Systematic Review and Final CDC Guideline on the Diagnosis and Management of Mild Traumatic Brain Injury Among Children, 45629-45630 [2018-19536]

Download as PDF Federal Register / Vol. 83, No. 175 / Monday, September 10, 2018 / Notices Registered speakers/organizations will be allowed five (5) minutes, and will need to provide written copies of their presentations. Requests to comment, together with presentations for the meeting, must be received by 5:00 p.m. EDT, on Friday, September 28, 2018. Please contact Mr. Dayton at the email address above to obtain meeting materials. FOR FURTHER INFORMATION CONTACT: Daniel S. Dayton, Designated Federal Officer, World War 1 Centennial Commission, 701 Pennsylvania Avenue NW, 123, Washington, DC 20004–2608, 202–380–0725 (Note: this is not a tollfree number). SUPPLEMENTARY INFORMATION: Background The World War One Centennial Commission was established by Public Law 112–272 (as amended), as a commission to ensure a suitable observance of the centennial of World War I, to provide for the designation of memorials to the service of members of the United States Armed Forces in World War I, and for other purposes. Under this authority, the Committee will plan, develop, and execute programs, projects, and activities to commemorate the centennial of World War I, encourage private organizations and State and local governments to organize and participate in activities commemorating the centennial of World War I, facilitate and coordinate activities throughout the United States relating to the centennial of World War I, serve as a clearinghouse for the collection and dissemination of information about events and plans for the centennial of World War I, and develop recommendations for Congress and the President for commemorating the centennial of World War I. Notice of this meeting is being provided according to the requirements of the Federal Advisory Committee Act, 5 U.S.C. App. 10(a)(2). daltland on DSKBBV9HB2PROD with NOTICES Agenda Tuesday October 2, 2018 Old Business: • Acceptance of minutes of last meeting • Public Comment Period New Business: • Executive Director’s Report— Executive Director Dayton • 2019 Signature Event Proposals— Executive Director Dan Dayton • Financial Committee Report— Commissioner Dunning • Education Committee Report— Commissioner O’Connell • ACE Committee Report— VerDate Sep<11>2014 17:54 Sep 07, 2018 Jkt 244001 Commissioner Monahan • Memorial Report—Vice Chair Fountain • Fundraising Report—Commissioner Sedgwick • International Report— Commissioner Seefried Other Business: • Chairman’s Report Upcoming Meeting Dates • January 22, 2019, via phone • April 21–22, 2019, Washington, DC • July 2019, Kansas City, MO Motion to Adjourn Dated: September 4, 2018. Daniel S. Dayton, Designated Federal Official, World War I Centennial Commission. [FR Doc. 2018–19491 Filed 9–7–18; 8:45 am] BILLING CODE 6820–95–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC–2017–0089] Systematic Review and Final CDC Guideline on the Diagnosis and Management of Mild Traumatic Brain Injury Among Children Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice; availability of final guidance. AGENCY: The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the availability of the Systematic Review and Final CDC Guideline on the Diagnosis and Management of Mild Traumatic Brain Injury Among Children. SUMMARY: CDC published the final Systematic Review and Final CDC Guideline on the Diagnosis and Management of Mild Traumatic Brain Injury Among Children on September 4, 2018 in JAMA Pediatrics. FOR FURTHER INFORMATION CONTACT: Arlene I. Greenspan, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, Mailstop F–63, Atlanta, Georgia 30341. Telephone: (770) 488–4694; email: duipinquiries@cdc.gov. SUPPLEMENTARY INFORMATION: On September 29, 2017, CDC published a notice in the Federal Register DATES: PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 45629 announcing the opening of a docket to obtain public comment on a Systematic Review of the evidence on the diagnosis, prognosis, and management of pediatric mild traumatic brain injury (mTBI), and an evidence-based Guideline that offers clinical recommendations for healthcare providers (82 FR 45588). CDC also provided an opportunity for public comments during the National Center for Injury Prevention and Control’s Board of Scientific Counselors meeting on September 7, 2016 (81 FR 49657). The Systematic Review and Guideline were developed through a rigorous process guided by the American Academy of Neurology methodology and 2010 National Academy of Sciences methodology for the development of evidence-based guidelines. An extensive review of the scientific literature, spanning 25 years of research, formed the basis of the Guideline. The goal of the CDC Guideline is to help healthcare providers take action to improve the health of their pediatric patients with mTBI. The Guideline consists of 19 clinical recommendation sets that cover diagnosis, prognosis, and management and treatment. These recommendations are applicable to healthcare providers working in inpatient, emergency, primary, and outpatient care settings. CDC received comments on the draft Systematic Review and Guideline from two external peer reviewers: b Both provided references for literature that was published following the close of the literature review period for the Guideline and Systematic Review. Both reviewers requested details about definitions of terms such as mTBI and concussion and how they are similar or different. b Other comments focused on how an existing consensus statement on sports-related concussion aligns with CDC recommendations; lack of information available on children who never seek medical attention to highlight this current information gap; and specificity of the recommendations for clinicians in the acute care and outpatient settings. CDC also received 10 public comments from professional organizations, academia, and the public: b Five were from medical and clinical professional organizations. These groups shared their perspective on diagnosis and treatment of mTBI and how specialty groups are affected differently. b Two were from community members and parents sharing their support of the work. E:\FR\FM\10SEN1.SGM 10SEN1 45630 Federal Register / Vol. 83, No. 175 / Monday, September 10, 2018 / Notices b One was from a commenter who did not provide an affiliation. The commenter shared concerns regarding how the level of evidence was graded. b One was from a healthcare provider who shared citations for consideration. b One was from an advocacy group that provided a comment outside the scope of the docket. A summary of the revisions made to the final Systematic Review and Guideline based on external peer reviewer comments are posted in the Supporting Documents section of the docket (document titled ‘‘Ped mTBI Guideline Response to Peer Reviewer Comments’’). CDC also revised the document based on public comments. For example, a few commenters expressed concern regarding recommendations not being applicable in the emergency care setting. As the clinical recommendations in the guideline were created for both the acute care and primary care setting, CDC added language to emphasize that the recommendations were drafted to be relevant for both settings. As another example, multiple comments were received regarding the content in the systematic review on the use of CT imaging. Commenters explained that current evidence that provides the basis for CT imaging focus on ruling out clinically-important traumatic brain injury among pediatric patients presenting with a TBI. In response, CDC revised the conclusion to specify that the recommendations are for children presenting with mTBI versus TBI of all severity levels in the acute care setting. All public and peer reviewer comments were carefully reviewed and considered to strengthen and improve the quality of the Systematic Review and Guideline. The final Systematic Review and Guideline on the Diagnosis and Management of Mild Traumatic Brain Injury Among Children can be found at https://jamanetwork.com/journals/ jamapediatrics/fullarticle/2698456? guestAccessKey=80a9ecdc-ea57-447da1b3-b4a87cadd40d (Guideline) and https://jamanetwork.com/journals/ jamapediatrics/fullarticle/2698455? guestAccessKey=24b78e3d-571f-49fb9daf-499d2b3e2cc1 (Systematic Review). Dated: September 5, 2018. Lauren Hoffmann, Acting Executive Secretary, Centers for Disease Control and Prevention. [FR Doc. 2018–19536 Filed 9–7–18; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Title: Tribal Maternal, Infant, and Early Childhood Home Visiting Program Quarterly Performance Reporting Form. OMB No.: New Collection. Description: The Administration for Children and Families (ACF), Office of Child Care, in collaboration with the Health Resources and Services Administration (HRSA), Maternal and Child Health Bureau, administers the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program, as authorized by Title V, Section 511 of the Social Security Act. The Administration for Children and Families administers the Tribal MIECHV Program while HRSA administers the State/Territory MIECHV Program. Tribal MIECHV discretionary grants support cooperative agreements to conduct community needs assessments; plan for and implement high-quality, culturallyrelevant, evidence-based home visiting programs in at-risk tribal communities; establish, measure, and report on progress toward meeting performance measures in six legislatively-mandated benchmark areas; and conduct rigorous evaluation activities to build the knowledge base on home visiting among Native populations. The proposed data collection form is as follows: In order to continuously monitor, provide grant oversight, quality improvement guidance, and technical assistance to Tribal MIECHV grantees, ACF is seeking to collect services utilization data on a quarterly basis. The Tribal MIECHV Quarterly Data Performance Reporting Form, is made up of five categories of data—program capacity, place-based services, family engagement, staff recruitment and retention and staff vacancies. This form will be used by Tribal MIECHV grantees that receive grants under the Tribal MIECHV Program to collect data in order to determine the caseload capacity grantees are achieving, where services are being delivered, the retention and attrition of enrolled families, and the retention and attrition of program staff on a quarterly basis. Respondents: Tribal Maternal, Infant, and Early Childhood Home Visiting Program Managers. The information collection does not include direct interaction with individuals or families that receive the services. daltland on DSKBBV9HB2PROD with NOTICES ANNUAL BURDEN ESTIMATES Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden hours Type of respondent Form name Tribal MIECHV Grantees .................. Tribal MIECHV Quarterly Reporting Form. 25 4 24 2,400 Total ........................................... ........................................................... ........................ ........................ ........................ 2,400 Estimated Total Annual Burden Hours: 2,400. In compliance with the requirements of the Paperwork Reduction Act of 1995 (Pub. L. 104–13, 44 U.S.C. Chap 35), the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of VerDate Sep<11>2014 17:54 Sep 07, 2018 Jkt 244001 information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW, Washington DC 20201. Attn: ACF Reports Clearance Officer. Email address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the E:\FR\FM\10SEN1.SGM 10SEN1

Agencies

[Federal Register Volume 83, Number 175 (Monday, September 10, 2018)]
[Notices]
[Pages 45629-45630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19536]


=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2017-0089]


Systematic Review and Final CDC Guideline on the Diagnosis and 
Management of Mild Traumatic Brain Injury Among Children

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice; availability of final guidance.

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

SUMMARY: The Centers for Disease Control and Prevention (CDC), located 
within the Department of Health and Human Services (HHS), announces the 
availability of the Systematic Review and Final CDC Guideline on the 
Diagnosis and Management of Mild Traumatic Brain Injury Among Children.

DATES: CDC published the final Systematic Review and Final CDC 
Guideline on the Diagnosis and Management of Mild Traumatic Brain 
Injury Among Children on September 4, 2018 in JAMA Pediatrics.

FOR FURTHER INFORMATION CONTACT: Arlene I. Greenspan, National Center 
for Injury Prevention and Control, Centers for Disease Control and 
Prevention, 4770 Buford Highway NE, Mailstop F-63, Atlanta, Georgia 
30341. Telephone: (770) 488-4694; email: [email protected].

SUPPLEMENTARY INFORMATION: On September 29, 2017, CDC published a 
notice in the Federal Register announcing the opening of a docket to 
obtain public comment on a Systematic Review of the evidence on the 
diagnosis, prognosis, and management of pediatric mild traumatic brain 
injury (mTBI), and an evidence-based Guideline that offers clinical 
recommendations for healthcare providers (82 FR 45588). CDC also 
provided an opportunity for public comments during the National Center 
for Injury Prevention and Control's Board of Scientific Counselors 
meeting on September 7, 2016 (81 FR 49657).
    The Systematic Review and Guideline were developed through a 
rigorous process guided by the American Academy of Neurology 
methodology and 2010 National Academy of Sciences methodology for the 
development of evidence-based guidelines. An extensive review of the 
scientific literature, spanning 25 years of research, formed the basis 
of the Guideline.
    The goal of the CDC Guideline is to help healthcare providers take 
action to improve the health of their pediatric patients with mTBI. The 
Guideline consists of 19 clinical recommendation sets that cover 
diagnosis, prognosis, and management and treatment. These 
recommendations are applicable to healthcare providers working in 
inpatient, emergency, primary, and outpatient care settings. CDC 
received comments on the draft Systematic Review and Guideline from two 
external peer reviewers:
    [ballot] Both provided references for literature that was published 
following the close of the literature review period for the Guideline 
and Systematic Review. Both reviewers requested details about 
definitions of terms such as mTBI and concussion and how they are 
similar or different.
    [ballot] Other comments focused on how an existing consensus 
statement on sports-related concussion aligns with CDC recommendations; 
lack of information available on children who never seek medical 
attention to highlight this current information gap; and specificity of 
the recommendations for clinicians in the acute care and outpatient 
settings.
    CDC also received 10 public comments from professional 
organizations, academia, and the public:
    [ballot] Five were from medical and clinical professional 
organizations. These groups shared their perspective on diagnosis and 
treatment of mTBI and how specialty groups are affected differently.
    [ballot] Two were from community members and parents sharing their 
support of the work.

[[Page 45630]]

    [ballot] One was from a commenter who did not provide an 
affiliation. The commenter shared concerns regarding how the level of 
evidence was graded.
    [ballot] One was from a healthcare provider who shared citations 
for consideration.
    [ballot] One was from an advocacy group that provided a comment 
outside the scope of the docket.
    A summary of the revisions made to the final Systematic Review and 
Guideline based on external peer reviewer comments are posted in the 
Supporting Documents section of the docket (document titled ``Ped mTBI 
Guideline Response to Peer Reviewer Comments'').
    CDC also revised the document based on public comments. For 
example, a few commenters expressed concern regarding recommendations 
not being applicable in the emergency care setting. As the clinical 
recommendations in the guideline were created for both the acute care 
and primary care setting, CDC added language to emphasize that the 
recommendations were drafted to be relevant for both settings. As 
another example, multiple comments were received regarding the content 
in the systematic review on the use of CT imaging. Commenters explained 
that current evidence that provides the basis for CT imaging focus on 
ruling out clinically-important traumatic brain injury among pediatric 
patients presenting with a TBI. In response, CDC revised the conclusion 
to specify that the recommendations are for children presenting with 
mTBI versus TBI of all severity levels in the acute care setting. All 
public and peer reviewer comments were carefully reviewed and 
considered to strengthen and improve the quality of the Systematic 
Review and Guideline. The final Systematic Review and Guideline on the 
Diagnosis and Management of Mild Traumatic Brain Injury Among Children 
can be found at https://jamanetwork.com/journals/jamapediatrics/fullarticle/2698456?guestAccessKey=80a9ecdc-ea57-447d-a1b3-b4a87cadd40d 
(Guideline) and https://jamanetwork.com/journals/jamapediatrics/fullarticle/2698455?guestAccessKey=24b78e3d-571f-49fb-9daf-499d2b3e2cc1 
(Systematic Review).

    Dated: September 5, 2018.
Lauren Hoffmann,
Acting Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2018-19536 Filed 9-7-18; 8:45 am]
 BILLING CODE 4163-18-P


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