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. 

ANNUAL BURDEN ESTIMATES

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden hours 

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 

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. 

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 


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Federal Register / Vol. 83, No. 175 / Monday, September 10, 2018 / Notices 45631 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert A. Sargis, 

Reports Clearance Officer. 

[FR Doc. 2018–19561 Filed 9–7–18; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3065] 

Memorandum of Understanding 

Addressing Certain Distributions of 

Compounded Drug Products Between 

the States and the Food and Drug 

Administration; Revised Draft; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; 

withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the availability for public 

comment of a revised draft standard 

memorandum of understanding (MOU) 

entitled ‘‘Memorandum of 

Understanding Addressing Certain 

Distributions of Compounded Drug 

Products Between the State of [insert 

State] and the U.S. Food and Drug 

Administration’’ (revised draft standard 

MOU). The revised draft standard MOU 

describes the responsibilities of a State 

that chooses to sign the MOU in 

investigating and responding to 

complaints related to compounded drug 

products compounded in the State and 

distributed outside the State and in 

addressing the interstate distribution of 

inordinate amounts of compounded 

drug products. 

FDA is also announcing the 

withdrawal of an earlier draft standard 

MOU entitled ‘‘Memorandum of 

Understanding Addressing Certain 

Distributions of Compounded Human 

Drug Products Between the State of 

[insert State] and the U.S. Food and 

Drug Administration,’’ which was 

issued in February 2015 (2015 draft 

standard MOU). The 2015 draft standard 

MOU is superseded by the revised draft 

standard MOU. 

DATES: FDA is withdrawing its draft 

standard MOU that published on 

February 19, 2015 (80 FR 8874), as of 

September 10, 2018. Submit either 

electronic or written comments on the 

revised draft standard MOU by 

December 10, 2018, to ensure that the 

Agency considers your comment on this 

draft MOU before it begins work on the 

final version of the MOU. Submit either 

electronic or written comments on 

information collection issues under the 

Paperwork Reduction Act of 1995 by 

December 10, 2018 (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of this 

document). 

ADDRESSES: You may submit comments 

on the MOU at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

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’’). 

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–N–3065 for ‘‘Memorandum of 

Understanding Addressing Certain 

Distributions of Compounded Drug 

Products Between the States and the 

Food and Drug Administration; Revised 

Draft; Availability.’’ 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/2015- 

23389.pdf. 

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. 

Submit written requests for single 

copies of the draft MOU to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft document. 


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