42316 Federal Register / Vol. 77, No. 138 / Wednesday, July 18, 2012 / Notices 

Kimberly S. Lane, 

Deputy Director, Office of Science Integrity, 

Office of the Associate Director for Science, 

Office of the Director, Centers for Disease 

Control and Prevention. 

[FR Doc. 2012–17456 Filed 7–17–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–643 and CMS– 

10185] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

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 & 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 function; 

(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. 

1. Type of Information Collection 

Request: Extension without change of a 

currently approved collection. Title of 

Information Collection: Hospice Survey 

and Deficiencies Report Form and 

Supporting Regulations. Use: CMS uses 

the information collected as the basis for 

certification decisions for hospices that 

wish to obtain or retain participation in 

the Medicare and Medicaid programs. 

The information is used by CMS 

regional offices, which have the 

delegated authority to certify Medicare 

facilities for participation, and by State 

Medicaid agencies, which have 

comparable authority under Medicaid. 

The information on the Hospice Survey 

and Deficiencies Report Form is coded 

for entry into the OSCAR system. The 

data is analyzed by the CMS regional 

offices and by the CMS central office 

components for program evaluation and 

monitoring purposes. The information is 

also available to the public upon 

request. Form Number: CMS–643 (OCN 

0938–0379). Frequency: Yearly. Affected 

Public: State, Local, or Tribal 

Governments. Number of Respondents: 

3,644. Total Annual Responses: 1,217. 

Total Annual Hours: 1,217. (For policy 

questions regarding this collection 

contact Kim Roche at 410–786–3524. 

For all other issues call 410–786–1326.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; 

Title of Information Collection: 

Medicare Part D Reporting 

Requirements and Supporting 

Regulations; Use: Title I of 42 CFR, Part 

423, § 423.514, requires each Part D 

Sponsor to have an effective procedure 

to provide statistics indicating: the cost 

of its operations, the patterns of 

utilization of its services, the 

availability, accessibility, and 

acceptability of its services, information 

demonstrating it has a fiscally sound 

operation and other matters as required 

by CMS. In addition, § 423.505 of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act 

(MMA), establishes as a contract 

provision that Part D Sponsors must 

comply with the reporting requirements 

for submitting drug claims and related 

information to CMS. Data collected via 

Medicare Part D Reporting 

Requirements is an integral resource for 

oversight, monitoring, compliance and 

auditing activities necessary to ensure 

quality provision of the Medicare 

Prescription Drug Benefit to 

beneficiaries. The data collected will be 

validated, analyzed, and utilized for 

trend reporting. 

The revisions for the CY 2013 include 

the removal, addition or both of data 

elements for the Prompt Payment by 

Part D Sponsors, Grievances, Fraud, 

Waste, and Abuse Compliance 

Programs, and Plan Oversight of Agents 

reporting sections; however, these 

changes resulted in no changes to the 

burden for these sections. In addition, 

we added data elements and revised 

data elements for the Medication 

Therapy Management Programs and the 

Coverage Determinations and 

Exceptions reporting sections, which 

resulted in an increase in burden hours 

for both sections. Lastly, we removed 

the following reporting sections and 

decreased burden estimates associated 

with these sections because these data 

are no longer necessary for monitoring 

through these reporting requirements: 

Access to Extended Day Supplies at 

Retail Pharmacies; and Pharmacy 

Support of E-prescribing. Form Number: 

CMS–10185 (OMB#: 0938–0992); 

Frequency: Yearly, Quarterly, SemiAnnually; Affected Public: Private 

Sector, business or other for-profit; 

Number of Respondents: 3,180; Total 

Annual Responses: 48,152; Total 

Annual Hours: 76,240. (For policy 

questions regarding this collection 

contact LaToyia Grant at 410–786–5434. 

For all other issues call 410–786–1326.) 

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.hhs.gov/ 

PaperworkReductionActof1995, or 

Email 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. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on August 17, 2012. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS 

Desk Officer, Fax Number: (202) 395– 

6974, Email: 

OIRA_submission@omb.eop.gov. 

Dated: July 12, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–17380 Filed 7–17–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–2567] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

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 & Medicaid 

Services (CMS) 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 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 138 / Wednesday, July 18, 2012 / Notices 42317 

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. 

1. Type of Information Collection 

Request: Extension without change of a 

currently approved collection. Title of 

Information Collection: Deficiencies and 

Plan of Correction (CMS–2567) and 

Supporting Regulations contained in 

42 CFR 488.18, 488.26, and 488.28. Use: 

Section 1864(a) of the Social Security 

Act requires that the Secretary use State 

survey agencies to conduct surveys to 

determine whether health care facilities 

meet Medicare and Clinical Laboratory 

Improvement Amendments 

participation requirements. The CMS– 

2567 form is the means by which the 

survey findings are documented. This 

section of the law further requires that 

compliance findings resulting from 

these surveys be made available to the 

public within 90 days of such surveys. 

The CMS–2567 from is the vehicle for 

this disclosure. The regulations at 42 

CFR 488.18 require that State survey 

agencies document all deficiency 

findings on a statement of deficiencies 

and plan of correction, which is the 

CMS–2567. 42 CFR 488.26 and 488.28 

further delineate how compliance 

findings must be recorded and that CMS 

prescribed forms must be used. 

The form is also used by health care 

facilities to document their plan of 

correction and by CMS, the States, 

facilities, purchasers, consumers, 

advocacy groups, and the public as a 

source of information about quality of 

care and facility compliance. 

Form Number: CMS–2567 (OCN 

0938–0391). Frequency: Yearly and 

occasionally. Affected Public: Private 

Sector (Business or other for-profit and 

not-for-profit institutions). Number of 

Respondents: 62,000. Total Annual 

Responses: 62,000. Total Annual Hours: 

134,540. (For policy questions regarding 

this collection contact Angela MasonElbert at 410–786–8279. For all other 

issues call 410–786–1326.) 

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.hhs.gov/ 

PaperworkReductionActof1995, or 

Email 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. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by September 17, 2012. 

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 lll, Room C4–26– 

05, 7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: July 12, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–17378 Filed 7–17–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0011] 

Establish a Patient-Based Registry To 

Evaluate the Association of 

Gadolinium Based Contrast Agents 

Exposure and Nephrogenic Systemic 

Fibrosis 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of grant funds for the 

support of the development of a patientbased registry to evaluate the 

association of gadolinium based contrast 

agents (GBCAs) exposure and 

nephrogenic systemic fibrosis (NSF). 

The goal of the GBCA project is to study 

the safety of the GBCAs when used as 

indicated. 

DATES: Important dates are as follows: 

1. The application due date is August 

1, 2012. 

2. The anticipated start date is 

September 13, 2012. 

3. The opening date is July 2, 2012. 

4. The expiration date is August, 2, 

2012. 

ADDRESSES: Submit the paper 

application to: Vieda Hubbard, Grants 

Management (HFA–500), 5630 Fishers 

Lane, Rockville, MD 20857, and a copy 

to Ira Krefting, Center for Drug 

Evaluation and Research, Division of 

Medical Imaging Products, 10903 New 

Hampshire Ave., Bldg. 22, rm. 2100, 

Silver Spring, MD 20993. For more 

information, see section III of the 

SUPPLEMENTARY INFORMATION section of 

this notice. 

FOR FURTHER INFORMATION AND

ADDITIONAL REQUIREMENTS CONTACT: Ira 

Krefting, Center for Drug Evaluation and 

Research (CDER), Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 2100, Silver Spring, 

MD 20993, 301–796–1135, Email: 

ira.krefting@fda.hhs.gov; or 

Vieda Hubbard, Office of Acquisitions 

and Grants Services (HFA–500), Food 

and Drug Administration, 5630 

Fishers Lane, rm. 2034, Rockville, MD 

20857, 301–827–7177, Email: 

vieda.hubbard@fda.hhs.gov. 

For more information on this funding 

opportunity announcement (FOA) and 

to obtain detailed requirements, please 

refer to the full FOA located at: http:// 

www.fda.gov/downloads/AboutFDA/ 

CentersOffices/ 

OfficeofMedicalProductsandTobacco/ 

CDER/UCM311309.pdf. 

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description 

RFA–FD–12–029 

93.103 

A. Background 

Annually, millions of patients 

undergo magnetic resonance imaging 

(MRI) and magnetic resonance 

angiography (MRA) procedures 

employing GBCAs. Postmarketing data 

indicate that six of the eight GBCAs 

approved for use in the United States 

have been directly implicated in the 

development of NSF, a newly 

characterized, potentially fatal systemic 

fibrotic skin and internal organ 

condition. Among the factors that may 

increase the risk for NSF are repeated or 

higher than recommended doses of 

GBCA and degree of renal impairment at 

the time of exposure; imaging patients 

with severe renal failure appear to be at 

highest risk. In one, early retrospective 

study of 370 patients with severe renal 

failure who received gadodiamide the 

estimated risk for development of NSF 

was 4 percent (Ref. 1). In a recent 

retrospective chart review study by 

Wang of 52,954 contrast MR 

examinations with restrictive guidelines 

for GBCA in patients with renal failure 

no new cases of NSF were found (Ref. 

2). 


tkelley on DSK3SPTVN1PROD with NOTICES