Agency Information Collection Activities: Submission for OMB Review; Comment Request
| Published date | 23 February 2021 |
| Citation | 86 FR 10971 |
| Record Number | 2021-03535 |
| Section | Notices |
| Court | Centers For Medicare & Medicaid Services |
10971
Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Notices
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/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
VerDate Sep<11>2014 18:36 Feb 22, 2021 Jkt 253001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 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.
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
VerDate Sep<11>2014 18:36 Feb 22, 2021 Jkt 253001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\23FEN1.SGM 23FEN1
