Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Notices 44569 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Parents/Guardians .......................................... Web Survey .................................................... 900 1 10/60 

Parents/Guardians .......................................... Follow-up web survey .................................... 900 1 1/60 

Parents/Guardians .......................................... Focus Group Screener ................................... 60 1 5/60 

Parents/Guardians .......................................... Focus Group Informed Consent .................... 54 1 5/60 

Parents/Guardians .......................................... Focus Group Moderator ................................. 54 1 1 

__________________________________ 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2013–17799 Filed 7–23–13; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10268, CMS– 

10287, CMS–R–70, CMS–R–72, CMS–R–247, 

CMS–10151, CMS–10380, CMS–10286, and 

CMS–10339] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

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 

(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 

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 August 23, 2013. 

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) 395–6974, 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: Reinstatement of a currently 

approved collection; Title of 

Information Collection: Consolidated 

Renal Operations in a Web Enabled 

Network (CROWNWeb) Third-party 

Submission Authorization Form; Use: 

The Consolidated Renal Operations in a 

Web Enabled Network (CROWNWeb) 

Third-Party Submission Authorization 

form (CWTPSA) is to be completed by 

‘‘Facility Administrators’’ 

(administrators of CMS-certified dialysis 

facilities) if they intend to authorize a 

third party (a business with which the 

facility is associated, or an independent 

vendor) to submit data to us to comply 

with the recently-revised Conditions for 

Coverage of dialysis facilities. The 

CROWNWeb system is the system used 

as the collection point of data necessary 

for entitlement of ESRD patients to 

Medicare benefits and for Federal 

Government monitoring and assessing 

of the quality and types of care provided 

to renal patients. The information 

collected through the CWTPSA form 

will allow us along with our contractors 

to receive data from authorized parties 

acting on behalf of CMS-certified 

dialysis facilities. Since February 2009, 

we have received 4,160 CWTPSA forms 

and anticipates that they will continue 

to receive no more than 400 new 

CWTPSA forms annually to address the 

creation of new facilities under the 

current participating ‘‘third party 

submitters.’’ Form Number: CMS–10268 

(OCN: 0938–1052); Frequency: 

Occasionally; Affected Public: Private 

Sector—Business or other for-profits 

and Not-for-profit institutions; Number 

of Respondents: 400; Total Annual 

Responses: 400; Total Annual Hours: 

34. (For policy questions regarding this 

collection contact Michelle Tucker at 

410–786–0736.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Medicare 

Quality of Care Complaint Form; Use: In 


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44570 Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Notices 

accordance with Section 1154(a)(14) of 

the Social Security Act, Quality 

Improvement Organizations (QIOs) are 

required to conduct appropriate reviews 

of all written complaints submitted by 

beneficiaries concerning the quality of 

care received. The Medicare Quality of 

Care Complaint Form will be used by 

Medicare beneficiaries to submit quality 

of care complaints. This form will 

establish a standard form for all 

beneficiaries to utilize and ensure 

pertinent information is obtained by 

QIOs to effectively process these 

complaints. Form Number: CMS–10287 

(OCN: 0938–1102); Frequency: 

Reporting—Occasionally; Affected 

Public: Individuals or Households; 

Number of Respondents: 3,500; Total 

Annual Responses: 3,500; Total Annual 

Hours: 583. (For policy questions 

regarding this collection contact Coles 

Mercier at 410–786–2112.) 

3. Type of Information Collection 

Request: Reinstatement with a change of 

a previously approved collection; Title 

of Information Collection: Information 

Collection Requirements in HSQ–110, 

Acquisition, Protection and Disclosure 

of Peer review Organization Information 

and Supporting Regulations in 42 CFR, 

Sections 480.104, 480.105, 480.116, and 

480.134; Use: The Peer Review 

Improvement Act of 1982 authorizes 

quality improvement organizations 

(QIOs), formally known as peer review 

organizations (PROs), to acquire 

information necessary to fulfill their 

duties and functions and places limits 

on disclosure of the information. The 

QIOs are required to provide notices to 

the affected parties when disclosing 

information about them. These 

requirements serve to protect the rights 

of the affected parties. The information 

provided in these notices is used by the 

patients, practitioners and providers to: 

obtain access to the data maintained and 

collected on them by the QIOs; add 

additional data or make changes to 

existing QIO data; and reflect in the 

QIO’s record the reasons for the QIO’s 

disagreeing with an individual’s or 

provider’s request for amendment.: 

Form Number: CMS–R–70 (OCN: 0938– 

0426); Frequency: Reporting—On 

occasion; Affected Public: Business or 

other for-profits; Number of 

Respondents: 400; Total Annual 

Responses: 21,200; Total Annual Hours: 

42,400. (For policy questions regarding 

this collection contact Coles Mercier at 

410–786–2112.) 

4. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: 

Information Collection Requirements in 

42 CFR 478.18, 478.34, 478.36, 478.42, 

QIO Reconsiderations and Appeals; Use: 

In the event that a beneficiary, provider, 

physician, or other practitioner does not 

agree with the initial determination of a 

Quality Improvement Organization 

(QIO) or a QIO subcontractor, it is 

within that party’s rights to request 

reconsideration. The information 

collection requirements 42 CFR 478.18, 

478.34, 478.36, and 478.42, contain 

procedures for QIOs to use in 

reconsideration of initial 

determinations. The information 

requirements contained in these 

regulations are on QIOs to provide 

information to parties requesting the 

reconsideration. These parties will use 

the information as guidelines for appeal 

rights in instances where issues are 

actively being disputed. Form Number: 

CMS–R–72 (OCN: 0938–0443); 

Frequency: Reporting—On occasion; 

Affected Public: Individuals or 

Households and Business or other forprofit institutions; Number of 

Respondents: 2,590; Total Annual 

Responses: 5,228; Total Annual Hours: 

2,822. (For policy questions regarding 

this collection contact Coles Mercier at 

410–786–2112.) 

5. Type of Information Collection 

Request: Reinstatement with a change of 

a previously approved collection; Title 

of Information Collection: Expanded 

Coverage for Diabetes Outpatient SelfManagement Training Services and 

Supporting Regulations Contained in 42 

CFR 410.141, 410.142, 410.143, 410.144, 

410.145, 410.146, 414.63; Use: 

According to the National Health and 

Nutrition Examination Survey 

(NHANES), as many as 18.7 percent of 

Americans over age 65 are at risk for 

developing diabetes. The goals in the 

management of diabetes are to achieve 

normal metabolic control and reduce 

the risk of micro- and macro-vascular 

complications. Numerous epidemiologic 

and interventional studies point to the 

necessity of maintaining good glycemic 

control to reduce the risk of the 

complications of diabetes. Despite this 

knowledge, diabetes remains the leading 

cause of blindness, lower extremity 

amputations and kidney disease 

requiring dialysis. Diabetes and its 

complications are primary or secondary 

factors in an estimated 9 percent of 

hospitalizations (Aubert, RE, et al., 

Diabetes-related hospitalizations and 

hospital utilization. In: Diabetes in 

America. 2nd ed. National Institutes of 

Health, National Institute of Diabetes 

and Digestive and Kidney Disease, NIH, 

Pub. No 95–1468–1995: 553–570). 

Overall, beneficiaries with diabetes are 

hospitalized 1.5 times more often than 

beneficiaries without diabetes. HCFA– 

3002–F provided for uniform coverage 

of diabetes outpatient self-management 

training services. These services include 

educational and training services 

furnished to a beneficiary with diabetes 

by an entity approved to furnish the 

services. The physician or qualified 

non-physician practitioner treating the 

beneficiary’s diabetes would certify that 

these services are needed as part of a 

comprehensive plan of care. This rule 

established the quality standards that an 

entity would be required to meet in 

order to participate in furnishing 

diabetes outpatient self-management 

training services. It set forth payment 

amounts that have been established in 

consultation with appropriate diabetes 

organizations. It implements section 

4105 of the Balanced Budget Act of 

1997. Form Number: CMS–R–247 (OCN: 

0938–0818); Frequency: Recordkeeping 

and Reporting—Occasionally; Affected 

Public: Business or other for-profit 

institutions; Number of Respondents: 

5327; Total Annual Responses: 63,924; 

Total Annual Hours: 197,542. (For 

policy questions regarding this 

collection contact Kristin Shifflett at 

410–786–4133.) 

6. Type of Information Collection 

Request: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: Data Collection 

for Medicare Beneficiaries Receiving 

Implantable Cardioverter-Defibrillators 

for Primary Prevention of Sudden 

Cardiac Death; Use: We provide 

coverage for implantable cardioverterdefibrillators (ICDs) for secondary 

prevention of sudden cardiac death 

based on extensive evidence showing 

that use of ICDs among patients with a 

certain set of physiologic conditions are 

effective. Accordingly, we consider 

coverage for ICDs reasonable and 

necessary under Section 1862 (a) (1) (A) 

of the Social Security Act. However, 

evidence for use of ICDs for primary 

prevention of sudden cardiac death is 

less compelling for certain patients. 

To encourage responsible and 

appropriate use of ICDs, we issued a 

‘‘Decision Memo for Implantable 

Defibrillators’’ on January 27, 2005, 

indicating that ICDs will be covered for 

primary prevention of sudden cardiac 

death if the beneficiary is enrolled in 

either an FDA-approved category B IDE 

clinical trial (42 CFR 405.201), a trial 

under the CMS Clinical Trial Policy 

(NCD Manual § 310.1) or a qualifying 

prospective data collection system 

(either a practical clinical trial or 

prospective systematic data collection, 

which is sometimes referred to as a 

registry). Form Number: CMS–10151 

(OMB#: 0938–0967); Frequency: 

Occasionally; Affected Public: Private 


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Sector; Business or other for-profits, 

Not-for-profit institutions; Number of 

Respondents: 1,702; Total Annual 

Responses: 82; Total Annual Hours: 

139,356. (For policy questions regarding 

this collection contact JoAnna Baldwin 

at 410–786–7205.) 

7. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Reporting 

Requirements for Grants to Support 

States in Health Insurance Rate Review 

and Pricing Transparency—Cycles I, II, 

and III; Use: Under the Section 1003 of 

the Affordable Care Act (ACA) (Section 

2794 of the Public Health Service Act), 

the Secretary, in conjunction with the 

states and territories, 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(c) requires the 

Secretary to establish the Rate Review 

Grant Program to States to assist states 

to implement this provision. In 

addition, Section 2794(c) requires the 

Rate Review Grant Program to assist 

states in the establishment and 

enhancement of ‘‘Data Centers’’ that 

collect, analyze, and disseminate health 

care pricing data to the public. 

The U.S. Department of Health and 

Human Services (HHS) released the Rate 

Review Grants Cycle I funding 

opportunity twice—first to states (and 

the District of Columbia) in June 2010 

and then to the territories and the five 

states that did not apply during the first 

release, (http://www.hhs.gov/ociio/

initiative/final_premium_review_grant_

solicitation.pdf). The second release was 

due to the decision that the territories 

were subject to provisions of the ACA 

and hence eligible for the Rate Review 

Grants. Forty-five (45) states, 5 U.S. 

territories, and the District of Columbia 

were awarded grants. On February 24, 

2011, HHS released the Funding 

Opportunity Award (FOA) for Cycle II 

Rate Review Grants. On December 21, 

2012, Cycle II of the Rate Review Grant 

Program was amended in order to 

include an additional application date. 

Thirty (30) states, the District of 

Columbia, and three territories were 

awarded grants in Cycle II. 

On May 8, 2013, CMS published the 

Cycle III Funding Opportunity 

Announcement, ‘‘Grants to Support 

States in Health Insurance Rate Review 

and Pricing Transparency’’. On July 12, 

2013, the Funding Opportunity 

Announcement for Cycle III of the Rate 

Review Grants Program was amended in 

order to extend the deadline for 

submission of Letters of Intent. 

Concurrent with the publication of the 

Funding Opportunity Announcement 

for Cycle III, CMS published associated 

grantee reporting requirements 

consisting of: (4) quarterly reports, (5) 

rate review transaction data reports 

(quarterly and annual), (1) annual 

report, and (1) final report from all 

grantees. This information collection is 

required for effective monitoring of 

grantees and to fulfill statutory 

requirements under section 

2794(b)(1)(A) of the ACA that requires 

grantees, as a condition of receiving a 

grant authorized under section 2794(c) 

of the ACA, to report to the Secretary 

information about premium increases. 

Form Number: CMS–10380 (OCN: 

0938–1121); Frequency: Annually; On 

Occasion; Affected Public: Public 

Sector—State and Territory 

Governments; Number of Respondents: 

56; Total Annual Responses: 1,001; 

Total Annual Hours: 31,378; (For policy 

questions regarding this collection 

contact Sarah Norman at 301–492– 

4185.) 

8. Type of Information Collection 

Request: Reinstatement with change of a 

previously approved information 

collection; Title of Information 

Collection: Notice of Research Exception 

under the Genetic Information 

Nondiscrimination Act; Use: Under the 

Genetic Information Nondiscrimination 

Act of 2008 (GINA), a plan or issuer may 

request (but not require) a genetic test in 

connection with certain research 

activities so long as such activities 

comply with specific requirements, 

including: (i) The research complies 

with 45 CFR part 46 or equivalent 

Federal regulations and applicable State 

or local law or regulations for the 

protection of human subjects in 

research; (ii) the request for the 

participant or beneficiary (or in the case 

of a minor child, the legal guardian of 

such beneficiary) is made in writing and 

clearly indicates that compliance with 

the request is voluntary and that noncompliance will have no effect on 

eligibility for benefits or premium or 

contribution amounts; and (iii) no 

genetic information collected or 

acquired will be used for underwriting 

purposes. The Secretary of Labor or the 

Secretary of Health and Human Services 

is required to be notified if a group 

health plan or health insurance issuer 

intends to claim the research exception 

permitted under Title I of GINA. 

Nonfederal governmental group health 

plans and issuers solely in the 

individual health insurance market or 

Medigap market will be required to file 

with the Centers for Medicare & 

Medicaid Services (CMS). The Notice of 

Research Exception under the Genetic 

Information Nondiscrimination Act is a 

model notice that can be completed by 

group health plans and health insurance 

issuers and filed with either the 

Department of Labor or CMS to comply 

with the notification requirement. Form 

Number: CMS–10286 (OCN: 0938– 

1077); Frequency: On Occasion; 

Affected Public: State, Local, or Tribal 

Governments, Private Sector; Number of 

Respondents: 2; Total Annual 

Responses: 2; Total Annual Hours: 1; 

(For policy questions regarding this 

collection contact Usree 

Bandyopadhyay at 410–786–6650.) 

9. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Pre-Existing 

Health Insurance Plan and Supporting 

Regulations; Use: On March 23, 2010, 

the President signed into law H.R. 3590, 

the Patient Protection and Affordable 

Care Act (Affordable Care Act), Public 

Law 111–148. Section 1101 of the law 

establishes a ‘‘temporary high risk 

health insurance pool program’’ (which 

has been named the Pre-Existing 

Condition Insurance Plan, or PCIP) to 

provide health insurance coverage to 

currently uninsured individuals with 

pre-existing conditions. The law 

authorizes HHS to carry out the program 

directly or through contracts with states 

or private, non-profit entities. 

We are requesting an extension of this 

package because this information is 

needed to assure that PCIP programs are 

established timely and effectively. This 

request is being made based on 

regulations and guidance that have been 

issued and contracts which have been 

executed by HHS with states or an 

entity on their behalf participating in 

the PCIP program. PCIP is also referred 

to as the temporary qualified high risk 

insurance pool program, as it is called 

in the Affordable Care Act, but we have 

adopted the term PCIP to better describe 

the program and avoid confusion with 

the existing state high risk pool 

programs. Form Number: CMS–10339 

(OMB#: 0938–1100); Frequency: 

Reporting—On occasion; Affected 

Public: state governments; Number of 

Respondents: 51; Total Annual 

Responses: 2,652; Total Annual Hours: 

36,924. (For policy questions regarding 

this collection contact William Brice at 

410–786–1777.) 

Dated: July 19, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–17821 Filed 7–23–13; 8:45 am] 

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