Federal Register / Vol. 87, No. 7 / Tuesday, January 11, 2022 / Notices 1417 

infocollection@acf.hhs.gov. Identify all 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: This study will collect 

information from Court Improvement 

Program (CIP) staff to (1) understand 

data capacity and current use of 

performance measures and (2) gather 

feedback from the performance measure 

pilot process. This will be accomplished 

using two instruments: 

JCAMP CIP Data Capacity Survey 

The survey asks CIPs about their 

current capacity to collect specific data 

elements from the following six 

categories of measurement: (1) Legal and 

judicial context (e.g., court docketing), 

(2) Practices (e.g., attorney pre-petition 

legal practice), (3) Short-term outcomes 

that happen during hearings (e.g., 

discussion of key issues), (4) 

Intermediate outcomes that happen 

during the case (e.g., judicial 

continuity), (5) Long-term outcomes that 

happen after case closure (e.g., child 

safety), and (6) Cross-cutting themes 

(e.g., equity). The survey asks about 

capacity broadly and then specifically 

for a series of subcategories. 

JCAMP Pilot Site Debrief Form 

The JCAMP Pilot Site Debrief Form is 

a survey developed to be administered 

to CIP staff who have assisted with 

piloting of the performance measures. 

The survey asks participants about the 

challenges and successes in collecting 

pilot data for the measures, their 

confidence in collecting the data going 

forward, and suggestions for improving 

future efforts. 

Respondents: Respondents include 

CIP Administrators and staff. 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Total 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total 

burden hours 

Annual 

burden hours 

JCAMP CIP Data Capacity Survey ..................................... 106 1 .83 264 88 

JCAMP Pilot Debrief Form .................................................. 24 1 .25 18 6 

Estimated Total Annual Burden 

Hours: 94. 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: Section 5106, Public Law 

111–320, the Child Abuse Prevention 

and Treatment Act Reauthorization Act 

of 2010, and titles IV–B and IV–E of the 

Social Security Act. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–00238 Filed 1–10–22; 8:45 am] 

BILLING CODE 4184–29–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0053] 

Notifying the Food and Drug 

Administration of a Permanent 

Discontinuance or Interruption in 

Manufacturing of a Device Under 

Section 506J of the Federal Food, 

Drug, and Cosmetic Act; 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 ‘‘Notifying FDA of a 

Permanent Discontinuance or 

Interruption in Manufacturing of a 

Device Under Section 506J of the FD&C 

Act.’’ The Federal Food, Drug, and 

Cosmetic Act (FD&C Act) requires 

manufacturers to notify FDA of a 

permanent discontinuance in the 

manufacture of certain devices or an 

interruption in the manufacture of 

certain devices that is likely to lead to 

a meaningful disruption in supply of 

that device in the United States. This 

guidance is intended to assist 

manufacturers in providing timely, 

informative notifications about changes 

in the production of certain medical 

device products that will help prevent 

or mitigate shortages of such devices 

during or in advance of a public health 

emergency. FDA is issuing this guidance 

to implement amendments to the FD&C 

Act by the Coronavirus Aid, Relief, and 

Economic Security Act (CARES Act), as 

it relates to device shortages and 

potential device shortages during or in 

advance of a public health emergency. 

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 March 14, 2022 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 


khammond on DSKJM1Z7X2PROD with NOTICES
1418 Federal Register / Vol. 87, No. 7 / Tuesday, January 11, 2022 / Notices 

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– 

2022–D–0053 for ‘‘Notifying FDA of a 

Permanent Discontinuance or 

Interruption in Manufacturing of a 

Device Under Section 506J of the FD&C 

Act.’’ 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 draft guidance 

document entitled ‘‘Notifying FDA of a 

Permanent Discontinuance or 

Interruption in Manufacturing of a 

Device Under Section 506J of the FD&C 

Act’’ 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 or the 

Center for Biologics Evaluation and 

Research, Office of Communication, 

Outreach, and Development, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20903. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

Brittany Caldwell, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5556, Silver Spring, 

MD 20993–0002, 301–796–5900 or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993, 240–402– 

7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On March 27, 2020, the CARES Act 

was signed into law. Section 3121 of the 

CARES Act amends the FD&C Act by 

adding section 506J to the statute. 

Section 506J of the FD&C Act (21 U.S.C. 

356j) provides the Secretary of Health 

and Human Services with new 

authorities intended to help prevent or 

mitigate medical device shortages 

‘‘during, or in advance of, a public 

health emergency declared by the 

Secretary under section 319 of the 

Public Health Service Act.’’ 

FDA is issuing this guidance to clarify 

and make recommendations regarding 

who should notify FDA, what 

information to include in the 

notification, and how to notify FDA, 

during or in advance of a public health 

emergency, regardless of the type of 

public health emergency. During a 

specific public health emergency, FDA 

may issue additional supplemental 

information to this guidance, through 

FDA’s website or a supplemental 

guidance, to assist manufacturers in 

determining whether a notification 

under section 506J of the FD&C Act 

(hereafter referred to as a ‘‘506J 

notification’’) is required during a 

public health emergency. 

FDA is issuing this draft guidance to 

assist stakeholders in the Agency’s 

implementation of section 506J(a) of the 

FD&C Act outside of the COVID–19 

Public Health Emergency. This draft 

guidance is not intended to supersede 

the COVID–19 Public Health Emergency 

Guidance, ‘‘Notifying CDRH of a 

Permanent Discontinuance or 

Interruption in Manufacturing of a 

Device under 506J of the FD&C Act 

during the COVID–19 Public Health 

Emergency’’ available at https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 

notifying-cdrh-permanentdiscontinuance-or-interruptionmanufacturing-device-under-section506j-fdc, which will be withdrawn at 

the end of the COVID–19 Public Health 

Emergency. Should this guidance be 

finalized before the COVID–19 public 

health emergency declaration expires or 

is withdrawn, the COVID–19 Public 

Health Emergency Guidance will be 

applicable for 506J related issues with 

respect to COVID–19. 

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 ‘‘Notifying FDA of a Permanent 

Discontinuance or Interruption in 

Manufacturing of a Device Under 

Section 506J of the FD&C Act’’. 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 draft guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 7 / Tuesday, January 11, 2022 / Notices 1419 

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, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents or 

https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/ 

biologics-guidances. Persons unable to 

download an electronic copy of 

‘‘Notifying FDA of a Permanent 

Discontinuance or Interruption in 

Manufacturing of a Device Under 

Section 506J of the FD&C Act’’ may send 

an email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number 21003 and complete 

title to identify the guidance you are 

requesting. 

III. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information. 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. 3501–3521). The 

collections of information in section 

506J of the FD&C Act have been 

approved by OMB as listed in the 

following table: 

21 CFR part; guidance; or FDA form Topic OMB Control 

No. 

506J ............................................................................................ Shortages Data Collection .......................................................... 0910–0491 

IV. Other Issues for Consideration 

The Agency invites comments on the 

‘‘Notifying FDA of a Permanent 

Discontinuance or Interruption in 

Manufacturing of a Device Under 

Section 506J of the FD&C Act’’ draft 

guidance, in general, and on the 

following questions, in particular: 

• Section 506J of the FD&C Act 

requires notifications ‘‘during, or in 

advance of’’ a public health emergency. 

Does the draft guidance provide 

sufficient clarity regarding what FDA 

considers to be ‘‘in advance of a public 

health emergency’’? Is there additional 

information that you believe would be 

helpful? If so, what? 

• Are there other situations or 

circumstances that could lead to a 

situation that could be considered to be 

‘‘in advance of a public health 

emergency’’? 

• FDA has proposed providing 

supplemental information during 

specific public health emergencies, 

which is intended to contain 

information specific to that public 

health emergency to assist 

manufacturers in providing 

notifications. Is there specific 

information that you believe should be 

conveyed in such supplements? 

• Are there circumstances where it is 

unclear whether you should notify 

FDA? How could FDA provide clarity? 

• Should FDA notify stakeholders 

when an event is considered to be ‘‘in 

advance of a public health emergency’’, 

and if so, how should FDA best do so? 

• FDA recommends that 

manufacturers provide updates to 

notifications every two weeks unless 

otherwise indicated based on the nature 

of the situation, including the expected 

timeline for recovery, even if the status 

remains unchanged. Please provide 

feedback on this proposed frequency. 

• How can FDA best disseminate 

supplemental information during or in 

advance of a public health emergency to 

manufacturers and other stakeholders? 

• How can FDA keep all stakeholders, 

including healthcare providers and 

patients, better informed regarding 

shortages during or in advance of a 

public health emergency? 

• In the draft guidance document, 

Appendix A displays an example of 

supplemental information for an 

epidemic or pandemic that FDA 

believes would be helpful to assess the 

overall state of the market and help 

inform potential mitigations. What 

additional information might be helpful 

for other public health emergencies? 

Dated: January 5, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–00321 Filed 1–10–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–0609] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Drug Supply Chain 

Security Act Implementation 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by February 

10, 2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0806. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–45, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Drug Supply Chain Security Act 

Implementation 

OMB Control Number 0910–0806— 

Revision 

This information collection supports 

Agency implementation of provisions in 

section 582 of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) regarding 

the pharmaceutical distribution supply 

chain. Section 202 of the Drug Supply 

Chain Security Act (DSCSA) (Title II of 

Pub. L. 113–54), added sections 581 and 

582 to the FD&C Act (21 U.S.C. 360eee 

and 360eee-1) and governs the tracing of 

certain pharmaceutical drugs, outlining 

critical steps for an electronic 

interoperable system to identify these 


khammond on DSKJM1Z7X2PROD with NOTICES