36332 Federal Register / Vol. 87, No. 116 / Thursday, June 16, 2022 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

Information collection activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Total operating 

and 

maintenance 

costs 

Total .................................................. ........................ ........................ ........................ ........................ ........................ 352,000 

1There are no capital costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Information collection activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

CLIA Waiver Recordkeeping as discussed in FDA Guidance .................................................................................. 13 1 13 2,800 36,400 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

We have revised the information 

collection to include coverage 

previously accounted for under OMB 

control number 0910–0598 and 

discussed in revised Agency guidance. 

We otherwise retain our estimates of the 

burden we attribute to the individual 

elements included in the information 

collection. 

Dated: June 9, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12929 Filed 6–15–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0571] 

Ortho-phthalates for Food Contact 

Use; Request for Information 

Correction 

In notice document 2022–10532, 

appearing on pages 31090–31091, in the 

issue of Friday, May 20, 2022, make the 

following correction: 

On page 31090, in the first column, in 

the standard document heading, the 

Subject line that reads ‘‘Ortho-phthlates 

for Food Contact Use; Request for 

Information’’ is corrected to read 

‘‘Ortho-phthalates for Food Contact Use; 

Request for Information’’. 

[FR Doc. C1–2022–10532 Filed 6–15–22; 8:45 am] 

BILLING CODE 0099–10–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–1470] 

Technical Performance Assessment of 

Quantitative Imaging in Radiological 

Device Premarket Submissions; 

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 a final 

guidance entitled ‘‘Technical 

Performance Assessment of Quantitative 

Imaging in Radiological Device 

Premarket Submissions.’’ FDA is issuing 

this guidance to provide 

recommendations for manufacturers 

about the information that should be 

included in premarket submissions for 

radiological devices that include 

quantitative imaging functions. This 

guidance document is broadly 

applicable to a variety of premarket 

submission types (i.e., premarket 

approval applications (PMAs), 

humanitarian device exemption (HDE) 

applications, premarket notification 

(510(k)) submissions, investigational 

device exemption (IDE) applications, 

and De Novo requests) for these devices 

and should be used in conjunction with 

existing device- and submission-specific 

guidance documents. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on June 16, 2022. 

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.’’ 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 116 / Thursday, June 16, 2022 / Notices 36333 

Instructions: All submissions received 

must include the Docket No. FDA– 

2019–D–1470 for ‘‘Technical 

Performance Assessment of Quantitative 

Imaging in Radiological Device 

Premarket Submissions.’’ 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, 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 

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 guidance 

document entitled ‘‘Technical 

Performance Assessment of Quantitative 

Imaging in Radiological Device 

Premarket Submissions’’ to the Office of 

Policy, 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: Jana 

Delfino, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 62, Rm. 3116, Silver Spring, 

MD 20993–0002, 301–796–6503. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is issuing this guidance to 

provide recommendations for 

manufacturers about the information 

that should be included in premarket 

submissions for radiological devices 

that include quantitative imaging 

functions. This guidance document is 

broadly applicable to a variety of 

premarket submission types (i.e., PMAs, 

HDE applications, 510(k) submissions, 

IDE applications, and De Novo requests) 

for these devices and should be used in 

conjunction with existing device- and 

submission-specific guidance 

documents. 

This guidance document clarifies that, 

in general, manufacturers preparing 

premarket submissions for radiological 

devices that include quantitative 

imaging functions should provide 

performance specifications for the 

quantitative imaging functions, 

supporting performance data to 

demonstrate that the quantitative 

imaging functions meet those 

performance specifications, and 

sufficient information for the end user 

to obtain, understand, and interpret the 

values provided by the quantitative 

imaging functions. 

A notice of availability of the draft 

guidance appeared in the Federal 

Register of April 19, 2019 (84 FR 

16517). FDA considered comments 

received and revised the guidance as 

appropriate in response to the 

comments, including clarification in 

scope that the guidance is intended to 

provide recommendations for 

radiological devices with quantitative 

imaging functions, and other technical 

clarifications. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on technical 

performance assessment of quantitative 

imaging in radiological device 

premarket submissions. 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. 

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. This 

guidance document is also available at 

https://www.regulations.gov or https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

Persons unable to download an 

electronic copy of ‘‘Technical 

Performance Assessment of Quantitative 

Imaging in Radiological Device 

Premarket Submissions’’ may send an 

email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number 18017 and complete 

title to identify the guidance you are 

requesting. 

III. Paperwork Reduction Act of 1995 

While this guidance contains no new 

collection of information, it does 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 this guidance. 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
36334 Federal Register / Vol. 87, No. 116 / Thursday, June 16, 2022 / Notices 

21 CFR part or guidance Topic OMB control 

No. 

814, subparts A through E ........................................................................................... Premarket approval .................................. 0910–0231 

814, subpart H .............................................................................................................. Humanitarian Device Exemption .............. 0910–0332 

812 ................................................................................................................................ Investigational Device Exemption ............. 0910–0078 

‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’ ... De Novo classification process ................ 0910–0844 

‘‘Requests for Feedback and Meetings for Medical Device Submissions: The QSubmission Program and Meetings with Food and Drug Administration Staff’’.Q-submissions; pre-submissions .............. 0910–0756 

800, 801, and 809 ........................................................................................................ Medical Device Labeling Regulations ...... 0910–0485 

Dated: June 9, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12930 Filed 6–15–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0955–0020] 

Agency Information Collection 

Request; 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before August 15, 2022. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 795–7714. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0955–0020–60D 

and project title for reference, to 

Sherrette A. Funn, email: 

Sherrette.Funn@hhs.gov, or call (202) 

795–7714 the Reports Clearance Officer. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: United States 

Core Data for Interoperability New Data 

Element. 

Type of Collection: Revision. 

OMB No.: 0955–0020—Office of the 

National Coordinator for Health 

Information Technology—Specific 

program collecting the data (is 

applicable). 

Abstract: The Office of the National 

Coordinator for Health Information 

Technology is seeking the revision on a 

previously approved by OMB #0955– 

0020 information collection request 

item ‘‘United States Core Data for 

Interoperability (USCDI) New Data 

Element Submission Form.’’ The USCDI 

is a standardized set of health data 

classes and constituent data elements 

used to support nationwide, 

interoperable health information 

exchange. The USCDI Version 1 is the 

required standard data elements set to 

which all health IT developers must 

conform to obtain ONC certification. 

This certification is required for 

participation in some federal healthcare 

payment plans. In order to ensure the 

USCDI remains current and reflects the 

needs of the health IT community, ONC 

has established a predictable, 

transparent, and collaborative process to 

solicit broad stakeholder input to 

expand the USCDI. Anyone, including 

ONC staff, staff from other federal 

agencies, and other stakeholders may 

submit proposals for new data elements 

and classes. ONC will evaluate each 

submission and provide feedback to the 

submitter. ONC will draft a new version 

of the USCDI based on these 

submissions and this draft will undergo 

review by ONC’s federal advisory 

committee, the Health Information 

Technology Advisory Committee 

(HITAC), as well as by the general 

public. Upon approval by the National 

Coordinator for Health Information 

Technology, new data classes and data 

elements from these submissions will be 

added to the newest version of the 

USCDI standard for integration into 

health information technology products 

such as electronic health records. ONC 

is seeking approval to continue to 

collect this information from health IT 

stakeholders. 

Need and Proposed Use of the 

Information: The information collected 

from this submission system is needed 

as it will comprise the sum total of the 

items ONC will evaluate for addition to 

the next version of the USCDI. The 

requested data will provide supporting 

documentation to justify addition of the 

data elements to the USCDI, and, if the 

documentation does justify addition to 

the USCDI, to one of several levels of 

candidate data elements for future 

development and consideration. The 

requested data and ONC’s evaluation of 

the data will be publicly available for 

review at any time to provide 

transparency and predictability in the 

USCDI expansion process. It will 

contain information about the submitter 

to allow ONC to provide direct feedback 

to submitters on ONC’s evaluation of 

such submission. 

Likely Respondents: Likely 

respondents to this new submission 

system will be various health IT 

stakeholders including health care 

providers, standards development 

organizations, health IT developers and 

vendors as well as members of the 

HITAC. 

The total annual burden hours 

estimated for this ICR are summarized 

in the table below. 

ANNUALIZED BURDEN HOUR TABLE

Forms 

(if necessary) 

Respondents 

(if necessary) 

Number of 

respondents 

Number of 

responses per 

respondents 

Average 

burden per 

response 

Total burden 

hours 

USCDI Submission .............................................................. ........................ 200 1 20/60 67 


khammond on DSKJM1Z7X2PROD with NOTICES