14540 Federal Register / Vol. 87, No. 50 / Tuesday, March 15, 2022 / Notices 

approval, of any drug product under the 

FD&C Act. The proposal also offered 

Ms. Varona an opportunity to request a 

hearing, providing her 30 days from the 

date of receipt of the letter in which to 

file the request, and advised her that 

failure to request a hearing constituted 

an election not to use the opportunity 

for a hearing and a waiver of any 

contentions concerning this action. Ms. 

Varona received the proposal on 

November 22, 2021. She did not request 

a hearing within the timeframe 

prescribed by regulation and has, 

therefore, waived her opportunity for a 

hearing and any contentions concerning 

her debarment (21 CFR part 12). 

II. Findings and Order 

Therefore, the Assistant 

Commissioner, Office of Human and 

Animal Food Operations, under section 

306(a)(2)(A) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Ms. Varona 

has been convicted of a felony under 

Federal law for conduct relating to the 

development or approval, including the 

process of development or approval, of 

any drug product under the FD&C Act. 

As a result of the foregoing finding, 

Ms. Varona is permanently debarred 

from providing services in any capacity 

to a person with an approved or 

pending drug product application, 

effective (see DATES) (see sections 

306(a)(2)(A) and 306(c)(2)(A)(ii) of the 

FD&C Act, (21 U.S.C. 355a(2)(A) and 

335a(c)(2)(A)(ii))). Any person with an 

approved or pending drug product 

application who knowingly employs or 

retains as a consultant or contractor, or 

otherwise uses the services of Ms. 

Varona in any capacity during her 

debarment, will be subject to civil 

money penalties (section 307(a)(6) of the 

FD&C Act (21 U.S.C. 335b(a)(6))). If Ms. 

Varona provides services in any 

capacity to a person with an approved 

or pending drug product application 

during her period of debarment, she will 

be subject to civil money penalties 

(section 307(a)(7) of the FD&C Act). In 

addition, FDA will not accept or review 

any abbreviated new drug application 

from Ms. Varona during her period of 

debarment, other than in connection 

with an audit under section 306 of the 

FD&C Act (section 306(c)(1)(B) of the 

FD&C Act). Note that, for purposes of 

sections 306 and 307 of the FD&C Act, 

a ‘‘drug product’’ is defined as a drug 

subject to regulation under section 505, 

512, or 802 of the FD&C Act (21 U.S.C. 

355, 360b, 382) or under section 351 of 

the Public Health Service Act (42 U.S.C. 

262) (section 201(dd) of the FD&C Act 

(21 U.S.C. 321(dd))). 

Any application by Ms. Varona for 

special termination of debarment under 

section 306(d)(4) of the FD&C Act 

should be identified with Docket No. 

FDA–2021–N–0968 and sent to the 

Division of Dockets Management (see 

ADDRESSES). The public availability of 

information in these submissions is 

governed by 21 CFR 10.20. 

Publicly available submissions will be 

placed in the docket and will be 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff (see 

ADDRESSES) between 9 a.m. and 4 p.m., 

Monday through Friday, 240–402–7500. 

Dated: March 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05401 Filed 3–14–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0375] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Agreement for 

Shipment of Devices for Sterilization 

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 requirements relating to 

shipment of nonsterile devices that are 

to be sterilized elsewhere or are shipped 

to other establishments for further 

processing, labeling, or repacking. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 16, 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 May 16, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of May 16, 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–0375 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Agreement for Shipment of Devices for 

Sterilization.’’ 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 


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Federal Register / Vol. 87, No. 50 / Tuesday, March 15, 2022 / Notices 14541 

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. 

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. 

Agreement for Shipment of Devices for 

Sterilization—21 CFR 801.150 

OMB Control Number 0910–0131— 

Extension 

Under sections 501(c) and 502(a) of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 351(c) and 352(a)), 

nonsterile devices that are labeled as 

sterile but are in interstate transit to a 

facility to be sterilized are adulterated 

and misbranded. FDA regulations at 

§ 801.150(e) (21 CFR 801.150(e)) 

establish a control mechanism by which 

firms may manufacture and label 

medical devices as sterile at one 

establishment and ship the devices in 

interstate commerce for sterilization at 

another establishment, a practice that 

facilitates the processing of devices and 

is economically necessary for some 

firms. 

Under § 801.150(e)(1), manufacturers 

and sterilizers may sign an agreement 

containing the following: (1) Contact 

information of the firms involved and 

the identification of the signature 

authority of the shipper and receiver, (2) 

instructions for maintaining 

accountability of the number of units in 

each shipment, (3) acknowledgment that 

the devices that are nonsterile are being 

shipped for further processing, and (4) 

specifications for sterilization 

processing. This agreement allows the 

manufacturer to ship misbranded 

products to be sterilized without 

initiating regulatory action and provides 

FDA with a means to protect consumers 

from use of nonsterile products. During 

routine plant inspections, FDA normally 

reviews agreements that must be kept 

for 2 years after final shipment or 

delivery of devices (see § 801.150(a)(2)). 

The respondents to this collection of 

information are device manufacturers 

and contract sterilizers. FDA’s estimate 

of the reporting burden is based on data 

obtained from industry in recent years. 

It is estimated that each of the firms 

subject to this requirement prepares an 

average of 37.5 written agreements each 

year. This estimate varies greatly, from 

1 to 218, because some firms provide 

sterilization services on a part-time 

basis for only 1 customer, while others 

are large facilities with many customers. 

The average time required to prepare 

each written agreement is estimated to 

be 4 hours. This estimate varies 

depending on whether the agreement is 

the initial agreement or an annual 

renewal, on the format each firm elects 

to use, and on the length of time 

required to reach agreement. The 

estimate applies only to those portions 

of the written agreement that pertain to 

the requirements imposed by this 

regulation. The written agreement 

generally also includes contractual 

agreements that are a usual and 

customary business practice. The 

recordkeeping requirements of 

§ 801.150(a)(2) consist of making copies 

and maintaining the records required 

under the third-party disclosure section 

of this collection. 

FDA estimates the burden of this 

collection of information as follows: 


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14542 Federal Register / Vol. 87, No. 50 / Tuesday, March 15, 2022 / Notices 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR Part Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 2

Record retention, 801.150(a)(2) ................................. 218 37.5 8,175 0.50 (30 minutes) .... 4088 

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

2 Rounded to the nearest hour. 

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR Part Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Agreement and labeling requirements, 801.150(e) ............. 218 37.5 8,175 4 32,700 

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

Our estimated burden for the 

information collection reflects an 

overall increase of 27,778 hours and a 

corresponding increase of 6,175 

responses/records. We attribute this 

adjustment to an increase in the number 

of submissions we received over the last 

few years. 

Dated: March 2, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05402 Filed 3–14–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health (NIH) 

National Institute of Mental Health 

(NIMH); Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the Interagency Autism 

Coordinating Committee. 

The purpose of the IACC meeting is 

to discuss business, agency updates, and 

issues related to autism spectrum 

disorder (ASD) research and services 

activities. The meeting will be held as 

a virtual meeting and is open to the 

public. Individuals who plan to view 

the virtual meeting and need special 

assistance or other reasonable 

accommodations to view the meeting 

should notify the Contact Person listed 

below at least seven (7) business days in 

advance of the meeting. The open 

session will be videocast and can be 

accessed from the NIH Videocast 

website (http://videocast.nih.gov/). 

Name of Committee: Interagency Autism 

Coordinating Committee (IACC). 

Date: April 13–14, 2022. 

Time: Wednesday, April 13, 2022, 1:00 

p.m. to 5:00 p.m. ET. 

Meeting Access: Wednesday, April 13, 

2022, https://videocast.nih.gov/watch=44688. 

Time: Thursday, April 14, 2022, 1:00 p.m. 

to 5:00 p.m. ET. 

Meeting Access: Thursday, April 14, 2022, 

https://videocast.nih.gov/watch=44690 

Agenda: To discuss business, updates, and 

issues related to ASD research and services 

activities. 

Cost: The meeting is free and open to the 

public. 

Registration: A registration web link will 

be posted on the IACC website 

(www.iacc.hhs.gov) prior to the meeting. Preregistration is recommended. 

Deadlines: Written/Virtual Public 

Comment Due Date: Friday, April 1, 2022, by 

5:00 p.m. ET, Public Comment Guidelines, 

For public comment instructions, see below. 

Contact Person: Ms. Rebecca Martin, Office 

of Autism Research Coordination, National 

Institute of Mental Health, NIH, 6001 

Executive Boulevard, Bethesda, MD 20892– 

9669, Phone: 301–435–0886, email: 

IACCPublicInquiries@mail.nih.gov. 

Public Comments 

The IACC welcomes public comments 

from members of the autism community 

and asks the community to review and 

adhere to its Public Comment 

Guidelines. In the 2016–2017 IACC 

Strategic Plan, the IACC listed the 

‘‘Spirit of Collaboration’’ as one of its 

core values, stating that, ‘‘We will treat 

others with respect, listen with open 

minds to the diverse views of people on 

the autism spectrum and their families, 

thoughtfully consider community input, 

and foster discussions where 

participants can comfortably offer 

opposing opinions.’’ In keeping with 

this core value, the IACC and the NIMH 

Office of Autism Research Coordination 

(OARC) ask that members of the public 

who provide public comments or 

participate in meetings of the IACC also 

seek to treat others with respect and 

consideration in their communications 

and actions, even when discussing 

issues of genuine concern or 

disagreement. 

As the IACC will be updating its 

Strategic Plan, comments related to 

issues that the community would like to 

see highlighted in the new IACC 

Strategic Plan are welcome. Comments 

may be submitted in writing via email 

to IACCPublicInquiries@mail.nih.gov or 

using the web form at: https://

iacc.hhs.gov/meetings/publiccomments/submit/index.jsp by 5:00 

p.m. ET on Friday, April 1, 2022. A 

limited number of slots are available for 

individuals to provide a 2–3-minute 

summary or excerpt of their written 

comment to the Committee live during 

the virtual meeting using the virtual 

platform. For those interested in that 

opportunity, please indicate ‘‘Interested 

in providing virtual comment’’ in your 

written submission, along with your 

name, address, email, phone number, 

and professional/organizational 

affiliation so that OARC staff can 

contact you if a slot is available for you 

to provide a summary or excerpt of your 

comment via the virtual platform during 

the meeting. For any given meeting, 

priority for live virtual comment slots 

will be given to those who have not 

previously provided live virtual 

comments in the current calendar year. 

This will help ensure that as many 

individuals as possible have an 

opportunity to share comments. 

Commenters going over their allotted 3- 

minute slot may be asked to conclude 

immediately in order to allow other 

comments and the rest of the meeting to 

proceed on schedule. 

Public comments received by 5:00 

p.m. ET on Friday, April 1, 2022, will 

be provided to the Committee prior to 

the meeting for their consideration. Any 

written comments received after 5:00 

p.m. ET, April 1, 2022, may be provided 

to the Committee either before or after 


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I I I I 

I I I I