Federal Register / Vol. 76, No. 131 / Friday, July 8, 2011 / Notices 40369 

when the price of the item exceeds 

$10,000 or when the aggregate amount 

paid for the item or functionally 

equivalent items in the preceding fiscal 

year was $10,000 or more. 

Contracting officers use the 

information to verify offeror/contractor 

compliance with solicitation and 

contract requirements regarding the use 

of recovered materials. Additionally, 

agencies use the information in the 

annual review and monitoring of the 

effectiveness of the affirmative 

procurement programs required by 

RCRA. 

B. Annual Reporting Burden 

Respondents: 64,350. 

Responses per Respondent: 1. 

Annual Responses: 64,350. 

Hours per Response: .325. 

Total Burden Hours: 20,914. 

Obtaining Copies of Proposals: 

Requesters may obtain a copy of the 

information collection documents from 

the General Services Administration, 

Regulatory Secretariat (MVCB), 1275 

First Street, NE., Washington, DC 20405, 

telephone (202) 501–4755. Please cite 

OMB control No. 9000–0134, 

Environmentally Sound Products, in all 

correspondence. 

Dated: July 1, 2011. 

Laura Auletta, 

Acting Director, Office of Governmentwide 

Acquisition Policy, Office of Acquisition 

Policy. 

[FR Doc. 2011–17218 Filed 7–7–11; 8:45 am] 

BILLING CODE 6820–EP–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10388, CMS– 

10252, CMS–R–235, CMS–304 and CMS– 

304a, CMS–368 and CMS–R–144, CMS– 

10123 and CMS–10124] 

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: New collection; Title of 

Information Collection: Section 1115 

Demonstration HIV and AIDS 

Application Template; Use: Section 

1115 of the Social Security Act (the Act) 

allows the Secretary of the Department 

of Health and Human Services (the 

Secretary) to waive selected provisions 

of section 1902 of the Act for 

experimental, pilot, or demonstration 

projects (demonstrations), and to 

provide Federal Financial Participation 

(FFP) for demonstration costs which 

would not otherwise be considered as 

expenditures under the Medicaid State 

plan, when the Secretary finds that the 

demonstrations are likely to assist in 

promoting the objectives of Medicaid. 

While some States have applied for 

section 1115 demonstrations, many 

have not because the process is long and 

often tenuous. The purpose of the 

application template is to streamline the 

process by collecting the minimally 

acceptable amount of information 

required to appropriately review a 

demonstration request. The template 

will minimize the amount of time the 

State spends preparing a demonstration 

request and it should shorten the review 

process because the required 

information should be present. Form 

Number: CMS–10388 (OMB#: 0938– 

NEW); Frequency: Once; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

56; Total Annual Responses: 6; Total 

Annual Hours: 270; (For policy 

questions regarding this collection 

contact Robin Preston at 410–786–3420. 

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

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Certificate of 

Destruction for Data Acquired from the 

Centers for Medicare and Medicaid 

Services; Use: The Certificate of 

Destruction is used by recipients of 

CMS data to certify that they have 

destroyed the data they have received 

through a CMS Data Use Agreement 

(DUA). The DUA requires the 

destruction of the data at the completion 

of the project/expiration of the DUA. 

The DUA addresses the conditions 

under which CMS will disclose and the 

User will maintain CMS data that are 

protected by the Privacy Act of 1974, 

§ 552a and the Health Insurance 

Portability Accountability Act of 1996. 

CMS has developed policies and 

procedures for such disclosures that are 

based on the Privacy Act and the Health 

Insurance Portability Act (HIPAA). The 

Certificate of Destruction is required to 

close out the DUA and to ensure the 

data are destroyed and not used for 

another purpose. Form Number: CMS– 

10252 (OMB#: 0938–1046); Frequency: 

On occasion; Affected Public: Business 

or other for-profit; Number of 

Respondents: 500; Total Annual 

Responses: 500; Total Annual Hours: 

84. (For policy questions regarding this 

collection, contact Sharon Kavanagh at 

(410) 786–5441. For all other issues call 

(410) 786–1326.) 

3. Type of Information Collection 

Request: Reinstatement of a previously 

approved collection; Title of 

Information Collection: Data Use 

Agreement (DUA) for Data Acquired 

from the Centers for Medicare & 

Medicaid Services (CMS); Use: The 

Privacy Act of 1976, § 552a requires the 

Centers for Medicare & Medicaid 

Services (CMS) to track all disclosures 

of the agency’s Personally Identifiable 

Information (PII) and the exceptions for 

these data releases. CMS is also required 

by the Health Insurance Portability and 

Accountability Act (HIPAA) of 1996 and 

the Federal Information Security 

Management Act (FISMA) of 2002 to 

properly protect all PII data maintained 

by the agency. When entities request 

CMS PII data, they enter into a Data Use 

Agreement (DUA) with CMS. The DUA 

stipulates that the recipient of CMS PII 

data must properly protect the data 

according to FISMA and also provide 

for its appropriate destruction at the 

completion of the project/study or the 

expiration date of the DUA. The DUA 

form enables the data recipient and 

CMS to document the request and 

approval for release of CMS PII data. 

The form requires the submitter to 

provide the Requestor’s organization; 

project/study name; CMS contract 

number (if applicable); data descriptions 

and the years of the data; retention date; 

attachments to the agreement; name, 

title, contact information to include 

address, city, state, zip code, phone, email, signature and date signed by the 

requester and custodian; disclosure 

provision; name of Federal Agency 

sponsor; Federal Representative name, 

title, contact information, signature, 

date; CMS representative name, title, 

contact information, signature and date; 

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40370 Federal Register / Vol. 76, No. 131 / Friday, July 8, 2011 / Notices 

and concurrence/non-concurrence 

signatures and dates from 3 CMS 

System Manager or Business Owners. 

While the data elements collected are 

not subject to change, the 

individualized clauses that are 

incorporated into any specific DUA are 

subject to change based on a specific 

case or situation such as disclosures to 

states, oversight agencies or DUAs for 

disproportionate share hospital (DSH) 

data requests as well as updates to 

DUAs with additional data descriptions, 

changes to the requestor or adding 

custodians to current DUAs. Form 

Number: CMS–R–235 (OCN: 0938–0734) 

Frequency: Once; Affected Public: 

Private Sector—Business or other Forprofits and Not-for-profit Institutions; 

Number of Respondents: 2,200; Number 

of Responses: 2,200; Total Annual 

Hours: 916. (For policy questions 

regarding this collection, contact Sharon 

Kavanagh at 410–786–5441. For all 

other issues call (410) 786–1326.) 

4. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Medicaid Drug 

Rebate Program—Labelers 

Reconciliation of State Invoice (CMS– 

304) and Prior Quarter Adjustment 

Statement (CMS–304a); Use: Section 

1927(b)(2) of the Social Security Act 

establishes manufacturer requirements 

for paying quarterly rebates to States as 

part of the Medicaid Drug Rebate 

Program. Specifically, in order to 

receive a rebate on drugs dispensed to 

Medicaid recipients, States are required 

to submit quarterly utilization data to 

drug manufacturers that have national 

rebate agreements with the Federal 

Government. Form CMS–304 is used by 

manufacturers for both unit adjustments 

and disputes in response to the State’s 

invoice for current quarter utilization. 

The form CMS–304a is required only in 

those instances where a manufacturer 

discovers unit adjustments and/or 

disputes from a previous quarter’s State 

invoice. Both forms are used to 

reconcile drug rebate payments made by 

manufacturer with the State invoices of 

rebates due; Form Numbers: CMS–304 

and CMS–304a (OMB#: 0938–0676); 

Frequency: Quarterly; Affected Public: 

Private Sector: Business or other forprofits; Number of Respondents: 1,011; 

Total Annual Responses: 4,044; Total 

Annual Hours: 183,120. (For policy 

questions regarding this collection 

contact Andrea Wellington at 410–786– 

3490. For all other issues call 410–786– 

1326.) 

5. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: State Medicaid 

Drug Rebate Forms: CMS–368 

(Administrative Data) and CMS–R–144 

(Quarterly Report Data); Use: Section 

1927(b)(2) of the Social Security Act 

establishes State requirements for 

reporting drug utilization data to CMS 

and to drug manufacturers participating 

in the Medicaid Drug Rebate Program. 

Specifically, in order to receive a rebate 

on drugs dispensed to Medicaid 

recipients, States are required to submit 

quarterly utilization data reports to drug 

manufacturers that have national rebate 

agreements with the Federal 

Government. In addition, a copy of 

these reports must also be submitted to 

CMS. Form CMS–R–144 is used by the 

States to submit this utilization 

information to both manufacturers and 

CMS. Form CMS–368 is a report of 

contact for the State to name the 

individuals involved in the drug rebate 

program and is required only in those 

instances where a change to the original 

data submittal is necessary. The ability 

to require the reporting of any changes 

to these data is necessary to the efficient 

operation of the rebate program; Form 

Numbers: CMS–R–144 and CMS–368 

(OMB#: 0938–0852); Frequency: 

Quarterly; Affected Public: State, Local 

or Tribal Governments; Number of 

Respondents: 56; Total Annual 

Responses: 224; Total Annual Hours: 

12,101. (For policy questions regarding 

this collection contact Andrea 

Wellington at 410–786–3490. For all 

other issues call 410–786–1326.) 

6. Type of Information Collection 

Request: Extension of a currently 

approved collection; 

7. Title of Information Collection: 

Notice of Provider Non-Coverage (CMS– 

10123) and Detailed Explanation of 

Non-Coverage (CMS–10124); Use: The 

Notice of Medicare Provider NonCoverage (CMS–10123) is used to 

inform fee-for-service Medicare 

beneficiaries of the determination that 

their provider services will end, and of 

their right to an expedited review of that 

determination. The Detailed 

Explanation of Non-Coverage (CMS– 

10124) is used to provide beneficiaries 

who request an expedited determination 

with detailed information of why the 

services should end. The revised Notice 

of Provider Non-Coverage and Detailed 

Explanation of Provider Non-Coverage 

will no longer require use of the 

beneficiary’s Medicare number as a 

patient identifier. Instead, when 

applicable, providers may use a number 

that helps to link the notice with a 

related claim. Form Number: CMS– 

10123 and 10124 (OMB#: 0938–0953); 

Frequency: Occasionally; Affected 

Public: Business or other for-profit, Notfor-profit institutions, and Individuals 

or households; Number of Respondents: 

5,314,164; Total Annual Responses: 

5,314,194; Total Annual Hours: 885,699. 

(For policy questions regarding this 

collection contact Janet Miller at 404– 

562–1799. 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 8, 2011. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS Desk 

Officer, Fax Number: (202) 395–6974, Email: OIRA_submission@omb.eop.gov. 

Dated: July 1, 2011. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2011–17052 Filed 7–7–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10209] 

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 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

mstockstill on DSK4VPTVN1PROD with NOTICES