Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination and Removal of a Foreign Manufacturer's Goods From Detention Without Physical Examination; Draft Guidance for Industry; Availability, 9852-9854 [2024-02838]
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9852
Federal Register / Vol. 89, No. 29 / Monday, February 12, 2024 / Notices
Country Bancshares, Inc. and indirectly
retain voting shares of Llano National
Bank, both of Llano, Texas.
Board of Governors of the Federal Reserve
System.
Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
[FR Doc. 2024–02807 Filed 2–9–24; 8:45 am]
BILLING CODE P
information related to equity activities
and strategies to mitigate challenges.
DATES: Comments due within 30 days of
publication. OMB must make a decision
about the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. You can also obtain
copies of the proposed collection of
information by emailing infocollection@
acf.hhs.gov. Identify all emailed
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: The State PREP has
mandatory, formula allotments for state
and territories to apply. The process is
for states and territories to submit and
for ACYF/FYSB to collect their state
plans and semi-annual performance
progress reports.
Purpose and Use of the Information
Collection: The state plan offers
information about the proposed state
project and has been and will continue
to be used as the primary basis to
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for Office of Management
and Budget (OMB) Review; State
Personal Responsibility Education
Program (PREP) (OMB #0970–0380)
Family and Youth Services
Bureau, Administration for Children
and Families, U.S. Department of Health
and Human Services.
ACTION: Request for public comments.
AGENCY:
The Family and Youth
Services Bureau (FYSB) within the
Administration on Children, Youth and
Families (ACYF) is requesting a 3-year
extension of the State Personal
Responsibility Program (PREP) state
plans and performance progress report
(OMB #0970–0380, expiration 12/31/
2023). There are no changes requested
to the state plan, but there are changes
requested to the performance progress
report. Changes include the addition of
SUMMARY:
determine whether or not the project
meets the minimum requirements of the
legislation for the grant award. There are
no changes proposed to the state plan;
FYSB is requesting to use these plans
for another 3 years.
The Performance Progress Reports are
collected semi-annually and inform the
monitoring of the grantees’ program
design, program evaluation,
management improvement, service
quality, and compliance with agreed
upon goals. ACYF/FYSB has used and
will continue to use the information to
ensure effective service delivery for
program participants. Finally, the data
from this collection will be used to
report outcomes and efficiencies and
will provide valuable information to
policy makers and key stakeholders in
the development of program and
research efforts. Changes are proposed
to the Performance Progress Reports and
include the addition of information
related to equity activities and strategies
to mitigate challenges. Information on
equity activities will be used to support
the FYSB Equity Action Plan objectives
and to inform the development of T&TA
resources, as needed. The purpose of
including strategies to mitigate
challenges is to allow grant recipients to
demonstrate how they overcome
challenges. This information can be
used to inform peer to peer sharing.
Respondents: All 52 states and
territories that are still eligible to accept
their State PREP mandatory, formula
allotments for funding.
ANNUAL BURDEN ESTIMATES
Instrument
Total number
of respondents
Annual
number of
responses per
respondent
52
52
1
2
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State Plans ......................................................................................................
Performance Progress Reports .......................................................................
Estimated Total Annual Burden
Hours: 3,744.
Authority: Section 513 of the Social
Security Act (42 U.S.C. 713), as
amended by section 50503 of the
Bipartisan Budget Act of 2018 (Pub. L.
115–123) extended by Division CC, Title
III, Section 302 of the Consolidated
Appropriations Act, 2021 (Pub. L. 116–
260).
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–02749 Filed 2–9–24; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–5303]
Recommendations for Collecting
Representative Samples for Food
Testing Used as Evidence for Release
of Certain Fish and Fishery Products
Subject to Detention Without Physical
Examination and Removal of a Foreign
Manufacturer’s Goods From Detention
Without Physical Examination; Draft
Guidance for Industry; Availability
BILLING CODE 4184–37–P
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
21:06 Feb 09, 2024
Jkt 262001
PO 00000
Frm 00019
Fmt 4703
Sfmt 4703
ACTION:
Average
burden hours
per response
Annual burden
hours
40
16
2,080
1,664
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a draft
guidance for industry entitled
‘‘Recommendations for Collecting
Representative Samples for Food
Testing Used as Evidence for Release of
Certain Fish and Fishery Products
Subject to Detention Without Physical
Examination (DWPE) and Removal of a
Foreign Manufacturer’s Goods from
DWPE.’’ The draft guidance, when
finalized, will provide
recommendations for collecting a
representative sample for products
subject to DWPE under an import alert
SUMMARY:
E:\FR\FM\12FEN1.SGM
12FEN1
Federal Register / Vol. 89, No. 29 / Monday, February 12, 2024 / Notices
due to the appearance of adulteration
caused by pathogens, unlawful animal
drugs, scombrotoxin (histamine), and/or
decomposition. When finalized, the
draft guidance will also help foreign
manufacturers and other processors of
fish and fishery products subject to
DWPE introduce evidence to FDA to
support a request to have products
removed from DWPE.
DATES: Submit either electronic or
written comments on the draft guidance
by April 12, 2024 to ensure that we
consider your comment on the draft
guidance before we begin work on the
final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
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’’).
khammond on DSKJM1Z7X2PROD with NOTICES
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–
VerDate Sep<11>2014
21:06 Feb 09, 2024
Jkt 262001
2023–D–5303 for ‘‘Recommendations
for Collecting Representative Samples
for Food Testing Used as Evidence for
Release of Certain Fish and Fishery
Products Subject to Detention Without
Physical Examination (DWPE) and
Removal of a Foreign Manufacturer’s
Goods from DWPE; Draft Guidance for
Industry.’’ Received comments 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.’’ We
will review this copy, including the
claimed confidential information, in our
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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Seafood Safety, Office of
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
9853
Food Safety, Center for Food Safety and
Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two selfaddressed adhesive labels to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance.
FOR FURTHER INFORMATION CONTACT:
Steven Bloodgood, Office of Food Safety
(HFS–325), Center for Food Safety and
Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–5316;
or Holli Kubicki, Office of Regulations
and Policy (HFS–024), Center for Food
Safety and Applied Nutrition, Food and
Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–2378.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of
a draft guidance for industry entitled
‘‘Recommendations for Collecting
Representative Samples for Food
Testing Used as Evidence for Release of
Certain Fish and Fishery Products
Subject to Detention Without Physical
Examination (DWPE) and Removal of a
Foreign Manufacturer’s Goods from
DWPE.’’ We are issuing the draft
guidance consistent with our good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the current
thinking of FDA on this topic. It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternate approach if it
satisfies the requirements of the
applicable statutes and regulations.
Under section 801(a)(3) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 381(a)(3)), an article of
food imported or offered for import into
the United States is subject to refusal of
admission if it appears ‘‘from the
examination of such samples or
otherwise’’ to be adulterated. FDA
issues import alerts to inform its field
staff about products that appear to be in
violation of FDA’s laws and regulations
and thus may be detained without
physical examination. We may subject
future shipments of fish or fishery
products to DWPE when there is
information that causes future
shipments of a product or products to
appear violative within the meaning of
section 801(a) of the FD&C Act. Such
information may exist based on the
violative history of a product,
manufacturer, shipper, grower,
importer, geographic area, or country.
To carry out the provisions of section
801(a) of the FD&C Act when we detain
E:\FR\FM\12FEN1.SGM
12FEN1
khammond on DSKJM1Z7X2PROD with NOTICES
9854
Federal Register / Vol. 89, No. 29 / Monday, February 12, 2024 / Notices
an article that appears violative, we
provide notice to the owner or
consignee of the nature of the violation
and the right to present testimony
regarding the admissibility of the article
(21 CFR 1.94). Frequently, owners or
consignees submit analytical test results
based on samples taken from the article
subject to DWPE as evidence
demonstrating admissibility. We then
determine if the testimony (analytical
package, information, or other evidence)
is sufficient. If the evidence is adequate
to overcome the appearance of the
violation(s), FDA will allow the article
to proceed for entry into the United
States. If the evidence is not adequate to
remove the appearance of the
violation(s), the entry will be refused
admission into the United States.
In addition, interested parties may
request that their products be removed
from DWPE. FDA decisions to remove a
product, manufacturer, or other entity
from DWPE are based on evidence
establishing that the conditions that
gave rise to the appearance of a
violation have been resolved and we
have confidence that future shipments
of the product to the United States will
be in compliance with the FD&C Act.
FDA may consider analytical results
from successful consecutive tests as part
of the evidence to support removal from
DWPE.
The draft guidance, when finalized,
will provide recommendations for
collecting a representative sample for
products subject to DWPE under an
import alert due to the appearance of
adulteration caused by pathogens,
unlawful animal drugs, scombrotoxin
(histamine), and/or decomposition.
When finalized, the draft guidance will
also help foreign manufacturers and
other processors of fish and fishery
products subject to DWPE introduce
evidence to FDA to support a request to
have products removed from DWPE.
The recommendations in the draft
guidance include sample sizes based on
a critical nonconformities sampling
strategy. Using this statistical sampling
equation, the amount of sampling
recommended can be structured
commensurate with the level of
concern, and risk to consumers,
associated with the type of adulteration
to be addressed. For more information,
see ‘‘Derivation of Sampling
Recommendations Related to
Recommendations for Collecting
Representative Samples for Food
Testing Used as Evidence for Release of
Certain Fish and Fishery Products
Subject to Detention Without Physical
Examination (DWPE) and Removal of a
Foreign Manufacturer’s Goods from
DWPE; Guidance for Industry’’ (Ref. 1).
VerDate Sep<11>2014
21:06 Feb 09, 2024
Jkt 262001
As the draft guidance makes clear,
persons may propose alternative
sampling plans and explain the basis for
such alternatives.
We note that the draft guidance refers
to the final rule entitled ‘‘Laboratory
Accreditation for Analyses of Foods’’
(LAAF Rule, which is codified at 21
CFR part 1, subpart R). FDA is taking a
stepwise approach to implementing the
LAAF Rule based, in part, on reaching
sufficient LAAF-accredited laboratory
capacity for food testing (see 86 FR
68728 at 68739 and 68740, December 3,
2021). FDA may publish one or more
documents in the Federal Register
giving owners and consignees 6 months’
notice before requiring them to use a
LAAF-accredited laboratory for food
testing covered by the rule (id.). We will
monitor LAAF Rule implementation
and update any final guidance based on
this draft guidance accordingly.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in 21 CFR part 1, subpart R
have been approved under OMB control
number 0910–0898.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/FoodGuidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov. Use the
FDA website listed in the previous
sentence to find the most current
version of the guidance.
IV. Reference
The following reference is on display
at the Dockets Management Staff (see
ADDRESSES) and is available for viewing
by interested persons between 9 a.m.
and 4 p.m., Monday through Friday; it
is also available electronically at https://
www.regulations.gov.
1. FDA, ‘‘Derivation of Sampling
Recommendations Related to
Recommendations for Collecting
Representative Samples for Food Testing
Used as Evidence for Release of Certain
Fish and Fishery Products Subject to
Detention Without Physical Examination
(DWPE) and Removal of a Foreign
Manufacturer’s Goods from DWPE;
Guidance for Industry.’’
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
Dated: February 7, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–02838 Filed 2–9–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–4974]
Advanced Manufacturing Technologies
Designation Program; Draft Guidance
for Industry; Availability; Agency
Information Collection Activities;
Proposed Collection; Extension of
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; extension
of comment period.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
extending the comment period for the
notice of availability entitled
‘‘Advanced Manufacturing Technologies
Designation Program; Draft Guidance for
Industry; Availability; Agency
Information Collection Activities;
Proposed Collection; Comment
Request’’ that appeared in the Federal
Register of December 13, 2023. The
Agency is taking this action in response
to requests for an extension to allow
interested persons additional time to
submit comments.
DATES: FDA is extending the comment
period on the document published on
December 13, 2023 (88 FR 86333).
Either electronic or written comments
must be submitted by March 13, 2024.
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
March 13, 2024. 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
E:\FR\FM\12FEN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 29 (Monday, February 12, 2024)]
[Notices]
[Pages 9852-9854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-02838]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-5303]
Recommendations for Collecting Representative Samples for Food
Testing Used as Evidence for Release of Certain Fish and Fishery
Products Subject to Detention Without Physical Examination and Removal
of a Foreign Manufacturer's Goods From Detention Without Physical
Examination; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft guidance for industry entitled
``Recommendations for Collecting Representative Samples for Food
Testing Used as Evidence for Release of Certain Fish and Fishery
Products Subject to Detention Without Physical Examination (DWPE) and
Removal of a Foreign Manufacturer's Goods from DWPE.'' The draft
guidance, when finalized, will provide recommendations for collecting a
representative sample for products subject to DWPE under an import
alert
[[Page 9853]]
due to the appearance of adulteration caused by pathogens, unlawful
animal drugs, scombrotoxin (histamine), and/or decomposition. When
finalized, the draft guidance will also help foreign manufacturers and
other processors of fish and fishery products subject to DWPE introduce
evidence to FDA to support a request to have products removed from
DWPE.
DATES: Submit either electronic or written comments on the draft
guidance by April 12, 2024 to ensure that we consider your comment on
the draft guidance before we begin work on the final version of the
guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
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-2023-D-5303 for ``Recommendations for Collecting Representative
Samples for Food Testing Used as Evidence for Release of Certain Fish
and Fishery Products Subject to Detention Without Physical Examination
(DWPE) and Removal of a Foreign Manufacturer's Goods from DWPE; Draft
Guidance for Industry.'' Received comments 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.'' We will review
this copy, including the claimed confidential information, in our
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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Division of Seafood Safety, Office of Food Safety, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740. Send two self-addressed adhesive labels to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: Steven Bloodgood, Office of Food
Safety (HFS-325), Center for Food Safety and Applied Nutrition, Food
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-5316; or Holli Kubicki, Office of Regulations and Policy (HFS-024),
Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a draft guidance for industry
entitled ``Recommendations for Collecting Representative Samples for
Food Testing Used as Evidence for Release of Certain Fish and Fishery
Products Subject to Detention Without Physical Examination (DWPE) and
Removal of a Foreign Manufacturer's Goods from DWPE.'' We are issuing
the draft guidance consistent with our good guidance practices
regulation (21 CFR 10.115). The draft guidance, when finalized, will
represent the current thinking of FDA on this topic. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternate approach if it satisfies the
requirements of the applicable statutes and regulations.
Under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 381(a)(3)), an article of food imported or
offered for import into the United States is subject to refusal of
admission if it appears ``from the examination of such samples or
otherwise'' to be adulterated. FDA issues import alerts to inform its
field staff about products that appear to be in violation of FDA's laws
and regulations and thus may be detained without physical examination.
We may subject future shipments of fish or fishery products to DWPE
when there is information that causes future shipments of a product or
products to appear violative within the meaning of section 801(a) of
the FD&C Act. Such information may exist based on the violative history
of a product, manufacturer, shipper, grower, importer, geographic area,
or country.
To carry out the provisions of section 801(a) of the FD&C Act when
we detain
[[Page 9854]]
an article that appears violative, we provide notice to the owner or
consignee of the nature of the violation and the right to present
testimony regarding the admissibility of the article (21 CFR 1.94).
Frequently, owners or consignees submit analytical test results based
on samples taken from the article subject to DWPE as evidence
demonstrating admissibility. We then determine if the testimony
(analytical package, information, or other evidence) is sufficient. If
the evidence is adequate to overcome the appearance of the
violation(s), FDA will allow the article to proceed for entry into the
United States. If the evidence is not adequate to remove the appearance
of the violation(s), the entry will be refused admission into the
United States.
In addition, interested parties may request that their products be
removed from DWPE. FDA decisions to remove a product, manufacturer, or
other entity from DWPE are based on evidence establishing that the
conditions that gave rise to the appearance of a violation have been
resolved and we have confidence that future shipments of the product to
the United States will be in compliance with the FD&C Act. FDA may
consider analytical results from successful consecutive tests as part
of the evidence to support removal from DWPE.
The draft guidance, when finalized, will provide recommendations
for collecting a representative sample for products subject to DWPE
under an import alert due to the appearance of adulteration caused by
pathogens, unlawful animal drugs, scombrotoxin (histamine), and/or
decomposition. When finalized, the draft guidance will also help
foreign manufacturers and other processors of fish and fishery products
subject to DWPE introduce evidence to FDA to support a request to have
products removed from DWPE.
The recommendations in the draft guidance include sample sizes
based on a critical nonconformities sampling strategy. Using this
statistical sampling equation, the amount of sampling recommended can
be structured commensurate with the level of concern, and risk to
consumers, associated with the type of adulteration to be addressed.
For more information, see ``Derivation of Sampling Recommendations
Related to Recommendations for Collecting Representative Samples for
Food Testing Used as Evidence for Release of Certain Fish and Fishery
Products Subject to Detention Without Physical Examination (DWPE) and
Removal of a Foreign Manufacturer's Goods from DWPE; Guidance for
Industry'' (Ref. 1). As the draft guidance makes clear, persons may
propose alternative sampling plans and explain the basis for such
alternatives.
We note that the draft guidance refers to the final rule entitled
``Laboratory Accreditation for Analyses of Foods'' (LAAF Rule, which is
codified at 21 CFR part 1, subpart R). FDA is taking a stepwise
approach to implementing the LAAF Rule based, in part, on reaching
sufficient LAAF-accredited laboratory capacity for food testing (see 86
FR 68728 at 68739 and 68740, December 3, 2021). FDA may publish one or
more documents in the Federal Register giving owners and consignees 6
months' notice before requiring them to use a LAAF-accredited
laboratory for food testing covered by the rule (id.). We will monitor
LAAF Rule implementation and update any final guidance based on this
draft guidance accordingly.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR part 1, subpart R have been approved under OMB control number
0910-0898.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/FoodGuidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.
IV. Reference
The following reference is on display at the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at https://www.regulations.gov.
1. FDA, ``Derivation of Sampling Recommendations Related to
Recommendations for Collecting Representative Samples for Food
Testing Used as Evidence for Release of Certain Fish and Fishery
Products Subject to Detention Without Physical Examination (DWPE)
and Removal of a Foreign Manufacturer's Goods from DWPE; Guidance
for Industry.''
Dated: February 7, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-02838 Filed 2-9-24; 8:45 am]
BILLING CODE 4164-01-P
