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This draft guidance refers to 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Does the draft guidance provide 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 


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1420 Federal Register / Vol. 87, No. 7 / Tuesday, January 11, 2022 / Notices 

products as they are distributed within 

the United States. 

To strengthen FDA’s ability to help 

protect consumers from exposure to 

drugs that may be counterfeit, stolen, 

contaminated, or otherwise harmful, 

section 203 of the DSCSA added 

enhanced security provisions to section 

582 of the FD&C Act. The terms and 

definitions established in section 581 of 

the FD&C Act are applicable to 

provisions set forth in section 582, 

which require the capture, exchange, 

and verification of pharmaceutical drug 

product transaction information, 

transaction history, and transaction 

statements by respondents. Section 582 

of the FD&C Act also requires that 

certain notifications are made by 

respondents to FDA and provides for 

respondent notification disclosures 

applicable to suspect and illegitimate 

product data elements. The 

recordkeeping and notification 

provisions included in section 582 also 

provide for inspection of records by 

FDA and establish minimum retention 

schedules. Finally, section 582 of the 

FD&C Act provides for the 

establishment of waivers, exceptions, 

and exemptions from any of the 

requirements. 

To assist respondents with reporting 

requirements, we developed Form FDA 

3911 entitled Drug Notification and the 

corresponding instructional document 

‘‘INSTRUCTIONS FOR COMPLETION 

OF FORM FDA 3911—DRUG 

NOTIFICATION.’’ Form FDA 3911 and 

the instructions are available from, and 

may be completed using, our website at 

https://www.fda.gov/drugs/drug-supplychain-security-act-dscsa/drugnotifications-frequently-askedquestions. Form FDA 3911 is intended 

to provide a uniform format for initial 

notifications, followup notifications, 

and requests for the termination of a 

notification. The guidance document 

entitled ‘‘Drug Supply Chain Security 

Act Implementation: Identification of 

Suspect Product and Notification’’ 

(Revision 1, June 2021; available at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/drug-supply-chain-securityact-implementation-identificationsuspect-product-and-notification) was 

developed to assist respondents with 

identifying a suspect product as defined 

at section 581(21) of the FD&C Act and 

in making determinations in this regard. 

We also developed the draft guidance 

document entitled ‘‘Waivers, 

Exceptions, and Exemptions from the 

Requirements of Section 582 of the 

Federal Food, Drug, and Cosmetic Act’’ 

(May 2018; available at https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 

waivers-exceptions-and-exemptionsrequirements-section-582-federal-fooddrug-and-cosmetic-act). Respondents 

seeking waivers, exceptions, or 

exemptions from any of the 

requirements may submit a request to 

FDA. The draft guidance explains 

Agency established processes by which: 

(1) A trading partner may request a 

waiver from certain requirements in 

section 582 of the FD&C Act if it would 

result in an undue economic hardship 

or for emergency medical reasons; (2) a 

manufacturer or repackager may request 

an exception to the section 582 

requirements related to product 

identifiers if a product is packaged in a 

container too small or otherwise unable 

to accommodate a label with sufficient 

space to bear the required information; 

and (3) FDA may determine other 

products or transactions that shall be 

exempt from requirements of section 

582. 

Respondents to the information 

collection are manufacturers, wholesale 

distributors (‘‘wholesalers’’), dispensers, 

and repackagers, as defined in section 

581 of the FD&C Act, of pharmaceutical 

drug products. 

In the Federal Register of September 

3, 2021 (86 FR 49538), we published a 

60-day notice soliciting public comment 

on the proposed collection of 

information. A few comments were 

received requesting that FDA clarify the 

scope of the information collection 

request. We appreciate these comments. 

Although our 60-day notice discussed 

both draft and final guidance documents 

pertaining to topic-specific statutory 

requirements found in section 582 of the 

FD&C Act, not all the guidance 

documents discussed in the notice 

included information collection as 

defined by the PRA and subject to 

review and approval by OMB. Rather, 

consistent with regulations found in 21 

CFR 10.115, guidance documents are 

intended to communicate the Agency’s 

thinking on a particular topic and can 

therefore be helpful to respondents in 

understanding related information 

collection activities. 

To clarify however, this information 

collection request is intended to account 

for the burden respondents may incur 

from completing and submitting 

notifications as required by section 582 

of the FD&C Act using Form FDA 3911, 

consistent with the corresponding 

instructions, as well as the burden that 

may be attributable to information 

collection associated with the required 

disclosures/notifications to trading 

partners and discussed in the guidance 

document entitled ‘‘Drug Supply Chain 

Security Act Implementation: 

Identification of Suspect Product and 

Notification.’’ The information 

collection request is also intended to 

account for the burden that respondents 

may incur associated with requesting 

waivers, exceptions, and exemptions 

provided for in section 582(a)(3) of the 

FD&C Act. To enable respondents to 

make such requests, we are currently 

utilizing information collection 

recommendations discussed in the draft 

guidance document entitled ‘‘Waivers, 

Exceptions, and Exemptions from the 

Requirements of Section 582 of the 

Federal Food, Drug, and Cosmetic Act.’’ 

Specifically, the draft guidance instructs 

respondents on submitting requests and 

identifies responsible Agency review 

components. 

The comments also provided feedback 

on the accuracy of our burden estimates. 

In response to these comments, we have 

revised our estimate of the burden of the 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Sec. 582 of the FD&C Act; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average time 

per response 

(in hours) 

Total hours 

Notifications of illegitimate product: Form FDA 3911 .......... 500 28.2 14,100 8 112,800 

Consultation/terminations of notification of illegitimate 

product (Notifications Guidance, sec. IV.B) ..................... 500 1 500 1 500 

582(a)(3); Waivers, exceptions, and exemptions of any requirement: 

Request submissions (Waivers Guidance, sec. III.A.) ........ 20 1 20 80 1,600 

Material changes (Waivers Guidance, sec. III.D) ................ 1 1 1 16 16 


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Federal Register / Vol. 87, No. 7 / Tuesday, January 11, 2022 / Notices 1421 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

Sec. 582 of the FD&C Act; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average time 

per response 

(in hours) 

Total hours 

Request renewals (Waivers Guidance, sec. III) .................. 1 1 1 16 16 

Total .............................................................................. ........................ ........................ ........................ ........................ 114,932 

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

TABLE 2—ESTIMATED ANNUAL DISCLOSURE BURDEN 1

Sec. 582 of the FD&C Act; activity Number of 

respondents 

Number of 

disclosures 

per respondent 

Total 

disclosures 

Average time 

per disclosure 

(in hours) 

Total hours 

Illegitimate product notifications to trading partners (Notifications Guidance, sec. III.B) ............................................ 500 310 155,000 8 1,240,000 

Illegitimate product notification terminations to trading partners (Notifications Guidance, sec. III) .............................. 500 310 155,000 4 620,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,860,000 

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

We have reorganized the information 

collection by respondent activity and 

clarified where information collection 

elements are discussed in the respective 

guidance documents. Based on 

illegitimate product notifications FDA 

has already received, we previously 

estimated a total of 250 respondents. 

However, we have considered industry 

feedback indicating that more 

notifications may be submitted based on 

stakeholder understanding of FDA’s 

recent clarification of stolen product in 

the ‘‘Definitions of Suspect Product and 

Illegitimate Product for Verification 

Obligations Under the Drug Supply 

Chain Security Act’’ draft guidance 

(June 2021; available at https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 

definitions-suspect-product-andillegitimate-product-verificationobligations-under-drug-supply). As 

such, we have increased our number of 

estimated respondents to 500 and 

assume 40 percent are manufacturers 

(200), 50 percent are wholesale 

distributors (250), and 10 percent are 

pharmacies (50). Because 

manufacturers, repackagers, and 

wholesale distributors are collectively 

responsible for prescription drugs from 

the point of manufacturing through 

distribution in the drug supply chain, 

we continue to assume that these three 

trading partners submit most 

notifications of illegitimate products. 

In response to industry feedback, we 

have increased our estimate of the 

average time per response from 1 hour 

to 8 hours to more accurately reflect the 

burden respondents may incur in 

satisfying the information collection. 

We have otherwise retained the average 

burden per response for activities 

associated with consultations and 

waiver/exception/exemption requests. 

Finally, also based on public comment 

and industry feedback, we have 

increased our estimate of the average 

number of disclosures/notifications per 

respondent, as well as our assumption 

of the average time necessary for each 

disclosure notification, for an increase 

from 66,070 to 1,860,000 hours 

annually. 

As a result of these adjustments, our 

estimated burden for the information 

collection reflects a cumulative increase 

since the last OMB review and approval. 

We attribute this increase to a more 

recent evaluation of the information 

collection and informal 

communications with industry and 

other interested stakeholders regarding 

burden estimates. 

Dated: January 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–00327 Filed 1–10–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Telehealth 

Resource Center Performance 

Measurement Tool, OMB No. 0915– 

0361—Extension 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than March 14, 2022. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or by mail to the 

HRSA Information Collection Clearance 

Officer, Room 14N136B, 5600 Fishers 

Lane, Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Samantha Miller, the acting 


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