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, 60840-60842 [2021-24063]
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60840
Federal Register / Vol. 86, No. 211 / Thursday, November 4, 2021 / Notices
This draft guidance identifies the
software information generally
necessary for evaluating the safety and
effectiveness of a device in a premarket
submission. The recommendations in
this draft guidance also may help
facilitate FDA’s premarket review. This
draft guidance describes information
that typically would be generated and
documented during software
development, verification, and design
validation. The least burdensome
approach was applied to identify the
minimum amount of information that,
based on our experience, would
generally be needed to support a
premarket submission for a device that
uses software. During premarket review,
FDA may request additional information
that is needed to evaluate the
submission.
When final, this document will
replace FDA’s ‘‘Guidance for the
Content of Premarket Submissions for
Software Contained in Medical Devices’’
issued on May 11, 2005, and it will
update FDA’s thinking related to the
documentation recommended for the
review of device software functions in
premarket submissions.
biologics/guidance-complianceregulatory-information-biologics/
biologics-guidances. Persons unable to
download an electronic copy of
‘‘Content of Premarket Submissions for
Device Software Functions’’ may send
an email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number 337 and complete
title to identify the guidance you are
requesting.
II. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This
guidance document is also available at
https://www.regulations.gov, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents or
https://www.fda.gov/vaccines-blood-
III. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in the following FDA
regulations, guidance, and forms have
been approved by OMB as listed in the
following table:
21 CFR part; guidance; or FDA
form
Topic
807, subpart E .................................
814, subparts A through E ..............
814, subpart H .................................
812 ...................................................
‘‘De Novo Classification Process
(Evaluation of Automatic Class III
Designation)’’.
800, 801, and 809 ...........................
820 ...................................................
Premarket notification ...........................................................................................................
Premarket approval ...............................................................................................................
Humanitarian Device Exemption ...........................................................................................
Investigational Device Exemption .........................................................................................
De Novo classification process .............................................................................................
0910–0120
0910–0231
0910–0332
0910–0078
0910–0844
Medical Device Labeling Regulations ...................................................................................
Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation ..............
0910–0485
0910–0073
Dated: October 29, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–24061 Filed 11–3–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–1112]
lotter on DSK11XQN23PROD with NOTICES1
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Content of Premarket Submissions
for Device Software Functions.’’ It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
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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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).
OMB control
No.
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.
SUMMARY:
ADDRESSES:
Submit either electronic or
written comments on the collection of
information by January 3, 2022.
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
DATES:
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Federal Register / Vol. 86, No. 211 / Thursday, November 4, 2021 / Notices
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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
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17:57 Nov 03, 2021
Jkt 256001
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-201509-18/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, PRAStaff@
fda.hhs.gov.
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
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60841
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/interstatecertified-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
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Federal Register / Vol. 86, No. 211 / Thursday, November 4, 2021 / Notices
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 FDAregulated 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
Form FDA
No.
Activity
Number of
responses
per
respondent
Average
burden per
response
Total annual
responses
Total hours
Submission of Interstate Shellfish Dealer’s Certificate ....................
Submission of Other Records Related to Participation in the
NSSP.
3038
N/A
40
13
57
1
2,280
13
0.10 (6 minutes) .........
0.25 (15 minutes) .......
228
3.25
Total ..........................................................................................
....................
....................
....................
....................
.....................................
231.25
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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Number of
respondents
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Biodefense Science Board
Office of the Assistant
Secretary for Preparedness and
Response (ASPR), Department of Health
and Human Services (HHS).
AGENCY:
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ACTION:
Notice.
The National Biodefense
Science Board (NBSB or the Board) is
authorized under Section 319M of the
Public Health Service (PHS) Act, as
added by section 402 of the Pandemic
and All-Hazards Preparedness Act of
2006 and amended by section 404 of the
Pandemic and All-Hazards
Preparedness Reauthorization Act. The
Board is governed by the Federal
Advisory Committee Act (5 U.S.C. app.),
which sets forth standards for the
formation and use of advisory
committees. The NBSB provides expert
advice and guidance on scientific,
technical, and other matters of special
interest to the Department of Health and
Human Services (HHS) regarding
current and future chemical, biological,
nuclear, and radiological agents,
whether naturally occurring, accidental,
or deliberate. Authority to manage and
operate the NBSB, including to receive
SUMMARY:
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advice and recommendations from the
Board, has been delegated by the
Secretary of HHS to the Assistant
Secretary for Preparedness and
Response (ASPR). The NBSB will meet
in public (virtually) on December 16,
2021, to provide advice and
recommendations to ASPR regarding the
development of the 2023–2026 National
Health Security Strategy and to discuss
other matters of current important for
public health emergency preparedness,
response, and recovery. A more detailed
agenda will be available on the NBSB
meeting website https://www.phe.gov/
nbsb.
Procedures for Public Participation:
Members of the public may attend the
meeting via a toll-free phone number or
Zoom teleconference, which requires
pre-registration. The meeting link to
pre-register will be posted on the
meeting website https://www.phe.gov/
nbsb. Members of the public may
provide written comments or submit
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
