[Federal Register Volume 87, Number 89 (Monday, May 9, 2022)]
[Notices]
[Pages 27650-27651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-09888]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1112]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Interstate Shellfish 
Dealer's Certificate and Participation in the National Shellfish 
Sanitation Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) 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: Submit written comments (including recommendations) on the 
collection of information by June 8, 2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0021. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

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 Dealer's Certificate and Participation in the 
National Shellfish Sanitary Program

OMB Control Number 0910-0021--Extension

    Under section 243 of the Public Health Service Act (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 authority, FDA participates with State regulatory 
agencies, some foreign nations, and the U.S. 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 dealers. Each participating State and foreign nation monitors 
its molluscan shellfish production and issues certificates for those 
dealers that meet the State or foreign shellfish control authority's 
criteria. Each participating State and nation provides a certificate of 
its certified shellfish dealers to FDA on Form FDA 3038, ``Interstate 
Shellfish Dealer's Certificate'' (available at https://www.fda.gov/media/72094/download). FDA uses this information to publish the 
``Interstate Certified Shellfish Shippers List (ICSSL),'' a monthly 
comprehensive listing of all molluscan shellfish dealers certified 
under the cooperative program (available at https://www.fda.gov/food/federalstate-food-programs/interstate-certified-shellfish-shippers-list). If FDA did not collect the information necessary to compile this 
list, participating States would not be able to identify and prevent 
the distribution in the United States of shellfish processed by 
uncertified dealers. Consequently, the NSSP would not be able to 
control the distribution of uncertified and possibly unsafe shellfish 
in interstate commerce. Without the ICSSL, the effectiveness of the 
NSSP would be nullified. The ICSSL is also used to identify U.S. 
shellfish dealers eligible to obtain health certificates and export to 
certain countries or regions.
    FDA has been collecting information to construct the ICSSL since 
2001. FDA is seeking to add one new data field to Form FDA 3038, the 
``FDA Establishment Identifier'' (FEI number). The FEI number is a 
unique number assigned by FDA to identify FDA-regulated facilities. FDA 
will explore whether the FEI can be used to retrieve data on shellfish 
dealers from existing FDA systems, which could reduce the number of 
required data elements that firms have to submit on Form FDA 3038.
    The information collection also includes providing certain 
documents demonstrating compliance with the NSSP. When a competent 
authority in another country conducts an evaluation to determine 
whether the U.S. food safety control measures for molluscan shellfish 
are equivalent to their system of controls, the competent authority may 
require FDA to provide information and records demonstrating compliance 
with the provisions of the NSSP. Only those firms that comply with the 
NSSP would be permitted to export molluscan shellfish to a country 
whose competent authority determined that the U.S. system of controls 
is equivalent to their own controls. FDA uses this information to 
support the export of U.S. shellfish to countries whose competent 
authorities have determined the U.S. system of food safety controls to 
be equivalent to their own system of controls by demonstrating that the 
exporter is in compliance with the U.S. system of controls specified in 
the NSSP.
    For example, to implement the European Commission's (EC) 
determination that the U.S. system of food safety controls for raw 
bivalve molluscan shellfish is equivalent to the European Union's (EU) 
system of controls, the EC is requiring FDA to provide documentation 
collected from NSSP-participating shellfish control authorities with 
firms seeking to export raw molluscan shellfish to the EU. This 
documentation includes, but is not limited to:
     A list of growing areas with an Approved classification;
     the most recent sanitary survey for each growing area with 
an Approved classification; and
     the most recent inspection report for each firm seeking to 
export shellfish to the EU.
    Some competent authorities may require additional information to 
conduct an equivalence assessment or to implement an equivalence 
determination, or both. We plan to provide respondents with information 
about the specific documentation that is required for each equivalence 
assessment. For those competent authorities that recognize the U.S. 
system as equivalent, additional documentation may be needed to 
implement that determination.
    Description of Respondents: Respondents to this collection are 
participating State and local regulatory agencies and foreign nations.

[[Page 27651]]

    In the Federal Register of November 4, 2022 (86 FR 60840), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                         Number of
              Activity                 Form FDA No.      Number of     responses per   Total annual       Average burden per response       Total hours
                                                        respondents     respondent       responses
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Submission of Interstate Shellfish              3038              40              57           2,280  0.10 (6 minutes)..................             228
 Dealer's Certificate.
Submission of Other Records Related              N/A              13               1              13  0.25 (15 minutes).................            3.25
 to Participation in the NSSP.
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    Total...........................  ..............  ..............  ..............  ..............  ..................................          231.25
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate. This estimate is based on our experience with this 
information collection and the number of certificates received in the 
past 3 years, which has remained constant.

    Dated: May 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09888 Filed 5-6-22; 8:45 am]
BILLING CODE 4164-01-P