63302 Federal Register / Vol. 76, No. 197 / Wednesday, October 12, 2011 / Notices 

Frequency of Response: 1. 

Average minutes per response: 15. 

Burden hours: 125. 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid 

Office of Management and Budget 

control number. 

Keith Tucker, 

Paperwork Reduction Act Clearance Officer, 

Office of the Secretary. 

[FR Doc. 2011–26319 Filed 10–11–11; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare and Medicaid 

Services 

[Document Identifier CMS–10379] 

Emergency Clearance: Public 

Information Collection Requirements 

Submitted to the Office of Management 

and Budget (OMB) 

AGENCY: Center for Medicare and 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare and Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

We are, however, requesting an 

emergency review of the information 

collection referenced below. In 

compliance with the requirement of 

section 3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, we have 

submitted to the Office of Management 

and Budget (OMB) the following 

requirements for emergency review. We 

are requesting an emergency review 

because the collection of this 

information is needed before the 

expiration of the normal time limits 

under OMB’s regulations at 5 CFR 

1320.13. This is necessary to ensure 

compliance with an initiative of the 

Administration. We cannot reasonably 

comply with the normal clearance 

procedures in that public harm is 

reasonably likely to result if normal 

clearance procedures are followed as 

stated in 5 CFR 1320.13(a)(2)(i). The 

approval of this data collection process 

is essential to ensuring that consumers 

enrolled in individual and small group 

association products receive the 

consumer protections provided under 

Section 1003 of the Affordable Care Act. 

In absence of this change, a significant 

number of individual and small group 

rate increases for the 2012 plan year 

would not be subject to the review and 

public disclosure requirements of the 

rate review program and, instead, would 

be subject to rate increases that are 

largely unregulated. 

1. Type of Information Collection 

Request: Revision of a currently 

approved; Title of Information 

Collection: Rate Increase Disclosure and 

Review Reporting Requirements (45 

CFR Part 154). Use: Under the Section 

1003 of the Affordable Care Act (Section 

2794 of the Public Health Service Act), 

The Secretary, in conjunction with the 

States, is required to establish a process 

for the annual review, beginning with 

the 2010 plan year, of unreasonable 

increases in premiums for health 

insurance coverage. Section 2794 directs 

the Secretary to ensure the public 

disclosure of information of 

unreasonable rate increases and 

justification for those increases. 

On December 23, 2010, CMS 

published a proposed rate review 

regulation in the Federal Register for 

public comment (Rate Increase 

Disclosure and Review Rule, 75 FR 

81004). CMS revised the proposed rule 

based on the public comments and 

published the final rate review 

regulation in the Federal Register on 

May 19, 2011. The final rule defines the 

unreasonable rate review process and 

issuer reporting and disclosure 

requirements (Rate Increase Disclosure 

and Review Rule, 76 FR 29964). The 

regulation establishes the following 

reporting requirements: 

• The Preliminary Justification: This 

data collection is required of all health 

insurance issuers for all rate increases 

that exceed the ‘‘subject to review’’’ 

reporting threshold as defined in the 

rule. This information will be posted on 

an HHS Web site. 

• Rate Review Final Determination: 

This data collection requires States with 

effective rate review programs and CMS 

to report their review findings and 

unreasonable rate increase 

determinations on all rate increases that 

are subject to review. This information 

will be posted on an HHS Web site. 

• The Final Justification for An 

Unreasonable Rate Increase: This data 

collection is required of health 

insurance issuers that elect to 

implement a rate increase that is 

determined to be unreasonable based on 

State or CMS review. This information 

will be posted on the Health Insurance 

Issuer’s Web site and on a CMS Web 

site. 

1. Preliminary Justification 

The Preliminary Justification consists 

of three parts, Part I: Rate Increase 

Summary, Part II: Written Explanation 

of the Rate Increase, and Part III: Rate 

Filing Documentation. Issuers must 

complete Parts I and II for all rate 

increases that exceed the reporting 

threshold as defined in the rule. As 

described in the preamble of the rule, 

this information would be collected to 

provide consumers with basic 

information on all rate increases that are 

subject to review under the rate review 

program. 

Under the rule, ‘‘subject to review’’ 

rate increases would be reviewed by 

either States or CMS, depending on 

whether a State has an effective rate 

review program. Issuers would only be 

required to submit Part III of the 

Preliminary Justification when CMS is 

conducting the review of a rate increase 

that is ‘‘subject to review.’’ Accordingly, 

Part III requires health insurance issuers 

to provide detailed rate data that would 

be used for the purposes of conducting 

thorough actuarial reviews and for 

making determinations about whether 

rate increases are unreasonable. 

This Notice contains the following 

information about the Preliminary 

Justification: 

• Preliminary Justification Issuer 

Instructions: health insurance issuer 

instructions for completing all three 

parts of the Preliminary Justification. 

• Part I Worksheet: a standardized 

Excel worksheet that must be used to 

complete Part I of the Preliminary 

Justification. 

• Sample internet display of the Rate 

Review Consumer Disclosure: 

Information provided in the Preliminary 

Justification would be posted on an 

HHS Web site. This sample display 

shows how the information contained in 

the Part I Worksheet would be displayed 

to consumers. 

2. Rate Review Final Determination 

Under the rule, States and CMS 

would have to provide a Rate Review 

Final Determination at the close of their 

review of all ‘‘subject to review’’ rate 

increases. The Rate Review Final 


jlentini on DSK4TPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 197 / Wednesday, October 12, 2011 / Notices 63303 

Determination must provide the State’s 

or CMS’ determination on whether a 

rate increases is ‘unreasonable’. Section 

154.301(a)(3) of the rule provides a list 

of actuarial review elements that must 

be taken into account as part of the rate 

review process. The Final 

Determination must provide a brief 

statement explaining how the review of 

elements set forth in § 154.301(a)(3) 

caused the State or CMS to arrive at its 

determination that the rate is 

unreasonable. 

The Rate Review Final Determination 

will be entered into a data entry text box 

in the Rate Review Data Collection 

System. CMS is estimating that this 

statement would be approximately a 

paragraph in length. There is no specific 

form or set of instructions associated 

with this reporting requirement, apart 

from the reporting requirements 

provided in the rule. The information 

provided in the Rate Review Final 

Determination will be posted as part of 

the rate review consumer disclosure 

information on an HHS Web site. 

3. Final Justification for An 

Unreasonable Rate Increase 

The rule states that if a health 

insurance issuer implements a rate 

increase determined by CMS or a State 

to be unreasonable, the health insurance 

issuer must provide a Final Justification 

for an Unreasonable Rate Increase. In 

the Final Justification, issuers would 

have to provide a short statement about 

why they are electing to implement an 

unreasonable rate increase. This 

statement would be entered into a data 

entry text box in the Rate Review Data 

Collection System and would not need 

to be more than a paragraph or two in 

length. There is no form or instructions 

associated with this statement apart 

from the requirements provided in the 

regulation. 

The Final Justification Statement will 

be posted on an HHS Web site in the 

same location as the Preliminary 

Justification and Rate Review Final 

Determination. Additionally, health 

insurance issuers implementing rate 

increases that were determined to be 

unreasonable, must post all of this 

information—the Preliminary 

Justification, the Rate Review Final 

Determination, and the Final 

Justification Statement on their Web 

sites for a period of 3 years. 

In addition to the aforementioned 

requirements, we have revised the 

information collection request as a 

result of an amendment to the 

regulation discussed in the final rule 

that published September 6, 2011 (76 

FR 54969). The amendment to the rate 

review final rule updated the 

applicability of the rate review 

requirements to include products that 

would be considered part of the 

individual or small group market had 

they not been sold through associations, 

including those that are consider to be 

large group products under State law or 

have been otherwise excluded from 

State’s existing definitions for 

individual and small group products. 

This change will result in an increase in 

the total number of rate increases that 

are subject to the rate review reporting 

requirements. The amendment did not 

propose any changes to the information 

that issuers must submit for each rate 

increase. Thus, burden associated with 

each rate increase submission remains 

unchanged from the final rate review 

rule. Form Number: CMS–10379; (OCN: 

0938–1141) Frequency: Annually; 

Affected Public: Private Sector and 

States; Number of Respondents: 452; 

Number of Responses: 1,201; Total 

Annual Hours: 15,213. (For policy 

questions regarding this collection, 

contact Sally McCarty at (301) 492– 

4489. For all other issues call 410–786– 

1326.) 

CMS is requesting OMB review and 

approval of this collection by October 

31, 2011, with a 180-day approval 

period. Written comments and 

recommendations will be considered 

from the public if received by the 

individuals designated below by 

October 21, 2011. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web Site 

address at http://www.cms.gov/ 

PaperworkReductionActof1995/PRAL/ 

list.asp or E-mail your request, 

including your address, phone number, 

OMB number, and CMS document 

identifier, to Paperwork@cms.hhs.gov, 

or call the Reports Clearance Office on 

(410) 786–1326. 

Interested persons are invited to send 

comments regarding the burden or any 

other aspect of these collections of 

information requirements. However, as 

noted above, comments on these 

information collection and 

recordkeeping requirements must be 

received via one of the following 

methods by October 21, 2011. 

1. Electronically. You may submit 

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) 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. 

3. By E-mail to OMB. OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, E-mail: 

OIRA_submission@omb.eop.gov. 

Dated: October 6, 2011. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2011–26344 Filed 10–7–11; 11:15 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0694] 

Guidance for Industry on Warnings 

and Precautions, Contraindications, 

and Boxed Warning Sections of 

Labeling for Human Prescription Drug 

and Biological Products—Content and 

Format; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Warnings and Precautions, 

Contraindications, and Boxed Warning 

Sections of Labeling for Human 

Prescription Drug and Biological 

Products—Content and Format.’’ This 

guidance is intended to assist applicants 

and reviewers in drafting the ‘‘Warnings 

and Precautions, Contraindications, and 

Boxed Warning’’ sections of labeling for 

human prescription drug and biological 

products. The recommendations in this 

guidance will help ensure that the 

labeling is clear, useful, informative, 

and to the extent possible, consistent in 

content and format. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Silver Spring, MD 

20993–0002. Send one self-addressed 

adhesive label to assist that office in 

processing your requests. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 


jlentini on DSK4TPTVN1PROD with NOTICES