[Federal Register: August 28, 2003 (Volume 68, Number 167)]
[Page 51787-51788]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0199]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Importer's Entry 

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
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 (the PRA).

DATES:  Fax written comments on the collection of information by 
September 29, 2003.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on

[[Page 51788]]

the information collection are received, OMB recommends that written 
comments be faxed to the Office of Information and Regulatory Affairs, 
OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1472.

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 
goods to their final destinations; (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 he same time he/she files an entry for 
import with the U.S. Custom Service. FDA uses this 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 2002 was 5,496,954. The total 
number of entries less the disclaimer entries will represent the total 
FDA products entered into the automated system. A total of 53 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 
    In the Federal Register of May 23, 2003 (68 FR 28235), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden for this collection of information as 

                                 Table 1.--Estimated Annual Reporting Burden\1\
                                               Annual Frequency     Total Annual     Hours per
Section of the Act      No. of Respondents       per Response        Responses       Response      Total Hours
Section 801 for FY                    3,406                 652        2,955,595          .14           413,833
 2002 Updated
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    Dated: August 22, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-21982 Filed 8-27-03; 8:45 am]