[Federal Register Volume 65, Number 126 (Thursday, June 29, 2000)]
[Notices]
[Pages 40100-40101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16396]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-0914]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Importer's Entry Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by July 
31, 2000.

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: 
Wendy Taylor, Desk Officer for FDA.

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

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Importer's Entry Notice (OMB Control Number 0910-0046)--Extension

    Section 801 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 381) charges FDA with the following responsibilities: (1) 
Ensuring that foreign-origin FDA-regulated foods, drugs, cosmetics, 
medical devices, and radiological health products offered for import 
into the United States meet the same requirements of the act as do 
domestic products; and (2) preventing shipments from entering the 
country if they are not in compliance.
    The information collected by FDA consists of the following: (1) 
Product code, an alpha-numeric series of characters that identifies 
each product FDA regulates; (2) FDA country of origin, the country 
where the FDA-registered or FDA-responsible firm is located; (3) FDA 
manufacturer, the party who manufactured, grew, assembled, or otherwise 
processed the goods (if more than one, the last party who substantially 
transformed the product); (4) shipper, the party responsible for 
packing, consolidating, or arranging the shipment of the goods to their 
final destination; (5) quantity and value of the shipment; and (6) if 
appropriate, affirmation of compliance, a code that conveys specific 
FDA information, such as registration number, foreign government 
certification, etc. This information is collected electronically by the 
entry filer via the U.S. Customs Service's Automated Commercial System 
at the same time he/she files an entry for import with the U.S. Customs 
Service. FDA uses the information to make admissibility decisions about 
FDA-regulated products offered for import into the United States.
    The annual reporting burden is derived from the basic processes and 
procedures used in fiscal year (FY) 1995. The total number of entries 
submitted to the automated system in FY 1999 was 5,077,493. The total 
number of entries less the disclaimer entries will represent the total 
FDA products entered into the automated system. A total of 51 percent 
of all entries entered into the automated system were entries dealing 
with FDA-regulated products. The number of respondents is a count of 
filers who submit entry data for foreign-origin FDA-regulated products. 
The estimated reporting burden is based on information obtained by FDA 
contacting some potential respondents. Disclaimer entries are not FDA 
commodities.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 40101]]



                                 Table 1.--Estimated Annual Reporting Burden \1\
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                                              Annual
           No. of Respondents             Frequency  per  Total Annual Responses     Hours per      Total Hours
                                             Response                                Response
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3,886                                         652           2,533,355                    .14      354,669
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    In theFederal Register of March 22, 2000 (65 FR 15340), the agency 
requested comments on the proposed collections of information. No 
comments were received.

    Dated: June 22, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-16396 Filed 6-28-00; 8:45 am]
BILLING CODE 4160-01-F