[Federal Register Volume 84, Number 231 (Monday, December 2, 2019)]
[Notices]
[Pages 65991-65992]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26017]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Request for Information on ``Update on Selected Topics in Asthma 
Management 2020: A Report From the National Asthma Education and 
Prevention Program Coordinating Committee (NAEPPCC) Expert Panel Report 
4 (EPR-4) Working Group''

AGENCY: National Institutes of Health, HHS.

ACTION: Request for Information.

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

SUMMARY: 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.

DATES: 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.

ADDRESSES: Submissions may be submitted electronically to [https://www.epr4workgroup.org/Asthma2020Guidelines] or by mail to 
[[email protected]].

FOR FURTHER INFORMATION CONTACT: 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, [email protected], 301-496-1051.

SUPPLEMENTARY INFORMATION:

The NHLBI NAEPPCC

    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:
     Identify all Federal programs that carry out asthma-
related activities.
     Develop, in consultation with appropriate federal agencies 
and professional and voluntary health organizations, a Federal plan for 
responding to asthma.

[[Page 65992]]

    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 Asthma Guidelines

    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.

NAEPPCC Expert Panel Report 4 (EPR-4) Working Group

    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.
     Role of Immunotherapy in the Treatment of Asthma
     Intermittent Inhaled Corticosteroids and Long-Acting 
Muscarinic Antagonist for Asthma
     Effectiveness of Indoor Allergen Reduction in Management 
of Asthma
     Effectiveness and Safety of Bronchial Thermoplasty in 
Management of Asthma
     The Clinical Utility of Fractional Exhaled Nitric Oxide 
(FeNO) in Asthma Management
    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]
BILLING CODE 4140-01-P