Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining Lists of United States Establishments With Interest in Exporting Center for Food Safety and Applied Nutrition-Regulated Products, 3814-3817 [2022-01376]
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Federal Register / Vol. 87, No. 16 / Tuesday, January 25, 2022 / Notices
513(a)(1)(B) of the FD&C Act). This
information collection is a measure that
FDA determined to be necessary to
provide reasonable assurance of safety
and effectiveness of reagents for
detection of specific novel influenza A
viruses.
FDA issued an order classifying the
H5 (Asian lineage) diagnostic device
into class II on March 22, 2006 (71 FR
14377), establishing the special controls
necessary to provide reasonable
assurance of the safety and effectiveness
of that device and similar future
devices. The new classification was
codified in 21 CFR 866.3332, a
regulation that describes the new
classification for reagents for detection
of specific novel influenza A viruses
and sets forth the special controls that
help to provide a reasonable assurance
of the safety and effectiveness of devices
classified under that regulation. The
regulation refers to the document
entitled ‘‘Class II Special Controls
Guidance Document: Reagents for
Detection of Specific Novel Influenza A
Viruses,’’ which provides
recommendations for measures to help
provide a reasonable assurance of safety
and effectiveness for these reagents. The
guidance recommends that sponsors
obtain and analyze postmarket data to
ensure the continued reliability of their
device in detecting the specific novel
influenza A virus that it is intended to
detect, particularly given the propensity
for influenza viruses to mutate and the
potential for changes in disease
prevalence over time. The guidance
document is available on our website at:
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/ucm078583.htm.
As updated sequences for novel
influenza A viruses become available
from the World Health Organization,
National Institutes of Health, and other
public health entities, sponsors of
reagents for detection of specific novel
influenza A viruses will collect this
information, compare them with the
primer/probe sequences in their
devices, and incorporate the result of
these analyses into their quality
management system, as required by 21
CFR 820.100(a)(1). These analyses will
be evaluated against the device design
validation and risk analysis required by
21 CFR 820.30(g) to determine if any
design changes may be necessary.
FDA estimates that 12 respondents
will be affected annually. The
respondent will collect this information
twice per year; each response is
estimated to take 15 hours. This results
in a total data collection burden of 360
hours.
The guidance also refers to previously
approved information collections found
in FDA regulations. The collections of
information in 21 CFR part 801 have
been approved under OMB control
number 0910–0485; the collections of
information in 21 CFR part 807, subpart
E have been approved under OMB
control number 0910–0120; and the
collections of information in 21 CFR
part 820 have been approved under
OMB control number 0910–0073.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity
Recordkeeping regarding reagents for detection of specific
novel influenza A viruses .................................................
1 There
Number of
records per
recordkeeper
12
2
Average
burden per
recordkeeping
24
Total hours
15
360
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall increase of 330 hours and a
corresponding increase of 22 records.
We attribute this adjustment to an
increase in the number of devices of this
type being manufactured over the last
few years.
Dated: January 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–01369 Filed 1–24–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–4042]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Establishing and
Maintaining Lists of United States
Establishments With Interest in
Exporting Center for Food Safety and
Applied Nutrition-Regulated Products
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
SUMMARY:
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Total annual
records
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to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection associated with export lists
for products regulated by the Center for
Food Safety and Applied Nutrition
(CFSAN).
Submit either electronic or
written comments on the collection of
information by March 28, 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 March 28,
2022. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of March 28, 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.
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
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Federal Register / Vol. 87, No. 16 / Tuesday, January 25, 2022 / Notices
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• 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–
2018–N–4042 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Establishing and Maintaining Lists of
U.S. Establishments with Interest in
Exporting Center for Food Safety and
Applied Nutrition-Regulated Products.’’
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
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17:19 Jan 24, 2022
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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:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, 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
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3815
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.
Establishing and Maintaining Lists of
U.S. Establishments With Interest in
Exporting CFSAN-Regulated Products
OMB Control Number 0910–0509—
Extension
The United States exports a large
volume and variety of foods in
international trade. Foreign
governments often require official
certification from the responsible
authority of the country of origin about
imported foods and establishments
involved in their production, storage, or
distribution. Some foreign governments
establish additional requirements with
which exporters are required to comply
and ask for additional assurances from
the responsible authority. Importing
countries may require, and FDA may
provide, official certification or
assurances for food products in different
forms, including certificates that
accompany specific products or lists of
establishments and products that
comply with certain requirements.
To facilitate exports of food subject to
importing country listing requirements,
FDA has historically provided official
certification in the form of country- and
product-specific export lists that
include establishments and their
products when: (1) The establishment
has expressed interest in exporting their
products to these countries; (2) the
establishment and the products are
subject to FDA’s jurisdiction; and (3) the
establishment can demonstrate that it is
in good regulatory standing for the
products it intends to export, and the
products are expected to comply with
applicable FDA requirements. As we
advised in the guidance document
‘‘Establishing and Maintaining a List of
U.S. Milk and Milk Product, Seafood,
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Federal Register / Vol. 87, No. 16 / Tuesday, January 25, 2022 / Notices
Infant Formula, and Formula for Young
Children Manufacturers/Processors with
Interest in Exporting to China,’’ FDA
considers ‘‘good regulatory standing’’ as
meaning that an establishment is in
substantial compliance with applicable
FDA requirements and is not the subject
of a pending enforcement action (e.g., an
injunction or seizure) or pending
administrative action (e.g., a warning
letter).
FDA has generally published
guidance documents for these countryand product-specific lists under the
authority of section 701(h) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 371(h)), which
authorizes the Secretary of Health and
Human Services (the Secretary) to
develop guidance documents with
public participation presenting the
views of the Secretary on matters under
the jurisdiction of FDA. The guidance
documents generally explain what
information establishments should
submit to FDA to be considered for
inclusion on the lists and what criteria
FDA intends to use to determine
eligibility for placement on the lists.
The guidance documents also explain
how FDA intends to update the lists and
communicate any new information to
the governments that requested the lists.
Finally, the guidance documents note
that the information is provided
voluntarily by establishments with the
understanding that it may be posted on
FDA’s external website and that it will
be communicated to, and possibly
further disseminated by, the government
that requested the list; thus, FDA
considers the information on the lists to
be information that is not protected
from disclosure under 5 U.S.C.
552(b)(4). The guidance documents
include ‘‘Establishing and Maintaining a
List of U.S. Dairy Product
Manufacturers/Processors with Interest
in Exporting to Chile’’ and ‘‘Establishing
and Maintaining a List of U.S. Milk and
Milk Product, Seafood, Infant Formula,
and Formula for Young Children
Manufacturers/Processors with Interest
in Exporting to China’’ available at
https://www.fda.gov/food/guidanceregulation-food-and-dietarysupplements/guidance-documentsregulatory-information-topic-food-anddietary-supplements. Additional
information about FDA’s Food Export
Lists program is available at https://
www.fda.gov/food/exporting-foodproducts-united-states/food-export-lists.
FDA has also published guidance on
export certification that contains useful
information that applies to export lists:
‘‘FDA Export Certification’’ available at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/fda-export-certification.
Foreign governments are increasingly
relying on certification as a strategy for
ensuring the safety of imported food
products, and many countries have
announced new requirements for lists of
establishments and products certified to
comply with certain food safety
requirements. FDA is committed to
facilitating compliance with new listing
requirements for U.S. establishments
that export FDA-regulated food
products. We also understand that
complying with multiple country- and
product-specific listing requirements
can be burdensome to U.S.
establishments. For this reason, we plan
to create a new list of establishments
and products certified for export that
would be offered to importing countries
in lieu of country-specific lists.
Application for inclusion on all
export lists will continue to be
voluntary. However, some foreign
governments may require inclusion on
export lists as a precondition for market
access or to satisfy other importing
country registration or approval
requirements. FDA uses the Export
Listing Module (ELM), an electronic
system (Form FDA 3972), to receive and
process applications for inclusion on
export lists for CFSAN-regulated
products. The ELM allows applicants to
provide information about the products
intended for export, the establishment
that produces those products, evidence
of the establishment’s compliance with
applicable requirements for the
products intended for export, and any
additional data or information (such as
third-party certifications) that foreign
governments may require. We request
that this information be updated every
2 years. Additional information and
screenshots of the ELM are available at
https://www.fda.gov/food/exportingfood-products-united-states/foodexport-lists. If an establishment is
unable to submit an application via the
ELM, it may contact CFSAN and request
assistance.
We use the information submitted by
establishments to determine eligibility
for certification and inclusion on the
export lists, which may be published on
our website or the websites of foreign
governments. The purpose of the lists is
to help CFSAN-regulated industries
meet the import requirements of foreign
governments. This collection of
information is intended to cover all of
CFSAN’s existing export lists, as well as
any additional export lists established
by the center.
FDA notes section 801 of the FD&C
Act (21 U.S.C. 381) also provides that
FDA may charge a fee of up to $175 if
the Agency issues export certification
within 20 days of receipt of a complete
request for such certification.
Description of Respondents:
Respondents to this collection of
information include U.S. establishments
subject to FDA/CFSAN jurisdiction that
wish to be included on export lists.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
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Activity
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours
New request .........................................................
New request + third party certification .................
Biennial update ....................................................
Biennial update + third party certification ............
Occasional updates ..............................................
167
85
132
58
60
5
2
4
2
2
835
170
528
116
120
1 ....................................
22 ..................................
0.5 (30 minutes) ............
22 ..................................
0.5 (30 minutes) ............
835
3,740
264
2,552
60
Total ..............................................................
........................
........................
1,769
.......................................
7,451
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, the estimated burden for
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this information collection has
decreased. The number of respondents
has declined dramatically since we
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transitioned to using the ELM, which
also allows us to collect more precise
data. These changes resulted in overall
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Federal Register / Vol. 87, No. 16 / Tuesday, January 25, 2022 / Notices
decreases of 3,421 responses and 14,837
burden hours.
Dated: January 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–01376 Filed 1–24–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0031]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Vaccines and Related
Biological Products Advisory
Committee. The general function of the
committee is to provide advice and
recommendations to FDA on regulatory
issues. The meeting will be open to the
public. FDA is establishing a docket for
public comment on this document.
DATES: The meeting will be held on
March 3, 2022, from 9 a.m. to 3:30 p.m.
Eastern Time.
ADDRESSES: Please note that due to the
impact of this COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform.
Answers to commonly asked questions,
including information regarding special
accommodations due to a disability,
visitor parking, and transportation, may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm. The online web
conference meeting will be available at
the following link on the day of the
meeting: https://youtu.be/
7fIEUdmn3AU.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2022–N–0031.
The docket will close on March 2, 2022.
Submit either electronic or written
comments on this public meeting by
March 2, 2022. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before February 23,
2022. The https://www.regulations.gov
electronic filing system will accept
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:19 Jan 24, 2022
Jkt 256001
comments until 11:59 p.m. Eastern Time
at the end of February 23, 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.
Comments received on or before
February 23, 2022, will be provided to
the committee. Comments received after
that date will be taken into
consideration by FDA. In the event that
the meeting is cancelled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
You may submit comments 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.’’
PO 00000
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3817
Instructions: All submissions received
must include the Docket No. FDA–
2022–N–0031 for ‘‘Vaccines and Related
Biological Products; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ 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.’’ FDA
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 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 the 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:
Prabhakara Atreya or Lisa Wheeler,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Silver Spring, MD
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]]>Agencies
[Federal Register Volume 87, Number 16 (Tuesday, January 25, 2022)]
[Notices]
[Pages 3814-3817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01376]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4042]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Establishing and Maintaining Lists of United States
Establishments With Interest in Exporting Center for Food Safety and
Applied Nutrition-Regulated Products
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
associated with export lists for products regulated by the Center for
Food Safety and Applied Nutrition (CFSAN).
DATES: Submit either electronic or written comments on the collection
of information by March 28, 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 March 28, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 28, 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:
[[Page 3815]]
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-2018-N-4042 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Establishing and Maintaining
Lists of U.S. Establishments with Interest in Exporting Center for Food
Safety and Applied Nutrition-Regulated Products.'' 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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[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.
Establishing and Maintaining Lists of U.S. Establishments With Interest
in Exporting CFSAN-Regulated Products
OMB Control Number 0910-0509--Extension
The United States exports a large volume and variety of foods in
international trade. Foreign governments often require official
certification from the responsible authority of the country of origin
about imported foods and establishments involved in their production,
storage, or distribution. Some foreign governments establish additional
requirements with which exporters are required to comply and ask for
additional assurances from the responsible authority. Importing
countries may require, and FDA may provide, official certification or
assurances for food products in different forms, including certificates
that accompany specific products or lists of establishments and
products that comply with certain requirements.
To facilitate exports of food subject to importing country listing
requirements, FDA has historically provided official certification in
the form of country- and product-specific export lists that include
establishments and their products when: (1) The establishment has
expressed interest in exporting their products to these countries; (2)
the establishment and the products are subject to FDA's jurisdiction;
and (3) the establishment can demonstrate that it is in good regulatory
standing for the products it intends to export, and the products are
expected to comply with applicable FDA requirements. As we advised in
the guidance document ``Establishing and Maintaining a List of U.S.
Milk and Milk Product, Seafood,
[[Page 3816]]
Infant Formula, and Formula for Young Children Manufacturers/Processors
with Interest in Exporting to China,'' FDA considers ``good regulatory
standing'' as meaning that an establishment is in substantial
compliance with applicable FDA requirements and is not the subject of a
pending enforcement action (e.g., an injunction or seizure) or pending
administrative action (e.g., a warning letter).
FDA has generally published guidance documents for these country-
and product-specific lists under the authority of section 701(h) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)),
which authorizes the Secretary of Health and Human Services (the
Secretary) to develop guidance documents with public participation
presenting the views of the Secretary on matters under the jurisdiction
of FDA. The guidance documents generally explain what information
establishments should submit to FDA to be considered for inclusion on
the lists and what criteria FDA intends to use to determine eligibility
for placement on the lists. The guidance documents also explain how FDA
intends to update the lists and communicate any new information to the
governments that requested the lists. Finally, the guidance documents
note that the information is provided voluntarily by establishments
with the understanding that it may be posted on FDA's external website
and that it will be communicated to, and possibly further disseminated
by, the government that requested the list; thus, FDA considers the
information on the lists to be information that is not protected from
disclosure under 5 U.S.C. 552(b)(4). The guidance documents include
``Establishing and Maintaining a List of U.S. Dairy Product
Manufacturers/Processors with Interest in Exporting to Chile'' and
``Establishing and Maintaining a List of U.S. Milk and Milk Product,
Seafood, Infant Formula, and Formula for Young Children Manufacturers/
Processors with Interest in Exporting to China'' available at https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/guidance-documents-regulatory-information-topic-food-and-dietary-supplements. Additional information about FDA's Food Export Lists
program is available at https://www.fda.gov/food/exporting-food-products-united-states/food-export-lists. FDA has also published
guidance on export certification that contains useful information that
applies to export lists: ``FDA Export Certification'' available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-export-certification.
Foreign governments are increasingly relying on certification as a
strategy for ensuring the safety of imported food products, and many
countries have announced new requirements for lists of establishments
and products certified to comply with certain food safety requirements.
FDA is committed to facilitating compliance with new listing
requirements for U.S. establishments that export FDA-regulated food
products. We also understand that complying with multiple country- and
product-specific listing requirements can be burdensome to U.S.
establishments. For this reason, we plan to create a new list of
establishments and products certified for export that would be offered
to importing countries in lieu of country-specific lists.
Application for inclusion on all export lists will continue to be
voluntary. However, some foreign governments may require inclusion on
export lists as a precondition for market access or to satisfy other
importing country registration or approval requirements. FDA uses the
Export Listing Module (ELM), an electronic system (Form FDA 3972), to
receive and process applications for inclusion on export lists for
CFSAN-regulated products. The ELM allows applicants to provide
information about the products intended for export, the establishment
that produces those products, evidence of the establishment's
compliance with applicable requirements for the products intended for
export, and any additional data or information (such as third-party
certifications) that foreign governments may require. We request that
this information be updated every 2 years. Additional information and
screenshots of the ELM are available at https://www.fda.gov/food/exporting-food-products-united-states/food-export-lists. If an
establishment is unable to submit an application via the ELM, it may
contact CFSAN and request assistance.
We use the information submitted by establishments to determine
eligibility for certification and inclusion on the export lists, which
may be published on our website or the websites of foreign governments.
The purpose of the lists is to help CFSAN-regulated industries meet the
import requirements of foreign governments. This collection of
information is intended to cover all of CFSAN's existing export lists,
as well as any additional export lists established by the center.
FDA notes section 801 of the FD&C Act (21 U.S.C. 381) also provides
that FDA may charge a fee of up to $175 if the Agency issues export
certification within 20 days of receipt of a complete request for such
certification.
Description of Respondents: Respondents to this collection of
information include U.S. establishments subject to FDA/CFSAN
jurisdiction that wish to be included on export lists.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
New request................... 167 5 835 1............... 835
New request + third party 85 2 170 22.............. 3,740
certification.
Biennial update............... 132 4 528 0.5 (30 minutes) 264
Biennial update + third party 58 2 116 22.............. 2,552
certification.
Occasional updates............ 60 2 120 0.5 (30 minutes) 60
---------------------------------------------------------------------------------
Total..................... .............. .............. 1,769 ................ 7,451
----------------------------------------------------------------------------------------------------------------
\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, the estimated burden for this information
collection has decreased. The number of respondents has declined
dramatically since we transitioned to using the ELM, which also allows
us to collect more precise data. These changes resulted in overall
[[Page 3817]]
decreases of 3,421 responses and 14,837 burden hours.
Dated: January 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01376 Filed 1-24-22; 8:45 am]
BILLING CODE 4164-01-P
