[Federal Register Volume 64, Number 135 (Thursday, July 15, 1999)]
[Notices]
[Pages 38202-38203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18079]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration
[HCFA-0209 and HCFA-1557]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Health Care Financing Administration, HHS.
    In compliance with the requirement of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Health Care Financing 
Administration (HCFA), 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 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

[[Page 38203]]

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 (CLIA) and 
Supporting Regulations in 42 CFR 493.1-493.2001; Form No.: HCFA-0209 
(OMB #0938-0151); Use: CLIA requires the Department of Health and Human 
Services (DHHS) to establish certification requirements for any 
laboratory that performs tests on human specimens, and to certify 
through the issuance of a certificate that those laboratories meet the 
requirements established by DHHS. The information collected on this 
survey form is used in the administrative pursuit of the 
Congressionally-mandated program with regard to regulation of 
laboratories participating in CLIA. Information on personnel 
qualifications of all technical personnel is needed to ensure the 
sample is representative of all laboratories; Frequency: Biennially; 
Affected Public: Business or other for profit, Not for profit 
institutions, Federal Government, and State, Local or Tribal 
Government; Number of Respondents: 26,500; Total Annual Responses: 
13,250; Total Annual Hours: 6,625.
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Survey Report 
Form Clinical Laboratory Improvement Amendments (CLIA) and Supporting 
Regulations in 42 CFR 493.1-493.2001; Form No.: HCFA-1557 (OMB #0938-
0544); Use: CLIA requires the Department of Health and Human Services 
(DHHS) to establish certification requirements for any laboratory that 
performs tests on human specimens, and to certify through the issuance 
of a certificate that those laboratories meet the requirements 
established by DHHS. The information collected on this survey form is 
used in the administrative pursuit of the Congressionally-mandated 
program with regard to regulation of laboratories participating in 
CLIA. In order for the State survey agency to report to HCFA its 
findings on facility compliance with the individual standards on which 
HCFA determines compliance, the surveyor completes the Survey Report 
Form. The Survey Worksheet provides space to document the surveyor's 
notes; Frequency: Biennially; Affected Public: Business or other for 
profit, Not for profit institutions, Federal Government, and State, 
Local or Tribal Government; Number of Respondents: 30,512; Total Annual 
Responses: 15,526; Total Annual Hours: 7,628.
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access HCFA's 
Web Site address at http://www.hcfa.gov/regs/prdact95.htm, or E-mail 
your request, including your address, phone number, OMB number, and 
HCFA document identifier, to P[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 HCFA Paperwork Clearance 
Officer designated at the following address: HCFA, Office of 
Information Services, Security and Standards Group, Division of HCFA 
Enterprise Standards, Attention: Louis Blank, Room N2-14-26, 7500 
Security Boulevard, Baltimore, Maryland 21244-1850.

    Dated: July 8, 1999.
John P. Burke III,
HCFA Reports Clearance Officer, HCFA Office of Information Services, 
Security and Standards Group, Division of HCFA Enterprise Standards.
[FR Doc. 99-18079 Filed 7-14-99; 8:45 am]
BILLING CODE 4120-03-P