Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Records Access Requirements for Food Facilities, 19489-19491 [2020-07275]
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Federal Register / Vol. 85, No. 67 / Tuesday, April 7, 2020 / Notices
mandate reporting and data collections
necessary to ensure that health
insurance issuers are meeting the
requirements of the Affordable Care Act.
These information collection
requirements are set forth in 45 CFR
part 156.
Information collected by the
Exchanges or Medicaid and CHIP
agencies will be used to determine
eligibility for coverage through the
Exchange and insurance affordability
programs (i.e., Medicaid, CHIP, and
advance payment of the premium tax
credits); evaluate how CMS can best
communicate eligibility and enrollment
updates to issuers; and assist consumers
in enrolling in a QHP if eligible.
Applicants include anyone who may be
eligible for coverage through any of
these programs. Form Number: CMS–
10592 (OMB control number: 0938–
1341); Frequency: Annually, Monthly,
Occasionally; Affected Public: Private
Sector: Business or other for-profits;
Number of Respondents: 250; Total
Annual Responses: 250; Total Annual
Hours: 131,750. (For policy questions
regarding this collection contact Anne
Pesto at 443–844–9966.)
Dated: April 1, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–07185 Filed 4–6–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0016]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Recordkeeping
and Records Access Requirements for
Food Facilities
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
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SUMMARY:
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identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2011–N–0016 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Recordkeeping and Records Access
Requirements for Food Facilities.’’
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.
• 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
Electronic Submissions
submission. You should submit two
copies total. One copy will include the
Submit electronic comments in the
information you claim to be confidential
following way:
• Federal eRulemaking Portal: https:// with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
www.regulations.gov. Follow the
CONFIDENTIAL INFORMATION.’’ The
instructions for submitting comments.
Agency will review this copy, including
Comments submitted electronically,
the claimed confidential information, in
including attachments, to https://
its consideration of comments. The
www.regulations.gov will be posted to
second copy, which will have the
the docket unchanged. Because your
claimed confidential information
comment will be made public, you are
solely responsible for ensuring that your redacted/blacked out, will be available
for public viewing and posted on
comment does not include any
https://www.regulations.gov. Submit
confidential information that you or a
both copies to the Dockets Management
third party may not wish to be posted,
Staff. If you do not wish your name and
such as medical information, your or
anyone else’s Social Security number, or contact information to be made publicly
confidential business information, such available, you can provide this
information on the cover sheet and not
as a manufacturing process. Please note
in the body of your comments and you
that if you include your name, contact
must identify this information as
information, or other information that
‘‘confidential.’’ Any information marked
identifies you in the body of your
as ‘‘confidential’’ will not be disclosed
comments, that information will be
except in accordance with 21 CFR 10.20
posted on https://www.regulations.gov.
and other applicable disclosure law. For
• If you want to submit a comment
more information about FDA’s posting
with confidential information that you
of comments to public dockets, see 80
do not wish to be made available to the
FR 56469, September 18, 2015, or access
public, submit the comment as a
the information at: https://
written/paper submission and in the
www.govinfo.gov/content/pkg/FR-2015manner detailed (see ‘‘Written/Paper
09-18/pdf/2015-23389.pdf.
Submissions’’ and ‘‘Instructions’’).
Docket: For access to the docket to
Written/Paper Submissions
read background documents or the
electronic and written/paper comments
Submit written/paper submissions as
received, go to https://
follows:
www.regulations.gov and insert the
• Mail/Hand Delivery/Courier (for
docket number, found in brackets in the
written/paper submissions): Dockets
Management Staff (HFA–305), Food and heading of this document, into the
‘‘Search’’ box and follow the prompts
Drug Administration, 5630 Fishers
and/or go to the Dockets Management
Lane, Rm. 1061, Rockville, MD 20852.
Staff, 5630 Fishers Lane, Rm. 1061,
• For written/paper comments
Rockville, MD 20852.
submitted to the Dockets Management
Staff, FDA will post your comment, as
FOR FURTHER INFORMATION CONTACT:
well as any attachments, except for
Domini Bean, Office of Operations,
information submitted, marked and
Food and Drug Administration, Three
solicits comments on the information
collection provisions of our
recordkeeping and records access
requirements for food facilities.
DATES: Submit either electronic or
written comments on the collection of
information by June 8, 2020.
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 June 8, 2020.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 8, 2020. 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.
PO 00000
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Federal Register / Vol. 85, No. 67 / Tuesday, April 7, 2020 / Notices
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
Recordkeeping and Records Access
Requirements for Food Facilities—21
CFR 1.337, 1.345, and 1.352
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.
SUPPLEMENTARY INFORMATION:
OMB Control Number 0910–0560—
Extension
The Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 added section 414
of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 350c), which
requires that persons who manufacture,
process, pack, hold, receive, distribute,
transport, or import food in the United
States establish and maintain records
identifying the immediate previous
sources and immediate subsequent
recipients of food. Sections 1.326
through 1.363 of our regulations (21
CFR 1.326 through 1.363) set forth the
requirements for recordkeeping and
records access. The requirement to
establish and maintain records improves
our ability to respond to, and further
contain, threats of serious adverse
health consequences or death to humans
or animals from accidental or deliberate
contamination of food.
Information maintained under these
regulations helps us identify and
quickly locate contaminated or
potentially contaminated food and
inform the appropriate individuals and
food facilities of specific terrorist
threats. Our regulations require that
records for non-transporters include the
name and full contact information of
sources, recipients, and transporters; an
adequate description of the food,
including the quantity and packaging;
and the receipt and shipping dates
(§§ 1.337 and 1.345). Required records
for transporters include the names of
consignor and consignee, points of
origin and destination, date of
shipment, number of packages,
description of freight, route of
movement and name of each carrier
participating in the transportation, and
transfer points through which shipment
moved (§ 1.352). Existing records may
be used if they contain all the required
information and are retained for the
required time period.
Section 101 of the FDA Food Safety
Modernization Act (FSMA) (Pub. L.
111–353) amended section 414(a) of the
FD&C Act and expanded our access to
records. Specifically, FSMA expanded
our access to records beyond records
relating to the specific suspect article of
food to records relating to any other
article of food that we reasonably
believe is likely to be affected in a
similar manner. In addition, we can
access records if we believe that there is
a reasonable probability that the use of
or exposure to an article of food, and
any other article of food that we
reasonably believe is likely to be
affected in a similar manner, will cause
serious adverse health consequences or
death to humans or animals. To gain
access to these records, our officer or
employee must present appropriate
credentials and a written notice, at
reasonable times and within reasonable
limits and in a reasonable manner.
The information collection provisions
of § 1.361 are exempt from OMB review
under 44 U.S.C. 3518(c)(1)(B)(ii) and 5
CFR 1320.4(a)(2) as collections of
information obtained during the
conduct of an administrative action,
investigation, or audit involving an
agency against specific individuals or
entities. The regulations at 5 CFR
1320.3(c) provide that the exception in
5 CFR 1320.4(a)(2) applies during the
entire course of the investigation, audit,
or action, but only after a case file or
equivalent is opened with respect to a
particular party. Such a case file would
be opened as part of the request to
access records under § 1.361.
Accordingly, we have not included an
estimate of burden hours associated
with § 1.361 in table 1.
Description of Respondents:
Respondents to this collection of
information are persons that
manufacture, process, pack, hold,
receive, distribute, transport, or import
food in the United States who are
required to establish and maintain
records, including persons that engage
in both interstate and intrastate
commerce.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
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21 CFR section; activity
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
1.337, 1.345, and 1.352 (Records maintenance) ................
1.337, 1.345, and 1.352 (Learning for new firms) ...............
379,493
18,975
1
1
379,493
18,975
6.61
4.5
2,508,449
85,388
Total ..............................................................................
........................
........................
........................
........................
2,593,837
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 85, No. 67 / Tuesday, April 7, 2020 / Notices
Based on a review of the information
collection since our last request for
OMB approval, we have made
adjustments to our burden estimate to
account for advances in information and
communication technology that have
occurred in the last decade. Because the
transition from paper-based to
electronic records systems is
widespread, we estimate that the
average burden per recordkeeping has
decreased by 50 percent. With regards to
records maintenance, we estimate that
approximately 379,493 facilities each
spend half the amount of time from the
13.228 hours previously reported to 6.61
hours collecting, recording, and
checking for accuracy of the limited
amount of additional information
required by the regulations, for a total of
2,508,449 hours annually. In addition,
we estimate that new firms entering the
affected businesses incur a burden from
learning the regulatory requirements
and understanding the records required
for compliance. In this regard, we
estimate the number of new firms
entering the affected businesses is 5
percent of 379,493, or 18,975 firms.
Thus, we estimate that approximately
18,975 facilities each spend, on average,
4.5 hours learning about the
recordkeeping and records access
requirements, for a total of 85,388 hours
annually. This estimate reflects a
reduction from 4.79 to 4.5 average hours
per facility to account for the increase
in facilities using internet, which
increased from 71 to 99 percent. We
estimate that approximately the same
number of firms (18,975) exit the group
of affected businesses in any given year,
resulting in no growth in the number of
total firms reported on line 1 of table 1.
and Drug Administration (FDA), like
other government agencies, is taking the
necessary steps to ensure the Agency is
prepared to continue our vital public
health mission in the event that our dayto-day operations are impacted by the
COVID–19 public health emergency.
Therefore, we are canceling or
postponing all non-essential meetings
through the month of April. We will
reassess on an ongoing basis for future
months. Therefore, this meeting is being
postponed. The meeting was announced
in the Federal Register on February 20,
2020.
FOR FURTHER INFORMATION CONTACT:
LaToya Bonner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, Fax: 301–847–8533, email:
PADAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting,
which was announced in the Federal
Register of February 20, 2020 (85 FR
9780).
Dated: April 1, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[Docket No. FDA–2019–N–5550]
[FR Doc. 2020–07275 Filed 4–6–20; 8:45 am]
BILLING CODE 4164–01–P
Dated: April 1, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–07262 Filed 4–6–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
khammond on DSKJM1Z7X2PROD with NOTICES
Food and Drug Administration,
HHS.
ACTION:
Food and Drug Administration
SUMMARY:
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The meeting of the
Pulmonary-Allergy Drugs Advisory
Committee (PADAC) scheduled for
April 21, 2020, is postponed. The Food
SUMMARY:
VerDate Sep<11>2014
18:22 Apr 06, 2020
Jkt 250001
Dated: April 1, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
BILLING CODE 4164–01–P
AGENCY:
Pulmonary-Allergy Drugs Advisory
Committee; Postponed
York, NY 10016: ANDA 073191,
Triamterene and Hydrochlorothiazide
Capsules USP, 50 milligrams (mg)/25
mg; ANDA 076075, Econazole Nitrate
Cream, 1%; ANDA 076192, Ribavirin
Capsules USP, 200 mg; ANDA 076514,
Midodrine Hydrochloride (HCl) Tablets
USP, 2.5 mg, 5 mg, and 10 mg; ANDA
086809, Spironolactone Tablets USP, 25
mg; ANDA 090288, Naratriptan Tablets
USP, Equivalent to (EQ) 1 mg base and
EQ 2.5 mg base; and ANDA 203384,
Epinastine HCl Ophthalmic Solution,
0.05%. Before FDA withdrew the
approval of these ANDAs, CASI
Pharmaceuticals, Inc., informed FDA
that it did not want the approval of the
ANDAs withdrawn. Because CASI
Pharmaceuticals, Inc., timely requested
that approval of these ANDAs not be
withdrawn, the approval of ANDAs
073191, 076075, 076192, 076514,
086809, 090288, and 203384 is still in
effect.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Wednesday, January
8, 2020 (85 FR 909), in FR Doc. 2020–
00076, on page 909, the following
correction is made:
1. On pages 909 and 910, in the table,
the entries for ANDAs 073191, 076075,
076192, 076514, 086809, 090288, and
203384 are removed.
[FR Doc. 2020–07265 Filed 4–6–20; 8:45 am]
Elite Laboratories, Inc., et al.;
Withdrawal of Approval of 23
Abbreviated New Drug Applications;
Correction
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2020–N–0626]
19491
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on January 8, 2020. The
document announced the withdrawal of
approval of 23 abbreviated new drug
applications (ANDAs) from multiple
applicants, withdrawn as of February 7,
2020. The document indicated that FDA
was withdrawing approval of the
following seven ANDAs after receiving
a withdrawal request from CASI
Pharmaceuticals, Inc., c/o Target Health,
Inc., 261 Madison Ave., 24th Floor, New
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Ryan White HIV/AIDS Program Part F;
AIDS Education and Training Centers;
National HIV Curriculum e-Learning
Platform: Technology Operations and
Maintenance Project
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice of supplemental award.
AGENCY:
HRSA’s HIV/AIDS Bureau
will award $100,000 in supplemental
funding to the University of Washington
to support the AIDS Education and
Training Centers’ (AETC) National HIV
SUMMARY:
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]]>Agencies
[Federal Register Volume 85, Number 67 (Tuesday, April 7, 2020)]
[Notices]
[Pages 19489-19491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07275]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0016]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Recordkeeping and Records Access Requirements for Food
Facilities
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions of
our recordkeeping and records access requirements for food facilities.
DATES: Submit either electronic or written comments on the collection
of information by June 8, 2020.
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 June 8, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 8, 2020. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to 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-2011-N-0016 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Recordkeeping and Records Access
Requirements for Food Facilities.'' 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.
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.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three
[[Page 19490]]
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.
Recordkeeping and Records Access Requirements for Food Facilities--21
CFR 1.337, 1.345, and 1.352
OMB Control Number 0910-0560--Extension
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 added section 414 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 350c), which requires that persons
who manufacture, process, pack, hold, receive, distribute, transport,
or import food in the United States establish and maintain records
identifying the immediate previous sources and immediate subsequent
recipients of food. Sections 1.326 through 1.363 of our regulations (21
CFR 1.326 through 1.363) set forth the requirements for recordkeeping
and records access. The requirement to establish and maintain records
improves our ability to respond to, and further contain, threats of
serious adverse health consequences or death to humans or animals from
accidental or deliberate contamination of food.
Information maintained under these regulations helps us identify
and quickly locate contaminated or potentially contaminated food and
inform the appropriate individuals and food facilities of specific
terrorist threats. Our regulations require that records for non-
transporters include the name and full contact information of sources,
recipients, and transporters; an adequate description of the food,
including the quantity and packaging; and the receipt and shipping
dates (Sec. Sec. 1.337 and 1.345). Required records for transporters
include the names of consignor and consignee, points of origin and
destination, date of shipment, number of packages, description of
freight, route of movement and name of each carrier participating in
the transportation, and transfer points through which shipment moved
(Sec. 1.352). Existing records may be used if they contain all the
required information and are retained for the required time period.
Section 101 of the FDA Food Safety Modernization Act (FSMA) (Pub.
L. 111-353) amended section 414(a) of the FD&C Act and expanded our
access to records. Specifically, FSMA expanded our access to records
beyond records relating to the specific suspect article of food to
records relating to any other article of food that we reasonably
believe is likely to be affected in a similar manner. In addition, we
can access records if we believe that there is a reasonable probability
that the use of or exposure to an article of food, and any other
article of food that we reasonably believe is likely to be affected in
a similar manner, will cause serious adverse health consequences or
death to humans or animals. To gain access to these records, our
officer or employee must present appropriate credentials and a written
notice, at reasonable times and within reasonable limits and in a
reasonable manner.
The information collection provisions of Sec. 1.361 are exempt
from OMB review under 44 U.S.C. 3518(c)(1)(B)(ii) and 5 CFR
1320.4(a)(2) as collections of information obtained during the conduct
of an administrative action, investigation, or audit involving an
agency against specific individuals or entities. The regulations at 5
CFR 1320.3(c) provide that the exception in 5 CFR 1320.4(a)(2) applies
during the entire course of the investigation, audit, or action, but
only after a case file or equivalent is opened with respect to a
particular party. Such a case file would be opened as part of the
request to access records under Sec. 1.361. Accordingly, we have not
included an estimate of burden hours associated with Sec. 1.361 in
table 1.
Description of Respondents: Respondents to this collection of
information are persons that manufacture, process, pack, hold, receive,
distribute, transport, or import food in the United States who are
required to establish and maintain records, including persons that
engage in both interstate and intrastate commerce.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section; activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
1.337, 1.345, and 1.352 (Records 379,493 1 379,493 6.61 2,508,449
maintenance)...................
1.337, 1.345, and 1.352 18,975 1 18,975 4.5 85,388
(Learning for new firms).......
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Total....................... .............. .............. .............. .............. 2,593,837
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 19491]]
Based on a review of the information collection since our last
request for OMB approval, we have made adjustments to our burden
estimate to account for advances in information and communication
technology that have occurred in the last decade. Because the
transition from paper-based to electronic records systems is
widespread, we estimate that the average burden per recordkeeping has
decreased by 50 percent. With regards to records maintenance, we
estimate that approximately 379,493 facilities each spend half the
amount of time from the 13.228 hours previously reported to 6.61 hours
collecting, recording, and checking for accuracy of the limited amount
of additional information required by the regulations, for a total of
2,508,449 hours annually. In addition, we estimate that new firms
entering the affected businesses incur a burden from learning the
regulatory requirements and understanding the records required for
compliance. In this regard, we estimate the number of new firms
entering the affected businesses is 5 percent of 379,493, or 18,975
firms. Thus, we estimate that approximately 18,975 facilities each
spend, on average, 4.5 hours learning about the recordkeeping and
records access requirements, for a total of 85,388 hours annually. This
estimate reflects a reduction from 4.79 to 4.5 average hours per
facility to account for the increase in facilities using internet,
which increased from 71 to 99 percent. We estimate that approximately
the same number of firms (18,975) exit the group of affected businesses
in any given year, resulting in no growth in the number of total firms
reported on line 1 of table 1.
Dated: April 1, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-07275 Filed 4-6-20; 8:45 am]
BILLING CODE 4164-01-P
