26464 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–18–18AFX; Docket No. CDC–2018– 

0052] 

Proposed Data Collection Submitted 

for Public Comment and 

Recommendations 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), as part of 

its continuing effort to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other Federal 

agencies the opportunity to comment on 

a proposed and/or continuing 

information collection, as required by 

the Paperwork Reduction Act of 1995. 

This notice invites comment on a 

proposed information collection project 

titled Traumatic Brain Injury Disparities 

in Rural Areas (TBIDRA). This study 

will conduct a formative research to 

understand the challenges that rural 

healthcare providers face when 

diagnosing, treating, and managing 

traumatic brain injury (TBI) and develop 

a knowledge base to address gaps in 

services to improve clinical care and 

TBI outcomes in rural communities. 

DATES: CDC must receive written 

comments on or before August 6, 2018. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2018– 

0052 by any of the following methods: 

• Federal eRulemaking Portal: 

Regulations.gov. Follow the instructions 

for submitting comments. 

• Mail: Jeffrey M. Zirger, Information 

Collection Review Office, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE, MS–D74, Atlanta, 

Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. CDC will post, without 

change, all relevant comments to 

Regulations.gov. 

Please note: Submit all comments 

through the Federal eRulemaking portal 

(regulations.gov) or by U.S. mail to the 

address listed above. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the information collection plan and 

instruments, contact Jeffery M. Zirger, 

Information Collection Review Office, 

Centers for Disease Control and 

Prevention, 1600 Clifton Road NE, MS– 

D74, Atlanta, Georgia 30329; phone: 

404–639–7570; Email: omb@cdc.gov. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), Federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. In addition, the PRA also 

requires Federal agencies to provide a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each new 

proposed collection, each proposed 

extension of existing collection of 

information, and each reinstatement of 

previously approved information 

collection before submitting the 

collection to the OMB for approval. To 

comply with this requirement, we are 

publishing this notice of a proposed 

data collection as described below. 

The OMB is particularly interested in 

comments that will help: 

1. Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

2. Evaluate the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

3. Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

4. Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submissions 

of responses. 

5. Assess information collection costs. 

Proposed Project 

Traumatic Brain Injury Disparities in 

Rural Areas (TBIDRA)—New—National 

Center for Injury Prevention and Control 

(NCIPC), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

Traumatic Brain Injury (TBI) is a 

significant public health concern in the 

United States, research indicates that 

residents of rural areas have both higher 

incidence and higher mortality rates 

from TBI than do residents of urban 

areas, and that the prevalence of TBIrelated disability in rural geographical 

areas is higher than in urban and 

suburban areas. The obstacles 

healthcare providers and patients face 

in rural areas are vastly different than 

those in urban areas. There is little 

published research specifically related 

to the challenges rural providers face in 

TBI diagnosis and treatment, and even 

less examination into effective ways to 

address gaps in service and improve TBI 

outcomes. The National Center for 

Injury Prevention and Control at the 

CDC, in a 2015 ‘‘Report to Congress on 

TBI in the United States,’’ determined 

that certain population groups, 

including residents of rural geographic 

areas, require special consideration 

when it comes to researching TBI. 

This is a new Information Collection 

Request for 2 years to collect 

information on challenges that rural 

healthcare providers face in diagnosing, 

treating, and managing TBI of all 

severities and develop a knowledge base 

upon which we can begin to address 

gaps in services to improve clinical care 

and TBI outcomes in rural communities. 

The target population for the data 

collection effort includes physicians, 

nurse practitioners (NPs), and physician 

assistants (PAs) in selected specialties 

(general or family practice, emergency 

medicine, pediatrics) working in direct 

patient care in rural and urban areas. 

The focus of the study is rural 

healthcare providers; urban healthcare 

providers will be included in this study 

to allow for comparison in identifying 

the distinct challenges and 

opportunities for rural healthcare 

providers. This study has two data 

collection methods. A web survey to 

gather quantitative data on the unique 

challenges faced by rural clinicians, and 

focus groups to gain deeper insight into 

the context supporting and/or inhibiting 

access to comprehensive TBI evaluation 

and treatment, the study will collect 

qualitative data through focus groups 

with rural clinicians. 

The proposed information collection 

is authorized by the Public Health 

Services Act (PHS Act) which provides 

the legislative means for states to 

advance public health across the 

lifespan and to reduce health 

disparities. 

The total estimated annualized 

burden hours is 200. There are no costs 

to respondents other than their time. 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 26465 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Health care providers (Primary Care 

Physician, Emergency Physician, 

Nurse Practitioner and Physician 

Assistant).

TBI Provider Survey ......................... 600 1 15/60 150 

Focus group screener ...................... 36 1 5/60 3 

Focus group questionnaire .............. 31 1 5/60 3 

Focus group discussion guide ......... 31 1 85/60 44 

Total ........................................... ........................................................... ........................ ........................ ........................ 200 

Jeffrey M. Zirger, 

Acting Chief, Information Collection Review 

Office, Office of Scientific Integrity, Office 

of the Associate Director for Science, Office 

of the Director, Centers for Disease Control 

and Prevention. 

[FR Doc. 2018–12251 Filed 6–6–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–N–0451] 

Food and Drug Administration 

Modernization Act of 1997: 

Modifications to the List of Recognized 

Standards, Recognition List Number: 

049 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing a publication containing 

modifications the Agency is making to 

the list of standards FDA recognizes for 

use in premarket reviews (FDA 

Recognized Consensus Standards). This 

publication, entitled ‘‘Modifications to 

the List of Recognized Standards, 

Recognition List Number: 049’’ 

(Recognition List Number: 049), will 

assist manufacturers who elect to 

declare conformity with consensus 

standards to meet certain requirements 

for medical devices. 

DATES: These modifications to the list of 

recognized standards are applicable 

June 7, 2018. 

ADDRESSES: You may submit comments 

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– 

2004–N–0451 for ‘‘Food and Drug 

Administration Modernization Act of 

1997: Modifications to the List of 

Recognized Standards, Recognition List 

Number: 049.’’ 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. FDA will consider any 

comments received in determining 

whether to amend the current listing of 

modifications to the list of recognized 

standards, Recognition List Number: 

049. 

• 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 


sradovich on DSK3GMQ082PROD with NOTICES