36330 Federal Register / Vol. 87, No. 116 / Thursday, June 16, 2022 / Notices 

Although the citizen petition did not 

address the 100-mg strength, that 

strength has also been discontinued. On 

our own initiative, we have also 

determined whether that strength was 

withdrawn for safety or effectiveness 

reasons. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that THEO–DUR 

(theophylline) extended-release tablets, 

100 mg and 300 mg, were not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that this drug product was 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of THEO– 

DUR (theophylline) extended-release 

tablets, 100 mg and 300 mg, from sale. 

We have also independently evaluated 

relevant literature and data for possible 

postmarketing adverse events. We have 

found no information that would 

indicate that this drug product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list THEO–DUR 

(theophylline) extended-release tablets, 

100 mg and 300 mg, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. FDA will not 

begin procedures to withdraw approval 

of approved ANDAs that refer to this 

drug product. Additional ANDAs for 

this drug product may also be approved 

by the Agency as long as they meet all 

other legal and regulatory requirements 

for the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: June 10, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12920 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–2013–N–0514] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Administrative 

Procedures for Clinical Laboratory 

Improvement Amendments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection associated with 

implementation of the Clinical 

Laboratory Improvement Amendments 

of 1988 (CLIA). 

DATES: Submit either electronic or 

written comments on the collection of 

information by August 15, 2022. 

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 August 15, 

2022. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of August 15, 2022. 

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. 

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– 

2013–N–0514 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Administrative Procedures for Clinical 

Laboratory Improvement Amendments 

Categorization.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), 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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 116 / Thursday, June 16, 2022 / Notices 36331 

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. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St, North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Administrative Procedures for Clinical 

Laboratory Improvement Amendments 

of 1988 

OMB Control Number 0910–0607— 

Revision 

This information collection helps 

support implementation of statutory 

provisions applicable to laboratories 

that conduct testing on human 

specimen under CLIA. These 

requirements are codified in 42 U.S.C. 

263a and implementing regulations are 

found in 42 CFR 493. Regulations in 42 

CFR 493.17 set forth certain notice 

requirements and establish test 

categorization criteria with regard to 

laboratory tests and are implemented by 

FDA’s Center for Devices and 

Radiological Health. The guidance 

document entitled ‘‘Administrative 

Procedures for CLIA Categorization’’ 

(available at https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/administrativeprocedures-clia-categorization) 

describes procedures FDA uses to assign 

the complexity category to a device. 

Typically, FDA assigns complexity 

categorizations to devices at the time of 

clearance or approval of the device. In 

some cases, however, a manufacturer 

may request CLIA categorization even if 

FDA is not simultaneously reviewing a 

510(k) or premarket approval 

application. One example is when a 

manufacturer requests that FDA assign 

CLIA categorization to a previously 

cleared device that has changed names 

since the original CLIA categorization. 

Another example is when a device is 

exempt from premarket review. In such 

cases, the guidance recommends that 

manufacturers provide FDA with a copy 

of the package insert for the device and 

a cover letter indicating why the 

manufacturer is requesting a 

categorization (e.g., name change, 

exempt from 510(k) review). The 

guidance recommends that in the 

correspondence to FDA the 

manufacturer should identify the 

product code and classification as well 

as reference to the original 510(k) when 

this is available. 

We are revising the information 

collection to include provisions 

associated with certificates of waiver. 

On February 26, 2020, FDA revised the 

guidance document entitled 

‘‘Recommendations for Clinical 

Laboratory Improvement Amendments 

of 1988 (CLIA) Waiver Applications for 

Manufacturers of In Vitro Diagnostic 

Devices—Guidance for Industry and 

FDA Staff’’ (available at https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 

recommendations-clinical-laboratoryimprovement-amendments-1988-cliawaiver-applications). This guidance 

describes recommendations for device 

manufacturers submitting to FDA an 

application for determination that a 

cleared or approved device meets this 

CLIA standard (CLIA waiver 

application). The guidance recommends 

that CLIA waiver applications include a 

description of the features of the device 

that make it ‘‘simple’’; a report 

describing a hazard analysis that 

identifies potential sources of error, 

including a summary of the design and 

results of flex studies and conclusions 

drawn from the flex studies; a 

description of fail-safe and failure alert 

mechanisms and a description of the 

studies validating these mechanisms; a 

description of clinical tests that 

demonstrate the accuracy of the test in 

the hands of intended operators; and 

statistical analyses of clinical study 

results. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

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 

Request for CLIA categorization (see 42 

CFR 493.17) ......................................... 80 5 400 1 400 $2,000 

CLIA Waiver Application Submissions .... 13 1 13 1,200 15,600 350,000 


khammond on DSKJM1Z7X2PROD with NOTICES
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