Agency Information Collection Activities; Proposed Collection; Comment Request; Interstate Shellfish Dealer's Certificate and Participation in the National Shellfish Sanitation Program, 103832-103835 [2024-30228]
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103832
Federal Register / Vol. 89, No. 244 / Thursday, December 19, 2024 / Notices
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, please access the CMS PRA
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
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Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10325 Disclosure and
Recordkeeping Requirements for
Grandfathered Health Plans Under the
Affordable Care Act
Under the PRA (44 U.S.C. 3501–
3520), Federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘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
requires Federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collections
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Disclosure and
Recordkeeping Requirements for
Grandfathered Health Plans under the
Affordable Care Act; Use: Section 1251
of the Affordable Care Act provides that
certain plans and health insurance
coverage in existence as of March 23,
2010, known as grandfathered health
plans, are not required to comply with
certain statutory provisions in the Act.
The final regulations titled ‘‘Final Rules
under the Affordable Care Act for
Grandfathered Plans, Preexisting
Condition Exclusions, Lifetime and
Annual Limits, Rescissions, Dependent
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Coverage, Appeals, and Patient
Protections’’ (80 FR 72192, November
18, 2015) require that, to maintain its
status as a grandfathered health plan, a
plan must maintain records
documenting the terms of the plan in
effect on March 23, 2010, and any other
documents that are necessary to verify,
explain, or clarify status as a
grandfathered health plan. The plan
must make such records available for
examination upon request by
participants, beneficiaries, individual
policy subscribers, or a State or Federal
agency official. A grandfathered health
plan is also required to include a
statement in any summary of benefits
under the plan or health insurance
coverage that the plan or coverage
believes it is a grandfathered health plan
within the meaning of section 1251 of
the Affordable Care Act and provide
contact information for questions and
complaints. In addition, a grandfathered
group health plan that is changing
health insurance issuers is required to
provide the succeeding health insurance
issuer (and the succeeding health
insurance issuer must require)
documentation of plan terms (including
benefits, cost sharing, employer
contributions, and annual limits) under
the prior health insurance coverage
sufficient to make a determination
whether the standards of paragraph
§ 147.140(g)(1) of the 2015 final
regulations are exceeded. It is also
required that, for an insured group
health plan (or a multiemployer plan)
that is a grandfathered plan, the relevant
policies, certificates, contracts of
insurance, or plan documents must
disclose in a prominent and effective
manner that employers, employee
organizations, or plan sponsors, as
applicable, are required to notify the
issuer (or multiemployer plan) if the
contribution rate changes at any point
during the plan year. Form Number:
CMS–10325 (OMB Control Number:
0938–1093); Frequency: On Occasion;
Affected Public: Private Sector, State,
Local or Tribal governments; Number of
Respondents: 14,603; Total Annual
Responses: 2,094,506; Total Annual
Hours: 40. (For policy questions
regarding this collection contact Adam
Pellillo at 667–290–9621.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–30202 Filed 12–18–24; 8:45 am]
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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.
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.
SUMMARY:
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,
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Federal Register / Vol. 89, No. 244 / Thursday, December 19, 2024 / Notices
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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
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18:08 Dec 18, 2024
Jkt 265001
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:
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, 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
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
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103833
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
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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). We also
provide information on our website at
https://www.fda.gov/federal-state-localtribal-and-territorial-officials/statecooperative-programs/fda-nationalshellfish-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 NSSPparticipating 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
FDA form
No.
Activity
Submission of Interstate Shellfish Dealer’s
Certificate.
Submission of NSSP Compliance Documentation.
Submission of Samples and Analytical Results.
Total ..........................................................
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1 There
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per
response
3038
40
57
2,280
0.10 (6 minutes) .....
228
N/A
13
1
13
0.25 (15 minutes) ..
3
N/A
35
2
70
0.50 (30 minutes) ...
35
................
........................
........................
........................
................................
266
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Sep<11>2014
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Jkt 265001
Total
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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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–5234]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Labeling:
Notification Procedures for Statements
on Dietary Supplements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 regulation
requiring the manufacturer, packer, or
distributor of a dietary supplement to
notify us that it is marketing a dietary
supplement product that bears on its
label or in its labeling a statement
provided for in the Federal Food, Drug,
and Cosmetic Act (FD&C Act).
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
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:08 Dec 18, 2024
Jkt 265001
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,
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–5234 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Food
Labeling: Notification Procedures for
Statements on Dietary Supplements.’’
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
PO 00000
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Fmt 4703
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103835
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-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:
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, 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.
E:\FR\FM\19DEN1.SGM
19DEN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity FDA form Number of responses per Total annual Average burden per response Total
No. respondents respondent responses hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
-------------------------------------------------------------------------------------------------------------
Total................................. ......... .............. .............. .............. ...................................... 266
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
