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Device Exemptions; Draft Guidance for 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 


daltland on DSKBBV9HB2PROD with NOTICES
45248 Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 

1See sections 513(a)(3)(C), 515(c)(5)(C), 

515(d)(1)(B)(ii), and 515B(e)(2)(C) of the FD&C Act 

(21 U.S.C. 360c(a)(3)(C), 360e(c)(5)(C), 

360e(d)(1)(B)(ii), and 360e–3(e)(2)(C)); 21 CFR 

814.82). 

2See section 515B of the FD&C Act (21 U.S.C. 

360e–3), as created by section 3051 of the Cures Act 

(Pub. L. 114–255) and amended by section 901 of 

FDARA (Pub. L. 115–52). 

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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Consideration of 

Uncertainty in Making Benefit-Risk 

Determinations in Medical Device 

Premarket Approvals, De Novo 

Classifications, and Humanitarian 

Device Exemptions’’ to the Office of the 

Center Director, Guidance and Policy 

Development, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

Sonja Fulmer, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5451, Silver Spring, 

MD 20993–0002, 240–402–5979. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Medical Device Amendments of 

1976 (Pub. L. 94–295) to the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) established a risk-based framework 

for the regulation of medical devices. 

The law established a three-tiered risk 

classification system based on the risk 

posed to patients should the device fail 

to perform as intended. Under this 

system, devices that pose greater risks to 

patients are subject to more regulatory 

controls and requirements. Generally, in 

premarket decision-making for devices, 

there exists some uncertainty around 

benefits and risks. The Agency generally 

provides marketing authorization for a 

device when it meets the applicable 

standards, including that its benefits 

outweigh its risks. 

In 2015, following pilots conducted 

over 4 years, FDA established the 

Expedited Access Pathway Program as a 

voluntary program for certain medical 

devices that address an unmet need in 

the treatment or diagnosis of lifethreatening or irreversibly debilitating 

diseases or conditions. Under this 

program, an eligible device subject to a 

PMA could be approved with greater 

uncertainty about the product’s benefits 

and risks, provided that, among other 

requirements, the data still support a 

reasonable assurance of safety and 

effectiveness, including that the 

probable benefits of the device outweigh 

its risks for a patient population with 

unmet medical needs. For devices 

subject to PMA, the Agency has the 

authority to impose, when warranted, 

postmarket requirements, including 

post-approval studies and postmarket 

surveillance, as a condition of approval, 

which could be used to address this 

greater uncertainty.1 In the 

Breakthrough Device provisions of the 

FD&C Act, as added by the 21st Century 

Cures Act (Cures Act) and amended by 

the FDA Reauthorization Act of 2017 

(FDARA), Congress codified and 

expanded this program to include 

devices reviewed through a 510(k) 

notification.2

This draft guidance provides further 

information on how FDA considers 

uncertainty in benefit-risk 

determinations for PMAs, De Novo 

requests, and HDE applications. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on consideration of uncertainty in 

making benefit-risk determinations in 

medical device premarket approvals, De 

Novo classifications, and humanitarian 

device exemptions. It does not establish 

any rights for any person and is not 

binding on FDA or the public. You can 

use an alternative approach if it satisfies 

the requirements of the applicable 

statutes and regulations. This guidance 

is not subject to Executive Order 12866. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. This 

guidance document is also available at 

https://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘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’’ may send an 

email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number 17039 to identify the 

guidance you are requesting. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 801 have 

been approved under OMB control 

number 0910–0485; the collections of 

information for De Novo classification 

requests have been approved under 

OMB control number 0910–0844; the 

collections of information in 21 CFR 

part 814, subparts A through E, have 

been approved under OMB control 

number 0910–0231; the collections of 

information in 21 CFR part 814, subpart 

H, have been approved under OMB 

control number 0910–0332; and the 

collections of information in 21 CFR 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 45249 

part 822 have been approved under 

OMB control number 0910–0449. 

Dated: August 30, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19249 Filed 9–5–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3233] 

Request for Nominations for Voting 

Members on a Public Advisory 

Committee; Technical Electronic 

Product Radiation Safety Standards 

Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for members to serve on 

the Technical Electronic Product 

Radiation Safety Standards Committee 

(TEPRSSC) in the Center for Devices 

and Radiological Health. Nominations 

will be accepted for current and 

upcoming vacancies effective with this 

notice. 

FDA seeks to include the views of 

women and men, members of all racial 

and ethnic groups, and individuals with 

and without disabilities on its advisory 

committees and, therefore, encourages 

nominations of appropriately qualified 

candidates from these groups. 

DATES: Nominations received on or 

before November 5, 2018 will be given 

first consideration for membership on 

TEPRSSC. Nominations received after 

November 5, 2018 will be considered for 

nomination to the committee as later 

vacancies occur. 

ADDRESSES: All nominations for 

membership should be sent 

electronically by accessing FDA’s 

Advisory Committee Membership 

Nomination Portal at https://

www.accessdata.fda.gov/scripts/ 

FACTRSPortal/FACTRS/index.cfm or by 

mail to Advisory Committee Oversight 

and Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993–0002. Information about 

becoming a member on an FDA advisory 

committee can also be obtained by 

visiting FDA’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Patricio G. Garcia, Office of Device 

Evaluation, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. G610, Silver Spring, 

MD 20993–0002, 301–796–6875, email: 

Patricio.Garcia@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nominations for voting 

members on TEPRSSC that include 

three general public representatives. 

I. General Description of the 

Committee’s Duties 

The committee provides advice and 

consultation to the Commissioner of 

Food and Drugs (Commissioner) on the 

technical feasibility, reasonableness, 

and practicability of performance 

standards for electronic products to 

control the emission of radiation from 

such products, and may recommend 

electronic product radiation safety 

standards to the Commissioner for 

consideration. 

II. Criteria for Voting Members 

The committee consists of a core of 15 

voting members including the Chair. 

Members and the Chair are selected by 

the Commissioner or designee from 

among authorities knowledgeable in the 

fields of science or engineering, 

applicable to electronic product 

radiation safety. Members will be 

invited to serve for overlapping terms of 

up to 4 years. Terms of more than 2 

years are contingent upon the renewal 

of the committee by appropriate action 

prior to its expiration. 

III. Nomination Procedures 

Any interested person may nominate 

one or more qualified individuals for 

membership on the committee. Selfnominations are also accepted. 

Nominations must include a current, 

complete re ́sume ́ or curriculum vitae for 

each nominee, including current 

business address and/or home address, 

telephone number, and email address if 

available, and a signed copy of the 

Acknowledgement and Consent form 

available at the FDA Advisory 

Nomination Portal (see ADDRESSES). 

Nominations must also specify the 

advisory committee for which the 

nominee is recommended. Nominations 

must also acknowledge that the 

nominee is aware of the nomination 

unless self-nominated. FDA will ask 

potential candidates to provide detailed 

information concerning such matters 

related to financial holdings, 

employment, and research grants and/or 

contracts to permit evaluation of 

possible sources of conflicts of interest. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: August 31, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19355 Filed 9–5–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–1999–D–0081, FDA– 

2008–D–0205, FDA–2018–D–2173, FDA– 

2018–D–2236, FDA–2018–D–2238, and FDA– 

2018–D–2258] 

Draft Guidances Relating to the 

Development of Human Gene Therapy 

Products; Availability; Extension of 

Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification; extension of 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

extending the comment period for the 

notices of availability for six draft 

guidance documents relating to the 

development of human gene therapy 

products that appeared in the Federal 

Register of July 12, 2018. The Agency is 

taking this action in response to 

requests for an extension to allow 

interested persons additional time to 

submit comments and any new 

information. 

DATES: FDA is extending the comment 

period on the six documents that 

published on July 12, 2018 (see 

SUPPLEMENTARY INFORMATION). Submit 

either electronic or written comments 

by December 10, 2018, to ensure that the 

Agency considers your comment on 

these draft guidances before it begins 

work on the final version of the 

guidances. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before December 10, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of December 10, 2018. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 


daltland on DSKBBV9HB2PROD with NOTICES