[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
