[Federal Register Volume 68, Number 112 (Wednesday, June 11, 2003)]
[Notices]
[Pages 34979-34980]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14622]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-0053]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Interstate Shellfish Dealers Certificate

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 
11, 2003.

ADDRESSES: The Office of Management and Budget (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 written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: Fumie Yakota, Desk 
Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Information 
Resources Management (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.

Interstate Shellfish Dealers Certificate (OMB Control Number 0910-
0021)--Extension

    Under 42 U.S.C. 243, FDA is required to cooperate with, and aid, 
State and local authorities in the enforcement of their health 
regulations and is authorized to assist States in the prevention and 
suppression of communicable diseases. Under this

[[Page 34980]]

authority, FDA participates with State regulatory agencies, some 
foreign nations, and the molluscan shellfish industry in the National 
Shellfish Sanitation Program (NSSP).
    The NSSP is a voluntary, cooperative program to promote the safety 
of molluscan shellfish by providing for the classification and patrol 
of shellfish growing waters and for the inspection and certification of 
shellfish processors. Each participating State and foreign nation 
monitors its molluscan shellfish processors and issues certificates for 
those that meet the State or foreign shellfish control authority's 
criteria. Each participating State and nation provides a certificate of 
its certified shellfish processors to FDA on Form FDA 3038 entitled 
``Interstate Shellfish Dealer's Certificate.'' FDA uses this 
information to publish the ``Interstate Certified Shellfish Shippers 
List,'' a monthly comprehensive listing of all molluscan shellfish 
processors certified under the cooperative program. If FDA did not 
collect the information necessary to compile this list, participating 
States would not be able to identify and keep out shellfish processed 
by uncertified processors in other States and foreign nations. 
Consequently, the NSSP would not be able to control the distribution of 
uncertified, and possibly unsafe, shellfish in interstate commerce, and 
its effectiveness would be nullified.
    In the Federal Register of March 6, 2003 (68 FR 10730), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                 Annual Frequency    Total Annual     Hours per
       FDA Form No.         No. of Respondents     per Response        Responses      Response      Total Hours
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FDA 3038                           34                  62             2,108               .10         211
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    This estimate is based on the numbers of certificates received in 
the past 3 years.

    Dated: June 3, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-14622 Filed 6-10-03; 8:45 am]
BILLING CODE 4160-01-S