[Federal Register Volume 70, Number 220 (Wednesday, November 16, 2005)]
[Notices]
[Pages 69576-69577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-22671]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0290]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
December 16, 2005.

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 the information 
collection are received, OMB recommends that 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: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

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 the same time that person 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 2004 was 6,626,827. 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 
while contacting potential respondents. Disclaimer entries are not FDA 
commodities.
    In the Federal Register of August 3, 2005 (70 FR 44656), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. One comment was received.
    The Government of Canada is concerned that the methodology used 
does not take into consideration the additional burden of FDA's interim 
final prior notice and regulation rules which came into effect December 
2003. They urged FDA to amend the methodology used to take into 
consideration the additional burden associated with all requirements 
for providing information concerning foreign-origin FDA-regulated 
foods. Of particular concern is the burden resulting from the 
implementation of the prior notice and regulation rules under the 
Public Health Security and Bioterrorism Preparedness and Response Act 
of 2002.
    The burden for the prior notice and regulation rules is reported 
and approved under OMB Control Number 0910-0520; expiration date 
October 31, 2006.
    FDA estimates the burden of the collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             No. of         Annual Frequency       Total Annual         Hours per
                  21 U.S.C. Section                       Respondents         per Response          Responses           Response          Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
801                                                                3,406                 1,089          3,709,134                 .14            519,279
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 69577]]

    Dated: November 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-22671 Filed 11-15-05; 8:45 am]
BILLING CODE 4160-01-S