Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Food Facilities, 35393-35395 [2019-15636]
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35393
Federal Register / Vol. 84, No. 141 / Tuesday, July 23, 2019 / Notices
these methods of communication might
be used when there is a foodborne
illness outbreak, food recall, or other
situation requiring expedited FDA food,
dietary supplement, cosmetics, or
animal food or feed communications. So
that FDA may better protect the public
health, the Agency needs quick
turnaround information to help ensure
its messaging has reached the target
audience, has been effective, and, if
needed, to update its communications
during these events.
FDA will only submit individual
collections for approval under this
generic clearance if they meet the
following conditions:
• The collections are voluntary;
• The collections are low burden for
participants (based on considerations of
total burden hours, total number of
participants, or burden hours per
participant) and are low cost for both
the participants and the Federal
Government;
• The collections are
noncontroversial;
• Personally identifiable information
(PII) is collected only to the extent
necessary 1 and is not retained;
• Information gathered will not be
used for the purpose of substantially
informing influential policy decisions; 2
and
• Information gathered will yield
qualitative findings; the collections will
not be designed or used as though the
results are generalizable to the
population of study.
If these conditions are not met, FDA
will submit an information collection
request to OMB for approval through the
normal PRA process.
To obtain approval for an individual
collection that meets the conditions of
this generic clearance, an abbreviated
supporting statement will be submitted
to OMB along with supporting
documentation (e.g., a copy of the
survey, focus group moderator guide, or
in-depth interviewing guide).
Individual collections will also
undergo review by FDA senior
leadership in the Center for Food Safety
and Applied Nutrition, PRA specialists,
and an institutional review board.
Respondents to this collection of
information include a wide range of
consumers and other FDA stakeholders
such as producers and manufacturers
who are regulated under FDA-regulated
food and cosmetic products, dietary
supplements, and animal food and feed.
In the Federal Register of April 2,
2019 (84 FR 12617), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received no
comments.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Survey type
Total annual
responses
Average burden hours
per response
Total hours
In-depth Interviews, Cognitive Interviews Screener
In-depth Interviews, Cognitive Interviews ................
In-depth Interviews Screener ...................................
In-depth Interviews ...................................................
Survey Cognitive Interviews Screener .....................
Survey Cognitive Interviews ....................................
Pretest survey screener ...........................................
Pretest survey ..........................................................
Self-Administered Surveys—Study Screener ..........
Self-Administered Surveys .......................................
Focus Group/Small Group, Cognitive Groups
Screener.
Focus Group/Small Group, Cognitive Groups .........
Focus Group/Small Group Participant Screening ...
Focus Group/Small Group Discussion ....................
45
9
900
180
45
9
750
150
75,000
15,000
180
1
1
1
1
1
1
1
1
1
1
1
45
9
900
180
45
9
750
150
75,000
15,000
180
0.083 (5 minutes) ......
1 ................................
0.083 (5 minutes) ......
1 ................................
0.083 (5 minutes) ......
1 ................................
0.083 (5 minutes) ......
0.25 (15 minutes) ......
0.083 (5 minutes) ......
0.25 (15 minutes) ......
0.083 (5 minutes) ......
4
9
75
180
4
9
62.25
38
6,225
3,750
15
60
720
240
1
1
1
60
720
240
1.5 (90 minutes) ........
0.083 (5 minutes) ......
1.5 (90 minutes) ........
90
60
360
Total ..................................................................
........................
........................
........................
....................................
10,881.25
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
This is a new collection of
information whose total estimated
annual burden is 10,881.25 hours.
Current estimates are based on both
historical numbers of participants from
past projects as well as estimates for
projects to be conducted in the next 3
years. The number of participants to be
included in each new individual survey
will vary, depending on the nature of
the compliance efforts and the target
audience.
jspears on DSK30JT082PROD with NOTICES
Number of
responses per
respondent
Dated: July 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15623 Filed 7–22–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0065]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Registration of
Food Facilities
AGENCY:
Food and Drug Administration,
HHS.
1 For example, collections that collect PII to
provide remuneration for participants of focus
groups, in-depth interviews, and cognitive
laboratory studies will be submitted under this
request. All privacy act requirements will be met.
VerDate Sep<11>2014
16:43 Jul 22, 2019
Jkt 247001
2 As defined in OMB and Agency Information
Quality Guidelines, ‘‘influential’’ means that ‘‘an
agency can reasonably determine that
dissemination of the information will have or does
have a clear and substantial impact on important
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public policies or important private sector
decisions.’’
E:\FR\FM\23JYN1.SGM
23JYN1
35394
ACTION:
Federal Register / Vol. 84, No. 141 / Tuesday, July 23, 2019 / Notices
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: Fax written comments on the
collection of information by August 22,
2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0502. 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, PRAStaff@
fda.hhs.gov.
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.
SUMMARY:
Registration of Food Facilities
OMB Control Number 0910–0502—
Extension
The Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism
Act) amended the Federal Food, Drug,
and Cosmetic Act (FD&C Act), which,
among other things, requires domestic
and foreign facilities that manufacture,
process, pack, or hold food for human
or animal consumption in the United
States to register with FDA. Sections
1.230 to 1.235 of our regulations (21
CFR 1.230 to 1.235) set forth the
requirements for the registration of food
facilities. Information provided to us
under these regulations helps us to
notify quickly the facilities that might
be affected by a deliberate or accidental
contamination of the food supply. In
addition, data collected through
registration is used to support FDA
enforcement activities and to screen
imported food shipments.
Advance notice of imported food
allows FDA, with the support of the
Bureau of Customs and Border
Protection, to target import inspections
more effectively and help protect the
nation’s food supply against terrorist
acts and other public health
emergencies. If a facility is not
registered or the registration for a
facility is not updated when necessary,
we may not be able to contact the
facility and may not be able to target
import inspections effectively in case of
a known or potential threat to the food
supply or other food-related emergency,
putting consumers at risk of consuming
hazardous food products that could
cause serious adverse health
consequences or death.
To assist respondents of the
information collection we developed the
following forms. Each facility that
manufactures, processes, packs, or holds
food for human or animal consumption
in the United States must register with
FDA using Form FDA 3537 entitled
‘‘Food Facility Registration’’ (§ 1.231),
unless exempt under 21 CFR 1.226 from
the requirement to register. To cancel a
registration, respondents must use Form
FDA 3537a entitled ‘‘Cancellation of
Food Facility Registration’’ (§ 1.235).
The terms ‘‘Form FDA 3537’’ and ‘‘Form
FDA 3537a’’ refer to both the paper
version of each form and the electronic
system known as the Food Facility
Registration Module, which is available
at https://www.access.fda.gov.
Beginning in January 2020, registrations,
updates, and cancellations will be
required to be submitted electronically.
Domestic facilities are required to
register whether or not food from the
facility enters interstate commerce.
Foreign facilities that manufacture,
process, pack, or hold food also are
required to register unless food from
that facility undergoes further
processing (including packaging) by
another foreign facility outside the
United States. However, if the further
manufacturing/processing conducted by
the subsequent facility consists of
adding labeling or any similar activity of
a de minimis nature, the former facility
is required to register.
In addition to the initial registration
requirements, a facility is required to
submit timely updates within 60 days of
a change to any required information on
its registration form, using Form FDA
3537 (§ 1.234), and to cancel its
registration when the facility ceases to
operate or is sold to new owners or
ceases to manufacture, process, pack, or
hold food for consumption in the
United States, using Form FDA 3537a
(§ 1.235).
Registration is one of several tools
under the Bioterrorism Act that enables
us to act quickly in responding to a
threatened or actual bioterrorist attack
on the U.S. food supply or other foodrelated emergency. Further, in the event
of an outbreak of foodborne illness, the
information provided helps us
determine the source and cause of the
event and enables us to quickly notify
food facilities that might be affected by
an outbreak, terrorist attack, or other
emergency. Finally, the registration
requirements enable us to quickly
identify and remove from commerce an
article of food for which there is a
reasonable probability that the use of, or
exposure to, such article of food will
cause serious adverse health
consequences or death to humans or
animals.
Description of Respondents:
Respondents to this collection of
information are owners, operators, or
agents in charge of domestic or foreign
facilities that manufacture, process,
pack, or hold food for human or animal
consumption in the United States.
In the Federal Register of April 19,
2019 (84 FR 16519), we published a 60day notice requesting public comment
on the proposed collection of
information. One comment was received
offering general support for the
information collection.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
jspears on DSK30JT082PROD with NOTICES
Activity; 21 CFR section
New domestic facility registration; 1.230–1.233.
New foreign facility registration; 1.230–1.233.
Updates; 1.234 ....................
Cancellations; 1.235 ...........
VerDate Sep<11>2014
16:43 Jul 22, 2019
FDA form No.2
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours
3537
9,795
1
9,795
2.7 ......................................
26,447
3537
13,697
1
13,697
8.7 ......................................
119,164
3537
3537a
53,836
6,390
1
1
53,836
6,390
1.2 ......................................
1 .........................................
64,603
6,390
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Federal Register / Vol. 84, No. 141 / Tuesday, July 23, 2019 / Notices
35395
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Activity; 21 CFR section
FDA form No.2
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours
Biennial renewals; 1.235 .....
3rd party registration
verification.
U.S. Agent verification ........
3537
3537
97,883
41,256
1
1
97,883
41,256
0.38 (23 minutes) ...............
0.25 (15 minutes) ...............
37,196
10,314
3537
57,070
1
57,070
0.25 (15 minutes) ...............
14,268
Total .............................
........................
........................
........................
........................
.............................................
278,382
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Forms FDA 3537 and FDA 3537a refer to both the paper version of the form and the electronic system known as the Food Facility Registration Module, which is available at https://www.access.fda.gov.
These burden figures are based on
currently available data and reflect an
overall decrease to the information
collection by 174,395 and 31,370 hours.
The decrease results from the realization
of burden associated with implementing
measures on newly established
electronic registration requirements.
Dated: July 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15636 Filed 7–22–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–4119]
Food Safety Modernization Act ThirdParty Certification Program User Fee
Rate for Fiscal Year 2020
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
fiscal year (FY) 2020 annual fee rate for
recognized accreditation bodies and
accredited certification bodies, and the
fee rate for accreditation bodies
applying to be recognized in the thirdparty certification program that is
authorized by the Federal Food, Drug,
and Cosmetic Act (FD&C Act), as
amended by the FDA Food Safety
Modernization Act (FSMA). We are also
announcing the fee rate for certification
bodies that are applying to be directly
accredited by FDA.
DATES: This fee is effective October 1,
2019.
jspears on DSK30JT082PROD with NOTICES
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Donald Prater, Office of Food Policy and
Response, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 3202, Silver Spring,
MD 20993, 301–348–3007.
VerDate Sep<11>2014
16:43 Jul 22, 2019
Jkt 247001
SUPPLEMENTARY INFORMATION:
I. Background
Section 307 of FSMA (Pub. L. 111–
153), Accreditation of Third-Party
Auditors, amended the FD&C Act to
create a new provision, section 808,
under the same name. Section 808 of the
FD&C Act (21 U.S.C. 384d) directs FDA
to establish a program for accreditation
of third-party certification bodies 1
conducting food safety audits and
issuing food and facility certifications to
eligible foreign entities (including
registered foreign food facilities) that
meet our applicable requirements.
Under this provision, we established a
system for FDA to recognize
accreditation bodies to accredit
certification bodies, except for limited
circumstances in which we may directly
accredit certification bodies to
participate in the third-party
certification program.
Section 808(c)(8) of the FD&C Act
directs FDA to establish a
reimbursement (user fee) program by
which we assess fees and require
reimbursement for the work FDA
performs to establish and administer the
third-party certification program under
section 808 of the FD&C Act. The user
fee program for the third-party
certification program was established by
a final rule entitled ‘‘Amendments to
Accreditation of Third-Party
Certification Bodies To Conduct Food
Safety Audits and To Issue
Certifications To Provide for the User
Fee Program’’ (81 FR 90186, December
14, 2016).
The FSMA FY 2020 third-party
certification program user fee rate
announced in this notice is effective on
October 1, 2019, and will remain in
effect through September 30, 2020.
1 For the reasons explained in the third-party
certification final rule (80 FR 74570 at 74578 to
74579, November 27, 2015), and for consistency
with the implementing regulations for the thirdparty certification program in 21 CFR parts 1, 11,
and 16, this notice uses the term ‘‘third-party
certification body’’ rather than the term ‘‘third-party
auditor’’ used in section 808(a)(3) of the FD&C Act.
PO 00000
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Fmt 4703
Sfmt 4703
II. Estimating the Average Cost of a
Supported Direct FDA Work Hour for
FY 2020
FDA must estimate its costs for each
activity in order to establish fee rates for
FY 2020. In each year, the costs of salary
(or personnel compensation) and
benefits for FDA employees account for
between 50 and 60 percent of the funds
available to, and used by, FDA. Almost
all of the remaining funds (operating
funds) available to FDA are used to
support FDA employees for paying rent,
travel, utility, information technology,
and other operating costs.
A. Estimating the Full Cost per Direct
Work Hour in FY 2020
Full-time Equivalent (FTE) reflects the
total number of regular straight-time
hours—not including overtime or
holiday hours—worked by employees,
divided by the number of compensable
hours applicable to each fiscal year.
Annual leave, sick leave, compensatory
time off, and other approved leave
categories are considered ‘‘hours
worked’’ for purposes of defining FTE
employment.
In general, the starting point for
estimating the full cost per direct work
hour is to estimate the cost of an FTE
or paid staff year. Calculating an
Agency-wide total cost per FTE requires
three primary cost elements: Payroll,
non-payroll, and rent.
We have used an average of past year
cost elements to predict the FY 2020
cost. The FY 2020 FDA-wide average
cost for payroll (salaries and benefits) is
$160,885; non-payroll—including
equipment, supplies, information
technology, general and administrative
overhead—is $92,828; and rent,
including cost allocation analysis and
adjustments for other rent and rentrelated costs, is $24,888 per paid staff
year, excluding travel costs.
Summing the average cost of an FTE
for payroll, non-payroll, and rent, brings
the FY 2020 average fully supported
cost to $278,602 per FTE, excluding
travel costs. FDA will use this base unit
E:\FR\FM\23JYN1.SGM
23JYN1
]]>Agencies
[Federal Register Volume 84, Number 141 (Tuesday, July 23, 2019)]
[Notices]
[Pages 35393-35395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15636]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0065]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Registration of Food
Facilities
AGENCY: Food and Drug Administration, HHS.
[[Page 35394]]
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: Fax written comments on the collection of information by August
22, 2019.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0502.
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.
Registration of Food Facilities
OMB Control Number 0910-0502--Extension
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism Act) amended the Federal Food,
Drug, and Cosmetic Act (FD&C Act), which, among other things, requires
domestic and foreign facilities that manufacture, process, pack, or
hold food for human or animal consumption in the United States to
register with FDA. Sections 1.230 to 1.235 of our regulations (21 CFR
1.230 to 1.235) set forth the requirements for the registration of food
facilities. Information provided to us under these regulations helps us
to notify quickly the facilities that might be affected by a deliberate
or accidental contamination of the food supply. In addition, data
collected through registration is used to support FDA enforcement
activities and to screen imported food shipments.
Advance notice of imported food allows FDA, with the support of the
Bureau of Customs and Border Protection, to target import inspections
more effectively and help protect the nation's food supply against
terrorist acts and other public health emergencies. If a facility is
not registered or the registration for a facility is not updated when
necessary, we may not be able to contact the facility and may not be
able to target import inspections effectively in case of a known or
potential threat to the food supply or other food-related emergency,
putting consumers at risk of consuming hazardous food products that
could cause serious adverse health consequences or death.
To assist respondents of the information collection we developed
the following forms. Each facility that manufactures, processes, packs,
or holds food for human or animal consumption in the United States must
register with FDA using Form FDA 3537 entitled ``Food Facility
Registration'' (Sec. 1.231), unless exempt under 21 CFR 1.226 from the
requirement to register. To cancel a registration, respondents must use
Form FDA 3537a entitled ``Cancellation of Food Facility Registration''
(Sec. 1.235). The terms ``Form FDA 3537'' and ``Form FDA 3537a'' refer
to both the paper version of each form and the electronic system known
as the Food Facility Registration Module, which is available at https://www.access.fda.gov. Beginning in January 2020, registrations, updates,
and cancellations will be required to be submitted electronically.
Domestic facilities are required to register whether or not food from
the facility enters interstate commerce. Foreign facilities that
manufacture, process, pack, or hold food also are required to register
unless food from that facility undergoes further processing (including
packaging) by another foreign facility outside the United States.
However, if the further manufacturing/processing conducted by the
subsequent facility consists of adding labeling or any similar activity
of a de minimis nature, the former facility is required to register.
In addition to the initial registration requirements, a facility is
required to submit timely updates within 60 days of a change to any
required information on its registration form, using Form FDA 3537
(Sec. 1.234), and to cancel its registration when the facility ceases
to operate or is sold to new owners or ceases to manufacture, process,
pack, or hold food for consumption in the United States, using Form FDA
3537a (Sec. 1.235).
Registration is one of several tools under the Bioterrorism Act
that enables us to act quickly in responding to a threatened or actual
bioterrorist attack on the U.S. food supply or other food-related
emergency. Further, in the event of an outbreak of foodborne illness,
the information provided helps us determine the source and cause of the
event and enables us to quickly notify food facilities that might be
affected by an outbreak, terrorist attack, or other emergency. Finally,
the registration requirements enable us to quickly identify and remove
from commerce an article of food for which there is a reasonable
probability that the use of, or exposure to, such article of food will
cause serious adverse health consequences or death to humans or
animals.
Description of Respondents: Respondents to this collection of
information are owners, operators, or agents in charge of domestic or
foreign facilities that manufacture, process, pack, or hold food for
human or animal consumption in the United States.
In the Federal Register of April 19, 2019 (84 FR 16519), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received offering general
support for the information collection.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity; 21 CFR section FDA form Number of responses per Total annual Average burden per response Total hours
No.\2\ respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
New domestic facility registration; 1.230- 3537 9,795 1 9,795 2.7......................... 26,447
1.233.
New foreign facility registration; 1.230- 3537 13,697 1 13,697 8.7......................... 119,164
1.233.
Updates; 1.234............................ 3537 53,836 1 53,836 1.2......................... 64,603
Cancellations; 1.235...................... 3537a 6,390 1 6,390 1........................... 6,390
[[Page 35395]]
Biennial renewals; 1.235.................. 3537 97,883 1 97,883 0.38 (23 minutes)........... 37,196
3rd party registration verification....... 3537 41,256 1 41,256 0.25 (15 minutes)........... 10,314
U.S. Agent verification................... 3537 57,070 1 57,070 0.25 (15 minutes)........... 14,268
-------------------------------------------------------------------------------------------------------------
Total................................. .............. .............. .............. .............. ............................ 278,382
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Forms FDA 3537 and FDA 3537a refer to both the paper version of the form and the electronic system known as the Food Facility Registration Module,
which is available at https://www.access.fda.gov.
These burden figures are based on currently available data and
reflect an overall decrease to the information collection by 174,395
and 31,370 hours. The decrease results from the realization of burden
associated with implementing measures on newly established electronic
registration requirements.
Dated: July 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15636 Filed 7-22-19; 8:45 am]
BILLING CODE 4164-01-P
