28524 Federal Register / Vol. 79, No. 95 / Friday, May 16, 2014 / Notices 

In the final rule for Stage 2 of 

meaningful use (77 FR 53967), we 

agreed that the burden on eligible 

providers, public health agencies and 

registries would be greatly reduced and 

established that we would create such a 

database and it would serve as the 

definitive information source for 

determining public health agency and 

registry readiness to receive electronic 

data associated with the public health 

meaningful use objectives. The 

information will be made publicly 

available on the CMS Web site 

(www.cms.gov/EHRincentiveprograms) 

in order to provide a centralized 

repository of this information to eligible 

providers and eliminate there multiple 

individual inquiries to multiple public 

health agencies and registries. Form 

Number: CMS–10499 (OMB control 

number: 0938—New); Frequency: 

Yearly; Affected Public: Private sector— 

Business or other for-profits and Notfor-profit institutions; Number of 

Respondents: 250; Total Annual 

Responses: 250; Total Annual Hours: 

83. (For policy questions regarding this 

collection contact Kathleen Connors de 

Laguna at 410–786–2256.) 

3. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Standards 

Related to Reinsurance, Risk Corridors, 

Risk Adjustment, and Payment Appeals; 

Use: The Affordable Care Act provides 

for three premium stabilization 

programs—a reinsurance program, a risk 

corridors program, and a risk 

adjustment program—to mitigate the 

negative impacts of adverse selection 

and market uncertainty. On March 23, 

2012, we published the Premium 

Stabilization Rule (77 FR 17220) to 

implement and set standards for these 

premium stabilization programs. On 

March 11, 2013, we published the final 

Notice of Benefit and Payment 

Parameters for 2014 (‘‘2014 Payment 

Notice’’) (78 FR 15410), to implement 

requirements for various programs 

established by the Affordable Care Act, 

establish standards for the cost-sharing 

reduction program and the premium tax 

credit program, to provide for the 

collection of user fees from issuers to 

fund operations of the Federallyfacilitated Exchange and the risk 

adjustment program in States where 

HHS operates risk adjustment, and to 

expand on standards set forth in the 

Premium Stabilization Rule. We 

published a proposed Notice of Benefit 

and Payment Parameters for 2015 

(‘‘2015 Payment Notice’’) on December 

02, 2013, to expand upon, modify, and 

clarify the provisions of the Premium 

Stabilization Rule, the 2014 Payment 

Notice, and the first and second final 

Program Integrity Rules (78 FR 54070 

and 78 FR 65046). 

The transitional reinsurance program 

and the temporary risk corridors 

program are designed to provide issuers 

with greater payment stability as 

insurance market reforms begin. The 

reinsurance program serves to reduce 

the uncertainty of insurance risk in the 

individual market in each State by 

making payments for high-cost 

enrollees. The HHS-administered risk 

corridors program serves to protect 

against rate-setting uncertainty with 

respect to qualified health plans by 

limiting the extent of issuer losses (and 

gains). The permanent risk adjustment 

program is intended to protect health 

insurance issuers that attract a 

disproportionate number of higher risk 

enrollees, that is, those with chronic 

conditions. These programs will support 

the effective functioning of the 

American Health Benefit Exchanges 

(‘‘Exchanges’’), which will become 

operational by January 1, 2014. The 

Exchanges are individual and small 

group health insurance marketplaces 

designed to enhance competition in the 

health insurance market and to expand 

access to affordable health insurance for 

millions of Americans. Individuals who 

enroll in qualified health plans (QHPs) 

through individual market Exchanges 

may receive premium tax credits to 

make health insurance more affordable 

and financial assistance to reduce cost 

sharing for health care services. The 

information collection requirements 

contained in this information collection 

request will enable States, HHS or both 

States and HHS to implement these 

programs, which will mitigate the 

impact of adverse selection in the 

individual and small group markets 

both inside and outside the Exchange. 

Form Number: CMS–10401 (OMB 

control number: 0938–1155); Frequency: 

Occasionally; Affected Public: State, 

Local and Tribal governments, Private 

sector—Business or other for-profits and 

Not-for-profit institutions; Number of 

Respondents: 2,520; Total Annual 

Responses: 15,600,081,744; Total 

Annual Hours: 17,469,624. (For policy 

questions regarding this collection 

contact Jaya Ghildyal at 301–492–5149.) 

Dated: May 13, 2014. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2014–11388 Filed 5–15–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–7032–CN] 

Health Insurance Marketplace, 

Medicare, Medicaid, and Children’s 

Health Insurance Programs; Meeting of 

the Advisory Panel on Outreach and 

Education (APOE), May 22, 2014; 

Corrections 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Correction notice. 

SUMMARY: This notice corrects an error 

in the notice of meeting that published 

in the May 2, 2014 Federal Register 

titled ‘‘Health Insurance Marketplace, 

Medicare, Medicaid, and Children’s 

Health Insurance Programs; Meeting of 

the Advisory Panel on Outreach and 

Education (APOE), May 22, 2014.’’ 

FOR FURTHER INFORMATION CONTACT: 

Kirsten Knutson, (410) 786–5886. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In FR Doc. 2014- 09989, which 

published in the May 2, 2014 Federal 

Register (79 FR 25133) titled ‘‘Health 

Insurance Marketplace, Medicare, 

Medicaid, and Children’s Health 

Insurance Programs; Meeting of the 

Advisory Panel on Outreach and 

Education (APOE), May 22, 2014’’, there 

was an error that is identified and 

corrected in the Correction of Errors 

section of this correction notice. 

II. Summary of Errors 

On page 25134, we made an error in 

providing information regarding the 

public’s offsite participation in the May 

22, 2014 APOE meeting. 

III. Correction of Errors 

In FR Doc. 2014–09989 of May 2, 

2014 (79 FR 25133), make the following 

correction: 

1. On page 25134, first column, 

second paragraph (ADDRESSES section), 

line 21, the phrase ‘‘engage virtually in 

the open meetings, this APOE meeting 

will be available to view via live Web 

streaming by visiting the link 

www.cms.gov/live during the designated 

time of the meeting.’’ is corrected to 

read ‘‘engage in the open meeting, this 

APOE meeting will be available for 

listening only via a conference call. To 

listen to the meeting, the public may 

dial 1–877–267–1577, then follow the 

instructions on the phone and enter the 

following meeting ID number, 996 925 

940, followed by the pound sign.’’ 


EMCDONALD on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 95 / Friday, May 16, 2014 / Notices 28525 

Authority: (Catalog of Federal Domestic 

Assistance Program No. 93.773, Medicare— 

Hospital Insurance, Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program, and Program No. 93.714, 

Medical Assistance Program) 

Dated: May 13, 2014. 

Kathleen Cantwell, 

Director, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2014–11380 Filed 5–15–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–N–0037] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Animal Drug User 

Fee Act Waivers and Reductions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) 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 June 16, 

2014. 

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, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0540. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 1350 Piccard 

Dr., PI50–400B, Rockville, MD 20850, 

PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Animal Drug User Fees and Fee 

Waivers and Reductions (OMB Control 

Number 0910–0540)—Extension 

Enacted on November 18, 2003, the 

Animal Drug User Fee Act (ADUFA) 

(Pub. L. 108–130) amended the Federal 

Food, Drug, and Cosmetic Act and 

requires FDA to assess and collect user 

fees for certain applications, products, 

establishments, and sponsors. It also 

requires the Agency to grant a waiver 

from, or a reduction of those fees in 

certain circumstances. Thus, to 

implement this statutory provision of 

ADUFA, FDA developed a guidance 

entitled ‘‘Guidance for Industry: Animal 

Drug User Fees and Fee Waivers and 

Reductions.’’ This document provides 

guidance on the types of fees FDA is 

authorized to collect under ADUFA, and 

how to request waivers and reductions 

from FDA’s animal drug user fees. 

Further, this guidance also describes the 

types of fees and fee waivers and 

reductions; what information FDA 

recommends be submitted in support of 

a request for a fee waiver or reduction; 

how to submit such a request; and 

FDA’s process for reviewing requests. 

Respondents to this collection of 

information are new animal drug 

sponsors. Requests for waivers or 

reductions may be submitted by a 

person paying any of the animal drug 

user fees assessed including application 

fees, product fees, establishment fees, or 

sponsor fees. 

In the Federal Register of February 

25, 2014 (79 FR 10532) FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden for this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

740(d)(1)(A); significant barrier to innovation.45 1 time for each application ............... 45 2 90 

740(d)(1)(B); fees exceed cost ......... 8 3.75 .................................................. 30 2 0.5 15 

740(d)(1)(C); free choice feeds ........ 5 1 time for each application ............... 5 2 10 

740(d)(1)(D); minor use or minor 

species.

76 1 time for each application ............... 76 2 152 

740(d)(1)(E); small business ............. 3 1 time for each application ............... 3 2 6 

Request for reconsideration of a decision.2 1 time for each application ............... 2 2 4 

Request for review—(user fee appeal officer).0 1 time for each application ............... 0 0 0 

Total ........................................... ........................ ........................................................... ........................ ........................ 277 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2 30 minutes. 

Based on FDA’s database system, from 

fiscal years 2010 to 2012 there were an 

estimated 173 sponsors subject to 

ADUFA. However, not all sponsors will 

have any submissions in a given year 

and some may have multiple 

submissions. The total number of 

waiver requests is based on the average 

number of submission types received by 

FDA in fiscal years 2010 to 2012. 


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