Notice2021-24063
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
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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
November 4, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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).
Full Text
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<title>Federal Register, Volume 86 Issue 211 (Thursday, November 4, 2021)</title>
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[Federal Register Volume 86, Number 211 (Thursday, November 4, 2021)]
[Notices]
[Pages 60840-60842]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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 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:
<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
[[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 <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-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 <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: 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,
<a href="/cdn-cgi/l/email-protection#451517041631242323052321246b2d2d366b222a33"><span class="__cf_email__" data-cfemail="f1a1a3b0a285909797b1979590df999982df969e87">[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 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 <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
[[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:
<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.
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
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