Federal Register / Vol. 83, No. 5 / Monday, January 8, 2018 / Notices 819 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10401] 

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 

March 9, 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 lll, 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 

http://www.cms.hhs.gov/Paperwork

ReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

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–10401 Standards Related to 

Reinsurance, Risk Corridors, and 

Risk Adjustment 

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: Revision of a previously 

approved collection; Title of 

Information Collection: Standards 

Related to Reinsurance, Risk Corridors, 

and Risk Adjustment; Use: The data 

collection and reporting requirements 

described below will be used by HHS to 

run the permanent risk adjustment 

program, including validation of data 

submitted by issuers, on behalf of States 

that requested HHS to run it for them. 

Risk adjustment is one of three (3) 

market stability programs established by 

the Patient Protection and Affordable 

Care Act and is intended to mitigate the 

impact of adverse selection in the 

individual and small group health 

insurance markets inside and outside of 

the Health Insurance Exchanges. HHS 

will also use this data to adjust the 

payment transfer formula for risk 

associated with high-cost enrollees. 

State regulators can use the reporting 

requirements outlined in this collection 

to request a reduction to the statewide 

average premium factor of the risk 

adjustment transfer formula, beginning 

for the 2019 benefit year, and thereby 

avoid having to establish their own 

programs. Issuers and providers can use 

the alternative reporting requirements 

for mental and behavioral health records 

described herein to comply with State 

privacy laws. Form Number: CMS– 

10401 (OMB control number: 0938– 

1155); Frequency: Yearly; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

700; Total Annual Responses: 

11,700,000,287; Total Annual Hours: 

5,828,037. (For policy questions 

regarding this collection contact Ernest 

Ayukawa at 410–492–5213.) 

Dated: January 2, 2018. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2018–00086 Filed 1–5–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0231] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Adverse Experience Reporting for 

Licensed Biological Products; and 

General Records 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by February 7, 

2018. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 


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