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National Institutes of Health, HHS.
Request for Information.
The Expert Panel Working Group of the NHLBI National Asthma Education and Prevention Program Coordinating Committee (NAEPPCC) is soliciting comments and suggestions from the public on “Update on Selected Topics in Asthma Management 2020: A Report from the Expert Panel Report-4 (EPR-4) Working Group.” This Request for Information (RFI) invites the scientific community, health professionals, organizations, patient communities, and the general public to provide comments and suggestions, including particular emphasis on the feasibility, acceptability, and capacity for implementation, of the proposed recommendations and implementation guidance. Responses to this RFI will be used to update and revise the report as necessary.
The NHLBI NAEPPCC RFI is open for public comment for a period of 35 days. Comments must be received by January 6, 2020 to ensure consideration. After the public comment period has closed, the comments received will be considered in a timely manner by the NHLBI NAEPPCC Expert Panel Working Group.
Submissions may be submitted electronically to [ https://www.epr4workgroup.org/Asthma2020Guidelines] or by mail to [ Asthma2020Guidelines@westat.com].
Questions about this request for information should be directed to Susan T. Shero, RN, MS, Executive Secretary, NAEPPCC, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Blvd., Rm. 9182, Bethesda, MD 20892, Asthma2020Guidelines@westat.com, 301-496-1051.
In August 2015, the National Asthma Education and Prevention Program Coordinating Committee (NAEPPCC) was chartered as a federal advisory committee in accordance with 424B of the Public Health Service Act, 42 U.S.C. 285b-7b, as amended. The committee is governed by the provisions of the Federal Advisory Committee Act (FACA), as amended (5 U.S.C App.), which sets forth standards for the formation and use of advisory committees. The NAEPPCC fulfills the charges of 424B of the Public Health Service Act, 42 U.S.C. 285b-7b, as amended:
The NAEPPCC also fulfills charges, similar to those above, set forth in the Children's Health Act of 2000 (Pub. L. 106-310). In addition, the Children's Health Act of 2000 tasks the NHLBI, through the NAEPPCC, with submitting recommendations to Congress on ways to strengthen and improve coordination of asthma-related activities of the federal government.
The NAEPPCC consists of representatives from the major scientific, professional, governmental, and voluntary organizations interested in asthma. The Committee's primary mission is to advise the NHLBI on matters concerning asthma and to facilitate the exchange of information on asthma activities among the member agencies and voluntary health organizations.
The NHLBI administers and coordinates the Coordinating Committee. The Coordinating Committee meetings are open to the public and include presentations and discussion on a variety of topics concerning asthma, including activities and projects of the Committee.
NHLBI produced its first asthma clinical practice guidelines in 1991 and an update was issued in 2007, Guidelines for the Diagnosis and Management of Asthma (EPR-3). In 2011, the National Asthma Education and Prevention Program concluded another update was needed and an Advisory Council of the NHLBI determined in 2012 that a needs assessment should be conducted prior to engaging in any guideline activity. In 2014, NHLBI Council convened an Asthma Expert Panel Working Group to conduct a needs assessment. The Working Group recommended that an update should be made to the 2007 clinical practice guidelines; identified five priority topics for immediate systematic review and update (subsequently changed to six priority topics); and recommended that the NHLBI maintain the NAEPP structure, coordinate the systematic reviews, and update the report. After public comments on the draft needs assessment report were received and reviewed, the Working Group recommended adding a sixth priority topic to the report.
The six priority topic areas identified by the Working Group are: (1) Adjustable medication dosing in recurrent wheezing and asthma (“intermittent therapy”), (2) long acting anti-muscarinic agents in asthma management as add-on to inhaled corticosteroids, (3) bronchial thermoplasty in adult severe asthma, (4) fractional exhaled nitric oxide (FeNO) in diagnosis, medication selection, and monitoring treatment response, (5) remediation of indoor allergens (house dust mites/pets), and (6) the role of immunotherapy in the treatment of asthma.
The Working Group also recommended that several emerging topic areas be acknowledged and monitored, but did not yet merit systematic review.
The NAEPPCC Expert Panel Working Group 4 (EPR-4) was established in 2018 to update selected topics in the 2007 Guidelines for the Diagnosis and Management of Asthma, Expert Panel Report 3 (EPR-3). The Expert Panel Working Group members used findings from the following NHLBI-supported systematic reviews to develop updates to the 2007 guidelines.
The Expert Panel Working Group members include asthma content experts, specialists and primary care clinicians, health policy experts, implementation and dissemination experts and individuals with experience using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. A methodologist provided technical support to the Working Group.
This RFI should not be construed as a solicitation for applications or proposals, or as an obligation in any way on the part of the United States Federal government. The Federal government will not pay for the preparation of any information submitted or for the government's use. Additionally, the government cannot guarantee the confidentiality of the information provided.
Dated: October 30, 2019.
James P. Kiley,
Director, Division of Lung Diseases, NHLBI.
[FR Doc. 2019-26017 Filed 11-29-19; 8:45 am]
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