[Federal Register Volume 64, Number 100 (Tuesday, May 25, 1999)]
[Notices]
[Pages 28203-28204]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-13152]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-1387]


Agency Information Collection Activities; Agency Emergency 
Processing Request Under OMB Review; Survey of Licensed Biologics 
Manufacturers and Registered Blood Establishments for Year 2000 
Compliance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of 
information concerns a survey of manufacturers of biological products, 
including both licensed biologics manufacturers and registered blood 
establishments, to obtain information about the Year 2000 compliance 
status of the facilities used to manufacture regulated products. The 
information will be made available to the public via FDA's web site.

DATES: Submit written comments on the collection of information by June 
1, 1999.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Desk Officer for FDA. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of 
this proposed collection of information under section 3507(j) of the 
PRA (44 U.S.C. 3507(j)) and 5 CFR 1320.13. FDA is requesting certain 
information on the Year 2000 compliance status of biologics 
manufacturing processes. This information is needed immediately in 
order to allow the agency to: (1) Assess the impact of the Year 2000 
problem on the continued availability of an adequate supply of safe and 
effective biological products, (2) properly advise the healthcare 
industry and U.S. public regarding the preparedness of the biologics 
industry, and (3) assess the need for additional government actions to 
address potential supply disruptions. This information is essential to 
the mission of the agency. The potential existence of the Year 2000 
problems in the biologics industry could pose potentially serious 
health and safety consequences. The use of normal clearance procedures 
would prolong the time needed to assess the Year 2000 compliance by 
regulated industry.
    FDA invites comments on: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Title: Survey of Licensed Biologics Manufacturers and Registered 
Blood Establishments for Year 2000 Compliance

    Facilities will be asked to provide information about their Year 
2000 readiness. They will also be asked if they have established 
contingency plans to address potential Year 2000 related problems and 
if those contingency plans address issues with foreign suppliers. The 
request will ask licensed manufacturers if they expect to file 
supplements to their applications for Year 2000 related manufacturing 
changes or as part of contingency planning. The survey will also 
request manufacturers to provide information about their plans and 
capability to increase production should there be an increased demand 
for their products. The survey will request that respondents identify 
contact information, including, where available, the address of a web 
site where more information about their Year 2000 activities can be 
found. The respondents will be able to provide information via 
facsimile or paper copy.
    FDA intends to use the survey information to provide information to 
health care providers and the general public on the status of Year 2000 
readiness of biologics facilities. FDA needs this information in a 
timely manner so as to have sufficient time in which to analyze the 
data received and make the information available.
    Respondents: Licensed biologics manufacturers and registered blood 
establishments.
    FDA estimated the number of respondents through its licensing and 
registration data bases. FDA estimates that it will take firms an 
average of 18 hours to collect, prepare, and submit the requested 
information.
    FDA estimates the burden for this collection of information as 
follows:

[[Page 28204]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                      Annual
               No. of Respondents                  Frequency per   Total Annual      Hours per      Total Hours
                                                     Response        Responses       Response
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3,600                                                   1           3,600              18          64,800
Total                                                                                              64,800
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: May 19, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-13152 Filed 5-24-99; 8:45 am]
BILLING CODE 4160-01-F