83 FR 18568 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 82 (April 27, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 82 (April 27, 2018)
| Page Range | 18568-18569 | |
| FR Document | 2018-08893 |
[Federal Register Volume 83, Number 82 (Friday, April 27, 2018)] [Notices] [Pages 18568-18569] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-08893] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS-838] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid 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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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 must be received by June 26, 2018. ADDRESSES: When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways: 1. Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for ``Comment or Submission'' or ``More Search Options'' to find the information collection document(s) that are accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number__, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. 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 https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]. 3. Call the Reports Clearance Office at (410) 786-1326. FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669. SUPPLEMENTARY INFORMATION: Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES). CMS-838 Medicare Credit Balance Reporting Requirements Under the 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 requires federal agencies to publish a 60-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. Information Collection 1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicare Credit Balance Reporting Requirements; Use: Quarterly credit balance reporting is needed to monitor and control the identification and timely collection of improper payments. Credit balances are mainly attributable to provider billing practices and cannot be eliminated by program functions; they will continue to occur. The OIG issued a Management Advisory Report (MAR) on their extended review of credit balances (See Attachment). They state that approximately 90 percent of credit balances result from providers: (1) Billing Medicare and a private insurer for the same service, (2) submitting duplicate billings for services in a manner which cannot be detected by system edits, and (3) billing for services not performed. The MAR recommends that CMS continue its plan of recovery by requiring hospitals to report Medicare credit balances to contractors on a quarterly basis. Form Number: CMS- 838 (OMB control number: 0938-0600); Frequency: Quarterly; Affected Public: Private sector (Business or other For-profits); Number of Respondents: 52,582; Total Annual Responses: [[Page 18569]] 210,328; Total Annual Hours: 630,984. (For policy questions regarding this collection contact Anita Crosier at 410-786-0217). Dated: April 24, 2018. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2018-08893 Filed 4-26-18; 8:45 am] BILLING CODE 4120-01-P
![18568 Federal Register / Vol. 83, No. 82 / Friday, April 27, 2018 / Notices
emerging pathogens. VSP also revised an opportunity for the public to Contents
the VSP Construction Guidelines as a comment on CMS’ intention to collect This notice sets out a summary of the
framework of consistent construction information from the public. Under the use and burden associated with the
and design guidelines related to public Paperwork Reduction Act of 1995 (the following information collections. More
health, including vessel facilities related PRA), federal agencies are required to detailed information can be found in
to food storage, preparation, and service publish notice in the Federal Register each collection’s supporting statement
and water bunkering, storage, concerning each proposed collection of and associated materials (see
disinfection, and distribution. information (including each proposed ADDRESSES).
CDC received five comments on the extension or reinstatement of an existing
document from industry and the public. collection of information) and to allow CMS–838 Medicare Credit Balance
Comments related to document format 60 days for public comment on the Reporting Requirements
(highlighted versions), height proposed action. Interested persons are Under the PRA (44 U.S.C. 3501–
requirements for handwashing stations, invited to send comments regarding our 3520), federal agencies must obtain
requirements for chlorine and pH burden estimates or any other aspect of approval from the Office of Management
monitoring of production water, this collection of information, including and Budget (OMB) for each collection of
language in specific sections of the the necessity and utility of the proposed information they conduct or sponsor.
Operations Manual, and a general information collection for the proper The term ‘‘collection of information’’ is
comment about the effectiveness of the performance of the agency’s functions,
program. defined in 44 U.S.C. 3502(3) and 5 CFR
the accuracy of the estimated burden, 1320.3(c) and includes agency requests
In response to the comments, CDC has ways to enhance the quality, utility, and
provided highlighted versions of the or requirements that members of the
clarity of the information to be public submit reports, keep records, or
2018 Operations Manual and collected, and the use of automated
Construction Guidelines and included provide information to a third party.
collection techniques or other forms of Section 3506(c)(2)(A) of the PRA
requirements for handwashing station information technology to minimize the
height and chlorine and pH monitoring. requires federal agencies to publish a
information collection burden. 60-day notice in the Federal Register
Regarding the comment suggesting
DATES: Comments must be received by concerning each proposed collection of
language changes, CDC developed the
June 26, 2018. information, including each proposed
draft 2018 Operations Manual through a
cooperative change request system with ADDRESSES: When commenting, please extension or reinstatement of an existing
industry. In 2015, CDC provided change reference the document identifier or collection of information, before
request forms and instructions to OMB control number. To be assured submitting the collection to OMB for
industry partners, then held in-person consideration, comments and approval. To comply with this
and web-based meetings with partners recommendations must be submitted in requirement, CMS is publishing this
over 2 years to review the change any one of the following ways: notice.
requests they submitted. Proposed 1. Electronically. You may send your
comments electronically to http:// Information Collection
substantive changes would need to be
accepted through the same process www.regulations.gov. Follow the 1. Type of Information Collection
before CDC could consider including instructions for ‘‘Comment or Request: Extension of a currently
them in the draft 2018 Operations Submission’’ or ‘‘More Search Options’’ approved collection; Title of
Manual. CDC took no action in response to find the information collection Information Collection: Medicare Credit
to the general comment about the document(s) that are accepting Balance Reporting Requirements; Use:
program being ineffective. CDC carefully comments. Quarterly credit balance reporting is
reviewed and considered all comments 2. By regular mail. You may mail needed to monitor and control the
in development of the final documents. written comments to the following identification and timely collection of
address: CMS, Office of Strategic improper payments. Credit balances are
Dated: April 23, 2018. Operations and Regulatory Affairs, mainly attributable to provider billing
Sandra Cashman, Division of Regulations Development, practices and cannot be eliminated by
Executive Secretary, Centers for Disease Attention: Document Identifier/OMB program functions; they will continue to
Control and Prevention. Control Numberll, Room C4–26–05, occur. The OIG issued a Management
[FR Doc. 2018–08870 Filed 4–26–18; 8:45 am] 7500 Security Boulevard, Baltimore, Advisory Report (MAR) on their
BILLING CODE 4163–18–P Maryland 21244–1850. extended review of credit balances (See
To obtain copies of a supporting Attachment). They state that
statement and any related forms for the approximately 90 percent of credit
DEPARTMENT OF HEALTH AND proposed collection(s) summarized in balances result from providers: (1)
HUMAN SERVICES this notice, you may make your request Billing Medicare and a private insurer
using one of following: for the same service, (2) submitting
Centers for Medicare & Medicaid 1. Access CMS’ website address at duplicate billings for services in a
Services https://www.cms.gov/Regulations-and- manner which cannot be detected by
[Document Identifiers: CMS–838] Guidance/Legislation/Paperwork system edits, and (3) billing for services
ReductionActof1995/PRA-Listing.html. not performed. The MAR recommends
Agency Information Collection 2. Email your request, including your that CMS continue its plan of recovery
Activities: Proposed Collection; address, phone number, OMB number, by requiring hospitals to report
daltland on DSKBBV9HB2PROD with NOTICES
Comment Request and CMS document identifier, to Medicare credit balances to contractors
Paperwork@cms.hhs.gov. on a quarterly basis. Form Number:
AGENCY: Centers for Medicare &
3. Call the Reports Clearance Office at CMS–838 (OMB control number: 0938–
Medicaid Services, HHS.
(410) 786–1326. 0600); Frequency: Quarterly; Affected
ACTION: Notice.
FOR FURTHER INFORMATION CONTACT: Public: Private sector (Business or other
SUMMARY: The Centers for Medicare & William Parham at (410) 786–4669. For-profits); Number of Respondents:
Medicaid Services (CMS) is announcing SUPPLEMENTARY INFORMATION: 52,582; Total Annual Responses:
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![Federal Register / Vol. 83, No. 82 / Friday, April 27, 2018 / Notices 18569
210,328; Total Annual Hours: 630,984. anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked
(For policy questions regarding this confidential business information, such as ‘‘confidential’’ will not be disclosed
collection contact Anita Crosier at 410– as a manufacturing process. Please note except in accordance with 21 CFR 10.20
786–0217). that if you include your name, contact and other applicable disclosure law. For
Dated: April 24, 2018. information, or other information that more information about FDA’s posting
identifies you in the body of your of comments to public dockets, see 80
William N. Parham, III,
comments, that information will be FR 56469, September 18, 2015, or access
Director, Paperwork Reduction Staff, Office
posted on https://www.regulations.gov. the information at: https://www.gpo.gov/
of Strategic Operations and Regulatory
• If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015-
Affairs.
with confidential information that you 23389.pdf.
[FR Doc. 2018–08893 Filed 4–26–18; 8:45 am]
do not wish to be made available to the Docket: For access to the docket to
BILLING CODE 4120–01–P
public, submit the comment as a read background documents or the
written/paper submission and in the electronic and written/paper comments
manner detailed (see ‘‘Written/Paper received, go to https://
DEPARTMENT OF HEALTH AND
Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the
HUMAN SERVICES
Written/Paper Submissions docket number, found in brackets in the
Food and Drug Administration heading of this document, into the
Submit written/paper submissions as ‘‘Search’’ box and follow the prompts
[Docket No. FDA–2017–D–2462] follows: and/or go to the Dockets Management
• Mail/Hand delivery/Courier (for
The Index of Legally Marketed Staff, 5630 Fishers Lane, Rm. 1061,
written/paper submissions): Dockets
Unapproved New Animal Drugs for Rockville, MD 20852.
Management Staff (HFA–305), Food and
Minor Species; Guidance for Industry; You may submit comments on any
Drug Administration, 5630 Fishers
Availability guidance at any time (see 21 CFR
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments 10.115(g)(5)).
AGENCY: Food and Drug Administration, submitted to the Dockets Management Submit written requests for single
HHS. Staff, FDA will post your comment, as copies of the guidance to the Policy and
ACTION: Notice of availability. well as any attachments, except for Regulations Staff (HFV–6), Center for
information submitted, marked, and Veterinary Medicine, Food and Drug
SUMMARY: The Food and Drug Administration, 7500 Standish Pl.,
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Administration (FDA) is announcing the Rockville, MD 20855. Send one self-
as detailed in ‘‘Instructions.’’
availability of guidance for industry Instructions: All submissions received addressed adhesive label to assist that
#210 entitled ‘‘The Index of Legally must include the Docket No. FDA– office in processing your requests. See
Marketed Unapproved New Animal 2017–D–2462 for ‘‘The Index of Legally the SUPPLEMENTARY INFORMATION section
Drugs for Minor Species.’’ This final Marketed Unapproved New Animal for electronic access to the draft
guidance describes the process for Drugs for Minor Species.’’ Received guidance document.
adding a new animal drug to the Index comments will be placed in the docket FOR FURTHER INFORMATION CONTACT:
of Legally Marketed Unapproved New and, except for those submitted as Dorothy Bailey, Center for Veterinary
Animal Drugs for Minor Species (the ‘‘Confidential Submissions,’’ publicly Medicine (HFV–50), Food and Drug
Index). The Index consists of a list of viewable at https://www.regulations.gov Administration, 7500 Standish Pl.,
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animal drugs for minor species that between 9 a.m. and 4 p.m., Monday dorothy.bailey@fda.hhs.gov.
meet the requirements of a certain through Friday. SUPPLEMENTARY INFORMATION:
section of the Federal Food, Drug, and • Confidential Submissions—To
Cosmetic Act (FD&C Act). submit a comment with confidential I. Background
DATES: The announcement of the information that you do not wish to be In the Federal Register of September
guidance is published in the Federal made publicly available, submit your 15, 2017 (82 FR 43381), FDA published
Register on April 27, 2018. comments only as a written/paper the notice of availability for a draft
ADDRESSES: You may submit either submission. You should submit two guidance entitled ‘‘The Index of Legally
electronic or written comments on copies total. One copy will include the Marketed Unapproved New Animal
Agency guidances at any time as information you claim to be confidential Drugs for Minor Species’’ giving
follows: with a heading or cover note that states interested persons until November 14,
‘‘THIS DOCUMENT CONTAINS 2017, to comment on the draft guidance.
Electronic Submissions CONFIDENTIAL INFORMATION’’. The FDA received several comments on the
Submit electronic comments in the Agency will review this copy, including draft guidance and those comments
following way: the claimed confidential information, in were considered as the guidance was
• Federal eRulemaking Portal: its consideration of comments. The finalized. Editorial changes were made
https://www.regulations.gov. Follow the second copy, which will have the to improve clarity. The guidance
instructions for submitting comments. claimed confidential information announced in this notice finalizes the
Comments submitted electronically, redacted/blacked out, will be available draft guidance dated September 2017.
including attachments, to https:// for public viewing and posted on The Index consists of a list of legally
www.regulations.gov will be posted to https://www.regulations.gov. Submit marketed unapproved new animal drugs
daltland on DSKBBV9HB2PROD with NOTICES
the docket unchanged. Because your both copies to the Dockets Management for minor species that meet the
comment will be made public, you are Staff. If you do not wish your name and requirements of section 572 of the FD&C
solely responsible for ensuring that your contact information to be made publicly Act.
comment does not include any available, you can provide this
confidential information that you or a information on the cover sheet and not II. Significance of Guidance
third party may not wish to be posted, in the body of your comments and you This level 1 guidance is being issued
such as medical information, your or must identify this information as consistent with FDA’s good guidance
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Document Created: 2018-04-27 01:46:17
Document Modified: 2018-04-27 01:46:17
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments must be received by June 26, 2018. | |
| Contact | William Parham at (410) 786-4669. | |
| FR Citation | 83 FR 18568 |
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