[Federal Register Volume 65, Number 56 (Wednesday, March 22, 2000)]
[Notices]
[Pages 15340-15341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7010]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-0914]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Importer's Entry Notice; Extension

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the electronic collection of 
data by FDA regarding FDA-regulated products of foreign origin that are 
being offered for import into the United States.

DATES: Submit written comments on the collection of information by May 
22, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, 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,

[[Page 15341]]

when appropriate, and other forms of information technology.

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 disclaimed 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. Disclaimed entries are not FDA 
commodities.
    FDA estimates the burden of this collection of information as 
follows:

             Table 1.--Estimated Annual Reporting Burden \1\
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                   Annual
    No. of       Frequency                            Hours per   Total
  Respondents       per      Total Annual Responses   Response    Hours
                  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.


    Dated: March 15, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-7010 Filed 3-21-00; 8:45 am]
BILLING CODE 4160-01-F