Notice2022-09888
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 9, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 89 (Monday, May 9, 2022)</title>
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[Federal Register Volume 87, Number 89 (Monday, May 9, 2022)]
[Notices]
[Pages 27650-27651]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#fcacaebdaf889d9a9abc9a989dd294948fd29b938a"><span class="__cf_email__" data-cfemail="66363427351207000026000207480e0e1548010910">[email protected]</span></a>.
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 <a href="https://www.fda.gov/media/72094/download">https://www.fda.gov/media/72094/download</a>). 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 <a href="https://www.fda.gov/food/federalstate-food-programs/interstate-certified-shellfish-shippers-list">https://www.fda.gov/food/federalstate-food-programs/interstate-certified-shellfish-shippers-list</a>). 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:
<bullet> A list of growing areas with an Approved classification;
<bullet> the most recent sanitary survey for each growing area with
an Approved classification; and
<bullet> 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
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