Federal Register / Vol. 79, No. 187 / Friday, September 26, 2014 / Notices 57933 

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 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. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by October 27, 2014: 

ADDRESSES: When commenting on the 

proposed information collections, 

please reference the document identifier 

or OMB control number. To be assured 

consideration, comments and 

recommendations must be received by 

the OMB desk officer via one of the 

following transmissions: OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–5806 OR, Email: 

OIRA_submission@omb.eop.gov. 

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’ Web site address at 

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

PaperworkReductionActof1995. 

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: 

Reports Clearance Office at (410) 786– 

1326. 

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: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Cost Sharing 

Reduction Reconciliation; Use: Under 

established Department of Health and 

Human Services (HHS) regulations, 

qualified health plan (QHP) issuers will 

receive estimated advance payments of 

cost-sharing reductions throughout the 

year. Each issuer will then be subject to 

a reconciliation process at the end of the 

benefit year to ensure that HHS 

reimburses each issuer only for actual 

cost sharing. This proposed collection 

establishes the data elements that a QHP 

issuer would be required to report to 

HHS in order to establish the costsharing reductions provided on behalf 

of enrollees for the benefit year. 

Comments were received and addressed 

in a Response to Comments document. 

Form Number: CMS–10526 (OMB 

control number: 0938–NEW); 

Frequency: Annually; Affected Public: 

Private sector—Business or other forprofits; Number of Respondents: 295; 

Total Annual Responses: 4 million; 

Total Annual Hours: 2,469. (For policy 

questions regarding this collection 

contact Patricia Meisol at 410–786– 

1917.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved information collection; Title 

of Information Collection: Medicaid 

Incentives for Prevention of Chronic 

Disease (MIPCD) Demonstration; Use: 

Under section 4108(d)(1) of the 

Affordable Care Act, we are required to 

contract with an independent entity or 

organization to conduct an evaluation of 

the Medicaid Incentives for Prevention 

of Chronic Disease (MIPCD) 

demonstration. The contractor will 

conduct state site visits, two rounds of 

focus group discussions, interviews 

with key program stakeholders, and 

field a beneficiary satisfaction survey. 

Both the state site visits and interviews 

with key program stakeholders will 

entail one-on-one interviews; however 

each set will have a unique data 

collection form. Thus, each evaluation 

task listed above has a separate data 

collection form and this proposed 

information collection encompasses six 

data collection forms. The purpose of 

the evaluation and assessment includes 

determining the following: 

• The effect of such initiatives on the 

use of health care services by Medicaid 

beneficiaries participating in the 

program; 

• The extent to which special 

populations (including adults with 

disabilities, adults with chronic 

illnesses, and children with special 

health care needs) are able to participate 

in the program; 

• The level of satisfaction of 

Medicaid beneficiaries with respect to 

the accessibility and quality of health 

care services provided through the 

program; and 

• The administrative costs incurred 

by state agencies that are responsible for 

administration of the program. 

Subsequent to the initial OMB 

approval issued January 23, 2014, we 

have added two Administrative Cost 

forms to the information collection. The 

burden estimates for this information 

collection have been revised to account 

for the burden associated with the new 

forms. Form Number: CMS–10477 

(OMB control number: 0938–1219); 

Frequency: Annually; Affected Public: 

Individuals and Households, Private 

sector—Business or other for-profits and 

Not-for-profit institutions, State, Local 

or Tribal Governments; Number of 

Respondents: 4,706; Total Annual 

Responses: 4,706; Total Annual Hours: 

2,236. (For policy questions regarding 

this collection contact Jean Scott at 410– 

786–6327.) 

Dated: September 23, 2014. 

Martique Jones, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2014–22980 Filed 9–25–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–4175–N] 

Medicare Program; Medicare Appeals; 

Adjustment to the Amount in 

Controversy Threshold Amounts for 

Calendar Year 2015 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

annual adjustment in the amount in 

controversy (AIC) threshold amounts for 

Administrative Law Judge (ALJ) 

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57934 Federal Register / Vol. 79, No. 187 / Friday, September 26, 2014 / Notices 

hearings and judicial review under the 

Medicare appeals process. The 

adjustment to the AIC threshold 

amounts will be effective for requests 

for ALJ hearings and judicial review 

filed on or after January 1, 2015. The 

calendar year 2015 AIC threshold 

amounts are $150 for ALJ hearings and 

$1,460 for judicial review. 

DATES: This notice is effective on 

January 1, 2015. 

FOR FURTHER INFORMATION CONTACT: Liz 

Hosna (Katherine.Hosna@cms.hhs.gov), 

(410) 786–4993. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 1869(b)(1)(E) of the Social 

Security Act (the Act), as amended by 

section 521 of the Medicare, Medicaid, 

and SCHIP Benefits Improvement and 

Protection Act of 2000 (BIPA), 

established the amount in controversy 

(AIC) threshold amounts for 

Administrative Law Judge (ALJ) hearing 

requests and judicial review at $100 and 

$1,000, respectively, for Medicare Part 

A and Part B appeals. Section 940 of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA), amended section 

1869(b)(1)(E) of the Act to require the 

AIC threshold amounts for ALJ hearings 

and judicial review to be adjusted 

annually. The AIC threshold amounts 

are to be adjusted, as of January 2005, 

by the percentage increase in the 

medical care component of the 

consumer price index (CPI) for all urban 

consumers (U.S. city average) for July 

2003 to July of the year preceding the 

year involved and rounded to the 

nearest multiple of $10. Section 

940(b)(2) of the MMA provided 

conforming amendments to apply the 

AIC adjustment requirement to 

Medicare Part C/Medicare Advantage 

(MA) appeals and certain health 

maintenance organization and 

competitive health plan appeals. Health 

care prepayment plans are also subject 

to MA appeals rules, including the AIC 

adjustment requirement. Section 101 of 

the MMA provides for the application of 

the AIC adjustment requirement to 

Medicare Part D appeals. 

A. Medicare Part A and Part B Appeals 

The statutory formula for the annual 

adjustment to the AIC threshold 

amounts for ALJ hearings and judicial 

review of Medicare Part A and Part B 

appeals, set forth at section 

1869(b)(1)(E) of the Act, is included in 

the applicable implementing 

regulations, 42 CFR 405.1006(b) and (c). 

The regulations require the Secretary of 

the Department of Health and Human 

Services (the Secretary) to publish 

changes to the AIC threshold amounts 

in the Federal Register 

(§ 405.1006(b)(2)). In order to be entitled 

to a hearing before an ALJ, a party to a 

proceeding must meet the AIC 

requirements at § 405.1006(b). Similarly, 

a party must meet the AIC requirements 

at § 405.1006(c) at the time judicial 

review is requested for the court to have 

jurisdiction over the appeal 

(§ 405.1136(a)). 

B. Medicare Part C/MA Appeals 

Section 940(b)(2) of the MMA applies 

the AIC adjustment requirement to 

Medicare Part C appeals by amending 

section 1852(g)(5) of the Act. The 

implementing regulations for Medicare 

Part C appeals are found at 42 CFR part 

422, subpart M. Specifically, §§ 422.600 

and 422.612 discuss the AIC threshold 

amounts for ALJ hearings and judicial 

review. Section 422.600 grants any party 

to the reconsideration, except the MA 

organization, who is dissatisfied with 

the reconsideration determination, a 

right to an ALJ hearing as long as the 

amount remaining in controversy after 

reconsideration meets the threshold 

requirement established annually by the 

Secretary. Section 422.612 states, in 

part, that any party, including the MA 

organization, may request judicial 

review if the AIC meets the threshold 

requirement established annually by the 

Secretary. 

C. Health Maintenance Organizations, 

Competitive Medical Plans, and Health 

Care Prepayment Plans 

Section 1876(c)(5)(B) of the Act states 

that the annual adjustment to the AIC 

dollar amounts set forth in section 

1869(b)(1)(E) of the Act applies to 

certain beneficiary appeals within the 

context of health maintenance 

organizations and competitive medical 

plans. The applicable implementing 

regulations for Medicare Part C appeals 

are set forth in 42 CFR part 422, subpart 

M, and as discussed previously, apply 

to these appeals. The Medicare Part C 

appeals rules also apply to health care 

prepayment plan appeals. 

D. Medicare Part D (Prescription Drug 

Plan) Appeals 

The annually adjusted AIC threshold 

amounts for ALJ hearings and judicial 

review that apply to Medicare Parts A, 

B, and C appeals also apply to Medicare 

Part D appeals. Section 101 of the MMA 

added section 1860D–4(h)(1) of the Act 

regarding Part D appeals. This statutory 

provision requires a prescription drug 

plan sponsor to meet the requirements 

set forth in sections 1852(g)(4) and (g)(5) 

of the Act, in a similar manner as MA 

organizations. As noted previously, the 

annually adjusted AIC threshold 

requirement was added to section 

1852(g)(5) of the Act by section 

940(b)(2)(A) of the MMA. The 

implementing regulations for Medicare 

Part D appeals can be found at 42 CFR 

part 423, subparts M and U. The 

regulations at § 423.562(c) prescribe 

that, unless the Part D appeals rules 

provide otherwise, the Part C appeals 

rules (including the annually adjusted 

AIC threshold amount) apply to Part D 

appeals to the extent they are 

appropriate. More specifically, 

§§ 423.1970 and 423.1976 of the Part D 

appeals rules discuss the AIC threshold 

amounts for ALJ hearings and judicial 

review. Section 423.1970(a) grants a Part 

D enrollee, who is dissatisfied with the 

independent review entity (IRE) 

reconsideration determination, a right to 

an ALJ hearing if the amount remaining 

in controversy after the IRE 

reconsideration meets the threshold 

amount established annually by the 

Secretary. Sections 423.1976(a) and (b) 

allow a Part D enrollee to request 

judicial review of an ALJ or MAC 

decision if, in part, the AIC meets the 

threshold amount established annually 

by the Secretary. 

II. Provisions of the Notice—Annual 

AIC Adjustments 

A. AIC Adjustment Formula and AIC 

Adjustments 

As previously noted, section 940 of 

the MMA requires that the AIC 

threshold amounts be adjusted 

annually, beginning in January 2005, by 

the percentage increase in the medical 

care component of the CPI for all urban 

consumers (U.S. city average) for July 

2003 to July of the year preceding the 

year involved and rounded to the 

nearest multiple of $10. 

B. Calendar Year 2015 

The AIC threshold amount for ALJ 

hearing requests will rise to $150 and 

the AIC threshold amount for judicial 

review will rise to $1,460 for CY 2015. 

These amounts are based on the 46.480 

percent increase in the medical care 

component of the CPI level, which was 

at 297.600 in July 2003 and rose to 

435.924 in July 2014. The AIC threshold 

amount for ALJ hearing requests 

changes to $146.48 based on the 46.480 

percent increase over the initial 

threshold amount of $100 established in 

2003. In accordance with section 

1869(b)(1)(E)(iii) of the Act, the adjusted 

threshold amounts are rounded to the 

nearest multiple of $10. Therefore, the 

CY 2015 AIC threshold amount for ALJ 

hearings is $150.00. The AIC threshold 

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Federal Register / Vol. 79, No. 187 / Friday, September 26, 2014 / Notices 57935 

amount for judicial review changes to 

$1,464.80 based on the 46.480 percent 

increase over the initial threshold 

amount of $1,000. This amount was 

rounded to the nearest multiple of $10, 

resulting in the CY 2015 AIC threshold 

amount of $1,460.00 for judicial review. 

C. Summary Table of Adjustments in 

the AIC Threshold Amounts 

In the following table we list the CYs 

2011 through 2015 threshold amounts. 

CY 2011 CY 2012 CY 2013 CY 2014 CY 2015 

ALJ Hearing ............................................................................................. $130 $130 $140 $140 $150 

Judicial Review ........................................................................................ 1,300 1,350 1,400 1,430 1,460 

III. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). 

Dated: September 11, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–22625 Filed 9–25–14; 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; Announcement of Office of 

Management and Budget Approval; 

Guidance for Industry: Animal Drug 

User Fees and Fee Waivers and 

Reductions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Guidance for Industry: Animal Drug 

User Fees and Fee Waivers and 

Reductions’’ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On July 

08, 2014, the Agency submitted a 

proposed collection of information 

entitled ‘‘Guidance for Industry: Animal 

Drug User Fees and Fee Waivers and 

Reductions’’ to OMB for review and 

clearance under 44 U.S.C. 3507. 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 OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0540. The 

approval expires on August 31, 2017. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/

public/do/PRAMain. 

Dated: September 23, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–22981 Filed 9–25–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0075] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Good Laboratory 

Practice Regulations for Nonclinical 

Studies 

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 

(PRA). 

DATES: Fax written comments on the 

collection of information by October 27, 

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 0910–0119. 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, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, 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. 

Good Laboratory Practice Regulations 

for Nonclinical Studies—21 CFR Part 

58 (OMB Control Number 0910–0119)— 

Extension 

Sections 409, 505, 512, and 515 of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 348, 355, 360b, 360e) and 

related statutes require manufacturers of 

food additives, human drugs and 

biological products, animal drugs, and 

medical devices to demonstrate the 

safety and utility of their product by 

submitting applications to FDA for 

research or marketing permits. Such 

applications contain, among other 

important items, full reports of all 

studies done to demonstrate product 

safety in man and/or other animals. In 

order to ensure adequate quality control 

for these studies and to provide an 

adequate degree of consumer protection, 

the Agency issued good laboratory 

practice (GLP) regulations for 

nonclinical laboratory studies in part 58 

(21 CFR part 58). The regulations 

specify minimum standards for the 

proper conduct of safety testing and 

contain sections on facilities, personnel, 

equipment, standard operating 

procedures (SOPs), test and control 

articles, quality assurance, protocol and 

conduct of a safety study, records and 

reports, and laboratory disqualification. 

Part 58 requires testing facilities 

engaged in conducting toxicological 

studies to retain, and make available to 

regulatory officials, records regarding 

compliance with GLPs. Records are 

maintained on file at each testing 

facility and examined there periodically 

by FDA inspectors. The GLP regulations 

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