45246 Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 

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. 2018–19296 Filed 9–5–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

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

0081] 

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 efforts to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other Federal 

agencies to take this 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 ‘‘Assessment of 

Outcomes Associated with the 

Preventive Health and Health Services 

Block Grant’’. This assessment will 

assess select cross-cutting outputs and 

outcomes of the Preventive Health and 

Health Services Block Grant and 

demonstrates the utility of the grant on 

a national level. 

DATES: CDC must receive written 

comments on or before November 5, 

2018. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2018– 

0081 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 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 

Assessment of Outcomes Associated 

with the Preventive Health and Health 

Services Block Grant—New—Office for 

State, Tribal, Local and Territorial 

Support (OSTLTS), Centers for Disease 

Control and Prevention (CDC). 

Background and Brief Description 

For more than 35 years, the 

Preventive Health and Health Services 

Block Grant (PHHS Block Grant) has 

provided flexible funding for all 50 

states, the District of Columbia, two 

American Indian tribes, five U.S. 

territories, and three freely associated 

states to address the unique public 

health needs of their jurisdictions in 

innovative and locally defined ways. 

First authorized by Congress in 1981 

through the Public Health Service Act 

(Pub. L. 102–531), the fundamental and 

enduring purpose of the grant has been 

to provide grantees with flexibility and 

control to address their priority public 

health needs. In 1992, Congress 

amended the law to align PHHS Block 

Grant funding priorities with the 22 

chapters specified in Healthy People 

(HP) 2000, a set of national objectives 

designed to guide health promotion and 

disease prevention efforts. Additional 

amendments included set-aside funds 

specifically dedicated to sex offense 

prevention and victim services, thus 

requiring grantees receiving this support 

to include related HP objectives and 

activities as part of their PHHS Block 

Grant-funded local programs. 

CDC is establishing a comprehensive, 

standardized method to collect data to 

describe select outputs and outcomes 

and ensure the accountability of the 

PHHS Block Grant. The CDC PHHS 

Block Grant Measurement Framework is 

an innovative approach to assessing 

cross-cutting outputs and outcomes 

resulting from grantees’ use of flexible 

grant funds. The framework defines four 

measures that enable CDC to 

standardize the collection of data on 

grantee achievements. The measures 

capture data on public health 

infrastructure improved (i.e., 

information systems improved and 

quality improved—efficiency and 

effectiveness improvements achieved in 

programs, services, and operations), 

emerging public health needs 

addressed, and evidence-based public 

health interventions implemented. 

The purpose of this information 

collection request (ICR) is to collect data 

that assess select cross-cutting outputs 

and outcomes of the grant (as defined by 

the framework measures) and that 

demonstrate the utility of the grant on 

a national level. This data collection 

will describe the outcomes of the PHHS 

Block Grant as a whole—not individual 

grantee activities or outcomes. Findings 

from this data collection will be used to: 

(1) Describe the outcomes and 

achievements of grantees’ public health 

efforts and identify how the use of 

PHHS Block Grant funds contributed to 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 45247 

those results, and (2) help assess how 

the PHHS Block Grant advances work of 

the public health system and provides 

evidence to support future budgetary 

requests. 

The respondent universe consists of 

61 PHHS Block Grant coordinators, or 

their designees, across 61 health 

departments (50 states, the District of 

Columbia, two tribes, five US territories, 

and three freely associated states). The 

assessment will be administered to 

PHHS Block Grant coordinators 

electronically via a web-based 

questionnaire. A link to the assessment 

will be provided by email invitation. 

The survey will be completed once 

every two years. The total annualized 

estimated burden is 46 hours. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden 

(in hours) 

PHHS Block Grant Coordinators, or 

Designees.

PHHS Block Grant Assessment ...... 61 1 45/60 46 

Total ........................................... ........................................................... ........................ ........................ ........................ 46 

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. 2018–19294 Filed 9–5–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–3130] 

Consideration of Uncertainty in Making 

Benefit-Risk Determinations in Medical 

Device Premarket Approvals, De Novo 

Classifications, and Humanitarian 

Device Exemptions; Draft Guidance for 

Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the draft 

guidance entitled ‘‘Consideration of 

Uncertainty in Making Benefit-Risk 

Determinations in Medical Device 

Premarket Approvals, De Novo 

Classifications, and Humanitarian 

Device Exemptions.’’ This guidance 

document describes FDA’s current 

approach to considering uncertainty in 

making benefit-risk determinations to 

support certain FDA premarket 

decisions for medical devices— 

premarket approval applications 

(PMAs), De Novo requests, and 

humanitarian device exemption (HDE) 

applications. This guidance document 

elaborates on the consideration of 

uncertainty as part of our overarching 

approach to a benefit-risk based 

framework that is intended to assure 

greater predictability, consistency, and 

efficiency through the application of 

least burdensome principles. This draft 

guidance also provides examples of how 

the principles for considering 

uncertainty could be applied in the 

context of clinical evidence and 

circumstances where greater uncertainty 

could be appropriate in premarket 

decisions, balanced by postmarket 

controls—PMAs for Breakthrough 

Devices and PMAs for devices for small 

patient populations. This draft guidance 

is not final nor is it in effect at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 5, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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–D–3130 for ‘‘Consideration of 

Uncertainty in Making Benefit-Risk 

Determinations in Medical Device 

Premarket Approvals, De Novo 

Classifications, and Humanitarian 

Device Exemptions; Draft Guidance for 

Industry and Food and Drug 

Administration Staff.’’ 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 


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