Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products, 48816-48819 [2016-17571]
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Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices
accredited issuing agencies, and consist
of a specific set of characters used to
identify the information immediately
following the data delimiter.
For purposes of this draft guidance,
we define ‘‘UDI carrier’’ as the means to
convey the UDI and any non-UDI
elements by using easily readable plaintext and AIDC forms. In the UDI carrier,
the data represented in the UDI should
precede any non-UDI elements and
should be distinguishable from the UDI
elements. The easily readable plain-text
form of the UDI should be ordered to
specify the DI first, followed by the PIs.
If there are any non-UDI elements in the
UDI carrier, the non-UDI elements
should follow the PIs that are part of the
UDI. For more information on non-UDI
elements capable of being included in
the UDI carrier, labelers should contact
their FDA-accredited issuing agency.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Unique Device Identification
System: Form and Content of the
Unique Device Identifier (UDI)’’. It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
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III. Request for Comments
FDA is seeking additional information
on this issue. FDA is particularly
interested in receiving information
relating to the following question: Are
there any additional standards, in
addition to those referenced in this draft
guidance, that should be used to
determine the print quality of the AIDC
form of the UDI?
IV. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm or at
https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm. Guidance
documents are also available at https://
www.regulations.gov. Persons unable to
download an electronic copy of
‘‘Unique Device Identification System:
Form and Content of the Unique Device
Identifier (UDI)’’ may send an email
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request to CDRH-Guidance@fda.hhs.gov
or ocod@fda.hhs.gov, or by calling 1–
800–835–4709 or 240–402–7800, to
receive an electronic copy of the
document. Please use the document
number GUD1500035 to identify the
guidance you are requesting.
V. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information described in FDA
regulations. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in 21 CFR
part 801 have been approved under
OMB control number 0910–0485, and
the collections of information in 21 CFR
part 830 have been approved under
OMB control number 0910–0720.
Dated: July 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–17554 Filed 7–25–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0879]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Procedures for the
Safe and Sanitary Processing and
Importing of Fish and Fishery Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA 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 (the 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
invites comments on the information
collection provisions of our regulations
requiring reporting and recordkeeping
for processors and importers of fish and
fishery products.
DATES: Submit either electronic or
written comments on the collection of
information by September 26, 2016.
SUMMARY:
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ADDRESSES:
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2013–N–0879 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Procedures for the Safe and Sanitary
Processing and Importing of Fish and
Fishery Products.’’ 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
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
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Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices
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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: 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.
‘‘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
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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.
Procedures for the Safe and Sanitary
Processing and Importing of Fish and
Fishery Products—21 CFR Part 123
OMB Control Number 0910–0354—
Extension
FDA regulations in part 123 (21 CFR
part 123) mandate the application of
hazard analysis and critical control
point (HACCP) principles to the
processing of seafood. HACCP is a
preventive system of hazard control
designed to help ensure the safety of
foods. The regulations were issued
under FDA’s statutory authority to
regulate food safety, including section
402(a)(1) and (4) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
342(a)(1) and (4)).
Certain provisions in part 123 require
that processors and importers of seafood
collect and record information. The
HACCP records compiled and
maintained by a seafood processor
primarily consist of the periodic
observations recorded at selected
monitoring points during processing
and packaging operations, as called for
in a processor’s HACCP plan (e.g., the
values for processing times,
temperatures, acidity, etc., as observed
at critical control points). The primary
purpose of HACCP records is to permit
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a processor to verify that products have
been produced within carefully
established processing parameters
(critical limits) that ensure that hazards
have been avoided.
HACCP records are normally
reviewed by appropriately trained
employees at the end of a production lot
or at the end of a day or week of
production to verify that control limits
have been maintained, or that
appropriate corrective actions were
taken if the critical limits were not
maintained. Such verification activities
are essential to ensure that the HACCP
system is working as planned. A review
of these records during the conduct of
periodic plant inspections also permits
FDA to determine whether the products
have been consistently processed in
conformance with appropriate HACCP
food safety controls.
Section 123.12 requires that importers
of seafood products take affirmative
steps and maintain records that verify
that the fish and fishery products they
offer for import into the United States
were processed in accordance with the
HACCP and sanitation provisions set
forth in part 123. These records are also
to be made available for review by FDA
as provided in § 123.12(c).
The time and costs of these
recordkeeping activities will vary
considerably among processors and
importers of fish and fishery products,
depending on the type and number of
products involved, and on the nature of
the equipment or instruments required
to monitor critical control points. The
burden estimate in table 1 includes only
those collections of information under
the seafood HACCP regulations that are
not already required under other
statutes and regulations. The estimate
also does not include collections of
information that are a usual and
customary part of businesses’ normal
activities. For example, the tagging and
labeling of molluscan shellfish (21 CFR
1240.60) is a customary and usual
practice among seafood processors.
Consequently, the estimates in table 1
account only for information collection
and recording requirements attributable
to part 123.
Description of respondents:
Respondents to this collection of
information include processors and
importers of seafood.
FDA estimates the burden of this
collection of information as follows:
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Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Average
burden per
recordkeeping 4
Number of
recordkeepers
Number of
records per
recordkeeper 3
50
1
50
16
800
15,000
4
60,000
.30
(18 minutes)
18,000
15,000
1
15,000
4
60,000
4,100
80
328,000
.20
(12 minutes)
65,600
123.6(c)(7); Document monitoring of critical control
points ........................................................................
15,000
280
4,200,000
.30
(18 minutes)
1,260,000
123.7(d); Undertake and prepare records of corrective actions due to a deviation from a critical limit ...
6,000
4
24,000
.10
(6 minutes)
2,400
123.8(d); Maintain records of the calibration of process-monitoring instruments and the performing of
any periodic end-product and in-process testing .....
15,000
47
705,000
70,500
123.11(c); Maintain sanitation control records ............
15,000
280
4,200,000
.10
(6 minutes)
.10
(6 minutes)
123.12(c); Maintain records that verify that the fish
and fishery products they offer for import into the
United States were processed in accordance with
the HACCP and sanitation provisions set forth in
part 123 ....................................................................
4,100
80
328,000
.10
(6 minutes)
32,800
123.12(a)(2); Prepare new written verification procedures to verify compliance of imports ......................
41
1
41
4
164
Total ......................................................................
........................
........................
........................
................................
1,930,264
21 CFR Section 2
123.6(a), (b), and (c); Prepare hazard analysis and
HACCP plan .............................................................
123.6(c)(5); Undertake and prepare records of corrective actions ..........................................................
123.8(a)(1) and (c); Reassess hazard analysis and
HACCP plan .............................................................
123.12(a)(2)(ii); Verify compliance of imports and prepare records of verification activities ........................
Total annual
records
Total hours
420,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates include the information collection requirements in the following sections:
§ 123.16—Smoked Fish—process controls (see § 123.6(b));
§ 123.28(a)—Source Controls—molluscan shellfish (see § 123.6(b));
§ 123.28(c) and (d)—Records—molluscan shellfish (see § 123.6(c)(7)).
3 Based on an estimated 280 working days per year.
4 Estimated average time per 8-hour work day unless one-time response.
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2 These
We base this hour burden estimate on
our experience with the application of
HACCP principles in food processing.
Further, the burdens have been
estimated using typical small seafood
processing firms as a model because
these firms represent a significant
proportion of the industry. The hour
burden of HACCP recordkeeping
activities will vary considerably among
processors and importers of fish and
fishery products, depending on the size
of the facility and complexity of the
HACCP control scheme (i.e., the number
of products and the number of hazards
controlled); the daily frequency that
control points are monitored and values
recorded; and also on the extent that
data recording time and cost are
minimized by the use of automated data
logging technology. The burden estimate
does not include burden hours for
activities that are a usual and customary
part of businesses’ normal activities. For
example, the tagging and labeling of
molluscan shellfish (§ 1240.60) is a
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customary and usual practice among
seafood processors.
Based on our records, we estimate
that there are 15,000 processors and
4,100 importers. We estimate that 50
processors will undertake the initial
preparation of a hazard analysis and
HAACP plan (§ 123.6(a), (b), and (c)).
We estimate the burden for the initial
preparation of a hazard analysis and
HAACP plan to be 16 hours per
processor for a total burden of 800
hours.
We estimate that all processors
(15,000 processors) will undertake and
keep records of four corrective action
plans (§ 123.6(c)(5)) for a total of 60,000
records. We estimate the burden for the
preparation of each record to be .30
hours for a total burden of 18,000 hours.
We estimate that all processors (15,000
processors) will annually reassess their
hazard analysis and HACCP plan
(§ 123.8(a)(1) and (c)). We estimate the
burden for the reassessment of the
hazard analysis and HAACP plan to be
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4 hours per processor for a total burden
of 60,000 hours.
We estimate that all importers (4,100
importers) will take affirmative steps to
verify compliance of imports and
prepare 80 records of their verification
activities (§ 123.12(a)(2)(ii)) for a total of
328,000 records. We estimate the
burden for the preparation of each
record to be .20 hours for a total burden
of 65,600 hours.
We estimate that all processors
(15,000 processors) will document the
monitoring of critical control points
(§ 123.6(c)(7)) at 280 records per
processor for a total of 4,200,000
records. We estimate the burden for the
preparation of each record to be .30
hours for a total burden of 1,260,000
hours.
We estimate that 40 percent of all
processors (6,000 processors) will
maintain records of any corrective
actions taken due to a deviation from a
critical limit (§ 123.7(d) at 4 records per
processor for a total of 24,000 records.
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We estimate the burden for the
preparation of each record to be .10
hours for a total burden of 2,400 hours.
We estimate that all processors
(15,000 processors) will maintain
records of the calibration of processmonitoring instruments and the
performing of any periodic end-product
and in-process testing (§ 123.8(d)) at 47
records per processor for a total of
705,000 records. We estimate the
burden for the preparation of each
record to be .10 hours for a total burden
of 70,500 hours.
We estimate that all processors
(15,000 processors) will maintain
sanitation control records (§ 123.11(c))
at 280 records per processor for a total
of 4,200,000 records. We estimate the
burden for the preparation of each
record to be .10 hours for a total burden
of 420,000 hours.
We estimate that all importers (4,100
importers) will maintain records that
verify that the fish and fishery products
they offer for import into the United
States were processed in accordance
with the HACCP and sanitation
provisions set forth in part 123
(§ 123.12(c)). We estimate that 80
records will be prepared per importer
for a total of 328,000 records. We
estimate the burden for the preparation
of each record to be .10 hours for a total
burden of 32,800 hours.
We estimate that 1 percent of all
importers (41 importers) will require
new written verification procedures to
verify compliance of imports
(§ 123.12(a)(2)). We estimate the burden
for preparing the new procedures to be
4 hours per importer for a total burden
of 164 hours.
Dated: July 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–17571 Filed 7–25–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Public Meeting of the Presidential
Commission for the Study of
Bioethical Issues
Presidential Commission for
the Study of Bioethical Issues, Office of
the Assistant Secretary for Health,
Office of the Secretary, Department of
Health and Human Services.
ACTION: Notice of meeting.
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AGENCY:
The Presidential Commission
for the Study of Bioethical Issues (the
Commission) will conduct its twentysixth meeting on August 31, 2016. At
this meeting, the Commission will
SUMMARY:
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reflect on the past, present, and future
impact of national bioethics advisory
bodies. Topics will include the history
of national bioethics advisory bodies
and their contributions to health policy,
perspectives about similar bodies
elsewhere, and discussion about what
the future holds for groups like the
Commission.
DATES: The meeting will take place
August 31, 2016, from 9 a.m. to
approximately 4 p.m.
ADDRESSES: Annenberg Public Policy
Center, 202 S. 36th St., Philadelphia, PA
19104.
FOR FURTHER INFORMATION CONTACT: Lisa
M. Lee, Executive Director, Presidential
Commission for the Study of Bioethical
Issues, 330 C Street SW., Suite L001,
Washington, DC 20201. Telephone:
202–795–7689. Email: Lisa.Lee@
bioethics.gov. Additional information
may be obtained at www.bioethics.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to the Federal Advisory Committee Act
of 1972, Public Law 92–463, 5 U.S.C.
app. 2, notice is hereby given of the
twenty-sixth meeting of the
Commission. The meeting will be open
to the public with attendance limited to
space available. The meeting will also
be webcast at www.bioethics.gov.
Under authority of Executive Order
13521, dated November 24, 2009, the
President established the Commission.
The Commission is an expert panel of
not more than 13 members who are
drawn from the fields of bioethics,
science, medicine, technology,
engineering, law, philosophy, theology,
or other areas of the humanities or
social sciences. The Commission
advises the President on bioethical
issues arising from advances in
biomedicine and related areas of science
and technology. The Commission seeks
to identify and promote policies and
practices that ensure scientific research,
health care delivery, and technological
innovation are conducted in a socially
and ethically responsible manner.
The main agenda for the
Commission’s twenty-sixth meeting is to
reflect upon the role of national
bioethics advisory bodies, both in the
US and abroad, in the past, present, and
future.
The Commission welcomes input
from anyone wishing to provide public
comment on any issue before it.
Respectful consideration of opposing
views and active participation by
citizens in public exchange of ideas
enhances overall public understanding
of the issues at hand and conclusions
reached by the Commission. The
Commission is particularly interested in
receiving comments and questions
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48819
during the meeting that are responsive
to specific sessions. Written comments
will be accepted in advance, during, and
after the meeting and are especially
welcome. Comments will be publicly
available, including any personally
identifiable or confidential business
information that they contain. Trade
secrets should not be submitted.
Written comments will be accepted by
email to info@bioethics.gov, or by mail
to the following address: Public
Commentary, Presidential Commission
for the Study of Bioethical Issues, 330
C Street SW., Suite L001, Washington,
DC 20201. To accommodate as many
individuals as possible, the time for
each question or comment may be
limited. If the number of individuals
wishing to pose a question or make a
comment is greater than can reasonably
be accommodated during the scheduled
meeting, the Commission may make a
random selection. Time permitting, we
will read aloud as many comments as
possible.
Anyone planning to attend the
meeting who needs special assistance,
such as sign language interpretation or
other reasonable accommodations,
should notify Esther Yoo by telephone
at (202) 795–7689, or email at
Esther.Yoo@bioethics.gov at least one
week in advance of the meeting. The
Commission will make every effort to
accommodate persons who need special
assistance.
Dated: July 8, 2016.
Lisa M. Lee,
Executive Director, Presidential Commission
for the Study of Bioethical Issues.
[FR Doc. 2016–17620 Filed 7–25–16; 8:45 am]
BILLING CODE 4154–06–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
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]]>Agencies
[Federal Register Volume 81, Number 143 (Tuesday, July 26, 2016)]
[Notices]
[Pages 48816-48819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17571]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0879]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Procedures for the Safe and Sanitary Processing and
Importing of Fish and Fishery Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA 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
(the 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 invites comments on the information collection
provisions of our regulations requiring reporting and recordkeeping for
processors and importers of fish and fishery products.
DATES: Submit either electronic or written comments on the collection
of information by September 26, 2016.
ADDRESSES: 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2013-N-0879 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Procedures for the Safe and
Sanitary Processing and Importing of Fish and Fishery Products.''
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 Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be
[[Page 48817]]
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 Division of Dockets
Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: 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.
``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.
Procedures for the Safe and Sanitary Processing and Importing of Fish
and Fishery Products--21 CFR Part 123
OMB Control Number 0910-0354--Extension
FDA regulations in part 123 (21 CFR part 123) mandate the
application of hazard analysis and critical control point (HACCP)
principles to the processing of seafood. HACCP is a preventive system
of hazard control designed to help ensure the safety of foods. The
regulations were issued under FDA's statutory authority to regulate
food safety, including section 402(a)(1) and (4) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) and (4)).
Certain provisions in part 123 require that processors and
importers of seafood collect and record information. The HACCP records
compiled and maintained by a seafood processor primarily consist of the
periodic observations recorded at selected monitoring points during
processing and packaging operations, as called for in a processor's
HACCP plan (e.g., the values for processing times, temperatures,
acidity, etc., as observed at critical control points). The primary
purpose of HACCP records is to permit a processor to verify that
products have been produced within carefully established processing
parameters (critical limits) that ensure that hazards have been
avoided.
HACCP records are normally reviewed by appropriately trained
employees at the end of a production lot or at the end of a day or week
of production to verify that control limits have been maintained, or
that appropriate corrective actions were taken if the critical limits
were not maintained. Such verification activities are essential to
ensure that the HACCP system is working as planned. A review of these
records during the conduct of periodic plant inspections also permits
FDA to determine whether the products have been consistently processed
in conformance with appropriate HACCP food safety controls.
Section 123.12 requires that importers of seafood products take
affirmative steps and maintain records that verify that the fish and
fishery products they offer for import into the United States were
processed in accordance with the HACCP and sanitation provisions set
forth in part 123. These records are also to be made available for
review by FDA as provided in Sec. 123.12(c).
The time and costs of these recordkeeping activities will vary
considerably among processors and importers of fish and fishery
products, depending on the type and number of products involved, and on
the nature of the equipment or instruments required to monitor critical
control points. The burden estimate in table 1 includes only those
collections of information under the seafood HACCP regulations that are
not already required under other statutes and regulations. The estimate
also does not include collections of information that are a usual and
customary part of businesses' normal activities. For example, the
tagging and labeling of molluscan shellfish (21 CFR 1240.60) is a
customary and usual practice among seafood processors. Consequently,
the estimates in table 1 account only for information collection and
recording requirements attributable to part 123.
Description of respondents: Respondents to this collection of
information include processors and importers of seafood.
FDA estimates the burden of this collection of information as
follows:
[[Page 48818]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of records per Total annual Average burden per
21 CFR Section \2\ recordkeepers recordkeeper records recordkeeping \4\ Total hours
\3\
----------------------------------------------------------------------------------------------------------------
123.6(a), (b), and (c); 50 1 50 16 800
Prepare hazard analysis and
HACCP plan.................
123.6(c)(5); Undertake and 15,000 4 60,000 .30 18,000
prepare records of (18 minutes)
corrective actions.........
123.8(a)(1) and (c); 15,000 1 15,000 4 60,000
Reassess hazard analysis
and HACCP plan.............
123.12(a)(2)(ii); Verify 4,100 80 328,000 .20 65,600
compliance of imports and (12 minutes)
prepare records of
verification activities....
123.6(c)(7); Document 15,000 280 4,200,000 .30 1,260,000
monitoring of critical (18 minutes)
control points.............
123.7(d); Undertake and 6,000 4 24,000 .10 2,400
prepare records of (6 minutes)
corrective actions due to a
deviation from a critical
limit......................
123.8(d); Maintain records 15,000 47 705,000 .10 70,500
of the calibration of (6 minutes)
process-monitoring
instruments and the
performing of any periodic
end-product and in-process
testing....................
123.11(c); Maintain 15,000 280 4,200,000 .10 420,000
sanitation control records. (6 minutes)
123.12(c); Maintain records 4,100 80 328,000 .10 32,800
that verify that the fish (6 minutes)
and fishery products they
offer for import into the
United States were
processed in accordance
with the HACCP and
sanitation provisions set
forth in part 123..........
123.12(a)(2); Prepare new 41 1 41 4 164
written verification
procedures to verify
compliance of imports......
-----------------------------------------------------------------------------------
Total................... .............. .............. .............. .................. 1,930,264
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ These estimates include the information collection requirements in the following sections:
Sec. 123.16--Smoked Fish--process controls (see Sec. 123.6(b));
Sec. 123.28(a)--Source Controls--molluscan shellfish (see Sec. 123.6(b));
Sec. 123.28(c) and (d)--Records--molluscan shellfish (see Sec. 123.6(c)(7)).
\3\ Based on an estimated 280 working days per year.
\4\ Estimated average time per 8-hour work day unless one-time response.
We base this hour burden estimate on our experience with the
application of HACCP principles in food processing. Further, the
burdens have been estimated using typical small seafood processing
firms as a model because these firms represent a significant proportion
of the industry. The hour burden of HACCP recordkeeping activities will
vary considerably among processors and importers of fish and fishery
products, depending on the size of the facility and complexity of the
HACCP control scheme (i.e., the number of products and the number of
hazards controlled); the daily frequency that control points are
monitored and values recorded; and also on the extent that data
recording time and cost are minimized by the use of automated data
logging technology. The burden estimate does not include burden hours
for activities that are a usual and customary part of businesses'
normal activities. For example, the tagging and labeling of molluscan
shellfish (Sec. 1240.60) is a customary and usual practice among
seafood processors.
Based on our records, we estimate that there are 15,000 processors
and 4,100 importers. We estimate that 50 processors will undertake the
initial preparation of a hazard analysis and HAACP plan (Sec.
123.6(a), (b), and (c)). We estimate the burden for the initial
preparation of a hazard analysis and HAACP plan to be 16 hours per
processor for a total burden of 800 hours.
We estimate that all processors (15,000 processors) will undertake
and keep records of four corrective action plans (Sec. 123.6(c)(5))
for a total of 60,000 records. We estimate the burden for the
preparation of each record to be .30 hours for a total burden of 18,000
hours. We estimate that all processors (15,000 processors) will
annually reassess their hazard analysis and HACCP plan (Sec.
123.8(a)(1) and (c)). We estimate the burden for the reassessment of
the hazard analysis and HAACP plan to be 4 hours per processor for a
total burden of 60,000 hours.
We estimate that all importers (4,100 importers) will take
affirmative steps to verify compliance of imports and prepare 80
records of their verification activities (Sec. 123.12(a)(2)(ii)) for a
total of 328,000 records. We estimate the burden for the preparation of
each record to be .20 hours for a total burden of 65,600 hours.
We estimate that all processors (15,000 processors) will document
the monitoring of critical control points (Sec. 123.6(c)(7)) at 280
records per processor for a total of 4,200,000 records. We estimate the
burden for the preparation of each record to be .30 hours for a total
burden of 1,260,000 hours.
We estimate that 40 percent of all processors (6,000 processors)
will maintain records of any corrective actions taken due to a
deviation from a critical limit (Sec. 123.7(d) at 4 records per
processor for a total of 24,000 records.
[[Page 48819]]
We estimate the burden for the preparation of each record to be .10
hours for a total burden of 2,400 hours.
We estimate that all processors (15,000 processors) will maintain
records of the calibration of process-monitoring instruments and the
performing of any periodic end-product and in-process testing (Sec.
123.8(d)) at 47 records per processor for a total of 705,000 records.
We estimate the burden for the preparation of each record to be .10
hours for a total burden of 70,500 hours.
We estimate that all processors (15,000 processors) will maintain
sanitation control records (Sec. 123.11(c)) at 280 records per
processor for a total of 4,200,000 records. We estimate the burden for
the preparation of each record to be .10 hours for a total burden of
420,000 hours.
We estimate that all importers (4,100 importers) will maintain
records that verify that the fish and fishery products they offer for
import into the United States were processed in accordance with the
HACCP and sanitation provisions set forth in part 123 (Sec.
123.12(c)). We estimate that 80 records will be prepared per importer
for a total of 328,000 records. We estimate the burden for the
preparation of each record to be .10 hours for a total burden of 32,800
hours.
We estimate that 1 percent of all importers (41 importers) will
require new written verification procedures to verify compliance of
imports (Sec. 123.12(a)(2)). We estimate the burden for preparing the
new procedures to be 4 hours per importer for a total burden of 164
hours.
Dated: July 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17571 Filed 7-25-16; 8:45 am]
BILLING CODE 4164-01-P
