Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping and Records Access Requirements for Food Facilities, 45888-45889 [2020-16546]
Download as PDF
<![CDATA[
45888
Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Notices
regardless of their employment status in
2020–2021.
ANNUAL BURDEN ESTIMATES
Annual
number of
respondents
Instrument
Home-based Provider Interview, Waves 1 and 2 ............................................
Center-based Provider Interview, Waves 1 and 2 ..........................................
Center-based Classroom Staff (Workforce) Interview, Waves 1 and 2 ..........
Estimated Total Annual Burden
Hours: 6,316.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: Child Care and Development
Block Grant Act (42 U.S.C. 9858 et seq.).
John M. Sweet Jr,
ACF/OPRE Certifying Officer.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Recordkeeping
and Records Access Requirements for
Food Facilities
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:38 Jul 29, 2020
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.
OMB Control Number 0910–0560—
Extension
[Docket No. FDA–2011–N–0016]
ACTION:
collection of information by August 31,
2020.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0560. Also include
the FDA docket number found in
brackets in the heading of this
document.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance. Recordkeeping
and Records Access Requirements for
Food Facilities—21 CFR 1.337, 1.345,
and 1.352.
BILLING CODE 4184–23–P
AGENCY:
3,375
5,850
3,533
SUPPLEMENTARY INFORMATION:
[FR Doc. 2020–16550 Filed 7–29–20; 8:45 am]
Jkt 250001
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
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1.5
1.5
1.5
Average
burden hours
per response
.33
.33
.33
Annual burden
hours
1,671
2,896
1,749
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: (1)
The name and full contact information
of sources, recipients, and transporters;
(2) an adequate description of the food,
including the quantity and packaging;
and (3) 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
E:\FR\FM\30JYN1.SGM
30JYN1
45889
Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Notices
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.
In the Federal Register of April 7,
2020 (85 FR 19489), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section; activity
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
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
records per
recordkeeper
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, 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,
VerDate Sep<11>2014
16:38 Jul 29, 2020
Jkt 250001
resulting in no growth in the number of
total firms reported on line 1 of table 1.
Dated: July 24, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–16546 Filed 7–29–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–0829]
Expiration Dating of Unit-Dose
Repackaged Solid Oral Dosage Form
Drug Products; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Expiration Dating of Unit-Dose
Repackaged Solid Oral Dosage Form
Drug Products.’’ The guidance describes
the circumstances under which FDA
generally does not intend to take action
regarding required stability studies for
unit-dose repackaged solid oral dosage
form drug products and appropriate
expiration dates under those
circumstances. This guidance finalizes
the revised draft guidance for industry
issued in August 2017.
DATES: The announcement of the
guidance is published in the Federal
Register on July 30, 2020.
SUMMARY:
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
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
E:\FR\FM\30JYN1.SGM
30JYN1
]]>Agencies
[Federal Register Volume 85, Number 147 (Thursday, July 30, 2020)]
[Notices]
[Pages 45888-45889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16546]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0016]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by August 31, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0560. Also include the FDA docket
number found in brackets in the heading of this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance. 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: (1) The name and full contact information of
sources, recipients, and transporters; (2) an adequate description of
the food, including the quantity and packaging; and (3) 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
[[Page 45889]]
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.
In the Federal Register of April 7, 2020 (85 FR 19489), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
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).......
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 2,593,837
----------------------------------------------------------------------------------------------------------------
\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, 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: July 24, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16546 Filed 7-29-20; 8:45 am]
BILLING CODE 4164-01-P
