[Federal Register Volume 86, Number 211 (Thursday, November 4, 2021)]
[Notices]
[Pages 60840-60842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24063]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Interstate Shellfish Dealer's Certificate and Other 
Records Related to 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, Agency, or we) 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: Submit either electronic or written comments on the collection 
of information by January 3, 2022.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 3, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 3, 2022. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is 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

[[Page 60841]]

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, 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-2021-N-1112 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Interstate Shellfish Dealer's 
Certificate and Other Records Related to 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: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[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 Other Records Related to 
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 are 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 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

[[Page 60842]]

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 the 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. If approved, FDA will use 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.
    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 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                          Number of
                                                 Form FDA    Number of    responses      Total
                   Activity                        No.      respondents      per         annual          Average  burden per  response       Total hours
                                                                          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 Other Records Related to                 N/A           13            1           13  0.25 (15 minutes).......................         3.25
 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: October 28, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-24063 Filed 11-3-21; 8:45 am]
BILLING CODE 4164-01-P


