Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Notices 10971 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers CMS–304/–304a, 

CMS–367a–d, and CMS–368/–R–144] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. 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 or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including the necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions, the accuracy of 

the estimated burden, ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and the use 

of automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by March 25, 2021. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ website address at 

website address at: https://

www.cms.gov/Regulations-andGuidance/Legislation/Paperwork

ReductionActof1995/PRA-Listing.html 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘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 publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Reconciliation 

of State Invoice (ROSI) and Prior 

Quarter Adjustment Statement (PQAS); 

Use: Form CMS–304 (ROSI) is used by 

manufacturers to respond to the state’s 

rebate invoice for current quarter 

utilization. Form CMS–304a (PQAS) is 

required only in those instances where 

a change to the original rebate data 

submittal is necessary. Effective July 1, 

2021, the Medicaid Drug Rebate 

Program (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 Forms CMS–304 and 

–304a. Separately, we are also updating 

corresponding collection of information 

requests (OMB 0938–0578 and OMB 

0938–0582) so that all the MDP file 

formats, field sizes, and verbiage will 

align across the MDRP. Form Number: 

CMS–304 and –304a (OMB control 

number: 0938–0676); Frequency: 

Quarterly; Affected Public: Private 

sector (Business or other for-profits); 

Number of Respondents: 749; Total 

Annual Responses: 5,841; Total Annual 

Hours: 248,584. (For policy questions 

regarding this collection contact Andrea 

Wellington at 410–786–3490.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Medicaid Drug 

Rebate Program Labeler Reporting 

Format; Use: Labelers transmit drug 

product and pricing data to CMS within 

30 days after the end of each calendar 

month and quarter. CMS calculates the 

unit rebate amount (URA) and the unit 

rebate offset amount (UROA) for each 

new drug application (NDC) and 

distributes to all State Medicaid 

agencies. States use the URA to invoice 

the labeler for rebates and the UROA to 

report onto CMS–64. The monthly data 

is used to calculate Federal Upper Limit 

(FUL) prices for applicable drugs and 

for states that opt to use this data to 

establish their pharmacy reimbursement 

methodology. 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 Forms CMS–367a 

(Quarterly Pricing), CMS–367b 

(Monthly Pricing), CMS–367c (Product 

Data), and CMS–367d (Manufacturer 

Contact Form). Separately, we are also 

updating corresponding collection of 

information requests (OMB 0938–0582 

and OMB 0938–0676) so that all the 

MDP file formats, field sizes, and 

verbiage will align across the MDRP. 

Form Number: CMS–367a, b, c, and d 

(OMB control number: 0938–0578); 

Frequency: Monthly, quarterly, and on 

occasion; Affected Public: Private sector 

(Business or other for-profits); Number 

of Respondents: 749; Total Annual 

Responses: 14,980; Total Annual Hours: 

558,979. (For policy questions regarding 

this collection contact Andrea 

Wellington at 410–786–3490.) 

3. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Medicaid Drug 

Rebate Program State Reporting Forms; 

Use: Form CMS 368 is a report of 

contact for the State to name the 

individuals involved in the Medicaid 

Drug Rebate Program (MDRP) and is 

required only in those instances where 

a change to the originally submitted 

data is necessary. The ability to require 

the reporting of any changes to these 

data is necessary to the efficient 

operation of these programs. Form 

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