[Federal Register Volume 61, Number 91 (Thursday, May 9, 1996)]
[Notices]
[Pages 21186-21187]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11598]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[INFO-96-16]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call the CDC Reports 
Clearance Officer on (404) 639-7090.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques for other 
forms of information technology. Send comments to Wilma Johnson, CDC 
Reports Clearance Officer, 1600 Clifton Road, MS-D24, Atlanta, GA 
30333. Written comments should be received within 60 days of this 
notice.

Proposed Projects

    1. Importation and Shipment of Etiologic Agents--(0920-0199)--
Revision--The Antiterrorism and Effective Death Penalty Act of 1996 
(Public Law 104-132) authorizes the Secretary of Health and Human 
Services (HHS) to regulate the transfer of certain infectious agents 
harmful to humans. The Centers for Disease Control and Prevention (CDC) 
is the agency within the Department responsible for promulgating 
regulations. CDC is proposing a rule designed to ensure that select 
infectious agents are not shipped to parties not equipped to handle 
them appropriately, or who do not have legitimate reasons to use them 
and to implement a system whereby scientists and researchers involved 
in legitimate research may continue transferring and receiving these 
agents without undue burdens. Respondents include laboratory facilities 
such as those operated by government agencies, universities, research 
institutions, and commercial entities.
    Those facilities requesting select infectious agents listed in the 
regulation must register with the Secretary of HHS, or with registering 
entities authorized by the Secretary, as capable and equipped to handle 
the select infectious agents in accordance with guidelines developed by 
CDC, the National Institutes for Health (NIH) and the Department of 
Defense.
    Once registered, facilities must complete a federally-developed 
form, CDC Form EA-101, for each transfer of the agent. Information on 
this form will include the name of the requestor and requesting 
facility, the name of the transferor and transferring facility, the 
name of the responsible facility official for the transferor and 
requestor, the requesting facility's registration number, the 
transferring facility's registration number, the name of the agent(s) 
being shipped, and the proposed use of the agent. The package is being 
revised to include burden for laboratories to register with the 
Secretary. The total cost to respondents is estimated at $14,490.

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                                                                                          Average               
                                                               Number of    Number of     burden/       Total   
                         Respondents                          respondents   responses/    response   Burden  (in
                                                                            respondent   (in hours)     hrs.)   
----------------------------------------------------------------------------------------------------------------
Laboratory..................................................          100           16          .36          576
Shippers....................................................           20           45          .97          873
                                                             ---------------------------------------------------
    Total...................................................  ...........  ...........  ...........        1,449
----------------------------------------------------------------------------------------------------------------

    2. 1997 National Health Interview Survey, Basic Module--(0920-
0214)--Revision--The annual National Health Interview Survey (NHIS) is 
a basic source of general statistics on the health of the U.S. 
population. Due to the integration of health surveys in the Department 
of Health and Human Services, the NHIS also has become the

[[Page 21187]]

sampling frame and first stage of data collection for other major 
surveys, including the Medical Expenditure Panel Survey, the National 
Survey of Family Growth, and the National Health and Nutrition 
Examination Survey. By linking to the NHIS, the analysis potential of 
these surveys increases. The NHIS has long been used by government, 
university, and private researchers to evaluate both general health and 
specific issues, such as cancer, AIDS, and childhood immunizations. 
Journalists use its data to inform the general public. It will continue 
to be a leading source of data for the Congressionally-mandated 
``Health US'' and related publications, as well as the single most 
important source of statistics to track progress toward the National 
Health Promotion and Disease Prevention Objectives, ``Healthy People 
2,000.''
    Because of survey integration and changes in the health and health 
care of the U.S. population, demands on the NHIS have changed and 
increased, leading to a major redesign which was tested and partially 
implemented in 1996. Improved information technology was included, 
especially computer assisted personal interviewing (CAPI). This 
clearance is for the first full year of data collection using the 
redesigned NHIS data system. This data collection, planned for January-
December 1997, will result in publication of new national estimates of 
health statistics and release of public use micro data files. The new 
data system is expected to be in the field for at least 10 years. The 
total cost to respondents is estimated at $697,500.

----------------------------------------------------------------------------------------------------------------
                                                                                          Average               
                                                               Number of    Number of     burden/       Total   
                         Respondents                          respondents   responses/    response    Burden (in
                                                                            respondent   (in hrs.)      hrs.)   
----------------------------------------------------------------------------------------------------------------
Family......................................................       42,000            1          0.5       21,000
Sample adult................................................       42,000            1          0.5       21,000
Sample child................................................       18,000            1         0.25        4,500
                                                             ---------------------------------------------------
      Total.................................................  ...........  ...........  ...........       46,500
----------------------------------------------------------------------------------------------------------------

    3. National Coal Workers' Autopsy Study Consent Release and History 
Form--(0920-0021)--Revision--Under the Federal Coal Mine Health & 
Safety Act of 1977, PL91-173 (amended the Federal Coal Mine & Safety 
Act of 1969), the Public Health Service has developed a nationwide 
autopsy program (NCWAS) for underground coal miners. The Consent 
Release and History Form is primarily used to obtain written 
authorization from the next-of-kin to perform an autopsy on the 
deceased miner. The study is a service program to aid surviving 
relatives in establishing eligibility for black lung compensation. 
Because a basic reason for the post-mortem exam is research (both 
epidemiological and clinical), included are a minimum of essential 
information regarding the deceased miner, his occupational history, and 
his smoking history. The data collected will be used by the staff at 
NIOSH for research purposes in defining the diagnostic criteria for 
coal workers' pneumoconiosis (black lung) and will be correlated with 
pathologic changes and x-ray findings. The total cost to respondents is 
estimated at $1,250.

----------------------------------------------------------------------------------------------------------------
                                                                                          Average               
                                                               Number of    Number of     burden/       Total   
                         Respondents                          respondents   responses/    response    Burden (in
                                                                            respondent   (in hrs.)      hrs.)   
----------------------------------------------------------------------------------------------------------------
Pathologist.................................................                                                    
Invoice.....................................................          300            1          .05           25
Report......................................................          300            1          .05           25
Next-of-Kin.................................................          300            1          .15           75
                                                             ---------------------------------------------------
      Total.................................................  ...........  ...........  ...........          125
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Wilma G. Johnson,
Acting Associate Director for Policy Planning and Evaluation, Centers 
for Disease Control and Prevention (CDC).
[FR Doc. 96-11598 Filed 5-8-96; 8:45 am]
BILLING CODE 4163-18-P