Agency Information Collection Activities: Submission for OMB Review; Comment Request, 10971-10972 [2021-03535]

Download as PDF Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: Centers for Medicare & Medicaid Services SUPPLEMENTARY INFORMATION: William Parham at (410) 786–4669. [Document Identifiers CMS–304/–304a, CMS–367a–d, and CMS–368/–R–144] Agency Information Collection Activities: Submission for OMB Review; Comment Request Centers for Medicare & Medicaid Services, Health and Human Services (HHS). ACTION: Notice. AGENCY: 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. SUMMARY: 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 DATES: VerDate Sep<11>2014 18:36 Feb 22, 2021 Jkt 253001 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 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 10971 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 E:\FR\FM\23FEN1.SGM 23FEN1 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. 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 SUMMARY: VerDate Sep<11>2014 18:36 Feb 22, 2021 Jkt 253001 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: PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 • 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-201509-18/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 E:\FR\FM\23FEN1.SGM 23FEN1

Agencies

[Federal Register Volume 86, Number 34 (Tuesday, February 23, 2021)]
[Notices]
[Pages 10971-10972]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03535]



[[Page 10971]]

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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-and-Guidance/Legislation/PaperworkReductionActof1995/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

[[Page 10972]]

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

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