0502 SS 2016 Extension and Revision by FSMA

Registration of Food Facilities under the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002
OMB Control No. 0910-0502
RIN 0910-AG69
SUPPORTING STATEMENT
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). 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. If a
facility is not registered or the registration for a facility is not updated when necessary, FDA 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.
FDA is amending its regulations governing food facility registration through its final rule entitled
“Amendments to Registration of Food Facilities.” The rulemaking codifies the requirements of
section 102 of the Food Safety Modernization Act (FSMA) that were self-implementing and
effective upon enactment of FSMA. The final rule also implements 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 in
order 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 and revised by the final rule, 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.

21 CFR 1.230 - 1.233; describes initial facility registration as well as registration renewal and
sets forth required information that the registration submission must contain, as well as method
of submission.
21 CFR 1.234; describes requirements for updating a facility’s registration.
21 CFR 1.235; describes the requirements for notifying FDA of registration cancellation.
21 CFR 1.245; describes the submission of waiver requests from the requirement under
§§ 1.231(a)(2) and (b), 1.234(d), and 1.235(d) that initial registration, renewals, updates, and
cancellations be submitted electronically.
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
amendments will 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 new collection provisions described above
will further help 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 final rule mandates 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
FDA is the only Federal agency collecting this information. While certain registration
requirements also exist at the state and local level, these requirements vary from jurisdiction to
jurisdiction in terms of the information required, facilities covered, and form of reporting. FDA
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requires consistent reporting of information and coverage of facilities in order to comply with the
requirement of section 415(a)(5) to compile and maintain an up-to-date list of registered food
facilities. Also, FDA is required to assign each food facility a unique registration number under
section 415(a)(4) of the FD&C Act. We are unaware of any duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
While we estimate that approximately ninety-nine percent (99%) of respondents are small
businesses, 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 7:00 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.
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 the Federal Register of April 9, 2015 (80 FR 19159), FDA published a proposed rule to revise
its regulations regarding the registration of food facilities. While we received many comments
regarding requirements of the rule, none of the comments specifically addressed the four
information collection topics solicited under the PRA. Comments in response to the rulemaking
may be found under docket no. FDA-2002-N-0323 and are discussed in the final rule found at 81
FR 45,912. As finalized, we believe the rulemaking imposes minimal burden on respondents as
necessary to comply with regulatory requirements for food facility registration.
9. Explanation of Any Payment or Gift to Respondents
FDA does not provide any payment or gift to respondents.
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
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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 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.
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
FDA estimates the burden for the information collection as follows:
Table 1 – Estimated One Time Reporting Burden1
Activity; 21 CFR
Section

Form
FDA

All facility
registrations; 1.2301.233
Waiver requests; 1.245

3537

3537

No. of
Respondents

No. of
Total
Avg. Burden Total
Responses per Annual
per Response Hours
Respondent
Responses
172,274
1
172,274
0.18 31,009
(11 mins)
2,121

1

TOTAL

2,121

0.17
(10 mins)

361
31,370

To determine the number of facilities in the above table, we assume that some of the participants
in the 2012 biennial registration renewal cycle were new registrants. We do not consider those
new registrations in estimating the total burden associated with the FSMA requirements. FDA
used the Small Business Administration’s (SBA’s) estimate that 12 percent of all businesses are
new. Although SBA’s estimate does not necessarily mean that 12 percent of all food facilities
are new, we nevertheless find the SBA’s estimate sufficiently relevant to apply to food facilities.
We therefore estimate that 12 percent of currently-registered food facilities were not registered at
the time of the 2012 registration renewal cycle. As such, we estimate that 88 percent of
currently-registered food facilities, or 172,274 facilities, were already registered in 2012.
Using our updated estimates for the time required to comply with the self-implementing FSMA
provisions, we now estimate that the requirement for an email address for a domestic facility’s
contact person and a foreign facility’s U.S. agent will take 1 minute. We also now estimate that
the assurance statement required by FSMA will take 5 minutes to provide, and that the postFSMA changes to food product categories will not result in any additional burden for facilities.
We also estimate the one-time burden from the new data elements in this final rule. We estimate
an increase in the average burden per response due to the new data elements required by this
final rule. FDA believes that the new information will be readily available to the firms. We
estimate that entering the four additional pieces of information that are currently optional will
require, on average, an additional minute for each new data element per response. The four
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additional pieces of information that are currently optional are: 1) preferred mailing address, 2)
e-mail address for the owner operator or agent in charge, 3) type of activity or type of storage
conducted at the facility, and 4) e-mail address of the emergency contact of a domestic facility.
As explained in the preamble to the final rule, we revised the final rule and no longer require
facilities to use D-U-N-S® numbers. Instead, the final rule requires the use of a unique facility
identifier (UFI) recognized as acceptable by FDA. We are also postponing the requirement to
submit a UFI until the registration renewal period beginning October 1, 2020. We estimate that
entering a unique facility identifier requires, on average, an additional minute per response.
Thus, we estimate that entering these five new data elements will require a total of five
additional minutes. We estimate that the submission of the FSMA data elements and new data
elements will jointly increase the one-time burden from those activities by a total of eleven
minutes (0.18 hour). The estimated onetime burden for currently-registered facilities is 172,274
facilities x 0.18 hours = 31,584 hours. According to 2014 registration data, 2,121 registrations
were from facilities that submitted paper registrations. We believe these same facilities are more
likely to request a waiver from the requirement to electronically submit their registration. We
estimate that it will take a respondent ten minutes to prepare the waiver request submission and
attach it to their paper Form FDA 3537 registration submission. Thus, the onetime burden of
submitting waiver requests is estimated to be 361 hours (2,121 x 0.17 hours). The estimated
total one-time burden for currently-registered facilities is therefore 31,370 hours.
FDA estimates the annual burden of the proposed rule’s revision of this information collection as
follows:
Table 2 – Estimated Annual Reporting Burden1
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
Biennial renewals; 1.235
3rd party registration
verification
U.S. Agent verification
TOTAL

No. of
Respondents

No. of
Responses per
Respondent

9,795

Total
Avg.
Total
Annual
Burden per
Responses
Response
1
9,795
2.7
26,447

13,697

1

13,697

8.7

119,164

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

1
1
1
1

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

1.5
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

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

The currently approved annual reporting burden for food facility registration under OMB Control
No. 0910-0502 is 468,117 hours . The estimated reporting burden for food facility registration
under this final rule is 278,382 hours, a decrease of 189,735 hours. This decrease is due to the
recently reduced number of active registrations in the food facility registration database.

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Our estimates of the number of facilities that will submit new facility registrations are based on
estimates by SBA that 12 percent of all businesses each year are new. As such, we estimate that
12 percent of registrations (or 23,500 registrations) are from new facilities entering the market.
As described in our Preliminary Regulatory Impact Analysis (PRIA), we estimate that on an
annualized basis 97,833 respondents will file biennial renewals, a decrease from the estimated
number of 224,930 respondents reported in the 2013 request for extension. These decreases are
due to recent reductions in the number of active registrations in the food facility registration
database and we have retained these estimates for the final rule.
Prior to FSMA, FDA estimated that the average burden associated with new domestic and
foreign facility registrations was a respective 2.5 and 8.5 hours. (See 75 FR 30033.) We expect
that the final rule will add an additional 11 minutes to that burden as a result of the required new
data elements. 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, as reflected in table 2, rows 1 and 2.
The final rule does not shorten the time period for updates from 60 calendar days to 30 calendar
days as originally proposed. In the PRA analysis for the proposed rule, in which we estimated
the burden for the proposed 30-day update requirement, we estimated that 68,518 respondents
(70% of facilities) would submit updates each year. For a 60-day update requirement, we
estimated that the number of respondents was 53,836 per year (55% of facilities). The average
burden per response for updates remains unchanged as 1.2 hours, as reflected in table 2 row 3.
In the proposed rule, we also proposed to shorten the time period to submit cancellations from 60
calendar days to 30 calendar days. Although we are not finalizing that proposal, we have not
changed our estimate of the average burden per response for cancellations because this final rule
does not add new data elements for cancellations.
The final rule also establishes an abbreviated renewal process, which modifies our previous
estimate that on average it will take 0.5 hours per renewal. With the option for an abbreviated
renewal process, we estimate that half the facilities will take 15 minutes per renewal using the
abbreviated renewal process and that half of facilities will take 30 minutes. This alters our
previous estimate of 0.5 hours to submit a renewal to an average of 0.38 hours (23 minutes) to
submit a renewal, as reported in table 2, row 5. This estimate takes into account that some
registered firms will be able to take advantage of the abbreviated renewal process, while other
firms will take more time to prepare and submit the renewal, as discussed in the PRIA.
Furthermore, the final rule establishes 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,
this final rule adds e-mail address 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. As described in the PRIA, we estimate that it takes fifteen minutes
(0.25 hour) to participate in FDA’s verification procedure. We have retained this estimate. We
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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 2, row 6.
For the U.S. agent verification process, in the PRIA we estimated 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 final rule also provides
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). As currently envisioned, 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 will allow 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.
Currently, 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). 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 2,
row 7.
12b. Annualized Cost Burden Estimate
The annual hourly cost burden to respondents is approximately $13,615,384. FDA estimates 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
2012, approximately $35.88/hour. Doubling this wage to account for overhead costs, FDA
estimates the average hourly cost to respondents to be $71.76/hour. Thus, the total estimated

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cost incurred by respondents for the information collection is $ 13,615,384 (189,735 burden
hours x $71.76/hr = $13,615,384).
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
FDA’s costs to add the data elements to both the paper version of Form FDA 3537 and the
electronic system known as the Food Facility Registration Module include changes to the design,
to the software and to the network interface. FDA estimates that these costs will total $280,000.
When added to the cost for the currently approved information collections, the total cost to
government is $8,709,000.
15. Explanation for Program Changes or Adjustments
The information collection has been revised to reflect new regulatory requirements. This results
in an overall increase of 73,492 responses and a decrease of 158,365 burden hours. These totals
include annual and one-time burdens. Specific adjustements are as follows:
IC #
Annual Responses
Annual Hours
1
-1,285
2
-6,203
3
-64,964
4 (No change)
0
5
-127,047
6 (New IC)
+41,256
7 (New IC)
+57,070
One time burdens
+174,395

-3,469
-57,946
-77,633
0
-75,269
+10,314
+14,268
+31,370

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.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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