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 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 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 http://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] BILLING CODE 4164–01–P 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] BILLING CODE 4165–15–P VerDate Sep<11>2014 18:12 Mar 09, 2018 Jkt 244001 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] BILLING CODE 4140–01–P 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. PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 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. E:\FR\FM\12MRN1.SGM 12MRN1

Agencies

[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]


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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 [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