[Federal Register Volume 64, Number 54 (Monday, March 22, 1999)] [Notices] [Pages 13801-13802] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 99-6882] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 99N-0462] Agency Emergency Processing Request Under OMB Review; Collection; Survey of Manufacturers, Distributors, Repackagers, and Other Drug Distribution Facilities 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, distributors, repackagers, and other drug distribution facilities of Year 2000 compliance. The list of the Year 2000 compliant facilities will be made available to the public via the World Wide Web. FDA is requesting OMB approval within 9 days of receipt of this submission.
Dates
Submit written comments on the collection of information by April 12, 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
Karen L. Nelson, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482.
Supplementary Information
Section 705(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 375(b)) permits the Secretary of Health and Human Services (the Secretary) to disseminate information regarding food, drugs, devices, and cosmetics in situations involving in the opinion of the Secretary imminent danger to health, or gross deception of the consumer. 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, i.e., manufacturer, drug distribution, etc., immediately to allow health care facilities and others to assess their vulnerability to Year 2000 problems and to make corrective actions, if necessary, well in advance of January 1, 2000. The potential existence of Year 2000 problems in the drug industry, could pose potentially serious health and safety consequences. The use of normal clearance procedures would prolong the time needed to assess 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 Drug Manufacturers, Distributors, and Repackagers, and Other Drug Distribution Facilities for Year 2000 Compliance
Facilities will be asked to provide a status on their Year 2000 readiness. They will also be asked if they have contingency plans. The survey will also ask if they have tested, verified, and certified their systems. The request will also ask for a single point of contact at the manufacturer to discuss information. The manufacturer will be able to provide facsimile, electronic, or paper copy of the information to FDA for inclusion in the web site data base. Government agencies, as well as health care facilities and the general public, will have access to the web site to be able to assess their vulnerability to Year 2000 problems and to take corrective actions, if necessary, in advance of January 1, 2000. The posting of information on compliant facilities is designed to provide health care facilities with a positive statement as to the status of compliant firms. Respondents: Manufacturers, distributors, repackagers, and others in the distribution chain of drug products. FDA estimates the burden of this collection as follows:
Table 1.--Estimated Annual Reporting Burden1 ---------------------------------------------------------------------------------------------------------------- Annual No. of Respondents Frequency per Total Annual Hours per Total Hours Response Responses Response ---------------------------------------------------------------------------------------------------------------- 4,000 1 4,000 18 72,000 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA mailing lists were used to estimate the number of firms who would be subject to this collection. FDA estimates that it will take firms an average of 18 hours to collect, prepare, and submit the requested information. These estimates include allowance for variance in the number to be reported by a manufacturer.
Dated: March 15, 1999. William K. Hubbard, Acting Deputy Commissioner for Policy. [FR Doc. 99-6882 Filed 3-19-99; 8:45 am] BILLING CODE 4160-01-F