0502 Registration of Food Facilities SSA 2019 Ext

United States Food and Drug Administration
Registration of Food Facilities
OMB Control No. 0910-0502
SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002
(the Bioterrorism Act) amended the Federal Food, Drug, and Cosmetic Act (the 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 the Food and Drug Administration (FDA or we).
Sections 1.230 - 1.235 of FDA’s regulations (21 CFR 1.230 - 1.235) set forth the
procedures for registration of food facilities. Information provided to FDA under these
regulations helps the agency 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 (CBP), to target import
inspections more effectively and help protect the nation's food supply against terrorist
acts and other public health emergencies.
On July 14, 2016, we amended our regulations governing food facility registration in
our final rule entitled “Amendments to Registration of Food Facilities,” (81 FR 45912).
The codified requirements of section 102 of the Food Safety Modernization Act
(FSMA) were self-implementing and effective upon enactment of FSMA. The
regulations also implement other requirements of section 102 of FSMA to include
mandatory electronic registration submissions beginning 2020; amendments to the retail
food establishment definition; and additional reporting requirements to improve the
utility of the food facility registration database.
Accordingly, we are requesting approval of the information collection provisions
associated with OMB control no. 0910-0502, as identified below, including Forms
FDA 3537 entitled, “Food Facility Registration,” and 3537a entitled, “Cancellation of
Food Facility Registration.”
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 http://www.access.fda.gov.
We therefore request extension of OMB approval for the information collection
provisions in subpart H of our General Enforcement Regulations setting forth

the requirements for the registration of food facilities, and the associated
electronic and paper-based forms, as discussed in this supporting statement.
2. Purpose and Use of the Information Collection
Registration is one of several tools implemented under the Bioterrorism Act that enables
FDA to act quickly in responding to a threatened or actual terrorist attack on the U.S. food
supply or other food-related emergency by giving FDA information about facilities that
manufacture/process, pack, or hold food for consumption in the United States. Further, in
the event of an outbreak of foodborne illness, such information helps FDA determine the
source and cause of the event. Also, registration information enables FDA to quickly
notify food facilities that might be affected by an outbreak, terrorist attack, threat, or other
emergency. These regulations further enhance FDA's capabilities with respect to
responding to food safety issues, and in addition, provide FDA with information we can
use to focus and better utilize our limited inspection resources. Implementation of the
collection provisions described above assist FDA 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. Respondents
are from the private sector (for-profit businesses).
3. Use of Improved Information Technology and Burden Reduction
FDA estimates that nearly ninety-nine percent (99%) of the respondents will use electronic
means to submit the required information. At the same time, the regulations mandate the
electronic submission of food facility registrations by 2020, while also allowing
respondents to submit a request for waiver of the requirement to electronically submit their
registration.
4. Efforts to Identify Duplication and Use of Similar Information
While certain registration requirements may exist at state and local levels, requirements
vary from jurisdiction to jurisdiction in terms of the information required, facilities
covered, and form of reporting. We require consistent reporting of information and
coverage of facilities to comply with the requirement of section 415(a)(5) to compile
and maintain an up-to-date list of registered food facilities. Also, we are required to
assign each food facility a unique registration number under section 415(a)(4) of the
FD&C Act.

2

5. Impact on Small Businesses or Other Small Entities
We estimate that approximately ninety-nine percent (99%) of respondents are small
businesses and we assist small businesses in complying with our regulatory
requirements through Regional Small Business Representatives and through the
scientific and administrative staffs within the agency. We also provide a Small
Business Guide on our website at http://www.fda.gov/oc/industry/. In addition, the
FDA Industry Systems Help Desk can answer computer system and technical questions,
as well as general questions about registration and will attempt to assist small
businesses to register. The Help Desk is available Monday through Friday from 7:30
a.m. to 11:00 p.m. Eastern Time.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with statutory requirements. Less
frequent collection may result in increased potential threats to the food supply or other
food-related 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.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment
in the Federal Register of April 19, 2019 (84 FR 16519). One comment was received
offering general support for the information collection.
9. Explanation of Any Payment or Gift to Respondents
No payment or gift is provided to respondents of the information collection.
10. Assurance of Confidentiality Provided to Respondents
Section 415(a)(5) of the FD&C Act provides that the list of facilities and any
registration documents submitted pursuant to section 415(a) of the FD&C Act
shall not be subject to disclosure under the Freedom of Information Act (FOIA) (5
U.S.C. § 552), and information derived from such list or registration document
shall not be subject to disclosure under FOIA to the extent that it discloses the
identity or location of a specific registered person. In addition, confidential
3

commercial information is protected from disclosure under FOIA in accordance
with section 552(a) and (b) (5 U.S.C. 552(a) and (b)) and by part 20. This ICR
does not request any personally identifiable information and includes a form that
does not require a Privacy Act Statement.
11. Justification for Sensitive Questions
This information collection does not involve questions that are of a personally sensitive
nature.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
We estimate the burden for the information collection as follows:
Table 1 – Estimated Annual Reporting Burden1
Activity; 21 CFR Section

No. of
Respondents

No. of
Responses per
Respondent

New domestic facility
registration; 1.230-1.233

9,795

1

Total
Annual
Responses
9,795

New foreign facility
registration; 1.230-1.233

13,697

1

13,697

8.7

119,164

Updates; 1.234
Cancellations; 1.235
Biennial renewals; 1.235
3rd party registration
verification
U.S. Agent verification
TOTAL

53,836
6,390
97,883
41,256

1
1
1
1

53,836
6,390
97,883
41,256

1.2
1
0.38
0.25

64,603
6,390
37,196
10,314

57,070

1

57,070
279,927

0.25

14,268
278,382

Avg.
Burden per
Response
2.7

Total

26,447

¹ There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on estimates by SBA that 12 percent of all businesses are new, we estimate that
all new facilities each year will be equal to 12 percent of the total number of registered
facilities. Thus, we estimate that each year there will be 9,795 new domestic and 13,697
new foreign facility registrations, and that the average burden for those new registrations
will be of 2.7 hours (2.5 hours plus 11 minutes) for new domestic facility registrations
and 8.7 hours (8.5 hours plus 11 minutes) for new foreign facility registrations for a total
of 26,447 and 119,164 burden hours, as reflected in table 1, rows 1 and 2.
The regulations do not shorten the time period for updates and we estimate that the
number of respondents is 53,836 per year (55% of facilities). The average burden per
response for updates is 1.2 hours for total estimated burden of 64,603 hours, as
reflected in table 1 row 3.

4

In the regulations, we have not changed our estimate of the average burden per response
for cancellations because these regulations do not add new data elements for
cancellations. The burden remains at 6,390 hours, as reflected in table 1, row 4.
The regulations also established an abbreviated renewal process, in which we estimate
that half the facilities take 15 minutes per renewal using the abbreviated renewal process
and of facilities take 30 minutes, for an estimate of 0.38 hours (23 minutes) to submit a
renewal for a total of 37,196 burden hours, as reported in table 1, row 5. This estimate
takes into account that some registered firms take advantage of the abbreviated renewal
process, while other firms take more time to prepare and submit the renewal.
The regulations establish a verification procedure for registrations submitted by
individuals other than the owner, operator, or agent in charge (third party registrations),
as well as a verification procedure for U.S. agents. In connection with requiring his
verification process, these regulations add e-mail addresses to the list of required
information identifying the individual who authorized submission of registrations
submitted by individuals other than the owner, operator, or agent in charge. We
estimate that it takes fifteen minutes (0.25 hour) to participate in FDA’s verification
procedure and further estimate that 82,513 registrations will be affected once every
other year, or 41,256 annually. Thus, the total annual burden of these verifications is
estimated to be 10,314 hours (41,256 x 0.25 hour = 10,314 hours), as reflected in table
1, row 6.
For the U.S. agent verification process, we estimate a resulting burden from the
verification procedure to be about 30 minutes (0.5 hours) by 114,139 affected
registrations once every two years, or 57,070 facility registrations annually. However,
the regulations also provide for the creation of a U.S. agent voluntary information
system (VIS), which we estimate will reduce the time for verification procedures for
U.S. agents by half (from 30 minutes to 15 minutes). The system is designed to ensure
the accuracy of U.S. agent information and enable U.S. agents to independently identify
the facility or facilities for which the agent has agreed to serve. Specifically, the system
allows a U.S. agent to directly provide their contact information (that is, the same
contact information required for foreign food facility registration) and the name of the
facility or facilities for which the agent has agreed to serve.
FDA only receives U.S. agent contact information through foreign food facility
registrations, many of which are created and updated by the facility, rather than the U.S.
agent for the facility. We expect that the system will allow agents to provide their
name, full mailing address, phone number, email address, and an emergency contact
phone number, as well as the name of the facility or facilities for which the agent agrees
to serve. After a U.S. agent provides this information, FDA will provide the agent with
an identification number that the agent could provide to foreign facilities it has agreed to
represent as a U.S. agent. If a foreign facility uses a U.S. agent identified in the system,
the facility will have the option of providing the name and identification number for the
U.S. agent in its registration rather than the specific U.S. agent’s contact information
required for food facility registrations (e.g., address, email address, phone number).
5

After using the identification number, and if the foreign facility name matches a facility
name the U.S. agent identified in the system, the U.S. agent contact information in the
system will then be linked and automatically populated in the foreign facility
registration. When the confirmation copy of a foreign facility registration is sent to the
U.S. agent, it will be sent to the contact information provided by the U.S. agent to
ensure that the U.S. agent is aware of the connection with each foreign facility
registration.
We expect that when a foreign facility uses an identification number for a registered
U.S. agent and the name of the facility matches the facility name the agent has
identified, that we will consider the use of that identification a verification of U.S. agent
information for purposes of the U.S. agent verification step. Thus, we estimate the total
annual burden of the foreign facility U.S. agent verifications to be 14,268 hours (57,070
x 0.25 hour = 14,268), as reflected in table 1, row 7.
12b. Annualized Cost Burden Estimate
The annual hourly cost burden to respondents is approximately $22,248,289. We
estimate that the average hourly wage for the employee preparing and submitting the
request for certification to be equivalent to a GS-12/Step-1 level in the locality pay area
of Washington-Baltimore in 2019 which is approximately $39.96/hour. Doubling this
wage to account for overhead costs, FDA estimates the average hourly cost to
respondents to be $79.92/hour. Thus, the total estimated cost incurred by respondents
for the information collection is $ 22,248,289 (278,382 burden hours x $79.92/hr =
$22,248,289).
Activity
Reporting

Total Burden
Hours
278,382

Hourly Wage Rate
$79.92

Total Respondent
Costs
$22,248,289

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start-up, operating, or maintenance costs associated with this
collection.
14. Annualized Cost to the Federal Government
The estimated annual cost to the Federal government is $1,066,716 to maintain an
electronic database and process paper submissions. We base our estimate on the
following:

6

FDA Costs
Modification/Enhancement/Maintenance/Steady State
Number of FTEs

$500,000
2

Cost per FTE, (Fully loaded GS-8/Step 2, 2019 Cost)

$107,608

Processing electronic and paper submissions

$350,000

Mailing Costs

1,500

Total

$1,066,716

15. Explanation for Program Changes or Adjustments
This information reflects adjustments. We have decreased the number of respondents
completing one-time registrations and waiver requests, thus realizing previous one-time
estimates. This results in an overall decrease by 174,395 responses (from 454,322 to
279,927), and by 31,370 hours (from 309,752 to 278,382). We have also uploaded
reported cost information to be reflected at www.reginfo.gov.
16. Plans for Tabulation and Publication and Project Time Schedule
The information from this collection will not be published.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of OMB expiration date is appropriate. FDA will display the OMB expiration date
as required by 5 CFR 1320.5.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

7