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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 [www.gpo.gov]
[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 https://www.regulations.gov 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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, 
[email protected].

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 https://www.fda.gov/media/72094/download). 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 https://www.fda.gov/food/federalstate-food-programs/interstate-certified-shellfish-shippers-list). We also provide information on our website at https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/state-cooperative-programs/fda-national-shellfish-sanitation-program, 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:
     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 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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