80114 Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 

Estimated Total Annual Burden 

Hours (State Agencies): 1,245. 

Annual Burden Estimates: URM 

Provider Agencies. 

Instrument 

Total 

number of 

respondents 

Total 

number of 

responses per 

respondent 

Average 

burden 

hours per 

response 

Total 

burden 

hours 

Annual 

burden 

hours 

ORR–3 Unaccompanied Refugee Minors Placement Report ................................................................................... 24 270 0.50 3,240 1,080 

ORR–4 Unaccompanied Refugee Minors Outcomes Report ................................................................................... 24 162 1.0 3,888 1,296 

Estimated Total Annual Burden 

Hours (Provider Agencies): 2,376. 

Annual Burden Estimates: Youth 

Participants. 

Instrument 

Total 

number of 

respondents 

Total 

number of 

responses per 

respondent 

Average burden 

hours per 

response 

Total 

burden 

hours 

Annual 

burden 

hours 

ORR–4 Unaccompanied Refugee Minors Outcomes Report ................................................................................... 1032 3 0.50 1,548 516 

Estimated Total Annual Burden 

Hours (Youth Participants): 516. 

Total Estimated Annual Burden 

Hours: 4,137. 

Authority: 8 U.S.C. 1522(d). 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2020–27194 Filed 12–10–20; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2019–D–1647, FDA– 

2019–D–1652, and FDA–2019–D–1650] 

Performance Criteria for Safety and 

Performance Based Pathway; 

Guidances 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 three 

device-specific final guidance 

documents for the Safety and 

Performance Based Pathway— 

specifically, ‘‘Spinal Plating Systems— 

Performance Criteria for Safety and 

Performance Based Pathway; Guidance 

for Industry and Food and Drug 

Administration Staff,’’ ‘‘Orthopedic 

Non-Spinal Metallic Bone Screws and 

Washers—Performance Criteria for 

Safety and Performance Based Pathway; 

Guidance for Industry and Food and 

Drug Administration Staff,’’ and 

‘‘Magnetic Resonance (MR) Receiveonly Coil—Performance Criteria for 

Safety and Performance Based Pathway; 

Guidance for Industry and Food and 

Drug Administration Staff.’’ The devicespecific guidances identified in this 

notice were developed in accordance 

with the final guidance entitled ‘‘Safety 

and Performance Based Pathway.’’ 

DATES: The announcement of the 

guidances is published in the Federal 

Register on December 11, 2020. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2019–D–1647 for ‘‘Spinal Plating 

Systems—Performance Criteria for 

Safety and Performance Based Pathway; 

Guidance for Industry and Food and 

Drug Administration Staff,’’ Docket No. 

FDA–2019–D–1652 for ‘‘Orthopedic 

Non-Spinal Metallic Bone Screws and 

Washers—Performance Criteria for 

Safety and Performance Based Pathway; 

Guidance for Industry and Food and 

Drug Administration Staff,’’ and Docket 

No. FDA–2019–D–1650 for ‘‘Magnetic 

Resonance (MR) Receive-only Coil— 

Performance Criteria for Safety and 

Performance Based Pathway; 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 


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Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 80115 

1Available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/ 

safety-and-performance-based-pathway. 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• 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.govinfo.gov/content/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, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

An electronic copy of the guidance 

documents are available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidances. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Spinal Plating 

Systems—Performance Criteria for 

Safety and Performance Based Pathway; 

Guidance for Industry and Food and 

Drug Administration Staff,’’ 

‘‘Orthopedic Non-Spinal Metallic Bone 

Screws and Washers—Performance 

Criteria for Safety and Performance 

Based Pathway; Guidance for Industry 

and Food and Drug Administration 

Staff,’’ or ‘‘Magnetic Resonance (MR) 

Receive-only Coil—Performance Criteria 

for Safety and Performance Based 

Pathway; Guidance for Industry and 

Food and Drug Administration Staff’’ to 

the Office of Policy, 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: 

Jason Ryans, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1613, Silver Spring, 

MD 20993–0002, 301–796–4908. 

SUPPLEMENTARY INFORMATION: 

I. Background 

These device-specific guidance 

documents provide performance criteria 

for premarket notification (510(k)) 

submissions to support the optional 

Safety and Performance Based Pathway, 

as described in the guidance entitled 

‘‘Safety and Performance Based 

Pathway.’’ 1 As described in that 

guidance, substantial equivalence is 

rooted in comparisons between new 

devices and predicate devices. However, 

the Federal Food, Drug, and Cosmetic 

Act does not preclude FDA from using 

performance criteria to facilitate this 

comparison. If a legally marketed device 

performs at certain levels relevant to its 

safety and effectiveness, and a new 

device meets those levels of 

performance for the same 

characteristics, FDA could find the new 

device as safe and effective as the 

legally marketed device. Instead of 

reviewing data from direct comparison 

testing between the two devices, FDA 

could support a finding of substantial 

equivalence with data demonstrating 

the new device meets the level of 

performance of an appropriate predicate 

device(s). Under this optional Safety 

and Performance Based Pathway, a 

submitter could satisfy the requirement 

to compare its device with a legally 

marketed device by, among other things, 

independently demonstrating that the 

device’s performance meets 

performance criteria as established in 

the above-listed guidances, rather than 

using direct predicate comparison 

testing for some of the performance 

characteristics. 

A notice of availability of the draft 

guidances ‘‘Spinal Plating Systems’’ and 

‘‘Orthopedic Non-Spinal Metallic Bone 

Screws and Washers’’ appeared in the 

Federal Register of September 20, 2019 

(84 FR 49528). A notice of availability 

of the draft guidance ‘‘Magnetic 

Resonance Coil’’ appeared in the 

Federal Register of December 9, 2019 

(84 FR 67272). FDA considered 

comments received on the ‘‘Spinal 

Plating Systems’’ guidance and revised 

the guidance as appropriate by 

clarifying the types of plates that are 

excluded from the scope of the guidance 

(i.e., occipital plates) and the lack of a 

specified minimum plate thickness. 

FDA considered comments received on 

the ‘‘Orthopedic Non-Spinal Metallic 

Bone Screws and Washers’’ guidance 

and revised the guidance as appropriate 

by expanding the scope of appropriate 

materials, clarifying the type of 

appropriate screw and washer design 

features, and clarifying the expectations 

for performance test methods and 

criteria. FDA considered comments 

received on the ‘‘Magnetic Resonance 

Coil’’ guidance and revised the guidance 

as appropriate by clarifying that the 

guidance is intended for receive-only 

magnetic resonance coils, expanding 

performance test methods with 

applicable FDA-recognized consensus 

standards, and clarifying the relation 

between performance testing and 

evaluations of interoperability. 

These guidances are being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidances represent the current 

thinking of FDA on performance criteria 

for ‘‘Spinal Plating Systems,’’ 

‘‘Orthopedic Non-Spinal Metallic Bone 

Screws and Washers,’’ and ‘‘Magnetic 

Resonance Coil.’’ They do not establish 

any rights for any person and are not 

binding on FDA or the public. You can 

use an alternative approach if it satisfies 

the requirements of the applicable 

statutes and regulations. 

II. Electronic Access 

Persons interested in obtaining a copy 

of the 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/medical-devices/ 

device-advice-comprehensiveregulatory-/assistance/guidancedocuments-medical-devices-andradiation-emitting-products. These 

guidance documents are also available 

at https://www.regulations.gov and at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Persons unable to download 

an electronic copy of either ‘‘Spinal 

Plating Systems—Performance Criteria 

for Safety and Performance Based 


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80116 Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 

Pathway; Guidance for Industry and 

Food and Drug Administration Staff’’ 

(document number 19008), ‘‘Orthopedic 

Non-Spinal Metallic Bone Screws and 

Washers—Performance Criteria for 

Safety and Performance Based Pathway; 

Guidance for Industry and Food and 

Drug Administration Staff’’ (document 

number 19009), or ‘‘Magnetic Resonance 

(MR) Receive-only Coil—Performance 

Criteria for Safety and Performance 

Based Pathway; Guidance for Industry 

and Food and Drug Administration 

Staff’’ (document number 19011) may 

send an email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 

use the document number and complete 

title to identify the guidance you are 

requesting. 

III. Paperwork Reduction Act of 1995 

While these guidances contain no 

collection of information, they do refer 

to previously approved FDA collections 

of information. Therefore, clearance by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for these 

guidances. The previously approved 

collections of information are subject to 

review by OMB under the PRA. The 

collections of information in the 

following FDA regulations and guidance 

have been approved by OMB as listed in 

the following table: 

21 CFR part or guidance Topic OMB control No. 

807, subpart E .......................................................................................................... Premarket notification ............................ 0910–0120 

‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission 

Program and Meetings with Food and Drug Administration Staff‘‘.

Q-submissions ....................................... 0910–0756 

Dated: December 7, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–27248 Filed 12–10–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA- 2019–N–4203] 

Advisory Committee; Bone, 

Reproductive and Urologic Drugs 

Advisory Committee; Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of advisory 

committee. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

renewal of the Bone, Reproductive and 

Urologic Drugs Advisory Committee by 

the Commissioner of Food and Drugs 

(the Commissioner). The Commissioner 

has determined that it is in the public 

interest to renew the Bone, 

Reproductive and Urologic Drugs 

Advisory Committee for an additional 2 

years beyond the charter expiration 

date. The new charter will be in effect 

until the March 23, 2022, expiration 

date. 

DATES: Authority for the Bone, 

Reproductive and Urologic Drugs 

Advisory Committee will expire on 

March 23, 2022 unless the 

Commissioner formally determines that 

renewal is in the public interest. 

FOR FURTHER INFORMATION CONTACT: 

Kalyani Bhatt, Division of Advisory 

Committee and Consultant 

Management, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, email: BRUDAC@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services pursuant to 45 CFR part 11 and 

by the General Services Administration, 

FDA is announcing the renewal of the 

Bone, Reproductive and Urologic Drugs 

Advisory Committee. The Committee is 

a discretionary Federal advisory 

committee established to provide advice 

to the Commissioner. 

The Bone, Reproductive and Urologic 

Drugs Advisory Committee advises the 

Commissioner or designee in 

discharging responsibilities as they 

relate to helping to ensure safe and 

effective drugs for human use and, as 

required, any other product for which 

FDA has regulatory responsibility. 

The Committee reviews and evaluates 

data on the safety and effectiveness of 

marketed and investigational human 

drug products for use in the practice of 

osteoporosis and metabolic bone 

disease, obstetrics, gynecology, urology 

and related specialties, and makes 

appropriate recommendations to the 

Commissioner. 

Under its Charter, the Committee 

shall consist of a core of 11 voting 

members including the Chair. Members 

and the Chair are selected by the 

Commissioner or designee from among 

authorities knowledgeable in the fields 

of osteoporosis and metabolic bone 

disease, obstetrics, gynecology, urology, 

pediatrics, epidemiology, or statistics 

and related specialties. Members will be 

invited to serve for overlapping terms of 

up to 4 years. Almost all non-Federal 

members of this committee serve as 

Special Government Employees. The 

core of voting members may include one 

technically qualified member, selected 

by the Commissioner or designee, who 

is identified with consumer interests 

and is recommended by either a 

consortium of consumer-oriented 

organizations or other interested 

persons. In addition to the voting 

members, the Committee may include 

one non-voting representative member 

who is identified with industry 

interests. There may also be an alternate 

industry representative. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/advisory-committees/ 

human-drug-advisory-committees/bonereproductive-and-urologic-drugsadvisory-committee-formerlyreproductive-health-drugs-advisory or 

by contacting the Designated Federal 

Officer (see FOR FURTHER INFORMATION

CONTACT). In light of the fact that no 

change has been made to the Committee 

name or description of duties, no 

amendment will be made to 21 CFR 

14.100. 

This document is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app.). For general information 

related to FDA advisory committees, 

please check https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: December 8, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–27289 Filed 12–10–20; 8:45 am] 

BILLING CODE 4164–01–P 


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