Notice2024-30228
Agency Information Collection Activities; Proposed Collection; Comment Request; Interstate Shellfish Dealer's Certificate and Participation in the National Shellfish Sanitation Program
Primary source
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Published
December 19, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the Interstate Shellfish Dealer's Certificate as well as the collection of other records related to participation in the National Shellfish Sanitation Program (NSSP).
Full Text
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<title>Federal Register, Volume 89 Issue 244 (Thursday, December 19, 2024)</title>
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[Federal Register Volume 89, Number 244 (Thursday, December 19, 2024)]
[Notices]
[Pages 103832-103835]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-30228]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5338]
Agency Information Collection Activities; Proposed Collection;
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 Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions of
the Interstate Shellfish Dealer's Certificate as well as the collection
of other records related to participation in the National Shellfish
Sanitation Program (NSSP).
DATES: Either electronic or written comments on the collection of
information must be submitted by February 18, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 18, 2025. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted,
[[Page 103833]]
such as medical information, your or anyone else's Social Security
number, or confidential business information, such as a manufacturing
process. Please note that if you include your name, contact
information, or other information that identifies you in the body of
your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2024-N-5338 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Interstate Shellfish Dealer's
Certificate and Participation in the National Shellfish Sanitation
Program.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
<a href="/cdn-cgi/l/email-protection#d484869587a0b5b2b294b2b0b5fabcbca7fab3bba2"><span class="__cf_email__" data-cfemail="f7a7a5b6a483969191b7919396d99f9f84d9909881">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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
[[Page 103834]]
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 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.
FDA estimates the burden of this 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
No. respondents respondent responses hours
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Submission of Interstate Shellfish 3038 40 57 2,280 0.10 (6 minutes)...................... 228
Dealer's Certificate.
Submission of NSSP Compliance N/A 13 1 13 0.25 (15 minutes)..................... 3
Documentation.
Submission of Samples and Analytical N/A 35 2 70 0.50 (30 minutes)..................... 35
Results.
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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.
[[Page 103835]]
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: December 12, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-30228 Filed 12-18-24; 8:45 am]
BILLING CODE 4164-01-P
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