10972 Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Notices 

CMS–R–144 is required from States 

quarterly to report utilization for any 

drugs paid for during that quarter. 

Effective July 1, 2021, the MDRP is 

updating to a new Medicaid Drug 

Programs (MDP) system which will now 

accept a delimited text file format, 

Comma Separated Values (.CSV), in 

addition to the current Text (.TXT) file 

format. We have also increased several 

file format data field sizes in order to 

accommodate the higher priced drugs 

that are entering the market. These 

changes in conjunction with numerous 

edits to verbiage are applicable to Form 

CMS–R–144. Separately, we are also 

updating corresponding collection of 

information requests (OMB 0938–0578 

and OMB 0938–0676) so that all the 

MDP file formats, field sizes, and 

verbiage will align across the MDRP. 

Form CMS–368 has been revised by 

removing the DUR State Contact 

information and description ‘‘Drug 

Utilization Review (DUR) Program.’’ 

This information is now accounted for 

under OMB 0938–0659. Form Number: 

CMS–368 and –R–144 (OMB control 

number: 0938–0582); Frequency: 

Quarterly and on occasion; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

56; Total Annual Responses: 290; Total 

Annual Hours: 13,669. (For policy 

questions regarding this collection 

contact Andrea Wellington at 410–786– 

3490.) 

Dated: February 17, 2021. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2021–03535 Filed 2–22–21; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0197] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Shortages Data 

Collections 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 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 revision of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collections associated with Shortages 

Data Collections and with notifications 

to FDA of an interruption or permanent 

discontinuance in manufacturing of 

certain medical devices as required by 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act). 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 26, 2021. 

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 April 26, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of April 26, 2021. 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– 

2012–N–0197 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Shortages 

Data Collection.’’ 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 

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 

Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Notices 10973 

1Under section 506J of the FD&C Act, 

manufacturers of the following devices must notify 

FDA of an interruption or permanent 

discontinuance in manufacturing: 

• Devices that are critical to public health during 

a public health emergency, including those that are 

life-supporting, life-sustaining, or intended for use 

in emergency medical care or during surgery; or 

• Devices for which FDA determines information 

on potential meaningful supply disruptions is 

needed during a public health emergency. 

See section 506J(a)(1) and (2) of the FD&C Act. 

2See section 506J(a) of the FD&C Act. 

3Available at: https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/ 

notifying-cdrh-permanent-discontinuance-orinterruption-manufacturing-device-under-section506j-fdc. 

‘‘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 revision 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. 

Shortages Data Collections 

OMB Control Number 0910–0491— 

Revision 

Under section 1003(d)(2) of the FD&C 

Act (21 U.S.C. 393(d)(2)), the 

Commissioner of Food and Drugs is 

authorized to implement general powers 

(including conducting research) to carry 

out effectively the mission of FDA. 

After the events of September 11, 

2001, and as part of broader 

counterterrorism and emergency 

preparedness activities, FDA’s Center 

for Devices and Radiological Health 

(CDRH) began developing operational 

plans and interventions that would 

enable CDRH to anticipate and respond 

to medical device shortages that might 

arise in the context of federally declared 

disasters/emergencies or regulatory 

actions. In particular, CDRH identified 

the need to acquire and maintain 

detailed data on domestic inventory, 

manufacturing capabilities, distribution 

plans, and raw material constraints for 

medical devices that would be in high 

demand and/or would be vulnerable to 

shortages in specific disaster/emergency 

situations or following specific 

regulatory actions. Such data could 

support prospective risk assessment, 

help inform risk mitigation strategies, 

support real-time decision making by 

the Department of Health and Human 

Services (HHS) during actual 

emergencies or emergency preparedness 

exercises, and mitigate or prevent harm 

to the public health. 

This voluntary data collection process 

consists of outreach to firms who have 

been identified as producing or 

distributing medical devices that may be 

considered essential to the response 

effort. In this initial outreach, the intent 

and goals of the data collection effort 

will be described, and the specific data 

request made. Data will be collected, 

using least burdensome methods, in a 

structured manner to answer specific 

questions. After the initial outreach, we 

will request updates to the information 

on a quarterly basis to keep the data 

current and accurate. Additional 

followup correspondence may 

occasionally be needed to verify/ 

validate data, confirm receipt of 

followup correspondence(s), and/or 

request additional details to further 

inform FDA’s public health response. 

These data, collected under section 

1003(d)(2) of the FD&C Act, are 

currently approved under OMB control 

number 0910–0491. We have made 

minor changes to this ‘‘Shortages data 

collection’’ at this time (see first row of 

table 1 of this document) to reflect 

additional learnings from recent 

experience. 

The Coronavirus Aid, Relief, and 

Economic Security Act (CARES Act) 

was enacted on March 27, 2020. Section 

3121 of the CARES Act amended the 

FD&C Act by adding section 506J (21 

U.S.C. 356j). Section 506J of the FD&C 

Act provides FDA with new authorities 

intended to help prevent or mitigate 

medical device shortages by requiring 

medical device manufacturers to inform 

FDA about changes in device 

manufacturing that could potentially 

lead to a device shortage. Apprised with 

that information, section 506J authorizes 

FDA to take several actions that may 

help to mitigate or avoid supply 

disruptions. 

Section 506J of the FD&C Act requires 

manufacturers of certain devices,1 to 

notify FDA ‘‘of a permanent 

discontinuance in the manufacture of 

the device’’ or an interruption in ‘‘the 

manufacture of the device that is likely 

to lead to a meaningful disruption in 

supply of that device in the United 

States’’ during or in advance of a 

declared public health emergency 

(PHE), and the reason for such 

discontinuance or interruption.2 Section 

506J requires FDA to take action based 

on that information, including (1) 

publicly posting a list of devices it 

determines to be in shortage, (2) 

publicly posting the reasons for the 

shortage, and (3) issuing letters to 

manufacturers that fail to comply with 

the notification requirements of section 

506J. 

Section 3087 of the 21st Century 

Cures Act, signed into law in December 

2016, added subsection (f) to section 

319 of the Public Health Service Act. 

This new subsection gives the HHS 

Secretary the authority to waive PRA 

requirements with respect to voluntary 

collections of information during a PHE, 

as declared by the Secretary, or when a 

disease or disorder is significantly likely 

to become a PHE. In 2020 FDA 

published the immediately in effect 

guidance document entitled ‘‘Notifying 

CDRH of a Permanent Discontinuance or 

Interruption in Manufacturing of a 

Device Under Section 506J of the FD&C 

Act During the COVID–19 Public Health 

Emergency (Revised)—Guidance for 

Industry and Food and Drug 

Administration Staff’’ (see 86 FR 106, 

January 4, 2021) 3 to implement section 

506J of the FD&C Act, as it relates to 

device shortages and potential device 

shortages occurring during the COVID– 

19 pandemic, for the duration of the 

COVID–19 PHE. The guidance includes 

10974 Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Notices 

4See https://aspe.hhs.gov/system/files/pdf/ 

258866/FDA-PHE-PRA-Waiver-Notice_COVID-19_

03.19.20.pdf. 

additional voluntary items that 

manufacturers could provide the 

Agency, including additional 

information about device manufacturing 

and supply, and updates to initial 

notifications. While PRA requirements 

for the voluntary information 

collections recommended in the 

guidance are waived 4 during the 

COVID–19 pandemic PHE using this 

new authority, mandatory collections 

such as those under section 506J of the 

FD&C Act may not be part of the waiver. 

FDA requested emergency clearance 

under 44 U.S.C. 3507(j) and 5 CFR 

1320.13 to immediately approve 

revision of OMB control number 0910– 

0491 to add the information collection 

required by section 506J of the FD&C 

Act, as amended. The emergency 

clearance approval expires on May 31, 

2021; therefore, CDRH is requesting a 

revision of OMB control number 0910– 

0491 to add the information collection 

required by 506J of the FD&C Act. 

FDA estimates the burden of this 

collection of information as follows: 

I. Shortages Data Collection Currently 

Approved Under OMB Control Number 

0910–0491 

FDA bases these estimates on past 

experiences with direct contact with the 

medical device manufacturers and 

distributors, and anticipated changes in 

the medical device manufacturing and 

distributions patterns for the specific 

devices that may be monitored. FDA 

estimates that there may be up to 500 

manufacturers and distributors for 

which there may be targeted outreach 

because their devices may be essential 

to the response effort. This targeted 

outreach will be conducted quarterly to 

either obtain primary data or to verify/ 

validate updated data (although 

additional outreach may be undertaken 

as needed). 

From the manufacturer and 

distributor’s point of view, the data 

being requested represent common data 

elements that they monitor and track as 

part of routine business operations and 

therefore are readily available. It is 

anticipated that for most manufacturers 

and distributors, the estimated time to 

fulfill CDRH’s data request will not 

exceed 30 minutes per request, or 2 

hours per year. 

II. Information Collection Under 

Section 506J of the FD&C Act and 

Related Voluntary Collections 

Based on current registration and 

listing data (approved under OMB 

control number 0910–0625), we 

estimate the number of respondents that 

will submit a notification under section 

506J of the FD&C Act to be 

approximately 20 percent of currently 

registered manufacturers. Data from our 

Registration & Listing system indicates 

that there are approximately 42,000 

unique FDA Establishment 

Identification registered manufacturers. 

Therefore, we estimate 8,400 

respondents per year. We believe that 

the burden as well as the provision of 

required information under section 506J 

of the FD&C Act—as well as additional 

voluntary information related to the 

determination (including additional 

issues that may impact the availability 

of the device, such as information about 

critical suppliers, potential mitigations, 

production capacity and market share, 

and notification updates)—is minimal 

and such information is readily 

available to manufacturers of the 

applicable devices. Therefore, we 

estimate the burden of this information 

collection to be 15 minutes or less per 

determination and notification. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Shortages data collection ............................................ 500 4 2,000 0.5 (30 minutes) ..... 1,000 

Information collection under section 506J of the 

FD&C Act.

8,400 1 8,400 0.25 (15 minutes) ... 2,100 

Additional voluntary collections related to section 

506J of the FD&C Act.

8,400 1 8,400 0.25 (15 minutes) ... 2,100 

Total ...................................................................... ........................ ........................ 18,800 ................................ 5,200 

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

The information collection reflects a 

revision to add the information 

collection required by section 506J of 

the FD&C Act (as amended by section 

3121 of the CARES Act) and additional 

voluntary collections related to section 

506J of the FD&C Act to OMB control 

number 0910–0491. 

Upon review of OMB control number 

0910–0491, we note that there is a dataentry error in the RISC/ORIA Combined 

Information System (ROCIS) for a 

previous information collection 

approval on February 3, 2020. 

Currently, ROCIS lists the total burden 

hours for that approval as 390 hours; the 

correct total burden hour estimate is 520 

hours. This error has carried through to 

the current total hour burden listed in 

ROCIS as 2,481 hours for the approval 

on November 24, 2020; the correct total 

burden hour estimate should be 2,611 

hours. We will correct this error upon 

submission of this information 

collection request to OMB. 

Additionally, we have updated the 

number of respondents in each 

information collection to reflect our 

current data and estimations. 

These revisions and adjustments 

reflect an overall increase of 2,589 hours 

to the (corrected) estimated total 

burden. 

Dated: February 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03630 Filed 2–22–21; 8:45 am] 

BILLING CODE 4164–01–P