Notice2025-11328
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
June 20, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 90 Issue 117 (Friday, June 20, 2025)</title>
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[Federal Register Volume 90, Number 117 (Friday, June 20, 2025)]
[Notices]
[Pages 26308-26309]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-11328]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5338]
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) 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 July 21, 2025.
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#c696948795b2a7a0a086a0a2a7e8aeaeb5e8a1a9b0"><span class="__cf_email__" data-cfemail="c090928193b4a1a6a680a6a4a1eea8a8b3eea7afb6">[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--Revision
Under section 243 of the Public Health Service Act (PHS 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. bivalve
molluscan shellfish industry in the NSSP.
Molluscan shellfish consumed fresh (raw) and fresh frozen poses
unique public health concerns. The safety of molluscan shellfish
directly reflects the cleanliness of the waters where they are grown.
Molluscan shellfish are sessile, filter-feeding organisms that pump
large quantities of water through their bodies during their normal
feeding process. The relationship between shellfish harvesting waters
that are contaminated with sewage and other forms of pollution and food
safety concerns has been demonstrated often. Additionally, bivalve
molluscan shellfish must be held, packed, and shipped under sanitary
conditions to prevent contamination subsequent to harvest and prior to
delivery to the consumer.
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 for download 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>). We also provide information on our website at <a href="https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/state-cooperative-programs/fda-national-shellfish-sanitation-program">https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/state-cooperative-programs/fda-national-shellfish-sanitation-program</a>, which
may serve as a helpful resource to respondents.
Under the authority of section 243 of the PHS Act, we are revising
this information collection to also collect from State regulatory
agencies samples of shellfish, along with metadata (date collected,
temperature, and location). If available, we are also collecting
analytical results needed to classify growing area waters for existing
and emerging food safety hazards and to ensure that shellfish products
of dealers
[[Page 26309]]
listed on the ICSSL are safe. Respondents will have already
independently collected samples at a given location/time (our request
is for an additional sample to be collected and sent to FDA for
analysis) and, in some cases (for requested existing analytical
results), conducted tests associated with information submitted as part
of samples and analytical results. Regarding the collection of samples,
FDA will provide shipping materials for transport and will bear any
shipping costs.
The information collection also includes respondents providing to
FDA 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 bivalve molluscan
shellfish are equivalent to its own 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 bivalve
molluscan shellfish to a country whose competent authority determined
that the U.S. system of controls is equivalent to their own controls.
FDA uses the information collection 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 follows 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 requires FDA to provide documentation
collected from NSSP-participating shellfish control authorities for
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 dealer seeking
to export bivalve molluscan shellfish to the EU.
The examples above are illustrative. Some competent authorities may
require additional information to conduct an equivalence assessment or
to implement an equivalence determination, or both. We 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.
Form FDA 3038 may be submitted on paper or submitted electronically
by State or international officials. These officials securely log into
a shellfish shippers account to fill out Form FDA 3038 electronically.
The information obtained from the form has been entirely automated. The
forms transmitted by the States, after approval by an FDA official, are
entered into an FDA computer database program that allows the addition,
deletion, download, and generation of the Interstate Certified
Shellfish Shippers List, published monthly in PDF format, and may be
updated daily when new data is available.
Description of Respondents: Respondents to this collection are
participating State regulatory agencies and foreign nations.
In the Federal Register of December 19, 2024 (89 FR 103832), we
published a 60-day notice soliciting comment on the proposed collection
of information. Although one comment was received offering support for
FDA's efforts in ensuring the safety of shellfish, it referenced
proposed rulemaking and therefore we are clarifying that this notice
pertains to FDA information collection activities subject to OMB review
and clearance under the PRA of 1995.
We estimate the burden of the collection of information as follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity FDA form Number of responses per Total annual Average burden per response Total hours
No. respondents respondent responses
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Submission of Interstate Shellfish Dealer's 3038 40 57 2,280 0.10 (6 minutes)............... 228
Certificate.
Submission of NSSP Compliance Documentation. N/A 13 1 13 0.25 (15 minutes).............. 3
Submission of Samples and Analytical Results N/A 35 2 70 0.50 (30 minutes).............. 35
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Total................................... ......... .............. .............. .............. ............................... 266
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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 increased our burden estimate by 35
hours and 70 responses due to the program change of collecting samples
and analytical results. We attribute the burden change to an increase
in responses. This estimate is based on our experience with this
information collection and the number of certificates received in the
past 3 years.
Dated: June 13, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11328 Filed 6-18-25; 8:45 am]
BILLING CODE 4164-01-P
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