[Federal Register Volume 70, Number 5 (Friday, January 7, 2005)]
[Notices]
[Page 1446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-311]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-209 and CMS-10008]


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, 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 of a currently 
approved collection; Title of Information Collection: Laboratory 
Personnel Report (Clinical Laboratory Improvement Amendments of 1988 
(CLIA)) and Supporting Regulations in 42 CFR 493.1357, 493.1363, 
493.1405, 493.1406, 493.1411, 493.1417, 493.1423, 493.1443, 493.1449, 
493.1455, 493.1461, 493.1462, 493.1469, 493.1483, 493.1489, and 
493.1491; Use: This form is used by the State agency to determine a 
laboratory's compliance with personnel qualifications under CLIA. This 
information is needed for a laboratory's certification and 
recertification; Form Number: CMS-209 (OMB: 0938-0151); 
Frequency: Biennially; Affected Public: Business or other for-profit, 
Not-for-profit institutions, Federal Government, and State, Local or 
Tribal Government; Number of Respondents: 21,000; Total Annual 
Responses: 10,500; Total Annual Hours: 5,250.
    2. Type of Information Collection: Revision of a currently approved 
collection; Title of Information Collection: Process and Information 
Required to Determine Eligibility of Drugs, Biologicals, and Radio-
pharmaceutical Agents for Transitional Pass-Through Provisions Under 
the Hospital Outpatient Prospective Payment System (OPPS) and 
Supporting Regulations in 42 CFR, Section 419.43; Use: Section 
1833(t)(6) of the Social Security Act provides for temporary additional 
payments or ``transitional pass-through payments'' for certain drugs 
and biological agents. Interested parties such as hospitals, 
pharmaceutical companies, and physicians can apply for transitional 
pass-through payment for drugs and biologicals used with services 
covered under the OPPS. CMS uses this information to determine if the 
criteria for making a transitional pass-through payment are met and if 
an interim HCPCS code for a new drug or biological is necessary. The 
revisions made to this collection include the addition of Section 303 
of the MMA. This new section establishes the use of the average sales 
price (ASP) methodology for payments; Form Number: CMS-1008 
(OMB 0938-0802); Frequency: On occasion; Affected Public: 
Business or other for-profit and Not-for-profit institutions; Number of 
Respondents: 58; Total Annual Responses: 58; Total Annual Hours: 203.
    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/regulations/pra/, or E-mail 
your request, including your address, phone number, OMB number, and CMS 
document identifier, to [email protected], or call the Reports 
Clearance Office on (410) 786-1326.
    Written comments and recommendations for the proposed information 
collections must be mailed within 60 days of this notice directly to 
the CMS Paperwork Reduction Act Reports Clearance Officer designated at 
the address below: CMS, Office of Strategic Operations and Regulatory 
Affairs, Division of Regulations Development, Attention: Melissa 
Musotto, Room C5-14-03, 7500 Security Boulevard, Baltimore, Maryland 
21244-1850.

    Dated: December 29, 2004.
John P. Burke, III,
CMS Paperwork Reduction Act Reports Clearance Officer, Officer of 
Strategic Operations and Regulatory Affairs, Regulations Development 
Group.
[FR Doc. 05-311 Filed 1-6-05; 8:45 am]
BILLING CODE 4120-03-M