[Federal Register Volume 62, Number 183 (Monday, September 22, 1997)]
[Notices]
[Pages 49519-49520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25020]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0380]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

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 (the PRA).

DATES: Submit written comments on the collection of information by 
October 22, 1997.

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.

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: In compliance with section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed

[[Page 49520]]

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 responsibility for assuring 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 for preventing shipments from entering the country if they are not 
in compliance.
    The information collected by FDA consists of the following: Product 
code, an alpha-numeric series of characters that identifies each 
product FDA regulates; FDA country of origin, the country where the 
FDA-registered or FDA-responsible firm is located; 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); shipper, the party responsible for packing, 
consolidating, or arranging the shipment of the goods to their final 
destination; quantity and value of the shipment; and, 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' 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.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table I.--Estimated Annual Reporting Burden                                  
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                        Annual frequency per       Total annual                                                 
  No. of respondents          response              responses          Hours per response        Total hours    
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2,505................          1,212.54           3,037,426                      0.07            229,693        
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There are no capital costs or operating and maintenance costs associated with this collection.                  

    The source of the estimate for the number of respondents is the 
number of importers who submitted entry data for foreign-origin FDA-
regulated products in 1996. The estimated reporting burden is based on 
information obtained by contacting several past respondents.

    Dated: September 12, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-25020 Filed 9-19-97; 8:45 am]
BILLING CODE 4160-01-F